Tedros is Sole Nominee For Next WHO Director-General 29/10/2021 Aishwarya Tendolkar Dr Tedros Adhanom Ghebreyesus. The incumbent Director-General of the World Health Organization (WHO), Dr Tedros Adhanom Ghebreyesus, is the sole nominee for his position, which will be decided upon at the 75th World Health Assembly in May 2022. With the backing of 28 member states, Tedros is likely to be re-appointed unopposed as the deadline to submit nominations was 23 September. Tedros, who was the first African to become the chief of the WHO., was nominated by Germany after his home country, Ethiopia, rejected nominating him for a second term, according to Reuters report. A former health and foreign minister of Ethiopia, Tedros has been accused by the Ethiopian Army Chief of supporting rebels in the conflict zone of Tigray in northern Ethiopia. Tedros is from Tigray. This tension is likely to have been the reason why only three African countries backed his re-appointment. My statement on the situation in #Ethiopia pic.twitter.com/WsFrbMzKj4 — Tedros Adhanom Ghebreyesus (@DrTedros) November 19, 2020 Since his election in 2017, Tedros has risen to more prominence in 2020 for his response and communication on the Covid-19 Pandemic. As a Director General, he is the chief technical and administrative officer. If re-elected, it will be his last term as the WHO chief since an incumbent Director-General can be re-appointed only once. Each term is for five years and the next term will begin in August 2022. Even though Germany called for support for Tedros’s nomination last month, the US, China, and the UK have not endorsed him, as per documents on the WHO website. Relations between the US and Tedros soured during former US President Donald Trump’s term, while China’s cold shoulder to Tedros may be traced to July 2020 when he asked China to provide more raw data on the origins of the COVID-19 pandemic and had asked them to be more “transparent and open and to cooperate”. “After witnessing up close the world’s response to the pandemic, I have a unique understanding of the dynamics that have brought us to where we are, and a deep commitment to making the global system fit for purpose, with WHO at its centre,” Tedros said in his written statement to the WHO in response to his nomination for re-appointment. Bring in the Bikes: Adopting Policies With Multiple Health Benefits 29/10/2021 Kerry Cullinan Simply by promoting cycling, government officials could address a range of problems including non-communicable diseases (NCDs), car crashes, stress and air pollution. But officials in different sectors seldom factor health into planning transport and urbanisation, said public health experts at a discussion on public health systems hosted this week by Vital Strategies. “The future of public health demands that we stop looking for single-issue solutions,” said Jordan’s Princess Dina Mired, Vital’s special envoy for NCDs. “The future of public health also demands that our health ministries be transformed from ministries of diseases to ministries of health. And this can only happen if we think more broadly about the connections that actually make a healthy society,” she added. “We are asking you to consider how transportation, energy, finance, development and education can be the building blocks to making deep and lasting changes that protect everyone everywhere.” This “intersectional” approach would see a range of government departments working together on “co-wins”, said speakers. “What we’re looking for is a policy or a set of interventions that will yield multiple benefits,” said Dr Nandita Murukutla, Vital’s vice-president for global policy and research. Taxing ultra-processed food For her, regulating ultra-processed food offers such an opportunity because such foods are linked to NCDs and obesity. They also have a detrimental effect on the environment, as key ingredients such as corn cause biodiversity loss, transporting the goods cause greenhouse gas emissions and their packaging causes wastage. “A win-win solution would be a reduction in the consumption of ultra-processed products through solutions such as taxes, which would make these products out of the reach of ordinary people, and provide ministries and governments with a source of revenue,” said Murukutla. The “low-hanging fruit” to address health and get income for post-COVID economic recovery is to raise taxes on tobacco, alcohol and sugary drinks, major risk factors for NCDs, to discourage people from consuming them, said Jeremias Paul, who heads the World Health Organization (WHO) fiscal policies for health unit. Paul also proposed removing government subsidies on corn, which is a major component of ultra-processed food, and giving small farmers producing healthy food subsidies instead. Cities that provide the space to enable people to use their bicycles safely was a win-win for Claudia Adriazola-Steil, Director of Health and Road Safety at the WRI Ross Center For Sustainable Cities. “If we can get people to cycle to work safely, this will bring down traffic crashes. Then we will see the levels of physical activity increasing and this means that we will have less chronic diseases – less heart disease, diabetes, obesity,” said Adriazola-Steil. She added that while there was a clamour for electric cars, these were not going to be introduced fast enough to keep the world from warming up over 1.5 degrees Celsius. Referring to research done by Oxford University’s Christian Brand, who found emissions from cycling 30 times lower per trip than driving a fossil fuel car, and about ten times lower than driving an electric one, she appealed to people to switch to bicycles and hybrid e-bikes. “So if you personally want to make a contribution to climate change, you can chip but of course, we’re not going to ask people to take a bike when it’s unsafe. And we really need to make that cheap,” said Adriazola-Steil, who commended the Heart Association for providing funding to encourage cycling. Factoring health into climate change “I think a lot about the public health co-benefits of climate change. And of course, the starting point is the public health consequences of climate change, which are enormous,” said Dan Kass, Vital’s vice-president of environmental health. Public health has not been considered when governments have made decisions about electrification and industrialisation, such as fuel subsidies for the fossil fuel industry, said Kass. While converting to renewable energy will cost money, Kass said that the potential savings “in terms of lives, saved, hospitalisations averted, children who thrive from avoidance of stunting or low birth weight” -– even if only applied to the air pollution aspect of climate emissions – would more than pay for the cost of the interventions necessary to green the economy. With the international climate change conference, COP26, beginning over the weekend, Kass says an agreement on reducing carbon emissions would be a win for health. “Countries have still yet to ratify what’s called Article Six, which is a pricing scheme for carbon,” says Kass. “Economists globally have near consensus that the most equitable, least regressive way to reduce consumption and emissions is to properly price carbon, and factor in all of the social consequences of business as usual and climate scenarios,” said Kass. The pricing would be distributed throughout the economic system, paid for by producers as well as consumers – and the effect would be to “incentivize investment in alternate technologies”. “We need to act like the earth is burning, because it is,” said Kass. But he warned that there isn’t yet a level of popular support for the urgency necessary to address climate change. “We need to make the benefits known to people in the near term,” said Kass. “Your air quality is going to be better, your water quality is going to be better, you’re going to have greater access to energy. Those things will drive public support for the hard decisions that have to be made.” Image Credits: Heybike/ Unsplash. ‘Zero Draft’ Report on WHO Reform Punts Pandemic Treaty Forward – Amidst Signals of US Warming to Initiative 28/10/2021 Elaine Ruth Fletcher Virtual World Health Assembly nerve center at WHO’s Geneva headquarters in May 2021, where member states agreed to explore a Pandemic Treaty to improve global health emergency response. A “Zero Draft” report by a WHO Working Group gives cautious endorsement to advancing negotiations over a new “Pandemic Treaty” among WHO’s 194 member states. That endorsement by the Working Group of member states remains couched in highly nuanced, diplomatic language that makes it clear how big the lift may be to actually negotiate a sharp, focused treaty over the most key issues that have slowed and sometimes paralyzed global pandemic response. Those issues range from a stronger mandate for WHO to enter countries and independently investigate outbreaks as they are unrolling on the ground – which has been a key issue for Europe and other high-income nations – to questions about vaccines and medicines access, which have become an overriding concern for low- and middle-income countries lacking sufficient supplies of basic tools to beat back COVID. However, the fact the document attempts to gives space to all of those issues is likely to prove reassuring to countries and civil society – that their diverse interests won’t be ignored. Significantly, a senior US diplomat, Colin McIff, is serving alongside Indonesia’s Grata Endah Werdaningtyas as the Co-Chair of “The Bureau” a group of six countries leading the Working Group discussions, which are open to all 194 WHA members. Others members of the leadership bureau include: Iraq, Botswana, Singapore and France. McIff’s leading role in the debates also signals a possible shift in the US position, whereby Washington may gradually get behind the treaty concept – after its initial scepticism, observers say. Colin McIff, Deputy Director of the US Office of Global Health, HHS has been a key leader in developing the Zero Draft. A paper published by US Secretary of State Anthony Blinken and US Secretary of Health And Human Services Xavier Beceerra last month in the US medical journal JAMA, had thrown cold water on the pandemic treaty concept that has galvanized Germany and other leading European Union countries, saying that it could “take years to accomplish.” They had argued for immediately strengthening the WHO’s International Health Regulations, which govern WHO member states’ responsibilities for detecting, reporting and responding to disease outbreaks that pose global health threats. World Health Assembly to consider way forward in November The World Health Assembly is set to consider a way forward on the pandemic treaty and other global health reforms in a special session scheduled for next month – as per a resolution that was adopted at the May 2021 WHA session. The WHA Working Group Zero Draft outlines three options for moving forward, including: reforms to existing International Health Regulations, internal reforms to the WHO, and a new Pandemic Treaty. One key conclusion, however, is that the existing IHR framework cannot be adapted to accommodate the raft of issues that the COVID pandemic has raised. And that, in and of itself, signals a growing consensus that a more sweeping and binding treaty arrangement may be necessary. “Repeatedly, Member States have returned to two key themes in the discussion: first, that the status quo is not acceptable to anyone and second, that the WGPR [Working Group on Strengthening WHo Preparedness and Response] must be willing to move forward in a flexible way that advances both of its linked mandates,” states a the Zero Draft executive summary. While acknowledging the “value in exploring the role of existing tools and mechanisms available to WHO for implementing relevant recommendations,” …. the Working Group “identified potential benefits of a new WHO convention, agreement or other international instrument for pandemic preparedness and response,” states the Zero Draft. ‘Off to a ‘really good start’ Some influential civil society activists have been wary about the treaty initiative – seeing it as a potential diversion from vaccine and medicines access issues, and specifically a proposed World Trade Organization waiver on intellectual property rights for COVID health products, upon which a number of key groups, such as Médecins Sans Frontières are overwhelmingly focused. Civil Society Activists Question Pandemic Treaty’s Ability to Address Global Health Inequalities But there are signs that those opinions are not entirely uniform. “We are happy with the zero draft; it identifies most of the issues that we think are important. You have attention to technology transfer, decentralization and manufacturing,” said Jamie Love of Knowledge Ecology International, in an interview with Health Policy Watch on Thursday. “I don’t know if it will go forward, but I think it’s really off to a good start.. “I think the WHO is the right place to have this conversation. And so far in the pre- meetings, I think the delegates have been talking about, and sensitive to issues about transparency. While describing the WTO negotiations over the IP waiver as immediately significant, Love suggested that a pandemic treaty could offer a more permanent, and legally-binding space, to attend to the long-term challenges around IP norms, medicines and vaccines pricing, as well as finance and legal frameworks for more publicly-supported R&D and decentralized manufacture of health products that would, in turn, foster more robust and versatile supply chains. “Affordability, access, pricing, technology transfer there is not a sort of handy place to go in the IHR framework,” Love said. US leadership of talks is significant 25 heads of government and international agencies have come together in support of the new pandemic treaty From both the two co-chairs, the US and Indonesia , the contributions have been “very positive,” Love added. And the US leadership role in the Zero draft formulation could also be a signal that Washington is warming to the treaty idea that it had initially opposed – much to the consternation of EU allies like Germany and European Council President Charles Michel, which have championed the Treaty along with about two dozen other countries – and WHO’s Director General Dr Tedros Adhanom Ghebreyesus. With @DrTedros we proposed an international #PandemicTreaty rooted in @WHO constitution. It would guarantee equity & inclusiveness. A legally binding instrument would be the most effective basis for prevention, surveillance, collection and exchange of scientific data.#WHS2021 pic.twitter.com/lbWkc3G5XE — Charles Michel (@eucopresident) October 25, 2021 “It’s very encouraging to us that Colin McIff has been so good in terms of the comments that he has been making and the direction that he has steered things,” said Love. “He’s a career negotiator and a popular guy. Everyone likes him, the drug companies like him, we like him. He’s a good listener.” Moreover, “Colin is widely respected in the US government. And so it does give us some hope that the US position on the pandemic treaty will change.” Love added that negotiations of a binding pandemic treaty now, ahead of another crisis, could help countries actually adhere to their commitments when a new global health threat actually emerges, as it inevitably will in an era of rapid climate change, ecosystem destruction, urbanization and international travel. “It’s better to make these decisions now, before people actually know who has the valuable assets [in terms of new medicines or vaccine candidates]. Ideally you can make commitments that make sense globally and locally because no one knows who is going to be the winners or the losers. “When there is no emergency people will talk a good game. But when the COVID emergency came along, one country after another peeled off from the solidarity talk. So looking for a more binding commitment actually makes it easier for countries to do the right thing when a pandemic hits.” Image Credits: EU Council. WHO Asks G-20 for $23.4 Billion to Fund COVID Vaccines, Tests & Treatments – and 550 Million Vaccine Doses Immediately! 28/10/2021 Elaine Ruth Fletcher The South Sudan Minster of Health, Elizabeth Chuei,received her first COVID-19 vaccine at Juba Teaching Hospital in mid-October as the country’s vaccine drive, interrupted in April with the halt of vaccine exports from India, restarts once more. Only 5 African countries currently are on track to meet a WHO 40% vaccination goal. Ahead of a critical G20 meeting this weekend, WHO and its partners are asking the world’s leading industrialized nations to come up with another US$ 23.4 billion over the course of the coming year to address stark shortages in COVID vaccines, tests and treatments remain dismally low in Africa and other parts of the developing world. The new strategy for the “Act Accelerator” initiative that is funding and distributing vaccines, tests and treatments to about 92 low- and middle-income nations, comes against the background of a continuing death toll of some 45,000 to 50,000 deaths a week, said WHO and other leaders of the Act-A in two separate press conferences Wednesday and Thursday. “While the world is now producing some 1.15 billion vaccine doses per month, vaccination coverage still ranges from 1 – 70%,” said Carl Bildt, WHO Special Envoy for the ACT-Accelerator, in a press briefing about the new ACT-A strategy on Wednesday, developed by the steering group of leading the consortium, which includes, WHO; UNICEF; the Global Fund; Gavi, The Vaccine Alliance; the Wellcome Trust, the Foundation for Innovative New Diagnostics (FIND), and the Oslo-based CEPI, which is funding vaccine R&D. Against that background, “the disease will continue in countries with very low vaccination coverage, and variants will continue to develop,” he said, adding that along with the constantly mounting death toll, “this is going to come back and affect everyone.” Today, WHO’s Africa office announced that just five out of Africa’s 54 WHO member states would meet the WHO goal to vaccinate 40% of its population by the end of 2021 (see related Health Policy Watch story). Message to G-20 – 550 million mor vaccine doses this year would allow 82 more countries to reach 40% vaccine coverage goal WHO data on vaccine inequalities around the world & FIND data on testing, as of 6 October, 2021 Speaking at a WHO press briefing on Thursday, WHO’s Dr Tedros Adhanom Ghebreyesus made a special appeal to G-20 nations to come through on promised vaccine donations – which so far have fallen far short of earlier commitments. He also called upon G-20 countries to support moves towards a Pandemic Treaty as well as the creation of a new “Global Health Threats Council”. “I have three requests for the G20 leaders,” said Tedros speaking at a press conference on Thursday, “First fully fund the Act Accelerator, second, support the creation of an overarching framework for global health security that that a legally binding treaty on pandemic preparedness and response, and thirdly, support the creation of a Global Health Threats Financing Board, supported by a financial intermediary fund, and hosted by the UN.” Dr Tedros’ remarks on a “Global Health Threats Financing Board” effectively combines two separate proposals that emerged from an Independent Panel report on pandemic preparedness and a more recent pan-European Commission on Pandemic Preparedness, which had suggested that a global board to more squarely address health finance issues could be useful. Added senior WHO Advisor, Bruce Aylward, “Some 82 countries are at risk of not reaching the 40% goals, only because a lack of vaccine supply. They can meet it [the goal] if the supply is there. They only need another 550 million doses through the COVAX initiative. So the big question to the G-20 is: are they going to say where those 550 million doses are going to come from? Because those 20 countries control the global vaccine supply between now and the end of this year, we are going to make about 3 billion doses of this vaccines. Can we take about ten days worth and see that it goes into COVAX. “This is a solvable problem, it is a question of political will and the manufacturers.. It’s a test of global solidarity.” Millions more deaths could be averted Jonas Gahr Store, Norway’s new prime minister Without global vaccine and treatments access, “We will not be able to achieve true economic and social recovery” added Norway’s new prime minister, Jonas Gahr Store, who made a guest appearance at the WHO briefing. Getting more vaccines to Africa and elsewhere could lead to “millions more deaths that could be averted” he said, referring to WHO estimate that reaching it’s vaccination coverage goals could save up to 5 million lives over the course of the next year. “As long as some people remain are exposed and vulnerable, we all are – in this globalized world,” Store added. Extreme shortage of COVID tests in LMICs is another hidden driver of the ongoing pandemic The extreme shortage of COVID tests in the same countries that lack vaccines, is one of the other, more hidden crises associated with the ongoing pandemic, pointed out Bill Rodriguez, CEO FIND at the Wednesday press briefing. “Roughly 3.5 billion tests for COVID-19 have been administered,” he said, “however less than 0.4% of tests have been performed in low income countries,” he pointed out. Among groups that aren’t vaccinated, it’s critical to roll our more tests in order to be able to rapidly target treatments to people that are infected – from vital oxygen supplies for the seriously ill to the first-ever COVID anti-viral pill, molnupiravir, that appears set to receive US Food and Drug Administration approval soon. Recent clinical trials have suggested that the drug reduces by 50% the risks of hospitalization and death among people who are mildly to moderately ill. And Merck, the developer of the treatment, has agreed to allow a generic version of the pill to be manufactured and distributed across most of the developing world. But in order to even administer such a treatment effectively, people have to be tested to determine if they are ill with COVID – or something else, noted Rodriguez. And that is just not happening today in low-income countries. “Testing is also critical to be able to do [genetic] sequencing to identify new variants,” he added, noting those variants threaten to bite back at already vaccinated high-income countries. To address the testing crisis, the new ACT strategy asks for some $7 billion more in funding for test kits – most of which would be invested in the procurement of rapid tests. “We want to try to reach a minimum target of administering one test per 1,000 people per day,” he said, referrring to the new ACT testing strategy. “To reach these targets we will need to test six times as many people as we have been doing in the past six months. And even if we do, we will still be testing at less than half the minimum rate as in high income countries.” Image Credits: UNICEF, WHO COVID dashboard & FIND Test Tracker . Only 5 African Countries On Track to Meet 40% Vaccine Coverage Goal by End 2021; Syringe Shortage is One of the Latest Obstacles 28/10/2021 Kerry Cullinan Only five African countries are likely to reach a WHO global goal of vaccinating 40% of their populations by the end of the year, and the continent’s roll-outs may be slowed further by a global shortage of the syringes need to administer vaccines. UNICEF has reported an imminent shortfall of up to 2.2 billion syringes for COVID-19 vaccination and routine immunization in the coming year, according to the World Health Organization’s (WHO) Africa region. This includes special 0.3ml syringes needed for the Pfizer-BioNTech COVID-19 doses, for which there is no global stockpile. “Early next year COVID-19 vaccines will start pouring into Africa, but a scarcity of syringes could paralyse progress,” WHO Africa Director Dr Matshidiso Moeti told a press briefing on Thursday. “Drastic measures must be taken to boost syringe production, fast. Countless African lives depend on it.” COVAX is trying to secure deals with syringe manufacturers, and through better planning to avoid deliveries outpacing the supply of syringes, the WHO reported. Only 6% of Africans – 77 million people – are fully vaccinated, while over 70% of high-income countries have already vaccinated more than 40% of their people. Three African countries – Seychelles, Mauritius and Morocco – have already vaccinated over 40% of their people, while only Tunisia and Cabo Verde are on track to reach this global WHO target by year-end. While COVAX has delivered around 50 million vaccines to Africa, the continent still faces a 275 million dose shortfall in order to vaccinate 40% of all Africans. Wave after wave Dr John Nkengasong, Director of the Africa Centers for Disease Control and Prevention (CDC), told an earlier media briefing that 82% of the continent had experienced a third wave of COVID, while seven countries had already had a fourth wave. “We are going to go from wave to wave unless we address the question of vaccinations,” said Nkengasong. While cases in most of Africa are going down, cases are rising in countries in the Central African countries of Gabon, Congo, Cameroon, as well as Egypt. COVID deaths in Nigeria increased by 66% and by 36% in Egypt, added Nkengasong. Meanwhile, the WHO urged countries to improve their vaccine roll-out readiness. Some 42% of countries have not yet completed district-level plans for their campaigns, while nearly 40% have not yet undertaken “intra-action reviews” which are key to refining and improving their vaccination campaigns,” according to the WHO The WHO is conducting emergency support missions to five African countries to help support, speed up and improve their COVID-19 vaccine rollouts, with plans for missions to another 10 countries this year. Image Credits: Wuestenigel/Flickr. Game-Changing COVID-19 Oral Treatment Set To Become Widely Accessible in Low- and Middle-Income Countries Upon Regulatory Approval 27/10/2021 Elaine Ruth Fletcher Merck laboratory that developed the new oral COVID treatment, molnupiravir A potentially game-changing antiviral treatment for COVID-19 that can be administered orally early on, and potentially head off much more serious cases, is set to be licensed for generic production in most low- and middle-income countries (LMICs), in an unprecedented breakthrough in access to a new COVID treatment. The historic deal, reached between the pharma company Merck Sharp & Dohme (Merck) and the Medicines Patent Pool paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell the treatment, molnupiravir at discounted prices to more than105 countries worldwide, once the drug has been approved by the US Food and Drug Administration and the World Health Organization. The agreement is the first time in the pandemic that a major pharma company has agreed to such an open-ended license for generic production of a newly developed drug. The drug, currently awaiting US FDA emergency review, reduced risks of hospitalization or death by about 50% among patients with mild or moderate COVID, according to the company reports of the results of its Phase III trial. The deal also represents a major coup for the Geneva-based MPP, a non-profit organization with a long track record of negotiating with big pharma innovators for broader generic production of costly new drugs for treating hepatitis, HIV, and other diseases. Until now, however, MPP had not been able to enter fully into the COVID medicines access fray – with pharma producers reluctant to negotiate with the non-profit over broad-based licenses for the generic production of COVID vaccines and drugs. Other new COVID drug treatments, such as the newly-approved monoclonal antibody cocktail REGEN-COV, remain expensive and hard to access in most LMICs. They are also more difficult to use – as they need to be administered intravenously. Charles Gore, MPP Executive Director, said of the breakthrough, “This transparent, public health-driven agreement is MPP’s first voluntary licence for a COVID-19 medical technology, and we hope that MSD’s agreement with MPP will be a strong encouragement to others.” The MPP is all the more meaningful as the new drug will be the first major COVID medication that can be administered orally to non-hospitalized patients, said WHO in a statement. ‘Best agreement any company has made’ The announcement was roundly hailed by WHO and other UN-affiliated agencies managing the UN-supported ACT-Accelerator initiative to broaden access to vaccines and drugs. A number of medicines access advocates who have bitterly criticized pharma for failing to issue more voluntary license deals for for other cutting edge vaccines and treatments, issued particularly warm statements about the Merck deal. Said Jamie Love, of Knowledge Ecology International, “The license between the MPP and Merck for the manufacture and sale of molnupiravir is the best agreement any company has made for licensing its intellectual property during the COVID-19 pandemic. “The 69-page license agreement is fully transparent, unlike the agreements with CEPI, COVAX, Operation Warp Speed, the Gates Foundation, the Wellcome Trust, other companies or most governments,” added Love referring to the other international and UN-supported initiatives on COVID drug and vaccine access. “The license makes it possible for any generic manufacture located anywhere the world to supply molnupiravir in the licensed territory, and provides a pathway for supplying to countries outside the licensed territory, when patents are not in place or subject to compulsory licenses. “The licensed area is large enough (more than half the world’s population) to induce efficient generic entry and economies of scale,” he added – while noting that the 18% population coverage in LAC is weakest – although a separate Merck deal with Brazil is reportedly underway. Concluded Love: “Given the objectives of scaling up production of molnupiravir at the lowest prices for the lowest income countries, the agreement is an impressive achievement for the Medicines Patent Pool and Merck deserves credit for being the first company to make a deal with the Medicines Patent Pool.” MSF calls out shortcomings of contract Even so, some civil society stakeholders, and notably Médecins Sans Frontières (MSF) said that the licensing arrangement “does not go far enough” expressing “disappointment with the limitations of this license, as its territory excludes nearly half of the world population and important upper-middle-income countries (UMICs) with robust manufacturing capacity, such as in Brazil and China.” Yuanqiong Hu, Senior Legal and Policy Advisor, MSF Access Campaign added that: “After more than a year of secrecy of companies’ bilateral deals in a pandemic, it is a welcomed step forward to have the first fully published voluntary license from MPP covering COVID19 medical tool. “However, a closer look reveals its limitations for increasing access to one of the first promising antiviral drugs for COVID-19. It’s disappointing…. Middle-income countries excluded from the license had 30 million COVID-19 infections in the first half of 2021, 50% of all infections in low- and middle-income countries. Medicines, Law and Policy, while generally positive, also called out a clause that would allow MPP terminate a sublicence agreement with a manufacturer of the new drug, in the case of a patent challenge – a clause reportedly included at the request of the drugs initial developers at DRIVE, a subsidiary of Emory University and Ridgeback Pharmaceuticals. Emory University has in fact waved royalties on the sale of the drug in low- and middle-income countries for as long as the WHO-declared international public health emergency continues. However the termination of sublicence clause also has provoked protests by students, who say that it could restrict or undermine the flexibility of the generic licensing agreement. Merith Basey, Executive Director for Universities Allied for Essential Medicines, a student-led movement that aims to change universities’ licensing practices told us: “Emory University has betrayed its mission to serve humanity by stifling global access to a potentially life-saving COVID treatment. Molnupiravir was developed on Emory’s campus with massive amounts of tax-payer funding, yet this license includes a stipulation demanding a no-patent challenge. We call on the institution to remove the clause and favor people over profit in the midst of a global pandemic that has killed over 5 million people so far.” Image Credits: Merck , Merck . Liver Cancer: Europe’s Public Health Ticking Time Bomb 27/10/2021 Thomas Berg & Maria Buti October is Liver Cancer Awareness month, and Europe has a liver cancer problem. Over the past two decades, there has been a 70% increase in liver cancer-related mortality in the region. In 2020, 87,000 Europeans were diagnosed with liver cancer while 78,000 died from the disease in the same year. Late diagnosis is a serious problem. About half of patients are only diagnosed in an advanced stage of cancer and have less than a year to live. Liver cancer is the sixth most common cancer and the third biggest cause of cancer-related deaths globally. In the US, the rate of deaths from liver cancer increased by 40% from 1990 to 2004 while the overall rate of non-liver cancer deaths declined by 18%. Projections for the US estimate that in 2030, liver cancer will be the third-leading cause of cancer-related deaths, surpassing breast, colorectal, and prostate cancers. There are many risk factors for developing liver cancer, and chronic liver diseases caused by viral hepatitis, alcohol, or fatty liver disease are the most important. Diabetes and obesity Non-alcohol fatty liver disease (NAFLD), which is often a consequence of obesity and diabetes, is the leading cause of death among 35 to 49-year-olds in the UK, making NAFLD a health threat that should not be underestimated. (The more severe form of NAFLD is called nonalcoholic steatohepatitis, or NASH). Outside of COVID-19, NAFLD is also about the fastest growing disease globally. It occurs in about one in four people around the world and has emerged as the most prominent cause of chronic liver disease. Experts predict that, over the next decade, NAFLD will become the leading cause of end-stage liver disease and liver transplantation. It is already the fastest-growing cause of hepatocellular carcinoma (HCC), the most common form of liver cancer worldwide. Faced with a ticking public health time bomb in Europe, we are clearly in a race against time to both prevent and treat this disease before the epidemic worsens and overwhelms health systems. Better treatment access Treatment of chronic liver diseases to avoid their progression to precancerous states like cirrhosis significantly reduces the risk of liver cancer, and this has been convincingly demonstrated. Improved and equal access to state-of-the-art management of these diseases is a core element in the fight against liver cancer. Although liver cancer remains one of the few cancers with increasing incidence and mortality, public awareness of liver cancer is much lower than for other cancers. As a consequence, patients who have liver cancer and patients who are at increased risk for liver cancer often face stigma in their social lives, and also in the medical settings. Treatment options for liver cancer have significantly improved over the recent years, which makes early diagnosis the most critical point. Case-finding strategies need to be implemented, at least in at-risk patients, as strongly recommended by clinical guidelines. Hepatitis B vaccinations Finally, we must directly tackle the key environmental factors that cause liver diseases and liver cancer. In addition, successful Hepatitis B vaccination programmes need to be continued and expanded as the core element of primary liver cancer prevention as it has the potential to prevent roughly twice as many cancer cases as HPV vaccination. Earlier this year the European Commission launched its Beating Cancer Plan in response to the fact that the EU region is home to a quarter of the world’s cancer cases and is facing an annual economic impact of €100 billion if urgent action is not taken. This plan is precisely what is needed to bring scientific societies, experts and patient groups together to move forward measures that can go a long way towards stopping liver cancer in its tracks. But these measures need to be coordinated across the region, led by the European Commission, and implemented by EU Member States. A starting point has to be the setting of standards for awareness, prevention, and management of liver cancer across the region. It is pivotal that we educate and raise awareness amongst everyone: healthcare professionals, patients and families, risk groups, policymakers and the general public. Liver cancer usually occurs as a consequence of underlying chronic liver disease and cirrhosis. Thus, the EU and Member States should implement preventive measures that include evidence-based strategies to reduce the burden of liver disease, focusing on reducing alcohol consumption and obesity, and on early detection and treatment of chronic liver disease. Early detection is critical for those patients with liver diseases associated with a high risk of liver cancer such viral hepatis B and C, alcohol-related and non-alcoholic fatty liver disease. The EU and Member States should add liver cancer to their screening list, at least for patients with underlying risk factors. In addition, existing programs providing the opportunity of early case finding of liver diseases should be leveraged where possible. The salivary screening for Hepatitis C using point of care testing is a good example and complements the WHO HCV program aiming at fighting HCC as well. Inter-disciplinary disease management But we also need improved access to better disease management for patients with liver cancer across all member states of the EU. This means a more structured pathway for the diagnosis and treatment of patients when they are receiving care in hospital, as an outpatient and then at home. That will require better inter-disciplinary cooperation between hepatology, oncology and other relevant disciplines and ideally collaborative clinical guidelines that are driven by comprehensive scientific evidence. Basic research continues to be a critical element for improving patient outcomes in liver cancer. There is still further knowledge needed about aetiology, rare liver cancer entities, markers and diagnostics which might facilitate early detection even in primary care. The EU and Member States should support such research projects and cross-country collaboration by setting up EU-wide platforms with the aim of sharing data and closing the gap between medical knowledge and clinical practice. The high standard of care in the EU is based on high-level science and research. In order to maintain these standards furthermore and drive improvements, it is essential to collect data collaboratively across all member states. The EU and Member States should support the setting up of specific patient registries for liver cancer. The collation of this data would facilitate surveillance, research and the overall management of patients with liver cancer. Care must be patient-centric. People living with liver cancer and their families should have unrestricted access to information, medical treatment, and measures to improve their quality of life, regardless of their life situation and ethnic origin. All patients with liver cancer should benefit from the same high standards of care wherever they are in Europe. Thomas Berg is the Secretary-General of the European Association for the Study of the Liver (EASL) and Head of the Division of Hepatology at Leipzig University Medical Center in Germany. Maria Buti is the EASL EU Policy Councillor and Professor of Medicine and Chief of Internal Medicine and Hepatology at the Hospital General Universitari Valle Hebron in Barcelona, Spain. US ‘Steps Aside’ to Give Africa Access to Moderna Vaccines 26/10/2021 Kerry Cullinan Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) The US government has enabled Africa to get access to 50 million Moderna COVID-19 vaccines by giving the continent its place in the vaccine queue, Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) said on Tuesday. “This is a time swap arrangement whereby the United States government basically stood aside for the next quarter so that we could access vaccines and purchase them ourselves,” Masiyiwa told a media briefing of the Africa Centers for Disease Control (CDC). AVAT will get 15 million Moderna doses in December and a further 35 million between January and March. It also has an option to buy 60 million more, delivered at 20 million doses per month, between April and June. “These doses are being purchased by AVAT courtesy of the United States government, which has been phenomenal in its support,” he added. South Africa’s President Cyril Ramaphosa and Kenya’s President Uhuru Kenyatta negotiated the deal directed with US President Joe Biden, said Masiyiwa. Other than a deal with Johnson and Johnson (J&J) for 400 million vaccines over 13 months from August, “none of the vaccine suppliers had any doses for us this year,” said Masiyiwa. The Africa Union has been able to get the J&J vaccines largely because they are being assembled by Aspen in South Africa – but even ensuring that these doses remained on the continent required reaching an agreement with the European Union, which initially planned to import the African-assembled vaccines. Jessye Lapenn, the US Ambassador to the African Union, praised AVAT’s leadership and expressed her country’s support for the continent’s vaccination efforts. The White House confirmed that it would defer the delivery of about 33 million Moderna vaccines to enable the African Union to buy the doses. Masiyiwa said the African Union’s long-term vision was for Moderna to reach a fit-and-fill agreement with an African manufacturer. The company recently announced that it wants to build a $500 million mRNA vaccine manufacturing facility in Africa. “We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe, said Moderna CEO Stéphane Bancel. Moderna said that it was “working on plans to allow it to fill doses of its COVID-19 vaccine in Africa as early as 2023, in parallel to building an mRNA vaccine manufacturing facility in Africa”. Moderna, which received millions of dollars in R&D support from the US government, has been under pressure from the Biden administration to supply low and middle income countries with vaccines. AVAT is currently supplying 39 African countries and 15 Caribbean countries, but only 8,7% of Africans have had at least one vaccine dose. Meanwhile, COVAX revealed on Monday that less than 10% of vaccine donations pledged to it by wealthy countries had been delivered. Of the 1.3 billion COVID-19 vaccine dose donations promised to COVAX by wealthy countries, only 150 million doses have actually arrived – around 9% – Gavi CEO Dr Seth Berkley told the World Health Summit. Joining the Africa CDC press briefing on Tuesday, Berkley said that COVAX had supplied 40% of Africa’s vaccine doses but the facility had experienced a major slowdown after India banned the export of AstraZeneca vaccines made it its country although COVAX had already paid for the vaccines. Debt Relief & National Economic Reforms Pitched as ‘Big Picture’ Global Health Solutions Ahead of G-20 Meeting 26/10/2021 Elaine Ruth Fletcher WHO Director General Dr Tedros Adhanom Ghebreyesus and Mariana Mazzucato, chair of the new WHO Council on the Economics of Health for All. An ambitious wish list of global economic and fiscal measures that the world should adopt to combat the COVID-19 pandemic has been floated by the World Health Organization- just ahead of a critical G-20 meeting of the world’s most industrialized nations this weekend. These include proposals for massive debt relief to debt-ridden countries and a re-direction of the IMF’s new offer of $US650 billion in “special drawing rights” away from richer nations to low- and middle-income countries. The laundry list of macroeconomic and fiscal measures proposed by the new WHO Council on the Economics of Health for All, was detailed today at one of the final sessions of the World Health Summit. Drafted by 10 top economists and health policy experts, Financing Health for All pushes the classic debates over access to medicines and health systems investments – into the realm of much broader fiscal and economic decisions that nations, both rich and poor need to make, according to the experts. That is, if they really want to beat down COVID-19 as well as prepare for the next pandemic. ‘Donor mentality’ is part of the problem WHO Director General, Dr Tedros Adhanom Ghebreyesus “It proposes a radical shift in economic thinking for global health,” said WHO Director General Dr Tedros Adhanom Ghebreyesus at the WHS session. He appeared with Mariana Mazzucato, Founding Director of the UCL Institute for Innovation and Public Purpose, and chair of the new health economics Council, which was launched by WHO in May 2021. “Instead of looking at health as a piece of the economy, it’s time to look at how the economy can support the societal goal of health for all,” said the WHO Director General. “Neither existing market mechanisms, with their focus on short term returns, nor development funds alone are enough,” he added. “They do not provide the global public goods on which we all depend, such as vaccines, nor do they address the major inequities, undermining equitable access. “The council is proposing bold, concrete actions for governments and multilateral organizations in three major areas, creating fiscal space, the direction of investment, and the governance of public and private financing for how this does not just mean more money. It means making the better, smarter and sustained investments that are needed to achieve health for all.” “We have to realize that this donor mentality is actually part of the problem,”said Mazzucato, “And that lots of the conditionalities that were set in the past on the loans provided to developing countries precisely made them weaker. The key priorities outlined by the brief, prepared by the ten-member expert group includes proposals that would leverage change from global to national level so as to: Create more “fiscal space” for countries to invest more in health, including through measures like international debt relief, a global corporate tax rate and a greater allocation to low-income countries of newly available IMF special drawing rights; Reshape national, tax, regulatory and investment rules to make them more favorable to health-related investments, e.g. in health systems and vaccine and medicines manufacture; Ensure stronger governance for private health markets – notably pharma innovators and manufacturers – using public regulations and investments to “crowd in and direct private finance towards improving health outcomes globally and equitably.” Other members of the Council include Vera Songwe, Executive Secetary of the Economic Commission for Africa; economists such as Jayata Ghosh, of the University of Massachusetts and Stephanie Kelton an expert on monetary policy at Stony Brook University; investment banker Vanessa Huang, and global health professionals such as Ilona Kickbusch, founding director of the Geneva Graduate Institute’s Global Health Centre; Senait Fissehea, of the University of Michigan; and planetary health expert Kate Raworth, of Oxford University’s Environmental Change Institute. More “quality money” – to fight the next pandemic Mariana Mazzucato, chair fo the new WHO Council on the Economics of Health for All Just “more money” is not enough to drive bigger investments in countries with poor-performing health systems, stressed Mazzucato, it needs to be “quality money” – money that does not translate into more crippling loan repayments once the initial phase of the pandemic crisis has passed. “Multilateral organizations should negotiate debt relief for low and middle income countries in such an important moment,…. redirecting [IMF] Special Drawing Rights towards investment in health, and especially vaccines,” she said. IMF special drawing rights are not considered as loans in the traditional sense of the word, but rather bolster countries’ reserves and thus their overall economic stability. “False constraints have been imposed on government’s fiscal spaces, often by multilateral institutions like the IMF and the World Bank.” Crippling debt restrictions and austerity measures traditionally have hit hardest on social welfare nets, including public health systems, meaning that low- and middle-income countries “weren’t allowed to create the kind of fiscal space that we highlight as the first key pillar,” she observed. “Over time, we have to be better prepared and that preparedness needs to be, in the long run, built on the ability to have a distributed manufacturing and industrial capacity [for health products] globally. “Because this will not be the last pandemic, you know. As the permafrost melts, apparently, there’s going to be all sorts of other viruses that come about. Climate change and this health crisis are really interlinked.” Along with debt relief the G-20 should advance credit rating reforms and “push for the enforcement of a minimum global corporate tax of at least 15%,” she added. National investment priorities Finance and health authorities need to work together more closely to expand local medicines and vaccine production and improve health systems. But as the brief underlines, the challenge is not only to reduce international pressures, through measures such as debt relief, but also to “change mindsets within countries that impose internal constraints on spending” – often in the name of false economies and fiscal prudence. That means a better understanding and alignment in Finance Ministries, of the importance of health priorities. “The bottom line is that countries must reverse the harmful effects of an austerity approach to public administration and public finance reforms,” said Mazzucato. She pointed to Kerala State, in India, as an example of a region that fared better because it focused investment into public health systems. “Internal constraints on government budgets are not insurmountable and governments actually have more room for increasing the fiscal limits on investments for health than they’re led to believe. “And it’s not just a matter of political choice, but also when a political will whether country can mobilize all the resources and levers that can to maximizing financing for health, such as innovative monetary policy, but also…, procurement policies using different levers – grants, loans, procurement to really catalyze new solutions…. “When we go to war, money is found, and during a health pandemic, money has been found, but that has been too little too late,” she observed. Public-Private sector should share ‘risks and rewards’ of innovation Finally, public-private sector relationships around critical issues such as vaccines and medicines innovation and manufacture need a reboot, the brief argues, sharing both the “risks and rewards” of innovation, in the words of Mazzucato – rather than leaving public entities to shoulder the risks while the private sector reaps most of the rewards. “We need public actors, we need philanthropies, but they need to work together in a different way,” she said. That means public contracts, loans, grants and other incentives that are offered to the private sector to develop new and more innovative vaccines, tests and treatments also need to come along with stronger conditions about how the final products they create may be used or distributed. “And this can be done by redesigning the terms and the conditions, structuring contracts, grants, transfers loans and partnerships between public and private actors. “Precisely because the public sector puts in so much of the money – especially in the early stage when it’s more risky and more capital intensive, and uncertain – these critical market-shaping public investments should ensure conditionalities around pricing – to make sure that we have access at the core -that we have vaccines that are globally accessible. Innovation – global, end-to-end and governed collectively In terms of intellectual property rights, she added that “it’s not about getting rid of patents, but we have to govern innovation and the patent system, with objectives in mind. “Making sure that patents are not too wide, too strong, hard to license upstream are core ways to govern the patent system. “It’s not about getting rid of patents, we have to govern innovation, and the patent system with objectives in mind,” she said. “More broadly, we need to shape a conducive regulatory tax, industrial and economic policy environment to ‘crowd in’ all sorts of different sources of finance at the same time, ensuring that we get the greatest multiplier effect, the greatest impact on health for all. Ultimately, however, she stressed that global health innovation platforms need to be “global, end-to-end, and governed collectively – shifting from a model where innovation is left to the market to a model aimed at delivering global common goods.” Image Credits: Marco Verch/Flickr. Civil Society Activists Question Pandemic Treaty’s Ability to Address Global Health Inequalities 26/10/2021 Kerry Cullinan A session of the 2020 World Health Assembly. Some civil society organisations (CSO) are sceptical about whether a ‘pandemic treaty’ is the best way to address future global health crises, while treaty supporters say it will provide a legal framework binding countries and global health bodies to more agile and rapid responses to future outbreaks. A session Monday sponsored by the Geneva Global Health Hub (G2H2) brought leading CSOs, diplomats, academics and even WHO’s chief legal counsel face to face to air those views, in the context of a research initiative on the treaty being undertaken by the hub. The debate comes just weeks ahead of a planned special session of the World Health Assembly which is to determine whether the global body will indeed move forward on a Treaty, as a key measure for improving pandemic response. The treaty initiative has been supported most visibly by European countries, led by European Commission President, Charles Michel, who in a separate session at the World Health Summit in Berlin that the treaty would guarantee “access to information, financing, vaccines and countermeasures. It would increase capacity and resilience – at all levels.” With @DrTedros we proposed an international #PandemicTreaty rooted in @WHO constitution. It would guarantee equity & inclusiveness. A legally binding instrument would be the most effective basis for prevention, surveillance, collection and exchange of scientific data.