TWN Info Service on WTO and Trade Issues (Dec06/05)

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. 

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Sangeeta Shashikant
Third World Network
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SUNS #6156 Wednesday 6 December 2006


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.


SUNS #6157 Thursday 7 December 2006


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 Canada said that the objective of the documents would be to try to summarize what the meeting had discussed and to instruct the Bureau of the Working Group and the Secretariat so that they can get on with the work in the coming year. Drafting of and discussions on the documents is expected to start on Thursday.

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 India, Thailand and Sudan.

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).

Brazil said that the main issue was that many of the vaccines, medicines and diagnostics have not been designed yet, and how much was it going to cost the health systems and individuals to access medicines. It added that IP was a central issue and greater efforts have to be made to ensure that science delivers.

Sudan, on behalf of the Eastern Mediterranean Region, agreed with Brazil that there was a need for clarity about the objective of the work that is to be carried out.It added that it was logical to develop a strategy before a work plan. It also said that it needs to be ensured that the recommendations in the Secretariat Document are sufficient.

India supported the idea of an overarching strategy and plan of action put forward by Sudan. It said that financial mechanisms have to be looked at as well, as funds will be needed.

India proposed that drafts on these areas be prepared within the current session of the Working Group so that in the inter-sessional period, further submissions can be asked for, and in the subsequent session a fairly mature draft can be negotiated and finalised for the purposes of the WHA. It also proposed the convening of a workshop to consider the proposed Global Strategy and Plan of Action and enable countries not present to make a contribution.

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, Brazil proposed that the Heads of Government sign an agreement that 0.7% of gross domestic product be dedicated to R&D.

Iran called for a revisit of the proposed elements by the Secretariat, adding that the document did not properly capture the recommendations of the Commission's report. It gave the example of Recommendation 4.26 of the Commission's report, which states that bilateral trade agreements should not incorporate TRIPS plus provisions, which is not included in the Secretariat Document.

Thailand was supportive of the Indian proposals and proposed a re-categorisation of the 6 categories proposed in the Secretariat Document and breaking up into smaller groups to come up with the necessary texts.

Kenya stressed that it was important in the early stage of deliberations to identify issues that affect the direction of the IGWG's work. It also raised the issue of financing for research and development.

Australia said that while it welcomed the report of the CIPIH, many recommendations have to be prioritised, preferably those that are practical. It also mentioned the need to be mindful of the other bodies that have technical expertise and interest in IP issues.

Ghana, on behalf of the African Group, said that the Secretariat Document does not contain some of the recommendations of the Commission's report. It proposed that areas of transfer of technology and management of IP be included.

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.

Kenya, in endorsing the elements, stressed that the elements should be linked to the recommendations of the Commission because only then can it be clarified who are the actors to implement the recommendations and to capture certain actions that may not be included. It added that the African Group recommendations numbered 1, 2, 3, 4, 5, 6, 11 referred to in Doc. A/PHI/IGWG/1/2 should be adopted as elements.

The US indicated that it would have a problem with allowing open access to all compound libraries. It also asked what is the definition of "affordable and technologically appropriate products" and who will determine the definition.

Thailand said that it saw action areas numbered (3) and (4) as low hanging fruit that can be achieved. However, it stressed that prioritising also depends on the region. On the latter issue, it added that there is a need for a global mechanism. It strongly favoured making compound libraries accessible, saying that WHO should be better equipped to do so.

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.

Brazil said that it is appropriate for the mandate of the IGWG to establish a field investigation to find out bottlenecks when it comes to medicines and diagnostics.

Brazil added that compound libraries are of great importance. It also stressed that an analysis to establish which compound libraries have been built on the basis of public funding needs to be undertaken.

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, Kenya said that the region has identified key recommendations which if implemented would ensure that the proposed action points are dealt with exhaustively. It also proposed that recommendations 13, 14, 18 found in document 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 US said that for the most part these are areas that it can support although it is the way that implementation is done that will matter. On the area of action no. 1, it said that it supports the objective, although the issue is how it is expressed in the plan of action. It made clear that it was against a mandatory approach, although it qualified its position by saying that if it had to do more,  that is not a problem. In relation to action no. 2, it said that it was desirable to know what the parameters were as there are many implications of a fora. In relation to action no. 4, it said that the matter raised proprietary issues that needs to be looked at appropriately.

Finland, on behalf of the EU, said that the EU is a considerable funder of R&D and indicated that it was prepared to allocate funding. However, it emphasised the need for policy coherence and said that supporting health research needs to be negotiated within development cooperation. It added that the WHO Secretariat should gather information on mechanisms that promote health research and should at the next meeting provide a proposal for funding arrangements, and estimate the costs of sharing information and the relation between this forum and other global actors. It also said that the Plan of Action should also include mechanisms to promote innovative R&D.

Brazil said that it was important to establish a link between priorities defined under the first heading with the actual promotion of research and development. It stressed that there was a need to know what funds are available once the priority diseases has been identified, what is the research capacity in developing countries, which institutes are available and capable of carrying out R& D as there is a need to build bridges between the institutions, as in that way, technology and research capacity can be transferred from developed to developing countries. It also said that the issue was not just financial cooperation but to provide a machinery to provide R&D.

Thailand said that action area number 1 was not an effective recommendation.  Commenting on recommendation 17 (Doc. A/PHI/IGWG/1/2) which is about governments continuing to develop forms of advance purchase schemes which may contribute to moving later stage vaccines, medicines and diagnostics as quickly as possible from development to delivery, it explained that medicines and vaccines were too costly for governments, in particular, poor governments to be able to afford them, to be able to benefit from advance purchase schemes. This is the case unless there are donors available.

Thailand strongly supported recommendation no 18 in document 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.

Kenya, on behalf of the African Group, proposed that an additional point on promotion of traditional medicines be added. It also spoke of a merger of points 3 and 4 into point 7 and the replacement of the word "or" with "and" in point no. 2.

It further proposed the adoption of recommendations no. 47, 48, 52, 56 in document A/PHI/IGWG/1/2. Kenya said that investment in human resources, as well as development and promotion of traditional medicines is key to future strategies. The latter has been ignored except in a few developing countries, it said.

The US cautioned that members should not ignore the work of other actors, member states, private sector and other international organisations such as WTO, WIPO and OECD. It underlined that the WHO should not be assigned responsibility that belongs to another organisation.

Thailand noted that the Secretariat's paper did not capture recommendation numbered 51 (Doc. A/PHI/IGWG/1/2) that states that "Developed countries should comply with their obligations under Article 66.2 of the TRIPS agreement and paragraph 7 of the Doha Declaration", although it is the lowest hanging fruit.