Organ and tissue transplantation is one of the clearest examples of an area where medical innovation cannot be separated from legal control. A successful transplant may depend on urgent clinical decisions, but the organ itself cannot be treated as an ordinary commodity. The law must address donor consent, medical suitability, allocation, death determination, transport, confidentiality, financial exploitation and the licensing of every professional and facility involved in the process.
The current UAE framework is centred on Federal Decree-Law No. 25 of 2023 Regarding the Donation and Transplantation of Organs and Tissues, as amended by Federal Decree-Law No. 15 of 2025. The amendments materially expanded the legislation beyond human organs and tissues by introducing a regulated pathway for certain non-human organs and tissues, including animal-derived and manufactured organs.
The statutory framework is now supplemented by Cabinet Resolution No. 61 of 2026, the current Executive Regulation, which came into force in 2026 and adds operational requirements for licensing, living-donor examinations and follow-up, paired donation, deceased-donor consent and other transplantation procedures.
The governing approach is strict but enabling: donation is permitted, organ commerce and trafficking are prohibited, facilities and physicians must be licensed, donors and recipients must receive appropriate medical protection, and emerging technologies can be used only through a separately controlled pathway.
The 2023 law replaced the older transplantation framework
Federal Decree-Law No. 25 of 2023 replaced the previous federal framework and created a more comprehensive national system for donation, removal, preservation, allocation, transport and transplantation.
Its objectives include:
- regulating and developing transplantation operations;
- ensuring fair allocation according to health need without discrimination based on gender, race, religion, social status or financial status;
- protecting donors and recipients;
- combating trafficking in human organs and tissues;
- preventing exploitation of patients and donors;
- supporting innovative transplantation solutions; and
- strengthening cooperation with other countries.
The National Center sits at the centre of the system
Article 5 gives the National Center broad powers over the transplantation system.
Its functions include developing licensing policies and standards, supervising licensed transplant establishments, promoting quality and safety, supporting training, conducting research, encouraging donation, cooperating with international organisations and maintaining the national databases required for transplant activity.
The national database includes lists of:
- patients who need organs or tissues;
- living donors;
- persons wishing to donate during life;
- persons who have made a will to donate after death;
- persons who record that they do not wish to donate after death; and
- removed organs and tissues for traceability purposes.
This national coordination is important because transplantation is not merely a relationship between one donor, one recipient and one hospital. Allocation, traceability and quality control require a system capable of tracking the organ from donor assessment through removal, transport and transplantation.
Only licensed physicians and licensed establishments may remove or transplant organs
Article 4 prohibits removal or transplantation of human organs, parts thereof or human tissues except through properly licensed specialist physicians working in health establishments licensed by the Ministry of Health and Prevention or the relevant health authority.
The 2026 Executive Regulation adds detailed licensing controls. A transplant establishment must have appropriate equipment, medical supplies, infrastructure, specialist personnel and an accredited laboratory meeting the standards adopted by the Ministry or health authority.
The establishment must also satisfy the National Center's procedures and current technical requirements.
Licensing is therefore service-specific. A general hospital licence does not automatically authorise organ retrieval or transplantation.
Licences require continuing performance, not one-time approval
Cabinet Resolution No. 61 of 2026 regulates licence renewal and requires transplant facilities to report operational information such as:
- the number of living donors;
- the number of deceased donors;
- the number and types of donated organs;
- the number of transplant procedures performed;
- the number of transplant recipients;
- success rates; and
- the extent of donor and recipient follow-up.
This turns licensing into an ongoing quality and governance process rather than an administrative certificate renewed without clinical evidence.
Living donation must be a donation, not a transaction
Article 7 provides that removal and transplantation between living persons may occur only by way of donation.
The law identifies the ordinary permitted family routes as:
- donation to relatives up to the fourth degree;
- donation to the relatives of either spouse, in respect of the other spouse, up to the fourth degree; and
- paired donation in accordance with the Executive Regulation.
Donation outside those categories can be permitted in specified circumstances, but requires approval from a special committee. That committee must verify the required medical reports and examinations and must satisfy itself that the proposed donation is free from suspicion of organ or tissue trafficking.
Consent must be free, informed and medically meaningful
The statutory concept of donation is based on consent without consideration.
