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Health law, like so many other areas of the law, has become increasingly internationalized in recent years. Global health issues, such as HIV/AIDS, outbreaks of avian influenza and severe acute respiratory syndrome (SARS), and the threat of bioterrorism, demonstrate both the ease with which public health emergencies can spread across the globe today and the need for coordinated multilateral responses. Recent developments in international health also drive home the point that international health issues have implications not only for medical professionals and health lawyers but also for those working on international trade law, intellectual property law, human rights, corporate law and many other areas of the law. Today, public health issues either affect, or have the potential to affect, all sectors of society. Several recent legal developments reflect the impact of international health issues. On May 23, the World Health Assembly adopted a revised version of the International Health Regulations (IHRs), the first significant revision of the regulations since 1969. See www.who.int/gb/ebwha/pdf-files/ WHA58/A58-55-en.pdf. Though a revised draft had been in the works, additional impetus for the revision came from the SARS outbreak of 2003, which infected more than 8,000 people in more than 25 countries, caused more than 1,700 deaths and cost the global economy billions of dollars. SARS highlighted the need to strengthen the international community’s public health preparedness. International regulations governing states’ responses to public health emergencies had existed since 1951, but the SARS epidemic revealed inadequacies in the then-current regulations, in large part because they covered only three infectious diseases (cholera, plague and yellow fever). The new IHRs set forth a clear, balanced mandate, stating that “[t]he purpose and scope of these Regulations are to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.” Article 2. The IHRs require each country to establish or designate a national center responsible for implementation of the IHRs that will serve as the contact point for the World Health Organization (WHO). Article 4. Under the IHRs, every country is required to develop and maintain the capacity to detect, assess and report certain public health events in accordance with the new regulations. Article 5. Countries must develop such capacity within five years of the new IHRs’ entry into force. The new IHRs provide for WHO assistance to countries needing help in developing such capacity. Under the new IHRs, countries will be required to notify WHO of any event (e.g., an outbreak of infectious disease) that may constitute a public health emergency of international concern. WHO will then have the authority to coordinate any needed international response to such an event. The IHRs also establish certain health-related rules for international trade and travel; outline procedures for governmental health agencies in the area of public health controls related to goods at airports, ports and other entry points; and set forth health procedures and documentation requirements for international travelers. The revised IHRs should enhance the individual capacity of each country to respond to public health emergencies and improve coordination of international efforts to address outbreaks of infectious disease and other public health emergencies. In turn, improving capacity to respond to public health crises will save lives and avoid potentially devastating economic losses caused by disease outbreaks. Tobacco and public health Although public health campaigns in the United States have targeted smoking for many years, according to WHO, globally more than 1.2 billion people still smoke and approximately 4.9 million tobacco-related deaths occur each year, more than the annual number of deaths related to AIDS, legal drugs, illegal drugs, road accidents, murder and suicide combined. In a 2004 report, WHO emphasized that tobacco’s impact on public health has significant implications for governments and businesses, including increased expenditures on health care and the financial cost of absenteeism from work. WHO, Building Blocks for Tobacco Control: a Handbook (2004). It also reported on environmental degradation caused by tobacco production. Attempting to address health, social and economic costs related to tobacco, WHO’s 192 member states unanimously adopted the WHO Framework Convention on Tobacco Control in May 2003. It was the first international legal instrument designed to reduce tobacco-related illness and deaths. On Feb. 27, the Convention on Tobacco Control entered into force. As of June 18, 168 countries had signed the convention and 69 of those countries had ratified or acceded to it. The United States has signed the convention, but, to date, has not ratified it. The Convention on Tobacco Control establishes a comprehensive framework for addressing the risks of exposure to and use of tobacco. States parties to the convention are required to “adopt and implement effective legislative, executive, administrative and/or other measures and cooperate, as appropriate, with other [countries] in developing appropriate policies for preventing and reducing tobacco consumption, nicotine addiction and exposure to tobacco smoke.” Article 5. Specifically, the Convention on Tobacco Control requires states parties to implement restrictions on tobacco advertising, sponsorship and promotion, and also establish new packaging and labeling of tobacco products. In addition, states parties must establish clean indoor air controls; implement or revise legislation to eliminate tobacco smuggling; and prohibit the sale of tobacco products to minors. As countries implement the Convention on Tobacco Control, tobacco-related illness and its associated economic costs should be reduced. The success of this effort may serve as a model for international agreements addressing other global health issues. HIV/AIDS Seemingly, no discussion of international health today is complete without consideration of the impact of HIV/AIDS. Current data indicate that, globally, approximately 40 million people are living with HIV, including more than 5 million who contracted the disease in 2004, and that more than 3 million people died of AIDS last year. UNAIDS, AIDS Epidemic Update 2 (December 2004). These numbers only begin to tell the story. In the hardest-hit countries, HIV/AIDS is reversing decades of progress-reducing life expectancy by decades, causing declining economic growth and worsening poverty. The disease has had an adverse impact on health care, education and other social services, labor