The chickens come home to roost

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.