WHO Group Strikes Landmark Deal On Global Framework For Flu Pandemics

After a week of discussions, a good part of which centred around intellectual property issues, World Health Organization members agreed to a framework aimed at better addressing future influenza pandemics and facilitating vaccines access for developing country populations, with industry contributions.

“[This] is a very significant victory for public health,” WHO Director General Margaret Chan said in statement.

Under the framework, when a pandemic arises, “influenza virus samples will be shared with partners who need the information to take steps to protect public health,” a WHO press release said.

A copy of the final, unedited text of the framework, as circulated by WHO, is available here [pdf]. It shows that consensus was reached on the key elements of the legal structure for the sharing of virus samples.

Details of how industry will participate in the new framework are still coming clear. Also, the deal did not appear to include language tying the outcome to a recent agreement on access and benefit-sharing of genetic resources at the UN Convention on Biological Diversity.

The WHO Open-Ended Working Group of Member States on Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits (OEWG/PIP) met from 11-15 April. The group finalised the deal in the early hours of 16 April after all-night negotiations.

The framework will be submitted to the 64th World Health Assembly (WHA), taking place from 16-24 May, for consideration and approval.

The agreed framework includes binding legal elements for WHO, national influenza laboratories and industry partners. The framework contains standard material transfer agreements (SMTAs) which were discussed last week. There is an “SMTA 1” establishing contractual terms within the existing WHO Global Influenza Surveillance Network, and an “SMTA 2” destined to address sharing of viruses outside the WHO network.

Developing countries have been reluctant to share their virus samples as they faced uncertainty about the access to and sharing of benefits from resulting vaccines.

Positive Reactions

A developing country official said last week’s negotiations were an important achievement, in particular the agreement on SMTAs. The framework is a significant improvement for WHO, the source said, with concrete consequences for the private sector.

Another developing country official told Intellectual Property Watch that most issues could be addressed, including the IP issue, maybe not to the fullest satisfaction of all delegations, but “given the nature of the negotiations, the deal that had been struck could perhaps be the most that the industry … could accommodate,” the source said.

A developed country source official told Intellectual Property Watch the outcome of the negotiations was satisfactory. The framework asked for industry contributions, such as a donation of 10 percent of their vaccines production, but left the industry the ability to choose whether to renounce their IP rights in compensation for accessing viruses.

Intellectual property issues had been at the heart of the discussions, with developed countries saying that IP rights are not a barrier to vaccines access and promote innovation, and developing countries expressing concern that IP contributes to higher prices and reduced accessibility of vaccines.

The framework will “help ensure more equitable access to affordable vaccines and at the same time, also guarantee the flow of virus samples into the WHO system,” according to the WHO release.

Chan said that the agreement “has reinforced my belief that global health in the 21st century hinges on bringing governments and key stakeholders like civil society and industry together to find solutions.”

Co-chair Juan José Gomez-Camacho of Mexico said in the statement: “It was an historic negotiation that proved that when governments show statesmanship, stature, responsibility and fine diplomacy, they can successfully meet the most pressing global challenges.”

“This agreement promotes global health security and solidarity in pandemic times,” co-chair Bente Angell-Hansen of Norway said in the release. “It reflects also a unique partnership with industry, and contains concrete measures of cooperation with both industry and civil society.”

The WHO began work on pandemics after the 2005 avian flu outbreak changed the dynamics of the debate. For a description of the background, see (IPW, WHO, 6 December 2010). WHO members recognised the importance of industry’s role heading into last week’s meeting (IPW, WHO, 12 April 2011).

Nagging Nagoya

According to several sources, no agreement could be reached on language regarding the Convention on Biological Diversity’s Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization. A consensus language still has to be found on this text at the World Health Assembly.

The Nagoya Protocol is an international instrument meant to facilitate access to genetic resources and the sharing of benefits arising from the utilisation of those resources. It will enter into force 90 days after the ratification by 50 parties. To date, eight countries have ratified it (IPW, IP Live, 8 April 2011).

One of the issues is whether influenza pathogens fall within the scope of the protocol.

Pharma Satisfied, NGOs Cautious

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said in a press released today that the meeting outcome will result in an effective global system to prepare for potential future influenza pandemics “recognizing a shared responsibility to help secure the world against” future outbreaks.

Non-governmental organisations (NGOs) and industry were consulted by the working group during the week. IFPMA said it “believes such discussions will provide a sound basis for the fine-tuning of the framework over the coming year.”

“The IFPMA’s submission was informed by the research-based industry’s experience and sought to build on the important voluntary contributions to the H1N1 (so-called Swine flu) pandemic that industry made,” they added.

“It would appear that the OEWG/PIP’s approach to intellectual property rights is in line with WHO reports that have concluded that IP rights have presented no barrier to supply of vaccines and antivirals to developing countries. IFPMA members will continue to ensure that IP rights do not present a barrier at the next pandemic,” IFPMA said. It added that the federation “gave the working group assurances that their members were prepared to consider, when appropriate, flexible approaches to meet this goal.”

An NGO source said that industry’s financial participation is not sufficient as industry has the capacity to contribute much more to benefit sharing. Funds will be harvested through a mechanism which will impose an annual partnership contribution, from 2012, from pharmaceutical manufacturers using the WHO Global Influenza Surveillance Network.

This contribution, amounting to 50 percent of the running cost of the WHO network, should be used for purposes of building capacities in developing countries, and helping them purchase vaccines, and not be used to fund the WHO Collaborating Centres for influenza in developed countries, the source said.