[A2k] The chickens come home to roost (Virus sharing, IPR, and CBD issues)

[Sangeeta]

The virus and benefit sharing discussion at the WHO begins on Monday, 8th
December 2008 in Geneva.

Below is a very interesting short article based on a longer paper by
the same author, who is a Senior Lecturer at the Griffith Law School,
Griffith University in Queensland (Australia).

The URL where the full paper can be downloaded is:
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=3D1279888

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http://www.onlineopinion.com.au/view.asp?article=3D8061&page=3D0

The chickens come home to roost

By Charles Lawson - posted Monday, 27 October 2008

Introduction
In late 2006 Indonesia stunned health authorities worldwide by
withholding H5N1 influenza virus samples collected in Indonesia. These
samples might otherwise have been expected to be provided to the World
Health Organisation (WHO) and its Global Influenza Surveillance
Network comprising the National Influenza Centres, WHO Collaborating
Centres on Influenza and WHO H5 Reference Laboratories.

The practice of collecting samples and then making them available is a
central element of the WHO=B9s Global Pandemic Influenza Action Plan to
Increase Vaccine Supply. The WHO=B9s response so far has been to convene
a range of meetings in an attempt to resolve Indonesia=B9s concerns and
guarantee access to Indonesian H5N1 influenza virus samples as part of
the WHO=B9s Strategic Action Plan for Pandemic Influenza and
International Health Regulations (2005).

This article addresses the legal context that might explain and
justify Indonesia=B9s actions, and concludes that Indonesia=B9s response
should have been expected given the response of other countries in
dealing with Indonesia=B9s (and others) concerns about access to patent
protected life saving medicines in other international forums.

Legal context
Indonesia has signed and ratified both the United Nation=B9s Convention
on Biological Diversity (CBD) and the World Trade Organisation=B9s (WTO)
Agreement on Trade Related Aspects of Intellectual Property Rights
(TRIPS). The CBD is an environmental agreement promoting the
conservation of biodiversity that was negotiated in the context that
poor countries with the majority of the Earth=B9s useful biological
diversity (the =B3South=B2) should benefit from the exploitation of that
diversity by the predominantly rich and technologically advanced
countries (the =B3North=B2).

This was addressed through provision for the fair and equitable
sharing of any benefits flowing from using accessing genetic
resources. Subsequent developments reduced this to a contractual
arrangement between the bio-prospector and the holder of the genetic
resources (through the voluntary Bonn Guidelines on Access to Genetic
Resources and Fair and Equitable Sharing of the Benefits Arising out
of their Utilisation), recognising that State jurisdictions controlled
the genetic resources and might determine how they were to be accessed.

In contrast, TRIPS is part of a broader trade agreement setting
minimum mandatory intellectual property standards that was intended to
reduce distortions and impediments to international trade. There
remains an unresolved tension between the paramountcy of environmental
objectives according to the CBD or trade objectives according to TRIPS
that has played out in a number of forums.

The tension essentially concerns whether or not intellectual property
standards can be relaxed with the predominantly poor countries with
the majority of the Earth=B9s useful biological diversity arguing that
they can, and the predominantly rich and technologically advanced
countries arguing that they cannot.

A similar tension was apparent during the negotiation of the WTO=B9s
Declaration on the TRIPS Agreement and Public Health where
predominantly poor countries grappled with accessing expensive patent
protected drugs for HIV-AIDS, tuberculosis, malaria and other epidemics.

The result was a limited concession in the text of the agreement
followed by an administrative gridlock on implementing the
resolutions, and an ongoing rejection of the predominantly poor
countries propositions about relaxing the mandatory patent stands set
out in TRIPS.

The outcome for countries like Indonesia has been difficult as the
voluntary CBD promised economic development to alleviate poverty
through the transfer of technology, know-how, financial support and
incentives has not eventuated, and the mandatory TRIPS has delivered
high prices and with little access to technology, little know-how,
little financial support and scarce incentives.

In essence, these tensions might be reduced to: =B3[t]he South wants the
technology and the North wants the South to have it. But while the
South sees itself as a potential partner, the North looks south and
sees only paying customers.=B2

This has been further exacerbated for Indonesia when an Indonesian
H5N1 virus sample was given to the WHO, which in turn gave it to an
Australian vaccine manufacturer that intended to patent (in some
respect) the vaccine. Indonesia would then have been obliged to
purchase the (high priced) patent protected vaccine (or compensate the
patent holder) in the event of a pandemic or pandemic preparations.

The Indonesia stance also needs to be considered in the context of
=B3forum shifting=B2 in the broader progression of ratchting up the rigour
of intellectual property in favour of intellectual property holders.
That is, the documented practice whereby =B3the United States and
European Union shift the standard-setting agenda from fora in which
they are encountering difficulties to those fora where they are likely
to succeed=B2.

The ongoing consequence of this practice has been the adoption of
=B3TRIPS-plus=B2 standards with a further strengthening of rights holder=B9=
s
intellectual property and a consequent decline in the ability of poor
countries to afford and access patented essential medicines. From this
perspective, shifting the CBD and TRIPS debates to the WHO merely
takes advantage of Indonesia=B9s superior position in the WHO in dealing
with this particular issue.

Discussion and conclusions
The elegance of Indonesia=B9s current position is that it accepts the
predominantly rich and technologically advanced countries=B9
propositions about the paramountcy of intellectual property and asks
them to comply with their rhetoric. In other words, enter into a CBD
consistent contract to access the H5N1 influenza virus samples
collected in Indonesia according to the terms and conditions
negotiated between Indonesia and the WHO, and limiting the potential
commercial uses through the negotiated ownership of intellectual
property (principally patents).

Unfortunately, this position also undermines the WHO=B9s careful
planning according to its Strategic Action Plan for Pandemic Influenza
and its other contingencies and the ability to respond to pandemic
influenza.

So far, the WHO has convened a range of intergovernmental meetings, an
interdisciplinary working group without resolution, and established a
virus tracking system and an advisory mechanism. The stalemate,
however, remains intact, albeit there is the prospect for a resolution
once the =B3price is right=B2.

This resolution, however, requires an appreciation of the broader
debates about development and that the predominantly rich and
technologically advanced countries address the impediments that have
so far limited the promised economic developments that might alleviate
poverty. This will almost certainly include the transfer of
technology, know-how, financial support and incentives.

Undoubtedly, Indonesia will be pursuing these possibilities knowing
that timely access to H5N1 influenza virus samples collected in
Indonesia is almost certainly critical to a successful global response
to pandemic influenza. Unlike the WTO=B9s Declaration on the TRIPS
Agreement and Public Health where the predominantly rich and
technologically advanced countries had the health solutions and could
dictate the details of an agreement, this time Indonesia has the
bargaining power.