Meeting of the WTO TRIPS Council on Thursday October 15.

 

Nearly 100 World Trade Organization member countries and entities could potentially swing behind a proposal by India and South Africa to enact a wide-ranging waiver of complex World Trade Organization requirements on the use of patented products, trade secrets and copyrights on health products during the pandemic, asserted the Médecins Sans Frontières (MSF) Access Campaign on Thursday.

MSF on Thursday called upon governments to support what it called “this game-changing step” that would allow countries worldwide to opt out of the granting and enforcement of patents and other IP related to COVID-19 drugs, vaccines, diagnostics and other health technologies for the duration of the pandemic.

The proposal for a “TRIPS Waiver” of the WTO’s requirements by India and South Africa, along with co-sponsors Eswatini and Kenya, is due to be discussed informally tomororw by WTO members, after a formal discussion last month at the WTO TRIPS Council.

The Council administers the complex rules around adherence to patent laws in international trade – Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as so-called TRIPS flexibilities that allow countries to disregard some patent rules, under certain conditions, during health emergencies.

But proponents say that the rules don’t go far enough in loosening the reins of IP control – so that low- and middle-income countries could rapidly gear up, produce and export generic or biosimilar versions of new up-and-coming drugs, such as monoclonal antibodies. Ditto for the barriers to producing COVID-19 vaccines using cutting-edge technologies like mRNA, which seem to have proved themselves in the results of Phase 3 clinical trials unveiled this week by both Moderna and Pfizer. 

Both sets of trials, involving tens of thousands of people found that the mRNA vaccines were about 95% effective in protecting people against COVID-19.  Almost as important was news that the Pfizer vaccine, developed jointly with BioNTech was 94 % effective in preventing COVID infections among older people, who are much more vulnerable to the disease.  

Race For Vaccine Distribution Set To Begin – Where, How & When ?
Most vaccine campaigns, like polio, have been aimed at children. COVID would target adults.

Pfizer is now poised to submit its vaccine for emergency use approval to the United States Food and Drug Administration by Friday, with Moderna to follow soon afterward.  With the prospects the vaccines may be approved by the FDA as early as December, the race will be on to roll out production and distribution – and the questions of who gets what vaccines first – will become all the more acute.  

But due to the huge logistics and financial challenges involved, vaccine distribution could very well prove to be even more challenging than the research itself. And low- and middle-income countries with long experience in getting the shorter end of the stick, when it comes to quickly getting access to new drug treatments, are becoming more and more anxious. 

According to an MSF background brief, based on informal polling and statements made at the 15-16 October TRIPS Council meeting, a majority of WTO members, some 99 countries, already support the waiver proposal either fully or in principle.  Those expressing full support, include: Argentina, Bangladesh, Egypt, Indonesia, Mali, Mauritius, Mozambique, Nepal, Nicaragua, Pakistan, Sri Lanka, Tunisia, and Venezuela. 

Perhaps more significant, however, is the growing list of countries that have “welcomed” the proposal and said it should be discussed further. Those include: global giant China, Turkey; Pacific influencers like the Philippines and Thailand; Latin America’s Chile, Colombia, Costa Rica, Ecuador, El Salvador, and Jamaica; and African powerhouses like Nigeria, Senegal and Tanzania. 

In addition, according to the MSF count, seen by Health Policy Watch, support has been expressed in principle by dozens of other countries as members of various WTO trade alliances, including: 

  • The “African Group”, including Botswana, Cabo Verde, Congo, Cote d’Ivoire, Democratic Republic of Congo, Ghana, Morocco, Namibia, Seychelles, Togo and Tunisia;  
  • Organization of African, Carribean and Pacific countries, specifically Antigua and Barbuda, Barbados, Belize, Cuba, Dominica, the Dominican Republic; Fiji, Ghana, Grenada, Guyana, Papua New Guinea, Saint Kits and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Samoa, Solomon Islands, Suriname, Tonga, Trinidad and Tobago, Vanuatu, the Bahamas, Comoros; Equatorial Guinea, Ethiopia, Sao Tomé and Principe, and Somalia.
  • Chad on behalf of most other members of the WTO’s “Least Developed Countries group not already supporting the proposal individually.  The group includes some 45 other African and Asian countries, as well as small island states; 

Against that growing wall of low- and middle-income country opinion,  most of the world’s developed countries have lined up against the waiver proposal, led by the United States, the United Kingdom, Australia, Japan and the European Union – but also including Switzerland, Brazil, Norway and Canada. 

Developed countries have largely grouped behind the WHO co-sponsored ACT Accelerator, including its COVAX facility – a procurement network that now includes 186 countries. COVAX aims to secure and distribute sufficient vaccinedoses to immunize health workers and at-risk populations globally by pooling large vaccine purchase orders to pharma, without upending patent rules. Similar schemes are underway, under the broader ACT umbrella, to pool and procure orders for the large-scale purchase of COVID medicines and diganostics.

European Union, South Africa, Norway and WHO Issue Call to G20 for Billions in Funding 
European Commission head Ursula von der Leyen, Melinda Gates, Norway’s Erna Solberg and (upper right) WHO’s Dr Tedros Adhanom Ghebreyesus speak at the Paris Peace Forum.

But that scheme still requires some US$ 28 billion in funds to ensure that some 92 countries that cannot afford to buy pricey new COVID vaccines, medicines and tests will obtain the products that they need. At the Paris Peace Forum last week, European leaders along with WHO issued an urgent appeal for money. On Thursday, WHO issued yet another high-level appeal ahead of this weekend’s planned G-20 Summit, being hosted  by Saudia Arabia, asking the Group of 20 most industrialized countries to “fully fund” the initiative, including an immediate $US 4.5 billion allocation of funds.

The letter, jointly authored by Norway’s Prime Minister, Erna Solberg, South African President Cyril Ramaphosa, President Ursula Von der Leyen of the European Commission and WHO’s Director General, Dr Tedros Adhanom Ghebreyesus, underlined that funds are now needed immediately to “lay the groundwork for mass procurement and delivery of COVID-19 tools around the world.

