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The WHO negotiations on public health, intellectual property and innovation ended last Saturday with substantial progress toward consensus on a draft strategy but the most contentious articles in the strategy still under brackets - indicating lack of agreement.
Ambassador Tom Mboya Okeyo of Kenya said the outcome’s impact will take time to see but that it was a good step. He noted consensus on provisions on access to medicines, and on flexibilities in the international IP system to accommodate access. "Also agreed were several provisions that could strengthen innovation on essential medicines and encourage sustainable financing mechanisms, and provisions that could help protect traditional medical knowledge, all of which are important to developing countries", he said.
WHO Director General Margaret Chan’s closing comments praised the assembled delegates at the 28 April to 3 May Intergovernmental Working Group on Public Health, Innovation, and Intellectual Property (IGWG) for reaching consensus on 107 paragraphs (many through deletions) that had been unresolved at the meeting’s start Monday.
Some key outcomes or debates were the proposed creation of an expert group on financing and the coordination of R&D, a mention of prizes as a possible alternative incentive for research and development, and policies on human clinical trials, competition, counterfeit medicines, and the role of the WHO on international IP and innovation issues.
Also significant was the apparent removal of advance market commitments, which would have created a mechanism for ensuring a market for new drugs, sources said.
One source also said there was now a separation of provisions relating to access from those relating to intellectual property rights. The group’s mandate from the 2006 Health Assembly was to agree on a strategy and plan of action to boost research and development of, and access to, treatments for diseases disproportionately affecting developing countries, in time for this year’s annual assembly.
If sufficient agreement is reached on the remaining items and the plan of action, implementation of the strategy should follow. But there was also a sense from many delegates that substantive work lies ahead, and some nongovernmental organisations expressed disappointment at the IGWG’s perceived lack of strong commitment to public health, and the potential lost opportunity to make a profound difference.
While the global strategy being drafted by the group is not legally binding, it is being taken seriously by governments and other stakeholders because it could have a significant impact on policy. "It is a political document," said one official. "It can have a lot of weight." Concerned entities and other nongovernmental organisations participating at the event were not entirely pleased with the outcome of the negotiating process.
Médecins Sans Frontières (MSF) sharply criticised the IGWG, saying it had "failed to take concrete action towards reforming a medical innovation system that largely disregards the health needs of millions of people in developing countries." Tido von Schoen-Angerer, director of MSF’s access to medicines campaign said that negotiators had not "risen to the challenge" of "prescrib[ing] change to a broken system."
He called the working group a "lost opportunity," particularly because there had been no consensus on the development of alternative research and development incentives.Jamie Love of Knowledge Ecology International said the IGWG "did next to nothing on identifying R&D priorities, estimating funding needs, or creating a framework for sustainable funding for priority R&D, three tasks central to its mission."
Nicoletta Dentico, policy and advocacy manager at the Drugs for Neglected Diseases Initiative (DNDi) said "the outcome of this intense week-long negotiation shows that some uncertain lights are looming, but still in a forest of thick shadows" that research on essential medicines still faces the "resistance of those who have set the direction of innovation so far" but that hopefully the ""spirit of Geneva" [would] clear, in the face of poor people’s needs, the shadows.
" MSF has said that, as the IGWG failed to arrive at strong conclusions, it is now up to the World Health Assembly "to translate bold ideas into concrete action."