#WHS2021 pic.twitter.com/lbWkc3G5XE — Charles Michel (@eucopresident) October 25, 2021 Diversion or game changer? 25 heads of government and international agencies have come together in support of the new pandemic treaty Some of the civil society organisations that have expressed disquiet about the treaty proposal perceive it as a potential distraction or diversion by wealthy countries from the so-called TRIPS waiver proposal, currently under consideration by thee World Trade Organization. The proposal by South Africa and India for a broad-based intellectual property waiver on COVID vaccines and treatments, now being debated by the WTO’s TRIPS Council , is perceived by civil society as a game changer that would help open the doors to despearately needed COVID vaccine and medicines manufacturing in Africa and the global South. Many of the European countries that have been among the most staunch opponents of the TRIPS waiver are also key pandemic treaty supporters, noted journalist Priti Patnaik, who is researching stakeholders’ views on the pandemic treaty for G2H2 -giving rise to the CSO suspicions. And yet at the same time, some developing countries have supported a pandemic treaty because they believe it would “rein in the influence of non-state actors, including powerful foundations, and get some binding obligations to apply to industry to avoid vaccine inequities in the future,” she added. ‘Switch-and-bait’ tactic Unni Karunakara, senior fellow at Yale’s Global Health Justice Partnership, said that the major focus should be on deploying available tools and medicines to every corner of the world, rather than negotiations over a new treaty: “Shouldn’t global vaccination coverage be an overwhelming priority now?” he asked. “We do have frameworks and tools. They’re not perfect, but there are enough tools for us to overcome this crisis together,” said Karunakara, a former president of Medecins sans Frontieres. “What is lacking, however, is the political will to share essential resources and tools, even with all of the treaties in place.” His comments reflecting the cynicism of other civil society activists who see “a big overlap between the countries that are blocking the TRIPS waiver, and the countries that are supporting the pandemic treaty. “So there’s a perception of a ‘switch-and-bait’ tactic that reeks of bad faith,” he added. And while transparency measures – such as the mandatory sharing of genetic materials by countries where outbreaks are suspected – have been discussed as key treaty features, similar mandates for transparency or sharing of vaccines and medicines technologies have been fiercely opposed by the EU, he pointed out. “TRIPS waiver-blocking countries have made the case for voluntary actions by pharma to ensure access to essential COVID-19 medical tools, so they treat Big Pharma with kid gloves,” Karunakara observered. “Interestingly, they take a very different tone and approach to the global south in the treaty, insisting on enforceability in the sharing of information and materials with WHO and other governments to allow for independent verification.” “The assumption here is that global south is the problem, that diseases originated in poor country, and pose national security risks to rich countries.” If you are against the treaty – what is your multilateral alternative? Björn Kümmel, at the WHO Executive Board’s January 2021 meeting. Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver – or the kinds of hidden agendas that civil society groups fear. “I doubt that it’s, from a logical point of view, right to say that even though a country has it stands on the TRIPS waiver, you can’t tackle other equity issues,” he told the G2H2 session. “That’s one angle to look at, the TRIPS waiver, but there are many more angles to be looked at. So to say that that is the only magic bullet, I think that would be fully wrong, I wouldn’t limit it to this. “I think that equity goes far beyond, and certainly, if a treaty was negotiated, it’s quite clear that this [TRIPS waive] will be put on the table, and that all governments will have to look at the different interests that are on the table and negotiate them with an open outcome.” He noted that the treaty was first proposed formally by Chile, not the European Commission, and has the support of a wide array of countries, including South Africa, Kenya, and Tunisia, as well as Thailand and Indonesia. Anything better than ‘Chaos’ we see now Describing the current global health situation as “dysfunctional”, Kümmel asked the G2H2 session: “If you are against the treaty, tell us what is your multilateral alternative to it, to be realistically implemented, lets say in the next five years?” “What the countries who are proposing a treaty are trying to say is: anything is better, than compared to the chaos that we’re seeing currently. “Legal clarity is needed, and it will be …a painful exercise for many of us, and most likely a difficult one for many governments, including mine, most likely also others. But in the end, it’s this is multilateralism.” Uniquely in the global health landscape – and unlike environment, trade or finance – there is a dearth of global treaty instruments. In fact, among the dozens of international treaties in force today, the only two binding instruments in global health today are the IHR and and the Framework Convention on Tobacco Control (FCTC), he pointed out. Pandemic is a ‘window of opportunity’ for bigger changes In light of the outstanding questions, however, the working group of countries that are preparing for the WHA special session had devised a “three-step approach” to their deliberations on a way forward. They are considering in parallel: WHO internal reform measures; revisions in the existing International Health Regulations that currently govern global emergency response; and finally, the Pandemic Treaty alternative. In terms of WHO reform, the conclusion has been that such measures would “not be sufficient in order to overcome the next pandemic,” Kümmel said. Amendments to the International Health Regulations (IHR) also would take time to negotiate. And a key question here is: “would they be a game changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” So against the other options, “an international binding agreement is interesting,” he said. “And why are many colleagues pushing for this to happen now? Well, it’s the reality that after Ebola and past pandemics the global community was unable to implement the lessons learned,” he said. And if negotiations don’t begin now, in the heat of the ongoing crisis, they will never happen at all. “Many of the international independent panels have called for bold recommendations to be implemented,” Kümmel reminded the group. “One of them is the treaty. But many of those recommendations have never reached successful implementation, because the window of opportunity for real structural changes normally vanishes with the next crisis to come after the pandemic.” The treaty would also retain WHO’s centrality as the nerve center of the global health architecture – amidst a plethora of new health initiatives emerging in Europe and elsewhere: “There are a multitude of ideas and recommendations, and the treaty is a legal framework into which most of the other recommendations would fit,” he said, in reference to recent proposals such as one by the Pan European Commission on Health and Sustainable Development to create a new global health board under G-20 auspices. Others have talked about a new global health finance board in association with the World Bank and/or a new UN-level Global Health Threats Council, under the auspices of the UN General Assembly. So the Pandemic Treaty is “also a mechanism to provide WHO with legitimacy after this crisis,” he stressed. “Obviously there are voices out there who could see alternative approaches. However, I think the ones who are in favour of this treaty have clearly articulated that WHO is the right forum because its the truly multilateral forum for global health.” WHO precedents for equitable access to vaccines? Germany is not the only actor that sees the treaty as a means of keeping WHO as the world’s main global health meeting place. WHO’s Director General Dr Tedros Adhanom Ghebreyesus has himself come out in support for the pandemic treaty measure – breaking ranks with previous agency heads who usually remained aloof of controversial measures under consideration by member states. WHO is therefore keenly interested in how civil society groups may help lead or shape views on the treaty negotiations – and this interest was reflected in a cameo appearance at the G2H2 event by Stephen Solomon, WHO’s principal legal officer. Solomon said it was “really helpful” to understand some of the “scepticism” around the pandemic treaty initiatives. “Understanding the the concern about an agenda driven issue here is very important for the [WHO] Secretariat,” Solomon told the group. At the same time, beyond the immediate COVID crisis, other WHO emergency response frameworks already in place also could perhaps benefit from the stronger legal backpone that a pandemic treaty might provide, he pointed out. One example is the Pandemic Influenza Preparedness (PIP) framework, which mandates that 10% of global flu pandemic vaccine production supply goes to WHO for direct distribution, based upon public health needs. Another is WHO’s Global Action Plan for influenza vaccines. These “are meant to address equity issues in a number of epidemics, not necessarily pandemics,” Solomon said. “I would be very interested in reactions to particular frameworks meant to address inequities, like the pandemic influenza preparedness (PIP) framework, not legally binding. Or like the WHO Global Action Plan (GAP) for influenza vaccines, also not legally binding. “But both are interesting and potentially of important reference to pandemic preparedness and response. PIP basically says 10% of global pandemic vaccine production supply goes to WHO for distribution on the declaration of an influenza pandemic for distribution based on public health needs, and we have legally binding contracts for that 10%,” said Solomon. “Could that be a reference point for responding to future pandemics? “If so, would it be useful to put that in more of a legal framework because of weaknesses within that structure – particularly the idea of countries not allowing export for vaccines already under contract?” Solomon asked. Similarly, the Global Action Plan for influenza vaccines was a 10-year, non-binding arrangement that aimed to better distribute capacity for flu vaccine production, including among low- and middle-income member states, he pointed out, asking: “Could that also benefit, or not, from a normatively binding architecture?” The final research report will be launched by G2H2 on 24 November. –Elaine Ruth Fletcher contributed to the writing of this story. 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Bring in the Bikes: Adopting Policies With Multiple Health Benefits 29/10/2021 Kerry Cullinan Simply by promoting cycling, government officials could address a range of problems including non-communicable diseases (NCDs), car crashes, stress and air pollution. But officials in different sectors seldom factor health into planning transport and urbanisation, said public health experts at a discussion on public health systems hosted this week by Vital Strategies. “The future of public health demands that we stop looking for single-issue solutions,” said Jordan’s Princess Dina Mired, Vital’s special envoy for NCDs. “The future of public health also demands that our health ministries be transformed from ministries of diseases to ministries of health. And this can only happen if we think more broadly about the connections that actually make a healthy society,” she added. “We are asking you to consider how transportation, energy, finance, development and education can be the building blocks to making deep and lasting changes that protect everyone everywhere.” This “intersectional” approach would see a range of government departments working together on “co-wins”, said speakers. “What we’re looking for is a policy or a set of interventions that will yield multiple benefits,” said Dr Nandita Murukutla, Vital’s vice-president for global policy and research. Taxing ultra-processed food For her, regulating ultra-processed food offers such an opportunity because such foods are linked to NCDs and obesity. They also have a detrimental effect on the environment, as key ingredients such as corn cause biodiversity loss, transporting the goods cause greenhouse gas emissions and their packaging causes wastage. “A win-win solution would be a reduction in the consumption of ultra-processed products through solutions such as taxes, which would make these products out of the reach of ordinary people, and provide ministries and governments with a source of revenue,” said Murukutla. The “low-hanging fruit” to address health and get income for post-COVID economic recovery is to raise taxes on tobacco, alcohol and sugary drinks, major risk factors for NCDs, to discourage people from consuming them, said Jeremias Paul, who heads the World Health Organization (WHO) fiscal policies for health unit. Paul also proposed removing government subsidies on corn, which is a major component of ultra-processed food, and giving small farmers producing healthy food subsidies instead. Cities that provide the space to enable people to use their bicycles safely was a win-win for Claudia Adriazola-Steil, Director of Health and Road Safety at the WRI Ross Center For Sustainable Cities. “If we can get people to cycle to work safely, this will bring down traffic crashes. Then we will see the levels of physical activity increasing and this means that we will have less chronic diseases – less heart disease, diabetes, obesity,” said Adriazola-Steil. She added that while there was a clamour for electric cars, these were not going to be introduced fast enough to keep the world from warming up over 1.5 degrees Celsius. Referring to research done by Oxford University’s Christian Brand, who found emissions from cycling 30 times lower per trip than driving a fossil fuel car, and about ten times lower than driving an electric one, she appealed to people to switch to bicycles and hybrid e-bikes. “So if you personally want to make a contribution to climate change, you can chip but of course, we’re not going to ask people to take a bike when it’s unsafe. And we really need to make that cheap,” said Adriazola-Steil, who commended the Heart Association for providing funding to encourage cycling. Factoring health into climate change “I think a lot about the public health co-benefits of climate change. And of course, the starting point is the public health consequences of climate change, which are enormous,” said Dan Kass, Vital’s vice-president of environmental health. Public health has not been considered when governments have made decisions about electrification and industrialisation, such as fuel subsidies for the fossil fuel industry, said Kass. While converting to renewable energy will cost money, Kass said that the potential savings “in terms of lives, saved, hospitalisations averted, children who thrive from avoidance of stunting or low birth weight” -– even if only applied to the air pollution aspect of climate emissions – would more than pay for the cost of the interventions necessary to green the economy. With the international climate change conference, COP26, beginning over the weekend, Kass says an agreement on reducing carbon emissions would be a win for health. “Countries have still yet to ratify what’s called Article Six, which is a pricing scheme for carbon,” says Kass. “Economists globally have near consensus that the most equitable, least regressive way to reduce consumption and emissions is to properly price carbon, and factor in all of the social consequences of business as usual and climate scenarios,” said Kass. The pricing would be distributed throughout the economic system, paid for by producers as well as consumers – and the effect would be to “incentivize investment in alternate technologies”. “We need to act like the earth is burning, because it is,” said Kass. But he warned that there isn’t yet a level of popular support for the urgency necessary to address climate change. “We need to make the benefits known to people in the near term,” said Kass. “Your air quality is going to be better, your water quality is going to be better, you’re going to have greater access to energy. Those things will drive public support for the hard decisions that have to be made.” Image Credits: Heybike/ Unsplash. ‘Zero Draft’ Report on WHO Reform Punts Pandemic Treaty Forward – Amidst Signals of US Warming to Initiative 28/10/2021 Elaine Ruth Fletcher Virtual World Health Assembly nerve center at WHO’s Geneva headquarters in May 2021, where member states agreed to explore a Pandemic Treaty to improve global health emergency response. A “Zero Draft” report by a WHO Working Group gives cautious endorsement to advancing negotiations over a new “Pandemic Treaty” among WHO’s 194 member states. That endorsement by the Working Group of member states remains couched in highly nuanced, diplomatic language that makes it clear how big the lift may be to actually negotiate a sharp, focused treaty over the most key issues that have slowed and sometimes paralyzed global pandemic response. Those issues range from a stronger mandate for WHO to enter countries and independently investigate outbreaks as they are unrolling on the ground – which has been a key issue for Europe and other high-income nations – to questions about vaccines and medicines access, which have become an overriding concern for low- and middle-income countries lacking sufficient supplies of basic tools to beat back COVID. However, the fact the document attempts to gives space to all of those issues is likely to prove reassuring to countries and civil society – that their diverse interests won’t be ignored. Significantly, a senior US diplomat, Colin McIff, is serving alongside Indonesia’s Grata Endah Werdaningtyas as the Co-Chair of “The Bureau” a group of six countries leading the Working Group discussions, which are open to all 194 WHA members. Others members of the leadership bureau include: Iraq, Botswana, Singapore and France. McIff’s leading role in the debates also signals a possible shift in the US position, whereby Washington may gradually get behind the treaty concept – after its initial scepticism, observers say. Colin McIff, Deputy Director of the US Office of Global Health, HHS has been a key leader in developing the Zero Draft. A paper published by US Secretary of State Anthony Blinken and US Secretary of Health And Human Services Xavier Beceerra last month in the US medical journal JAMA, had thrown cold water on the pandemic treaty concept that has galvanized Germany and other leading European Union countries, saying that it could “take years to accomplish.” They had argued for immediately strengthening the WHO’s International Health Regulations, which govern WHO member states’ responsibilities for detecting, reporting and responding to disease outbreaks that pose global health threats. World Health Assembly to consider way forward in November The World Health Assembly is set to consider a way forward on the pandemic treaty and other global health reforms in a special session scheduled for next month – as per a resolution that was adopted at the May 2021 WHA session. The WHA Working Group Zero Draft outlines three options for moving forward, including: reforms to existing International Health Regulations, internal reforms to the WHO, and a new Pandemic Treaty. One key conclusion, however, is that the existing IHR framework cannot be adapted to accommodate the raft of issues that the COVID pandemic has raised. And that, in and of itself, signals a growing consensus that a more sweeping and binding treaty arrangement may be necessary. “Repeatedly, Member States have returned to two key themes in the discussion: first, that the status quo is not acceptable to anyone and second, that the WGPR [Working Group on Strengthening WHo Preparedness and Response] must be willing to move forward in a flexible way that advances both of its linked mandates,” states a the Zero Draft executive summary. While acknowledging the “value in exploring the role of existing tools and mechanisms available to WHO for implementing relevant recommendations,” …. the Working Group “identified potential benefits of a new WHO convention, agreement or other international instrument for pandemic preparedness and response,” states the Zero Draft. ‘Off to a ‘really good start’ Some influential civil society activists have been wary about the treaty initiative – seeing it as a potential diversion from vaccine and medicines access issues, and specifically a proposed World Trade Organization waiver on intellectual property rights for COVID health products, upon which a number of key groups, such as Médecins Sans Frontières are overwhelmingly focused. Civil Society Activists Question Pandemic Treaty’s Ability to Address Global Health Inequalities But there are signs that those opinions are not entirely uniform. “We are happy with the zero draft; it identifies most of the issues that we think are important. You have attention to technology transfer, decentralization and manufacturing,” said Jamie Love of Knowledge Ecology International, in an interview with Health Policy Watch on Thursday. “I don’t know if it will go forward, but I think it’s really off to a good start.. “I think the WHO is the right place to have this conversation. And so far in the pre- meetings, I think the delegates have been talking about, and sensitive to issues about transparency. While describing the WTO negotiations over the IP waiver as immediately significant, Love suggested that a pandemic treaty could offer a more permanent, and legally-binding space, to attend to the long-term challenges around IP norms, medicines and vaccines pricing, as well as finance and legal frameworks for more publicly-supported R&D and decentralized manufacture of health products that would, in turn, foster more robust and versatile supply chains. “Affordability, access, pricing, technology transfer there is not a sort of handy place to go in the IHR framework,” Love said. US leadership of talks is significant 25 heads of government and international agencies have come together in support of the new pandemic treaty From both the two co-chairs, the US and Indonesia , the contributions have been “very positive,” Love added. And the US leadership role in the Zero draft formulation could also be a signal that Washington is warming to the treaty idea that it had initially opposed – much to the consternation of EU allies like Germany and European Council President Charles Michel, which have championed the Treaty along with about two dozen other countries – and WHO’s Director General Dr Tedros Adhanom Ghebreyesus. With @DrTedros we proposed an international #PandemicTreaty rooted in @WHO constitution. It would guarantee equity & inclusiveness. A legally binding instrument would be the most effective basis for prevention, surveillance, collection and exchange of scientific data.#WHS2021 pic.twitter.com/lbWkc3G5XE — Charles Michel (@eucopresident) October 25, 2021 “It’s very encouraging to us that Colin McIff has been so good in terms of the comments that he has been making and the direction that he has steered things,” said Love. “He’s a career negotiator and a popular guy. Everyone likes him, the drug companies like him, we like him. He’s a good listener.” Moreover, “Colin is widely respected in the US government. And so it does give us some hope that the US position on the pandemic treaty will change.” Love added that negotiations of a binding pandemic treaty now, ahead of another crisis, could help countries actually adhere to their commitments when a new global health threat actually emerges, as it inevitably will in an era of rapid climate change, ecosystem destruction, urbanization and international travel. “It’s better to make these decisions now, before people actually know who has the valuable assets [in terms of new medicines or vaccine candidates]. Ideally you can make commitments that make sense globally and locally because no one knows who is going to be the winners or the losers. “When there is no emergency people will talk a good game. But when the COVID emergency came along, one country after another peeled off from the solidarity talk. So looking for a more binding commitment actually makes it easier for countries to do the right thing when a pandemic hits.” Image Credits: EU Council. WHO Asks G-20 for $23.4 Billion to Fund COVID Vaccines, Tests & Treatments – and 550 Million Vaccine Doses Immediately! 28/10/2021 Elaine Ruth Fletcher The South Sudan Minster of Health, Elizabeth Chuei,received her first COVID-19 vaccine at Juba Teaching Hospital in mid-October as the country’s vaccine drive, interrupted in April with the halt of vaccine exports from India, restarts once more. Only 5 African countries currently are on track to meet a WHO 40% vaccination goal. Ahead of a critical G20 meeting this weekend, WHO and its partners are asking the world’s leading industrialized nations to come up with another US$ 23.4 billion over the course of the coming year to address stark shortages in COVID vaccines, tests and treatments remain dismally low in Africa and other parts of the developing world. The new strategy for the “Act Accelerator” initiative that is funding and distributing vaccines, tests and treatments to about 92 low- and middle-income nations, comes against the background of a continuing death toll of some 45,000 to 50,000 deaths a week, said WHO and other leaders of the Act-A in two separate press conferences Wednesday and Thursday. “While the world is now producing some 1.15 billion vaccine doses per month, vaccination coverage still ranges from 1 – 70%,” said Carl Bildt, WHO Special Envoy for the ACT-Accelerator, in a press briefing about the new ACT-A strategy on Wednesday, developed by the steering group of leading the consortium, which includes, WHO; UNICEF; the Global Fund; Gavi, The Vaccine Alliance; the Wellcome Trust, the Foundation for Innovative New Diagnostics (FIND), and the Oslo-based CEPI, which is funding vaccine R&D. Against that background, “the disease will continue in countries with very low vaccination coverage, and variants will continue to develop,” he said, adding that along with the constantly mounting death toll, “this is going to come back and affect everyone.” Today, WHO’s Africa office announced that just five out of Africa’s 54 WHO member states would meet the WHO goal to vaccinate 40% of its population by the end of 2021 (see related Health Policy Watch story). Message to G-20 – 550 million mor vaccine doses this year would allow 82 more countries to reach 40% vaccine coverage goal WHO data on vaccine inequalities around the world & FIND data on testing, as of 6 October, 2021 Speaking at a WHO press briefing on Thursday, WHO’s Dr Tedros Adhanom Ghebreyesus made a special appeal to G-20 nations to come through on promised vaccine donations – which so far have fallen far short of earlier commitments. He also called upon G-20 countries to support moves towards a Pandemic Treaty as well as the creation of a new “Global Health Threats Council”. “I have three requests for the G20 leaders,” said Tedros speaking at a press conference on Thursday, “First fully fund the Act Accelerator, second, support the creation of an overarching framework for global health security that that a legally binding treaty on pandemic preparedness and response, and thirdly, support the creation of a Global Health Threats Financing Board, supported by a financial intermediary fund, and hosted by the UN.” Dr Tedros’ remarks on a “Global Health Threats Financing Board” effectively combines two separate proposals that emerged from an Independent Panel report on pandemic preparedness and a more recent pan-European Commission on Pandemic Preparedness, which had suggested that a global board to more squarely address health finance issues could be useful. Added senior WHO Advisor, Bruce Aylward, “Some 82 countries are at risk of not reaching the 40% goals, only because a lack of vaccine supply. They can meet it [the goal] if the supply is there. They only need another 550 million doses through the COVAX initiative. So the big question to the G-20 is: are they going to say where those 550 million doses are going to come from? Because those 20 countries control the global vaccine supply between now and the end of this year, we are going to make about 3 billion doses of this vaccines. Can we take about ten days worth and see that it goes into COVAX. “This is a solvable problem, it is a question of political will and the manufacturers.. It’s a test of global solidarity.” Millions more deaths could be averted Jonas Gahr Store, Norway’s new prime minister Without global vaccine and treatments access, “We will not be able to achieve true economic and social recovery” added Norway’s new prime minister, Jonas Gahr Store, who made a guest appearance at the WHO briefing. Getting more vaccines to Africa and elsewhere could lead to “millions more deaths that could be averted” he said, referring to WHO estimate that reaching it’s vaccination coverage goals could save up to 5 million lives over the course of the next year. “As long as some people remain are exposed and vulnerable, we all are – in this globalized world,” Store added. Extreme shortage of COVID tests in LMICs is another hidden driver of the ongoing pandemic The extreme shortage of COVID tests in the same countries that lack vaccines, is one of the other, more hidden crises associated with the ongoing pandemic, pointed out Bill Rodriguez, CEO FIND at the Wednesday press briefing. “Roughly 3.5 billion tests for COVID-19 have been administered,” he said, “however less than 0.4% of tests have been performed in low income countries,” he pointed out. Among groups that aren’t vaccinated, it’s critical to roll our more tests in order to be able to rapidly target treatments to people that are infected – from vital oxygen supplies for the seriously ill to the first-ever COVID anti-viral pill, molnupiravir, that appears set to receive US Food and Drug Administration approval soon. Recent clinical trials have suggested that the drug reduces by 50% the risks of hospitalization and death among people who are mildly to moderately ill. And Merck, the developer of the treatment, has agreed to allow a generic version of the pill to be manufactured and distributed across most of the developing world. But in order to even administer such a treatment effectively, people have to be tested to determine if they are ill with COVID – or something else, noted Rodriguez. And that is just not happening today in low-income countries. “Testing is also critical to be able to do [genetic] sequencing to identify new variants,” he added, noting those variants threaten to bite back at already vaccinated high-income countries. To address the testing crisis, the new ACT strategy asks for some $7 billion more in funding for test kits – most of which would be invested in the procurement of rapid tests. “We want to try to reach a minimum target of administering one test per 1,000 people per day,” he said, referrring to the new ACT testing strategy. “To reach these targets we will need to test six times as many people as we have been doing in the past six months. And even if we do, we will still be testing at less than half the minimum rate as in high income countries.” Image Credits: UNICEF, WHO COVID dashboard & FIND Test Tracker . Only 5 African Countries On Track to Meet 40% Vaccine Coverage Goal by End 2021; Syringe Shortage is One of the Latest Obstacles 28/10/2021 Kerry Cullinan Only five African countries are likely to reach a WHO global goal of vaccinating 40% of their populations by the end of the year, and the continent’s roll-outs may be slowed further by a global shortage of the syringes need to administer vaccines. UNICEF has reported an imminent shortfall of up to 2.2 billion syringes for COVID-19 vaccination and routine immunization in the coming year, according to the World Health Organization’s (WHO) Africa region. This includes special 0.3ml syringes needed for the Pfizer-BioNTech COVID-19 doses, for which there is no global stockpile. “Early next year COVID-19 vaccines will start pouring into Africa, but a scarcity of syringes could paralyse progress,” WHO Africa Director Dr Matshidiso Moeti told a press briefing on Thursday. “Drastic measures must be taken to boost syringe production, fast. Countless African lives depend on it.” COVAX is trying to secure deals with syringe manufacturers, and through better planning to avoid deliveries outpacing the supply of syringes, the WHO reported. Only 6% of Africans – 77 million people – are fully vaccinated, while over 70% of high-income countries have already vaccinated more than 40% of their people. Three African countries – Seychelles, Mauritius and Morocco – have already vaccinated over 40% of their people, while only Tunisia and Cabo Verde are on track to reach this global WHO target by year-end. While COVAX has delivered around 50 million vaccines to Africa, the continent still faces a 275 million dose shortfall in order to vaccinate 40% of all Africans. Wave after wave Dr John Nkengasong, Director of the Africa Centers for Disease Control and Prevention (CDC), told an earlier media briefing that 82% of the continent had experienced a third wave of COVID, while seven countries had already had a fourth wave. “We are going to go from wave to wave unless we address the question of vaccinations,” said Nkengasong. While cases in most of Africa are going down, cases are rising in countries in the Central African countries of Gabon, Congo, Cameroon, as well as Egypt. COVID deaths in Nigeria increased by 66% and by 36% in Egypt, added Nkengasong. Meanwhile, the WHO urged countries to improve their vaccine roll-out readiness. Some 42% of countries have not yet completed district-level plans for their campaigns, while nearly 40% have not yet undertaken “intra-action reviews” which are key to refining and improving their vaccination campaigns,” according to the WHO The WHO is conducting emergency support missions to five African countries to help support, speed up and improve their COVID-19 vaccine rollouts, with plans for missions to another 10 countries this year. Image Credits: Wuestenigel/Flickr. Game-Changing COVID-19 Oral Treatment Set To Become Widely Accessible in Low- and Middle-Income Countries Upon Regulatory Approval 27/10/2021 Elaine Ruth Fletcher Merck laboratory that developed the new oral COVID treatment, molnupiravir A potentially game-changing antiviral treatment for COVID-19 that can be administered orally early on, and potentially head off much more serious cases, is set to be licensed for generic production in most low- and middle-income countries (LMICs), in an unprecedented breakthrough in access to a new COVID treatment. The historic deal, reached between the pharma company Merck Sharp & Dohme (Merck) and the Medicines Patent Pool paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell the treatment, molnupiravir at discounted prices to more than105 countries worldwide, once the drug has been approved by the US Food and Drug Administration and the World Health Organization. The agreement is the first time in the pandemic that a major pharma company has agreed to such an open-ended license for generic production of a newly developed drug. The drug, currently awaiting US FDA emergency review, reduced risks of hospitalization or death by about 50% among patients with mild or moderate COVID, according to the company reports of the results of its Phase III trial. The deal also represents a major coup for the Geneva-based MPP, a non-profit organization with a long track record of negotiating with big pharma innovators for broader generic production of costly new drugs for treating hepatitis, HIV, and other diseases. Until now, however, MPP had not been able to enter fully into the COVID medicines access fray – with pharma producers reluctant to negotiate with the non-profit over broad-based licenses for the generic production of COVID vaccines and drugs. Other new COVID drug treatments, such as the newly-approved monoclonal antibody cocktail REGEN-COV, remain expensive and hard to access in most LMICs. They are also more difficult to use – as they need to be administered intravenously. Charles Gore, MPP Executive Director, said of the breakthrough, “This transparent, public health-driven agreement is MPP’s first voluntary licence for a COVID-19 medical technology, and we hope that MSD’s agreement with MPP will be a strong encouragement to others.” The MPP is all the more meaningful as the new drug will be the first major COVID medication that can be administered orally to non-hospitalized patients, said WHO in a statement. ‘Best agreement any company has made’ The announcement was roundly hailed by WHO and other UN-affiliated agencies managing the UN-supported ACT-Accelerator initiative to broaden access to vaccines and drugs. A number of medicines access advocates who have bitterly criticized pharma for failing to issue more voluntary license deals for for other cutting edge vaccines and treatments, issued particularly warm statements about the Merck deal. Said Jamie Love, of Knowledge Ecology International, “The license between the MPP and Merck for the manufacture and sale of molnupiravir is the best agreement any company has made for licensing its intellectual property during the COVID-19 pandemic. “The 69-page license agreement is fully transparent, unlike the agreements with CEPI, COVAX, Operation Warp Speed, the Gates Foundation, the Wellcome Trust, other companies or most governments,” added Love referring to the other international and UN-supported initiatives on COVID drug and vaccine access. “The license makes it possible for any generic manufacture located anywhere the world to supply molnupiravir in the licensed territory, and provides a pathway for supplying to countries outside the licensed territory, when patents are not in place or subject to compulsory licenses. “The licensed area is large enough (more than half the world’s population) to induce efficient generic entry and economies of scale,” he added – while noting that the 18% population coverage in LAC is weakest – although a separate Merck deal with Brazil is reportedly underway. Concluded Love: “Given the objectives of scaling up production of molnupiravir at the lowest prices for the lowest income countries, the agreement is an impressive achievement for the Medicines Patent Pool and Merck deserves credit for being the first company to make a deal with the Medicines Patent Pool.” MSF calls out shortcomings of contract Even so, some civil society stakeholders, and notably Médecins Sans Frontières (MSF) said that the licensing arrangement “does not go far enough” expressing “disappointment with the limitations of this license, as its territory excludes nearly half of the world population and important upper-middle-income countries (UMICs) with robust manufacturing capacity, such as in Brazil and China.” Yuanqiong Hu, Senior Legal and Policy Advisor, MSF Access Campaign added that: “After more than a year of secrecy of companies’ bilateral deals in a pandemic, it is a welcomed step forward to have the first fully published voluntary license from MPP covering COVID19 medical tool. “However, a closer look reveals its limitations for increasing access to one of the first promising antiviral drugs for COVID-19. It’s disappointing…. Middle-income countries excluded from the license had 30 million COVID-19 infections in the first half of 2021, 50% of all infections in low- and middle-income countries. Medicines, Law and Policy, while generally positive, also called out a clause that would allow MPP terminate a sublicence agreement with a manufacturer of the new drug, in the case of a patent challenge – a clause reportedly included at the request of the drugs initial developers at DRIVE, a subsidiary of Emory University and Ridgeback Pharmaceuticals. Emory University has in fact waved royalties on the sale of the drug in low- and middle-income countries for as long as the WHO-declared international public health emergency continues. However the termination of sublicence clause also has provoked protests by students, who say that it could restrict or undermine the flexibility of the generic licensing agreement. Merith Basey, Executive Director for Universities Allied for Essential Medicines, a student-led movement that aims to change universities’ licensing practices told us: “Emory University has betrayed its mission to serve humanity by stifling global access to a potentially life-saving COVID treatment. Molnupiravir was developed on Emory’s campus with massive amounts of tax-payer funding, yet this license includes a stipulation demanding a no-patent challenge. We call on the institution to remove the clause and favor people over profit in the midst of a global pandemic that has killed over 5 million people so far.” Image Credits: Merck , Merck . Liver Cancer: Europe’s Public Health Ticking Time Bomb 27/10/2021 Thomas Berg & Maria Buti October is Liver Cancer Awareness month, and Europe has a liver cancer problem. Over the past two decades, there has been a 70% increase in liver cancer-related mortality in the region. In 2020, 87,000 Europeans were diagnosed with liver cancer while 78,000 died from the disease in the same year. Late diagnosis is a serious problem. About half of patients are only diagnosed in an advanced stage of cancer and have less than a year to live. Liver cancer is the sixth most common cancer and the third biggest cause of cancer-related deaths globally. In the US, the rate of deaths from liver cancer increased by 40% from 1990 to 2004 while the overall rate of non-liver cancer deaths declined by 18%. Projections for the US estimate that in 2030, liver cancer will be the third-leading cause of cancer-related deaths, surpassing breast, colorectal, and prostate cancers. There are many risk factors for developing liver cancer, and chronic liver diseases caused by viral hepatitis, alcohol, or fatty liver disease are the most important. Diabetes and obesity Non-alcohol fatty liver disease (NAFLD), which is often a consequence of obesity and diabetes, is the leading cause of death among 35 to 49-year-olds in the UK, making NAFLD a health threat that should not be underestimated. (The more severe form of NAFLD is called nonalcoholic steatohepatitis, or NASH). Outside of COVID-19, NAFLD is also about the fastest growing disease globally. It occurs in about one in four people around the world and has emerged as the most prominent cause of chronic liver disease. Experts predict that, over the next decade, NAFLD will become the leading cause of end-stage liver disease and liver transplantation. It is already the fastest-growing cause of hepatocellular carcinoma (HCC), the most common form of liver cancer worldwide. Faced with a ticking public health time bomb in Europe, we are clearly in a race against time to both prevent and treat this disease before the epidemic worsens and overwhelms health systems. Better treatment access Treatment of chronic liver diseases to avoid their progression to precancerous states like cirrhosis significantly reduces the risk of liver cancer, and this has been convincingly demonstrated. Improved and equal access to state-of-the-art management of these diseases is a core element in the fight against liver cancer. Although liver cancer remains one of the few cancers with increasing incidence and mortality, public awareness of liver cancer is much lower than for other cancers. As a consequence, patients who have liver cancer and patients who are at increased risk for liver cancer often face stigma in their social lives, and also in the medical settings. Treatment options for liver cancer have significantly improved over the recent years, which makes early diagnosis the most critical point. Case-finding strategies need to be implemented, at least in at-risk patients, as strongly recommended by clinical guidelines. Hepatitis B vaccinations Finally, we must directly tackle the key environmental factors that cause liver diseases and liver cancer. In addition, successful Hepatitis B vaccination programmes need to be continued and expanded as the core element of primary liver cancer prevention as it has the potential to prevent roughly twice as many cancer cases as HPV vaccination. Earlier this year the European Commission launched its Beating Cancer Plan in response to the fact that the EU region is home to a quarter of the world’s cancer cases and is facing an annual economic impact of €100 billion if urgent action is not taken. This plan is precisely what is needed to bring scientific societies, experts and patient groups together to move forward measures that can go a long way towards stopping liver cancer in its tracks. But these measures need to be coordinated across the region, led by the European Commission, and implemented by EU Member States. A starting point has to be the setting of standards for awareness, prevention, and management of liver cancer across the region. It is pivotal that we educate and raise awareness amongst everyone: healthcare professionals, patients and families, risk groups, policymakers and the general public. Liver cancer usually occurs as a consequence of underlying chronic liver disease and cirrhosis. Thus, the EU and Member States should implement preventive measures that include evidence-based strategies to reduce the burden of liver disease, focusing on reducing alcohol consumption and obesity, and on early detection and treatment of chronic liver disease. Early detection is critical for those patients with liver diseases associated with a high risk of liver cancer such viral hepatis B and C, alcohol-related and non-alcoholic fatty liver disease. The EU and Member States should add liver cancer to their screening list, at least for patients with underlying risk factors. In addition, existing programs providing the opportunity of early case finding of liver diseases should be leveraged where possible. The salivary screening for Hepatitis C using point of care testing is a good example and complements the WHO HCV program aiming at fighting HCC as well. Inter-disciplinary disease management But we also need improved access to better disease management for patients with liver cancer across all member states of the EU. This means a more structured pathway for the diagnosis and treatment of patients when they are receiving care in hospital, as an outpatient and then at home. That will require better inter-disciplinary cooperation between hepatology, oncology and other relevant disciplines and ideally collaborative clinical guidelines that are driven by comprehensive scientific evidence. Basic research continues to be a critical element for improving patient outcomes in liver cancer. There is still further knowledge needed about aetiology, rare liver cancer entities, markers and diagnostics which might facilitate early detection even in primary care. The EU and Member States should support such research projects and cross-country collaboration by setting up EU-wide platforms with the aim of sharing data and closing the gap between medical knowledge and clinical practice. The high standard of care in the EU is based on high-level science and research. In order to maintain these standards furthermore and drive improvements, it is essential to collect data collaboratively across all member states. The EU and Member States should support the setting up of specific patient registries for liver cancer. The collation of this data would facilitate surveillance, research and the overall management of patients with liver cancer. Care must be patient-centric. People living with liver cancer and their families should have unrestricted access to information, medical treatment, and measures to improve their quality of life, regardless of their life situation and ethnic origin. All patients with liver cancer should benefit from the same high standards of care wherever they are in Europe. Thomas Berg is the Secretary-General of the European Association for the Study of the Liver (EASL) and Head of the Division of Hepatology at Leipzig University Medical Center in Germany. Maria Buti is