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TWN Info Service on Intellectual Property Issues (Dec06/02) 07 December 2006
The World Health Organization's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) began its meeting on Monday. Please find below news stories on discussions that have been taking place at the meeting. Best
Wishes SUNS #6156 Wednesday 6 December 2006 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 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. 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
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. The
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 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, ---------------------------------------------------------- SUNS #6157 Thursday 7 December 2006 WORKING GROUP DISCUSSES ELEMENTS OF GLOBAL STRATEGY, PLAN OF ACTION Geneva, 6 Dec (Sangeeta Shashikant) -- The World Health Organization's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), at its meetings on Tuesday and Wednesday, held discussions on the elements of a global strategy and plan of action in relation to intellectual property, health R&D and public health. From the discussions, two documents - one on a global strategy and the other on a plan of action - are expected to be the two outputs of the Working Group, which is holding its first session from 4-8 December. The Working Group was established by the World Health Assembly in May 2006 through resolution 59.24. According to the resolution, 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." At
the meeting, Working Group Chair Peter Oldham of Thus far, most of the discussions (which began on Tuesday) have been on what will form the 'Elements of a Global Strategy and Plan of Action' and the basis of the discussions is WHO document A/PHI/IGWG/1/4 dated 2 November 2006 (Secretariat Document) wherein areas for action have been identified for the categories of prioritisation of research and development needs; promoting research and development; building innovation capacity; improving delivery and access; ensuring sustainable financing mechanisms; and establishing monitoring and reporting systems. Two other categories of IP and transfer of technology were added upon request by some Member States, and in a recent Secretariat Document (A/PHI/IGWG/1/4 Add.1), these categories have been elaborated. Discussions on the "Elements" is expected to inform the drafting of the documents on a Global Strategy and Plan of Action. The
move towards having these documents comes following support for such
an approach from many developing countries including Several developing countries and NGOs however raised concerns during the discussions that the Secretariat Document does not fully capture the recommendations of the Commission on Intellectual Property, Innovation & Public Health (CIPIH). It guided the meeting by saying that following the discussion on Elements, a drafting group could be formed to draft the overarching strategy and following that identify elements that should be included in the plan of action. On
the issue of financing, Most of Tuesday and Wednesday were spent by Member States making specific comments on each of the categories identified in the Secretariat paper. On the category of prioritising research and development needs, the Secretariat Paper identified the following areas of action: (1) identify gaps in current coverage of research in Type II (diseases incident in both rich and poor countries, but with a substantial proportion of the cases in poor countries) and Type III Diseases (diseases that are overwhelmingly or exclusively incident in the developing countries); (2) expand prioritization to include neglected diseases, as well as HIV/AIDS, malaria and tuberculosis; (3) set research priorities in developing countries so as to address public health needs and implement public health policy; (4) conduct research on affordable and technologically appropriate products to combat Type I diseases in developing countries; and (5) improve accessibility of compound libraries for identification of potential compounds. The
On the issue of compound libraries, the Swiss delegation raised the issue that many of the compound libraries are privately owned by companies and cannot be made public. It added that there are 3 kinds of approaches to research - market driven research done usually by the private sector, public funded curiosity research or needs driven research. Which part of the first two approaches should be needs driven, it asked. As to the category of "promoting research and development", the Secretariat paper lists the following areas for action: (1) devote a larger proportion of the health research and development budget of developed countries to the health needs of developing countries; (2) provide support for national health-research programmes through appropriate political action and long-term funding in developing countries; (3) set up a forum to enable more organized coordination and sharing of information; (4) promote discovery science in order to identify, validate and build up a sustainable portfolio of new products, whose development is facilitated through appropriate legal arrangements permitting unrestricted access to drug leads identified through the screening of compound libraries for diseases relevant to the public health needs of developing countries; and ( 5) promote early-stage drug research and development in developing countries (including basic research, lead identification, lead optimization and pre-clinical trials). On
this section, A/PHI/IGWG/1/2 be adopted as elements. The recommendations suggested for adoption include recommendations that governments, national authorities, and donors assign a higher priority to research on the development of new animal models, bio-markers, surrogate end-points and new models for assessing safety and efficacy which would increase efficiency of product development; to enhance sustainability of public private partnerships; to recognise the need for an international mechanism to increase global coordination and funding of medical research and development. In this regard, examine the proposal of a treaty for R&D submitted to the CIPIH. The
A/PHI/IGWG/1/2 which speaks about the need for an international mechanism to increase global coordination and funding of medical research and development, and in this regard the sponsors of the treaty proposal on medical research and development should undertake further work to develop these ideas so that governments and policy-makers may make an informed decision. It also indicated that the other South East Asian countries were similarly supportive of the idea of a global R&D treaty. Under the category of "Building Innovative Capacity", the areas of action identified by the Secretariat are: (1) provide support for development of innovative capacity through investment by developing countries in human resources and the knowledge base, especially in tertiary education; (2) intensify North-South or South-South partnerships and networks to support capacity building; (3) strengthen education and training in research and development, including management of intellectual property; (4) promote transfer of technology and production in developing countries through action by developed countries and pharmaceutical companies; ( 5) strengthen product regulatory capacity in developing countries, including improvement of ethical-review standards and clinical-trials capacity; (6) promote patent pools of upstream technologies or other mechanisms to promote innovation of products for priority diseases in developing countries; and (7) document and disseminate best practices in innovation observed in developing countries. It
further proposed the adoption of recommendations no. 47, 48, 52, 56
in document A/PHI/IGWG/1/2. The
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