Breakthroughs Blog: Access

Against a backdrop of mounting global health challenges, the 72nd World Health Assembly (WHA) convened last week, with politicians, philanthropists, business executives, and civil society leaders all descending upon Geneva. GHTC was on the scene—attending side events, technical briefings, and following the official agenda. Here are our top four takeaways from this year’s assembly:1. Universal Health Coverage (UHC) dominates WHA.Considered the theme of this year’s WHA and a core component of the platform of the World Health Organization (WHO) Director-General, UHC was a ubiquitous topic in Geneva as stakeholders prepare for the United Nations (UN) High-Level Meeting on UHC in September. Multiple side events and briefings focused on the topic with discussions yielding numerous calls to action from bolstering the inclusion of low- and middle-income country (LMIC) voices, to investing in community health workers, to making primary health care the central pillar of UHC. During the official WHA sessions, there was also strong consensus around the importance of leaving no one behind, equity in health, and a people-centric approach to UHC. The hotly anticipated zero draft of the Political Declaration of the High-level Meeting on UHC was also released last week. The draft is meant to serve as a baseline for members states who will ultimately endorse a political declaration at the high-level meeting this fall and reflects some of the feedback that civil society provided during the consultative process. The document features some encouraging language on health research and development (R&D): calling for improved availability, access, and affordability of quality medicines, vaccines, diagnostics, and other health technologies, and it encourages incentives for R&D, including stronger public-private partnerships. The draft also underlines the importance of investment in new health technologies.While the R&D community can be heartened by these inclusions, there are notable omissions. There was no direct mention of specific diseases affecting vulnerable populations in LMICs and no specific request or direct call for increased investment in R&D for new health tools.2. Contentious access debate at WHA ends with compromise resolution on drug and health product price transparency.Advocates anticipated that the access to medicines issue would be the one of the most contentious topics at this year’s WHA. They were right.After long and arduous negotiations which delayed the access to medicines session by several days, member states adopted a compromise resolution at WHA urging greater transparency on drug prices. The resolution calls on members to “take appropriate measures to publicly share information on the net prices of health products.” The most contentious element of the initial draft, which urged disclosure of R&D costs, particularly for clinical trials, was ultimately amended to feature language emphasizing the purely voluntary nature of those disclosures. While the resolution was celebrated as a landmark by the WHO Director-General, many member states were unhappy with the process, with Germany, the United Kingdom, and the United States expressing their discontent with the approach and timing.3. Ebola crisis keeps emergency preparedness at the top of the agenda.The worsening Ebola crisis in the Democratic Republic of the Congo loomed large at WHA, as tributes to health workers were featured throughout the proceedings. There was a common refrain during the week about the need for improved coordination in emergency preparedness between global actors and local communities, with many delegates from the global south, including WHO Director-General Dr. Tedros himself, emphasizing the importance of building trust and integrating community health workers in the process. From an R&D perspective, many stakeholders called for strengthening in-country capacity, including laboratory and clinical trial capacity, as an integral pillar of developing effective countermeasures.To better support member states in improving preparedness, WHO set up a new division specifically for emergency preparedness, as part of its reform process earlier this year, which will work in tandem with its existing workstreams on emergency response. WHO also welcomed the appointment of a UN emergency Ebola response coordinator to facilitate interagency activities. 4. Follow-up meeting to the UN High-Level meeting on Tuberculosis (TB) shows promise with accountability as key.Several sessions at WHA focused on the follow-up to previous political commitments, including the declaration from the UN High-Level Meeting on TB. It was encouraging to hear the United States, several members of the European Union, and a few other member states call for additional R&D to combat TB and underscore the need to develop new drugs and vaccines, scale up diagnostic capabilities, and invest in innovative technologies.WHO also released a multisectoral accountability framework to accelerate progress to end the TB epidemic, which was previously requested in 2018 by the WHA and the UN General Assembly. Several countries, including the United States, endorsed the framework during the official session, and WHO is looking to facilitate its adaptation and use by member states and their partners at country, regional, and global levels throughout 2019. This year’s WHA cemented the need for new approaches, partnerships, and models in order to deliver on many of the promises that were made as part of the 2030 agenda. The next few months will see a continuation of advances on the UHC agenda, movement on WHO reform, and implementation of newly adopted resolution and political commitments.

