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The annual World Health Assembly (WHA) has come and gone once again, and this time there’s a lot of exciting news to report on the innovation front. We were following most closely the debates on the post-Consultative Expert Working Group on Research & Development: Financing and Coordination (CEWG) and on the post-2015 development agenda, but themes related to regulatory system strengthening, access to essential medicines, and the value of research and development (R&D) were in the spotlight throughout the week. CEWG Last year, Member States agreed to move forward with a series of demonstration projects intended to explore new mechanisms for financing and coordinating research for neglected diseases—an action intended to address some of the CEWG’s 2012 recommendations. Four demonstration projects are currently underway—including two managed by GHTC members Drugs for Neglected Diseases initiative (DNDi) and Medicines for Malaria Venture—which are expected to report out during the 69th WHA in 2016 on their success in advancing alternative mechanisms for funding global health R&D, including the use of open access models and the principle of delinkage—or separating drug prices from the cost of R&D. Discussed throughout the week were the post-CEWG and the post-2015 development agenda, and themes related to regulatory system strengthening, access to essential medicines, and the value of R&D. Photo: PATH/Gabe Bienczycki Most notably, a resolution passed by Member States calls for the establishment of a pooled fund for R&D—to which Member States can voluntarily contribute—which will be housed at the World Health Organization (WHO) Special Programme for Research and Training in Tropical Diseases (TDR). Furthermore, in what is seen as a win by many in the global health community, delegates decided that the fund would be open to some categories of Type I diseases in addition to Type II and III diseases. Member States also heard about progress toward establishing a Global Health R&D Observatory to monitor funding flows for R&D funding and expenditures. The WHO secretariat reported that work to map potential models for the observatory and key stakeholders has already begun. Post-2015 development agenda During a technical briefing for Member States, representatives from the WHO secretariat outlined a proposed overarching health goal: Ensure healthy lives and universal health coverage at all ages. It also articulated four sub-goals: (1) achieve the health-related Millennium Development Goals (MDGs), (2) address the burden of noncommunicable diseases, injuries, and mental disorders, (3) achieve universal health coverage including financial risk protection, and (4) address the social and environmental determinants of health. Unfortunately, largely missing from the session was mention of innovation or the role of R&D in achieving these sub-goals. Along with COHRED, the Global Health Council (GHC), DNDi, and the International AIDS Vaccine Initiative, the GHTC hosted an official nongovernmental organization (NGO) side session to explore the role of R&D in the post-2015 development agenda. Speakers from the GAVI Alliance, the delegations of Senegal and Kenya, the INDEPTH Network, GlaxoSmithKline, GHC, and the WHO stressed that R&D for new innovative health tools is critical in making equitable and sustainable progress towards development goals. The event organizers developed a statement that is available to NGOs, academic institutions, Member States, and other partners for sign-on. Panelists closed by urging Member States and delegates to support health research and related policies and capacity building as a core component of a post-2015 agenda for equitable health and sustainable development. Early in the week, Member States also passed a resolution calling for new tuberculosis (TB) targets, which should be reflected in the post-2015 development agenda. The resolution specifically calls for a 95 percent reduction in deaths from TB by 2035 and notes research and innovation as one of three key pillars that will help achieve this goal. By the end of the week, Member States had approved a resolution on health in the post-2015 development agenda that called for completing the unfinished work of the health MDGs and noted the importance of universal health coverage and stronger health systems. Access and affordability Also hotly debated last week was how best to ensure access and affordability of essential medicines and other health products. The assembly passed a resolution on access to essential medicines calling upon Member States to improve the availability, affordability, quality, and rational use of essential medicines. Other debates also addressed access and affordability: In a resolution addressing hepatitis, Member States were asked to consider using the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities to promote access to specific pharmaceutical products. The Bill & Melinda Gates Foundation called upon the WHO to promote access in international trade negotiations. Dr. Chris Elias, president of the Gates Foundation’s Global Development Program, said, “It will be important, as [WHO Director-General] Dr. Chan mentioned, that as international trade agreements are negotiated, that we pay attention to the importance of accessibility for affordable healthcare commodities for the poorest countries in the world.” Sustainable access to vaccines at affordable prices was highlighted during a debate on the Global Vaccine Action Plan. Member States noted the importance of technology transfer to facilitate local manufacturing—one tactic that is used by product developers to drive prices down, build local capacity, and ensure supply availability. Regulatory systems strengthening Member States called upon WHO to coordinate with national regulatory authorities in continuing its role in regulating medicines through establishing necessary norms and standards, supporting regulatory capacity-building and strengthening safety monitoring programs, particularly through the WHO prequalification process. In an excellent side session organized by the US Food and Drug Administration and the government of Mexico, WHO stressed that the prequalification program is not intended to be a permanent solution and that the WHO secretariat will take steps in the future to devolve responsibility for ensuring safety and quality of health products to regional and national structures. All in all it was a busy but productive week. Now the responsibility for moving ahead with these resolutions rests with the WHO secretariat and the Member States themselves.

