By Tove Iren S. Gerhardsen and William New

A drafting group at the UN World Health Assembly today suggested a possible merger of two key intellectual property resolutions, including the establishment a global strategy and plan of action for research into diseases disproportionately affecting poor countries with action to be taken possibly within a year.

The Swiss chair of the drafting group proposed a text merging a resolution proposed by Brazil and Kenya on a global framework for essential medicine research and development (EB117 E13) and a resolution contained in a report on the WHO Commission on Intellectual Property, Innovations and Public Health’s (CIPIH) report published in April (IPW, Public Health, 24 May 2006).

The resolutions are under discussion in a technical committee at the assembly, which is the annual meeting of the 192 member states of the World Health Organization. At press time, the committee drafting group had returned to discussions on the chair’s text.

The original resolution based on the Brazil and Kenya proposal for a framework on essential health research and development called for a working group of interested member states to be set up to consider alternative incentive mechanisms for “needs-driven research, consistent with appropriate public interest issues.”

The chair’s new proposed text titled, “Public health, innovation and intellectual property rights: a plan of action with special focus on essential health research,” proposed the setting up of an intergovernmental working group open to all interested member states, which was suggested by both of the original resolutions.

The working group is to “develop a global strategy and plan of action which would provide a medium term framework for action to implement the recommendations of the commission.”

The CIPIH report makes some 50 recommendations on how research into and access to medicines for neglected diseases may be improved, and it appears the drafting group will look at all 50. This includes the proposal that bilateral trade agreements should take into account flexibilities from adherence to rules provided for in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The reference to flexibilities in bilaterals is still in brackets in the chair’s text, signifying a lack of full agreement.

The chair’s text proposed that the global strategy and plan of action should in particular address R&D “relevant to diseases that disproportionately affect developing countries,” and does not use the term “neglected diseases” that some proponents have used. It says clear objectives and priorities should be set and funding needs should be identified.

Under the draft, the working group is to report to the next World Health Assembly (the 60th) on the progress of developing a plan of action “involving areas for immediate implementation including mechanisms strengthening needs-driven research,” and submit a final plan to the 61st WHA.

A non-governmental organisation source said that Brazil had wanted to draw up a list of neglected diseases to be covered by the resolution and be updated regularly.

The 8-page chair’s text included three pages of text stripped out of the original resolutions, including specific references such as the Human Genome Project and the support of thousands of scientists and others for the resolutions. It also took out additional text on TRIPS flexibilities and bilateral trade deals, the WTO Doha Declaration on Development. Another item removed referred to intellectual property rights as “one of several tools to promote innovation, creativity, and the transfer of technology.”

CIPIH Chair Urges Global Framework

Ruth Dreifuss, a former Swiss president who chaired the CIPIH, told the technical committee that there is a need for a global framework. She said the report recognises that governments have “major responsibilities” in implementing the recommendations in the report, but the WHO also has a coordinating role, she said.

“Never have people hoped for so much from science,” Dreifuss said.

A key element in the debate is whether the proposed framework would lead to a legally binding arrangement, something US delegation lead William Steiger said his government could not support. In the Thursday committee debate, Kenya said the framework would not have to be legally binding. But in the closed drafting group meeting, another developing country said it should not preclude such an instrument from ever being created, sources said.

In the Thursday committee meeting, South Africa said on behalf of the African nations that they are disappointed with the report as it does not go far enough in its recommendations. It said that the price of medicines often far exceeds that of the cost of R&D and production and this is “abuse of IP policy.”

South Africa said a “dedicated action plan that will produce results” is needed to produce medicines for diseases disproportionately affecting developing countries but said it is unclear how the resolution aims to achieve this goal.

Japan said the current IP system is working effectively and there is no need for a new global framework. This was echoed by the International Federation of Pharmaceutical Manufacturers and Associations, which said the current R&D system is working, but that there is a need for more public-private partnerships.

The United States said the report was “generally evidence-based” but that it exceeds its mandate particularly when it refers to human rights. Also, it said there is no evidence that compulsory licenses will produce tangible results, despite a recommendation that these be used by countries as needed. The US delegate said more work is needed before a treaty can be agreed to.

Norway countered with the suggestion that these issues are related to human rights. It said the development of a global pan of action is “well worth examining” and more resources need to be put into R&D for neglected diseases. The Norwegian delegate said he agreed that patents are an important incentive for innovation, but said “IPRs are definitely not up to the challenges faced by poor countries.”

A representative from Oxfam said the two resolutions “provide an opportunity for revision of the global public health agenda in ways that recognise the extreme urgency of achieving access to medicines that are relevant to global public health, and that support from long-term, sustainable production of low-price public health goods through reinforcing competition, and by introducing innovative ways to finance R&D.”

There appear to be some differences as to whether the Brazil and Kenya resolution would cover neglected diseases only or diseases beyond this such as diabetes. James Love of the Consumer Project on Technology said the resolution should lead to norms and mechanisms, in the short term, for setting research priorities for neglected diseases as well as other diseases. In the long term it should lead to a treaty. Moreover, it should cover both public and private R&D. But others have sought to keep it limited.

EU Under Scrutiny On R&D Resolutions

At a 23 May event, Brazil and Kenya presented the resolution that came from their original proposal. At the event, Ellen ´t Hoen of Médicins Sans Frontières said that the supporters of the resolution “particularly count on European Union countries and governments” for support, adding that “the needs are enormous [and there is] no excuse for governments or WHO not to take action.”

Supporters of the resolutions this week have asserted that the European Commission position closely reflects the position on the pharmaceutical industry, and that it departs from an earlier position expressed by EU commissioner responsible for Health and Consumer Protection, Markos Kyprianou, in a letter faxed to a Member of Parliament in March. Commission officials declined to comment in detail on any of these issues.

Some also raised questions about the Commission’s competence in health matters, which are typically handled at the national level. On the IP resolutions, the Commission is speaking on behalf of the 25 EU member countries plus two accession countries, it said.

In the committee meeting, a European Commission official said that the two resolutions duplicate each other in large measures. The Commission is open to addressing this issue further, he said, but he emphasised that mechanisms and flexibilities already exist under the TRIPS agreement.

Industry Concerned About Global Framework Reference

At the Brazil and Kenya event, one industry representative told Intellectual Property Watch that the industry feared the reference to a “global framework” in the title, although this expression as well as much in the resolution is still in brackets, indicating that no agreement has been reached.

The source said many in the industry feared that the resolution did not address the lack of research into neglected diseases only, but aimed at “breaking up the IP-based research and development (R&D) system.”

He said the industry favours public-private partnerships instead and said that over the past five years such agreements have led to a “robust pipeline of 60 diseases” on which research is being conducted. The resolution, he argued, is “more ideologically driven than needs driven.”

The source said that “everybody agrees” that more research has to be carried out for these diseases but the partnerships and more public funding into these would be a better idea than what was suggested in the resolution.

A representative of the WHO Tropical Disease Research Centre said it is “very correct and proper” to focus on R&D but said research on how medicines are used and implemented is also needed after product development.

A representative for the International Policy Network, which is partially supported by the pharmaceutical industry, said that he found it “peculiar” that the resolution suggested to redesign the way in which R&D is being conducted for “minority diseases.” He also referred to a recent London School of Economics study which concluded that public-private partnerships are producing results.