The European Committee on Organs, Tissues and Cells (CD-P-TO) of the Council of Europe, with Secretariat support from the European Directorate for the Quality of Medicines & HealthCare (EDQM), has published a position paper entitled “The regulatory approach to ex situ manipulation of human organs”. Adopted by the CD-P-TO on 8 October 2026 and published by the EDQM on 23 October 2026, the policy document proposes a European regulatory approach for human organs that undergo ex situ (outside-the-body) assessment, preservation and interventions beyond conventional preservation before transplantation. Its central objective is to ensure that technological innovation does not alter the legal and ethical status of donated organs or undermine the principles governing organ donation and transplantation.

The position paper, published by the European Directorate for the Quality of Medicines & HealthCare (EDQM) on 23 October 2026, addresses the regulatory challenges arising from the growing use of technologies to assess, preserve, condition and repair human organs before transplantation. The EDQM provides Secretariat support to the CD-P-TO.

Ex situ manipulation creates new regulatory questions

Technologies such as machine perfusion allow organs to be assessed and treated outside the body before transplantation. More advanced interventions may include targeted repair, conditioning and therapeutic or preventive procedures, including genetic or enzymatic modifications. Some of these approaches remain experimental.

The position paper defines ex situ manipulation as processing or intervention performed on organs outside the human body that goes beyond static or dynamic preservation. These developments could increase the availability of transplantable organs and improve graft function and transplantation outcomes. However, they also raise questions about the legal classification and regulatory oversight of organs subjected to interventions beyond conventional preservation.

The CD-P-TO examines the risks associated with applying the medicines regulatory framework directly or indirectly to manipulated human organs. Although these procedures may involve medicinal products, medical devices or substances of human origin, the committee argues that the technologies used should not change the legal and ethical status of the donated organ itself.

Risks of applying medicines regulation to organs

The position paper identifies several potential consequences if manipulated organs were treated as medicinal products:

• Commercialisation: Pricing, market exclusivity and commercial incentives could blur the distinction between donated organs and commercial therapeutic products.
• Inequitable access: High development costs and premium pricing could cause access to transplantation to depend increasingly on financial resources rather than clinical need.
• Pressure on healthcare systems: Additional authorisation, licensing and regulatory costs could increase the financial burden on public transplantation programmes.

The committee also warns that routine application of the medicines framework to manipulated organs could progressively affect the wider pool of transplantable organs, potentially undermining public trust in donation and allocation systems.

These concerns relate primarily to the potential classification of the organs themselves as medicinal products. The position paper does not argue that technologies or products used in organ processing should be exempt from regulation. Instead, it calls for a distinction between the donated organ and the products, technologies and procedures used to manipulate it.

Six recommendations for a European regulatory model

The CD-P-TO proposes six measures for Council of Europe member states and relevant regulatory bodies:

1. Integrate manipulated organs into established donation programmes:
   Organ donation should take place through official, publicly managed programmes, with donor evaluation and selection based on scientific and ethical criteria.
2. Separate organ status from ownership of technology:
   Donated organs should remain non-commercial public resources, while technologies used to manipulate them may be subject to intellectual property rights. Technology providers should not acquire ownership rights over the organs.
3. Distinguish assessment from authorisation:
   A proportionate system should assess the quality, safety and efficacy of manipulated organs before clinical use, while authorisation decisions should remain under the responsibility of transplantation authorities.
4. Introduce specific authorisation for organ processing:
   Medicinal products developed specifically for organ processing and inextricably linked to the organs should be subject to an authorisation for organ processing rather than a marketing authorisation. Applicable pharmaceutical requirements for manufacturing authorisation, good manufacturing practice, quality, safety and regulatory oversight would remain in place.
5. Retain existing organ allocation systems:
   Distribution should continue to follow official waiting lists and clinical criteria, with decisions based on medical need rather than market considerations. Technology providers should have no role in recipient selection or organ allocation.
6. Safeguard the transplantation framework and non-commercialisation:
   Human organs should remain governed by transplantation law regardless of the interventions performed on them and should not be treated as commercial products.

Maintaining the boundary between organs and technologies

The central principle of the position paper is that a donated organ should retain its status as a human organ regardless of the interventions performed on it. The regulatory framework should therefore focus on the procedures and technologies used, with oversight proportionate to the nature of the intervention and the risks introduced.

Medicinal products used in organ processing would remain subject to applicable pharmaceutical legislation and quality, safety and efficacy requirements under the supervision of the relevant national authorities. The committee proposes that products specifically developed for organ manipulation and inextricably linked to the organs should be covered by a specific authorisation for organ processing, rather than a marketing authorisation. This distinction is intended to prevent the regulatory treatment of the processing products from indirectly turning donated organs into commercial products.

The paper also recognises that legitimate remuneration for transplantation-related services, recovery of justified costs and investment in research and development can coexist with the principle that human organs themselves must not generate financial gain.

The CD-P-TO presents the paper as a basis for developing a European model that supports responsible biomedical innovation without compromising the ethical foundations of organ donation. Its recommendations are intended to inform future regulatory approaches across Council of Europe member states. The position paper is not a binding legislative act and does not itself introduce new legal requirements or an operational authorisation procedure.