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Angie Drakulich was editorial director of Pharmaceutical Technology.
Cultivating a productive investment environment will require partnerships with a range of stakeholders.
President Obama launched the Global Health Initiative in May 2009 to introduce an integrated approach to the government's investments in global health. The initiative involves programs of the US Agency for International Development (USAID), the Department of Health and Human Services (HHS), PEPFAR, and the Peace Corps, among other agencies. Innovation and development are key components of the initiative's and the administration's goals. Pharmaceutical Technology spoke with Amie Batson, appointed by Obama to lead USAID's role in the initiative, about progress thus far and plans forward.
PharmTech: Why are innovation and development such a big push now now compared with past years?
Batson: At USAID, we realize the benefits of investing in innovation for global health go well beyond improvements in health. Some of the greatest advances in development have come from extending the reach of innovative breakthroughs to those who lack access health facilities. We are looking to build stronger partnerships with the development and scientific communities to support the creative thinkers who are developing the next generation of health technologies capable of reaching more people at reduced costs to maximize impact.
USAID Administrator Dr. Rajiv Shah has stated on several occasions that the largest opportunities to improve human health and the human condition do not lie in optimizing services to the 10–20 % of people in the developing world who have access to world-class health facilities. They lie in extending our reach to the 80-90% of people who do not.
PharmTech: What are some examples that have come about from the initiative to date?
Batson: This year, at the Bill and Melinda Gates Malaria Forum in Seattle, USAID welcomed the initial news of the Phase 3 efficacy trial that confirmed the RTS,S malaria vaccine is safe and effective, and could eventually add to our present package of malaria control interventions saving more lives among young children in Africa. In 2010, USAID proudly announced the first-ever proof of concept that a microbicide gel can effectively and safely reduce the transmission of HIV from men to vulnerable women, and placing the power of HIV prevention in the hands of women. The Global Alliance for TB Drug development is bringing a new drug combination to Phase III trials that could cut the duration of treatment by half and help overcome MDR-TB. With each advancement, we come closer to delivering more effective aid at a lower cost. In tough economic climates like this one, the question we should all be asking is what tangible benefits we will see for each dollar spent. There is no question that investing in the health technologies of tomorrow will reap incredible returns on our original investment, in lives and money saved.
PharmTech: USAID Administrator Shah has spoken about how the agency is trying to improve its relationship with the private industry to make communication easier and less bureaucratic. What is USAID looking to do in this regard? What types of new partnerships is the agency forming?
Batson: Cultivating a productive investment environment will require partnerships with a range of stakeholders in donor and host countries, including the private sector, civil society organizations, research institutions, foundations, and emerging and traditional donors. Our partnerships should reflect new models such as South–South and trilateral cooperation, and include meaningful roles for civil society and the private sector.
Leveraging the collective resources of partners through public-private partnerships allows the development community to capitalize on opportunities to extend the reach and depth of our programs. USAID's Global Development Alliance (GDA) is a premiere model for public-private partnerships, helping to significantly expand and deepen the impact of development assistance by linking US foreign assistance with the resources, expertise, and creativity of private sector partners. Since 2001, USAID has formed more than 900 alliances with over 1,700 distinct partners to leverage more than $9 billion in combined public and private resources. Across industry and sectors, USAID is working in partnership with both global and local corporations to increase our reach and the effectiveness of development projects.
PharmTech: Some goals of the administration and of USAID are to increase access to healthcare and treatment in developing nations, shorten the time of getting new vaccines to market (moving a 15-20 year timeframe closer to 1-5 years), and accelerating scale up of drug development. In what ways is USAID working to achieve these goals? Are there other important goals on USAID¹s agenda in terms of global health efforts?
Batson:One of the major obstacles to providing timely and quality treatment in the developing world is the inability to access health facilities. The reasons for this are many. Often times the nearest clinic is simply too far from the community where an individual lives. Other times the costs of services are too high or social norms prohibit women from seeking the care they so desperately need.
Through the Global Health Initiative, we are working to integrate healthcare services, so that when a woman travels to a clinic to receive treatment for HIV, she doesn’t have to travel to another clinic for pediatric services for her child. We are also working to train and empower community health workers who bring critical health services directly to the communities. The idea of offering health services at the community levels is critically important when you consider that 80%of people in the developing world will likely never set foot in a health facility.
