EWG: falling short of mandate?

Daniele Dionisio
Coordinator, “Access to Drugs: International Policies” - CLIA (Italian Network for International Fight against AIDS).
Advisor, “Availability of Drugs in the Developing Countries” - SIMIT (Italian Society for Infectious and Tropical Diseases)
Director, Division of Infectious Diseases, Pistoia Hospital, Pistoia, Italy
Tel: 0039-0573-352324; Fax: 0039-0573-352309; E-mail: d.dionisio@tiscali.it

The newly released EWG Executive Summary document http://apps.who.int/gb/ebwha/pdf_files/EB126/B126_6Add1-en.pdf looks like it would fall short of the Group mandate.
Indeed, analysis is lacking with regard to key proposals (including UNITAID patent pool, Health Impact Fund, Priority Review Voucher, Orphan Drug legislation models,....) aimed to address diseases that disproportionately affect the developing countries. While this omission sounds hardly understandable in the face of unquestionable public health needs, additional concern arises from careful examination of the entire report.
The report lacks originality as it almost literally repeats already established, assessed or agreed results, considerations and requirements. Amongst them: 1), the need for incentive structures to stimulate Research and Development (R&D) when there is no market or there is market failure in the production and diffusion of knowledge, 2) the internationally actual predominance of funding dedicated to non-communicable diseases, 3) the absence of global coordination of research and development for diseases generally and less so for Types II and III, 4) the awareness that tax mechanisms would provide greater results and certainty than voluntary contributions, 5) the awareness that Product Development Partnerships (PDPs) play as a major consolidator of public funding, investment risk, and global coordination of research and development in their given field, while offering high developing-country health impact and operational efficiency as the only mechanism that successfully stimulates early and ongoing involvement of multinational corporations, 6) the modest performance of direct grant developed country-based schemes, since they do not clearly and specifically target developing country needs and define developing country-relevant outputs, 7) the practical scope, value and limits of prize and advance market commitment models, 8) the lack of purchase agreements-bound mechanisms to decrease the price of new products, particularly if there is limited or no competition with similar products.

Additionally and intriguingly, the entire report looks like it would encounter multinational drug corporations' agreement as it avoids doing analysis of proposals/models felt as a threat to the brand industry interests. This would especially be the case for the UNITAID-endorsed patent pool model for newer medicines for HIV/AIDS epidemics (antiretrovirals-ARVs). Actually, as ARVs development remains profitable for the Western market, brand industry still perceives patent pooling for ARVs as a minefield that would offer the generic competitors lots of deeply exploitable opportunities, to the detriment of patent owner’s rights.

It is disappointing that the EWG report lacks patent pool analysis now that in low- and middle-income countries, 5 million ARVs-needing people (three quarters in sub-Saharan Africa) are still waiting for, while only 277 000 children (38% of those in need ) are benefiting from paediatric ARV treatments (http://www.who.int/hiv/pub/2009progressreport/en/index.html).

These figures alert to the fact that patent pools for ARVs are urgent matter: full availability of second/third line fixed-dose combination ARVs resulting from patent pools is top priority for the worst-off in the developing countries. Attaining this goal would counter bitter reality witnessing that ARVs are primarily developed for wealthy country markets, while trials are focused on coping with registration requirements in these countries and key research matters for resource-constrained populations are often only tackled long after drug registration and rolling-out in the Europe and USA.

That's why the UNITAID board on December 14, 2009 formally approved a patent pool model for AIDS medicines as the pre-requisite for the creation of the legal entity to manage and implement it (http://ictsd.org/i/news/bridgesweekly/66525).

Actually, the patent pool analysis giving up by the EWG lacks clear explanation, while evoking the already alleged responsiveness of the WHO EWG to industry lobbying (http://www.keionline.org/print/718) .