Addressing Risks Derived From the Commodification of Substances of Human Origin: A European Proposal Applicable Worldwide.
Journal
Transplantation
ISSN: 1534-6080
Titre abrégé: Transplantation
Pays: United States
ID NLM: 0132144
Informations de publication
Date de publication:
01 04 2023
01 04 2023
Historique:
medline:
4
4
2023
pubmed:
2
2
2023
entrez:
1
2
2023
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 36721301
doi: 10.1097/TP.0000000000004527
pii: 00007890-202304000-00018
pmc: PMC10065823
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
867-877Informations de copyright
Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.
Déclaration de conflit d'intérêts
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.
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