In November, 2008, the WHO had established an Expert Working Group on R&D Financing (EWG) for examining the existing financing and coordination of R&D and for reviewing proposals for new and innovative sources of funding to stimulate R&D related to diseases designated Type II and Type III and to identify the specific R&D needs of developing countries in relation to Type I diseases. Consisting of 24 experts and policy makers, the EWG is supposed to submit a final report to the World Health Assembly in May 2010. However, recently on June 30, 2009, 9 NGOs have sent a letter to the EWG that addresses issues about transparency, conflicts of interest, and EWG outcomes. A perusal of this letter may create the impression that EWG may not have been entirely living up to expectations as far as its work is concerned, especially with the U.S. Government and the Northern European countries favouring the pharmaceutical industry and the Gates Foundation tending to protect pharmaceutical giants and showing ideological leaning towards strong IPR.
Regarding the issues of transparency and balance, the said Letter points out the absence of any publicly available procedures outlining EWG’s conduct, like how the EWG Meetings are supposed to be held and how those attending the same would be governed. The meetings held by EWG are mostly non-public in nature, and the first meeting in January, 2009 was held without advance notice and featured attendance and presentations from selected stakeholders only, including the pharmaceutical industry, the Gates Foundation and several groups funded by the Foundation. The Letter alleged that such groups generally share similar views and collectively represent the status quo and that those in opposition were not given any chance to make their views heard. Moreover, EWG evaluates proposals in a secretive manner, especially regarding the identity of consultants hired, the proposed criteria, as well as its own meeting schedules and agendas. While the NGOs acknowledged EWG’s need to keep the proceedings of some meets confidential, they felt a need for greater transparency in the approach to obtain stakeholder input. Alternative models such as the public sessions held by the CIPIH had been suggested to address such concerns.
Next comes the point of conflicts of interest and lack of any guideline governing EWG’s response to the same. This issue assumes all the more significance owing to the differing opinions advanced pertaining to EWG’s area of functioning. With the pharmaceutical industry, product development partnerships and academic and other non-profit research institutions all vying to receive grants for medical R&D, there exist obvious incentives to skew EWG outcomes to favour separate institutions. The Gates Foundation also presents another quandary regarding conflict of interest, being a primary source of R&D funding on the one hand and supporter of policies clashing with some of the most controversial reforms explored in the CIPIH and IGWG processes on the other. Mention has also been made of the proposal to engage the George Institute to undertake a comparative review of alternative incentives, which will include the establishment of a stakeholder network. In at least one draft, this network would consist of 9 pharmaceutical companies and trade associations, 8 organizations that consist of the Gates Foundation or research organizations funded by the Gates Foundation, 7 government agencies from OECD countries, 5 government agencies from developing countries, and only one NGO critical of the status quo. Such a network, according to the NGOs would incorporate an unacceptable lack of balance, have many conflicts of interest, lack legitimacy, and be highly unlikely to recommend anything that would represent significant changes. The Letter urges EWG to recognize such potential conflicts and adopt policies in accordance thereto.
In addition, the Letter also puts forth a series of recommendations regarding the standards that a proposal in the EWG process ought to aspire to, following the same line as the CIPIH report and the Global Strategy and Plan of Action. According to the NGOs, sustainable systems of finance for medical R&D, including both sources of funding and possible incentive mechanisms, should be:
2. cost effective, and
3. ambitious enough to address real needs for innovation, and
4. include government funding,
5. require, when possible, open licensing of inventions and other IPR in developing country markets,
6. encourage or require open access to data, material and knowledge,
7. foster the transfer to and development of technology in developing countries,
8. condition financing to requirements for access,
9. promote a range of incentive schemes for research and development including addressing, where appropriate, the de-linkage of the costs of research and development and the price of health products,
10. when possible ensure sustainable and competitive supply of products from generic producers in developing countries, and be
11. accountable to governments and democratic processes.
Mention has also been made of the Biomedical R&D Treaty, which has been prescribed in the recent World Health Assembly to form a part of EWG’s consideration. The NGO’s especially stressed upon the importance of EWG’s review of the proposals made for future discussions regarding said treaty, including whether to consider recommending that the WHA revisit the question of the WHO role as a stakeholder in aforesaid discussions.
The NGO representatives, who have authored the aforesaid letter, include Jonathan Berger, Senior researcher and head of policy & research in the AIDS Law Project, South Africa; Dr. Oscar Lanza V. Coordinator of AIS Bolivia; Luis Villarroel, Director of Research in the Latinoamerican Centre of Intellectual Property Research for Development, CORPORACION INNOVARTE; Robert Weissman, Director of the Essential Action; German Holguin, Director General of the Fundación Misión Salud, Colombia; Tim Reed, Director of the Health Action International; Francisco A. Rossi. B., Director of the Fundación IFARMA-AIS Colombia; James Love, Director of the Knowledge Ecology International and Ethan Guillen, Executive Director of Universities Allied for Essential Medicines.
For text of the original letter, one may refer to the following link:
The author thanks Malini Aisola from Knowledge Ecology International for informing SPICY IP about this interesting letter. KEI, a renowned organization that seeks to provide solutions to the management of knowledge resources, undertakes and publishes research and new ideas, engages in global public interest advocacy, provides technical advice to governments, NGOs and firms, enhances transparency of policy making, monitors actions of key actors and provides forums for interested persons for discussion, has already reported the matter in their own blog and was among the NGO-s who had begun this laudable initiative in the first place.