STERREICHISCHES BUNDESINSTITUT FR GESUNDHEITSWESEN

BIG

Surveying, Assessing and Analysing the Pharmaceutical Sector in the 25 EU Member States

COMMISSIONED BY EUROPEAN COMMISSION - DG COMPETITION

Notice to the Reader: This report was produced by BIG for the European Commission and represents its views on the pharmaceutical sector reflecting the authors' state of knowledge as at Spring 2006. These views have not been adopted or in any way approved by the Commission and should not be relied upon as a statement of the Commission's or Competition Directorate General's views. The European Commission does not guarantee the accuracy of the data included in this report, nor does it accept responsibility for any use made thereof.

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sterreichisches Bundesinstitut fr Gesundheitswesen

BIG HealthEconomics

Surveying, Assessing and Analysing the Pharmaceutical Sector in the 25 EU Member StatesCountry ProfilesClaudia Habl Katja Antony Danielle Arts Michael Entleitner Barbara Frschl Christine Leopold Heidi Strzlinger Sabine Vogler Marion Weigl assisted by Romana Landauer

Vienna, July 2006

Commissioned by European Commission - DG Competition

List of Contents1 Introduction..........................................................................................................................................1 1.1 1.2 1.3 1.4 Background ...............................................................................................................................1 Objectives .................................................................................................................................2 Methodology..............................................................................................................................2 Outline .......................................................................................................................................3 1.4.1 Pharmaceutical System ...............................................................................................3 1.4.2 Pricing ..........................................................................................................................3 1.4.3 Reimbursement ...........................................................................................................3

2 Austria .................................................................................................................................................7 2.1 Pharmaceutical System ............................................................................................................7 2.1.1 Regulatory Framework and Authorities .......................................................................7 2.1.2 Market Players.......................................................................................................... 11 2.1.2.1 Pharmaceutical Industry..........................................................................11 2.1.2.2 Distribution ..............................................................................................12 2.1.2.3 Patients ...................................................................................................13 Pricing .................................................................................................................................... 15 2.2.1 Scope of Price Control.............................................................................................. 15 2.2.1.1 Manufacturer Price ..................................................................................16 2.2.1.2 Wholesale Price ......................................................................................18 2.2.1.3 Pharmacy Retail Price.............................................................................20 2.2.1.4 Value Added Tax (VAT) ..........................................................................22 2.2.2 Price related Cost-containment Measures ............................................................... 23 2.2.2.1 Pharmaco-economic Guidelines .............................................................23 2.2.2.2 Internal Price Referencing.......................................................................23 2.2.2.3 External Price Referencing / Cross Country Referencing.......................24 2.2.2.4 Price Freezes / Stops ..............................................................................24 2.2.2.5 Margin Cuts .............................................................................................24 2.2.2.6 Discounts and Rebates ...........................................................................25 2.2.2.7 Company Profit Controls .........................................................................26 2.2.2.8 Parallel Trade ..........................................................................................26 2.2.3 Co-Payments ............................................................................................................ 27 2.2.4 Information Transparency......................................................................................... 27 Reimbursement...................................................................................................................... 29 2.3.1 Pharmaceutical Lists and Reimbursement Categories ............................................ 30 2.3.1.1 Reimbursement Price..............................................................................30 2.3.1.2 Selection Criteria .....................................................................................34 2.3.1.3 Pharmaceuticals on Positive List ............................................................35 2.3.1.4 Generics ..................................................................................................36 2.3.1.5 Non-reimbursable Pharmaceuticals ........................................................37 2.3.1.6 Change in Approval by Head Physician..................................................37 2.3.1.7 Appeal Procedure....................................................................................38 2.3.1.8 Delisting...................................................................................................38 2.3.2 Reference Price System ........................................................................................... 38 2.3.3 Pharmaceutical Budgets........................................................................................... 38

2.2

2.3

V

2.3.4

Other Volume Control Oriented Measures ............................................................... 39 2.3.4.1 Prescription Monitoring and Other Doctors-related Measures................39 2.3.4.2 Generics and Parallel Trade ...................................................................39

2.4

Overview of the Reimbursement Market in Austria ............................................................... 41

3 Belgium............................................................................................................................................. 51 3.1 Pharmaceutical System ......................................................................................................... 51 3.1.1 Regulatory Framework and Authorities .................................................................... 51 3.1.2 Market Players.......................................................................................................... 55 3.1.2.1 Pharmaceutical Industry..........................................................................55 3.1.2.2 Distribution ..............................................................................................55 3.1.2.3 Patients ...................................................................................................57 3.1.3 Overview of the Pharmaceutical System.................................................................. 57 Pricing .................................................................................................................................... 59 3.2.1 Scope of Price Control.............................................................................................. 59 3.2.1.1 Manufacturer Price ..................................................................................60 3.2.1.2 Wholesale Price ......................................................................................61 3.2.1.3 Pharmacy Retail Price.............................................................................61 3.2.1.4 Value Added Tax (VAT) ..........................................................................62 3.2.2 Price Related Cost-containment Measures .............................................................. 62 3.2.2.1 Pharmaco-economic Evaluation .............................................................62 3.2.2.2 Internal Price Referencing.......................................................................62 3.2.2.3 External Price Referencing / Cross Country Referencing.......................62 3.2.2.4 Price Freezes / Stops ..............................................................................63 3.2.2.5 Price Cuts................................................................................................63 3.2.2.6 Margin Cuts .............................................................................................63 3.2.2.7 Discounts and Rebates ...........................................................................63 3.2.2.8 Company Profit Controls .........................................................................64 3.2.2.9 Promotion Control ...................................................................................64 3.2.2.10 Parallel Trade ..........................................................................................65 3.2.3 Co-Payments ............................................................................................................ 65 3.2.4 Information Transparency and Marketing................................................................. 66 Reimbursement...................................................................................................................... 67 3.3.1 Pharmaceutical Lists and Reimbursement Categories ............................................ 68 3.3.1.1 Reimbursement Price..............................................................................68 3.3.1.2 Selection Criteria .....................................................................................70 3.3.1.3 Pharmaceuticals on Positive List ............................................................70 3.3.1.4 Generics ..................................................................................................70 3.3.1.5 Non-reimbursable Pharmaceuticals ........................................................71 3.3.1.6 Delisting and Switches ............................................................................71 3.3.2 Reference Price System ........................................................................................... 71 3.3.3 Pharmaceutical Budgets........................................................................................... 72 3.3.4 Other Volume Control Oriented Measures ............................................................... 72 3.3.4.1 Prescription Monitoring and other Doctors-related Measures.................72 3.3.4.2 Generics and Parallel Trade ...................................................................73 Overview of the Reimbursement Market in Belgium.............................................................. 74

