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.

  After a busy week of negotiating police barricades and security checks in New York during the United Nations General Assembly (UNGA), we’re back in Washington, DC, with more thinking about the post-2015 development agenda and some reflections about what was heard throughout the week. First, hardly anyone seems to be talking about health as a component of the post-2015 development agenda—except the global health community. Although health remains a critical piece of the priorities coming from UN Member States—such as in the outcome document Member States endorsed during UNGA—the discussions among broader civil society groups last week tended to focus on other topics, like human rights, water and sanitation, environmental degradation, and inclusivity. R&D for new, innovative health tools will be essential to achieve any international development goals. Credit: PATH/Evelyn Hockstein That said, there does seem to be broad recognition there will be a health goal included in the post-2015 agenda, as well as more clarity on how such a goal might be framed. Though it’s unclear what the ultimate language will look like, there seems to be general accord that there will be one overarching health goal with related targets.These targets will call out such topics as: Universal health coverage. Non-communicable diseases. Child health. Maternal mortality. HIV and AIDS. Tuberculosis. Malaria. What is less clear is how innovation will fit into this goal. As we’ve said before, research and development (R&D) for new, innovative health tools will be essential to achieve any international development goals, as well as to enable more equitable and sustainable improvements across health services and health outcomes. Additionally, the discussions in New York raise some red flags about perceptions of the private sector—particularly, that some stakeholders view private industry as a monolith with only negative objectives. There is admittedly a spectrum of intentions when it comes to private industry and health. But when it comes to health R&D, it must be recognized that partnerships between the public and private sectors have been key to moving forward major public health successes: from established products like treatments for HIV and AIDS to new products such as a vaccine to prevent childhood diarrhea. Though we must determine how the private sector can be engaged in appropriate ways in discussions on a post-2015 development agenda, we certainly can’t exclude our private sector partners altogether from discussions about future sustainable development goals and plans to achieve them. GHTC will continue to follow the debates and engage in discussions alongside the rest of the health and development community. Next up: the Open Working Group on Sustainable Development Goals’ meetings in November and December, when the theme of science and technology will be discussed among many other topics.

This week, many GHTC members will be in New York for the sixty-eighth session of the United Nations’ General Assembly (UNGA), where, among other topics, progress toward meeting the Millennium Development Goals (MDGs) will be addressed. Especially relevant this year will be discussions around the post-2015 development agenda. As we close in on the year 2015, and thus the deadline for the MDGs, there is a great deal of speculation about what set of goals, targets, and indicators will drive our development work for the next period. We’ve seen hints through reports released by a High-Level Panel on the Post-2015 Development Agenda, and by the Secretary General himself. But much of the work remains to be done, and as of yet there is still a great deal of uncertainty about what the agenda will look like in its final form. We should know more after this week. Previous investments in research to develop new vaccines, drugs, diagnostics, and other tools have led to some of the greatest advances in global health to date. Credit: PATH. Although it was good to see achievements brought about by health science and technology noted in both reports, there is a strong need for greater recognition about the need for new medical innovations to carry us through this next period—as well as the commitments and leadership that will get us there. Previous investments in research to develop new vaccines, drugs, diagnostics, and other tools have led to some of the greatest advances in global health to date, saving countless lives and resulting in billions of dollars in cost savings. With sustained investment and support, further gains are achievable: from the eradication of polio, to the elimination of malaria; from controlling and ending the AIDS and TB epidemics, to effectively diagnosing and treating neglected tropical diseases. The post-2015 development agenda must prioritize innovation for health, and I’ll be listening and talking with development leaders this week to discuss how this can be achieved. Excitingly, innovation seems to be featured in a number of side events that will take place this week—including the MDG Innovation Forum. Through these events, global health and development partners intend to highlight the role that innovation, research and development, and public-private partnerships play in helping us to achieve our development goals. Research and development for new, innovative health tools will be essential to achieve any international development goals and enable more equitable and sustainable improvements across health services and health outcomes. I hope that global health innovation is strongly supported by leaders during this week’s UNGA and that the discussions held this week will result in concrete support for global health research and product development as a key component of the post-2015 development agenda.

