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In this guest post, Emily Donaldson—program coordinator at AVAC—and Tom Harmon—senior policy analyst at the International AIDS Vaccine Initiative (IAVI)—write about the state of HIV prevention research funding as the first-ever conference devoted solely to HIV prevention research and development (R&D) takes place in Cape Town, South Africa, this week. Progress toward new tools to prevent HIV infection—including vaccines, microbicides, the use of antiretroviral treatment as HIV prevention, pre-exposure prophylaxis (PrEP), and a host of other options—is being presented and discussed at the inaugural HIV Research for Prevention Conference (HIVR4P) in Cape Town this week. While much progress has been made over the last few years, a four percent decline in funding between 2012 and 2013 speaks to the uncertain nature of the global environment in which that research is taking place. Such cuts hinder the ability of the researchers in Cape Town and across the globe to continue their work and could delay progress toward efficacy trials and eventual rollout of new prevention options. Investment data for almost every technology being discussed in Cape Town can be found in HIV Prevention Research & Development Investment in 2013: In a changing global development, economic, and human rights landscape—the most recent annual report by the HIV Vaccines and Microbicides Resource Tracking Working Group. The data show that the US government continued to fund more than 70 percent of HIV prevention R&D efforts in 2013. The combination of recent funding cuts across all US government budgets and declines in European investment in HIV prevention R&D led to the overall decline in funding from the previous year. Relying on such a small number of very committed donors is problematic when one or more of those donors is forced to reduce their support.The report also highlights funding declines in nearly every category of HIV prevention R&D, underscoring an urgent need to sustain and diversify funding sources through partnerships between governments, philanthropies, and the biopharmaceutical industry. The 2013 data provoke a concern that HIV prevention R&D is increasingly becoming a lower priority for public agencies funding international development, as portfolios and priorities within those agencies shift. Global health and development negotiations such as those around developing successors to the United Nations’ Millennium Development Goals take place far from the context of most HIV prevention clinical trials, but such international commitment at the highest levels can keep HIV and AIDS a priority for development agencies that can bolster support for science, technology, and innovation in endemic countries to end the epidemic. The report also compiles the number of volunteers taking part in HIV prevention R&D trials, which totaled almost 670,000 people in 2013. Most of these individuals are based in sub-Saharan Africa where the epidemic has its most profound impact and where several large-scale treatment-as-prevention and voluntary medical male circumcision trials and projects are underway. However, that balance doesn’t cut across all new prevention technologies—80 percent of volunteers in vaccine and PrEP trials reside in the United States and Europe. Ensuring that new HIV prevention options are appropriate and acceptable means testing them in partnership with those regions and those communities that need them most. Such communities are represented here at HIVR4P, and we’re excited by the opportunity to see them mingling with the experts working tirelessly to improve the state of HIV prevention R&D science and in turn hasten an end to the AIDS epidemic. However, they can’t do it without a diverse, committed investment base. Funding data show signals of vulnerability in support for HIV prevention R&D and support the need for policymakers and advocates to ensure that the state of the field remains a healthy one. The HIV Vaccines and Microbicides Resource Tracking Working Group consists of AVAC, IAVI, and the Joint United Nations Programme on HIV and AIDS. The report and summary materials are available at www.hivresourcetracking.org.

