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In this guest post, Tricia Aung—the GHTC’s regulatory associate—writes about a new database that provides easy access to information on global health regulatory information. Before they can improve the lives of patients and communities, new global health technologies must undergo rigorous testing and evaluation to ensure that they are safe and effective. National regulatory authorities—like the US Food and Drug Administration (FDA) in the United States—are responsible for protecting the public health throughout this process, making sure that clinical trials are conducted safely, and reviewing trial results to determine whether the benefits of potential products for the population outweigh the risks. Since many global diseases are endemic in countries with limited regulatory capacity, getting regulatory approval can be a huge roadblock to getting products clinically tested, manufactured, and delivered. Regulations vary by country, so developers of new vaccines, drugs, and other health products often face the challenge of understanding and juggling numerous sets of regulatory requirements. This is further complicated by the fact that in many developing countries, it can be difficult to find information on regulatory requirements. The Global Health Regulatory Requirements Database provides consolidated access to country-level regulatory requirements, thereby aiding product developers, multilateral organizations, and advocates with getting products through clinical trial approval and designing programs to strengthen regulatory capacity. Photo: Richard Franco. The Global Health Regulatory Requirements Database, a new tool developed by the GHTC and supported by the Bill & Melinda Gates Foundation, is designed to help address this regulatory information gap. The database provides consolidated access to country-level regulatory requirements, thereby aiding product developers, multilateral organizations, and advocates with getting products through clinical trial approval and designing programs to strengthen regulatory capacity. Currently featuring 17 countries in Africa, Asia, and Latin America, the database is a central repository of high-level regulatory information and links to key guidance documents and regulatory resources. The database also offers users easy navigation from country to country and separates technology-specific information into three categories: drugs, vaccines, and diagnostics. Key data points include: Contact information for national regulatory authority representatives. Overview of clinical trial and product registration requirements, including data requirements, costs, estimated timelines, and pharmacovigilance requirements. Description of ethics review processes. Background on collaborations with other regulatory agencies, multilateral organizations, and capacity-building and harmonization initiatives. For example, the FDA offers trainings to enhance regulatory capacity building in developing countries. The agency also contributes to global efforts to improve regulatory harmonization in conjunction with partners like the World Health Organization. The database was designed to include a broad base of information, making it useful to many audiences. For example, researchers and regulatory affairs professionals can find the information they need to formulate effective regulatory strategies to gain approval to conduct clinical trials and market products. Creating a more informed, strategic regulatory plan that satisfies country requirements can help reduce regulatory delays that inhibit products from reaching people. The database also promotes systemic change by capturing the current state of national regulatory authorities in developing countries. It can help guide advocates in efforts to develop advocacy strategies to improve and streamline global regulatory processes. Further, stringent regulatory authorities, such as the FDA, and public health organizations can use the database to identify opportunities to provide technical assistance at the country level to strengthen the capacity of regulatory authorities, and encourage harmonization and policy reform. To deliver new health technologies to people as quickly and safely as possible, there needs to be a strong plan for regulatory approval and an enabling environment that supports regulatory review. The database can help address these needs and inspire lasting changes in the global health regulatory space.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The government shutdown is affecting health research and clinical care at the National Institutes of Health (NIH). The NIH—the biggest source of funding for medical research in the world—supports researchers and clinicians across the nation, meaning that universities and hospitals across the country are grappling with what the NIH shutdown might do to their work. Researchers from around the world will convene to discuss the latest advances and obstacles in the search for an HIV and AIDS vaccine next week at the AIDS Vaccine 2013 conference. In related news, scientists from the University of Cambridge have discovered that a mutant form of an immune protein can block infection and spread of HIV in immune cells. Their findings could lead to new ways of treating HIV by offering a new target for drug developers. Researchers at McMaster University in Canada have developed a new vaccine that could fight tuberculosis. The vaccine—developed from a genetically modified cold virus—would act as a booster to the currently used vaccine against the disease. The Washington Post provides a look at how agencies across the federal government —such as the Department of Health and Human Services, the US Food and Drug Administration, and the State Department—are dealing with the shutdown.

  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.

