WHO COMMITTEE MAKES PROGRESS, BUT FALLS SHORT OF AGREEMENT ON HEALTH INNOVATION

Government negotiators in a World Health Organization committee last week fell short of finalising a potential plan to encourage pharmaceutical innovation that better responds to the needs of people in poor countries. Although they agreed on much of the content of a draft global strategy, they had to leave some of the most contentious issues on the links between intellectual property and innovation unresolved.

The WHO's Working Group on Public Health, Innovation and Intellectual Property (IGWG) was created in 2006 with a two-year mandate to develop a global strategy - and financing plan - for identifying needs and promoting the discovery, development, and delivery of medicines. The committee was mandated to pay special attention to neglected diseases that predominantly affect people in poor countries. It was also charged with finding ways to encourage pharmaceutical innovation in developing nations.

The committee's recent meeting, which ran from 28 April to 3 May, was supposed to agree on a strategy and implementation plan to submit to the World Health Assembly later this month. Instead, the WHO's top decision-making body will have to determine how to deal with a number of potential provisions on which negotiators proved unable to find common ground.

Although this was scheduled to be the IGWG's last session, it is conceivable that the World Health Assembly could call for the group's work to be continued.

WHO Director-General Margaret Chan, in her opening remarks to the session, called the committee's work "a unique opportunity for public health" that could spur innovation and make healthcare products more affordable. "In essence, you are forging ways to tackle the gaps in access to healthcare, and, in so doing, to reduce the gaps in health outcomes," she said. "You are making the benefits of advances in medicine and science more inclusive."

Some have viewed the group's deliberations as an opportunity to explore alternatives to drug patents as a means of encouraging research, innovation and the development of new and affordable drugs. They argue that the patent-based model, which rewards innovation by allowing inventors to charge high monopoly prices, provides no incentive to respond to medical conditions suffered predominantly by poor people in developing countries. And by relying on high drug prices, it fails to balance innovation with affordability and access, they claim.

Certain public health advocacy groups expressed dissatisfaction with the outcome of the IGWG meeting, arguing that it had not prescribed any concrete action. Médecins Sans Frontières said that the negotiations had "failed to capitalise on the historic opportunity." Governments had failed to prescribe concrete change to a "broken system," said Tido von Schoen-Angerer, who heads MSF's Access Campaign. "What we need to see is a wider, more ambitious framework for R&D and political leadership, in particular from [the] WHO. The negotiations have left the greater part of the job undone."

Campaigners called it absurd that a provision stating that drug prices could impede access to treatment -- a point that they deem obvious -- was the subject of much heated debate before negotiators agreed on it. A number of issues were ultimately left within square brackets signalling disagreement, dealing with the right to health, the use of policies to prevent anti-competitive practices with respect to medicine and other healthcare products, and ensuring that future bilateral trade agreements do not provide intellectual property protections on healthcare that go beyond WTO requirements.

Others, including some government officials, countered that even the consensus parts of the draft strategy text represented an unprecedented affirmation of the WHO's ability to address intellectual property concerns. As critically, the text, brackets and all, did not close the door to future work on establishing incentives for innovation that would separate R&D costs from drug prices, such as prizes or creating a global treaty on medical research and development.

MSF acknowledged that proposals for research and development reform had remained on the table, crediting the efforts of their developing country sponsors. "It is now up to the World Health Assembly in May to translate bold ideas into concrete action, since this meeting failed to do so," said MSF in a press release.

James Love, of civil society group Knowledge Ecology International, said that the WHO negotiations were likely to continue beyond the May World Health Assembly into 2009 - and a new US presidential administration. Although he praised the draft strategy for mentioning issues such as prizes and patent pools, he said that it was "weak on the details of the follow-through." The committee had done little to identify research and development priorities or lay the groundwork for future funding, he said.

The International Federation of Pharmaceutical Manufacturers and Associations' Guy Willis said that his organisation's members were "pleased that the IGWG process has
resulted in agreement on many practical measures to help address remaining gaps" in improving healthcare in developing countries.

The 18-page draft strategy reached by 3 May, like earlier versions, focuses on eight elements: prioritising research and development needs; promoting research and development; building and improving innovative capacity; technology transfer; managing intellectual property for innovation and public health; improving delivery and access; promoting sustainable financing; and establishing monitoring and reporting systems.

In a provision from which the US is currently withholding consensus, the draft calls for the WHO to "play a strategic and pro-active role in contributing to pursue the agenda on 'public health, innovation and intellectual property'."

A consensus paragraph specifies that "Intellectual property rights are an important incentive in the development of new health care products. However, this incentive alone does not meet the need for the development of new products to fight diseases where the potential paying market is small or uncertain."

The text outlines several objectives for supporting research and development, particularly in developing countries, from creating public health libraries to making the results of government-funded research publicly available. It also calls for government to consider a "research exception" to address public health needs in developing countries, consistent with the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

One potential provision would have urged governments to consider pursuing competition policies in order to prevent "anti-competitive practices related to health products." Governments such as Italy have suspended patent protection for some drugs after finding patent-holders to have abused dominant market positions. However, US opposition meant that the provision remained within brackets, said Knowledge Ecology International's Thiru Balasubramaniam, who described it as "distressing" to see progress on remedying anti-competitive practices "roadblocked."

Fundamental disagreements notwithstanding, Health Action International's Christian Wagner-Ahlfs observed that governments had managed to find "consensus on items which some years ago they would not have even talked about."

The fate of remaining roadblocks will first be determined at the World Health Assembly, scheduled for 19-24 May.

The draft strategy text is available at http://www.who.int/phi/documents/IGWG_Outcome_document03Maypm.pdf.

ICTSD reporting.