WHO To Continue High-Priority Revision Of Pandemic Flu System

By William New
Members of the World Health Organization worked for days recently under the steady gaze of the WHO director general in an attempt to develop a new framework for the global influenza-sharing system designed as a safeguard against a pandemic.

Director General Margaret Chan said it was the most time she had spent in any single meeting since taking office in early 2007. Negotiations are expected to continue with increasing intensity in the coming year, according to draft meeting documents and officials. Yet despite the priority placed on the effort, the next full meeting is being considered for 8 months into the future.

There are expected to be meetings of a smaller working group with the chair early in 2008, likely starting in February, with the hope of making further progress on texts, sources said. But the full WHO Intergovernmental Meeting on Pandemic Influenza Preparedness is not expected to reconvene until after the May 2008 annual World Health Assembly, possibly in July.

The intergovernmental meeting on sharing of influenza viruses and access to vaccines and other benefits was held from 20 to 23 November. The effort was mandated by the May 2007 Health Assembly, and background documents for the meeting are at www.who.int/gb/pip.

Draft Meeting Documents:

Draft Meeting Report

Draft Meeting Statement

Draft Principles

Draft Operational Components

“I have never in my 10 months invested so much time in a meeting,” Chan told the meeting. “It is our duty to do that. But it is member states who have to decide the best way forward.” She reminded them that “millions and millions” of lives may depend on the outcome.

The meeting brought together health ministers and other officials to address the chilling prospect of a global pandemic should avian influenza, H5N1 virus, mutate into a human-to-human contagion. Officials predicted its spread worldwide would occur within months. Of particular concern is ensuring that developing and least-developed countries are able to obtain sufficient access to affordable treatment and related equipment to stop its spread.

Developing countries’ entrance into the system has raised new questions of fairness and equity that members were unable to resolve in the meeting, especially as an example of inequity has been cited where a developing country shared its virus and then did not receive fair access to the resulting vaccine.

Meanwhile, the head of the UN Food and Agriculture Organisation also called for a framework for addressing agricultural concerns. “We need a global framework of action that carefully considers the possible adverse social and economic consequences that those changes might bring, especially on the poorest populations and on the livelihoods of backyard poultry keepers,” FAO Director General Jacques Diouf told the 4-6 December New Delhi International Ministerial Conference on Avian and Pandemic Influenza.

But during the four-day WHO meeting in November, members worked to late hours in an effort to agree on basic texts for negotiation and were unable to do so. There were a series of unapproved texts that are expected to provide the basis for continuing talks.

In addition, proposals from Indonesia and Thailand for more dramatic change to the virus-sharing system (IPW, WHO, 21 November 2007) remain on the table, according to sources. Indonesia in particular is seeking a new system after identifying problems for developing countries that share their virus strains into the WHO system only to be offered high-priced vaccines they cannot afford.

Draft Principles

A preliminary set of principles on virus sharing and benefit sharing also were drafted with the presence of non-governmental organisations and the press at the meeting. The operational aspects were negotiated in private, with only two industry groups permitted to join.

The amount and nature of the bracketed, or not agreed, text in the principles shows the range of members’ differences. On virus-sharing, some emphasise the sovereign rights of nations over their biological resources or call for the use of alternative mechanisms for sharing and prior informed consent of the originating countries for virus transfer. Others insist on placing attention on the existing global sharing network, even to the point of deciding who gets to share in the benefits of virus-sharing.

On benefit-sharing, principles include access to vaccines for all countries in need, and the provision of technical assistance and support including establishing WHO collaborating centres for vaccine development in developing countries as well.

On intellectual property, the United States sought during the meeting to remove all discussion of IP rights from the WHO effort. But other countries insisted on it remaining, and some sought to ensure that IP rights not interfere with government’s ability to take public health measures.

Other principles address financing, collective action, sovereign rights and oversight mechanism. On the latter, a proposal calls for the WHO secretariat to review the functioning of the global network to identify strengths and weaknesses.

Operational Components

The text on operational components amounted to some 20 pages and covered virus sharing, benefit sharing, financing, an oversight mechanism, capacity building and technology transfer and need for collective action to address a pandemic.

Among the many proposals is to create WHO Collaborating Centres, which coordinate collection and distribution of the virus samples, in developing countries. Currently under the 60-year-old Global Influenza Surveillance Network, the centres exist only in developed countries. Proposals also touched on issues such as transparency, fairness and equity, use of seasonal vaccine, and provision of equipment and technical assistance.

