By William New
The annual World Health Assembly on Saturday adopted a global strategy aimed at filling the research gap for diseases afflicting developing countries that places the UN agency squarely in global intellectual property policymaking and despite compromises is the most significant reference document on IP and public health in years, according to sources involved in the drafting.

“This is the most important document since the Doha Declaration on Public Health,” said a leading developing country negotiator. “It deals with many issues to some extent not dealt with in the Doha Declaration.”

That declaration from the 2001 World Trade Organization ministerial in Doha, Qatar reaffirmed flexibilities in applying rules in the 1994 WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) available to developing countries.

World Health Organization Director General Margaret Chan in her closing remarks to the assembly plenary called the outcome on IP and innovation a “huge step forward.” With it, she said, “public health leaps ahead in addressing two fundamental and long-standing needs: to improve access to existing interventions, and to include diseases of the poor in the drive to develop new products.”

“This is a major breakthrough for public health, and I congratulate you all,” Chan said. “This is a breakthrough that will benefit many millions of people for many years to come. This is a contribution to fairness in health, and this is pro-active public health at its very best.”

Health advocates and developing country officials also praised the outcome despite substantive modifications during negotiations. Industry groups and developed countries appeared silent on the outcome.

James Love, director of health advocacy group Knowledge Ecology International, stated afterward: “Six and a half years after the Doha Declaration, and five years after the CIPIH [WHO Commission on Intellectual Property Rights, Innovation and Public Health] was created, the WHO has taken a big step forward to change the way we think about innovation and access to medicines.”

Love called the outcome “a lengthy and substantive document,” that represents consensus on difficult topics, “sometimes with impressive clarity,” that “were considered controversial only a short time ago.”

The new WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property also reaffirms the TRIPS flexibilities, plus requires a look to be taken at the health impact of trade measures, and contains a new paragraph on competition policy to prevent abuse of intellectual property rights, among nearly 50 provisions.

Key elements of the strategy include: providing an assessment of health needs in developing countries and identifying research and development priorities; implementing possible incentive schemes for R&D; improving R&D capacity in developing countries; boosting technology transfer; improving access to all health products; and securing sustainable financing for R&D in developing countries.

A primary goal is to promote R&D on diseases that disproportionately affect people in developing countries, as well as diseases substantially affecting both rich and poor nations.

“The strategy, if implemented, will address equitable access and address a long-term need for sustainable innovation,” Elil Renganathan, who heads the IP and public health effort at the WHO, told reporters on Wednesday. “We are very encouraged.”

Next Steps

Portions of the plan of action will be worked out in the coming year, including a progress indicator and costing of the plan, and come back to the Executive Board and 62nd Health Assembly in May 2009, said Renganathan, who is the executive secretary of the WHO Secretariat on Public Health, Innovation and Intellectual Property (PHI).

A key issue in the action plan is who will be the lead stakeholders on each action item, after governments. The debate is focussed on how prominent WHO’s role should be on IP issues, sources said. Developed countries and developed country pharmaceutical and biotechnology industries have pushed to limit WHO’s involvement in these issues.

“The resolution and strategy seek that WHO plays a central and strategic role in IP and innovation, within its mandate,” Renganathan said.

The director general will select an expert group designated by the adopted strategy, hopefully to be operating in the next 2-3 months in order to have something to report to the next WHO Executive Board meeting in January 2009, Renganathan said.

The secretariat will organise the follow-up work, including finalisation of the action plan, formation of the expert group, and monitoring and evaluating. It is unclear what the budget is for the activities in the current WHO budget, or what the costs are expected to be.

The WHO section on innovation and intellectual property will oversee the efforts, working with different WHO sections such as Tropical Disease Research, Initiative for Vaccine Research, Department of Medicines, Non-Communicable Diseases, and with regional offices. There will be a “degree of scaling up and new activities,” said Renganathan.

The assembly resolution is technically non-binding, but when members agree to a resolution, “it’s a commitment in some sense that they will take this forward,” he said.

In order to determine the cost of the resolution, the WHO department that handles financing will work over the coming months to develop a plan which will enable a determination of cost, he said. Then member states and stakeholders would step up.

“What is encouraging is that governments have clearly called for the WHO to play a strategic and central role in intellectual property,” Tido von Schoen-Angerer, director of the Médecins Sans Frontières (MSF) Access to Essential Medicines Campaign, said in a statement. “Countries have pledged to give health interests the pre-eminence they deserve when considering how to manage IP.”