“A commitment by G20 leaders at the G20 Summit in Riyadh to invest substantially in the ACT-Accelerator’s immediate funding gap of US$ 4.5 billion will immediately save lives, lay the groundwork for mass procurement and delivery of COVID-19 tools around the world and provide an exit strategy out of this global economic and human crisis,” the letter states.

“With this funding, and a joint commitment to spend a proportion of future stimulus on the COVID-19 tools needed globally, the G20 will build a foundation to end the pandemic. This year’s G20 Summit takes place during the most serious global crisis in memory and could mark on the most important moments in multilateral cooperation.

The letter, co-signed by South Africa, which is also leading the WTO waiver initiative, as well as by the EU’s Von der Leyen, whose countries oppose the same, also hints at how the G-20 leaders’ response could impact the future course of debate on the trade and IP front, stating:

“We need the G20 to continue to lead, not only in securing the necessary resources to end the COVID-19 pandemic, but also in addressing the crisis from a strategic macroeconomic perspective that transcends national and sectoral interests and demonstrates joint global action.”

In other words, if  rich countries step up to the bat with massive funding – and big pharma actively joins the ACT initiative with massive offers of voluntary licenses to expand needed vaccines and medicines production – then a polarizing debate at the WTO might be avoided. But if funds fall short, and low and middle income countries can’t access new, lifesaving technologies – then the WTO option may become much more attractive. And its sponsors have already suggested that they might even take the measure to a vote at the WTO – shattering the tradition of decision by consensus.

The Hurdle of Fair Distribution Of Patented Vaccine Supplies

Even if funds become available to purchase brand-name vaccines produced by Moderna, Pfizer and others through the ACT Accelerator, the next problem will be the rapid scale-up of vaccine manufacturing and thus supplies. 

Rich countries have already snapped up huge quantities, if not the lions share, of all of the vaccines that Moderna and Pfizer are planning to manufacture next year. And to hedge their bets further, those same countries have also made pre-orders of vaccine doses from other pharma companies which have other front-running candidates in final stage trials.

Moderna’s vaccine is particularly relevant to low and middle income countries because the vaccine can be stored at 2 ° to 8 ° C (36 ° to 46 ° F) for up to 30 days, for longer at around -20 C ° (-4 F °). In comparison, Pfizer’s vaccine needs ultra-cold storage temperatures of -70 C ° or below. 

The Boston-based Moderna has said that it is on track to manufacture 1 billion vaccine doses in 2021 in collaboration with the Swiss-based manfacturing firm Lonza, at sites in the USA and Visp, Switzerland.

But with pre-orders for some 300.5 million doses, and options to purchase another 480 million more doses – high income countries already have a corner on the market for 780.5 milion out of the 1 billion doses to be produced by Moderna in 2021. Countries with the largest pre-orders and options include the United States, the European Union, Canada, Switzerland and Japan.

Vaccine research at the US National Institutes of Health – the US government has poured billions into pharma R&D

That would mean up to 78% of Moderna’s available vaccine supply would go to countries representing just 12% of the world’s population, as a coalition of NGOs recently pointed out.

Another issue being raised by access groups is the potential price tag companies will put on their vaccines, versus the public subsidies that the same vaccine R&D has already received.  Leading pharma firms developing COVID vaccines have so far received some US$ 12 billion in public funds, according to MSF. That includes Moderna’s receipt of some US$ 2.48 billion in United States government public funds. And yet Moderna’s reported price tag for the two-dose vaccine at $US 50-60 per course is the reported to be the “highest cited for a potential vaccine so far.”

Moderna’s ‘No Patents Enforcement’ – MSF Says Its Not Enough 

Against the background of the pandemic, Moderna, as well as other pharma companies have already made gestures indicating that they would not try to do business as usual.

AstraZeneca, another firm with a vaccine in Phase 3 trials, has pledged to sell its vaccine, if approved,  on a not-for-profit basis for as long as the pandemic continues. The company, which co-developed its vaccine with researchers at the UK’s Oxford University, also recently signed a licensing agreement with Brazil’s world-class public research institution, Fundação Oswaldo Cruz (Fiocruz) to produce 100 million vaccine doses. But critics point out that, despite these moves, the no-profit clause may only be good until July, 2021.

Moderna, for its part, has pledged “not to enforce our patents” on its novel mRNA vaccine technology for the duration of the pandemic. In theory, this could mean that other vaccine manufacturers with capacity to make biosimilar versions  (the biological equivalent of generics) could theoretically step into the vacuum, as soon as the Moderna vaccine wins FDA approval, to scale up production much more. 

But access advocates say that Moderna’s pledge so far has not included any commitment to actually license its novel mRNA technology to other manufacturers, so that they could acquire the know-how to produce the novel vaccine.  

While pharma voices point out that many low- and middle-income countries don’t even have the capacity to handle sensitive vaccine technologies, some do. They include India, which is the other key co-sponsor of the WTO initaitive. 

And for countries like India, with significant pharma export potential, a WTO waiver could be far easier to manage, sources say, than the current IP “flexbilities” offered by the TRIPS system in cases of public health emergencies.

Those TRIPS flexibilities largely revolve around Article 31 and 31bis of the TRIPS agreement, which stipulate that countries may issue “compulsory licenses” for patented products.  But, they must do so on a case-by-case basis, and for use primarily in domestic markets.  MSF sums up the rules, and their limitations, like this: 

  • Article 31 requires that compulsory licenses are issued on a case-by-case basis and used predominantly to supply domestic markets, thereby limiting the ability of manufacturing countries to export to countries in need.
  • Article 31bis requires that any product produced and exported under a compulsory license be identified with specific packaging and quantities, which can lead to unnecessary delays in the context of COVID-19 where countries need urgent access to medical tools.

Concludes the MSF brief, despite the “no enforcement” pledge, Moderna, Pfizer and other large pharma firms engaged in promising vaccine trials would need to go much further with voluntary steps to really make a difference in the yawning demand that will open up as soon as new vaccines and drugs are approved: 

“Moderna must share all IP, including the necessary technology, data and know-how, so that other manufacturers can scale up production of these potentially lifesaving vaccines. Many COVID-19 vaccine developers, including Pfizer/BioNTech, have taken no steps towards licensing or transferring IP-protected technologies to enable increased global manufacturing capacity and supply.” 

