Disagreements Further Delay WHO IP Commission Report

A World Health Organization commission on intellectual property rights has failed to meet its deadline for a report that was to be presented to the WHO Executive Board later this month because of disagreement among its members.

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,” the CIPIH says.

The January 2006 deadline was already a postponement, as the 2003 WHA resolution requested the commission to present a final report “with concrete proposals” to the executive board at its 115th session, in January 2005. At the 116th session, which took place 26-28 May 2005, it was agreed the report should be ready in time for the 117th session of the WHO Executive Board set to meet on 23-28 January, 2006.

But this will not happen. Charles Clift, head of the secretariat of the CIPIH, said the commission would not be able to meet the deadline for submitting the report because it had not yet proved possible to reach agreement among some of the 10 members “on a number of issues” in the draft report. The commission will therefore meet again in a meeting on 16-17 January for further discussions. Clift declined to elaborate on the disagreements.

The commission published an 11-point, 3-page report on 22 December 2005 inviting the executive board to “note” the 3-page update. As for the final report, Clift said that it would be up to the executive board to decide how to proceed. The commission now expects the report to be ready in April, in time for the May World Health Assembly and next executive board meeting, it says.

Clift said that the chairperson of the commission, former Swiss President Ruth Dreifuss, would brief the executive board on the meeting of the commission and its outcome.

An observer, Nicoletta Dentico of the Drugs for Neglected Diseases initiative, said that it was “not entirely negative” that the report had been postponed again, as it showed the commitment of the chairperson and the WHO, and that they had “taken the task very seriously.” She also noted that this was a “delicate and complex subject” and the fact that there were opposing forces within the commission made it difficult to reach agreement.

Who are the Commission Members?

The commission’s 10 members were chosen based on expertise and experience in the issues under consideration, geographical distribution, diversity such as gender, occupational mix and discipline, the CIPIH says.

The non-governmental community has been dissatisfied with the composition, saying that the voices of developing countries have not been sufficiently represented, sources say. But it is difficult to pinpoint who some members represent.

A source familiar with the work of the commission said in an interview that the differences covered a wide range of issues and that some members held a view “very close to or directly influenced by big pharma.” These members have tended to minimize the implications of IP protection for access to medicines, and have opposed suggesting new actions such as a proposed research and development treaty, the source said.

The commission members are: Ruth Dreifuss; Raghunath Anand Mashelkar, director-general of India’s Council of Scientific and Industrial Research; Carlos Correa, Argentinian lawyer and professor, director of the Centre for Interdisciplinary Studies on Industrial Property and Economics Law, University of Buenos Aires; Mahmoud Fathalla, professor of obstetrics ad gynaecology, former dean of the medical school at Assiut University, Egypt, and chair of the WHO advisory committee on health research; Maria Freire, CEO of the Global Alliance for TB Drug Development (a not-for-profit, public-private partnership), and previously director of the Office of Technology Transfer at the US National Institutes of Health.

Other members include: Tshediso Matona, economist and trade policy expert, deputy director general in South Africa’s Department of Trade and Industry; Pakdee Pothisiri, senior deputy permanent secretary of health, Thailand, former secretary general of the Thai Food and Drug Administration; and Hiroko Yamane, professor of international economic law and European community law at the Graduate Institute for Policy Studies in Tokyo.

Another member is Fabio Pammolli, professor of economics and management at the University of Florence, and director of European pharmaceutical regulation and innovation systems at the University of Siena, whose mission goals include “understanding competition and competitiveness in the pharmaceutical industry: A careful characterization of the nature of competition, innovation, and industrial change within the industry” and founder of Siena Life Sciences, set up to create a biotech science park in Italy.

And finally, Trevor Jones, former director-general of the Association of the British Pharmaceutical Industry, sits on a number of biotechnology industry boards, former director of the Wellcome Foundation Limited. He was recently awarded a Scrip World Pharmaceutical News Lifetime Achievement Award. Scrip is the pharmaceutical industry’s business-to-business news magazine. Has also served on a number of national and international commissions and is a founder of the public-private partnership, Medicines for Malaria Venture.

Content of the Report

As for the content of the draft final report, the CIPIH is still holding the cards close to its chest. Clift said that until after the CIPIH’s upcoming meeting, he could not say anything more about the content of the report beyond what had been indicated in the December update. The reason was that at this stage it is still not clear what form the report would take.

The December update says that: “The commission’s report will consider both technical and policy issues and is likely to be structured as follows: Chapter 1 provides an overview and defines the problems being addressed; chapter 2 outlines the issues at the discovery stage, chapter 3, at the development stage, and chapter 4, at the delivery stage. Chapter 5 considers how to foster innovation in developing countries, and chapter 6 suggests ways to promote a sustainable framework for encouraging innovation and improving access.”

“The report is meant to come up with concrete proposals as to how the problems raised in its terms of reference might be addressed,” Clift said.

Dentico said that, generally, there is increasing evidence that the current IP scheme for medicines does not efficiently respond to health needs. There is “political space to be re-conquered by UN agencies,” she said.

The source familiar with the commission’s work, however, said that while the report would make some recommendations, “given the disagreement within the commission, it is unlikely to make any specific proposal to address the problem of diseases prevalent in developing countries.”

The December update notes that the CIPIH is “heartened by the growing public awareness of issues related to research, production and access of medicines for diseases prevalent in developing countries.” Such positive steps in 2005 included the commitment of the Group of Eight industrialized nations to increase development assistance by US$50 billion per year by 2010, the Live8 concerts around the world and the World Trade Organization’s permanent adoption of a 2003 waiver making it possible to export cheaper medicines to countries without adequate production facilities, Clift said.

Wide Variety of Submissions

Throughout the process the CIPIH has welcomed submissions from interested parties which have been posted on its website: http://www.who.int/intellectualproperty/submissions/en/. Clift said the range of contributors was balanced, including a wide range of stakeholders from the pharmaceutical industry, lobbyists, academics and non-governmental organisations.

As of early January 43 submissions had been made, but it is still possible to provide comments, the CIPIH says. Among the contributors are: the World Intellectual Property Organisation, the Consumer Project on Technology, the Swiss Federal Institute of Intellectual Property, the London School of Economics’ Pharmaceutical R&D Policy Project, the Biomedical Industry Advisory Group, and the International Chamber of Commerce.