UAE Healthcare / Pharma LawFederal Decree by Law No. (25) of 2023 Regarding the Donation and Transplantation of Organs and Tissues

Article (1) Definitions For the purposes of implementing the provisions of this Decree by Law, the following terms and expressions shall have the meaning assigned to each of them, unless the context requires otherwise: State : United Arab Emirates. Ministry : Ministry of Health and Prevention. Minister : Minister of Health and Prevention. Health Authority : The local governmental authority concerned with the regulation of health affairs in the State, each within the limits of its competence. National Center : The National Center for Donation and Transplantation of Human Organs and Tissues established within the Ministry. Person : Anyone who has attained the age of eighteen (18) Gregorian years, enjoys full mental capacity, and is not affected by any impediment to legal capacity.

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 2 Death : The complete separation from life, established in a certain and reliable manner, occurring either through the complete, final and irreversible cessation of the functions of the circulatory and respiratory systems, or through complete, final, and irreversible cessation of all brain functions, whereupon physicians determine that this cessation is irreversible, in accordance with the precise medical standards determined by a resolution issued by the Minister after the coordination with the Health Authorities. Organ : A set of interconnected human tissues and cells taken from the body of a living Person or from the body of a deceased human being and involved in specific vital functions in the human body. Tissue : A mixture of organic components, such as cells and fibers, which do not constitute an organ, and which, altogether, give rise to an anatomical identity consistent with the function of the tissue, such as bone, muscle, or nervous tis- sue, and includes both human and non-human tissue. Organ Removal : The removal of an organ or a part thereof, or tissue, with the aim of transplanting it into the body of a living human being for therapeutic purposes. Transplantation : The replacement of an organ, a part thereof, or healthy tissue that has been donated, with an organ or tissue whose function has ceased or failed. Donation : A legal act indicating the person’s consent, during their lifetime or after Death, with the consent of the relatives specified in Article (12) of this Decree by Law, to the removal of one or more organs, part thereof, or human tissue, with the aim of transplanting it into the body of a living human being, without consideration.

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 3 Will : A legal act by which a Person gives con-sent for one or more human organs, part thereof, or human tissue to be re-moved from their body after Death, without consideration. Executive Regulations : The Executive Regulations issued pursuant to the provisions of Article (33) of this Decree by Law.

Article (3) Decree by Law Objectives This Decree by Law aims to regulate the operations and procedures for the removal, transfer, transplantation and donation of human organs, parts thereof, and human tissues to ensure the effectiveness of the health system in the State, by achieving the following: 1. Supporting the culture of donating human organs, parts thereof, and human tissues by promoting the exercise of the right to donate. 2. Ensuring the fair distribution of donated human organs, parts thereof, and human tissues to patients in accordance with their health conditions, without regard to gender, race, religion, social or financial status. 3. Protecting the rights of both the donor and the recipient, and providing appropriate health care for each of them. 4. Combating trafficking in human organs and tissues and preventing the exploitation of the

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 4 patient's or donor's needs. 5. Applying innovative solutions in the removal, transfer, and transplantation of human organs and tissues. 6. Enhancing opportunities for cooperation and integration with other countries in the field of transfer and transplantation of human organs and tissues.

Article (5) National Center Competences The National Center shall be responsible for regulating donation procedures and the operations of removing, preserving, distributing, transferring, and transplanting human organs, parts thereof, and human tissues. In particular, it may exercise the following competences: 1. Proposing and developing policies and standards for licensing health establishments and physicians specializing in the removal and transplantation of human organs and tissues, in coordination with Health Authorities. 2. Supervising and monitoring health establishments licensed to perform the removal, transfer, and transplantation operations of human organs and tissues. 3. Providing the appropriate conditions to ensure the success of the operations for the removal, preservation, transfer and transplantation of human organs, parts thereof, and human tissues, including measures to maintain the quality and safety of human organs and tissues, in coordination with Health Authorities and concerned authorities in the

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 5 State. 4. Supervising the training and continuous development of physicians licensed in accordance with the provisions of Article (4) of this Decree by Law, as well as other physicians, health practitioners, individuals, and concerned authorities in the field of organ and tissue donation, removal, preservation, transfer, and transplantation, in coordination with Health Authorities. 5. Preparing and developing studies and research related to the latest technologies and practices in the field of donation, removal, preservation, transfer and transplantation of human organs and tissues, as well as the prevention of organ failure diseases. 6. Preparing the necessary programs to promote the culture of human organ and tissue donation, including the benefits and incentives to honor donors and their families. 7. Establishing and managing a national database that includes lists of patients whose health condition requires the transplantation of a human organ, part thereof, or tissue, donors, Persons wishing to donate during their lifetime, Persons who have made a Will to donate after Death, and Persons who express their unwillingness to donate after Death, as well as databases of removed human organs and tissues and their traceability. 8. Cooperating with regional and international organizations, authorities, and centers concerned with donating, removing, and transplanting human organs and tissues. 9. Any other competences assigned to the Center by the Minister.

