Testing for AIDS: uses and abuses

In response to the public outcry for mandatory testing for AIDS, this Article explores the major issues concerning the identification of persons with AIDS in society. The Article first studies testing procedures and the purposes behind them to determine if a call for mandatory testing of the general populace would better achieve society's objectives for identifying individuals with AIDS. Concluding that testing should not be required of the population as a whole, the Article then explores whether testing should be required of certain subpopulations which society perceives as likely to have or to spread the disease. In this context, too, the Article concludes that mandatory testing would be unwarranted, and that funds proposed for mandatory testing would be put to better use in education and universal precautions to prevent the further spread of AIDS.     

重大突发公共卫生危机下的药品专利强制许可——现实需要、伦理因应与法律安排

新型冠状病毒肺炎于2019年底在我国爆发并迅速扩散,引发了全国性的重大突发公共卫生危机。为实现特效专利药品的充分供给,实施药品专利强制许可是最为高效的选择,不仅可以消解药品专利市场运营中所固有的“反公有地”悲剧,同时也可以有效规避药品专利国际合作中技术劫持与贸易倾轧。对于以人为本的主体性原则和与人为善的有益性原则两项伦理准则的遵循,保证了药品专利强制许可实施的伦理正义;而对于药品专利强制许可申请主体扩展和药品专利强制许可补偿标准细化两项法律完善举措的采取,则使我国药品专利强制许可机制克服了自身缺陷,能够在实践中有序运行,为重大突发公共卫生危机的化解提供制度支撑。     

Barcelona 2002: law, ethics, and human rights. Juggling individual and collective concerns with respect to HIV/AIDS policies

Efforts to prevent the spread of HIV infection sometimes give rise to tensions between individual and collective rights. This article, based on a presentation by Nelson Varas-Díaz (abstract TuOrG1171), explores these tensions in the context of the laws and policies of eight Latin American countries: Costa Rica, Dominican Republic, Ecuador, Guatemala, Honduras, Nicaragua, Panama, and Puerto Rico. The article describes five elements of the response to HIV/AIDS in which tensions between individual and collective rights have surfaced: the participation of people living with HIV/AIDS on national commissions; the ability of HIV-positive persons to access antiretroviral medications; HIV-antibody testing practices; the confidentiality of health information; and the rights and duties of people living with HIV/AIDS. The article concludes that the success of programs designed to prevent the spread of HIV infection depends on the ability of societies and governments to balance the tensions between individual and collective rights.     

The medical review officer: a potential role for the medical examiner

Drug use in the workplace is a problem, both in terms of public health and expense. Workplace drug testing programs serve as deterrents to drug use. Model programs, such as that of the Department of Transportation, use urine screening and are federally regulated or follow federal standards. An essential participant in this process is the medical review officer (MRO), a licensed physician who interprets the laboratory results generated from a workplace drug testing program. As a result of their training and experience with toxicology, collection of evidence, testimony, and recognition of the physical signs of drug abuse, medical examiners and forensic pathologists are well suited to serve as MROs. Recent regulations require the completion of training courses and MRO certification as prerequisites for participation in federal drug testing programs. Several courses are available to train physicians to participate as MROs.     

Communicable disease and mental health: restrictions of the person

Laws for the protection of public health control either the environment, as in the case of sanitation or air pollution regulations, or human conduct. This Article deals with limitations imposed upon individuals in order to prevent the spread of communicable disease and the harm resulting from mental illness. The restraints discussed include compulsory examination and immunization, and forms of compulsory detention or commitment. This Article is a revised chapter of the author's Public Health Law Manual, first published by the American Public Health Association in 1965. The Manual is intended to help public health professionals to understand the law relevant to their practice, and to apply it more effectively.     

Legal rights and communicable disease: AIDS, the police power, and individual liberty

The policy debate over AIDS has focused on how to balance the rights of individuals who have the disease against the rights of the public. This paper examines the nature of both sets of rights by analyzing the development of public health law and its dominant visions today. The article argues that while once public health rights implied a vast reserve of community authority and obligation to prevent illness, today the rights of the public and those of individuals are seen as being in opposition. Public health jurisprudence now presupposes that illness is primarily a matter of individual concern. In this view, the science of medicine mediates the relationship between the individual and the public. This understanding of rights protects some of the interests of infected individuals, but is inadequate for addressing many of the major problems raised by the AIDS epidemic, particularly the spread of infection among the uninfected.     

Newborn screening in the genomics era

Newborn screening (NBS) exists in every state for the purpose of testing newborns for genetic medical conditions that can be severe, may be treatable, and are often not clinically evident at birth. While almost all of the diseases screened for in newborns have underlying genetic causes, NBS in its current form is performed not by testing for genetic mutations, but by testing for biochemical markers that indicate a disorder. The potential use of whole-genome newborn screening (WG-NBS) as an alternative to the current biochemical testing utilized for NBS would dramatically expand the quantity and types of information parents could learn from screening and is likely to have many implications, both positive and negative. As whole-genome sequencing (WGS) becomes more economical, it probably will be used for the purposes of NBS. However, such an expansion of NBS would contradict many of the principles that have historically guided public health screening programs and, if implemented without sufficient preparation, could result in insufficient infrastructure to accommodate the health care and data management needs that would arise. This article will first look at the past and present of NBS, then the rise of whole genome sequencing, before considering the challenges of WG-NBS, and will end with some thoughts on the path forward.     

The AIDS epidemic and gay bathhouses: a constitutional analysis

Some legal scholars propose that the right of privacy articulated by the United States Supreme Court should be extended to protect homosexual activity. In light of the advent of AIDS, should that extension include constitutional protection for homosexual men who frequent gay bathhouses? The author argues that although the government has the power to close the baths in the name of public health, it should not do so without careful and conscious balancing against the privacy rights infringed upon by its actions. Balancing the tension between public health policy and individual rights applies not only to the specific situation of the baths, but also to insurance companies' aim to test all single, young, male life and health policy applicants for exposure to the putative AIDS virus; to potential health department releases of names of those testing antibody-positive for HTLV-III; to the military's rumored plans to discharge all personnel suspected of having AIDS; and to school districts seeking to exclude children with AIDS.     

An ethical analysis of the mandatory exclusion of immigrants who test HIV-positive

On 20 September 2000, Canadian newspapers reported that Health Canada recommended to Citizenship and Immigration Canada (CIC) that testing all prospective immigrants for HIV, and excluding those testing positive, constitutes "the lowest health risk course of action." Subsequently, the Minister of Citizenship and Immigration stated that CIC is indeed considering implementing mandatory HIV testing for all prospective immigrants to Canada, and excluding all those testing positive (with the exception of refugees and family-class sponsored immigrants) from immigrating to Canada on both public health and "excessive cost" grounds. This proposal was met with vehement opposition from a broad range of organizations and individuals. In particular, they pointed out that, as stated in the International Guidelines on HIV/AIDS and Human Rights (UNHCHR/UNAIDS, 1998: para 105), "[t]here is no public health rationale for restricting liberty of movement or choice of residence on the ground of HIV status." At the time of going to print, no final decision had been made about whether mandatory HIV testing for all immigrants would be implemented. There are sound ethical, legal, and public policy arguments against imposing mandatory testing and excluding those who test HIV-positive.     

Medicare and Medicaid programs; hospital standard for potentially HIV infectious blood and blood products--HCFA. Final rule

This final rule requires hospitals participating in the Medicare and Medicaid programs to take appropriate action when the hospitals learn that they have received whole blood, blood components (including recovered plasma), source plasma, and source leukocytes (hereafter referred to as blood or blood products) that are at increased risk of transmitting Human Immunodeficiency Virus (HIV) infection. If the hospital learns that it has received blood or blood products collected from a donor recently exposed to HIV, before the donor has a sufficient level of antibody to be detected by the screening test for antibody to HIV, the hospital must quarantine any blood or blood products remaining in inventory pending confirmation testing. If the presence of HIV is confirmed by more specific testing, the hospital must notify patients who received the blood or blood product. This final rule is intended to ensure that proper health and safety steps are taken to minimize further spread of HIV infection. A final rule published elsewhere in this Federal Register by the Food and Drug Administration applies the same requirements to entities furnishing transfusion services that do not participate in the Medicare and Medicaid programs and clarifies the responsibilities of blood establishments to identify and notify the transfusion service that received affected blood and blood products.     

应对公共健康危机的药品专利强制许可实施困境与对策

药品专利强制许可作为一项应对公共健康危机的制度在国内外均得到了立法与政策体认.鉴于其所关涉利益关系的复杂性,这项制度从产生至今仍然争议不断.具体到这项制度的实施,其程序和效果存在更多不确定性.尽管当前一些国家已经通过实施强制许可以应对新冠肺炎疫情,但是围绕发展中国家能力不足、除了专利之外药品所涉其他知识产权许可的不确定性以及《与贸易有关的知识产权协定》第31条修正案的低援引率等方面仍然存在诸多争议.中国虽然建立了从立法到政策的专利强制许可规则体系,但是对于在公共健康危机背景下由政府部门决定实施的药品专利强制许可仍然缺乏更为明确细化的程序规定.我国需要在谦抑性、审慎性、灵活性的理念指引下,在切实保障专利权人权益的基础上完善药品专利强制许可的实施机制.     

论我国现行药品专利强制许可立法的不足与完善

面对艾滋病、SARS、禽流感等大规模传染性疾病对公共健康安全的威胁,世界贸易组织以及各国纷纷加强药品专利强制许可立法,当然,我国也不例外。但是,我国现行药品专利强制许可制度,仍然存在立法层次过多、颁发事由不明确、申请主体过窄等不足,在今后进一步完善相关立法时,应考虑在专利法中对药品专利强制许可做出专门的、完整的规定,并明确将公共健康利益需要作为颁发专利强制许可的事由,以及允许任何单位和个人成为药品专利强制许可的申请主体。     

Human tissue intended for transplantation--FDA. Interim rule; opportunity for public comment

The Food and Drug Administration (FDA) is issuing an interim rule to require certain infectious disease testing, donor screening, and recordkeeping to help prevent the transmission of AIDS and hepatitis through human tissue used in transplantation. The regulations are effective upon publication. FDA is taking this action in response to growing concerns that some human tissue products are being offered for transplantation use without even the minimum donor testing and screening needed to protect recipients against human immunodeficiency virus (HIV) infection and hepatitis infection. The new regulations require all facilities engaged in procurement, processing, storage, or distribution of human tissues intended for transplant to ensure that minimum required infectious disease testing has been performed and that records documenting such testing for each tissue are available for inspection by FDA. The regulations also provide authority for the agency to conduct inspections of such facilities and to detain, recall, or destroy tissue for which appropriate documentation is not available.     

Barcelona 2002: law, ethics, and human rights. The need for harm-reduction approaches in Eastern Europe and the former Soviet Union

In a region where HIV is spread primarily by injection drug use, harm-reduction strategies must be the mainstay of prevention efforts. In her plenary presentation to the XIV International Conference on AIDS on 9 July 2002, Kasia Malinowska-Sempruch asserts that if the world does not turn its attention to the emerging and exploding epidemic in Eastern Europe and the former Soviet Union, the region will suffer the same fate as Africa. The presentation explains that while their economies continue to struggle, the countries in the region have seen their public health systems crumble in the face of the twin health crises of injection drug use and HIV infection. The presentation demonstrates how current repressive laws and practices with respect to drug use serve only to fuel the epidemic. It describes harm-reduction approaches (such as needle exchanges and drug-treatment programs) and provides examples of how NGOs in the region have been attempting to implement such approaches, often with little or no support from governments. Finally, the presentation outlines other measures required to respond to the epidemic in the region, including ensuring that people infected with HIV can access care, treatment, and support services.     

Québec: an outbreak of HIV/AIDS-related stigma and discrimination

In the space of a few weeks in January 2004, actions by three different institutions in Québec combined to threaten the human rights of people living with HIV/AIDS, raise the spectre of mandatory HIV testing, and create unnecessary public fears about the spread of HIV infection. In response to what they called "the worst weeks in recent history for people living with HIV/AIDS in Québec," the Canadian HIV/AIDS Legal Network and COCQ-Sida (the Québec coalition of community-based organizations fighting AIDS) called for a province-wide campaign against HIV/AIDS-related stigma and discrimination. A victory was achieved when a Montréal catholic seminary announced that it had backed down from its initial proposal to mandatorily test all applicants for priesthood for HIV, but much more is needed to fight the rapid outbreak of mandatory-testing proposals.     