-Menaka Rao contributed to this story. 

 

Image Credits: WTO, Moderna TX, United Nations Photo, National Institutes of Health (NIH) .

Global health is acting out of a legacy of colonial influences, where rich countries dominate policies that determine how key health investments are made, and where distribution of health products may take place.

The current power dynamics in global health are a barrier to achieving health equity, partly because too many high-profile politicians are simply reluctant to listen to, or act upon, scientific evidence, and partly because of countries and institutions that wield disproportionate influence in today’s global health architecture aren’t willing to relinquish their power: a left-over of colonial influences.

Sarah Hawkes, director at the Centre of Gender and Global Health.

At the Geneva Health Forum session on Wednesday, ‘How do We Decolonialise Global Health?’, Sarah Hawkes, director at the Centre of Gender and Global Health, asked: “Why don’t people, particularly in political circles, use the evidence that’s in front of them?”

Hawkes urged that people in the global health sector need to evaluate “how we’ve ended up in a situation where very powerful political stakeholders are seen as anti-evidence and anti-science”.

Further confounding matters, she added: “We have ended up in a position in 2020 where those people with political power are not necessarily the same or equal to those with financial power.”

Health Equity – A Fragile Concept

Tammam Aloudat, Senior Strategic Advisor Access Campaign at Médecins Sans Frontières (MSF), noted that populist politics also have made health equity a fragile concept.

Tammam Aloudat, Senior Strategic Advisor Access Campaign at Médecins Sans Frontières (MSF).

And since financing and funding still determine many aspects of delivering health, he added: “What stands now is a set of norms that allocates resources, and that is controlled by power hierarchies, that can aim as much towards perpetuating their own power as towards improving health and prosperity.”

Global health is also acting out of a legacy of colonial influences, where rich countries dominate policies that determine how key health investments are made, and where distribution of health products may take place.

“Rarely has any colonial power, in classic colonialism, given up its position of power willingly by the kindness of their hearts,” Aloudat said.

Historically, those holding power relinquished control “because [they were] incentivized” one way or another. Without proper incentives, he argued, it may be difficult to convince countries and institutions that wield outsized power in the present day global health arena to commit to real health equity.

This is evident in the burgeoning debate over the fair distribution of COVID-19 vaccines. Two vaccines have now been reported to have an efficacy of greater than 90%, but how and when these will be administered in low- and middle-income countries (LMICs) remains unclear.

Stakeholders Must Acknowledge Global Health’s Colonial Legacy

In any case, it is important for stakeholders to acknowledge that global health’s legacy “isn’t all good and fuzzy”, keynote speaker Dr Mishal Khan said.

Dr Mishal Khan, Associate Professor at the London School of Hygiene and Tropical Medicine (LSHTM).

Khan, an Associate Professor at the London School of Hygiene and Tropical Medicine (LSHTM), said that global health players need to start thinking about how decolonisation could be framed, she added. Currently, it is proffered in a way that is so “naive” as to assume that everybody is on board and everybody cares.

In early November, when Khan spoke to Health Policy Watch, she noted that while colonialist influences in global health are ubiquitous, the issue still hasn’t attracted sufficient attention.

At the GHF session, she clarified that stakeholders in the health sector need to be “very clear on imagining what sort of new global health we want to see, and then looking into organizations and asking them what they are going to do.

“What steps are you going to take as an organization to become closer to that?”

Open Dialogue Needed On Decolonisation

Open dialogue and a commitment towards decentralisation are key to tackling colonialist influences, the panelists also stressed.

Seye Abimbola, Editor of BMJ Global Health.

Seye Abimbola, Editor of BMJ Global Health noted that an ‘open dialogue’ process would provide clarity on what changes stakeholders want to see, first of all.

“Getting clarity on what the change looks like is an incentive because it can help galvanise energy behind goals. Imagine what that world looks like, and start taking concrete steps,” Abimbola said.

COVID-19, moreover, has presented an opportunity for global health actors to realise that decentralizing power is feasible. For instance, Geneva’s global health organisations have been forced to shift more staff and responsibilities from headquarters to national and regional offices, as a result of travel restrictions that have dramatically curbed international travel.

More Acknowledgement of ‘Shared Burden’ of Universal Health Coverage Goal

The panellists also noted that the pandemic has strengthened awareness about the importance of universal health coverage (UHC) – among both rich and poor countries – in order to stave off future health threats.

Emanuele Capobianco, Director for Health and Care at the International Federation Of Red Cross And Red Crescent Societies.

Whereas “global health” used to be seen largely as a system to enable developing countries’ health systems, the pandemic has revealed – to many for the first time – that there are big gaps in UHC in developed countries as well, said Emanuele Capobianco, Director for Health and Care at the International Federation Of Red Cross And Red Crescent Societies.

“We are very passionate about UHC breaking away from an oppressive way of thinking. UHC breaks away from that, bringing issues of access to healthcare. From Malawi to Switzerland, health access predominates in the COVID pandemic,” Emanuele said.

Image Credits: Geneva Health Forum.

The COVID-19 pandemic did not so much create cracks in healthcare systems around the world, as it exposed weaknesses in them, participants at the Geneva Health Forum said Wednesday at a session on how health systems have fared during the COVID-19 pandemic.

Edward Kelley, Director of Integrated Health Services Universal Health Coverage and Life Course, WHO.

“We have found fragility everywhere,” said Edward Kelley, Director of Integrated Health Services Universal Health Coverage and Life Course, WHO, during the session entitled Health Systems Resilience in a Pandemic Crisis, co-sponsored by the World Economic Forum.

In order to strengthen healthcare systems so they can withstand the brunt of health emergencies, more private-public cooperation is critical, said Kelley and other participants, which also included a representative of India’s health ministry and the pharma sector.

For a long time, universal health coverage (UHC) has been seen as a primarily public sector function. This, however, should not be the case, according to Kelley: “There is no way we will get to where we need to be by making this anything but a public and private partnership.”

Shri Rajesh Bhushan, India’s Secretary of Health & Family Welfare, cited India’s experience in the pandemic, which saw unprecedented public-private health sector cooperation, while also keeping death rates low.

