The Regulatory Challenge of Biotechnology: Human Genetics, Food and Patents

Front Cover
Han Somsen
Edward Elgar Publishing, 2007 M01 1 - 290 pages
. . . a compilation of 12 invaluable contributions on this issue by internationally known experts in their respective fields. . . a valuable resource for academic professionals, policy makers and legislators, advocacy groups and scholars in legal and deve

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Contents

lessons from environmental policy
3
2 Rethinking regulatory governance for the age of biotechnology
19
PART II Regulating human genetics
37
GMOs biosafety and environmental decisionmaking
95
the two faces of the precautionary principle
118
three levels three issues
139
issues of EC law
156
plant genetic resources and agricultural trade reform
174
PART IV Regulating biotechnology through the patent system
201
10 Should we regulate biotechnology through the patent system? The case of terminator technology
203
exploring the interface between regulation and innovation regimes
214
measures to restore trust in the patent system
238
Index
257
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Page 134 - In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.
Page 108 - The products of the territory of any contracting party imported into the territory of any other contracting party shall be accorded treatment no less favourable than that accorded to like products of national origin in respect of all laws, regulations and requirements affecting their internal sale, offering for sale, purchase, transportation, distribution or use.
Page 236 - April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (the Clinical Trials Directive).
Page 213 - States became a member of the International Union for the Pro-tection of New Varieties of Plants (UPOV).
Page 73 - Tests which are predictive of genetic diseases or which serve either to identify the subject s a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counselling.
Page 134 - Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision...
Page 194 - Xn + n) which all enjoy in common in the sense that each individual's consumption of such a good leads to no subtraction from any other individual's consumption of that good...
Page 252 - Disposal of a removed part of the human body When in the course of an intervention any part of a human body is removed, it may be stored and used for a purpose other than that for which it was removed only if this is done in conformity with appropriate information and consent procedures.
Page 110 - Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health...

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