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In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. On HIV Vaccine Awareness Day, GHTC members the International AIDS Vaccine Initiative and AVAC have released new materials and data on the search for and potential impact of this new prevention tool. The House Appropriations Committee voted on its fiscal year 2013 State and Foreign Operations Appropriations bill and released a report that clarifies its funding intentions for global health programs. The GHTC and Policy Cures stress that all stages of research—from early science to the later stages of product development—are critical to the successful creation of new global health tools. A Food and Drug Administration advisory panel has recommended that the agency approve the first over-the-counter HIV test, a kit that could return results for consumers in the privacy of their homes.

Soma Ghoshal is a program officer with the Results for Development Institute. In this guest post, she writes about a recent event that examined a new World Health Organization (WHO) report on global health research and development (R&D) financing. The WHO Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) recently released a new report, titled “Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination.” The report lays out the working group’s vision for principles, policies, and a framework that should be embodied in a global R&D system to meet the needs of those for whom markets fail. On May 7, the Results for Development Institute, Georgetown University’s O’Neill Institute for National and Global Health, and the Harvard Global Health Institute co-hosted an event to debate and discuss this critical report—the first of its kind for a multilateral institution like the WHO. Held at the Results for Development Institute offices in Washington, DC, the event was attended by 65 interested R&D practitioners, policymakers, and other global health stakeholders. John-Arne Rottingen, the chair of the CEWG, kicked off the event with a keynote presentation emphasizing the need for better and more sustainable financing and coordination mechanisms for diseases affecting low- to middle-income countries. He mentioned four underlying concepts that should be the foundation of a global framework for health R&D: Affordable products can best be achieved through free open market competition in production. R&D costs and prices of products should be delinked. Upfront public financing of R&D is needed. R&D is reestablished as a global public good where there is need for collective action and agreed financing contributions to avoid free riding. Rottingen emphasized that these elements should be embodied in a global binding instrument such as an international convention or treaty. Much like the WHO Framework Convention on Tobacco Control, agreeing to convention for R&D with legal force and an associated financial commitment would be intended to represent a systematic and sustainable solution, brought about by collective political leadership. “This is the challenge for the world as a whole, which has guided our discussions and deliberations. We have framed our recommendations to indicate that finding solutions is the responsibility of all of us in this interdependent world, in developed and developing countries alike,” Rottingen said at the event. After Rottingen’s presentation, the first panel took the stage, moderated by Robert Hecht, managing director at Results for Development Institute. Discussants included: Nils Daulaire, Office of Global Health Affairs, Department of Health and Human Services. Judit Rius, Médecines sans Frontières Access Campaign. Paul Wilson, Results for Development Institute and Columbia University. Rachel Cohen, Drugs for Neglected Diseases initiative. A lively discussion ensued regarding the proposals for new funding and coordinating mechanisms. The timeliness of the report and the US Government’s involvement in global health R&D were also topics of discussion. Rius spoke about the concept of delinkage, or separating the cost of R&D from the end product price. She explained that high product prices reflect high costs associated with R&D, and by de-linking these two aspects, products can be made more affordable while R&D can still persist. Daulaire articulated the US Government’s stance on global health R&D, explaining that the US Government clearly has a vested interest in global health R&D, which has been plainly shown through its investments. While it is promising that there seems to be an emerging consensus about how to address global health R&D needs throughout the world, there is still much work that needs to be done to create a viable framework that moves beyond (successful) voluntary bilateral and philanthropic efforts to more sustainable global commitments. After a brief question and answer period, the second panel began its discussion, moderated by Larry Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University. The panelists included: Suerie Moon, Global Health Institute, Harvard University. Benn McGrady, O’Neill Institute, Georgetown University. Jamie Love, Knowledge Ecology International. This panel discussion focused on the binding instrument and the implications of using legal force to bring about collective action for R&D. Topics discussed included the international treaty on tobacco control and the merits of using a binding instrument for R&D. Moon highlighted that treaty backers will have to consider whether to seek an instrument that is universal, and potentially weaker, or go for a stronger treaty that includes fewer countries. McGrady noted how a convention on R&D may sort out problems that have kept R&D investments low, such as a lack of mobilization of relevant interest groups and a challenge in establishing common norms by which different countries should abide. In addition, Love commented on the merits of broadening the mandate of the WHO R&D Convention to encompass more than just developing countries, but rather to go for a “big” R&D treaty that includes R&D for non-communicable and other diseases affecting developed countries. Love felt that broadening the treaty scope has the potential to address more global health needs, which may be attractive to US or European country governments trying to control health care costs in times of austerity and who may be more willing to join if the treaty is seen as beneficial to their own populations. The event concluded with the clear message that although arriving at a consensus that more attention needs to be paid to R&D is progress in and of itself, this moment must be leveraged appropriately, and there is much work that needs to be done.

