News and Analysis • Volume 11 • Number 5 • August 2007

WHO Seeks to Strengthen Research on Neglected Diseases

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The World Health Organisation has released a revised draft global strategy and plan of action for innovation on diseases that disproportionately affect developing countries.

The 41-page document is a conglomeration of ideas, compiled by the WHO Secretariat on the basis of a text developed by the Intergovernmental Working Group (IGWG) on Public Health, Innovation, and Intellectual Property in December and written comments submitted from 22 countries and regional groups. The strategy aims to “provide a medium-term framework for an enhanced sustainable basis for needs-driven, essential research and development relevant to diseases that disproportionately affect developing countries.” In spite of criticism that the document is vague and unfocused, several stakeholders called it ‘a reasonable place’ to start negotiations.

Nuts and Bolts of the New Draft

The revised plan of action is structured around eight elements: prioritising research and development needs; promoting research and development; building and improving innovative capacity; transfer of technology; management of intellectual property; improving delivery and access; ensuring sustainable financing mechanisms, and; establishing monitoring and reporting systems. It leaves intact proposals from the previous draft, reorganises and simplifies some of the text, as well as incorporates many – though not all – suggestions by member states. The new draft also presents the plan of action in table format, linking specific actions to stakeholders, time frames and indicators of progress.

The document proposes a focus on 14 diseases, including diabetes, cardiovascular disease, cancer, HIV/AIDS, tuberculosis, chagas disease, dengue, leishmniasis and malaria. One observer admitted that he was ‘confused’ about where the scope of diseases came from, particularly since it was not raised in the country submissions.

Weaving It All Together

Where countries such as the US and Australia raised questions about including topics that are dealt with in other international fora, such as TRIPS-plus provisions in bilateral trade agreements, the draft softens the previous draft’s language by replacing “assure that bilateral trade agreements do not seek to incorporate ‘TRIPS-plus’ protection” with “promote bilateral trade agreements that do not incorporate ‘TRIPS-plus’ protection.” The plan of action names only governments as potential stakeholders in this regard.

As highlighted by several country submissions, the draft calls for greater collaboration between the WHO, the WTO and WIPO to strengthen education and training in the management of intellectual property. Sources at WIPO and the WTO have indicated that they are following the IGWG process and providing technical advice to the WHO upon request. However, they have indicated that the implementation of proposals that assign tasks to their organisations might require further reflection since both institutions have their own mandates and accountability structures.

At the same time, the revised text adds items suggested by countries, including Brazil’s proposal to assess the impact of data-exclusivity regulations. Where the Southeast Asian region called for the WHO to compile good practice and lessons on the implementation of TRIPS flexibilities, the new draft highlights the dissemination of best practices as a means of promoting legislation to apply TRIPS flexibilities.

The text does not change the element entitled ‘management of intellectual property’, which the US called ‘unclear’ and Brazil criticised for “mistakenly assum[ing] that the problems faced by developing countries [were] circumscribed to administrative concerns.”

Moreover, the draft leaves out several specific suggestions by countries such as the Southeast Asian region’s call for an ‘operational interpretation’ of ‘inventive steps’ relating to whether products for which patents have been applied are sufficiently innovative to warrant one. Nor does it adopt Egypt’s suggestion for a set of guidelines for the transfer of technology.

Counsellor Guilherme Patriota of Brazil highlighted two positive elements: (i) the use of flexibilities under the Doha Declaration on TRIPS and Public Health, and; (ii) further work on new models for innovation, especially those that aim to decouple prices from funding, such as the prize fund model.

The draft also calls for further discussion of patent pools, a medical research and development treaty, advanced-market commitments and public-private partnerships. In addition, it makes strong links between trade-related issues and access to medicines, including support for generic production of essential medicines, the removal of tariffs and taxes on health care products, and the use of best manufacturing practices.

While Spring Gombe and Thiru Balasubramaniam of Knowledge Ecology International commended the draft for its approach to access to medicines, support for the use of TRIPS flexibilities and new methods to create incentives for research and development for new medicines, they also called it “vague with neither a clear sense of ownership nor any sense of urgency.” Ellen ‘t Hoen of Médecins sans Frontières also said that the document lacked clear direction and allocation of responsibilities. She added, however, that it was encouraging to see that the plan did not “shy away from including new proposals such as a patent pool to deal with immediate access issues and new rules to incentivise R&D.”

Several delegations declined to comment on the text as negotiations on it were expected to start shortly. Regional consultations are expected to take place in August and September, and the next meeting of the IGWG is scheduled for 5-10 November . In principle, the final plan of action should be ready for adoption at the May 2008 meeting of the World Health Assembly.