The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK, from defining what counts as a medicine, through clinical trials, licensing, pharmacovigilance, marketing and funding. The question of global access to medicines is addressed because of its political importance, and because it offers a particularly stark illustration of the consequences of classifying medicines as a private rather than a public good. Two further specific challenges to the future of medicine's regulation are examined separately: first, pharmacogenetics, or the genetic targeting of medicines to subgroups of patients, and second, the possibility of using medicines to enhance well-being or performance, rather than treat disease. Throughout, the emphasis is on the role of regulation in shaping and influencing the operation of the medicines industry, an issue that is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.

click here for publisher's site

In this new addition to the Debating Law series, Emily Jackson and John Keown re-examine the legal and ethical parameters of the debate about euthanasia and assisted-dying. Emily Jackson argues that we owe it to everyone in society to do all that we can to ensure that they experience a 'good death'. For a small minority of patients who experience intolerable and unrelievable suffering, this may mean helping them to have an assisted death. In a liberal society, where people's moral views differ, we should not force individuals to experience deaths they find intolerable. This is not an argument in favour of dying. On the contrary, Jackson argues that legalisation could extend and enhance the lives of people whose present fear of the dying process causes them overwhelming distress. John Keown argues that voluntary euthanasia and physician-assisted suicide are gravely unethical and he defends their continued prohibition by law. He analyses the main arguments for relaxation of the law - including those which invoke the experience of jurisdictions which permit these practices - and finds them wanting. Relaxing the law would, he concludes, be both wrong in principle and dangerous in practice, not least for the dying, the disabled and the disadvantaged.

click here for publisher's site

Medical Law : Text, Cases, and Materials offers exactly what the title says - all of the explanation, commentary, and extracts from cases and key materials that students need to gain a thorough understanding of this complex topic. Key case extracts provide the legal context, facts, and background; extracts from materials, including from the most ground-breaking writers of today, provide differing ethical perspectives and outline current debates; and the author's insightful commentary ensures that readers understand the facts of the cases and can navigate the ethical landscape to form their own understanding of medical law.

click here for publisher's site

These essays explore the nature and limits of individual autonomy in law, policy and the work of regulatory agencies. Authors ask searching questions about the nature and scope of the regulation of 'private' lives, from intimacies, personal relationships and domestic lives to reproduction. They question the extent to which the law does, or should, protect individual autonomy. Recent rapid advances in the development of new technologies - particularly those concerned with human genetics and assisted reproduction - have generated new questions (practical, social, legal and ethical) about how far the state should intervene in individual decision making. Is there an inevitable tension between individual liberty and the common good? How might a workable balance between the public and the private be struck? How, indeed, should we think about 'autonomy'?

click here for publisher's site

Provides a clear and accessible analysis of the various ways in which human reproduction is regulated. A comprehensive exposition of the law relating to birth control, abortion, pregnancy, childbirth, surrogacy and assisted conception is accompanied by an exploration of some of the complex ethical dilemmas that emerge when one of the most intimate areas of human life is subjected to regulatory control. Throughout the book, two principal themes recur. First, particular emphasis is placed upon the special difficulties that arise in regulating new technological intervention in all aspects of the reproductive process. Second, the concept of reproductive autonomy is both interrogated and defended.  Winner of the 2002 Society of Legal Scholars’ Annual Prize for Outstanding Legal Scholarship by a Young Legal Scholar.

click here for publisher's site

This paper studies the preferences among healthcare workers towards pay schemes involving different levels of risk. It identifies which pay scheme individuals would prefer for themselves, and which they think is best in furthering health policy objectives. The paper adds, methodologically, a way of defining pay schemes that include different levels of risk. A questionnaire was mailed to a random sample of 1111 dentists. Respondents provided information about their current and preferred pay schemes, and indicated which pay scheme, in their opinion, would best further overall health policy objectives. A total of 504 dentists (45%) returned the questionnaire, and there was no indication of systematic non-response bias. All public dentists had a current pay scheme based on a fixed salary and the majority of individuals preferred a pay scheme with more income risk. Their preferred pay schemes coincided with the ones believed to further stabilise healthcare personnel. The predominant current pay scheme among private dentists was based solely on individual output, and the majority of respondents preferred this pay scheme. In addition, their preferred pay schemes coincided with the ones believed to further efficiency objectives. Both public and private dentists believed that pay schemes, furthering efficiency objectives, had to include more performance-related pay than the ones believed to further stability and quality objectives.

