Médecins Sans Frontières & Oxfam Consultation
26 January 2010, Geneva, Switzerland
Improving access and stimulating vaccine development for use in resource-poor settings
Consultation summary Introduction
Goals and objectives of the meeting
Introduction by Dr. Tido von Schoen-Angerer, MSF Access Campaign
- Médecins Sans Frontières (MSF) and Oxfam are in the process of developing new policy positions on vaccines. Outbreak response has always been a particular focus for MSF but the organisation is also highly committed to the introduction of new vaccines.
- There has been progress in increasing vaccine coverage and introduction of vaccines for Hepatitis B virus (HBV) and Haemophilus influenza type B (Hib) in recent years.
- Nevertheless, there are considerable limitations to the current model: new vaccines are not sufficiently affordable nor sufficiently adapted to developing country needs.
- The GAVI Alliance (GAVI) is facing an important financing shortfall which makes the issue of vaccine prices all the more important. Collective bargaining power, e.g. through the Pan-American Health Organization (PAHO) is no longer proving sufficient to achieve affordable prices for new vaccines.
- To address these challenges, significant adjustments and changes to current system might be necessary.
Meeting Conclusions Access to newer vaccines:
Lessons learnt in the past decade with attempts to introduce new vaccines in developing countries:
- The impact of competition to achieve price reductions, although very effective for EPI vaccines, has not yet been realised for the newest vaccines.
- Experiences with tiered pricing have so far been mixed and have not led yet to sustainable prices whether in low- or in middle-income countries, particular for new vaccines.
- Predictable demand alone is not leading to sufficiently reduced prices.
- The price of vaccines has in the past been a neglected question, owing to an assumption that the donor community would foot the bill for rising costs.
Implications on the GAVI model:
- Price reductions on newer vaccines such as PENTA, pneumococcal and rotavirus have been disappointing. There is an urgent need to try new strategies to bring down prices.
- The combination of high prices for newer vaccines and the dramatic downturn in funding commitments partly caused by the global economic slowdown means that GAVI is today facing a dramatic funding shortfall.
- Given the price of the newer vaccines the current country co-financing only represents a small fraction of total vaccine costs.
- GAVI’s current co-payment mechanism fails to create a market for more affordable vaccines: The country co-pay is the same for the most expensive and complex vaccine as for a cheaper but still adopted one. This is an aspect of the current model that needs to be revisited.
- Without significant change, the current system is not sustainable.
Setting priorities for vaccine funding and introduction is a major question today:
- GAVI’s financing shortfall is forcing a new prioritisation process.
- Upcoming decisions on priority setting will raise difficult governance issues on who will decide; developing countries themselves should have an important say.
- Decisions should also be guided by a list of “essential vaccines”. It will not be defendable to introduce new vaccines and leave, for example, measles insufficiently funded.
- Prioritisation at the global level will have to leave room for countries to make their own decisions based on local epidemiology fed by adequate surveillance.
Development and manufacture of adapted and affordable vaccines:
The current, market-based R&D system fails to address the need for improved, cheaper and more suitable versions of existing vaccines:
- Examples include rotavirus and pneumococcal vaccines, and more generally heat-stable vaccine technologies.
- Nor has GAVI addressed this gap
There is currently an opportunity to expand R&D and manufacturing capacity in developing countries. However, a number of mergers and acquisitions have taken place that raise the question for how long developing country manufacturers will remain independent from traditional manufacturers.
Greater investment into not-for-profit R&D is needed to meet the needs of developing countries.
- The success of the PATH/WHO partnership model in Men A could be replicated.
- WHO’s role is important because of its legitimacy in priority setting
- GAVI’s new strategy, currently undergoing redefinition, includes measures to encourage competition, better leverage price reductions, and support development of new or adaptation of existing products. Greater engagement of GAVI in this area will be needed to achieve its mission and for its own survival. It was however recognized that GAVI cannot become a core player in vaccine development.
- The creation of a new R&D entity needs careful analysis of pros and cons.
Technology and know-how transfer is key to shortening the time needed for competitive products to reach the market.
- A number of technology transfers of developing country-relevant vaccines have been performed successfully. The traditional thinking that transfer of technology must be a down stream approach, starting with fill/finish has not proven to be true – the case studies presented do not support that other models are not viable. The traditional approach tends to transfer a piece of non-critical know-how technology only.
- The technology transfer hub approach which uses technology and training platforms as an alternative to individual provider–recipient relationships has been used successfully in the context of the influenza vaccine. The technology transfer hub is a key concept that could be replicated for additional vaccines and taken to greater scale. The different technical and financial challenges for each vaccine would need to be considered.
- Publicly-owned or funded institutes provide an ideal base for a technology transfer hub. EU-based vaccinology institutions could collaborate in such an effort. Yet recent trends appear to be making this collaboration less likely, as evidenced by the decision by the Dutch government to privatize the Netherlands Vaccine Institute.
- When investing in technology transfer, intellectual property should be dealt with simultaneously.
IP needs addressing. Additional efforts to analyse, prevent or remove patent barriers are needed, including open licensing policies on the parts of universities and government research bodies and the use of TRIPS flexibilities when appropriate.
Regulatory requirements, for example through the WHO prequalification are one of the mechanisms to ensure that vaccines meet needs of developing countries in terms of presentations and serotypes.
Funding mechanisms for R&D should include both push and pull approaches, provide long-term predictable support and aim to ensure affordable products. To download the full summary of the MSF-Oxfam consultation, please click here
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