Biotechnology - Biotech Regulation and Business Strategy...

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Biotech Regulation and Business Strategy The European Market and Business Strategy 06.03.07 Inger-Johanne Sand
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What is bio-technology – in terms of regulation, – and why is it internationally regulated ? - regulating biotech. research, ethically, – such as cloníng, stem-cells, genetics, - the use of medical biotechnologies, - genetics, reproductive technologies, stemcells, - genetical information, - prenatal, - genetic diseases, - the use of bio-banks, - patents on biotech. innovations, intellectual property rights (IPR), - genetically modified organisms, - genetically modified food, - production, sale, - trade regulations, (IPR),
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Some of the qualitative aspects of the field of bio-tech regulation : - advanced and specialized scientific research, - the potential advantages for medical research, health, food production etc., - economic interests , growth industry, - genetics : - do we want all this knowledge ? - ethical considerations, - the risks : - changes in the biodiversity, - unpredictable risks, - controversial risks, Dilemma : - the need of international regulation vs. the different cultural and economic responses to it ,
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The field of the regulation of bio-technology consists of several, different and conflictual logics (rationalities) : - scientific – technological, - ethical: - what consequences are tolerable, - economic assessments, - political assessments : - industrial , health, food production, precaution, - legal regulation: - public, contractual, european, international, - risk, precaution,
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The different contexts of biotech regulation : National legislation : - normally all policy fields are treated on an equal and parallell basis, EU legislation : - free movement of goods and services, - art.28 ”quantitative restrictions on imports and all measures having eqivalent effect shall be prohibited….” - all obstacles prohibited unless justified for spec reasons exception clauses art. 30, - various particular directives, on GMOs, IPR, WTO/GATT : - GATT art.XI: - general elimination of quantitative restrictions, - SPS treaty, - art.XX, exception clauses,
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The EU : - the GMO-directive,EC-01/18, - legal protection of biotechnologival inventions, dir.98/44 - EC treaties – free trade, - regulation 1408/71 – health services, International : - WTO / SPS / TRIPS Agreements, - Convention on Biological Diversity - Bio-safety-protocol, - International Declaration on Human Genetic Data, - Universal Dclaration on the Human Genome and Human Rights, - Universal Declaration on Bioethics and Human Rights, - Helsinki Declaration, World Medical Association,
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The regulation of bio-technology as inter-, supra-, transnational and national : - research and the use of medical biotechnology : - national legislation, transnational standards, (reproduct. techn., treatment,) (ethical motivation) - ethically sensitive legislation – cloning, genetics: -
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This note was uploaded on 04/08/2008 for the course HIST HE35 taught by Professor Multiple during the Spring '08 term at Copenhagen Business School.

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Biotechnology - Biotech Regulation and Business Strategy...

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