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Opinion: The chickens come home to roost

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  • Opinion: The chickens come home to roost

    Source: http://www.onlineopinion.com.au/view...le=8061&page=0

    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?s Global Pandemic Influenza Action Plan to Increase Vaccine Supply. The WHO?s response so far has been to convene a range of meetings in an attempt to resolve Indonesia?s concerns and guarantee access to Indonesian H5N1 influenza virus samples as part of the WHO?s Strategic Action Plan for Pandemic Influenza and International Health Regulations (2005).

    This article addresses the legal context that might explain and justify Indonesia?s actions, and concludes that Indonesia?s response should have been expected given the response of other countries in dealing with Indonesia?s (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?s Convention on Biological Diversity (CBD) and the World Trade Organisation?s (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?s useful biological diversity (the ?South?) should benefit from the exploitation of that diversity by the predominantly rich and technologically advanced countries (the ?North?).

    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?s 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?s 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: ?[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.?

    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 ?forum shifting? in the broader progression of ratchting up the rigour of intellectual property in favour of intellectual property holders. That is, the documented practice whereby ?the 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?.

    The ongoing consequence of this practice has been the adoption of ?TRIPS-plus? standards with a further strengthening of rights holder?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?s superior position in the WHO in dealing with this particular issue.
    Discussion and conclusions

    The elegance of Indonesia?s current position is that it accepts the predominantly rich and technologically advanced countries? 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?s 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 ?price is right?.

    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?s 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.
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