PHARMACEUTICAL LAW IN THE EU AND THE US: The impact on public health and the pharmaceutical industry

Anthia ZammitPublications

PHARMACEUTICAL LAW IN THE EU AND THE US:

The impact on public health and the pharmaceutical industry

University of Malta, Faculty of Laws, 2010

The impact on public health and the pharmaceutical industry

 

TABLE OF CONTENTS

DECLARATION OF AUTHORSHIP.. 2

ABSTRACT. 3

TABLE OF STATUTES.. 9

TABLE OF CASES.. 14

ACKNOWLEDGEMENTS.. 17

LIST OF ABBREVIATIONS.. 18

INTRODUCTION.. 20

  1. Defining the area of study. 20
  2. Research Methodology. 21
  3. Pharmaceuticals as global, public and commercial goods. 22
  4. General Aims. 29
  5. Specific Objectives. 29

CHAPTER 1: AN OVERVIEW OF REGULATORY LEGISLATION.. 31

1.1           The need for legal regulation of medicinal products. 31

1.2           Defining a medicinal product 33

1.2.1            Classification of Medicines. 35

1.3           The Regulatory Agencies. 36

1.3.1            European Union. 36

1.3.2            United States of America. 37

1.4           Legal Regulation of Medicinal Products in the European Union. 38

1.5           Legal Regulation of Drugs in the United States of America. 39

1.6           Towards greater harmonisation. 41

1.7           Registration of medicinal products. 43

1.7.1            European Union. 43

1.7.2            United States of America. 45

1.8           Manufacture of Medicinal Products. 47

1.9           Distribution of Medicinal Products. 48

1.10        Pharmacovigilance. 48

1.11        The European Union’s legislative ‘Pharmaceutical Package’ 51

1.11.1         Stakeholder response. 55

1.12        Recent developments in Pharmaceutical Legislation and new advances in Medicinal Therapies   59

1.12.1         Orphan Drugs. 59

1.12.2         Paediatric Medicines. 62

1.12.3         Advanced Therapies and Personalised Medicine (Pharmacogenetics) 63

CHAPTER 2: PUBLIC HEALTH POLICY AND CONSUMER LAW.. 65

2.1           The Public Health dimension of medicinal products. 65

2.2           Health as a Fundamental Human Right 68

2.3           The Impact of European Union intervention on Public Health and Consumer Protection   70

2.4           Safeguarding Consumer Protection on both sides of the Atlantic. 72

2.4.1            Wyeth v. Levine: Preserving the patient’s right to redress and confirming manufacturer responsibility for drug safety.  73

2.4.2            Outcomes of Product Liability legislation. 76

2.5           Pricing and Reimbursement 80

2.6           Pharmaceutical Care in the United States. 85

2.6.1            Medicare. 85

2.6.2            Medicaid. 86

2.6.3            US Health Reform in 2010: Towards Universal Drug Coverage?. 88

CHAPTER 3: THE PHARMACEUTICAL INDUSTRY. 91

3.1           Corporate Social Responsibility and the Pursuit of Profit 91

3.2           The impact of Competition (Antitrust) Law and Intellectual Property Rights. 95

3.3           The European Union’s 2009 Pharmaceutical Sector Inquiry Report 106

CHAPTER 4: CONCLUSIONS AND RECOMMENDATIONS.. 109

4.1           The Impact of Drug Regulation. 109

4.2           Social objectives versus Economic priorities in Pharmaceutical Policy and Legislation   114

4.3           Promoting Pharmaceutical Innovation. 117

4.4           Achieving the Aims and Objectives of this Thesis. 120

4.5           Towards Preventive Medicine: A Proposal 124

4.6           Proposed Studies. 129

BIBLIOGRAPHY. 130