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This paper examines a patient with borderline mental capacity, where the healthcare team is conflicted about how to proceed. This case demonstrates the complicated intersection between undue influence and mental capacity, allowing us to explore how the law is applied in clinical practice. Patients have the right to decline or accept medical treatments offered to them. In Singapore, family members perceive a right to be involved in the decision-making process for sick and elderly patients. Elderly patients, dependent on mainly family members for care and support, sometimes submit to their overbearing influence resulting in decisions that fail to protect the patients’ own best interests. However, the clinicians’ own well-intentioned influence, driven by a desire for the best medical outcome can also be undue, and neither influence should seek to be a substitution for the patient’s decision. Following Re BKR [2015] SGCA 26, we are now obliged to examine how mental capacity can be affected by undue influence. A lack of capacity can be found when a patient fails to appreciate the presence of undue influence or is susceptible to undue influence due to their mental impairment causing their will to be overborne. This then paves the way for the health care team to decide based on best interests, because the patient is determined to be lacking in mental capacity.

This article assesses the regulatory framework relating to over-the-counter (OTC) sales of antibiotics for human use in India. The OTC sale of antibiotics is recognised as a pathway for the emergence of antimicrobial resistance (AMR); a serious public health challenge in need of urgent regulatory responses. Analytically, this article identifies opportunities within existing laws in India and highlights gaps that need to be filled by modifying existing laws or developing new ones. Conceptually, it suggests a need to reflect on the limits of traditional, top-down, ‘command-and control’ regulation and to think about alternative approaches. The article therefore advocates for an approach to regulation that incorporates two elements. First, it argues for a broader concept of regulation that encompasses binding as well as non-binding regulatory instruments and initiatives aimed at influencing stakeholder behaviour (including soft regulation, economic incentives, information campaigns and uses of technology). Second, it makes the case for enhanced stakeholder participation in regulatory design. The article will be relevant for health policy and drug regulators in India and other low- and middle-income countries, as well as legal scholars, social scientists and others interested in the regulation of OTC sales of antibiotics for AMR containment.

This chapter provides an overview of the current legal and policy landscape governing genetic testing in the context of insurance and employment in the UK. It focuses on the characteristic features of the UK regulatory regime, namely the decision to avoid including “genetic characteristics” within the general anti-discrimination legislation, and instead to regulate the use of genetic test results by insurers and employers through soft law guidance documents. Other relevant guidance documents and statutes are also considered. The overall adequacy of the UK regime, and the degree to which it satisfactorily reconciles the divergent interests of the various stakeholders, are examined critically.

This chapter reviews the evidence about the scale and significance of clinical trials in India. After describing some of the new social forms that service these trials it assesses the growth in their number from 2005 to 2012 and the reasons for—and implications of—a decline since then. The main argument is that the nascent Indian clinical trials industry rapidly adjusted to the opportunities provided by reforms, linked to India’s accession to the TRIPs agreement and the World Trade Organization in 2005. By contrast, Indian regulators were slow to come to terms with the challenges of responding to well-co-ordinated trial sponsors and contract research organizations.

Providing an apology which contains a factual explanation following a medical adverse incident may facilitate an amicable settlement and improve patient experience. Numerous apology laws exist with the aim of encouraging an apology but the lack of explicit and specific protection for factual admissions included in “full” apologies can give rise to legal disputes and deter their use. The new Hong Kong Apology Ordinance expressly prohibits the admission of a statement of fact in an apology as evidence of fault in a wide range of applicable proceedings and thus provides the clearest and most comprehensive apology protection to date. This should significantly encourage open medical disclosure and the provision of an apology when things go wrong. This paper examines the significance and implication of the Apology Ordinance in the medico-legal context.

Acute stroke care has undergone momentous changes in recent years with the introduction of intravenous thrombolysis, mechanical thrombectomy and integrated stroke services. While these are welcome developments, they also carry unique medico-legal challenges. In 2015, a patient from Greater Manchester was awarded over £1 million in compensation after ambulance paramedics failed to admit her to a specialist unit. This paper explores the medico-legal implications of this first but over looked thrombolysis-related claim in the United Kingdom. It is submitted that the highly time-dependent and multidisciplinary nature of acute stroke care may expose a host of healthcare personnel, both medical and non-medical, to risks of legal pursuit for failing to provide appropriate care, and that available scientific evidence will likely support such claims. The situation calls for an urgent and concerted effort at implementing improvement measures at national levels. A reminder of the legal consequences of substandard acute stroke care is timely and necessary.