The global health research community has a reason to celebrate this weekend. Yesterday, Senator Patty Murray (D-WA) introduced in the US Senate a significant piece of global health legislation that would strengthen global health research programming within the US Agency for International Development (USAID) and improve coordination of global health research and development (R&D) across the US government. The legislation—known as the 21st Century Global Health Technology Act—is companion legislation to the House version of the bill, HR 1515, which was introduced by Representatives Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) in April 2013 and is now awaiting consideration in the House Foreign Affairs Committee. The House and now Senate introduction of the bill shows a growing recognition among US policymakers of the critical role investments in research and innovation play in improving public health worldwide.The 21st Century Global Health Technology Act would strengthen global health research programming within the USAID and improve coordination of global health R&D across the US government.Senator Murray and the House authors set out to create legislation that would (1) encourage the development of health products that are affordable, culturally appropriate, and easy to use in low-resource health systems, and (2) would—importantly in these fiscally-constrained times—cost taxpayers nothing. Thus, this legislation doesn’t mandate new funding. Instead it focuses on improving efficiency, coordination and cooperation across agencies and existing programs.The bill focuses on three main areas. The legislation: Establishes USAID’s mandate to conduct global health R&D and calls on the agency to create an overarching strategy which would help fill current gaps. Asks USAID to coordinate and collaborate with other agencies to create a cross-government strategy for global health research. Codifies into law USAID’s Health Tech program—which focuses on developing medicines and health products for use in low-resource settings. Let’s break down the significance of each of the bill’s three main impact areas:Strengthening USAID global health R&D mandate While recognizing the historic work of USAID in developing new products for use in the developing world, the bill gives an official mandate for USAID to conduct R&D across its portfolio by telling the agency that it should include research as part of each type of global health work it undertakes. This ensures health R&D remains a central focus of USAID’s work and makes sure current gaps across the agency’s portfolio are filled.Coordinating/collaborating with other agencies The US government is currently involved in 200 of the 365 global health products in the R&D pipeline, with work spread across many agencies including USAID, the National Institutes of Health, the Centers for Disease Control and Prevention, the Department of Defense and the Food and Drug Administration. That means there are a lot of cooks in the global health R&D kitchen. This bill calls on USAID to coordinate and collaborate with the other US agencies involved in global health to develop a “whole-of-government” approach to global health research and improve outcomes, leveraging US funding and ensuring US tax dollars are well spent. While the bill doesn’t mandate how that coordination should occur, it does require USAID to report to Congress progress made on this objective.Codifying US Health Tech program The Health Tech program has existed at USAID for over 25 years. It forges collaborations between the public and private sector—known as public-private partnerships—to develop health technology solutions for people in the developing world. It has produced many innovative products, such as the vaccine vial monitor—which changes color to indicate whether a vaccine has been stored at a proper temperature and remains effective. So if the program already exists and works, than why does “codifying” it matter? This legislation would make the Health Tech program an official part of US law. That’s important because in a difficult fiscal climate in which cuts are occurring, the program’s inclusion in US law helps protect it from elimination and assure it can continue to carry out its work.So what’s next for the bill? As we all know from the singing Bill on Capitol Hill, Senator Murray’s introduction of this legislation in the Senate represents one of the first steps in the long process it must go through to become US law. The bill will now be referred to the Senate Committee on Foreign Relations for further consideration.While the path ahead for the legislation is still uncertain, it’s worth pausing to celebrate this initial victory. The fact that this legislation has been championed by Senator Murray and such significant advocates in the House indicates recognition by US policymakers that global health R&D is both critical to US health and foreign policy goals and a smart economic investment. After all, sixty-four cents of every US dollar invested in global health research goes directly to US-based researchers.So this weekend when you are out with friends and family, raise a glass to Senator Murray for being a steadfast advocate and tirelessly working to advance US leadership in global health R&D.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Yesterday, Senator Patty Murray (D-WA) introduced in the US Senate a significant piece of global health legislation that would strengthen global health research programming within the US Agency for International Development and improve coordination of global health research and development across the US government. The legislation—known as the 21st Century Global Health Technology Act—is companion legislation to the House version of the bill, HR 1515, which was introduced by Representatives Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) in April 2013. Knight Therapeutics—the developer of a new treatment for the parasitic disease leishmaniasis—is looking to be the first company to auction off the priority review voucher it received from the Food and Drug Administration (FDA). The company received this voucher—which it can redeem to have any drug moved to the front of FDA’s line for product review—following the approval of its leishmaniasis drug Impavido in late March. A Guardian article on the vaccine cold chain discusses the logistical challenges for the global health community in delivering and administering vaccines—which require constant refrigeration for efficacy—in environments with unreliable electricity and infrastructure. It calls for the next generation of vaccines to be developed with the goal of eliminating a burdensome cold chain and notes the success of the MenAfriVac™ vaccine for meningitis which can be used for up to four days outside the cold chain. During the World Health Assembly, UNITAID, the Drugs for Neglected Diseases initiative, and the Medicines Patent Pool launched a new initiative to develop and deliver improved treatments for children suffering from HIV and AIDS. The initiative–known as the Paediatric HIV Treatment Initiative (PHTI)–will focus on three areas: (1) research and development; (2) intellectual property; and (3) market-shaping to ensure availability of treatment regiments for children living with HIV and AIDS. The World Health Organization released a new document on its efforts to find innovative financing for neglected diseases. The documents states there is a $50 million budget line for demonstration projects and the Global Health R&D Observatory over four years, but did not make clear where the observatory would be situated.

