A series of meetings intended to set out a global framework for dealing with a potential pandemic completed its last session Saturday night with progress made but several essential issues still uncompleted.

Notable areas of success included a consensus text on a pandemic influenza preparedness benefit-sharing system for the framework, and near consensus on definitions of terms used within the framework, which is important as the definitions determine the scope of applicability of the agreement.

But a legally-binding standard material transfer agreement (SMTA) for the exchange of materials related to viruses and vaccines – an appendix to the framework, viewed as the most critical element of the negotiation by most stakeholders – is not yet complete after a US-led attempt to rewrite the language. Other missing pieces include the ‘objective’ of the framework, and parts of the framework text that reference the SMTA.

The Intergovernmental Meeting on Pandemic Influenza Preparedness (IGM) had its final meeting from 15-16 May, against the backdrop of a potential pandemic threat from the H1N1 virus, or swine flu.

At issue in the negotiations is what kind of framework can be found to balance access to and benefits from genetic resources found in developing countries and products made from those resources, often coming from developed countries.

Hopes were that a full agreement could be reached in what has proved to be a difficult negotiation over how to effectively ensure that vaccine manufacturers have access to the materials they need to manufacture medication and developing countries have access to the medications they need to protect their people.

The work of the meeting is now completed, said meeting Chair Jane Halton of Australia, and the way forward on remaining areas of work – including on intellectual property issues – will need to be decided by the World Health Assembly, (WHA) which meets from 18-22 May.

Precedent-Setting Negotiation?

Implicitly, more was riding on the negotiation than viruses and vaccines. A declaration made at an early April meeting of the Convention on Biological Diversity Access and Benefit Sharing working group and obtained by Intellectual Property Watch connects the CBD’s broader work on biological resources with the work at WHO on influenza viruses.

The declaration – by a “group of like-minded megadiverse countries” – calls for recognition of the “sovereign rights of states over their biological resources,” including viruses and other pathogenic organisms, and asked that the work of the IGM recognise “the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from commercial and other utilisation of genetic resources.”

But it is a commonly expressed concern of developed countries that too many restrictions – and uncertainty over the ability to obtain and enforce patent rights – can hinder incentives for innovation. A source raised concern that if the pandemic meeting “blocks innovation here, where else [could it be blocked] potentially?”

SMTA Raises Hackles But No Deal

Early in the meeting, several developed countries led by the United States attempted to narrow the scope of the SMTA, but were prevented by concerned developing countries.

The SMTA is seen as essential by developing countries and public-health nongovernmental agencies because it is their binding guarantee that they will have access to influenza vaccines, as they can be expensive and as nearly all manufacturing capacity for influenza-related medicaments is located in the developed world.

Developed countries and industry groups mentioned that a too-broad SMTA could hinder the speedy transfer of materials in a situation where time is of the essence, and worried that guaranteeing too many benefits would threaten their ability to recoup research and development costs.

Over the last few weeks, thousands of supplies have been transferred related to swine flu without an SMTA, a source told Intellectual Property Watch. The bureaucracy associated with a need for every party to a transfer to sign an agreement “would have slowed things down, and imperilled people’s lives,” the source added. “We need to recalculate how we’re approaching this issue.”

But a separate source from a developing country said the SMTA is there because the system is not equal. “We give you the virus, this serves you to make the vaccines,” the delegate explained, but then the vaccines are too expensive for developing countries to afford.

A statement from the South East Asia Regional Organization was starker:

The current situation of H1N1 outbreak, it said, was used to “build pressure on the ongoing IGM process, and undermined the negotiated chair’s text, which we have built together for the past two years.” The statement refers to an informal “brainstorming” session held at the Canadian mission on 13 May.

At this informal consultation, a source said, the United States had proposed not having an SMTA at all. Later, the country wrote and submitted its own draft SMTA text to the negotiation, which was much shorter than the draft SMTA the meeting had been working on. This version was supported by the EU and Japan, according to several sources.

This text, said a developing country delegate, was “minimalist” – “just a contract” without obligations for the recipient of materials.

This is “unacceptable,” said a Brazilian delegate, as it “doesn’t go to the heart of the problem,” which is the need for access to benefits.

US delegation lead Amb. Robert Loftis, the US special representative for avian and pandemic influenza, said the country just wanted to ensure that the system was “quick, easy, and transparent.” Assistance to developing countries belongs in the framework, he added, not the SMTA.

Some drafts of the SMTA created obligations that were too broad, making it “unclear if the parties to the SMTA would be able to fulfil them,” Loftis said. This “unknowable liability” is problematic, he added.

There was also a lengthy discussion during the meeting on whether the SMTA should apply to laboratories outside of the World Health Organization network, sources told Intellectual Property Watch. The risk, said countries who felt it should, is that materials given to WHO with the intent to prevent a pandemic could, when transferred to private companies, be used for different and possibly nefarious purposes.

Reflecting the views of countries who felt it should not, Loftis said it is “not appropriate for WHO to be telling private entities” what they should do with materials, and said the SMTA should cease to apply after the first transfer.

Participation Problems

Brazil requested early during the second day of negotiations that civil society have the right to be in the negotiating room, a proposal supported by at least Bangladesh, India and Indonesia, according to sources. Civil society needs to be represented in discussions over public health, said Brazil.

Nongovernmental agencies can be in the negotiating room if invited by member states. Two – the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the Developing Country Vaccine Manufacturers Network – had been in the room already, but groups representing public health interests were not permitted.

In the ensuing discussion, Japan said that the technical specification, which industry has, was an important contribution to the discussion, and asked the reason for including other groups, according to sources. The US then proposed that the substantive discussions be limited to member states only, according to several sources. A US delegate told Intellectual Property Watch later that they were “obviously in favour of civil society participation,” but in the “appropriate time and place.” The delegate did not specify when and where that is.

Where the work on pandemic influenza preparedness will go in the future is now in the hands of the World Health Assembly.

Meanwhile, the WHO nursing staff in the WHO lobby helpfully handed out packages of tissues and disinfectant to delegates packaged with information about what to do “if someone has flu-like symptoms.”