the EASL EU Policy Councillor and Professor of Medicine and Chief of Internal Medicine and Hepatology at the Hospital General Universitari Valle Hebron in Barcelona, Spain. US ‘Steps Aside’ to Give Africa Access to Moderna Vaccines 26/10/2021 Kerry Cullinan Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) The US government has enabled Africa to get access to 50 million Moderna COVID-19 vaccines by giving the continent its place in the vaccine queue, Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) said on Tuesday. “This is a time swap arrangement whereby the United States government basically stood aside for the next quarter so that we could access vaccines and purchase them ourselves,” Masiyiwa told a media briefing of the Africa Centers for Disease Control (CDC). AVAT will get 15 million Moderna doses in December and a further 35 million between January and March. It also has an option to buy 60 million more, delivered at 20 million doses per month, between April and June. “These doses are being purchased by AVAT courtesy of the United States government, which has been phenomenal in its support,” he added. South Africa’s President Cyril Ramaphosa and Kenya’s President Uhuru Kenyatta negotiated the deal directed with US President Joe Biden, said Masiyiwa. Other than a deal with Johnson and Johnson (J&J) for 400 million vaccines over 13 months from August, “none of the vaccine suppliers had any doses for us this year,” said Masiyiwa. The Africa Union has been able to get the J&J vaccines largely because they are being assembled by Aspen in South Africa – but even ensuring that these doses remained on the continent required reaching an agreement with the European Union, which initially planned to import the African-assembled vaccines. Jessye Lapenn, the US Ambassador to the African Union, praised AVAT’s leadership and expressed her country’s support for the continent’s vaccination efforts. The White House confirmed that it would defer the delivery of about 33 million Moderna vaccines to enable the African Union to buy the doses. Masiyiwa said the African Union’s long-term vision was for Moderna to reach a fit-and-fill agreement with an African manufacturer. The company recently announced that it wants to build a $500 million mRNA vaccine manufacturing facility in Africa. “We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe, said Moderna CEO Stéphane Bancel. Moderna said that it was “working on plans to allow it to fill doses of its COVID-19 vaccine in Africa as early as 2023, in parallel to building an mRNA vaccine manufacturing facility in Africa”. Moderna, which received millions of dollars in R&D support from the US government, has been under pressure from the Biden administration to supply low and middle income countries with vaccines. AVAT is currently supplying 39 African countries and 15 Caribbean countries, but only 8,7% of Africans have had at least one vaccine dose. Meanwhile, COVAX revealed on Monday that less than 10% of vaccine donations pledged to it by wealthy countries had been delivered. Of the 1.3 billion COVID-19 vaccine dose donations promised to COVAX by wealthy countries, only 150 million doses have actually arrived – around 9% – Gavi CEO Dr Seth Berkley told the World Health Summit. Joining the Africa CDC press briefing on Tuesday, Berkley said that COVAX had supplied 40% of Africa’s vaccine doses but the facility had experienced a major slowdown after India banned the export of AstraZeneca vaccines made it its country although COVAX had already paid for the vaccines. Debt Relief & National Economic Reforms Pitched as ‘Big Picture’ Global Health Solutions Ahead of G-20 Meeting 26/10/2021 Elaine Ruth Fletcher WHO Director General Dr Tedros Adhanom Ghebreyesus and Mariana Mazzucato, chair of the new WHO Council on the Economics of Health for All. An ambitious wish list of global economic and fiscal measures that the world should adopt to combat the COVID-19 pandemic has been floated by the World Health Organization- just ahead of a critical G-20 meeting of the world’s most industrialized nations this weekend. These include proposals for massive debt relief to debt-ridden countries and a re-direction of the IMF’s new offer of $US650 billion in “special drawing rights” away from richer nations to low- and middle-income countries. The laundry list of macroeconomic and fiscal measures proposed by the new WHO Council on the Economics of Health for All, was detailed today at one of the final sessions of the World Health Summit. Drafted by 10 top economists and health policy experts, Financing Health for All pushes the classic debates over access to medicines and health systems investments – into the realm of much broader fiscal and economic decisions that nations, both rich and poor need to make, according to the experts. That is, if they really want to beat down COVID-19 as well as prepare for the next pandemic. ‘Donor mentality’ is part of the problem WHO Director General, Dr Tedros Adhanom Ghebreyesus “It proposes a radical shift in economic thinking for global health,” said WHO Director General Dr Tedros Adhanom Ghebreyesus at the WHS session. He appeared with Mariana Mazzucato, Founding Director of the UCL Institute for Innovation and Public Purpose, and chair of the new health economics Council, which was launched by WHO in May 2021. “Instead of looking at health as a piece of the economy, it’s time to look at how the economy can support the societal goal of health for all,” said the WHO Director General. “Neither existing market mechanisms, with their focus on short term returns, nor development funds alone are enough,” he added. “They do not provide the global public goods on which we all depend, such as vaccines, nor do they address the major inequities, undermining equitable access. “The council is proposing bold, concrete actions for governments and multilateral organizations in three major areas, creating fiscal space, the direction of investment, and the governance of public and private financing for how this does not just mean more money. It means making the better, smarter and sustained investments that are needed to achieve health for all.” “We have to realize that this donor mentality is actually part of the problem,”said Mazzucato, “And that lots of the conditionalities that were set in the past on the loans provided to developing countries precisely made them weaker. The key priorities outlined by the brief, prepared by the ten-member expert group includes proposals that would leverage change from global to national level so as to: Create more “fiscal space” for countries to invest more in health, including through measures like international debt relief, a global corporate tax rate and a greater allocation to low-income countries of newly available IMF special drawing rights; Reshape national, tax, regulatory and investment rules to make them more favorable to health-related investments, e.g. in health systems and vaccine and medicines manufacture; Ensure stronger governance for private health markets – notably pharma innovators and manufacturers – using public regulations and investments to “crowd in and direct private finance towards improving health outcomes globally and equitably.” Other members of the Council include Vera Songwe, Executive Secetary of the Economic Commission for Africa; economists such as Jayata Ghosh, of the University of Massachusetts and Stephanie Kelton an expert on monetary policy at Stony Brook University; investment banker Vanessa Huang, and global health professionals such as Ilona Kickbusch, founding director of the Geneva Graduate Institute’s Global Health Centre; Senait Fissehea, of the University of Michigan; and planetary health expert Kate Raworth, of Oxford University’s Environmental Change Institute. More “quality money” – to fight the next pandemic Mariana Mazzucato, chair fo the new WHO Council on the Economics of Health for All Just “more money” is not enough to drive bigger investments in countries with poor-performing health systems, stressed Mazzucato, it needs to be “quality money” – money that does not translate into more crippling loan repayments once the initial phase of the pandemic crisis has passed. “Multilateral organizations should negotiate debt relief for low and middle income countries in such an important moment,…. redirecting [IMF] Special Drawing Rights towards investment in health, and especially vaccines,” she said. IMF special drawing rights are not considered as loans in the traditional sense of the word, but rather bolster countries’ reserves and thus their overall economic stability. “False constraints have been imposed on government’s fiscal spaces, often by multilateral institutions like the IMF and the World Bank.” Crippling debt restrictions and austerity measures traditionally have hit hardest on social welfare nets, including public health systems, meaning that low- and middle-income countries “weren’t allowed to create the kind of fiscal space that we highlight as the first key pillar,” she observed. “Over time, we have to be better prepared and that preparedness needs to be, in the long run, built on the ability to have a distributed manufacturing and industrial capacity [for health products] globally. “Because this will not be the last pandemic, you know. As the permafrost melts, apparently, there’s going to be all sorts of other viruses that come about. Climate change and this health crisis are really interlinked.” Along with debt relief the G-20 should advance credit rating reforms and “push for the enforcement of a minimum global corporate tax of at least 15%,” she added. National investment priorities Finance and health authorities need to work together more closely to expand local medicines and vaccine production and improve health systems. But as the brief underlines, the challenge is not only to reduce international pressures, through measures such as debt relief, but also to “change mindsets within countries that impose internal constraints on spending” – often in the name of false economies and fiscal prudence. That means a better understanding and alignment in Finance Ministries, of the importance of health priorities. “The bottom line is that countries must reverse the harmful effects of an austerity approach to public administration and public finance reforms,” said Mazzucato. She pointed to Kerala State, in India, as an example of a region that fared better because it focused investment into public health systems. “Internal constraints on government budgets are not insurmountable and governments actually have more room for increasing the fiscal limits on investments for health than they’re led to believe. “And it’s not just a matter of political choice, but also when a political will whether country can mobilize all the resources and levers that can to maximizing financing for health, such as innovative monetary policy, but also…, procurement policies using different levers – grants, loans, procurement to really catalyze new solutions…. “When we go to war, money is found, and during a health pandemic, money has been found, but that has been too little too late,” she observed. Public-Private sector should share ‘risks and rewards’ of innovation Finally, public-private sector relationships around critical issues such as vaccines and medicines innovation and manufacture need a reboot, the brief argues, sharing both the “risks and rewards” of innovation, in the words of Mazzucato – rather than leaving public entities to shoulder the risks while the private sector reaps most of the rewards. “We need public actors, we need philanthropies, but they need to work together in a different way,” she said. That means public contracts, loans, grants and other incentives that are offered to the private sector to develop new and more innovative vaccines, tests and treatments also need to come along with stronger conditions about how the final products they create may be used or distributed. “And this can be done by redesigning the terms and the conditions, structuring contracts, grants, transfers loans and partnerships between public and private actors. “Precisely because the public sector puts in so much of the money – especially in the early stage when it’s more risky and more capital intensive, and uncertain – these critical market-shaping public investments should ensure conditionalities around pricing – to make sure that we have access at the core -that we have vaccines that are globally accessible. Innovation – global, end-to-end and governed collectively In terms of intellectual property rights, she added that “it’s not about getting rid of patents, but we have to govern innovation and the patent system, with objectives in mind. “Making sure that patents are not too wide, too strong, hard to license upstream are core ways to govern the patent system. “It’s not about getting rid of patents, we have to govern innovation, and the patent system with objectives in mind,” she said. “More broadly, we need to shape a conducive regulatory tax, industrial and economic policy environment to ‘crowd in’ all sorts of different sources of finance at the same time, ensuring that we get the greatest multiplier effect, the greatest impact on health for all. Ultimately, however, she stressed that global health innovation platforms need to be “global, end-to-end, and governed collectively – shifting from a model where innovation is left to the market to a model aimed at delivering global common goods.” Image Credits: Marco Verch/Flickr. Civil Society Activists Question Pandemic Treaty’s Ability to Address Global Health Inequalities 26/10/2021 Kerry Cullinan A session of the 2020 World Health Assembly. Some civil society organisations (CSO) are sceptical about whether a ‘pandemic treaty’ is the best way to address future global health crises, while treaty supporters say it will provide a legal framework binding countries and global health bodies to more agile and rapid responses to future outbreaks. A session Monday sponsored by the Geneva Global Health Hub (G2H2) brought leading CSOs, diplomats, academics and even WHO’s chief legal counsel face to face to air those views, in the context of a research initiative on the treaty being undertaken by the hub. The debate comes just weeks ahead of a planned special session of the World Health Assembly which is to determine whether the global body will indeed move forward on a Treaty, as a key measure for improving pandemic response. The treaty initiative has been supported most visibly by European countries, led by European Commission President, Charles Michel, who in a separate session at the World Health Summit in Berlin that the treaty would guarantee “access to information, financing, vaccines and countermeasures. It would increase capacity and resilience – at all levels.” With @DrTedros we proposed an international #PandemicTreaty rooted in @WHO constitution. It would guarantee equity & inclusiveness. A legally binding instrument would be the most effective basis for prevention, surveillance, collection and exchange of scientific data.#WHS2021 pic.twitter.com/lbWkc3G5XE — Charles Michel (@eucopresident) October 25, 2021 Diversion or game changer? 25 heads of government and international agencies have come together in support of the new pandemic treaty Some of the civil society organisations that have expressed disquiet about the treaty proposal perceive it as a potential distraction or diversion by wealthy countries from the so-called TRIPS waiver proposal, currently under consideration by thee World Trade Organization. The proposal by South Africa and India for a broad-based intellectual property waiver on COVID vaccines and treatments, now being debated by the WTO’s TRIPS Council , is perceived by civil society as a game changer that would help open the doors to despearately needed COVID vaccine and medicines manufacturing in Africa and the global South. Many of the European countries that have been among the most staunch opponents of the TRIPS waiver are also key pandemic treaty supporters, noted journalist Priti Patnaik, who is researching stakeholders’ views on the pandemic treaty for G2H2 -giving rise to the CSO suspicions. And yet at the same time, some developing countries have supported a pandemic treaty because they believe it would “rein in the influence of non-state actors, including powerful foundations, and get some binding obligations to apply to industry to avoid vaccine inequities in the future,” she added. ‘Switch-and-bait’ tactic Unni Karunakara, senior fellow at Yale’s Global Health Justice Partnership, said that the major focus should be on deploying available tools and medicines to every corner of the world, rather than negotiations over a new treaty: “Shouldn’t global vaccination coverage be an overwhelming priority now?” he asked. “We do have frameworks and tools. They’re not perfect, but there are enough tools for us to overcome this crisis together,” said Karunakara, a former president of Medecins sans Frontieres. “What is lacking, however, is the political will to share essential resources and tools, even with all of the treaties in place.” His comments reflecting the cynicism of other civil society activists who see “a big overlap between the countries that are blocking the TRIPS waiver, and the countries that are supporting the pandemic treaty. “So there’s a perception of a ‘switch-and-bait’ tactic that reeks of bad faith,” he added. And while transparency measures – such as the mandatory sharing of genetic materials by countries where outbreaks are suspected – have been discussed as key treaty features, similar mandates for transparency or sharing of vaccines and medicines technologies have been fiercely opposed by the EU, he pointed out. “TRIPS waiver-blocking countries have made the case for voluntary actions by pharma to ensure access to essential COVID-19 medical tools, so they treat Big Pharma with kid gloves,” Karunakara observered. “Interestingly, they take a very different tone and approach to the global south in the treaty, insisting on enforceability in the sharing of information and materials with WHO and other governments to allow for independent verification.” “The assumption here is that global south is the problem, that diseases originated in poor country, and pose national security risks to rich countries.” If you are against the treaty – what is your multilateral alternative? Björn Kümmel, at the WHO Executive Board’s January 2021 meeting. Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver – or the kinds of hidden agendas that civil society groups fear. “I doubt that it’s, from a logical point of view, right to say that even though a country has it stands on the TRIPS waiver, you can’t tackle other equity issues,” he told the G2H2 session. “That’s one angle to look at, the TRIPS waiver, but there are many more angles to be looked at. So to say that that is the only magic bullet, I think that would be fully wrong, I wouldn’t limit it to this. “I think that equity goes far beyond, and certainly, if a treaty was negotiated, it’s quite clear that this [TRIPS waive] will be put on the table, and that all governments will have to look at the different interests that are on the table and negotiate them with an open outcome.” He noted that the treaty was first proposed formally by Chile, not the European Commission, and has the support of a wide array of countries, including South Africa, Kenya, and Tunisia, as well as Thailand and Indonesia. Anything better than ‘Chaos’ we see now Describing the current global health situation as “dysfunctional”, Kümmel asked the G2H2 session: “If you are against the treaty, tell us what is your multilateral alternative to it, to be realistically implemented, lets say in the next five years?” “What the countries who are proposing a treaty are trying to say is: anything is better, than compared to the chaos that we’re seeing currently. “Legal clarity is needed, and it will be …a painful exercise for many of us, and most likely a difficult one for many governments, including mine, most likely also others. But in the end, it’s this is multilateralism.” Uniquely in the global health landscape – and unlike environment, trade or finance – there is a dearth of global treaty instruments. In fact, among the dozens of international treaties in force today, the only two binding instruments in global health today are the IHR and and the Framework Convention on Tobacco Control (FCTC), he pointed out. Pandemic is a ‘window of opportunity’ for bigger changes In light of the outstanding questions, however, the working group of countries that are preparing for the WHA special session had devised a “three-step approach” to their deliberations on a way forward. They are considering in parallel: WHO internal reform measures; revisions in the existing International Health Regulations that currently govern global emergency response; and finally, the Pandemic Treaty alternative. In terms of WHO reform, the conclusion has been that such measures would “not be sufficient in order to overcome the next pandemic,” Kümmel said. Amendments to the International Health Regulations (IHR) also would take time to negotiate. And a key question here is: “would they be a game changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” So against the other options, “an international binding agreement is interesting,” he said. “And why are many colleagues pushing for this to happen now? Well, it’s the reality that after Ebola and past pandemics the global community was unable to implement the lessons learned,” he said. And if negotiations don’t begin now, in the heat of the ongoing crisis, they will never happen at all. “Many of the international independent panels have called for bold recommendations to be implemented,” Kümmel reminded the group. “One of them is the treaty. But many of those recommendations have never reached successful implementation, because the window of opportunity for real structural changes normally vanishes with the next crisis to come after the pandemic.” The treaty would also retain WHO’s centrality as the nerve center of the global health architecture – amidst a plethora of new health initiatives emerging in Europe and elsewhere: “There are a multitude of ideas and recommendations, and the treaty is a legal framework into which most of the other recommendations would fit,” he said, in reference to recent proposals such as one by the Pan European Commission on Health and Sustainable Development to create a new global health board under G-20 auspices. Others have talked about a new global health finance board in association with the World Bank and/or a new UN-level Global Health Threats Council, under the auspices of the UN General Assembly. So the Pandemic Treaty is “also a mechanism to provide WHO with legitimacy after this crisis,” he stressed. “Obviously there are voices out there who could see alternative approaches. However, I think the ones who are in favour of this treaty have clearly articulated that WHO is the right forum because its the truly multilateral forum for global health.” WHO precedents for equitable access to vaccines? Germany is not the only actor that sees the treaty as a means of keeping WHO as the world’s main global health meeting place. WHO’s Director General Dr Tedros Adhanom Ghebreyesus has himself come out in support for the pandemic treaty measure – breaking ranks with previous agency heads who usually remained aloof of controversial measures under consideration by member states. WHO is therefore keenly interested in how civil society groups may help lead or shape views on the treaty negotiations – and this interest was reflected in a cameo appearance at the G2H2 event by Stephen Solomon, WHO’s principal legal officer. Solomon said it was “really helpful” to understand some of the “scepticism” around the pandemic treaty initiatives. “Understanding the the concern about an agenda driven issue here is very important for the [WHO] Secretariat,” Solomon told the group. At the same time, beyond the immediate COVID crisis, other WHO emergency response frameworks already in place also could perhaps benefit from the stronger legal backpone that a pandemic treaty might provide, he pointed out. One example is the Pandemic Influenza Preparedness (PIP) framework, which mandates that 10% of global flu pandemic vaccine production supply goes to WHO for direct distribution, based upon public health needs. Another is WHO’s Global Action Plan for influenza vaccines. These “are meant to address equity issues in a number of epidemics, not necessarily pandemics,” Solomon said. “I would be very interested in reactions to particular frameworks meant to address inequities, like the pandemic influenza preparedness (PIP) framework, not legally binding. Or like the WHO Global Action Plan (GAP) for influenza vaccines, also not legally binding. “But both are interesting and potentially of important reference to pandemic preparedness and response. PIP basically says 10% of global pandemic vaccine production supply goes to WHO for distribution on the declaration of an influenza pandemic for distribution based on public health needs, and we have legally binding contracts for that 10%,” said Solomon. “Could that be a reference point for responding to future pandemics? “If so, would it be useful to put that in more of a legal framework because of weaknesses within that structure – particularly the idea of countries not allowing export for vaccines already under contract?” Solomon asked. Similarly, the Global Action Plan for influenza vaccines was a 10-year, non-binding arrangement that aimed to better distribute capacity for flu vaccine production, including among low- and middle-income member states, he pointed out, asking: “Could that also benefit, or not, from a normatively binding architecture?” The final research report will be launched by G2H2 on 24 November. –Elaine Ruth Fletcher contributed to the writing of this story. 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‘Zero Draft’ Report on WHO Reform Punts Pandemic Treaty Forward – Amidst Signals of US Warming to Initiative 28/10/2021 Elaine Ruth Fletcher Virtual World Health Assembly nerve center at WHO’s Geneva headquarters in May 2021, where member states agreed to explore a Pandemic Treaty to improve global health emergency response. A “Zero Draft” report by a WHO Working Group gives cautious endorsement to advancing negotiations over a new “Pandemic Treaty” among WHO’s 194 member states. That endorsement by the Working Group of member states remains couched in highly nuanced, diplomatic language that makes it clear how big the lift may be to actually negotiate a sharp, focused treaty over the most key issues that have slowed and sometimes paralyzed global pandemic response. Those issues range from a stronger mandate for WHO to enter countries and independently investigate outbreaks as they are unrolling on the ground – which has been a key issue for Europe and other high-income nations – to questions about vaccines and medicines access, which have become an overriding concern for low- and middle-income countries lacking sufficient supplies of basic tools to beat back COVID. However, the fact the document attempts to gives space to all of those issues is likely to prove reassuring to countries and civil society – that their diverse interests won’t be ignored. Significantly, a senior US diplomat, Colin McIff, is serving alongside Indonesia’s Grata Endah Werdaningtyas as the Co-Chair of “The Bureau” a group of six countries leading the Working Group discussions, which are open to all 194 WHA members. Others members of the leadership bureau include: Iraq, Botswana, Singapore and France. McIff’s leading role in the debates also signals a possible shift in the US position, whereby Washington may gradually get behind the treaty concept – after its initial scepticism, observers say. Colin McIff, Deputy Director of the US Office of Global Health, HHS has been a key leader in developing the Zero Draft. A paper published by US Secretary of State Anthony Blinken and US Secretary of Health And Human Services Xavier Beceerra last month in the US medical journal JAMA, had thrown cold water on the pandemic treaty concept that has galvanized Germany and other leading European Union countries, saying that it could “take years to accomplish.” They had argued for immediately strengthening the WHO’s International Health Regulations, which govern WHO member states’ responsibilities for detecting, reporting and responding to disease outbreaks that pose global health threats. World Health Assembly to consider way forward in November The World Health Assembly is set to consider a way forward on the pandemic treaty and other global health reforms in a special session scheduled for next month – as per a resolution that was adopted at the May 2021 WHA session. The WHA Working Group Zero Draft outlines three options for moving forward, including: reforms to existing International Health Regulations, internal reforms to the WHO, and a new Pandemic Treaty. One key conclusion, however, is that the existing IHR framework cannot be adapted to accommodate the raft of issues that the COVID pandemic has raised. And that, in and of itself, signals a growing consensus that a more sweeping and binding treaty arrangement may be necessary. “Repeatedly, Member States have returned to two key themes in the discussion: first, that the status quo is not acceptable to anyone and second, that the WGPR [Working Group on Strengthening WHo Preparedness and Response] must be willing to move forward in a flexible way that advances both of its linked mandates,” states a the Zero Draft executive summary. While acknowledging the “value in exploring the role of existing tools and mechanisms available to WHO for implementing relevant recommendations,” …. the Working Group “identified potential benefits of a new WHO convention, agreement or other international instrument for pandemic preparedness and response,” states the Zero Draft. ‘Off to a ‘really good start’ Some influential civil society activists have been wary about the treaty initiative – seeing it as a potential diversion from vaccine and medicines access issues, and specifically a proposed World Trade Organization waiver on intellectual property rights for COVID health products, upon which a number of key groups, such as Médecins Sans Frontières are overwhelmingly focused. Civil Society Activists Question Pandemic Treaty’s Ability to Address Global Health Inequalities But there are signs that those opinions are not entirely uniform. “We are happy with the zero draft; it identifies most of the issues that we think are important. You have attention to technology transfer, decentralization and manufacturing,” said Jamie Love of Knowledge Ecology International, in an interview with Health Policy Watch on Thursday. “I don’t know if it will go forward, but I think it’s really off to a good start.. “I think the WHO is the right place to have this conversation. And so far in the pre- meetings, I think the delegates have been talking about, and sensitive to issues about transparency. While describing the WTO negotiations over the IP waiver as immediately significant, Love suggested that a pandemic treaty could offer a more permanent, and legally-binding space, to attend to the long-term challenges around IP norms, medicines and vaccines pricing, as well as finance and legal frameworks for more publicly-supported R&D and decentralized manufacture of health products that would, in turn, foster more robust and versatile supply chains. “Affordability, access, pricing, technology transfer there is not a sort of handy place to go in the IHR framework,” Love said. US leadership of talks is significant 25 heads of government and international agencies have come together in support of the new pandemic treaty From both the two co-chairs, the US and Indonesia , the contributions have been “very positive,” Love added. And the US leadership role in the Zero draft formulation could also be a signal that Washington is warming to the treaty idea that it had initially opposed – much to the consternation of EU allies like Germany and European Council President Charles Michel, which have championed the Treaty along with about two dozen other countries – and WHO’s Director General Dr Tedros Adhanom Ghebreyesus. With @DrTedros we proposed an international #PandemicTreaty rooted in @WHO constitution. It would guarantee equity & inclusiveness. A legally binding instrument would be the most effective basis for prevention, surveillance, collection and exchange of scientific data.#WHS2021 pic.twitter.com/lbWkc3G5XE — Charles Michel (@eucopresident) October 25, 2021 “It’s very encouraging to us that Colin McIff has been so good in terms of the comments that he has been making and the direction that he has steered things,” said Love. “He’s a career negotiator and a popular guy. Everyone likes him, the drug companies like him, we like him. He’s a good listener.” Moreover, “Colin is widely respected in the US government. And so it does give us some hope that the US position on the pandemic treaty will change.” Love added that negotiations of a binding pandemic treaty now, ahead of another crisis, could help countries actually adhere to their commitments when a new global health threat actually emerges, as it inevitably will in an era of rapid climate change, ecosystem destruction, urbanization and international travel. “It’s better to make these decisions now, before people actually know who has the valuable assets [in terms of new medicines or vaccine candidates]. Ideally you can make commitments that make sense globally and locally because no one knows who is going to be the winners or the losers. “When there is no emergency people will talk a good game. But when the COVID emergency came along, one country after another peeled off from the solidarity talk. So looking for a more binding commitment actually makes it easier for countries to do the right thing when a pandemic hits.” Image Credits: EU Council. WHO Asks G-20 for $23.4 Billion to Fund COVID Vaccines, Tests & Treatments – and 550 Million Vaccine Doses Immediately! 28/10/2021 Elaine Ruth Fletcher The South Sudan Minster of Health, Elizabeth Chuei,received her first COVID-19 vaccine at Juba Teaching Hospital in mid-October as the country’s vaccine drive, interrupted in April with the halt of vaccine exports from India, restarts once more. Only 5 African countries currently are on track to meet a WHO 40% vaccination goal. Ahead of a critical G20 meeting this weekend, WHO and its partners are asking the world’s leading industrialized nations to come up with another US$ 23.4 billion over the course of the coming year to address stark shortages in COVID vaccines, tests and treatments remain dismally low in Africa and other parts of the developing world. The new strategy for the “Act Accelerator” initiative that is funding and distributing vaccines, tests and treatments to about 92 low- and middle-income nations, comes against the background of a continuing death toll of some 45,000 to 50,000 deaths a week, said WHO and other leaders of the Act-A in two separate press conferences Wednesday and Thursday. “While the world is now producing some 1.15 billion vaccine doses per month, vaccination coverage still ranges from 1 – 70%,” said Carl Bildt, WHO Special Envoy for the ACT-Accelerator, in a press briefing about the new ACT-A strategy on Wednesday, developed by the steering group of leading the consortium, which includes, WHO; UNICEF; the Global Fund; Gavi, The Vaccine Alliance; the Wellcome Trust, the Foundation for Innovative New Diagnostics (FIND), and the Oslo-based CEPI, which is funding vaccine R&D. Against that background, “the disease will continue in countries with very low vaccination coverage, and variants will continue to develop,” he said, adding that along with the constantly mounting death toll, “this is going to come back and affect everyone.” Today, WHO’s Africa office announced that just five out of Africa’s 54 WHO member states would meet the WHO goal to vaccinate 40% of its population by the end of 2021 (see related Health Policy Watch story). Message to G-20 – 550 million mor vaccine doses this year would allow 82 more countries to reach 40% vaccine coverage goal WHO data on vaccine inequalities around the world & FIND data on testing, as of 6 October, 2021 Speaking at a WHO press briefing on Thursday, WHO’s Dr Tedros Adhanom Ghebreyesus made a special appeal to G-20 nations to come through on promised vaccine donations – which so far have fallen far short of earlier commitments. He also called upon G-20 countries to support moves towards a Pandemic Treaty as well as the creation of a new “Global Health Threats Council”. “I have three requests for the G20 leaders,” said Tedros speaking at a press conference on Thursday, “First fully fund the Act Accelerator, second, support the creation of an overarching framework for global health security that that a legally binding treaty on pandemic preparedness and response, and thirdly, support the creation of a Global Health Threats Financing Board, supported by a financial intermediary fund, and hosted by the UN.” Dr Tedros’ remarks on a “Global Health Threats Financing Board” effectively combines two separate proposals that emerged from an Independent Panel report on pandemic preparedness and a more recent pan-European Commission on Pandemic Preparedness, which had suggested that a global board to more squarely address health finance issues could be useful. Added senior WHO Advisor, Bruce Aylward, “Some 82 countries are at risk of not reaching the 40% goals, only because a lack of vaccine supply. They can meet it [the goal] if the supply is there. They only need another 550 million doses through the COVAX initiative. So the big question to the G-20 is: are they going to say where those 550 million doses are going to come from? Because those 20 countries control the global vaccine supply between now and the end of this year, we are going to make about 3 billion doses of this vaccines. Can we take about ten days worth and see that it goes into COVAX. “This is a solvable problem, it is a question of political will and the manufacturers.. It’s a test of global solidarity.” Millions more deaths could be averted Jonas Gahr Store, Norway’s new prime minister Without global vaccine and treatments access, “We will not be able to achieve true economic and social recovery” added Norway’s new prime minister, Jonas Gahr Store, who made a guest appearance at the WHO briefing. Getting more vaccines to Africa and elsewhere could lead to “millions more deaths that could be averted” he said, referring to WHO estimate that reaching it’s vaccination coverage goals could save up to 5 million lives over the course of the next year. “As long as some people remain are exposed and vulnerable, we all are – in this globalized world,” Store added. Extreme shortage of COVID tests in LMICs is another hidden driver of the ongoing pandemic The extreme shortage of COVID tests in the same countries that lack vaccines, is one of the other, more hidden crises associated with the ongoing pandemic, pointed out Bill Rodriguez, CEO FIND at the Wednesday press briefing. “Roughly 3.5 billion tests for COVID-19 have been administered,” he said, “however less than 0.4% of tests have been performed in low income countries,” he pointed out. Among groups that aren’t vaccinated, it’s critical to roll our more tests in order to be able to rapidly target treatments to people that are infected – from vital oxygen supplies for the seriously ill to the first-ever COVID anti-viral pill, molnupiravir, that appears set to receive US Food and Drug Administration approval soon. Recent clinical trials have suggested that the drug reduces by 50% the risks of hospitalization and death among people who are mildly to moderately ill. And Merck, the developer of the treatment, has agreed to allow a generic version of the pill to be manufactured and distributed across most of the developing world. But in order to even administer such a treatment effectively, people have to be tested to determine if they are ill with COVID – or something else, noted Rodriguez. And that is just not happening today in low-income countries. “Testing is also critical to be able to do [genetic] sequencing to identify new variants,” he added, noting those variants threaten to bite back at already vaccinated high-income countries. To address the testing crisis, the new ACT strategy asks for some $7 billion more in funding for test kits – most of which would be invested in the procurement of rapid tests. “We want to try to reach a minimum target of administering one test per 1,000 people per day,” he said, referrring to the new ACT testing strategy. “To reach these targets we will need to test six times as many people as we have been doing in the past six months. And even if we do, we will still be testing at less than half the minimum rate as in high income countries.” Image Credits: UNICEF, WHO COVID dashboard & FIND Test Tracker . Only 5 African Countries On Track to Meet 40% Vaccine Coverage Goal by End 2021; Syringe Shortage is One of the Latest Obstacles 28/10/2021 Kerry Cullinan Only five African countries are likely to reach a WHO global goal of vaccinating 40% of their populations by the end of the year, and the continent’s roll-outs may be slowed further by a global shortage of the syringes need to administer vaccines. UNICEF has reported an imminent shortfall of up to 2.2 billion syringes for COVID-19 vaccination and routine immunization in the coming year, according to the World Health Organization’s (WHO) Africa region. This includes special 0.3ml syringes needed for the Pfizer-BioNTech COVID-19 doses, for which there is no global stockpile. “Early next year COVID-19 vaccines will start pouring into Africa, but a scarcity of syringes could paralyse progress,” WHO Africa Director Dr Matshidiso Moeti told a press briefing on Thursday. “Drastic measures must be taken to boost syringe production, fast. Countless African lives depend on it.” COVAX is trying to secure deals with syringe manufacturers, and through better planning to avoid deliveries outpacing the supply of syringes, the WHO reported. Only 6% of Africans – 77 million people – are fully vaccinated, while over 70% of high-income countries have already vaccinated more than 40% of their people. Three African countries – Seychelles, Mauritius and Morocco – have already vaccinated over 40% of their people, while only Tunisia and Cabo Verde are on track to reach this global WHO target by year-end. While COVAX has delivered around 50 million vaccines to Africa, the continent still faces a 275 million dose shortfall in order to vaccinate 40% of all Africans. Wave after wave Dr John Nkengasong, Director of the Africa Centers for Disease Control and Prevention (CDC), told an earlier media briefing that 82% of the continent had experienced a third wave of COVID, while seven countries had already had a fourth wave. “We are going to go from wave to wave unless we address the question of vaccinations,” said Nkengasong. While cases in most of Africa are going down, cases are rising in countries in the Central African countries of Gabon, Congo, Cameroon, as well as Egypt. COVID deaths in Nigeria increased by 66% and by 36% in Egypt, added Nkengasong. Meanwhile, the WHO urged countries to improve their vaccine roll-out readiness. Some 42% of countries have not yet completed district-level plans for their campaigns, while nearly 40% have not yet undertaken “intra-action reviews” which are key to refining and improving their vaccination campaigns,” according to the WHO The WHO is conducting emergency support missions to five African countries to help support, speed up and improve their COVID-19 vaccine rollouts, with plans for missions to another 10 countries this year. Image Credits: Wuestenigel/Flickr. Game-Changing COVID-19 Oral Treatment Set To Become Widely Accessible in Low- and Middle-Income Countries Upon Regulatory Approval 27/10/2021 Elaine Ruth Fletcher Merck laboratory that developed the new oral COVID treatment, molnupiravir A potentially game-changing antiviral treatment for COVID-19 that can be administered orally early on, and potentially head off much more serious cases, is set to be licensed for generic production in most low- and middle-income countries (LMICs), in an unprecedented breakthrough in access to a new COVID treatment. The historic deal, reached between the pharma company Merck Sharp & Dohme (Merck) and the Medicines Patent Pool paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell the treatment, molnupiravir at discounted prices to more than105 countries worldwide, once the drug has been approved by the US Food and Drug Administration and the World Health Organization. The agreement is the first time in the pandemic that a major pharma company has agreed to such an open-ended license for generic production of a newly developed drug. The drug, currently awaiting US FDA emergency review, reduced risks of hospitalization or death by about 50% among patients with mild or moderate COVID, according to the company reports of the results of its Phase III trial. The deal also represents a major coup for the Geneva-based MPP, a non-profit organization with a long track record of negotiating with big pharma innovators for broader generic production of costly new drugs for treating hepatitis, HIV, and other diseases. Until now, however, MPP had not been able to enter fully into the COVID medicines access fray – with pharma producers reluctant to negotiate with the non-profit over broad-based licenses for the generic production of COVID vaccines and drugs. Other new COVID drug treatments, such as the newly-approved monoclonal antibody cocktail REGEN-COV, remain expensive and hard to access in most LMICs. They are also more difficult to use – as they need to be administered intravenously. Charles Gore, MPP Executive Director, said of the breakthrough, “This transparent, public health-driven agreement is MPP’s first voluntary licence for a COVID-19 medical technology, and we hope that MSD’s agreement with MPP will be a strong encouragement to others.” The MPP is all the more meaningful as the new drug will be the first major COVID medication that can be administered orally to non-hospitalized patients, said WHO in a statement. ‘Best agreement any company has made’ The announcement was roundly hailed by WHO and other UN-affiliated agencies managing the UN-supported ACT-Accelerator initiative to broaden access to vaccines and drugs. A number of medicines access advocates who have bitterly criticized pharma for failing to issue more voluntary license deals for for other cutting edge vaccines and treatments, issued particularly warm statements about the Merck deal. Said Jamie Love, of Knowledge Ecology International, “The license between the MPP and Merck for the manufacture and sale of molnupiravir is the best agreement any company has made for licensing its intellectual property during the COVID-19 pandemic. “The 69-page license agreement is fully transparent, unlike the agreements with CEPI, COVAX, Operation Warp Speed, the Gates Foundation, the Wellcome Trust, other companies or most governments,” added Love referring to the other international and UN-supported initiatives on COVID drug and vaccine access. “The license makes it possible for any generic manufacture located anywhere the world to supply molnupiravir in the licensed territory, and provides a pathway for supplying to countries outside the licensed territory, when patents are not in place or subject to compulsory licenses. “The licensed area is large enough (more than half the world’s population) to induce efficient generic entry and economies of scale,” he added – while noting that the 18% population coverage in LAC is weakest – although a separate Merck deal with Brazil is reportedly underway. Concluded Love: “Given the objectives of scaling up production of molnupiravir at the lowest prices for the lowest income countries, the agreement is an impressive achievement for the Medicines Patent Pool and Merck deserves credit for being the first company to make a deal with the Medicines Patent Pool.” MSF calls out shortcomings of contract Even so, some civil society stakeholders, and notably Médecins Sans Frontières (MSF) said that the licensing arrangement “does not go far enough” expressing “disappointment with the limitations of this license, as its territory excludes nearly half of the world population and important upper-middle-income countries (UMICs) with robust manufacturing capacity, such as in Brazil and China.” Yuanqiong Hu, Senior Legal and Policy Advisor, MSF Access Campaign added that: “After more than a year of secrecy of companies’ bilateral deals in a pandemic, it is a welcomed step forward to have the first fully published voluntary license from MPP covering COVID19 medical tool. “However, a closer look reveals its limitations for increasing access to one of the first promising antiviral drugs for COVID-19. It’s disappointing…. Middle-income countries excluded from the license had 30 million COVID-19 infections in the first half of 2021, 50% of all infections in low- and middle-income countries. Medicines, Law and Policy, while generally positive, also called out a clause that would allow MPP terminate a sublicence agreement with a manufacturer of the new drug, in the case of a patent challenge – a clause reportedly included at the request of the drugs initial developers at DRIVE, a subsidiary of Emory University and Ridgeback Pharmaceuticals. Emory University has in fact waved royalties on the sale of the drug in low- and middle-income countries for as long as the WHO-declared international public health emergency continues. However the termination of sublicence clause also has provoked protests by students, who say that it could restrict or undermine the flexibility of the generic licensing agreement. Merith Basey, Executive Director for Universities Allied for Essential Medicines, a student-led movement that aims to change universities’ licensing practices told us: “Emory University has betrayed its mission to serve humanity by stifling global access to a potentially life-saving COVID treatment. Molnupiravir was developed on Emory’s campus with massive amounts of tax-payer funding, yet this license includes a stipulation demanding a no-patent challenge. We call on the institution to remove the clause and favor people over profit in the midst of a global pandemic that has killed over 5 million people so far.” Image Credits: Merck , Merck . Liver Cancer: Europe’s Public Health Ticking Time Bomb 27/10/2021 Thomas Berg & Maria Buti October is Liver Cancer Awareness month, and Europe has a liver cancer problem. Over the past two decades, there has been a 70% increase in liver cancer-related mortality in the region. In 2020, 87,000 Europeans were diagnosed with liver cancer while 78,000 died from the disease in the same year. Late diagnosis is a serious problem. About half of patients are only diagnosed in an advanced stage of cancer and have less than a year to live. Liver cancer is the sixth most common cancer and the third biggest cause of cancer-related deaths globally. In the US, the rate of deaths from liver cancer increased by 40% from 1990 to 2004 while the overall rate of non-liver cancer deaths declined by 18%. Projections for the US estimate that in 2030, liver cancer will be the third-leading cause of cancer-related deaths, surpassing breast, colorectal, and prostate cancers. There are many risk factors for developing liver cancer, and chronic liver diseases caused by viral hepatitis, alcohol, or fatty liver disease are the most important. Diabetes and obesity