This post originally appeared on the Center for Global Health R&D Policy Assessment blog. Depending on who you ask, you’ll come up with a number of different definitions for what exactly characterizes a neglected disease, as there’s no generally accepted definition. I personally like the one offered by the NIH: “Global health organizations define neglected diseases as those that are prevalent among impoverished and marginalized populations in the developing world. Tropical environments, poor living conditions, and limited access to health care contribute to the risk and spread of these diseases.” But even this definition leaves something lacking. There are a number of conditions that cause severe morbidity or mortality in low and middle-income countries and still go unrecognized when we talk about neglected diseases. For instance, we at the Global Health Technologies Coalition (GHTC) tend to think of “neglected” in terms of the urgent need for tools to prevent, diagnose, treat, and generally improve the health of people in low- and middle-income countries around the world. If increased investments from governments and other stakeholders in research and development (R&D) are needed to create new and improved products for a certain disease or health need in the developing world, then we would define that health issue as neglected. As an example, reproductive health issues and sexually transmitted infections can have devastating health effects for women on par with infectious diseases like tuberculosis, malaria, and neglected tropical diseases. Although pregnancy is not often thought of as a neglected condition, it could be, as there is an incredible demand for contraceptive options that don’t yet exist. Additionally, issues like non-communicable diseases are not traditionally neglected when considering the amount of funding and other investments pharmaceutical companies devote to developing products for conditions like diabetes. However, the distinct technological and infrastructure needs of health systems in the developing world, as well as the alarming climb in the prevalence of non-communicable diseases in these settings, have made them a much more urgent concern. But why should a definition matter anyway? For those of us thinking about global health policy, terms and nomenclature are important. Consider, for instance, one of the many programs implemented by the US government to improve public health around the world. The US Food and Drug Administration’s (FDA) priority review voucher program lists specific diseases that are eligible for the agency’s incentive program. This list leaves out a whole host of neglected diseases. Among them is Chagas disease, which Congress has been attempting to include via new legislation for the past two years. This disease remains ineligible for the incentive according to the legislation and guidelines governing the program. So we need to adapt the way we think about neglected health needs worldwide to reflect conditions—like pregnancy and reproductive health needs—that impact people worldwide, in addition to infectious diseases. Perhaps instead of framing our thinking around neglected diseases, we should instead consider a different term: neglected conditions. By changing our thinking on neglected conditions, we open the door to increased attention, support, and programming to address all of these pressing health needs as a package—from infectious disease to childhood health needs like nutrition, reproductive health issues, and pregnancy-related complications. For instance, new and improved contraceptive and microbicide products, including multipurpose prevention technologies under development, could be an easy, cost-effective way to help women plan their pregnancies, address reproductive health needs, and prevent HIV and other STIs. We also may be able to leverage funding and government policies to give greater attention to the important conditions and other contributing factors to illness that don’t fit precisely into current definitions of neglected disease. Programs like PEPFAR have evolved from a narrow focus on urgent needs related to HIV and AIDS to one that considers the impact of other diseases and conditions, like malaria, TB, nutrition, family planning, and others. This evolution has created important successes for the program, and has pushed programs and policymakers to think outside typical disease boundaries. The US government is the largest supporter of research and other programs for neglected conditions worldwide and, as demonstrated by the FDA’s priority review program above, implements a number of programs that can have important impact on the development of critically-needed new tools. Given that the US government has long been a leader in supporting R&D for a range of global health diseases and conditions, leadership cannot abandon this legacy now. There are significant gaps in the development of new tools to address neglected conditions, and there is a critical unmet need for tools that address reproductive health, non-communicable disease in low-resource settings, and other health issues. By changing our definition of neglected diseases to include neglected conditions, the US government and other governments, donors, and advocates can make an even greater impact on health worldwide.

It’s been a busy twelve months for the team at the Global Health Technologies Coalition! A year ago today, we launched Breakthroughs with the intention of sharing global health research and development (R&D) news and stories that bridge the divide between science and policy. Since that time, there have been a number of advances we’ve applauded and stories that have touched us. Here are some of our team’s favorite posts: This year has been another interesting and non-traditional one for congressional action on the federal budget. In a series of blog posts, we took a look at the potential for budget cuts and sequestration, and explored what this might mean for global health R&D. What do presidential hopefuls Mitt Romney (R) and Barack Obama (D) think about R&D? We gave some attention to how the nominees’ platforms might affect research to develop new global health technologies. One of the year’s most exciting scientific advances was the US Food and Drug Administration’s (FDA) approval of the drug Truvada to be used as an HIV prevention prophylaxis among certain groups at risk for infection. We explored how FDA has developed an increasingly critical role in global health. Last year, Congress approved and funded the National Institutes of Health’s (NIH) National Center for Advancing Translational Sciences, intended to promote research aimed at speeding the development of therapeutics and diagnostic tools for a wide range of diseases. While we’ve been excited about the potential for this program to speed the development of new global health technologies, we were disappointed in the lack of global health leadership when the center’s advisory council was named earlier this year. Our communications officer reflects on her personal journey with diabetes, and the difficulty that children in the developing world face when being diagnosed for neglected tropical diseases. A series of photos from our travels tell the story of how lifesaving tools are making a difference in communities across Kenya, and how current research is on the cusp of developing some of the most exciting new tools in global public health in recent years. A series of photos, like the one above, from our travels tell the story of how lifesaving tools are making a difference in communities across Kenya, and how current research is on the cusp of developing some of the most exciting new tools in global public health in recent years. Photo credit: PATH/Evelyn Hockstein We’ve featured a range of great guest bloggers as well. On World AIDS Day, leaders at the NIH and the Department of Defense both wrote about the impact their agencies have on research to help end the AIDS pandemic. Guest blogs from the US Agency for International Development and the Global Health Initiative team highlighted the importance of science, technology, and innovation to our nation’s diplomacy programs. From the need to advance women’s health and address contraceptive needs, to the gaps in the development of drugs for neglected tropical diseases, to efforts to develop new TB treatment regimens and a TB vaccine, our coalition members illustrated the critical need for an investment in science to address a range of diseases and conditions. We’ve been busy working on a few other projects this year, too. In February, we released our third annual policy report at a congressional briefing, and April brought our first analysis piece on US investments in global health R&D. It’s been quite a year, and we’re glad that you’ve been along with us for the ride! We’re confident that Breakthrough’s second year will be full of the same policy developments and excitement, breaking news from our members, and great stories of how R&D is changing lives. We hope that you stay tuned.

