WHO Renews Delicate Effort On Pandemic Influenza Virus-Sharing

By Kaitlin Mara
An avian influenza outbreak would be a public health disaster, but for the World Health Organization to adequately prepare for that risk, member states must come to a resolution on intellectual property issues related to virus and vaccine sharing.

They hope to do so this week, as the Intergovernmental Meeting on Pandemic Influenza Preparedness gathers from 8 to 13 December, alongside a meeting of an open-ended working group tasked with revising terms of reference for laboratories and centres collaborating with the WHO, drafting terms for virus and data sharing.

Director General Margaret Chan opened the meeting, stating she could “think of no other health event that is so rapidly global in its sweep, or so potentially devastating in terms of human illness and deaths, and severe economic and social disruption.” She stressed a “sense of urgency” and urged the group to reach consensus on remaining items. The full text of her opening speech is available here: Margaret Chan Opening Speech.

Major issues on the table for the meeting include: finalising definitions of terms such as “pandemic influenza preparedness biological materials” and what to call the network of influenza laboratories; coming up with terms for a standard materials transfer agreement for influenza-related biological materials; terms of reference for laboratories within the World Health Organization network; and a mechanism for benefit-sharing, in particular with regards to stockpiles of influenza vaccines and making sure that vaccines are affordable for developing countries.

But a source familiar with the negotiation told Intellectual Property Watch that the “sticking point” of the meeting would be IP issues contained within the larger categories on the table, as there is “too much separation” between stances.

Another source mentioned the same concern, saying the danger this week is “we might not conclude” and would have to send a document not fully negotiated to the WHO Executive Board meeting in January. The secretariat is scheduled to make [pdf] a report on virus sharing and access to vaccines and other benefits at the EB, which is to be held from 19 to 27 January 2009.

At issue with intellectual property are divergent, and strongly held, views over the ownership of viruses, as well as vaccines, and over mechanisms that might be used to ensure functional sharing of those viruses.

The debate falls on which deserves more intellectual property protection: a virus or a vaccine developed from it.

Indonesia, supported by other developing countries and several non-governmental organisations, believes that its IP rights over virus strains originating within its borders allow for them to set conditions on their use. In return for “donating” strains of avian influenza viruses to research laboratories and vaccine manufacturers, Indonesia contends it should get a guarantee to ensure vaccines which arise from those strains will be shared at affordable prices.

A group of 118 “non-aligned movement” countries, led by Indonesia and chaired by Cuba according to a source who is among the members, are asking for a clearly defined and transparent mechanism on benefit-sharing with relation to vaccines developed on this disease.

“When genetic resources are used to develop vaccines,” the source said, “we have to ensure that beneficiaries are not just developed countries.”

Among their concerns, the source explained to Intellectual Property Watch, is that as soon as a vaccine is patented, there’s “no guarantee of affordability” of that vaccine to developing nations.

Other nations, notably the United States according to several sources, believe that virus sharing is necessary, especially when countries lack the capacity to develop vaccines themselves.

There also is concern that any decision taken regarding genetic resources at the World Health Organization might have a precedent-setting effect at a related debate happening at the World Trade Organization, over the possible amendment of WTO IP agreement to include mandatory disclosure of genetic resources in patent applications, a source said. A recent paper from Griffith University Law School in Australia discusses the relationship between the two issues and argues that failing to negotiate with Indonesia in this case could damage respect for intellectual property as a whole.

Other concerns that were raised by developing countries included a “messy” negotiation process, a third source said, in which some member states, particularly those from developing countries, felt that their concerns were not well included in a chair’s text released in June. Another source later told Intellectual Property Watch that some of the concerns had been addressed in a later draft of the chair’s text. The latest draft version of the chair’s text is available here [pdf].

Bracketed, or as yet unagreed to, text to be resolved this week in relation to IP issues include the possibility of vaccine manufacturers being urged to grant royalty-free licences on technology and know-how derived from virus-related materials donated by that member state; whether or not institutions providing or receiving virus-related material can assert IP rights over them; and whether or not royalty-free licences should be mandated in case of a pandemic from those organisations and institutions inventing patentable processes and/or products using virus-related material.

Kaitlin Mara may be reached at kmara@ip-watch.ch.