The work of the member governments calls into question a longstanding WHO system for global sharing of disease strains, and involves questions of limitations on access from patents imposed on vaccines, in some cases developed from flu strains shared under the WHO system.

The WHO Intergovernmental Meeting on Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits is being held from 20 to 23 November. The effort was mandated by the May World Health Assembly. Documents and background for the meeting is at http://www.who.int/gb/pip.

“We must never lose sight of what a pandemic can mean under the unique conditions of the 21st century,” WHO Director General Margaret Chan told the meeting. She said pandemic are recurring and that nations must prepare themselves for situations where up to 25 percent of the workforce is incapacitated. There would be a “meltdown” of basic services and a slowdown of economic activity.

“For WHO, the biggest issue is the threat that an influenza pandemic poses for global health security,” Chan said. “Vulnerability is universal. A pandemic will, by its very nature, reach every corner of the earth, and it will do so within a matter of months. This shared vulnerability calls for shared responsibility, and collective action to fulfil that responsibility. In terms of the risk of disease, we really are all in the same boat.”

Under the Global Influenza Surveillance Network (GISN), countries are expected to send H5N1 virus strains from avian flu victims to WHO-operated regional collaboration centres. But this mechanism has been called into question by some developing countries, who suggest it may not be fair to them in case of a crisis.

“In term of preparedness, access to vaccines is almost certainly the greatest concern in countries that lack their own manufacturing capacity,” Chan said. She said the surveillance network was created in 1947 to assess risks through analysis of shared viruses in order to avoid another devastating global influenza pandemic. She said the current process is aimed addressing weaknesses identified in that system and that it is unique that the threats are already known, giving time to prepare.

Countries already have begun developing pandemic preparedness plans, she said, such as Uganda, which used its plan to stop dead an August outbreak of Marburg hemorrhagic fever.

Meeting Labours at Outset

The negotiating meeting, chaired by Jane Halton, who is secretary of the Australian Health and Ageing Department, spent much of the first day on procedural matters, trying to establish a base document from which to work and laying the groundwork for debates to come.

Issues under consideration include benefit sharing, virus sharing, collective action, sovereign rights, capacity building, intellectual property, oversight mechanism, technology transfer, transparency and accountability. The focus turned early to benefit sharing and principles and objectives.

The meeting took note of an expert report commissioned by the WHO secretariat on patent issues related to influenza viruses and their genes. The report, which sought to be neutral, described the current situation, where there has been a “rapid, recent increase in patenting activity” relating to avian flu, both in the context of vaccines but also in diagnosis and treatment.

Several possibilities were explored for a starting document. Some sought to discuss new proposals by Indonesia and Thailand, some supported the unapproved chair’s report from a mid-summer meeting in Singapore of a subgroup on the issue, and Brazil suggested working from the text of the May Health Assembly Resolution 60.28, which had provoked this group’s creation. The discussion will continue on Wednesday.

Indonesian, Thai Proposals

There also were new proposals on the first morning from Indonesia and Thailand. Indonesia’s proposal is to “urgently develop a new system for virus access and fair and equitable sharing of benefits arising from the use of the virus.” The new system, which would replace the existing system, would emphasise the national sovereign rights of members over their biological resources. It would involve creation of a WHO stockpile of vaccines, and allow access to specimens or viruses through standard material transfer agreements with a number of other conditions. These include requiring manufacturers to get origin country consent to obtain seed virus from the system, and the prevention of intellectual property rights on the virus or any part of it.

Thailand laid out draft standard terms and conditions for “the transfer and use of influenza biological materials and fair and equitable benefits sharing between member states the WHO.” Its proposal would establish a global influenza vaccine fund with weighted contributions that would involve advanced purchase agreements to obtain vaccines. The terms would establish the sovereignty of governments and provide free access to information on viruses, and oblige countries to participate in the fund, which would be managed by a board.

Indonesia Charges Unfair Treatment

The government of Indonesia took a strong position at the outset of the meeting in favour of ensuring equal access for developing countries, and charged unfairness in the WHO system. Indonesia has come under pressure for withholding samples of the avian flu strain occurring there out of concern that sharing it to the WHO process would lead it to be expensive and unavailable for its population.

