Hauskeller Christine
Perspect Biol Med. 2018;61(1):42-58. doi: 10.1353/pbm.2018.0026.
Current European regulations hinder the compilation of the evidence that would be required to bring safe and effective autologous stem cell-based interventions (SCBIs) into standard clinical care. European agencies have expanded their regulations to cover all new SCBIs and research. They establish demanding conditions for cell retrieval, processing, and application. Drawing on empirical sociological findings from the implementation of the first phase III stem cell clinical trial in Europe, this article examines ethical problems effected by that policy, such as that the costs of bringing treatments to market means new autologous SCBIs may remain untested and that this plays in favor of the growing direct-to-consumer market, and that the research pathways in regenerative medicine and the role of clinician-scientists in developing new treatments are restricted, because the regulations are biased to enable specific SCBIs that are of interest to industry. This situation contradicts the moral and social concerns in favor of new treatments and patient interests, which the regulations supposedly safeguard. To align the aims and effects of policy better, European regulatory authorities should reconfigure their regulations to advance a fair and effective governance regime that allows pursuit of all promising SCBIs.
当前的欧洲法规阻碍了将安全有效的自体干细胞干预措施（SCBIs）纳入标准临床护理所需证据的收集。欧洲机构已扩大其法规范围，涵盖所有新的SCBIs和研究。它们为细胞采集、处理和应用设定了严格的条件。本文借鉴欧洲首个III期干细胞临床试验实施过程中的实证社会学研究结果，审视了该政策引发的伦理问题，比如将治疗推向市场的成本意味着新的自体SCBIs可能仍未得到测试，这有利于不断增长的直接面向消费者的市场，而且再生医学的研究途径以及临床科学家在开发新疗法中的作用受到限制，因为这些法规存在偏向，以支持行业感兴趣的特定SCBIs。这种情况与支持新疗法和患者利益的道德及社会关切相矛盾，而这些法规本应保障这些利益。为了更好地使政策的目标和效果保持一致，欧洲监管机构应重新制定其法规，以推进一个公平有效的治理体系，允许对所有有前景的SCBIs进行探索。
