What to watch at WHA 71

The 71st World Health Assembly (WHA), held from May 21-26 in Geneva, featured all the expected verbal jousting over policy positions on key issues facing the World Health Organization (WHO) and the broader global health community, though the resolutions touching on research and development (R&D) ultimately passed by consensus. In particular, three items stood out.Access to medicinesAs anticipated, the debate on access to medicines featured some aggressive verbal sparring by member states, but in the end, all this talk produced only incremental action: Member states passed a resolution tasking the WHO secretariat with developing a roadmap to address access to medicines to be presented at next year’s WHA.Member states have long agreed on the importance of improving access to medicines, but have long struggled to achieve consensus on actions WHO should take in pursuit of this aim, despite many working groups and expert committees offering their own sets of recommendations. Countries used this WHA agenda item as another opportunity to pontificate on their disparate and entrenched views. The US representative was particularly bullish in her remarks this year, stating that senior WHO officials should focus on WHO’s core mandate rather than becoming “political activists” on topics like intellectual property (IP) and arguing that other countries are “free riding” on the health R&D investments of US taxpayers.Despite these verbal fireworks, it was clear that no country was willing to be the one to upset the carefully negotiated resolution language from the January Executive Board (EB) meeting calling for the WHO secretariat to establish this roadmap. As result, while strong language was the order of the day, the resolution passed unanimously without any textual changes. Per the resolution, WHO will now undertake a consultation process to develop a consensus work plan for consideration at next year’s EB and WHA. The team tasked with developing this plan has a tall order ahead of them, and it will remain to be seen whether they can forge a consensus path forward in an area where others before them have faltered. It is also unclear whether nongovernmental organizations in official relations with WHO will be included in the consultation process, but GHTC will continue to call for an appropriate role for civil society.Global Strategy and Plan of Action on Public Health, Innovation and Intellectual PropertyA close companion to the agenda item on access to medicines was WHA’s consideration of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA-IP), which is the current iteration of a more than decade-long process to define WHO’s role in governing IP within the United Nations system. Up for debate was whether WHO should implement a diverse range of recommendations put forward by a WHO expert review panel—recommendations that have received mixed support among different member states. Coming out of the EB meeting, board members had hammered out what they saw as a compromise resolution—the text called for WHO to implement items from the report that were already “consistent with WHO’s existing mandate and authorities” to ensure some steps would move forward, while essentially tabling the other recommendations which lacked consensus. Many wondered going into WHA whether this consensus would stand or whether member states would attempt to re-litigate the resolution text.Like the access agenda item, this debate also saw a lot of verbal jousting. Clashing comments from the United States and India provided—in microcosm—a view of the state of the debate on WHO’s mandate in IP. On one side, member states including India, Brazil, Colombia, and others argued for a robust and expansive embrace of the more far-reaching recommendations contained in the expert report. These include a call for a percentage of GDP spending target for R&D to support health in low- and middle-income countries, full implementation of the recommendations from the UN Secretary-General’s High-Level Panel on Access to Medicines, and the pursuit of mechanisms to move the global innovation ecosystem to delink pricing from R&D costs.On the other side, the United States and other countries argued for a more limited mandate for WHO and supported the compromise resolution text calling for WHO to only implement recommendations already aligned with its strategy and mandate. Under this view, WHO could proceed to implement those points on which there is clear consensus, effectively confining future activities to the scope of existing ones. On a more positive note, the US statement also called out strong support for WHO’s regulatory strengthening and harmonization activities and for strengthening R&D capacity globally overall.Despite the widely incongruent views of which direction WHO should take over the coming years, countries were not willing to take the risk of reopening the text of the resolution, fearing that they might very well have more to lose than they could possibly gain by re-litigating the text. As a result, WHO’s path forward in this space remains muddled and largely the status quo.Preparations for the High-Level Meeting on TuberculosisIn a refreshing change from the contentious debates on access and IP, the assembly also considered a number of documents and plans related to WHO’s input into preparations for the upcoming High-Level Meeting (HLM) on Tuberculosis (TB) in September. Of particular note, the draft multisectoral accountability framework cited, among example actions that should be taken, the “development and implementation of a global strategy for tuberculosis research and development, including the development and facilitation of international tuberculosis research networks.” While this language does not represent a concrete WHO commitment and no organization was identified as responsible for the strategy, it is still a positive acknowledgment of the need for R&D for TB technologies.In addition, in his remarks concluding the debate on TB, WHO Director-General Dr. Tedros Ghebreyesus made a strong statement of his support for R&D to address drug-resistant TB and antimicrobial resistance (AMR) more broadly. He noted that one cannot talk about AMR without talking about TB and vice versa, and that one cannot talk about TB nor AMR without talking about R&D. He then singled out cross-sector collaboration on R&D as being particularly important, remarking that “FENSA [the Framework of Engagement with Non-State Actors] is not meant to be a fence,” and that he hoped to bring the private sector to the table in an appropriate fashion. The ways in which Dr. Tedros’ desire to foster cross-sector collaboration manifests (or not) in the preparations for the HLM will be highly indicative of whether FENSA will actually serve to foster or conversely hinder collaboration moving forward.Key takeawaysUltimately, debate at this year’s WHA reinforced what many watching the global R&D ecosystem already knew; there is a fundamental tension over the very foundation of how global health R&D should be supported, and this tension was in no way resolved. On the one hand are proponents for moving toward delinkage and mechanisms to reshape incentives for R&D in ways that separate the costs of R&D from the sale price of products. On the other are those who argue that access is a much larger question than simply IP and trade laws and that focusing on those topics to the exclusion of other issues like regulatory barriers does a disservice to the dialogue. The one thing we can all agree on is that this dialogue will certainly continue, and GHTC will continue keeping you up to speed.

