Żaneta Zemła-Pacud - Böcker

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.

This innovative book explores the complex interplay between intellectual property for biotechnological innovations and human rights. Examining the clash between the drive to incentivise innovations that can fulfil human needs and the desire to grant global access to healthcare technologies, it presents thoughtful solutions to the challenges of protecting the human rights of all parties impacted by biotechnological patents and other relevant IP rights.After laying out the essential biotechnological innovations of the last 40 years, the authors conduct an in-depth analysis of European exclusive rights relating to biotechnology and healthcare, with particular attention to five key European jurisdictions - France, Germany, Italy, Poland and the UK. Delving into complex legal and ethical disputes over the rights to privacy, integrity, autonomy, health and science, the book argues for a more balanced patent system, protecting both human rights and intellectual property.This book will be a thought-provoking read for legal scholars, practitioners and policy-makers in the fields of biotechnology, pharmaceutical law, human rights law and intellectual property law. With its in-depth discussion of cutting-edge advances in biotechnology and the laws related to it, it will also prove enlightening for scholars and students interested in engaging with the field for the first time.