Before a living donation, Article 8 requires the competent physician to conduct medical and psychological assessment of the donor and to verify:
- the donor's physical health;
- the donor's psychological and mental condition;
- that nothing is affecting the donor's consent;
- that the organ or tissue is medically suitable and free from dangerous disease;
- biological compatibility with the recipient; and
- that removal will not threaten the donor's life or cause harm beyond medically accepted limits.
The physician must also inform the donor of confirmed and potential medical consequences and other possible effects on personal, family and professional life.
The legal validity of living donation depends on more than a signed form. The clinical team must be able to demonstrate that the donor's decision was voluntary, informed and not distorted by pressure, financial inducement or medical unsuitability.
The donor can withdraw before removal
Article 14 protects the donor's continuing autonomy.
A living donor may withdraw from donation without restriction before removal of the organ, part, tissue or bone marrow. Once the organ or tissue has already been removed in accordance with law, however, the donor cannot demand its return.
Withdrawal rights are particularly important in living donation because family pressure can develop after the clinical process has already begun.
Facilities should therefore confirm willingness repeatedly rather than treating the first consent as irrevocable.
Paired donation is expressly regulated
The 2023 law expressly recognises paired donation, and the 2026 Executive Regulation provides the operational framework.
A typical paired-donation situation arises where one patient needs an organ and has a willing donor who is biologically incompatible, while a second patient from another family also has an incompatible willing donor. If each donor is compatible with the other family's recipient, the two donations can be matched.
The Executive Regulation requires written and authenticated consent and a clear explanation to both families of the incompatibility and the role of paired exchange.
It also addresses the difficult situation in which the paired procedures are not simultaneous and one donor withdraws after the other donation has already occurred. The framework provides protection mechanisms for the affected patient, including priority-list treatment or referral to the relevant committee where appropriate.
Bone marrow has a special statutory pathway
Article 10 creates a specific exception for bone-marrow transplantation.
A licensed health establishment may extract bone marrow from a person who fully or partially lacks legal capacity for transplantation to that person's parent, child or sibling, provided that:
- the legal guardian gives written consent;
- the donor will not be harmed;
- no better therapeutic alternative is available; and
- the procedure follows recognised medical standards.
The 2026 Executive Regulation states that recognised bone-marrow examination and treatment protocols in force in the UAE apply, together with any additional controls issued by the National Center.
Living donors are entitled to continuing healthcare
Article 9 requires licensed health establishments to provide comprehensive healthcare and psychological support to living donors and recipients before, during and after transplantation.
The 2026 Executive Regulation expands this duty by requiring appropriate pre-removal assessment, perioperative care and post-donation monitoring.
A transplant programme should therefore treat donor follow-up as part of the transplantation service rather than considering the donor's case complete when the organ is removed.
Deceased donation begins with the donor's recorded wishes
Article 11 allows a person to record unwillingness to donate after death.
If a person has not recorded unwillingness, donation after death may be possible with the consent required from the legal guardian or relatives under Article 12.
The National Center's database therefore plays an important role in preserving and verifying the person's recorded donation position.
Family consent follows a statutory order of priority
Where the deceased did not record unwillingness to donate, Article 12 permits donation with written and documented consent from the legal guardian or specified relatives.
The statutory priority includes:
- father;
- mother;
- children;
- spouse;
- grandfather;
- siblings; and
- the specified paternal-uncle category.
Where persons within the same level disagree, the law provides a rule for resolving that conflict based on seniority within that degree.
Cabinet Resolution No. 61 of 2026 then regulates the form of consent. It may be authenticated through approved electronic signature, notarial or embassy authentication, or a declaration before a designated National Center employee. Special procedures also apply where the relative is outside the UAE.
Unidentified deceased persons require prosecution involvement
The 2026 Executive Regulation creates a specific pathway for an unidentified deceased person.
The National Center must coordinate with the police and Public Prosecution to establish identity and locate qualifying relatives.
If identity cannot be established and the Public Prosecution confirms that position, the National Center may coordinate a medical suitability assessment, subject to additional safeguards where the death is suspicious or under criminal investigation.
If the deceased is suitable for donation, approval of the Public Prosecution must be obtained before the organ-removal process proceeds.
Death must be established independently of the transplant team
The law defines death by reference to irreversible cessation of circulatory and respiratory function or complete and irreversible cessation of all brain functions under the applicable medical standards.
