This book analyses 4 central pieces of EU pharmaceutical
regulation: the Orphan Drugs Regulation, the Paediatric Regulation,
the Supplementary Protection Certificate Regulation, and the ATMP
(Advanced Therapy Medicinal Products) Regulation. These four
regulatory instruments constitute focal points in the
pharmaceutical industry’s approach to modern business and legal
strategy. Their central role is justified by the way these
regulatory instruments interact with each other and with the patent
system, and by the considerable impact they (as a whole) have for
the evergreening of exclusive rights on pharmaceutical products.
The book guides the reader through the latest case law and
legislative developments and discusses how these influence
strategic legal and business choices in the pharmaceutical
industry. It brings to the forefront the often-overlooked
significance of the legislative architecture of the EU
pharmaceutical regulatory framework, and evaluates its results
through the lens of the efficiency test. The book is an important
resource for academics and practitioners interested in updated case
law and an in-depth analysis of these four regulations. It is also
important for those interested in legislative studies, evaluation
of legislation and a critical approach to legislative architecture.
General
| Imprint: |
Hart Publishing
|
| Country of origin: |
United Kingdom |
| Release date: |
October 2021 |
| Authors: |
Frantzeska Papadopoulou
|
| Dimensions: |
234 x 156mm (L x W) |
| Format: |
Hardcover
|
| Pages: |
312 |
| ISBN-13: |
978-1-5099-5028-7 |
| Categories: |
Books
Promotions
|
| LSN: |
1-5099-5028-1 |
| Barcode: |
9781509950287 |
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