WHO Group Lays Foundation For Global Neglected Diseases R&D Plan

By Tove Iren S. Gerhardsen
During a 4-8 December meeting of some 100 World Health Organization (WHO) member states and other stakeholders, the foundation was laid for discussions of a global plan for providing medicines for diseases predominantly affecting poor countries. The process will continue in the coming year, and a second intergovernmental meeting is scheduled for October 2007.

In the meantime, a report will be submitted to the WHO Executive Board meeting in January 2007, and regional meetings may be held in the run-up to the next meeting. A final report is due to be submitted to the World Health Assembly in May 2008, the WHO said.

This was the first meeting of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG).

Participants’ reactions after the meeting were mixed with some expressing disappointment that more was not done. Expectation going into the uncommon format varied widely. Perspectives on the working group do not appear to clearly divide along North-South lines.

The meeting made “some progress” although “perhaps not as much [as we] would have liked,” the chair, Peter Oldham of Canada, said at the end, adding that the whole process had been “very compressed.”

Developing countries were praised by many participants, however, for bringing many of the issues of concern to them back into the papers under discussion in the meeting. This was despite what sources said was pressure from the United States beforehand [see related story to come], and an unbalanced representation vis-à-vis developed countries. Some 95 least-developed or developing countries of WHO’s 193 member states were not present, according to the meeting participant list.

Two developed country officials said that this was the first meeting involving a range of controversial issues, and having an outline of a process was therefore not bad. While somewhat disappointed about the outcome, one of them said there had been “a lot of goodwill.” One noted, however, that there is “a lot to do over the next 12 months,” and another developed country delegate said that the meeting had “not agreed to anything at all.”

This was “not an entirely satisfactory first step,” one participant said from a developing country perspective, but added that one has a government-led momentum building up. Yet a third stated that this was a “total disaster, just like they wanted,” as there was not a clearer way ahead.

“We are in a mess, but we will have a good result,” another developed country official said. Developed countries appeared to vary somewhat on how much the group should focus on the three areas of its mandate: public health, intellectual property rights, and innovation.

Elil Renganathan of the WHO working group secretariat told Intellectual Property Watch that the meeting had provided a framework for the whole exercise, adding that this was the first time innovation and access to medicines had been discussed at the same time.

Tussle Over IP in Global Plan

The group was created and tasked by the World Health Assembly in May to come up with a global strategy and plan of action for providing medicines for diseases predominantly affecting poor countries, based on the recommendations of the WHO Commission on Public Health, Innovation and Intellectual Property Rights (CIPIH). The mandate of the group was “to provide a medium-term framework based on the recommendations of the commission,” according to resolution WHA59.24.

A paper from the meeting’s discussions, entitled: “Elements of a global strategy and plan of action, Progress to date in the Intergovernmental Working Group,” [A/PHI/IGWG/1/5] will form the basis of further work. Separate papers on strategy and plan of action were combined on the final day.

WHO will post online members’ statements made late in week and not reflected in the latest draft if they are submitted in written form by February, it said. WHO will prepare a new document reflecting all comments made by member states at the meeting by June 2007, relating both to the global strategy and the plan of action.

A number of countries welcomed the meeting’s paper, but the United States said it was “a step backwards of what we had yesterday [7 December].” But all in all a developed country official said the United States viewed the meeting as a good outcome that had moved the process forward, although it emphasised that nothing had been agreed to.

The paper contains elements for a global plan of action, including prioritising research and development needs, promoting research and development, building and improving innovative capacity, transfer of technology, management of intellectual property, improving delivery and access, ensuring sustainable financing mechanisms, and establishing monitoring and reporting systems. It also contains a global strategy, including “making intellectual property work for health.”

Based on this, the “bureau,” consisting of the chair and the five regional vice-chairs, will send a short report to the WHO Executive Board meeting in January 2007.

The discussions may also continue at regional meetings in the meantime, as countries such as Brazil and Canada said the momentum should be sustained.

The working group meeting will not, however, be able to report on any agreed, identified early action points of the plan that can be implemented immediately, despite a mandate to do so in the original assembly resolution. Some countries had specific suggestions, such as Brazil, Switzerland (which held a separate meeting with various member states of diverse backgrounds) and Thailand, but there was not enough time to prepare a written document on early actions, WHO said.

There was quite a degree of difference between countries in terms of preparedness, with some having officials from health, foreign affairs as well as development agencies present, while others came to the meeting without having done their “homework,” and were apparently quite unprepared for the exercise.