“For the first time ever, various state governments and the Union [central] Government closely coordinated with the private sector healthcare providers to repurpose their ICU, oxygen and isolation beds, to suit the needs of COVID,” said India’s Secretary of Health & Family Welfare, Shri Rajesh Bhushan.

Shri Rajesh Bhushan, Secretary of Health & Family Welfare, India.

In fact, while India has seen 8.8 million reported COVID cases, that is still only about 25% as many, per capita, as the US. And, per capita, India has recorded half as many deaths.

Whereas the global mortality rate from people with confirmed cases of COVID hovers around 2.46%, the mortality rate in India is 1.48%. This translates to 2.5 deaths per million population, which is about 10 times less than the US, “and quite a bit less than other countries in Europe like Belgium,” added Bhushan.

Digital Care Allowed for Better Resource Prioritization

The partnership space should not only cater for physical modes of healthcare provision. Rather, it needs to extend to the digital or virtual approaches of dispensing care. AstraZeneca executive vice president, Iskra Reic, described how the multinational pharmaceutical company partnered with the UK’s NHS during the COVID pandemic to create what is dubbed a ‘virtual ward’ for COVID patients.

This digital solution allowed vulnerable and at-risk patients to get care without physical interaction with a physician.

Reic, who oversees operations in Europe and Canada, said that the digital solution has eased the workload for physicians, in addition to easing pressure on the healthcare system and patient traffic, something which in and of itself can be a risk factor for COVID-19 transmission.

“It has helped physicians prioritize, and really focus their time and effort on those who are at the highest risk.”

Image Credits: Geneva Health Forum.

Healthcare workers wear protective gear at a community-based testing site for COVID-19 in Madagascar, OCtober 2020.

Experts met at the Geneva Health Forum (GHF) this week to discuss the successes and challenges met in expanding social health protection to achieve Universal Health Coverage (UHC).

Every year, around 100 million people are pushed into “extreme poverty” because they have to pay for health care, and over 800 million people – almost 12% of the world’s population – spend at least 10% of their household budget on health care costs, according to WHO figures.

With half of the world’s population still not having access to the health services they need because of financial constraints, social health protection – meaning any kind of financial system that assures access to health care, including both free national health insurance or affordable health insurance plans – is vital to bridge this gap and reach the goal of UHC set by the 2030 Sustainable Development Agenda.

“A number of countries are trying to strengthen their efforts and expand social health protection as a right – a right to be enjoyed by everybody,” said Claude Meyer from P4H Social Health Protection Network, speaking at a GHF event on Tuesday to discuss global efforts to extend social health protection systems to achieve UHC. “But they are often confronted with what we call fragmented systems of coverage, and these fragmented systems of coverage affect equity.”

The GHF invited three experts to reflect on the ways this fragmentation of health care can be reduced while extending coverage, and offer examples of methods in practice across different countries.

Merging Social Health Protection Systems

Valeria Schmitt, deputy director of the social protection department at the International Labor Organization (ILO), discussed how merging different systems could serve to reduce admin costs and ensure healthcare services are more widely available.

“Regarding fragmentation of institutions, it’s very clear that instead of having two or even three institutions in charge of access to health care, as it is the case in Thailand for instance, merging the operations would reduce admin costs,” said Schmitt.

But such a move is by no means easy. Thailand has been attempting to merge the three systems into one for many years to level up inequalities between the care available for the three different social groups that are protected by each scheme – civil servants, workers in the so-called formal sector, and informal workers .

Aungsumalee Pholpark, lecturer at the department of society and health at Mahidol University in Thailand, explained that, if achieved, combining the three schemes into one would hopefully solve problems that exist in the current systems, where informal workers often receive lower standards of care.

Difficulty Reaching the Most Vulnerable Populations

There are also specific challenges within certain populations, the panelists noted, especially hard to reach communities that may be remote from central administrations and institutions. Matthew MacGregor from the Global Fund discussed how, as countries make changes and transition between systems to achieve UHC, the most vulnerable populations are at risk of being left behind.

“At the Global Fund, enhancing equity and making sure that services reach the most vulnerable and are sustained even beyond our financing is a critical and major piece of our work,” said MacGregor. He emphasised the importance of external funding to strengthen public health systems and outreach programmes to make sure health care services, when available, can actually reach the most vulnerable populations.

A New Recognition for UHC After COVID-19

The experts also discussed the key lessons of COVID-19 in terms of UHC – primarily the importance of investing in social protection systems for health coverage.

“Countries that already had relatively strong social protection institutions in place were able to react to COVID-19 much more rapidly and efficiently,” said Schmitt, citing the example of Indonesia, which has invested heavily in its national health insurance system for many years and was able to rapidly distribute testing and treatment widely among the population.

Schmitt also noted how COVID-19 had highlighted the need to ensure people at all levels of society had equitable access to a high standard of health care, and the ability of governments to make this happen.

“I think COVID-19 has shown that when you have the political will, you can implement social health protection and social protection in general, and that there is solidarity at the level of the international community,” she said. “So this gives a message of hope that if all the countries want to achieve universal health coverage and universal social protection, they can make this happen.”

Health Policy Watch Watch is collaborating with Geneva Solutions, a new non-profit Geneva platform for constructive journalism covering International Geneva

Image Credits: Flickr – World Bank.

antimicrobial resistance test on bacteria in petri dish
Recent AMR successes include increased prominence in global discussion and a robustly funded discovery-stage and translational research but momentum and public communication have been long-standing issues.

The COVID-19 pandemic has underlined the need to dramatically step up the combat against drug-resistant bacteria, viruses and other pathogens. The world can’t afford to be caught again by surprise with the spread of a dangerous infectious disease for which there is no cure, a growing chorus of global health leaders are warning as the world observes World Antimicrobial Awareness Week (18 – 24 November).

“The antimicrobial resistance (AMR) agenda must move forward with renewed vigor and momentum in the global health space, one that can fit into a post COVID-19 narrative,” says Timothy Jinks, Head of the Drug Resistance Infections Program at Wellcome Trust.

Timothy Jinks, Head of Wellcome Trust’s Drug Resistant Infections Priority Program, speaking on Wellcome Trust’s “The Global Response to AMR” Report

He spoke as the Wellcome Trust released a new update on “The Global Response to AMR” that said concrete progress on attacking the root causes of AMR had been too slow and key priorities like water, sanitation, and hygiene (WASH) and infection prevention and control (IPC) have not been addressed.

