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 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;