One non-governmental source said that “both sides,” referring to the WHO secretariat and delegations (citing the European Union, which spoke with different voices), seemed unprepared. This was partly understandable given time constraints, she said, but was also unacceptable considering that the meeting cost $600,000, as stated by WHO.

Opening WHO Documents Omit Key CIPIH Provisions

During the week, developing countries managed to get many of the issues dear to them, particularly those related to new ways of thinking about intellectual property rights and medicines, into the discussion paper that was prepared by WHO in advance.

The strategy and plan of action was supposed to be based on the CIPIH report, but according to an analysis “non-paper” issued by the Netherlands, there were a number of issues omitted from the initial paper prepared by WHO.

Renganathan said that WHO had had to reduce the 60 recommendations of the CIPIH to a “manageable number,” and a tangible number of action points. Moreover, the selection had been based on what it is realistic to expect can be achieved in a 10-year time frame. WHO had prepared the paper, however, in cooperation with all the WHO six regional offices.

Many of the omitted recommendations were brought back in during the week and are now reflected in the final paper, but Brazil still took issue with the process toward the end. Brazil told the meeting that the discussion paper, as of 7 December, was inadequate as it still did not reflect affordability and price of medicines, patent pooling and access to health as an overriding human right.

Having compared the initial WHO paper with the approximately 60 recommendations in the CIPIH report, a number of the CIPIH’s proposals on using flexibilities in the patent system were left out of the paper, the Netherlands said.

Almost all of the CIPIH recommendations sought by Brazil in a submission paper during the 1-15 November online consultation process on the group were left out, according to the Dutch paper. “Everything Brazil found important is not in there,” Sabina Voogd, senior policy advisor at the Dutch Ministry of Foreign Affairs, told Intellectual Property Watch.

Voogd said that issues highlighted in Brazil’s submission, such as technology transfer to developing countries according to Article 7 of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), “early working” exception and general encouragement of generic market entry upon patent expiry, data exclusivity regulations related to clinical trials data that delays the entry of generic medicines and ensuring strict application of the patentability criteria, were not included in the original draft.

Many of these measures were worked in during the discussions, including language on avoiding “TRIPS-plus” requirements in bilateral trade agreements (beyond the TRIPS requirements), references to Article 66.2 of the TRIPS agreement on technology transfer, and the “early working” system for generics (IPW, Public Health, 7 December 2006).

Voogd said it is the “mystery of the whole thing” why the WHO secretariat had not just listed all the CIPIH recommendations, or indicated with number references which recommendations had been included in the document. She suggested that the member states could now lean on the Dutch non-paper to bring issues back into the discussion paper. She said members should “not throw away all that valuable work done by the CIPIH.”

A Kenyan official said on 7 December that the drafts were only “a piece of a skeleton” and that after the week’s “information-gathering session,” the documents would be totally different on 8 December, indicating the large number of suggestions from the CIPIH report that developing countries in particular demanded be brought back in.

A number of sources credited the work of the African Group and members such as Thailand and Kenya in adding other CIPIH provisions. A number of delegations, including the European Union, India, New Zealand, Norway and the United States, welcomed the paper issued on 7 December, in which the secretariat had worked in the discussions during the week. India said negotiations on the issues should start later.

On 8 December, two participants, including one from a developed country, said that the atmosphere had been good and cooperative in the meeting until Brazil made its statement on 7 December.

Experts and NGO Participation

In addition to national government officials, there were WHO-appointed experts and non-governmental representatives in attendance. Throughout the meeting, delegates sought clarification on what basis the experts had been selected, and why the procedure for non-governmental and intergovernmental organisations to get access had been complicated.

A number of sources have questioned why, in particular, the intergovernmental organisation, the South Centre, was not given special accreditation (it does not have WHO “effective relations” status), especially as it was indicated at the meeting that it had been difficult to get developing country experts on short notice, sources said. Internal WHO email correspondence from before the meeting suggests that legally an exception might have been possible.

Paragraph 4 of resolution WHA59.24 states that the director general to “invite experts and a limited number of concerned public and private entities to attend the sessions.”

On 8 December the meeting decided to implement a “fast-track” system for this kind of accreditation for future meetings of the group, as a WHO source said it could take at least three years to get official relations with WHO. One of the experts welcomed the fast-track approach, and said the unclear instructions of the meeting had made for an “uneasy” experience of the experts.

Tove Iren S. Gerhardsen may be reached at tgerhardsen@ip-watch.ch.