A G20 Health Ministers Declaration, issued after a two-day meeting of ministers in Okayama Japan, has endorsed rapid achievement of universal health coverage, a more effective support of healthy ageing, increased attention to health emergencies and their underlying causes such as poverty and weak health systems, and more forceful action on antimicrobial resistance (AMR).

The detailed 11-page statement by health ministers of the world’s 20 largest economies – goes well beyond the more general commitment by G20 leaders to advance global health goals, which was issued at the close of their two-day meeting on 27-28 June.

The health ministers’ declaration reaffirmed the political declaration of the high-level UN meeting on Universal Health Coverage that took place 23 September, Universal health coverage: moving together to build a healthier world – which set a goal of covering every person worldwide with quality, affordable health services by 2030.

The ministerial declaration emphasized that achieving UHC would require strengthened primary health care systems first and foremost: “We recognize that high quality and safe primary health care including access to medicines, vaccination, nutrition, water and sanitation, health promotion, and disease prevention as well as managing antimicrobial resistance is a cornerstone for UHC.”

As part of the commitment to UHC, the ministers also reaffirmed pledges to “end the epidemics of AIDS, tuberculosis and malaria” in accordance with the Sustainable Development Goal targets; eradicate polio; support immunization; advance digital health technologies; and strengthen the capacities of the health workforce.

The declaration also gave extensive attention to healthy ageing, affirming: “active and healthy ageing as one of our priorities.  To support active and healthy aging, we will strive to optimize the opportunities for good health at all stages of life, to end ageism and discrimination against older people, to ensure older people are respected and enabled to exercise their rights and fully contribute to the society.”

In terms of ageing, health investments should also focus on ways to extend healthy life expectancy, including promoting research and development on reduction of risk factors for, and early treatment of dementia.  Investments should be made by other sectors in more age-friendly and dementia inclusive environments, the statement said.

In a section on management of health risks and health security, the ministers stressed that: “Outbreaks and other health emergencies are exacerbated by poverty, disadvantage, impact of social determinants of health or inadequate response capacity of health systems. Strengthening health systems, reinforcing primary health care as a cornerstone for universal health coverage is essential to stop the spread of infectious diseases and respond to health emergencies.”

The ministers added that “urgent action” needs to be taken to address the global threat of AMR, and welcomed the recent report of the United Nations Interagency Coordination Group on Antimicrobial Resistance (IACG)  “No Time to Wait: Securing the Future from Drug Resistant Infections“, as a practical guide to addressing AMR risk factors.

The declaration also noted that “improved practices and policy measures to provide clean water, sanitation, vaccination, and hygiene to improve infection prevention and control” can be a key components in combating AMR.

See the full text of the Declaration here.

The World Health Organization and UN Environment kicked off a week-long campaign asking countries to take more assertive action to ban lead paint, coinciding with International Lead Poisoning Prevention Week.

The Global Alliance to Ban Lead Paint,  a WHO-UN Environment Partnership involving countries and civil society, has set a goal to ban lead paint in all countries by 2020. To date, only 73 of the 194 WHO member states have legally binding control measures on lead paint.

“Of course this is an achievement, but we need more – much more. In fact, we need to triple our efforts,” said Dr. Maria Neira, director of WHO’s Department of Public Health, Social and Environmental Determinants of Health at WHO, in a video message. “Lead paint [poisoning] is preventable, and that’s why we need to attack the source of exposure to lead. Paints can be made without toxic lead – safe paints exist. That’s why it’s time to ban lead paint.“

According to WHO, there is no minimum “safe” level of exposure to lead, which is particularly toxic to children, and can reduce their IQ along with increasing the risk of developmental and behavioral problems. Lead paint is a leading source of domestic lead exposure in children.

The week-long campaign has three objectives:

  • Raise awareness about the health effects of lead poisoning;
  • Highlight countries’ and partners’ efforts to prevent childhood lead poisoning;
  • Urge further action to eliminate lead paint through regulatory action at country level.

Achieving these objectives falls under the broader Sustainable Development Goals agenda that aims to improve the management of “chemicals and all wastes throughout their life cycle” in an “environmentally sound” way and “significantly reduce their release to air, water and soil in order to minimize their adverse impacts on human health and the environment” by 2020.  This, WHO says, would “substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water, and soil pollution and contamination” by 2030.

Exposure to lead can also impact the reproductive system, kidneys, and cardiovascular system, along with impairing immune function. In 2017 alone, lead poisoning accounted for 1.06 million deaths, according to the Institute for Health Metrics and Evaluation (IHME). The IHME also estimates that in 2016, lead exposures accounted for 63.2% of the global burden of certain types of developmental intellectual disabilities, 10.3% of the global burden of high-blood pressure associated heart disease, 5.6% of the global burden of coronary heart disease and 6.2% of the global burden of stroke.

Lead poisoning results in a staggering global economic cost of $977 billion annually – with China and India bearing the brunt of the loss at $227 billion and $236 billion lost annually.

“We would like to call on governments, academia, industry civil society, on everyone… to raise awareness and address the devastating effects of lead exposure, especially for children,” said Neira, urging all stakeholders to hold events on the dangers of lead poisoning this week.  The campaign includes a series of posters, videos and social media materials in six languages that can be freely downloaded by individuals and groups that want to share the campaign messages.

Image Credits: UN Environment/ Global Alliance to Ban Lead Paint, WHO.

The World Health Organization is not yet ready to declare that the Ebola public health emergency in the Democratic Republic of Congo is over – despite significant recent declines in the pace of new infections.

WHO Director General Dr Tedros Adhanom Ghebreyesus said Friday that he did not find it prudent to end the “Public Health Emergency of International Concern (PHEIC)” designation for the DRC outbreak, due to continued uncertainties about the rate of case transmission in rural areas, where new infections are not always reported.

