干细胞生物技术的伦理研究:法国和欧洲的法规和伦理考量

Research in Biotechnology with Stem Cells:French and European Regulations and Ethical Concerns

生物技术的研究与应用中所使用的生物材料涉及其来源问题。是否应该使用人类干细胞或胚胎干细胞?关于人类干细胞,法国于1994年即规定人体不可侵犯且不是财产,人体不能买卖,也不能成为专利。在欧洲,欧洲理事会《关于人权与生物医学公约》规定:由每个国家自行批准是否可以进行胚胎研究。从完全禁止到允许核移植研究,欧洲各国之间存在差异。关于细胞商业化及专利的问题,欧盟《关于生物技术发明的法律保护指令》提到:生物技术发明对社会的发展至关重要,只有充分的保护才可以使其获利,并促进贸易。

The use of biological material for biotechnology applications and research raises the question of sources. Should we use human stem cells or embryonic stem cells？ For human stem cells, since 1994, the French law considers the human body is inviolable and cannot be subject of property that means no trade and no patent. In Europe, the Oviedo convention （Council of Europe） on human rights and biomedicine says： it is up to each country to authorize the embryo research. There are differences among countries in Europe, from a total ban to an approval of the research with nuclear transfer. Regarding commercialization of cells and patentability, the European directive on legal protection of biological inventions says., biotechnology inventions are essential for the development of the community; only adequate protection can make them profitable and facilitate trade.