The Law and Ethics of the Pharmaceutical Industry

Cover......Page 1
The Law and Ethics of the Pharmaceutical Industry......Page 4
Preface......Page 6
Acknowledgements......Page 10
List of Boxes, Figures and Tables......Page 12
Table of Contents......Page 14
Part A: The Definition of Standards......Page 20
1.1 The Concept of a Pharmaceutical Product......Page 22
1.2 The Development of the Pharmaceutical Industry......Page 24
1.3 The Unique Nature of the Pharmaceutical Field and the Need for Rules......Page 26
1.5 Types of Industrial Firms Engaged in the Pharmaceutical Field......Page 29
1.5.1. Research-based companies......Page 30
1.5.2. “Generic” manufacturers......Page 31
1.6. The Reputation of the Pharmaceutical Industry......Page 33
2.1.1. General......Page 36
2.1.2. A basis in human rights......Page 38
2.1.3. The notion of business ethics......Page 41
2.2.1. Contract and sale of goods......Page 50
2.2.2. The law of tort and non-contractual liability......Page 52
2.2.3. Consumer protection legislation......Page 54
2.2.4. Intellectual property; trademarks, patents and data exclusivity......Page 57
2.2.5. Social and employment law......Page 73
2.2.6. Environmental law......Page 75
2.2.7. Company law and reporting obligations......Page 77
2.3. Competitive and Financial Pressures......Page 78
2.4. Political Influences......Page 79
2.5. The Influence of Litigation......Page 80
2.6. Public Relations and the Public Image......Page 83
2.7. The Location of the Company Conscience......Page 85
2.8.1. Types of codes......Page 87
2.8.2. Style and content of codes......Page 92
2.8.3. The usefulness of codes......Page 93
2.9. Transnational Corporations and Influences......Page 95
2.10. “Corporate Social Responsibility” and Government......Page 100
3.1. General Considerations......Page 104
3.2.1. A basis in trust......Page 105
3.2.2. Professional pharmacy in industry......Page 108
3.2.3. Allocation of general pharmaceutical responsibilities......Page 110
3.2.4. Trade interests vs. professional interests......Page 111
3.3.2. Current medical expertise......Page 114
3.3.3. The duty of care......Page 115
3.3.4. Confidentiality......Page 116
3.3.5. Allocation of general medical responsibility......Page 118
3.3.6. A code of ethics for pharmaceutical physicians?......Page 120
3.4.1. The evolution of modern drug regulation......Page 122
3.4.2. Policy, legislation and regulation......Page 127
3.4.3. Issues of responsibility and liability......Page 132
3.4.4. Relationship of the applicant to the regulatory agency......Page 134
3.4.5. Old vs. new products......Page 138
3.4.6. The global coverage of law and regulation......Page 139
3.4.7. Criticism of regulatory standards; deregulation......Page 142
3.4.8. The role of the WHO......Page 148
3.5. Self-regulation in the Pharmaceutical Industry......Page 151
Part B: Acceptance and Implementation of Standards......Page 154
4.1. Pre-marketing and Post-marketing Duties......Page 156
4.2.1. The legal concept of quality......Page 160
4.2.2. Establishment and maintenance of quality standards......Page 161
4.2.3. Packaging and distribution......Page 168
4.2.4. Nature and extent of quality defects......Page 169
4.2.5. Liability for quality defects......Page 170
4.3.1. The legal concept of safety......Page 173
4.3.2. Physical, social and mental injury......Page 176
4.3.3. Initial evidence of safety......Page 178
4.3.4. Adverse reaction monitoring systems......Page 181
4.3.5. Role and duties of industry in ADR monitoring......Page 184
4.3.7. Pregnancy, lactation and beyond9......Page 187
4.3.8. Relevance of regulatory approval to civil liability for injury......Page 189
4.4.1. The legal concept of efficacy......Page 192
4.4.2. Warranties and guarantees......Page 193
4.4.3. Efficacy of “old” drugs......Page 196
4.4.4. Proof of efficacy......Page 197
4.4.5. Publication bias......Page 198
4.4.6. Efficacy and compassion......Page 199
5.1. Need Marketing be Controlled by Law?......Page 202
5.2. Marketing Codes: from WHO onwards......Page 203
5.3. Can Marketing be Controlled by Law and Rule Making?......Page 204
5.4. Basic Information......Page 213
5.5. Persuasion......Page 217
5.5.2. Common points of dispute......Page 218
5.5.3. The detailman......Page 221
5.5.4. Advertising of prescription items to the public (“D.T.C.”)......Page 225
