WHO Board Wrestles With IP And Public Health Report, R&D Proposal

The Executive Board of the World Health Organisation this week is struggling with how to proceed on issues of intellectual property rights, innovation and public health.

The issues are being addressed by a special commission which failed to meet a mandate to present its report to the board this week. At the same time, two developing countries have introduced a proposal to the board to establish a new global framework for research and development (R&D) for medicines for public health needs.

At the board meeting on Thursday, discussion of the report and the resolution for a new R&D framework were linked, but there were disagreements on how to proceed. The two issues were discussed under board meeting agenda item 4.10 relating to intellectual property rights, innovation and public health. A committee of the board was created to review the report when published in April, prior to the 22-27 May World Health Assembly.

The R&D issue was debated on Thursday morning, and a special Thursday midday meeting failed to complete work on the R&D proposal. After a heated debate on how to proceed in the plenary meeting on Thursday afternoon, the secretariat proposed postponing further discussion on the R&D proposal to Friday out of an obligation to ensure the availability of translators. Despite pressure from some countries to continue discussions later on Thursday without translators, the secretariat strongly recommended the delay, as WHO’s Director General Lee Jong-wook said that a meeting without full language support would set a “very bad precedent for the organisation,” and added that the WHO had to “pay attention to resources.”

The decision to postpone discussions was made after Rwanda and France said they would prefer not to proceed without translators. The R&D issue is expected to be discussed in a working group to meet Friday from 12:30 to 3:30 p.m, and later by the board.

Critics from the non-governmental organisation community believed the debate on the translations was a maneuver to avoid discussing the resolution altogether. “I am very concerned,” said Ellen ‘t Hoen of Médecins sans Frontières. “This does not show a very strong WHO secretariat commitment to R&D.” She added that it was not at all unusual to have drafting group meetings without translations.

In the debate Thursday, a number of developed countries indicated a preference to wait to address the R&D proposal until the report is issued. The report could result in a separate resolution, according to the board chairman. Others wanted to continue discussing the R&D resolution in parallel.

The resolution (EB117/Conf. Paper No 3), proposing a new global framework for R&D which would also safeguard needs-driven research benefiting patients in resource-poor settings, was formally submitted by Brazil and Kenya to WHO on 23 January (IPW, UN, 24 January 2006).

Focus Group to Brief May Assembly on CIPIH Report

The WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) was set up in February 2004 based on a 2003 World Health Assembly resolution (WHA56.27). Its mission is to collect data from different actors involved in intellectual property rights, innovation and public health and to analyse how incentives and funding mechanisms may be created for research into, and the development of, medicines for diseases that disproportionately affect developing countries, according to the CIPIH (IPW, Public health, 23 January 2006).

One of the reasons why the discussions around the R&D resolution grew more complex than perhaps had been foreseen was that it became linked to the report not being ready.

CIPIH Chairwoman Ruth Dreifuss told the board Thursday that she regretted that the report was not ready and said the commission needs a “few more weeks,” as the “consulting and listening” had lasted longer than the commission had expected. She said the ambition was to provide a rigorous analysis that would open the debate on IP.

Dreifuss reported on the commission’s latest meeting held on 16-18 January, and said that the report should be ready in April in time for the assembly.

Dreifuss added that the commission wants to reach a “meaningful consensus” and this takes time, but it largely had been able to complete its work last week and just had to reshape its recommendations for action.

She later noted that the commission would attempt to show the “broad range of matters” associated with the issue, and said that instead of settling for a “soft consensus,” the commission could end up trying to make “transparent” the points on which the members differed.

Kenya said it was “a bit disappointed” that the CIPIH report was not submitted on time. The delegate also made a personal appeal for its R&D resolution “for the sake of the poor people of the world who require health treatment but cannot afford it. They cannot wait any more.”

Sudan and France also said they regretted that the report was not ready, and France requested a more precise time frame. The secretariat responded that the report should be ready by the second week of April, when an English translation would be posted on the CIPIH’s website.

A number of countries supported a proposal from Bolivia to set up a committee representing the board to meet once the report is out to analyse and “digest” it, in order to help the board have a position before the assembly. It was decided that each region would choose two representatives for a 12-member group (although open to additional participants) to meet in Geneva at the end of April, and possibly prepare a resolution based on the report.

Way Forward for Health and IP?

But this did not solve the problem of whether to concentrate discussion of intellectual property, innovation and public health in the report or go forward with the separate R&D resolution.

Developed countries wanted to wait for the report, while Kenya and others wanted to discuss the two in parallel and start consultations on the R&D resolution right away. Portugal, speaking on behalf of the European Union, said the current R&D draft resolution “needs to be subject to significant further work,” and Australia said the “report must be the basis for going forward.” One source indicated that countries such as the United States and Switzerland wanted to build on the report, but could be open to incorporating parts from the R&D resolution.

Eric Noehrenberg of the International Federation of Pharmaceutical Manufacturers Associations, told Intellectual Property Watch that it was difficult to say which resolution should be supported as we “do not know the report” yet, but he questioned whether two resolutions were better than one.

Noehrenberg said that the CIPIH report would be very broad and probably go beyond the R&D resolution, which he said was “ambiguously written” and only addresses one of the issues the CIPIH report would cover after two years of work. He therefore favoured a “good discussion in light of the report” when published in April.

‘t Hoen welcomed that R&D discussions now took place at the WHO as it had tended to focus on “lofty goals” such as the “3 by 5” initiative (3 million people on anti-retrovirals for HIV/AIDS by 2005) but not how to get there. She also noted that there had been a consensus among the board members as to the urgency and need for more R&D and no country had said they did not like the R&D resolution, but the disagreements were procedural.

External Support Rises for R&D Resolution

Outside the board meeting, the R&D resolution has received support from more than 240 scientists, including Nobel laureates such as Sir John Sulston, industry representatives such as Alex Matter of Novartis Singapore, and Richard Horton of The Lancet. The letter was read out loud for the board by Sir John Sulston on Thursday.

A statement was also made for the board on Thursday by Consumers International on behalf of 234 consumer groups and organisations in 113 countries, expressing a strong support for “the timely and important proposal” put forwarded by Brazil and Kenya.

Also, a 23 January letter from members of the European Parliament (representing Finland, Italy, the United Kingdom and the Netherlands) stating support for the R&D resolution was sent to EU Commissioner for Health and Consumer Protection Markos Kyprianou, with a copy to WHO’s Lee.

Separately, during the Thursday midday consultation on the R&D resolution it was suggested that a paragraph referring to the United Nations Development Programme 2005 Human Development Report be dropped, according to a delegate.

The paragraph quoted the report in saying that the World Trade Organization’s Agreement on Trade-Related Aspects Intellectual Property Rights (TRIPS), “along with ‘TRIPS-plus’ variants in regional and bilateral agreements, strikes the wrong balance between the interests of technology holders and the wider public interest.”