By Paul Garwood
Next month’s round of negotiations on a United Nations plan to boost access to medicines for the world’s poor are set for a rough ride, with countries and regions split on contentious issues such as intellectual property rights and how to spur drug innovation for the benefit of all.

The World Health Organization’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) holds its second session on 5-10 November in Geneva to try to finalise a draft strategy and action plan on how to boost affordable drug discovery, development and delivery for diseases, mainly those affecting the poor. If completed, the draft will go before WHO’s Executive Board meeting in January 2008 and, potentially, to the World Health Assembly for endorsement four months later.

At the heart of the plan is finding an optimal way to boost research and development of affordable health care products so people, particularly in developing countries, can receive treatment for diseases, with an emphasis on neglected conditions including tuberculosis, malaria and HIV/AIDS. But the interplay between rich and poor nations, the use of flexibilities in international trade law for access to medicines, and pressure from industry and civil society groups on crucial issues such as IP and costs have handed WHO a daunting mandate to reach consensus on a single strategy to meet the world’s medicinal needs, according to sources.

Elil Renganathan, executive secretary of WHO’s Secretariat on Public Health Innovation and Intellectual Property, said the IGWG process is the first to deal with the two most crucial aspects concerning availability of health products: innovation and access.

“It is clear we were never going to please everybody but we were trying to make the process as open and transparent as possible and make sure as many of the stakeholders are involved,” Renganathan told Intellectual Property Watch. “It is an extremely important process that is going to have a major impact on innovation and access. The strategy is designed to foster innovation, build capacity and improve access.”

Making this happen is the hard part, with diplomats from some member states questioning whether a compromise can be reached during only five days of talks in Geneva.

“There are so many actors and issues and we have to recognise the possibility there might not be an outcome and that might mean that this process is a failure,” said one official who asked to be identified only as a Western diplomat. “It would be unfortunate if that would be the outcome.”

Some developed countries, and the large pharmaceutical companies operating within them, though in agreement on the need to stimulate innovation on neglected diseases, are intent on ensuring that increased access to medicines has no negative cost implications for the drug-making industry, including loss of IP rights.

Call for Action, Leadership

But developing states and civil society groups argue more must be done to stimulate innovation in health care products to treat neglected diseases in poorer countries. They are also calling for increased access to technology and knowledge, as well as capacity building, to help produce affordable drugs, vaccines and diagnostics.

Ahmed Ogwell, head of international health relations at Kenya’s Health Ministry and a vice chair of the IGWG process for the African region, said a new mechanism is needed to promote innovation of health care products for neglected diseases.

“Intellectual property has failed to ensure that access to health products is possible amongst the poor, especially in Africa, so that mechanism needs to be looked at and modified to respond to our needs,” Ogwell said. “We need to look at all possible mechanisms to provide funds so innovation is happening.”

Ogwell was critical of the draft plan provided by the WHO Secretariat ahead of the November meeting, arguing that it did not adequately address the funding mechanisms needed to foster drug innovation in markets where little profit exists for manufacturers. “Intellectual property is not the main issue here. If we don’t have a proper financing mechanism we won’t be able address any objectives,” he said.

Funding mechanisms for drug research and development being floated in the IGWG process include public-private partnerships, prizes for innovators and advanced market commitments to subsidise the future purchase of a vaccine not yet available.

The Kenyan official also slammed the WHO draft for not providing clear enough guidance on who would lead the innovation and access responsibilities in countries. “The draft plan of action is very general about roles,” he said. “There is a list of people going to be responsible for a particular activity but it doesn’t give a leader. We must be very clear on who is responsible for delivery.”

For weeks, regional groupings of countries, nongovernmental organisations, industry groups and individuals have been pouring over the draft document plan, which WHO officials said had to be as sweeping as possible to include as many of the member state inputs as possible before further refinement took place at the November meeting.

Consultations Ongoing

Efforts have started between South stakeholders to reach consensus on key issues ahead of the session. “It is critical that we seek consensus with the other regions before the negotiations otherwise it will be very taxing in terms of being able to do it in five days,” Ogwell said. “We are holding a lot of informal consultations across regions to thrash out some difficult things before the meeting.”

One such region is Latin America, led by countries like Brazil. The Latin Americans are seeking greater access to health care product-making knowledge, including the technological capacity needed to produce generic drugs.

Rodrigo Estrela, of Brazil’s UN mission in Geneva, said consensus among the Group of Americas countries, including Latin American and Caribbean nations, the United States and Canada, will be possible only if the latter two agreed, at least in part, with the demands of the region’s developing countries.