Authored by Elodie Jambert & Elizabeth Poll, Medicines for Malaria Venture, Switzerland; Panayota Bird, GSK; and Dr Marcus Lacerda, Fiocruz, Brazil  The Amazon is a renowned hotspot for biodiversity, but it’s also a hotspot for malaria. Brazil is one of the Latin American countries with the heaviest burden of malaria, with its Amazon region accounting for 99.5 percent of all national cases. Tackling malaria in Brazil is complicated by the fact that the vast majority of the burden is caused by the malaria parasite Plasmodium vivax. After causing an initial bout of malaria symptoms, this species of parasite has the ability to hide dormant in the liver of infected people, only to re-emerge and cause symptoms again several weeks to several months after initial infection. Another compounding issue is that the only medicine currently available to stop such relapse is primaquine–a medicine approved in the 1950s that must be taken for at least seven days. Given this lengthy course of treatment, many patients fail to complete the full course. It’s a challenge to explain to patients why they should take seven days of pills to treat something that appears to have resolved after the third day (the duration of treatment of the initial acute P. vivax malaria bout). As a result, the medicine often doesn’t work, and transmission of relapsing malaria is perpetuated. In Brazil, over the last 20 years, the burden of the more deadly Plasmodium falciparum has fallen from 50 to 10−15 percent. Yet, progress against P. vivax is yet to see the same success; this parasite now causes 89 percent of malaria cases. While P. vivax doesn’t kill as many people as P. falciparum, it is still debilitating, can also be lethal, and has substantial economic impact on families and nations. As such, it’s important to keep the attention of policymakers focused on malaria even in the face of other pressing public health issues, such as Zika and chikungunya viruses.A new solution for relapsing P. vivax in sightChildren in the village of Boa Vista, on the border of the Juma Reserve in the Brazilian Amazon. Photo: Neil Palmer/CIATFortunately, a new solution to tackle relapsing P. vivax malaria could be in sight. Medicines for Malaria Venture (MMV) and GSK have collaborated to develop a new, single-dose anti-relapse medicine, tafenoquine. The medicine was submitted for regulatory review to the US Food and Drug Administration and Australian Therapeutic Goods Administration at the end of 2017. If approved, it could be an important new treatment for individuals suffering from relapsing malaria, and could help to eliminate the disease in the Amazon.MMV and GSK have developed an access strategy together with in-country partners and are preparing the ground for the medicine’s potential launch in endemic countries. Country-level briefings are ongoing with the National Malaria Control Programmes (NMCP) in Brazil and six other endemic countries (Thailand, Ethiopia, Vietnam, Cambodia, Peru, and Colombia); their goal is to assess interest in introducing the new medicine into national practice and to understand what type of evidence NMCPs would need to support policy adoption. Developing diagnostics to make anti-relapse medicines safer for allPATH rapid diagnostic test to support treatment and elimination of P. vivax. Photo: PATHIntroduction of tafenoquine faces one additional challenge: As is the case with primaquine, people with a genetic deficiency in a specific enzyme known as glucose-6-phosphate dehydrogenase (G6PD) can suffer potentially serious side effects. On average, 8 percent of people in malaria-endemic countries are deficient in this enzyme. To reduce the risk of patients suffering this side effect, PATH is supporting development of a point-of-care diagnostic test to identify patients’ G6PD status and determine whether tafenoquine or primaquine can be safely administered. Concomitant use of this point-of-care diagnostic test will be critical for the correct and well-tolerated use of tafenoquine. Despite the World Health Organization’s recommendation that G6PD tests guide the use of primaquine, few endemic countries routinely use such testing today. In Brazil, the prevalence of G6PD deficiency varies depending on the immigration profile of the region. Most published papers on the subject estimate that the average prevalence among men in Brazil is around 5 percent, a statistic recently confirmed with preliminary data from a government-supported prevalence survey in endemic areas of the Brazilian Amazon.In light of this, additional data is being gathered. Initial preparations for an implementation study are underway in Brazil to demonstrate how a quantitative G6PD test would work in practice, prior to use of tafenoquine in the healthcare system. It is planned for the study to begin after regulatory approval of tafenoquine is granted. The team is also working with academics to model the cost effectiveness of the medicine paired with a G6PD test compared to current standard of care (primaquine without a test), as well as the potential impact of tafenoquine on malaria transmission and elimination. The Brazilian government will use these findings as it considers broader deployment of the intervention throughout malaria-endemic areas.Tafenoquine has potential for significant impact both for the individuals that suffer from this disease as well as for the regions focused on malaria elimination. We await the regulatory decisions on the medicine and will continue to work together as a team of partners to prepare the ground in the Brazilian Amazon to help make it malaria-free for all.