Article (7) Donation of Human Organs and Tissues Between Living Persons 1. It is prohibited to remove and transplant any human organ, part thereof, or human tissue between living Persons except as a donation. 2. It is not permissible to donate any human organ, part thereof, or human tissue, except in the following cases: a. Donation to relatives up to the fourth degree. b. Donation to the relatives of either spouse, in respect of the other spouse, up to the fourth degree. c. Paired donation of human organs and tissues in accordance with the controls specified by the Executive Regulations. 3. As an exception to the provisions of Clause (2) of this Article, donation may be permitted in cases other than those referred to in Clause (2), provided that the following controls are observed: a. The approval of a special committee, the formation and rules of procedure of which shall be determined by a resolution to be issued by the Minister or the Head of the Health Authority, as the case may be, after coordination with the National Center. b. The committee referred to in Paragraph (a) of this Clause shall, for the purposes of issuing approval for the donation, ensure that the competent physician has fulfilled the reports and examinations referred to in Article (8) of this Decree by Law in accordance with the recognized medical principles, and shall verify that the donation is free from any suspicion of trafficking in human organs and tissues. c. Any other controls to be determined by a resolution issued by the Minister after coordination with the Health Authority.

Article (8) Medical Examinations for Donation Between Living Persons 1. Before performing an operation to remove or transplant an organ, part thereof, or tissue, the competent physician shall ensure that the transplantation is the most appropriate means of treating the patient.

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 7 2. The competent physician shall conduct the following examinations prior to the removal of an organ, a part thereof, or human tissue: a. Verifying the donor's physical health in accordance with recognized medical principles. b. Verifying the psychological and mental condition of the donor, and ensuring that nothing affects their consent. c. Verifying the safety of the organ, part thereof, or human tissue intended to be transferred and that it is free from diseases that may threaten the patient's life, in accordance with recognized medical principles. d. Verifying the compatibility of the organ, part thereof, or human tissue with the patient's body. e. Verifying that the removal will not threaten the donor's life or cause them harm beyond what is medically accepted. 3. All results of the examinations referred to in Clause (2) of this Article shall be proven by virtue of a medical report certified by the health establishment licensed to perform the removal of the human organ, part thereof, or human tissue. 4. The licensed physician shall inform the donor before removing the human organ, part thereof, or human tissue of the confirmed and potential health consequences, and any other possible effects that may occur in their personal, family, or professional life, in accordance with the form approved by the National Center. 5. The licensed physician shall be prohibited from initiating the removal or transplantation procedure if they are aware of any violation of any of the provisions of the preceding Clauses.

Article (9) Health Care 1. The licensed health establishment shall provide comprehensive health care and psychological support to both the living donor and the recipient before, during, and after the removal and transplantation of a human organ, a part thereof, or human tissue, including all necessary examinations and treatments required after carrying out the

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 8 removal and transplantation in accordance with the controls specified by the Executive Regulations. 2. Diagnostic, therapeutic, and surgical procedures carried out before, during, and after the removal and transplantation of a human organ, a part thereof, or tissue shall be deemed health services subject to insurance coverage in all health insurance systems in the State, in accordance with what is determined by the Executive Regulations.

Article (10) Bone Marrow Transplantation 1. Notwithstanding the provisions of Article (6) of this Decree by Law, a licensed health establishment may extract bone marrow from a Person who fully or partially lacks legal capacity to transplant it into one of the parents, children, or siblings of the donor, provided that the following is satisfied: a. The written consent of the legal guardian of the donor shall be obtained. b. No harm shall be caused to the donor. c. No better therapeutic alternatives are available for the recipient. d. The bone marrow extraction and transplantation are carried out according to recognized medical standards. 2. The Executive Regulations shall specify the controls and procedures for bone marrow extraction and transplantation.

