Health "Brexternalities": The Brexit Effect on Health and Health Care outside the United Kingdom.

The principal effects of Brexit on health and health care will fall within the United Kingdom, and all forms of Brexit have overwhelmingly negative implications for health care and health within the UK. This article focuses on the external effects of Brexit ("Brexternalities") for health and health care. The EU is a particularly powerful institutional and legal arrangement for managing economic and political externalities in health policy as in any other policy. Equally, when a state leaves the EU, the manner of leaving will result in better or worse management of relevant externalities. Brexternalities thus involve questions about policy legitimacy and accountability. Health Brexternalities do not fall equally in all EU countries. They are felt more distinctly in the context of those elements of health policy that are most closely entwined with the UK's health policy (e.g., on the island of Ireland, certain areas of Spain, and other parts of southern Europe). Some health Brexternalities, such as in medicine safety, will be imposed on the whole population of the EU. And some health Brexternalities, such as communicable disease control, will be felt globally.

Innovation, informed consent, health research and the Supreme Court: Montgomery v Lanarkshire - a brave new world?

The Supreme Court decision in Montgomery v Lanarkshire ([2015] UKSC11) has been hailed as a landmark not least because the Court enshrines the doctrine of informed consent formally into English law for the first time in relation to medical treatment. This paper explores the decision in Montgomery. It examines what its implications may be in the future for the consent process in relation to health research and innovative treatment and whether it may prove a watershed moment leading to changing dialogues and expectations in relation to consent. First, the paper explores the concept of 'informed consent' in clinical research as seen through international, Council of Europe and EU instruments. Second, it considers how English law currently governs the provision of information to research participants in the context of clinical research. It questions whether such an approach will be sustainable in the future. Third, it discusses the decision of the UK Supreme Court in Montgomery v Lanarkshire and asks what might be the impact of this Supreme Court decision in the health research context. It asks whether Montgomery may result in new approaches to consent in health research and innovative treatment.

Reforming the EU Clinical Trials Directive: streamlining processes or a radical "new" agenda?.

From its conception the EU Clinical Trials Directive met with controversy. Some saw it as an unnecessary inhibitor to scientific research, introducing bureaucracy which was unduly expensive, slowing down the clinical trial approval system. The Directive however also enshrined respect for fundamental rights in relation to clinical trials decision-making and impacted upon the domestic law of member states facilitating the alignment of trial review processes. Nearly a decade after its implementation the EU is moving towards implementation of further reform in this area, from a Directive to a Regulation, from a system placing the research ethics system at the heart of the clinical trials approval committee to one which does not and which represents a see change in international and domestic approaches to research ethics. This article critically examines the proposed reform of the regulation of clinical trials on medicinal product through the introduction of a new EU Regulation and asks whether this can be seen as a natural streamlining of processes or a radical new agenda in EU health law and regulation.

Faith, belief, fundamental rights and delivering health care in a modern NHS: an unrealistic aspiration?

This paper considers the way in which English law safeguards fundamental rights to respect for faith and belief in relation to the delivery of health care. It explores the implications of the Human Rights Act 1998 and the Equality Act 2010. It explores some of the challenges in attempting to reconcile fundamental rights to faith and belief and the delivery of health care, both now and in the future and whether this is a realistic aspiration in a state funded health care service.

The ageing population: is it time for an international convention of rights?

An increasing ageing population gives rise to many challenges for healthcare delivery. The need to ensure that there is respect for the rights and the dignity of older patients has been a consistent theme over the last decade. However, the vulnerability of this group of patients was highlighted again recently in a highly critical Health Service Commissioners Report. This article explores the case for a more overt form of rights protection and whether there is a case for a Human Rights Convention for the Older Person.

Can doctors lawfully kill competent patients who want to die?

This article explores the case of Nicklinson v Ministry of Justice (2012), in which a man with locked-in syndrome sought leave to challenge the current law concerning euthanasia. This is a preliminary hearing outlining the legal arguments being brought to trial; however, the article suggests that the significance of this case is likely to be considerable. It will require the English courts to consider the application of the doctrine of necessity and the application of the Human Rights Act in the context of active euthanasia by clinicians, rather than simply assisted suicide.

Exploring patients' rights: what does the NHS Constitution tell us?

On 8 March 2012, the NHS published the latest version of its Constitution. In this article, the author explores the background of the debate regarding patients' rights and entitlements in the NHS. The author also discusses the provisions of the NHS Constitution, noting that it is largely a statement of existing principles, rather than a bold statement of rights. The paper suggests that, in some instances, its discussion of rights may suggest that patients have broader rights than may in fact be the case. The Constitution is currently under review, and the author recommends that the way forward for a society where the provision of care is likely to be more complex would be the introduction of a Patients' Rights Act.

