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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., Competing Interests: N.C. is member of the Governing Council of the Agencia Española de Medicamentos y Productos Sanitarios (Spanish Medicine and Medical Device Agency), pro bono appointment (as expert of recognized prestige in the field of Health Sciences, not representing any institution). The other authors declare no conflicts of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Kidney transplantation (KT) is the best therapeutic option for patients with end-stage renal disease in terms of survival, quality of life and cost-effectiveness. The fundamental difference of KT with respect to other therapies is that the process depends on the availability of organs for clinical use, availability that is insufficient to cover the increasing transplantation needs of the population. Another relevant feature of transplantation is that it entails a risk of transmission of diseases from donor to recipient, a risk that can be minimized, but not completely eliminated. Due to its characteristics and its unique nature (the human being), KT requires a specific regulation that guarantees the protection of all those who participate in the process: donors and their families, patients in need of a transplant, recipients of organs and healthcareprofessionals involved. In this article, we reviewthe ethical-legal standards that regulate the practice of kidney donation and transplantation at the international level and analyze the ethical-legal framework that is applicable in Spain.

A recent call for self-sufficiency in transplantation issued by the WHO faces variable worldwide activity, in which Spain occupies a privileged position, with deceased donation rates of 33-35per million population (pmp) and 85 transplants pmp. An evaluation of current challenges, including a decrease in deaths because of traffic accidents and cerebrovascular diseases, and a diversity of cultures in Spain, has been followed by a comprehensive strategy to increase organ availability. Actions include an earlier referral of possible donors to the transplant coordination teams, a benchmarking project to identify critical success factors in donation after brain death, new family approach and care methods, and the development of additional training courses aimed at specific groups of professionals, supported by their corresponding societies. Consensus documents to improve knowledge about safety limits for organ donation have been developed to minimize inappropriate discarding of organs. Use of organs from expanded criteria donors under an 'old for old' allocation policy has resulted from adaptation to the progressive decline of optimal organs. National strategic plans to deal better with organ shortage, while respecting solid ethical standards, are essential, as reflected in the WHO Guiding Principles and the Istanbul Declaration on Organ Trafficking and Transplant tourism., (© 2011 The Authors. Transplant International © 2011 European Society for Organ Transplantation.)