Ethical, professional and legal regulation of medical practice

Moral or ethical codes of practice represent one of the oldest forms of medical regulation. Legislation such as the Medical Practice Act 1992 (NSW) enables regulatory bodies to create codes of practice for medical practitioners. Such codes can become an important aspect of disciplinary proceedings by providing the yardstick against which practitioners' conduct is evaluated. An important aspect of the New South Wales Board's Code of Professional Conduct 2005 is the obligation for doctors to report adverse events which reflect on the performance or conduct of colleagues. This is part of an increasing impetus to report adverse events in the interest of public safety. In the long- term this is a constructive development as it is likely to lead to improvements in identification of risks and hazards and thereby to result in better service provision and community health.     

Competition policy: consequences of restrictive trade practices and price-fixing provisions for medical practitioners in Australia and New Zealand

Competition laws have only applied to many participants in the health care industry in Australia and New Zealand since the mid 1990s. Since then, the Australian Competition and Consumer Commission has considered a number of applications by medical practitioner associations and private hospitals to authorise potentially anti-competitive conduct, while the New Zealand Commerce Commission has successfully prosecuted a group of ophthalmologists. Amongst medical practitioners, however, there is still confusion and misunderstanding concerning the type of conduct caught by the Australian Trade Practices Act 1974 (Cth) and the New Zealand Commerce Act 1986 (NZ). This is of serious concern given the substantial penalties associated with price-fixing and restrictive trade practices. This article examines the provisions of these Acts most relevant to medical practitioners as well as a number of determinations and judicial decisions. To provide practical assistance to medical practitioners, the key lessons are extracted.     

Medical professionals convicted of accessing child pornography--presumptive lifetime prohibition on paediatric practice? Health Care Complaints Commission v Wingate

Health Care Complaints Commission v Wingate [2007] NSWCA 326 concerns an appeal from the New South Wales Medical Tribunal regarding its findings on professional misconduct outside the practice of medicine in relation to a doctor convicted of possessing child pornography. The latest in a number of cases on this issue in Australia, it highlights the complexity of such decisions before medical tribunals and boards, as well as the diversity of approaches taken. Considering both this case and the recent Medical Practitioners Board of Victoria case of Re Stephanopoulos [2006] MPBV 12, this column argues that Australian tribunals and medical boards may not yet have achieved the right balance here in terms of protecting public safety and the reputation of the profession as a whole. It makes the case for a position statement from Australian professional bodies to create a presumption of a lifetime prohibition on paediatric practice after a medical professional has been convicted of accessing child pornography.     

Invisible hand or fatherly hand? Problems of paternalism in the New Perspective on health

This article examines the charge that the "New Perspective" on health (as exemplified by the Lalonde Report in Canada, by Prevention and Health in the United Kingdom) represents an abandonment of liberal principles in favor of a collectivist and paternalistic role for the state. It looks first at the problems confronting modern health policy, and at the reasoning behind the New Perspective's approach. It then explores whether and how the charge of paternalism applies to that approach, and just what such a charge implies. The article concludes with a discussion of the "liberal paternalist" viewpoint towards health policy, a viewpoint that combines respect for individual liberty with an interest in taking effective public action to improve the health status of modern populations.     

The Legal Regulation of Medical Science

Recent developments in reproductive technology have stimulated widespread public debate and controversy, especially regarding the social, ethical, moral, and legal implications of in vitro fertilization and human embryo experimentation. These issues have received a great deal of public attention in Australia over the past two decades. Some jurisdictions have implemented legislation to regulate and prohibit aspects of medical science. This discussion examines the emergence and career of the Infertility (Medical Procedures) Act 1984 in Australia and its regulation of embryo experimentation. The central argument is that law neither simply reacts to scientific developments nor merely reflects alleged community values, but actively constitutes and defines the boundaries of medical science. This fluidity or flexibility provides medical scientists with opportunities to make claims for the legitimate right to undertake certain experiments free from the interference of nonscientists. The controversy surrounding embryo experimentation highlights the ambiguities in distinguishing the proper sphere of science from ethical and legal jurisdictions.     

Back to the future? Diabetes, HIV, and the boundaries of public health

The control of infectious diseases has traditionally fallen to public health and the clinical care of chronic diseases to private medicine. In New York City, however, the Department of Health and Mental Hygiene (DOHMH) has recently sought to expand its responsibilities in the oversight and management of chronic-disease care. In December 2005, in an effort to control epidemic rates of diabetes, the DOHMH began implementing a bold new plan for increased disease surveillance through electronic, laboratory-based reporting of A1C test results (a robust measure of blood-sugar levels). The controversy A1C reporting produced was relatively contained, but when Dr. Thomas Frieden, New York City health commissioner, called for the state to begin tracking viral loads and drug resistance among patients with HIV, both the medical community and a wider public took notice and have started to grapple with the meaning of expanded surveillance. In the context of the past century of medical surveillance in America, we analyze the current debates, focusing first on diabetes and then HIV. We identify the points of contention that arise from the city's proposed blend of public health surveillance, disease management, and quality improvement and suggest an approach to balancing the measures' perils and promises.     