Universal health coverage (UHC)—the idea that everyone, everywhere, should be able to access quality health services—will take center stage at the World Health Assembly (WHA) later this month. World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus has made UHC a top priority, as his institution estimates that at least half of the world’s population still does not have full coverage of essential health services.While there are many building blocks to achieve UHC—from galvanizing political will and investment to strengthening health systems and training health personnel—one integral pillar that is too often overlooked is innovation—the creation of new and improved drugs, vaccines, and diagnostic tools. Global health research and development (R&D) is indispensable in delivering on the vision of quality health for all. R&D a vital component to achieve UHCHealth systems cannot meet the fundamental needs of their populations without high-quality and accessible drugs, vaccines, and diagnostics with which to treat, prevent, and detect disease. Today, we still lack many of the tools needed to combat diseases and conditions that exact a tremendous health burden in the world’s poorest places. No preventative vaccines exist for many neglected diseases, including Chagas, leishmaniasis, and chikungunya, and treatments available are often inadequate or toxic. Tuberculosis (TB) sufferers today face six to twenty months of treatment, involving thousands of pills and painful injections. We still don’t have the right tests to diagnose many infectious diseases at point of care, leaving patients wondering and waiting for care. The goal of ending AIDS will remain out of reach without a vaccine or cure. Meanwhile, growing antimicrobial resistance (AMR) against malaria, TB, and other infectious diseases threatens to roll back progress and is adding even greater urgency to the need to develop new innovations to prevent emerging resistance. Neglected diseases affect hundreds of millions of people worldwide and jeopardize achieving UHC for the most vulnerable among us.As the global community invests in policies and programs that support UHC, it must also prioritize R&D for new health technologies, especially where markets don’t catalyze these investments on their own. It will be impossible to truly deliver quality care for all without new innovations. Delivering the next generation of lifesaving health technologies will require strong political commitment and increased investment from all nations. To make that happen, it’s critical that the world explicitly acknowledge the importance of global health R&D to attaining UHC.WHO’s role WHO has a crucial role to play in strengthening R&D and access to achieve UHC. Through its global convening power, WHO sets the agenda and is often the institution policymakers rely upon to frame their countries’ health priorities and lead the implementation of important programs vital to improving access to quality treatment and services. For example, WHO’s essential medicines and diagnostic lists are highly vetted, evidence-based recommendations that provide member states with a robust framework to determine key investment, health service, and policy priorities. WHO also provides technical expertise and capacity-building programs to build regulatory frameworks that accelerate access to medicines and create stronger enabling environments for global health R&D. This includes supporting the development of laboratory systems and infrastructure, as well as clinical trial capacity. For everything ranging from establishing safety standards, to producing treatment guidelines for infectious diseases, to designating good clinical research practices, WHO sets the normative technical standards and provides clear targets for low- and middle-income countries for health system strengthening. WHO must continue to use its global convening power to facilitate coordination and alignment of priorities in order to advance the UHC agenda. This is why the 72nd WHA meeting presents the global health community with an opportunity to ensure that WHO continues to play a significant role in supporting R&D by stepping up its efforts to catalyze additional investment, build capacity, and provide resources to stakeholders to facilitate the development and effective deployment of tools to patients globally. While governments can, and should, play a leading role in the global UHC movement, WHO will also play an important part in making the vision of quality health for all a reality. As the world gets ready to descend on Geneva for WHA week, global health advocates should remember that there is no UHC without R&D.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. According to a report released last week by the Access to Medicines Foundation, just five companies are carrying out 63 percent of the urgently needed research and development projects for priority health areas such as HIV and AIDS, tuberculosis, Chagas disease, and leishmaniasis. This reliance on a small group of companies contributes to a fragile ecosystem, according to the report authors. A change in strategy for any of the companies could put access to medicines in low- and middle-income countries (LMICs) at risk. The Access to Medicines index, an independent report released every two years, ranks the world’s 20 largest pharmaceutical companies based on their efforts to make their medicines available in LMICs. This year, GlaxoSmithKline—the developer of a single-dose drug to prevent malaria relapse—tops the list of companies in the overall ranking.  Recruitment of women in Uganda has begun for a phase 3 clinical trial, which will assess if a long-acting injectable antiretroviral called Cabotegravir, administered every two months, is safe and effective as a form of Pre-Exposure Prophylaxis (PrEP) to reduce an individual’s risk of contracting HIV when exposed to the virus. This recruitment is part of a large-scale, five-year trial that will be conducted in six additional countries—including Kenya, Malawi, Botswana, Zimbabwe, South Africa, and Swaziland—among approximately 3,200 HIV-negative individuals who are at a high risk of contracting the virus. If Cabotegravir proves to be safe and efficacious, it would offer a new alternative for individuals on PrEP other than taking daily oral pills. A vaccine to prevent Zika virus infection was found to be safe and induce an immune response in an early stage trial, according to an announcement released on November 19 from developer Emergent BioSolutions Inc. and partner Valneva SE. The vaccine, VLA1601, was tested in two doses in 67 adult trial participants. The initial results contained analyses up to day 56, after the first vaccination. Final analysis will take place up to day 208 and is expected to be released in the first quarter of 2019. Emergent BioSolutions Inc. announced an exclusive worldwide licensing deal for Valneva SE’s Zika vaccine in July of last year.

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.