Regulating cosmetic surgery: a scalpel where it is needed.

This paper considers the recent controversies around the regulation of cosmetic surgery procedures. The author suggests that any review considering reform of the law in this area should not only look at issues concerning the safety of the procedures and competence of the practitioners, but should also address the question of which procedures should be allowed. In particular, the author advocates that there should be a review as to the whether cosmetic procedures should be made available to those under the age of 18 years. The paper also discusses analogous legislation in Queensland, Australia and explores whether this could be a useful model for legislative reform.

Assisted suicide: a right to professionally-aided death?

The article examines the recent decision in the case of Re AM (2012), in which a man in a locked in state seeks assistance in dying. The preliminary hearing in this case decided in January 2012 concerns whether AM's lawyers can provide professional assistance in relation to providing information about assisted suicide. The article explores the issue of professional assistance in the suicide process; something which is particularly controversial following the recent guidelines (The Crown Prosecution Service, 2010) on prosecution in the case of assisted suicide.

Sex selection and abortion: a case for legal re-evaluation?

This question of sex selection and abortion in the UK was highlighted by recent reports in a national newspaper. This paper explores the current legal position and whether there is a case for reforming the law to align the situation of abortion with that of sex selection in the context of pre-implantation genetic diagnosis.

Reforming the law concerning assisted dying.

The question of whether English law should be reformed to legalize assisted dying has been the cause of heated debate over many years. The courts have consistently rejected challenges to change the law in the area. However in 2009 Debbie Purdy achieved success in requiring the Director of Public Prosecutions to produce prosecution guidelines on assisted suicide. This paper explores the current law in the area and examines the proposals for reform of the Falconer Commission which were published in January 2012.

Using anonymized NHS data without consent: a step too far?

On 5 December 2011, the Government announced that NHS data will be made more widely available to researchers (BBC News, 2011). David Cameron suggested that 'everyone was to be a research patient' (BBC News, 2011) with anonymized NHS patient data being opened up to researchers in the private sector as well as the NHS. The proposals envisaged that all such data is opened up to researchers unless patients opt out. This article explores the relationship between patient privacy, confidentiality and the public interest, and asks whether anonymization is simply enough or whether we need a broader debate as to what constitutes disclosure in the public interest and its boundaries.

Privacy, confidentiality and abortion statistics: a question of public interest?

The precise nature and scope of healthcare confidentiality has long been the subject of debate. While the obligation of confidentiality is integral to professional ethical codes and is also safeguarded under English law through the equitable remedy of breach of confidence, underpinned by the right to privacy enshrined in Article 8 of the Human Rights Act 1998, it has never been regarded as absolute. But when can and should personal information be made available for statistical and research purposes and what if the information in question is highly sensitive information, such as that relating to the termination of pregnancy after 24 weeks? This article explores the case of In the Matter of an Appeal to the Information Tribunal under section 57 of the Freedom of Information Act 2000, concerning the decision of the Department of Health to withhold some statistical data from the publication of its annual abortion statistics. The specific data being withheld concerned the termination for serious fetal handicap under section 1(1)d of the Abortion Act 1967. The paper explores the implications of this case, which relate both to the nature and scope of personal privacy. It suggests that lessons can be drawn from this case about public interest and use of statistical information and also about general policy issues concerning the legal regulation of confidentiality and privacy in the future.

Accountability, governance and biobanks: the ethics and governance committee as guardian or as toothless tiger?

The huge potential of biobanks/genetic databases for the research community has been recognised across jurisdictions in both publicly funded and commercial sectors. But although there is tremendous potential there are likewise potential difficulties. The long-term storage of personal health information and samples poses major challenges. This is an area is fraught with ethical and legal uncertainties. Biobanks raise many questions of the control of rights, of consent, of privacy and confidentiality and of property in human material. It is thus unsurprising then that there has been a lively debate as to how biobanks should operate, the boundaries of participation and what governance structure, if any they should adopt, a debate which has been engaged in across the academic community and by funders and researchers alike. This paper asks despite the good intentions can ad hoc ethics and ethics and governance committees long term provide an effective solution to the legal and regulatory challenges arising from biobanks.

The new EU healthcare rights directive: greater uniformity?

On 9th March 2011 the new EU Directive on Patients' Rights in Cross-border Healthcare was adopted. This article explores its implications for the delivery of health care in the UK. It notes that the final version of the Directive provides much greater discretion to member states to control access to resources than was suggested in early drafts of the Directive. It explores the situations in which care can be subject to prior authorization and suggests that perhaps the greatest long-term impact of the Directive will not be in patient mobility as such but rather in relation to its impact on broader standard setting across the EU.