WHO MEMBERS ADOPT RESOLUTION ON PHARMACEUTICAL INNOVATION

Intellectual property issues were prominent at the World Health Organization's annual summit in Geneva from 14-23 May. After extensive negotiations, member states adopted a last-minute resolution based on a Brazilian proposal calling for the global health body to take on an expanded role in encouraging health research and access.

The resolution on "Public Health, Innovation and Intellectual Property" was adopted at the closing plenary of the 60th World Health Assembly, which is the supreme decision-making body of the WHO's 193 member states. However, the US made a statement to disassociate itself from the decision.

The resolution largely refers to the role of the WHO secretariat in supporting the work of a working group charged with developing a framework for supporting sustainable, needs-driven, essential medical research and development (R&D). Brazil said its proposal was designed to give better "stewardship" to the Intergovernmental Working Group on Public Health, Innovation, and Intellectual Property (IGWG) process, which some see as an opportunity to explore alternatives to drug patents as a means of encouraging innovation and the development of new and affordable drugs for diseases that disproportionately affect developing countries. The IGWG was set up last year to negotiate a global strategy on essential health research based on the recommendations of the WHO Commission on Intellectual Property, Innovation, and Public Health (CIPIH) (see BRIDGES Weekly, 31 May 2006).

Chilean delegate Maximiliano Santa Cruz said the resolution will "provide new impetus to push the process forward." It was valuable to reiterate prior commitments, and "to have the secretariat on board," he said.

Notably, the resolution requests the WHO secretariat to help develop proposals on "a range of incentive mechanisms for addressing the linkage between paying for the cost of R&D and the prices of medicines, vaccines, diagnostic kits, and other health care products." Sources report that Brazil and others had originally put forward language referring to the explicit separation of R&D costs from drug prices, which was supported by Canada, Chile, and Norway, But objections from the US, Japan, and the EU eventually led to this compromise, suggested by Switzerland. Chile's Santa Cruz said it was a "good resolution" because initial negotiating positions had been "worlds apart."

In addition, the resolution requests the WHO secretariat to provide "technical and policy support to countries that intend to make use of the flexibilities contained in the [WTO] Agreement on Trade-Related Aspects of Intellectual Property Rights [TRIPS] and other international agreements." In theory, this would see the WHO taking a greater role in the interpretation of TRIPS flexibilities, such as compulsory licenses to temporarily override drug patents, to promote health.

The resolution also asks for further WHO support for "regional consultative meetings in order to set regional priorities that will inform the work of the IGWG." At a technical briefing on the IGWG at the Assembly on 17 May, concerns were raised about the level of participation of African and Latin American countries in these consultations, which IGWG Chair Peter Oldham of Canada described as "absolutely critical". IGWG Vice-Chair Ahmed Ogwell, head of international health relations at the Kenyan health ministry, said "the process is not running well in our part of the world," and appealed for support for consultations in Africa.

At the briefing, WHO Director-General Margaret Chan said she had been struck by the complexities involved in the IGWG but that she was increasingly aware of the importance of intellectual property rights to member states. Sources said her comments were greeted by delegates following doubts about the WHO secretariat's commitment to the IGWG process.

Assistant Director-General Howard Zucker also clarified that the IGWG could be extended beyond its current timeframe, which calls for the group to prepare a strategy and plan of action in time for next year's World Health Assembly in May 2008 following a final meeting this November. "We take our cues from member states on these items," he said, in response to members' concern that divergence among their submissions made agreement unrealistic by then (see BRIDGES Weekly, 25 April 2007).

At the summit's closing session, Chan added, "I am fully committed to [the IGWG] process and have noted your desire to move forward faster ... We must make a tremendous effort. We know our incentive: the prevention of large numbers of needless deaths and suffering."

Resolutions on Malaria, Avian Flu and Children's Medicines

The World Health Assembly also dealt with the relationship between intellectual property and public health in resolutions negotiated on avian flu, malaria, and medicines for children.

A last-minute resolution was agreed on the 'Sharing of Influenza viruses and access to vaccines and other benefits', proposed by Indonesia for a "transparent, fair and equitable sharing of benefits" from vaccines developed from virus samples. The country's Health Minister, Siti Fadillah Supari, explained its decision to suspend sample-sharing of the H5N1 bird flu virus with the WHO last December, saying that the government had been concerned that the WHO had passed some samples on without consent, which could have in turn resulted in intellectual property rights that denied developing countries "equitable access" to future vaccines.

A draft resolution on malaria was agreed after small group consultations mainly between Kenya and the US. Each had submitted a proposal in January, differing primarily in terms of their references to TRIPS flexibilities. Kenya and other developing countries wanted to urge members to provide for full use of flexibilities in their legislation "to increase access to anti-malarial medicines, diagnostics and preventive technologies." In contrast, the US, along with Switzerland and Japan among others, did not want TRIPS flexibilities to be mentioned in connection with access to the products. The compromise, reached on 21 May, inserted a definition of "pharmaceutical products" into an explanatory footnote that referenced the 2001 WTO Doha Declaration on TRIPS and Public Health. A similar footnote had been part of the compromise on the Brazil IGWG resolution as well, sources said.

Brazil and Thailand were active in inserting language on TRIPS flexibilities, the IGWG and access to essential medicines in a resolution on "Better Medicines for Children".

On a related note, a source told Bridges that Brazil and Thailand's recent decisions to issue compulsory licences for patented AIDS drugs were not discussed in any detail during the World Health Assembly, contrary to some expectations (see BRIDGES Weekly, 9 May 2007). Meanwhile, Thai Minister of Public Health Mongkol Na Songkhla announced that Brazil and Thailand would sign a "cooperation agreement" on health development, including research into flu vaccines, in August.

ICTSD reporting; "Indonesia Lifts Bird Flu Sample Ban", FINANCIAL TIMES, 15 May 2007; "WHO Head Expresses Commitment to Strengthen IP Working Group", INTELLECTUAL PROPERTY WATCH, 20 May 2007; "Thailand, Brazil to Sign Health Cooperation Agreement," THAI NEW AGENCY, 20 May 2007; "WHO Members Reach Preliminary Agreement on Malaria", IP-Watch, 21 May 2007; "World Health Assembly Closes," WORLD HEALTH ORGANIZATION, 23 May 2007.