EUROPEAN PHARMACEUTICAL PRICING AND REIMBURSEMENT

TABLE OF CONTENTS i

LIST OF TABLES v

I EXECUTIVE SUMMARY 6

A. Overview of Pharmaceutical Pricing and Reimbursement in Europe 6

B. France 7

C. Germany 8

D. Italy 9

E. Spain 10

F. United Kingdom 11

G. Sources for All Chapters 12

II. EUROPE 16

A. Overview of Pharmaceutical Pricing, Reimbursement, Pharmacoeconomics, and Distribution in Europe 16

B. Sources for Europe Chapter 17

III. FRANCE 18

A. Pharmaceutical Pricing Policies in France 19

1. The Negotiation Process 19

2. Key Pricing Considerations 19

3. The "Sector Accord" and Product Contracts 20

4. National Spending Caps 21

5. Active Promotion of Generics 21

6. Price Cuts 21

7. Expiration of the "Sector Accord" 22

8. Industry Call for Pricing Reform 22

B. Pharmaceutical Reimbursement Policies in France 23

1. Key Considerations in Reimbursement 23

2. De-Listings Rare 23

3. A Call to Reduce Decision-Making Time 24

C. Pharmacoeconomic Policies in France 25

1. Formal Pharmacoeconomic Evaluation 25

D. Pharmaceutical Distribution Channels in France 27

1. Value-Added Tax (VAT) 27

2. Prices and Parallel Exporting 27

3. Price List 27

4. Mark-Ups 28

E. Outlook for Pharmaceutical Pricing, Reimbursement, Pharmacoeconomics, and Distribution in France 29

F. Key Contacts for Pharmaceutical Pricing, Reimbursement, Pharmacoeconomics, and Distribution in France 30

1. Agence Francaise De Securite Sanitaire Des Produits De Sante (AFSSAPS) 30

2. Caisse National D'Assurance Maladie Des Travailleurs Salaries (CNAMTS) 32

3. Syndicat National De L'Industrie Pharmaceutique (SNIP) 32

G. Sources for France Chapter 33

IV. GERMANY 34

A. Pharmaceutical Pricing Policies in Germany 34

1. Reference Price System (Non-Patent Protected Products) 34

2. Industry Contribution Staves Off Price Cut 36

B. Pharmaceutical Reimbursement Policies in Germany 37

1. The "Negative List" 37

2. A Potential "Positive List" 37

C. Pharmacoeconomic Policies in Germany 39

1. The Principle of Cost-Effectiveness 39

D. Pharmaceutical Distribution Channels in Germany 40

1. Regulated Margins 40

2. High Prices and Parallel Importation 40

3. Aut Idem Plan for Substitution 40

4. Price List 41

5. Mail-Order Pharmacies 41

E. Outlook for Pharmaceutical Pricing, Reimbursement, Pharmacoeconomics, and Distribution in Germany 43

F. Key Contacts for Pharmaceutical Pricing, Reimbursement, Pharmacoeconomics, and Distribution in Germany 44

1. Gesetzliche Krankenversicherund (GKV) 44

2. Berufsverband Der Arzneimittelhersteller (BAH) 44

3. Verband Forschender Arzneimittelhersteller 45

4. Deutscher Generikaverband 45

5. Bundesinstitut Fur Arzneimittel Und Medizinprodukte 46

G. Sources for Germany Chapter 47

V. ITALY 48

A. Pharmaceutical Pricing Policies in Italy 48

1. International Reference Pricing 49

2. Factors Considered in Pricing Decisions 49

3. Process and Timing 49

4. Nationwide Price Cuts 50

5. Price Increase Postponed Indefinitely 51

6. Therapeutic Reference Pricing 51

7. Monitoring Activities 51

B. Pharmaceutical Reimbursement Policies in Italy 52

1. Toward Cost-Benefit Classification of Patented Products 52

2. Reimbursement Classification System 52

3. Increased Regional Control and Modifications to the System of Co-Payments 53

4. Demographics-Based Co-Payment Exemptions 54

5. Product De-Listing and Industry Paybacks 55

