TWN Info Service on Intellectual Property Issues (June 07/01)

04 June 2007


WHA AGREES ON HEALTH, INNOVATION AND IP AFTER INITIAL DIVISIONS

Among the most contentious and important decisions taken by the 60th World Health Assembly which ended on Wednesday (23 May) was the adoption of the resolution on public health, innovation and intellectual property.

Adoption of this resolution was seen as giving a much-needed boost to the work of the Inter-governmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) set up by the previous WHA in 2006

The resolution addresses the issue of public health, innovation and intellectual property in general, and in particular, the work of the IGWG which is tasked with developing a global strategy and action plan for a medium-term framework based on the recommendations of the Commission on Intellectual Property Rights, Innovation and Public Health.

Initially there was plenty of opposition by many developed countries against adoption of the resolution first proposed by Brazil. However in the end, the lone dissenting voice was only the US. At the plenary session to adopt the WHA resolution, the United States stated that it could not accept the resolution on public health, innovation and intellectual property but that it would not block the consensus process. The US stated that it disassociated itself from the adoption of the resolution and that it therefore did not consider it to be a consensus text.

Full text of the Resolution is available at
http://www.who.int/gb/ebwha/pdf_files/WHA60/A60_R30-en.pdf

Generally the Resolution requests the WHO Director General to:

(1) to ensure technical and financial support to the Intergovernmental Working Group in
order to facilitate completion of its tasks in time for its report to the Sixty-first World Health Assembly;

(2) to provide as appropriate, upon request, in collaboration with other competent international organizations, technical and policy support to countries that intend to make use of the flexibilities contained in the agreement on Trade-Related Aspects of Intellectual Property Rights and other international agreements in order to promote access to pharmaceutical products,1 and to implement the Doha Ministerial Declaration on the TRIPS Agreement and Public Health and other WTO instruments;

(3) to provide technical and financial support for regional consultative meetings in order to set regional priorities that will inform the work of the Intergovernmental Working Group;

(4) to encourage the development of proposals for health-needs driven research and development for discussion at the Intergovernmental Working Group that includes a range of incentive mechanisms including also addressing the linkage between the cost of research and development and the price of medicines, vaccines, diagnostic kits and other health-care products and a method for tailoring the optimal mix of incentives to a particular condition or product, with the objective of addressing diseases that disproportionately affect developing countries;

(5) to prepare background documents on each of the eight proposed elements of the plan of action, as identified by the Intergovernmental Working Group, including:
• a matrix on ongoing activities and current gaps;
• a matrix on current proposals referring to key stakeholders;
• the financial implications of those proposals.

A brief report on the Resolution and the deliberations during the WHA on the Resolution was reported in SUNS #6258 Friday 25 May 2007 and is reproduced here with permission.

Best Wishes
Sangeeta Shashikant
Third World Network
Tel: +41 (0) 22 908 3550
Fax: + 41 (0) 22 908 3551



WHA AGREES ON HEALTH, INNOVATION AND IP AFTER INITIAL DIVISIONS


Geneva, 24 May (Lim Li Lin) -- Among the most contentious and important decisions taken by the 60th World Health Assembly which ended on Wednesday (23 May) was the adoption of the resolution on public health, innovation and intellectual property.

Adoption of this resolution was seen as giving a much-needed boost to the work of the Inter-governmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) set up by the previous WHA in 2006.

The first meeting last year of the IGWG (which is tasked with producing a global strategy and plan of action on the issue) was regarded by many as a failure, as little progress was achieved and there has been a perceived lack of interest by the WHO Secretariat in giving leadership or resources to the process.

At this WHA, several developing-country delegations and health-related NGOs urged the WHO and its Director-General Margaret Chan to place high priority to the health, innovation and intellectual property issue.
In a committee session to discuss the topic last Thursday, the Director-General pledged her commitment to the issue. (See SUNS #6255 dated 22 May 2007. )

Brazil then spear-headed the discussion of a draft resolution, which was then discussed in a working group on Monday and Tuesday. A compromise text was put before a committee and adopted. However, there was a lone dissenting voice.

At the plenary session to adopt the WHA resolution, the United States stated that it could not accept the resolution on public health, innovation and intellectual property but that it would not block the consensus process. The US stated that it disassociated itself from the adoption of the resolution and that it therefore did not consider it to be a consensus text.