For financing, a proposal would follow the Global Influenza Vaccine Fund, and would assess annual contributions from member states based on level of economic development.

Interim Statement

A loose agreement emerged to call for two immediate measures: setting up a traceability mechanism for tracking all shared viruses, and a WHO advisory mechanism to oversee the system’s functioning. There was an intensive effort to produce a statement from the meeting but it could not be agreed, so an interim statement was circulated that includes these measures, plus highlights the importance of international collaboration and collective action, and the “urgent need for fair, transparent, equitable and effective international mechanisms” aimed at fair and equitable sharing of benefits.

The statement also acknowledges a “breakdown of trust” in the system of international collaboration and collective action, and that the current system does not deliver a level of fairness, transparency and equity. The statement also commits WHO members to continue using the system in good faith.

The African Group sought to halt talks on the final evening, arguing that they felt “rushed” into the final draft statement and had no further direction from their capitals on how to proceed. But the chair pushed them to allow talks to continue, and the group agreed on the understanding that any outcome would be subject to consideration and approval. Talks then continued for several more hours.

An official from a large developing country stressed the importance of a transparent process “to ensure that loopholes of the past do not recur in the future.” What is needed, therefore, the official said, is to develop a framework that is transparent and validates itself. This should be overseen by the WHO, the official said.

“You need a framework and not a verbal assurance that these things will not happen,” the official said.

An official from the African Group said near the end that the meeting had a slow start, and that the regional group had difficulty accepting proposals put on the table even though the region supports the effort. “The idea is good itself,” he said. “The meat is good.”

Fast Opportunities for Industry

Industry during the week raised the prospects for addressing the pandemic problem in the increasing use of seasonal vaccines and efforts to reduce prices and increase availability as manufacturing capacity increases. A developed-country pharmaceutical industry participant said the talks went well after a slow start, and that industry would agree to meet the needs of any country with public health concerns. But he cited other measures that countries need to take as well to help contain outbreaks, plus build infrastructure and provide surveillance of public health threats.

A joint civil society statement was issued at the meeting signed by nearly 60 organisations from around the world. The statement raised concern about the “present imbalanced system on which countries are asked to contribute viruses to the WHO global influenza system but in which the developing countries are not assured they can have access to vaccines and other health products required to deal with the problem of influenza.”

The civil society group provided detailed reasons for its concerns and then called on governments to act immediately to correct the situation by establishing a new framework oriented toward public health needs in developing countries. It provided explicit details on what the framework should accomplish, such as ensuring that institutions and companies receiving viruses or parts do not patent them, as reportedly occurred.

Studies circulated at the November meeting showed a rapid rise in patenting of influenza virus and related elements. The WHO produced a paper on “Patent Issues Related to Influenza Viruses and their Genes,” dated 7 November (A/PIP/IGM/3).

Another produced by the World Intellectual Property Organization showed a historically high level of patenting activity related “in some way” to the avian flu virus occurring now. “The general trend is striking: of all relevant international applications since the first instance recorded in 1983, some 35 percent were published in the first nine months of 2007,” a working version of the WIPO paper said.

A paper circulated at the meeting by the Third World Network entitled “Some Intellectual Property Issues Related to H5N1 Influenza Viruses, Research and Vaccines” by Edward Hammond from the US-based Sunshine Project also showed a recent sharp upswing in the number of patent applications for influenza virus (or parts of it), as well as vaccines, treatments and diagnostics.

The WHO also produced at the outset of the meeting a summary of progress on developing frameworks and mechanisms for an international stockpile of vaccines and fair and equitable sharing of vaccines, document number A/PIP/IGM/2 Rev.1. The meeting also worked on a glossary of terms.

The negotiations were at times difficult. Meeting Chair Jane Halton, secretary of the Australian Health and Ageing Department, at times got testy with delegates, and some members raised concern that she was inserting her own proposals into the process.

Halton also advised the full assembly not to speak with the media in their countries about this process.

Before the New Delhi meeting, a new report was released that showed despite capacity building over the past two years, countries must maintain their vigilance and cooperation against a possible pandemic. The report was based on data from 143 nations and was released in New York by the World Bank and David Nabarro, the senior UN system influenza coordinator.

William New may be reached at wnew@ip-watch.ch.