6. Price Caps and a New Reimbursement Class for Generics 55

7. National and Regional Product De-listing 55

8. Industry Paybacks 55

C. Pharmacoeconomics Policies in Italy 56

D. Pharmaceutical Distribution Channels in Italy 57

1. Low Prices and Parallel Trade 57

2. Mark-Ups and VAT 57

3. Fixed Rebates from Pharmacies to the National Health Service 58

4. Generic Substitution Rights 58

E. Outlook for Pharmaceutical Pricing, Reimbursement, Pharmacoeconomics, and Distribution in Italy 59

F. Key Contacts for Pharmaceutical Pricing, Reimbursement, Pharmacoeconomics, and Distribution in Italy 60

1. Comitato Interministeriale Per La Programmazione Economica (CIPE) Interministerial Committee for Economic Planning Unit for Drug Surveillance 60

2. Ministero Della Salute 61

3. Servizio Sanitario Nazionale (SSN) 64

4. Farmindustria 64

5. Regional Health Authorities in Italy 65

G. Sources for Italy Chapter 70

VI. SPAIN 72

A. Pharmaceutical Pricing in Spain 72

1. Health Care Decentralization 73

2. Reporting Prices 74

3. Spending Caps 74

4. Price Cuts 74

5. Product Copies and the Introduction of Patents 74

6. Industry Subsidies for Health Care 74

7. Introduction of Generics and the Reference Price System (RPS) 75

B. Pharmaceutical Reimbursement Policies in Spain 76

1. The Defunct National Reimbursement System 76

2. Moving Toward Regional Control 77

3. Process and Timing 77

C. Pharmacoeconomic Policies in Spain 78

D. Pharmaceutical Distribution Channels in Spain 79

1. Low Prices and Parallel Exporting 79

2. Regulated Mark-Ups 79

3. Boosting Generics 79

E. Outlook for Pharmaceutical Pricing, Reimbursement, Pharmacoeconomics, and Distribution in Spain 80

F. Key Contacts for Pharmaceutical Pricing, Reimbursement, Pharmacoeconomics, and Distribution in Spain 81

1. Comision Interministerial De Precios De Los Medicamentos 81

2. Agencia Espanola Del Medicamento 82

3. Ministerio De Sanidad Y Consumo 83

4. Gestion De Prestaciones Farmaceuticas 83

5. Insalud 83

6. Key Regional Health Authorities in Spain 83

G. Sources for Spain Chapter 86

VII. UNITED KINGDOM 87

A. Pharmaceutical Pricing Policies in the United Kingdom 87

1. Pharmaceutical Price Regulation Scheme (PPRS) 87

2. Maximum Prices for Generics 88

3. Rationalizing Pharmaceutical Use Through the National Institute for Clinical Excellence (NICE) 90

4. Risk-Sharing Deals 90

B. Pharmaceutical Reimbursement Policies in the United Kingdom 91

1. Reimbursable Products 91

2. The "Blacklist" and the "Greylist" 92

3. Reimbursement Authorities 92

4. Co-Payments 93

5. Improving Clinical and Cost-Effectiveness of Prescribing 93

6. Pressure for Use of Expensive Drugs 93

7. Timing for Reimbursement Decisions 94

C. Pharmacoeconomic Policies in the United Kingdom 95

D. Pharmaceutical Distribution Channels in the United Kingdom 96

1. Discounts and the "Claw-Back" 96

2. Controls on Profitability 97

3. Value-Added Tax (VAT) 97

4. Price Lists 97

E. Outlook for Pharmaceutical Pricing, Reimbursement, Pharmacoeconomics, and Distribution in the United Kingdom 98

F. Key Contacts in Pharmaceutical Pricing, Reimbursement, Pharmacoeconomics, and Distribution in the United Kingdom 99

1. National Health Service (NHS) 99

2. Department of Health 102

3. Association of the British Pharmaceutical Industry (ABPI) 103

4. American Pharmaceuticals Group (APG) 103

G. Sources for UK Chapter 104