The Continuing Global Spread of Avian Influenza A (H5N1) and Its Implications for International Law
November 07, 2005
The outbreak of avian influenza A (H5N1) that began in mid-December 2003 in Asia and became a global crisis in early 2004 has continued to spread and raise alarms nationally and internationally during 2005. In the past few months, the threat to human health posed by the continuing global spread of avian influenza has grown significantly in its political, economic, and governance importance, becoming in the words of political commentator Fareed Zakaria, "a threat worse than terror." This Insight focuses on the latest developments concerning avian influenza and their implications for international law.
Epidemiological Developments Concerning Avian Influenza
As of November 1, 2005, the World Health Organization (WHO) reported a total of 122 human cases of avian influenza and 62 deaths from four countries in Asia. These numbers are small compared to other global health problems, such as the HIV/AIDS pandemic, but the statistics do not tell the whole story of the threat that avian influenza presents.
From the first time humans contracted avian influenza from infected birds in Hong Kong in 1997, public health officials have feared that the H5N1 virus would mutate into a virulent pathogen easily transmissible from human to human. The spread of avian influenza through bird populations across Asia in 2004-2005 has alarmed public health authorities because it has increased the opportunities for humans to contract the virus and for the virus to mix genetic material with a human host, possibly producing a fully transmissible pandemic virus.
The appearance of such a virus in today's globalized world has raised the specter of a pandemic of equal or greater ferocity than the 1918-1919 influenza pandemic, which killed millions worldwide. These fears have intensified in 2005 even though the H5N1 virus has not yet demonstrated human-to-human transmissibility, except perhaps through very close contact with an infected person.
First, the H5N1 virus has spread in bird populations across Asia into Europe. Cases of H5N1 infections in birds have been confirmed in Croatia, Kazakhstan, Russia, Romania, Turkey, and the United Kingdom; suspected cases have been identified in Greece and Sweden. Preliminary evidence of avian flu has also been reported in Germany. The expansion of the H5N1 virus? geographic range, combined with the virus becoming endemic in many Asian countries, increases its opportunities to engage in genetic re-assortment with human hosts. WHO has warned that the recent spread of the H5N1 virus to new areas increases both the chances for human cases and the probability that a pandemic will occur.
Second, new scientific information has deepened concerns about the potential for the H5N1 virus to trigger an influenza pandemic. Researchers have found that the influenza virus that caused the 1918-1919 pandemic appears to have been an entirely avian-like virus that adapted to humans. In addition, this research identified in the H5N1 virus a number of features also found in the incredibly virulent 1918-1919 virus. Other recent scientific research has indicated that the H5N1 virus may be developing resistance to oseltamivir (Tamiflu), one of the few antiviral therapies available for treatment of human cases of H5N1 infection.
Political Developments Concerning Avian Influenza
Although the avian influenza problem has been high on the agendas of the WHO, the UN Food and Agriculture Organization (FAO), and the World Organization for Animal Health (OIE) since the end of 2003, recent actions taken by international organizations and states indicate that the political importance of avian influenza has dramatically increased. At the UN, the Secretary-General has appointed a Senior UN System Coordinator for Avian and Human Influenza, who is charged with coordinating the UN's contribution to the global effort against avian influenza and any potential human influenza pandemic. WHO, FAO, OIE, and the World Bank are holding a partners meeting on avian influenza and human pandemic influenza on November 7-9. Regional organizations, such as APEC, ASEAN, and the EU, have all initiated heightened diplomatic and public health efforts in response to the avian influenza threat. On October 24-25, Canada hosted a ministerial meeting on pandemic influenza preparedness, at which government representatives from 30 countries and nine international organizations called for accelerated influenza preparedness action.
In the United States, the Bush administration has created a multi-agency task force on pandemic influenza that meets daily and that involves the CIA and the National Security Council. The United States has also launched the International Partnership on Avian and Pandemic Influenza, placed pandemic influenza cooperation on its bilateral diplomatic agenda with China, and issued its national strategy on pandemic influenza preparedness. The U.S. Congress has also become engaged with the threat of pandemic influenza. For example, the Senate passed appropriations measures for pandemic influenza preparedness on September 28th ($3.9 billion) and on October 27th ($8 billion).
Avian Influenza and Specific Areas of International Law
The January 2004 ASIL Insight on avian influenza identified international law on infectious disease control, animal health, trade in goods, intellectual property rights, human rights, and principles of state responsibility as implicated by the spread of the H5N1 virus. These areas of international law remain relevant to the continuing global spread of avian influenza, but developments in 2004 and 2005 have highlighted international law on infectious disease control and intellectual property rights.
The New International Health Regulations
In May 2005, WHO adopted the new International Health Regulations (IHR), which radically transform the international law applicable to identifying and responding to the international spread of diseases. The new IHR will not enter into force until 2007, but in the meantime the growing threat posed by the spread of avian influenza has reinforced the importance to global health governance of the principles found in them. Of particular significance are the obligations states parties will have to build and maintain core surveillance and response capacities to be able to handle the international spread of disease. The core capacity provisions require states parties to establish specific public health capabilities at local, intermediate, and national levels and at designated airports, ports, and ground crossings. These capabilities include the ability to detect disease events, assess their significance, report them to the appropriate level of health-care response, verify reported events, and determine and implement appropriate and effective public health responses.
