The Life Sciences Law Review: Editor's Preface

The tenth edition of The Life Sciences Law Review covers a total of 30 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, like its predecessor, was dominated by the covid-19 pandemic. Manufacturers of healthcare products continued to expedite the development and testing of drugs, biologics, diagnostics and personal protective equipment. Vaccines, many making use of novel technologies, have moved from the laboratory to the clinic and then to patients in record times; a matter of months rather than years or decades. Regulatory agencies have reviewed marketing applications with unprecedented speed and efficiency. Manufacturers and international organisations have worked closely together in an effort to ensure equitable access to vaccines and other important healthcare products in low- and middle-income countries, but much work remains to be done. In the wake of the pandemic, it is to be hoped that governments learn from the lessons of covid-19, placing systems and structures in place for the next pandemic or other health emergency and expediting the development and approval of new healthcare products to deal with endemic health issues such as cancer, coronary heart disease and genetic disorders.

In times like these, 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 that 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 year's publication will be especially 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.

Richard Kingham
Covington & Burling LLP
Washington, DC
February 2022

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