Public‐Private Arbitration and the Public Interest under English Law

Together with the increase in the number of public‐private contracts, recent years have seen a marked proliferation in public‐private arbitrations. This article explores the public interest implications which may arise in such arbitrations and examines how public‐private arbitration is treated under English law. We argue that, due to the lack of a developed administrative law sphere in England and the historical development of arbitration as an exclusively private mode of dispute resolution, the current legal framework of arbitration in England has developed around the private law paradigm of a commercial dispute involving private actors. This private law paradigm results in a conceptual and legal void in respect of how public interest is accounted for, and protected, in arbitrations involving public bodies under English law. Therefore, we suggest that English arbitration law needs to be amended to adequately protect the private interest in public‐private arbitration.     

This Time,it's for Real: The Health and Social Care Act 2012

This article examines the Health and Social Care Act 2012 and associated reforms to the National Health Service in England. It focuses on the Act's policy of making the NHS market more ‘real’, by both encouraging and compelling NHS bodies to act as ‘market players’. The article considers whether the reforms are compatible with the constitutional requirements of accountability for the provision of a public service such as the NHS. It argues that the reforms threaten accountability for three reasons: they make the Secretary of State for Health's relationship with the NHS more complex, they create opaque networks of non‐statutory bodies which may influence NHS decision‐making, and (especially in relation to competition) they ‘juridify’ policy choices as matters of law. Taken together, these arguments suggest that there is force in the claim that the reforms will contribute to ‘creeping’ – and thus unaccountable – privatisation of the NHS.     

Transforming Public Health Law: The Turning Point Model State Public Health Act

Law is an essential tool for improving public health infrastructure and outcomes; however, existing state statutory public health laws may be insufficient. Built over decades in response to various diseases/conditions, public health laws are antiquated, divergent, and confusing. The Turning Point Public Health Statute Modernization National Collaborative addressed the need for public health law reform by producing a comprehensive model state act. The Act provides scientifically, ethically, and legally sound provisions on public health infrastructure, powers, duties, and practice. This article examines (1) how statutory law can be a tool for improving the public's health, (2) existing needs for public health law reform, (3) themes and provisions of the Turning Point Act, and (4) how it is being used by public health practitioners.     

Analysis of legal cases for prevention of elder abuse: decisions from New Zealand

Elder abuse is a universal concern and is gaining greater public and professional attention. This increased concern to protect elders is internationally evident in policy reform, multidisciplinary research and education. Yet neglect in care settings continues. This research responds by contributing to the international effort to promote humane care for elders who are in a position of dependence, particularly in residential facilities. The legal cases that result from some complaints by aggrieved elders and their advocates may offer insights that are relevant for prevention. While the law is often viewed merely as a system of control, it may also be a resource for learning, particularly in the context of abuse prevention. Although the analysis references New Zealand law, the discussion may have broader application by indicating factors that precede, or trigger, unacceptable conduct. By understanding what went wrong and why, we may decrease the likelihood of future incidents. Also, understanding the legal ramifications may have a deterrent effect. Many advocates and activists have asked how we can ensure that abuses do not recur; some answers may lie within the legal cases themselves. How may recent legal cases be used to prevent mistreatment of elders in residential facilities? This question is applied to select decisions of New Zealand's Health and Disability Commissioner, Human Rights Review Tribunal and Health Practitioners Disciplinary Tribunal. While each body has distinct functions, relevant factors identified within the cases may reveal information that is of interest to elderly people and their advocates, caregivers, health educators and professional registration bodies. The research is timely in light of New Zealand's Review of Elder Abuse and Neglect Prevention Services in New Zealand (Department of Child Youth and Family Services, 2004) and New Zealand's Positive Ageing Strategy (Office of Senior Citizens, 2001). This article incorporates current debates regarding the use and analysis of legal cases and suggests that such analyses offer learning opportunities.     

Judicial responses to the protected confidential communications legislation in Australia

The article examines the background, aims and scope of recent legislation enacted in New South Wales, Victoria and South Australia to protect from disclosure in court of "confidential communications" generated in the context of counselling persons who allege that they were victims of sexual offenses. In drafting the "confidential communications" legislation, the legislators undertook a difficult task of balancing the public interest in therapeutic confidentiality that would encourage victims of sexual assaults to report these offenses and seek psychological and psychiatric care on the one hand, and the public interest in fairness of the trial, which may be prejudiced by exclusion of evidence pertinent to the forensic process on the other. In South Australia this task was fulfilled with greater success than in New South Wales and Victoria.     

Culling bad apples, blowing whistles and the Health Practitioners Competence Assurance Act 2003 (NZ)

The Health Practitioners Competence Assurance Act 2003 (NZ) became New Zealand law on 18 September 2003. This article looks at the background to the Act and reasons for resistance to it. It discusses the record so far on the medical profession's self-regulation of fitness-to-practise issues and the legal duties of practitioners who have reason to believe a colleague is putting patients at risk. It looks at some of the changes the Act brings, compares the experience of English and American medico-legal reforms, where applicable, and attempts to draw some conclusions on the chances for successful change.     

