IP Issues May Spark Debate At World Health Assembly

By Tove Iren S. Gerhardsen
Intellectual property rights issues could play a significant role in the annual World Health Assembly which begins next week. While not the most prominent topic for the assembly, IP is expected to arise in discussions on malaria, avian influenza and in the “mid-term” progress report of a contested working group on IP and public health.

The 14-23 May assembly, the annual meeting of the 193 members of the World Health Organization (WHO), may also see debate over developing countries’ use of international trade flexibilities to allow importation of cheaper versions of patented pharmaceuticals, sources said.

Indonesia will propose amendments to a draft resolution on ownership and sharing of avian flu virus samples for vaccines to ensure access for developing countries; there is disagreement about language on intellectual property rights in a malaria draft resolution; and the one-year progress report of the IP working group will be presented, sources said.

A top IP priority of the United States for the assembly will be to focus on innovation issues. “Our priority related to IPR issues is to be sure the WHA recognises the importance of IPR to promote innovation,” a US official told Intellectual Property Watch.

IGWG “Mid-term” Review

The progress update on the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) will be the most “direct” IP issue on the draft agenda. The group has been tasked with drawing up a global strategy and plan of action by May 2008 in order to provide a medium-term framework based on the recommendation of a previous WHO commission (WHA59.24). The plan and strategy will deal with the link between public health, innovation and IP, especially as they relate to the lack of treatments for neglected diseases.

The report will be presented by the WHO secretariat. A seven-page document (A60/27) has been provided to member states before the meeting, and this will be the background document for the agenda item on the IGWG, a WHO official said.

The report chronologically outlines the activities of the group since May 2006, and what is planned up to its second and last session, scheduled for 5-10 November. It says that recently submitted comments by member states will be incorporated into a revised working document, which a WHO official has said is expected to be ready in July. The health assembly is invited to “note” the report.

An annex clusters the countries’ suggested “areas for early implementation,” meaning areas in which both developed and developing countries, donors, companies as well as WHO can start working before the plan is ready. The submissions were made at the time of a March hearing on the subject and have not been agreed collectively.

The annex suggests that: Developing countries strengthen their research programmes; WHO help ensure access to “compound libraries”; and that patenting, licensing, patent pools and flexibilities to international trade laws are all used in ways that foster research into neglected diseases. On development, public-private partnerships are encouraged to strengthen and expand donor deals and be more transparent; and obligations under trade law to transfer technology to developing countries are highlighted. WHO is asked to monitor the impact of IP on health, and members to report their related activities.

Separately, a technical briefing on public health, innovation and IP will be held on 17 May, WHO said.

Also, some sources indicated that the use by developing countries of flexibilities in international trade law to import cheaper generic versions of patented medicines for public health may come up under this agenda item. Thailand (IPW, Public Health, 22 December 2007), Malaysia and Brazil (IPW, Public Health, 7 May 2007) are among the countries having done so.

In a 2 May letter to WHO member governments, Médecins Sans Frontières (MSF) said, “WHO should be proactive in giving technical and policy assistance to countries that want to make use of the flexibilities in patent law to increase access to existing medicines.” It added, “The IGWG should also support and further develop proposals for pro-health management of intellectual property.”

MSF suggests an immediate action for the IGWG to develop and support “a global tuberculosis R&D [research and development] strategy as pilot activity under a global R&D framework.”

Debate Expected on Avian Flu

The issue of patents, prices and access to avian influenza treatments appears to become particularly hot for the assembly.

“Some member states led by Indonesia will be tabling a new resolution (EB120.R7) on avian flu specifically on the proper handling and disposition of viral samples,” a developing country official told Intellectual Property Watch. “The resolution will ensure the proper handling of the viral samples that are sent to the WHO.”

Indonesia recently received attention when it declined to share its avian flu virus samples with the international system run by WHO out of fear that it would not get access to highly-priced, patented vaccines developed based on the samples (IPW, Public Health, 8 March 2007). The issue has apparently since been resolved, but “Indonesia is not taking any chances, hence a plan to introduce this resolution at the WHA,” the source said.

