Home >
New Releases >
Law >
Regulatory Protection in the Pharmaceutical and Life Science Industries: Challenges, Opportunities and Ongoing Reform

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

Author: Żaneta Zemła-Pacud
Publisher: Edward Elgar Publishing
ISBN: 9781035332274
Published In: July 2025
Format: Hardback
Jurisdiction: U.K. ? Disclaimer:
Countri(es) stated herein are used as reference only

List Price: RM702.00

RM680.94 Save RM21.06 (3%)

Download Order Form

Add to Wishlist
| Add to Compare

Description
Contents

Details

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.

Regulatory protection in the pharmaceutical and life science industries: an introduction ix

PART I Regulatory protection for medicinal products'

Introduction to the regulation of market authorisation for medicinal products '

Data and market exclusivity for reference medicinal products '

Regulatory exclusivities and rewards for paediatric products '

Regulatory protection for orphan drugs

PART II Reform of the EU pharmaceutical regulation'

The EU Pharmaceutical Strategy and the context of the ongoing reform '

Revision of the regulatory protection for reference medicinal products '

Revision of the regulatory protection for paediatric medicines '

Revision of the regulatory protection for orphan medicinal products '

Transferrable vouchers for new antimicrobial medicines '