WHO hails pharma R&D “breakthrough”

By Lynne Taylor

Delegates at the annual Assembly of the World Health Organisation (WHO) have backed a major new initiative which aims to promote new approaches to pharmaceutical R&D and enhance access to medicines. Their approval of the Global Strategy on Public Health, Innovation and Intellectual Property was described by WHO director-general Dr Margaret Chan as “a major breaktbrough for public health that will benefit many millions of people for many years to come.”

“This is pro-active public health at its very best,” added Dr Chan, as she close the 61st World Health Assembly (WHA) on Saturday (May 24).

The Strategy approved by the policy-setting Assembly, which was attended by a record 2,704 delegates from 190 nations, aims to provide a framework for enhancing essential R&D which has relevance to diseases impacting developing countries and making it sustainable. Part of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) on a Global Strategy and Plan of Action, the initiative also calls on Dr Chan to finalise a plan to provide drugmakers with greater incentives to conduct such research, with the setting-up of an expert group to examine proposals for new and innovative sources of funding. However, the Assembly failed to resolve issues relating to significant elements of the initiative such as time-frames, progress indications and estimated funding needs, and delegates urged Dr Chan to finalise these “urgently.”

A provision put forward by delegates from least-developed nations which sought to put the right to health before commercial interests was dropped from the final resolution before the full Assembly vote, after strong opposition from developed nations.

Nevertheless, the initiative has been welcomed, with reservations, by advocacy groups such as Knowledge Ecology International (KEI), which said the WHO had taken “a big step forward to change the way we think about innovation and access to medicines.” It was “unfortunate,” said KEI spokesman James Love, that the Assembly had failed to address the estimation of R&D funding needs or create a framework for sustainable sources of funding, and also that the WHO Secretariat has yet to engage on the issue of new mechanisms that de-link R&D incentives from product prices. However, he added: “these and other issues will be the subject of the next round of negotiations, which will begin very soon.”

Advocacy group Essential Action said it particularly welcomed that the Assembly had agreed: – to explore R&D incentives like prizes that do not rely on patent monopolies and the prospect of charging high drug prices as a reward to innovators; – to encourage future discussions of an R&D Treaty, which would involve agreement that all countries should have to contribute to global R&D, or at least participate in the R&D system, but that there should be differential obligations based on degrees of wealth; – that developing countries must be encouraged to adopt and implement legislation that contains measures to prevent and penalize anti-competitive practices regarding pharmaceutical patents; – on the importance of creating a global patent database for pharmaceuticals to promote both innovation and access to medicines; and – that the WHO has a crucial role to play regarding health-related implications of patent and related intellectual property rules.

“What is encouraging is that governments have clearly called for the WHO to play a strategic and central role in intellectual property,” added Tido von Schoen-Angerer, director of the Access to Essential Medicines Campaign at the humanitarian agency Medecins Sans Frontieres (MSF).

“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,” said Dr von Schoen-Angerer, who called on the proposed expert group to take on more ambitious proposals to change the way essential health R&D is financed, “including for example through the creation of a prize fund to boost the development of tuberculosis diagnostics.”

– Other initiatives endorsed by the Assembly included a six-year action plan to tackle noncommunicable diseases, particularly cardiovascular diseases, diabetes, cancers and chronic respiratory diseases, which caused 60% of all deaths in 2005 and are now the leading threats to health.