World Health Assembly: WHO Carves Out Leadership Role In “Vaccine Decade”28/05/2012 by Rachel Marusak Hermann for Intellectual Property Watch Leave a Comment Print This Post With a generous pledge and a grand vision, Bill Gates launched the “Decade of Vaccines” two years ago. By endorsing a “Global Vaccine Action Plan” during the World Health Assembly last week, the world’s health authority stands as the lead agency in advancing the initiative. The 65th World Health Assembly (WHA), which met 21-26 May, endorsed the Global Vaccine Action Plan (GVAP), a broad set of objectives, goals and guiding principles to increase worldwide access to immunisation.Although member states and stakeholders widely supported the plan, some said that greater attention needed to be given to addressing the high-cost of new vaccines and that products needed to be better adapted for use in developing countries. Others called for the need to hammer out details related to governance and financial implications.Vaccine Decade OriginsThe Bill and Melinda Gates Foundation launched the Decade of Vaccines (DoV) initiative in 2010 with a $10 billion pledge “to help research, develop and deliver vaccines for the world’s poorest countries” over the next ten years. The announcement received widespread support from the global health community and the Decade of Vaccines Collaboration was created to provide oversight in advancing the Gates’ vision.Members of the Decade of Vaccines Collaboration Leadership Council include: WHO Director General Margaret Chan, Global Alliance for Vaccines and Immunization (GAVI) CEO Seth Barkley, and President of the Global Development Program at the Bill and Melinda Gates Foundation, Christopher Elias.Last year during the 64th WHA, after Bill Gates addressed the Assembly (IPW, WHO, 17 May 2011), member states called for the development of a global vaccine action plan. With input from more than 1,100 people from 142 countries and 297 organisations, the DoV Collaboration drove the development of the draft Global Vaccine Action Plan. WHA agenda item A65/22 is available here.The Global Vaccine Action Plan says that “now is the time for showing commitment to achieving the full potential of immunization.” It points to the vision for the Decade of Vaccines, which is “to extend, by 2020 and beyond, the full benefit of immunization to all people, regardless of where they are born, who they are or where they live.”The action plan outlines goals, objectives, and guiding principles, and includes an estimate of resources required to realise the ambitious vision. The goals are: to achieve a world free of polio, meet global and regional elimination targets; meet vaccination coverage targets in every region, country and community; develop and introduce new and improved vaccines and technologies; and exceed the Millennium Development Goal 4 target for reducing child mortality. Guiding principles focus on country ownership, shared responsibility and partnership, equity, integration, sustainability, and innovation.Facing Immunisation ChallengesDuring the 65th WHA committee meeting which reviewed the plan, several developing countries remarked that in order to introduce new vaccines, prohibitive pricing needed to be dealt with. In the statement from Thailand, this sentiment was underlined.“Another major structural barrier to ‘vaccine self-reliance’ in low- and middle-income countries is the high cost of new vaccines that are often monopolized. Adoption of new vaccines is not possible in resource constraint setting until a generic version of vaccines becomes available in the market, often 10 to 15 years after the first launch of new vaccines,” said the official from Thailand.To address the issue of affordability, the delegation from Thailand suggested that a strategy “to promote affordability” was needed, in particular “a range of incentive mechanisms to de-link the R&D cost and the vaccine price.”Thailand suggested that these issues could be reflected in the fifth strategic objective, which calls for immunisation programmes to have “sustainable access to predictable funding, quality supply and innovative technologies.” In this section, the action plan calls for innovative pricing and procurement mechanisms. But it does not specify the exploration of alternative options to the patent system, where the high cost of R&D is paid for through a time-limited monopoly on the exclusive rights of a vaccine, as Thailand’s delegation suggests.Other developing countries, including the African region, identified a need to address challenges in the overall healthcare landscape in order to achieve broad immunisation scale-up. Representing the African countries, the Egyptian delegation pointed to a lack of skilled workers and poor quality healthcare services.Médecins Sans Frontières (MSF, Doctors Without Borders) echoed the sentiment and provided examples of challenges in “reaching infants with even the basic package of vaccines.” Some 20 per cent of children go unvaccinated every year. MSF called on countries to address “the shortcomings of their immunisation programmes immediately.”Furthermore, MSF pointed to the need to develop products that are easier to use in developing countries. They cited a need for “adapted products that are more thermostable, easier to administer – that is without injection – and requiring fewer doses.” MSF’s statement to the committee is available here.One of the key principles of the Global Vaccine Action Plan is to place the responsibility of providing immunisations services for all in the hands of individual countries. The importance of country ownership, one of the six guiding principles of the plan, was emphasised by several public health stakeholders during a side event hosted by the International Federation of Pharmaceutical Manufactures and Associations (IFPMA) on 21 May.During the panel discussion, Ciro De Quadros, steering committee co-chair of the DoV Collaboration and executive vice president of the Sabin Vaccine Institute, said, “This has to be a country-owned program. We cannot continue anymore with activities that just come from the top down. And I think that countries are committed to that.”The Global Vaccine Action Plan also calls for the development of an accountability framework to ensure national ownership and measure progress. It specifies that starting in 2013, progress should be reviewed annually by country, the WHO regional committees, and the WHA.Calls for Further DiscussionsBut some member states and stakeholders say the plan does not go far enough in defining responsibilities and detailing action items.During the 65th WHA, on behalf of the IFPMA, Laetitia Bigger, manager of vaccines policy, said that while the industry association supports the initiative, “further efforts should be undertaken to refine the plan.”This requires clarifying interaction vis-à-vis other global vaccine programs and partnerships; prioritizing objectives and identifying opportunities for synergies amongst them; and defining human and financial resource needs and funding sources. In addition, further dialogue is needed to develop an accountability framework, which would define stakeholders’ roles and responsibilities, targeted indicators and a monitoring process,” Bigger said. IFPMA’s statement is available here [pdf].Similarly, the EU delegation, while expressing support for the action, said, “We would like to understand better the proposed governance structure which is foreseen in the action plan and how it relates to other initiatives such as GAVI.” The EU official also said there was a need for discussions on the “financial implications of it.”According to a press release issued by the Decade of Vaccines Collaboration, further implementation details will emerge as the plan is adopted at the regional and country level, noting, “Country involvement in this process reinforces a key tenet of the GVAP, which is to increase ownership of immunization programs. The collaboration will also establish a monitoring and evaluation framework and finalize estimates for funding needs as well as potential cost savings.”Related Articles:Bill Gates Calls For “Vaccine Decade;” Explains How Patent System Drives Public Health Aid World Health Assembly: IP Considerations Play Key Role In Final Outcomes Curbing Vaccine Costs Key To Extending Global Immunisation Reach Rachel Marusak Hermann may be reached at email@example.com.