Community engagement activities raise awareness of Ebola in the DRC.

While there has been a steep decline in the number of cases over the past few weeks,  continued circulation of the virus in hard-to-reach communities means that the risk of further Ebola resurgence nationally or regionally remains high, the WHO Director General said, following a meeting with the International Health Regulations (IHR) Emergency Committee.

“The public health emergency of international concern will be maintained for the next 3 months… This outbreak remains a complex and dangerous outbreak. We need the full force of all partners to bring this outbreak under control and meet the needs of all people affected,” said Tedros in a press conference. He said his decision was in line with the IHR recommendations, following their review of the latest data on the situation today.

In a related development, the European Medicines Agency (EMA) announced that it would issue a conditional marketing approval for the Ebola vaccine (rVSV-ZEBOV-GP ) produced by Merck, which has been given to more than 236,000 people in the DRC outbreak and shown to be highly effective in protecting people from the virus.

WHO declared a PHEIC for the current Ebola outbreak on July 17, just two weeks before the EVD outbreak in the DRC hit its one-year anniversary. To date, there have been 3228 total cases (3114 confirmed & 114 probable), including 2157 deaths and 1038 survivors, with 15 new confirmed cases between and 14 new confirmed cases the week prior, significantly down from a peak of 126 cases per week in April and 85 per week in August.

However, the risk of the outbreak spreading nationally and regionally remains high due to the shift in transmission to more rural areas, bringing new operational challenges to identifying and treating cases.

Major security risks and difficulties in accessing remote areas, along with low awareness about the dangers of the Ebola virus and a lack of community engagement, have hindered the public health response in these new hotspots.

For instance, a recent WHO survey conducted in Mandima Health Zone, where most of the cases from the past three weeks have originated, found that less than half of the respondents would call an Ebola hotline if they suspected a member of their community of having Ebola.

Just under half of respondents said that they would encourage a family member suspected of having Ebola to seek treatment at an Ebola Treatment Center. This, WHO said, reaffirms the importance of engaging communities in response activities in upcoming weeks to ensure prompt case reporting, investigation of suspected cases, treatment in health centers, vaccination of suspected Ebola contacts, and safe burial of Ebola victims.

Outbreak preparedness activities are being conducted in the DRC and neighboring countries to mitigate the risk of resurgence, with support from a consortium of international partners (See related Op-Ed).

However, WHO is still facing a funding shortfall of at least US $70.5 million for outbreak response activities in the DRC and US$ 16.7 million for strengthening regional preparedness. Dr Tedros appealed to donors and regional countries to increase funding, calling the current lack of funding for regional preparedness “grossly inadequate.”

“This is dangerously shortsighted,” Tedros warned.

He highlighted that WHO and partners have in recent weeks actually stepped up efforts to control Ebola, emphasizing that “although the outbreak is concentrated in a smaller geographic area, we must treat every case as if it is the first, because every single case has the potential to spark a new and bigger outbreak.”

First Ebola Vaccine to Gain Conditional EMA Approval
A health worker administers the Merck vaccine to an Ebola contact.

The Merck vaccine is the first Ebola vaccine candidate to receive conditional marketing approval from the EMA, and the first licensed doses will hit the market in mid-2020.

The vaccine protects against the Zaire strain of the Ebola virus – the strain that caused the devastating 2014 West African outbreak and is one of the major strains currently circulating in the DRC.

“This vaccine has already saved many lives in the current Ebola outbreak, and the decision by European regulator will help it to eventually save many more,” said Dr Tedros, WHO Director-General, in a press release.

WHO is concurrently taking steps to prequalify the vaccine, a move which will give the green light for other countries to begin looking into licensing the product. However, the announcements are unlikely to impact how the vaccine is currently accessed or administered on the ground in the DRC.

Under this emergency context, the vaccine is licensed for use under a highly monitored research protocol, also known as an “expanded access” or “compassionate use” protocol. Under normal regulatory processes, new medical products can take years to reach market. WHO approves use of novel drugs and vaccines in emergency situations under such “expanded access” protocols to increase timely access to life-saving innovations.

To date, the Merck vaccine has been administered to 236,000 people impacted by the current outbreak, including more than 60,000 health and frontline workers in the DRC, Uganda, South Sudan, Rwanda and Burundi.

WHO, collaborating initially with the Government of Guinea, initiated a randomized trial to test the efficacy of the vaccine during the West Africa Ebola outbreak in 2015.

A global coalition of funders and researchers provided the critical support required for the success of the clinical trial. Funders included the Canadian Government (through the Public Health Agency of Canada, Canadian Institutes of Health Research, International Development Research Centre, Global Affairs Canada); the Norwegian Ministry of Foreign Affairs (through the Research Council of Norway’s GLOBVAC programme); the Wellcome Trust; the UK government through the Department for International Development; and Médecins Sans Frontières.

WHO is working with Gavi, the Vaccines Alliance, UNICEF and other partners to develop a Global Ebola Vaccines Security Plan, as increased supply capacity and multiple manufacturers will be needed in the short- to medium-term to meet the anticipated demand for the Ebola vaccine.

Elaine Ruth Fletcher contributed reporting to this story.

Image Credits: OMS RDC Twitter, World Health Organization Twitter.

In August, the Democratic Republic of the Congo (DRC) passed a milestone—surpassing 3,000 cases of Ebola since the outbreak began over a year ago. While the number of new infections has since slowed, there continue to be cases in hard to reach areas, posing challenges to response teams. The outbreak response has been complex, with security concerns hampering proven interventions.