The death determination process must remain separate from the incentives of the transplant procedure. Current transplantation practice therefore requires clinical verification under the legally approved standards before organs are removed from a deceased donor.
Dubai transplant standards, for example, require documented confirmation of brain death and separate documentation of donation consent before organ allocation and transplantation.
Anti-trafficking rules begin with a ban on sale and purchase
Article 19 contains the core statutory prohibitions.
It prohibits everyone—including healthcare establishments, physicians and other healthcare personnel—from:
- selling or purchasing human organs, parts or tissues;
- demanding consideration for them;
- advertising or promoting their sale or purchase; and
- mediating such transactions.
The law therefore attacks the commercial market at several levels: donor payment, buyer payment, advertising, brokerage and professional participation.
Trafficking carries severe criminal penalties
Article 21 provides a specific transplantation-law offence for anyone who traffics, or mediates with the intention of trafficking, in organs, parts or human tissues by any means, including information-technology means.
The penalty includes imprisonment of at least five years and a fine ranging from AED 200,000 to AED 2 million.
Article 22 separately criminalises selling, purchasing, offering, advertising, promoting, brokering or financing the sale or purchase of an organ, part thereof or human tissue, with imprisonment and fines ranging from AED 100,000 to AED 1 million.
The Human Trafficking Law can apply independently
Organ trafficking can also fall within Federal Decree-Law No. 24 of 2023 on Combating Human Trafficking.
That law treats removal of human organs or tissues as a form of exploitation where the trafficking elements are present, including recruitment, transport, receipt or control of a person through force, threat, coercion, fraud, abuse of authority or exploitation of vulnerability.
The general human-trafficking penalty is temporary imprisonment of at least five years and a minimum fine of AED 1 million, with life imprisonment and higher fines possible in aggravating circumstances.
Consent of the victim does not neutralise the trafficking offence where the statutory coercive or exploitative means are present.
Legitimate medical charges are different from payment for the organ
The anti-commercialisation rule does not mean transplant medicine must be provided without any healthcare charges.
The legal distinction is between:
- legitimate costs of hospitalisation, surgery, diagnostics, preservation, transport and professional healthcare services; and
- consideration paid for the human organ or tissue itself.
Facilities should structure invoices and donor-support programmes carefully so that payment for medical services cannot be mischaracterised as consideration for the organ.
Allocation must be based on medical need, not wealth
Fair allocation is one of the law's express objectives.
The National Center's priority lists and transplant databases are designed to support allocation according to patients' health conditions rather than gender, race, religion, social status or financial position.
The law also creates specified priority benefits for certain donors and relatives, but those statutory incentives operate within the national allocation framework and should not be confused with private purchase of priority.
Donor and recipient identity is protected
Article 15 establishes confidentiality between donor and recipient.
The recipient and the recipient's family ordinarily may not be informed of the donor's identity, and the deceased donor's family ordinarily may not be told the recipient's identity, except under National Center controls or judicial order.
This protects both privacy and the integrity of the non-commercial donation system.
Transport inside the UAE requires traceability
Article 17 permits transfer of human organs, parts and tissues between licensed health establishments within the UAE, but the organ must travel with defined documentation.
This includes:
- a report identifying the organ or tissue and its characteristics;
- confirmation of safety and absence of diseases threatening the recipient;
- preservation time and method;
- donor medical-examination results; and
- vehicle or transport information.
The transport process should therefore preserve both biological viability and legal traceability.
Cross-border transfer requires accredited institutions and anti-trafficking checks
Article 17 also regulates import and export of human organs and tissues.
For inbound transfer, the exporting entity must be accredited in the country of origin. For outbound transfer, the receiving entity must be accredited in the destination country.
The required documentation includes medical and preservation information and confirmation that there is no suspicion of organ or tissue trafficking.
International transfer is therefore a regulated clinical movement, not a private arrangement between donor and recipient.
The 2025 amendment opened a new legal pathway for non-human organs
Federal Decree-Law No. 15 of 2025 introduced the most technologically significant change to the UAE transplantation framework.
The amendment expanded the regime to cover non-human organs and tissues, including animal-derived organs and manufactured organs.
This is important because it creates a legal pathway for technologies that may include carefully regulated xenotransplantation and engineered or manufactured replacement organs, rather than forcing every new technology into rules designed only for human donors.
