WHO GROUP ON HEALTH, INNOVATION, AND INTELLECTUAL PROPERTY HOLDS FIRST MEETING

Delegates from more than 100 member states of the World Health Organization (WHO), joined by civil society and industry representatives, met in Geneva on 4-8 December to chart a way forward on a plan to promote research on diseases that disproportionately affect people in poor countries.

The new Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property was established in May 2006 by the WHO's top decision-making body, the World Health Assembly (WHA). It was mandated to draw up a medium-term framework based on the findings of an earlier WHO Commission on Intellectual Property Rights, Innovation, and Public Health (CIPIH). After two years of investigations, that commission had in April 2006 produced a report containing some 60-odd recommendations relating to the discovery, development, and delivery of medicines, as well as innovation for health research in developing countries.

The IGWG was charged with agreeing on a global strategy and plan of action to submit to the 2008 World Health Assembly, "giving particular attention to needs-driven research and other potential areas for early implementation."

Some see the new working group as an opportunity to explore alternatives to drug patents as a means of encouraging the development of new and affordable drugs. One proposal under consideration calls for a global treaty for funding pharmaceutical innovation, which would have governments fund research and development (R&D) and make the findings public. Drugs thus developed could then be produced and sold cheaply, since manufacturers would not have to recoup heavy expenditures on research.

Bernard Pecoul of the Drugs For Neglected Diseases Initiative described the IGWG's work as providing a chance to "overcome today's fatal imbalance in health research and development and to improve the access situation of the million patients suffering from diseases which disproportionately affect developing countries."

"It's about saving lives," acting WHO Director-General Anders Nordström said of the group's task at its opening session. "It's about making sure people don't die because they don't have access to health-care products."

Building on the CIPIH's report

During the IGWG meeting, government negotiators discussed a document based on the CIPIH report that had been prepared by the WHO Secretariat, with input from pharmaceutical sector and NGO representatives. Called the "Elements of a global strategy and plan of action," it included sections on how to identify research and development priorities, promote research and development, and build innovative capacity. It also addressed improving delivery and access; ensuring sustainable financing mechanisms; and establishing monitoring and reporting systems.

Countries met in regional groupings to examine the text. The Secretariat incorporated their comments into the body of the text, with the stated aim of being "as inclusive as possible."

Ultimately, member countries agreed to break the document into two annexes -- one on the plan of action and the other on the global strategy. They expanded the plan of action to include elements on technology transfer and the management of intellectual property. This includes recommendations such as to "encourage innovations adapted to realities of health-care delivery in developing countries."

The global strategy annex stresses that "high quality research and the generation and application of knowledge are critical for achieving the internationally agreed health-related development goals." Drawing from the WHO constitution, past resolutions, and the CIPIH report, it sets out principles, challenges, and responsibilities, declaring that "efforts to develop new products will be of no value if they cannot be made available and accessible to those who need them."

With regard to alternative ways of promoting medical research and development, an Indian delegate suggested that the IGWG could set up a "trust fund" and establish rules for how it would be funded and accessed. Brazil suggested that governments should aim to devote 0.7 percent of GDP to research and development. A ten-member regional group of countries from South and Southeast Asia, and a 22-member group of North African and Middle Eastern countries both expressed support for the notion of a global treaty on research and development.

Defenders of the existing patent system, including the pharmaceutical industry, have been sceptical of attempts to develop complementary structures to promote innovation. They claim that intellectual property rules are only a small part of the problem with regard to access to medicine.

Managing the time crunch

Due to the limited time available for incorporating members' comments, the chair of the IGWG, Peter Oldham (Canada), explained on the final day of the meeting that governments would have until the end of February to provide additional observations and corrections to the document. The IGWG will meet again for a week in October 2007 to finalise the text so that it can be presented to the World Health Assembly in May 2008.

In the meantime, Oldham recommended that members continue work by linking IGWG issues with other WHO meetings, explaining that "we are not going to be able to crunch this in one week."

The Secretariat is expected to update the document to include comments submitted by the end of February, and make it available by June 2007.

Early implementation

As the meeting came to a close, countries turned their attention to identifying relatively easy-to-obtain 'low-hanging fruit' among the CIPIH's recommendations, in order to slate them for early implementation. However, a delegate from Brazil contended that delegations should make this assessment "with great care," rather than "hurrying through it."

In the end, countries agreed that they would be able to discuss early implementation at the January 2007 meeting of the WHO Executive Board, the 34-member panel responsible for implementing the decisions of the World Health Assembly.

Participation of other stakeholders

The WHO Secretariat had identified and invited several experts and institutions to formally participate in the meeting, in response to a WHA resolution (59.24) requesting it to "invite experts and a limited number of concerned public and private entities to attend the sessions of intergovernmental working group and provide advice and expertise."

Throughout the meeting, participants asked questions about the role in the working group of such experts and civil society. In particular, a South African delegate, speaking on behalf of the African region, asked how experts had been selected for participation, as well as how civil society could take part in the meeting.

Countries including the US suggested that member states should have been informed about the Secretariat's plans to appoint experts. Additionally, some observers questioned why the South Centre, an intergovernmental organisation, was not invited to attend as an expert. Members agreed that for future talks, governments would be invited to advise the Director-General on experts to include in upcoming meetings.

Additionally, at the request of countries including Canada, the US, and Kenya, the IGWG agreed to explore a "fast-track" accreditation process for members of civil society to participate in future meetings. Normally, it takes non-governmental organisations three to four years to establish official relations with the WHO.

One observer suggested that the talks should have been more "globally representative," complaining that the delegate list excluded more than half of WHO's member states and many least developed countries.

Others noted that the Secretariat's document that was the basis of discussions for the meeting did not reflect the entire CIPIH report. Sabina Voogd of the Dutch ministry of foreign affairs told Intellectual Property Watch that the "mystery of the whole thing" is why the Secretariat did not list all of the CIPIH recommendations.

Documents from the IGWG meeting are available online at http://www.who.int/gb/phi/.

ICTSD reporting; "WHO Group Lays Foundation For Global Neglected Diseases R&D Plan," INTELLECTUAL PROPERTY WATCH, 11 December 2006; "Global strategies need truly global discussions," LANCET, 8 December 2006; "Working Group Discusses Elements of Global Strategy, Plan of Action" SOUTH-NORTH DEVELOPMENT MONITOR (SUNS), 7 December 2006; "WHO Panel Weighs Radical Ideas," SCIENCE, 1 December 2006.