The most recent outbreak of pandemic influenza was mild, but the World Health Organization is still working on a plan of what to do should another, more severe outbreak ever occur. States will come together this month in another attempt to finalise this plan.

The pandemic plan has defied consensus resolution for several years due to disagreements about a standard material transfer agreement, including intellectual property rights provisions, for the sharing of viruses and other pandemic-related materials and, equally, for sharing related benefits.

The meeting of the Open-Ended Working Group [pdf] on Pandemic Influenza Preparedness is set for 13-17 December. This open-ended working group is the latest in a series of attempts to conclude a framework on pandemic influenza preparedness.

Aware of the importance of this plan, delegates have been gathering informally outside the WHO in recent weeks to prepare for what they hope will be a successful negotiation. Recently, the co-chairs of the Open-Ended Working Group gathered several critical country representatives at the Mexican mission on 24 November to discuss the process for the December negotiation, according to sources. The point was in part to agree on procedure and other “non-core issues,” said one source, so that time is not wasted during a negotiation which has serious substantive issues to tackle.

The two major points that will be focal areas of the upcoming meeting are the initial results of technical studies being prepared by the World Health Organization to aid the working group in its efforts to complete the framework, and then the remaining issues outstanding.

The studies are covering the “current activity, financing and unmet financial and other needs” related to: building capacity in laboratories and for surveillance as well as for vaccine production, and increasing access to and affordability of vaccines, diagnostics and other pandemic preparedness and response materials, the outline says.

The outstanding issues include the text of a standard material transfer agreement for use within the WHO network of laboratories and a possible SMTA for use when materials are transferred outside the network, for example to pharmaceutical companies.

As yet undecided is what comprises the WHO network, though there are proposals to just use the Global Influenza Surveillance Network, the WHO mechanism monitoring and response to create influenza vaccines. Also undecided is the definition of “pandemic influenza preparedness biological materials.” These definitions are important as they determine the scope of the framework under negotiation. A further area not yet having reached consensus is whether to include a reference to the World Trade Organization Doha Declaration on the Trade-Related Aspects of Intellectual Property Rights Agreement and Public Health.

The latest text of the framework, with brackets (or remaining non-agreed areas) is available here [pdf].

The working outline for the technical studies is available here [pdf]. The studies are intended to run through March 2011, the outline says, though preliminary findings were to be made available in English to the open-ended working group as of 1 December.

The Open-Ended Working Group is meant to report on its progress to the WHO Executive Board meeting, scheduled for 17-25 January 2011. A finished product is hoped for by the May 2011 World Health Assembly.

Background

This is the second working group set up to find a consensus solution to handling potential influenza outbreaks. After the avian influenza outbreak in 2005, WHO members agreed to set up the Intergovernmental Meeting on Pandemic Influenza Preparedness: Sharing of influenza viruses and access to vaccine and other benefits. This group met for the first time in November 2007, with a deadline of May 2009 to complete its work. The documentation of these meetings is available here.

But in May 2009, members were unable to finish a framework for pandemic influenza preparedness, and passed on the decision to the World Health Assembly (IPW, WHO, 18 May 2009).

The 2009 World Health Assembly gave the WHO director general responsibility for taking forward the pandemic influenza process in hopes of reaching a final agreement in time for the 2010 January Executive Board meeting (IPW, WHO, 22 May 2009).

Though a WHO declaration in June 2009 that swine flu was a global pandemic put pressure on negotiations, a consensus was still not forthcoming by January 2010. So a new Open-ended Working Group of Member States On Pandemic Influenza Preparedness: Sharing of influenza viruses and access to vaccine and other benefits was launched. It met for the first time 10-12 May, and recommended that the 2010 WHA allow it to continue meeting until the 2011 WHA (IPW, WHO, 14 May 2010). This was approved.

Chan told member states at the 2010 World Health Assembly that it was “just plain lucky” that the swine flu had not been a more dangerous virus (IPW, WHO, 18 May 2010).

The swine flu pandemic was declared over in August 2010, amid criticisms that its severity had been exaggerated. An external review of the WHO’s response to the pandemic is ongoing, with a final report on its findings expected at the WHA in May 2011.

The December meeting of the Open-Ended Working Group will be its second formal gathering.