The Life Sciences Law Review covers a total of 37 jurisdictions, providing an overview of legal requirements of interest to pharmaceutical, biotechnology and medical device companies. The chapters are arranged 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.
Now, more than ever, it is important for leaders in the pharmaceutical and medical device industries and their advisers to be knowledgeable about the laws and regulations in major jurisdictions around the world. In the past year, there have been significant developments in the regulation of drugs and medical devices, especially in the United States, where a new law – the 21st Century Cures Act – was passed at the end of 2016. There are prospects for further developments in the coming year. The new president and the Republican-controlled Congress will consider legislative measures affecting the pharmaceutical and medical device sectors, including proposed repeal of the Affordable Care Act, continuing inquiries into pricing of medical products and reauthorisation of user fee laws that fund a substantial part of the drug and device approval processes. The United Kingdom will initiate formal proceedings to begin the process of withdrawing from the European Union, with potential consequences for the medical products sectors. Other jurisdictions, including China and India, are considering reforms to their regulatory systems for medicinal products.
Richard Kingham is a senior counsel in the firm of Covington & Burling LLP, where he serves as co-head of the life sciences industry group and the industry, regulatory and legislative practice group. He previously served as the managing partner of the firm’s London office and as a member of the firm-wide management committee. Since joining the firm in 1973, he has concentrated on regulation of pharmaceuticals and related products. He has acted for most of the major pharmaceutical and biotechnology companies in the United States and Europe, as well as the principal trade associations of the pharmaceutical industry. He has served on committees of the World Health Organization, the Center for Global Development, the Institute of Medicine of the US National Academy of Sciences and the National Institutes of Health. He is currently an adjunct professor at the Georgetown University Law Center, and he has lectured at the University of Virginia School of Law and the graduate programme in pharmaceutical medicine at Cardiff University. He received his law degree in 1973 from the University of Virginia, where he served as articles editor of the law review and was elected to the Order of the Coif (the law school honour society).
The publisher acknowledges and thanks the following for their learned assistance throughout the preparation of this book: