Ever since the early discussions that preceded the adoption of the European legislation, questions were raised about the protection of persons from whom the cells are derived and about the weight ethical issues should have in these provisions. After a strong debate, the Commission adopted the position that ethics was within the competence of the national Member States (Hervey T.K. and Black H., 2005) and, therefore, only the main principles (such as informed consent or Data Protection) could be mentioned in the Directives.
However the ethical debate is present across the European Union and in its institutions. In fact, one study (Theracel study, unpublished) has surveyed that, since 1998, 11 opinions of the European Group of Ethics (EGE) were related to the uses of stem cells in Europe, since 1998. The first opinions were essentially concerned by the status of embryos, to evolve a few years later to the specific issues related to the use of cell therapy (Cells as medicinal product). This report concludes that ethical issues related to the use of human cells for health actually do play an important role at the EU level, namely within the framework of bioethical principles conventionally used in the field of protection of the human being. Interestingly, the large range of topics covered by the EGE in relation to cells, such as patents, Tissue banks, research etc., appears to follow a common ethical inspiration: the precautionary principle.
The European Parliament has established a strong tradition to edict recommendations and resolutions to ensure the respect of bioethical principles for the use of body elements in the context of health. Following the report delivered in June 2012 on “Voluntary and unpaid donation of tissues and cells” the European Parliament has adopted a resolution (September 2013) where core principles have been highlighted :
- the need to support international collaborations and exchanges of best practices,
- the need to reassert issues like informed consent, anonymity, traceability, information and unpaid donation and to respect the integrity of the person
Even though the EU has no legal competence in this area, the EU Charter of fundamental rights has to be respected as well as the judgments of the Court of Justice of the EU.