Overview

Official position paper by the Council of Europe’s European Committee on Organs, Tissues and Cells (CD-P-TO), adopted on 8 October 2026. This document outlines a regulatory approach for human organs that undergo ex situ manipulation, including genetic or enzymatic modifications, prior to transplantation.

Risks of Classifying Manipulated Organs as Medicinal Products

• Ethical conflicts: Regulating organs as medicinal products may blur the fundamental ethical distinction between a donated human organ and a commercial therapeutic product, potentially undermining public trust.
• Inequity in patient access: High development costs and premium pricing could result in access to transplantation being determined by financial resources rather than clinical need.
• Risks to healthcare sustainability: Additional costs from pharmaceutical manufacturing requirements, licensing, and market pricing could place severe financial pressure on public transplant programmes.

Six Recommendations for a European Regulatory Model

1. Integration into regular donation programmes: Manipulated organs should be managed within official, publicly managed organ donation programmes based on scientific and ethical criteria.
2. Distinction of ownership: Donated organs must remain non-commercial public resources, while intellectual property rights may only apply to the technologies (e.g., perfusion systems, medicinal products) used to manipulate them.
3. Distinction between assessment and authorisation: Assessment of quality, safety, and efficacy may involve pharmaceutical standards, but the final authorisation for clinical use should remain under the purview of transplant authorities.
4. Specific authorisation for organ processing: Medicinal products developed for and inextricably linked to organ processing should be subject to an authorisation for organ processing, rather than a standard marketing authorisation.
5. Incorporation into existing allocation systems: Organ distribution must continue to be guided solely by clinical criteria and official waiting lists, with technology providers having no role in recipient selection.
6. Safeguarding non-commercialisation: Regardless of any ex situ interventions, human organs must remain regulated under the transplantation framework and should not be treated as commercial products.