This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that has developed since the 1960s. In general, product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility that a product might be harmful, whereas establishing liability in litigation requires proving that the product was actually harmful. As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control.

This book explores how concerns can be raised about the NHS, why raising concerns hasn't always improved standards, and how a no-fault open culture approach could drive improvements. The book describes a wide range of mechanisms for raising concerns about the NHS, including complaints, the ombudsman, litigation, HSIB, and the major inquiries since 2000, across the various UK jurisdictions. The NHS approach is contextualised within the broader societal developments in dispute resolution, accountability, and regulation. The authors take a holistic view, and outline practical solutions for reforming how the NHS responds to problems. These should improve the situation for those raising concerns and for those working within the NHS, as well as providing cost savings. The no-fault approaches proposed in the book provide long-term sustainable solutions to systemic problems, which are particularly timely given the impact of the COVID-19 pandemic on the NHS. The book will be of interest to academics, researchers, ADR practitioners, practising lawyers, and policy makers.

This ground-breaking book takes a fresh look at potential non-litigation solutions to providing personal injury compensation. It is the first systematic comparative study of such a large number - over forty - of personal injury compensation schemes. It covers the drivers for their creation, the frameworks under which they operate, the criteria and thresholds used, the compensation offered, the claims process, statistics on throughput and costs, and analysis of financial costings. It also considers and compares the successes and failings of these schemes. Many different types of redress providers are studied. These include the comprehensive no-blame coverage offered by the New Zealand Accident Compensation Corporation; the widely used Patient, Pharmaceutical, Motor Accident and Workers Compensation Insurance systems of the Nordic states; the far smaller issue-focused schemes like the UK Thalidomide and vCJD Trusts; vaccine damage schemes that exist in many countries; as well as motor vehicle schemes from the USA. Conclusions are drawn about the functions, essential requirements, architecture, scope, operation and performance of personal injury compensation systems. The relationships between such schemes, the courts and regulators are also discussed, and both calls and need for reforms are noted. Noting the wide calls for reform of NHS medical negligence litigation within the UK, and its replacement with a no blame approach, the authors' findings outline options for future policy in this area. This major contribution builds on general shifts from courts to ADR, and from blame to no blame in regulation, and is a work that has the potential to have a major impact on the field of personal injury redress. With contributions by Raymond Byrne, Claire Bright, Shuna Mason, Magdalena Tulibacka, Matti Urho, Mary Walker and Herbert Woopen.