To up the political ante, WHO will be launching Friday a new “One Health Global Leaders Group on Antimicrobial Resistance” (AMR) – led by Sheikh Hasina, Prime Minister of Bangladesh and Mia Mottley, Prime Minister of Barbados – whose mission will be to give the issue more visibility among other world leaders. The “One Health Global Leaders” initiative was first announced in August by the  WHO, the Food and Agriculture Organization (FAO) and the World Organization for Animal Health (OIE)- which are trying to work together more closely to curb both human and animal use of precious drugs – which is one of the key drivers of AMR.

“The world is in an arms race against antimicrobial resistance and we hope the new group will consider solutions on all fronts against AMR, including encouraging sustainable production of antimicrobials,” said Alba Tiley, the Global Director of the Sustainable Antibiotics Program at Centrient Pharmaceuticals, regarding the WHO initiative. Centrient, a generic pharma firm based in Rotterdam, Netherlands, is one of the few remaining antibiotic manufacturers in Europe. Their portfolio covers many medicines on the WHO Essential Medicines list including amoxicillin, penicillin and cephalosporins. 

“We need to make sure the very process of making these life-saving medicines does not contribute to antibiotics losing their effectiveness.”

Three Critical Gaps – Wellcome Trust Report

AMR already causes some 700,000 deaths annually. But if current trends are not reversed, that number could rise to 10 million per year by 2050, a special UN task force has warned.

As antimicrobial drugs lose their efficacy due to AMR, risks of prolonged hospital stays or additional surgical interventions increase substantially. AMR burdens health systems already struggling with cost inflation, and damages national economies from increasing illness and death that further hit health budgets. These health and economic burdens disproportionately fall on low and middle-income countries (LMICs). The Wellcome Trust report zeroes in on what it describes as three key gaps in global AMR response, that drive the risk of irreparable loss of valuable drugs.

  • Ambition has not translated into action. Though there has been a prominent increase of global discussion on AMR over the past three to four years, this has not translated into a broader implementation of initiatives, especially in LMICs, where AMR typically competes for political attention and resources with other public health topics.
  • The most critical drivers of AMR need to be prioritized. The ‘big tent’ approach of the AMR response to date has increased awareness among a broad range of stakeholders. However, AMR experts are concerned that the multifaceted nature of the issue, the complexity of its narrative, and the multitude of possible interventions are paralysing the community, preventing impactful action.
  • The AMR agenda was losing momentum before SARS-CoV-2 emerged. And now? Already in late 2019, a growing circle of experts perceived the AMR agenda as losing momentum, due in part to the complexities of communicating about the issue to the broader public. The COVID-19 pandemic has exacerbated those concerns.
The report notes that the COVID-19 pandemic has demonstrated how vital it is to conduct R&D to combat novel and drug-resistant viruses

New Opportunities – and Solutions

At the same time, now that politicians and the broad public have seen what damage an invisible virus can wreak, when no drug treatment exists, the time may be more ripe for warnings that this could happen again – very soon – if AMR trends aren’t vigorously addressed.

Wellcome Trust’s key preventative measures for the next decade

The Wellcome Trust report etches out a way forward for the next decade. The plan of attack focuses not only on accelerating the pace of R&D for new drug therapies to replace those rendered impotent by drug resistant bugs, but also limiting abuse of drugs in use now. Among the key preventive measures, are:

Human consumption of antibiotics: Optimising human consumption of antimicrobials requires guaranteed access for those who need treatment – but adequate stewardship to limit overuse and abuse. This requires much stricter regulation of sales and use of classes of antibiotics and antiviral agents to which bacteria have developed, or are beginning to develop, resistance. In particular, greater restrictions on over-the-counter sales to the public – and more public awareness about the appropriate use of such drugs, is needed.

Antimicrobial use in animals: A response that is preventative that doesn’t focus purely on treatment requires a holistic perspective that includes other topics such as ensuring appropriate antimicrobial use in animals. There needs to be a more prudent use of drugs needed for humans in the livestock sector, which is one of the world’s largest consumers of antibiotics, particularly in the USA, Europe and other OECD countries.

Water, sanitation, and hygiene (WASH): Access to clean water and better management of sewage runoff both prevents infections, reducing the need for drugs in the first place,  as well as reducing untreated waste streams laced with antibiotics or other drug residues that act as reservoirs where drug resistant pathogens might breed.

Infection prevention and control (IPC): IPC measures in hospitals and communities reduce the need for antibiotics and their consumption.

Surveillance: Right now, only about one-third of countries gather data and report systematically on use of antimicrobial drugs.  Much more effective surveillance systems also are critical to understanding the problem, designing and implementing interventions, and assessing the effectiveness of the response, the report underlines.

Livestock applications of antibiotics in metric tons/year, among countries reporting use. (The Antibiotic Footprint)

Scaling up Research and Development for New Drugs

Research and development also needs to be scaled up dramatically, the report emphasizes. This has already begun to happen, with the establishment of a new Global Antibiotic Research and Development Partnership (GARDP), created by the World Health Organization (WHO) and Drugs for Neglected Diseases initiative (DNDi), which aims to drive more private and public investment into R&D to replenish the antibiotic drug pipeline. In July an AMR Action Fund of nearly $1 billion was also established by more than 20 leading biopharmaceutical companies, with a mission to bring 2-4 new antibiotics to patients by 2030.

In addition to that, the Wellcome report also underlines that in light of the COVID-19 pandemic – the source of which is a virus, not a bacteria – that R&D to combat new and drug-resistant strains of viruses, and other pathogens must also occur continuously and sustainably.

In addition, by preventing infection in humans and animals, vaccines play an important role in reducing antimicrobial consumption.

Can COVID be an Opportunity?

Despite the complexity of the issue, this week is seeing a flurry of activity that suggests the ripples of a broader awakening about AMR.

During Wellcome Trust’s panel on Wednesday, global leaders brought up AMR’s unique role in the face of the COVID-19 pandemic. 

