[Ip-health] IP-Watch: Disagreements Remain In WHO Talks On Virus-Sharing After Chan Proposal

[Thiru Balasubramaniam]

http://www.ip-watch.org/weblog/2009/10/22/disagreements-remain-in-who-talks=
-on-virus-sharing-after-chan-proposal/

22 October 2009
Disagreements Remain In WHO Talks On Virus-Sharing After Chan Proposal
By Kaitlin Mara @ 12:12 pm

World Health Organization members this week offered views on the
global system for virus- and benefit-sharing for pandemic influenza
following recently proposed solutions by Director General Margaret
Chan aimed at changing the current, ad-hoc model to a more
predictable, sustainably-funded system.

=93Even with the best intentions in the world, limited manufacturing
capacity stands in the way of a completely fair and just system for
the sharing of benefits,=94 Chan said in a speech[pdf] at the opening of
the meeting. =93Though most countries will have at least some access to
vaccines, wealthy countries will be able to immunize a far greater
proportion of their populations than will be the case in poorer
countries.=94

The new document containing Chan=92s proposals, available here [pdf],
sets out guidelines for a standard material transfer agreement (SMTA)
for those participating in the system, as well as draft text on
intellectual property rights. The task of completing these two
sections was handed to the director general at the World Health
Assembly in May (IPW, WHO, 22 May 2009), after members of an
intergovernmental committee tasked with creating a framework for
handling pandemic influenza outbreaks had failed to reach agreement on
them. The intergovernmental committee did reach agreement on other
parts of the framework, including a set of principles for sharing
viruses and benefits for pandemic influenza preparedness.

Meanwhile, the WHO along with the World Bank and the UN Children=92s
Fund (UNICEF) released yesterday a report entitled =93The State of the
World=92s Vaccines and Immunization=94 [pdf].

The report found that vaccines =93still do not reach an estimated 24
million children who are most at risk,=94 says a press release, adding
that an additional US $1billion will be needed annually to immunise
those children. However, the rate of vaccinations is rising in the
developing world, which the release says is due to an increase in the
capacity of developing countries to manufacture vaccines, thanks to
help from the vaccine-financing partnership the GAVI Alliance. The
full report can be read here.

Within the WHO framework, the SMTA and intellectual property sections
proved particularly controversial in the agreement because they will
determine which parts of the pandemic influenza framework are legally
binding, and who will be bound. Also at issue are definitions =96 for
instance of the term =93genetic materials=94 =96 are important, as they
determine the scope of the agreement.

The director general=92s closed-door consultations on 19 and 20 October
were an informal sounding board and not a negotiation, so decisions
were not taken, sources said. Chan will report on member states=92
views, which still differ, to the WHO=92s next decision-making meeting,
the Executive Board, from 18-23 January 2010. The Executive Board will
then make recommendations on how to proceed.

Entering the final round of the meeting, several sources at this
week=92s event said fundamental disagreements from last May still stand,
and could make it difficult to reach agreement in January.

These disagreements mainly concern the scope of the SMTA. Some
countries and pharmaceutical manufacturers argued that if it is too
broad it will slow down the transfer of vaccines and related material
at precisely the time when speed is most needed. Other countries and
civil society groups argued that if it is too narrow then benefit-
sharing commitments will be avoidable and developing countries will be
left without affordable access to needed medicines.

A statement given on behalf of countries who have pledged to donate
vaccines for the current epidemic outbreak of H1N1, or =93swine flu,=94
says that the effort - which also includes the pledges of
manufacturers - =93exemplifies our vision of shared responsibility=94 and
=93our actions during the present pandemic may serve as important inputs
to building future predictable and sustainable responses to new
pandemics and other health emergencies.=94 It urges the WHO secretariat
to identify lessons from the donation effort for future plans.

The statement was made by the United States on behalf of: Australia,
Belgium, France, Germany, Italy, Japan, New Zealand, Norway,
Switzerland, Thailand, United Kingdom, and the United States.

Brazil has also pledged to donate vaccines, though did not sign on to
the statement. =93Despite our efforts,=94 Brazil said in its statement to
the informal meeting, =93most people living in developing countries will
not have access to H1N1 vaccines, in view of the limited global
production capacity and impediments to access vaccine production
technologies.=94

Brazil then called for an increase in aid to developing countries to
help with the acquisition of technology for vaccine manufacture, and
for commitments to be added to the SMTA on how vaccine manufacturers
from all over the world will share benefits arising from the sharing
of influenza materials through the WHO system.

Critically, the current set of pledges was done without the benefit of
a completed SMTA or an intellectual property rights agreement. Some
argue that this is proof that these parts of the framework are not
necessary to ensure equitable distribution of vaccines. Others argue
that a legal framework is needed to guarantee benefits, as reliance
upon donations is too uncertain to protect vulnerable people in the
case of a global health emergency.

A statement by =93like-minded=94 countries Bolivia, Brazil, Cuba, Egypt,
India, Indonesia, Iran, Nigeria and Sri Lanka said, =93while ad hoc
solutions, including donations =85 can be useful=94 they will not provide
a sustainable solution. Capacity building, affordable access to
innovation, and an IP system that is balanced with principles of
access to medicine are essential, the statement added. It also called
for a =93single undertaking approach,=94 which would mean no parts of the
framework are considered agreed until it is all agreed.

Chan=92s Proposed SMTA

The SMTA as proposed by Chan would apply to all laboratories =93within
the WHO Network,=94 but would not apply to laboratories outside the
network, even if they receive influenza-related materials. This would,
says Chan=92s text, allow =93flexibility to recognise the differences
between manufacturers,=94 and as a practical way of handling the
=93potentially unlimited=94 number of labs that could request material,
too many for WHO to enter into arrangements with.

Chan=92s proposal requires the provider of materials to consent to those
materials being passed to pharmaceutical manufacturers, so long as
those manufacturers have or are developing a benefit-sharing
arrangement with WHO in accordance with the guiding principles of the
pandemic influenza preparedness framework. It says that holders of any
IP rights derived from the materials =93should grant to WHO=94 a non-
exclusive, royalty-free sub-licensable license.=94

But this language, said Sangeeta Shashikant of the Third World
Network, does not include a basic principle previously agreed by
member states, which drafted the pandemic influenza framework with the
requirement that both virus- and benefit-sharing be addressed on an
equal footing.

Also, she cited Shakeel Bhatti of the International Treaty on Genetic
Resources for Food and Agriculture, who has said there had been 89,000
transfers of genetic material under their SMTA in the first 8 months
of its operation [pdf]. The SMTA of the plant treaty was looked at as
one of the models for the pandemic SMTA.

Disputes will be resolved by the director general, the proposed SMTA
says, who may single-handedly revoke the WHO designation of a
laboratory in case of violations.

But this is problematic, said Shashikant, as a UN agency should
function at the direction of its member states. In addition, an SMTA
is meant to be a legal contract, and the text of this agreement falls
short from a legal perspective, she said in part because it lacks a
legal recourse for dispute settlement, especially if parties disagree
with the director=92s decision.

Chan also proposed text for the unresolved part of the framework
dealing with intellectual property rights. Her text, if accepted by
members, would be added to section five of the pandemic preparedness
framework, which deals with virus sharing. It reads that member states
=93should urge entities that receive=94 materials under the framework and
subsequently obtain IP rights on derivatives of those materials to
=93agree to grant to WHO a non-exclusive, royalty-free, sub-licensable
license with respect to such rights.=94

Kaitlin Mara may be reached at kmara@ip-watch.ch.

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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997