By William New with Kaitlin Mara
Government officials tasked this week through the United Nations with finding ways to develop and deliver treatment for overlooked diseases afflicting the globe’s poor are making uneven but persistent progress in negotiations.

Debate has been slow at times, according to participants, sticking on the lofty introductory language to the draft text under negotiation, which will form a strategy and the basis for an ensuing action plan. An agreement was reached to keep open discussion of alternatives including a research and development treaty. But disagreements have slowed progress in areas such as access to drug compound libraries, and the overall aim of the negotiations, participants said.

The World Health Organization Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) is meeting from 5 to 10 November. The group has focused mainly on the strategy, and, with two days left to go, some participants are projecting that another meeting will be needed to finish work sometime early next year. The group must complete work by the May World Health Assembly.

The basic problem being addressed by the group is that industry has not been able to conduct research and development on some drugs disproportionately afflicting the developing world because the markets cannot meet the costs of drug development. Talks are occurring in two groups simultaneously, each taking different sections of the draft text. As of Thursday night, intellectual property provisions had not been discussed directly.

Negotiations bogged down on the aim of the group, according to sources, as the United States and possibly others balked at the suggestion that the group is to come up with alternative incentive schemes, versus complementary ones. This goes to a philosophical disagreement over whether the existing system is working and might be added on to, or whether significant change is needed.

The language on 8 November read: “encourage and support the application and management of intellectual property in a manner that maximizes health-related innovation, especially to meet the R&D needs of developing countries, protects public health and promotes access to [health products]/[medicines] for all, as well as explore and implement, where appropriate, [innovative]/ [alternative] incentive schemes for R&D [to complement the existing ones].

Another sticking point on which agreement was not possible relates to the creation of accessible compound libraries, especially in developing countries, so that innovation might grow. Discord arose over the dissemination of information, with caveats suggesting it be “where appropriate” and on a voluntary basis, sources said. The 8 November text of Article 2.5 of Element 1 on prioritising R&D needs included language that is not agreed on whether there should be open databases and compound libraries that include unrestricted “access to drug leads identified through the screening of compound libraries.”

One breakthrough, according to some participants, is the consensus to continue discussions on instruments to address research and development (R&D). The agreed language states: “Encourage further exploratory discussion on the utility of possible instruments or mechanisms for essential health and biomedical R&D including inter alia an essential health and biomedical R&D treaty.”

This idea, which could potentially lead to the revamping of the global system based on high drug prices to recover R&D costs, was embraced by public health advocates, though it was downplayed by industry and US sources.

“We were all surprised to see the language of the R&D treaty move forward without brackets,” said James Love, director of Knowledge Ecology International, who credited Canada, India, Kenya, Norway, United Kingdom and “surprisingly” the United States.

Love said removing any reference to an R&D treaty was a top priority of the pharmaceutical industry, and he called on industry to support it. “It’s not an attack on them,” he said. “It’s really an attempt to solve some problems of identifying research priorities, finding money to do things and setting other norms which advance the idea of research and development.”

Love added: “I think this demonstrates that there’s a growing consensus that it’s time for a consumer interest and the public health community be more proactive and take charge of the R & D agenda.”

Industry representatives denied privately that the R&D treaty was their top priority, and said they were not opposed to the language as written as it is rather broad and does not overtly call for a treaty. Developed countries and their industries have been wary of any call for a treaty negotiation on health and IP or innovation.

But another health advocate, who said generally that the text does not sufficiently commit countries to action, said the R&D treatylanguage is important to ensure global momentum is kept up to address the problems. Funding is another key concern, the source said.

Yet others have raised concern that the text under negotiation does not refer much to the predecessor report of the Commission on Public Health, Innovation and Intellectual Property that led to the IGWG’s creation. Many of the issues being discussed here were addressed in carefully negotiated terms in that process, which finished in 2006.

Negotiations are being taken rather seriously, some have sought to remind officials that this is not a treaty negotiation and the outcome is not legally binding.

Geopolitics at Play

As in any negotiation, attempts are made to form coalitions, or to break up others’. But reports suggest that efforts to prevent some policies from getting through have reached beyond usual diplomacy. For instance, the United States appears to have used pressure at the national capital level prior to and outside of the working group meeting with the effect of breaking up consensus among Latin American nations.

Apart from Colombia, which generally has remained close to the United States on issues, there appeared to be general support in the region for positions developed by a number of governments in Rio de Janeiro in September. The document from what is now referred to as the ‘Rio Group’ includes principles aimed at ensuring social rights to public health take precedence over intellectual property rights.

But Mexico has drawn criticism at the meeting for a surprise turnaround in its position. It signed on to the Rio document but now in the meeting has argued against the inclusion of provisions from Rio, which has led to speculation of its being pressured by the United States.

Several Latin countries have reported receiving phone calls and demarches from the United States. Demarches are high-level intergovernmental communications hand-delivered directly from one top official to another. According to a copy obtained by Knowledge Ecology International, governments were warned that support for certain provisions might violate the terms of bilateral trade agreements signed with the United States. The use of demarches has been confirmed by Intellectual Property Watch.

After being contacted, some health ministries were confronted with trade, intellectual property, and foreign policy officials within the countries, sources said.

Within the European Union, there also is some difference of opinion as certain countries such as Sweden have been seen as taking a hard line against the WHO’s role in IP issues, and provisions on flexibilities within the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), according to a nongovernmental participant.

Industry groups, according to a representative, are concerned about preserving data exclusivity, which gives the rights holder control over its test data for five to 10 years.

Many of the issues being debated were discussed at well-attended Saturday event hosted by Médecins sans Frontières.

Chan Urges Progress

WHO Director-General Margaret Chan opened the second session of the IGWG with a call to focus the negotiations on the need for equitable access to medicine and the need to stimulate R&D on health issues affecting primarily the developing world.

Public health, which she said is essential to achieve poverty reduction, “cannot move forward without innovation.” Such innovation is needed constantly, both to extend treatment to people and places that are underserved - either because little research has been done on diseases that disproportionately affect their communities, or because diagnostic and treatment methods are too complicated to be implemented in those communities - and to ensure that available treatment keeps pace with changing needs, as diseases mutate or sick individuals develop drug resistance.

While acknowledging the complexity of issues surrounding research and development of new medicines, especially those involving trade, legal, and economic regulation, Chan pointed out the importance of affordability in health care and also the urgency of implementing workable solutions to public health problems.

William New may be reached at wnew@ip-watch.ch.