In order not to later block promising therapeutic benefits for type 1 diabetes patients it is essential that ethical and legal issues are identified for the whole process from obtainment of hESC to the clinical application of commercial products on a large scale. Ethical and legal issues as well as public and patient concerns need to be anticipated and analysed based on scholarship in ethics and law. Although centred on Swedish legislation, regulatory structure and practice, many aspects and implications are similar in several countries. The ethical questions are related to the moral status of the embryo, issues around patentability, sharing and access to data, information and consent procedures and issues around fairness on who shall have access to therapy. Of paramount interest is also to place the proposed research and development practice within the context of public and patient perceptions and how to proceed in order to deserve and maintain trust. As to the legal aspects, studies of the European law have not yet been undertaken in this field nor have studies of the national implications. A comparison between EU member states, such as Sweden, Germany and France, would lead to new perspectives on how EU law is implemented in the field but also on practical legal tools used or not used and the reasons why. Furthermore, the result of such a study would be beneficial for a comparison with US law.
Embryonic stem cells
Biomedical ethics and regulation