The Global Health Technologies Coalition (GHTC) today released the fifth and final paper and a summary of findings paper in its briefing series examining financing, accessibility, regulatory, and capacity issues facing nonprofits engaged in global health research and development (R&D). The five-part series aims to inform policymakers and other stakeholders with an interest in advancing R&D to meet health needs in low- and middle-income countries (LMICs). The series focuses on nonprofit product development organizations (NPPDs), or nongovernmental organizations that partner with the public, philanthropic, and private sectors to develop health products specifically targeting poverty-related and neglected diseases in LMICs.NPPDs play a vital role in bringing together the fragmented resources and expertise of the various sectors involved in neglected disease R&D. The fifth and final paper examines efforts by NPPDs to strengthen the research and manufacturing capacity of academic, nongovernmental, and commercial partners in LMICs. The summary of findings paper provides an overview of the key challenges, lessons, and potential solutions identified by NPPDs in their efforts to advance the development of new vaccines, drugs, diagnostics, microbicides, and other health products for LMICs. The final paper on capacity-strengthening finds that while the mission of NPPDs is developing new health products, rather than capacity-building, many NPPDs have had to actively invest in improving the capacity and infrastructure of their local product development partners. This is because research and manufacturing infrastructure in LMICs remains weak, and many local partners have limited or no experience in conducting research and manufacturing in line with international safety and quality standards. NPPDs are engaged in capacity-strengthening work such as upgrading research and manufacturing facilitates, providing training across many skill sets, and transferring technological knowledge. In the capacity paper, NPPDs offer a set of key lessons that they and their partners have learned in trying to strengthen local research and manufacturing capacity to bring new health technologies to those most in need: There must be a shared commitment among partners to comply with international technical and ethical standards to ensure volunteers’ safety and rights as well as to facilitate access to high-quality products among those in need. Capacity-strengthening investments must weigh accelerating the near-term availability of much-needed products against the potential of lengthier timelines to increase capacity. At times, the need to accelerate access to a product may take precedence over local capacity strengthening. Capacity strengthening should enable home-grown solutions and local product development to be responsive to existing needs and emerging challenges. These efforts should enable local engagement and country ownership of health research, related product development, and manufacturing in endemic countries. Capacity-strengthening investment needs to be sustainable and enable LMICs to leverage the value of this increased capacity for their continued future growth. Because capacity strengthening can be a time-consuming and complex endeavor, donors and governments in endemic countries must commit to financing and enforcing international research and manufacturing standards to ensure an even playing field for the long-term sustainability of these efforts. The summary paper concludes that NPPDs face a number of challenges including insufficient funding, shortcomings in regulatory systems, and limited local research and manufacturing capacity which hinder progress on R&D for poverty-related and neglected diseases in LMICs. However, NPPDs have identified a number of solutions to address these challenges including working toward securing more predictable, stable, and long-term funding across all phases of product development, diversifying funding sources and improving coordination across funders. As well, NPPDs are seeking policy changes and sustainable funding to improve regulatory capacity and pathways and working to strengthen local partners’ research and manufacturing capacities to meet international standards. This fifth and final paper—Briefing Paper, Volume 5: Working with partners to strengthen local research and manufacturing capacity—and the summary of findings paper—Advancing research and development to address poverty-related and neglected diseases and conditions—are part of a series from the GHTC that examines financing, accessibility, regulatory, and capacity issues facing NPPDs. The series aims to inform global policy and financing discussions about R&D for neglected and poverty-related diseases affecting LMICs.