The Medical Innovation Bill continues its journey through Parliament. On 23 January 2015, it was debated for the final time in the House of Lords and with one final amendment, the House moved to support the Bill, which then moved to the House of Commons on 26 January. It will be debated again on 27 February 2015. The Bill’s purpose is to encourage responsible innovation in medical treatment. Although this goal is laudable, it is argued that the Bill is unnecessary and has the potential to undermine the very cause it aims to advance. More useful for encouraging responsible innovation is the continued education of health-care professionals on how the law already supports practitioners who look to improve care through responsible innovation.

The paper considers the role of Scottish culture and history, real or imagined, in the commercialisation of iconic Scottish creations such as tartan and Scotch whisky. It notes that many of the forms of legal protection available to the producers of such products were developed to encourage individual innovation, not designed to address communal interests in the preservation of national or group identities and heritage. This may be one reason why, as is illustrated by the case of tartan, these rights offer patchy and incomplete protection to ‘authentic’ Scottish products. Over time, however, the UK has developed various forms of collective protection for cultural products such as Harris Tweed, the effectiveness of which is explored in this article. The final part of the paper considers the importance, in a globalising world, of European Union and international protection for valuable cultural ‘products’. But protection, whether at the national or international level, necessitates a difficult balance to be drawn between the interest in cultural innovation and development, on the one hand, and cultural preservation and the protection of the commercial interests of specific communities, on the other. The article concludes by exploring some of the practical and conceptual challenges associated with determining whether a product should be considered part of the cultural patrimony of the world or, rather, the property of a specific nation or cultural group. ‘…cultural diversity is strengthened by the free flow of ideas, and…is nurtured by constant exchanges and interaction between cultures…’ (Preamble to the 2005 UNESCO Convention on the Protection and Promotion of the Diversity of Cultural Expressions)

The relationship between the ethical standards for the governance of clinical trials and market forces can be complex and problematc. This article uses India as a case study to explore this nexus. From the mid-2000s, India became a popular destination for foreign-sponsored clinical trials. The Indian government had sought to both attract clinical trials and ensure these would be run in line with internationally accepted ethical norms. Reports of controversial medical research, however, triggered debate about the robustness and suitability of India’s regulatory system. In response to civil society pressure and interventions by the Supreme Court, the Indian government proposed additional measures aimed at strengthening protections for clinical trial participants. Whilst the reforms can be seen as a victory for human rights activists, they have also been criticised as being overly burdensome for sponsors. Indeed, their announcement prompted an exodus of clinical trials from India. Fearful of losing business to ‘rival’ countries, the Indian government is revisiting some of its proposals. The Indian example suggests that research ethics frameworks and national policies for economic development are increasingly intertwined. Host countries are in theory free to improve the lot of research participants, but doing so may make them appear less attractive to foreign sponsors, who can simply shift their activities to more industry-friendly jurisdictions. Although these economic pressures are unlikely to lead to a regulatory ‘race to the bottom’, they may limit host countries’ ability to enact socially desirable reforms.

Doctors are often unsure about whether apologising to patients will leave them open to legal consequences. Among the many implications of the Bawa-Garba case, the idea that even a doctor’s written reflections in their portfolio could later be used against the doctor in court has raised concerns in the medical community. This uncertainty could affect doctors’ willingness to disclose mistakes and to give patients the apologies they deserve.The situation is complicated by the fact that the statutory duties of candour in England and Wales and in Scotland, now require health service organisations and practitioners to give a factual explanation and to apologise to the affected parties after a notifiable incident. Although it is widely thought that existing apology laws in Great Britain would confer sufficient protection, a closer look at the complex matter of apology protection indicates that the situation is far from straightforward. This paper examines some of the legal issues of apologies and their implications for healthcare professionals.

Section 14(4) of the Human Fertilisation and Embryology Act 2008 imposes – within the general licensing conditions listed in the Human Fertilisation and Embryology Act 1990 – a prohibition to prevent the selection and implantation of embryos for the purpose of creating a child who will be born with a “serious disability.” This article offers a perspective that demonstrates the problematic nature of the consultation, review, and legislative reform process surrounding s 14(4). The term “serious disability” is not defined within the legislation, but we highlight the fact that s 14(4) was passed with the case of selecting deaf children in mind. We consider some of the literature on the topic of disability and deafness, which, we think, casts some doubt on the view that deafness is a “serious disability.” The main position we advance is that the lack of serious engagement with alternative viewpoints during the legislative process was unsatisfactory. We argue that the contested nature of deafness necessitates a...