Genetic discrimination: the use of genetically based diagnostic and prognostic tests by employers and insurers

Genetic discrimination is detrimental to public health programs, as well as to society generally. Advances in genetic testing and screening, accelerated and prompted by the Human Genome Initiative, increase society's ability to detect and monitor chromosomal differences. These technologies and their resulting genomic data will enhance medical science, but may also encourage discrimination. Although few employers or insurers currently utilize genetic screening, testing or data, rising employee benefit costs and market forces create powerful incentives for usage. Current municipal, state and federal laws, including the Americans with Disabilities Act (ADA), may not sufficiently protect employees and insureds from genetic discrimination. While municipal and state protections should not be overlooked, the ADA's sweeping scope may currently provide the most comprehensive safeguard. Federal laws banning discrimination on the basis of race or sex might also successfully redress some forms of genetic discrimination. Genetic technologies' advent necessitates efforts to rectify state and federal statutory coverage gaps, strictly regulate employers and produce comprehensive guidelines regarding its use.     

Health care policy issues in the drug abuser treatment field

As we enter the 1990s drug abuse has once again become a major health concern, and for the first time the drug treatment field has had to address many of the policy, regulation, and planning issues resulting from cost inflation that have become commonplace in other parts of the health care field. To avoid serious errors and confusion, drug abuse health policies must recognize the very different needs of the public and private sectors. The public sector, where poor addicts receive drug treatment provided or purchased by the government, has long suffered from chronically inadequate funding. Although responses to several epidemics (heroin, crack, and AIDS) have produced periods of increased allocations for drug abuse treatment, more often than not long waiting lists at programs have rationed treatment to lower-income addicts seeking care. Low salary levels have limited the quality of public treatment services, and the absence of resources has hindered the development of programs that respond to new technical developments and drug abuse problems, such as the crack epidemic. Despite severe resource shortages, the public drug treatment system has sometimes used resources inefficiently, with little attention to appropriateness of admissions, lengths of stay, ambulatory treatment modalities, or varying levels of care. Public sector goals for the 1990s should include filling current shortages in drug treatment services, developing adequate long-term funding for treating addicts who lack third-party coverage, modernizing the treatment system, developing new patterns of practice that use existing resources more efficiently, and developing a plan for treating intravenous drug users infected with the AIDS virus. In the private sector, the advent of working- and middle-class demand for drug treatment in the 1970s and 1980s has produced a new drug treatment system that suffers from many of the policy problems common to the rest of health care. Drug abuse in the workplace has resulted in much wider coverage of substance abuse services by insurance companies and HMOs. The availability of third-party funds has spawned a for-profit chemical dependency treatment industry. The high cost of private residential treatment services has caused significant cost inflation. Cost-containment measures, which are a new phenomenon for this field and are inappropriate for the public sector, have led to the same confusion and debates that they have produced in other areas of health care.(ABSTRACT TRUNCATED AT 400 WORDS)     

HIV-related stigma and discrimination--the epidemic continues

This article is one of a series commissioned to mark the tenth anniversary of the Canadian HIV/AIDS Legal Network, discussing past developments and future directions in areas of policy and law related to HIV/AIDS. It looks at HIV-related stigma and discrimination. The article summarizes the present situation as described in reports from numerous countries throughout the world. It reviews the institutional, non-institutional, and structural dimensions of HIV-related discrimination. It also identifies some essential components of anti-discrimination efforts: legal protection; public, workplace, and health-care programs; community mobilization; and strategizing on the determinants of health.     

Managing AIDS in the workplace

Because of the AIDS epidemic and the protections afforded individuals with AIDS under the Americans with Disabilities Act (ADA), employers are well advised to ensure compliance under applicable law to reduce exposure to employee claims of discrimination and to efficiently manage workplace issues associated with AIDS. Employers should implement AIDS policies and programs designed to educate their workforce to reduce the spread of AIDS and to clear up any misunderstandings about the disease which could wreak havoc in the workplace. This article summarizes suggested action steps for employers and outside resources to consult for guidance.