Even with the availability of a vaccine and new treatments, the complicated political and social dynamics have hindered efforts. It’s a sobering reminder that the development of robust systems to prevent, detect, and respond to health threats is critical to saving lives.

Dr. Tedros Adhanom Ghebreyesus, the Director General of the World Health Organization (WHO), has stressed throughout the DRC Ebola crises of the need to build stronger health systems that can prevent epidemics before they occur. And specifically, support dedicated epidemic preparedness efforts.

A global strategy, executed locally, to improve preparedness

A critical tool to gauge a country’s preparedness ahead of a crisis is the Joint External Evaluation (JEE), a tool developed by WHO to assess how ready countries are to find, stop, and prevent epidemics. The recent completion of the 100th JEE is evidence that the tool has received widespread uptake since it was launched in Tanzania in 2016 – although many gaps identified in the JEE have yet to be addressed.

The JEE is a transparent, external assessment of health emergency preparedness designed to identify how ready a country is to prevent, detect, and respond to public health threats such as Ebola, yellow fever, and pandemic influenza. A peer-to-peer measurement, it acts as a kind of report card, where countries first evaluate themselves and are then joined by an external group of international experts. The evaluation covers 19 specific preparedness areas ranging from real-time surveillance to risk communications and national legislation, policy, and financing.

Each of the 19 areas is comprised of a series of indicators which are assigned scores during the peer-to-peer evaluation. Collectively, the information gathered through the JEE, including average national scores, provides important insight into the overall strength of a country’s system to deal with disease threats and other health emergencies. Countries lead the process with operational and technical support from WHO and other partners.

In the DRC, this has translated into a series of practical and critical initiatives to build stronger risk communication and community engagement teams; spread messages about the importance of seeking Ebola care early at health facilities; facilitate activities around vaccination, infection prevention and control; and ensure safe and dignified burials. Uganda and Rwanda have both stepped up their preparedness to prevent spread in their countries by operating vaccine drives, conducting border screenings for people with possible Ebola symptoms, improving cross-border collaboration and communication to reduce fear and keep borders open, and establishing isolation units and Ebola treatment centers.

Africa leads the world in evaluating preparedness – but many gaps identified

Nearly half of all countries with completed JEEs are in the WHO African Region, with 91 percent of African countries having completed an assessment. However, African countries have the lowest average JEE score (41 on a scale of 100) – the DRC scored only 35% in its recent assessment.

Of the nine countries sharing a border with DRC, none of the WHO priority 1 countries have achieved an average JEE score above 60% (Uganda, Rwanda, South Sudan, and Burundi). And of the WHO priority 2 countries, none have scored above 50% (Zambia, Tanzania, Central African Republic and Republic of Congo; Angola has not yet carried out a JEE). These scores indicate that these countries are underprepared and remain vulnerable to real risks that are playing out within the region.

The WHO Eastern Mediterranean and South-East Asia Regions also have high JEE completion rates (86% and 73% respectively), with marginally higher average scores (59% and 52% respectively). Countries in other WHO regions have also undergone the JEE assessment process, although their average scores are generally higher.

Emergency preparedness is directly related to the quality of the health systems in a country, and the amount of resources used to strengthen it. However, as shown by the uptake of JEEs in regions like Africa, low and lower-income countries have taken greater initiative to assess gaps as the first step to improving their preparedness.

Since 2016 the JEE has identified more than 7,000 action items that must be addressed, giving us a playbook to make the world safer from epidemics. Although some countries are reasonably well prepared, many lack basic systems to find, stop, and prevent infectious disease threats. Many are developing national action plans but have yet to implement them. The gaps in preparedness, if not urgently addressed, make it not a question of if, but when the next devastating epidemic will strike.

Empowering progress

The results of these assessments show many countries have strong immunization programs, disease surveillance, and laboratory networks. This likely reflects the financial resources provided by global donors and the technical assistance devoted to these areas. In contrast, critical areas such as legal frameworks, financing, disease-specific assessment and planning, and emergency response operations are among the weakest. This includes laws that set a legal precedent for disease control and preparedness, as well as activation and mandate of Emergency Operations Centers. Without these critical pieces, countries remain unprepared and unable to adequately protect their people, neighboring countries, and the world.

But progress is happening. Countries are starting to take action to fill their preparedness gaps. Nigeria developed a National Action Plan for Health Security and obtained funding from the World Bank and others to close gaps and improve preparedness. Uganda and many other countries are also using the JEE results to allow donors and partners to know which areas need the most support.

The second round of JEEs, to begin soon, will show us how these countries have progressed in just a few short years. Stepping up preparedness is difficult and will require sustained commitment from countries and from the global community. We must continue to conduct rigorous assessments while increasing support for countries.

And this support must include financing – from within and outside each country – as well as technical support. The World Bank estimates that annual global funding for effective preparedness is currently about $4.5 billion short. This may sound like a lot, but it’s less than a dollar per person per year, and far less than the cost of responding to disease outbreaks after they occur.

Recent studies show that every $1 spent on preparedness is worth more than $2 in the event of a public health emergency. In the absence of preparedness, costs will be high. SARS cost between $30-50 billion worldwide, and the 2014-2016 Ebola outbreak cost $53 billion in the three affected West African countries. A severe global pandemic could cost trillions, up to 5 percent of global GDP.

Completing over 100 JEEs illustrates the commitment of the global community to assess gaps in our ability to fight health threats. Now we must work with countries to translate JEE recommendations into urgent action that will close the gaps and prevent, detect, and respond to threats to public health.

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Amanda McClelland is Senior Vice President, Prevent Epidemics of Resolve to Save Lives, an initiative of Vital Strategies. Dr. Stella Chungong is Chief Country Capacity Assessment, Monitoring and Evaluation, WHO.

