Breakthroughs Blog: WHO

In this guest post, Beth P. Bell—director of the National Center for Emerging and Zoonotic Infectious Diseases—and Tom Kenyon—director of the Center for Disease Control and Prevention’s (CDC) Center for Global Heath—write about a new initiative from the US government to address global health security. The US government’s recent commitment to global health security recognizes that health security is an essential part of every nation’s national security. As both Department of Health and Human Services Secretary Kathleen Sebelius and CDC Director Tom Frieden have said, “A health threat anywhere is a health threat everywhere.” These threats may come from naturally occurring disease outbreaks, the emergence of drug-resistance, or by the intentional or accidental release of dangerous pathogens. They may occur anywhere on the planet at any time. Mitigation of such threats is greatly enhanced when the nations in which they may arise are able to detect them early, respond rapidly, and prevent them from happening again—or better still, from happening in the first place. In February, the United States joined with 28 other countries, the World Health Organization (WHO), and 3 other international organizations to launch the Global Health Security Agenda. At the launch, the United States made a commitment to working with 30 countries over the next 5 years to establish and strengthen their abilities to prevent, detect, and respond to infectious disease threats. In fiscal year (FY) 2014, a group of 12 nations will accelerate engagement in these global health security strengthening partnerships with US agencies. Pending additional resources, more countries will be added in FY 2015 and beyond. Global health security is embodied in a comprehensive set of specific targets to prevent, detect, and respond to infectious disease threats. These objectives are based in part on the WHO’s revised International Health Regulations (IHR (2005)) which established core requirements for monitoring public health threats globally and responding rapidly and effectively to contain them. Although adopted by nearly every nation on earth, fewer than 20 percent of Member States who signed on to the IHR (2005) are in full compliance. One of the major objectives of the US government’s global health security effort is to greatly increase IHR compliance. Partner countries will develop systems, policies, and procedures to prevent or mitigate outbreaks. Prevention priorities include: Monitoring and slowing antimicrobial resistance (AR), the ability of bacterial and viral pathogens to acquire resistance to antimicrobial drugs. Nations should have at least one reference laboratory able to identify—and to report—at least three of the seven WHO priority AR pathogens using standardized detection assays. Practices and policies to prevent animal diseases from spilling over into human populations. Immunization of at least 90 percent of each nation’s 1-year-olds with at least one dose of measles vaccine (or a combination vaccine including measles). Having this capacity means a nation is able to adequately carry out other immunization and health-care efforts. The United States will also work with countries to create and strengthen real-time networks of information systems to detect outbreaks, and up-to-date rapid diagnostic tests to enable their laboratories to conduct at least five of 10 core tests for high-risk and high-priority diseases. Six of these core tests are for diseases that are among the WHO Top 10 Causes of Death in low-income countries: influenza virus, poliovirus, HIV, tuberculosis, malaria, and typhoid fever. The remaining four tests will be selected by the partner country based on national public health concerns. Other priorities will strengthen countries’ abilities to detect global disease threats including: Surveillance for potential public health emergencies. Interconnected electronic reporting systems. Training for doctors, veterinarians, biostaticians, lab scientists, and field epidemiologists. The United States will also assist partner countries to develop skills and build systems to mount effective responses to health threats. These include establishing emergency operation centers (EOCs) with rapid-response teams and linkage to a network of labs that monitor for disease outbreaks. The goal is for an EOC to be able to activate a coordinated response within two hours of detecting a public health emergency. Nobody knows where the next health threat will arise. In a world linked by international travel and commerce, no nation is more than a plane flight away from any other. Global health security is a key element of every country’s national health security. For more information, please visit CDC’s global health security website at http://www.cdc.gov/globalhealth/security/.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. In this year’s State of the Union, President Obama mentioned “federally-funded research” and recognized that “there are entire industries based on vaccines that stay ahead of drug-resistant bacteria.” While a modest statement, the President’s recognition of these important US contributions to global health is significant. Last week during the World Health Organization Executive Board meeting, Member States met to discuss moving forward on eight demonstration projects that would look at new ways to spur research and development (R&D) for diseases that affect populations in low- and middle-income countries. However, some advocates were disappointed that the topic of alternative funding mechanisms for global health R&D was not substantively debated. The US Agency for International Development (USAID) announced this week that the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 Tenofovir gel trial was the winner of the agency’s Science and Technology Pioneers Prize. The prize recognizes “excellence in the use of science and technology to solve development challenges.” This is the first year USAID has awarded the prize. The Swiss Federal Department of Home Affairs and the Federal Department of Foreign Affairs, and the Bill & Melinda Gates Foundation have signed a Memorandum of Understanding to improve access to health interventions through the strengthening of regulatory systems. The partnership could improve and accelerate access to health interventions and therapeutic products in resource-constraint countries.