Applicants in Europe are left with few options for the patent protection of hES cell-related technology.

In recent years, a new tobacco ‘endgame’ has been proposed: the denial of tobacco sale to any citizen born after a certain year, thus creating new tobacco-free generations. The proposal would not directly affect current smokers, but would impose a restriction on potential future generations of smokers. This paper examines some key legal and ethical issues raised by this proposal, critically assessing how an obligation to protect human rights might limit or support a state's ability to phase out tobacco.

Autologous adult stem cells (ASCs) are increasingly being administered to patients with limited evidence from clinical trials that they are safe and effective. The marketing of autologous ASCs predominantly over the Internet by companies based in low-to-middle income countries, such as the Bahamas, Mexico, India and China, is well documented.(1, 2) However, even in countries such as the United States, Japan, and Australia, physicians are prescribing autologous ASCs to patients outside the context of clinical trials. These doctors often form part of loose collaborative networks of clinicians, businesses, patients and researchers operating both domestically and across national boundaries. The emergence of these networks not only puts patients who seek out these interventions at risk: it threatens to undermine the very basis of ‘good medical practice’. funded by the Ministry of Education, Singapore, and the Humanities and Social Sciences (HSS) Division of the Office of the Deputy President (Research and Technology) at the National University of Singapore (NUS

Can a World Trade Organization (WTO) Member exclude an invention from patentability on the grounds of ordre public or morality whilst at the same time permitting the sale and distribution of the invention within its territory? This is a question raised by recent developments in Europe, where moral restrictions have been placed on the patentability of ‘uses of human embryos’, yet human embryonic stem cell (hESC) research, which involves the destruction of human embryos, is permitted and encouraged within numerous EU Member States, and indeed, also funded through the central EU science budget. This chapter assesses whether such an incoherent regulatory landscape would survive WTO scrutiny. The chapter argues that in general, if a WTO Member has not attempted to ban the commercial exploitation of a certain invention within its borders, measures prohibiting the patenting of that invention on moral grounds would likely be viewed as constituting an unjustified restriction on international trade. More concretely, it is suggested that the WTO Member would be found to be in violation of its obligation under the TRIPS Agreement to make patents available without ‘discrimination’ as to the field of technology.

Autologous adult stem cells (ASCs) are being administered by physicians for indications that have not been demonstrated as safe and effective in formal clinical trials. Examination of regulatory frameworks across five countries suggests that balancing the demands of research with clinical freedom has created structural weaknesses that are being exploited. funded by the Ministry of Education, Singapore, and the Humanities and Social Sciences (HSS) Division of the Office of the Deputy President (Research and Technology) at the National University of Singapore (NUS).

This textbook has provided a framework for exploring medical law and ethics for more than 35 years. It provides extensive examination of the interrelationship between ethical medical practice and the law. The authors offer their own opinions on current debates and controversies, and encourage readers to formulate their own views and arguments. Medical law is significantly shaped by the courts, and this book provides extensive coverage of recent judicial decisions as well as statutory developments. This eleventh edition continues to take a comparative approach, as in the case of assisted suicide, and also on the growing influence of international instruments and collaborations, as demonstrated in the field of health research. Despite the prospect of Brexit, the book continues to offer a dedicated and in-depth chapter on the influence of EU law on the field. The book is essential reading for any serious medical law student or practitioner, as well as being of interest to all those involved in the delivery and regulation of modern health care. New or updated material includes: a new chapter bringing together the range of ethico-legal issues affecting children, including minors and consent, data protection and research with children; detailed discussion of the high-profile court decisions involving Charlie Gard and Alfie Evans regarding medically futile treatment of infants; consideration of the Supreme Court ruling in Darnley v Croydon Health Services and the implications for A&E departments and their duty of care to patients; discussion of updated GMC guidance on Confidentiality (2017); fully updated discussion of the case law and changes in regulation of international surrogacy; and consideration throughout of the of the General Data Protection Regulation, which came in May 2018.