Indonesia's Decision to Withhold Influenza Virus Samples from the World Health Organization: Implications for International Law
In February 2007, international media reported that Indonesia had decided not to continue to share with the World Health Organization (WHO) samples of avian influenza A (H5N1) strains appearing in Indonesia. Instead, Indonesia decided to pursue a commercial arrangement with a pharmaceutical company, which would use the samples to develop an avian influenza vaccine for Indonesia. This move created concern and controversy in global health circles because, in the words of a New York Times editorial, it "threatens the global effort to track the [H5N1] virus and develop vaccines." In addition, the action occurs as fears about the emergence of pandemic influenza continue to grow. This Insight analyzes Indonesia's decision to withhold avian influenza samples from WHO and the decision's implications for international law.
Indonesia's Decision to Withhold Viral Samples of Avian Influenza A (H5N1)
According to WHO, the epidemic of avian influenza A (H5N1) has hit Indonesia hard. As of February 16, 2007, WHO reported that Indonesia had 81 human cases (second only to Vietnam's 93 cases) and 63 deaths, more than any other country in which avian influenza has appeared. The severity of the threat in Indonesia makes the country particularly important in global efforts to track and fight avian influenza.
In early February 2007, international media reported that Indonesia had stopped sharing avian influenza samples collected in its territory with WHO and had entered into negotiations with the pharmaceutical company Baxter International for the development of vaccines against avian influenza. Indonesia's actions flowed from its concerns with how pharmaceutical companies in the developed world used virus samples Indonesia had provided to WHO for vaccine development, without any compensation for Indonesia or any arrangement that would provide Indonesia affordable access to the vaccines developed.
According to the Financial Times, "Indonesia blamed the World Health Organization" for the government's decision to stop sharing samples of the H5N1 bird flu virus, claiming that the United Nations agency passed them on to pharmaceutical companies to make vaccines that Jakarta had to buy at high prices." Indonesia was particularly upset that an Australian pharmaceutical company developed an avian influenza vaccine from a sample provided to WHO by Indonesia. Indonesia intended its agreement with Baxter International to provide it with intellectual property rights over the samples and access to any vaccines developed from the samples.
Indonesia's actions sent shock waves through the global health community, which has been trying to construct multilateral strategies for fighting avian influenza and preparing for pandemic influenza. For reasons explained below, Indonesia's decisions threatened critical aspects of the public health approaches being built to address avian and pandemic influenza. Many experts criticized Indonesia for jeopardizing global public health cooperation, but support for Indonesia's position was also frequently voiced, especially with respect to Indonesia's highlighting of the inequitable manner in which the current global strategies operate for many developing countries, which share information and samples but receive insufficient help from developed countries.
Thailand raised similar issues at WHO's Executive Board meeting in January 2007, and its representative argued that "[w]e are sending our virus [samples] to the rich countries to produce antivirals and vaccines. And when the pandemic occurs, they survive and we die. . . . We are not opposed to the sharing of information and virus [samples], but on the condition that every country will have equal opportunity to get access to vaccine and antivirals if such a pandemic occurs."
Reflecting the alarm felt in global public health, WHO met with the Indonesian government to find a way to re-start sample sharing and to address Indonesia's concerns about inequitable access to avian and pandemic influenza vaccines. On February 16, 2007, the Indonesian Ministry of Health and WHO issued a Joint Statement under which Indonesia agreed that "the responsible, free and rapid sharing of influenza viruses with WHO, including H5N1, is necessary for global public health security" and agreed to "resume sharing viruses for this purpose."
For its part, WHO supported Indonesia's decision to discuss contractual arrangements with pharmaceutical companies for vaccine production and agreed to work with Indonesia and other countries "to assess and develop potential mechanisms, including Material Transfer Agreements, that could promote equitable distribution and availability of pandemic influenza vaccines developed and produced from these viruses." Indonesia and WHO also agreed to convene a meeting in the Asia and Pacific region "to identify mechanisms for equitable access to influenza vaccine and production."
News reports indicated, however, a lack of agreement between WHO and Indonesia about when Indonesia would begin sharing samples again. The WHO representative, Dr. David Heymann, expressed his hope that Indonesia would start sample sharing again within a week or two after the Joint Statement. The Indonesia Health Minister indicated, however, that sharing would only begin again once the new mechanism for equitable access to influenza vaccine and production were in place.