我国食品安全风险评估科学顾问的合法性危机及其克服

我国食品安全风险评估科学顾问的合法性危机既体现在"作为行为"中,也体现在"不作为行为"中,突出表现为社会对其作出的风险评估结论持不信任态度。原因在于:科学顾问缺乏科学上的卓越性和独立性及其活动缺乏透明性。需要设计公正和科学的科学顾问成员的遴选制度、广泛和有效地支撑其开展风险评估工作的网络体系、精密和完整的利益声明规则、合理和全面的食品安全风险评估活动的公开等制度来有效克服科学顾问的合法性危机。     

Private Power, Public Interest: An Examination of Search Engine Accountability

As information becomes a critical commodity in modern society,the issue is raised whether the entities that manage accessto information, that are tools for public discourse and democracy,should be accountable to the public. The Internet has transformedhow we communicate, and search engines have emerged as managersof information, organizing and categorizing content in a coherent,accessible manner thereby shaping the Internet user's experience.This article examines whether search engines should have publicinterest obligations. In order to answer this question, thisarticle first examines comparative public interest regulatorystructures, and the growing importance of the Internet to publicdiscourse. Then examined is how the algorithmic designs andmanual manipulation of rankings by search engines affects thepublic interest without a sufficient accountability structure.Finally, the values necessary to a public interest frameworkare suggested.     

Internet domain names and the interaction with intellectual property

This is the fourth in a series of articles looking at the interaction between Internet domain names and intellectual property. It outlines the ICANN dispute resolution procedure for gTLDs whereby objectionable domain names can be transferred away from their registrants or cancelled. It also compares this to legal proceedings in the UK Courts and outlines a referral to the European Court of Justice on issues relating to a trade mark registration as the basis or legitimate interest for a .eu domain name registration.     

Recent developments in German health law

Health law provides the regulatory constitution for the medical and healthcare system. It covers individual medical treatment as well as public healthcare provision and is insofar medical law as well as social security law (statutory health insurance law). The medical and health sciences (public health sciences) are the main complementary disciplines of health law. This article gives an account of some representative developments in both fields which have taken place in the last three years.     

精神障碍医学鉴定制度设计及相关问题探究

《精神卫生法》对于精神病人合法权益的保障、社会安全防卫作用的实现具有重要意义,其不仅能为精神病患者和监护人提供非自愿住院治疗的救济渠道,在一定程度上避免“被精神病”现象的发生,同时能够保障社会公共秩序和社会公众人身安全.在对精神障碍医学鉴定的制度设计及作用进行分析的基础之上,正确辨析精神障碍医学鉴定的实施主体以及管理模式、并对精神障碍医学鉴定的实施主体、要求、委托主体等有关内容进行阐述,以期为精神障碍医学鉴定制度的良性运行提供保障.     

Medical device review at the Food and Drug Administration: lessons from magnetic resonance spectroscopy and biliary lithotripsy

Medical devices marketed in the United States must satisfy FDA standards of safety and effectiveness. Many observers have criticized the FDA medical device review process as both time consuming and unpredictable. In this note, Lawrence Makow examines the Agency's treatment of two novel medical technologies, magnetic resonance spectroscopy and biliary extracorporeal shockwave lithotripsy. He concludes that the outcomes of these cases exemplify the mismatch between clinical utility and FDA approval status that has prompted concerns about lack of predictability. Mr. Makow asserts that this mismatch results from the FDA's implementation of the medical device statute rather than from the statute itself. He proposes an asymmetric standard for evaluating the safety and efficacy of new medical devices. While the safety showing would always require a high burden of proof, the efficacy standard would vary depending on the relationship between the device's safety and efficacy. Under this asymmetric standard, the FDA could better manage its workload and achieve more predictable results without sacrificing the public interest in avoiding injury from unproven medical devices.     

婚生否认之诉原告资格的立法完善和规范适用

对于婚生否认之诉的原告,目前我国法采取了明确列举的方式,所规定的原告范围较窄。当其他可能的原告起诉时,法院或严格适用法律规范,或扩大原告范围,产生了矛盾裁判。立法应当对能够成立诉权并启动司法审判的适格原告作出周全选择和判断。基于身份权的专属性及国家意欲保护的权利和价值,亲子关系的主体,即父母、子女均有婚生否认之诉原告资格;生父仅在婚生亲子关系不利于子女最佳利益或损害公共利益时,才附条件地具有婚生否认之诉原告资格;父死亡后的继承人因无专属身份关系以及身份公益优位于财产私益的法理,不具有婚生否认之诉原告资格。在立法作出周全选择后,司法实践应当准确把握婚生否认之诉属于形成之诉的本质及立法的文义和目的,遵循形成之诉原告的法定性和封闭性,不得扩大原告范围。