The Regulatory Challenge of Biotechnology: Human Genetics, Food and Patents
. . . 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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2 Rethinking regulatory governance for the age of biotechnology
PART II Regulating human genetics
GMOs biosafety and environmental decisionmaking
the two faces of the precautionary principle
three levels three issues
issues of EC law
plant genetic resources and agricultural trade reform
PART IV Regulating biotechnology through the patent system
10 Should we regulate biotechnology through the patent system? The case of terminator technology
exploring the interface between regulation and innovation regimes
measures to restore trust in the patent system
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adopted aﬀect agricultural application Article authorization beneﬁts Bioethics biotech biotechnology biotechnology regulation Brownsword Cartagena cell research coexistence measures commercial Commission’s Community concerns Council crop germplasm decision Deliberate Release Directive developing countries diﬀerent diﬃcult draft economic eﬀects embryos environment environmental ethical European Commission example farmers ﬁeld ﬁrst Food and Feed gene genetic testing Genetically Modiﬁed Organisms global GM crops GM food GMCs GMOs human genetics industry inﬂuence informed consent Intellectual Property Intellectual Property Rights International inventions issues legislation license maize Member moral norms notiﬁcation oﬀer Oﬃce Oﬃcial Overwalle patent law patent system PGRFA plant genetic resources political potential practice precautionary principle protection Protocol reﬂect regime regu regulatory risk assessment scientiﬁc seed signiﬁcant social society speciﬁc SPS Agreement standards Stem Cell suﬃcient terminator technology therapeutic cloning trade transgenic Treaty World Trade Organization
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 äs 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...