COVID-19’s impact on the AMR global response

“So while COVID-19 is taking over the public health dialogue, it simultaneously has opportunities through this pandemic that we should strategize around. This is prevention’s moment; prevention has never been sexier,” says Lindsey Denny, a health advisor at Global Water 2020, and a global health practitioner with experience across Africa, Asia, and Latin America. Denny spoke to how the pandemic has generated a better understanding of public health principles such as WASH and the importance of PPE. “We can and should capitalize on advocating both to decision makers and to the broader public for WASH and IPC strategies.” 

Jyoti Jyoshi, Head of the South Asia Center for Disease Dynamics, Economics, and Policy, discussed the need for the AMR community to integrate itself more so into the global health sphere. “The AMR community should tie in with the large global health preparedness and systemic response agenda. Because we don’t live in isolation. Infections don’t need visas. It’s a flat wall – people travel just as microbials and chemicals like antibiotics do.” 

There was also a joint statement on the AMR threat issued today by very diverse group of actors, including: the International Alliance of Patient Organizations, the International Hospital Federation, the International Society for Quality in Health Care, and the International Federation of Pharmaceutical Manufacturers and Associations.

The statement supports innovative partnerships of healthcare providers, patients and the business sector in tackling the growing AMR threat.

In an op-ed in Geneva Solutions, Neda Milevska, vice-chair of the International Alliance of Patients’ Organizations, says it is also the patient’s responsibility to become more aware about the need to prevent the abuse and overuse of antibiotics and other drugs.

She describes the approach as one that can also enhance patient empowerment, saying that so far, the power of patients has been ignored by policymakers in the battle against AMR, even though personal behaviour plays a major role: “Among patients today, there is widespread practice of self-treatment with antibiotics. This is stimulated even more so by the COVID-19 pandemic, as physicians have increasingly prescribed antibiotics to stave off increased illness, which feeds back into the loop of drug-resistance.

“It is always politically sensitive to mention that patients have some responsibility. But, no amounts of funding to develop new drugs or curb AMR now will work, if people at the grassroots continue to abuse their life-saving potential. The magnitude of people’s power is so great .. .and it can be destructive or productive.”

Image Credits: DFID – UK Department for International Development, Wellcome Trust, USAID Asia/Flickr, antibioticfootprint.net.

Contributing to human progress: open innovation for infectious diseases

Finding the right combination of open innovation – that is the free sharing of expertise, knowledge and data – and intellectual property (IP) that may drive private  investments in expensive new technologies, can be a difficult balancing act to attain.

But as the COVID-19 pandemic has underlined, it is more and more critical to etch that golden mean, in order to support successful collaborations between academia, industry and government entities and also make the end products widely accessible and affordable, said speakers at a Geneva Health Forum (GHF) during a session on the potential of Open Innovation to support R&D on infectious diseases on Monday. The forum brought together experts from both private and non-profit sectors.

Kelly Chibale, Neville Isdell Chair in African-centric Drug Discovery, University of Cape Town.

“During the early stages of scientific discoveries, the whole question of IP and data ownership can often become more complex than the actual science itself,” said Benjamin Perry, Senior Discovery Manager at the Drugs for Neglected Diseases Initiative (DNDi).

Even though IP and science share an intricate interface, IP remains an important aspect of attracting investments to new pharma ventures in Africa, said Kelly Chibale, the Neville Isdell Chair in African-centric Drug Discovery, University of Cape Town.

“In order to attract development partners, such as pharmaceutical companies for example, it is necessary to ensure the IP is secured because it gives the company the freedom to operate,” he said.

But Chibale also stressed the critical role that the government plays in R&D collaborations, saying that the partnership model that his MRC team uses also involves academia and industry in not-for-profit R&D product development.

In Research on Neglected Diseases IP Disputes Are Muted

At the Geneva-based Drugs for Neglected Diseases Initiative (DNDi), a Geneva-based health non-profit, the focus is on curing diseases that are prevalent among the world’s poorest populations and offer little promise of financial reward to innovators. So it is possible to get a new medicine all the way through the R&D pipeline and into the hands of  patients, without having to debate the issue of  intellectual property position, said Perry.

Benjamin Perry, Senior Discovery Manager at the Drugs for Neglected Diseases Initiative (DNDi).

Perry cited a project he runs, where chemistry students in 25 universities in different countries are working on the same project collaboratively, without the need for IP. These institutions include the University of Otago in New Zealand, University of Ghana and the University of Geneva in Switzerland as well as a couple of universities in the UK and the US.

“This has been enabled by the agreement that there will be no IP taken on this,” said Perry.

While some private sector companies still want to claim certain IP rights when they support certain aspects of DNDi’s research, the non-profit has formulas for arranging this, which also ensure up front that patients’ access to the final end-product at an affordable price will be guaranteed.

For its part, the collaboration between the World Intellectual Property Organisation (WIPO) with a number of organizations, is now helping advance early stage research on neglected tropical diseases, malaria and TB, through an initiative known as WIPO Research.

“What we do is we connect researchers with company scientists and leading pharmaceutical companies,” explained Charles Randolph, Head of Global Health at WIPO.

The initiative started 10 years ago, with about 30 academic research institutions. The network has  since grown to 150-plus institutions in 43 countries in six continents.

“Why [open innovation and open collaboration] in global health?” asked Thomas Spangenberg, Head, Global Health Drug Discovery at Merck, which co-sponsored the GHF session.

By dedicating resources to open research into neglected areas of infectious disease research, pharma companies fulfill an important corporate responsibility, he said.

“We believe that innovation occurs at the scientific interface. By collaborating, we can pull resources and make the model more sustainable,” he said.

Image Credits: Geneva Health Forum.

New guidelines detail how household spices and accessible medicines have been used across India’s population during the pandemic.

Use of Ayurvedic medicines, already on the rise worldwide, has soared even higher during the pandemic.

But few people may be aware that at least one country, India, actually has an entire ministry devoted to promoting use of these traditional remedies, that have been used for centuries: the Indian Ministry for Ayurveda, Yoga, Unani, Siddha, and Homeopathy (AYUSH).

Appearing at the Geneva Health Forum on Tuesday, India’s Minister for AYUSH, Shripad Yesso Naik, presented the ministry’s guidelines for using traditional treatments, like Ayurveda and Yoga, to build health and immunity against COVID-19.

