[A2k] Press release: Agreement on influenza virus sharing and benefit sharing is a step forward but has some shortcomings

Sangeeta ssangeeta at myjaring.net
Tue Apr 19 08:29:13 PDT 2011


PRESS RELEASE 
19th April 2011

by Berne Declaration & Third World Network
 
Agreement on influenza virus sharing and benefit sharing is a step forward
but has some shortcomings
 
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 WHO¹s 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 WHO¹s 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 WHO¹s 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
³Standard Material Transfer Agreement² (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 WHO¹s 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 countries¹ demands by developed countries, in
particular the United States.  This resistance significantly diluted the
benefit sharing obligations and protected the industries¹ 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.
 
For more details please contact:
 
Sangeeta Shashikant
Third World Network
Tel (h/p Geneva): +41 (0) 78 757 2331
Tel (h/p London): +44 (0) 79 721 75128
Email: ssangeetash at gmail.com
 
Patrick Durisch
Berne Declaration 
Tel (h/p): +41 794136015
Email: durisch at ladb.ch





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