[Editor's note 4/1/16:The Global Health Regulatory Requirements Database is no longer part of GHTC. The global health regulatory team's member site is now hosted on the Gates Foundation PDP forum.] Photo: FDA/Michael J. Ermarth Navigating global regulatory processes is a critical component to the development and introduction of global health technologies. New drugs, vaccines, medical devices, and diagnostics must be evaluated and registered by national regulatory authorities before they can reach patients who need them. These technologies are typically intended for use in low- and middle-income countries (LMICs) which often have limited regulatory capacity and evolving regulatory requirements. As a result, securing clinical trial and product registration approval from national regulatory authorities can be a considerable hurdle for product developers. The GHTC’s Global Health Regulatory Requirements Database, developed with support from the Bill & Melinda Gates Foundation, is a tool that helps product developers and global health advocates better understand and navigate regulatory requirements of LMICs. The database serves as a critical information tool to help facilitate the testing and launch of new, lifesaving global health technologies. Here are four reasons why you should check it out: 1. It’s easy to use. Organized by country and technology type, the database features high-level summaries of regulatory requirements for 25 countries in Africa, Asia, Europe, and Latin America. The database conveniently consolidates regulatory requirements for these countries in one place, so users don't have to spend as much time tracking down regulatory information for different countries. Think of it as Cliff Notes for global health regulatory processes. 2. It’s comprehensive, but still comprehensible. Users can access top-line information on regulatory authority structure, relevant harmonization initiatives, ethics review processes, clinical trial and product registration application requirements, and pharmacovigilance requirements. You can also find links to key guidances and other relevant resources. All the information is presented in an easy-to-scan format so you can find what you seek. 3. It’s regularly updated. In August 2014, the Global Health Technologies Coalition (GHTC) completed its annual verification of the database. All information in the database is systematically reviewed on an annual basis, and significant changes to country regulatory requirements also are added on an ad-hoc basis. 4. It’s constantly expanding. During the last year, the GHTC introduced eight new countries to the database—Bangladesh, Ghana, Malawi, Malaysia, Nepal, Peru, Russia, and Ukraine! The GHTC also recently added country-specific labeling requirements and expanded information on regulatory authority collaborations with the World Health Organization and stringent regulatory authorities like the US Food and Drug Administration and European Medicines Agency. Whether you are a global health product developer or an advocate, you’ll find the database to be a useful tool. It can help product developers access necessary information to formulate a regulatory strategy, and can help advocates identify areas to provide and champion technical assistance for capacity development, harmonization, and other ways to advance global regulatory processes.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. National Geographic takes an in-depth looks at how scientific hurdles, ethical concerns, and politics have slowed progress on the development of a vaccine against Ebola. The piece traces the development of the experimental vaccines and treatments currently being tested and examines how funding constraints and ethical decisions on how to allocate research funds relative to disease burden have impeded the development of an Ebola vaccine. Devex previews the conversation and debate that will soon unfold about how the world will successfully finance the Sustainable Development Goals. In July 2015, the international development community will gather in Addis Ababa, Ethiopia at the International Conference on Financing for Development to tackle this issue. With many traditional donor countries still struggling economically and failing to meet funding targets for development assistance, the article discusses the challenge of putting together a plan to finance what looks to be an ambitious set of developments goals. Malaria No More and the Bill & Melinda Gates Foundation explore the next generation of treatments that seek to eliminate the malaria parasite from the human body. While malaria research has traditionally focused on blocking transmission of the parasite by protecting people from mosquito bites, new research is exploring ways to interrupt the transmission of the parasite from man back to mosquito. In an interview on NBC’s Meet the Press, Dr. Anthony Fauci—head of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health—said he disagreed with Dr. Francis Collins statement last week that an Ebola vaccine would likely have already been discovered if it were not for federal budget cuts. While Dr. Fauci noted that budget cuts have slowed down research overall, he said he would not speculate about what medical developments were prevented as a result of these cuts.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The first vaccine against hookworm has been shown to be safe in clinical trials in Brazil, according to researchers from the Sabin Vaccine Institute Product Development Partnership who led the trial. The vaccine—which was developed by the HOOKVAC consortium—was well tolerated by 102 healthy volunteers, and blood tests indicated they developed an immune response. The Bill & Melinda Gates Foundation’s Grand Challenges in Global Health program celebrated its 10th anniversary recently. The Economist takes a look at the past ten years and discusses the program’s successes, disappointments, and what its future holds. In an interview with the Huffington Post, Dr. Francis Collins—director of the National Institutes of Health— said that a vaccine for Ebola would likely have been discovered were it not for budget cuts experienced by the agency. "Frankly, if we had not gone through our 10-year slide in research support, we probably would have had a vaccine in time for this that would've gone through clinical trials and would have been ready,” said Collins. The BMJ blog looked at the challenge countries face in accessing lifesaving drugs and vaccines as they shift from classification as low-income countries to middle-income countries (MICs). Due to tiered pricing structure and market segmentation plans implemented by pharmaceutical companies and aid organizations, as a country enters the MIC tier, it often is excluded from access to the lowest priced medicines and vaccines.