Emerging technology remains heavily controlled
The amended Article 18 does not create a general permission to implant any experimental organ.
Before a non-human organ or tissue may be transplanted, the current framework requires controls including:
- the procedure must be medically appropriate for the patient's condition;
- animal-organ removal must occur under the required Ministry or health-authority licensing;
- the health establishment and any manufacturing entity must hold the necessary approvals;
- the organ or tissue must undergo approved clinical and laboratory testing;
- medical efficacy and biological safety must be established;
- unapproved animal species or unauthorised genetic modification or biological treatment cannot be used without approval;
- the source and safety of the organ or tissue must be verified;
- biological compatibility with the recipient must be assessed;
- the patient or legal representative must receive information about known and potential consequences and provide written consent; and
- a dedicated committee must approve the procedure before transplantation.
The law therefore treats innovation as a regulated clinical pathway, not as an exception from transplant regulation.
Manufactured organs create new traceability obligations
The amended law requires the National Center to maintain a national database for non-human organs used in transplantation.
For manufactured organs, the database may include information concerning:
- the manufacturing entity;
- biological composition;
- clinical-trial results;
- safety and efficacy data; and
- other information required by the National Center.
All stages of the transplantation procedure are to be documented and monitored.
This signals a move toward lifecycle regulation: the regulator is not only concerned with the moment of implantation, but also with manufacturing history, evidence base, patient outcomes and post-procedure safety.
Non-human organ transport requires further regulatory control
The amended law authorises the Cabinet to determine substantive controls and procedures for movement of non-human organs and tissues between health establishments in the UAE and across the national border.
The Ministry must also issue procedural guides and technical forms and update them in line with medical and scientific developments.
As a result, an institution considering xenotransplantation or a manufactured organ should not rely only on the wording of Article 18. It should confirm that the required current implementing guides, permits and health-authority standards are in place for the specific technology.
Emerging technologies do not remove medical-liability risk
Novel technology can increase, rather than reduce, the importance of informed consent and professional standard of care.
A transplant team using an animal-derived or manufactured organ may need to address:
- limited long-term evidence;
- infection or zoonotic risk;
- immune rejection;
- device or manufacturing failure;
- unknown long-term complications;
- post-transplant surveillance;
- data reporting obligations;
- the need for future replacement or intervention; and
- alternative conventional treatments.
Federal transplantation authorisation does not automatically eliminate wider duties under medical-liability, professional-practice and patient-consent legislation.
Licensing and compliance failures can trigger criminal exposure
The transplantation law contains serious penalties for unlicensed activity.
Article 25 applies to persons who establish or operate an unlicensed private transplant establishment, physicians who perform removal or transplantation without the required licence, unlawful living-donor removal and specified violations involving non-human transplantation.
The 2025 amendment provides that breaches of the non-human organ controls can attract imprisonment and fines between AED 100,000 and AED 2 million, or either penalty.
Facilities should therefore treat licence scope, physician privileges and technology-specific approvals as criminal-compliance issues, not merely administrative paperwork.
Local health-authority standards operate alongside federal law
Federal law establishes the national legal framework, but local health authorities can impose detailed technical standards for transplant programmes.
Dubai Health Authority, for example, has current standards covering kidney transplantation, liver and pancreas transplantation, heart and lung transplantation, vascularised composite allograft transplantation and deceased-donor donation services.
These standards regulate practical issues such as facility capabilities, multidisciplinary staffing, donor assessment, recipient evaluation, informed consent, donor identification, brain-death documentation, infection control and continuity of care.
A facility should therefore audit both:
- compliance with Federal Decree-Law No. 25 of 2023 and Cabinet Resolution No. 61 of 2026; and
- the current standards of the health authority that licenses the transplant service.
A practical donor-consent matrix
| Scenario | Core consent / approval requirement |
|---|---|
| Living related donation | Voluntary donation, medical and psychological suitability, informed donor consent and statutory relationship rules. |
| Living unrelated donation | Special committee approval plus verification of medical suitability and absence of trafficking concerns. |
| Paired donation | Written authenticated reciprocal consent and compliance with the 2026 paired-donation controls. |
| Bone marrow from person lacking full capacity | Guardian's written consent, no donor harm, no better therapeutic alternative and recognised medical standards. |
| Deceased donor with no recorded objection | Consent from guardian or qualifying relative according to the statutory priority and 2026 authentication procedure. |
| Unidentified deceased person | National Center, police and Public Prosecution process plus medical suitability and prosecution approval. |
| Non-human / manufactured organ | Written patient consent plus specialist, establishment, testing and committee approvals under amended Article 18. |
A practical compliance checklist for transplant centres
- Verify the exact transplant licence. Confirm that the establishment and each physician are authorised for the specific removal and transplant activity.
