Breakthroughs Blog: WHO

On Thursday, March 26, 2015, the Global Health Technologies Coalition (GHTC) launched its sixth annual policy report titled Meeting the challenge, seizing the opportunity: US leadership can advance global health R&D with a luncheon and panel discussion on Capitol Hill. The recent Ebola crisis was a common theme as panelists discussed what lessons could be learned about the need for further global health research and development (R&D) to enhance America’s preparedness to address future health threats. Dr. Joanne Carter—executive director of GHTC member RESULTS and moderator of the event—opened the discussion by reflecting on recent successes in global health R&D, while also emphasizing the need for increased investments in tools to tackle existing and emerging public health challenges. Carter noted how years of budget stagnation and sequester cuts have stymied the development of promising technologies and eroded US preparedness to tackle global health threats like Ebola. She expressed that “as we have achieved hard fought gains, challenging fiscal circumstances have put funding for global health product development at risk. Global health crises like Ebola and emerging obstacles like antibiotic drug resistance have demonstrated that existing tools are not enough. If we are going to successfully combat these challenges and reach our goal of a healthier world, we must continue to innovate.” Panelist Daniel Bausch, MD, MP&TM—senior consultant for the Clinical Team in the Department of Pandemic and Epidemic Diseases at the World Health Organization—echoed the need for forward-looking investments in R&D and preparedness, noting that the world has spent much more money fighting Ebola than it would cost to prevent the epidemic. Bausch maintained that while the US and global response to the Ebola crisis was unprecedented, we must learn from our failures to combat future epidemics. He underscored that R&D should be treated as a preventative measure, rather than a response to a crisis, reminding the audience that the clinical trial process can take years, even decades. Bausch called for increased long-term US government investments in global health R&D and strengthening health systems and R&D infrastructure in developing nations, noting that in an increasingly interconnected world “US health is global health.” Panelist Ann Mei Chang—executive director of the US Global Development Lab at the US Agency for International Development (USAID)—echoed Bausch’s remarks admitting that the US government is “much better at responding to crises than investing long term.” Bausch further cited the challenges that budget cuts pose for global health researchers, explaining that “if you’re a researcher in a university setting, you probably spend at least 50 percent of your time looking for funding.” He further remarked that research is often stalled because researchers lack the funding to continue their work in an already long and difficult process. Panelist Captain Michael Schmoyer—director of the Office of Pandemics and Emerging Threats at the US Department of Health and Human Services (HHS)—remarked that there were bright spots in the US response to Ebola, including the ability of US agencies to collaborate and work together. He asserted that during the outbreak, coordination between HHS, the Centers for Disease Control and Prevention (CDC), USAID, the Department of Defense (DoD), and the Food and Drug Administration was unprecedented. Captain Schmoyer confessed that agency leaders surprised themselves with their ability to work effectively together and that the response to the Ebola crisis could serve as a model for US agency coordination moving forward. He cited the example of how HHS worked with other agencies including the DOD, CDC, and USAID to set up the first medical unit to care for those healthcare workings responding to Ebola. The other panelists agreed that partnership and collaboration, both across the US government and with other sectors, is essential to advancing global health R&D during times of crises and under normal circumstances. Chang discussed how the US Global Development Lab at USAID advances R&D by leveraging existing funding through diverse partnership from different sectors including the private sectors, nongovernmental organizations, universities, and local government. She emphasized the value of open innovation, through calls for proposals and ideas, to elevate previously untapped voices. Chang cited an example of the value of this collaborative model during the Ebola outbreak. USAID partnered with the White House Office of Science and Technology, CDC, and DoD to launch the Fighting Ebola Grand Challenge for Development, focused on improving the personal protective equipment used by healthcare workers on the front line. Chang said the competition received ideas from engineers, architects, and even wedding dress designers, and now USAID is working with a manufacturer to develop the winning design and introduce it into the field. Captain Schmoyer further endorsed the value of partnership noting that some of the simplest, but most invaluable, ideas generated in the Ebola response resulted from consulting new partners. All three panelists agreed that there were lessons the US could learn from the Ebola crisis to enhance our nation’s preparedness to respond to future health threats. Carter closed the event by noting that “As the world creates a new agenda for global development and seeks to confront existing and emerging health challenges, the time is right for US policymakers to strengthen the nation’s investments in research and product development and reaffirm our resolve to harness American ingenuity to save lives, improve health, and enhance economic prosperity and security around the world.” She called on US policymakers to “meet the challenge and seize the opportunity.” For more information, find the full report here and an accompanying piece on the site Medium.