The most transformative technology at our disposal, vaccines, ensures protection against killer diseases, whether children are immunized by pediatricians in the U.S. or by health workers in rural clinics in Africa. By making quality vaccines available at affordable and sustainable prices, manufacturers are contributing to an international commitment to protect more children. If we expand the coverage of existing vaccines and introduce new vaccines against pneumonia and diarrhea, we can save the lives of 4 million children over the next five years.
PharmTech: How can new drug products, including vaccines, be better introduced to developing populations? What are the key priorities in terms of advancing technology (e.g., meeting transportation or distribution challenges)?
Batson: Countries need to know how best to use data to find their greatest numbers of missed children and target those children with optimal approaches whether that means outreach, quarterly child health days, school-based approaches or targeting indigenous populations. Distribution and cold-chain challenges vary from country to country and in some larger countries, state to state. Clearly countries have identified cold chain as a rate-limiting step with regard to new vaccine introduction. The supply chain has largely been undervalued and many countries do not have an adequate record of the status of cold chain equipment, maintenance requirements and trained logisticians.
PharmTech: What can industry expect going forward in terms of working with USAID to get its new products or vaccines to developing nations? What type of assistance may be provided and what are the timeframes?
Batson: USAID is going to continue to focus on what we do best. That is we will continue to work with our partners at global, regional, and country levels to provide varying support. We work with WHO and UNICEF, as well as our other donor partners, GAVI, the Gates Foundation, and most importantly, countries themselves. USAID is not the only partner to industry with regard to getting programmatically suitable vaccines developed and used in developing countries. Together, the US government makes tremendous investments in vaccines from basic research and development to field level strengthening of immunization programs.
PharmTech: Can you talk about the large commitment the US recently made to GAVI and what this will achieve? Does USAID have any other financing programs in the pipeline?
Batson: To reiterate, one of the most transformative technologies at our disposal is vaccines. The United States' coordinated support for GAVI complements the efforts of the National Institutes of Health, the Centers for Disease Control and Prevention, and USAID in the research, development and sustained use of vaccines in robust, country owned immunization programs.
The US commitment leverages the billions of dollars that other donors have committed to GAVI, multiplying the impact of our funding more than eight-fold, and allowed GAVI to negotiate a price reduction of 67% on rotavirus vaccines so more of the world's most vulnerable people will be protected against preventable diseases.
Combined with other donors, our funding will enable the Alliance to provide countries with sufficient amounts of programmatically suitable vaccines to immunize an additional 243 million children in the poorest countries with vaccines against pneumococcal disease, rotavirus, Haemophilus influenzae type b (Hib), hepatitis B, meningitis A, and yellow fever, and ensure the complete rollout of pentavalent vaccine. Experience delivering vaccines to expanded target populations could also serve to strengthen immunization programs to put the world in a position to save more lives with potential future vaccines against malaria, tuberculosis, and HIV.
PharmTech: Once a new drug or vaccine is introduced a developing-nation market, what are USAID's goals for ensuring that the country can sustain the administration, purchase, and distribution of that product?
Bastson: We strongly support the GAVI co-financing strategy that requires all countries to make a co-payment for every dose of vaccine provided to that country through GAVI procurement. The relatively recent revisions to the GAVI's co-financing policy requires a larger payment for countries closer to 'graduation.' We want countries to be mindful of their financial obligations but we want to continue working with our partners on the expansion of the evidence base for decision making so that when countries have to make hard decisions about how to spend their money, they will realize the tremendous health impact vaccines have.
PharmTech: Many individuals seem to be opposed to global health efforts compared with say, focusing on the US healthcare system at home. What can be done to overcome this perspective?
Bastson:We recognize that global health is vital to our national security. Improving the health of people in the developing world drives economic growth, fights poverty, and strengthens families, communities and countries. Investing in the health of people in developing countries reduces the instability that fuels war and conflict. Fighting global disease directly protects our health in the United States because infectious diseases know no borders. A continued effort to communicate the value and incredible return on investment from our global health efforts will be key to maintaining this support through the uncertain economic times ahead.