Article (11) Donation of Human Organs and Tissues After Death 1. Any Person who does not wish to donate any of their organs, parts thereof, or human tissues after Death shall record their unwillingness in accordance with the mechanism specified in the Executive Regulations. 2. If a Person has not recorded, during their lifetime, their unwillingness to donate any of their organs, parts thereof, or human tissues, it shall be permissible, after Death, to remove any human organs, parts, or human tissues from their body, provided that the consent of the legal guardian or any of the relatives is obtained in accordance with Article (12) of this

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 9 Decree by Law. 3. The Cabinet, upon the proposal of the Minister and after coordination with Health Authorities and other concerned authorities, shall determine the cases, conditions, and procedures for the implementation of the provisions of this Article, and develop any mechanism it deems appropriate to obtain the consent of the legal guardian or relatives.

Article (12) Conditions for Donation of Human Organs and Tissues After Death 1. It shall be permissible to remove a human organ, part thereof, and human tissue from the body of a deceased Person who had not recorded their unwillingness to donate after Death, or from the body of a deceased Person who fully or partially lacked legal capacity, provided that the consent of the legal guardian or any of the relatives specified herein is obtained. The following order of priority shall be observed when obtaining consent: a. Father. b. Mother. c. Children. d. Spouse. e. Grandfather. f. Siblings. g. Paternal uncle (agnate), with the full-blooded uncle taking precedence over the half uncle. 2. In the event of disagreement among relatives of the same degree of priority, the opinion of the eldest shall prevail, with no distinction between males and females in this regard. 3. In all cases, the consent must be written and documented in accordance with the procedures specified in the Executive Regulations.

Article (13) Regulations for the Removal of Human Organs and Tissues After Death The following regulations shall be observed when removing a human organ, part thereof, or human tissue from the body of a deceased Person:

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 10 1. Confirmation of the occurrence of Death. 2. In case of brain death, such Death must be proven by a medical report issued by a medical committee formed by virtue of a decision issued by the Minister or the Head of the relevant Health Authority. The committee shall comprise (3) three physicians, including a neurologist or neurosurgeon, and a cardiovascular physician or surgeon, provided that it shall not include the physician assigned to perform the removal or transplanting of the human organ, part thereof, or human tissue, nor the owner of the health establishment in which the procedure will be performed, nor any of its partners. Death shall be established by the unanimous opinion of all physician members of the committee. 3. The specialized physician shall perform the following examinations before the removal of the human organ, part thereof, or human tissue: a. Verifying the health of the human organ, part thereof, or human tissue intended for transplantation and confirming that it is free of diseases that may threaten the patient's life, in accordance with recognized medical standards. b. Verifying the compatibility of the human organ, part thereof, or human tissue with the patient's body. 4. All results of the examinations referred to in Clause (3) of this Article shall be documented in a medical report certified by the health establishment licensed to perform the removal of the human organ, part thereof, or human tissue. 5. The removal of the human organ, part thereof, or human tissue must be performed in a manner that does not disfigure the body. 6. Not to disclose any information related to the body of the deceased except in cases determined by the legislation in force in this regard or required for the procedures and operations related to removal or transplantation. 7. Any additional regulations specified in the Executive Regulations, including rules for the removal of a human organ, part thereof, and human tissue from the body of a deceased Person in case of an accident or an unidentified individual.

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 11

Article (16) Incentives and Benefits 1. The following categories shall be given priority in the list of those in need of a human organ, part thereof, or human tissue transplantation, if their medical condition requires it: a. The living donor and any of their relatives up to the fourth degree of kinship. b. Any Person who expressed willingness to donate or made a will to donate, and any of their relatives up to the fourth degree of kinship. c. Relatives of the deceased donor up to the fourth degree of kinship. 2. The National Center shall provide medical, insurance, or in-kind benefits to the categories referred to in Clause (1) of this Article, subject to a decision issued by the Minister to

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 12 determine such benefits after coordination with the Health Authorities and other concerned authorities.

Article (17) Transfer of Human Organs and Tissues 1. The transfer of human organs, parts thereof, and human tissues between health establishments within the State is permissible, provided that the licensed health establishment transferring the removed organ submits the following documents therewith: a. A report specifying the type of the removed organ being transferred, its characteristics, confirmation of its health and freedom from diseases that may threaten the patient's life, and details of its preservation duration and methods. b. A medical report on the results of medical examinations related to the donor. c. Data of the vehicle transporting the removed organ. 2. Subject to the provisions of international agreements and treaties ratified or to which it is a party, it is permissible to transfer human organs, parts thereof, and human tissues to and from the State in accordance with the following controls: a. In the event of transporting to the State, the authority responsible for exporting the removed organ must be accredited in the country of origin. b. In the event of transporting from the State, the authority responsible for receiving the removed organ must be accredited in the receiving country. c. An accredited report from the country of origin that includes specifying the type of the removed human organ, part thereof, or tissue being transferred, its characteristics, confirmation of its health and freedom from diseases that may threaten the patient's life, and details of its preservation duration and methods. d. An accredited medical report from the country of origin that includes the results of the donor's medical examinations. e. Confirmation that there is no suspicion of trafficking in human organs or tissues. 3. The Minister, after coordination with Health Authorities and other concerned authorities, may determine additional controls for the transfer of human organs, parts thereof, or

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 13 human tissues between health establishments within the State, and to or from the State.