WHO is moving forward on creating of new pooled fund to finance R&D. PATH/Patrick McKern In this guest post, Alexandra Heumber—head of policy affairs at the Drugs for Neglected Diseases initiative—discusses actions taken during the World Health Organization (WHO)’s Executive Board meeting which could impact financing for the research and development (R&D) of new health technologies for developing countries. Earlier this week, the WHO’s Executive Board concluded its 136th annual executive board meeting. Given the Ebola epidemic and ongoing debates about chronic underinvestment in health R&D for developing countries, it was no surprise that global health R&D featured prominently on the board’s agenda. The board discussed the follow-up of the report of the Consultative Expert Working Group on Research and Development (CEWG): Financing and Coordination, which proposed establishing a voluntary pooled fund to finance global health R&D. The board agreed to move forward with establishing this fund at the WHO Special Programme for Research and Training in Tropical Diseases (TDR). The fund will finance R&D for type II and III diseases, as well as specific needs of developing countries in relations to type I diseases. During discussions, member states stressed the importance of this fund, recalling the CEWG recommendations and citing the Ebola crisis and growing antimicrobial drug resistance in justifying its urgent need. At the same time, member states recognized that the success of the fund will depend on securing adequate funding, particularly new funding from new donors. There was broad agreement among member states representing different regions to move forward in creating the fund and more broadly in setting up the four elements to serve as a framework to monitor, coordinate, and finance global health R&D based on the CEWG report. These include: The global R&D observatory to monitor funding for R&D and expenditures A coordinating body with a scientific review committee The pooled fund at TDR Ongoing demonstration projects to illustrate how the fund would work and how CEWG principles such as delinkage—separating drug prices from the cost of R&D—and incentive mechanisms could be implemented During the board meeting, several member states pledged funding to advance these ongoing efforts: Switzerland pledged US$6 million to the demonstration projects and observatory budget line, of which $4 million has already been allocated to the TDR pooled fund. The remaining $2 million will be awarded through matching grants from low- and middle-income countries (LMICs) at the rate of $1 for every $2 contributed. Forty-thousand will be used to start the global health R&D observatory. Norway pledged $1.3 million including$650,000 to the TDR pooled fund and $650,000 to be awarded through matching grants from LMICs, again at the rate of $1 for every $2 contributed. Brazil pledged $1 million. It is encouraging to see the overall CEWG process being reinvigorated and concrete outcomes moving forward. Nevertheless, more mobilization by stakeholders and member states, including political and financial commitments, must occur. Public leadership by all countries is now crucial to make the proposed framework a reality.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Kathy Neuzil, director of Vaccine Access and Delivery at PATH, reflects on the lessons learned from Meningitis Vaccine Project (MVP) in light of the achievement of its final milestone: World Health Organization prequalification of an infant version of the meningitis A MenAfriVac® vaccine. MenAfriVac® was approved for people aged 1 to 29 years in 2010, and has since been used to effectively protect 215 million people in sub-Saharan Africa. Neuzil attributes MVP’s success to the tenacity of its team and the inclusion of country partners at every stage from product development to distribution. A new type of antibiotic may be the key to treating drug-resistant infections, according to a study published in Nature last week. The antibiotic, teixobactin, was extracted from dirt, and fights infections by targeting the fatty molecules that bacteria use to build their cell walls. While most antibiotics target the bacteria’s DNA, which can be easily mutated, the study’s lead researcher, Kim Lewis, believes it would take at least 30 years for the fatty molecules to mutate and thus develop resistance to teixobactin. The antibiotic has been successfully tested on mice with no side effects, and could be available for use in humans in five to six years. Johnson & Johnson has started human trials of an experimental Ebola vaccine in the United Kingdom, and hopes to expand testing to approximately 2,000 people by mid-February. Johnson & Johnson has produced over 400,000 courses of the vaccine and has invested significantly in the Danish pharmaceutical company Bavarian Nordic to develop a booster shot to enhance the efficacy of the vaccine and to promote long-term protection against Ebola. Dr. Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), sat down with Ryan Hohman of Friends of Cancer Research last week to discuss hot topics in FDA drug policy. Hamburg affirmed the FDA’s commitment to expediting research and development of new treatments, stating that in this “critical time for biomedical research and innovation” the FDA has a role to play in “translating all of the exciting new discoveries and opportunities and science into real world products that matter for people.”

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. This month at the Saving Lives at Birth: A Grand Challenge for Development’s DevelopmentXChange event in Washington, DC, bright minds from all over the world came together to display groundbreaking prevention and treatment approaches for pregnant women and newborns in low- and middle-income countries. The event also offered an opportunity for policymakers and decision makers to talk about the importance of science, research, and innovation for global health. During last week’s US-Africa Leaders Summit, the White House released a fact sheet on American and African cooperation for global health. As the world’s largest donor to global health, the United States is committed to working with African governments to improve the health of its citizens—including achieving an AIDS-free generation, ending preventable maternal and child deaths, enhancing global health security, and supporting African countries invest in the health of its own citizens. The World Health Organization said it thinks an Ebola vaccine should be ready for public use by 2015. There is currently no vaccine or cure for Ebola, which is currently widespread in parts of West Africa and has killed over 900 people since March of this year. This year’s outbreak is the biggest ever reported since Ebola was discovered over 40 years ago. In the Huffington Post’s blog, Dr. Jonathan Mermin—director of the Center for Disease Control and Prevention’s National Center for HIV and AIDS, Viral Hepatitis, Sexually Transmitted Diseases, and Tuberculosis (TB) Prevention—writes about the desperate need for new tools to prevent, detect, and treat TB and that “until we have better ways of detecting and treating TB, thousands of Americans and millions of people worldwide will continue to suffer from an illness that should have been consigned to history long ago.” An experimental vaccine to prevent dengue could be commercially available by July 2015, according to the vaccine’s makers—pharmaceutical company Sanofi Pasteur. There is currently no vaccine to prevent this mosquito-borne disease that affects thousands of people—mainly in low- and middle-income countries—every year.