5.6. Disease Mongering......Page 226
5.7. Financial Incentives......Page 228
5.8. Education......Page 230
5.9. Miscellaneous Forms of Promotion......Page 231
5.10. Future Law and Policy......Page 233
6.1. Pharmaceutical Prices and Controversies......Page 234
6.2. The Level of Spending......Page 238
6.3. The Manufacturer’s Costs......Page 239
6.4. The Ethics of Pricing and Profits......Page 241
6.5. How does Society Control the Prices of Medicines?......Page 243
6.5.1. Calculation of a “fair” supply price......Page 244
6.5.2. Reference pricing (Huttin 2002)......Page 245
6.5.3. Economic evaluation of prices......Page 246
6.5.4. Control of profits and expenses......Page 247
6.7. Parallel Importation and the Question of Re-importation......Page 248
6.8. Future Approaches to Pricing......Page 253
7.1. Innovation and Duty......Page 254
7.2. The Innovation Controversy......Page 257
7.3.1. The real cost of a new drug......Page 258
7.3.2. Research expenditure within the company......Page 259
7.3.3. Innovation trends over time......Page 261
7.3.4. The spectrum of drugs reaching the market......Page 263
7.3.5. The non-industrial role in drug innovation......Page 266
7.4.1. Should the innovation process change?......Page 268
7.4.3. Is outside action necessary?......Page 271
7.4.4. The Drugs for Neglected Diseases Initiative......Page 272
7.4.5. Governments, communities and donors......Page 273
7.4.6. Independent non-profit research centres......Page 275
7.4.7. Official incentives to true innovation......Page 276
7.4.8. A total approach to innovation......Page 279
8.1. Pharmaceuticals in Developing Countries......Page 282
8.2. The Basis of Duty for Industry......Page 284
8.3. Industrial Performance in the Third World......Page 288
8.4. An Overview of Obligations......Page 290
8.5. Quality, Safety and Efficacy......Page 291
8.6. Access, Prices and Affordability......Page 292
8.7. Research and Development......Page 296
8.9. Clinical Investigation in Developing Countries......Page 298
8.10. Partnerships and Organizational Links......Page 301
8.11. Donations......Page 304
8.12. Essential Drugs......Page 306
8.14. Perspectives......Page 307
9.1. Ethics of Animal Studies......Page 310
9.2.1. General principles of human experimentation......Page 313
9.2.2. Sponsor and investigator......Page 314
9.2.3. The responsibilities of the sponsor......Page 317
9.3.1. The nature of self-medication......Page 320
9.3.2. Emergent concepts in self-medication......Page 323
9.3.3. Promotion and labelling......Page 325
9.4. Manufacturing and Supply of Vaccines......Page 329
9.3.4. Liability for self-medication products......Page 328
9.5. Blood and Blood Products......Page 333
9.6.1. Legal instruments governing controlled substances......Page 335
9.6.2. Duties of the manufacturer......Page 336
9.6.3. Ethics and controlled substances......Page 338
9.7.1. Products on the borderline......Page 339
9.7.2. “Nutritional Supplements” in the US......Page 340
9.7.3. Miscellaneous products......Page 341
9.8. Orphan Drugs......Page 345
9.9. Veterinary Drugs......Page 346
10.1. The Nature of the Generic Drug Industry......Page 348
10.2. The Significance of the Generic Industry......Page 349
10.3. Governments, Laws and Generics......Page 350
10.4. Generic Drugs in US Law......Page 351
10.5. Generic Drugs in the European Union......Page 353
10.6. Generic Drugs in India......Page 354
10.7. Generics and Data Exclusivity......Page 356
10.8. Generic Substitution......Page 357
10.9. Generic Biologicals, Biogenerics and Biosimilars......Page 359
10.10. The Future Status of the Generic Pharmaceutical Industry......Page 361
11.1. The Ethics of Contraception......Page 364
11.2. The “Morning after Pill”......Page 365
11.3. Abortifacients......Page 366
11.4. Patenting of Biological Materials......Page 367
11.5. Future Involvement in Social Controversy......Page 369
12.2. The Trouble with Law......Page 372
12.3. The Trouble with Governments......Page 374
12.4.1. The discrepancy......Page 377
12.4.2. The perils of success......Page 378
12.4.4. Attitude to the law......Page 379
12.5.1. Is change essential?......Page 381
12.5.3. The flow of money......Page 384
12.5.4. Bigger, better and broader?......Page 385
12.5.6. Forwards......Page 386
List of Selected References......Page 388
Index......Page 412