click here for full text via CUP [ON CAMPUS]
click here for full text via CUP [OFF CAMPUS]

Discusses the significance in terms of patient care of the decision to permit NHS patients to use top-up payments for pharmaceuticals, particularly cancer-related pharmaceuticals. Examines: (1) the origins and role of the National Health Service Act 1946; (2) the use of top-up payments; (3) the guidance of the Department of Health allowing patients to purchase medicines, and both the associated requirements for a separate delivery from the patient's NHS care and the implications for NHS rationing; and (4) NICE's supplementary advice on "end of life" treatment and its implications for appraisal committees.

click here for full text via Swetwise [ON CAMPUS]
click here for full text via Swetwise [OFF CAMPUS]

This article critically evaluates the Medicines and Healthcare products Regulatory Agency’s announcement, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear. This article assesses the existence of significant gaps in the duty of candour which had been assumed to exist between drugs companies and the regulator, and reflects upon what this episode tells us about the robustness, or otherwise, of the UK’s regulation of medicines.

click here for full text via JME [ON CAMPUS]
click here for full text via JME [OFF CAMPUS]

click here for full text via Swetwise [ON CAMPUS]
click here for full text via Swetwise [OFF CAMPUS]

This article challenges the idea that there could be a convincing secular version of the principle that human life is sacred, and explores the significance this has for the law. A number of secular justifications for the claim that there is something intrinsically, as opposed to instrumentally, valuable about human life have been mooted, most eloquently by Ronald Dworkin. While secular explanations for the sanctity of human life are undeniably attractive, this article will maintain that they do not have logic on their side. Having argued that the ‘sanctity principle’ makes sense only as an article of religious faith, the implications this has for the law are explored. In relation to end-of-life decision-making, the sanctity principle has been invoked to justify a sharp line between deliberately ending life and failing to prolong it. This article will conclude by arguing that a rejection of the sanctity principle might, in certain circumstances, cause us to focus instead on the extent to which death harms someone.

click here for full text via OUP [ON CAMPUS]
click here for full text via OUP [OFF CAMPUS]

Death has diverse religious, social, legal, and medical aspects and is one of the main areas in which medicine and the law intersect. In this volume, we ask: What is the meaning of death in contemporary Britain, and in other cultures, and how has it changed over time? The essays in this collection tackle the diverse ways in which death is now experienced in modern society, in the process answering a wide variety of questions: How is death defined by law? Do the dead have legal rights? What is one allowed to have and not have done to one's body after death? What are the rights of next of kin in this respect? What compensation exists for death and how is death valued? What is happening to the law on euthanasia and suicide? Is there a human right to die? What is the principle of sanctity of life? What of criminal offences against the dead? How are the traditions of death still played out in religion? How have customs and traditions of the disposal of bodies and funerals changed? What happens to donated bodies in the biomedical setting where anatomical education is permitted? What processes are employed by police when investigating suspicious deaths? What of representations of death? These and other questions are the subject of this challenging and diverse set of essays.

click here for publisher's site

Does the right to 'found a family' (Article 12) mean that prisoners and their partners should be granted access to artificial insemination facilities? In Dickson v United Kingdom the European Court of Human Rights, by a majority, decided that the UK was entitled to restrict prisoners' access to AI to exceptional cases only. The Dicksons did not qualify, despite the fact that Mrs Dickson would be too old to conceive naturally when Mr Dickson was released from prison. In this note, I explore the Court's reasoning and challenge some of the assumptions which underpin the majority's judgment.

click here for access via Lexis [ON CAMPUS]
click here for access via Lexis [OFF CAMPUS]
[nb. search by article title]

