Last-Minute Progress Made On Pandemic Flu; More Still To Come

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By Kaitlin Mara
Significant strides were made at last week’s World Health Organization meeting on pandemic influenza preparedness, as assembled delegates searched for – and found – a way to satisfy member states’ differing views on the need for access to viruses and related biological materials and the need for access to vaccines and other benefits. Yet still-contentious issues – including intellectual property rights and definitions – remain unresolved, with delegates hoping informal intersessional work will facilitate the search for consensus when the meeting resumes next May.

The compromise text found on virus and benefit sharing reads: “Recognise that member states have a commitment to share on an equal footing H5N1 and other influenza viruses of human pandemic potential and the benefits considering these as equally important parts of the collective action for global public health.”

The drafting of this language was seen as a key success of the 8-13 December WHO Intergovernmental Meeting on Pandemic Influenza Preparedness (IGM).

Earlier versions of the phrasing had involved debates over “voluntary” versus “mandatory” frameworks, and had not been able to bring consensus. But informal discussions between key member states – mainly Indonesia and the United States – produced mutually acceptable language that was widely hailed as one of the key steps forward in this meeting.

The connection between virus and benefit sharing had been a “bone of contention” between the two states, said Abdulsalam Nasidi, director of public health in Nigeria.

The commitment language was “a breakthrough,” said another delegate. But intellectual property rights issues are “still pending,” the delegate said, and will be difficult as the positions on them represent two opposite visions.

Intellectual property is “another tough issue,” said Widjaja Lukito, advisor to the Indonesian minister on health and public policy, one that was “too big” to get into at this meeting. But he added that achieving benefit sharing was an initial priority and finding compromise in that regard represented significant progress.

This meeting essentially “avoided [the IP issues] in recognition of how contentious they are,” said a developed country delegate. But the issue will have to be addressed in a standard material transfer agreement for the movement of biological materials, a key outcome of the IGM that has yet to be finalised, the delegate added.

It was decided in final plenary to suspend the IGM and reconvene it in connection with the next World Health Assembly, currently scheduled for May 2009. The meeting’s concluding progress report, available here [pdf], notes that the IGM as well as two working groups made progress on the chair’s text [pdf], which is a draft pandemic influenza preparedness framework for the sharing of influenza viruses and access to vaccines and other benefits. The group also nearly finalised a set of guiding principles for the framework, chief among which was the commitment to share viruses and benefits.

In the meantime, the body asked the director general to undertake several technical measures to prepare for the resumed session, including work on further developing a mechanism for virus tracing, the preparation of terms of reference for the network of WHO Collaborating Centers on Influenza, the WHO H5 Reference Laboratories, Essential Regulatory Laboratories and National Influenza Centers; the preparation of a revised version of the standard material transfer agreement’s technical section, and to prepare a report identifying needs and priorities – including financing options – for benefits proposed in the pandemic influenza preparedness (PIP) framework text.

Intellectual Property Issues Still On Table

The key IP issues for member states relate to what material may be patented – ie, whole viruses, parts of viruses, or technologies and other products that could be developed from those viruses or parts – and over what benefit a source country or a researcher can derive from ownership, meeting Chair Jane Halton of Australia reported to assembled delegates during a plenary on the morning of 12 December.

There are technicalities that still need to be clarified before drafting the language on intellectual property will be possible, she added.

“These are such core issues,” said a US delegate during the plenary session “there are questions as to whether or not this is even the correct forum for intellectual property issues.”

However, a Brazilian delegate asserted that “this is the proper forum,” reminding the plenary that a Global Strategy on Public Health, Innovation and Intellectual Property had been approved earlier this year, which changed the mandate of what the WHO can discuss. Further, the delegate said, “Brazil maintains the position of talking about anything related to public health at the WHO.”

Perhaps, said Nasidi after the final plenary, it could be that “IP is not the most important issue.” If it could be agreed that vaccine manufacturers would grant free licences to all countries able to produce vaccines, especially in the event of a pandemic, and in order to save lives, then this allows public health to be a priority without the need to contest IP ownership.

Standard Material Transfers, Definitions

A delegate from a major developing country cautioned after the end of the meeting on 13 December not to be “over-optimistic” as despite good work being done, challenges remain. In particular, the delegate said, there is the issue of making the agreed framework applicable to those outside the WHO network of institutions and research centres that might receive PIP biological materials. This would require a mechanism being built into the standard material transfer agreement (SMTA), which is not yet finalised.

Part of the difficulty in settling the SMTA is that an agreed upon definition of the “PIP biological materials” it will cover has yet to be found. The United States is pushing for a narrow definition of such materials, one that, among other things, excludes virus proteins and other parts of the virus, gene sequencing information, cells and cell parts, and antibodies and proteins derived from the virus in favour of a definition focussed on “wild type” influenza viruses and virus isolates (IPW, WHO, 11 December 2008).

There was also discussion over whether institutions, organisations and entities providing or receiving biological materials through the framework could seek to claim IP rights over those materials. The US said in plenary it wants to ensure the SMTA will not affect “obligations or restrictions that arise from” IP rights, and Brazil intervened to say that it wanted assurance that IP rights will not be claimed over biological materials shared in the system.

Nigeria said it could accept IP if royalty-free licences are available to developing countries “at all times… to use products and processes developed from… biological materials” shared through the framework.

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

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