3.2

3.3

3.4

4 Cyprus .............................................................................................................................................. 81

VI

4.1

Pharmaceutical System ......................................................................................................... 81 4.1.1 Regulatory Framework and Authorities .................................................................... 81 4.1.2 Market Players.......................................................................................................... 83 4.1.2.1 Pharmaceutical Industry..........................................................................83 4.1.2.2 Distribution ..............................................................................................84 4.1.2.3 Patients ...................................................................................................84 Pricing .................................................................................................................................... 87 4.2.1 Scope of Price Control.............................................................................................. 87 4.2.1.1 Manufacturer Price ..................................................................................88 4.2.1.2 Wholesale Price ......................................................................................89 4.2.1.3 Pharmacy Retail Price.............................................................................89 4.2.1.4 Value Added Tax (VAT) ..........................................................................90 4.2.2 Price Related Cost-containment Measures .............................................................. 90 4.2.2.1 Pharmaco-economic Evaluation .............................................................90 4.2.2.2 Public Procurement .................................................................................90 4.2.2.3 External Price Referencing / Cross Country Referencing.......................90 4.2.2.4 Price Freezes / Stops ..............................................................................90 4.2.2.5 Margin Cuts .............................................................................................91 4.2.2.6 Discounts and Rebates ...........................................................................91 4.2.2.7 Company Profit Controls .........................................................................91 4.2.2.8 Parallel Trade ..........................................................................................91 4.2.3 Co-Payments ............................................................................................................ 91 4.2.4 Information Transparency......................................................................................... 91 Reimbursement...................................................................................................................... 92 4.3.1 Pharmaceutical Lists and Reimbursement Categories ............................................ 92 4.3.1.1 Reimbursement Price..............................................................................92 4.3.1.2 Pharmaceuticals on Positive List ............................................................92 4.3.1.3 Generics ..................................................................................................93 4.3.1.4 Non-reimbursable Pharmaceuticals ........................................................93 4.3.1.5 Appeal Procedure....................................................................................93 4.3.1.6 Delisting and Switches ............................................................................93 4.3.2 Reference Price System ........................................................................................... 93 4.3.3 Pharmaceutical Budgets........................................................................................... 93 4.3.4 Other Volume Control Oriented Measures ............................................................... 94 4.3.4.1 Prescription Monitoring and Other Doctors-related Measures................94 4.3.4.2 Generics ..................................................................................................94 Overview of the Reimbursement Market in Cyprus ............................................................... 94

4.2

4.3

4.4

5 Czech Republic .............................................................................................................................. 103 5.1 Pharmaceutical System ....................................................................................................... 103 5.1.1 Regulatory Framework and Authorities .................................................................. 103 5.1.2 Market Players........................................................................................................ 106 5.1.2.1 Pharmaceutical Industry....................................................................... 106 5.1.2.2 Distribution ........................................................................................... 106 5.1.2.3 Patients ................................................................................................ 107 5.1.3 Overview of the Pharmaceutical System................................................................ 108 Pricing .................................................................................................................................. 109 5.2.1 Scope of Price Control............................................................................................ 109

5.2

VII

5.2.2

5.2.3 5.2.4 5.3

5.2.1.1 Manufacturer Price ............................................................................... 110 5.2.1.2 Wholesale Price ................................................................................... 110 5.2.1.3 Pharmacy Retail Price.......................................................................... 110 5.2.1.4 Value Added Tax (VAT) ....................................................................... 110 Price Related Cost-containment Measures ............................................................ 111 5.2.2.1 Pharmaco-economic Evaluation .......................................................... 111 5.2.2.2 Internal Price Referencing.................................................................... 111 5.2.2.3 External Price Referencing / Cross-country Referencing .................... 111 5.2.2.4 Price Freezes / Stops ........................................................................... 111 5.2.2.5 Margin Cuts .......................................................................................... 111 5.2.2.6 Discounts and Rebates ........................................................................ 111 5.2.2.7 Company Profit Controls ...................................................................... 112 5.2.2.8 Parallel Trade ....................................................................................... 112 Co-Payments .......................................................................................................... 112 Information Transparency and Marketing............................................................... 112

Reimbursement.................................................................................................................... 113 5.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 114 5.3.1.1 Pharmaceuticals on Positive List ......................................................... 115 5.3.1.2 Generics ............................................................................................... 115 5.3.1.3 Non-reimbursable Pharmaceuticals ..................................................... 116 5.3.1.4 Appeal Procedure................................................................................. 116 5.3.1.5 Delisting................................................................................................ 116 5.3.2 Reference Price System ......................................................................................... 116 5.3.3 Pharmaceutical Budgets......................................................................................... 117 5.3.4 Other Volume Control Oriented Measures ............................................................. 117 5.3.4.1 Prescription Monitoring and Other Doctors-related Measures............. 117 5.3.4.2 Generics ............................................................................................... 118 Overview of the Reimbursement Market in the Czech Republic ......................................... 119

5.4

6 Denmark ......................................................................................................................................... 127 6.1 Pharmaceutical System ....................................................................................................... 127 6.1.1 Regulatory Framework and Authorities .................................................................. 127 6.1.2 Market Players........................................................................................................ 131 6.1.2.1 Pharmaceutical Industry....................................................................... 131 6.1.2.2 Distribution ........................................................................................... 131 6.1.2.3 Patients ................................................................................................ 132 6.1.3 Overview of the Pharmaceutical System................................................................ 133 Pricing .................................................................................................................................. 136 6.2.1 Scope of Price Control............................................................................................ 136 6.2.1.1 Manufacturer Price ............................................................................... 137 6.2.1.2 Wholesale Price ................................................................................... 137 6.2.1.3 Pharmacy Retail Price.......................................................................... 138 6.2.1.4 Value Added Tax (VAT) ....................................................................... 139 6.2.2 Price Related Cost-containment Measures ............................................................ 139 6.2.2.1 Pharmaco-economic Evaluation .......................................................... 139 6.2.2.2 Internal Price Referencing.................................................................... 140 6.2.2.3 External Price Referencing / Cross Country Referencing.................... 140 6.2.2.4 Price Freezes/Stops ............................................................................. 141 6.2.2.5 Margin Cuts .......................................................................................... 141

