UAE Government Amends Federal Decree-Law On Organ Donation And Transplantation For Enhanced Patient Safety

The UAE Government has introduced changes to its Federal Decree-Law on organ and tissue donation and transplantation. These amendments aim to enhance patient safety, modernise healthcare legislation, and align with international medical practices. The updated law now includes provisions for using animal-derived or manufactured organs, ensuring strict controls to protect patients and prevent unsafe practices.

The revised law expands its scope to cover non-human organs and tissues, including those from animals and manufactured sources. It mandates a regulatory framework governing their use. Transplantation of these organs is allowed only when it is the best medical option for the patient. A licence from the Ministry of Health and Prevention or relevant authorities is required for removing any animal organ for transplantation.

Health facilities and manufacturing entities must obtain necessary permits before proceeding with transplants. All clinical and laboratory tests must confirm the safety and effectiveness of the organ or tissue. A specialist physician must ensure biological compatibility between the organ and the patient, inform them of potential health implications, and secure written consent.

A dedicated committee must approve each transplant procedure beforehand. The Ministry will provide procedural guidelines, technical standards, and regulatory templates to ensure compliance with current medical advancements. Additionally, a national database at the National Centre will record all non-human organs used in transplants, including their biological composition, clinical trial results, and safety data.

The UAE Cabinet holds authority over regulating the transfer of non-human organs and tissues within or outside the country. This includes setting controls for their movement between health facilities in the UAE or internationally. Detailed documentation of all stages of transplantation procedures is mandatory.

Penalties for Non-Compliance

The law imposes strict penalties on any health facility, manufacturing entity, or specialist physician violating regulations on non-human organ transfers or transplants. Violators face imprisonment or fines ranging from AED 100,000 to AED 2 million. This underscores the UAE’s commitment to maintaining high standards in biomedical innovation while ensuring public safety.

These amendments reflect the UAE's dedication to advancing health legislation in line with scientific progress in organ manufacturing technologies. By adopting these measures, the nation aims to provide access to modern treatment options based on validated technologies while upholding stringent legal frameworks.

With inputs from WAM