The avian influenza crisis has highlighted how unprepared most countries, including developed countries such as the United States, are to deal with pandemic influenza. The new IHR do not, however, obligate states parties to raise financial resources for increasing public health capacity around the world, especially in developing countries. A failure to generate sufficient resources to support national and international surveillance and response capacities will significantly undermine the contributions the new IHR can make to global health.
International Law on Intellectual Property Rights
Pandemic influenza preparedness plans call for countries to stockpile antiviral therapies for use if a pandemic occurs. Roche, a Swiss company, is the patent holder and sole manufacturer of one of the recommended antivirals, Tamiflu. Growing fears about avian influenza?s potential to stimulate a pandemic of human influenza have increased demand for Tamiflu beyond Roche?s manufacturing capabilities.
Roche's reluctance to license other pharmaceutical companies to make Tamiflu led to calls for countries to issue compulsory licenses for the manufacture of Tamiflu. Those calling for compulsory licenses argued that such licenses would be justified under the exceptions to exclusive use by a patent holder found in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), particularly as interpreted by the Doha Declaration on the TRIPS Agreement and Public Health. The exceptions contemplate waivers of exclusive use rights in a national emergency or in other circumstances of extreme urgency, including public health crises.
In the face of the growing momentum for compulsory licenses and increased political pressure from members of the U.S. Congress, Roche eventually agreed to negotiate licenses to allow other companies to manufacture Tamiflu. Nevertheless, some countries, such as India, remain interested in pursuing compulsory licenses to boost Tamiflu production.
Avian Influenza and the Responsibility to Protect in International Law
The dangers posed by the continued global spread of avian influenza, together with other worsening global disease problems, have raised the question whether the emerging international legal norm of the responsibility to protect populations from serious, avoidable harm should address not only large-scale, violent atrocities but also serious public health threats. Recent blueprints for reforming the UN stressed the necessity for global public health improvements and supported the responsibility-to-protect principle, but these documents did not bring public health into the scope of the principle. Noting the massive death and suffering diseases cause every year, Anne-Marie Slaughter, Dean of the Woodrow Wilson School of Public and International Affairs at Princeton, has asked, "If human security is our aim, why on earth should we privilege the saving of lives from violence over the saving of lives from disease?"
The increased potential for pandemic influenza, combined with the serious deficiencies in public health preparedness nationally and internationally, makes the individual and collective responsibility to protect public health one of the most important global governance questions countries face today.
About the author
David P. Fidler, an ASIL member, is Professor of Law and Harry T. Ice Faculty Fellow at Indiana University School of Law, Bloomington and a Senior Scholar at the Center for Law and the Public's Health, Georgetown and Johns Hopkins Universities.
 For an earlier Insight on avian influenza, see D. P. Fidler, Global Outbreak of Avian Influenza A (H5N1) and International Law, January 2004, at http://www.asil.org/insights/insigh125.htm.
 F. Zakaria, A Threat Worse Than Terror, Newsweek, Oct. 31, 2005.
 WHO, Cumulative Number of Confirmed Human Cases of Avian Influenza A/(H5N1) Reported to WHO, Nov. 1, 2005, at http://www.who.int/csr/disease/avian_influenza/country/cases_table_2005_11_
 The avian influenza outbreak in Hong Kong in 1997 infected 18 people, six of whom died from the infection. Massive and rapid culling of poultry populations in Hong Kong contained the outbreak and prevented its spread to other countries.
 Writing Committee of the World Health Organization Consultation on Human Influenza A/H5, 353 New England Journal of Medicine 1374-1385 (Sept. 29, 2005); WHO, Avian Influenza Frequently Asked Questions, Oct. 19, 2005, at http://www.who.int/csr/disease/avian_influenza/avian_faqs/en/index.html.
 Eurosurveillance, Avian Influenza Outbreaks in the WHO European Region and Public Health Actions, Nov. 1, 2005, at http://www.eurosurveillance.org/ew/2005/051027.asp#2; European Influenza Surveillance Scheme, Update on Avian Influenza A(H5N1) in Europe, Oct. 23, 2005, at http://www.eiss.org/news.cgi.
 EU Bans Live Birds in Flu Fight, CNN.com, Oct. 25, 2005, at http://www.cnn.com/2005/HEALTH/conditions/10/25/birdflu.main/index.html; V. Elliott, R. Watson, and D. Rose, Ministers Consider Bird Imports Ban After Avian Flu Hits Germany, The Times (London), Oct. 26, 2005, at http://www.timesonline.co.uk/article/0,,25149-1843586,00.html.
 WHO, supra note 5.