6.2

VIII

6.2.3 6.2.4 6.3

6.2.2.6 Discounts and Rebates ........................................................................ 141 6.2.2.7 Company Profit Controls ...................................................................... 142 6.2.2.8 Parallel Trade ....................................................................................... 142 Co-Payments .......................................................................................................... 142 Information Transparency and Marketing............................................................... 144

Reimbursement.................................................................................................................... 145 6.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 146 6.3.1.1 Reimbursement Price........................................................................... 146 6.3.1.2 Selection Criteria .................................................................................. 146 6.3.1.3 General and Individual reimbursement ................................................ 147 6.3.1.4 Generics and parallel traded products ................................................. 148 6.3.1.5 Non-reimbursable Pharmaceuticals ..................................................... 150 6.3.1.6 Appeal Procedure................................................................................. 150 6.3.1.7 Switches ............................................................................................... 150 6.3.2 Reference Price System ......................................................................................... 151 6.3.3 Pharmaceutical Budgets......................................................................................... 152 6.3.4 Other Volume Control Oriented Measures ............................................................. 152 6.3.4.1 Prescription Monitoring and Other Doctors-related Measures............. 152 Overview of the Reimbursement Market in Denmark .......................................................... 153

6.4

7 Estonia............................................................................................................................................ 161 7.1 Pharmaceutical System ....................................................................................................... 161 7.1.1 Regulatory Framework and Authorities .................................................................. 161 7.1.2 Market Players........................................................................................................ 163 7.1.2.1 Pharmaceutical Industry....................................................................... 163 7.1.2.2 Distribution ........................................................................................... 163 7.1.2.3 Patients ................................................................................................ 164 7.1.3 Overview of the Pharmaceutical System................................................................ 164 Pricing .................................................................................................................................. 166 7.2.1 Scope of Price Control............................................................................................ 166 7.2.1.1 Manufacturer Price ............................................................................... 167 7.2.1.2 Wholesale Price ................................................................................... 167 7.2.1.3 Pharmacy Retail Price.......................................................................... 168 7.2.1.4 Value Added Tax (VAT) ....................................................................... 168 7.2.2 Price related Cost-containment Measures ............................................................. 169 7.2.2.1 Pharmaco-economic Evaluation .......................................................... 169 7.2.2.2 Internal Price Referencing.................................................................... 169 7.2.2.3 External Price Referencing / Cross Country Referencing.................... 169 7.2.2.4 Price Freezes / Stops ........................................................................... 169 7.2.2.5 Margin Cuts .......................................................................................... 169 7.2.2.6 Discounts and Rebates ........................................................................ 169 7.2.2.7 Company Profit Controls ...................................................................... 170 7.2.2.8 Parallel Trade ....................................................................................... 170 7.2.3 Co-Payments .......................................................................................................... 170 7.2.4 Information Transparency and Marketing............................................................... 170 Reimbursement.................................................................................................................... 171 7.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 172 7.3.1.1 Reimbursement Price........................................................................... 173

7.2

7.3

IX

7.3.2 7.3.3 7.3.4

7.3.1.2 Selection Criteria .................................................................................. 173 7.3.1.3 Pharmaceuticals on Positive List ......................................................... 173 7.3.1.4 Generics ............................................................................................... 173 7.3.1.5 Non-reimbursable Pharmaceuticals ..................................................... 174 7.3.1.6 Delisting and Switches ......................................................................... 174 Reference Price System ......................................................................................... 174 Pharmaceutical Budgets......................................................................................... 175 Other Volume Control Oriented Measures ............................................................. 175 7.3.4.1 Prescription Monitoring and Other Doctors-related Measures............. 175 7.3.4.2 Generics ............................................................................................... 175

7.4

Overview of the Reimbursement Market in Estonia............................................................. 176

8 Finland............................................................................................................................................ 183 8.1 Pharmaceutical System ....................................................................................................... 183 8.1.1 Regulatory Framework and Authorities .................................................................. 183 8.1.2 Market Players........................................................................................................ 187 8.1.2.1 Pharmaceutical Industry....................................................................... 187 8.1.2.2 Distribution ........................................................................................... 187 8.1.2.3 Patients ................................................................................................ 188 8.1.3 Overview of the Pharmaceutical System................................................................ 188 Pricing .................................................................................................................................. 191 8.2.1 Scope of Price Control............................................................................................ 191 8.2.1.1 Manufacturer Price ............................................................................... 192 8.2.1.2 Wholesale Price ................................................................................... 193 8.2.1.3 Pharmacy Retail Price.......................................................................... 193 8.2.1.4 Value Added Tax (VAT) ....................................................................... 194 8.2.2 Price related Cost-containment Measures ............................................................. 194 8.2.2.1 Pharmaco-economic Evaluation .......................................................... 194 8.2.2.2 Internal Price Referencing.................................................................... 195 8.2.2.3 External Price Referencing / Cross Country Referencing.................... 195 8.2.2.4 Price Freezes / Stops ........................................................................... 196 8.2.2.5 Margin Cuts .......................................................................................... 197 8.2.2.6 Discounts and Rebates ........................................................................ 197 8.2.2.7 Company Profit Controls ...................................................................... 197 8.2.2.8 Parallel Trade ....................................................................................... 197 8.2.3 Co-Payments .......................................................................................................... 198 8.2.4 Information Transparency and Marketing............................................................... 199 Reimbursement.................................................................................................................... 200 8.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 200 8.3.1.1 Reimbursement Price........................................................................... 200 8.3.1.2 Pharmaceuticals on Positive List ......................................................... 201 8.3.1.3 Selection Criteria .................................................................................. 202 8.3.1.4 Generics ............................................................................................... 203 8.3.1.5 Non-reimbursable Pharmaceuticals ..................................................... 205 8.3.1.6 Appeal Procedure................................................................................. 206 8.3.1.7 Delisting, Withdrawals and Switches ................................................... 206 8.3.2 Reference Price System ......................................................................................... 207 8.3.3 Pharmaceutical Budgets......................................................................................... 207 8.3.4 Other Volume Control Oriented Measures ............................................................. 208

