The
Pandemic Influenza Preparedness Framework agreed to at a meeting of the WHO
early Saturday morning (16th April 2011) will for the first time put in place
terms and conditions to govern the sharing of influenza viruses of pandemic potential and the resulting benefits.
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
WHOs 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 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 WHOs
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 HealthAssembly in
May. It is hoped that at some stage the level of benefits can be
reconsidered and improved