Officials Working Informally Toward May Consensus On Avian Flu Preparedness

An informal meeting last week brought together interested parties from different regional groups, as well as representatives from vaccine manufacturers, as a part of a process to resolve contentious issues on pandemic influenza preparedness remaining from the last formal meeting in December.

These issues included intellectual property rights, details of a proposed standard material transfer agreement for the exchange of viruses, and benefits to those developing solutions for a possible pandemic influenza virus.

The meeting took place in Montreux, Switzerland, and according to a source lasted from 30 March to 2 April and involved about 25 member states. The World Health Organization, under whose auspices falls the formal Intergovernmental Meeting on Pandemic Influenza Preparedness (IGM), did not convene the Montreux meeting.

A WHO spokesperson confirmed that the secretariat did have a presence at the meeting, but emphasised that the gathering’s purpose was to solicit a wide range of views in an informal atmosphere.

Intellectual property rights are a key issue in the pandemic influenza debates because they are the medium through which exchange of needed materials is negotiated and may affect the speed at which a vaccine could be manufactured.

Western vaccine manufacturers – where most of the worlds influenza vaccine manufacturing capacity is located – need access to strains of the virus, which are the genetic resources of countries who have already seen outbreaks of bird flu. And countries in the developing world without vaccine manufacturing capacity want to ensure that they can also benefit from the new vaccines, over which there are likely to be patent protections.

The WHO secretariat is engaged in ongoing technical work on a mechanism for virus tracing, 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, preparation of a report identifying needs and priorities – including financing options – for benefits proposed in the pandemic influenza preparedness (PIP) framework text.

Meetings on the Global Influenza Surveillance Network and the reference centres to take place at the end of April are a part of the larger body of work that the secretariat was asked to undertake at the last formal IGM meeting, which ran from 8-13 December. Another IGM is scheduled for 15-16 May.

The intent of the consultations was to allow countries to move on issues before the next formal meeting of the IGM, to be held in close to the World Health Assembly in May. The WHA is meeting 28 to 30 May.

Such consultations had been planned from the meeting in December, when it was realised that several points – mostly on IP-related issues – were too contentious to be resolved then (IPW, WHO, 15 December 2008).

Several sources who attended last week’s invite-only meeting indicated that the exchange of ideas, early enough to allow delegates to consult with their capitals again before the next formal meeting, was intended to facilitate the goal of reaching consensus when the full group reconvenes. Discussions are likely to continue through electronic communication, a source said.

A developing country source said that the group had reached informal agreements to limit the scope of the standard material transfer agreement (SMTA) framework to pandemic influenza (rather than include also seasonal influenza) and that a paragraph on benefit-sharing that had been bracketed (that is, not yet reached consensus) would be included in the preamble.

The source added that developing countries are still calling for benefit sharing in the body of the SMTA. Also remaining is the issue of defining genetic material related to pandemic influenza potential, and whether the SMTA framework will cover gene sequences. This issue is of particular importance to the United States, as it will dictate the scope of applicability of an agreement coming out of the IGM (IPW, WHO, 11 December 2008).

Norway chaired the meeting. One source explained this is because of their role in an initiative on Global Health and Foreign Policy, and in the Oslo Ministerial Declaration on the same issue. Officials from the country declined to comment on the meeting.

The vaccine manufacturers, four members of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) – one from the secretariat and one each from pharmaceutical manufacturers Sanofi, GlaxoSmithKline, and Novartis – and one a member of the Developing Country Vaccine Manufacturing Network (DCVMN), were invited to provide information related to the process of creating vaccines, such as how long they take to manufacture.

A spokesperson for IFPMA said that the meeting was positive, as unlike other meetings staged by the WHO, “companies were able to speak directly to member states and explain the technical issues and concerns they have.”

David Daout, the representative from DCVMN, explained that industry representatives primarily gave feedback on the draft SMTA [pdf], and in particular an “option for consideration” on a still-bracketed article that says:

“The recipient shall not seek to obtain any intellectual property rights in connection with such PIP biological materials, unless the recipient agrees to grant to WHO a royalty-free, non-exclusive, transferable licence with respect to such rights. WHO may then transfer this licence to developing countries, with appropriate terms and conditions, as determined by the director-general in accordance with sound public health principles, with transparent rules and procedures, informed by expert guidance and evidence.”

DCVMN agreed to this article – as it would not otherwise make sense that WHO supplied the virus materials but then could not get back licences in return – but the IFPMA did not, the source said.

Intellectual property rights can represent a barrier to access to influenza vaccine-related technology, Daout explained. It is often difficult to find a company willing to licence adjuvants, which enhance immune response to a vaccine. And technology transfer is difficult, as to be effective it may require not just flexibilities in IP rights but also weeks of technicians’ time devoted to training and testing of the trainees.

IP rights might be a particular issue in the case of pandemic avian influenza. Traditional methods, in place for decades, for creating influenza vaccines involve growing the virus in eleven-day old fertilised hens’ eggs. Not only does this present the problem of having enough such eggs available at short notice in the case of an outbreak, one of the initial stop-gap measures to prevent the spread of bird flu is to slaughter chickens. Vaccines made via cell culture manufacturing technology are less tied to limited resources, but are also still in the costly research and development phase, and thus might be subject to IP protection [pdf].