News

In this guest post, Sarah Alexander—director of external relations for the Global Alliance to Prevent Prematurity and Stillbirth (GAPPS)—writes about the groundswell of momentum surrounding maternal and child health and the role research and development (R&D) can play in helping more babies have a healthy start to life. You may have noticed maternal and child health has been garnering a lot of attention lately. At the Saving Every Woman Every Child Global Summit in Toronto last week, the focus was on ending preventable deaths of mothers and children under 5, and the government of Canada pledged $3.5 billion toward those efforts. The week prior marked the launch of the Every Newborn series in The Lancet, as well as the endorsement of the Every Newborn Action Plan by the World Health Assembly in Geneva. Later this month, the Partnership for Maternal, Newborn & Child Health’s Third Annual Partners’ Forum will be held in Johannesburg. All of these events are building on each other and creating a groundswell that will help forge a blueprint for the post-Millennium Development Goal era.The momentum these efforts have gained is impressive, and great strides have been made in saving the lives of mothers and babies around the world. As the global health community looks toward the next 15 years, we are encouraged that more and more plans are incorporating R&D as pillars of a maternal and newborn health agenda. A focus on R&D will allow researchers to look upstream and investigate new ways of preventing problems from occurring in the first place—exemplifying the maxim that prevention is better than cure.There has been a groundswell of momentum for maternal and child health. There are many opportunities for high-impact R&D as part of the agenda. Photo: PATH/Mike WangAt the GAPPS—an initiative of Seattle Children's—we understand and advocate for all the great work that is being done to treat newborns—especially in low-resource settings—to give them a better chance of survival. With our focus on preterm birth and stillbirth, we envision a scenario where instead of treating infants born prematurely or laying to rest nearly 3 million stillborn babies every year, we could instead identify issues in utero and develop therapies to prevent preterm birth, stillbirth, and other pregnancy complications before they occur.Babies born too soon can face lifelong health complications, including respiratory issues, vision and hearing loss, cerebral palsy, developmental delays, and more. Stillborn babies are often not acknowledged with birth or death certificates, or prioritized in health efforts. While it’s essential that known interventions are scaled up to help save the lives of mothers and newborns, we are glad to see a comprehensive R&D movement picking up steam.There are many opportunities for high-impact R&D in maternal and newborn health. For example, new technologies allow for increased biomarker discovery and therapeutics development, which could allow doctors to screen for and treat conditions in pregnant women and their babies before birth, helping more babies have a healthy start to life.With so much momentum building around maternal and child health, we’re glad to see R&D into prevention is being prioritized so that one day every birth can be a healthy birth.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Kaitlin Christenson, director of the GHTC, summarizes news out of the World Health Assembly (WHA) impacting the global health research and development (R&D) community including debates on the post-Consultative Expert Working Group on Research and Development: Financing and Coordination and post-2015 development agenda, and themes related to regulatory system strengthening, access to essential medicines, and the value of R&D. Renate Baehr—executive director of Deutsche Stiftung Weltbevoelkerung—writes about the next rendition of the European & Developing Countries Clinical Trials Partnership and how its expansion will impact more lives in low- and middle-income countries. She discusses how the program has been broadened to include neglected tropical diseases and how African countries will now fully participate in the group’s governance and decision making. The Canadian government announced it would provide $12 million to Grand Challenges Canada to finance innovations to improve maternal and child health in the developing world. The funding will support 65 projects to be implemented across 25 low-and middle-income countries. The announcement came in advance of the Canadian Prime Minister’s global summit on maternal, newborn, and child health taking place in Toronto from May 28-30. Wired reports on the passage of a resolution at WHA to create a global action plan to tackle the emerging problem of antibiotic resistance that will include exploring technology innovations in diagnostic testing and new drug development. The article notes that some experts believe this will not do enough to stem the problem and are calling for the creation of an intergovernmental body on antibiotic resistance that would be similar to the Intergovernmental Panel on Climate Change.

