Overview

This book offers the first complete and up-to-date analysis of the European Union's regulation of medicines. Through a reasoned description ranging from regulatory developments to the jurisprudence of the Court of Justice of the European Union, it delineates the current European pharmaceutical regulation system. Moreover, the economic and social implications caused by the market fragmentation linked to disparities in national pricing and reimbursement schemes of pharmaceuticals are also explored here.In what was theorized to be a patchwork of rules and roles, the potential growth of the pharmaceutical industry is hampered and important inequalities in patient access are growing. What will be the next moves of European Union legislation to address the aging of the population, the higher incidence of some diseases and the growing costs of innovative medicines? Answers to such questions are offered in this book.

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9781527531413

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This concise work offers an analysis of the regulation of medicines by the EU, discussing both the legal and - briefly - the economic aspects of that regulation. It presents in some depth the EU legislation relating to various aspects of the pharmaceutical system, including the regulation of clinical trials, the manufacturing of pharmaceuticals, their distribution and advertising. The author also discusses the ECJ case law on pharmaceuticals from several angles, viz. free movement of goods, competition law, and fundamental rights, as well as some EU soft law instruments. Some economic aspects, such as pricing, are also addressed. Common Market Law Review, 2020

Author Information

Giuditta Savonitto received an Integrated Master of Arts in Law at Bocconi University, Italy, and attended a course on Health Technology Assessment at SDA Bocconi School of Management in Milan, Italy. She is currently working in a law firm in Milan as a trainee lawyer specialised in International and European Union law.

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