Non-alcohol fatty liver disease (NAFLD), which is often a consequence of obesity and diabetes, is the leading cause of death among 35 to 49-year-olds in the UK, making NAFLD a health threat that should not be underestimated. (The more severe form of NAFLD is called nonalcoholic steatohepatitis, or NASH). Outside of COVID-19, NAFLD is also about the fastest growing disease globally. It occurs in about one in four people around the world and has emerged as the most prominent cause of chronic liver disease. Experts predict that, over the next decade, NAFLD will become the leading cause of end-stage liver disease and liver transplantation. It is already the fastest-growing cause of hepatocellular carcinoma (HCC), the most common form of liver cancer worldwide. Faced with a ticking public health time bomb in Europe, we are clearly in a race against time to both prevent and treat this disease before the epidemic worsens and overwhelms health systems. Better treatment access Treatment of chronic liver diseases to avoid their progression to precancerous states like cirrhosis significantly reduces the risk of liver cancer, and this has been convincingly demonstrated. Improved and equal access to state-of-the-art management of these diseases is a core element in the fight against liver cancer. Although liver cancer remains one of the few cancers with increasing incidence and mortality, public awareness of liver cancer is much lower than for other cancers. As a consequence, patients who have liver cancer and patients who are at increased risk for liver cancer often face stigma in their social lives, and also in the medical settings. Treatment options for liver cancer have significantly improved over the recent years, which makes early diagnosis the most critical point. Case-finding strategies need to be implemented, at least in at-risk patients, as strongly recommended by clinical guidelines. Hepatitis B vaccinations Finally, we must directly tackle the key environmental factors that cause liver diseases and liver cancer. In addition, successful Hepatitis B vaccination programmes need to be continued and expanded as the core element of primary liver cancer prevention as it has the potential to prevent roughly twice as many cancer cases as HPV vaccination. Earlier this year the European Commission launched its Beating Cancer Plan in response to the fact that the EU region is home to a quarter of the world’s cancer cases and is facing an annual economic impact of €100 billion if urgent action is not taken. This plan is precisely what is needed to bring scientific societies, experts and patient groups together to move forward measures that can go a long way towards stopping liver cancer in its tracks. But these measures need to be coordinated across the region, led by the European Commission, and implemented by EU Member States. A starting point has to be the setting of standards for awareness, prevention, and management of liver cancer across the region. It is pivotal that we educate and raise awareness amongst everyone: healthcare professionals, patients and families, risk groups, policymakers and the general public. Liver cancer usually occurs as a consequence of underlying chronic liver disease and cirrhosis. Thus, the EU and Member States should implement preventive measures that include evidence-based strategies to reduce the burden of liver disease, focusing on reducing alcohol consumption and obesity, and on early detection and treatment of chronic liver disease. Early detection is critical for those patients with liver diseases associated with a high risk of liver cancer such viral hepatis B and C, alcohol-related and non-alcoholic fatty liver disease. The EU and Member States should add liver cancer to their screening list, at least for patients with underlying risk factors. In addition, existing programs providing the opportunity of early case finding of liver diseases should be leveraged where possible. The salivary screening for Hepatitis C using point of care testing is a good example and complements the WHO HCV program aiming at fighting HCC as well. Inter-disciplinary disease management But we also need improved access to better disease management for patients with liver cancer across all member states of the EU. This means a more structured pathway for the diagnosis and treatment of patients when they are receiving care in hospital, as an outpatient and then at home. That will require better inter-disciplinary cooperation between hepatology, oncology and other relevant disciplines and ideally collaborative clinical guidelines that are driven by comprehensive scientific evidence. Basic research continues to be a critical element for improving patient outcomes in liver cancer. There is still further knowledge needed about aetiology, rare liver cancer entities, markers and diagnostics which might facilitate early detection even in primary care. The EU and Member States should support such research projects and cross-country collaboration by setting up EU-wide platforms with the aim of sharing data and closing the gap between medical knowledge and clinical practice. The high standard of care in the EU is based on high-level science and research. In order to maintain these standards furthermore and drive improvements, it is essential to collect data collaboratively across all member states. The EU and Member States should support the setting up of specific patient registries for liver cancer. The collation of this data would facilitate surveillance, research and the overall management of patients with liver cancer. Care must be patient-centric. People living with liver cancer and their families should have unrestricted access to information, medical treatment, and measures to improve their quality of life, regardless of their life situation and ethnic origin. All patients with liver cancer should benefit from the same high standards of care wherever they are in Europe. Thomas Berg is the Secretary-General of the European Association for the Study of the Liver (EASL) and Head of the Division of Hepatology at Leipzig University Medical Center in Germany. Maria Buti is the EASL EU Policy Councillor and Professor of Medicine and Chief of Internal Medicine and Hepatology at the Hospital General Universitari Valle Hebron in Barcelona, Spain. US ‘Steps Aside’ to Give Africa Access to Moderna Vaccines 26/10/2021 Kerry Cullinan Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) The US government has enabled Africa to get access to 50 million Moderna COVID-19 vaccines by giving the continent its place in the vaccine queue, Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) said on Tuesday. “This is a time swap arrangement whereby the United States government basically stood aside for the next quarter so that we could access vaccines and purchase them ourselves,” Masiyiwa told a media briefing of the Africa Centers for Disease Control (CDC). AVAT will get 15 million Moderna doses in December and a further 35 million between January and March. It also has an option to buy 60 million more, delivered at 20 million doses per month, between April and June. “These doses are being purchased by AVAT courtesy of the United States government, which has been phenomenal in its support,” he added. South Africa’s President Cyril Ramaphosa and Kenya’s President Uhuru Kenyatta negotiated the deal directed with US President Joe Biden, said Masiyiwa. Other than a deal with Johnson and Johnson (J&J) for 400 million vaccines over 13 months from August, “none of the vaccine suppliers had any doses for us this year,” said Masiyiwa. The Africa Union has been able to get the J&J vaccines largely because they are being assembled by Aspen in South Africa – but even ensuring that these doses remained on the continent required reaching an agreement with the European Union, which initially planned to import the African-assembled vaccines. Jessye Lapenn, the US Ambassador to the African Union, praised AVAT’s leadership and expressed her country’s support for the continent’s vaccination efforts. The White House confirmed that it would defer the delivery of about 33 million Moderna vaccines to enable the African Union to buy the doses. Masiyiwa said the African Union’s long-term vision was for Moderna to reach a fit-and-fill agreement with an African manufacturer. The company recently announced that it wants to build a $500 million mRNA vaccine manufacturing facility in Africa. “We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe, said Moderna CEO Stéphane Bancel. Moderna said that it was “working on plans to allow it to fill doses of its COVID-19 vaccine in Africa as early as 2023, in parallel to building an mRNA vaccine manufacturing facility in Africa”. Moderna, which received millions of dollars in R&D support from the US government, has been under pressure from the Biden administration to supply low and middle income countries with vaccines. AVAT is currently supplying 39 African countries and 15 Caribbean countries, but only 8,7% of Africans have had at least one vaccine dose. Meanwhile, COVAX revealed on Monday that less than 10% of vaccine donations pledged to it by wealthy countries had been delivered. Of the 1.3 billion COVID-19 vaccine dose donations promised to COVAX by wealthy countries, only 150 million doses have actually arrived – around 9% – Gavi CEO Dr Seth Berkley told the World Health Summit. Joining the Africa CDC press briefing on Tuesday, Berkley said that COVAX had supplied 40% of Africa’s vaccine doses but the facility had experienced a major slowdown after India banned the export of AstraZeneca vaccines made it its country although COVAX had already paid for the vaccines. Debt Relief & National Economic Reforms Pitched as ‘Big Picture’ Global Health Solutions Ahead of G-20 Meeting 26/10/2021 Elaine Ruth Fletcher WHO Director General Dr Tedros Adhanom Ghebreyesus and Mariana Mazzucato, chair of the new WHO Council on the Economics of Health for All. An ambitious wish list of global economic and fiscal measures that the world should adopt to combat the COVID-19 pandemic has been floated by the World Health Organization- just ahead of a critical G-20 meeting of the world’s most industrialized nations this weekend. These include proposals for massive debt relief to debt-ridden countries and a re-direction of the IMF’s new offer of $US650 billion in “special drawing rights” away from richer nations to low- and middle-income countries. The laundry list of macroeconomic and fiscal measures proposed by the new WHO Council on the Economics of Health for All, was detailed today at one of the final sessions of the World Health Summit. Drafted by 10 top economists and health policy experts, Financing Health for All pushes the classic debates over access to medicines and health systems investments – into the realm of much broader fiscal and economic decisions that nations, both rich and poor need to make, according to the experts. That is, if they really want to beat down COVID-19 as well as prepare for the next pandemic. ‘Donor mentality’ is part of the problem WHO Director General, Dr Tedros Adhanom Ghebreyesus “It proposes a radical shift in economic thinking for global health,” said WHO Director General Dr Tedros Adhanom Ghebreyesus at the WHS session. He appeared with Mariana Mazzucato, Founding Director of the UCL Institute for Innovation and Public Purpose, and chair of the new health economics Council, which was launched by WHO in May 2021. “Instead of looking at health as a piece of the economy, it’s time to look at how the economy can support the societal goal of health for all,” said the WHO Director General. “Neither existing market mechanisms, with their focus on short term returns, nor development funds alone are enough,” he added. “They do not provide the global public goods on which we all depend, such as vaccines, nor do they address the major inequities, undermining equitable access. “The council is proposing bold, concrete actions for governments and multilateral organizations in three major areas, creating fiscal space, the direction of investment, and the governance of public and private financing for how this does not just mean more money. It means making the better, smarter and sustained investments that are needed to achieve health for all.” “We have to realize that this donor mentality is actually part of the problem,”said Mazzucato, “And that lots of the conditionalities that were set in the past on the loans provided to developing countries precisely made them weaker. The key priorities outlined by the brief, prepared by the ten-member expert group includes proposals that would leverage change from global to national level so as to: Create more “fiscal space” for countries to invest more in health, including through measures like international debt relief, a global corporate tax rate and a greater allocation to low-income countries of newly available IMF special drawing rights; Reshape national, tax, regulatory and investment rules to make them more favorable to health-related investments, e.g. in health systems and vaccine and medicines manufacture; Ensure stronger governance for private health markets – notably pharma innovators and manufacturers – using public regulations and investments to “crowd in and direct private finance towards improving health outcomes globally and equitably.” Other members of the Council include Vera Songwe, Executive Secetary of the Economic Commission for Africa; economists such as Jayata Ghosh, of the University of Massachusetts and Stephanie Kelton an expert on monetary policy at Stony Brook University; investment banker Vanessa Huang, and global health professionals such as Ilona Kickbusch, founding director of the Geneva Graduate Institute’s Global Health Centre; Senait Fissehea, of the University of Michigan; and planetary health expert Kate Raworth, of Oxford University’s Environmental Change Institute. More “quality money” – to fight the next pandemic Mariana Mazzucato, chair fo the new WHO Council on the Economics of Health for All Just “more money” is not enough to drive bigger investments in countries with poor-performing health systems, stressed Mazzucato, it needs to be “quality money” – money that does not translate into more crippling loan repayments once the initial phase of the pandemic crisis has passed. “Multilateral organizations should negotiate debt relief for low and middle income countries in such an important moment,…. redirecting [IMF] Special Drawing Rights towards investment in health, and especially vaccines,” she said. IMF special drawing rights are not considered as loans in the traditional sense of the word, but rather bolster countries’ reserves and thus their overall economic stability. “False constraints have been imposed on government’s fiscal spaces, often by multilateral institutions like the IMF and the World Bank.” Crippling debt restrictions and austerity measures traditionally have hit hardest on social welfare nets, including public health systems, meaning that low- and middle-income countries “weren’t allowed to create the kind of fiscal space that we highlight as the first key pillar,” she observed. “Over time, we have to be better prepared and that preparedness needs to be, in the long run, built on the ability to have a distributed manufacturing and industrial capacity [for health products] globally. “Because this will not be the last pandemic, you know. As the permafrost melts, apparently, there’s going to be all sorts of other viruses that come about. Climate change and this health crisis are really interlinked.” Along with debt relief the G-20 should advance credit rating reforms and “push for the enforcement of a minimum global corporate tax of at least 15%,” she added. National investment priorities Finance and health authorities need to work together more closely to expand local medicines and vaccine production and improve health systems. But as the brief underlines, the challenge is not only to reduce international pressures, through measures such as debt relief, but also to “change mindsets within countries that impose internal constraints on spending” – often in the name of false economies and fiscal prudence. That means a better understanding and alignment in Finance Ministries, of the importance of health priorities. “The bottom line is that countries must reverse the harmful effects of an austerity approach to public administration and public finance reforms,” said Mazzucato. She pointed to Kerala State, in India, as an example of a region that fared better because it focused investment into public health systems. “Internal constraints on government budgets are not insurmountable and governments actually have more room for increasing the fiscal limits on investments for health than they’re led to believe. “And it’s not just a matter of political choice, but also when a political will whether country can mobilize all the resources and levers that can to maximizing financing for health, such as innovative monetary policy, but also…, procurement policies using different levers – grants, loans, procurement to really catalyze new solutions…. “When we go to war, money is found, and during a health pandemic, money has been found, but that has been too little too late,” she observed. Public-Private sector should share ‘risks and rewards’ of innovation Finally, public-private sector relationships around critical issues such as vaccines and medicines innovation and manufacture need a reboot, the brief argues, sharing both the “risks and rewards” of innovation, in the words of Mazzucato – rather than leaving public entities to shoulder the risks while the private sector reaps most of the rewards. “We need public actors, we need philanthropies, but they need to work together in a different way,” she said. That means public contracts, loans, grants and other incentives that are offered to the private sector to develop new and more innovative vaccines, tests and treatments also need to come along with stronger conditions about how the final products they create may be used or distributed. “And this can be done by redesigning the terms and the conditions, structuring contracts, grants, transfers loans and partnerships between public and private actors. “Precisely because the public sector puts in so much of the money – especially in the early stage when it’s more risky and more capital intensive, and uncertain – these critical market-shaping public investments should ensure conditionalities around pricing – to make sure that we have access at the core -that we have vaccines that are globally accessible. Innovation – global, end-to-end and governed collectively In terms of intellectual property rights, she added that “it’s not about getting rid of patents, but we have to govern innovation and the patent system, with objectives in mind. “Making sure that patents are not too wide, too strong, hard to license upstream are core ways to govern the patent system. “It’s not about getting rid of patents, we have to govern innovation, and the patent system with objectives in mind,” she said. “More broadly, we need to shape a conducive regulatory tax, industrial and economic policy environment to ‘crowd in’ all sorts of different sources of finance at the same time, ensuring that we get the greatest multiplier effect, the greatest impact on health for all. Ultimately, however, she stressed that global health innovation platforms need to be “global, end-to-end, and governed collectively – shifting from a model where innovation is left to the market to a model aimed at delivering global common goods.” Image Credits: Marco Verch/Flickr. Civil Society Activists Question Pandemic Treaty’s Ability to Address Global Health Inequalities 26/10/2021 Kerry Cullinan A session of the 2020 World Health Assembly. Some civil society organisations (CSO) are sceptical about whether a ‘pandemic treaty’ is the best way to address future global health crises, while treaty supporters say it will provide a legal framework binding countries and global health bodies to more agile and rapid responses to future outbreaks. A session Monday sponsored by the Geneva Global Health Hub (G2H2) brought leading CSOs, diplomats, academics and even WHO’s chief legal counsel face to face to air those views, in the context of a research initiative on the treaty being undertaken by the hub. The debate comes just weeks ahead of a planned special session of the World Health Assembly which is to determine whether the global body will indeed move forward on a Treaty, as a key measure for improving pandemic response. The treaty initiative has been supported most visibly by European countries, led by European Commission President, Charles Michel, who in a separate session at the World Health Summit in Berlin that the treaty would guarantee “access to information, financing, vaccines and countermeasures. It would increase capacity and resilience – at all levels.” With @DrTedros we proposed an international #PandemicTreaty rooted in @WHO constitution. It would guarantee equity & inclusiveness. A legally binding instrument would be the most effective basis for prevention, surveillance, collection and exchange of scientific data.#WHS2021 pic.twitter.com/lbWkc3G5XE — Charles Michel (@eucopresident) October 25, 2021 Diversion or game changer? 25 heads of government and international agencies have come together in support of the new pandemic treaty Some of the civil society organisations that have expressed disquiet about the treaty proposal perceive it as a potential distraction or diversion by wealthy countries from the so-called TRIPS waiver proposal, currently under consideration by thee World Trade Organization. The proposal by South Africa and India for a broad-based intellectual property waiver on COVID vaccines and treatments, now being debated by the WTO’s TRIPS Council , is perceived by civil society as a game changer that would help open the doors to despearately needed COVID vaccine and medicines manufacturing in Africa and the global South. Many of the European countries that have been among the most staunch opponents of the TRIPS waiver are also key pandemic treaty supporters, noted journalist Priti Patnaik, who is researching stakeholders’ views on the pandemic treaty for G2H2 -giving rise to the CSO suspicions. And yet at the same time, some developing countries have supported a pandemic treaty because they believe it would “rein in the influence of non-state actors, including powerful foundations, and get some binding obligations to apply to industry to avoid vaccine inequities in the future,” she added. ‘Switch-and-bait’ tactic Unni Karunakara, senior fellow at Yale’s Global Health Justice Partnership, said that the major focus should be on deploying available tools and medicines to every corner of the world, rather than negotiations over a new treaty: “Shouldn’t global vaccination coverage be an overwhelming priority now?” he asked. “We do have frameworks and tools. They’re not perfect, but there are enough tools for us to overcome this crisis together,” said Karunakara, a former president of Medecins sans Frontieres. “What is lacking, however, is the political will to share essential resources and tools, even with all of the treaties in place.” His comments reflecting the cynicism of other civil society activists who see “a big overlap between the countries that are blocking the TRIPS waiver, and the countries that are supporting the pandemic treaty. “So there’s a perception of a ‘switch-and-bait’ tactic that reeks of bad faith,” he added. And while transparency measures – such as the mandatory sharing of genetic materials by countries where outbreaks are suspected – have been discussed as key treaty features, similar mandates for transparency or sharing of vaccines and medicines technologies have been fiercely opposed by the EU, he pointed out. “TRIPS waiver-blocking countries have made the case for voluntary actions by pharma to ensure access to essential COVID-19 medical tools, so they treat Big Pharma with kid gloves,” Karunakara observered. “Interestingly, they take a very different tone and approach to the global south in the treaty, insisting on enforceability in the sharing of information and materials with WHO and other governments to allow for independent verification.” “The assumption here is that global south is the problem, that diseases originated in poor country, and pose national security risks to rich countries.” If you are against the treaty – what is your multilateral alternative? Björn Kümmel, at the WHO Executive Board’s January 2021 meeting. Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver – or the kinds of hidden agendas that civil society groups fear. “I doubt that it’s, from a logical point of view, right to say that even though a country has it stands on the TRIPS waiver, you can’t tackle other equity issues,” he told the G2H2 session. “That’s one angle to look at, the TRIPS waiver, but there are many more angles to be looked at. So to say that that is the only magic bullet, I think that would be fully wrong, I wouldn’t limit it to this. “I think that equity goes far beyond, and certainly, if a treaty was negotiated, it’s quite clear that this [TRIPS waive] will be put on the table, and that all governments will have to look at the different interests that are on the table and negotiate them with an open outcome.” He noted that the treaty was first proposed formally by Chile, not the European Commission, and has the support of a wide array of countries, including South Africa, Kenya, and Tunisia, as well as Thailand and Indonesia. Anything better than ‘Chaos’ we see now Describing the current global health situation as “dysfunctional”, Kümmel asked the G2H2 session: “If you are against the treaty, tell us what is your multilateral alternative to it, to be realistically implemented, lets say in the next five years?” “What the countries who are proposing a treaty are trying to say is: anything is better, than compared to the chaos that we’re seeing currently. “Legal clarity is needed, and it will be …a painful exercise for many of us, and most likely a difficult one for many governments, including mine, most likely also others. But in the end, it’s this is multilateralism.” Uniquely in the global health landscape – and unlike environment, trade or finance – there is a dearth of global treaty instruments. In fact, among the dozens of international treaties in force today, the only two binding instruments in global health today are the IHR and and the Framework Convention on Tobacco Control (FCTC), he pointed out. Pandemic is a ‘window of opportunity’ for bigger changes In light of the outstanding questions, however, the working group of countries that are preparing for the WHA special session had devised a “three-step approach” to their deliberations on a way forward. They are considering in parallel: WHO internal reform measures; revisions in the existing International Health Regulations that currently govern global emergency response; and finally, the Pandemic Treaty alternative. In terms of WHO reform, the conclusion has been that such measures would “not be sufficient in order to overcome the next pandemic,” Kümmel said. Amendments to the International Health Regulations (IHR) also would take time to negotiate. And a key question here is: “would they be a game changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” So against the other options, “an international binding agreement is interesting,” he said. “And why are many colleagues pushing for this to happen now? Well, it’s the reality that after Ebola and past pandemics the global community was unable to implement the lessons learned,” he said. And if negotiations don’t begin now, in the heat of the ongoing crisis, they will never happen at all. “Many of the international independent panels have called for bold recommendations to be implemented,” Kümmel reminded the group. “One of them is the treaty. But many of those recommendations have never reached successful implementation, because the window of opportunity for real structural changes normally vanishes with the next crisis to come after the pandemic.” The treaty would also retain WHO’s centrality as the nerve center of the global health architecture – amidst a plethora of new health initiatives emerging in Europe and elsewhere: “There are a multitude of ideas and recommendations, and the treaty is a legal framework into which most of the other recommendations would fit,” he said, in reference to recent proposals such as one by the Pan European Commission on Health and Sustainable Development to create a new global health board under G-20 auspices. Others have talked about a new global health finance board in association with the World Bank and/or a new UN-level Global Health Threats Council, under the auspices of the UN General Assembly. So the Pandemic Treaty is “also a mechanism to provide WHO with legitimacy after this crisis,” he stressed. “Obviously there are voices out there who could see alternative approaches. However, I think the ones who are in favour of this treaty have clearly articulated that WHO is the right forum because its the truly multilateral forum for global health.” WHO precedents for equitable access to vaccines? Germany is not the only actor that sees the treaty as a means of keeping WHO as the world’s main global health meeting place. WHO’s Director General Dr Tedros Adhanom Ghebreyesus has himself come out in support for the pandemic treaty measure – breaking ranks with previous agency heads who usually remained aloof of controversial measures under consideration by member states. WHO is therefore keenly interested in how civil society groups may help lead or shape views on the treaty negotiations – and this interest was reflected in a cameo appearance at the G2H2 event by Stephen Solomon, WHO’s principal legal officer. Solomon said it was “really helpful” to understand some of the “scepticism” around the pandemic treaty initiatives. “Understanding the the concern about an agenda driven issue here is very important for the [WHO] Secretariat,” Solomon told the group. At the same time, beyond the immediate COVID crisis, other WHO emergency response frameworks already in place also could perhaps benefit from the stronger legal backpone that a pandemic treaty might provide, he pointed out. One example is the Pandemic Influenza Preparedness (PIP) framework, which mandates that 10% of global flu pandemic vaccine production supply goes to WHO for direct distribution, based upon public health needs. Another is WHO’s Global Action Plan for influenza vaccines. These “are meant to address equity issues in a number of epidemics, not necessarily pandemics,” Solomon said. “I would be very interested in reactions to particular frameworks meant to address inequities, like the pandemic influenza preparedness (PIP) framework, not legally binding. Or like the WHO Global Action Plan (GAP) for influenza vaccines, also not legally binding. “But both are interesting and potentially of important reference to pandemic preparedness and response. PIP basically says 10% of global pandemic vaccine production supply goes to WHO for distribution on the declaration of an influenza pandemic for distribution based on public health needs, and we have legally binding contracts for that 10%,” said Solomon. “Could that be a reference point for responding to future pandemics? “If so, would it be useful to put that in more of a legal framework because of weaknesses within that structure – particularly the idea of countries not allowing export for vaccines already under contract?” Solomon asked. Similarly, the Global Action Plan for influenza vaccines was a 10-year, non-binding arrangement that aimed to better distribute capacity for flu vaccine production, including among low- and middle-income member states, he pointed out, asking: “Could that also benefit, or not, from a normatively binding architecture?” The final research report will be launched by G2H2 on 24 November. –Elaine Ruth Fletcher contributed to the writing of this story. 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WHO Asks G-20 for $23.4 Billion to Fund COVID Vaccines, Tests & Treatments – and 550 Million Vaccine Doses Immediately! 28/10/2021 Elaine Ruth Fletcher The South Sudan Minster of Health, Elizabeth Chuei,received her first COVID-19 vaccine at Juba Teaching Hospital in mid-October as the country’s vaccine drive, interrupted in April with the halt of vaccine exports from India, restarts once more. Only 5 African countries currently are on track to meet a WHO 40% vaccination goal. Ahead of a critical G20 meeting this weekend, WHO and its partners are asking the world’s leading industrialized nations to come up with another US$ 23.4 billion over the course of the coming year to address stark shortages in COVID vaccines, tests and treatments remain dismally low in Africa and other parts of the developing world. The new strategy for the “Act Accelerator” initiative that is funding and distributing vaccines, tests and treatments to about 92 low- and middle-income nations, comes against the background of a continuing death toll of some 45,000 to 50,000 deaths a week, said WHO and other leaders of the Act-A in two separate press conferences Wednesday and Thursday. “While the world is now producing some 1.15 billion vaccine doses per month, vaccination coverage still ranges from 1 – 70%,” said Carl Bildt, WHO Special Envoy for the ACT-Accelerator, in a press briefing about the new ACT-A strategy on Wednesday, developed by the steering group of leading the consortium, which includes, WHO; UNICEF; the Global Fund; Gavi, The Vaccine Alliance; the Wellcome Trust, the Foundation for Innovative New Diagnostics (FIND), and the Oslo-based CEPI, which is funding vaccine R&D. Against that background, “the disease will continue in countries with very low vaccination coverage, and variants will continue to develop,” he said, adding that along with the constantly mounting death toll, “this is going to come back and affect everyone.” Today, WHO’s Africa office announced that just five out of Africa’s 54 WHO member states would meet the WHO goal to vaccinate 40% of its population by the end of 2021 (see related Health Policy Watch story). Message to G-20 – 550 million mor vaccine doses this year would allow 82 more countries to reach 40% vaccine coverage goal WHO data on vaccine inequalities around the world & FIND data on testing, as of 6 October, 2021 Speaking at a WHO press briefing on Thursday, WHO’s Dr Tedros Adhanom Ghebreyesus made a special appeal to G-20 nations to come through on promised vaccine donations – which so far have fallen far short of earlier commitments. He also called upon G-20 countries to support moves towards a Pandemic Treaty as well as the creation of a new “Global Health Threats Council”. “I have three requests for the G20 leaders,” said Tedros speaking at a press conference on Thursday, “First fully fund the Act Accelerator, second, support the creation of an overarching framework for global health security that that a legally binding treaty on pandemic preparedness and response, and thirdly, support the creation of a Global Health Threats Financing Board, supported by a financial intermediary fund, and hosted by the UN.” Dr Tedros’ remarks on a “Global Health Threats Financing Board” effectively combines two separate proposals that emerged from an Independent Panel report on pandemic preparedness and a more recent pan-European Commission on Pandemic Preparedness, which had suggested that a global board to more squarely address health finance issues could be useful. Added senior WHO Advisor, Bruce Aylward, “Some 82 countries are at risk of not reaching the 40% goals, only because a lack of vaccine supply. They can meet it [the goal] if the supply is there. They only need another 550 million doses through the COVAX initiative. So the big question to the G-20 is: are they going to say where those 550 million doses are going to come from? Because those 20 countries control the global vaccine supply between now and the end of this year, we are going to make about 3 billion doses of this vaccines. Can we take about ten days worth and see that it goes into COVAX. “This is a solvable problem, it is a question of political will and the manufacturers.. It’s a test of global solidarity.” Millions more deaths could be averted Jonas Gahr Store, Norway’s new prime minister Without global vaccine and treatments access, “We will not be able to achieve true economic and social recovery” added Norway’s new prime minister, Jonas Gahr Store, who made a guest appearance at the WHO briefing. Getting more vaccines to Africa and elsewhere could lead to “millions more deaths that could be averted” he said, referring to WHO estimate that reaching it’s vaccination coverage goals could save up to 5 million lives over the course of the next year. “As long as some people remain are exposed and vulnerable, we all are – in this globalized world,” Store added. Extreme shortage of COVID tests in LMICs is another hidden driver of the ongoing pandemic The extreme shortage of COVID tests in the same countries that lack vaccines, is one of the other, more hidden crises associated with the ongoing pandemic, pointed out Bill Rodriguez, CEO FIND at the Wednesday press briefing. “Roughly 3.5 billion tests for COVID-19 have been administered,” he said, “however less than 0.4% of tests have been performed in low income countries,” he pointed out. Among groups that aren’t vaccinated, it’s critical to roll our more tests in order to be able to rapidly target treatments to people that are infected – from vital oxygen supplies for the seriously ill to the first-ever COVID anti-viral pill, molnupiravir, that appears set to receive US Food and Drug Administration approval soon. Recent clinical trials have suggested that the drug reduces by 50% the risks of hospitalization and death among people who are mildly to moderately ill. And Merck, the developer of the treatment, has agreed to allow a generic version of the pill to be manufactured and distributed across most of the developing world. But in order to even administer such a treatment effectively, people have to be tested to determine if they are ill with COVID – or something else, noted Rodriguez. And that is just not happening today in low-income countries. “Testing is also critical to be able to do [genetic] sequencing to identify new variants,” he added, noting those variants threaten to bite back at already vaccinated high-income countries. To address the testing crisis, the new ACT strategy asks for some $7 billion more in funding for test kits – most of which would be invested in the procurement of rapid tests. “We want to try to reach a minimum target of administering one test per 1,000 people per day,” he said, referrring to the new ACT testing strategy. “To reach these targets we will need to test six times as many people as we have been doing in the past six months. And even if we do, we will still be testing at less than half the minimum rate as in high income countries.” Image Credits: UNICEF, WHO COVID dashboard & FIND Test Tracker . Only 5 African Countries On Track to Meet 40% Vaccine Coverage Goal by End 2021; Syringe Shortage is One of the Latest Obstacles 28/10/2021 Kerry Cullinan Only five African countries are likely to reach a WHO global goal of vaccinating 40% of their populations by the end of the year, and the continent’s roll-outs may be slowed further by a global shortage of the syringes need to administer vaccines. UNICEF has reported an imminent shortfall of up to 2.2 billion syringes for COVID-19 vaccination and routine immunization in the coming year, according to the World Health Organization’s (WHO) Africa region. This includes special 0.3ml syringes needed for the Pfizer-BioNTech COVID-19 doses, for which there is no global stockpile. “Early next year COVID-19 vaccines will start pouring into Africa, but a scarcity of syringes could paralyse progress,” WHO Africa Director Dr Matshidiso Moeti told a press briefing on Thursday. “Drastic measures must be taken to boost syringe production, fast. Countless African lives depend on it.” COVAX is trying to secure deals with syringe manufacturers, and through better planning to avoid deliveries outpacing the supply of syringes, the WHO reported. Only 6% of Africans – 77 million people – are fully vaccinated, while over 70% of high-income countries have already vaccinated more than 40% of their people. Three African countries – Seychelles, Mauritius and Morocco – have already vaccinated over 40% of their people, while only Tunisia and Cabo Verde are on track to reach this global WHO target by year-end. While COVAX has delivered around 50 million vaccines to Africa, the continent still faces a 275 million dose shortfall in order to vaccinate 40% of all Africans. Wave after wave Dr John Nkengasong, Director of the Africa Centers for Disease Control and Prevention (CDC), told an earlier media briefing that 82% of the continent had experienced a third wave of COVID, while seven countries had already had a fourth wave. “We are going to go from wave to wave unless we address the question of vaccinations,” said Nkengasong. While cases in most of Africa are going down, cases are rising in countries in the Central African countries of Gabon, Congo, Cameroon, as well as Egypt. COVID deaths in Nigeria increased by 66% and by 36% in Egypt, added Nkengasong. Meanwhile, the WHO urged countries to improve their vaccine roll-out readiness. Some 42% of countries have not yet completed district-level plans for their campaigns, while nearly 40% have not yet undertaken “intra-action reviews” which are key to refining and improving their vaccination campaigns,” according to the WHO The WHO is conducting emergency support missions to five African countries to help support, speed up and improve their COVID-19 vaccine rollouts, with plans for missions to another 10 countries this year. Image Credits: Wuestenigel/Flickr. Game-Changing COVID-19 Oral Treatment Set To Become Widely Accessible in Low- and Middle-Income Countries Upon Regulatory Approval 27/10/2021 Elaine Ruth Fletcher Merck laboratory that developed the new oral COVID treatment, molnupiravir A potentially game-changing antiviral treatment for COVID-19 that can be administered orally early on, and potentially head off much more serious cases, is set to be licensed for generic production in most low- and middle-income countries (LMICs), in an unprecedented breakthrough in access to a new COVID treatment. The historic deal, reached between the pharma company Merck Sharp & Dohme (Merck) and the Medicines Patent Pool paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell the treatment, molnupiravir at discounted prices to more than105 countries worldwide, once the drug has been approved by the US Food and Drug Administration and the World Health Organization. The agreement is the first time in the pandemic that a major pharma company has agreed to such an open-ended license for generic production of a newly developed drug. The drug, currently awaiting US FDA emergency review, reduced risks of hospitalization or death by about 50% among patients with mild or moderate COVID, according to the company reports of the results of its Phase III trial. The deal also represents a major coup for the Geneva-based MPP, a non-profit organization with a long track record of negotiating with big pharma innovators for broader generic production of costly new drugs for treating hepatitis, HIV, and other diseases. Until now, however, MPP had not been able to enter fully into the COVID medicines access fray – with pharma producers reluctant to negotiate with the non-profit over broad-based licenses for the generic production of COVID vaccines and drugs. Other new COVID drug treatments, such as the newly-approved monoclonal antibody cocktail REGEN-COV, remain expensive and hard to access in most LMICs. They are also more difficult to use – as they need to be administered intravenously. Charles Gore, MPP Executive Director, said of the breakthrough, “This transparent, public health-driven agreement is MPP’s first voluntary licence for a COVID-19 medical technology, and we hope that MSD’s agreement with MPP will be a strong encouragement to others.” The MPP is all the more meaningful as the new drug will be the first major COVID medication that can be administered orally to non-hospitalized patients, said WHO in a statement. ‘Best agreement any company has made’ The announcement was roundly hailed by WHO and other UN-affiliated agencies managing the UN-supported ACT-Accelerator initiative to broaden access to vaccines and drugs. A number of medicines access advocates who have bitterly criticized pharma for failing to issue more voluntary license deals for for other cutting edge vaccines and treatments, issued particularly warm statements about the Merck deal. Said Jamie Love, of Knowledge Ecology International, “The license between the MPP and Merck for the manufacture and sale of molnupiravir is the best agreement any company has made for licensing its intellectual property during the COVID-19 pandemic. “The 69-page license agreement is fully transparent, unlike the agreements with CEPI, COVAX, Operation Warp Speed, the Gates Foundation, the Wellcome Trust, other companies or most governments,” added Love referring to the other international and UN-supported initiatives on COVID drug and vaccine access. “The license makes it possible for any generic manufacture located anywhere the world to supply molnupiravir in the licensed territory, and provides a pathway for supplying to countries outside the licensed territory, when patents are not in place or subject to compulsory licenses. “The licensed area is large enough (more than half the world’s population) to induce efficient generic entry and economies of scale,” he added – while noting that the 18% population coverage in LAC is weakest – although a separate Merck deal with Brazil is reportedly underway. Concluded Love: “Given the objectives of scaling up production of molnupiravir at the lowest prices for the lowest income countries, the agreement is an impressive achievement for the Medicines Patent Pool and Merck deserves credit for being the first company to make a deal with the Medicines Patent Pool.” MSF calls out shortcomings of contract Even so, some civil society stakeholders, and notably Médecins Sans Frontières (MSF) said that the licensing arrangement “does not go far enough” expressing “disappointment with the limitations of this license, as its territory excludes nearly half of the world population and important upper-middle-income countries (UMICs) with robust manufacturing capacity, such as in Brazil and China.” Yuanqiong Hu, Senior Legal and Policy Advisor, MSF Access Campaign added that: “After more than a year of secrecy of companies’ bilateral deals in a pandemic, it is a welcomed step forward to have the first fully published voluntary license from MPP covering COVID19 medical tool. “However, a closer look reveals its limitations for increasing access to one of the first promising antiviral drugs for COVID-19. It’s disappointing…. Middle-income countries excluded from the license had 30 million COVID-19 infections in the first half of 2021, 50% of all infections in low- and middle-income countries. Medicines, Law and Policy, while generally positive, also called out a clause that would allow MPP terminate a sublicence agreement with a manufacturer of the new drug, in the case of a patent challenge – a clause reportedly included at the request of the drugs initial developers at DRIVE, a subsidiary of Emory University and Ridgeback Pharmaceuticals. Emory University has in fact waved royalties on the sale of the drug in low- and middle-income countries for as long as the WHO-declared international public health emergency continues. However the termination of sublicence clause also has provoked protests by students, who say that it could restrict or undermine the flexibility of the generic licensing agreement. Merith Basey, Executive Director for Universities Allied for Essential Medicines, a student-led movement that aims to change universities’ licensing practices told us: “Emory University has betrayed its mission to serve humanity by stifling global access to a potentially life-saving COVID treatment. Molnupiravir was developed on Emory’s campus with massive amounts of tax-payer funding, yet this license includes a stipulation demanding a no-patent challenge. We call on the institution to remove the clause and favor people over profit in the midst of a global pandemic that has killed over 5 million people so far.” Image Credits: Merck , Merck . Liver Cancer: Europe’s Public Health Ticking Time Bomb 27/10/2021 Thomas Berg & Maria Buti October is Liver Cancer Awareness month, and Europe has a liver cancer problem. Over the past two decades, there has been a 70% increase in liver cancer-related mortality in the region. In 2020, 87,000 Europeans were diagnosed with liver cancer while 78,000 died from the disease in the same year. Late diagnosis is a serious problem. About half of patients are only diagnosed in an advanced stage of cancer and have less than a year to live. Liver cancer is the sixth most common cancer and the third biggest cause of cancer-related deaths globally. In the US, the rate of deaths from liver cancer increased by 40% from 1990 to 2004 while the overall rate of non-liver cancer deaths declined by 18%. Projections for the US estimate that in 2030, liver cancer will be the third-leading cause of cancer-related deaths, surpassing breast, colorectal, and prostate cancers. There are many risk factors for developing liver cancer, and chronic liver diseases caused by viral hepatitis, alcohol, or fatty liver disease are the most important. Diabetes and obesity Non-alcohol fatty liver disease (NAFLD), which is often a consequence of obesity and diabetes, is the leading cause of death among 35 to 49-year-olds in the UK, making NAFLD a health threat that should not be underestimated. (The more severe form of NAFLD is called nonalcoholic steatohepatitis, or NASH). Outside of COVID-19, NAFLD is also about the fastest growing disease globally. It occurs in about one in four people around the world and has emerged as the most prominent cause of chronic liver disease. Experts predict that, over the next decade, NAFLD will become the leading cause of end-stage liver disease and liver transplantation. It is already the fastest-growing cause of hepatocellular carcinoma (HCC), the most common form of liver cancer worldwide. Faced with a ticking public health time bomb in Europe, we are clearly in a race against time to both prevent and treat this disease before the epidemic worsens and overwhelms health systems. Better treatment access Treatment of chronic liver diseases to avoid their progression to precancerous states like cirrhosis significantly reduces the risk of liver cancer, and this has been convincingly demonstrated. Improved and equal access to state-of-the-art management of these diseases is a core element in the fight against liver cancer. Although liver cancer remains one of the few cancers with increasing incidence and mortality, public awareness of liver cancer is much lower than for other cancers. As a consequence, patients who have liver cancer and patients who are at increased risk for liver cancer often face stigma in their social lives, and also in the medical settings. Treatment options for liver cancer have significantly improved over the recent years, which makes early diagnosis the most critical point. Case-finding strategies need to be implemented, at least in at-risk patients, as strongly recommended by clinical guidelines. Hepatitis B vaccinations Finally, we