WHO Members Take Small Steps With New Medicine R&D Plan In Novel Exercise

By Tove Iren S. Gerhardsen
Participants in this week’s ground-breaking meeting of a World Health Organization group working to stimulate research on neglected diseases hailed the cooperative spirit of the group after three days. But early in the 7 December session, the mood changed as some countries took issue with papers drafted by the secretariat reflecting discussion so far.

On 5 and 6 December, countries seemed to welcome the route the World Health Organization (WHO) intergovernmental working group on medicine research and development is taking this week.

“It will be successful,” one developed country official said on 6 December, while acknowledging that the mechanisms for the process had yet to be worked out.

“I think we have something going on,” a Brazilian official told Intellectual Property Watch at the end of the 6 December meeting.

Other officials pointed out that the meeting had made small steps in the right direction. “[We] keep peddling the bicycle [although] sometimes I wish it was a tricycle,” the chair, Peter Oldham from the Canadian mission in Geneva, said at the end of the meeting on 6 December.

Oldham was commended by a number of officials in interviews, including the head of the Thai delegation, Dr Viroj Tangcharoensathien. “The chair is fair and captures different views,” he said.

The 4-8 December meeting of the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) has moved into substantive discussions about what elements should be part of a possible strategy and plan of action for new research and development of medicines for diseases predominantly affecting developing countries. This dates back to a mandate from the World Health Assembly in May (IPW, Public Health, 27 May 2006).

On 6 December, the group discussed two issues that the African countries in particular had requested be discussed as separate items, namely “technology transfer to improve innovation capacity” and “management of intellectual property.”

These were added to six other elements that the WHO secretariat had prepared in a document based on the recommendations from the WHO Commission on Intellectual Property, Innovation and Public Health (CIPIH), which published its report in April (IPW, Public Health, 3 April 2006).

All these elements with comments were included in documents that were distributed on 7 December, and discussed in plenary, one on a plan of action and one on a global strategy. Brazil, however, took issue with the papers and said health objectives should not be placed at the “mercy” of IP objectives.

In the 5 and 6 December discussions, Thailand took a strong lead in the discussions of IP and transfers of technology. While Oldham had talked about delegates being “sparrows in the trees” (referencing the large size of the conference room), the Thai delegate remarked later that “this sparrow is not afraid of the eagle” (referring to the United States).

Thailand recently issued a compulsory license for a medicine patented by pharmaceutical company Merck. As a result, Merck cut the price in half. The two sides plan to meet next week to resolve the company’s concerns, according to the Thai official.

Thailand’s Tangcharoensathien told Intellectual Property Watch that his government had met with five developing countries in New Delhi before the meeting to compare the WHO documents with the CIPIH report. He said that some key elements had been, deliberately or not, left out of the WHO documents, most notably related to World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). “Our objective is to bring this back to reflect the spirit of the commission report,” he said.

On technology transfer, one of the bullet points under “areas of action” reads: “developed countries to comply with their obligations under Article 66.2 of TRIPS” which calls for developed country transfers of technology.

But the Thai delegate said that he had looked at seven of the reports of developed countries to the WTO on this issue, and none of these mentioned pharmaceuticals. “I think we are misled on the 66.2 [article],” he said. India also referred to 66.2 and said some mechanisms should be developed to ensure that commitments in the TRIPS agreement are being held.

A WTO official clarified that Article 66.2 does not specifically refer to transfer of pharmaceutical production knowledge, but noted that the WTO Doha Declaration from 2001 re-iterates developed countries’ commitments to transfers of technology. He also noted that the WTO considered flexibilities to go beyond just TRIPS Paragraph 31bis (allowing countries to export medicines under compulsory license to countries without adequate production facilities).

Brazil said it had had “good experience” with transfers of technology, and mentioned a vaccine initiative with GlaxoSmithKline as an example. This “is a very opportune practice,” it said.

The United States said that transfers of technology cannot be forced, but gave a number of examples of such transfers to China, India, Korea and Mexico related to vaccines.

Sudan said that such transfers should benefit national development and not individual countries.

IP Management

Under the category of IP management, one action point reads: “developed and developing countries to enact legislation for application of the flexibilities provided for in TRIPS.”

Iran, on behalf of the Eastern Mediterranean countries, said that patent protection was “ever-strengthening,” referring to “TRIPS-plus” (meaning that protection requirements are stronger than those in international trade law) standards in bilateral agreements. He said, “A paradigm shift is needed in this area.”

Thailand asked to include specific language on flexibilities in the elements that will go into the future plan of action. Stating that bilateral trade agreements should not seek to incorporate TRIPS-plus protection, which was stated in the CIPIH report. African countries supported this.

The European Commission said that patents have helped to generate innovations that have been beneficial to all actors, and that measures in the plan “need not, and should not, adversely affect the patent system.” It also said that the European Union respects compulsory licensing, but simply by being available it could reduce prices and does not necessarily have to be used.

Switzerland said that instead of going beyond the IP system the WHO plan should complement the IP system. It also said the group should look where it could bring value instead of trying to do the work of other organizations such as the World Intellectual Property Organization or the WTO. Other countries, including the United States, also emphasised this point.

The International Federation of Pharmaceutical Manufacturers and Associations said it was willing to work with the group to “define the constructive role intellectual property rights [can] play.”

India welcomed the idea of patent pools as mentioned in the secretariat document on elements for a global treaty and plan of action, and it also called for a treaty arrangement for neglected diseases.

On 5 December, France supported the idea of patent pooling and Finland, on behalf of the European Union, said that it in principle support the idea of a patent pool, and is “open to explore new work on this.”

“Countries seem to be open to new ideas of alternative ways of innovation,” Ellen ‘t Hoen of Médicins Sans Frontières and one of the experts to the group told Intellectual Property Watch.

James Love of the Consumer Project on Technology said that the plan should focus on better use of existing flexibilities to IP regulation as well as new ways, including patent pools and a more systematic use of compulsory licensing. He also called on the WHO to open up the accreditation procedure.

Brazil emphasized the issue of access to medicines. “It is access to products that really counts.” Norway also said that it had pushed for having language on access and not only research and development included in the resolution. Switzerland supported this.

WIPO said that it looked with WHO on the “objective to improve public health.”

The Gates Foundation said that all need to get together to seek a “collective solution.”

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