Hart Studies in Law and Health – Serie

This book delineates the scope of permissible compulsory mental health interventions under the Convention on the Rights of Persons with Disabilities (CRPD). The initial impetus for this study was provided by a conflict between two competing positions within the current debate over the future of coercive psychiatry. According to one position, defended by the CRPD Committee, among others, compulsory mental health care necessarily violates the prohibition of discrimination. According to the competing position, supported by the vast majority of states, compulsion is sometimes necessary to protect health and life and, if coupled with appropriate legal safeguards, it is lawful under such circumstances. This book disputes both positions and argues that the scope of permissible compulsory care can be identified using proportionality reasoning. Drawing on the work of Robert Alexy, it develops a framework for proportionality assessments within the context of non-discrimination. The framework can assist decision-makers to design principled and evidence-based mental health care regimes. This book thus provides a new way forward for states parties looking to reform their mental health care regimes and to improve compliance with the CRPD. It will appeal to academics and practitioners engaged in mental health reform in the post-CRPD era.

This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy.Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union’s reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.

This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy.Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union’s reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.

Market driven healthcare is massively divisive. Opponents argue that a competition approach to medical treatment negatively impacts on quality, while advocates point to increased efficiencies. This book casts a critical eye over both positions to show that the concerns over quality are in fact real. Taking a two part approach, it unveils the fault lines along which healthcare provision and the pursuit of quality would in certain cases clash. It then shows how competition authorities can only effectively assess competition concerns when they ask the fundamental question of how the concept of healthcare quality should be defined and factored into their decisions. Drawing on UK, US and EU examples, it explores antitrust and merger cases in hospital, medical and health insurance markets to give an accurate depiction of the reality and challenges of regulating competition in healthcare provision.

Market driven healthcare is massively divisive. Opponents argue that a competition approach to medical treatment negatively impacts on quality, while advocates point to increased efficiencies. This book casts a critical eye over both positions to show that the concerns over quality are in fact real. Taking a two part approach, it unveils the fault lines along which healthcare provision and the pursuit of quality would in certain cases clash. It then shows how competition authorities can only effectively assess competition concerns when they ask the fundamental question of how the concept of healthcare quality should be defined and factored into their decisions. Drawing on UK, US and EU examples, it explores antitrust and merger cases in hospital, medical and health insurance markets to give an accurate depiction of the reality and challenges of regulating competition in healthcare provision.

This book delineates the scope of permissible compulsory mental health interventions under the Convention on the Rights of Persons with Disabilities (CRPD). The initial impetus for this study was provided by a conflict between two competing positions within the current debate over the future of coercive psychiatry. According to one position, defended by the CRPD Committee, among others, compulsory mental health care necessarily violates the prohibition of discrimination. According to the competing position, supported by the vast majority of states, compulsion is sometimes necessary to protect health and life and, if coupled with appropriate legal safeguards, it is lawful under such circumstances. This book disputes both positions and argues that the scope of permissible compulsory care can be identified using proportionality reasoning. Drawing on the work of Robert Alexy, it develops a framework for proportionality assessments within the context of non-discrimination. The framework can assist decision-makers to design principled and evidence-based mental health care regimes. This book thus provides a new way forward for states parties looking to reform their mental health care regimes and to improve compliance with the CRPD. It will appeal to academics and practitioners engaged in mental health reform in the post-CRPD era.

What does the UK's exit from the EU mean for health and the NHS?This book explains the legal and practical implications of Brexit on the NHS: its staffing; especially on the island of Ireland; medicines, medical devices and equipment; and biomedical research. It considers the UK’s post-Brexit trade agreements and what they mean for health, and discusses the effects of the COVID-19 pandemic on post-Brexit health law.To put the legal analysis in context, the book draws on over 400 conversations the authors had with people in the north of England and Northern Ireland, interviews with over 40 health policy stakeholders, details of a film about their research made with ShoutOut UK, the authors’ work with Parliaments and governments across the UK, and their collaborations with key actors like the NHS Confederation, the British Medical Association, and Cancer Research UK. The book shows that the language people use to talk about hoped-for legitimate post-Brexit health governance suggests a great deal of faith in law and legal process among ‘ordinary people’, but the opposite from ‘insider elites’.Not What The Bus Promised puts the authors’ knowledge and experiences centre frame, rather than claiming to express ‘objective reality’. It will be of interest to any reader who cares about the NHS and wants to understand its present and future.

What does the UK's exit from the EU mean for health and the NHS?This book explains the legal and practical implications of Brexit on the NHS: its staffing; especially on the island of Ireland; medicines, medical devices and equipment; and biomedical research. It considers the UK’s post-Brexit trade agreements and what they mean for health, and discusses the effects of the COVID-19 pandemic on post-Brexit health law.To put the legal analysis in context, the book draws on over 400 conversations the authors had with people in the north of England and Northern Ireland, interviews with over 40 health policy stakeholders, details of a film about their research made with ShoutOut UK, the authors’ work with Parliaments and governments across the UK, and their collaborations with key actors like the NHS Confederation, the British Medical Association, and Cancer Research UK. The book shows that the language people use to talk about hoped-for legitimate post-Brexit health governance suggests a great deal of faith in law and legal process among ‘ordinary people’, but the opposite from ‘insider elites’.Not What The Bus Promised puts the authors’ knowledge and experiences centre frame, rather than claiming to express ‘objective reality’. It will be of interest to any reader who cares about the NHS and wants to understand its present and future.

This book explores the fundamental and inextricable relationship between regulation, intellectual property, competition law, and public health in pharmaceutical markets, examining their interconnections and the delicate balance between the various interests and policy goals at stake. Although pharmaceutical markets are heavily regulated and subject to close antitrust scrutiny, there is a constant requirement for existing rules and policies to tackle a number of persistent, complex issues. The variety of anti-competitive practices occurring in this sector, the worrying rise in drug prices, and major, far-reaching concerns over the accessibility of medicines are sources of frequent controversy in academic and policy debates. Understanding the unique features and dynamics of the pharmaceutical industry requires a tailored and multifaceted approach. The study is enhanced by the adoption of a comparative perspective, tracing convergence and divergence between EU and US systems through the analysis of relevant applicable rules, significant cases, and policy choices. Pursuant to this rigorous approach, the book provides an original and thought-provoking critique of the challenges of regulating pharmaceutical markets.