In this guest post, Renate Baehr—executive director of Deutsche Stiftung Weltbevoelkerung—writes about the next rendition of the European & Developing Countries Clinical Trials Partnership (EDCTP) and how its expansion will impact more lives in low- and middle-income countries. April 2014 was an important month for European support for global health research and development (R&D). Already the world’s leading contributor of development assistance (as measured by Official Development Assistance), and at the forefront of R&D in the health and pharmaceutical sectors, the European Union (EU) has agreed to significantly increase its budgetary support for global health R&D to tackle poverty-related and neglected diseases. Last month, the European Parliament and EU Member States reached an agreement on the successor to EDCTP —imaginatively entitled—EDCTP2. The EDCTP was established in 2003 and is a partnership of 16 European countries—among which 14 are members of the EU—and 48 sub-Saharan African countries, funded through the EU’s multiannual R&D budget, Horizon 2020. Its original objective when founded was to address the critical need for new and innovative medical products to prevent, diagnose, and treat HIV and AIDS, malaria, and tuberculosis (TB). Following its successful first cycle, both the scope and the budget of EDCTP have now been expanded. With a budget of €683 million, EDCTP2 will spearhead collaborative efforts to support the clinical development of new or improved diagnostics, drugs, vaccines, and microbicides against HIV and AIDS, TB, and malaria. The scope of EDCTP will also expand to include neglected tropical diseases (NTDs) prevalent in sub-Saharan Africa (excluding Chagas disease). Additionally, at a meeting in The Hague at the beginning of this month, the program welcomed eight African countries to join EDCTP. This is the first time in the program’s history that African countries will formally participate, a move which will for the first time enable their full participation in the EDCTP’s governance and decision-making structures through the EDCTP General Assembly. Why is this important? Because poverty-related neglected diseases—namely HIV and AIDS, malaria, TB, and the 17 NTDs listed by the World Health Organization here—affect more than one billion people across the globe. To respond to this challenge, EDCTP2 is directed towards supporting and developing much-needed, affordable, innovative, and quality health products to prevent, diagnose, and treat neglected infectious diseases. Not only is it targeted at having new products developed for market release by the end of the program, but in order to ensure that the successes of the program are sustained, EDCTP2 will also focus on increasing transnational research and developing research capacities in sub-Saharan Africa where they are needed on the ground. Breakthroughs achieved by EDCTP2 over the next 10-years have the potential to transform the lives of millions of people living with the devastating effects of TB, HIV and AIDS, and malaria. Global health R&D can have a direct impact on the health of people living in low- and middle-income countries, lifting a burden of diseases that stifles economic growth and prevents young men and women from reaching their full potential, socially and economically. EDCTP2 is one contribution to ending this, and we call on EU Member States to take this example and follow suit by ramping up their own funding for innovative ways to fight these diseases and advance global health. We look forward with interest as to how it will progress in the coming years. For more information on our work and what we are doing on global health R&D, check out our blog!

