PARTICIPANTS SATISFIED WITH PROGRESS IN WHO TALKS ON BOLSTERING MEDICAL INNOVATION

Members of the World Health Organisation (WHO) on 10 November ended a week of talks without coming up with a draft plan to promote medical innovation, instead noting that they had made meaningful progress and that the negotiations would resume next year.

The WHO Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property is charged with developing a global strategy and plan of action on vital health research specific to the public health needs of developing countries in time for the May 2008 World Health Assembly. The recent session of the committee had in theory been expected to complete a draft strategy and action plan. The IGWG is now set to pursue further work in January 2008, and meet again from 28 April to 3 May.

Ahmed Ogwell, head of international relations at the Kenyan health ministry and vice-chair of the IGWG, stated that participants - governments, the drug industry, and civil society groups - were on "the path to results." Building trust and consensus had proved slower than expected, he allowed, but nevertheless, they were moving.

"I've been very much impressed by the level of engagement, the participation of all delegates… by the passion... and the spirit of friendship," WHO Director General Margaret Chan told delegates at the session's close, describing the meeting as "historic." The "spirit of compromise… moves us forwards," she added.

Chan reiterated her commitment to "moving the organisation forward in the areas" of intellectual property rights, innovation, and public health. "We are gearing ourselves up to do more," she stated. "I will need your specific guidance from the strategies and plan of action." Sources say that the WHO Secretariat is preparing to scale up technical cooperation efforts, and is working on a comprehensive plan to better address existing mandates on issues such as incentives for medical innovation, technology transfer, and access to health products.

Inching towards consensus

The principal basis for negotiations last week was a draft strategy and global plan of action that the WHO Secretariat had issued on 31 July, incorporating comments made by countries and regional groups after the IGWG's first meeting. The global strategy text outlined its context, aim, and focus, and outlined ideas for dealing with issues such as prioritising research and development needs, building and improving innovative capacity, transfer of technology, and intellectual property rights.

During the first day of the meeting, a paper produced by 14 Latin American countries at one of a worldwide series of regional conferences on the IGWG process - the so-called 'Rio text' -- was incorporated into the working draft (see BRIDGES Weekly, 7 November 2007). This document was more emphatic than the Secretariat's text about the need to explore new ways of de-linking research and development (R&D) costs from drug prices, as well as on the use of flexibilities in trade rules to promote public health.

To negotiate the text, members split into parallel drafting groups open only to government representatives and appointed experts. These meetings ran late into the evenings. One of the crucial issues they dealt with was a section comprised of eleven principles outlined in the Rio text addressing issues including the right to health, the relationship between intellectual property and access to medicines, and innovative capacity in developing countries. During the talks last week, members reached consensus on several of them, but have yet to resolve two remaining principles. For instance, officials could not agree on whether to include the Rio document's assertion that "the right to health takes precedence over commercial interests," or an alternative phrase, reportedly advanced by the EU, specifying that "the objectives of public health and the interests of trade should be appropriately balanced and coordinated." There is also not consensus on a proposed principle stating that "the right of everyone to the enjoyment of the highest attainable standard of physical and mental health is recognised as a fundamental human right in the international human rights instruments."

Much of the discussion focused on the issue of intellectual property rights. Ultimately, the working draft included a section on "Application and Management of intellectual property to contribute to innovation and promote public health" as 'Element 5'. Agreed text in this section states that "there is a crucial need to strengthen innovative capacity as well as capacity to manage and apply intellectual property in developing countries including … the use to the full of the provisions in the [WTO] TRIPS Agreement." One proposed section of text that is still placed within square brackets signifying disagreement calls for the creation of "user friendly global databases on the status of health-related patents." Central to this discussion is how the WHO and the World Intellectual Property Organization should work together to manage such databases, and how the information they contain might be used.

Another outstanding issue is whether the global strategy should focus on the fourteen diseases outlined in a footnote in the WHO Secretariat's July draft, including HIV/AIDS, Tuberculosis, Chagas disease, diabetes, and cancer (see BRIDGES Weekly, 5 September 2007). Several governments -- including that of Brazil and several African nations -- expressed interest in a broader focus, which would allow for adjustments to meet countries' respective health needs. Members agreed to revisit this issue at a later time.

Optimism in spite of slow progress

Though participants were overwhelmingly positive about the meeting, progress was slow, with one observer likening the focus on virtually every word and comma to the caution that marks formal treaty negotiations. Such slow progress was attributed to external pressures, divisions within regional groupings, and disagreements both among governments and within them (such as between trade and health ministries). For instance, several initial supporters of the Rio text, including Mexico, Costa Rica, and Peru, went on to distance themselves from it during the course of the meeting. Additionally, progress was slowed by long discussions over procedural questions, such as those relating to the framework for negotiations, fair representation for smaller delegations, the number and scope of drafting groups, and the transparency of the working group.

A few onlookers questioned whether WHO members actually made much progress towards developing a concrete global strategy and plan of action that goes beyond current agreements. Others suggested that it was too soon to say, and the overall assessment was uniformly positive.

"We didn't finish the global strategy and plan of action," said Syed Ali Asad Gillani (Pakistan), "but significant progress has been made."

One EU official expressed satisfaction with the commitment shown by all participants. Although slightly disappointed that the work could not be finished, the source suggested that they were on the "right course" to do so in the next meeting.

"What is most encouraging is that governments have decided that business as usual won't do anymore," said Michel Lotrowska of Medecins sans Frontieres' Access to Essential Medicines Campaign. "They are open to exploring entirely new ways of financing essential health research, in such a way that the fruits of innovation are accessible to those who need it the most."

Acknowledging the slow progress, Guy Willis of the International Federation of Pharmaceutical Manufacturers called the IGWG's subject matter "fiendishly complex," suggesting that it is "important to take the time to get it right."

IGWG Chair Peter Oldham (Canada) closed the second session by likening the process to a mountain ascent. While the pinnacle was not reached on this attempt he concluded that "You and I and the Secretariat, have gotten us to a high base camp preparing to attack the summit… gird up your loins, let us go up together."

In preparation for the resumption of the committee's work, the WHO Secretariat is until 31 January accepting comments from members on parts of the text that have not yet been the subject of negotiation. It is planning to issue documents in March on the comments received and the inter-sessional work.

ICTSD reporting.