Image Credits: Resolve to Save Lives/Vital Strategies.

The world is not on track to reach the 2020 targets of the End TB Strategy, according to the World Health Organization’s latest Global Tuberculosis Report, published on Thursday.

On a more positive note, 2018 saw a reduction in the number of TB deaths with some 1.5 million deaths from TB, down from 1.6 million in 2017, according to a WHO press release. The number of new cases of TB also has been declining steadily in recent years. However, the burden remains high among low-income and marginalized populations: around 10 million people developed TB in 2018, WHO officials said in a press conference.

In Southeast Asia, a patient with multi-drug resistant TB receives his daily treatment.

While most high-burden countries are not on track to reach 2020 goals for ending TB as an “epidemic”, the report found that there are a handful of high TB burden countries in Africa and Asia that are on track to meet 2020 targets to reduce TB morbidity and mortality, as well as countries in WHO’s European Region.

Kenya, Lesotho, Myanmar, the Russian Federation, South Africa, the United Republic of Tanzania, and Zimbabwe were highlighted as high-burden countries on track for ending TB as an epidemic. Progress in TB control was credited to improved access to treatment, driven by technical advances in diagnostics and high-level political commitment to reducing the TB burden.

However, the total reduction in TB incidence between 2015 and 2018 was only 6.3%, falling considerably short of the End TB Strategy milestone of a 20% reduction between 2015 and 2020.

Globally, the number of TB deaths fell by 11%  between 2015 and 2018 was 11%, also less than one third of the way towards the End TB goal of a 35% reduction in TB deaths by 2020.

“WHO stands behind every country and person who decides that TB is not in their future,” Tereza Kaseva, director of WHO’s Global TB Programme, WHO, said in a press conference. “TB remains the world’s leading infectious killer,” she noted, calling for “urgent acceleration across all sectors” to reach the 3 million people that “missed out from receiving lifesaving TB treatment in 2018.”

“TB is a preventable, treatable, and curable disease. It is possible to accelerate our progress and reach our targets – it works when we have high level political commitments and those commitments are translated into actions.”

 

Image Credits: USAID Asia.

A request by South Africa to the World Trade Organization (WTO) TRIPS Council to “address the transparency of R&D costs and pricing of medicines and health technologies” is expected to be reviewed Friday, 18 October 2019 as the TRIPS Council meets this week for its third session this year.

The TRIPS Council, the administrative body for the 1995 TRIPS Agreement, will thus become the third international  body to take up the issue of drug pricing, following a landmark resolution by the World Health Assembly (WHA) in May urging countries to adopt transparency policies, followed by a Human Rights Council Resolution in July.

While the discussion at the third annual meeting (17-18 October) is unlikely to have immediate policy impacts, it will highlight the political barriers that countries face in using TRIPS flexibilities, which can involve threats of political repercussions far from the pharma arena.

The request by South Africa is also the latest in a series of moves by individual countries, as well as civil society, to move the transparency agenda further forward following the adoption of a landmark WHA resolution.

The United Kingdom’s Labour Party leader, Jeremy Corbyn, highlighted the high price of Orkambi, a life-saving cystic fibrosis drug, in a speech at his party conference in September, saying that the Labour Party, if elected, would override patent protections for excessively-priced medicines. Civil society watchdog, Observatoire Transparence Médicaments, appeared in front of the French Parliament to discuss a “transparency checklist” – a document that proposes establishing a public database of R&D and drug pricing data from different countries.

And earlier this month, Malta’s deputy prime minister and one of the leaders of the “Valletta Group,” composed of Italy, Malta, and eight other European states. described a new initiative by the group to share drug pricing data in an effort to improve their collective bargaining power to negotiate down prices with pharmaceutical companies.

High-level regional officials have also brought the issue to their forums, with the outgoing European Union Health Commissioner, Vykenis Andriukaitus calling transparency “a priority of the Commission.”

“We need transparency on public investment in R&D and pricing to ensure supply of affordable meds… Public funding should be reflected in the price and be given back in case of launch of successful products,” Andriukaitus said at the European Health Forum (Gastein).

High drug prices have been a major barrier to accessing treatment for many patients in countries of all income levels.

Defendants of the high costs of new medications say that the prices are justified in light of the risks and costs associated with R&D. Yet research and development information, including information about the associated costs, is highly protected, so that the true cost of R&D for many or most drugs remains largely unknown.

The issue is particularly thorny in the debate about drugs where the initial research was carried out in public institutions or subsidized by public grants.

The TRIPS Agreement, a two-decades old global trade agreement, created important categories of exemptions for governments, whereby they could bypass certain patent protections in cases where patents have impeded access to new products, including new essential medicines.

So called “TRIPS flexibilities” allow those governments to issue “compulsory licenses” for local production of patented drugs under certain conditions, parallel importation of patented drugs from generic producers, or other curbs on patent rights, so as to bring down prices. But implementation of these flexibilities has seen mixed results.

Transparency as a Facilitator of TRIPS Implementation

Historically, low- and middle- income countries that have trouble affording costly new medicines for complex chronic conditions or rare diseases such as cancer and cystic fibrosis have pushed forward the transparency agenda. But drug prices have skyrocketed to a point where even high-income countries are now looking for ways to bring down prices.

A researcher tests the efficacy of a generic drug in the United States.

In an Op-Ed published in the Financial Times on 17 October, Suerie Moon, co-director of the Geneva Graduate Institute’s Global Health Centre, pointed to the recent proposals floated in the United Kingdom, the EU and by players on both sides of the US political spectrum as evidence that drug pricing and transparency have become key issues in broader political campaigns.  Her op-ed entitled “There are solutions to the global drug price problem” looks at next steps that countries could take in the wake of the WHA price transparency resolution.

