Pharming (eBook)

Preface 7
Foreword 9
Short table of contents 11
Comprehensive table of contents 13
List of abbreviations 19
1 Introduction 21
2 The technology of pharming 29
2.1 Recombinant pharmaceutical proteins – the advent of biotechnology 29
2.2 Plants as a production platform for recombinant biopharmaceuticals 31
2.3 Animals as a production platform for recombinant biopharmaceuticals 47
2.4 Quality and safety of the product 83
2.5 Choice of expression systems 84
2.6 References 86
3 Risk assessment of plant pharming and animal pharming 93
3.1 Environmental risks and co-existence of plants genetically modified for production of pharmaceuticals 93
3.2 Environmental risks of animal pharming 113
3.3 References 115
4 The welfare of pharming animals 121
4.1 Introduction 121
4.2 Animal welfare risks 122
4.3 The concept and assessment of animal welfare 124
4.4 Animal welfare considerations in the animal pharming production phase 125
4.5 Animal welfare considerations in the development phase 129
4.6 Conclusions 135
4.7 References 137
5 Public views and attitudes to pharming 141
5.1 Introduction 141
5.2 Methodological considerations 146
5.3 Attitudes to pharming in advanced societies: awareness and evaluative perspectives 151
5.4 A differentiated landscape of perceptions of pharming 156
5.5 Preferences for methods of production of pharmaceuticals 162
5.6 Awareness and acceptance of plant and animal pharming 163
5.7 Elements of an explanatory model 164
5.8 Conclusions 172
5.9 Tables 173
5.10 References 196
6 The ethical evaluation of pharming 199
6.1 Introduction 199
6.2 Foundations of moral reasoning 200
6.3 Common moral concerns regarding pharming 204
6.4 Risk assessment and risk-benefit analysis 213
6.5 References 218
7 The role of patents in the development of pharming 221
7.1 The general justification of patents 221
7.2 The existing regulatory framework 222
7.3 Basic rules on patentability of biological products, biological material and biological and microbiological processes 223
7.4 Extent of protection 225
7.5 Mandatory licenses 226
7.6 Patents as obstacles to innovation in pharming? 227
7.7 References 231
8 Legal problems of pharming 233
8.1 Introduction 233
8.2 Development phase I: Protection from risks to the environment caused by the use and release of GMOs 233
8.3 Development phase II: Animal protection 261
8.4 Development phase III: Protection of occupational safety and health in the development of recombinant medicinal products 275
8.5 Development phase IV: Regulation of development medicinal products 277
8.6 Market authorization phase 278
8.7 Production phase 287
8.8 References 303
9 Conclusions and recommendations 311
9.1 Pharming technology and its market 311
9.2 Public attitudes and moral evaluation 312
9.3 The assessment and management of risks associated with pharming 314
Glossary 323
Appendix: Examples of GM pharmaceutical crops and animals 335
List of authors 343
Index 349