Article (18) Non-Human Organs and Non-Human Tissues 1. For the purposes of implementing the provisions of this Decree by Law, a non-human organ means a collection of non-human tissues or structures that perform one or more functions when transplanted into the human body, and includes: a. Animal organ, an organ or tissue derived from a living animal, whether produced naturally, genetically modified, or biologically cultured, and transplanted for therapeutic purposes into the human body. b. Engineered organ, an artificial structure produced using techniques such as three- dimensional bioprinting, tissue engineering, or other advanced techniques approved by the Ministry or the Health Authority, intended to perform a vital function in the human body, without being derived from or manufactured from live human or animal tissues. 2. The transfer of non-human organs and non-human tissues and xenotransplantation thereof into the human body shall be permitted in accordance with the conditions and controls issued by a resolution of the Cabinet, taking into consideration the following: a. Transplantation of the non-human organ or non-human tissue shall be the most appropriate means of treating the patient, which shall be verified by the specialized physician. b. Removal of any animal organ for the purpose of transplantation or use in transplantation is prohibited without obtaining a license from the Ministry or the Health Authority. c. The health establishment shall obtain a license from the Health Authority before using any non-human organ in transplantation, specifying the type and source of the non- human organ. d. The entity manufacturing the non-human organ or non-human tissue shall obtain a license from the Health Authority and approval from the relevant authorities in the State.

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 14 e. Transplantation of any non-human organ or non-human tissue is prohibited except through a specialized licensed physician. f. Non-human organs and non-human tissues used for transplantation shall have undergone all approved clinical and laboratory testing, demonstrating their medical efficacy and biological safety according to the standards approved by the Ministry. g. The use of non-human organs or tissues derived from medically unapproved animal species or subject to unauthorized genetic modification or biological treatment is prohibited unless authorized by the Ministry or the Health Authority. h. The licensed health establishment and specialized physician shall verify the safety of the non-human organ or tissue, its source, and freedom from diseases that may endanger the patient or public health, in accordance with the scientific standards approved by the Ministry, and shall complete all necessary procedures to perform the transplantation. i. The licensed health establishment and specialized physician shall verify the biological compatibility of the non-human organ or tissue with the patient’s body, based on scientific standards approved by the Ministry and internationally recognized medical practice, prior to transplantation. j. The specialized physician shall inform the patient or their legal representative of all potential and confirmed health consequences of the transplantation of the non- human organ or tissue and obtain written consent therefrom, using the form approved by the National Center. k. Approval by a special committee, established and operating in accordance with a decision issued by the Minister or the head of the Health Authority, as the case may be, after coordination with the National Center. 3. The licensed health establishment shall provide comprehensive healthcare to the recipient before, during, and after the transplantation of the non-human organ, part thereof, or non-human tissue, including all examinations and treatments required following the transplantation. 4. The Health Authorities and other concerned authorities shall conduct periodic inspections of health establishments and entities manufacturing non-human organs or tissues.

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 15 5. A national database shall be established at the National Center in which every non-human organ used in transplantation shall be recorded. For engineered organs, the database shall include data related to the manufacturing entity, biological composition, results of clinical trials, and any other information as determined by the National Center. 6. The National Center shall document all stages of the transplantation procedure in the database referred to in Clause (5) of this Article, monitor potential effects, assess the efficacy and safety of this type of transplantation, and review and evaluate the outcomes of procedures and medical reports. 7. The Cabinet, upon the proposal of the Minister and after coordination with the Health Authorities and other concerned authorities, shall determine the substantive controls regulating the transfer of non-human organs, parts thereof, and non-human tissues between health establishments within the State, as well as the controls and procedures for their transfer to and from the State. 8. The Ministry, after coordination with the Health Authorities and other concerned authorities, shall issue the procedural guides and technical forms necessary for the implementation of this Article and shall update them periodically in accordance with medical and scientific developments.

