A much-anticipated World Health Organization (WHO) report by a special commission looking at the relationship between intellectual property rights and research and development into diseases disproportionately affecting developing countries, makes some 50 recommendations on how to improve the situation.

The 228-page report of the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) stops short of denouncing existing patent systems relating to medicines, but instead: targets measures to be taken at the national level; highlights the need for more partnerships and funding; urges companies to take more responsibility; and suggests the WHO play a greater role in coordination. It also calls for further consideration of numerous alternative approaches to the current R&D raised in recent years, and urges caution for countries entering into negotiations for bilateral free trade agreements.

Former Swiss President Ruth Dreifuss, the chairperson of the commission, told Intellectual Property Watch that this was “not a recipe book” for solutions. Rather, it is “a comprehensive but cautious analysis,” she told a 30 March telephone call with editors.

She said that overall, the report concluded that patents are not a main barrier to innovation and access and does not advocate changes in patent rules, but that there should also be other incentives.

The delayed CIPIH report is being published against the backdrop of strong disagreement among the 10 commission members who had agreed to be independent and not share the report outside the commission. But the draft was apparently leaked last autumn to a pharmaceutical industry representative whose tracking language appeared in a Microsoft Word version of the draft report submitted to the commission by one member (IPW, Public Health, 23 January 2006).

In the telephone discussion, Dreifuss acknowledged that at some point, she had “had the opportunity” to remind the members that they were supposed to be independent. The commission also has made clear that those tracking marks never appeared in the final version of the report.

Consensus with Reservations

Despite the consensus nature of the report overall, five of the 10 commission members included reservations in the annex to the report, taking issue with various parts of it. Three of these are considered to be close to the industry side of the debate.

Dreifuss said that the “commission as a whole has accepted the report” and that it was “absolutely common” to publish reservations.

Dreifuss noted that some of the commission members had wanted the report to be more “pushy” on the use of compulsory licenses and similar mechanisms, but she emphasised that in general there was a consensus on the report.

Carlos Correa of the University of Buenos Aires and Pakdee Pothisiri, senior deputy permanent secretary of health in Thailand, argue in their joint reservation that the report “has not sufficiently elaborated on the profound distortions currently observed in the functioning of the patent system” which they argue benefit the pharmaceutical industry and hinders access to generics. They also argue that by focusing on everything from discovery to delivery the report goes beyond its mandate.

Trevor Jones, director of R&D at the Wellcome Foundation Limited, took issue with the direct link between patent ownership, product price and access in the developing world which he says the report implies. Jones argued that prices are not based on patents, and that patents do not hinder access but rather poverty and lack of infrastructure do. Fabio Pammolli of the University of Florence agrees with Jones’ price argument, saying that the patent status does not prevent procurement schemes or price controls.

Hiroko Yamane of the National Graduate Institute for Policy Studies in Japan said the report should have had “more evidence-based analyses of different patent policy options for developing countries.”

Cross-sectoral Recommendations

The report involves a wide range of actors, including developed and developing country governments, pharmaceutical and biotechnology companies, donors, public-private partnerships, patient and civil society groups, and various international organisations.

While developed country governments are asked to step up funding and R&D into diseases mostly affecting developing countries, the developing countries are asked to foster R&D and improve infrastructure. Companies are asked to make their pricing policies more transparent, but the report also says that, “access to drugs cannot depend on the decisions of private companies but is also a government responsibility.”

Dreifuss said a main target of the report is the WHO, where a draft resolution on a new global framework for R&D has been forwarded to the World Health Assembly in May (IPW, Public Health, 28 January 2006). Dreifuss believed that either there would be an additional WHO resolution based on the report or it could be merged with the current draft resolution, which was a proposal from Brazil and Kenya.

The report mentions this R&D resolution but says, “the sponsors of the medical R&D treaty proposal should undertake further work to develop these ideas so that governments and policymakers may make an informed decision.”

In general, the report urges the WHO to play an important role in the development of new incentives for research into and access to medicines in developing countries, Dreifuss said.

The report suggests a number of specific areas in which the WHO can increase its involvement in IP issues, sometimes in collaboration with the World Intellectual Property Organization (WIPO), for example in promoting patent pools for upstream technologies, or in developing a database of information about patents. The report also suggests that the WHO help strengthen the clinical trial and regulatory infrastructure in developing countries, and bring together partners in a “standing forum” to coordinate discovery efforts.

Heightened WHO Involvement in TRIPS and FTAs

The report also provides recommendations on the implementation of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and issues such as data exclusivity in the free trade agreements (FTAs) that the United States is negotiating bilaterally with other countries. It reinforces the 2001 declaration of the Doha, Qatar WTO ministerial, which itself reinforced countries’ rights to use the flexibilities built into the TRIPS agreement.

The WHO should assist countries in implementing the TRIPS agreement, Dreifuss said. The report refers a number of times to TRIPS flexibilities, such as compulsory licensing. For example, it says that, “countries should provide in their legislation powers to use compulsory licensing, in accordance with the TRIPS agreement.”

It also refers to an August 2003 WTO agreement, made permanent in TRIPS in December 2005, allowing countries with inadequate production facilities to import medicines produced under compulsory license.

The report notes, however, that the 2003 decision “has not yet been used by any importing country,” and thus suggests that, “Its effectiveness needs to be kept under review and appropriate changes considered to achieve a workable solution, if necessary.”

In addition, the report urges that experts from health ministries participate in bilateral trade negotiations.

Caution was given to countries being pushed in bilateral negotiations beyond TRIPS. The report says, “A public health justification should be required for data protection rules going beyond what is required by the TRIPS agreement,” adding that “ … developing countries should not impose restrictions for the use of or reliance on such data in ways that would exclude fair competition or impede the use of flexibilities built into TRIPS.” It states directly that bilateral trade agreements should not seek to include TRIPS-plus requirements that may impede access to medicines.

At the press conference, Dreifuss said that data exclusivity was one point on which the commission had had a “large discussion.” She said that the commission believed that generic medicines should not be hindered in obtaining market access immediately upon patent expiry.

Dreifuss also highlighted that the report asked the WHO to play an active role in developing a “global plan of action” on access. The report says that this should “ensure enhanced and sustainable funding for developing and making accessible products to address diseases that disproportionately affect developing countries.”

But at a 3 April press conference, WHO Director General Lee Jong-wook said that this would not be in the form of a new fund or initiative such as the Global Fund to Fight Aids, Tuberculosis and Malaria.

The report is now available at www.who.int in six languages.