“Italy blazed a trail at the World Health Organization in shaping the passage of the historic transparency resolution (WHA72.8)…At the World Trade Organization, South Africa has crossed the Rubicon in bringing the transparency debate into the halls of the TRIPS Council,” said the Geneva Representative of Knowledge Ecology International (KEI), Thiru Balasubramaniam.

The WTO TRIPS Council is expected to accept South Africa’s request, which “will challenge trade negotiators to provide state practice on measures to enhance the transparency of R&D costs including “information on grants, tax credits or any other public sector subsidies and incentives,” said Balasubramaniam.

In its submission to the TRIPS Council, South Africa said, “The current model of medical innovation [based on patent protections] is ill-equipped to respond to the increasing emergence of infectious diseases, the unprecedented explosion of NCDs and neglected tropical diseases.”

South Africa argues that “abuse of IP rights” is difficult to monitor when there is no “reliable, transparent, and sufficiently detailed data on the costs of R&D inputs (including information on the role of public funding and subsidies), the medical benefits and added therapeutic value of products.”

Quoting the UN Secretary General’s High-level Panel on Access to Medicines, South Africa pointed to the panel’s observation of “transparency as a component of good governance, especially where civil society and patient groups rely on transparency of information. Transparency, as further stated, can also ensure fairness during negotiations that take place between biomedical companies and procurement organizations.”

In recent years, the WTO TRIPS Council, the governing body for the TRIPS Agreement, has focused its attention on aspects of intellectual property and innovation including innovation incubators, sports, and university technology partnership. According to Knowledge Ecology International, an intellectual property watchdog, the past few years have seen developing countries such as South Africa, India and Brazil pushing for agenda items to be more related to issues of “public interest.”

Mixed Success In Implementation of TRIPS Flexibilities

WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which entered into force in 1995 attempted to strike a balance between the long term social objective of providing incentives for future inventions, and the short term objective of allowing people to use existing inventions and creations.

But in the case of public health, the adoption of the TRIPS minimum standards resulted into a significant loss of policy flexibilities by developing countries in regulating the granting and use of pharmaceutical patents and controlling the cost of medicines, notes a South Centre assessment.

The Agreement, however, did provide for so called “TRIPS flexibilities” allowing governments to take certain measures to remedy anti-competitive practices and in situations of clear public health needs. These included issuing producers “compulsory licensing” to produce generic versions of patented products or engaging in the “parallel importation” of products when the appropriate patented product was either unavailable or too expensive.

In 2001, the rights of countries to make use of TRIPS flexibilities for public health were reaffirmed under the Doha Declaration on the TRIPS Agreement and Public Health. More recently, a WTO protocol amending the TRIPS Agreement to permit the granting of special compulsory licenses for the export of medicines entered into force on 23 January 2017.

A variety of ARV drugs used to treat HIV infection.

Over the past 15 years, TRIPS flexibilities were a major tool used in health milestones such as the decisions by South Africa, Brazil, and other low- and lower middle income countries to produce and use generic anti-retroviral (ARV) drugs for treatment of HIV/AIDS.

But in lesser profile cases, countries have been less successful in wielding the tools – or reluctant to use them at all because of the inherent political pressures. For instance, countries such as Colombia have been discouraged by the US and Switzerland from issuing a compulsory license for imatinib, an expensive cancer drug for which Novartis, a Swiss company, holds many national patents.

And over two decades on – no authoritative international body has done a truly comprehensive and systematic mapping and assessment of experience with TRIPS – another reason why the South African question to WTO is relevant.

Elaine Ruth Fletcher contributed reporting to this story.

Image Credits: NIAID, WTO, FDA/Michael Ermarth.

The risk of future Ebola outbreaks could be greatly reduced by more aggressive climate mitigation measures along with rapid progress on the Sustainable Development Goals, according to a new paper published in Nature Communications. Led by researchers at University College London, the article is the first study to examine the potential effects of global warming and the ecology of the Ebola virus (EVD) circulation among animal “hosts” on future Ebola outbreaks in human populations.

The study, Impacts of environmental and socio-economic factors on emergence and epidemic potential of Ebola in Africa, is a complex modelling exercise that demonstrates how progress on climate mitigation and strengthened health systems could reduce the impact of future outbreaks of the major Ebola virus strains that are endemic to key parts of Africa. Conversely, future outbreaks are likely to expand greatly their geographic reach if climate mitigation measures stall and progress on sustainable development is weak, according to the simulations, which were built around past experiences with outbreaks around Africa.

Under current trends of “business as usual emissions” and unsustainable development, which exacerbates poverty and stresses health systems, there could be a 14.7% increase in the geographic span of areas at risk of Ebola outbreaks, the study concludes.  Future Ebola outbreaks could thus reach countries such as Ghana and Nigeria that were relatively unscathed by the West African epidemic of 2014-2016 (which was focused around Guinea, Sierre Leone and Liberia). Uganda, Kenya, and Rwanda were also noted as areas in East Africa that could see potential Ebola outbreaks in business-as-usual scenarios.

Conversely, effective climate mitigation and sustainable development measures could actually reduce the geographic span of major outbreaks, decreasing the total area at risk of large-scale epidemics by 47%.

Change in future risk of EVD cases caused by Zaire Ebola virus (EBOV) for 2070. Maps represent mean change in per grid cell (0.0416°—5.6 km at equator) Ebola case probability is higher in red and lower in blue. Rows and columns show all reasonable combinations of the different scenarios of global change with the lower right indicating the best-case scenario (High climate mitigation, high sustainable development) and the top left indicating the worst-case scenario (“Business as usual emissions” and unsustainable development).

