The UAE government issues a federal decree law amending some provisions of the Organ and Tissue Donation and Transplantation Law
Abu Dhabi, December 10, 2017 – The UAE government issued a federal decree law amending some provisions of the federal decree law regarding donation and transplantation of organs and tissues, within the framework of the UAE’s keenness to develop its health legislative system and enhance patient safety, in line with the country’s goals in modernizing health legislation and keeping pace with the latest global practices.
The decree law comes in line with international health policies that rely on the use of animal organs or manufactured organs as advanced therapeutic solutions, used in accordance with precise technical and medical controls and standards that ensure patient safety and prevent any unregulated or unsafe practices. This amendment reflects the UAE’s approach to establishing the rule of law, achieving the highest levels of health protection, and ensuring the availability of treatment options based on modern and advanced scientific standards.
The decree law included changing its title to “Concerning Donation and Transplantation of Organs and Tissues,” reflecting the comprehensive nature of the law after expanding the scope of its application to include non-human organs and tissues, and regulating the provisions related to non-human organs, by stipulating that the non-human organ includes the animal organ and the manufactured organ.
The decree law affirmed the permissibility of transferring and transplanting non-human organs and tissues according to clear conditions, including the need for transplantation to be the most appropriate treatment option for the medical condition, prohibiting the removal of any animal organ for the purposes of transplantation without a license from the Ministry of Health and Community Protection or health authorities, requiring health facilities and manufacturers to obtain the necessary licenses, and verifying the conduct of clinical and laboratory tests that prove the effectiveness and safety of the organ or tissue.
The decree law also obliges the specialist doctor to ensure the vital compatibility between the organ and the patient’s body, and to inform the patient or his legal representative of all possible and confirmed health effects that may result from the transplant, and to obtain written approval for this, in addition to requiring the approval of a special committee before performing the operation, provided that the Ministry issues the procedural guides and technical models necessary to implement these provisions and update them periodically in accordance with medical and scientific developments.
The decree law stipulates the establishment of a national database at the National Center in which all non-human organs used in transplantation are recorded, including data on the biosynthesis of the manufactured organ, the results of clinical trials, and all information related to the safety and effectiveness of these medical technologies, with all stages of the transplantation process documented in detail.
The decree law also granted the Council of Ministers the authority to determine the controls and procedures regulating the transfer of non-human organs, their parts, and non-human tissues between health facilities within the country or their transfer to and from the country.
In terms of penalties, the decree law stressed the application of strict penalties against anyone who violates the controls on the transfer and transplantation of non-human organs, their parts, and non-human tissues, whether from health facilities, manufacturers, or a specialist doctor. The amendment stipulates that anyone who commits any violation of those controls shall be punished with imprisonment and a fine of not less than one hundred thousand dirhams and not more than two million dirhams, or one of these two penalties.
These amendments confirm the UAE’s keenness to adopt advanced health legislation that keeps pace with scientific development in the fields of biomedicine and techniques for manufacturing tissues and organs, enhances patient protection, establishes community safety, and prevents any practices that may pose a threat to public health. It also reflects the state’s continued commitment to building an integrated legislative system that ensures the highest levels of regulation and control at all stages of transportation and agricultural operations, and contributes to supporting the state’s efforts in providing world-class health services.
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