WHO Working Group on IPRs and Health holds first meeting

Geneva, 5 Dec (Sangeeta Shashikant) -- The World Health Organization's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) began its first session on Monday where procedural issues dominated much of the discussions.

Among the procedural issues that emerged at the meeting were the election of a Chairman and Vice-Chairs, the participation of experts in the Working Group, and how to structure the discussions of the Working Group.

The Working Group was established by the World Health Assembly (WHA) (in resolution 59.24) in May 2006. (See SUNS #6036 dated 30 May 2006.)

According to resolution 59.24, the Working Group is tasked with "drawing up a global strategy and plan of action in order to provide a medium-term framework based on the recommendations of the Commission [on Intellectual Property Rights, Innovation and Public Health]".

The resolution stresses that "Such a strategy and plan of action aims at, inter alia, securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area."

The IGWG (meeting from 4 to 8 December) is expected to report to the 60th World Health Assembly (in 2007), through the Executive Board, on progress made and to submit the final global strategy and plan of action to the 61st World Health Assembly (in 2008), also through the Executive Board.

The meeting on Monday got underway with the Advisor to the WHO Director-General, Denis Aitken, presiding, as there was no agreement on the election of the relevant Chairs for the meeting, although several consultations had been conducted previously.

However, by Monday afternoon, it was agreed that Peter Oldham, Counsellor of the Canadian Mission in Geneva, will be the Chair. The Vice Chairs, representing geographical balance, are from the Netherlands (Mr B. Wijnberg), Libya (Dr H. Gashut), Kenya (Rapporteur) (Dr A. E. O. Ogwell), Singapore (Mr. Jaya Ratnam), and India (Mr. N. Dayal).

Several countries questioned the Secretariat on how the "experts" that are participating in the meeting were nominated, as the resolution does allow the Director-General to invite the experts and a limited number of concerned public and private entities to attend the sessions of the Working Group and to provide advice and expertise, "as necessary, upon request of the Chair, taking into account the need to avoid conflicts of interest".

The experts invited to the meeting include Dr. B. Pecoul and Mrs. N. Dentico from the Drugs for Neglected Diseases Initiative (DNDi); Dr. T. Von Schoen Angerer and Ms. E. 't Hoen from Medecins Sans Frontieres; Ms. L. Feisee from the Biotechnology Industry Organization; Mrs B. Callan and Ms. C. Sampogna from the Organisation for Economic Cooperation and Development (OECD); Mr. E. Iverson from the Bill & Melinda Gates Foundation; Mr. R. Wilder from Sidley Austin LLP; and experts from the World Trade Organization (WTO), the World Intellectual Property Organization (WIPO), the Global Forum for Health Research and the Indian Council for Medical Research.

South Africa, on behalf of the African Group, asked for clarification from the WHO Legal Counsel on how the experts were chosen, since a Chair had not been elected yet and Member States did not have input as to their selection.

The WHO Legal Counsel, Gian Luca Burci, responded by saying that his reading of Paragraph 4(3) of resolution WHA 59.24 indicated that the Assembly requested the WHO Director-General to "invite experts".

The US disagreed with the interpretation of the Legal Counsel and raised the point that the resolution did not give authority to the Director-General to appoint experts prior to the election of the Chair. It was regrettable that the Member States were not told of the Secretariat's plans to invite experts. The US stressed that the election has to be upon the request of the Chair. It also noted that the resolution provides that a limited number of public and private entities could also participate.

In response, Howard Zucker, Assistant Director-General of Health Technology and Pharmaceuticals, said that WHO had invited a limited number of persons representing a broad range of key stakeholders that are considered experts with outstanding authority in their field and they have a responsibility to provide advice.

Regarding the structure of the discussions, the African Group proposed the division of the Working Group into three sub-groups. It is proposed that the sub-groups conduct discussions according to the classification of (1) research and development, (2) trade agreements and pricing of medicines, and (3) strengthening of health systems. However, no agreement was reached and discussions are expected to continue.

Brazil stressed that the role of the WHO in this debate is primordial and the issues relating to commerce and trade, and IP and innovation is important for public health and should not be left merely to economic forums. It welcomed the fact that the matter of innovation is being debated here in the interest of health.

The US said that the CIPIH (Commission on IPRs, Innovation and Public Health) report targets many actors. However, work has to be focused on areas that fall within the core competency of this organization. It also said that the challenge was to determine how fast to move while avoiding a one-size-fits-all approach.

Norway expressed disagreement and said that the other plans of action of WHO such as the Global Strategy on Diet do speak about other international organizations. It asks companies to do certain things and the industry has taken the recommendations very seriously. Norway added that they should not be excluded.

The WHA resolution which set up the Working Group is actually a negotiated amalgamation of two draft resolutions - one proposed by the WHO secretariat based on the CIPIH recommendations and the other proposed by Kenya and Brazil.

This point was stressed by Charles Clift, head of the Secretariat of the CIPIH when delivering a statement on behalf of the Chairperson of the Commission Ruth Dreifuss. He also added that the IGWG "needs to consider the recommendations of the CIPIH alongside the proposals contained in the Kenya/Brazil resolution".

Clift said that because of the complexity of the innovation process, the Commission thought it necessary to look at the bigger picture. Thus it sought reasons why, in spite of a greater effort in recent years, R&D has not yet produced the results hoped for, or even expected, for poor people in developing countries. It therefore placed this issue in a broader perspective, including, for example, regulation and the determinants of access to new as well as existing medicines, as well as the importance of political commitment, in both developed and developing countries, in promoting innovation and access.

He also said that the Commission's terms of reference made it clear that the focus of its enquiry should be the development of new diagnostics, vaccines and medicines to treat diseases which disproportionately affect developing countries, but quickly concluded, however, that innovation was pointless in the absence of favourable conditions for poor people in developing countries to access existing, as well as new, products.

The framework for the Commission's report was the innovation process which it categorized sequentially as discovery, development and delivery. It then considered specifically how to foster innovation in developing countries and how one might move towards a plan to promote sustainable innovation and access for products required to prevent, diagnose and treat diseases which disproportionately affect developing countries.

The detailed recommendations are many, and are listed in the report and in document A/PHI/IGWG/1/2, and are directed at different stakeholders including governments, industry, the WHO and other organisations, Clift said. He added that the recommendations should form, as the report proposes, a menu for consideration by governmental and non-governmental stakeholders.

Some developing countries raised several pertinent matters particularly in relation to the WTO TRIPS agreement. For example, India, while stressing its commitment to continue to supply generic medicines, highlighted the problem of ever-greening of patents.

Thailand said that it had recently announced a decision to issue a compulsory license to import and manufacture a key HIV/AIDS drug Efavirenz. It also said that it is looking at the impact of TRIPS and TRIPS-plus on healthcare costs and access.