Regulatory Protection in the Pharmaceutical and Life Science Industries: Challenges, Opportunities and Ongoing Reform

This book examines the EU framework for regulatory protection in life science industries, with a particular focus on the pharmaceutical sector. Żaneta Zemła-Pacud discusses the rules of regulatory exclusivities and rewards for innovative life science products and the regulatory data underlying them. The author presents the framework''s meaning for the sector as a sui generis instrument of protection of intellectual property (IP) and provides an up-to-date analysis of the legislation driving EU reform of pharmaceutical regulation.

The author outlines basic principles of pharmaceutical regulation relevant to regulatory protection of innovative medicinal products, orphan and paediatric drugs, and delves into the complexities of regulatory protection for them. The book depicts how regulatory exclusivities and rewards are granted and enforced, how they are used in IP strategies and what challenges they bring. Against this background, the author presents and comments on coming changes to the system. To complete the picture of regulatory protection in the EU, the book presents how it functions in other life science sectors, including agrochemical and food industries. It also depicts the system of regulatory protection in the context of other protective regimes, especially in light of the protection of regulatory data against disclosure. Finally, it categorises regulatory protection within European civil law tradition.

This book is an insightful and stimulating contribution to the literature in intellectual property and pharmaceutical law, and an important read for scholars in those fields, as well as policymakers involved in the legal reform of the pharmaceutical sector. Practising lawyers, judges and national regulators will greatly benefit from the timely insights into the field.