A group of eminent experts accused of conflicts of interest over the undue influence granted to the pharmaceutical industry, publish a report whose methodology is described as foggy and whose conclusions are criticised for being insufficiently ambitious: some of the more difficult discussions that took place at the May 2010 World Health Assembly centred on the controversial work of the Expert Working Group on research and development financing and coordination.
The Expert Working Group, or EWG, was created by World Health Organization in 2008, the result of several years of analysis and complex negotiations at WHO around the issues of medical innovation and access to medicines, which culminated in an internationally-agreed Global Strategy and Plan of Action. The EWG was charged with finding new ways to pay for, and prioritise, health research and the development of new medical products.
It was hoped the EWG would identify solutions able to address the neglected medical needs of people in developing countries and to develop new drugs, diagnostics and vaccines at affordable prices. This meant exploring the potential of innovative financing mechanisms such as prize funds, taxes on financial transactions or currency exchanges, an intergovernmental R&D treaty, Advance Market Commitments, and so on.
The EWG, however, failed to deliver – producing a report that shied away from the bold solutions needed to address the fundamental flaws in today’s predominant system for medical research. Based on patent monopolies to reward research, this is a system that leaves the diseases of the poor neglected, and prices new medicines beyond the means of millions of patients. Despite these evident and well-documented flaws in the system, the EWG report very much advocated for the status quo – perhaps, unsurprisingly, given that in late 2009 the report was leaked to the pharmaceutical industry, who stand to lose the most from any change to the system.
During the discussions at the 2010 World Health Assembly, many Member States expressed their disappointment over the shortcomings of the EWG’s work. Countries objected to the failings in the process adopted by the EWG, particularly the conflicts of interests of some of the EWG members. Member States also criticized the content of the EWG report, as its conclusions failed to address the impact of intellectual property on access to medicines, and ignored the need to explore financial mechanisms that can overcome the problems posed by a patent-based system for R&D. The agreement reached by Member States to move forward from this low point was encouraging. Thanks to a new Resolution putting things back on track, a new Consultative Expert Working Group (CEWG) on R&D Financing will be established, with strong oversight by Member States and strict rules on transparency and conflicts of interest. The CEWG will examine ambitious proposals, some of which are supported by MSF, that de-link the cost of R&D from the price of products. There is also renewed interested in looking at whether new global rules are needed to encourage new approaches such as an R&D treaty. These proposals had previously been dismissed by the former EWG, but were reintroduced on the insistence of several developing countries.
“We are very pleased,” said Michelle Childs, Director Policy Advocacy at the MSF Access Campaign. “This is a very good Resolution. The Member States have recognised the limitations of the EWG report - in terms of process transparency and substance - and have put in place measures to address these. Crucially they have addressed the fact that the EWG did not look at proposals to stimulate research and development against the principle of delinking the cost of research from the price of the product.”
“This is explicitly recognised as a key principle and they have restored the exploration and promotion of innovative proposals that allow delinking, such as the proposals from Bolivia Barbados, Bangladesh and Suriname, including a prize fund for a much-needed tuberculosis point-of-care diagnostic.”
“The Resolution also says that in the long-term, proposals that allow for sustainable change should be looked at. One of these is the R&D treaty - in 2009, the World Health Assembly said discussions on an R&D treaty would not be continued. Today, the WHA has mandated Member States to do just this.”
This is a considerable step forward, as after the debacle of the EWG, a new process for examining medical R&D financing proposals has been set up, under strong oversight by Member States, with an ambitious remit, and free from conflicts of interest.