 J. K. Taubenberger et al., Characterization of the 1918 Influenza Virus Polymerase Genes, 437 Nature 889-893 (Oct. 6, 2005).
 Writing Committee of the World Health Organization Consultation on Human Influenza A/H5, supra note 5; Q. Mai Le et al., Avian Flu: Isolation of Drug-Resistant H5N1 Virus, 437 Nature 1108 (Oct. 20, 2005).
 Particularly important in stimulating high-level political interest in avian influenza were articles that appeared in the July/August 2005 issue of Foreign Affairs: L. Garrett, The Next Pandemic?, 84(4) Foreign Affairs 3 (2005); M.T. Osterholm, Preparing for the Next Pandemic, id. 24; and W.B. Karesh and R.A. Cook, The Human-Animal Link, id. 38.
 Secretary-General Appoints Dr. David Nabarro as Senior UN System Coordinator for Avian and Human Influenza, Sept. 29, 2005, UN Doc. SG/A/946, at http://www.un.org/News/Press/docs/2005/sga946.doc.htm.
 WHO, Partners Meeting on Avian Influenza and Human Pandemic Influenza, at http://www.who.int/mediacentre/events/2005/meeting_avian_influenza/en/print.html.
 Asia Pacific Economic Cooperation, Regional Health Threats: Avian Influenza, at http://www.apec.org/apec/apec_groups/som_special_task_groups/health_task_force
 Southeast Asia Works on Avian Influenza Preparedness, EINet, at http://depts.washington.edu/einet/?a=printArticle&print=908.
 EU Action on Avian Influenza, at http://www.europa.eu.int/comm/food/animal/diseases/controlmeasures/avian/index_en.htm.
 Health Canada, Ottawa Meeting an Important Step in Global Preparation for a Possible Pandemic, Oct. 25, 2005, at http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/2005/2005_pan-flu_e.html.
 L. Garrett, Analysis of Recent Developments Concerning Avian Influenza, Council on Foreign Relations Global Health Program, Oct. 6, 2005.
 U.S. Department of State, Fact Sheet: U.S. Launches International Partnership on Avian and Pandemic Influenza, Sept. 22, 2005.
 Garrett, supra note 18.
 White House, President Outlines Pandemic Influenza Preparations and Response, Nov. 1, 2005, at http://www.whitehouse.gov/news/releases/2005/11/20051101-1.html.
 L. Garrett, A $3.9 Billion First Strike, Los Angeles Times, Oct. 7, 2005, at http://www.cfr.org/publication/8993/39billion_first_strike.html.
 Chiron Gets Contract for Bird Flu Vaccine, Washington Post, Oct. 27, 2005, at http://www.washingtonpost.com/wp-dyn/content/article/2005/10/27/AR2005102701178.html.
 World Health Assembly, Revision of the International Health Regulations, WHA58.3, May 23, 2005, 44 International Legal Materials 1013 (2005). For a summary, see G. S. Schatz, International Health Regulations: New Mandate for Scientific Cooperation, ASIL Insight, Aug. 2, 2005, at http://www.asil.org/insights/2005/08/insights050802.html.
 For a detailed analysis of the new IHR, see D. P. Fidler, From International Sanitary Conventions to Global Health Security: The New International Health Regulations, 4 Chinese Journal of International Law (2005) (in press).
 IHR, supra note 23, Articles 5.1 and 13.1 and Annex 1.
 WHO, Responding to the Avian Influenza Pandemic Threat: Recommended Strategic Actions, WHO/CDS/CSR/GIP/2005.8 (2005), at 11.
 S. Russell, Flu Vaccine Maker Won't Share Patent; Roche Rejects Calls to Allow Production of Generic Versions, San Francisco Chronicle, Oct. 13, 2005, at A1.
 TRIPS Agreement, Article 31, at http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm.
 Doha Declaration on the TRIPS Agreement and Public Health, Nov. 14, 2001, at http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm; Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, Aug. 30, 2003, at http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm.
 D. Henderson, Firm Agrees to Discuss Licensing Bird Flu Drug, Boston Globe, Oct. 21, 2005, at A3.
 Intellectual Property Watch, Indian Industy Pushing for Compulsory Licenses for Tamiflu, Oct. 25, 2005, at http://www.ip-watch.org/weblog/index.php?p=117&res=1024_ff&print=0.
 Report of the Secretary-General's High-Level Panel on Threats, Challenges and Change, A More Secure World: Our Shared Responsibility (2004); UN Secretary-General, In Larger Freedom: Towards Development, Security and Human Rights for All--Report of the Secretary-General, UN Doc. A/59/2005, Mar. 21, 2005; UN General Assembly, World Summit Outcome, UN Doc. A/60/L.1, Sept. 20, 2005.
 A.-M. Slaughter, Security, Solidarity, and Sovereignty: The Grand Themes of UN Reform, 99 American Journal of International Law 619, 624 (2005).
 For further elaboration, see D. P. Fidler, The UN and the Responsibility to Practice Public Health, 2 Journal of International Law & International Relations (2005) (in press).