To understand the implications of Indonesia's actions for international law concerning global health, some background on the importance of pathogen samples to public health and the problem of inequitable access to vaccines is needed.
The Importance of Pathogen Samples: Public Health Surveillance and Intervention
Public health authorities require access to samples of viral or bacterial strains that cause communicable diseases in order to undertake surveillance and develop intervention strategies. Analyzing pathogen samples allows public health officials to understand what disease-causing organisms are circulating within populations. Such samples are very important for conducting surveillance on changes in pathogen strains, such as the development of drug-resistant strains. Surveillance information allows public health to update diagnostic reagents and to develop interventions (e.g., vaccines, antibiotics) to address the characteristics of the viral or bacterial strain in question.
The strategies on influenza illustrate the critical role viral samples play in global public health. WHO established the WHO Global Influenza Surveillance Network in 1952, which is comprised of collaborating centers and national influenza centers that collect samples of influenza strains circulating in various regions of the world. The centers share and analyze these strains, and the data from these analyses informs the recommendations that guide the development of influenza vaccines, which countries use to protect their populations from the seasonal emergence and global spread of influenza viruses.
Without samples, public health authorities cannot conduct effective surveillance or make scientifically informed recommendations on vaccines, and pharmaceutical companies could not develop vaccines needed to reduce influenza-related morbidity and mortality. Current fears about the potential for avian influenza to mutate into virulent strains capable of sustained human-to-human transmission highlight the urgency of having access to samples of avian influenza strains. The importance of such samples explains why public health officials reacted with such alarm to Indonesia's decisions.
Indonesia's Actions and Equitable Access to Vaccines
Indonesia's decision to stop sharing samples with WHO flows from its concern that it and other developing countries are not treated equitably after they share samples with WHO. Vaccine development based on the samples occurs mainly by pharmaceutical companies in developed countries, which patent their vaccines, making them more expensive for developing countries to obtain. In addition, given that influenza vaccine manufacturing capabilities are mainly found in developed countries, developing countries fear that they will have little to no access to vaccine if a pandemic strain emerges. Thus, developing-country participation in sharing viral samples to support global surveillance produces a process that renders access to vaccine interventions inequitable.
In a context permeated by concerns about pandemic influenza, such inequitable access reduces incentives for developing countries to participate fully in sample sharing for surveillance purposes. Instead, Indonesia's negotiations for a commercial arrangement with Baxter International reveal a desire to exploit the potential of the samples more directly for the benefit of Indonesia and perhaps other developing countries.
Influenza Samples and International Law
Intellectual Property Issues
Indonesia's actions highlight problems that intellectual property rights cause in global public health. Controversies pitting public health against patent rights protected by international law have flared in the contexts of access to anti-retrovirals for HIV/AIDS, ciprofloxacin for treating victims of the anthrax attacks in the United States, and anti-virals for pandemic influenza preparedness and response strategies.
In each case, public health advocates have argued that patents reduce access to drugs needed for effective interventions against infectious diseases. Indonesia's decision again raises concerns that patents obtained for avian and pandemic influenza vaccines by pharmaceutical companies in the developed world will adversely affect access to such vaccines in the developing world. Indonesia's strategy put a new twist into the intellectual property debate, however, because it decided to protect its intellectual property rights in the samples by negotiating directly with a pharmaceutical company.
The context surrounding the samples episode is reminiscent of controversies involving alleged "biopiracy" by pharmaceutical companies that patented drugs derived from indigenous plants and traditional medicinal practices in developing countries. These allegations raised concerns that developing countries, the origin of exploited biological resources, did not receive benefits once pharmaceutical companies patented and profited from the drugs derived from such resources. One policy response to "biopiracy" involved developing-country governments reasserting sovereign control over biological resources in their territories.
In essence, Indonesia is doing likewise by asserting sovereign control and property rights over samples collected in its territory. Whether other developing countries follow Indonesia's lead remains to be seen. Indonesia's stance has raised the stakes in the controversies about intellectual property rights and global health, and the World Health Assembly is scheduled in May 2007 "to debate a resolution regarding the extent to which nations can claim intellectual property rights over diseases that emerge within their borders."
Customary International Law on Influenza Sample Sharing?
The long history of States sharing influenza samples as part of WHO's Global Influenza Surveillance Network raises the possible argument that States are legally obliged, under customary international law, to share such samples. Given the critical importance of global access to influenza samples, particularly in terms of transforming knowledge from the samples into vaccines that can reduce significant death and human suffering globally, the obligation to share samples may qualify for jus cogens status. This line of reasoning would mean Indonesia's actions were illegal under international law.