The guidelines – which have been translated into 9 languages including English and Chinese – detail how household spices and accessible medicines have been used across India’s population, and were issued by the Indian Ministry for Ayurveda, Yoga, Unani, Siddha, and Homeopathy (AYUSH).

Yesso Naik, the Indian Minister for AYUSH, said: “India has shown the path to combat with COVID-19 by improving the general immunity – by using Yoga and other Indian traditional systems of medicine.”

He added: “An advisory has been issued about self care guidelines and preventative health measures for boosting immunity. For example, a nasal application of oil, herbal tea made up of spices commonly available in every household and Ayurvedic medicine like sanshamani vati and Chyawanprash.”

This follows WHO’s announcement last week that it will set up a Global Centre for Traditional Medicine in India.

Clinical Trials for AYUSH Must be ‘Rigorous’

Over the last few years, the Ministry of AYUSH has taken several measures to regulate the traditional medicine manufacturing industry, with a particular emphasis on researching the medical systems.

Since the beginning of the COVID-19 pandemic in India, the Ministry of AYUSH has been conducting research into AYUSH interventions, including releasing a protocol for clinical trials on AYUSH treatments.

Naik said that so far, soome 67 AYUSH clinical research studies have been undertaken in India that examine the use of AYUSH treatments to relieve symptoms of COVID-19, most of which  are near completion.”

The Indian government also issued an additional Post-COVID management protocol this September mostly with inputs from the AYUSH ministry, including recommendations of practicing Yoga and taking some other Ayurvedic medicines, that is said to improve immunity.

Dr Ritu Priya Mehrotra, Professor at the Centre of Social Medicine and Community Health, at Jawaharlal Nehru University, noted that the pandemic has created an “excellent opportunity to conduct some good studies related to AYUSH”.

She warned, however, that these studies accord value to traditional interventions for their medical potential, but still “need to be conducted rigorously” to see how they measure up scientifically. There has been widespread criticism in the Indian medical community over the promotion of traditional Indian remedies that have not undergone rigorous clinical trials and studies.

She also warned against the what she called “pharmaceuticalisation” of these traditional medicinal approaches: the idea that certain remedies, if proven to be effective, might be reduced only to medicinal formulations, ignoring the holistic principles that traditional medicine also emphasize with respect to the importance of healthy lifestyles, the practice of meditation and exercise such as yoga.

climate change effect on maize ears crop
A woman shows how her maize ears have dried in the drought stricken garden. A new report has shown that countries most affected by climate change receive only a fraction of available funding for climate change adaptation.

Climate change poses an even greater threat to public health than the COVID-19 pandemic – and needs to be treated with equal urgency, Jagan Chapagain, Secretary-General of the International Federation of the Red Cross and Red Crescent Societies (IFRC), told a virtual news conference on Tuesday.

He was speaking at Tuesday’s launch of the IFRC’s World Disasters Report 2020, which finds that a rising wave of extreme weather and climate-related events have killed more than 410,000 people over the past decade.

“Of course, the COVID is there, it’s in front of us, it is affecting our families, our friends, our relatives. It’s a very, very serious crisis the world is facing currently,” Chapagain said.

But, he warned that “climate change will have a more significant medium and long term impact on the human life and on Earth… and unfortunately, there is no vaccine for climate change”.

The report finds that over the past decade, 83% of all disasters triggered by natural hazards were caused by extreme weather and climate-related events such as storms, floods and heatwaves. Together, these disasters have killed more than 410,000 people and affected 1.7 billion people. Meanwhile, efforts to tackle climate change are failing those people who are most at risk from its effects.  Those countries most affected by climate change receive only a fraction of the funding that is available for adapting to climate change, the report found.

At-Risk Populations Not Receiving Full Funding

The report shows that countries most affected by climate change receive only a fraction of the funding that is available for climate change adaptation, meaning the populations most at risk are not protected.

Analysis by the IFRC showed that none of the 20 countries most vulnerable to climate change were among those that received the most funding for adaptation.

People receive food assistance during the dry season in the Sahel. The region has suffered from extended droughts due to climate change.

Somalia, the most vulnerable country, ranked 71st for funding disbursements per person. Meanwhile, more than half of the countries categorised as highly vulnerable to climate change received less than $1 per person in climate adaptation funding, while two countries – the Central African Republic and North Korea – received none at all. Of the countries with the highest disbursement for climate adaptation, none had high or very high vulnerability scores.

“There is a certain amount of climate adaptation funding out there [which is] really needed in a lot of countries, but there are some particular countries that are particularly vulnerable, many of which are fragile, and they are getting left out,” said the report’s editor, Kirsten Hagon, in a press conference on Monday. “One of the things we would like to see happen with this report is to really push for an increased investment in those countries that are currently left behind.”

Given the steady increase in the number of climate and weather-related disasters, the failure to protect the people most vulnerable to climate change is alarming. According to the report, the average number of climate and weather-related disasters per decade has increased nearly 35 per cent since the 1990s.

No Vaccine for Climate Change

More than 100 disasters have taken place since the start of the pandemic in March this year, affecting more than 50 million people. Pandemic response and recovery are at the top of most governments’ agendas, but the IFRC are urging governments not to let the pandemic detract from making climate change a priority.

“We are slowly learning to deal with the pandemic…and once we have vaccines available, hopefully in the next two years, we should be able to largely manage the impact of the virus,” IFRC Secretary General Jagan Chapagain told Geneva Solutions. “But unfortunately there is no vaccine for climate change, and the depth and scale of the impact it is having and will have on the planet would be much more significant, and extremely difficult to reverse.”

Dead and dying animals at the Dambas, Arbajahan, Kenya, which has dried up due to successive years of very little rain.

Chapagain argues that the massive stimulus packages being developed around the world to respond to COVID-19 are an opportunity to “build forward better”, prioritising a green recovery that not only tackles the causes of climate change but also makes communities more resilient to future climate-related disasters.