The purpose of this article is to comment upon an interesting gap in the criticism heaped upon Woo Suk Hwang following the revelation that his apparently groundbreaking stem cell research involved both the falsification of data and the unethical recruitment of egg donors. It is, of course, unsurprising that his fraudulent research and a possible breach of the Helsinki Declaration have come under considerable scrutiny. More interesting, in my view, is that there has been very little interest in the fact that human embryos may have been pointlessly destroyed. It is generally believed that research involving human embryos is legitimate only when it serves an important scientific purpose. Hwang’s research could serve no useful scientific purpose, and hence it would be difficult, if not impossible, to justify the destruction of embryos. I ask whether the comparative lack of interest in this aspect of the Korean stem cell research scandal points to a shift in our attitudes towards the instrumental use of the early human embryo.

click here for full text via Cambridge Journals [ON CAMPUS]
click here for full text via Cambridge Journals [OFF CAMPUS]

This collection brings together essays from leading figures in the field of medical law and ethics which address the key issues currently challenging scholars in the field. It has also been compiled as a lasting testimony to the work of one of the most eminent scholars in the area, Professor Ken Mason. The collection marks the academic crowning of a career which has laid one of the foundation stones of an entire discipline. The wide-ranging contents and the standing of the contributors mean that the volume will be an invaluable resource for anyone studying or working in medical law or medical ethics.

click here for publisher's site

Relevant to students, academics and practitioners across the globe, this original volume highlights contemporary issues associated with assisted reproduction and embryology and critically analyzes the law surrounding human reproduction in the light of case law and technological developments since the Human Fertilisation and Embryology Act (HFE Act) Act was passed in 1990. Tackling issues from an interdisciplinary perspective, the authors identify and evaluate areas that have provoked intense public and academic debate as well as those where further or renewed regulation is needed. Focusing primarily on the legal and ethical issues involved in regulating this area in the UK, which is at the forefront of developing legislation in this area, this book has international relevance as many countries have used the UK as a model for their own legislation. This text is suitable for a broad range of readers, including legal academics, law students and practitioners interested in the areas of medical/healthcare law and ethics, bioethics and moral philosophy, family law, sociology and reproductive medicine and genetics.

click here for publisher's site

Examining specific areas of family law from a feminist perspective, this book assesses the impact that feminism has had upon family law. It is deliberately broad in scope, as it takes the view that family law cannot be defined in a traditional way. In addition to issues of long-standing concern for feminists, it explores issues of current legal and political preoccupation such as civil partnerships, home-sharing, reproductive technologies and new initiatives in regulating family practices through criminal law, including domestic violence and youth justice.

click here for publisher's site

This book provides an accessible introduction to jurisprudence and legal theory. It sets out a course of study that offers a highly effective series of introductions into a wide variety of theories and theoretical perspectives, from traditional approaches such as Natural Law to modern ones such as Feminist Theory, Economic Analysis of Law and Foucault and Law,

click here for publisher's site

This introductory text sets out to make the links between sociological theories of the body and actual human behaviour and experience. It covers a broad range of topics, from long-standing sociological concerns to more contemporary issues. With a focus on the changeability of the body, it examines the part that bodies play in the social construction of categories such as race, sexuality and disability and explores how we express ourselves through our bodies, whether in eating, dress or pain. It also debates how the body is regulated, both through the life course and in reproduction.

click here for publisher's site

This article challenges the assumption that their future children's welfare is a relevant consideration when deciding whether to provide a person with assisted conception services. It does not argue that infertility treatment ought to be available as of right. Rather, this article's proposal is that section 13(5) - which specifies that no-one shall receive assistance with conception unless account has first been taken of the welfare of any child who might be born - should be deleted from the Human Fertilisation and Embryology Act 1990. Extending the 'welfare principle' to decisions taken prior to a child's conception is shown to be unjust, meaningless and inconsistent with existing legal principle.

click here for full text via Swetwise [ON CAMPUS]
click here for full text via Swetwise [OFF CAMPUS]