8.2

8.3

X

8.3.4.1 8.3.4.2 8.4

Prescription Monitoring and Other Doctors-related Measures............. 208 Generics and Parallel Trade ................................................................ 209

Overview of the Reimbursement Market in Finland............................................................. 210

9 France ............................................................................................................................................ 219 9.1 Pharmaceutical System ....................................................................................................... 219 9.1.1 Regulatory Framework and Authorities .................................................................. 219 9.1.2 Market Players........................................................................................................ 223 9.1.2.1 Pharmaceutical Industry....................................................................... 223 9.1.2.2 Distribution ........................................................................................... 224 9.1.2.3 Patients ................................................................................................ 224 9.1.3 Overview of the Pharmaceutical System................................................................ 225 Pricing .................................................................................................................................. 227 9.2.1 Scope of Price Control............................................................................................ 227 9.2.1.1 Manufacturer Price ............................................................................... 228 9.2.1.2 Wholesale Price ................................................................................... 231 9.2.1.3 Pharmacy Retail Price.......................................................................... 231 9.2.1.4 Value Added Tax (VAT) ....................................................................... 232 9.2.2 Price Related Cost-containment Measures ............................................................ 232 9.2.2.1 Pharmaco-economic Evaluation .......................................................... 232 9.2.2.2 Internal Price Referencing.................................................................... 232 9.2.2.3 External Price Referencing / Cross Country Referencing.................... 232 9.2.2.4 Price Cuts............................................................................................. 233 9.2.2.5 Margin Cuts .......................................................................................... 233 9.2.2.6 Discounts and Rebates ........................................................................ 234 9.2.2.7 Claw-back............................................................................................. 234 9.2.2.8 Company Profit Control and Promotion Control................................... 235 9.2.2.9 Parallel Trade ....................................................................................... 236 9.2.3 Co-Payments .......................................................................................................... 236 9.2.4 Information Transparency and Marketing............................................................... 237 Reimbursement.................................................................................................................... 237 9.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 238 9.3.1.1 Reimbursement Price........................................................................... 238 9.3.1.2 Selection Criteria .................................................................................. 238 9.3.1.3 Pharmaceuticals on Positive List ......................................................... 239 9.3.1.4 Generics ............................................................................................... 239 9.3.1.5 Non-reimbursable Pharmaceuticals ..................................................... 240 9.3.1.6 Delisting................................................................................................ 240 9.3.2 Reference Price System ......................................................................................... 240 9.3.3 Pharmaceutical Budgets......................................................................................... 241 9.3.4 Other Volume Control Oriented Measures ............................................................. 242 9.3.4.1 Prescription Monitoring and Other Doctors-related Measures............. 242 9.3.4.2 Generics ............................................................................................... 243 Overview of the Reimbursement Market in France ............................................................. 244

9.2

9.3

9.4

10 Germany......................................................................................................................................... 253 10.1 Pharmaceutical System ....................................................................................................... 253 10.1.1 Regulatory Framework and Authorities .................................................................. 253

XI

10.1.2 Market Players........................................................................................................ 256 10.1.2.1 Pharmaceutical Industry....................................................................... 256 10.1.2.2 Distribution ........................................................................................... 257 10.1.2.3 Patients ................................................................................................ 257 10.1.3 Overview of the Pharmaceutical System................................................................ 257 10.2 Pricing ................................................................................................................................ 259 10.2.1 Scope of Price Control............................................................................................ 259 10.2.1.1 Manufacturer Price ............................................................................... 259 10.2.1.2 Wholesale Price ................................................................................... 259 10.2.1.3 Pharmacy Retail Price.......................................................................... 261 10.2.1.4 Value Added Tax (VAT) ....................................................................... 262 10.2.2 Price Related Cost-containment Measures ............................................................ 262 10.2.2.1 Internal Price Referencing.................................................................... 262 10.2.2.2 External Price Referencing .................................................................. 262 10.2.2.3 Price Freezes / Stops ........................................................................... 262 10.2.2.4 Discounts and Rebates ........................................................................ 263 10.2.2.5 Parallel Trade ....................................................................................... 263 10.2.3 Co-Payments .......................................................................................................... 264 10.2.4 Information Transparency and Marketing............................................................... 264 10.3 Reimbursement.................................................................................................................... 265 10.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 265 10.3.1.1 Reimbursement Price........................................................................... 265 10.3.1.2 Reimbursable Pharmaceuticals ........................................................... 265 10.3.1.3 Generics ............................................................................................... 265 10.3.1.4 Non-reimbursable Pharmaceuticals ..................................................... 266 10.3.1.5 Delisting................................................................................................ 266 10.3.2 Reference Price System ......................................................................................... 266 10.3.3 Pharmaceutical Budgets......................................................................................... 267 10.3.4 Other Volume Control Oriented Measures ............................................................. 268 10.3.4.1 Prescription Monitoring and Other Doctors-related Measures............ 268 10.3.4.2 Generics and Parallel Trade ................................................................ 268 10.4 Overview of the Pharmaceutical Market in Germany .......................................................... 270 11 Greece............................................................................................................................................ 277 11.1 Pharmaceutical System ....................................................................................................... 277 11.1.1 Regulatory Framework and Authorities .................................................................. 277 11.1.2 Market Players........................................................................................................ 281 11.1.2.1 Pharmaceutical Industry....................................................................... 281 11.1.2.2 Distribution ........................................................................................... 281 11.1.2.3 Patients ................................................................................................ 281 11.1.3 Overview of the Pharmaceutical System................................................................ 282 11.2 Pricing ................................................................................................................................ 283 11.2.1 Scope of Price Control............................................................................................ 283 11.2.1.1 Manufacturer Price ............................................................................... 284 11.2.1.2 Wholesale Price ................................................................................... 285 11.2.1.3 Pharmacy Retail Price.......................................................................... 285 11.2.1.4 Value Added Tax (VAT) ....................................................................... 285 11.2.2 Price related Cost-containment Measures ............................................................. 285