Climate change is a driver of EVD because it is is associated with expansion of the range of animal EVD hosts such as fruit bats, which prefer warm, wet climates and are believed to constitute an important animal reservoir for the virus.

Climate change and related environmental changes such as deforestation, urbanization and land use changes associated with agricultural expansion are all known factors that can intensify human contact with a range of disease-carrying animals, which are harbored by natural ecosystems. In the case of EVD, bush-meat hunting could also increase infection risks, the authors noted although this factor was not included in their model due to insufficient data. Climate-driven migration may also increase person-to-person disease transmission, related to migration from areas of drought and extreme weather, as well as further stress already overburdened health systems. However, more data on such interactions is needed to definitively predict the effect of increased human-animal contact on EVD outbreak risk.

The authors soberly note that current global commitments for climate action will be unlikely to induce the “wholesale change” in climate change drivers that would be required to also decrease risks of EVD. Therefore, they suggest that efforts to decrease poverty in Central and Western Africa, while expanding access to healthcare resources appears to be the most realistic approach to reducing future EVD disease risk regionally and globally.

Image Credits: Nature.

Some 822 million people worldwide suffer from hunger, and climate change is driving rising food insecurity in countries struck by worsening patterns of drought, flooding and other extreme weather that reduces  crop yields and livestock production among for the rural poor, as well as causing food price spikes for urban populations, according to the 2018 Global Hunger Index (GHI), released on Tuesday.

According to the report, there were some 37 million more hungry people in the world in 2018 as compared to 2015, when the number of those going hungry was 785 million. Some 43 out of 117 countries have serious levels of hunger, and 4 countries (Chad, Madagascar, Yemen, and Zambia) suffer from alarming hunger levels. And the Central African Republic has patterns of extremely alarming hunger, according to the report, produced annually by the NGO, Concern Worldwide, along with Welthungerhilfe, a German aid organization.

Hunger is increasingly linked to climate-induced changes in patterns of rainfall in regions a dispersed as Honduras and Africa’s Sahel and Lake Chad Basin, where the livelihoods of herdsmen and herdswomen “are evaporating with the lake itself,” said Mary Robinson, former UN High Commissioner for Human Rights and also former president of Ireland, in a preface to this year’s report, which focuses on the climate theme.

“That is the greatest injustice of climate change—that those who bear the least responsibility for climate change are the ones who will suffer the most,” she said, “We can no longer afford to regard the 2030 [Sustainable Development] Agenda and the Paris Climate Agreement as voluntary and a matter for each member state to decide on its own. Instead, the full implementation of both has become imperative in order to secure a livable world for our children and grandchildren. This requires a change of mind-set at the global political level.”

High-income countries are not included in the GHI but other indicators reflect food insecurity experienced by the poor in rich countries. The Food Insecurity Experience Scale—a measure of hunger used in developed countries although not directly comparable to the GHI—shows that in the European Union, 18 percent of households with children under age 15 experience moderate or severe food insecurity.  This year’s GHI report also notes that:

Composition of the Global Hunger Index: Source: Wiesmann et al. (2015). Note: The values of each of the four component indicators are standardized. See Appendix A for the complete GHI formula and Appendix B for the sources of data.
  • Climate change, driven by an average global temperature rise that is already at 1°C above pre-industrial levels, is threatening the ability of food systems to sustainably feed the world’s population.
  • Climate change is increasing the threats to those who currently already suffer from hunger and undernutrition.
  • There is a strong correlation between GHI scores and levels of vulnerability/readiness to climate change. Countries with high GHI scores are often also highly vulnerable to climate change but have the least capacity to adapt; several countries with low GHI scores are the least vulnerable and most ready.
  • Climate change also affects the quality and safety of food. It can lead to production of toxins on crops and worsen the nutritional value of cultivated food.  For example, it can reduce the concentrations of protein, zinc, and iron in crops.  As a result, an estimated additional additional 122 million people could experience protein deficiencies and another 175 million more people could be deficient in zinc and by 2050.

The Global Hunger Index (GHI) is a peer-reviewed tool designed to comprehensively measure and track hunger at global, regional, and national levels. GHI scores are calculated each year to assess progress and setbacks in combating hunger. See this link for more details about assessment tools used.

Image Credits: Global Hunger Index , Global Hunger Index.

The World Health Organization aims to expand mental health coverage to 100 million more people in 12 priority countries by 2023 as part of a new Special Initiative for Mental Health launched Monday at start of the 11th World Mental Health Forum.

Over 20 health ministers from around the world gathered in Geneva along with NGO representatives and WHO officials for the two-day forum, whose theme this year is “Enhancing Country Action on Mental Health.” The Special Initiative is just the latest global action WHO has taken to integrate mental health into its non-communicable disease platform. Just last year, the WHO Director-General called for the agency to accelerate implementation of mental health initiatives in its work.

Since then, the “political interest” in mental health has been “converted” into “large-scale political action,” noted Ren Minghui, assistant deputy-general of Universal Health Coverage, Communicable Disease, and Non-Communicable Disease at the World Health Organization. He citing the first ever technical briefing on mental health at the World Health Assembly in May, new advocacy campaigns around suicide prevention such as the #SpeakYourMind campaign, and recent international conferences to discuss mental health in crisis situations as examples of global efforts in mental health.

“I strongly believe the World Health Organization’s Special Initiative on Mental Health will serve as a further catalyst to the development of this important era for public health,” said Ren.

The goal is to ensure “quality and affordable mental health care,” said Devora Kestel, director of the WHO Department of Mental Health and Substance Abuse.

