By Tove Iren S. Gerhardsen
The World Health Organization’s (WHO) new draft negotiating document for the final round of what has become an intense process of analysing medicines innovation and intellectual property narrows the focus to about a dozen diseases but is wide-ranging on policy options, seemingly encompassing all proposals. In early reactions, some criticised the draft for lacking specificity, even to the point of being “fundamentally flawed”.

The document will serve as a basis for negotiations at the second and last meeting of the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) on 5-10 November.

The document (draft global strategy and plan of action, A/PH/IGWG/2/2) “will be discussed at the regional consultations and should be the basis for negotiations at IGWG-2 in November,” a WHO source told Intellectual Property Watch. Meetings of WHO regional committees have been scheduled for August and September (IPW Monthly Reporter, Vol. 4., No. 6).

[Editor's Note: In the meantime, WHO will hold an online consultation process in August and September through which member states and others can comment on the draft document as well as on the latest resolution in the process, WHA60.30, from this year’s World Health Assembly, WHO said.]

The IGWG has been tasked with forming by May 2008 a “global strategy and plan of action” for boosting research and development (R&D) of medicines for non-prioritised or neglected diseases, predominantly found in developing countries.

The new document says (in a footnote) that the strategy will focus on 14 such diseases, including diabetes, cancer, HIV/AIDS and Chagas disease. Up to now, there has been some confusion about how many and which diseases might be considered neglected.

The document, released on 31 July, is based on a “progress to date” document prepared at the end of the first meeting of the IGWG, held on 4-8 December 2006 (IPW, Public Health, 11 December 2006). The meeting agreed to focus discussion on eight areas or “elements,” and these are elaborated upon in the new document, both relating to the strategy and actions.

In preparing the new text, the WHO secretariat considered additional comments and input from member states and others since the last meeting through a hearing process that ended this spring. The text only lists what countries want in positive terms, meaning that if some countries disagree with the draft, they will have to request the deletion or amendment of existing parts of the text.

Strategy Includes Flexibilities, IP Management

The document focuses first on the strategy and then on the actions. On the draft strategy, the document lists a number of proposals, including promoting legislation to apply flexibilities consistent with the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and other international agreements, promoting upstream R&D in developing countries by considering legislation compliant with TRIPS research exemptions, and “promoting transfer of technology and the production of health products in developing countries.”

The draft also suggests promoting bilateral trade deals that do not contain “TRIPS-plus” requirements and that such bilateral deals should be “regularly monitored” as to their impact on health, the pharmaceutical industry should reduce prices for developing countries, public private partnerships should be boosted and further discussion, [Clarification: further discussion of] a medical R&D treaty should be supported and complementary incentive schemes separating innovation from prices should be explored and implemented.

The draft strategy specifically encourages WHO to get more involved in IP in collaboration with WTO and the World Intellectual Property Organization to “strengthen education and training in the management of intellectual property.”

Management of IP also is an element in the document without further specification of what this would mean. For example, it says, “There is a crucial need to strengthen capacities in developing countries to manage intellectual property.”

The strategy should be reviewed by the World Health Assembly every two years, starting at the end of 2009, with a comprehensive evaluation every four years, extending the process until 2015, the document says.

The plan of action is laid out separately, still around the eight elements. It lists who would do what by when. For example, WHO would identify gaps in R&D for neglected diseases in 2008, the pharmaceutical industry would help facilitate upstream research by 2008-2015, WHO would coordinate the process until 2015 and governments would work on prioritising strategies and increasing funding for R&D (especially developing country governments). The actions involve a wide range of stakeholders, including nongovernmental organisations, UN organisations, the industry and research institutions.

Early Criticism over Breadth

But the sheer breadth of the document has been criticised.

“The draft plan of action is fundamentally flawed because it is based on the premise of trying to accommodate conflicting points of view and the result is 80 un-prioritised ‘specific actions’ which are not really specific or actionable at all,” said a close observer who asked to remain anonymous. “The ‘specific actions’ are simply aspirational - they embody no specific commitments by governments to particular actions.”

“A real plan would focus on a few key priorities - for finance, institutions and new incentive mechanisms; set targets for which governments or other stakeholders could be held accountable; and identify lead institutions responsible for delivering and monitoring outcomes envisaged in the plan. Because of the process involved in the IGWG it will now be very difficult to turn this sow’s ear into a silk purse,” the source said.

Ellen ‘t Hoen of Médecins Sans Frontières also had mixed feelings about the document. “It has ‘everything to be done by anyone’ in it,” she said. “So far, the document lacks clear direction and allocation of responsibilities. However, it is encouraging to see that it does 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.”

A pharmaceutical industry source told Intellectual Property Watch that it was welcome that the document reflected the IGWG’s original scope of work laid out in the 2006 report of the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) and had the ambition to cover “it all.” But the source was concerned that the focus appeared to be not only on IP but even more narrowly on flexibilities related to TRIPS and compulsory licensing in particular.

A compulsory license is issued by a government and allows the use of a patented subject und certain conditions (for example, for non-commercial use) without the consent of the patent holder.

As for suggestions to avoid TRIPS-plus in bilateral trade deals, that was already a “done deal” as the United States has already adopted restrictions in this area, the industry source said (IPW, WTO/TRIPS, 24 July 2007).

The industry source said that the risk was that if industry accepted a broad and balanced approach, some of the NGOs and stakeholders would only be interested in two or three of the bullet points in the plan. If the only outcome of the IGWG process would be that WHO helps countries with TRIPS flexibilities, “this is a failure,” the industry source said.

The document was “cautiously welcomed” by international civil society observers, Knowledge Ecology International (KEI) said. Spring Gombe and Thiru Balasubramaniam of KEI said: “[T]he draft contains some welcome statements of access to medicines, support for the use of TRIPS flexibilities and new methods to create incentives for R&D for new medicines. However, the plan of action is vague with neither a clear sense of ownership nor any sense of urgency. There is a further danger … that if all stakeholders are considered equally responsible for every point of the plan of action, there can be no one held accountable when no action is taken. The biggest omission is the absence of any reference to money.”

The eight elements are: Prioritising R&D needs, promoting R&D, 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. They “provide the organising principles for the plan of action,” the document states.

Tove Gerhardsen may be reached at tgerhardsen@ip-watch.ch.