XII

11.2.2.1 Pharmaco-economic Evaluation .......................................................... 285 11.2.2.2 Internal Price Referencing.................................................................... 286 11.2.2.3 External Price Referencing / Cross Country Referencing.................... 286 11.2.2.4 Price Freezes / Cuts............................................................................. 286 11.2.2.5 Margin Cuts .......................................................................................... 286 11.2.2.6 Discounts and Rebates ........................................................................ 286 11.2.2.7 Promotional Control.............................................................................. 287 11.2.2.8 Parallel Trade ....................................................................................... 287 11.2.3 Co-Payments .......................................................................................................... 287 11.2.4 Information Transparency and Marketing............................................................... 288 11.3 Reimbursement.................................................................................................................... 289 11.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 289 11.3.1.1 Reimbursement Price........................................................................... 290 11.3.1.2 Selection Criteria .................................................................................. 290 11.3.1.3 Generics ............................................................................................... 290 11.3.1.4 Non-reimbursable Pharmaceuticals ..................................................... 290 11.3.1.5 Delisting................................................................................................ 291 11.3.2 Reference Price System ......................................................................................... 291 11.3.3 Pharmaceutical Budgets......................................................................................... 291 11.3.4 Other Volume Control Oriented Measures ............................................................. 291 11.3.4.1 Prescription Monitoring and Other Doctors-related Measures............. 291 11.3.4.2 Generics and Parallel Trade ................................................................ 292 11.4 Overview of the Reimbursement Market in Greece............................................................. 292 12 Hungary .......................................................................................................................................... 299 12.1 Pharmaceutical System ....................................................................................................... 299 12.1.1 Regulatory Framework and Authorities .................................................................. 299 12.1.2 Market Players........................................................................................................ 303 12.1.2.1 Pharmaceutical Industry....................................................................... 303 12.1.2.2 Distribution ........................................................................................... 303 12.1.2.3 Patients ................................................................................................ 304 12.1.3 Overview of the Pharmaceutical System................................................................ 305 12.2 Pricing ................................................................................................................................ 307 12.2.1 Scope of Price Control............................................................................................ 307 12.2.1.1 Manufacturer Price ............................................................................... 308 12.2.1.2 Wholesale Price ................................................................................... 309 12.2.1.3 Pharmacy Retail Price.......................................................................... 310 12.2.1.4 Value Added Tax (VAT) ....................................................................... 312 12.2.2 Price related Cost-containment Measures ............................................................. 312 12.2.2.1 Pharmaco-economic Evaluation .......................................................... 312 12.2.2.2 Internal Price Referencing.................................................................... 312 12.2.2.3 External Price Referencing / Cross Country Referencing.................... 313 12.2.2.4 Price Stops / Cuts................................................................................. 313 12.2.2.5 Margin Cuts .......................................................................................... 314 12.2.2.6 Discounts and Rebates ........................................................................ 314 12.2.2.7 Company Profit Controls ...................................................................... 315 12.2.2.8 Parallel Trade ....................................................................................... 315 12.2.3 Co-Payments .......................................................................................................... 316 12.2.4 Information Transparency and Marketing............................................................... 317 XIII

12.3 Reimbursement.................................................................................................................... 320 12.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 321 12.3.1.1 Reimbursement Price........................................................................... 322 12.3.1.2 Selection Criteria .................................................................................. 323 12.3.1.3 Pharmaceuticals on Positive List ......................................................... 323 12.3.1.4 Generics ............................................................................................... 324 12.3.1.5 Non-reimbursable Pharmaceuticals ..................................................... 324 12.3.1.6 Appeal Procedure................................................................................. 324 12.3.1.7 Delisting................................................................................................ 324 12.3.2 Reference Price System ......................................................................................... 325 12.3.3 Pharmaceutical Budgets......................................................................................... 325 12.3.4 Other Volume Control Oriented Measures ............................................................. 326 12.3.4.1 Prescription Monitoring and other Doctors-related Measures.............. 326 12.3.4.2 Generics and Parallel Trade ................................................................ 326 12.4 Overview of the Reimbursement Market in Hungary ........................................................... 327 13 Ireland............................................................................................................................................. 337 13.1 Pharmaceutical System ....................................................................................................... 337 13.1.1 Regulatory Framework and Authorities .................................................................. 337 13.1.2 Market Players........................................................................................................ 341 13.1.2.1 Pharmaceutical Industry....................................................................... 341 13.1.2.2 Distribution ........................................................................................... 341 13.1.2.3 Patients ................................................................................................ 342 13.2 Overview of Pharmaceutical System ................................................................................... 342 13.3 Pricing ................................................................................................................................ 344 13.3.1 Scope of Price Control............................................................................................ 344 13.3.1.1 Manufacturer Price ............................................................................... 346 13.3.1.2 Wholesale Price ................................................................................... 346 13.3.1.3 Pharmacy Retail Price.......................................................................... 347 13.3.1.4 Value Added Tax (VAT) ....................................................................... 348 13.3.2 Price Related Cost-containment Measures ............................................................ 348 13.3.2.1 Pharmaco-economic Evaluation .......................................................... 348 13.3.2.2 Internal Price Referencing.................................................................... 349 13.3.2.3 External Price Referencing / Cross country Referencing..................... 349 13.3.2.4 Price Freezes / Stops ........................................................................... 349 13.3.2.5 Margin Cuts .......................................................................................... 349 13.3.2.6 Discounts, Rebates and Company Profit Controls............................... 349 13.3.2.7 Parallel Trade ....................................................................................... 350 13.3.3 Co-Payments .......................................................................................................... 351 13.3.4 Information Transparency....................................................................................... 351 13.4 Reimbursement.................................................................................................................... 352 13.4.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 353 13.4.1.1 Community Drug Schemes .................................................................. 353 13.4.1.2 Pharmaceuticals on Positive List ......................................................... 356 13.4.1.3 Generics ............................................................................................... 356 13.4.1.4 Non-reimbursable Pharmaceuticals ..................................................... 356 13.4.2 Reference Price System ......................................................................................... 356 13.4.3 Pharmaceutical Budgets......................................................................................... 356

XIV

13.4.4 Other Volume Control Oriented Measures ............................................................. 357 13.4.4.1 Prescription Monitoring and Other Doctors-related Measures............. 357 13.4.4.2 Generics and parallel trade .................................................................. 357 13.5 Overview of the Reimbursement Market in Ireland.............................................................. 359 14 Italy ............................................................................................................................................. 365