An Indonesian health official told Intellectual Property Watch that developing countries sharing such samples with the international community should be ensured equal access to vaccines being developed, at an affordable price. Indonesia is therefore preparing language from a declaration and recommendations from two high-level meetings held in Jakarta 26-28 March. He said the system for virus-sharing that have been in place for the past 50 years had been an “unfair mechanism” as developing countries did not benefit from, and have access to, the vaccines themselves. Indonesia wanted some conditions (in addition to the “best practices” spelled out in EB120.R7) such as insurance that the samples would not be used for commercial reasons, he said, adding that Indonesia hoped for support from developing countries at the assembly, he said. It appears to be garnering support from a number of developing countries, according to one source.

The official said information had not been received from the capital that the government had shared its samples with WHO, but he believed this was still its intention.

April Meeting Sets WHO Agenda on Avian Flu

Under the item avian and pandemic influenza, a draft resolution (EB120.R7) as well as summary points from a 25 April Geneva meeting on avian influenza vaccine stockpiling are expected to be discussed. WHO also said at the Geneva meeting that it would present the next phase of the H5N1 plan at the assembly, and Director General Margaret Chan suggested producing a roadmap for the way forward. She suggested WHO should take “concrete steps as a matter of urgency” after the assembly.

At the April meeting, the issue of intellectual property rights received little mention, although an Asian Development Bank official speaking on his own behalf pointed out that instead of providing money for developing countries, resources should be given to accelerate techniques and one has to “look at the question of IP.”

Six developing countries have been given $2.5 million each by WHO, United States and Japan to develop a three-step plan boosting production in developing countries, a source said. Technology transfer is part of this plan, a WHO source said.

The French chair of the meeting told Intellectual Property Watch that influenza virus had traditionally been “free of IP,” and this was also true for the avian flu H5N1 virus, which exists in birds. He said companies could mutate the virus and patent it, but it was risky business as it was likely to mutate again very quickly.

Malaria and TRIPS

There also is a draft resolution on malaria on the table (EB120.R16), which contains two proposed wordings on intellectual property rights for the assembly to consider (IPW, Public Health, 6 February 2007).

At the 22-30 January WHO Executive Board meeting, it was mainly the United States and Kenya that differed on the language, sources said. The United States referred to language in an earlier agreed resolution (WHA57.14), which says member states should consider, when necessary, adapting national legislation to allow them to use trade law IP flexibilities. But it did not want to link this directly to proposed language on access to medicines and technologies, which might encourage the use of the flexibilities, sources said. “Kenya wanted a language that ‘urges’ member states to ‘include’ in their legislation TRIPS (WTO Agreement on Trade-Related Aspects of Intellectual Property Rights) flexibilities in order to improve access to anti-malarial drugs, diagnostics and technology,” a Kenyan source said.

“I have had some informal discussions with Kenya about the malaria resolution, but we have not yet reached a meeting of the minds,” the US official said.

Taiwan Ties Avian Flu to WHO Accession

Another issue related to avian flu is Taiwan’s effort to gain full membership at the WHO, separately from China. It currently has observer status [Correction: Taiwan does not have observer status but has applied for this for many years. Now it is applying for full membership, sources said.] but fears that that will not allow it to address concerns about avian flu outbreaks. Taiwan issued a compulsory license (for the production of Roche’s Tamiflu) in 2005 (valid until 31 December 2007), which it so far has not used, a source said. Taiwan (as Chinese Taipei) joined the World Trade Organization as a full member just after China in 2001.

“We submitted our application in mid-April, but the WHO decided not to take care of it by quoting WHA25.1 resolution [regarding changes to the WHO constitution],” a Taiwanese health official told Intellectual Property Watch. “However, our application has become the common concern of permanent missions and other organisations.”

“We are not included in the WHO’s Global Influenza Surveillance Network, though our Centers for Disease Control, as our National Influenza Center [NIC] applied before,” the official said. CDC Director Steve Kuo requested WHO to include Taiwan in the network. “However,” the official said, “the NIC is designated by national health authority, which by WHO’s definition is in Beijing.” Another related issue is the implementation of International Health Regulations which will start on 15 June, he said, adding, “We are afraid of being left out of the system.”

Side Events

There are several side events being planned for the assembly. An International Policy Network-organised event with Knowledge Ecology International (KEI)’s James Love and Andrew Farlow of the Saïd Business School, University of Oxford will be held on 17 May. On 16 May, the International Federation of Pharmaceutical Manufacturers and Associations is holding an event to launch a clinical trials portal as well as a new edition of its book, “Partnerships to Build Healthier Societies in the Developing World,” it said. Also during the week, Churches’ Action for Health and KEI are planning events.

Assembly documents are available at: http://www.who.int/gb/

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