Regulatory Protection in the Pharmaceutical and Life Science Industries Challenges, Opportunities and Ongoing Reform
Produktdetaljer
Biografisk notat
Żaneta Zemła-Pacud, Associate Professor, Institute of Law Studies, Polish Academy of Sciences, Warsaw, Poland<i>‘This book is a timely and important contribution to the scholarship and practice of intellectual property and pharmaceutical law. With clarity and depth, it brings to light an often-underexplored yet increasingly pivotal element of the life sciences innovation ecosystem: regulatory exclusivities. While patents and supplementary protection certificates have long dominated discourse around innovation incentives, this work reveals how regulatory data protection and market exclusivity have come to play an equally, if not more, decisive role in determining when generic competition can enter the market.</i>
Rich in legal insight and grounded in a nuanced understanding of EU regulatory frameworks, the book systematically unpacks the complex layers of data and market exclusivity across the pharmaceutical, food, and agrochemical sectors. It not only details the legal architecture of current EU regulations but also offers a forward-looking analysis of ongoing legislative reforms, including the European Commission’s 2023 proposals and their broader implications.
What distinguishes this book is its careful balance between detailed legal analysis and practical insight. It explores regulatory exclusivities as a distinct, sui generis form of intellectual property within the framework of EU law, while situating the discussion in a broader international context, including relevant aspects of the TRIPS Agreement. Rather than advocating a singular theory, the author presents a thoughtful exploration of the legal categorisation of regulatory protection and its implications for both policy and practice. The inclusion of emerging mechanisms—such as transferable exclusivity vouchers and provisions for repurposed medicines—broadens the scope of the study and highlights the dynamic and evolving nature of regulatory exclusivities in EU pharmaceutical legislation.'
- Frantzeska Papadopoulou, Stockholm University, Sweden,
<i>‘The book fills a significant gap in the existing literature by analysing in great detail the crucial role played by regulatory exclusivities in the EU. Żaneta Zemła-Pacud writes with clarity and expertise to provide important new insights into the EU framework of regulatory exclusivities and rewards for life science products.’</i>
- Duncan Matthews, Queen Mary University of London, UK,
<i>‘In recent years, governments have enacted a confusing mélange of data and market exclusivities, particularly in the health sciences arena. In this book, Żaneta Zemła-Pacud, a rising star in the intellectual property firmament, studies their collective impact on accessibility, quality, and innovation incentives. For students of the intellectual property system and policymakers in the life sciences space, this volume is a must-read.’</i>
- Rochelle Dreyfuss, New York University School of Law, USA,
The book illustrates how regulatory exclusivities and rewards are granted, what protection they confer, and how they can be enforced. Recognising their practical importance, it further presents how regulatory protection is integrated into IP strategies and what challenges this may pose. Against this background, the author presents and comments on coming changes to the system and provides an up-to-date analysis of the legislation driving EU reform of pharmaceutical regulation. To complete the picture of regulatory protection in the EU, the book situates the system within the framework of other protective regimes, including the protection of regulatory data against disclosure. Finally, referring to European civil law tradition, the author carefully analyses the framework’s normative legal bases and proposes categorising regulatory protection as a sui generis instrument of protection for Intellectual Property.
This book is an insightful and stimulating contribution to the literature on intellectual property and pharmaceutical law. It is an essential read for scholars in those fields and policymakers involved in the legal reform of the pharmaceutical sector. Practising lawyers, judges, and national regulators will greatly benefit from timely insights into the field.