14.1 Pharmaceutical System ....................................................................................................... 365 14.1.1 Regulatory Framework and Authorities .................................................................. 365 14.1.2 Market Players........................................................................................................ 369 14.1.2.1 Pharmaceutical Industry....................................................................... 369 14.1.2.2 Distribution ........................................................................................... 370 14.1.2.3 Patients ................................................................................................ 372 14.1.3 Overview of the Pharmaceutical System................................................................ 373 14.2 Pricing ................................................................................................................................ 374 14.2.1 Scope of Price Control............................................................................................ 374 14.2.1.1 Manufacturer Price ............................................................................... 374 14.2.1.2 Wholesale Price ................................................................................... 377 14.2.1.3 Pharmacy Retail Price.......................................................................... 377 14.2.1.4 Value Added Tax (VAT) ....................................................................... 377 14.2.2 Price Related Cost-containment Measures ............................................................ 378 14.2.2.1 Pharmaco-economic Evaluation .......................................................... 378 14.2.2.2 Internal Price Referencing.................................................................... 378 14.2.2.3 External Price Referencing / Cross Country Referencing.................... 378 14.2.2.4 Price Freezes / Stops ........................................................................... 378 14.2.2.5 Price Cuts............................................................................................. 378 14.2.2.6 Margin Cuts .......................................................................................... 379 14.2.2.7 Discounts and Rebates ........................................................................ 380 14.2.2.8 Company Profit and Promotion Controls.............................................. 381 14.2.2.9 Parallel Trade ....................................................................................... 382 14.2.3 Co-Payments .......................................................................................................... 382 14.2.4 Information Transparency and Marketing............................................................... 383 14.3 Reimbursement.................................................................................................................... 384 14.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 384 14.3.1.1 Reimbursement Price........................................................................... 385 14.3.1.2 Selection Criteria .................................................................................. 385 14.3.1.3 Pharmaceuticals on Positive List ......................................................... 386 14.3.1.4 Generics ............................................................................................... 386 14.3.1.5 Non-reimbursable Pharmaceuticals ..................................................... 386 14.3.1.6 Delisting and switches.......................................................................... 387 14.3.2 Reference Price System ......................................................................................... 387 14.3.3 Pharmaceutical Budgets......................................................................................... 388 14.3.4 Other Volume Control Oriented Measures ............................................................. 388 14.3.4.1 Prescription Monitoring and Other Doctors-related Measures............. 388 14.3.4.2 Generics and Parallel Trade ................................................................ 389 14.4 Overview of the Reimbursement Market in Italy .................................................................. 390 15 Latvia ............................................................................................................................................. 397 15.1 Pharmaceutical System ....................................................................................................... 397

XV

15.1.1 Regulatory Framework and Authorities .................................................................. 397 15.1.2 Market Players........................................................................................................ 399 15.1.2.1 Pharmaceutical Industry....................................................................... 399 15.1.2.2 Distribution ........................................................................................... 400 15.1.2.3 Patients ................................................................................................ 400 15.1.3 Overview of the Pharmaceutical System................................................................ 401 15.2 Pricing ................................................................................................................................ 402 15.2.1 Scope of Price Control............................................................................................ 402 15.2.1.1 Manufacturer Price ............................................................................... 403 15.2.1.2 Wholesale Price ................................................................................... 403 15.2.1.3 Pharmacy Retail Price.......................................................................... 404 15.2.1.4 Value Added Tax (VAT) ....................................................................... 405 15.2.2 Price Related Cost-containment Measures ............................................................ 405 15.2.2.1 Pharmaco-economic Evaluation .......................................................... 405 15.2.2.2 Internal Price Referencing.................................................................... 406 15.2.2.3 External Price Referencing / Cross Country Referencing.................... 406 15.2.2.4 Price Freezes / Stops ........................................................................... 406 15.2.2.5 Margin Cuts .......................................................................................... 406 15.2.2.6 Discounts and Rebates ........................................................................ 406 15.2.2.7 Parallel Trade ....................................................................................... 406 15.2.3 Co-Payments .......................................................................................................... 407 15.2.4 Information Transparency and Marketing............................................................... 407 15.3 Reimbursement.................................................................................................................... 408 15.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 408 15.3.1.1 Reimbursement Price........................................................................... 409 15.3.1.2 Selection Criteria .................................................................................. 409 15.3.1.3 Pharmaceuticals on Positive List ......................................................... 409 15.3.1.4 Generics ............................................................................................... 410 15.3.1.5 Non-reimbursable Pharmaceuticals ..................................................... 410 15.3.1.6 Delisting................................................................................................ 410 15.3.2 Reference Price System ......................................................................................... 410 15.3.3 Pharmaceutical Budgets......................................................................................... 410 15.3.4 Other Volume Control Oriented Measures ............................................................. 411 15.3.4.1 Prescription Monitoring and Other Doctors-related Measures............. 411 15.3.4.2 Generics and Parallel Trade ................................................................ 411 15.4 Overview of the Reimbursement Market in Latvia ............................................................... 412 16 Lithuania ......................................................................................................................................... 421 16.1 Pharmaceutical System ....................................................................................................... 421 16.1.1 Regulatory Framework and Authorities .................................................................. 421 16.1.2 Market Players........................................................................................................ 425 16.1.2.1 Pharmaceutical Industry....................................................................... 425 16.1.2.2 Distribution ........................................................................................... 425 16.1.2.3 Patients ................................................................................................ 426 16.1.3 Overview - Pharmaceutical System........................................................................ 426 16.2 Pricing ................................................................................................................................ 429 16.2.1 Scope of Price Control............................................................................................ 429 16.2.1.1 Manufacturer Price ............................................................................... 430