Two key strategic aims will guide the Special Initiative. They include:

  1. Advancing mental health policies, advocacy, and human rights:
    • Globally, position mental health high on the development and humanitarian agendas;
    • Engage local champions, people who use mental health services, and their organizations and empower them to participate in the development and implementation of mental health policies, strategies, laws and services;
    • Ensure mental health policies, strategies and laws are developed and operationalized based on international human rights standards;
    • Raise Media and community awareness about the importance of mental health across the life course;
    • Align human and financial resources for mental health with the needs.
  2. Scaling up interventions and services across community-based, general health and specialist settings:
    • Scale up quality, affordable mental health care across health and social services;
    • Integrate quality, affordable mental health care into relevant programmes (e.g. for HIV, gender-based violence, disabilities);
    • Include mental health and psychosocial support in preparedness, response and recovery in emergencies;
    • Develop and implement priority interventions for groups in positions of vulnerability (e.g. women, children, youth, older people, staff);
    • Document, monitor and evaluate implementation to improve services;

The 12 countries chosen to pilot the initiative will be finalized during the forum, with preference to countries that have made mental health a priority in their national agendas, the WHO officials said.

US$ 60 million of “catalytic funding” will be needed in kick start the plan, but as the programmes would be embedded in existing health systems only US $1 million per country per year would then be needed to sustain programming in the 4 years afterwards. WHO is still fundraising for the plan.

The WHO is making sustainability of the initiative a priority, Kestel said. This is in contrast to implementing well-designed “single interventions” that are very successful in the short term, but then risk cancellation when special funding runs out because there is “no system designed around them.”

According to WHO, mental health disorders account for 1 out of every 5 years lived with disability globally and cause over US$ 1 trillion per year in economic losses. Someone dies by suicide every 40 seconds, and suicide mortality disproportionately affects young people and elderly women in low- and middle-income countries. People with mental health conditions are also more likely to face other physical health problems (e.g. HIV, TB, and noncommunicable diseases), reducing their life expectancy by as much as 10-20 years.

Taking a human rights perspective, Kestel pointed to the political declaration on Universal Health Coverage issued last month in New York City at a High Level Meeting of the United Nations General Assembly, and quoted the declaration’s reaffirmation of “the right for every human being, without distinction of any kind, to the enjoyment of the highest attainable standard of physical and mental health.”

“We intend to contribute [to realizing the right to health] through our Special Initiative,” said Kestel.

 

Image Credits: WHO/S. Volkov, WHO.

Measles is undergoing a worrisome worldwide resurgence, and it has killed more people in the Democratic Republic of Congo than the current Ebola outbreak – which is finally showing signs of decline, said a panel of vaccine experts in a WHO press briefing on Thursday.

A child gets vaccinated against measles during the outbreak in the DRC.

Meanwhile, a worldwide shortage of human papillomavirus (HPV) vaccine, which protects girls and women from cervical cancer, is confounding efforts to expand coverage, warranting a temporary change in vaccine strategy to focus more exclusively on pre-adolescent girls, said the experts who spoke just after the close of a biannual meeting of the Strategic Advisory Group of Experts on Immunization (SAGE), the principal expert advisory group to WHO for vaccines and immunization.

And Pakistan and Afghanistan are seeing a worrisome resurgence of the wild polio virus, serotype 1. Vaccine-derived polio cases seen in some countries also continue to thwart global eradication efforts – although experts are hopeful that a novel oral polio vaccine (nOPV2) under expedited development and production will demonstrate far greater efficacy in preventing vaccine-derived cases. The new polio vaccine could be ready for deployment as early as June 2020.

Coming the day after donors finalized commitments of US$ 14 billion to the Global Fund to Fight AIDS, Tuberculosis and Malaria, the SAGE briefing was a sober reminder that vaccine-preventable diseases including measles/rubella, polio and HPV remain major challenges for health systems in both affluent countries as well as some of the most underserved regions of the world.

On a more positive note, the Commission of the Global Polio Eradication Initiative will meet next week in Geneva to determine if the world can be certified as free of the wild polio virus serotype 3 – which has not been detected anywhere in the world since 2012.  Africa might be eligible for certification as free of all wild polio viruses by 2020, the group said.

“There is bad and good news on polio,” declared Michel Zaffran, director of WHO’s Polio Eradication Initiative. “The good news is that Serotype 3 of wild polio virus, has not been detected anywhere in the world since 2012. The Global Certification Commission will be reviewing the data  next week, and might be in a position to certify that Serotype 3 of the wild polio virus has been eradicated from the world.

“The [other] good news is that the wild polio virus has not been detected on the African continent for over 3 three years, that is why the region of Africa might be eligible for certification next year,” Zaffran added, noting that Serotype 2 of the wild virus was already eradicated some years ago.

A girl receives an oral polio vaccine in India.

On the downside, serotype 1 of the wild polio virus remains a challenge in Afghanistan and Pakistan, where vaccine coverage is spotty in some regions, and Pakistan has seen a significant upsurge this year with over 70 cases.

In terms of tackling persistent cases of vaccine-derived polio, Zaffran said that the Initiative is working with an Indonesian manufacturer to produce over 100 million doses of the new oral formulation (nOPV2) even while clinical trials are ongoing in parallel.

He said that if the clinical trial results, due to be released in February, show it to be efficacious, “at best case scenario we will have over 100 million doses available for use in June of next year”.

Below is a wrap-up of details on other vaccine issues covered at the SAGE meeting. A new draft global immunization strategy for the coming decade is also currently being finalized and should be released soon for review followed by final approval at the May 2020 World Health Assembly, the experts said.

