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Annex 14: Regulatory Review Introduction This annex sets out the findings for Task 1.6, which calls for the preparation of a comprehensive description of the legal framework concerning the Blue Biotechnology sector. At the outset it is to be noted that the legal framework in question is complex, extensive and multi-layered in that it involves aspects of international law (the body of law that regulates the relationship between States and other actors recognised under international law), European Union (EU) law and the national or domestic laws of the Member States as well as third countries. In terms of its scope it includes, in no particular order, aspects of the law of the sea, intellectual property law, contract law, biotechnology law, product sector regulatory law, liability law and last, but not least, the body of law that regulates the acquisition and use of genetic resources. The terms of reference to the Study provide, however, that special attention should be given to: (a) the exploitation and bio prospecting of marine resources in international waters; and (b) access to marine bio-resources data and information. Moreover, many of the detailed legal and regulatory issues that form part of the legal framework for the Blue Biotechnology sector apply to biotechnology products in general. Thus, for example, the regulatory requirements necessary to obtain approval for the marketing of Blue Biotechnology pharmaceutical products are, in principle, no different to those necessary for the placing on the market of other biotechnology pharmaceutical products. This annex therefore focuses on the issues that are specifically referred to in the terms of reference and which can truly be said to form part of the Blue Biotechnology sector. This annex is set out in eight parts, including this introduction. In terms of its order it follows the logical path for the development of Blue Biotechnology products from the initial acquisition of genetic resource through and beyond their introduction on to the market. The starting point is the acquisition of the marine genetic material that provides the basic building blocks for marine biotechnology. The legal rules that regulate this topic are the subject of part two. A key feature of the international legal framework that regulates access to genetic resources is the notion of ‘benefit sharing’: more specifically access to such resources is provided on the basis that the benefits of such access will be shared with the provider country. Benefit sharing, and in particular recent developments in international (and EU) law concerning this topic are considered in part three. In the case of Blue Biotechnology, as with other biotechnology sectors, the main ‘product’ from natural resources derives from the genetic information that they contain. Such information is protected through a range of intellectual property rights, which are considered in part four. The issue of benefit sharing is next re-visited in part five in connection with intellectual property rights. The legal framework for the use, manufacturing and marketing of Blue Biotechnology products is considered in part six while liability issues are considered in part seven. Finally a number of conclusions are drawn in part eight. Study in support of Impact Assessment work on Blue Biotechnology 191

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