The Legislative Evolution in the Regulation of Non-Human Organ Transplantation

5 min 16 sec February 18, 2026 (Edited) الترجمة العربية

Written by

Mohamed Al Marzouqi

Partner,
Head of Office – Abu Dhabi,
Co Head of Dispute Resolution

m.almarzouqi@tamimi.com View LinkedIn Profile

Dr. Omar Al Azawe

Of Counsel

o.alazawe@tamimi.com View LinkedIn Profile

Introduction

The Federal Decree-Law No. (15) of 2025, promulgated on 1 October 2025 and effective from 1 January 2026, introduces substantial amendments to Federal Decree-Law No. (25) of 2023 concerning the donation and transplantation of human organs and tissues (the “Decree-Law”). The amendments align the legal framework with rapid scientific and technological advances in transplantation and further the Decree-Law’s objective of enabling innovative solutions for the excision, transfer, and transplantation of organs and tissues. The most consequential changes modify Articles (18) and (25) to regulate the emerging field of non-human organs and tissues.

I. Change to the Title of the Decree-Law

To reflect its expanded scope, the title of the Decree-Law is revised from “Concerning the Donation and Transplantation of Human Organs and Tissues” to “Concerning the Donation and Transplantation of Organs and Tissues.” This change necessitates corresponding updates to institutional names. For example, “The National Centre for the Donation and Transplantation of Human Organs and Tissues” becomes “The National Centre for the Donation and Transplantation of Organs and Tissues.”

II. Substantive Amendments to Article (18)

A. From Limited Regulation to a Comprehensive Framework

Under the prior law issued in 2003, Article (18), titled “Non-Human Tissues,” governed only the excision and transfer of non-human tissues and imposed limited controls. Those controls required, among other things, a specialist physician’s confirmation that non-human tissue transplantation was the most suitable treatment; verification of safety, origin, and disease-free status; confirmation of compatibility with the patient; and disclosure to the patient of all potential and certain health outcomes.

In 2025, Article (18) is retitled “Non-Human Organs and Non-Human Tissues,” signifying a comprehensive expansion of regulatory scope. The amendment defines a non-human organ as a collection of non-human tissues or structures that perform one or more specific functions when transplanted into the human body. It recognises two principal categories:

Animal Organ – An organ or tissue obtained from a living animal-whether naturally produced, genetically modified, or biologically cultivated-and transplanted into the human body for therapeutic purposes. This definition reflects openness to contemporary techniques in cross-species organ transplantation, including xenotransplantation.

Manufactured Organ – An artificial construct produced through techniques such as three-dimensional bioprinting, tissue engineering, or other advanced technologies approved by the Ministry or the Health Authority. These organs are designed to perform vital functions and are not derived from living human or animal tissues. The explicit recognition of manufactured organs marks a legislative first, creating a clear pathway for the adoption of modern biotechnologies.

B. Strict Conditions and Controls

The amendment permits the transfer and transplantation of non-human organs and tissues into the human body subject to detailed conditions and controls, to be further specified by Cabinet decision, and anchored by the following regulatory pillars:

Medical Controls – Transplantation of a non-human organ or tissue must be the most appropriate treatment for the patient, as confirmed by a specialist physician. All non-human organs and tissues used in transplantation must undergo approved clinical and laboratory testing to demonstrate medical efficacy and biological safety according to Ministry-approved standards. Licensed facilities and specialist physicians must verify safety, confirm source, ensure the materials are disease-free, and complete all necessary procedural steps. Biological compatibility with the patient must be established based on Ministry-approved scientific and accepted medical standards prior to transplantation.

Licensing Controls – It is prohibited to excise or transplant any animal organ without a licence from the Ministry or the Health Authority. Health facilities must obtain a licence specifying the type and source of any non-human organ used in transplantation. Entities that manufacture non-human organs or tissues must be licensed by the Health Authority and approved by the relevant State authorities. Only duly licensed specialist physicians may perform transplantation procedures involving non-human materials.

Biological Safety Controls – The use of non-human organs or tissues from animal species that are not medically approved, or that have undergone genetic modifications or biological processing without proper authorisation, is prohibited.

Informed Consent – The specialist physician must inform the patient or legal representative of all potential and certain health outcomes prior to the operation and secure written consent using the National Centre’s approved form.

Special Committee Approval – Completion of donation and transplantation procedures requires prior approval from a special committee. The Minister or Head of the Health Authority, as applicable, will determine the committee’s composition and procedures in coordination with the National Centre for Organ and Tissue Donation and Transplantation.

C. Healthcare Obligations, Oversight, and National Database

Licensed health facilities must provide comprehensive healthcare to recipients before, during, and after the transplantation of a non-human organ (or part thereof) or non-human tissue, including all necessary examinations and treatments post-transplantation. Health authorities and other competent regulators must conduct periodic inspections of both health facilities and manufacturing entities.

A national database will be established at the National Centre to register every non-human organ used in transplantation. For manufactured organs, the database must include data on the manufacturing entity, biological composition, clinical trial results, and other information specified by the National Centre. The National Centre must document all stages of each transplantation, monitor potential effects, evaluate efficacy and safety, and review outcomes and medical reports.

1. Transfer Regulation and Procedural Guidance

The Cabinet is tasked with setting substantive controls for the transfer of non-human organs, parts thereof, and non-human tissues between health facilities within the State, as well as procedures for transfers to and from the State. These controls will be issued upon the Minister of Health and Prevention’s proposal and after coordination with health authorities and other relevant bodies. The Ministry must also issue procedural guides and technical forms necessary to implement Article (18), and update them periodically to reflect medical and scientific developments.

III. Amendments to Article (25) – Penalties

Under the former 2023 text, Article (25) provided imprisonment and a fine of AED 100,000 to AED 2 million for three categories of violations: operating a private health facility for excision or transplantation of human organs or tissues without a licence; a physician performing such procedures without a licence; and excising an organ or tissue from a living person without complying with Article (7).

In 2025, a fourth paragraph is added to penalise violations of Clause (2) of Article (18), which addresses non-human organs and tissues, with imprisonment and a fine of AED 100,000 to AED 2 million, or either penalty. The inclusion of the phrase “or either of these two penalties” expressly grants the judiciary discretion to impose imprisonment, a fine, or both, tailored to the circumstances of the offence.