“Strategy 2020 aims to address the challenges of reaching everyone, with a focus on those who remain left out. It is a people, country and data-focused strategy, with an emphasis on strengthening primary health care,” said Kate O’Brien, WHO Director, Department of Immunization, Vaccines and Biologicals, of the new ten-year strategic plan.

HPV Supply Shortage Warrants Change in Vaccine Strategy  

To address the HPV vaccine shortage, Alejandro Cravioto, SAGE Chairman, said that the expert group would recommend that immunization of teenage boys be temporarily suspended in order to redirect available supplies and efforts on girls, who are directly vulnerable to cervical cancer.

A young girl gets vaccinated against HPV in Sao Paulo, Brazil.

He said that the strategic change would allow countries to “focus use of the vaccine on the groups that would profit more from the vaccination,” adding that current evidence shows that “postponing vaccination of boys is not a public health problem” although the evidence supports vaccinating boys at a later stage, when there is more vaccine available – insofar as boys/men can also transmit the virus to unvaccinated girls/women through sexual contact.

He also noted that many countries with a high level of cervical cancer are not getting the vaccine at all.

“Constraints in the supply of the vaccine have made us think about how can we improve the access to this vaccine, start protecting women in countries that have a high level of cervical cancer,” he said. “We need to use the vaccine that is available in the most efficient way, and to start vaccinating as many girls as possible, whether by age 9 or 11, we need to immunize them before the age of 14, which is before the age of sexual activity.”

But he also stressed that the SAGE recommendations are made to the WHO Director General, “and it is up to the countries to decide if they take on the recommendations made.”

He said that the SAGE panel was also recommending that WHO support the creation of a Global Access Forum specifically for vaccines, where global health officials could interact with the producers, and with other stakeholders on improving access to vaccines whose availability is constrained. “How do we provide a system of access that protects everyone in need and allows us to use vaccines in a more effective way? This Forum is something to be created that would allow us to move not only in the HPV field, but other vaccines.”

Measles, a Worldwide Epidemic

“The world is facing an alarming upsurge in measles cases and deaths in all regions,” said O’Brien. She noted that the epidemic is driven by incomplete coverage of children with the two-dose vaccine, particularly in areas where healthy systems are weak and in conflict zones. But in affluent countries there are pockets of vaccine resistance where fears about vaccine safety or religious beliefs are driving epidemics.

A young girl receives a measles vaccination in Ukraine, which has consistently suffered from vaccine shortages.

“Some 80 countries have achieved and are maintaining the elimination, it is technically feasible to do, with the tools we have, but it requires day and day out vigilance so that coverage remains high,” she emphasized.  “If you don’t keep your eye on the ball, it can slip back.

So far only one WHO region, the Americas, had achieved measles elimination, meaning that there is no transmission and circulation of the virus within or between countries.

“Unfortunately the Americas region lost its elimination status as a result of the ongoing transmission in Brazil and Venezuela,” she noted. In Europe, the UK and the Czech Republic have also lost elimination status.

“The reasons vary from country to country and situation to situation, but the the majority reason is lack of access to the vaccine; the vaccine not available, services insufficient. In high income countries there are sub pockets of the population where immunization is very low. In the US, where coverage is extremely high, there are communities that have very low coverage, and when the virus is introduced in the community, that virus is going to move from child to child.”

A large measles outbreak in the DRC has already “claimed more lives than Ebola, disrupting families, livelihoods and economies,” she added. Along with the deployment of Ebola vaccines, however, campaigns to vaccinate measles have been accelerated “children and adults been vaccinated evermore against a range of diseases.”

Joachim Hombach, SAGE executive secretary, stressed that given the current resurgence of measles, the final “eradication” of the disease remains a distant goal, and countries should focus on ramping up efforts to “eliminate” transmission within and across their borders.

“To have a defined goal for eradication in the measles situation is really not obtainable but what we are proposing is that everyone should go back to the elimination goals and look at the prospect of how we can ramp up the elimination and control of the outbreak and then decide in the long run of how we are going to tackle other [eradication],” he said.

Second Ebola Vaccine is Valuable Tool in Arsenal Even as Outbreak Finally Declines

O’Brien also said that a much-discussed second Ebola vaccine, a two-stage vaccine produced by Johnson & Johnson is soon to be deployed in areas of DRC where there is no direct Ebola transmission.  This decision was taken insofar as the first Ebola vaccine to be deployed, produced by Merck, offers more immediate coverage and has already demonstrated high efficacy in the active transmission zones where some 230,000 people have been immunized.

Response worker prepares an Ebola vaccine in the DRC.

However, even as the current DRC Ebola outbreak seems to be finally in a pattern of decline – with just 14 cases reported in the past week, the Johnson & Johnson vaccine could be useful in offering additional protection to recipients against  future Ebola outbreak risks.

Notably, the Johnson & Johnson formula is intended to offer protection against different Ebola strains that commonly circulate in the region, while the Merck vaccine only offers protection against the  strain of the virus that prompted the current outbreak, ongoing since August 2018.

“Is it worth continuing with this investigating product? The answer is absolutely yes,” said Hombach, ”because we cannot assure at some point that there will not be a surge, as you know this product has different characteristics, there might be value for this type of product, and it is important to have choice of product available as well as a broader supply base.

“We need to look forward to preventive vaccination approaches in the future, this is something where we think this vaccine could play a significant role.

“It [Johnson&Johnson vaccine] is also a vaccine that is composed of non-replicating viruses, in contrast to the Merck vaccines, so may come with less concerns for contraindications. This would need to be evaluated over time, whether the vaccine is effective against the different strains, but if so, it could provide significant additional interest in this product.”

Image Credits: WHO DRC Office Twitter, CDC Global, WHO PAHO, UN Ukraine, WHO Twitter.