Agreement on influenza virus sharing and benefit sharing is a step forward but has some shortcomings

While the agreement reached on the Framework is a milestone as it obliges the pharmaceutical industry and other entities (that benefit from the WHO virus sharing scheme) to engage in sharing of benefits, the Framework does not go far enough to secure from the industry and other entities a reasonable level of benefits nor are there mandatory commitments to share knowledge, technology and know-how with developing countries on the production of vaccines, and other products.

Negotiations on a Framework began following the 2007 World Health Assembly when it emerged that WHO’s virus sharing scheme was not regulated and was inequitable. Developing countries that shared biological materials such as the viruses that cause influenza faced difficulties in gaining access to affordable vaccines and anti-virals as well as to technology and know-how to produce them; while the multinational pharmaceutical industry had access to influenza viruses and commercially profited from the virus sharing system without having to share any benefits with the international community. Developed countries also gained from WHO’s virus sharing scheme as they had the resources to obtain vaccines through pre-purchase agreements with the manufacturers.

The negotiations on the Framework were aimed at bringing about more equity in WHO’s virus sharing scheme by ensuring the fair and equitable sharing of benefits to enable better pandemic preparedness by developing countries.

The Framework and the accompanying contractual instruments known as “Standard Material Transfer Agreement” (SMTA) contain terms and conditions governing the sharing of influenza viruses and the resulting benefits.

Such terms and conditions require that the WHO Network laboratories to use the biological materials received as per the agreed Terms of Reference and do not allow them to make intellectual property claims over the biological materials shared with the laboratories.

Under the Framework the influenza vaccines, diagnostic and anti-viral manufacturers are expected to make an annual monetary contribution of an amount equivalent to 50% of the running costs of the WHO’s virus sharing system (which for 2010 was at USD 56 million). These manufacturers and other recipients of biological material are also required to commit to other benefits, to be selected from a list of benefit sharing options that includes providing at least 10% of vaccine or anti-virals, reserving a portion of production for sale at an affordable price and the granting of non-exclusive licenses at affordable royalties or royalty free to developing countries for the production of vaccines and other products.

While the agreement reached on the Framework is a milestone as it obligates, through the SMTA, benefit sharing by industry and other entities that benefit from the WHO virus sharing scheme, the Framework does not go far enough to secure from the industry and other entities a reasonable level of predictable benefits nor are there concrete mandatory commitments to share knowledge, technology and know-how.

In particular, the amount of annual monetary contributions and the level of in-kind contributions from the industry are far too low, since the revenues they obtain from the sales of influenza vaccines and other products have amounted to billions of dollars. The $20-30 million monetary contribution and the 10% vaccines/anti-virals set aside are far too little to meet the needs of developing countries (which account for 80% of world population) in the event of a pandemic outbreak. These benefits should have been set at higher levels.

Also, the granting of non-exclusive licenses at affordable royalties or royalty free to developing countries for the production of vaccines and other products needed in a pandemic is only a voluntary benefit sharing option under the SMTA. This should instead have been listed as a stand-alone mandatory benefit to facilitate the sharing of knowledge, technology, and know-how, which developing countries need to prepare themselves to counter influenza pandemic.

During the negotiations the developing countries had requested for greater benefits. However the outcome was disappointing due to the resistance against the developing countries’ demands by developed countries, in particular the United States. This resistance significantly diluted the benefit sharing obligations and protected the industries’ profits and intellectual property.

The Framework also fails to contain any reference to relevant key international instruments that is the Convention of Biological Diversity and the Nagoya Protocol on Access and Benefit Sharing that obligates the sharing of fair and equitable benefit sharing once access to biological materials is provided.

Despite these shortcomings, the Framework is an important step forward towards a system for the sharing of influenza viruses and resulting benefits.

It is understood that the framework will be put before the World Health Assembly in May. It is hoped that at some stage the level of benefits can be reconsidered and improved.
 

• The Pandemic Influenza Preparedness Framework