Regulatory Protection in the Pharmaceutical and Life Science Industries

Challenges, Opportunities and Ongoing Reform
This book comprehensively elaborates on the EU framework for regulatory protection in life science industries. Żaneta Zemła-Pacud discusses the rules governing regulatory exclusivities and rewards for both innovative life science products and the regulatory data underlying them. The analysis focuses primarily on pharmaceuticals, such as reference medicinal products, orphan drugs and paediatric medicines, but it also encompasses goods from the agrochemical and food sectors, such as plant protection products, novel food, genetically modified food and feed.

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.

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