In this guest post, Jenny Howell—senior policy & advocacy associate at PATH working with the GHTC—writes about how the government shutdown and budget negotiations in Congress will impact global health research and development (R&D) programs across the federal government. She also provides an update on new legislation that would impact the President’s Emergency Plan for AIDS Relief (PEPFAR). It’s been a hectic few weeks in Washington. When House Majority Leader Eric Cantor (R-VA) canceled last week’s scheduled recess—and lawmakers from both chambers stayed to work over the weekend—we hoped that policymakers could successfully prevent a government shutdown. Because members of Congress have been unable to agree on long-term budget deals, funding for the government has been based on short-term continuing resolutions (CR)—stopgap budgets that fund the government for a few months at a time. The last short-term deal, passed in March, funded the government through the end of September, requiring Congress to pass a new CR by midnight on September 30 or face a federal shutdown. What the shutdown means in practical terms varies across the government--from Congress to agencies such as USAID, NIH, CDC, and FDA. The past week has been a Ping-Pong between competing House and Senate budget bills, with Republicans in the House insisting on a CR that is coupled with the defunding or delay of the Affordable Care Act. Senate leaders, on the other hand, pledged that they will only consider a “clean CR,” or a bill that doesn’t contain major policy changes but only deals with funding. What the shutdown means in practical terms varies across the government. Congress On the Hill, it’s up to lawmakers to determine which staffers serve essential functions and which staffers are non-essential. Therefore, staffing will vary greatly from office-to-office. USAID The US Agency for International Development (USAID) issued a guidance outlining a few possible scenarios, but indicated that the majority of its contracts and grants are not dependent on new appropriations and will continue operations. The agency has promised to contact partners who have grants or contracts that will be directly impacted by the government shutdown. While most ongoing programs should remain safe with existing funding, this also means USAID won’t be investing in any new R&D funding, contracts, or grants until a budget deal is reached. HHS The Department of Health and Human Services (HHS) has also released its contingency plan in the case of a shutdown. The National Institutes of Health (NIH) will continue caring for patients in current clinical centers. However, health research will be severely impacted as NIH will not accept new patients for clinical research. This is on top of an already exhausted post-sequestration budget that NIH Director Dr. Francis Collins has described as delaying innovation. The Centers for Disease Control and Prevention (CDC) will continue to operate its 24/7 operations center, as well as activities funded through mandatory spending like PEPFAR, the Global AIDS program, and the Vaccines for Children program. The shutdown does impact CDC’s ability to support the annual flu program and much of its ongoing disease surveillance and R&D activities. The Food and Drug Administration (FDA) will continue activities related to critical public health issues, but will cease the majority of lab research, routine inspections, monitoring, and notification programs. The FDA will continue the majority of its programs linked to user fees, including product approvals, but approval times may be delayed as a result of understaffing. Moving on PEPFAR Amidst the tension of the budget battle, members of Congress have seemingly found something they agree on. On September 24, Sens. Robert Menendez (D-NJ) and Bob Corker (R-TN) introduced The PEPFAR Stewardship and Oversight Act of 2013 (S 1545). A day later, Reps. Eliot Engel (D-NY), Ed Royce (R-CA), Barbara Lee (D-CA), and Ileana Ros-Lehtinen (R-FL) introduced a companion bill in the House (HR 3177) Most of the PEPFAR program can continue to operate as long as Congress appropriates funds. However, some components—mostly reporting requirements—could end without renewal. The bill introduced last week is by no means a full reauthorization and is extremely limited in scope, only extending the PEPFAR program as it relates to HIV and AIDS with no specific extension of tuberculosis (TB) or malaria programming or funding. PEPFAR currently supports a variety of global health R&D projects, including research on microbicides and vaccines for HIV and AIDS, TB, and malaria. Bill status The bill is already moving quickly and with the addition of a short manager’s amendment, it was approved by the Senate Committee on Foreign Relations by voice vote earlier this week. The manager’s amendment added reporting requirements to include reporting on co-infections and co-morbidities of HIV and AIDS, including TB, as well as country efforts to improve health work force issues. The government shutdown makes next steps for the bill uncertain, but the strong bipartisan support makes it likely that leadership in both chambers will fast track the bill and bring it up for consideration without additional amendments. Looking ahead We hope support for PEPFAR isn’t the only thing Congress can come to an agreement on this week. While uncertainty about the impact of the shutdown remains high, the quicker that lawmakers can reach an agreement the less severe the negative effects will be across our nation and around the world. Whatever the outcome, we’ll continue to track the progress and its potential impact on global health R&D.