must directly tackle the key environmental factors that cause liver diseases and liver cancer. In addition, successful Hepatitis B vaccination programmes need to be continued and expanded as the core element of primary liver cancer prevention as it has the potential to prevent roughly twice as many cancer cases as HPV vaccination. Earlier this year the European Commission launched its Beating Cancer Plan in response to the fact that the EU region is home to a quarter of the world’s cancer cases and is facing an annual economic impact of €100 billion if urgent action is not taken. This plan is precisely what is needed to bring scientific societies, experts and patient groups together to move forward measures that can go a long way towards stopping liver cancer in its tracks. But these measures need to be coordinated across the region, led by the European Commission, and implemented by EU Member States. A starting point has to be the setting of standards for awareness, prevention, and management of liver cancer across the region. It is pivotal that we educate and raise awareness amongst everyone: healthcare professionals, patients and families, risk groups, policymakers and the general public. Liver cancer usually occurs as a consequence of underlying chronic liver disease and cirrhosis. Thus, the EU and Member States should implement preventive measures that include evidence-based strategies to reduce the burden of liver disease, focusing on reducing alcohol consumption and obesity, and on early detection and treatment of chronic liver disease. Early detection is critical for those patients with liver diseases associated with a high risk of liver cancer such viral hepatis B and C, alcohol-related and non-alcoholic fatty liver disease. The EU and Member States should add liver cancer to their screening list, at least for patients with underlying risk factors. In addition, existing programs providing the opportunity of early case finding of liver diseases should be leveraged where possible. The salivary screening for Hepatitis C using point of care testing is a good example and complements the WHO HCV program aiming at fighting HCC as well. Inter-disciplinary disease management But we also need improved access to better disease management for patients with liver cancer across all member states of the EU. This means a more structured pathway for the diagnosis and treatment of patients when they are receiving care in hospital, as an outpatient and then at home. That will require better inter-disciplinary cooperation between hepatology, oncology and other relevant disciplines and ideally collaborative clinical guidelines that are driven by comprehensive scientific evidence. Basic research continues to be a critical element for improving patient outcomes in liver cancer. There is still further knowledge needed about aetiology, rare liver cancer entities, markers and diagnostics which might facilitate early detection even in primary care. The EU and Member States should support such research projects and cross-country collaboration by setting up EU-wide platforms with the aim of sharing data and closing the gap between medical knowledge and clinical practice. The high standard of care in the EU is based on high-level science and research. In order to maintain these standards furthermore and drive improvements, it is essential to collect data collaboratively across all member states. The EU and Member States should support the setting up of specific patient registries for liver cancer. The collation of this data would facilitate surveillance, research and the overall management of patients with liver cancer. Care must be patient-centric. People living with liver cancer and their families should have unrestricted access to information, medical treatment, and measures to improve their quality of life, regardless of their life situation and ethnic origin. All patients with liver cancer should benefit from the same high standards of care wherever they are in Europe. Thomas Berg is the Secretary-General of the European Association for the Study of the Liver (EASL) and Head of the Division of Hepatology at Leipzig University Medical Center in Germany. Maria Buti is the EASL EU Policy Councillor and Professor of Medicine and Chief of Internal Medicine and Hepatology at the Hospital General Universitari Valle Hebron in Barcelona, Spain. US ‘Steps Aside’ to Give Africa Access to Moderna Vaccines 26/10/2021 Kerry Cullinan Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) The US government has enabled Africa to get access to 50 million Moderna COVID-19 vaccines by giving the continent its place in the vaccine queue, Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) said on Tuesday. “This is a time swap arrangement whereby the United States government basically stood aside for the next quarter so that we could access vaccines and purchase them ourselves,” Masiyiwa told a media briefing of the Africa Centers for Disease Control (CDC). AVAT will get 15 million Moderna doses in December and a further 35 million between January and March. It also has an option to buy 60 million more, delivered at 20 million doses per month, between April and June. “These doses are being purchased by AVAT courtesy of the United States government, which has been phenomenal in its support,” he added. South Africa’s President Cyril Ramaphosa and Kenya’s President Uhuru Kenyatta negotiated the deal directed with US President Joe Biden, said Masiyiwa. Other than a deal with Johnson and Johnson (J&J) for 400 million vaccines over 13 months from August, “none of the vaccine suppliers had any doses for us this year,” said Masiyiwa. The Africa Union has been able to get the J&J vaccines largely because they are being assembled by Aspen in South Africa – but even ensuring that these doses remained on the continent required reaching an agreement with the European Union, which initially planned to import the African-assembled vaccines. Jessye Lapenn, the US Ambassador to the African Union, praised AVAT’s leadership and expressed her country’s support for the continent’s vaccination efforts. The White House confirmed that it would defer the delivery of about 33 million Moderna vaccines to enable the African Union to buy the doses. Masiyiwa said the African Union’s long-term vision was for Moderna to reach a fit-and-fill agreement with an African manufacturer. The company recently announced that it wants to build a $500 million mRNA vaccine manufacturing facility in Africa. “We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe, said Moderna CEO Stéphane Bancel. Moderna said that it was “working on plans to allow it to fill doses of its COVID-19 vaccine in Africa as early as 2023, in parallel to building an mRNA vaccine manufacturing facility in Africa”. Moderna, which received millions of dollars in R&D support from the US government, has been under pressure from the Biden administration to supply low and middle income countries with vaccines. AVAT is currently supplying 39 African countries and 15 Caribbean countries, but only 8,7% of Africans have had at least one vaccine dose. Meanwhile, COVAX revealed on Monday that less than 10% of vaccine donations pledged to it by wealthy countries had been delivered. Of the 1.3 billion COVID-19 vaccine dose donations promised to COVAX by wealthy countries, only 150 million doses have actually arrived – around 9% – Gavi CEO Dr Seth Berkley told the World Health Summit. Joining the Africa CDC press briefing on Tuesday, Berkley said that COVAX had supplied 40% of Africa’s vaccine doses but the facility had experienced a major slowdown after India banned the export of AstraZeneca vaccines made it its country although COVAX had already paid for the vaccines. Debt Relief & National Economic Reforms Pitched as ‘Big Picture’ Global Health Solutions Ahead of G-20 Meeting 26/10/2021 Elaine Ruth Fletcher WHO Director General Dr Tedros Adhanom Ghebreyesus and Mariana Mazzucato, chair of the new WHO Council on the Economics of Health for All. An ambitious wish list of global economic and fiscal measures that the world should adopt to combat the COVID-19 pandemic has been floated by the World Health Organization- just ahead of a critical G-20 meeting of the world’s most industrialized nations this weekend. These include proposals for massive debt relief to debt-ridden countries and a re-direction of the IMF’s new offer of $US650 billion in “special drawing rights” away from richer nations to low- and middle-income countries. The laundry list of macroeconomic and fiscal measures proposed by the new WHO Council on the Economics of Health for All, was detailed today at one of the final sessions of the World Health Summit. Drafted by 10 top economists and health policy experts, Financing Health for All pushes the classic debates over access to medicines and health systems investments – into the realm of much broader fiscal and economic decisions that nations, both rich and poor need to make, according to the experts. That is, if they really want to beat down COVID-19 as well as prepare for the next pandemic. ‘Donor mentality’ is part of the problem WHO Director General, Dr Tedros Adhanom Ghebreyesus “It proposes a radical shift in economic thinking for global health,” said WHO Director General Dr Tedros Adhanom Ghebreyesus at the WHS session. He appeared with Mariana Mazzucato, Founding Director of the UCL Institute for Innovation and Public Purpose, and chair of the new health economics Council, which was launched by WHO in May 2021. “Instead of looking at health as a piece of the economy, it’s time to look at how the economy can support the societal goal of health for all,” said the WHO Director General. “Neither existing market mechanisms, with their focus on short term returns, nor development funds alone are enough,” he added. “They do not provide the global public goods on which we all depend, such as vaccines, nor do they address the major inequities, undermining equitable access. “The council is proposing bold, concrete actions for governments and multilateral organizations in three major areas, creating fiscal space, the direction of investment, and the governance of public and private financing for how this does not just mean more money. It means making the better, smarter and sustained investments that are needed to achieve health for all.” “We have to realize that this donor mentality is actually part of the problem,”said Mazzucato, “And that lots of the conditionalities that were set in the past on the loans provided to developing countries precisely made them weaker. The key priorities outlined by the brief, prepared by the ten-member expert group includes proposals that would leverage change from global to national level so as to: Create more “fiscal space” for countries to invest more in health, including through measures like international debt relief, a global corporate tax rate and a greater allocation to low-income countries of newly available IMF special drawing rights; Reshape national, tax, regulatory and investment rules to make them more favorable to health-related investments, e.g. in health systems and vaccine and medicines manufacture; Ensure stronger governance for private health markets – notably pharma innovators and manufacturers – using public regulations and investments to “crowd in and direct private finance towards improving health outcomes globally and equitably.” Other members of the Council include Vera Songwe, Executive Secetary of the Economic Commission for Africa; economists such as Jayata Ghosh, of the University of Massachusetts and Stephanie Kelton an expert on monetary policy at Stony Brook University; investment banker Vanessa Huang, and global health professionals such as Ilona Kickbusch, founding director of the Geneva Graduate Institute’s Global Health Centre; Senait Fissehea, of the University of Michigan; and planetary health expert Kate Raworth, of Oxford University’s Environmental Change Institute. More “quality money” – to fight the next pandemic Mariana Mazzucato, chair fo the new WHO Council on the Economics of Health for All Just “more money” is not enough to drive bigger investments in countries with poor-performing health systems, stressed Mazzucato, it needs to be “quality money” – money that does not translate into more crippling loan repayments once the initial phase of the pandemic crisis has passed. “Multilateral organizations should negotiate debt relief for low and middle income countries in such an important moment,…. redirecting [IMF] Special Drawing Rights towards investment in health, and especially vaccines,” she said. IMF special drawing rights are not considered as loans in the traditional sense of the word, but rather bolster countries’ reserves and thus their overall economic stability. “False constraints have been imposed on government’s fiscal spaces, often by multilateral institutions like the IMF and the World Bank.” Crippling debt restrictions and austerity measures traditionally have hit hardest on social welfare nets, including public health systems, meaning that low- and middle-income countries “weren’t allowed to create the kind of fiscal space that we highlight as the first key pillar,” she observed. “Over time, we have to be better prepared and that preparedness needs to be, in the long run, built on the ability to have a distributed manufacturing and industrial capacity [for health products] globally. “Because this will not be the last pandemic, you know. As the permafrost melts, apparently, there’s going to be all sorts of other viruses that come about. Climate change and this health crisis are really interlinked.” Along with debt relief the G-20 should advance credit rating reforms and “push for the enforcement of a minimum global corporate tax of at least 15%,” she added. National investment priorities Finance and health authorities need to work together more closely to expand local medicines and vaccine production and improve health systems. But as the brief underlines, the challenge is not only to reduce international pressures, through measures such as debt relief, but also to “change mindsets within countries that impose internal constraints on spending” – often in the name of false economies and fiscal prudence. That means a better understanding and alignment in Finance Ministries, of the importance of health priorities. “The bottom line is that countries must reverse the harmful effects of an austerity approach to public administration and public finance reforms,” said Mazzucato. She pointed to Kerala State, in India, as an example of a region that fared better because it focused investment into public health systems. “Internal constraints on government budgets are not insurmountable and governments actually have more room for increasing the fiscal limits on investments for health than they’re led to believe. “And it’s not just a matter of political choice, but also when a political will whether country can mobilize all the resources and levers that can to maximizing financing for health, such as innovative monetary policy, but also…, procurement policies using different levers – grants, loans, procurement to really catalyze new solutions…. “When we go to war, money is found, and during a health pandemic, money has been found, but that has been too little too late,” she observed. Public-Private sector should share ‘risks and rewards’ of innovation Finally, public-private sector relationships around critical issues such as vaccines and medicines innovation and manufacture need a reboot, the brief argues, sharing both the “risks and rewards” of innovation, in the words of Mazzucato – rather than leaving public entities to shoulder the risks while the private sector reaps most of the rewards. “We need public actors, we need philanthropies, but they need to work together in a different way,” she said. That means public contracts, loans, grants and other incentives that are offered to the private sector to develop new and more innovative vaccines, tests and treatments also need to come along with stronger conditions about how the final products they create may be used or distributed. “And this can be done by redesigning the terms and the conditions, structuring contracts, grants, transfers loans and partnerships between public and private actors. “Precisely because the public sector puts in so much of the money – especially in the early stage when it’s more risky and more capital intensive, and uncertain – these critical market-shaping public investments should ensure conditionalities around pricing – to make sure that we have access at the core -that we have vaccines that are globally accessible. Innovation – global, end-to-end and governed collectively In terms of intellectual property rights, she added that “it’s not about getting rid of patents, but we have to govern innovation and the patent system, with objectives in mind. “Making sure that patents are not too wide, too strong, hard to license upstream are core ways to govern the patent system. “It’s not about getting rid of patents, we have to govern innovation, and the patent system with objectives in mind,” she said. “More broadly, we need to shape a conducive regulatory tax, industrial and economic policy environment to ‘crowd in’ all sorts of different sources of finance at the same time, ensuring that we get the greatest multiplier effect, the greatest impact on health for all. Ultimately, however, she stressed that global health innovation platforms need to be “global, end-to-end, and governed collectively – shifting from a model where innovation is left to the market to a model aimed at delivering global common goods.” Image Credits: Marco Verch/Flickr. Civil Society Activists Question Pandemic Treaty’s Ability to Address Global Health Inequalities 26/10/2021 Kerry Cullinan A session of the 2020 World Health Assembly. Some civil society organisations (CSO) are sceptical about whether a ‘pandemic treaty’ is the best way to address future global health crises, while treaty supporters say it will provide a legal framework binding countries and global health bodies to more agile and rapid responses to future outbreaks. A session Monday sponsored by the Geneva Global Health Hub (G2H2) brought leading CSOs, diplomats, academics and even WHO’s chief legal counsel face to face to air those views, in the context of a research initiative on the treaty being undertaken by the hub. The debate comes just weeks ahead of a planned special session of the World Health Assembly which is to determine whether the global body will indeed move forward on a Treaty, as a key measure for improving pandemic response. The treaty initiative has been supported most visibly by European countries, led by European Commission President, Charles Michel, who in a separate session at the World Health Summit in Berlin that the treaty would guarantee “access to information, financing, vaccines and countermeasures. It would increase capacity and resilience – at all levels.” With @DrTedros we proposed an international #PandemicTreaty rooted in @WHO constitution. It would guarantee equity & inclusiveness. A legally binding instrument would be the most effective basis for prevention, surveillance, collection and exchange of scientific data.#WHS2021 pic.twitter.com/lbWkc3G5XE — Charles Michel (@eucopresident) October 25, 2021 Diversion or game changer? 25 heads of government and international agencies have come together in support of the new pandemic treaty Some of the civil society organisations that have expressed disquiet about the treaty proposal perceive it as a potential distraction or diversion by wealthy countries from the so-called TRIPS waiver proposal, currently under consideration by thee World Trade Organization. The proposal by South Africa and India for a broad-based intellectual property waiver on COVID vaccines and treatments, now being debated by the WTO’s TRIPS Council , is perceived by civil society as a game changer that would help open the doors to despearately needed COVID vaccine and medicines manufacturing in Africa and the global South. Many of the European countries that have been among the most staunch opponents of the TRIPS waiver are also key pandemic treaty supporters, noted journalist Priti Patnaik, who is researching stakeholders’ views on the pandemic treaty for G2H2 -giving rise to the CSO suspicions. And yet at the same time, some developing countries have supported a pandemic treaty because they believe it would “rein in the influence of non-state actors, including powerful foundations, and get some binding obligations to apply to industry to avoid vaccine inequities in the future,” she added. ‘Switch-and-bait’ tactic Unni Karunakara, senior fellow at Yale’s Global Health Justice Partnership, said that the major focus should be on deploying available tools and medicines to every corner of the world, rather than negotiations over a new treaty: “Shouldn’t global vaccination coverage be an overwhelming priority now?” he asked. “We do have frameworks and tools. They’re not perfect, but there are enough tools for us to overcome this crisis together,” said Karunakara, a former president of Medecins sans Frontieres. “What is lacking, however, is the political will to share essential resources and tools, even with all of the treaties in place.” His comments reflecting the cynicism of other civil society activists who see “a big overlap between the countries that are blocking the TRIPS waiver, and the countries that are supporting the pandemic treaty. “So there’s a perception of a ‘switch-and-bait’ tactic that reeks of bad faith,” he added. And while transparency measures – such as the mandatory sharing of genetic materials by countries where outbreaks are suspected – have been discussed as key treaty features, similar mandates for transparency or sharing of vaccines and medicines technologies have been fiercely opposed by the EU, he pointed out. “TRIPS waiver-blocking countries have made the case for voluntary actions by pharma to ensure access to essential COVID-19 medical tools, so they treat Big Pharma with kid gloves,” Karunakara observered. “Interestingly, they take a very different tone and approach to the global south in the treaty, insisting on enforceability in the sharing of information and materials with WHO and other governments to allow for independent verification.” “The assumption here is that global south is the problem, that diseases originated in poor country, and pose national security risks to rich countries.” If you are against the treaty – what is your multilateral alternative? Björn Kümmel, at the WHO Executive Board’s January 2021 meeting. Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver – or the kinds of hidden agendas that civil society groups fear. “I doubt that it’s, from a logical point of view, right to say that even though a country has it stands on the TRIPS waiver, you can’t tackle other equity issues,” he told the G2H2 session. “That’s one angle to look at, the TRIPS waiver, but there are many more angles to be looked at. So to say that that is the only magic bullet, I think that would be fully wrong, I wouldn’t limit it to this. “I think that equity goes far beyond, and certainly, if a treaty was negotiated, it’s quite clear that this [TRIPS waive] will be put on the table, and that all governments will have to look at the different interests that are on the table and negotiate them with an open outcome.” He noted that the treaty was first proposed formally by Chile, not the European Commission, and has the support of a wide array of countries, including South Africa, Kenya, and Tunisia, as well as Thailand and Indonesia. Anything better than ‘Chaos’ we see now Describing the current global health situation as “dysfunctional”, Kümmel asked the G2H2 session: “If you are against the treaty, tell us what is your multilateral alternative to it, to be realistically implemented, lets say in the next five years?” “What the countries who are proposing a treaty are trying to say is: anything is better, than compared to the chaos that we’re seeing currently. “Legal clarity is needed, and it will be …a painful exercise for many of us, and most likely a difficult one for many governments, including mine, most likely also others. But in the end, it’s this is multilateralism.” Uniquely in the global health landscape – and unlike environment, trade or finance – there is a dearth of global treaty instruments. In fact, among the dozens of international treaties in force today, the only two binding instruments in global health today are the IHR and and the Framework Convention on Tobacco Control (FCTC), he pointed out. Pandemic is a ‘window of opportunity’ for bigger changes In light of the outstanding questions, however, the working group of countries that are preparing for the WHA special session had devised a “three-step approach” to their deliberations on a way forward. They are considering in parallel: WHO internal reform measures; revisions in the existing International Health Regulations that currently govern global emergency response; and finally, the Pandemic Treaty alternative. In terms of WHO reform, the conclusion has been that such measures would “not be sufficient in order to overcome the next pandemic,” Kümmel said. Amendments to the International Health Regulations (IHR) also would take time to negotiate. And a key question here is: “would they be a game changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” So against the other options, “an international binding agreement is interesting,” he said. “And why are many colleagues pushing for this to happen now? Well, it’s the reality that after Ebola and past pandemics the global community was unable to implement the lessons learned,” he said. And if negotiations don’t begin now, in the heat of the ongoing crisis, they will never happen at all. “Many of the international independent panels have called for bold recommendations to be implemented,” Kümmel reminded the group. “One of them is the treaty. But many of those recommendations have never reached successful implementation, because the window of opportunity for real structural changes normally vanishes with the next crisis to come after the pandemic.” The treaty would also retain WHO’s centrality as the nerve center of the global health architecture – amidst a plethora of new health initiatives emerging in Europe and elsewhere: “There are a multitude of ideas and recommendations, and the treaty is a legal framework into which most of the other recommendations would fit,” he said, in reference to recent proposals such as one by the Pan European Commission on Health and Sustainable Development to create a new global health board under G-20 auspices. Others have talked about a new global health finance board in association with the World Bank and/or a new UN-level Global Health Threats Council, under the auspices of the UN General Assembly. So the Pandemic Treaty is “also a mechanism to provide WHO with legitimacy after this crisis,” he stressed. “Obviously there are voices out there who could see alternative approaches. However, I think the ones who are in favour of this treaty have clearly articulated that WHO is the right forum because its the truly multilateral forum for global health.” WHO precedents for equitable access to vaccines? Germany is not the only actor that sees the treaty as a means of keeping WHO as the world’s main global health meeting place. WHO’s Director General Dr Tedros Adhanom Ghebreyesus has himself come out in support for the pandemic treaty measure – breaking ranks with previous agency heads who usually remained aloof of controversial measures under consideration by member states. WHO is therefore keenly interested in how civil society groups may help lead or shape views on the treaty negotiations – and this interest was reflected in a cameo appearance at the G2H2 event by Stephen Solomon, WHO’s principal legal officer. Solomon said it was “really helpful” to understand some of the “scepticism” around the pandemic treaty initiatives. “Understanding the the concern about an agenda driven issue here is very important for the [WHO] Secretariat,” Solomon told the group. At the same time, beyond the immediate COVID crisis, other WHO emergency response frameworks already in place also could perhaps benefit from the stronger legal backpone that a pandemic treaty might provide, he pointed out. One example is the Pandemic Influenza Preparedness (PIP) framework, which mandates that 10% of global flu pandemic vaccine production supply goes to WHO for direct distribution, based upon public health needs. Another is WHO’s Global Action Plan for influenza vaccines. These “are meant to address equity issues in a number of epidemics, not necessarily pandemics,” Solomon said. “I would be very interested in reactions to particular frameworks meant to address inequities, like the pandemic influenza preparedness (PIP) framework, not legally binding. Or like the WHO Global Action Plan (GAP) for influenza vaccines, also not legally binding. “But both are interesting and potentially of important reference to pandemic preparedness and response. PIP basically says 10% of global pandemic vaccine production supply goes to WHO for distribution on the declaration of an influenza pandemic for distribution based on public health needs, and we have legally binding contracts for that 10%,” said Solomon. “Could that be a reference point for responding to future pandemics? “If so, would it be useful to put that in more of a legal framework because of weaknesses within that structure – particularly the idea of countries not allowing export for vaccines already under contract?” Solomon asked. Similarly, the Global Action Plan for influenza vaccines was a 10-year, non-binding arrangement that aimed to better distribute capacity for flu vaccine production, including among low- and middle-income member states, he pointed out, asking: “Could that also benefit, or not, from a normatively binding architecture?” The final research report will be launched by G2H2 on 24 November. –Elaine Ruth Fletcher contributed to the writing of this story. 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Only 5 African Countries On Track to Meet 40% Vaccine Coverage Goal by End 2021; Syringe Shortage is One of the Latest Obstacles 28/10/2021 Kerry Cullinan Only five African countries are likely to reach a WHO global goal of vaccinating 40% of their populations by the end of the year, and the continent’s roll-outs may be slowed further by a global shortage of the syringes need to administer vaccines. UNICEF has reported an imminent shortfall of up to 2.2 billion syringes for COVID-19 vaccination and routine immunization in the coming year, according to the World Health Organization’s (WHO) Africa region. This includes special 0.3ml syringes needed for the Pfizer-BioNTech COVID-19 doses, for which there is no global stockpile. “Early next year COVID-19 vaccines will start pouring into Africa, but a scarcity of syringes could paralyse progress,” WHO Africa Director Dr Matshidiso Moeti told a press briefing on Thursday. “Drastic measures must be taken to boost syringe production, fast. Countless African lives depend on it.” COVAX is trying to secure deals with syringe manufacturers, and through better planning to avoid deliveries outpacing the supply of syringes, the WHO reported. Only 6% of Africans – 77 million people – are fully vaccinated, while over 70% of high-income countries have already vaccinated more than 40% of their people. Three African countries – Seychelles, Mauritius and Morocco – have already vaccinated over 40% of their people, while only Tunisia and Cabo Verde are on track to reach this global WHO target by year-end. While COVAX has delivered around 50 million vaccines to Africa, the continent still faces a 275 million dose shortfall in order to vaccinate 40% of all Africans. Wave after wave Dr John Nkengasong, Director of the Africa Centers for Disease Control and Prevention (CDC), told an earlier media briefing that 82% of the continent had experienced a third wave of COVID, while seven countries had already had a fourth wave. “We are going to go from wave to wave unless we address the question of vaccinations,” said Nkengasong. While cases in most of Africa are going down, cases are rising in countries in the Central African countries of Gabon, Congo, Cameroon, as well as Egypt. COVID deaths in Nigeria increased by 66% and by 36% in Egypt, added Nkengasong. Meanwhile, the WHO urged countries to improve their vaccine roll-out readiness. Some 42% of countries have not yet completed district-level plans for their campaigns, while nearly 40% have not yet undertaken “intra-action reviews” which are key to refining and improving their vaccination campaigns,” according to the WHO The WHO is conducting emergency support missions to five African countries to help support, speed up and improve their COVID-19 vaccine rollouts, with plans for missions to another 10 countries this year. Image Credits: Wuestenigel/Flickr. Game-Changing COVID-19 Oral Treatment Set To Become Widely Accessible in Low- and Middle-Income Countries Upon Regulatory Approval 27/10/2021 Elaine Ruth Fletcher Merck laboratory that developed the new oral COVID treatment, molnupiravir A potentially game-changing antiviral treatment for COVID-19 that can be administered orally early on, and potentially head off much more serious cases, is set to be licensed for generic production in most low- and middle-income countries (LMICs), in an unprecedented breakthrough in access to a new COVID treatment. The historic deal, reached between the pharma company Merck Sharp & Dohme (Merck) and the Medicines Patent Pool paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell the treatment, molnupiravir at discounted prices to more than105 countries worldwide, once the drug has been approved by the US Food and Drug Administration and the World Health Organization. The agreement is the first time in the pandemic that a major pharma company has agreed to such an open-ended license for generic production of a newly developed drug. The drug, currently awaiting US FDA emergency review, reduced risks of hospitalization or death by about 50% among patients with mild or moderate COVID, according to the company reports of the results of its Phase III trial. The deal also represents a major coup for the Geneva-based MPP, a non-profit organization with a long track record of negotiating with big pharma innovators for broader generic production of costly new drugs for treating hepatitis, HIV, and other diseases. Until now, however, MPP had not been able to enter fully into the COVID medicines access fray – with pharma producers reluctant to negotiate with the non-profit over broad-based licenses for the generic production of COVID vaccines and drugs. Other new COVID drug treatments, such as the newly-approved monoclonal antibody cocktail REGEN-COV, remain expensive and hard to access in most LMICs. They are also more difficult to use – as they need to be administered intravenously. Charles Gore, MPP Executive Director, said of the breakthrough, “This transparent, public health-driven agreement is MPP’s first voluntary licence for a COVID-19 medical technology, and we hope that MSD’s agreement with MPP will be a strong encouragement to others.” The MPP is all the more meaningful as the new drug will be the first major COVID medication that can be administered orally to non-hospitalized patients, said WHO in a statement. ‘Best agreement any company has made’ The announcement was roundly hailed by WHO and other UN-affiliated agencies managing the UN-supported ACT-Accelerator initiative to broaden access to vaccines and drugs. A number of medicines access advocates who have bitterly criticized pharma for failing to issue more voluntary license deals for for other cutting edge vaccines and treatments, issued particularly warm statements about the Merck deal. Said Jamie Love, of Knowledge Ecology International, “The license between the MPP and Merck for the manufacture and sale of molnupiravir is the best agreement any company has made for licensing its intellectual property during the COVID-19 pandemic. “The 69-page license agreement is fully transparent, unlike the agreements with CEPI, COVAX, Operation Warp Speed, the Gates Foundation, the Wellcome Trust, other companies or most governments,” added Love referring to the other international and UN-supported initiatives on COVID drug and vaccine access. “The license makes it possible for any generic manufacture located anywhere the world to supply molnupiravir in the licensed territory, and provides a pathway for supplying to countries outside the licensed territory, when patents are not in place or subject to compulsory licenses. “The licensed area is large enough (more than half the world’s population) to induce efficient generic entry and economies of scale,” he added – while noting that the 18% population coverage in LAC is weakest – although a separate Merck deal with Brazil is reportedly underway. Concluded Love: “Given the objectives of scaling up production of molnupiravir at the lowest prices for the lowest income countries, the agreement is an impressive achievement for the Medicines Patent Pool and Merck deserves credit for being the first company to make a deal with the Medicines Patent Pool.” MSF calls out shortcomings of contract Even so, some civil society stakeholders, and notably Médecins Sans Frontières (MSF) said that the licensing arrangement “does not go far enough” expressing “disappointment with the limitations of this license, as its territory excludes nearly half of the world population and important upper-middle-income countries (UMICs) with robust manufacturing capacity, such as in Brazil and China.” Yuanqiong Hu, Senior Legal and Policy Advisor, MSF Access Campaign added that: “After more than a year of secrecy of companies’ bilateral deals in a pandemic, it is a welcomed step forward to have the first fully published voluntary license from MPP covering COVID19 medical tool. “However, a closer look reveals its limitations for increasing access to one of the first promising antiviral drugs for COVID-19. It’s disappointing…. Middle-income countries excluded from the license had 30 million COVID-19 infections in the first half of 2021, 50% of all infections in low- and middle-income countries. Medicines, Law and Policy, while generally positive, also called out a clause that would allow MPP terminate a sublicence agreement with a manufacturer of the new drug, in the case of a patent challenge – a clause reportedly included at the request of the drugs initial developers at DRIVE, a subsidiary of Emory University and Ridgeback Pharmaceuticals. Emory University has in fact waved royalties on the sale of the drug in low- and middle-income countries for as long as the WHO-declared international public health emergency continues. However the termination of sublicence clause also has provoked protests by students, who say that it could restrict or undermine the flexibility of the generic licensing agreement. Merith Basey, Executive Director for Universities Allied for Essential Medicines, a student-led movement that aims to change universities’ licensing practices told us: “Emory University has betrayed its mission to serve humanity by stifling global access to a potentially life-saving COVID treatment. Molnupiravir was developed on Emory’s campus with massive amounts of tax-payer funding, yet this license includes a stipulation demanding a no-patent challenge. We call on the institution to remove the clause and favor people over profit in the midst of a global pandemic that has killed over 5 million people so far.” Image Credits: Merck , Merck . Liver Cancer: Europe’s Public Health Ticking Time Bomb 27/10/2021 Thomas Berg & Maria Buti October is Liver Cancer Awareness month, and Europe has a liver cancer problem. Over the past two decades, there has been a 70% increase in liver cancer-related mortality in the region. In 2020, 87,000 Europeans were diagnosed with liver cancer while 78,000 died from the disease in the same year. Late diagnosis is a serious problem. About half of patients are only diagnosed in an advanced stage of cancer and have less than a year to live. Liver cancer is the sixth most common cancer and the third biggest cause of cancer-related deaths globally. In the US, the rate of deaths from liver cancer increased by 40% from 1990 to 2004 while the overall rate of non-liver cancer deaths declined by 18%. Projections for the US estimate that in 2030, liver cancer will be the third-leading cause of cancer-related deaths, surpassing breast, colorectal, and prostate cancers. There are many risk factors for developing liver cancer, and chronic liver diseases caused by viral hepatitis, alcohol, or fatty liver disease are the most important. Diabetes and obesity Non-alcohol fatty liver disease (NAFLD), which is often a consequence of obesity and diabetes, is the leading cause of death among 35 to 49-year-olds in the UK, making NAFLD a health threat that should not be underestimated. (The more severe form of NAFLD is called nonalcoholic steatohepatitis, or NASH). Outside of COVID-19, NAFLD is also about the fastest growing disease globally. It occurs in about one in four people around the world and has emerged as the most prominent cause of chronic liver disease. Experts predict that, over the next decade, NAFLD will become the leading cause of end-stage liver disease and liver transplantation. It is already the fastest-growing cause of hepatocellular carcinoma (HCC), the most common form of liver cancer worldwide. Faced with a ticking public health time bomb in Europe, we are clearly in a race against time to both prevent and treat this disease before the epidemic worsens and overwhelms health systems. Better treatment access Treatment of chronic liver diseases to avoid their progression to precancerous states like cirrhosis significantly reduces the risk of liver cancer, and this has been convincingly demonstrated. Improved and equal access to state-of-the-art management of these diseases is a core element in the fight against liver cancer. Although liver cancer remains one of the few cancers with increasing incidence and mortality, public awareness of liver cancer is much lower than for other cancers. As a consequence, patients who have liver cancer and patients who are at increased risk for liver cancer often face stigma in their social lives, and also in the medical settings. Treatment options for liver cancer have significantly improved over the recent years, which makes early diagnosis the most critical point. Case-finding strategies need to be implemented, at least in at-risk patients, as strongly recommended by clinical guidelines. Hepatitis B vaccinations Finally, we must directly tackle the key environmental factors that cause liver diseases and liver cancer. In addition, successful Hepatitis B vaccination programmes need to be continued and expanded as the core element of primary liver cancer prevention as it has the potential to prevent roughly twice as many cancer cases as HPV vaccination. Earlier this year the European Commission launched its Beating Cancer Plan in response to the fact that the EU region is home to a quarter of the world’s cancer cases and is facing an annual economic impact of €100 billion if urgent action is not taken. This plan is precisely what is needed to bring scientific societies, experts and patient groups together to move forward measures that can go a long way towards stopping liver cancer in its tracks. But these measures need to be coordinated across the region, led by the European Commission, and implemented by EU Member States. A starting point has to be the setting of standards for awareness, prevention, and management of liver cancer across the region. It is pivotal that we educate and raise awareness amongst everyone: healthcare professionals, patients and families, risk groups, policymakers and the general public. Liver cancer usually occurs as a consequence of underlying chronic liver disease and cirrhosis. Thus, the EU and Member States should implement preventive measures that include evidence-based strategies to reduce the burden of liver disease, focusing on reducing alcohol consumption and obesity, and on early detection and treatment of chronic liver disease. Early detection is critical for those patients with liver diseases associated with a high risk of liver cancer such viral hepatis B and C, alcohol-related and non-alcoholic fatty liver disease. The EU and Member States should add liver cancer to their screening list, at least for patients with underlying risk factors. In addition, existing programs providing the opportunity of early case finding of liver diseases should be leveraged where possible. The salivary screening for Hepatitis C using point of care testing is a good example and complements the WHO HCV program aiming at fighting HCC as well. Inter-disciplinary disease management But we also need improved access to better disease management for patients with liver cancer across all member states of the EU. This means a more structured pathway for the diagnosis and treatment of patients when they are receiving care in hospital, as an outpatient and then at home. That will require better inter-disciplinary cooperation between hepatology, oncology and other relevant disciplines and ideally collaborative clinical guidelines that are driven by comprehensive scientific evidence. Basic research continues to be a critical element for improving patient outcomes in liver cancer. There is still further knowledge needed about aetiology, rare liver cancer entities, markers and diagnostics which might facilitate early detection even in primary care. The EU and Member States should support such research projects and cross-country collaboration by setting up EU-wide platforms with the aim of sharing data and closing the gap between medical knowledge and clinical practice. The high standard of care in the EU is based on high-level science and research. In order to maintain these standards furthermore and drive improvements, it is essential to collect data collaboratively across all member states. The EU and Member States should support the setting up of specific patient registries for liver cancer. The collation of this data would facilitate surveillance, research and the overall management of patients with liver cancer. Care must be patient-centric. People living with liver cancer and their families should have unrestricted access to information, medical treatment, and measures to improve their quality of life, regardless of their life situation and ethnic origin. All patients with liver cancer should benefit from the same high standards of care wherever they are in Europe. Thomas Berg is the Secretary-General of the European Association for the Study of the Liver (EASL) and Head of the Division of Hepatology at Leipzig University Medical Center in Germany. Maria Buti is the EASL EU Policy Councillor and Professor of Medicine and Chief of Internal Medicine and Hepatology at the Hospital General Universitari Valle Hebron in Barcelona, Spain. US ‘Steps Aside’ to Give Africa Access to Moderna Vaccines 26/10/2021 Kerry Cullinan Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) The US government has enabled Africa to get access to 50 million Moderna COVID-19 vaccines by giving the continent its place in the vaccine queue, Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) said on Tuesday. “This is a time swap arrangement whereby the United States government basically stood aside for the next quarter so that we could access vaccines and purchase them ourselves,” Masiyiwa told a media briefing of the Africa Centers for Disease Control (CDC). AVAT will get 15 million Moderna doses in December and a further 35 million between January and March. It also has an option to buy 60 million more, delivered at 20 million doses per month, between April and June. “These doses are being purchased by AVAT courtesy of the United States government, which has been phenomenal in its support,” he added. South Africa’s President Cyril Ramaphosa and Kenya’s President Uhuru Kenyatta negotiated the deal directed with US President Joe Biden, said Masiyiwa. Other than a deal with Johnson and Johnson (J&J) for 400 million vaccines over 13 months from August, “none of the vaccine suppliers had any doses for us this year,” said Masiyiwa. The Africa Union has been able to get the J&J vaccines largely because they are being assembled by Aspen in South Africa – but even ensuring that these doses remained on the continent required reaching an agreement with the European Union, which initially planned to import the African-assembled vaccines. Jessye Lapenn, the US Ambassador to the African Union, praised AVAT’s leadership and expressed her country’s support for the continent’s vaccination efforts. The White House confirmed that it would defer the delivery of about 33 million Moderna vaccines to enable the African Union to buy the doses. Masiyiwa said the African Union’s long-term vision was for Moderna to reach a fit-and-fill agreement with an African manufacturer. The company recently announced that it wants to build a $500 million mRNA vaccine manufacturing facility in Africa. “We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe, said Moderna CEO Stéphane Bancel. Moderna said that it was “working on plans to allow it to fill doses of its COVID-19 vaccine in Africa as early as 2023, in parallel to building an mRNA vaccine manufacturing facility in Africa”. Moderna, which received millions of dollars in R&D support from the US government, has been under pressure from the Biden administration to supply low and middle income countries with vaccines. AVAT is currently supplying 39 African countries and 15 Caribbean countries, but only 8,7% of Africans have had at least one vaccine dose. Meanwhile, COVAX revealed on Monday that less than 10% of vaccine donations pledged to it by wealthy countries had been delivered. Of the 1.3 billion COVID-19 vaccine dose donations promised to COVAX by wealthy countries, only 150 million doses have actually arrived – around 9% – Gavi CEO Dr Seth Berkley told the World Health Summit. Joining the Africa CDC press briefing on Tuesday, Berkley said that COVAX had supplied 40% of Africa’s vaccine doses but the facility had experienced a major slowdown after India banned the export of AstraZeneca vaccines made it its country although COVAX had already paid for the vaccines. Debt Relief & National Economic Reforms Pitched as ‘Big Picture’ Global Health Solutions Ahead of G-20 Meeting 26/10/2021 Elaine Ruth Fletcher WHO Director General Dr Tedros Adhanom Ghebreyesus and Mariana Mazzucato, chair of the new WHO Council on the Economics of Health for All. An ambitious wish list of global economic and fiscal measures that the world should adopt to combat the COVID-19 pandemic has been floated by the World Health Organization- just ahead of a critical G-20 meeting of the world’s most industrialized nations this weekend. These include proposals for massive debt relief to debt-ridden countries and a re-direction of the IMF’s new offer of $US650 billion in “special drawing rights” away from richer nations to low- and middle-income countries. The laundry list of macroeconomic and fiscal measures proposed by the new WHO Council on the Economics of Health for All, was detailed today at one of the final sessions of the World Health Summit. Drafted by 10 top economists and health policy experts, Financing Health for All pushes the classic debates over access to medicines and health systems investments – into the realm of much broader fiscal and economic decisions that nations, both rich and poor