WHO MEMBERS DIVIDED OVER PLAN FOR PROMOTING PHARMACEUTICAL INNOVATION

The World Health Organization (WHO) last week made public member governments' written comments on the development of a global strategy and plan of action for research and development on diseases that disproportionately affect poor countries. Differences persist, even though countries are scheduled to wrap up their discussions in the autumn.

To date, nineteen countries and regional groups have submitted their views on the initial draft texts drawn up in December 2006 by the Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property (see BRIDGES Weekly, 13 December 2006).

Created by WHO members in 2006, the new working group is mandated to draw up a medium-term framework to support sustainable, needs-driven, essential medical research and development (R&D), in accordance with the findings of the global health body's Commission on Intellectual Property Rights, Innovation, and Public Health (CIPIH). Some see the group's deliberations as an opportunity to explore alternatives to drug patents as a means of encouraging innovation and the development of new and affordable drugs.
The working draft of the IGWG's plan of action has attracted a wide range of recommendations on topics including the strengthening of innovative capacity, transfer of technology, management of intellectual property, and financing mechanisms.

The sharpest division between governments relates to the WHO's role in dealing with international intellectual property rules, particularly the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Especially controversial was whether the action plan should deal with promoting the use of legal flexibilities in the TRIPS Agreement which make it easier to bring generic drugs to market and are widely considered to be crucial to the affordability of medicines.

Brazil suggested that many IP-related matters deserve increased attention, such as the full implementation of TRIPS flexibilities, ensuring the immediate entry of generic medicines into markets following patent expiry, and improving the patent approval process. It suggested "mapping out the various flexibilities provided for in international agreements that might be relevant to ensure access to medicines."

Malaysia called for a "re-evaluation of the current (IP) system with emphasis on ensuring that public health needs are not adversely affected by strong intellectual property rights."

At the same time, several developed countries argued that the TRIPS Agreement and IP rules in bilateral trade agreements fell "outside the mandate of the WHO." The US indicated that the IGWG should not consider several specific issues present in the current draft action plan, including topics such as legal flexibilities in the TRIPS, bilateral trade agreements, compulsory licensing, and provisions encouraging generic entry upon patent expiry. It said that they were more appropriate to the scope and mandate of the WTO and the World Intellectual Property Organization (WIPO).

Australia said that it "cannot accept any binding proposal that bilateral agreements not contain 'TRIPS-plus' provisions," which entail IP obligations beyond those required by the TRIPS Agreement. Further, it endorsed a proposal for cooperation with WIPO, the WTO, and other international bodies "taking into account their mandates."

Other controversial issues included alternative financing mechanisms for promoting pharmaceutical innovation. One such proposal seeks a global treaty that would have governments fund medical R&D and then make the findings public, allowing drugs thus produced to be manufactured and sold cheaply since there would be no research costs to offset. Another mechanism envisions the collective management of intellectual property rights through patent pools. A third model would be based on 'prize funds', and would give innovators monetary awards tied to improvements in healthcare outcomes.

Bangladesh proposed that the IGWG consider the prize fund model, noting that its separation of incentives for innovation from drug prices would ensure low prices for medical inventions. The country also backed calls for giving the proposed R&D treaty formal consideration. In contrast, the US submission stated that it does not support any new funding mechanisms. Japan recommended use of existing mechanisms to promote R&D efficiently.

A submission from Iran suggested that innovative new health related products should be shared between developed and developing countries, in order to counteract the "brain drain" caused by developing country scientists who emigrate and contribute to the development of innovation in industrialised countries. A paper from the US, on the other hand, held that developing countries should "strengthen their own human resources," and address the migration of health professionals in a manner that respects the freedom of individuals to emigrate and build a better life for themselves and their families.

One underlying theme in the submissions was the need for more information and best practices about innovation promotion. The EU wants more background information on the elements of the action plan, and raised questions about impediments at the national and international level to investment in R&D, as well as options for improving policy coherence. Thailand called for the compilation of "good practice and lessons on the implementation of TRIPS flexibilities," noting that experience sharing would be very useful for cross-fertilization among developing countries. The US suggested that the WHO collaborate with WIPO to compile and disseminate best practices to improve health-related innovation.

Ellen 't Hoen of Médecins Sans Frontières told Bridges that the IGWG process had thus far focused on procedures, and lacked discussion on substance. Now, member states were debating concrete proposals.

Spring Gombe and Thiru Balasubramaniam of Knowledge Ecology International praised countries including Bangladesh, Bolivia, Iran, Norway, India, Thailand, and East Timor for showing "great leadership in recognising the need for examining new methods of stimulating research and development, pledging their support for the prize system as a method for rewarding R&D in lieu of high drug prices." They also expressed hope that the African countries, which had played a leading role at the inception of the IGWG process, would make new submissions in light of the issue's importance to them.

The Secretariat will incorporate countries' comments on the current draft text into a revised version by July. The IGWG is scheduled to meet for its final session in November 2007. In principle, the final plan of action should be ready for adoption at the May 2008 session of the World Health Assembly, the WHO's top decision-making body. Bangladesh and Bolivia have expressed concern that there is simply not enough time for the IGWG to complete its work by then, and called for a one-year extension to 2009 (see BRIDGES Weekly, 7 March 2007).

Documents relating to the IGWG, including the country submissions are available at: http://www.who.int/phi/en/

ICTSD reporting.