XVI

16.2.1.2 Wholesale Price ................................................................................... 430 16.2.1.3 Pharmaceutical Retail Price ................................................................. 431 16.2.1.4 Value Added Tax (VAT) ....................................................................... 432 16.2.2 Price Related Cost-containment Measures ............................................................ 432 16.2.2.1 Pharmaco-economic Evaluation .......................................................... 432 16.2.2.2 Internal Price Referencing.................................................................... 433 16.2.2.3 External Price Referencing / Cross Country Referencing.................... 433 16.2.2.4 Price Freezes / Cuts............................................................................. 434 16.2.2.5 Margin Cuts .......................................................................................... 434 16.2.2.6 Discounts and Rebates ........................................................................ 434 16.2.2.7 Company Profit Controls ...................................................................... 434 16.2.2.8 Parallel Trade ....................................................................................... 435 16.2.3 Co-Payments .......................................................................................................... 435 16.2.4 Information Transparency and Marketing............................................................... 436 16.3 Reimbursement.................................................................................................................... 437 16.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 438 16.3.1.1 Reimbursement Price........................................................................... 439 16.3.1.2 Selection Criteria .................................................................................. 439 16.3.1.3 Pharmaceuticals on Positive List ......................................................... 440 16.3.1.4 Generics ............................................................................................... 440 16.3.1.5 Non-reimbursable Pharmaceuticals ..................................................... 440 16.3.1.6 Appeal Procedure................................................................................. 441 16.3.1.7 Delisting................................................................................................ 441 16.3.2 Reference Price System ......................................................................................... 441 16.3.3 Pharmaceutical Budgets......................................................................................... 441 16.3.4 Other Volume Control Oriented Measures ............................................................. 442 16.3.4.1 Prescription Monitoring and Other Doctors-related Measures............. 442 16.3.4.2 Generics and Parallel Trade ................................................................ 442 16.4 Overview of the Reimbursement Market in Lithuania .......................................................... 443 17 Luxembourg.................................................................................................................................... 451 17.1 Pharmaceutical System ....................................................................................................... 451 17.1.1 Regulatory Framework and Authorities .................................................................. 451 17.1.2 Market Players........................................................................................................ 454 17.1.2.1 Pharmaceutical Industry....................................................................... 454 17.1.2.2 Distribution ........................................................................................... 454 17.1.2.3 Patients ................................................................................................ 455 17.1.3 Overview of the Pharmaceutical System................................................................ 455 17.2 Pricing ................................................................................................................................ 457 17.2.1 Scope of Price Control............................................................................................ 457 17.2.1.1 Manufacturer Price ............................................................................... 458 17.2.1.2 Wholesale Price ................................................................................... 458 17.2.1.3 Pharmacy Retail Price.......................................................................... 458 17.2.1.4 Value Added Tax (VAT) ....................................................................... 460 17.2.2 Price related Cost-containment Measures ............................................................. 460 17.2.2.1 Pharmaco-economic Evaluation .......................................................... 460 17.2.2.2 Internal Price Referencing.................................................................... 460 17.2.2.3 External Price Referencing / Cross Country Referencing.................... 460 17.2.2.4 Price Freezes / Stops ........................................................................... 460 XVII

17.2.2.5 Margin Cuts .......................................................................................... 460 17.2.2.6 Discounts and Rebates ........................................................................ 460 17.2.2.7 Parallel Trade ....................................................................................... 461 17.2.3 Co-Payment ............................................................................................................ 461 17.2.4 Information Transparency and Marketing............................................................... 461 17.3 Reimbursement.................................................................................................................... 462 17.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 463 17.3.1.1 Reimbursement Price........................................................................... 463 17.3.1.2 Selection Criteria .................................................................................. 464 17.3.1.3 Pharmaceuticals on Positive List ......................................................... 464 17.3.1.4 Generics ............................................................................................... 464 17.3.1.5 Non-reimbursable Pharmaceuticals ..................................................... 464 17.3.1.6 Appeal Procedure................................................................................. 464 17.3.1.7 Delisting and Switches ......................................................................... 465 17.3.2 Reference Price System ......................................................................................... 465 17.3.3 Pharmaceutical Budgets......................................................................................... 465 17.3.4 Other Volume Control Oriented Measures ............................................................. 465 17.3.4.1 Prescription Monitoring and other Doctors-related Measures.............. 465 17.3.4.2 Generics ............................................................................................... 466 17.4 Overview of the Reimbursement Market in Luxembourg.................................................... 466 18 Malta ............................................................................................................................................. 473 18.1 Pharmaceutical System ....................................................................................................... 473 18.1.1 Regulatory Framework and Authorities .................................................................. 473 18.1.2 Market Players........................................................................................................ 476 18.1.2.1 Pharmaceutical Industry....................................................................... 476 18.1.2.2 Distribution ........................................................................................... 476 18.1.2.3 Patients ................................................................................................ 477 18.1.3 Overview of the Pharmaceutical System................................................................ 477 18.2 Pricing ................................................................................................................................ 480 18.2.1 Scope of Price Control............................................................................................ 480 18.2.1.1 Manufacturer Price ............................................................................... 481 18.2.1.2 Wholesale Price ................................................................................... 481 18.2.1.3 Pharmacy Retail Price.......................................................................... 481 18.2.1.4 Value Added Tax (VAT) ....................................................................... 482 18.2.2 Price Related Cost-containment Measures ............................................................ 482 18.2.2.1 Pharmaco-economic Evaluation .......................................................... 482 18.2.2.2 Public Procurement .............................................................................. 482 18.2.2.3 External Price Referencing / Cross Country Referencing.................... 482 18.2.2.4 Price Freezes / Stops ........................................................................... 482 18.2.2.5 Margin Cuts .......................................................................................... 482 18.2.2.6 Discounts and Rebates ........................................................................ 482 18.2.2.7 Company Profit Controls ...................................................................... 483 18.2.2.8 Parallel Trade ....................................................................................... 483 18.2.3 Co-Payments .......................................................................................................... 484 18.2.4 Information Transparency and Marketing............................................................... 485 18.3 Reimbursement.................................................................................................................... 485 18.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 485

