PHM-Exch> TWN Press Release: IGM on Pandemic Preparedness fails to resolve critical elements

Tue May 19 02:17:29 PDT 2009

From: Sangeeta <sangeeta at thirdworldnetwork.net>
Third World Network

*PRESS RELEASE: IGM on Pandemic Influenza Preparedness fails to resolve
critical elements*
18 May 2009

Governments at the World Health Organisation have failed to agree on a
framework that guarantees affected countries access to affordable
anti-virals and vaccines during a pandemic, and access to the technology and
know-how needed to build research, development and production capacity.

While some progress was made on some elements of the framework at the
Intergovernmental Meeting (IGM) on Pandemic Influenza Preparedness that
ended on Saturday 16 May 2009 in the WHO headquarters in Geneva, crucial
components for a transparent, fair and equitable virus and benefit-sharing
framework remain unresolved.

One critical component is the Standard Material Transfer Agreement (SMTA)
that was earlier agreed to be a component of the framework but is now
objected to by several developed countries in particular the United States.

Material transfer agreements are commonly used for the transfer of
biological materials. It is a contractual agreement between the providers
and the recipients of biological materials and sets out the terms of use of
the biological materials provided and benefit sharing obligations. In the
case of the IGM a standard agreement is proposed wherein the form and
content of the SMTA is negotiated by WHO members. In this way every transfer
of biological materials will be subject to the same terms and conditions,
without any further negotiations.

Having a SMTA as part of the framework is central to the successful
implementation of any global framework on virus and benefit sharing.

The IGM negotiations can only be called successful if there is a framework
(including the SMTA) that contains benefit-sharing elements that assures
affected countries (in particular developing countries) that they will have
sufficient and affordable anti-virals and vaccines to treat their
populations.

Limited availability of vaccines requires a strategy for equitable
distribution of the vaccines in preparing for a pandemic and during the
pandemic period, and the WHO framework and SMTA must deliver on such a
strategy.

The IGM negotiations must also provide mechanisms for the sharing of
intellectual property rights (IP).

While countries are requested to give up on their sovereign rights over the
biological materials, a right recognised under the United Nations Convention
on Biological Diversity, manufactuers are unwilling to share their
intellectual property protected technology and know-how.

Latest technologies and know-how such as adjuvants and cell lines for
vaccine production are covered by patents and other IPRs. For example
several adjuvants (substances added to a vaccine in order to enhance its
immunological effect, thus reducing the amount of antigen needed per
vaccines dose, thus its importance during a pandemic) are proprietary e.g.
MF 59 is owned by Novartis; AS03 is owned by GSK; AF03 is owned by Sanofi
Aventis; biotechnological adjuvants are owned by companies such as Juventus,
Intercell etc.

Furthermore, except for egg-based Œclassic¹ flu vaccines which has few IPR
impediments (except where proprietary adjuvants are used), newer vaccine
producing technologies have or will have extensive intellectual property
protection. The new technologies include cell-culture produced vaccines,
live attenuated (LAIV) and second generation biotech vaccines, (e.g. virus
like particles, DNA vaccines). The scope of protection includes patents on
cell lines and production systems, trade secrets on the safety profile of
cell lines and other formulations.

Experience from SARS and avian flu shows that recipients of biological
materials such as WHO laboratories and commercial entities often claim
patents over the biological materials received and parts thereof as well as
their specific uses.

For example in 2008, an international patent application surfaced in which
the US Centres for Disease Control (CDC) and US National Institutes of
Health claimed ownership of certain Indonesian influenza virus genes. The US
CDC is a WHO collaborating centre but applied for a patent for a new vaccine
against influenza, particularly for bird flu (H5N1). The vaccine
incorporates genes from a H5N1 strain isolated from an Indonesian human
victim of bird flu in 2005. The strain that contains the genes was
transferred to the WHO Global Influenza Surveillance Network by Indonesia
for characterization for public health purposes, but may wind up as the
property of the US government.*[1]* The patent application also claims
similar vaccines that incorporate genes of flu viral strains from Thailand
(A/Thailand/1(KAN-1)/04) and A/Ck/Thailand/1/04), Hong Kong (A/Hong
Kong/156/97) and South Korea (A/Ck/Korea/ES/03).

In addition to the US CDC, there is evidence that another US-based WHO
Collaborating Centre, St. Jude Children's Research Hospital in Memphis,
Tennessee, has improperly capitalized on its WHO status in order to make
proprietary claims.*[2]*

Without a system that delivers on concrete fair and equitable
benefit-sharing and identifies mechanisms to overcome the intellectual
property barriers, developing countries are likely to be left without
sufficient or affordable vaccines or treatments since the companies making
them are located in developed countries which would want to ensure the
scarce supplies are given to their own people first.

*Since the start of the WHO IGM process, several measures on benefit sharing
have been proposed by developing countries including:*

   - Obligating (through SMTA) commercial entities that receive virus
   samples to contribute a portion of its production to WHO stockpiles and to
   reserve a portion of vaccines and anti-virals for developing countries and
   make them available at reasonable costs;
   - Obligating provision of royalty-free licenses to entities in developing
   countries to use IP protected technology and know-how to enable vaccine and
   anti-viral production manufacturing in those countries;
   - Obligating commercial entities to contribute a portion of their profits
   to a fund, which could be used for purchasing the needed vaccines or
   anti-virals as well as building manufacturing and other relevant capacity in
   developing countries.

* On measures to overcome patent and other IPR barriers there are the
following proposals:*

   - that recipients (i.e WHO centres as well as the private sector) of
   virus  samples should not claim patents over the samples or parts thereof.
   - that recipients of virus samples that are designated as WHO centres
   i.e. as WHO Collaborating Centre, H5 Reference Laboratory or as Essential
   Regulatory Laboratory should not claim patents over products or processes
   developed using biological materials
   - that recipients of virus samples that are commercial entities should
   not claim patents over products or processes developed using biological
   materials or alternatively should grant on request royalty free licenses to
   developing countries.

We believe that the above proposals should be a part of the framework and
SMTA for virus and benefit sharing and will go a long way to ensure that
developing countries will have access to affordable anti-virals and vaccines
and the appropriate technology to make such products.

*For more information please contact:*
Sangeeta Shashikant
Representative Geneva Office
Third World Network
Mobile: +41 (0) 78 757 2331
Office: +41 (0) 22 908 3550
Email: sangeeta at thirdworldnetwork.net

*[1] See
http://www.twnside.org.sg/title2/health.info/2008/twnhealthinfo20080804.htm

[2] See http://www.twnside.org.sg/title2/avian.flu/papers/patent.paper.pdf*
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