REVISED WHO PLAN FOR PHARMACEUTICAL R&D CALLED A 'REASONABLE PLACE TO START'

The World Health Organization has released an updated version of a potential plan to spur innovation aimed at developing affordable treatments for diseases that disproportionately affect poor countries.

The forty-one page document, dated 31 July, contains a wide range of ideas for how to identify research needs, ramp up pharmaceutical development and innovative capacity, and improve access to medicines. Notably, it highlights the relationship between intellectual property and pharmaceutical innovation, both through the use of flexibilities in WTO rules and the exploration of incentives outside the traditional patent system. The suggestions in the draft plan were based on a text developed at the last meeting of the WHO's Intergovernmental Working Group (IGWG) on Public Health, Innovation, and Intellectual Property as well as written comments submitted by 22 countries and regional groups (see BRIDGES Weekly, 25 April 2007).

Although critics called the new draft vague and unfocused, WHO officials defended the decision to include most proposals rather than discarding several to produce a more targeted plan of action. There is "a thin line to be walked between including too little or too much," argued one vice-chair of the committee. Another official told Bridges that a less inclusive text would not have been consonant with the secretariat's approach to the talks in the IGWG. "We have sought to sort out the concerns of all parties with a passionate interest in advancing research and development for neglected diseases," added WHO Assistant Director-General Howard Zucker.

GlaxoSmithKline's Jon Pender said that the text formed "a reasonable basis for discussion."

Health activists say that only a small share of global spending on medical research focuses on problems faced predominantly by developing countries, even though they account for the bulk of avoidable ill-health. Some see the ongoing deliberations at the WHO as an opportunity to explore alternatives to drug patents as a means of encouraging innovation and the development of new and affordable drugs.

Nuts and bolts of the new draft

The draft global strategy states that despite recent progress on innovation and access to medicines, the sheer scale of "avoidable suffering and mortality" means that "more must be done." To this end, it 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." It focuses on "diseases or conditions of significant public health importance in developing countries for which an adequate treatment for use in resource-poor settings is not available."

Like the previous version, the revised plan of action is structured around eight elements: prioritising research and development needs; promoting research and development; building and improving innovative capacity; technology transfer; managing intellectual property; improving delivery and access; ensuring sustainable financing mechanisms; and establishing monitoring and reporting systems. It simplifies parts of the earlier text, and incorporates many -- though not all - suggestions by governments. The new draft presents the plan in table format, linking specific actions to stakeholders, time frames, and measurable indicators of progress.

Additionally, the draft proposes a focus on 14 diseases, including diabetes, cardiovascular disease, cancer, HIV/AIDS, tuberculosis, Chagas disease, dengue, leishmaniasis, and malaria. One source admitted that he was "puzzled" about where this came from, especially since as it was not raised in the country submissions.

Another close observer of the process noted that the plan failed to include concrete instructions on precisely how to accomplish the various priorities, such as identifying research gaps. Also absent were details on how any of this would be funded.

Alternatives to patents discussed

The new draft softens language on the appropriate level of intellectual property protection in bilateral trade agreements, following questions from the US and Australia about whether the WHO text should address issues dealt with in other international fora. For instance, a phrase saying that governments should "assure that bilateral trade agreements do not seek to incorporate 'TRIPS-plus' protection" is replaced with "promote bilateral trade agreements that do not incorporate 'TRIPS-plus' protection."

As highlighted by several country submissions, the draft calls for greater collaboration between the WHO, the WTO and the World Intellectual Property Organization for purposes such as strengthening education and training in the management of intellectual property. In this regard, sources at WIPO and the WTO have indicated that they are providing technical advice to the WHO upon request. However, they added that implementing proposals that assign tasks to other international organisations might require further reflection, since institutions have their own mandates and accountability structures.

At the same time, the revised text added items suggested by countries, such as Brazil's proposal to assess the impact of data-exclusivity regulations. In response to the South-East Asia region's call 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 that makes use of TRIPS flexibilities.

The draft does not change the element entitled, "management of intellectual property." The US government, a traditionally strong proponent of far-reaching intellectual property rights, had called this "unclear." Brazil, on the other hand, criticised it for "mistakenly assum[ing] that the problems faced by developing countries on this matter are circumscribed to administrative concerns" alone, rather than obstacles to innovation and access arising from the structure of existing intellectual property protections.

However, the draft does not adopt some specific suggestions by countries, such as the South-East Asia Region's call for an "operational interpretation of 'inventive steps,'" relating to the technical term used in the evaluation of whether a patent applicant's invention is sufficiently innovative to deserve a patent. Nor does the draft adopt Egypt's suggestion for a set of guidelines for the transfer of technology.

Guilherme Patriota, a counsellor at Brazil's mission in Geneva, said that he was "not dissatisfied" with the draft and called it a "fair start." He noted that it contains two important elements: the use of flexibilities under the 2001 Doha Declaration on TRIPS and Public Health, and work on new models for innovation, especially those that aim to decouple drug prices from research 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, as ways of encouraging innovation and lowering drug costs. Patent pools, for instance, are created when patent owners agree to licence their innovations as a package, allowing third party licensees to exploit the technology encompassed by the entire bundle. Although such arrangements can lead to economies of scale, lower prices, and increased innovation, no pharmaceutical patent pool has yet been formed. Advanced market commitments are binding promises, generally by governments, to purchase a vaccine or medicine if and when it is developed. Canada, Italy, Norway, Russia, and the UK this year launched one such attempt, encouraging research targeting pneumococcal diseases, a major cause of pneumonia and meningitis.

The new text also 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.

Spring Gombe and Thiru Balasubramaniam of Knowledge Ecology International were mixed in their response to the draft. They noted that it "contains some welcome statements of access to medicines, support for the use of TRIPS flexibilities and new methods to create incentives for research and development for new medicines," but said that "the plan of action is vague with neither a clear sense of ownership nor any sense of urgency."

Médecins Sans Frontières' Ellen 't Hoen was similarly lukewarm, telling Intellectual Property Watch that "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."

Several member governments were reluctant to comment on the text, as they will soon have to enter into negotiations on it. Regional consultations are scheduled for August and September, and the second meeting of the IGWG is scheduled for 5-10 November.

In principle, the final plan of action should be ready for members to adopt at the May 2008 meeting of the World Health Assembly, though members such as Bolivia and Bangladesh, have recommended a one-year extension.

The WHO's Zucker anticipates "a very lively discussion" at the committee's meeting in November.

ICTSD reporting; "WHO Draft Negotiating Text on IP Cautiously Received," INTELLECTUAL PROPERTY WATCH, 8 August 2007.