“We need more money for R&D, but money is not the only answer – we also need new models for incentivising the R&D and ensuring access to new drugs and diagnostics,” von Schoen-Angerer said. He further urged the upcoming expert working group to “take serious steps to move forward” on the strategy, and “to take on more ambitious proposals to change the way essential health R&D is financed, including for example through the creation of prize fund to boost the development of tuberculosis diagnostics.”

KEI’s Love said his group was impressed that the assembly was strong on the use of compulsory licensing and other flexibilities, and recommended that drug registration requirements conform to the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects. He also highlighted the assembly’s support for work on a biomedical R&D treaty, collective management of intellectual property rights, and “the use of new mechanisms, like prizes, to provide innovative incentives that are not linked to product prices.”

But Love called it “unfortunate” that the assembly left unfinished the estimation of funding needs for priority R&D or the creation of a framework for sustainable sources of funding. These and discussion of “new mechanisms that de-link R&D incentives from product prices” await member states in the next round of negotiations, he said.

Speaking in committee just prior to the final plenary, Bolivia made an intervention concerning the relationship between the resolution and six proposals from Bolivia and Barbados from April that suggested alternative approaches. Bolivia asked that the meeting minutes reflect the fact that these proposals were appropriate for consideration by the expert group working on creative methods of finance to stimulating R&D, according to a participant. The request by Bolivia was agreed upon.

Background

Patents on medical products provide right holders with monopolies for a limited period of time, intended as the reward for research and development. Most patents are held by owners in developed countries.

WHO undertook to draft a strategy on IP and health after it was agreed that incentives are lacking for industry to invest substantially in diseases predominantly affecting poor populations, known as neglected diseases. This assembly marks the end of the two-year mandate of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), set up by the 2006 assembly.

In a fact sheet circulated this week, WHO said, “member states endorsed by consensus a strategy designed to promote new thinking in innovation and access to medicines, which would encourage needs-driven research rather than purely market-driven R&D to target diseases which disproportionately [affect] people in developing countries.”

The texts

The final texts of the 19-24 May World Health Assembly resolution, global strategy and plan of action will not be available for days, according to the WHO. The strategy contains eight overarching elements, in addition to the context and principles.

The latest available texts were from Saturday morning, 24 May, available for subscribers on www.ip-watch.org.

[Update: the final text is now available; click here for access.]

“If this strategy is put in place, we will have new medicines for diseases” for which there are now a limited number of medicines, Renganathan said.

The resolution and global strategy changed slightly on the final day of the assembly, mainly to reflect the unfinished plan of action.

Item 1 of the resolution changed to now say the assembly “Adopts the global strategy and agreed parts of the plan of action [footnote: on the specific actions and stakeholders components] on public health, innovation and intellectual property, attached to this resolution.”

The stakeholders components refers to who will be lead stakeholders and who will be secondary, a subject of significant debate in the plan of action during the week. A key aspect is whether WHO has a lead role on some IP issues, sources said.

Resolution item 4.1 now requests the director general “to provide support for member states, upon request, in implementing the global strategy and agreed parts of the plan of action without prejudice to existing mandates.”

Also, member states removed the list of five actions under the Quick Start programme, including to: map global R&D activities, establish baselines and identify research gaps; improve cooperation, collaboration and information-sharing in health R&D; support R&D and promote standard-setting for traditional medicines in developing countries; develop and strengthen regulatory capacity, including safety, efficacy, quality and ethical review; and support information-sharing and capacity building in the application and management of intellectual property for health innovation and public health, in collaboration with other relevant international agencies.

Also on the last day, members dropped references to a right to health (referenced by Bolivia above) and the World Intellectual Property Organization Development Agenda (IPW, WHO, 24 May 2008).

Provisions related to data exclusivity, test data, patentability criteria, anti-counterfeiting were cut from the text Friday night after differences could not be surmounted (IPW, WHO, 24 May 2008).

A separate assembly draft resolution on counterfeiting was deferred to next year. And, in another matter, a new, more centralised WHO publication policy was pushed through the Executive Board meeting immediately after the assembly (see story to follow).

WHO and some member states insist the plan will make a difference.

“Developing countries will get additional support in the R&D going on in their countries,” said Renganathan. It includes centres of excellence, training of researchers, a push for technology transfer, and provides a format for flexibilities under the WTO TRIPS agreement. Governments also hope to receive funding to support activities in their countries.

William New may be reached at wnew@ip-watch.ch.