need to make, according to the experts. That is, if they really want to beat down COVID-19 as well as prepare for the next pandemic. ‘Donor mentality’ is part of the problem WHO Director General, Dr Tedros Adhanom Ghebreyesus “It proposes a radical shift in economic thinking for global health,” said WHO Director General Dr Tedros Adhanom Ghebreyesus at the WHS session. He appeared with Mariana Mazzucato, Founding Director of the UCL Institute for Innovation and Public Purpose, and chair of the new health economics Council, which was launched by WHO in May 2021. “Instead of looking at health as a piece of the economy, it’s time to look at how the economy can support the societal goal of health for all,” said the WHO Director General. “Neither existing market mechanisms, with their focus on short term returns, nor development funds alone are enough,” he added. “They do not provide the global public goods on which we all depend, such as vaccines, nor do they address the major inequities, undermining equitable access. “The council is proposing bold, concrete actions for governments and multilateral organizations in three major areas, creating fiscal space, the direction of investment, and the governance of public and private financing for how this does not just mean more money. It means making the better, smarter and sustained investments that are needed to achieve health for all.” “We have to realize that this donor mentality is actually part of the problem,”said Mazzucato, “And that lots of the conditionalities that were set in the past on the loans provided to developing countries precisely made them weaker. The key priorities outlined by the brief, prepared by the ten-member expert group includes proposals that would leverage change from global to national level so as to: Create more “fiscal space” for countries to invest more in health, including through measures like international debt relief, a global corporate tax rate and a greater allocation to low-income countries of newly available IMF special drawing rights; Reshape national, tax, regulatory and investment rules to make them more favorable to health-related investments, e.g. in health systems and vaccine and medicines manufacture; Ensure stronger governance for private health markets – notably pharma innovators and manufacturers – using public regulations and investments to “crowd in and direct private finance towards improving health outcomes globally and equitably.” Other members of the Council include Vera Songwe, Executive Secetary of the Economic Commission for Africa; economists such as Jayata Ghosh, of the University of Massachusetts and Stephanie Kelton an expert on monetary policy at Stony Brook University; investment banker Vanessa Huang, and global health professionals such as Ilona Kickbusch, founding director of the Geneva Graduate Institute’s Global Health Centre; Senait Fissehea, of the University of Michigan; and planetary health expert Kate Raworth, of Oxford University’s Environmental Change Institute. More “quality money” – to fight the next pandemic Mariana Mazzucato, chair fo the new WHO Council on the Economics of Health for All Just “more money” is not enough to drive bigger investments in countries with poor-performing health systems, stressed Mazzucato, it needs to be “quality money” – money that does not translate into more crippling loan repayments once the initial phase of the pandemic crisis has passed. “Multilateral organizations should negotiate debt relief for low and middle income countries in such an important moment,…. redirecting [IMF] Special Drawing Rights towards investment in health, and especially vaccines,” she said. IMF special drawing rights are not considered as loans in the traditional sense of the word, but rather bolster countries’ reserves and thus their overall economic stability. “False constraints have been imposed on government’s fiscal spaces, often by multilateral institutions like the IMF and the World Bank.” Crippling debt restrictions and austerity measures traditionally have hit hardest on social welfare nets, including public health systems, meaning that low- and middle-income countries “weren’t allowed to create the kind of fiscal space that we highlight as the first key pillar,” she observed. “Over time, we have to be better prepared and that preparedness needs to be, in the long run, built on the ability to have a distributed manufacturing and industrial capacity [for health products] globally. “Because this will not be the last pandemic, you know. As the permafrost melts, apparently, there’s going to be all sorts of other viruses that come about. Climate change and this health crisis are really interlinked.” Along with debt relief the G-20 should advance credit rating reforms and “push for the enforcement of a minimum global corporate tax of at least 15%,” she added. National investment priorities Finance and health authorities need to work together more closely to expand local medicines and vaccine production and improve health systems. But as the brief underlines, the challenge is not only to reduce international pressures, through measures such as debt relief, but also to “change mindsets within countries that impose internal constraints on spending” – often in the name of false economies and fiscal prudence. That means a better understanding and alignment in Finance Ministries, of the importance of health priorities. “The bottom line is that countries must reverse the harmful effects of an austerity approach to public administration and public finance reforms,” said Mazzucato. She pointed to Kerala State, in India, as an example of a region that fared better because it focused investment into public health systems. “Internal constraints on government budgets are not insurmountable and governments actually have more room for increasing the fiscal limits on investments for health than they’re led to believe. “And it’s not just a matter of political choice, but also when a political will whether country can mobilize all the resources and levers that can to maximizing financing for health, such as innovative monetary policy, but also…, procurement policies using different levers – grants, loans, procurement to really catalyze new solutions…. “When we go to war, money is found, and during a health pandemic, money has been found, but that has been too little too late,” she observed. Public-Private sector should share ‘risks and rewards’ of innovation Finally, public-private sector relationships around critical issues such as vaccines and medicines innovation and manufacture need a reboot, the brief argues, sharing both the “risks and rewards” of innovation, in the words of Mazzucato – rather than leaving public entities to shoulder the risks while the private sector reaps most of the rewards. “We need public actors, we need philanthropies, but they need to work together in a different way,” she said. That means public contracts, loans, grants and other incentives that are offered to the private sector to develop new and more innovative vaccines, tests and treatments also need to come along with stronger conditions about how the final products they create may be used or distributed. “And this can be done by redesigning the terms and the conditions, structuring contracts, grants, transfers loans and partnerships between public and private actors. “Precisely because the public sector puts in so much of the money – especially in the early stage when it’s more risky and more capital intensive, and uncertain – these critical market-shaping public investments should ensure conditionalities around pricing – to make sure that we have access at the core -that we have vaccines that are globally accessible. Innovation – global, end-to-end and governed collectively In terms of intellectual property rights, she added that “it’s not about getting rid of patents, but we have to govern innovation and the patent system, with objectives in mind. “Making sure that patents are not too wide, too strong, hard to license upstream are core ways to govern the patent system. “It’s not about getting rid of patents, we have to govern innovation, and the patent system with objectives in mind,” she said. “More broadly, we need to shape a conducive regulatory tax, industrial and economic policy environment to ‘crowd in’ all sorts of different sources of finance at the same time, ensuring that we get the greatest multiplier effect, the greatest impact on health for all. Ultimately, however, she stressed that global health innovation platforms need to be “global, end-to-end, and governed collectively – shifting from a model where innovation is left to the market to a model aimed at delivering global common goods.” Image Credits: Marco Verch/Flickr. Civil Society Activists Question Pandemic Treaty’s Ability to Address Global Health Inequalities 26/10/2021 Kerry Cullinan A session of the 2020 World Health Assembly. Some civil society organisations (CSO) are sceptical about whether a ‘pandemic treaty’ is the best way to address future global health crises, while treaty supporters say it will provide a legal framework binding countries and global health bodies to more agile and rapid responses to future outbreaks. A session Monday sponsored by the Geneva Global Health Hub (G2H2) brought leading CSOs, diplomats, academics and even WHO’s chief legal counsel face to face to air those views, in the context of a research initiative on the treaty being undertaken by the hub. The debate comes just weeks ahead of a planned special session of the World Health Assembly which is to determine whether the global body will indeed move forward on a Treaty, as a key measure for improving pandemic response. The treaty initiative has been supported most visibly by European countries, led by European Commission President, Charles Michel, who in a separate session at the World Health Summit in Berlin that the treaty would guarantee “access to information, financing, vaccines and countermeasures. It would increase capacity and resilience – at all levels.” With @DrTedros we proposed an international #PandemicTreaty rooted in @WHO constitution. It would guarantee equity & inclusiveness. A legally binding instrument would be the most effective basis for prevention, surveillance, collection and exchange of scientific data.#WHS2021 pic.twitter.com/lbWkc3G5XE — Charles Michel (@eucopresident) October 25, 2021 Diversion or game changer? 25 heads of government and international agencies have come together in support of the new pandemic treaty Some of the civil society organisations that have expressed disquiet about the treaty proposal perceive it as a potential distraction or diversion by wealthy countries from the so-called TRIPS waiver proposal, currently under consideration by thee World Trade Organization. The proposal by South Africa and India for a broad-based intellectual property waiver on COVID vaccines and treatments, now being debated by the WTO’s TRIPS Council , is perceived by civil society as a game changer that would help open the doors to despearately needed COVID vaccine and medicines manufacturing in Africa and the global South. Many of the European countries that have been among the most staunch opponents of the TRIPS waiver are also key pandemic treaty supporters, noted journalist Priti Patnaik, who is researching stakeholders’ views on the pandemic treaty for G2H2 -giving rise to the CSO suspicions. And yet at the same time, some developing countries have supported a pandemic treaty because they believe it would “rein in the influence of non-state actors, including powerful foundations, and get some binding obligations to apply to industry to avoid vaccine inequities in the future,” she added. ‘Switch-and-bait’ tactic Unni Karunakara, senior fellow at Yale’s Global Health Justice Partnership, said that the major focus should be on deploying available tools and medicines to every corner of the world, rather than negotiations over a new treaty: “Shouldn’t global vaccination coverage be an overwhelming priority now?” he asked. “We do have frameworks and tools. They’re not perfect, but there are enough tools for us to overcome this crisis together,” said Karunakara, a former president of Medecins sans Frontieres. “What is lacking, however, is the political will to share essential resources and tools, even with all of the treaties in place.” His comments reflecting the cynicism of other civil society activists who see “a big overlap between the countries that are blocking the TRIPS waiver, and the countries that are supporting the pandemic treaty. “So there’s a perception of a ‘switch-and-bait’ tactic that reeks of bad faith,” he added. And while transparency measures – such as the mandatory sharing of genetic materials by countries where outbreaks are suspected – have been discussed as key treaty features, similar mandates for transparency or sharing of vaccines and medicines technologies have been fiercely opposed by the EU, he pointed out. “TRIPS waiver-blocking countries have made the case for voluntary actions by pharma to ensure access to essential COVID-19 medical tools, so they treat Big Pharma with kid gloves,” Karunakara observered. “Interestingly, they take a very different tone and approach to the global south in the treaty, insisting on enforceability in the sharing of information and materials with WHO and other governments to allow for independent verification.” “The assumption here is that global south is the problem, that diseases originated in poor country, and pose national security risks to rich countries.” If you are against the treaty – what is your multilateral alternative? Björn Kümmel, at the WHO Executive Board’s January 2021 meeting. Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver – or the kinds of hidden agendas that civil society groups fear. “I doubt that it’s, from a logical point of view, right to say that even though a country has it stands on the TRIPS waiver, you can’t tackle other equity issues,” he told the G2H2 session. “That’s one angle to look at, the TRIPS waiver, but there are many more angles to be looked at. So to say that that is the only magic bullet, I think that would be fully wrong, I wouldn’t limit it to this. “I think that equity goes far beyond, and certainly, if a treaty was negotiated, it’s quite clear that this [TRIPS waive] will be put on the table, and that all governments will have to look at the different interests that are on the table and negotiate them with an open outcome.” He noted that the treaty was first proposed formally by Chile, not the European Commission, and has the support of a wide array of countries, including South Africa, Kenya, and Tunisia, as well as Thailand and Indonesia. Anything better than ‘Chaos’ we see now Describing the current global health situation as “dysfunctional”, Kümmel asked the G2H2 session: “If you are against the treaty, tell us what is your multilateral alternative to it, to be realistically implemented, lets say in the next five years?” “What the countries who are proposing a treaty are trying to say is: anything is better, than compared to the chaos that we’re seeing currently. “Legal clarity is needed, and it will be …a painful exercise for many of us, and most likely a difficult one for many governments, including mine, most likely also others. But in the end, it’s this is multilateralism.” Uniquely in the global health landscape – and unlike environment, trade or finance – there is a dearth of global treaty instruments. In fact, among the dozens of international treaties in force today, the only two binding instruments in global health today are the IHR and and the Framework Convention on Tobacco Control (FCTC), he pointed out. Pandemic is a ‘window of opportunity’ for bigger changes In light of the outstanding questions, however, the working group of countries that are preparing for the WHA special session had devised a “three-step approach” to their deliberations on a way forward. They are considering in parallel: WHO internal reform measures; revisions in the existing International Health Regulations that currently govern global emergency response; and finally, the Pandemic Treaty alternative. In terms of WHO reform, the conclusion has been that such measures would “not be sufficient in order to overcome the next pandemic,” Kümmel said. Amendments to the International Health Regulations (IHR) also would take time to negotiate. And a key question here is: “would they be a game changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” So against the other options, “an international binding agreement is interesting,” he said. “And why are many colleagues pushing for this to happen now? Well, it’s the reality that after Ebola and past pandemics the global community was unable to implement the lessons learned,” he said. And if negotiations don’t begin now, in the heat of the ongoing crisis, they will never happen at all. “Many of the international independent panels have called for bold recommendations to be implemented,” Kümmel reminded the group. “One of them is the treaty. But many of those recommendations have never reached successful implementation, because the window of opportunity for real structural changes normally vanishes with the next crisis to come after the pandemic.” The treaty would also retain WHO’s centrality as the nerve center of the global health architecture – amidst a plethora of new health initiatives emerging in Europe and elsewhere: “There are a multitude of ideas and recommendations, and the treaty is a legal framework into which most of the other recommendations would fit,” he said, in reference to recent proposals such as one by the Pan European Commission on Health and Sustainable Development to create a new global health board under G-20 auspices. Others have talked about a new global health finance board in association with the World Bank and/or a new UN-level Global Health Threats Council, under the auspices of the UN General Assembly. So the Pandemic Treaty is “also a mechanism to provide WHO with legitimacy after this crisis,” he stressed. “Obviously there are voices out there who could see alternative approaches. However, I think the ones who are in favour of this treaty have clearly articulated that WHO is the right forum because its the truly multilateral forum for global health.” WHO precedents for equitable access to vaccines? Germany is not the only actor that sees the treaty as a means of keeping WHO as the world’s main global health meeting place. WHO’s Director General Dr Tedros Adhanom Ghebreyesus has himself come out in support for the pandemic treaty measure – breaking ranks with previous agency heads who usually remained aloof of controversial measures under consideration by member states. WHO is therefore keenly interested in how civil society groups may help lead or shape views on the treaty negotiations – and this interest was reflected in a cameo appearance at the G2H2 event by Stephen Solomon, WHO’s principal legal officer. Solomon said it was “really helpful” to understand some of the “scepticism” around the pandemic treaty initiatives. “Understanding the the concern about an agenda driven issue here is very important for the [WHO] Secretariat,” Solomon told the group. At the same time, beyond the immediate COVID crisis, other WHO emergency response frameworks already in place also could perhaps benefit from the stronger legal backpone that a pandemic treaty might provide, he pointed out. One example is the Pandemic Influenza Preparedness (PIP) framework, which mandates that 10% of global flu pandemic vaccine production supply goes to WHO for direct distribution, based upon public health needs. Another is WHO’s Global Action Plan for influenza vaccines. These “are meant to address equity issues in a number of epidemics, not necessarily pandemics,” Solomon said. “I would be very interested in reactions to particular frameworks meant to address inequities, like the pandemic influenza preparedness (PIP) framework, not legally binding. Or like the WHO Global Action Plan (GAP) for influenza vaccines, also not legally binding. “But both are interesting and potentially of important reference to pandemic preparedness and response. PIP basically says 10% of global pandemic vaccine production supply goes to WHO for distribution on the declaration of an influenza pandemic for distribution based on public health needs, and we have legally binding contracts for that 10%,” said Solomon. “Could that be a reference point for responding to future pandemics? “If so, would it be useful to put that in more of a legal framework because of weaknesses within that structure – particularly the idea of countries not allowing export for vaccines already under contract?” Solomon asked. Similarly, the Global Action Plan for influenza vaccines was a 10-year, non-binding arrangement that aimed to better distribute capacity for flu vaccine production, including among low- and middle-income member states, he pointed out, asking: “Could that also benefit, or not, from a normatively binding architecture?” The final research report will be launched by G2H2 on 24 November. –Elaine Ruth Fletcher contributed to the writing of this story. Image Credits: WHO / Antoine Tardy, EU Council, C Black, WHO. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Game-Changing COVID-19 Oral Treatment Set To Become Widely Accessible in Low- and Middle-Income Countries Upon Regulatory Approval 27/10/2021 Elaine Ruth Fletcher Merck laboratory that developed the new oral COVID treatment, molnupiravir A potentially game-changing antiviral treatment for COVID-19 that can be administered orally early on, and potentially head off much more serious cases, is set to be licensed for generic production in most low- and middle-income countries (LMICs), in an unprecedented breakthrough in access to a new COVID treatment. The historic deal, reached between the pharma company Merck Sharp & Dohme (Merck) and the Medicines Patent Pool paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell the treatment, molnupiravir at discounted prices to more than105 countries worldwide, once the drug has been approved by the US Food and Drug Administration and the World Health Organization. The agreement is the first time in the pandemic that a major pharma company has agreed to such an open-ended license for generic production of a newly developed drug. The drug, currently awaiting US FDA emergency review, reduced risks of hospitalization or death by about 50% among patients with mild or moderate COVID, according to the company reports of the results of its Phase III trial. The deal also represents a major coup for the Geneva-based MPP, a non-profit organization with a long track record of negotiating with big pharma innovators for broader generic production of costly new drugs for treating hepatitis, HIV, and other diseases. Until now, however, MPP had not been able to enter fully into the COVID medicines access fray – with pharma producers reluctant to negotiate with the non-profit over broad-based licenses for the generic production of COVID vaccines and drugs. Other new COVID drug treatments, such as the newly-approved monoclonal antibody cocktail REGEN-COV, remain expensive and hard to access in most LMICs. They are also more difficult to use – as they need to be administered intravenously. Charles Gore, MPP Executive Director, said of the breakthrough, “This transparent, public health-driven agreement is MPP’s first voluntary licence for a COVID-19 medical technology, and we hope that MSD’s agreement with MPP will be a strong encouragement to others.” The MPP is all the more meaningful as the new drug will be the first major COVID medication that can be administered orally to non-hospitalized patients, said WHO in a statement. ‘Best agreement any company has made’ The announcement was roundly hailed by WHO and other UN-affiliated agencies managing the UN-supported ACT-Accelerator initiative to broaden access to vaccines and drugs. A number of medicines access advocates who have bitterly criticized pharma for failing to issue more voluntary license deals for for other cutting edge vaccines and treatments, issued particularly warm statements about the Merck deal. Said Jamie Love, of Knowledge Ecology International, “The license between the MPP and Merck for the manufacture and sale of molnupiravir is the best agreement any company has made for licensing its intellectual property during the COVID-19 pandemic. “The 69-page license agreement is fully transparent, unlike the agreements with CEPI, COVAX, Operation Warp Speed, the Gates Foundation, the Wellcome Trust, other companies or most governments,” added Love referring to the other international and UN-supported initiatives on COVID drug and vaccine access. “The license makes it possible for any generic manufacture located anywhere the world to supply molnupiravir in the licensed territory, and provides a pathway for supplying to countries outside the licensed territory, when patents are not in place or subject to compulsory licenses. “The licensed area is large enough (more than half the world’s population) to induce efficient generic entry and economies of scale,” he added – while noting that the 18% population coverage in LAC is weakest – although a separate Merck deal with Brazil is reportedly underway. Concluded Love: “Given the objectives of scaling up production of molnupiravir at the lowest prices for the lowest income countries, the agreement is an impressive achievement for the Medicines Patent Pool and Merck deserves credit for being the first company to make a deal with the Medicines Patent Pool.” MSF calls out shortcomings of contract Even so, some civil society stakeholders, and notably Médecins Sans Frontières (MSF) said that the licensing arrangement “does not go far enough” expressing “disappointment with the limitations of this license, as its territory excludes nearly half of the world population and important upper-middle-income countries (UMICs) with robust manufacturing capacity, such as in Brazil and China.” Yuanqiong Hu, Senior Legal and Policy Advisor, MSF Access Campaign added that: “After more than a year of secrecy of companies’ bilateral deals in a pandemic, it is a welcomed step forward to have the first fully published voluntary license from MPP covering COVID19 medical tool. “However, a closer look reveals its limitations for increasing access to one of the first promising antiviral drugs for COVID-19. It’s disappointing…. Middle-income countries excluded from the license had 30 million COVID-19 infections in the first half of 2021, 50% of all infections in low- and middle-income countries. Medicines, Law and Policy, while generally positive, also called out a clause that would allow MPP terminate a sublicence agreement with a manufacturer of the new drug, in the case of a patent challenge – a clause reportedly included at the request of the drugs initial developers at DRIVE, a subsidiary of Emory University and Ridgeback Pharmaceuticals. Emory University has in fact waved royalties on the sale of the drug in low- and middle-income countries for as long as the WHO-declared international public health emergency continues. However the termination of sublicence clause also has provoked protests by students, who say that it could restrict or undermine the flexibility of the generic licensing agreement. Merith Basey, Executive Director for Universities Allied for Essential Medicines, a student-led movement that aims to change universities’ licensing practices told us: “Emory University has betrayed its mission to serve humanity by stifling global access to a potentially life-saving COVID treatment. Molnupiravir was developed on Emory’s campus with massive amounts of tax-payer funding, yet this license includes a stipulation demanding a no-patent challenge. We call on the institution to remove the clause and favor people over profit in the midst of a global pandemic that has killed over 5 million people so far.” Image Credits: Merck , Merck . Liver Cancer: Europe’s Public Health Ticking Time Bomb 27/10/2021 Thomas Berg & Maria Buti October is Liver Cancer Awareness month, and Europe has a liver cancer problem. Over the past two decades, there has been a 70% increase in liver cancer-related mortality in the region. In 2020, 87,000 Europeans were diagnosed with liver cancer while 78,000 died from the disease in the same year. Late diagnosis is a serious problem. About half of patients are only diagnosed in an advanced stage of cancer and have less than a year to live. Liver cancer is the sixth most common cancer and the third biggest cause of cancer-related deaths globally. In the US, the rate of deaths from liver cancer increased by 40% from 1990 to 2004 while the overall rate of non-liver cancer deaths declined by 18%. Projections for the US estimate that in 2030, liver cancer will be the third-leading cause of cancer-related deaths, surpassing breast, colorectal, and prostate cancers. There are many risk factors for developing liver cancer, and chronic liver diseases caused by viral hepatitis, alcohol, or fatty liver disease are the most important. Diabetes and obesity Non-alcohol fatty liver disease (NAFLD), which is often a consequence of obesity and diabetes, is the leading cause of death among 35 to 49-year-olds in the UK, making NAFLD a health threat that should not be underestimated. (The more severe form of NAFLD is called nonalcoholic steatohepatitis, or NASH). Outside of COVID-19, NAFLD is also about the fastest growing disease globally. It occurs in about one in four people around the world and has emerged as the most prominent cause of chronic liver disease. Experts predict that, over the next decade, NAFLD will become the leading cause of end-stage liver disease and liver transplantation. It is already the fastest-growing cause of hepatocellular carcinoma (HCC), the most common form of liver cancer worldwide. Faced with a ticking public health time bomb in Europe, we are clearly in a race against time to both prevent and treat this disease before the epidemic worsens and overwhelms health systems. Better treatment access Treatment of chronic liver diseases to avoid their progression to precancerous states like cirrhosis significantly reduces the risk of liver cancer, and this has been convincingly demonstrated. Improved and equal access to state-of-the-art management of these diseases is a core element in the fight against liver cancer. Although liver cancer remains one of the few cancers with increasing incidence and mortality, public awareness of liver cancer is much lower than for other cancers. As a consequence, patients who have liver cancer and patients who are at increased risk for liver cancer often face stigma in their social lives, and also in the medical settings. Treatment options for liver cancer have significantly improved over the recent years, which makes early diagnosis the most critical point. Case-finding strategies need to be implemented, at least in at-risk patients, as strongly recommended by clinical guidelines. Hepatitis B vaccinations Finally, we must directly tackle the key environmental factors that cause liver diseases and liver cancer. In addition, successful Hepatitis B vaccination programmes need to be continued and expanded as the core element of primary liver cancer prevention as it has the potential to prevent roughly twice as many cancer cases as HPV vaccination. Earlier this year the European Commission launched its Beating Cancer Plan in response to the fact that the EU region is home to a quarter of the world’s cancer cases and is facing an annual economic impact of €100 billion if urgent action is not taken. This plan is precisely what is needed to bring scientific societies, experts and patient groups together to move forward measures that can go a long way towards stopping liver cancer in its tracks. But these measures need to be coordinated across the region, led by the European Commission, and implemented by EU Member States. A starting point has to be the setting of standards for awareness, prevention, and management of liver cancer across the region. It is pivotal that we educate and raise awareness amongst everyone: healthcare professionals, patients and families, risk groups, policymakers and the general public. Liver cancer usually occurs as a consequence of underlying chronic liver disease and cirrhosis. Thus, the EU and Member States should implement preventive measures that include evidence-based strategies to reduce the burden of liver disease, focusing on reducing alcohol consumption and obesity, and on early detection and treatment of chronic liver disease. Early detection is critical for those patients with liver diseases associated with a high risk of liver cancer such viral hepatis B and C, alcohol-related and non-alcoholic fatty liver disease. The EU and Member States should add liver cancer to their screening list, at least for patients with underlying risk factors. In addition, existing programs providing the opportunity of early case finding of liver diseases should be leveraged where possible. The salivary screening for Hepatitis C using point of care testing is a good example and complements the WHO HCV program aiming at fighting HCC as well. Inter-disciplinary disease management But we also need improved access to better disease management for patients with liver cancer across all member states of the EU. This means a more structured pathway for the diagnosis and treatment of patients when they are receiving care in hospital, as an outpatient and then at home. That will require better inter-disciplinary cooperation between hepatology, oncology and other relevant disciplines and ideally collaborative clinical guidelines that are driven by comprehensive scientific evidence. Basic research continues to be a critical element for improving patient outcomes in liver cancer. There is still further knowledge needed about aetiology, rare liver cancer entities, markers and diagnostics which might facilitate early detection even in primary care. The EU and Member States should support such research projects and cross-country collaboration by setting up EU-wide platforms with the aim of sharing data and closing the gap between medical knowledge and clinical practice. The high standard of care in the EU is based on high-level science and research. In order to maintain these standards furthermore and drive improvements, it is essential to collect data collaboratively across all member states. The EU and Member States should support the setting up of specific patient registries for liver cancer. The collation of this data would facilitate surveillance, research and the overall management of patients with liver cancer. Care must be patient-centric. People living with liver cancer and their families should have unrestricted access to information, medical treatment, and measures to improve their quality of life, regardless of their life situation and ethnic origin. All patients with liver cancer should benefit from the same high standards of care wherever they are in Europe. Thomas Berg is the Secretary-General of the European Association for the Study of the Liver (EASL) and Head of the Division of Hepatology at Leipzig University Medical Center in Germany. Maria Buti is the EASL EU Policy Councillor and Professor of Medicine and Chief of Internal Medicine and Hepatology at the Hospital General Universitari Valle Hebron in Barcelona, Spain. US ‘Steps Aside’ to Give Africa Access to Moderna Vaccines 26/10/2021 Kerry Cullinan Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) The US government has enabled Africa to get access to 50 million Moderna COVID-19 vaccines by giving the continent its place in the vaccine queue, Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) said on Tuesday. “This is a time swap arrangement whereby the United States government basically stood aside for the next quarter so that we could access vaccines and purchase them ourselves,” Masiyiwa told a media briefing of the Africa Centers for Disease Control (CDC). AVAT will get 15 million Moderna doses in December and a further 35 million between January and March. It also has an option to buy 60 million more, delivered at 20 million doses per month, between April and June. “These doses are being purchased by AVAT courtesy of the United States government, which has been phenomenal in its support,” he added. South Africa’s President Cyril Ramaphosa and Kenya’s President Uhuru Kenyatta negotiated the deal directed with US President Joe Biden, said Masiyiwa. Other than a deal with Johnson and Johnson (J&J) for 400 million vaccines over 13 months from August, “none of the vaccine suppliers had any doses for us this year,” said Masiyiwa. The Africa Union has been able to get the J&J vaccines largely because they are being assembled by Aspen in South Africa – but even ensuring that these doses remained on the continent required reaching an agreement with the European Union, which initially planned to import the African-assembled vaccines. Jessye Lapenn, the US Ambassador to the African Union, praised AVAT’s leadership and expressed her country’s support for the continent’s vaccination efforts. The White House confirmed that it would defer the delivery of about 33 million Moderna vaccines to enable the African Union to buy the doses. Masiyiwa said the African Union’s long-term vision was for Moderna to reach a fit-and-fill agreement with an African manufacturer. The company recently announced that it wants to build a $500 million mRNA vaccine manufacturing facility in Africa. “We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe, said Moderna CEO Stéphane Bancel. Moderna said that it was “working on plans to allow it to fill doses of its COVID-19 vaccine in Africa as early as 2023, in parallel to building an mRNA vaccine manufacturing facility in Africa”. Moderna, which received millions of dollars in R&D support from the US government, has been under pressure from the Biden administration to supply low and middle income countries with vaccines. AVAT is currently supplying 39 African countries and 15 Caribbean countries, but only 8,7% of Africans have had at least one vaccine dose. Meanwhile, COVAX revealed on Monday that less than 10% of vaccine donations pledged to it by wealthy countries had been delivered. Of the 1.3 billion COVID-19 vaccine dose donations promised to COVAX by wealthy countries, only 150 million doses have actually arrived – around 9% – Gavi CEO Dr Seth Berkley told the World Health Summit. Joining the Africa CDC press briefing on Tuesday, Berkley said that COVAX had supplied 40% of Africa’s vaccine doses but the facility had experienced a major slowdown after India banned the export of AstraZeneca vaccines made it its country although COVAX had already paid for the vaccines. Debt Relief & National Economic Reforms Pitched as ‘Big Picture’ Global Health Solutions Ahead of G-20 Meeting 26/10/2021 Elaine Ruth Fletcher WHO Director General Dr Tedros Adhanom Ghebreyesus and Mariana Mazzucato, chair of the new WHO Council on the Economics of Health for All. An ambitious wish list of global economic and fiscal measures that the world should adopt to combat the COVID-19 pandemic has been floated by the World Health Organization- just ahead of a critical G-20 meeting of the world’s most industrialized nations this weekend. These include proposals for massive debt relief to debt-ridden countries and a re-direction of the IMF’s new offer of $US650 billion in “special drawing rights” away from richer nations to low- and middle-income countries. The laundry list of macroeconomic and fiscal measures proposed by the new WHO Council on the Economics of Health for All, was detailed today at one of the final sessions of the World Health Summit. Drafted by 10 top economists and health policy experts, Financing Health for All pushes the classic debates over access to medicines and health systems investments – into the realm of much broader fiscal and economic decisions that nations, both rich and poor need to make, according to the experts. That is, if they really want to beat down COVID-19 as well as prepare for the next pandemic. ‘Donor mentality’ is part of the problem WHO Director General, Dr Tedros Adhanom Ghebreyesus “It proposes a radical shift in economic thinking for global health,” said WHO Director General Dr Tedros Adhanom Ghebreyesus at the WHS session. He appeared with Mariana Mazzucato, Founding Director of the UCL Institute for Innovation and Public Purpose, and chair of the new health economics Council, which was launched by WHO in May 2021. “Instead of looking at health as a piece of the economy, it’s time to look at how the economy can support the societal goal of health for all,” said the WHO Director General. “Neither existing market mechanisms, with their focus on short term returns, nor development funds alone are enough,” he added. “They do not provide the global public goods on which we all depend, such as vaccines, nor do they address the major inequities, undermining equitable access. “The council is proposing bold, concrete actions for governments and multilateral organizations in three major areas, creating fiscal space, the direction of investment, and the governance of public and private financing for how this does not just mean more money. It means making the better, smarter and sustained investments that are needed to achieve health for all.” “We have to realize that this donor mentality is actually part of the problem,”said Mazzucato, “And that lots of the conditionalities that were set in the past on the loans provided to developing countries precisely made them weaker. The key priorities outlined by the brief, prepared by the ten-member expert group includes proposals that would leverage change from global to national level so as to: Create more “fiscal space” for countries to invest more in health, including through measures like international debt relief, a global corporate tax rate and a greater allocation to low-income countries of newly available IMF special drawing rights; Reshape national, tax, regulatory and investment rules to make them more favorable to health-related investments, e.g. in health systems and vaccine and medicines manufacture; Ensure stronger governance for private health markets – notably pharma innovators and manufacturers – using public regulations and investments to “crowd in and direct private finance towards improving health outcomes globally and equitably.” Other members of the Council include Vera Songwe, Executive Secetary of the Economic Commission for Africa; economists such as Jayata Ghosh, of the University of Massachusetts and Stephanie Kelton an expert on monetary policy at Stony Brook University; investment banker Vanessa Huang, and global health professionals such as Ilona Kickbusch, founding director of the Geneva Graduate Institute’s Global Health Centre; Senait Fissehea, of the University of Michigan; and planetary health expert Kate Raworth, of Oxford University’s Environmental Change Institute. More “quality money” – to fight the next pandemic Mariana Mazzucato, chair fo the new WHO Council on the Economics of Health for All Just “more money” is not enough to drive bigger investments in countries with poor-performing health systems, stressed Mazzucato, it needs to be “quality money” – money that does not translate into more crippling loan repayments once the initial phase of the pandemic crisis has passed. “Multilateral organizations should negotiate debt relief for low and middle income countries in such an important moment,…. redirecting [IMF] Special Drawing Rights towards investment in health, and especially vaccines,” she said. IMF special drawing rights are not considered as loans in the traditional sense of the word, but rather bolster countries’ reserves and thus their overall economic stability. “False constraints have been imposed on government’s fiscal spaces, often by multilateral institutions like the IMF and the World Bank.” Crippling debt restrictions and austerity measures traditionally have hit hardest on social welfare nets, including public health systems, meaning that low- and middle-income countries “weren’t allowed to create the kind of fiscal space that we highlight as the first key pillar,” she observed. “Over time, we have to be better prepared and that preparedness needs to be, in the long run, built on the ability to have a distributed manufacturing and industrial capacity [for health products] globally. “Because this will not be the last pandemic, you know. As the permafrost melts, apparently, there’s going to be all sorts of other viruses that come about. Climate change and this health crisis are really interlinked.” Along with debt relief the G-20 should advance credit rating reforms and “push for the enforcement of a minimum global corporate tax of at least 15%,” she added. National investment priorities Finance and health authorities need to work together more closely to expand local medicines and vaccine production and improve health systems. But as the brief underlines, the challenge is not only to reduce international pressures, through measures such as debt relief, but also to “change mindsets within countries that impose internal constraints on spending” – often in the name of false economies and fiscal prudence. That means a better understanding and alignment in Finance Ministries, of the importance of health priorities. “The bottom line is that countries must reverse the harmful effects of an austerity approach to public administration and public finance reforms,” said Mazzucato. She pointed to Kerala State, in India, as an example of a region that fared better because it focused investment into public health systems. “Internal constraints on government budgets are not insurmountable and governments actually have more room for increasing the fiscal limits on investments for health than they’re led to believe. “And it’s not just a matter of political choice, but also when a political will whether country can mobilize all the resources and levers that can to maximizing financing for health, such as innovative monetary policy, but also…, procurement policies using different levers – grants, loans, procurement to really catalyze new solutions…. “When we go to war, money is found, and during a health pandemic, money has been found, but that has been too little too late,” she observed. Public-Private sector should share ‘risks and rewards’ of innovation Finally, public-private sector relationships around critical issues such as vaccines and medicines innovation and manufacture need a reboot, the brief argues, sharing both the “risks and rewards” of innovation, in the words of Mazzucato – rather than leaving public entities to shoulder the risks while the private sector reaps most of the rewards. “We need public actors, we need philanthropies, but they need to work together in a different way,” she said. That means public contracts, loans, grants and other incentives that are offered to the private sector to develop new and more innovative vaccines, tests and treatments also need to come along with stronger conditions about how the final products they create may be used or distributed. “And this can be done by redesigning the terms and the conditions, structuring contracts, grants, transfers loans and partnerships between public and private actors. “Precisely because the public sector puts in so much of the money – especially in the early stage when it’s more risky and more capital intensive, and uncertain – these critical market-shaping public investments should ensure conditionalities around pricing – to make sure that we have access at the core -that we have vaccines that are globally accessible. Innovation – global, end-to-end and governed collectively In terms of intellectual property rights, she added that “it’s not about getting rid of patents, but we have to govern innovation and the patent system, with objectives in mind. “Making sure that patents are not too wide, too strong, hard to license upstream are core ways to govern the patent system. “It’s not about getting rid of patents, we have to govern innovation, and the patent system with objectives in mind,” she said. “More broadly, we need to shape a conducive regulatory tax, industrial and economic policy environment to ‘crowd in’ all sorts of different sources of finance at the same time, ensuring that we get the greatest multiplier effect, the greatest impact on health for all. Ultimately, however, she stressed that global health innovation platforms need to be “global, end-to-end, and governed collectively – shifting from a model where innovation is left to the market to a model aimed at delivering global common goods.” Image Credits: Marco Verch/Flickr. Civil Society Activists Question Pandemic Treaty’s Ability to Address Global Health Inequalities 26/10/2021 Kerry Cullinan A session of the 2020 World Health Assembly. Some civil society organisations (CSO) are sceptical about whether a ‘pandemic treaty’ is the best way to address future global health crises, while treaty supporters say it will provide a legal framework binding countries and global health bodies to more agile and rapid responses to future outbreaks. A session Monday sponsored by the Geneva Global Health Hub (G2H2) brought leading CSOs, diplomats, academics and even WHO’s chief legal counsel face to face to air those views, in the context of a research initiative on the treaty being undertaken by the hub. The debate comes just weeks ahead of a planned special session of the World Health Assembly which is to determine whether the global body will indeed move forward on a Treaty, as a key measure for improving pandemic response. The treaty initiative has been supported most visibly by European countries, led by European Commission President, Charles Michel, who in a separate session at the World Health Summit in Berlin that the treaty would guarantee “access to information, financing, vaccines and countermeasures. It would increase capacity and resilience – at all levels.” With @DrTedros we proposed an international #PandemicTreaty rooted in @WHO constitution. It would guarantee equity & inclusiveness. A legally binding instrument would be the most effective basis for prevention, surveillance, collection and exchange of scientific data.#WHS2021 pic.twitter.com/lbWkc3G5XE — Charles Michel (@eucopresident) October 25, 2021 Diversion or game changer? 