4th Global Meeting on Implementing New and Under-utilized Vaccines, 23-25 June 2010
Crucial Conversations: Vaccine access and R&D - Opportunities, challenges, and the people behind the ideas
Background
Expanding access to new vaccines requires a multi-pronged approach involving a wide range of stakeholders at the global and national levels. The last decade has seen several advances that have led to improvements in accessibility to and affordability of new vaccines, including the inception of the GAVI Alliance, commitments to tiered pricing by manufacturers, innovative financing, such as the Advanced Market Commitment, to name a few. Building on the momentum from some of these earlier innovations, more can be done to further improve access to life-saving vaccines in the future.
One aspect that has received considerable attention is the role of vaccine research and development, including the contributions of multinational and emerging country manufacturers to improving access. Over time, many ideas have been put forth that have elements of both push and pull designed to incentivize manufacturer’s willingness to address the challenge of access. A recent report jointly released by Oxfam and MSF outlined several possible opportunities for increasing access to new vaccines through R&D based mechanisms.
Moving from ideas to practical, effective solutions requires that various stakeholders work together in a spirit grounded in common purpose and intent. The first step is for stakeholders to engage in a dialogue.
Main Topics of Discussion
- Assumptions have been made that if vaccine prices come down, there will be donors to pay for them but that has not turned out to be sufficient.
- Generally, there has been a separation between the work of shaping the product and the work of implementing what products we have. In contrast, the MenA project was a good example of identifying what was needed first and developing the product needed.
- There is no single answer on how to lower prices. Successful organizations are ones that deal with complex issues but not by oversimplifying them. Tier pricing allows lowest possible prices to lower income countries. If only focus on price, may have unintended consequences on investment on new products in the future or maintaining safety.
- It was noted that GSK has an abendazole donation program and Merck has an ivermectin donation program, so drug donation programs for developing countries exist - what is the role of vaccine donation programs for countries to expand access? Both panellists felt vaccine donation program have a role for limited purposes but felt they were not a long-term or comprehensive solution for sustainability and could undermine development of competitive markets.
- Creation of a competitive market requires companies with know-how and ability to enter the market as well as market predictability to reduce risk for investment to develop a vaccine.
- Costs of producing a vaccine include the costs of the failures that occur before one has a successful product and the high burden of regulatory requirements which need to be met.
- Companies are very sensitive to costs and try as much as possible to reduce costs by having collaborations such as tech transfers and production in less expensive locations. But any time a product is changed, there is a new expense to meet regulatory requirements. It would actually be cheaper for industry to have more standardization (e.g., VVMs on all products) but countries often don't want the same products, so industry can only standardize to a certain degree.
- Value-based pricing is a black box for countries but further transparency could be seen as dangerous by companies; it is not clear what the middle ground is for appropriate vaccine pricing.
- The Clinton Foundation has been very successful with HIV drugs with regards to assessing costs and reasonable prices. How was this accomplished? Per CHAI, they learned that every market is different when they moved from antiretroviral (ARV) drugs to the malaria drugmarket. CHAI achieved 60, 70, 80% reductions in costs when ARV manufacturers were willing to open their books and be transparent about costs. For malaria, this approach with transparency almost caused a massive loss of manufacturers from the market place and this would have lead to disappearance of supply.
- With big pharmaceutical companies purchasing developing country manufacturers as with Sanofi buying up Shantha, how much competition really exists?
- For PCV, there was a cost of goods analysis done although it may not have contributed much to AMC pricing.
- There is a lot of intense activity occurring to define preferred vaccine product profiles to shape the products we have.
- When vaccines were developed and produced in the public sector, cost of production plus a margin was reasonable as a vaccine price. Now that governments have left vaccine production to private sector, this approach to pricing may not still be possible. A solutions-based approach was attempted through the ADIPs where cost at which producers were willing to produce and at which countries were willing to purchase were reviewed. That approach to pricing may no longer be possible, either.