This post originally appeared on the ONE blog. As the International AIDS Conference descends on DC later this month — the first time this conference has been held in the United States in over 20 years — there couldn’t be a better time to reflect on the scientific gains that have emerged over the past several months, and how a wide range of dedicated Americans are pushing this HIV and AIDS research forward. Just last month, one of GHTC’s member organizations, the Maryland-based International Partnership for Microbicides, launched a new study to determine whether a monthly antiretroviral (ARV)-containing vaginal ring can safely and effectively help prevent HIV infection in women. Advocates have long called for more female-initiated HIV prevention options, like a microbicide gel or ring. If proven to be efficacious, the ring would provide women with a discreet and easy-to-use form of protection and could provide new power by putting HIV prevention in the hands of women. The US government has historically played a major role in pushing forward a research and development (R&D) agenda for HIV and AIDS, and the past few months are no exception. For example, the US Food and Drug Administration (FDA) has been particularly active in reviewing new HIV and AIDS tools that have successfully emerged from the research pipeline. The US government and partners worldwide have long supported research for new tools to prevent, test, and treat HIV and AIDS. At this Kenya AIDS Vaccine Institute lab in Nairobi, US support is helping to advance research for an HIV and AIDS vaccine. Photo credit: PATH/Evelyn Hockstein Earlier this summer, an FDA advisory council recommended that the agency approve the use of the ARV Truvada, made by Gilead Sciences, by certain high-risk, HIV-negative people as a preventive measure against HIV in a method known as pre-exposure prophylaxis (PrEP). Although the FDA will not make a final decision until mid-September, an approval by the FDA would signify a new way forward in preventing HIV infection in the US and across the globe. And just a few days ago, the first-ever take home HIV test was approved by the FDA. Although some questions remain around the implementation of the home test, it is an important step forward in providing greater testing access to the many individuals in the US who are unaware of their HIV status. In addition to the FDA, a host of US federal agencies have long been committed to advancing HIV and AIDS R&D. A new report released earlier this year by the GHTC and Policy Cures illustrates the impact of US government support for new HIV tools, like an HIV vaccine and the woman’s condom. Both the woman’s condom and many HIV vaccine candidates have been developed in partnerships with the US government alongside philanthropic organizations and industry. Without the critical support from the US government and partners around the world, we would not be as close to creating these and other breakthrough technologies in the fight against HIV and AIDS. For instance, new modeling data released by the New York-based International AIDS Vaccine Initiative shows that a safe, preventive HIV vaccine that is accessible and affordable can help us end the AIDS pandemic. IAVI’s data shows that even a 50 percent effective HIV vaccine could prevent over five million new HIV infections over a decade, once introduced to a segment of the population in low- and middle-income countries. This is a critical moment in the fight against AIDS, and the first International AIDS Conference to be held in the US in more than two decades provides a tremendous opportunity for US policymakers to recommit the US government to advancing new tools for HIV prevention, diagnosis, and treatment. It’s my hope that US policymakers -– both members of Congress, particularly as they continue to move forward with the annual appropriations process, and the Administration — listen to the thousands of researchers, advocates, people living with HIV, and others who will be calling for new tools to help curb and eventually end this epidemic at the International AIDS Conference later this month. Kaitlin Christenson is the GHTC's coalition director.