Stem Cell Patent: European Patent Law and Ethics

Project Summary

Stem cell research, and embryonic stem cell research in particular, offers the prospect of developing therapies for serious life-threatening diseases. At the same time, human embryonic stem cell research raises difficult and controversial moral questions which are reflected in a variety of moral perspectives and regulatory regimes already adopted or currently being developed in EU Member States. These vary from total prohibition to qualified authorisation in different forms and degrees.decorative image

The diversity of legal regimes regulating human embryonic stem cell research in Europe together with the subsidiarity principle, which devolves competency on legislation concerning ethical questions to Member States, has created uncertainty as to the legal scope of the ‘moral exclusion’ clause in Article 6 of Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (the Biotech Directive).

Clarification of the scope of Article 6 is essential to foster research and investment in Europe whilst ensuring that such research is conducted within clear ethical limits which address the concerns of society. The project aims to provide an analysis of the EU patent system, as applied to biotechnological inventions in general and to human embryonic stem cells related technology in particular with a view to ascertain the legal effect of ethical or legal divergence on European Patent Law.

The multi-facetted nature of the question raised requires the combined efforts of experts from different disciplines to contribute to the coordination, analysis and dissemination of knowledge in this area. The multidisciplinary character of the group of researchers carrying out the project is intended to bring the required breadth and depth of expertise to bear on the project.

 

 

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