“It will be very difficult because many Latin American countries are making proposals that change the entire nature of the secretariat’s text in some sense and we don’t know if the United States would be willing to accept that,” Estrela told Intellectual Property Watch.

WHO Trade Ties

Latin American countries want WHO to play a stronger role in promoting the flexibilities in the 2001 Doha Declaration concerning the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Estrela said. TRIPS contains flexibilities allowing countries, particularly in the developing world, to issue compulsory licenses to local manufacturers make generic versions of drugs to safeguard public health in national emergencies or for non-commercial purposes without seeking patent-holder approval. The Doha Declaration reinforced these flexibilities.

“Developed countries used to say IP rights were not an issue for WHO, but instead for WTO,” Estrela said. “Now it is clear that WHO has work to do in this area, including supporting measures contained in TRIPS regarding flexibilities.”

A set of eight principles promoted in the Latin American submission, which was formalised during a September meeting in Rio de Janeiro, was among a number of documents the Western official criticised as being too “human rights based.”

The Rio principles stress that the right to health protection is universal and takes precedence over commercial interests. IP rights should not restrict the promotion of technological innovation and the transfer of technology, according to the submission. The Latin American principles also stress the need to promote wide use of TRIPS provisions and the importance of research and development into areas of greatest importance for countries.

Geneva-based Thai diplomat Prangtip Kanchanahattakij agreed that the IGWG process must enable developing countries to make better use of the TRIPS flexibilities. “We want to see capacity building to help countries handle IP issues and TRIPS flexibilities,” Kanchanahattakij said. “Countries with experience in navigating the TRIPS flexibilities need to share their experiences with developing nations needing access to medicines.” Thailand has been a leader in making use of TRIPS compulsory licensing provisions to produce AIDS anti-retrovirals, which has in turn fuelled legal action and political wrangling with pharmaceutical companies and Western capitals.

The Western diplomat said contentious issues on the IGWG agenda involved data exclusivity, patent pools and the results of clinical trials, all issues that revolve around access to knowledge. Some developed countries, such as the United States, support the notion of data exclusivity, which involves patent holders maintaining control over information related to medicines and innovations. Such measures are referred to as TRIPS-plus conditions, which run opposite to flexibilities provided under TRIPS, and are obligations that poorer countries often must accept to enter into bilateral trade agreements with richer nations.

“We continue to believe that it is important to protect IP rights and innovation spurs the development of needed products,” the diplomat said. “At the same time there are things that countries, both developed and developing, can do to stimulate more research in the area of neglected diseases and come up with new financing mechanisms, from advanced market commitments to prize funds.”

The diplomat said there was opposition in the West to plans for a research and development treaty, which Latin American and African nations are supporting to help establish research priorities, as well as identify funding needs and mechanisms. “I don’t think a treaty will work because not many countries would become a party to it, including mine,” the Western official said.

Matti Rajala of the European Commission delegation in Geneva said WHO’s draft plan provided a good basis for talks in November and opportunities existed for agreement, including in areas of boosting research and development. But the upcoming meeting, he added, was still likely to be challenging.

“It will not be a very easy week in November, but we are coming to these negotiations with positive and constructive points of departure,” Rajala said. “The areas of boosting needs-driven R&D are of utmost importance, but the question is how can we make them work or push the development so that there will be adequate resources in these endeavours. That remains challenging.”

“There might be issues where solutions can be more easily found and some where it could take very much effort,” added Rajala, saying he was unable to elaborate.

Building on the CIPIH

Médecins Sans Frontières said the WHO draft plan risked “failing to build” on its pre-cursor, a report released by WHO’s Commission on Intellectual Property, Innovation and Public Health (CIPIH), claiming the IGWG document did “not sufficiently” advance CIPIH’s findings and 60 recommendations that prompted the IGWG.

“Some of the points of the plan of action seem to disregard the analyses and conclusions of the CIPIH report and want to redo the work, or to water down the language or strength of the report’s recommendations considerably,” MSF argued in its submission to the IGWG process.

In particular, MSF claimed the IGWG draft overestimated IP’s role in drug innovation, in which CIPIH reported that “patents are not a relevant factor in stimulating R&D and bringing new products to the market” for diseases affecting millions in poor countries.

But WHO’s Renganathan said the IGWG process had done its best to achieve neutrality, while leaving the negotiations open for countries to decide among themselves on the best way forward. “Member states have different interests and needs but I believe there is a spirit of wanting to work together and come to a solution,” he said. “We have tried our best to do this, but ultimately it is a member state-driven process.”

Paul Garwood may be reached at info@ip-watch.ch.