“Broadly we have seen global solidarity around COVID-19, and there have been quite huge stimulus packages announced by different governments,” explained Chapagain. “It will really be a massive lost opportunity if governments and organisations do not use those massive stimulus packages in ways that are climate friendly, and that not only don’t do harm but actually strengthen recovery in a more green, inclusive, and adaptive manner. This is absolutely possible.”

Humanitarians Urged to Make Climate Change a Priority

The IFRC is also encouraging investment in early warning systems and anticipatory action to reduce risks and prevent disasters before they happen, calling on humanitarian organisations in particular to step-up their implementation of early action plans.

“Unfortunately, climate change has already happened, and it’s increasing the frequency and intensity of disasters, so of course we will have to continue to respond rapidly and at scale to save lives,” said Chapagain. He explained that many organisations have made progress towards facilitating anticipatory responses in recent years, but more can be done to invest in forecasting systems and encourage forecast-based financing.

The IFRC has also urged humanitarian organisations to ensure their work on the ground is sustainable and always keeps climate change in mind. The pandemic has highlighted the importance of local actors in humanitarian response, and made practices such as distributing cash rather than importing goods overseas more commonplace. Organisations should focus on putting resources in the hands of communities most affected by climate change and supporting their efforts to adapt and build resilience against future shocks.

“As we have seen during COVID-19, the local actors are very capable of responding,” said Chapagain. “I think recognising that, investing in them, and really empowering the local response makes a huge, huge difference.”

Health Policy Watch Watch is collaborating with Geneva Solutions, a new non-profit Geneva platform for constructive journalism covering International Geneva.

Image Credits: Pablo Tosco/Oxfam, EC/ECHO/Anouk Delafortrie, Brendan Cox / Oxfam.

The test, which is currently available on prescription use only, can provide results within 30 minutes.

The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular-based single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. in a press release on Tuesday. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “We look forward to proactively working with test developers to support the availability of more at-home test options.”  Link to the FDA press release here.

 

Image Credits: Flickr: Prachatai.

Healthcare worker in the COVID-19 intensive care unit in San Salvatore Hospital in Pesaro, Italy in March.

The world’s 27 million nurses and midwives – who comprise 60% of the health workforce – are not only excluded from the health system’s corridors of power, but also have faced new levels of censure and reprisal during the COVID-19 pandemic when they protested dangerous or abusive working conditions, said expert panel members at the Geneva Health Forum on Monday.

Along with the widespread shortages of personal protective equipment (PPE) that put many nurses lives at risk and led to at least 20,000 deaths, the pandemic period has seen the suspension of labour laws in some countries, increased discrimination against healthcare workers, and employers’ restrictions or censorship of nurses who dared to speak about their working conditions. 

Speaking on the panel ‘The Year of the Nurse and Midwife 2020 – A Catalyst for Change’ on Monday, Soosmita Sinha, President of the Health Law Institute, said: “There were cases globally, and especially in the US, where … nurses could not talk to social media, nurses could not talk to government organizations. There were repercussions from employers.”

Soosmita Sinha, President of the Health Law Institute, at the Geneva Health Forum session on Monday.

In an interview with Bloomberg News in March, Ruth Schubert, a spokesperson for the Washington State Nurses Association, observed that “hospitals are muzzling nurses and other health-care workers in an attempt to preserve their image”, threatening to fire employees if they talked to the media without authorization or publicized their working conditions.  

Two states in the US, Colorado and Virginia, expanded whistleblower protections to apply to these circumstances and allow nurses to report issues to their employers, social media, and other organizations. Other states enacted laws enabling healthcare workers to bring their own PPE if the hospital had a shortage.

“We’ve heard reports of nurses having to work long hours, not being able to take vacations, working when they’re sick … how is it compromising patient safety? If nurses are not safe, can patients really be safe in that environment? Aren’t we actually making them vectors of COVID to pass on to the next person?” posed Sinha. 

Healthcare workers form between 2% and 3% of the population in most countries, yet data has shown that the healthcare worker COVID-19 infection rate is 10-14%. Of the 54 million total COVID-19 infections globally, some 5 million could be healthcare workers. 

Nurses Needed in Leadership Positions and Decision Making Bodies

The panelists reviewed WHO’s first-ever State of the World’s Nursing Report released in April, which highlighted the unrecognized contributions of nurses to health systems and called for new policy measures and investments to strengthen the nursing workforce.

“We need to hear and see and be advised by nursing leadership voices at all levels through our health systems,” said Howard Catton, CEO of the International Council of Nurses. “It would bring this nursing perspective into the heart of decision making about how service is delivered and also into political decision making as well.” 

Howard Catton, CEO of the International Council of Nurses, at the Geneva Health Forum session on the Year of the Nurse and Midwife.

The ability of nurses to influence policies is essential because “they understand the reality on the ground,” Sinha said. Nurses account for 60% of the health workforce and provide 90% of primary health care.

“It is absolutely necessary to have nurses in all the decision making bodies, to have nurses in the COVID management taskforce, to have a government chief nurse, to have the voices and the views of nurses everywhere and to have influence … and not just to be used for managing crises,” said Roswitha Koch Heepen, senior member of the Swiss Nurses Association. 

Nurses have played a vital role on the frontlines of combating the pandemic and they will be essential in global vaccination efforts for COVID-19. Globally, nurses administer and lead the majority of vaccination programs, and they are crucial to a safe and efficient rollout of a COVID-19 vaccine – alongside pharmacists and refrigerated truck drivers. They have largely been left out of vaccination discussions, however. 

“Where is the nursing voice in terms of the big policy decisions? Where is the nursing voice in terms of managing the mass vaccination response?” said Catton. 

The State of the World’s Nursing Report highlighted the need to create at least 6 million nursing jobs by 2030, primarily in low- and middle-income countries. Elisabeth Iro, WHO Chief Nursing Officer, highlighted that without this increase “the ability to adequately respond to the COVID-19 pandemic or similar crises in the future is compromised and would jeopardize our collective ability to achieve Universal Health Coverage targets”.

“If you don’t have a nurse in place or a pharmacist to give that vaccination, it doesn’t matter how much of the vaccination we have or how we got to that point,” said Sinha.

The Geneva Health Forum runs from 16-18 November. Follow Health Policy Watch’s coverage here and on Twitter.

Image Credits: Alberto Giuliani, Geneva Health Forum.