forces, economic growth, foreign investment and the politics of numerous countries. HIV/AIDS raises countless challenges ranging from legal issues involved in research and development of new drugs to treat individuals with HIV to access-to-care issues, including the affordability and availability of anti-retroviral therapies in developing countries. In addition, discrimination against individuals living with HIV/AIDS remains a significant problem globally, and today more than 14 million children orphaned as a result of AIDS are in need of assistance and protection from human rights abuses. In fact, the far-reaching effects of HIV/AIDS have implications for attorneys working in almost all areas of the law. Access to pharmaceuticals is one of the issues that cut across many areas of the law. It implicates health and human rights issues, trade and intellectual property law, as well as corporate law issues confronted by international transactional lawyers. Recent efforts have attempted to balance due regard for patent protection with the urgent need to provide health care to millions of HIV-infected individuals living in developing countries that cannot afford to provide high-cost drug treatment to its population. The World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the subsequent Doha Declaration on the TRIPS Agreement and Public Health establish an intellectual property regime that recognizes that exceptions to patent law may be necessary in certain circumstances and ensures that “the TRIPS Agreement does not and should not prevent members from taking measures to protect public health.” Doha Declaration, Article 4. The Doha Declaration explicitly permits countries to take steps to promote access to medicines for all. The TRIPS regime also provides for a transition period for developing countries, as they bring their laws into compliance with TRIPS. Notably, Jan. 1 marked the end of the transition period for certain countries, including India, the world’s largest producer of generic drugs. India’s parliament passed a new patent law in March, bringing its laws into compliance with the TRIPS regime. The new law provides additional protection for patentholders but leaves unanswered many important questions as to how the poorest countries will fare given the resulting increased restrictions on their access to generic drugs for the treatment of HIV/AIDS and other diseases. Balancing intellectual property rights with the need to respond to the HIV/AIDS crisis will continue to be one of the fundamental challenges for the international community in the coming years. However, it is not the only essential issue for HIV-affected communities. Stigma and discrimination experienced by HIV-affected individuals and families highlight the need in many countries for more effective anti-discrimination laws and better enforcement mechanisms in order to protect those individuals affected by HIV/AIDS. Similarly, the plight of the millions of children orphaned as a result of AIDS calls for improvements in legal measures to protect children from various forms of discrimination and exploitation. Today, such children are at risk of being deprived of access to schools and health care facilities and are vulnerable to abusive practices such as forced labor, prostitution and trafficking. In short, as HIV/AIDS affects almost every sector of society, it has implications for almost all areas of practice, from corporate and trade law to human rights and criminal law. Other areas of focus International health is by no means limited to combating diseases that can travel across international boundaries. Multilateral efforts are ongoing with respect to a host of other public health issues that may not cross borders but are of concern in all parts of the world. Stem cell research and mental health issues are just two such areas that have been the subject of international focus. International efforts related to stem cell research reached a milestone on March 23, with the United Nations’ adoption of the U.N. Declaration on Human Cloning. U.N. GAOR, 59th Sess., A/Res/59/280 (2005). The U.S.-backed resolution calls on countries to prohibit reproductive cloning, adopt measures to protect human life in the application of life sciences and “prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life.” Although the Declaration is not legally binding and leaves some issues unsettled (notably, some governments have questioned whether the language of the declaration still permits therapeutic cloning), it represents a significant step in the direction of a uniform standard. Meanwhile, stem cell research continues to evolve rapidly, as evidenced by the announcement in May that scientists in South Korea had created 11 stem cell lines that are genetically matched to specific individuals and potentially could be developed to replace failing tissues in those patients. Global developments such as this breakthrough will require U.S. lawmakers and research institutions to continue to be engaged in international efforts to legislate and monitor stem cell research. While ethical issues surrounding stem cell research have garnered much attention, mental health issues have often been overlooked. Earlier this year, however, European WHO member states adopted a Mental Health Declaration and Action Plan for Europe, available at www.euro.who.int/mentalhealth2005. In doing so, European governments committed to raising awareness about mental health issues, tackling stigma and discrimination, reducing the incidence of mental health problems and suicide, and developing comprehensive mental health systems that cover promotion, prevention, treatment and rehabilitation, care and recovery. These efforts demonstrate that even as globalization makes it easier for disease to spread quickly across international borders, it provides greater opportunities for collaboration on health care issues of mutual concern. Infectious disease outbreaks, tobacco-related illness, the impact of HIV/AIDS, stem cell research and mental health are just a handful of the many issues in international health today that command attention. Their effects are felt well beyond the health world and require coordinated responses that address the health, social, economic and legal needs of affected communities. Each of these issues also highlights the fact that there is a role for the legal profession in international health, and it is essential that attorneys meet that need. Jonathan Todres is chair of the International Health Law Committee of the American Bar Association Section of International Law and an acting assistant professor at New York University School of Law.

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