Article (19) Prohibitions Everyone, including health establishments, physicians, and other personnel in health establishments, is prohibited from engaging in the following: 1. Selling or purchasing human organs, parts thereof, or human tissues by any means, or demanding any consideration for them, or advertising, promoting, or mediating such transactions. 2. Removing, transplanting, or transferring human organs, parts thereof, or human tissues that carry genetic characteristics, or part thereof. 3. Donating a human organ, part thereof, or human tissue if the living donor is a Person who fully or partially lacks legal capacity, without regard to the consent of their legal guardian or custodian, without prejudice to the provisions of Article (10) of this Decree by Law.

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 16 4. Removing a human organ, part thereof, or human tissue if it is proven that the Person had recorded their unwillingness to donate any of their organs, parts thereof, or tissues after Death, and has not withdrawn that record. 5. Advertising, promoting, or mediating the removal or transplantation of human organs, parts thereof, or human tissues, or calling for such actions, unless the purpose thereof is to encourage donation in accordance with the controls stipulated by a decision issued by the Minister after coordination with Health Authorities. 6. Disclosing health data or information of the donor, patient, or recipient, except in cases required by the legislation in force in this regard. 7. Financing the removal and transplantation of human organs, parts thereof, or human tissues when it is known that the donation was made in exchange for financial consideration. 8. Health establishments receiving amounts exceeding the costs determined by the Ministry or Health Authority for performing any of the removal or transplantation of human organs, parts thereof, or human tissues. 9. Physicians or personnel of health establishments accepting or receiving payment for the removal or transplant of human organs, parts thereof, or human tissues from entities other than the health establishment.

Article (20) Penalties A penalty of imprisonment for a period not less than (10) ten years and a fine of not less than (AED 500,000) five hundred thousand dirhams and not exceeding (AED 2,000,000) two million dirhams shall be imposed on anyone who removes any human organ, part thereof, or human tissue from a living Person surreptitiously, by deceit, coercion, or without the consent of the donor, their legal guardian, or any of their relatives, in violation of the provisions of this Decree by Law. If any of these acts are committed against a Person who fully or partially lacks legal capacity, this shall constitute an aggravating circumstance. The penalty shall be death or life imprisonment and a fine not less than (AED 1,000,000) one million dirhams and not exceeding (AED 2,000,000) two million dirhams if the act results in

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 17 the Death or total disability of the donor.

Article (24) A penalty of imprisonment and a fine of not less than (AED 100,000) one hundred thousand dirhams and not exceeding (AED 1,000,000) one million dirhams shall be imposed on anyone who: 1. Removes one or more human organs, part thereof, or human tissues from the body of a living person in violation of the provisions of Article (8) of this Decree by Law. If the act results in the Death or total disability of the donor, the punishment shall be imprisonment for a period not less than (5) five years and a fine of not less than (AED 500,000) five

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 18 hundred thousand dirhams and not exceeding (AED 2,000,000) two million dirhams. 2. Removes, transplants, or transfers any human organ, part thereof, or human tissue that carries genetic characteristics. 3. Removes one or more human organs, part of it, or human tissues from the body of a deceased Person in violation of the provisions of Article (12) or Article (13) of this Decree by Law. 4. Extracts bone marrow from a Person who fully or partially lacks legal capacity in violation of the provisions of Article (10) of this Decree by Law.

Article (25) Any person shall be punished by imprisonment and by a fine of not less than (AED 100,000) one hundred thousand dirhams and not exceeding (AED 2,000,000) two million dirhams or by either of these two penalties, if they: 1. Establish or operate a private health establishment for the removal or transplantation of human organs and tissues without obtaining a license to do so in accordance with the provisions of Article (4) of this Decree by Law. 2. Is a physician who performs operations for the removal or transplantation of human organs and tissues without obtaining a license in accordance with the provisions of Article (4) of this Decree by Law. 3. Remove one or more human organs, parts thereof, or human tissues from the body of a living person in violation of the provisions of Article (7) of this Decree by Law. 4. Anyone who violates the provisions of Clause (2) of Article (18) of this Decree by Law.

Article (26) 1. A penalty of imprisonment for a period of not less than one year and a fine of not less than (AED 50,000) fifty thousand dirhams and not exceeding (AED 500,000) five hundred thousand dirhams, or by either of these two penalties, shall be imposed on anyone who violates the provision of Clause (6) of Article (19) of this Decree by Law. 2. A fine not less than (AED 500,000) five hundred thousand dirhams and not exceeding (AED 3,000,000) three million dirhams shall be imposed on any licensed health

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Federal Decree by Law of 2023 Regarding the Donation and Transplantation of Organs and Tissues 19 establishment that violates the provisions of Clause (1) of Article (9) of this Decree by Law.