Coordinación Autonómica de Trasplantes de Andalucía, Servicio Andaluz de Salud, Sevilla, Spain.
Banc de Sang i Teixits, Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain.
Transplantation. 2023 Apr 1;107(4):867-877. doi: 10.1097/TP.0000000000004527. Epub 2023 Feb 1.
In view of the public consultation recently launched by the World Health Organization on Regulatory Convergence of Cell and Gene Therapy Products and the Proposal for a Regulation on substances of human origin (SoHO) repealing the European Union Directives on Blood and on Tissues and Cells, an opportunity arises to define an ethical and transparent framework of collaboration between industry and authorities responsible for SoHO-derived products, comprising medicines, medical devices, transfusion, and transplantation. The commodification of SoHO-derived medicinal products and medical devices entails important risks to the sustainability of healthcare systems and threatens the equitable access of patients to innovative therapies. It may also jeopardize the principle of altruistic donation of SoHO that is required for the treatment and survival of thousands of patients every year. This article puts forward several proposals aimed at reconciling the ethical principles of voluntary and unpaid SoHO donation and the noncommercialization of the human body with obtaining a profit that allows business activities, while ensuring high quality, safety, and efficacy standards of tissues and cells for clinical use.
鉴于世界卫生组织最近就细胞和基因治疗产品监管趋同以及关于人体源物质（SoHO）的法规提案展开公开咨询，该提案旨在为负责 SoHO 衍生产品（包括药品、医疗器械、输血和移植）的行业和主管部门之间建立一个合乎伦理且透明的合作框架。SoHO 衍生的药品和医疗器械的商品化给医疗保健系统的可持续性带来了重大风险，也威胁到患者获得创新疗法的公平机会。它还可能危及每年为数以千计的患者的治疗和生存所需的 SoHO 无私捐赠原则。本文提出了几项建议，旨在协调自愿和无偿的 SoHO 捐赠的伦理原则以及人体的非商业化与获取利润之间的关系，从而使商业活动成为可能，同时确保组织和细胞用于临床使用的高质量、安全性和疗效标准。