XVIII

18.3.1.1 Reimbursement Price........................................................................... 486 18.3.1.2 Selection Criteria .................................................................................. 486 18.3.1.3 Pharmaceuticals on Positive List ......................................................... 486 18.3.1.4 Generics ............................................................................................... 486 18.3.1.5 Non-reimbursable Pharmaceuticals ..................................................... 487 18.3.1.6 Appeal Procedure................................................................................. 487 18.3.1.7 Delisting................................................................................................ 487 18.3.2 Reference Price System ......................................................................................... 487 18.3.3 Pharmaceutical Budgets......................................................................................... 487 18.3.4 Other Volume Control Oriented Measures ............................................................. 487 18.3.4.1 Prescription Monitoring and Other Doctors-related Measures............. 487 18.3.4.2 Generics and Parallel Trade ................................................................ 488 18.4 Overview of the Reimbursement Market in Malta ................................................................ 488 19 Netherlands .................................................................................................................................... 497 19.1 Pharmaceutical System ....................................................................................................... 497 19.1.1 Regulatory Framework and Authorities .................................................................. 497 19.1.2 Market Players........................................................................................................ 501 19.1.2.1 Pharmaceutical Industry....................................................................... 501 19.1.2.2 Distribution ........................................................................................... 502 19.1.2.3 Patients ................................................................................................ 503 19.1.3 Overview of the Pharmaceutical System................................................................ 503 19.2 Pricing ................................................................................................................................ 505 19.2.1 Scope of Price Control............................................................................................ 505 19.2.1.1 Manufacturer Price ............................................................................... 506 19.2.1.2 Wholesale Price ................................................................................... 506 19.2.1.3 Pharmacy Retail Price.......................................................................... 507 19.2.1.4 Value Added Tax (VAT) ....................................................................... 508 19.2.2 Price Related Cost-containment Measures ............................................................ 508 19.2.2.1 Pharmaco-economic Evaluation .......................................................... 508 19.2.2.2 External Price Referencing / Cross Country Referencing.................... 508 19.2.2.3 Price Freezes and Price Cuts .............................................................. 509 19.2.2.4 Discounts and Rebates ........................................................................ 509 19.2.2.5 Parallel Trade ....................................................................................... 511 19.2.3 Co-Payments .......................................................................................................... 511 19.2.4 Information Transparency and Marketing............................................................... 512 19.3 Reimbursement.................................................................................................................... 513 19.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 513 19.3.1.1 Reimbursement Price........................................................................... 514 19.3.1.2 Selection Criteria .................................................................................. 514 19.3.1.3 Pharmaceuticals on Positive List ......................................................... 515 19.3.1.4 Generics ............................................................................................... 515 19.3.1.5 Non-reimbursable Pharmaceuticals ..................................................... 515 19.3.1.6 Appeal Procedure................................................................................. 515 19.3.1.7 Delisting and Switches ......................................................................... 516 19.3.2 Reference Price System ......................................................................................... 516 19.3.3 Pharmaceutical Budgets......................................................................................... 517 19.3.4 Other Volume Control Oriented Measures ............................................................. 518 19.3.4.1 Prescription Monitoring and Other Doctors-related Measures............. 518 XIX

19.3.4.2

Generics and Parallel Trade ................................................................ 518

19.4 Overview of the Reimbursement Market in the Netherlands ............................................... 520 20 Poland ............................................................................................................................................ 527 20.1 Pharmaceutical System ....................................................................................................... 527 20.1.1 Regulatory Framework and Authorities .................................................................. 527 20.1.2 Market Players........................................................................................................ 531 20.1.2.1 Pharmaceutical Industry....................................................................... 531 20.1.2.2 Distribution ........................................................................................... 532 20.1.2.3 Patients ................................................................................................ 532 20.1.3 Overview of the Pharmaceutical System................................................................ 533 20.2 Pricing ................................................................................................................................ 535 20.2.1 Scope of Price Control............................................................................................ 535 20.2.1.1 Manufacturer Price ............................................................................... 537 20.2.1.2 Wholesale Price ................................................................................... 537 20.2.1.3 Pharmacy Retail Price.......................................................................... 537 20.2.1.4 Value Added Tax (VAT) ....................................................................... 538 20.2.1.5 Hospital Price ....................................................................................... 538 20.2.2 Price Related Cost-containment Measures ............................................................ 539 20.2.2.1 Pharmaco-economic Evaluation .......................................................... 539 20.2.2.2 Internal Price Referencing.................................................................... 539 20.2.2.3 External Price Referencing / Cross Country Referencing.................... 539 20.2.2.4 Price cuts.............................................................................................. 540 20.2.2.5 Margin Cuts .......................................................................................... 540 20.2.2.6 Discounts and Rebates ........................................................................ 540 20.2.2.7 Parallel Trade ....................................................................................... 540 20.2.3 Co-Payments .......................................................................................................... 540 20.2.4 Information Transparency and Marketing............................................................... 541 20.3 Reimbursement.................................................................................................................... 542 20.3.1 Pharmaceutical Lists and Reimbursement Categories .......................................... 543 20.3.1.1 Reimbursement Price........................................................................... 543 20.3.1.2 Selection Criteria .................................................................................. 544 20.3.1.3 Pharmaceuticals on Positive List ......................................................... 544 20.3.1.4 Generics ............................................................................................... 544 20.3.1.5 Non-reimbursable Pharmaceuticals ..................................................... 544 20.3.1.6 Appeal Procedure................................................................................. 544 20.3.1.7 Delisting and Switches ......................................................................... 545 20.3.2 Reference Price System ......................................................................................... 545 20.3.3 Pharmaceutical Budgets......................................................................................... 546 20.3.4 Other Volume Control Oriented Measures ............................................................. 546 20.3.4.1 Prescription Monitoring and Other Doctors-related Measures............. 546 20.3.4.2 Generics and Parallel Trade ................................................................ 546 20.4 Overview of the Reimbursement Market in Poland ............................................................. 547 21 Portugal .......................................................................................................................................... 557 21.1 Pharmaceutical System ....................................................................................................... 557 21.1.1 Regulatory Framework and Authorities .................................................................. 557 21.1.2 Market Players........................................................................................................ 561

XX

21.1.2.1 Pharmaceutical Industry....................................................................... 561 21.1.2.2 Distribution ........................................................................................... 562 21.1.2.3 Patients ................................................................................................ 563 21.1.3 Overview of the Pharmaceutical System................................................................ 564 21.2 Pricing ................................................................................................................................ 566 21.2.1 Scope of Price Control............................................................................................ 566 21.2.1.1 Manufacturer Price ............................................................................... 567 21.2.1.2 Wholesale Price ................................................................................... 569 21.2.1.3 Pharmacy Retail Price.......................................................................... 569 21.2.1.4 Value Added Tax (VAT) ....................................................................... 570 21.2.2 Price Related Cost-containment Measures ............................................................ 570 21.2.2.1 Pharmac