The annual World Health Assembly (WHA) has come and gone once again, and this time there’s a lot of exciting news to report on the innovation front. We were following most closely the debates on the post-Consultative Expert Working Group on Research & Development: Financing and Coordination (CEWG) and on the post-2015 development agenda, but themes related to regulatory system strengthening, access to essential medicines, and the value of research and development (R&D) were in the spotlight throughout the week. CEWG Last year, Member States agreed to move forward with a series of demonstration projects intended to explore new mechanisms for financing and coordinating research for neglected diseases—an action intended to address some of the CEWG’s 2012 recommendations. Four demonstration projects are currently underway—including two managed by GHTC members Drugs for Neglected Diseases initiative (DNDi) and Medicines for Malaria Venture—which are expected to report out during the 69th WHA in 2016 on their success in advancing alternative mechanisms for funding global health R&D, including the use of open access models and the principle of delinkage—or separating drug prices from the cost of R&D. Discussed throughout the week were the post-CEWG and the post-2015 development agenda, and themes related to regulatory system strengthening, access to essential medicines, and the value of R&D. Photo: PATH/Gabe Bienczycki Most notably, a resolution passed by Member States calls for the establishment of a pooled fund for R&D—to which Member States can voluntarily contribute—which will be housed at the World Health Organization (WHO) Special Programme for Research and Training in Tropical Diseases (TDR). Furthermore, in what is seen as a win by many in the global health community, delegates decided that the fund would be open to some categories of Type I diseases in addition to Type II and III diseases. Member States also heard about progress toward establishing a Global Health R&D Observatory to monitor funding flows for R&D funding and expenditures. The WHO secretariat reported that work to map potential models for the observatory and key stakeholders has already begun. Post-2015 development agenda During a technical briefing for Member States, representatives from the WHO secretariat outlined a proposed overarching health goal: Ensure healthy lives and universal health coverage at all ages. It also articulated four sub-goals: (1) achieve the health-related Millennium Development Goals (MDGs), (2) address the burden of noncommunicable diseases, injuries, and mental disorders, (3) achieve universal health coverage including financial risk protection, and (4) address the social and environmental determinants of health. Unfortunately, largely missing from the session was mention of innovation or the role of R&D in achieving these sub-goals. Along with COHRED, the Global Health Council (GHC), DNDi, and the International AIDS Vaccine Initiative, the GHTC hosted an official nongovernmental organization (NGO) side session to explore the role of R&D in the post-2015 development agenda. Speakers from the GAVI Alliance, the delegations of Senegal and Kenya, the INDEPTH Network, GlaxoSmithKline, GHC, and the WHO stressed that R&D for new innovative health tools is critical in making equitable and sustainable progress towards development goals. The event organizers developed a statement that is available to NGOs, academic institutions, Member States, and other partners for sign-on. Panelists closed by urging Member States and delegates to support health research and related policies and capacity building as a core component of a post-2015 agenda for equitable health and sustainable development. Early in the week, Member States also passed a resolution calling for new tuberculosis (TB) targets, which should be reflected in the post-2015 development agenda. The resolution specifically calls for a 95 percent reduction in deaths from TB by 2035 and notes research and innovation as one of three key pillars that will help achieve this goal. By the end of the week, Member States had approved a resolution on health in the post-2015 development agenda that called for completing the unfinished work of the health MDGs and noted the importance of universal health coverage and stronger health systems. Access and affordability Also hotly debated last week was how best to ensure access and affordability of essential medicines and other health products. The assembly passed a resolution on access to essential medicines calling upon Member States to improve the availability, affordability, quality, and rational use of essential medicines. Other debates also addressed access and affordability: In a resolution addressing hepatitis, Member States were asked to consider using the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities to promote access to specific pharmaceutical products. The Bill & Melinda Gates Foundation called upon the WHO to promote access in international trade negotiations. Dr. Chris Elias, president of the Gates Foundation’s Global Development Program, said, “It will be important, as [WHO Director-General] Dr. Chan mentioned, that as international trade agreements are negotiated, that we pay attention to the importance of accessibility for affordable healthcare commodities for the poorest countries in the world.” Sustainable access to vaccines at affordable prices was highlighted during a debate on the Global Vaccine Action Plan. Member States noted the importance of technology transfer to facilitate local manufacturing—one tactic that is used by product developers to drive prices down, build local capacity, and ensure supply availability. Regulatory systems strengthening Member States called upon WHO to coordinate with national regulatory authorities in continuing its role in regulating medicines through establishing necessary norms and standards, supporting regulatory capacity-building and strengthening safety monitoring programs, particularly through the WHO prequalification process. In an excellent side session organized by the US Food and Drug Administration and the government of Mexico, WHO stressed that the prequalification program is not intended to be a permanent solution and that the WHO secretariat will take steps in the future to devolve responsibility for ensuring safety and quality of health products to regional and national structures. All in all it was a busy but productive week. Now the responsibility for moving ahead with these resolutions rests with the WHO secretariat and the Member States themselves.