  As 2014 gets into full swing, the GHTC is looking ahead to many exciting developments on both the global health research and development (R&D) and policy landscapes: A step in the right direction: Policymakers in Congress recently passed both a budget deal for fiscal year (FY) 2014 and FY 2015, as well as a final appropriations package for FY 2014. The package included mixed results for global health research, however the compromise may hallmark a step towards a more “normal” appropriations process for FY 2015. We’ll be watching to see if policymakers boost support for the accounts—like those at the National Institutes of Health—that were hammered by the shutdown and budget sequester. Progress towards new malaria tools: In late 2013, GHTC member Medicines for Malaria Ventures received expedited regulatory approval from the US Food and Drug Administration to move treatment candidate tafenoquine into Phase III trials. And, the most recent clinical trial results of the RTS,S malaria vaccine candidate, released last year by partners PATH Malaria Vaccine Initiative and GlaxoSmithKline (GSK), have spurred excitement that the vaccine may be WHO-approved by 2015. To start the process, GSK announced plans to submit a regulatory application through the European Medicines Agency later this year. 21st Century Global Health Technology Act: Now that Congress has finalized its FY 2014 budget and moved on to other priorities, at the top of our list is the 21st Century Global Health Technology Act. The legislation was introduced in April of 2013 in the House of Representatives by Reps. Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) and boosts global health R&D programming at the US Agency for International Development. Rumors are a companion Senate version is coming very soon, so stay tuned! Exciting new research is coming up in 2014. Photo: PATH/Evelyn Hockstein R&D takes the stage at WHO: The World Health Organization (WHO) has made some progress in implementing the health R&D resolution it passed in 2013—including reviewing proposals for demonstration projects aimed at promoting R&D for medical products. The World Health Assembly will have eight finalists to choose from at its meeting this May. Horizon 2020 begins: In late 2013, the European Union approved €80 billion in funding for Horizon 2020—the European Parliament’s framework for research and innovation. This represents an increase in funding compared with previous years, and includes an emphasis on public-private partnerships for research. It will be interesting to see how this program affects the global health R&D landscape. State of the Union: This time last year, we were anticipating the start of President Obama’s 2nd term, and what shifts in agency and congressional leadership would mean for US global health research programs. The 2012 and 2013 State of the Union addresses emphasized harnessing innovation to make progress in health, education, and other areas. We’ll be watching this Tuesday night to see how the President plans to build on progress made in the remainder of his term. A new era for the President’s Emergency Plan for AIDS Relief: In other Administration news, Dr. Deborah Birx was recently nominated to be the new US Global AIDS Coordinator. Dr. Birx currently heads the Global HIV and AIDS program at the Centers for Disease Control and Prevention (CDC), and previously ran the Military HIV Research Program (MHRP) at the Department of Defense. We’re excited to see a leader in global health research take the reins of one of the US government’s most important global health programs. Pending her confirmation, it will be intriguing to see where Dr. Birx takes the agency, and how research for new global health tools will play a role. All health is global: Speaking of the CDC, two of the five most pressing health priorities that CDC’s Director Dr. Tom Frieden identified in a recent interview involve big impacts in global health research: eradicating polio and combating disease that originates outside of the United States. Between new research advancements and policy progress, there is clearly a lot we’re excited about for 2014. What new developments in global health R&D are you looking forward to? Ashley Bennett is GHTC's policy officer.

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.