There was high drama at the World Health Assembly this year as WHO member states fought over a compelling new proposal that could help the development of newer and better drugs, vaccines and tests for patients in developing countries.
The proposed convention was the main recommendation put forward by a WHO expert report that arose from a ten-year deliberation process on how to set right the skewed priorities of the current R&D system that sees multiple new products developed each year for people in developed countries – but pays very little attention to the diseases that hit people in poor countries hardest.
Michelle Childs, Director of Policy & Advocacy at the MSF Access Campaign, explains in greater detail what occurred during the WHA with R&D and what happens next.
Q: The new proposal comes after a decade of deliberations and is included along with other recommendations handed to WHO member states – what are the key recommendations from the WHO expert report?
The central thrust of the report is that a sustainable solution for R&D must be found that will make sure that the medical needs of people in developing countries are prioritised and adequately funded. The report reviews a number of different proposals for stimulating R&D and ultimately concludes that for these to be successful, an overarching framework is needed to set priorities, secure funding and at the same time make sure that new vaccines, drugs and tests are developed in a way that the final products are adapted to the needs of and made affordable for these communities.
Q: So how would the proposed convention provide such a framework and how would it work in practice?
The fine details remain to be worked out by the countries that will draw this up, but the convention would be binding so all governments would be required to contribute financially to support R&D in key priority areas and to ensure that the research they are funding leads to medical tools that are affordable and accessible.
Crucially the convention would be designed so as to separate—or de-link—the cost of R&D from the price of medical products, so that these are made affordable. The present model of R&D means that currently those investment costs have to be paid for by charging high prices for the final product.
Q: Why are these negotiations important to MSF?
Every day MSF field teams grapple with the fact that the drugs, diagnostics and vaccines needed to treat patients are unavailable, unsuitable or unaffordable. Governments ultimately have the responsibility and power to help alter this and create a sustainable global framework. A convention could speed up the development of drugs, diagnostics and vaccines designed for the medical needs of people in countries where we work and similar contexts.
For example: no new TB drugs have come to market since the 1960s. The current drug pipeline will not be able to produce the number of new drugs needed to eliminate TB. More effective treatments for drug-resistant TB are needed and for the rising number of children who are infected with drug-resistant TB, where no paediatric formulations of drugs exist. There is a need for new treatments and diagnostics for kala azar, Chagas disease and sleeping sickness; and for vaccines that do not need to be refrigerated or can be given without an injection.
Q: What actually happened at the WHA – why did the proposal seem to stall?
There were extremely tough negotiations with the US, the EU — led by France — and Japan making every effort to block progress on what health experts agree should be the way forward to meet the medical needs of people in developing countries.
Four resolutions in all were put forward in a very short space of time – with conflicting aims – developing countries such as Kenya and Latin American countries supporting the idea of the convention and wealthy countries opposing. People are calling it the ‘Battle of the Resolutions’! To give you some idea of the drama involved, at one point the idea was completely dropped and yet 24 hours later it was back on the table. Finally a compromise solution was agreed.
Q: What is the compromise solution and what happens next?
The outcome of that battle is that member states have agreed to a process for reviewing the report’s recommendations alongside other proposals that could lead to concrete proposals and actions. There will be consultations held by governments at the national level as well as discussions at the WHO’s regional meetings this summer. Following that, the WHO will convene a meeting open to all WHO member states to take place in Geneva in October or November of this year. This meeting will build on the outcomes of the national and regional meetings and provide countries with the opportunity to analyse thoroughly the recommendations of the report, and ultimately develop proposals for research coordination, financing and tracking R&D expenditures.
From there, these proposals will then go formally to the WHO Executive Board in January 2013- a delegated board of member states- who will then determine how this will be followed up on the agenda for the next World Health Assembly in May 2013.
Q: What happens meanwhile?
We hope the national and regional meetings will give a number of those developing countries who have shown interest in the concept the time they need to build the necessary support and momentum to really drive the report’s recommendations forward.
I also think it is an opportunity for the US and others who were so intransigent in these negotiations to reflect on the reality that we still need a global solution to the lack of R&D for people in developing countries. Their attempts to derail, water down or delay this weren’t acceptable and this does give them an opportunity to delve deeper into these issues. The issue will not go away. The present approach is too ad hoc and fragile. The report made a clear and compelling case for a global framework to set R&D priorities, secure adequate funding and ensure the products are affordable and accessible. The onus is on them to demonstrate how this problem will be addressed. More of the same is not a solution.
Q: What has MSF’s reaction been to these events?
We are disappointed we didn’t see an immediate decision to move forward on this binding agreement, but we are encouraged that a process was agreed upon and is still advancing. We will continue to document through our own experiences in the field why a new convention is necessary to deliver the quality medical tools we need in order to give our patients the best medical care.