- Confirm donor legal status. Identify whether the case is living-related, living-unrelated, paired, deceased or another statutory pathway.
- Test voluntariness. Screen for pressure, payment, family coercion and trafficking indicators.
- Complete donor medical and psychological assessment. Document suitability and expected risks.
- Use the National Center forms and procedures. Do not rely solely on internal hospital forms.
- Protect withdrawal rights. Reconfirm living-donor consent before removal.
- Document deceased-donor authority. Verify the donor's recorded position and obtain family consent where legally required.
- Separate death determination from transplantation incentives. Follow the approved clinical standards.
- Maintain organ traceability. Every organ should be trackable through retrieval, preservation, transport, receipt and implantation.
- Control financial flows. Ensure legitimate medical charges cannot be confused with payment for an organ.
- Audit confidentiality. Protect donor and recipient identities and medical information.
- Check cross-border accreditation. Confirm exporting and receiving institutions and anti-trafficking documentation.
- Use a technology-specific pathway for non-human organs. Confirm testing, source, biological compatibility, committee approval and regulatory permits.
- Maintain long-term follow-up. Donor and recipient care continues after surgery.
- Escalate suspected trafficking immediately. A clinical team should not proceed where the donor relationship, financial arrangements or recruitment process creates unresolved trafficking concerns.
Key takeaway
The UAE transplantation framework is designed to make organ donation possible without allowing organs to become commodities. Federal Decree-Law No. 25 of 2023 requires licensed professionals and facilities, informed and voluntary living donation, regulated deceased-donor consent, national allocation and traceability, continuing care and strict controls on transport.
The anti-trafficking regime is deliberately strong. Sale, purchase, advertising, brokering and financing of human organs and tissues are prohibited, and trafficking offences can trigger substantial imprisonment and financial penalties under both the transplantation statute and the separate Human Trafficking Law.
The most significant recent development is the 2025 amendment introducing a framework for animal-derived and manufactured organs. The UAE has therefore moved beyond a regulatory system designed only for conventional human donation. But the new pathway remains tightly controlled through licensing, clinical and laboratory testing, biological-compatibility assessment, written consent, committee approval, national-database registration and continuing regulatory oversight.
For transplant programmes, the compliance task is therefore increasingly multidisciplinary: transplant medicine, donor ethics, criminal-law risk, licensing, logistics, medical liability and advanced biomedical technology now operate within the same regulatory structure.
HZ Legal can assist hospitals, transplant programmes, healthcare groups, physicians, donors, recipients and biomedical companies with UAE organ and tissue transplantation regulation, consent, licensing, anti-trafficking compliance, paired donation, cross-border organ transfer, transplant disputes and emerging non-human or manufactured-organ technologies.
Official and authoritative sources
- UAE Legislation — Federal Decree-Law No. 25 of 2023 Regarding the Donation and Transplantation of Organs and Tissues, as amended.
- Ministry of Health and Prevention — Federal Decree-Law No. 15 of 2025 amending the organ and tissue transplantation framework.
- UAE Legislation — Cabinet Resolution No. 61 of 2026, Executive Regulation of Federal Decree-Law No. 25 of 2023.
- Ministry of Health and Prevention — Cabinet Resolution No. 61 of 2026.
- UAE Legislation — Federal Decree-Law No. 24 of 2023 on Combating Human Trafficking.
- Official UAE Government Portal — Organ donation and transplant.
- Dubai Health Authority — Standards for Heart and Lung Transplant Services.
- Dubai Health Authority — Standards for Liver and Pancreas Transplant Services.
This article provides general legal and regulatory information only and does not constitute medical advice or case-specific legal advice. Transplantation requirements depend on donor status, organ type, facility licence, health-authority standards, consent documentation, medical suitability and current National Center procedures. Emerging non-human organ technologies require additional technical and regulatory approval and should not be treated as generally available solely because the federal law now provides a legal framework for them.

