After a week of negotiations continued through Friday night and into Saturday morning, an open-ended working-group meeting of Member States successfully agreed upon a framework to ensure that in a pandemic, influenza virus samples will be shared with partners who need the information to take steps to protect public health.

The working-group meeting was convened under the authority of the World Health Assembly and coordinated by WHO.

Responding effectively to future flu pandemics

The new framework includes certain binding legal regimes for WHO, national influenza laboratories around the world and industry partners in both developed and developing countries that will strengthen how the world responds more effectively with the next flu pandemic. By making sure that the roles and obligations among key players are better established than in the past – including through the use of contracts – the framework will help increase and expedite access to essential vaccines, antivirals and diagnostic kits, especially for outbreak areas.

In addition, the framework will also put the world in a better position for seasonal influenza and potential pandemic threats such as the H5N1 virus, because some key activities will begin before the next pandemic, such as greater support for strengthening laboratories and surveillance, and partnership contributions from the industry.

Knowing the exact makeup of a virus is critical

During an influenza outbreak, knowing the exact makeup of the virus is critical for monitoring the spread of the disease, for knowing the potential of the virus to cause a pandemic and for creating the life-saving vaccines as well as other technological benefits. However, developing countries often have limited access to these vaccines for several reasons.

• They often do not have their own manufacturing capacity.
• Global supplies can be limited when there is a surge in demand as is seen during pandemics.
• Vaccines can often be priced out of the reach of some countries.

Equitable access

The new 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 so that the critical information and analyses needed to assess public health risks and develop vaccines are available.

A significant victory for public health

“This has been a long journey to come to this agreement, but the end result is a very significant victory for public health,” says Dr Margaret Chan, Director-General of WHO. “It 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.”

The legal regimes will address clear roles and responsibilities of WHO, national labs and vaccine and pharmaceutical manufacturers.

A coherent and unified global approach

“The framework provides a much more coherent and unified global approach for ensuring that influenza viruses are available to the WHO system for monitoring and development of critical benefits such as vaccines, antiviral drugs and scientific information while, at the same time, ensuring more equitable access to these benefits by developing countries,” says Dr Keiji Fukuda, Assistant Director-General of Health Security and Environment at WHO.

A historic negotiation promoting global health security

The working group was co-chaired by Ambassador Juan José Gomez-Camacho (Mexico) and Ambassador Bente Angell-Hansen (Norway) and included the participation of WHO Member States, industry representatives, civil society and other organizations involved in influenza pandemic preparedness.

“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,” says Gomez-Camacho. “It also helped us realize that public and private partnerships that bring together governments, corporations and civil society are extraordinarily powerful tools that, in the future, I believe will be the only possible way for the world to face these incredibly complex challenges.”

“This agreement promotes global health security and solidarity in pandemic times. It reflects also a unique partnership with industry, and contains concrete measures of cooperation with both industry and civil society,” says Angell-Hansen. “I am grateful to the very many who contributed to this positive outcome. It demonstrates what we can achieve through health diplomacy in WHO.”

The agreed upon framework will be presented to the World Health Assembly in May for its consideration and approval.

The negotiations by 193 WHO Member States began in November 2007 amid concerns that the avian influenza (H5N1) virus in South-East Asia could become a human pandemic.