Recent scientific advances have made it possible to produce biopharmaceuticals in genetically modified plants and animals, such as maize, tobacco, goats, and chickens. This new branch of biotechnology is termed pharming, composed of the terms pharmaceuticals and farming. Pharming constitutes an overlap of red and green biotechnology. It offers the prospect of a quicker, cheaper, and more flexible production of biopharmaceuticals compared with current production processes. This is a promising perspective in light of the rapidly growing market of biopharmaceuticals, although the economic competitiveness of pharming remains to be proven. Besides possible benefits for producers, patients and health care systems, pharming also raises a number of complex ecological, social, moral and legal questions that have as yet not been thoroughly discussed.
The present book contains the findings of an interdisciplinary research project that has addressed a large range of questions associated with pharming: An analysis of the state-of-the-art of plant pharming and animal pharming technologies is followed by an assessment of environmental risks related to pharming and welfare risks for pharming animals. Public views and attitudes to pharming are investigated on the basis of a comprehensive survey in 15 countries. Moreover, ethical and legal questions, posed by present and foreseeable future practices of pharming, are analysed. The concluding chapter presents the authors main findings and recommendations, addressed to science, industry, politics and general public interested in the chances and risks of this upcoming field of biotechnology.

1;Preface;7 2;Foreword;9 3;Short table of contents;11 4;Comprehensive table of contents;13 5;List of abbreviations;19 6;1 Introduction;21 7;2 The technology of pharming;29 7.1;2.1 Recombinant pharmaceutical proteins - the advent of biotechnology;29 7.2;2.2 Plants as a production platform for recombinant biopharmaceuticals;31 7.3;2.3 Animals as a production platform for recombinant biopharmaceuticals;47 7.4;2.4 Quality and safety of the product;83 7.5;2.5 Choice of expression systems;84 7.6;2.6 References;86 8;3 Risk assessment of plant pharming and animal pharming;93 8.1;3.1 Environmental risks and co-existence of plants genetically modified for production of pharmaceuticals;93 8.2;3.2 Environmental risks of animal pharming;113 8.3;3.3 References;115 9;4 The welfare of pharming animals;121 9.1;4.1 Introduction;121 9.2;4.2 Animal welfare risks;122 9.3;4.3 The concept and assessment of animal welfare;124 9.4;4.4 Animal welfare considerations in the animal pharming production phase;125 9.5;4.5 Animal welfare considerations in the development phase;129 9.6;4.6 Conclusions;135 9.7;4.7 References;137 10;5 Public views and attitudes to pharming;141 10.1;5.1 Introduction;141 10.2;5.2 Methodological considerations;146 10.3;5.3 Attitudes to pharming in advanced societies: awareness and evaluative perspectives;151 10.4;5.4 A differentiated landscape of perceptions of pharming;156 10.5;5.5 Preferences for methods of production of pharmaceuticals;162 10.6;5.6 Awareness and acceptance of plant and animal pharming;163 10.7;5.7 Elements of an explanatory model;164 10.8;5.8 Conclusions;172 10.9;5.9 Tables;173 10.10;5.10 References;196 11;6 The ethical evaluation of pharming;199 11.1;6.1 Introduction;199 11.2;6.2 Foundations of moral reasoning;200 11.3;6.3 Common moral concerns regarding pharming;204 11.4;6.4 Risk assessment and risk-benefit analysis;213 11.5;6.5 References;218 12;7 The role of patents in the development of pharming;221 12.1;7.1 The general justification of patents;221 12.2;7.2 The existing regulatory framework;222 12.3;7.3 Basic rules on patentability of biological products, biological material and biological and microbiological processes;223 12.4;7.4 Extent of protection;225 12.5;7.5 Mandatory licenses;226 12.6;7.6 Patents as obstacles to innovation in pharming?;227 12.7;7.7 References;231 13;8 Legal problems of pharming;233 13.1;8.1 Introduction;233 13.2;8.2 Development phase I: Protection from risks to the environment caused by the use and release of GMOs;233 13.3;8.3 Development phase II: Animal protection;261 13.4;8.4 Development phase III: Protection of occupational safety and health in the development of recombinant medicinal products;275 13.5;8.5 Development phase IV: Regulation of development medicinal products;277 13.6;8.6 Market authorization phase;278 13.7;8.7 Production phase;287 13.8;8.8 References;303 14;9 Conclusions and recommendations;311 14.1;9.1 Pharming technology and its market;311 14.2;9.2 Public attitudes and moral evaluation;312 14.3;9.3 The assessment and management of risks associated with pharming;314 15;Glossary;323 16;Appendix: Examples of GM pharmaceutical crops and animals;335 17;List of authors;343 18;Index;349