WHO Reaches Virus Sharing Agreement After Four-Year Debate

4 May 2011

Members of the World Health Organization (WHO) reached agreement in principle on a framework that, if ratified by the World Health Assembly this month, would create a unified mechanism for the sharing of pandemic influenza viruses in the case of a pandemic.

The prospective agreement has been called a "milestone" by WHO officials, governments, and industry members, as it would be the first of its kind to create a framework for managing the sharing of influenza viruses of pandemic proportions and ensuring that poor countries have better access to vaccines.

Pandemic influenza differs from seasonal influenza viruses in that pandemics are caused by new influenza viruses that have adapted to humans, like the avian flu (H5N1) and swine flu (H1N1) viruses. According to the WHO, these viruses exhibit "pandemic potential" because they are still in circulation today and humans have little to no immunity to them.  Health experts predict that the world may be on the brink of another major influenza pandemic such as the Spanish influenza pandemic of 1918, which killed 40 million people. The most recent major influenza pandemic killed 1 million people in 1968.

Four years of controversy come to an end

The framework has its origins in a controversy which arose in recent years after some developing countries expressed the fear that the avian flu (H5N1) virus samples they shared with the WHO's Global Influenza Surveillance Network (GISN) would be used to develop high-cost patented vaccines that they would be unable to afford. In protest, Indonesia - which has reported the highest number of H5N1 infections and deaths since the first outbreak in 2003 -- decided to withhold flu samples from the WHO in 2006. Meanwhile, developed countries emphasised the cost and effort that goes into the development of influenza vaccines and pandemic response. Indonesia's decision prompted the 2007 session of the World Health Assembly - the key WHO decision making body - to address the concerns over virus sharing in an open-ended working group.

Slow progress between 2008 and 2010 was nevertheless marked by achievements such as the establishment of processes to revise the terms of reference for laboratories, as well as their practices in terms of virus-sharing and vaccine production. The working group also mobilised resources through the WHO Global Pandemic Influenza Action Plan to Increase Vaccine Supply to establish a tracking system for pandemic viruses and a stockpile of vaccines for use in developing countries.

The Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits is intended to establish a unified approach to global preparedness to future influenza pandemics by creating binding legal processes for the WHO, influenza labs, and industry partners in developed and developing countries.

The objective of the framework, as agreed to in the working group, is "to improve pandemic influenza preparedness and response, and strengthen the protection against the pandemic influenza by improving and strengthening the WHO global influenza surveillance and response system (WHO GISRS), with the objective of a fair, transparent, equitable, efficient, effective system for, on an equal footing, (i) the sharing of H5N1 and other influenza viruses with human pandemic potential and (ii) access to vaccines and sharing of other benefits."

The framework is accompanied by legal instruments called "Standard Material Transfer Agreements" (SMTAs) that would regulate how the influenza viruses are shared. SMTA 1 deals with virus-sharing within the WHO's influenza surveillance network, while SMTA 2 addresses virus-sharing outside it. Agreement with industry was reached after intense negotiations only days before the working group's final agreement.

One of the most important elements of the framework is the obligation for the pharmaceutical industry to contribute half of the Global Influenza Surveillance Network's running costs and to commit 10 percent of vaccines and anti-virals for use in developing countries.

A copy of the final, unedited PDF text of the framework is available here.

Reactions to the agreement

WHO officials called the framework a significant victory for public health and praised the ability of members and stakeholders to responsibly find solutions to key issues. Margaret Chan, director-general of the WHO, said that though the journey was a long one, it reinforced the "belief that global health in the 21st century hinges on bringing governments and key stakeholders like civil society and industry together to find solutions."

Working group Co-Chair Juan José Gomez-Camacho (Mexico) called the negotiation "historic," while Co-Chair Bente Angell-Hansen (Norway) said the framework "reflects a unique partnership with industry, and contains concrete measures of cooperation with both industry and civil society."

However, there are concerns by some civil society groups that the framework does little to ensure that the pharmaceutical industry does not disproportionately benefit from virus samples while leaving developing countries without adequate access to vaccines or other products.

In a joint press statement, Third World Network (TWN) and the Berne Declaration argued that "the $20-30 million annual monetary contribution required of manufacturers and the 10 percent of vaccines/anti-viral medicines set aside are far too little to meet the needs of developing countries (which account for 80 percent of the world population)  in the event of a pandemic outbreak. These benefits should have been set at higher levels". At the same time, they recognised the framework as "an important step forward towards a system for the sharing of influenza viruses and resulting benefits."

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), for its part, said in a statement that it welcomed the outcome and commits to making sure IFPMA members "continue to ensure that intellectual property rights do not present a barrier at the next pandemic."

A developing country negotiator pointed that while the agreement didn't meet all their demands, the framework represented a realistic outcome about what could be possibly agreed to. He added that the Framework and its Annexes will be reviewed by 2016 with a view to proposing revisions reflecting developments as appropriate, to the World Health Assembly in 2017, through the WHO Executive Board.

Intellectual Property issues

Intellectual property was one of the difficult issues in the negotiations, as debates ensued over technology transfer and intellectual property rights on biological materials, such as viruses and human or animal samples.  Developing countries sought to obtain commitments that once virus-sharing occurs, recipients would be bound to grant non-exclusive licenses to developing country manufacturers.

Ultimately, SMTA 1 notes that "neither the provider nor the recipient should seek to obtain any intellectual property rights (IPRs) on the materials."

Relationship with the CBD Nagoya Protocol

The WHO framework comes only months after parties to the Convention on Biological Diversity (CBD) adopted the "Nagoya Protocol on Access to Genetic Resources and the Fair and equitable Sharing of the benefits Arising from their Utilization." The scope of the two agreements could overlap as the Nagoya Protocol contains a special provision on "emergency situations that threaten or damage human [...] health" stipulating that countries shall consider granting "expeditious fair and equitable sharing of benefits [...] including access to affordable treatment [...] in developing countries" in such situations. The protocol also contains a benefit-sharing obligation for all genetic resources, including pathogens.

Though the Nagoya Protocol has been adopted, disagreement on its scope and relation to other international instruments lingers on. This was clearly reflected during the WHO talks as contrasting opinions persisted regarding whether the framework should reference the Nagoya Protocol.

While a group of developing countries saw their interest in a strong PIP framework reflected in the Nagoya protocol,  the European Centre for Disease Prevention and Control for one argued that the fundamental principle of Nagoya -- that "countries ‘own' their natural resources" - "does not fit well with the way that micro-organisms behave." For the moment the matter remains unresolved.

The document will be submitted to the World Health Assembly on 16-24 May for detailed review and adoption.

ICTSD reporting. "Significant agreement on sharing of influenza viruses samples and benefit sharing at a global Open Ended Working Group", ECDC, 20 April 2011; "Agreement on influenza virus sharing and benefit sharing is a step forward but has some shortcomings", THIRD WORLD NETWORK, 20 April 2011: "WHO Group Strikes Landmark Deal on Global Framework for Flu Pandemics", IP WATCH, 18 April 2011.

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