MSF Statement on the WHO Consultative Expert Working Group on Research and Development at the 28th PAHO Pan American Sanitary Conference
Speaker: Judit Rius, US Manager of the MSF Access Campaign
MSF would like to thank PAHO and its Member States for the opportunity to share our perspective on this important discussion. As a treatment provider implementing medical humanitarian operations in nearly 70 countries, MSF welcomes the report of the CEWG that has built on a decade’s work at WHO on the need to address the problems of medical innovation for developing countries. That the current research and development (R&D) system fails to deliver for the developing world is a problem that MSF cannot ignore. All too often, the diagnostic tools, medicines or vaccines we need on a daily basis are unsuitable, unaffordable or simply unavailable.
Undoubtedly, there has been progress in the last 10 years, with a few new products launched and promising ones under development. But progress is fragile and ad hoc, financing is not secure, R&D priorities are not clearly defined, and there is an overdependence on donor philanthropy and corporate social responsibility. Affordability is also an issue, with price barriers an intrinsic feature of today’s R&D system. With increasingly globalized intellectual property standards, access barriers for many countries in the Americas are growing. Voluntary initiatives to overcome these barriers for newer medicines have largely excluded many countries in the Americas. Countries are usually paying exorbitant prices for the newest drugs. The high price of newer vaccines is another area of concern.
These problems stem from the current system for drug, diagnostic and vaccine development, which is predominately driven by commercial rewards rather than health needs. With the costs of R&D being recouped primarily through high product prices. MSF shares the CEWG assessment that the principle of de-linkage - separating the cost of R&D from the price of products - is key to ensuring access and, as such, should be included in the Convention’s principles. A guiding principle for Member States and an objective of this negotiation should be to build R&D norms that ensure affordability and access are addressed from the beginning of the innovation process.
The CEWG report made a number of other recommendations, including establishing an Observatory to better monitor and coordinate R&D efforts. This is important, but it is not new. As early as 1990, calls for better coordination resulted in the creation of several initiatives with a mandate for coordination. However, as stated by the CEWG itself, experience shows that ‘work on priority setting not linked to downstream decision-making processes regarding funding may have too little impact in achieving coordination.’
The report’s central conclusion is that in order for these mechanisms to be successful and for sustainable and significant progress to be made, there is a need for an overarching framework: a binding convention. MSF believes the CEWG report has rightly concluded that there is a need for multilateral action. We believe the main functions of an R&D Convention should be:
- To establish an evidence-based and inclusive process that sets the priorities for medical R&D;
- To link these global priorities to adequate and sustainable financing; and
- To create global norms that ensure money is used to stimulate R&D in the most effective way and that the results of R&D are accessible and affordable to all in need
As for the nature of the multilateral instrument, CEWG recommends a binding convention. Experience demonstrates that soft norms alone are not enough and that binding norms are needed. There are binding laws to protect and enforce the interests of private right holders in the TRIPS Agreement and in other trade and investment agreements. Binding norms are needed to provide a framework to support R&D initiatives and secure access to and affordability of the fruits of public research.
As for next steps – it is for Member States to decide on the exact types and levels of commitments that are needed and how they will be enforced. Some countries in the region are demanding this level of detail in an attempt to delay the process. We do not believe countries have to reach consensus on all the issues under discussion before starting negotiations. As negotiations on other conventions have shown, some detailed issues may be saved for later protocols, including the level of financial commitments, targets and the role that institutions should play. The most important step at this stage is for countries to agree on the start of the negotiation process and to start focusing on possible objectives, principles, scope and functions of this global instrument in preparation for the WHO November meeting.
In conclusion, MSF agrees with the main CEWG recommendation that, “on balance we consider that the time has come for Member States to begin a process leading to the negotiation of a binding agreement on R&D relevant to the health needs of developing countries.” After more than 10 years of discussions, we cannot wait longer. We need collective action and leadership from WHO, PAHO and from Member States.
Thank you