The seventh edition of The Life Sciences Law Review covers a total of 34 jurisdictions, providing an overview of legal requirements of interest to pharmaceutical, biotechnology and medical device companies. The chapters are arranged so as to describe requirements throughout the life cycle of a regulated product, from discovery to clinical trials, the marketing authorisation process and post-approval controls. Certain other legal matters of special interest to manufacturers of medical products – including administrative remedies, pricing and reimbursement, competition law, special liability regimes and commercial transactions – are also covered. Finally, there is a special chapter on international harmonisation, which is of increasing importance in many of the regulatory systems that are described in the national chapters.
The past year has seen a number of significant developments. After many years of negotiations and false starts, the United States and EU have finally begun to implement a programme of mutual recognition of inspections of drug manufacturing establishments, thus simplifying the shipment of drug products between the jurisdictions and freeing resources to carry out more inspections in third countries. In the meantime, the United States continues to debate whether to repeal the comprehensive medical care legislation enacted during the Obama administration, and is now considering measures to improve the transparency of pricing for prescription drugs. The United Kingdom is addressing changes to drug regulatory systems that must accompany the c ountry's planned withdrawal from the EU, and drug and device manufacturers are actively planning for the effects of Brexit on their supply chains. The governments in India and China continue to consider changes in their regulatory systems for drugs and medical devices.
It is vitally important that lawyers who advise companies in the life sciences sector and the business executives whom they serve have a working knowledge of the regulations and policies that govern drugs, biologics and medical devices. It is equally important to keep up to date with developments in the regulatory systems, which govern access to the market, pricing and reimbursement, advertising and promotion, and numerous other matters that are essential to success. It is our hope that this annual publication will be helpful in this respect.
All of the chapters have been written by leading experts within the relevant jurisdiction. They are an impressive group, and it is a pleasure to be associated with them in the preparation of this publication.