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Tesi Dottorato Doctoral School in Comparative and European Legal Studies XXV cycle Ph.D. thesis “Synthetic biology, concerns and risks: looking for a (constitutionally oriented) regulatory framework and a system of governance for a new emerging technology” Thesis supervisor: Ph.D. Candidate: Prof. Carlo Casonato Ilaria Anna Colussi Academic Year 2011-2012 Ph. D. Candidate: Ilaria Anna Colussi “Synthetic biology, concerns and risks: looking for a (constitutionally oriented) regulatory framework and a system of governance for a new emerging technology” Thesis supervisor: Prof. Carlo Casonato Academic Year 2011-2012 Curriculum: Public Law Area: Comparative Public Law XXV cycle Final Exam: 18 th April 2013 Examination Board: Prof. Lorenzo Chieffi, University of Naples Prof. Aitziber Emaldi Cirión, University of Deusto/Bilbao Prof. Alessandra Magliaro, University of Trento Prof. Federico Gustavo Pizzetti, University of Milan “When you set out on your journey to Ithaca, pray that the road is long, full of adventure, full of knowledge. The Lestrygonians and the Cyclops, the angry Poseidon - do not fear them: You will never find such as these on your path, if your thoughts remain lofty, if a fine emotion touches your spirit and your body. The Lestrygonians and the Cyclops, the fierce Poseidon you will never encounter, if you do not carry them within your soul, if your soul does not set them up before you. Pray that the road is long. That the summer mornings are many, when, with such pleasure, with such joy you will enter ports seen for the first time; stop at Phoenician markets, and purchase fine merchandise, mother-of-pearl and coral, amber and ebony, and sensual perfumes of all kinds, as many sensual perfumes as you can; visit many Egyptian cities, to learn and learn from scholars. Always keep Ithaca in your mind. To arrive there is your ultimate goal. But do not hurry the voyage at all. It is better to let it last for many years; and to anchor at the island when you are old, rich with all you have gained on the way, not expecting that Ithaca will offer you riches. Ithaca has given you the beautiful voyage. Without her you would have never set out on the road. She has nothing more to give you. And if you find her poor, Ithaca has not deceived you. Wise as you have become, with so much experience, you must already have understood what Ithaca means”. (C. Kavafis) Dedicated to this Ph.D.: a hard, but in the end rewarding journey, that gave me the opportunity to travel around the world, meet brilliant people, experience life in many of its facets, including pain, discouragement, hope, persistence, satisfaction, and let me taste a bit of the anxiety, the thirst and beauty of research. TABLE OF CONTENTS Pg. ABSTRACT ......................................................................................................... ix INTRODUCTION ................................................................................................ 1 CHAPTER I SYNTHETIC BIOLOGY BETWEEN EVOLUTION AND REVOLUTION Introduction: Science and Technology, a Rich and Complex Scenery ............... 9 1. What is Synthetic Biology? Historical Steps in Search of a Definition .......... 10 2. Sub-fields of Synthetic Biology ....................................................................... 16 2.1. Advanced Genetic Engineering ..................................................................... 17 2.2. DNA-based Device Construction .................................................................. 17 2.3. Synthetic Genomics or Genome-driven Cell Engineering (Construction of Minimal Genome) .......................................................................................... 19 2.4. Protocell Creation or In Vitro Synthetic Biology (Creation of the Minimal Cell) ............................................................................................................... 20 2.5. Unnatural Molecular Biology (Design of new Biological Entities) ............. 21 2.6. In Silico Approach ......................................................................................... 22 2.7. Xeno-biology ................................................................................................. 23 2.8. Synthetic Microbial Consortia ...................................................................... 23 3. Classification of Synthetic Products, Approaches and Achieved Results ....... 24 3.1. Products ........................................................................................................ 24 3.2. Approaches .................................................................................................... 25 3.2.1. Top-down Approach ............................................................................ 25 3.2.2. Bottom-up Approach ........................................................................... 26 4. Potential and Effective Benefits from Applications of Synthetic Biology ...... 28 4.1. In the Environment, for Agriculture and Food ............................................. 29 4.2. In Energy, Industrial and Chemical Field .................................................... 30 4.3. In the Biomedical Sector ............................................................................... 31 5. Challenges, Risks and Concerns of Synthetic Biology .................................... 32 5.1. Biosafety risks ............................................................................................... 33 5.2. Biosecurity risks ............................................................................................ 35 5.3. Challenges to Intellectual Property Rights ................................................... 37 5.4. International Justice Concerns ..................................................................... 40 5.5. Ethical Concerns of a Different Nature ........................................................ 41 Conclusion ............................................................................................................ 44 CHAPTER II THE GOVERNANCE OF CONCERNS AND RISKS ARISING IN THE CONTEXT OF SYNTHETIC BIOLOGY ........................................................... 45 A Premise: the Notion of “Governance” .............................................................. 46 Part I: How to Manage the Concerns and Risks of Synthetic Biology? .............. 47 1. The Traditional Model of Risk Assessment, Risk Management and Risk Communication ............................................................................................... 48 2. Reframing Risks and Concerns in Synthetic Biology ...................................... 50 3. The “Risk Assessment” within Synthetic Biology ........................................... 50 4. The “Concern Assessment” within Synthetic Biology .................................... 55 5. The “Risk and Concern Management” within Synthetic Biology ................... 55 5.1. The “Prudent Vigilance” Model ................................................................... 57 5.2. The Precautionary Principle ......................................................................... 64 5.2.1. The Weak Version and its Limits ......................................................... 68 5.2.2. The Moderate Version and its Limits .................................................. 70 5.2.3. The Strong Version and its Limits ....................................................... 71 5.2.4. The “Anti-catastrophe” Version and its Limits .................................. 74 5.2.5. The Procedural Version and its Limits ............................................... 75 ii 5.2.6. The Precautionary Principle in International Law ............................. 77 5.2.6.1. “Hard” and “Soft Law”. ....................................................... 77 5.2.6.2. Judicial Cases ...................................................................... 79 5.2.7. The Precautionary Principle in European Union Law ....................... 81 5.2.7.1. Treaties, “Hard Law” and “Soft Law” ................................ 81 5.2.7.2. Case-Law .............................................................................. 86 5.2.8. The Precautionary Principle in the United States of America ............ 90 5.2.9. The Precautionary Principle in the United Kingdom ......................... 92 5.2.10. The Precautionary Principle in Italy ................................................ 93 5.3. Cost-Benefit Analysis .................................................................................... 98 5.3.1. Cost-Benefit Analysis as such and its Limits ....................................... 99 5.3.2. Risk-Benefit Analysis and its Limits .................................................... 101 5.3.3. Risk Trade-Off Analysis and its Limits ................................................ 103 5.3.4. Cost-Benefit Analysis in International Law ........................................ 104 5.3.5. Cost-Benefit Analysis in European Union Law .................................. 105 5.3.6. Cost-Benefit Analysis in the United States of America ....................... 106 5.3.7. Cost-Benefit Analysis in the United Kingdom ..................................... 107 5.3.8. Cost-Benefit Analysis in Italy .............................................................. 107 5.4. The Proactionary Principle and its Limits .................................................... 108 5.4.1. The Application of the Proactionary Principle ................................... 111 6. The “Risk and Concern Communication” within Synthetic Biology .............
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