By Kaitlin Mara
Four days into one-week “critical” negotiations on pandemic influenza preparedness, World Health Organization members had yet to tackle areas of core disagreement and participants were expressing doubt as to whether consensus can be achieved by week’s end.

Details on the definition of “Pandemic Influenza Preparedness (PIP) Biological Materials,” on the content of a standard material transfer agreement for virus sharing, and on the interconnection between a mechanism for virus-sharing and a mechanism for sharing of benefits from vaccine development have yet to be discussed or have been pushed until later in the meeting for more substantive discussion and hoped-for consensus.

These interrelated topics represent core differences between member states and thus are likely to be most difficult to resolve at the WHO Pandemic Influenza Preparedness Intergovernmental Meeting, gathering this week in Geneva from 8 to 13 December.

Member states have been meeting in working groups for the past two days to hash out language on a system for the sharing of viruses, for the sharing of benefits, and for governance and review of the PIP framework, and were meeting Thursday evening in plenary to discuss progress.

Yet there is still “confusion and lack of specific ideas” on what constitutes benefit sharing, a participant said, and most importantly disagreement over whether a system to share benefits would be voluntary or obligatory. The standard material transfer Agreement (SMTA), which will require any entity accepting “PIP Biological Materials” to abide by a set of terms and conditions as laid out in the agreement.

The SMTA is a binding contract forming an annex to a non-binding framework of recommendations, explained another participant. This adds a contradictory element to this week’s negotiation, and, said a separate source, means aspects of the framework not in the SMTA will carry significant less weight.

Defining ‘Biological Materials’

What the term “PIP biological materials” means is likely to be a key area of controversy, as it is essential to determining the scope of many provisions within the PIP Framework, notably the SMTA.

The chair’s text working definition is wide, saying the term includes:

“original clinical specimen believed to contain H5N1 or other influenza virus with human pandemic potential provided for the purposes of influenza testing and any material generated from that specimen by a [WHO network] laboratory, including virus isolates or related hybrid viruses created through laboratory techniques or resulting from laboratory techniques used on the clinical specimen, virus nucleic acid, virus protein and other parts of the virus, genes, gene sequence information, peptides, cells and cell parts and derivatives, functional subunits of the materials, expression products of the materials, purified or fractionated subsets of the materials, clones and sub clones derived from the materials, and antibodies, proteins and other biological materials derived, synthesized or otherwise obtained from the materials.”

But the United States in plenary earlier this week had proposed replacing that definition with one much narrower in scope:

“original clinical specimen of H5N1 or other wild type influenza virus with human pandemic potential provided for the purpose of risk assessment and influenza testing for the H5N1 sub type or other sub type of influenza virus with human pandemic potential; any virus isolate of the H5N1 subtype or other subtype of influenza virus with human pandemic potential; high growth reassortant viruses and candidate vaccine viruses generated therefrom.”

A US delegate explained to Intellectual Property Watch that the country’s main concern was to “maintain focus on public health and not politics,” adding that the broader definition invited debates on intellectual property ownership.

The US proposal is, the delegate said, the minimum needed definition to achieve public health objectives but also a definition the delegation felt could reach consensus this week.

“We thought with this minimum [definition] it might be possible to reach consensus,” the delegate said, adding “and hopefully convince member states that public health objectives should take priority over any IP agenda.”

But other member states worry that a narrower definition will reduce the scope of any outcome of this week’s intergovernmental meeting. An Indonesian delegate said the definition of biological materials should match the actual use of such materials in the development of technology. Samples of, for example, infected blood contain useful genetic material aside from just a wild-type virus. The definition should include all such material.

An Indian delegate said a concern of narrowing the definition is that it would provide a loophole to get out of obligations in a finalised PIP framework that uses the definition.

The Importance of Benefit Sharing

“If virus sharing is mandatory then benefit sharing should also be mandatory,” said the delegate from Indonesia, which is seen as a key demander of a benefit sharing system. This is because the country has had the greatest incidence of avian influenza, and counts many of the viruses and other biological materials countries seek to use in research as its genetic resources.

The South East Asian Region (SEAR) countries, represented by India, in a 9 December statement expressed dismay that the focus of discussions had “been towards consolidating the system, structure and mechanisms of virus sharing alone” while “benefit sharing has been relegated to the realm of the vague and the obscure.” Virus sharing alone, the statement said, “does not, to our understanding, deliver global public health protection in times of a pandemic.”

The Non-Aligned Movement of member states, primarily developing countries, also called for both a “recognition of the sovereign right of states over their biological resources” and “effective, transparent, fair and equitable benefits sharing.”

Others, notably the US and Japan, have questioned the express link between virus and benefit sharing. A US delegate explained to Intellectual Property Watch they were most concerned about a “one to one correspondence” between sharing a virus and receiving a benefit. Benefits should be globally applicable, the delegate said.

However, an Indonesian diplomat said that the country wants a multilateral system of benefit sharing and was uncertain where the “one to one” interpretation came from.

Meanwhile, WHO Director General Margaret Chan said earlier this week that for the WHO’s part, they will continue to “remind member states of remaining risk” for which not a single country is fully prepared.

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