Case 18 Compromising Public Health: the World Health Organisation, Indonesia and Baxter Pharmaceuticals Mark Dinnen This chapter links to Chapter 19 of The Globalization of World Politics. Transnational actors and international organizations in global politics Chapter 19 of The Globalization of World Politics demonstrates that global politics has expanded to incorporate a number of alternative actors outside of the traditional state. Transnational corporations (TNCs) and intergovernmental organizations (IGOs) now play a significant role in the maintenance of international order. This case study explores the political and social ramifications of a TNC altering a global norm and threatening the health security of the world. A cause for concern In 1918, an outbreak of influenza, coined the Spanish Flu, became a pandemic. The significance of Spanish Flu rests in the overwhelming death toll; in the space of a few months, the Spanish Flu took the lives of an estimated fifty million people. The world’s population has increased from its 1918 level of 1.8 billion to 6.8 billion in 2007, and researchers estimate the potential death toll from a major influenza pandemic today could be more than 64 million (Murray et al. 2006). Globalization has resulted in a world health situation that is more interdependent than in the past. This interdependence has also exposed a major fragility in the system hitherto undetected. In the wake of the Spanish Flu, the World Health Organization (WHO) formulated a pandemic preparedness strategy. For more than 50 years, the countries of the world have voluntarily supplied the WHO with samples of influenza virus strains. In sharing these samples, the WHO is able to advise countries on the probable seasonal outbreaks of flu, allowing the countries to develop vaccines to protect their population from possible infection. The WHO system allows for the submitted virus samples to be made available to any company with an interest in using them to develop a vaccine. The notion behind the WHO system is one of the common good— IGOs and TNCs working together to produce the most effective vaccines against emerging pandemic threats, thereby protecting the common interest of humankind. The TNCs, however, typically sell these vaccines for profit. In recent years, the World Health Organisation has been concerned at the likelihood of the influenza virus H5N1 (more commonly known as Bird Flu) spreading in pandemic proportions. Since its initial outbreak in Hong Kong, Bird Flu has spread to twelve countries, infecting over 280 persons and resulting in 170 deaths.1 A country steps up In July 2005, Indonesia’s Ministry of Health confirmed the country’s first laboratorydiagnosed H5N1 case in a human, when on 12 July a thirty-eight year-old father of two died. While his two daughters subsequently died from symptoms related to Bird Flu, laboratory test results were unable to prove an acute human-to-human H5N1 infection. Two years later, Indonesia has the ominous claim to the highest death toll, with over 70% of its infections proving fatal. The Indonesian Government, however, appears motivated in ensuring its people have access to any successful vaccine. In January 2007, a company contracted by the Australian Government announced that it had developed a Bird Flu vaccine cultivated from the Indonesian strain of the virus. The Indonesian media reported that its Health Ministry was approached by Australian CSL Limited, who offered to sell a vaccine for protection against Indonesian strains of the Bird Flu. CSL Limited had acquired the Indonesian strain of Bird Flu through the WHO bank of samples. Given that Indonesia was never consulted or rewarded as part of the vaccine production process, the Indonesian Government, somewhat disgruntled, took the drastic step of suspending its supply of Bird Flu samples to the WHO. An investigation of the actions of Indonesia (the Government), Baxter International (the TNC) and the World Health Organization (the IGO) evidences the weaknesses within the global health system. Stakeholders were taken aback when Indonesia decided to stop sharing samples of H5N1 virus with the WHO. Global media reports suggested that the Indonesian Government withheld the samples as they decided to exert control over its strain of H5N1 virus, claiming it to be Indonesian ‘intellectual property’. The media hypothesized that Indonesia was in negotiations with Baxter International, a transnational pharmaceutical company specialising in the production of cell-based vaccines. It was not long before the media revealed an agreement between the Indonesian Government and Baxter International to produce a vaccine based on a dedicated supply of Indonesian H5N1 virus samples. Initially, Indonesia argued that its version of Bird Flu was its ‘intellectual property’, arguing that the country cannot share samples for free. Subsequent conjecture in the press painted Indonesia as both the sinner withholding vital samples, and the saint standing alone against the might of greedy pharmaceutical TNCs. Biological intellectual property? Indonesia’s defence of intellectual property rights invoked worldwide debate as to how a virus could become the property of an individual state. The 1992 Convention on Biological Diversity, signed by 152 countries, reaffirms that States have sovereign rights over their own biological resources. Furthermore, it defines biological resources as including genetic resources, organisms or parts thereof, populations or any other biotic component of ecosystems with actual or potential use or value for humanity. 