“As an organisation which governs health care of the world, WHO needs a fair, transparent and equitable mechanism,” Indonesian Health Minister Siti Fadilah Supari told the meeting. “Ironically, since avian influenza existed in Indonesia, we have been experiencing unfair and non-transparent mechanisms in virus sharing which has been linked to vaccine production.”

By sharing virus samples with the global flu network, developing countries are requested to release their viruses but then lose their right to them and do not know what they are used for, Supari said.

“The moment when developing or poor countries need vaccines, they have to purchase them at high prices, and, one of the financial consequences is that they may need loans from other developed countries,” Supari continued. “The unfairness that was given by the WHO could threaten global health security and also is a new type of oppression to developing nations by developed countries.”

Supari named three ways in which her country was treated unfairly. She charged that when Indonesia needed to procure Tamiflu, seen as potentially effective against avian flu, it had all been stockpiled by developed countries. Secondly, the DNA sequence for risk assessment and vaccine production was held exclusively by WHO-affiliated scientists, which Indonesia corrected by releasing the H5N1 sequence data to gene banks. Finally, Supari said, several developed country companies offered her vaccine and diagnostic kit developed from the Vietnamese flu strain.

Supari painted an unfavourable image of grieving family members in Vietnam learning that the viruses shared with the WHO mechanism ended up as a “commercial commodity” for developed countries. In sum, Indonesia suggested that a new mechanism is needed.

The Problem with IP and Vaccines

The European Union through its current president Portugal took issue with an aspect of the WHO secretariat’s suggestion to pursue with member states and vaccine manufacturers an advance commitment mechanism. This mechanism sets a pre-defined quantity of vaccine to be released by producers, which would guarantee access for countries lacking manufacturing capacity.

The United States said the “sense of urgency” must be maintained, and pointed to a variety of preparations for a possible pandemic that reach beyond access to vaccines, such as rapid response or measures to mitigate the spread at the community level. It also criticised any withholding from the global system, but said countries sharing their samples should not expect something in return every time. Instead, they could get technical assistance. Finally, the US said, “We cannot accept any approach that undermines intellectual property rights.”

Edward Hammond of the Sunshine Project prepared a report on IP issues related to avian flu viruses that tracked the recent “dramatic rise” in patent applications related to influenza. As developed countries funnel public funds into a biomedical research and development system based on patents, “some key government players in the WHO GISN are fuelling the patent surge and, in fact, are politically and legally obligated to encourage such claims because they are an integral component of their health systems,” Hammond wrote.

The Third World Network and the Sunshine Project, nongovernmental groups, circulated views at the meeting urging the prevention of patenting of flu viruses in the global system. In a brief paper that appeared to echo the Indonesian proposal, they stressed the importance of national sovereignty over how its viruses are used, and commitments to fair and equitable benefit sharing from research. The groups called for the rewriting of terms of reference between the WHO and the collaborating centres, and material transfer agreements for the movement of viruses. Furthermore, there should be no IP rights related to influenza, and tracking of virus transfers by WHO.

Separately, the World Intellectual Property Organization last week issues a technical report on patents related to influenza viruses and their genes. It did not advocate any position but provided background, WIPO said.

Seasonal Vaccine

Another key issue at the meeting is the increasing use of seasonal vaccines and efforts to reduce prices and increase availability as manufacturing capacity increases.

The Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and the Developing Country Vaccine Manufacturers Network are recognised by the meeting to provide comments if called upon. IFPMA said in materials provided to negotiators that its Influenza Vaccine Supply task force members have invested billions of dollars in developing capabilities to deliver vaccines against seasonal, avian and pandemic influenza. The group said increased manufacturing for seasonal flu also will increase manufacturing capabilities for a pandemic. Industry should have the capacity to produce several billion doses of pandemic vaccines by 2010, IFPMA said.

“I fully support any effort that leads to greater and more equitable access to pandemic vaccines. Vaccines are the best insurance policy for public health,” said Chan, later adding. “Millions of people outside this hall depend on us to make progress.”