The argument that customary international law regulates influenza-sample sharing is, however, weak because the sense that States are legally bound (opinio juris) to such sharing is not present. Finding evidence that States have participated in WHO's Global Influenza Surveillance Network under a sense of legal obligation would be impossible because the Network has operated without reference to international law since its establishment in the 1950s.
International Health Regulations (2005)
In May 2005, WHO adopted the International Health Regulations (2005), a new treaty that transforms international law on public health. The IHR (2005) will enter into force in June 2007, but analyzing this treaty proves useful in thinking about the international legal implications of Indonesia's actions. In other words, would withholding influenza or other pathogen samples violate this treaty once it enters into force?
The significant changes made in the IHR (2005) include surveillance obligations for States Parties to report information to WHO concerning any event that may constitute a public health emergency of international concern (Article 6.1). The IHR (2005) require States Parties to notify WHO of any cases of human influenza caused by a new subtype (Annex 2).
The IHR (2005) also require States Parties to "continue to communicate to WHO timely, accurate and sufficiently detailed public health information available to it on the notified event, where possible including case definitions, laboratory results, source and type of the risk, number of cases and deaths, conditions affecting the spread of the disease and the health measures employed; and report, when necessary, the difficulties faced and support needed in responding to the potential public health emergency of international concern" (Article 6.2). The list of possible forms of information that must be communicated to WHO is not exclusive, so other types of information would be caught as well.
The IHR (2005) do not, however, define what "public health information" means, and physical samples of pathogens might not fall within the plain meaning of "information." Samples certainly yield information (e.g., genetic sequences) that a State Party to the IHR (2005) would have to report to WHO, but the sample itself is not arguably public health information.
The IHR (2005)'s surveillance obligations do not specifically require States Parties to share biological substances with WHO. The only provision that mentions biological substances states that: "States Parties shall, subject to national law and taking into account relevant international guidelines, facilitate the transport, entry, exit, processing and disposal of biological substances and diagnostic specimens, reagents and other diagnostic materials for verification and public health response purposes under these Regulations" (Article 46). This rule does not impose a duty on States Parties that collect samples to share them with WHO. It merely creates an obligation to facilitate the transport of biological substances.
The IHR (2005)'s negotiating record confirms this interpretation. An earlier negotiating text included, for example, the following provision: "In the context of a suspected intentional release of a biological, chemical or radionuclear agent, States shall immediately provide to WHO all relevant public health information, materials and samples, for verification and response purposes." This provision does not appear in the IHR (2005), and, even so, it only imposed a duty to share samples in cases where a State Party suspected the intentional use of a biological, chemical, or radionuclear substance, which does not include the natural emergence of avian or pandemic influenza strains.
Thus, Indonesia's actions would not violate the IHR (2005), which, when they enter into force, will be the leading international legal framework concerning global surveillance for diseases that could cause public health emergencies of international concern, which would include pandemic influenza. This reality buttresses the conclusion that customary international law does not require States to share the pathogen samples with WHO.
Violation of the International Human Right to Health?
Criticism of Indonesia sometimes mentioned the health dangers Indonesia created by not sharing samples. Could withholding pathogen samples violate international human rights law, particularly the right to health? Under the International Covenant on Economic, Social, and Cultural Rights, States Parties are required to engage in international cooperation with respect to the progressive realization of ?the right of everyone to the enjoyment of the highest attainable standard of physical and mental health? (Articles 2.1, 12.1). This obligation includes taking steps necessary for the ?prevention, treatment and control of epidemic, endemic, occupational and other diseases? (Article 12.2(c)). Indonesia?s actions may worry right to health advocates because of its potentially adverse global consequences for international cooperation against the influenza threat.
The argument that failure to share samples violates the right to health through a failure to engage in international cooperation would be difficult to sustain. The precise obligations created by the right to health remain unsettled, particularly the duty to participate in international cooperation. In Indonesia's case, the samples are not from a strain of influenza that is readily transmissible from human-to-human, and thus this strain is not the cause of cross-border disease spread. Most countries in the world are not experiencing human epidemics caused by the avian influenza virus. In addition, Indonesia could argue that its decisions reflect an attempt to use the samples to improve the chances of protecting the health of Indonesians from avian and pandemic influenza, an outcome that would support Indonesia's progressive realization of the right to health of its people.