1 As at 4 April 2007 (World Health Organisation) Eventually it became common knowledge that the Government was in negotiations with Baxter. Baxter already had contracts in place with a variety of European countries and the United States of America to develop and stockpile vaccines to protect their respective citizens against the H5N1 virus. While no binding arrangements were signed between Baxter and the Indonesian Government, a memorandum of understanding, to ‘provide a framework for future discussions and negotiations related to any formal collaboration or supply agreements for pandemic vaccine’ was agreed upon (Baxter International 2007). This arrangement suggests that Indonesian officials felt the country was entitled to compensation for the use of its virus samples. In the following weeks, it was divulged that Indonesia’s primary concern was in relation to the disparities within the current global system of health security. Foreign vaccine producers use free samples provided by one country to develop a vaccine and sell back the product at a profit. Indeed, the majority of influenza vaccines are cultivated from samples taken from countries that do not posses the ability to produce seasonal flu vaccines, let alone complex Bird Flu vaccinations. This concern is not new, yet the globalized health system appears to have long accepted the inequity. The WHO concede that should an H5N1 pandemic occur, the stockpiles of vaccines would fail to provide the protection required by several billion doses—the main shortfall would be in developing nations where the cost of stockpiling vaccines is prohibitive. Influenza vaccine versus Bird Flu vaccine Each year the WHO issues the suggested ‘make-up’ for the seasonal Influenza vaccine. This ‘make-up’ is cultivated from the shared samples it has accumulated, which change annually, and is mainly used by developed nations to protect their population. Bird Flu vaccine is the vaccine developed from the H5N1 strain of Bird Flu. The WHO initiated negotiations with Indonesia in an effort to restart the collaborative and necessary process of vaccine development. At the conclusion of these negotiations, Indonesia was praised for its leadership in alerting the international community ‘to the needs of developing countries to benefit from sharing virus samples, including access to quality pandemic vaccines at affordable prices’ (World Health Organisation 2007). In a change of attitude, the Indonesian Health Minister agreed to the importance of responsible, free and rapid sharing of the influenza virus with the WHO, and the necessity to enhance global health security. However, Indonesia did not rapidly re-establish the sharing of viruses with the WHO. The Indonesian Health Minister, Siti Failah Supari, told reporters that Indonesia had no intention of sharing its virus samples until there was a change in the international vaccine exchange system (Centre for Infectious Disease Research and Policy 2007). Indonesia’s stance was taken despite a letter from the WHO DirectorGeneral, Margaret Chan, promising Indonesia that its viral specimens would be used ‘for public health risk assessment purposes only’. A stand-off of global proportions ensued—a government, an IGO and a TNC, all attempting to realise their respective core business goals fractured the global convention on health security. Three months after Indonesia first stopped supplying the samples, the WHO announced that collaborating centres mandates over and operations with H5N1 samples would be altered to accommodate Indonesia’s demands. While vaccine production was still a matter for individual countries to negotiate with producers, the WHO would work with pharmaceutical companies with a view to creating a stockpile of vaccines. Is this a win for the underdog nations or is it yet another example of Western IGOs manipulating a situation to profit from Western dominance? Questions • Which political group do you believe should have the main say over the H5N1 virus samples: the Indonesian Government, the World Health Organization or Baxter International? • What other reasons may Indonesia have for denying access to their samples of Bird Flu? • What will the rest of the global health/political machine do in regard to Indonesia’s actions? What mechanisms may they utilise? Web resources http://www.who.int/csr/disease/avian_influenza/en/index.html The World Health Organizations Avian Influenza website includes the latest information, situation updates as well as links to the WHO’s Media Centre. http://www.cidrap.umn.edu/ The Centre for Infectious Disease Research and Policy, University of Minnesota. This website offers a comprehensive list of resources pertaining to global health security issues, such as: Pandemic Influenza, Avian Flu and Bioterrorism. References Baxter International 2007, Baxter Continues Collaborations with Global Health Authorities to Advance Pandemic Preparedness, (Deerfield, Illinois: Baxter Worldwide), Available: http://www.baxter.com/about_baxter/news_room/news_releases/2007/02-0707-indonesia.html [16 March 2007] Centre for Infectious Disease Research and Policy 2007, Indonesia Wants Legal pact on Sharing H5N1 Samples, (Minneapolis: University of Minnesota), Available: http://www.cidrap.umn.edu/cidrap/content/influenza/avianflu/news/mar1407in do.html [16 March 2007] Murray C.J., Lopez A. D., Chin, B., Feehan, D. and Hill, K. 2006, ‘Estimation of Potential Global Pandemic Influenza Mortality on the basis of Vital Registry Data From the 1918–20 Pandemic: a Quantitative Analysis’, The Lancet, 368: 2211–2218. World Health Organization 2007, Sharing of Avian Influenza virus and Pandemic Production, (Geneva: World Health Organization and The Indonesian Ministry of Health), Available: http://www.who.int/mediacentre/news/statements/2007/s02/en/print.html [13 March 2007].