Global health technology legislation introduced in Senate and what that means

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.

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.