The European Court of Human Rights’Ruling on Unproven Stem Cell Therapies: A Missed Opportunity?

Dec 22, 2014

Authors: Emmanuelle Rial-Sebbag and Alessandro Blasimme

Article in World Stem Cell Report 2014. Stem Cells and Development. December 2014, 23(S1).

Abstract: On May 6th 2014, the European Court of Human Rights added yet a new element to the judicial history of stem cells as it ruled in Durisotto v. Italy [appeal n. 62804/13]. The ruling rejected a patient claim to access an unproven cell therapy—an outcome that is certainly to be welcomed. However, this ruling is a missed occasion to clarify and reaffirm some important legal distinctions that could have greatly benefited the whole field of regenerative medicine. We claim that the ethical and political assumptions that sustain the regulation of expanded access programs to new therapies should be carefully scrutinized, with particular attention to the justifications for the risks connected to unconventional therapies. A clear legal definition of what counts as compassionate cure as distinct from unregulated and untested therapies cannot be provided unless those points are previously addressed.

Part of this work is supported by the EUCelLEX project.