Rial-Sebbag Emmanuelle, Blasimme Alessandro
Paul Sabatier Département d'épidémiologie et de santé publique, Faculté de Médecine, UMR 1027, INSERM, Université de Toulouse 3, Toulouse, France .
Stem Cells Dev. 2014 Dec;23 Suppl 1(Suppl 1):39-43. doi: 10.1089/scd.2014.0361.
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.
2014年5月6日,欧洲人权法院在“杜里索托诉意大利案”(上诉编号:62804/13)的裁决中,为干细胞司法历史增添了新内容。该裁决驳回了患者获取未经证实的细胞疗法的诉求——这一结果无疑值得欢迎。然而,此次裁决错失了一个澄清和重申一些重要法律区别的机会,而这些区别本可极大地惠及整个再生医学领域。我们认为,支撑新疗法扩大准入计划监管的伦理和政治假设应得到仔细审视,尤其要关注与非常规疗法相关风险的正当理由。除非事先解决这些问题,否则无法明确界定什么是有同情心的治疗,有别于不受监管和未经测试的疗法。