WHO Moves Closer To Guidelines On Avian Flu Sharing, Access

By Tove Iren S. Gerhardsen
Members of the World Health Organization (WHO) this week agreed on principles for sharing avian influenza virus samples through a global network. But the real terms and new guidelines related to intellectual property rights were put off until an October meeting in Indonesia, sources said.

The agreement was reached near the end of the 14-23 May World Health Assembly, following six days of closed-door drafting group meetings on the matter.

The group discussed a draft resolution (WHO language for proposal or agreement) from the January Executive Board meeting on best practices for sharing virus samples, a proposal from the United States on mechanisms for sharing avian flu viruses and a proposal from a group of developing countries led by Indonesia focusing on access to vaccines, particularly for developing countries (IPW, WHO, 16 May 2007).

“We are very happy” that this resolution was adopted, a spokesperson for the Indonesian government told Intellectual Property Watch, highlighting principles such as making the sharing system more transparent and equitable and ensuring that vaccines would be available price, especially for developing countries.

Indonesia stopped sharing virus samples from people with the virus with the WHO-led international network of research and development centres some months ago. It said it feared that the viruses would be shared outside the network to develop patented vaccines too expensive for Indonesians to access (IPW, Public Health, 8 March 2007).

Indonesia at various points has signalled a resumption of sharing, but backed off recently when the 2005 guidelines for this WHO system were removed from the WHO website, an official told Intellectual Property Watch. Indonesia intends to begin sharing viruses again once the guidelines are firmly in place, officials said, which may not be until October at the earliest.

An Indonesian government spokesperson said guidelines would be developed at a high-level WHO meeting scheduled for October in Jakarta, adding that this would be a meeting to “continue this resolution.”

“Right now there is no guideline on the sharing of viruses,” the spokesperson said. “If somebody wants to have our virus,” Indonesia would consider sharing it provided there were “material transfer documents” in place. She noted that in the past, Indonesia shared its viruses freely without any guarantee that a company would not patent it and later try to sell it back to Indonesia at prices above its public health budget.

The spokesperson said Indonesia would also consider sharing with private companies, adding that it already has signed a memorandum of understanding with the company Baxter (IPW, Public Health, 8 March 2007).

In explaining its position at the closing of the assembly on 23 May, the United States said that, “no nation can go it alone,” and that it was the legal obligation of each nation to share virus samples on a timely basis, calling for a “free flow” of virus samples. It also urged WHO to collaborate with the World Intellectual Property Organization and the World Trade Organization when addressing any issue related to intellectual property rights.

US Health and Human Services Secretary Mike Leavitt said in a statement, “I am also pleased that the resolution emphasises the need for increased vaccine access. The United States strongly supports the WHO’s efforts to meet the long-term global need for an influenza vaccine through the Global Pandemic Influenza Action Plan to Increase Vaccine Supply, and has provided $10 million to this effort.”

“The United States works with the WHO and international partners throughout the world to enhance global surveillance and pandemic preparedness,” Leavitt said. “This collaboration is based on four important principles: transparency, rapid reporting, sharing of data, and scientific cooperation. In that spirit, we continue to call on countries everywhere to share influenza samples openly and rapidly, without preconditions,” he said.

The resolution was adopted by member states at the assembly, meaning that it will guide WHO and member countries’ work in this area from now on in a soft law manner.

Highlights of the Agreement

The agreement safeguards that all member countries share virus samples, but also emphasises the need for access and sharing of the benefits. Member states are urged “to continue to support, strengthen and improve the WHO Global Influenza Surveillance Network and its procedures through the timely sharing of viruses and specimens with WHO Collaboration Centres.”

In its first draft, Indonesia referred to access and benefit sharing, and “prior informed consent” as it is stated in the UN Convention on Biological Diversity (CBD). This would mean that as a virus could be considered a biological resource over which states have sovereign rights, requiring anyone using this material to get consent (“prior informed consent” on “mutually agreed terms”) from the owner.

A proposal is currently under discussion at the World Trade Organization on whether parties should be required to disclose the source of such genetic material in patent applications for products developed based on such material (IPW, WTO/TRIPS, 1 June 2006).

The CBD, which the United States has not ratified, is not mentioned in the final agreement, but it recognises, “the sovereign right of states over their biological resources, and the importance of collective action to mitigate public health risks.”

On intellectual property, the WHO agreement recognises that IP rights “do not and should not prevent member states from taking measures to protect public health.”

The agreement also states that WHO frameworks and mechanisms should take into consideration specific needs of developing countries such as “facilitation of acquisition by developing countries of capacity of manufacturing in-country influenza vaccine.” They also need technical assistance to enhance local research and surveillance capacity, and be ensured access to WHO-developed influenza vaccine viruses for all manufacturers. WHO is asked to develop mechanisms and guidelines to ensure “fair and equitable distribution” of vaccines at affordable prices in times of a pandemic. WHO is also asked to establish with member states an international stockpile of vaccines.

The agreement also sets up an interdisciplinary working group, consisting of four member states from each of WHO’s six regions, to further revise the “terms of reference” of WHO collaborating centres. An expert report “on the patent issues” related to influenza viruses and its genes will be commissioned and be reported to the group, which will report to the assembly next year. The patent issues relate to who may own the patents on the products developed based on the virus samples shared with the WHO system.

Finally, the agreement safeguards that any use of influenza viruses outside the scope of the terms of reference of the WHO collaboration centres or any related national or international influenza centre may only happen after a request has been submitted directly to the provider of the virus, it being a national centre or laboratory.

In her closing remarks at the assembly, WHO Director General Margaret Chan also said she wanted to underscore the importance of this decision.

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