Lack of an International Legal Framework for Equitable Sharing of Scarce Public Health Resources: The Development of Treaty Law?
The preceding analysis of different areas of international law implicated by States withholding pathogen samples from WHO underscores the lack of an international legal or governance framework that addresses the equitable sharing of scarce public health resources, particularly in times of public health emergencies. The same problem has emerged with the scarcity of anti-viral drugs, such as Tamiflu, considered potentially important in interventions against pandemic influenza. Public health experts have acknowledged that developing countries' access to anti-virals in the event of pandemic influenza will be poor to non-existent.
Indonesia's behavior may encourage other States to act unilaterally, or to seek out preferential arrangements for access to public health information, samples, or drugs, vaccines, or technology to produce anti-virals and vaccines. Some experts have argued that the United States is securing privileged access to global surveillance and response networks. The Joint Statement mentions that Indonesia and WHO will assess and develop potential new mechanisms to promote equitable availability and distribution of pandemic influenza vaccines.
One mechanism the Joint Statement mentions is a "Material Transfer Agreement," which would, in all likelihood, be a treaty under international law. Indonesia's actions may, thus, stimulate the development of treaty law in an area historically devoid of such agreements. Whether such treaty law will support a multilateral strategy against avian and pandemic influenza, or fragments the strategy into disconnected, and perhaps competing, treaties remains to be seen.
The reactions to Indonesia's decision highlight the seriousness of this development in the global strategies against avian and pandemic influenza. The Joint Statement may allow public health officials to breathe a temporary sigh of relief, but the Joint Statement has not, by any means, resolved the underlying problems that gave rise to Indonesia's action in the first place.
David P. Fidler is Professor of Law and Harry T. Ice Faculty Fellow, Indiana University School of Law, Bloomington and a Member of the ASIL Insights Editorial Board.
 Indonesia's Avian Flu Holdout, New York Times, Feb. 16, at.
 WHO, Cumulative Number of Confirmed Human Cases of Avian Influenza A/(H5N1) Reported to WHO, Feb. 16, 2007, at http://www.who.int/csr/disease/avian_influenza/country/cases_table_2007_
 See, e.g., J. Aglionby and A. Jack, Indonesia Withholds Genetic Samples of Bird Flu, Financial Times USA, Feb. 6, 2007, at 1.
 J. Aglionby and A. Jack, Indonesia Accuses WHO of Misusing Flu Sample H5N1, Financial Times, Feb. 8, 2007, at 9.
 Reuters, Indonesia, Baxter Sign Pact on Bird Flu Vaccine, Feb. 7, 2007, at http://www.alertnet.org/thenews/newsdesk/JAK76679.htm.
 Quoted in H. Branswell, Porr Countries Insisting on Bird Flu Rules; They Want Fair Share of Vaccines, Hamilton Spectator, Feb. 12, 2007, at A05.
 Joint Statement from the Ministry of Health, Indonesia and the World Health Organization Regarding the Sharing of Avian Influenza Viruses and Pandemic Vaccine Production, Feb. 16, 2007, Statement WHO/2, at http://www.who.int/mediacentre/news/statements/2007/s02/en/index.html.
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 WHO, Global Influenza Surveillance, at http://www.who.int/csr/disease/influenza/influenzanetwork/en/index.html.
 J. Aglionby, B. Hall, A. Jack, and J. Wiggns, UK Poultry is Banned From Six Countries; Indonesia Halts Sharing of Viral "Bird Flu" Samples, Financial Times, Feb. 6, 2007, at 1 (quoting the Director-General of Indonesia's National Institute of Health Research and Development as saying that "the step to withhold samples was taken because the government wanted to retain control of the intellectual property rights of the most deadly strain of the virus").
 J. Aglionby, Indonesia Agrees to Share Bird Flu Samples, Financial Times, Feb. 17, 2007, at 7.
 See D. P. Fidler, From International Sanitary Conventions to Global Health Governance: The New International Health Regulations, 4 Chinese Journal of International Law 325 (2005).
 WHO, International Health Regulations: Working Paper for Regional Consultations, IGWG/IHR/Working paper/12.2003, Jan. 12, 2004, Article 41.
 International Covenant on Economic, Social, and Cultural Rights, Dec. 16, 1966, 993 UNTS 3.
 P. Calain, Exploring the International Arena of Global Public Health Surveillance, 22 Health Policy and Planning 2, 6 (2007).