As the world looks to the World Health Assembly for a plan of action in case of pandemic, delegates are negotiating remaining parts of a framework for pandemic influenza preparedness, and an associated model agreement for the movement of virus and vaccine-related materials.

A procedural agreement might come as early as Tuesday afternoon, but it remains to be seen whether agreement can be reached on how to handle uncompleted work.

The annual assembly, meeting from 18-22 May, opened Monday with pandemic influenza, climate change, and the financial crises the most cited public health threats.

Two key IP-related areas remain on the agenda: the ongoing implementation of a global strategy on IP and innovation, and the remaining unresolved areas of an agreement on pandemic flu preparedness, which include the way intellectual property will be used in virus- and benefit-sharing.

Discussion on counterfeit medication, another top IP issue, has been postponed for discussion at the next WHA in 2010. The WHA is the annual decision-making meeting of the World Health Organization.

The Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property is scheduled to be discussed [pdf] on Tuesday and Wednesday.

Pandemic Flu Talks Ongoing

The Intergovernmental Meeting on Pandemic Influenza Preparedness (IGM), mandated to find solutions for equitable access and benefit sharing, had its final meeting from 15-16 May (IPW, WHO, 18 May 2009). At its close, several key issues remained unresolved, as bracketed text in the latest draft of the framework [pdf], though there was progress on areas of the framework related to benefit-sharing and definitions.

Coming to the WHA with this incomplete body of work, delegates faced a decision whether to implement consensus parts of the agreement, and how to handle remaining work.

Some developing countries were concerned that if the framework goes ahead without agreement on the whole, then key remaining elements – notably the Standard Material Transfer Agreement (SMTA), a legally-binding document – will never be dealt with. This concern was due in part to the fact that other countries had sought over the weekend to limit the scope of the SMTA.

But there is also clear global pressure to have some kind of action on influenza, and key aspects of the framework which have been agreed to, such as language on benefit sharing, are valuable to developing countries.

Way Forward On Pandemic Flu?

Nigeria, supported by developed countries, proposed at a Monday evening working group a way forward, including implementation of agreed elements and smaller, potentially informal meetings on remaining elements. The Nigerian text reads:

“The sixty-second World Health Assembly decided to request the Director-General to work with Member States to take forward the elements of the Pandemic Influenza Preparedness framework for the sharing of influenza viruses and access to vaccines and other benefits on which the intergovernmental meeting (IGM) reached consensus. The assembly decided to request the director-general to support consultations among Member States on some key remaining elements, conclude outstanding issues through a select group of experts, the bureau of the IGM or through the informal process, and report to the Executive Board at its 126th session to be held in January 2010.”

Voicing support for this proposal Monday evening were the Czech Republic on behalf of the European Union, the United States, Japan, and Mexico.

But Brazil said that the process was not yet concluded and that accepting the proposal as is would give the “false impression” that the negotiation had been concluded, and asked that talks be continued Tuesday.

Tuesday morning, Brazil, Indonesia, and India drafted new language on the way forward that calls for a more formalised process. Drafting of this proposal was still ongoing by press time, but an early copy obtained by Intellectual Property Watch requests the director general to work with member states “to take forward the agreed parts of the Pandemic Influenza Preparedness Framework.”

It further asks that the director general “facilitate and support further negotiations among all member states to conclude the remaining elements, including the Standard Material Transfer Agreement (SMTA) and its annex, and report the outcomes of such negotiations to the 126th Executive Board.” The annex of the SMTA includes definitions of terms used within the agreement, according to a source.

Formal discussion on the issue is expected Tuesday afternoon; informal discussions among member states continue in the meanwhile.

Meanwhile, developed countries appear to have been working behind the scenes to secure influenza medication for their populations. The Wall Street Journal reported that Austria, Canada, Denmark, Sweden, Switzerland, and the United Kingdom have been making deals with pharmaceutical vaccine manufacturers. The United States also is hedging its bets, but through building capacity in the vaccine manufacturing sector that will provide them with first access to the vaccines, the report said.

US Secretary of Health and Human Services Kathleen Sebelius on Monday downplayed pandemic anxieties to the assembly, saying that the US is “cautiously optimistic that this virus might be less severe than was first feared, based on initial reports from our close neighbour, Mexico.”

Consumer Group Urges US, EU Cooperation; Low-Cost Medicines

Meanwhile, the Trans-Atlantic Consumer Dialogue, a forum of US and European consumer groups, issued a resolution on pandemics calling for the US and EU governments to work with the WHO to encourage the take-up of generics and to take measures to avoid intellectual property pitfalls on the way to better access to medicines.

The text, available here, calls for the “EU and the US government to work with the WHO to create policies that realistically address concerns over the management of intellectual property and the supply of and access to generic medicines and vaccines, notably in the context of pandemics.”

It asks for the governments to collaborate with WHO to create patent landscape on treatments relevant to pandemic-related illnesses and an influenza patent pool, and to cooperate with the World Trade Organization and the World Intellectual Property Organization for a comprehensive assessment in of all IP-related barriers to the manufacture and distribution of medicines.

It further asks for several measures to increase supply of generic medicines, including capacity building for generic producers, stockpiling of generics, and WHO pre-qualification without regard to IP rights on pandemic related medications (this process reviews the safety of drugs intended for purchase by UN bodies).

Global Strategy Remains Priority

Leslie Ramsammy of Guyana, the president of the 2008 WHA, said in his opening speech that the 2008 agreement on the global strategy and plan of action represented a “significant new tool to improve health.” The president of last year’s assembly gave the speech before handing over the presidency to this year’s president, Nimal Siripala de Silva of Sri Lanka.

And WHO Director General Margaret Chan opened the assembly Monday by emphasising that public health requires “fair access to affordable medical products and other interventions.”

“I urge you, in particular, to complete work under the item on public health, innovation and intellectual property,” she said. “We are so very close.”

NGOs Press For Global Strategy Finalisation

Seven nongovernmental organisations Monday sent a letter to WHO member states [pdf], also calling for the finalisation of outstanding areas of the global strategy and plan of action. They are: Essential Action, Health Action International, Health Gap, Knowledge Ecology International, Médecins Sans Frontières, Oxfam International, and the Third World Network.

The letter encourages further work on progress indicators [pdf] for measuring the plan of action, and in particular to focus more on qualitative measurements. It is not just the number of policies, it says, but “the effect and the impact of these policy measures on public health” that matters. It also calls for the WHO to remember the role of civil society as a stakeholder in the implementation process.

Meanwhile, the team dealing with the global strategy at WHO has expanded. Peter Beyer, an official with the Swiss intellectual property office, is joining the team on Public Health, Innovation and Intellectual Property (PHI).

Currently led by Elil Renganathan, Executive Secretary of PHI, this group is responsible for overseeing the implementation of the global strategy. Beyer has been seconded to the WHO for two years, beginning this June, according to sources.