The WHO’s Consultative Expert Working Group (CEWG) on R&D proposal for a new WHO Convention on health R&D has been widely praised by public health groups (See http://www.keionline.org/node/1399). The CEWG proposal for a treaty has also, at least so far, avoided much criticism from the pharmaceutical industry, even though it strongly embraces the notion of delinkage of R&D costs from product prices, open innovation, and technology transfer and capacity building in developing countries. The muted industry reaction was a consequence of the CEWG decision to narrow the scope of the proposal, along the lines of a series of WHO agreements, going back to 2003, that focused the work on the special health problems of developing countries. For example, on page 6 of the CEWG Report, it presents its terms of reference as follows:
Considering resolution WHA61.21 which requests the Director-General “to establish urgently a results-oriented and time-limited expert working group to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development related to Type II and Type III diseases and the specific research and development needs of developing countries in relation to Type I diseases .”
Type I diseases are those have have roughly the same incidence everywhere, and for which the large market in high income countries is associated with sufficient incentives to produce new products. Examples of Type I diseases would be cancer, heart disease, diabetes, asthma, etc. Type II diseases would be those with enough of a market in high income markets to induce some R&D, but for which most patients live in developing countries. The three main examples of Type II diseases are HIV/AIDS, tuberculosis and malaria (including in particular the travelers market). Type III diseases are those for which almost all patients are poor people living in developing countries, and for which there is almost no economic incentive at present to undertake commercial R&D (Chagas disease, river blindness, other “neglected tropical diseases”).
The view in 2003, and often repeated throughout the WHO negotiations on new R&D funding mechanism, was that it was too politically divisive for the WHO to tackle the R&D model for Type I diseases, where big pharma companies made most of their money, but that there was space to experiment with the Type II and Type III diseases, and for some special issues of adopting Type I treatments to resource poor settings.
In the past few weeks the CEWG and others have been testing this approach, to see if WHO country negotiators are still on board. But 2012 is not 2003, and among the many differences are (a) a major financial crisis in high income (and increasingly highly indebted high income) countries, and (b) more willingness to look at new approaches to R&D for everything. For example, the head of the European Federation of Pharmaceutical Industries and Associations (EFIPA) recently endorsed the use of prizes to reward the development of new antibiotic drugs, and the US Senate HELP committee is asking the US National Academies to study various models for de-linkage for HIV/AIDS, antibiotics and other products (See: http://www.keionline.org/node/1402). As another sign of the changing times, the Gates Foundation, which normally is closely aligned with big PhRMA companies, has recently invested the design of new innovation inducement prizes for diagnostic devices and other R&D targets.
Many high income countries are inclined to delay or oppose the R&D treaty almost entirely on the grounds that they do not want to embrace a new financial commitment that is seen largely as a new obligation to pay for health problems in developing countries. These countries are struggling with budget cuts at home and cuts in foreign development and health programs abroad. This problem is made worse, politically, by calling for a new global pooled R&D fund that would present a new funding obligation, even to countries that have historically performed well in terms of supporting such research.
One way of making the R&D treaty more acceptable to high income countries is to permit countries to meet their pooled funding obligations by choosing of several pooled funding managers (such as, for example, some of the existing PDP projects), subject to the money being spent on projects that are consistent with both global R&D priorities and also the new policies on such topics as de-linkage, capacity building and technology transfer, and to “count” the contributions that high income countries already make to such programs, so that the R&D treaty is seen as a way of leveraging these investments, and lifting the overall effort, while driving the de-linkage policies deeper into a better funded effort. But this is may not be enough for some countries.
In some informal discussions, KEI has suggested the WHO consider broadening the scope of the R&D treaty, to address more global health needs, including those not explicitly seen as a transfer of income to developing countries. In these discussions, the special problems of funding more R&D for new antibiotic drugs or products for influenza pandemics, using the de-linkage model, seems to have appeal to some governments searching for a way to explain why their tax dollars would be used to support the new treaty effort. There may be other areas where more open source/de-linkage R&D funding collaborations would have appeal, including for the development of new diagnostic tests, building upon the benefits of the open source genomic projects and other scientific advancements, or to fund independent clinical trials to test products.
The notion of broadening the mandate of the WHO R&D Convention flies in the face of the older conventional wisdom about how to make the project “attractive” to high income countries, but it may be appropriate in the current period of European and U.S. austerity measures. In the end, the R&D treaty needs to be seen as something that provides real benefits to WHO member states, including both high income and developing country members.