25 heads of government and international agencies have come together in support of the new pandemic treaty Some of the civil society organisations that have expressed disquiet about the treaty proposal perceive it as a potential distraction or diversion by wealthy countries from the so-called TRIPS waiver proposal, currently under consideration by thee World Trade Organization. The proposal by South Africa and India for a broad-based intellectual property waiver on COVID vaccines and treatments, now being debated by the WTO’s TRIPS Council , is perceived by civil society as a game changer that would help open the doors to despearately needed COVID vaccine and medicines manufacturing in Africa and the global South. Many of the European countries that have been among the most staunch opponents of the TRIPS waiver are also key pandemic treaty supporters, noted journalist Priti Patnaik, who is researching stakeholders’ views on the pandemic treaty for G2H2 -giving rise to the CSO suspicions. And yet at the same time, some developing countries have supported a pandemic treaty because they believe it would “rein in the influence of non-state actors, including powerful foundations, and get some binding obligations to apply to industry to avoid vaccine inequities in the future,” she added. ‘Switch-and-bait’ tactic Unni Karunakara, senior fellow at Yale’s Global Health Justice Partnership, said that the major focus should be on deploying available tools and medicines to every corner of the world, rather than negotiations over a new treaty: “Shouldn’t global vaccination coverage be an overwhelming priority now?” he asked. “We do have frameworks and tools. They’re not perfect, but there are enough tools for us to overcome this crisis together,” said Karunakara, a former president of Medecins sans Frontieres. “What is lacking, however, is the political will to share essential resources and tools, even with all of the treaties in place.” His comments reflecting the cynicism of other civil society activists who see “a big overlap between the countries that are blocking the TRIPS waiver, and the countries that are supporting the pandemic treaty. “So there’s a perception of a ‘switch-and-bait’ tactic that reeks of bad faith,” he added. And while transparency measures – such as the mandatory sharing of genetic materials by countries where outbreaks are suspected – have been discussed as key treaty features, similar mandates for transparency or sharing of vaccines and medicines technologies have been fiercely opposed by the EU, he pointed out. “TRIPS waiver-blocking countries have made the case for voluntary actions by pharma to ensure access to essential COVID-19 medical tools, so they treat Big Pharma with kid gloves,” Karunakara observered. “Interestingly, they take a very different tone and approach to the global south in the treaty, insisting on enforceability in the sharing of information and materials with WHO and other governments to allow for independent verification.” “The assumption here is that global south is the problem, that diseases originated in poor country, and pose national security risks to rich countries.” If you are against the treaty – what is your multilateral alternative? Björn Kümmel, at the WHO Executive Board’s January 2021 meeting. Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver – or the kinds of hidden agendas that civil society groups fear. “I doubt that it’s, from a logical point of view, right to say that even though a country has it stands on the TRIPS waiver, you can’t tackle other equity issues,” he told the G2H2 session. “That’s one angle to look at, the TRIPS waiver, but there are many more angles to be looked at. So to say that that is the only magic bullet, I think that would be fully wrong, I wouldn’t limit it to this. “I think that equity goes far beyond, and certainly, if a treaty was negotiated, it’s quite clear that this [TRIPS waive] will be put on the table, and that all governments will have to look at the different interests that are on the table and negotiate them with an open outcome.” He noted that the treaty was first proposed formally by Chile, not the European Commission, and has the support of a wide array of countries, including South Africa, Kenya, and Tunisia, as well as Thailand and Indonesia. Anything better than ‘Chaos’ we see now Describing the current global health situation as “dysfunctional”, Kümmel asked the G2H2 session: “If you are against the treaty, tell us what is your multilateral alternative to it, to be realistically implemented, lets say in the next five years?” “What the countries who are proposing a treaty are trying to say is: anything is better, than compared to the chaos that we’re seeing currently. “Legal clarity is needed, and it will be …a painful exercise for many of us, and most likely a difficult one for many governments, including mine, most likely also others. But in the end, it’s this is multilateralism.” Uniquely in the global health landscape – and unlike environment, trade or finance – there is a dearth of global treaty instruments. In fact, among the dozens of international treaties in force today, the only two binding instruments in global health today are the IHR and and the Framework Convention on Tobacco Control (FCTC), he pointed out. Pandemic is a ‘window of opportunity’ for bigger changes In light of the outstanding questions, however, the working group of countries that are preparing for the WHA special session had devised a “three-step approach” to their deliberations on a way forward. They are considering in parallel: WHO internal reform measures; revisions in the existing International Health Regulations that currently govern global emergency response; and finally, the Pandemic Treaty alternative. In terms of WHO reform, the conclusion has been that such measures would “not be sufficient in order to overcome the next pandemic,” Kümmel said. Amendments to the International Health Regulations (IHR) also would take time to negotiate. And a key question here is: “would they be a game changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” So against the other options, “an international binding agreement is interesting,” he said. “And why are many colleagues pushing for this to happen now? Well, it’s the reality that after Ebola and past pandemics the global community was unable to implement the lessons learned,” he said. And if negotiations don’t begin now, in the heat of the ongoing crisis, they will never happen at all. “Many of the international independent panels have called for bold recommendations to be implemented,” Kümmel reminded the group. “One of them is the treaty. But many of those recommendations have never reached successful implementation, because the window of opportunity for real structural changes normally vanishes with the next crisis to come after the pandemic.” The treaty would also retain WHO’s centrality as the nerve center of the global health architecture – amidst a plethora of new health initiatives emerging in Europe and elsewhere: “There are a multitude of ideas and recommendations, and the treaty is a legal framework into which most of the other recommendations would fit,” he said, in reference to recent proposals such as one by the Pan European Commission on Health and Sustainable Development to create a new global health board under G-20 auspices. Others have talked about a new global health finance board in association with the World Bank and/or a new UN-level Global Health Threats Council, under the auspices of the UN General Assembly. So the Pandemic Treaty is “also a mechanism to provide WHO with legitimacy after this crisis,” he stressed. “Obviously there are voices out there who could see alternative approaches. However, I think the ones who are in favour of this treaty have clearly articulated that WHO is the right forum because its the truly multilateral forum for global health.” WHO precedents for equitable access to vaccines? Germany is not the only actor that sees the treaty as a means of keeping WHO as the world’s main global health meeting place. WHO’s Director General Dr Tedros Adhanom Ghebreyesus has himself come out in support for the pandemic treaty measure – breaking ranks with previous agency heads who usually remained aloof of controversial measures under consideration by member states. WHO is therefore keenly interested in how civil society groups may help lead or shape views on the treaty negotiations – and this interest was reflected in a cameo appearance at the G2H2 event by Stephen Solomon, WHO’s principal legal officer. Solomon said it was “really helpful” to understand some of the “scepticism” around the pandemic treaty initiatives. “Understanding the the concern about an agenda driven issue here is very important for the [WHO] Secretariat,” Solomon told the group. At the same time, beyond the immediate COVID crisis, other WHO emergency response frameworks already in place also could perhaps benefit from the stronger legal backpone that a pandemic treaty might provide, he pointed out. One example is the Pandemic Influenza Preparedness (PIP) framework, which mandates that 10% of global flu pandemic vaccine production supply goes to WHO for direct distribution, based upon public health needs. Another is WHO’s Global Action Plan for influenza vaccines. These “are meant to address equity issues in a number of epidemics, not necessarily pandemics,” Solomon said. “I would be very interested in reactions to particular frameworks meant to address inequities, like the pandemic influenza preparedness (PIP) framework, not legally binding. Or like the WHO Global Action Plan (GAP) for influenza vaccines, also not legally binding. “But both are interesting and potentially of important reference to pandemic preparedness and response. PIP basically says 10% of global pandemic vaccine production supply goes to WHO for distribution on the declaration of an influenza pandemic for distribution based on public health needs, and we have legally binding contracts for that 10%,” said Solomon. “Could that be a reference point for responding to future pandemics? “If so, would it be useful to put that in more of a legal framework because of weaknesses within that structure – particularly the idea of countries not allowing export for vaccines already under contract?” Solomon asked. Similarly, the Global Action Plan for influenza vaccines was a 10-year, non-binding arrangement that aimed to better distribute capacity for flu vaccine production, including among low- and middle-income member states, he pointed out, asking: “Could that also benefit, or not, from a normatively binding architecture?” The final research report will be launched by G2H2 on 24 November. –Elaine Ruth Fletcher contributed to the writing of this story. 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Liver Cancer: Europe’s Public Health Ticking Time Bomb 27/10/2021 Thomas Berg & Maria Buti October is Liver Cancer Awareness month, and Europe has a liver cancer problem. Over the past two decades, there has been a 70% increase in liver cancer-related mortality in the region. In 2020, 87,000 Europeans were diagnosed with liver cancer while 78,000 died from the disease in the same year. Late diagnosis is a serious problem. About half of patients are only diagnosed in an advanced stage of cancer and have less than a year to live. Liver cancer is the sixth most common cancer and the third biggest cause of cancer-related deaths globally. In the US, the rate of deaths from liver cancer increased by 40% from 1990 to 2004 while the overall rate of non-liver cancer deaths declined by 18%. Projections for the US estimate that in 2030, liver cancer will be the third-leading cause of cancer-related deaths, surpassing breast, colorectal, and prostate cancers. There are many risk factors for developing liver cancer, and chronic liver diseases caused by viral hepatitis, alcohol, or fatty liver disease are the most important. Diabetes and obesity Non-alcohol fatty liver disease (NAFLD), which is often a consequence of obesity and diabetes, is the leading cause of death among 35 to 49-year-olds in the UK, making NAFLD a health threat that should not be underestimated. (The more severe form of NAFLD is called nonalcoholic steatohepatitis, or NASH). Outside of COVID-19, NAFLD is also about the fastest growing disease globally. It occurs in about one in four people around the world and has emerged as the most prominent cause of chronic liver disease. Experts predict that, over the next decade, NAFLD will become the leading cause of end-stage liver disease and liver transplantation. It is already the fastest-growing cause of hepatocellular carcinoma (HCC), the most common form of liver cancer worldwide. Faced with a ticking public health time bomb in Europe, we are clearly in a race against time to both prevent and treat this disease before the epidemic worsens and overwhelms health systems. Better treatment access Treatment of chronic liver diseases to avoid their progression to precancerous states like cirrhosis significantly reduces the risk of liver cancer, and this has been convincingly demonstrated. Improved and equal access to state-of-the-art management of these diseases is a core element in the fight against liver cancer. Although liver cancer remains one of the few cancers with increasing incidence and mortality, public awareness of liver cancer is much lower than for other cancers. As a consequence, patients who have liver cancer and patients who are at increased risk for liver cancer often face stigma in their social lives, and also in the medical settings. Treatment options for liver cancer have significantly improved over the recent years, which makes early diagnosis the most critical point. Case-finding strategies need to be implemented, at least in at-risk patients, as strongly recommended by clinical guidelines. Hepatitis B vaccinations Finally, we must directly tackle the key environmental factors that cause liver diseases and liver cancer. In addition, successful Hepatitis B vaccination programmes need to be continued and expanded as the core element of primary liver cancer prevention as it has the potential to prevent roughly twice as many cancer cases as HPV vaccination. Earlier this year the European Commission launched its Beating Cancer Plan in response to the fact that the EU region is home to a quarter of the world’s cancer cases and is facing an annual economic impact of €100 billion if urgent action is not taken. This plan is precisely what is needed to bring scientific societies, experts and patient groups together to move forward measures that can go a long way towards stopping liver cancer in its tracks. But these measures need to be coordinated across the region, led by the European Commission, and implemented by EU Member States. A starting point has to be the setting of standards for awareness, prevention, and management of liver cancer across the region. It is pivotal that we educate and raise awareness amongst everyone: healthcare professionals, patients and families, risk groups, policymakers and the general public. Liver cancer usually occurs as a consequence of underlying chronic liver disease and cirrhosis. Thus, the EU and Member States should implement preventive measures that include evidence-based strategies to reduce the burden of liver disease, focusing on reducing alcohol consumption and obesity, and on early detection and treatment of chronic liver disease. Early detection is critical for those patients with liver diseases associated with a high risk of liver cancer such viral hepatis B and C, alcohol-related and non-alcoholic fatty liver disease. The EU and Member States should add liver cancer to their screening list, at least for patients with underlying risk factors. In addition, existing programs providing the opportunity of early case finding of liver diseases should be leveraged where possible. The salivary screening for Hepatitis C using point of care testing is a good example and complements the WHO HCV program aiming at fighting HCC as well. Inter-disciplinary disease management But we also need improved access to better disease management for patients with liver cancer across all member states of the EU. This means a more structured pathway for the diagnosis and treatment of patients when they are receiving care in hospital, as an outpatient and then at home. That will require better inter-disciplinary cooperation between hepatology, oncology and other relevant disciplines and ideally collaborative clinical guidelines that are driven by comprehensive scientific evidence. Basic research continues to be a critical element for improving patient outcomes in liver cancer. There is still further knowledge needed about aetiology, rare liver cancer entities, markers and diagnostics which might facilitate early detection even in primary care. The EU and Member States should support such research projects and cross-country collaboration by setting up EU-wide platforms with the aim of sharing data and closing the gap between medical knowledge and clinical practice. The high standard of care in the EU is based on high-level science and research. In order to maintain these standards furthermore and drive improvements, it is essential to collect data collaboratively across all member states. The EU and Member States should support the setting up of specific patient registries for liver cancer. The collation of this data would facilitate surveillance, research and the overall management of patients with liver cancer. Care must be patient-centric. People living with liver cancer and their families should have unrestricted access to information, medical treatment, and measures to improve their quality of life, regardless of their life situation and ethnic origin. All patients with liver cancer should benefit from the same high standards of care wherever they are in Europe. Thomas Berg is the Secretary-General of the European Association for the Study of the Liver (EASL) and Head of the Division of Hepatology at Leipzig University Medical Center in Germany. Maria Buti is the EASL EU Policy Councillor and Professor of Medicine and Chief of Internal Medicine and Hepatology at the Hospital General Universitari Valle Hebron in Barcelona, Spain. US ‘Steps Aside’ to Give Africa Access to Moderna Vaccines 26/10/2021 Kerry Cullinan Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) The US government has enabled Africa to get access to 50 million Moderna COVID-19 vaccines by giving the continent its place in the vaccine queue, Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) said on Tuesday. “This is a time swap arrangement whereby the United States government basically stood aside for the next quarter so that we could access vaccines and purchase them ourselves,” Masiyiwa told a media briefing of the Africa Centers for Disease Control (CDC). AVAT will get 15 million Moderna doses in December and a further 35 million between January and March. It also has an option to buy 60 million more, delivered at 20 million doses per month, between April and June. “These doses are being purchased by AVAT courtesy of the United States government, which has been phenomenal in its support,” he added. South Africa’s President Cyril Ramaphosa and Kenya’s President Uhuru Kenyatta negotiated the deal directed with US President Joe Biden, said Masiyiwa. Other than a deal with Johnson and Johnson (J&J) for 400 million vaccines over 13 months from August, “none of the vaccine suppliers had any doses for us this year,” said Masiyiwa. The Africa Union has been able to get the J&J vaccines largely because they are being assembled by Aspen in South Africa – but even ensuring that these doses remained on the continent required reaching an agreement with the European Union, which initially planned to import the African-assembled vaccines. Jessye Lapenn, the US Ambassador to the African Union, praised AVAT’s leadership and expressed her country’s support for the continent’s vaccination efforts. The White House confirmed that it would defer the delivery of about 33 million Moderna vaccines to enable the African Union to buy the doses. Masiyiwa said the African Union’s long-term vision was for Moderna to reach a fit-and-fill agreement with an African manufacturer. The company recently announced that it wants to build a $500 million mRNA vaccine manufacturing facility in Africa. “We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe, said Moderna CEO Stéphane Bancel. Moderna said that it was “working on plans to allow it to fill doses of its COVID-19 vaccine in Africa as early as 2023, in parallel to building an mRNA vaccine manufacturing facility in Africa”. Moderna, which received millions of dollars in R&D support from the US government, has been under pressure from the Biden administration to supply low and middle income countries with vaccines. AVAT is currently supplying 39 African countries and 15 Caribbean countries, but only 8,7% of Africans have had at least one vaccine dose. Meanwhile, COVAX revealed on Monday that less than 10% of vaccine donations pledged to it by wealthy countries had been delivered. Of the 1.3 billion COVID-19 vaccine dose donations promised to COVAX by wealthy countries, only 150 million doses have actually arrived – around 9% – Gavi CEO Dr Seth Berkley told the World Health Summit. Joining the Africa CDC press briefing on Tuesday, Berkley said that COVAX had supplied 40% of Africa’s vaccine doses but the facility had experienced a major slowdown after India banned the export of AstraZeneca vaccines made it its country although COVAX had already paid for the vaccines. Debt Relief & National Economic Reforms Pitched as ‘Big Picture’ Global Health Solutions Ahead of G-20 Meeting 26/10/2021 Elaine Ruth Fletcher WHO Director General Dr Tedros Adhanom Ghebreyesus and Mariana Mazzucato, chair of the new WHO Council on the Economics of Health for All. An ambitious wish list of global economic and fiscal measures that the world should adopt to combat the COVID-19 pandemic has been floated by the World Health Organization- just ahead of a critical G-20 meeting of the world’s most industrialized nations this weekend. These include proposals for massive debt relief to debt-ridden countries and a re-direction of the IMF’s new offer of $US650 billion in “special drawing rights” away from richer nations to low- and middle-income countries. The laundry list of macroeconomic and fiscal measures proposed by the new WHO Council on the Economics of Health for All, was detailed today at one of the final sessions of the World Health Summit. Drafted by 10 top economists and health policy experts, Financing Health for All pushes the classic debates over access to medicines and health systems investments – into the realm of much broader fiscal and economic decisions that nations, both rich and poor need to make, according to the experts. That is, if they really want to beat down COVID-19 as well as prepare for the next pandemic. ‘Donor mentality’ is part of the problem WHO Director General, Dr Tedros Adhanom Ghebreyesus “It proposes a radical shift in economic thinking for global health,” said WHO Director General Dr Tedros Adhanom Ghebreyesus at the WHS session. He appeared with Mariana Mazzucato, Founding Director of the UCL Institute for Innovation and Public Purpose, and chair of the new health economics Council, which was launched by WHO in May 2021. “Instead of looking at health as a piece of the economy, it’s time to look at how the economy can support the societal goal of health for all,” said the WHO Director General. “Neither existing market mechanisms, with their focus on short term returns, nor development funds alone are enough,” he added. “They do not provide the global public goods on which we all depend, such as vaccines, nor do they address the major inequities, undermining equitable access. “The council is proposing bold, concrete actions for governments and multilateral organizations in three major areas, creating fiscal space, the direction of investment, and the governance of public and private financing for how this does not just mean more money. It means making the better, smarter and sustained investments that are needed to achieve health for all.” “We have to realize that this donor mentality is actually part of the problem,”said Mazzucato, “And that lots of the conditionalities that were set in the past on the loans provided to developing countries precisely made them weaker. The key priorities outlined by the brief, prepared by the ten-member expert group includes proposals that would leverage change from global to national level so as to: Create more “fiscal space” for countries to invest more in health, including through measures like international debt relief, a global corporate tax rate and a greater allocation to low-income countries of newly available IMF special drawing rights; Reshape national, tax, regulatory and investment rules to make them more favorable to health-related investments, e.g. in health systems and vaccine and medicines manufacture; Ensure stronger governance for private health markets – notably pharma innovators and manufacturers – using public regulations and investments to “crowd in and direct private finance towards improving health outcomes globally and equitably.” Other members of the Council include Vera Songwe, Executive Secetary of the Economic Commission for Africa; economists such as Jayata Ghosh, of the University of Massachusetts and Stephanie Kelton an expert on monetary policy at Stony Brook University; investment banker Vanessa Huang, and global health professionals such as Ilona Kickbusch, founding director of the Geneva Graduate Institute’s Global Health Centre; Senait Fissehea, of the University of Michigan; and planetary health expert Kate Raworth, of Oxford University’s Environmental Change Institute. More “quality money” – to fight the next pandemic Mariana Mazzucato, chair fo the new WHO Council on the Economics of Health for All Just “more money” is not enough to drive bigger investments in countries with poor-performing health systems, stressed Mazzucato, it needs to be “quality money” – money that does not translate into more crippling loan repayments once the initial phase of the pandemic crisis has passed. “Multilateral organizations should negotiate debt relief for low and middle income countries in such an important moment,…. redirecting [IMF] Special Drawing Rights towards investment in health, and especially vaccines,” she said. IMF special drawing rights are not considered as loans in the traditional sense of the word, but rather bolster countries’ reserves and thus their overall economic stability. “False constraints have been imposed on government’s fiscal spaces, often by multilateral institutions like the IMF and the World Bank.” Crippling debt restrictions and austerity measures traditionally have hit hardest on social welfare nets, including public health systems, meaning that low- and middle-income countries “weren’t allowed to create the kind of fiscal space that we highlight as the first key pillar,” she observed. “Over time, we have to be better prepared and that preparedness needs to be, in the long run, built on the ability to have a distributed manufacturing and industrial capacity [for health products] globally. “Because this will not be the last pandemic, you know. As the permafrost melts, apparently, there’s going to be all sorts of other viruses that come about. Climate change and this health crisis are really interlinked.” Along with debt relief the G-20 should advance credit rating reforms and “push for the enforcement of a minimum global corporate tax of at least 15%,” she added. National investment priorities Finance and health authorities need to work together more closely to expand local medicines and vaccine production and improve health systems. But as the brief underlines, the challenge is not only to reduce international pressures, through measures such as debt relief, but also to “change mindsets within countries that impose internal constraints on spending” – often in the name of false economies and fiscal prudence. That means a better understanding and alignment in Finance Ministries, of the importance of health priorities. “The bottom line is that countries must reverse the harmful effects of an austerity approach to public administration and public finance reforms,” said Mazzucato. She pointed to Kerala State, in India, as an example of a region that fared better because it focused investment into public health systems. “Internal constraints on government budgets are not insurmountable and governments actually have more room for increasing the fiscal limits on investments for health than they’re led to believe. “And it’s not just a matter of political choice, but also when a political will whether country can mobilize all the resources and levers that can to maximizing financing for health, such as innovative monetary policy, but also…, procurement policies using different levers – grants, loans, procurement to really catalyze new solutions…. “When we go to war, money is found, and during a health pandemic, money has been found, but that has been too little too late,” she observed. Public-Private sector should share ‘risks and rewards’ of innovation Finally, public-private sector relationships around critical issues such as vaccines and medicines innovation and manufacture need a reboot, the brief argues, sharing both the “risks and rewards” of innovation, in the words of Mazzucato – rather than leaving public entities to shoulder the risks while the private sector reaps most of the rewards. “We need public actors, we need philanthropies, but they need to work together in a different way,” she said. That means public contracts, loans, grants and other incentives that are offered to the private sector to develop new and more innovative vaccines, tests and treatments also need to come along with stronger conditions about how the final products they create may be used or distributed. “And this can be done by redesigning the terms and the conditions, structuring contracts, grants, transfers loans and partnerships between public and private actors. “Precisely because the public sector puts in so much of the money – especially in the early stage when it’s more risky and more capital intensive, and uncertain – these critical market-shaping public investments should ensure conditionalities around pricing – to make sure that we have access at the core -that we have vaccines that are globally accessible. Innovation – global, end-to-end and governed collectively In terms of intellectual property rights, she added that “it’s not about getting rid of patents, but we have to govern innovation and the patent system, with objectives in mind. “Making sure that patents are not too wide, too strong, hard to license upstream are core ways to govern the patent system. “It’s not about getting rid of patents, we have to govern innovation, and the patent system with objectives in mind,” she said. “More broadly, we need to shape a conducive regulatory tax, industrial and economic policy environment to ‘crowd in’ all sorts of different sources of finance at the same time, ensuring that we get the greatest multiplier effect, the greatest impact on health for all. Ultimately, however, she stressed that global health innovation platforms need to be “global, end-to-end, and governed collectively – shifting from a model where innovation is left to the market to a model aimed at delivering global common goods.” Image Credits: Marco Verch/Flickr. Civil Society Activists Question Pandemic Treaty’s Ability to Address Global Health Inequalities 26/10/2021 Kerry Cullinan A session of the 2020 World Health Assembly. Some civil society organisations (CSO) are sceptical about whether a ‘pandemic treaty’ is the best way to address future global health crises, while treaty supporters say it will provide a legal framework binding countries and global health bodies to more agile and rapid responses to future outbreaks. A session Monday sponsored by the Geneva Global Health Hub (G2H2) brought leading CSOs, diplomats, academics and even WHO’s chief legal counsel face to face to air those views, in the context of a research initiative on the treaty being undertaken by the hub. The debate comes just weeks ahead of a planned special session of the World Health Assembly which is to determine whether the global body will indeed move forward on a Treaty, as a key measure for improving pandemic response. The treaty initiative has been supported most visibly by European countries, led by European Commission President, Charles Michel, who in a separate session at the World Health Summit in Berlin that the treaty would guarantee “access to information, financing, vaccines and countermeasures. It would increase capacity and resilience – at all levels.” With @DrTedros we proposed an international #PandemicTreaty rooted in @WHO constitution. It would guarantee equity & inclusiveness. A legally binding instrument would be the most effective basis for prevention, surveillance, collection and exchange of scientific data.#WHS2021 pic.twitter.com/lbWkc3G5XE — Charles Michel (@eucopresident) October 25, 2021 Diversion or game changer? 25 heads of government and international agencies have come together in support of the new pandemic treaty Some of the civil society organisations that have expressed disquiet about the treaty proposal perceive it as a potential distraction or diversion by wealthy countries from the so-called TRIPS waiver proposal, currently under consideration by thee World Trade Organization. The proposal by South Africa and India for a broad-based intellectual property waiver on COVID vaccines and treatments, now being debated by the WTO’s TRIPS Council , is perceived by civil society as a game changer that would help open the doors to despearately needed COVID vaccine and medicines manufacturing in Africa and the global South. Many of the European countries that have been among the most staunch opponents of the TRIPS waiver are also key pandemic treaty supporters, noted journalist Priti Patnaik, who is researching stakeholders’ views on the pandemic treaty for G2H2 -giving rise to the CSO suspicions. And yet at the same time, some developing countries have supported a pandemic treaty because they believe it would “rein in the influence of non-state actors, including powerful foundations, and get some binding obligations to apply to industry to avoid vaccine inequities in the future,” she added. ‘Switch-and-bait’ tactic Unni Karunakara, senior fellow at Yale’s Global Health Justice Partnership, said that the major focus should be on deploying available tools and medicines to every corner of the world, rather than negotiations over a new treaty: “Shouldn’t global vaccination coverage be an overwhelming priority now?” he asked. “We do have frameworks and tools. They’re not perfect, but there are enough tools for us to overcome this crisis together,” said Karunakara, a former president of Medecins sans Frontieres. “What is lacking, however, is the political will to share essential resources and tools, even with all of the treaties in place.” His comments reflecting the cynicism of other civil society activists who see “a big overlap between the countries that are blocking the TRIPS waiver, and the countries that are supporting the pandemic treaty. “So there’s a perception of a ‘switch-and-bait’ tactic that reeks of bad faith,” he added. And while transparency measures – such as the mandatory sharing of genetic materials by countries where outbreaks are suspected – have been discussed as key treaty features, similar mandates for transparency or sharing of vaccines and medicines technologies have been fiercely opposed by the EU, he pointed out. “TRIPS waiver-blocking countries have made the case for voluntary actions by pharma to ensure access to essential COVID-19 medical tools, so they treat Big Pharma with kid gloves,” Karunakara observered. “Interestingly, they take a very different tone and approach to the global south in the treaty, insisting on enforceability in the sharing of information and materials with WHO and other governments to allow for independent verification.” “The assumption here is that global south is the problem, that diseases originated in poor country, and pose national security risks to rich countries.” If you are against the treaty – what is your multilateral alternative? Björn Kümmel, at the WHO Executive Board’s January 2021 meeting. Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver – or the kinds of hidden agendas that civil society groups fear. “I doubt that it’s, from a logical point of view, right to say that even though a country has it stands on the TRIPS waiver, you can’t tackle other equity issues,” he told the G2H2 session. “That’s one angle to look at, the TRIPS waiver, but there are many more angles to be looked at. So to say that that is the only magic bullet, I think that would be fully wrong, I wouldn’t limit it to this. “I think that equity goes far beyond, and certainly, if a treaty was negotiated, it’s quite clear that this [TRIPS waive] will be put on the table, and that all governments will have to look at the different interests that are on the table and negotiate them with an open outcome.” He noted that the treaty was first proposed formally by Chile, not the European Commission, and has the support of a wide array of countries, including South Africa, Kenya, and Tunisia, as well as Thailand and Indonesia. Anything better than ‘Chaos’ we see now Describing the current global health situation as “dysfunctional”, Kümmel asked the G2H2 session: “If you are against the treaty, tell us what is your multilateral alternative to it, to be realistically implemented, lets say in the next five years?” “What the countries who are proposing a treaty are trying to say is: anything is better, than compared to the chaos that we’re seeing currently. “Legal clarity is needed, and it will be …a painful exercise for many of us, and most likely a difficult one for many governments, including mine, most likely also others. But in the end, it’s this is multilateralism.” Uniquely in the global health landscape – and unlike environment, trade or finance – there is a dearth of global treaty instruments. In fact, among the dozens of international treaties in force today, the only two binding instruments in global health today are the IHR and and the Framework Convention on Tobacco Control (FCTC), he pointed out. Pandemic is a ‘window of opportunity’ for bigger changes In light of the outstanding questions, however, the working group of countries that are preparing for the WHA special session had devised a “three-step approach” to their deliberations on a way forward. They are considering in parallel: WHO internal reform measures; revisions in the existing International Health Regulations that currently govern global emergency response; and finally, the Pandemic Treaty alternative. In terms of WHO reform, the conclusion has been that such measures would “not be sufficient in order to overcome the next pandemic,” Kümmel said. Amendments to the International Health Regulations (IHR) also would take time to negotiate. And a key question here is: “would they be a game changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” So against the other options, “an international binding agreement is interesting,” he said. “And why are many colleagues pushing for this to happen now? Well, it’s the reality that after Ebola and past pandemics the global community was unable to implement the lessons learned,” he said. And if negotiations don’t begin now, in the heat of the ongoing crisis, they will never happen at all. “Many of the international independent panels have called for bold recommendations to be implemented,” Kümmel reminded the group. “One of them is the treaty. But many of those recommendations have never reached successful implementation, because the window of opportunity for real structural changes normally vanishes with the next crisis to come after the pandemic.” The treaty would also retain WHO’s centrality as the nerve center of the global health architecture – amidst a plethora of new health initiatives emerging in Europe and elsewhere: “There are a multitude of ideas and recommendations, and the treaty is a legal framework into which most of the other recommendations would fit,” he said, in reference to recent proposals such as one by the Pan European Commission on Health and Sustainable Development to create a new global health board under G-20 auspices. Others have talked about a new global health finance board in association with the World Bank and/or a new UN-level Global Health Threats Council, under the auspices of the UN General Assembly. So the Pandemic Treaty is “also a mechanism to provide WHO with legitimacy after this crisis,” he stressed. “Obviously there are voices out there who could see alternative approaches. However, I think the ones who are in favour of this treaty have clearly articulated that WHO is the right forum because its the truly multilateral forum for global health.” WHO precedents for equitable access to vaccines? Germany is not the only actor that sees the treaty as a means of keeping WHO as the world’s main global health meeting place. WHO’s Director General Dr Tedros Adhanom Ghebreyesus has himself come out in support for the pandemic treaty measure – breaking ranks with previous agency heads who usually remained aloof of controversial measures under consideration by member states. WHO is therefore keenly interested in how civil society groups may help lead or shape views on the treaty negotiations – and this interest was reflected in a cameo appearance at the G2H2 event by Stephen Solomon, WHO’s principal legal officer. Solomon said it was “really helpful” to understand some of the “scepticism” around the pandemic treaty initiatives. “Understanding the the concern about an agenda driven issue here is very important for the [WHO] Secretariat,” Solomon told the group. At the same time, beyond the immediate COVID crisis, other WHO emergency response frameworks already in place also could perhaps benefit from the stronger legal backpone that a pandemic treaty might provide, he pointed out. One example is the Pandemic Influenza Preparedness (PIP) framework, which mandates that 10% of global flu pandemic vaccine production supply goes to WHO for direct distribution, based upon public health needs. Another is WHO’s Global Action Plan for influenza vaccines. These “are meant to address equity issues in a number of epidemics, not necessarily pandemics,” Solomon said. “I would be very interested in reactions to particular frameworks meant to address inequities, like the pandemic influenza preparedness (PIP) framework, not legally binding. Or like the WHO Global Action Plan (GAP) for influenza vaccines, also not legally binding. “But both are interesting and potentially of important reference to pandemic preparedness and response. PIP basically says 10% of global pandemic vaccine production supply goes to WHO for distribution on the declaration of an influenza pandemic for distribution based on public health needs, and we have legally binding contracts for that 10%,” said Solomon. “Could that be a reference point for responding to future pandemics? “If so, would it be useful to put that in more of a legal framework because of weaknesses within that structure – particularly the idea of countries not allowing export for vaccines already under contract?” Solomon asked. Similarly, the Global Action Plan for influenza vaccines was a 10-year, non-binding arrangement that aimed to better distribute capacity for flu vaccine production, including among low- and middle-income member states, he pointed out, asking: “Could that also benefit, or not, from a normatively binding architecture?” The final research report will be launched by G2H2 on 24 November. –Elaine Ruth Fletcher contributed to the writing of this story. 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US ‘Steps Aside’ to Give Africa Access to Moderna Vaccines 26/10/2021 Kerry Cullinan Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) The US government has enabled Africa to get access to 50 million Moderna COVID-19 vaccines by giving the continent its place in the vaccine queue, Strive Masiyiwa, head of the African Vaccine Acquisition Trust (AVAT) said on Tuesday. “This is a time swap arrangement whereby the United States government basically stood aside for the next quarter so that we could access vaccines and purchase them ourselves,” Masiyiwa told a media briefing of the Africa Centers for Disease Control (CDC). AVAT will get 15 million Moderna doses in December and a further 35 million between January and March. It also has an option to buy 60 million more, delivered at 20 million doses per month, between April and June. “These doses are being purchased by AVAT courtesy of the United States government, which has been phenomenal in its support,” he added. South Africa’s President Cyril Ramaphosa and Kenya’s President Uhuru Kenyatta negotiated the deal directed with US President Joe Biden, said Masiyiwa. Other than a deal with Johnson and Johnson (J&J) for 400 million vaccines over 13 months from August, “none of the vaccine suppliers had any doses for us this year,” said Masiyiwa. The Africa Union has been able to get the J&J vaccines largely because they are being assembled by Aspen in South Africa – but even ensuring that these doses remained on the continent required reaching an agreement with the European Union, which initially planned to import the African-assembled vaccines. Jessye Lapenn, the US Ambassador to the African Union, praised AVAT’s leadership and expressed her country’s support for the continent’s vaccination efforts. The White House confirmed that it would defer the delivery of about 33 million Moderna vaccines to enable the African Union to buy the doses. Masiyiwa said the African Union’s long-term vision was for Moderna to reach a fit-and-fill agreement with an African manufacturer. The company recently announced that it wants to build a $500 million mRNA vaccine manufacturing facility in Africa. “We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe, said Moderna CEO Stéphane Bancel. Moderna said that it was “working on plans to allow it to fill doses of its COVID-19 vaccine in Africa as early as 2023, in parallel to building an mRNA vaccine manufacturing facility in Africa”. Moderna, which received millions of dollars in R&D support from the US government, has been under pressure from the Biden administration to supply low and middle income countries with vaccines. AVAT is currently supplying 39 African countries and 15 Caribbean countries, but only 8,7% of Africans have had at least one vaccine dose. Meanwhile, COVAX revealed on Monday that less than 10% of vaccine donations pledged to it by wealthy countries had been delivered. Of the 1.3 billion COVID-19 vaccine dose donations promised to COVAX by wealthy countries, only 150 million doses have actually arrived – around 9% – Gavi CEO Dr Seth Berkley told the World Health Summit. Joining the Africa CDC press briefing on Tuesday, Berkley said that COVAX had supplied 40% of Africa’s vaccine doses but the facility had experienced a major slowdown after India banned the export of AstraZeneca vaccines made it its country although COVAX had already paid for the vaccines. Debt Relief & National Economic Reforms Pitched as ‘Big Picture’ Global Health Solutions Ahead of G-20 Meeting 26/10/2021 Elaine Ruth Fletcher WHO Director General Dr Tedros Adhanom Ghebreyesus and Mariana Mazzucato, chair of the new WHO Council on the Economics of Health for All. An ambitious wish list of global economic and fiscal measures that the world should adopt to combat the COVID-19 pandemic has been floated by the World Health Organization- just ahead of a critical G-20 meeting of the world’s most industrialized nations this weekend. These include proposals for massive debt relief to debt-ridden countries and a re-direction of the IMF’s new offer of $US650 billion in “special drawing rights” away from richer nations to low- and middle-income countries. The laundry list of macroeconomic and fiscal measures proposed by the new WHO Council on the Economics of Health for All, was detailed today at one of the final sessions of the World Health Summit. Drafted by 10 top economists and health policy experts, Financing Health for All pushes the classic debates over access to medicines and health systems investments – into the realm of much broader fiscal and economic decisions that nations, both rich and poor need to make, according to the experts. That is, if they really want to beat down COVID-19 as well as prepare for the next pandemic. ‘Donor mentality’ is part of the problem WHO Director General, Dr Tedros Adhanom Ghebreyesus “It proposes a radical shift in economic thinking for global health,” said WHO Director General Dr Tedros Adhanom Ghebreyesus at the WHS session. He appeared with Mariana Mazzucato, Founding Director of the UCL Institute for Innovation and Public Purpose, and chair of the new health economics Council, which was launched by WHO in May 2021. “Instead of looking at health as a piece of the economy, it’s time to look at how the economy can support the societal goal of health for all,” said the WHO Director General. “Neither existing market mechanisms, with their focus on short term returns, nor development funds alone are enough,” he added. “They do not provide the global public goods on which we all depend, such as vaccines, nor do they address the major inequities, undermining equitable access. “The council is proposing bold, concrete actions for governments and multilateral organizations in three major areas, creating fiscal space, the direction of investment, and the governance of public and private financing for how this does not just mean more money. It means making the better, smarter and sustained investments that are needed to achieve health for all.” “We have to realize that this donor mentality is actually part of the problem,”said Mazzucato, “And that lots of the conditionalities that were set in the past on the loans provided to developing countries precisely made them weaker. The key priorities outlined by the brief, prepared by the ten-member expert group includes proposals that would leverage change from global to national level so as to: Create more “fiscal space” for countries to invest more in health, including through measures like international debt relief, a global corporate tax rate and a greater allocation to low-income countries of newly available IMF special drawing rights; Reshape national, tax, regulatory and investment rules to make them more favorable to health-related investments, e.g. in health systems and vaccine and medicines manufacture; Ensure stronger governance for private health markets – notably pharma innovators and manufacturers – using public regulations and investments to “crowd in and direct private finance towards improving health outcomes globally and equitably.” Other members of the Council include Vera Songwe, Executive Secetary of the Economic Commission for Africa; economists such as Jayata Ghosh, of the University of Massachusetts and Stephanie Kelton an expert on monetary policy at Stony Brook University; investment banker Vanessa Huang, and global health professionals such as Ilona Kickbusch, founding director of the Geneva Graduate Institute’s Global Health Centre; Senait Fissehea, of the University of Michigan; and planetary health expert Kate Raworth, of Oxford University’s Environmental Change Institute. More “quality money” – to fight the next pandemic Mariana Mazzucato, chair fo the new WHO Council on the Economics of Health for All Just “more money” is not enough to drive bigger investments in countries with poor-performing health systems, stressed Mazzucato, it needs to be “quality money” – money that does not translate into more crippling loan repayments once the initial phase of the pandemic crisis has passed. “Multilateral organizations should negotiate debt relief for low and middle income countries in such an important moment,…. redirecting [IMF] Special Drawing Rights towards investment in health, and especially vaccines,” she said. IMF special drawing rights are not considered as loans in the traditional sense of the word, but rather bolster countries’ reserves and thus their overall economic stability. “False constraints have been imposed on government’s fiscal spaces, often by multilateral institutions like the IMF and the World Bank.” Crippling debt restrictions and austerity measures traditionally have hit hardest on social welfare nets, including public health systems, meaning that low- and middle-income countries “weren’t allowed to create the kind of fiscal space that we highlight as the first key pillar,” she observed. “Over time, we have to be better prepared and that preparedness needs to be, in the long run, built on the ability to have a distributed manufacturing and industrial capacity [for health products] globally. “Because this will not be the last pandemic, you know. As the permafrost melts, apparently, there’s going to be all sorts of other viruses that come about. Climate change and this health crisis are really interlinked.” Along with debt relief the G-20 should advance credit rating reforms and “push for the enforcement of a minimum global corporate tax of at least 15%,” she added. National investment priorities Finance and health authorities need to work together more closely to expand local medicines and vaccine production and improve health systems. But as the brief underlines, the challenge is not only to reduce international pressures, through measures such as debt relief, but also to “change mindsets within countries that impose internal constraints on spending” – often in the name of false economies and fiscal prudence. That means a better understanding and alignment in Finance Ministries, of the importance of health priorities. “The bottom line is that countries must reverse the harmful effects of an austerity approach to public administration and public finance reforms,” said Mazzucato. She pointed to Kerala State, in India, as an example of a region that fared better because it focused investment into public health systems. “Internal constraints on government budgets are not insurmountable and governments actually have more room for increasing the fiscal limits on investments for health than they’re led to believe. “And it’s not just a matter of political choice, but also when a political will whether country can mobilize all the resources and levers that can to maximizing financing for health, such as innovative monetary policy, but also…, procurement policies using different levers – grants, loans, procurement to really catalyze new solutions…. “When we go to war, money is found, and during a health pandemic, money has been found, but that has been too little too late,” she observed. Public-Private sector should share ‘risks and rewards’ of innovation Finally, public-private sector relationships around critical issues such as vaccines and medicines innovation and manufacture need a reboot, the brief argues, sharing both the “risks and rewards” of innovation, in the words of Mazzucato – rather than leaving public entities to shoulder the risks while the private sector reaps most of the rewards. “We need public actors, we need philanthropies, but they need to work together in a different way,” she said. That means public contracts, loans, grants and other incentives that are offered to the private sector to develop new and more innovative vaccines, tests and treatments also need to come along with stronger conditions about how the final products they create may be used or distributed. “And this can be done by redesigning the terms and the conditions, structuring contracts, grants, transfers loans and partnerships between public and private actors. “Precisely because the public sector puts in so much of the money – especially in the early stage when it’s more risky and more capital intensive, and uncertain – these critical market-shaping public investments should ensure conditionalities around pricing – to make sure that we have access at the core -that we have vaccines that are globally accessible. Innovation – global, end-to-end and governed collectively In terms of intellectual property rights, she added that “it’s not about getting rid of patents, but we have to govern innovation and the patent system, with objectives in mind. “Making sure that patents are not too wide, too strong, hard to license upstream are core ways to govern the patent system. “It’s not about getting rid of patents, we have to govern innovation, and the patent system with objectives in mind,” she said. “More broadly, we need to shape a conducive regulatory tax, industrial and economic policy environment to ‘crowd in’ all sorts of different sources of finance at the same time, ensuring that we get the greatest multiplier effect, the greatest impact on health for all. Ultimately, however, she stressed that global health innovation platforms need to be “global, end-to-end, and governed collectively – shifting from a model where innovation is left to the market to a model aimed at delivering global common goods.” Image Credits: Marco Verch/Flickr. Civil Society Activists Question Pandemic Treaty’s Ability to Address Global Health Inequalities 26/10/2021 Kerry Cullinan A session of the 2020 World Health Assembly. Some civil society organisations (CSO) are sceptical about whether a ‘pandemic treaty’ is the best way to address future global health crises, while treaty supporters say it will provide a legal framework binding countries and global health bodies to more agile and rapid responses to future outbreaks. A session Monday sponsored by the Geneva Global Health Hub (G2H2) brought leading CSOs, diplomats, academics and even WHO’s chief legal counsel face to face to air those views, in the context of a research initiative on the treaty being undertaken by the hub. The debate comes just weeks ahead of a planned special session of the World Health Assembly which is to determine whether the global body will indeed move forward on a Treaty, as a key measure for improving pandemic response. The treaty initiative has been supported most visibly by European countries, led by European Commission President, Charles Michel, who in a separate session at the World Health Summit in Berlin that the treaty would guarantee “access to information, financing, vaccines and countermeasures. It would increase capacity and resilience – at all levels.” With @DrTedros we proposed an international #PandemicTreaty rooted in @WHO constitution. It would guarantee equity & inclusiveness. A legally binding instrument would be the most effective basis for prevention, surveillance, collection and exchange of scientific data.