TWN Info Service on Health Issues (May 06/4)

29 May 2006

WHA to discuss IPRs and R&D framework

Two important draft resolutions of particular concern to the developing countries will be debated at the WHA. They are a ‘global framework on essential health research and development’ and ‘public health, innovation and IPRs’. However some developed countries are expected to restrict the proposals if these may affect the interests of the drug firms. The report below delves into the process of the drafts at the WHA’s executive board and the bracketed (contentious) paragraphs that need to be tackled.

It is reproduced with permission from the South-North Development Monitor (SUNS) # 6032, 22 May 2006.

With best wishes
Evelyne Hong

IPRs and R&D framework to be contentious issues at WHA

By Martin Khor, Geneva, 19 May 2006

One of the highlights of the World Health Assembly which begins here on Monday will be the discussion on intellectual property rights, which is an agenda item with two resolutions linked to it.

One of the resolutions is on a global framework on essential health research and development, which had originally been proposed by Kenya and Brazil. The other is on "public health, innovation and IPRs", and it relates directly to the report on the WHO Commission on IPRs, Innovation and Public Health (CIPIH) which was recently issued.

There is a great deal of interest in the issue and especially on the two proposals, on the part of developing country delegations, and among health and development NGOs, scientists and researchers.

Groups such as Drugs for Neglected Diseases Initiative, Medicins Sans Frontieres, and CP Tech, as well as renowned scientists such as the Nobel laureate Sir John Sulston, have joined in a campaign for a global medical R&D framework, in support of the resolutions.

While many developing countries are geared up to promote the two resolutions, some major developed countries (especially the United States) are expected to place restrictions on the actions being proposed and on the underlying principles. They will be watching out for the interests of the big pharmaceutical drug firms, which fear that government regulation may affect their commercial interests.

There are some issues in common in both resolutions, which also contain a few proposals on similar topics. Both draft resolutions call for a global framework or convention for R&D that responds to the needs of neglected diseases and patients. They also both deal with the treatment of IPRs, and particularly raise concerns about the health effects of bilateral free trade agreements.

Discussions on the two draft resolutions have taken place at the WHA's executive board in January and April, and there are several remaining contentious issues. As a result, there are brackets around some of the texts, especially on the operational parts that call for action on the part of member states or the World Health Organisation secretariat.

The draft resolution on health R&D has been transmitted by the WHA Executive Board which discussed it in January. It is based on the need to develop new medicines for diseases that primarily affect the world's poorest people, and of the need for additional funding for R&D for new vaccines, diagnostics and pharmaceuticals for illnesses that disproportionately affect developing countries.

The draft also contains a paragraph on the importance of a balance between IPRs and the public domain and the need to implement IPR rules in a manner consistent with the human right to health and the promotion of follow-up innovation. This is placed within brackets, denoting lack of consensus.

The draft urges member states to make global health and medicines a strategic sector and to act to emphasise priorities in R&D addressed to poor patients.

Member states are also urged to take an active part in establishing a framework for defining global health priorities in supporting essential medical R&D based on equitable cost sharing and incentives to invest in useful R&D in the areas of patients' need and public interest. Many of the words in this paragraph are in brackets.

Also bracketed is a paragraph urging member states to encourage that bilateral trade agreements take into account the flexibilities in the TRIPS agreement, and that the CIPIH report is included in the WHO's regional committees in 2006.

In its most important operational section, the draft requests the WHO Director-General to establish an open-ended working group of interested member states to consider proposals to establish a global framework for supporting needs-driven research, consistent with public interest issues. The reference to establishing a global framework is in brackets.

Another suggested action is for the Director-General to submit a final report of the working group by May 2008 and to suggest alternative simplified systems for protecting intellectual property with a view to enhancing accessibility to health innovations and building capacity for product development and delivery in developed and developing countries.

The second resolution, on public health, innovation and IPRs, was discussed by a working group of the Executive Board in April, in response to the release of the CIPIH report.

The draft resolution had not yet been placed on the WHO website by early Friday afternoon. However, a version of the draft obtained by the SUNS urges member states to consider the report's recommendations (and its implementation) and to contribute to developing a global strategy and plan of action.

It also urges member states to take advantage of the flexibilities in the TRIPS agreement, and "to ensure that bilateral trade agreements do not seek to incorporate TRIPS-plus protection in ways that may reduce access to medicines in developing countries." These provisions are in brackets.

The draft also requests the WHO Director-General to establish an intergovernmental working group (representative of the six WHO regions) to develop a global strategy and plan of action, built on the CIPIH recommendations, in particular, ways of addressing diseases that disproportionately affect developing countries.

The Director-General is also asked to report on progress of the plan of action, to publish a periodic update of a public health based R&D report for pharmaceuticals, and to monitor from a public health perspective the impact of IPRs on the development of and access to health care products.

Also inserted in the draft is a proposal by Brazil for consultations to elaborate a Framework Convention on research, development and innovation on public health, in order to define priorities and financing alternatives on research, development and innovation in health.

Speaking on Friday at a forum on the CIPIH report, organised by the MSF, Dr AEO Ogwell of the Kenyan Health Ministry explained the rationale of the Kenya-Brazil draft resolution on R&D.

"The problem is that there are diseases affecting poor countries, and treatment requires equipment for diagnosis and drugs, and research is needed to develop both," said Ogwell, who is one of the prime movers of the resolution.

"Our resolution asks for a re-focusing of priorities so as to give primacy to diagnostics and drugs aimed at treating people and diseases that are neglected. It is time for governments to take responsibility to protect people's health. We can't continue to produce drugs only for those who are able to pay, we must cover the majority who are poor."

Another resolution before the WHA is on international trade and health. It urges member states to promote national dialogue to consider the interplay between trade and health, to adopt policies and laws that address these issues, and address potential challenges that trade and trade agreements may have for health.

Member states are also urged to establish coordination mechanisms involving ministries of finance, health and trade to address health related aspects of trade; to generate coherence in trade and health policies; and develop capacity to analyse opportunities and challenges of trade and trade agreements for health outcomes.

The WHO Director-General is requested to provide support to members states to frame coherent policies to address the trade and health relationship; to build their capacity to understand implications (and address the challenges) of trade and trade agreements for health; and to work with other organisations to support trade and health policy coherence at regional and global levels.

The resolution is expected to be adopted without controversy as there are no brackets in the text, which reflects that disagreements have been ironed out at the Executive Board.