On Thursday, the House Appropriations Committee will vote on a State and Foreign Operations (SFOPS) appropriations bill for fiscal year (FY) 2013, which will include funding levels for global health and other programs at the State Department and US Agency for International Development (USAID). This vote follows last week’s markup of the bill by the House SFOPS appropriations subcommittee. Overall, the subcommittee’s bill had mixed results for global health and other programs at USAID: while some programs were sustained at FY 2012 levels, others saw significant budget cuts that will affect the agency’s efforts worldwide. Under the subcommittee’s bill, the entire State and Foreign Operations account was cut by nine percent. Many bipartisan programs like the President’s Emergency Program for AIDS Relief (PEPFAR) were flat-funded at FY 2012 levels. USAID’s global health funding, which contributes to global health research and development (R&D) projects, was cut by six percent, a decrease of roughly $150 million. USAID’s operating budget was also slashed by 5%, which will affect all of its programs. No funding levels were outlined for the many disease-specific programs at USAID. These disease-specific funding levels could be added to later versions of the bill, or could be left up to the Obama Administration once the entire appropriations process is completed. The only exception was family planning, which was slashed by one-quarter and given a new overall funding cap of $461 million—$149 million below the FY 2012 levels. It’s important to remember that the final SFOPS budget for FY 2013 will probably look different from the House bill being considered this week. The Senate is working on its own version of the appropriations bill, and both versions will eventually have to be negotiated if Congress follows a typical appropriations process (which it hasn’t done in the past few years). Whatever the final SFOPS budget looks like, it’s critical that Congress fully funds USAID so it can continue its work in all areas of global health, including the agency’s support of R&D to develop new health tools. And if it’s left to the Administration to make decisions about disease-specific program funding at USAID, funding for R&D and innovation for all disease areas needs to remain a top priority at the agency. USAID plays a huge role not just in funding product development to combat global health challenges, but also ensuring that new technologies are appropriate for the communities where they will be used. Some of the tools that have benefited from USAID funding and expertise include the RTS,S malaria vaccine candidate, the groundbreaking CAPRISA microbicide trials, and the Xpert TB diagnostic. USAID also works in partnership with many critical players in the global health R&D space, such as other US agencies, the private sector, nongovernmental organizations, and universities. It’s clear that USAID has seen major successes in its support for global health R&D. As the House Appropriations Committee votes on the SFOPS bill on Thursday and the budget process continues, Congress will have to decide whether it should boldly support USAID’s goal of developing new health tools—tools that are projected to save millions of lives—or withdraw this support and risk halting scientific advancement in its tracks.

Late last week, the National Center for Advancing Translational Science (NCATS) at the National Institutes of Health (NIH) unveiled a pilot program that aims to speed the creation of new drugs. Under the program, three pharmaceutical companies have agreed to make dozens of their failed compounds available to researchers, who will investigate if the compounds can be re-purposed into successful treatments for other diseases. The HIV and AIDS drug AZT, which was born out of an unsuccessful cancer treatment, has been cited as a prime example of the potential for this new program. At the launch event, NIH Director Francis Collins highlighted that the NIH needs to “speed the pace at which we are turning discoveries into better health outcomes.” He also emphasized the urgent need for new cures for patients suffering without any available treatment options. With NCATS, an exciting potential exists for new tools to combat neglected global health diseases. Photo credit: PATH The new program embodies the public-private partnership model. In 2013, $20 million in US Government grants from the NIH will fund researchers to work with compounds provided by private-sector pharmaceutical companies in pursuit of new treatments. As of now, over 20 compounds have been committed by the three companies. Kathy Hudson, acting deputy director of NCATS, hopes that many more will be available by the time the program releases its first Request for Applications (RFA) next month. No information is currently available from NCATS on what compounds will be available, or what diseases the program hopes to tackle. We won’t have that information until the RFA is public. In setting his goals for NIH at the beginning of his tenure, Collins stated that global health would be a top priority for NIH as an organization. Now that NCATS—which focuses on spurring drug development for neglected diseases of the developing world, as well as rare diseases—is established and this new program has been launched, an exciting potential exists for new tools to combat neglected global health diseases. Since its inception, NCATS has unfortunately been slow to take up initiatives that target global health diseases, as many of the NCATS programs announced thus far focus primarily on rare diseases that affect US populations. Rare diseases absolutely deserve funding, support, and targeted research—as do global health diseases. As shown in our recently released report, the United States leads the world in global health research and development. Under this leadership, who knows what groundbreaking cures for global health diseases could be created with the compounds included in the new program? At the press conference, patient advocate Michael Manganiello spoke enthusiastically about his experience as a patient saved by AZT. “Without partnerships between the NIH and industry, I would not be here to give this statement today,” he said. HIV and AIDS is just one example of the range of global health diseases that remain in urgent need of new tools. Think of how far we have advanced from a time when there were no treatments for HIV and AIDS, and think of what progress could be made in other neglected diseases under this new program. With this new therapeutics program, NIH and NCATS have created an exciting, innovative model for collaboration between the public and private sectors. They should be applauded for it. Now NCATS must ensure that research for neglected diseases is encouraged and supported through this initiative. NCATS has the opportunity to jump start innovation that will one day save lives and create better health outcomes—an opportunity that should be shared with patients around the world.