#WHS2021 pic.twitter.com/lbWkc3G5XE — Charles Michel (@eucopresident) October 25, 2021 Diversion or game changer? 25 heads of government and international agencies have come together in support of the new pandemic treaty Some of the civil society organisations that have expressed disquiet about the treaty proposal perceive it as a potential distraction or diversion by wealthy countries from the so-called TRIPS waiver proposal, currently under consideration by thee World Trade Organization. The proposal by South Africa and India for a broad-based intellectual property waiver on COVID vaccines and treatments, now being debated by the WTO’s TRIPS Council , is perceived by civil society as a game changer that would help open the doors to despearately needed COVID vaccine and medicines manufacturing in Africa and the global South. Many of the European countries that have been among the most staunch opponents of the TRIPS waiver are also key pandemic treaty supporters, noted journalist Priti Patnaik, who is researching stakeholders’ views on the pandemic treaty for G2H2 -giving rise to the CSO suspicions. And yet at the same time, some developing countries have supported a pandemic treaty because they believe it would “rein in the influence of non-state actors, including powerful foundations, and get some binding obligations to apply to industry to avoid vaccine inequities in the future,” she added. ‘Switch-and-bait’ tactic Unni Karunakara, senior fellow at Yale’s Global Health Justice Partnership, said that the major focus should be on deploying available tools and medicines to every corner of the world, rather than negotiations over a new treaty: “Shouldn’t global vaccination coverage be an overwhelming priority now?” he asked. “We do have frameworks and tools. They’re not perfect, but there are enough tools for us to overcome this crisis together,” said Karunakara, a former president of Medecins sans Frontieres. “What is lacking, however, is the political will to share essential resources and tools, even with all of the treaties in place.” His comments reflecting the cynicism of other civil society activists who see “a big overlap between the countries that are blocking the TRIPS waiver, and the countries that are supporting the pandemic treaty. “So there’s a perception of a ‘switch-and-bait’ tactic that reeks of bad faith,” he added. And while transparency measures – such as the mandatory sharing of genetic materials by countries where outbreaks are suspected – have been discussed as key treaty features, similar mandates for transparency or sharing of vaccines and medicines technologies have been fiercely opposed by the EU, he pointed out. “TRIPS waiver-blocking countries have made the case for voluntary actions by pharma to ensure access to essential COVID-19 medical tools, so they treat Big Pharma with kid gloves,” Karunakara observered. “Interestingly, they take a very different tone and approach to the global south in the treaty, insisting on enforceability in the sharing of information and materials with WHO and other governments to allow for independent verification.” “The assumption here is that global south is the problem, that diseases originated in poor country, and pose national security risks to rich countries.” If you are against the treaty – what is your multilateral alternative? Björn Kümmel, at the WHO Executive Board’s January 2021 meeting. Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver – or the kinds of hidden agendas that civil society groups fear. “I doubt that it’s, from a logical point of view, right to say that even though a country has it stands on the TRIPS waiver, you can’t tackle other equity issues,” he told the G2H2 session. “That’s one angle to look at, the TRIPS waiver, but there are many more angles to be looked at. So to say that that is the only magic bullet, I think that would be fully wrong, I wouldn’t limit it to this. “I think that equity goes far beyond, and certainly, if a treaty was negotiated, it’s quite clear that this [TRIPS waive] will be put on the table, and that all governments will have to look at the different interests that are on the table and negotiate them with an open outcome.” He noted that the treaty was first proposed formally by Chile, not the European Commission, and has the support of a wide array of countries, including South Africa, Kenya, and Tunisia, as well as Thailand and Indonesia. Anything better than ‘Chaos’ we see now Describing the current global health situation as “dysfunctional”, Kümmel asked the G2H2 session: “If you are against the treaty, tell us what is your multilateral alternative to it, to be realistically implemented, lets say in the next five years?” “What the countries who are proposing a treaty are trying to say is: anything is better, than compared to the chaos that we’re seeing currently. “Legal clarity is needed, and it will be …a painful exercise for many of us, and most likely a difficult one for many governments, including mine, most likely also others. But in the end, it’s this is multilateralism.” Uniquely in the global health landscape – and unlike environment, trade or finance – there is a dearth of global treaty instruments. In fact, among the dozens of international treaties in force today, the only two binding instruments in global health today are the IHR and and the Framework Convention on Tobacco Control (FCTC), he pointed out. Pandemic is a ‘window of opportunity’ for bigger changes In light of the outstanding questions, however, the working group of countries that are preparing for the WHA special session had devised a “three-step approach” to their deliberations on a way forward. They are considering in parallel: WHO internal reform measures; revisions in the existing International Health Regulations that currently govern global emergency response; and finally, the Pandemic Treaty alternative. In terms of WHO reform, the conclusion has been that such measures would “not be sufficient in order to overcome the next pandemic,” Kümmel said. Amendments to the International Health Regulations (IHR) also would take time to negotiate. And a key question here is: “would they be a game changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” So against the other options, “an international binding agreement is interesting,” he said. “And why are many colleagues pushing for this to happen now? Well, it’s the reality that after Ebola and past pandemics the global community was unable to implement the lessons learned,” he said. And if negotiations don’t begin now, in the heat of the ongoing crisis, they will never happen at all. “Many of the international independent panels have called for bold recommendations to be implemented,” Kümmel reminded the group. “One of them is the treaty. But many of those recommendations have never reached successful implementation, because the window of opportunity for real structural changes normally vanishes with the next crisis to come after the pandemic.” The treaty would also retain WHO’s centrality as the nerve center of the global health architecture – amidst a plethora of new health initiatives emerging in Europe and elsewhere: “There are a multitude of ideas and recommendations, and the treaty is a legal framework into which most of the other recommendations would fit,” he said, in reference to recent proposals such as one by the Pan European Commission on Health and Sustainable Development to create a new global health board under G-20 auspices. Others have talked about a new global health finance board in association with the World Bank and/or a new UN-level Global Health Threats Council, under the auspices of the UN General Assembly. So the Pandemic Treaty is “also a mechanism to provide WHO with legitimacy after this crisis,” he stressed. “Obviously there are voices out there who could see alternative approaches. However, I think the ones who are in favour of this treaty have clearly articulated that WHO is the right forum because its the truly multilateral forum for global health.” WHO precedents for equitable access to vaccines? Germany is not the only actor that sees the treaty as a means of keeping WHO as the world’s main global health meeting place. WHO’s Director General Dr Tedros Adhanom Ghebreyesus has himself come out in support for the pandemic treaty measure – breaking ranks with previous agency heads who usually remained aloof of controversial measures under consideration by member states. WHO is therefore keenly interested in how civil society groups may help lead or shape views on the treaty negotiations – and this interest was reflected in a cameo appearance at the G2H2 event by Stephen Solomon, WHO’s principal legal officer. Solomon said it was “really helpful” to understand some of the “scepticism” around the pandemic treaty initiatives. “Understanding the the concern about an agenda driven issue here is very important for the [WHO] Secretariat,” Solomon told the group. At the same time, beyond the immediate COVID crisis, other WHO emergency response frameworks already in place also could perhaps benefit from the stronger legal backpone that a pandemic treaty might provide, he pointed out. One example is the Pandemic Influenza Preparedness (PIP) framework, which mandates that 10% of global flu pandemic vaccine production supply goes to WHO for direct distribution, based upon public health needs. Another is WHO’s Global Action Plan for influenza vaccines. These “are meant to address equity issues in a number of epidemics, not necessarily pandemics,” Solomon said. “I would be very interested in reactions to particular frameworks meant to address inequities, like the pandemic influenza preparedness (PIP) framework, not legally binding. Or like the WHO Global Action Plan (GAP) for influenza vaccines, also not legally binding. “But both are interesting and potentially of important reference to pandemic preparedness and response. PIP basically says 10% of global pandemic vaccine production supply goes to WHO for distribution on the declaration of an influenza pandemic for distribution based on public health needs, and we have legally binding contracts for that 10%,” said Solomon. “Could that be a reference point for responding to future pandemics? “If so, would it be useful to put that in more of a legal framework because of weaknesses within that structure – particularly the idea of countries not allowing export for vaccines already under contract?” Solomon asked. Similarly, the Global Action Plan for influenza vaccines was a 10-year, non-binding arrangement that aimed to better distribute capacity for flu vaccine production, including among low- and middle-income member states, he pointed out, asking: “Could that also benefit, or not, from a normatively binding architecture?” The final research report will be launched by G2H2 on 24 November. –Elaine Ruth Fletcher contributed to the writing of this story. 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Debt Relief & National Economic Reforms Pitched as ‘Big Picture’ Global Health Solutions Ahead of G-20 Meeting 26/10/2021 Elaine Ruth Fletcher WHO Director General Dr Tedros Adhanom Ghebreyesus and Mariana Mazzucato, chair of the new WHO Council on the Economics of Health for All. An ambitious wish list of global economic and fiscal measures that the world should adopt to combat the COVID-19 pandemic has been floated by the World Health Organization- just ahead of a critical G-20 meeting of the world’s most industrialized nations this weekend. These include proposals for massive debt relief to debt-ridden countries and a re-direction of the IMF’s new offer of $US650 billion in “special drawing rights” away from richer nations to low- and middle-income countries. The laundry list of macroeconomic and fiscal measures proposed by the new WHO Council on the Economics of Health for All, was detailed today at one of the final sessions of the World Health Summit. Drafted by 10 top economists and health policy experts, Financing Health for All pushes the classic debates over access to medicines and health systems investments – into the realm of much broader fiscal and economic decisions that nations, both rich and poor need to make, according to the experts. That is, if they really want to beat down COVID-19 as well as prepare for the next pandemic. ‘Donor mentality’ is part of the problem WHO Director General, Dr Tedros Adhanom Ghebreyesus “It proposes a radical shift in economic thinking for global health,” said WHO Director General Dr Tedros Adhanom Ghebreyesus at the WHS session. He appeared with Mariana Mazzucato, Founding Director of the UCL Institute for Innovation and Public Purpose, and chair of the new health economics Council, which was launched by WHO in May 2021. “Instead of looking at health as a piece of the economy, it’s time to look at how the economy can support the societal goal of health for all,” said the WHO Director General. “Neither existing market mechanisms, with their focus on short term returns, nor development funds alone are enough,” he added. “They do not provide the global public goods on which we all depend, such as vaccines, nor do they address the major inequities, undermining equitable access. “The council is proposing bold, concrete actions for governments and multilateral organizations in three major areas, creating fiscal space, the direction of investment, and the governance of public and private financing for how this does not just mean more money. It means making the better, smarter and sustained investments that are needed to achieve health for all.” “We have to realize that this donor mentality is actually part of the problem,”said Mazzucato, “And that lots of the conditionalities that were set in the past on the loans provided to developing countries precisely made them weaker. The key priorities outlined by the brief, prepared by the ten-member expert group includes proposals that would leverage change from global to national level so as to: Create more “fiscal space” for countries to invest more in health, including through measures like international debt relief, a global corporate tax rate and a greater allocation to low-income countries of newly available IMF special drawing rights; Reshape national, tax, regulatory and investment rules to make them more favorable to health-related investments, e.g. in health systems and vaccine and medicines manufacture; Ensure stronger governance for private health markets – notably pharma innovators and manufacturers – using public regulations and investments to “crowd in and direct private finance towards improving health outcomes globally and equitably.” Other members of the Council include Vera Songwe, Executive Secetary of the Economic Commission for Africa; economists such as Jayata Ghosh, of the University of Massachusetts and Stephanie Kelton an expert on monetary policy at Stony Brook University; investment banker Vanessa Huang, and global health professionals such as Ilona Kickbusch, founding director of the Geneva Graduate Institute’s Global Health Centre; Senait Fissehea, of the University of Michigan; and planetary health expert Kate Raworth, of Oxford University’s Environmental Change Institute. More “quality money” – to fight the next pandemic Mariana Mazzucato, chair fo the new WHO Council on the Economics of Health for All Just “more money” is not enough to drive bigger investments in countries with poor-performing health systems, stressed Mazzucato, it needs to be “quality money” – money that does not translate into more crippling loan repayments once the initial phase of the pandemic crisis has passed. “Multilateral organizations should negotiate debt relief for low and middle income countries in such an important moment,…. redirecting [IMF] Special Drawing Rights towards investment in health, and especially vaccines,” she said. IMF special drawing rights are not considered as loans in the traditional sense of the word, but rather bolster countries’ reserves and thus their overall economic stability. “False constraints have been imposed on government’s fiscal spaces, often by multilateral institutions like the IMF and the World Bank.” Crippling debt restrictions and austerity measures traditionally have hit hardest on social welfare nets, including public health systems, meaning that low- and middle-income countries “weren’t allowed to create the kind of fiscal space that we highlight as the first key pillar,” she observed. “Over time, we have to be better prepared and that preparedness needs to be, in the long run, built on the ability to have a distributed manufacturing and industrial capacity [for health products] globally. “Because this will not be the last pandemic, you know. As the permafrost melts, apparently, there’s going to be all sorts of other viruses that come about. Climate change and this health crisis are really interlinked.” Along with debt relief the G-20 should advance credit rating reforms and “push for the enforcement of a minimum global corporate tax of at least 15%,” she added. National investment priorities Finance and health authorities need to work together more closely to expand local medicines and vaccine production and improve health systems. But as the brief underlines, the challenge is not only to reduce international pressures, through measures such as debt relief, but also to “change mindsets within countries that impose internal constraints on spending” – often in the name of false economies and fiscal prudence. That means a better understanding and alignment in Finance Ministries, of the importance of health priorities. “The bottom line is that countries must reverse the harmful effects of an austerity approach to public administration and public finance reforms,” said Mazzucato. She pointed to Kerala State, in India, as an example of a region that fared better because it focused investment into public health systems. “Internal constraints on government budgets are not insurmountable and governments actually have more room for increasing the fiscal limits on investments for health than they’re led to believe. “And it’s not just a matter of political choice, but also when a political will whether country can mobilize all the resources and levers that can to maximizing financing for health, such as innovative monetary policy, but also…, procurement policies using different levers – grants, loans, procurement to really catalyze new solutions…. “When we go to war, money is found, and during a health pandemic, money has been found, but that has been too little too late,” she observed. Public-Private sector should share ‘risks and rewards’ of innovation Finally, public-private sector relationships around critical issues such as vaccines and medicines innovation and manufacture need a reboot, the brief argues, sharing both the “risks and rewards” of innovation, in the words of Mazzucato – rather than leaving public entities to shoulder the risks while the private sector reaps most of the rewards. “We need public actors, we need philanthropies, but they need to work together in a different way,” she said. That means public contracts, loans, grants and other incentives that are offered to the private sector to develop new and more innovative vaccines, tests and treatments also need to come along with stronger conditions about how the final products they create may be used or distributed. “And this can be done by redesigning the terms and the conditions, structuring contracts, grants, transfers loans and partnerships between public and private actors. “Precisely because the public sector puts in so much of the money – especially in the early stage when it’s more risky and more capital intensive, and uncertain – these critical market-shaping public investments should ensure conditionalities around pricing – to make sure that we have access at the core -that we have vaccines that are globally accessible. Innovation – global, end-to-end and governed collectively In terms of intellectual property rights, she added that “it’s not about getting rid of patents, but we have to govern innovation and the patent system, with objectives in mind. “Making sure that patents are not too wide, too strong, hard to license upstream are core ways to govern the patent system. “It’s not about getting rid of patents, we have to govern innovation, and the patent system with objectives in mind,” she said. “More broadly, we need to shape a conducive regulatory tax, industrial and economic policy environment to ‘crowd in’ all sorts of different sources of finance at the same time, ensuring that we get the greatest multiplier effect, the greatest impact on health for all. Ultimately, however, she stressed that global health innovation platforms need to be “global, end-to-end, and governed collectively – shifting from a model where innovation is left to the market to a model aimed at delivering global common goods.” Image Credits: Marco Verch/Flickr. Civil Society Activists Question Pandemic Treaty’s Ability to Address Global Health Inequalities 26/10/2021 Kerry Cullinan A session of the 2020 World Health Assembly. Some civil society organisations (CSO) are sceptical about whether a ‘pandemic treaty’ is the best way to address future global health crises, while treaty supporters say it will provide a legal framework binding countries and global health bodies to more agile and rapid responses to future outbreaks. A session Monday sponsored by the Geneva Global Health Hub (G2H2) brought leading CSOs, diplomats, academics and even WHO’s chief legal counsel face to face to air those views, in the context of a research initiative on the treaty being undertaken by the hub. The debate comes just weeks ahead of a planned special session of the World Health Assembly which is to determine whether the global body will indeed move forward on a Treaty, as a key measure for improving pandemic response. The treaty initiative has been supported most visibly by European countries, led by European Commission President, Charles Michel, who in a separate session at the World Health Summit in Berlin that the treaty would guarantee “access to information, financing, vaccines and countermeasures. It would increase capacity and resilience – at all levels.” With @DrTedros we proposed an international #PandemicTreaty rooted in @WHO constitution. It would guarantee equity & inclusiveness. A legally binding instrument would be the most effective basis for prevention, surveillance, collection and exchange of scientific data.#WHS2021 pic.twitter.com/lbWkc3G5XE — Charles Michel (@eucopresident) October 25, 2021 Diversion or game changer? 25 heads of government and international agencies have come together in support of the new pandemic treaty Some of the civil society organisations that have expressed disquiet about the treaty proposal perceive it as a potential distraction or diversion by wealthy countries from the so-called TRIPS waiver proposal, currently under consideration by thee World Trade Organization. The proposal by South Africa and India for a broad-based intellectual property waiver on COVID vaccines and treatments, now being debated by the WTO’s TRIPS Council , is perceived by civil society as a game changer that would help open the doors to despearately needed COVID vaccine and medicines manufacturing in Africa and the global South. Many of the European countries that have been among the most staunch opponents of the TRIPS waiver are also key pandemic treaty supporters, noted journalist Priti Patnaik, who is researching stakeholders’ views on the pandemic treaty for G2H2 -giving rise to the CSO suspicions. And yet at the same time, some developing countries have supported a pandemic treaty because they believe it would “rein in the influence of non-state actors, including powerful foundations, and get some binding obligations to apply to industry to avoid vaccine inequities in the future,” she added. ‘Switch-and-bait’ tactic Unni Karunakara, senior fellow at Yale’s Global Health Justice Partnership, said that the major focus should be on deploying available tools and medicines to every corner of the world, rather than negotiations over a new treaty: “Shouldn’t global vaccination coverage be an overwhelming priority now?” he asked. “We do have frameworks and tools. They’re not perfect, but there are enough tools for us to overcome this crisis together,” said Karunakara, a former president of Medecins sans Frontieres. “What is lacking, however, is the political will to share essential resources and tools, even with all of the treaties in place.” His comments reflecting the cynicism of other civil society activists who see “a big overlap between the countries that are blocking the TRIPS waiver, and the countries that are supporting the pandemic treaty. “So there’s a perception of a ‘switch-and-bait’ tactic that reeks of bad faith,” he added. And while transparency measures – such as the mandatory sharing of genetic materials by countries where outbreaks are suspected – have been discussed as key treaty features, similar mandates for transparency or sharing of vaccines and medicines technologies have been fiercely opposed by the EU, he pointed out. “TRIPS waiver-blocking countries have made the case for voluntary actions by pharma to ensure access to essential COVID-19 medical tools, so they treat Big Pharma with kid gloves,” Karunakara observered. “Interestingly, they take a very different tone and approach to the global south in the treaty, insisting on enforceability in the sharing of information and materials with WHO and other governments to allow for independent verification.” “The assumption here is that global south is the problem, that diseases originated in poor country, and pose national security risks to rich countries.” If you are against the treaty – what is your multilateral alternative? Björn Kümmel, at the WHO Executive Board’s January 2021 meeting. Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver – or the kinds of hidden agendas that civil society groups fear. “I doubt that it’s, from a logical point of view, right to say that even though a country has it stands on the TRIPS waiver, you can’t tackle other equity issues,” he told the G2H2 session. “That’s one angle to look at, the TRIPS waiver, but there are many more angles to be looked at. So to say that that is the only magic bullet, I think that would be fully wrong, I wouldn’t limit it to this. “I think that equity goes far beyond, and certainly, if a treaty was negotiated, it’s quite clear that this [TRIPS waive] will be put on the table, and that all governments will have to look at the different interests that are on the table and negotiate them with an open outcome.” He noted that the treaty was first proposed formally by Chile, not the European Commission, and has the support of a wide array of countries, including South Africa, Kenya, and Tunisia, as well as Thailand and Indonesia. Anything better than ‘Chaos’ we see now Describing the current global health situation as “dysfunctional”, Kümmel asked the G2H2 session: “If you are against the treaty, tell us what is your multilateral alternative to it, to be realistically implemented, lets say in the next five years?” “What the countries who are proposing a treaty are trying to say is: anything is better, than compared to the chaos that we’re seeing currently. “Legal clarity is needed, and it will be …a painful exercise for many of us, and most likely a difficult one for many governments, including mine, most likely also others. But in the end, it’s this is multilateralism.” Uniquely in the global health landscape – and unlike environment, trade or finance – there is a dearth of global treaty instruments. In fact, among the dozens of international treaties in force today, the only two binding instruments in global health today are the IHR and and the Framework Convention on Tobacco Control (FCTC), he pointed out. Pandemic is a ‘window of opportunity’ for bigger changes In light of the outstanding questions, however, the working group of countries that are preparing for the WHA special session had devised a “three-step approach” to their deliberations on a way forward. They are considering in parallel: WHO internal reform measures; revisions in the existing International Health Regulations that currently govern global emergency response; and finally, the Pandemic Treaty alternative. In terms of WHO reform, the conclusion has been that such measures would “not be sufficient in order to overcome the next pandemic,” Kümmel said. Amendments to the International Health Regulations (IHR) also would take time to negotiate. And a key question here is: “would they be a game changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” So against the other options, “an international binding agreement is interesting,” he said. “And why are many colleagues pushing for this to happen now? Well, it’s the reality that after Ebola and past pandemics the global community was unable to implement the lessons learned,” he said. And if negotiations don’t begin now, in the heat of the ongoing crisis, they will never happen at all. “Many of the international independent panels have called for bold recommendations to be implemented,” Kümmel reminded the group. “One of them is the treaty. But many of those recommendations have never reached successful implementation, because the window of opportunity for real structural changes normally vanishes with the next crisis to come after the pandemic.” The treaty would also retain WHO’s centrality as the nerve center of the global health architecture – amidst a plethora of new health initiatives emerging in Europe and elsewhere: “There are a multitude of ideas and recommendations, and the treaty is a legal framework into which most of the other recommendations would fit,” he said, in reference to recent proposals such as one by the Pan European Commission on Health and Sustainable Development to create a new global health board under G-20 auspices. Others have talked about a new global health finance board in association with the World Bank and/or a new UN-level Global Health Threats Council, under the auspices of the UN General Assembly. So the Pandemic Treaty is “also a mechanism to provide WHO with legitimacy after this crisis,” he stressed. “Obviously there are voices out there who could see alternative approaches. However, I think the ones who are in favour of this treaty have clearly articulated that WHO is the right forum because its the truly multilateral forum for global health.” WHO precedents for equitable access to vaccines? Germany is not the only actor that sees the treaty as a means of keeping WHO as the world’s main global health meeting place. WHO’s Director General Dr Tedros Adhanom Ghebreyesus has himself come out in support for the pandemic treaty measure – breaking ranks with previous agency heads who usually remained aloof of controversial measures under consideration by member states. WHO is therefore keenly interested in how civil society groups may help lead or shape views on the treaty negotiations – and this interest was reflected in a cameo appearance at the G2H2 event by Stephen Solomon, WHO’s principal legal officer. Solomon said it was “really helpful” to understand some of the “scepticism” around the pandemic treaty initiatives. “Understanding the the concern about an agenda driven issue here is very important for the [WHO] Secretariat,” Solomon told the group. At the same time, beyond the immediate COVID crisis, other WHO emergency response frameworks already in place also could perhaps benefit from the stronger legal backpone that a pandemic treaty might provide, he pointed out. One example is the Pandemic Influenza Preparedness (PIP) framework, which mandates that 10% of global flu pandemic vaccine production supply goes to WHO for direct distribution, based upon public health needs. Another is WHO’s Global Action Plan for influenza vaccines. These “are meant to address equity issues in a number of epidemics, not necessarily pandemics,” Solomon said. “I would be very interested in reactions to particular frameworks meant to address inequities, like the pandemic influenza preparedness (PIP) framework, not legally binding. Or like the WHO Global Action Plan (GAP) for influenza vaccines, also not legally binding. “But both are interesting and potentially of important reference to pandemic preparedness and response. PIP basically says 10% of global pandemic vaccine production supply goes to WHO for distribution on the declaration of an influenza pandemic for distribution based on public health needs, and we have legally binding contracts for that 10%,” said Solomon. “Could that be a reference point for responding to future pandemics? “If so, would it be useful to put that in more of a legal framework because of weaknesses within that structure – particularly the idea of countries not allowing export for vaccines already under contract?” Solomon asked. Similarly, the Global Action Plan for influenza vaccines was a 10-year, non-binding arrangement that aimed to better distribute capacity for flu vaccine production, including among low- and middle-income member states, he pointed out, asking: “Could that also benefit, or not, from a normatively binding architecture?” The final research report will be launched by G2H2 on 24 November. –Elaine Ruth Fletcher contributed to the writing of this story. Image Credits: WHO / Antoine Tardy, EU Council, C Black, WHO. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy
Civil Society Activists Question Pandemic Treaty’s Ability to Address Global Health Inequalities 26/10/2021 Kerry Cullinan A session of the 2020 World Health Assembly. Some civil society organisations (CSO) are sceptical about whether a ‘pandemic treaty’ is the best way to address future global health crises, while treaty supporters say it will provide a legal framework binding countries and global health bodies to more agile and rapid responses to future outbreaks. A session Monday sponsored by the Geneva Global Health Hub (G2H2) brought leading CSOs, diplomats, academics and even WHO’s chief legal counsel face to face to air those views, in the context of a research initiative on the treaty being undertaken by the hub. The debate comes just weeks ahead of a planned special session of the World Health Assembly which is to determine whether the global body will indeed move forward on a Treaty, as a key measure for improving pandemic response. The treaty initiative has been supported most visibly by European countries, led by European Commission President, Charles Michel, who in a separate session at the World Health Summit in Berlin that the treaty would guarantee “access to information, financing, vaccines and countermeasures. It would increase capacity and resilience – at all levels.” With @DrTedros we proposed an international #PandemicTreaty rooted in @WHO constitution. It would guarantee equity & inclusiveness. A legally binding instrument would be the most effective basis for prevention, surveillance, collection and exchange of scientific data.#WHS2021 pic.twitter.com/lbWkc3G5XE — Charles Michel (@eucopresident) October 25, 2021 Diversion or game changer? 25 heads of government and international agencies have come together in support of the new pandemic treaty Some of the civil society organisations that have expressed disquiet about the treaty proposal perceive it as a potential distraction or diversion by wealthy countries from the so-called TRIPS waiver proposal, currently under consideration by thee World Trade Organization. The proposal by South Africa and India for a broad-based intellectual property waiver on COVID vaccines and treatments, now being debated by the WTO’s TRIPS Council , is perceived by civil society as a game changer that would help open the doors to despearately needed COVID vaccine and medicines manufacturing in Africa and the global South. Many of the European countries that have been among the most staunch opponents of the TRIPS waiver are also key pandemic treaty supporters, noted journalist Priti Patnaik, who is researching stakeholders’ views on the pandemic treaty for G2H2 -giving rise to the CSO suspicions. And yet at the same time, some developing countries have supported a pandemic treaty because they believe it would “rein in the influence of non-state actors, including powerful foundations, and get some binding obligations to apply to industry to avoid vaccine inequities in the future,” she added. ‘Switch-and-bait’ tactic Unni Karunakara, senior fellow at Yale’s Global Health Justice Partnership, said that the major focus should be on deploying available tools and medicines to every corner of the world, rather than negotiations over a new treaty: “Shouldn’t global vaccination coverage be an overwhelming priority now?” he asked. “We do have frameworks and tools. They’re not perfect, but there are enough tools for us to overcome this crisis together,” said Karunakara, a former president of Medecins sans Frontieres. “What is lacking, however, is the political will to share essential resources and tools, even with all of the treaties in place.” His comments reflecting the cynicism of other civil society activists who see “a big overlap between the countries that are blocking the TRIPS waiver, and the countries that are supporting the pandemic treaty. “So there’s a perception of a ‘switch-and-bait’ tactic that reeks of bad faith,” he added. And while transparency measures – such as the mandatory sharing of genetic materials by countries where outbreaks are suspected – have been discussed as key treaty features, similar mandates for transparency or sharing of vaccines and medicines technologies have been fiercely opposed by the EU, he pointed out. “TRIPS waiver-blocking countries have made the case for voluntary actions by pharma to ensure access to essential COVID-19 medical tools, so they treat Big Pharma with kid gloves,” Karunakara observered. “Interestingly, they take a very different tone and approach to the global south in the treaty, insisting on enforceability in the sharing of information and materials with WHO and other governments to allow for independent verification.” “The assumption here is that global south is the problem, that diseases originated in poor country, and pose national security risks to rich countries.” If you are against the treaty – what is your multilateral alternative? Björn Kümmel, at the WHO Executive Board’s January 2021 meeting. Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver – or the kinds of hidden agendas that civil society groups fear. “I doubt that it’s, from a logical point of view, right to say that even though a country has it stands on the TRIPS waiver, you can’t tackle other equity issues,” he told the G2H2 session. “That’s one angle to look at, the TRIPS waiver, but there are many more angles to be looked at. So to say that that is the only magic bullet, I think that would be fully wrong, I wouldn’t limit it to this. “I think that equity goes far beyond, and certainly, if a treaty was negotiated, it’s quite clear that this [TRIPS waive] will be put on the table, and that all governments will have to look at the different interests that are on the table and negotiate them with an open outcome.” He noted that the treaty was first proposed formally by Chile, not the European Commission, and has the support of a wide array of countries, including South Africa, Kenya, and Tunisia, as well as Thailand and Indonesia. Anything better than ‘Chaos’ we see now Describing the current global health situation as “dysfunctional”, Kümmel asked the G2H2 session: “If you are against the treaty, tell us what is your multilateral alternative to it, to be realistically implemented, lets say in the next five years?” “What the countries who are proposing a treaty are trying to say is: anything is better, than compared to the chaos that we’re seeing currently. “Legal clarity is needed, and it will be …a painful exercise for many of us, and most likely a difficult one for many governments, including mine, most likely also others. But in the end, it’s this is multilateralism.” Uniquely in the global health landscape – and unlike environment, trade or finance – there is a dearth of global treaty instruments. In fact, among the dozens of international treaties in force today, the only two binding instruments in global health today are the IHR and and the Framework Convention on Tobacco Control (FCTC), he pointed out. Pandemic is a ‘window of opportunity’ for bigger changes In light of the outstanding questions, however, the working group of countries that are preparing for the WHA special session had devised a “three-step approach” to their deliberations on a way forward. They are considering in parallel: WHO internal reform measures; revisions in the existing International Health Regulations that currently govern global emergency response; and finally, the Pandemic Treaty alternative. In terms of WHO reform, the conclusion has been that such measures would “not be sufficient in order to overcome the next pandemic,” Kümmel said. Amendments to the International Health Regulations (IHR) also would take time to negotiate. And a key question here is: “would they be a game changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” So against the other options, “an international binding agreement is interesting,” he said. “And why are many colleagues pushing for this to happen now? Well, it’s the reality that after Ebola and past pandemics the global community was unable to implement the lessons learned,” he said. And if negotiations don’t begin now, in the heat of the ongoing crisis, they will never happen at all. “Many of the international independent panels have called for bold recommendations to be implemented,” Kümmel reminded the group. “One of them is the treaty. But many of those recommendations have never reached successful implementation, because the window of opportunity for real structural changes normally vanishes with the next crisis to come after the pandemic.” The treaty would also retain WHO’s centrality as the nerve center of the global health architecture – amidst a plethora of new health initiatives emerging in Europe and elsewhere: “There are a multitude of ideas and recommendations, and the treaty is a legal framework into which most of the other recommendations would fit,” he said, in reference to recent proposals such as one by the Pan European Commission on Health and Sustainable Development to create a new global health board under G-20 auspices. Others have talked about a new global health finance board in association with the World Bank and/or a new UN-level Global Health Threats Council, under the auspices of the UN General Assembly. So the Pandemic Treaty is “also a mechanism to provide WHO with legitimacy after this crisis,” he stressed. “Obviously there are voices out there who could see alternative approaches. However, I think the ones who are in favour of this treaty have clearly articulated that WHO is the right forum because its the truly multilateral forum for global health.” WHO precedents for equitable access to vaccines? Germany is not the only actor that sees the treaty as a means of keeping WHO as the world’s main global health meeting place. WHO’s Director General Dr Tedros Adhanom Ghebreyesus has himself come out in support for the pandemic treaty measure – breaking ranks with previous agency heads who usually remained aloof of controversial measures under consideration by member states. WHO is therefore keenly interested in how civil society groups may help lead or shape views on the treaty negotiations – and this interest was reflected in a cameo appearance at the G2H2 event by Stephen Solomon, WHO’s principal legal officer. Solomon said it was “really helpful” to understand some of the “scepticism” around the pandemic treaty initiatives. “Understanding the the concern about an agenda driven issue here is very important for the [WHO] Secretariat,” Solomon told the group. At the same time, beyond the immediate COVID crisis, other WHO emergency response frameworks already in place also could perhaps benefit from the stronger legal backpone that a pandemic treaty might provide, he pointed out. One example is the Pandemic Influenza Preparedness (PIP) framework, which mandates that 10% of global flu pandemic vaccine production supply goes to WHO for direct distribution, based upon public health needs. Another is WHO’s Global Action Plan for influenza vaccines. These “are meant to address equity issues in a number of epidemics, not necessarily pandemics,” Solomon said. “I would be very interested in reactions to particular frameworks meant to address inequities, like the pandemic influenza preparedness (PIP) framework, not legally binding. Or like the WHO Global Action Plan (GAP) for influenza vaccines, also not legally binding. “But both are interesting and potentially of important reference to pandemic preparedness and response. PIP basically says 10% of global pandemic vaccine production supply goes to WHO for distribution on the declaration of an influenza pandemic for distribution based on public health needs, and we have legally binding contracts for that 10%,” said Solomon. “Could that be a reference point for responding to future pandemics? “If so, would it be useful to put that in more of a legal framework because of weaknesses within that structure – particularly the idea of countries not allowing export for vaccines already under contract?” Solomon asked. Similarly, the Global Action Plan for influenza vaccines was a 10-year, non-binding arrangement that aimed to better distribute capacity for flu vaccine production, including among low- and middle-income member states, he pointed out, asking: “Could that also benefit, or not, from a normatively binding architecture?” The final research report will be launched by G2H2 on 24 November. –Elaine Ruth Fletcher contributed to the writing of this story. 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