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Informationen zum Autor Frantzeska Papadopoulou is Associate Professor in Intellectual Property Rights and the Head of the IP Group at the Law Faculty of Stockholm University, Sweden. She is one of the founders of the Stockholm IP Law Review and has extensive experience as a practitioner in the field of patent law and regulatory rights. Vorwort This book provides an in-depth analysis of the SPC, the Orphan Drugs, the Paediatric and the ATMP Regulation, with a focus on the practical and theoretical implications of their legislative architecture. Zusammenfassung 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. Inhaltsverzeichnis 1. Regulating the EU Pharmaceutical Sector: A Multilayered Challenge 1. The Pharmaceutical Sector: A Need for Regulation 2. The Structure of the Pharmaceutical Industry in Europe 3. EU Competence in the Field of Public Health 4. Effective Legislation and Regulatory Rights 5. The Structure of the Book 2. Setting the Stage for Regulatory Rights: The Regulatory Agencies and the Marketing Authorisation Procedure 1. Regulatory Authorities 2. The Marketing Authorisation Procedure 3. Concluding Remarks 3. Data Exclusivity 1. The Legal Framework 2. Clinical Data3. The Marketing Authorisation Procedure and Directive 2001/83 – Original Pharmaceuticals 4. Marketing Authorisation for Generic Products 5. The Weaknesses of the System 6. Data Exclusivity for Paediatric Medicines that are Not Patent-Protected 7. Concluding Remarks 4. The Supplementary Protection Certificate 1. Background to the Legal Framework 2. The Legal Framework 3. The Subject of Protection 4. The Rights Granted 5. The SPC Beneficiary 6. Concluding Remarks 5. The Paediatric Extension 1. Background 2. The General Legal Framework 3. A New Committee to Implement the Legal Framework: The Role of the Paediatric Committee (PDCO) 4. The PIP 5. PIP Compliance Control 6. Exemptions and Waivers 7. The Incentives of the Regulation 8. Rewards for Orphan Medicinal Products under Regulation 1901/2006 9. Other Incentives in the System 10. Post-approval Obligations 11. Concluding Remarks 6. Orphan Drugs 1. Background to the Legal Framework 2. Procedural Aspects 3. The Criteria for Orphan Drugs Designation 4. Marketing Authorisation of Orphan Drugs 5. The Incentives of the Orphan Drug Designation 6. Post-grant Obligations of the Sponsor 7. Difficulties in the Interpretation of Orphan Drugs Regulation Case Law 8. Concluding Remarks 7. Advanced Therapy Medicinal Products 1. The Legal Framework 2. Definitions of Key Terms in the ATMP Regulation 3. The ATMP Regulation and Other European Legislation 4. Marketing Authorisation for...