Experts of the WHO process pointed out that despite the dissenting opinion, the resolution has been adopted by the WHA. If need be, a resolution can be voted on, with a majority vote needed to carry it. In this case, a vote was not necessary and the US delegation said that it would not block the consensus process.

The US did not clarify which parts of the resolution it was objecting to.

The resolution addresses the issue of public health, innovation and intellectual property in general, and in particular, the work of the IGWG. The IGWG is tasked with developing a global strategy and action plan for a medium-term framework based on the recommendations of the Commission on Intellectual Property Rights, Innovation and Public Health.

The framework aims to secure an enhanced and sustainable basis for needs-driven essential health research and development on diseases that disproportionately affect developing countries. Clear objectives and priorities for research are to be proposed by the Working Group.

The strategy and action plan will be presented to the 61st World Health Assembly next year. The second and final session of the Working Group will be held in November this year. The first meeting of the Working Group examined elements of a draft action plan. Potential areas for early implementation were suggested; however, these have not been endorsed by the member states.

The final resolution expresses appreciation to the Director-General for her commitment to the process spearheaded by the IGWG and encourages her to guide the process to draw up the global strategy and plan of action.

It requests the Director-General to ensure technical and financial support to the Working Group to facilitate completion of its tasks; and to provide technical and financial support for regional consultative meetings for regional priority-setting that will inform the deliberations of the Working Group.

The resolution also requests the Director-General "to provide as appropriate, upon request, in collaboration with other competent international organizations, technical and policy support to countries that intend to make use of the flexibilities contained in the agreement on Trade-Related Aspects of Intellectual Property Rights and other international agreements in order to promote access to pharmaceutical products and to implement the Doha Ministerial Declaration on the TRIPS Agreement and Public Health and other WTO instruments."

This paragraph is a watered-down version of the original Brazilian draft. This had requested that the Director-General provide technical and policy assistance to countries that want to make use of their legal flexibilities under the TRIPS Agreement to increase access to medicines, vaccines, diagnostic tools and other healthcare products in implementing the WTO Doha Ministerial Declaration on Public Health.

The call on the WHO to support countries intending to make use of TRIPS flexibilities (such as compulsory licensing) was prompted by the disappointment felt by several developing countries that the WHO leadership had not come out in support of developing countries (recently, Thailand and Brazil) that have issued compulsory licenses to enable the supply of cheaper generic drugs.

The WHO Secretariat has also been perceived to have slowed down or stopped its previous technical assistance to developing countries on the legal and policy issues involved in the relationship between TRIPS and public health, and on the policy and practical aspects of compulsory licensing within the TRIPS framework.

The resolution also requests the WHO Director-General "to encourage the development of proposals for heath-needs driven research and development" at the Working Group "that includes a range of incentive mechanisms including also addressing the linkage of the cost of research and development and the price of medicines, vaccines, diagnostic kits and other health-care products, and a method for tailoring the optimal mix of incentives to a particular condition or product, with the objective of addressing diseases that disproportionately affect developing countries."

This paragraph was also a compromise text. The original Brazilian proposal mentioned incentive measures that include those that separate paying for the cost of research and development from the price of medicines and other health-care products.

This crucial point was not agreed to by developed countries in this explicit way at the drafting group. It thus remained in square brackets when the resolution was discussed in the larger committee.

Switzerland proposed language which was finally accepted, that the incentive mechanisms include addressing the linkage of the cost of R& D and the prices of medicines, etc.

Finally, the resolution also requests the WHO Director-General to prepare
background documents on each of the eight proposed elements of the action plan including a matrix on ongoing activities and current gaps, a matrix on current proposals referring to key stakeholders, and the financial implications of such proposals.

During the initial discussion on the Brazilian draft, the US, the EU, Switzerland and Canada expressed disquiet. Switzerland and Canada suggested that the proposal would pre-empt the work of the Working Group. Argentina, Bolivia, Chile and Ecuador supported the Brazilian proposal.

A drafting group was established to work on the resolution. Initially, it was unable to make any progress because the Member States could not agree and were not willing to be flexible. But further negotiations finally yielded some progress with the agreement on the final text, with only the US expressing its reservation at the final plenary session.