Human Organ Donation Law in Saudi Arabia

Human Organ Donation Law in the Kingdom of Saudi Arabia is a set of legal rules and procedures that regulate the process of human organ donation in the Kingdom. The law was issued by Royal Decree on April 1, 2021, and the Council of Ministers' decision issued on March 30, 2021.

The Human Organ Donation Law consists of twenty-seven articles and includes: definitions, organ donation or the bequest to donate human organs, organ transplantation, withdrawal of donation, procedures for organ transplantation, obligations of healthcare facilities, viability of the human organ, cases prohibiting organ donation, examination of the human organ, dignity of the donor and protection from abuse or mutilation, verification of death for the purpose of organ donation, monetary or in-kind compensation, prohibitions for healthcare facilities, the Supreme Medical Commission, licensing, updating information and data, monitoring the medical conditions of donors and ensuring adequate services for recipients, procedural work models, organ transplant waiting lists, regulations and conditions for granting privileges to donors or the deceased's heirs, violations and penalties, oversight, inspection and violation detection, claims for compensation, preparation of the regulations, publication, and enforcement.

The Human Organ Donation Law permits a person to donate or bequeath any of their human organs, provided it does not conflict with the provisions of Islamic law. The donation must be written and documented. It is permissible to transplant human organs from a deceased person with the consent of their closest heir. If the heirs cannot be identified, consent must be obtained from the nearest relative. If there are multiple relatives of the same rank, the consent of at least the majority is required.

Both the donor, before the removal of the donated organ, and the bequeathing donor, before their death, may withdraw from the donation without any restrictions or conditions. Human organ transplant operations may only be conducted in licensed healthcare facilities. The living donor must undergo an examination by psychiatrists and social specialists to ensure no factors could affect the validity of their consent to donate. The donor must also undergo a comprehensive medical examination by a qualified and specialized medical team to confirm their health and readiness for the donation. The donor must be clearly informed of all confirmed and potential consequences of the organ removal procedure.

The Human Organ Donation Law prohibits organ donation if the organ is essential for the donor's life, if donating it would result in the donor’s death, the loss of function of a complete organ, or prevent the donor from performing their usual life activities. It is also prohibited if the medical team deems the transplantation unlikely to succeed in the recipient if the donor is a living person with diminished or no legal capacity, where the consent of their guardian or caretaker is not valid, or if the individual has expressed a wish not to donate after death. Additionally, donation is forbidden if the organ is involved in the production of reproductive cells that carry genetic traits, or a part thereof.

The law prohibits the donor, their heirs, or relatives from requesting or receiving any form of monetary or in-kind compensation in any way, whether from the recipient, their relatives, healthcare facilities, or others, as a result of the donor’s or their heirs' or relatives' consent to donate after the donor’s death. The law also prohibits the recipient, their relatives, or others from offering any form of monetary or in-kind compensation in any way to the donor, their heirs, or relatives, as a result of the donor’s or their heirs' or relatives' consent to donate after the donor’s death.

The law prohibits healthcare facilities from using any of the donated organs for purposes other than those for which the donation was intended. An exception is made in cases where the organ cannot be transplanted into the intended recipient, or if it is not possible to obtain subsequent consent from the donor or from those authorized to give consent regarding the use of the organ. In all cases, coordination with the Saudi Center for Organ Transplantation must be ensured when handling the organ. It is also prohibited not to report, or to delay reporting, cases of death specified by the executive regulations of the Human Organ Donation Law to the Saudi Center for Organ Transplantation when they occur within a healthcare facility. Additionally, it is prohibited to transplant a human organ that has been removed in execution of a judicial ruling. It is also prohibited to receive any form of monetary or in-kind compensation in any way for organ donation. This does not include the financial compensation for costs or services provided by healthcare facilities when performing organ transplant procedures. It is likewise prohibited to offer or provide any form of monetary or in-kind compensation, in any way, to the donor, their heirs, or relatives, or to act as an intermediary in such transactions, as a result of organ donation.

The Human Organ Donation Law includes regulations for organ donation, such as ensuring the dignity of the donor during the removal of the organ and protecting the donor from any form of abuse or mutilation. It is prohibited to disclose any information related to the donor's body, whether alive or deceased. The verification of death for the purpose of organ donation must be conducted in accordance with the conditions and regulations specified by the executive regulations of the Human Organ Donation Law.

The Saudi Center for Organ Transplantation is responsible for preparing national waiting lists for organ transplants for patients with end-stage organ failure. It also determines the priorities for organ transplant eligibility and oversees how organ donation procedures are monitored and documented, all within a detailed procedural guide and clear rules.

The Saudi Health Council prepares a special guide outlining the regulations and conditions for granting material, in-kind, or moral benefits, awarding incentive rewards, prioritizing employment opportunities, or providing scholarships to donors or the heirs of the deceased, following their consent to donate after the donation procedure has been completed.

The penalty for violating the Human Organ Donation Law can reach a fine of SAR500,000 and, in some cases, up to SAR1,000,000, along with imprisonment for up to two years. The Public Prosecution is responsible for investigating and prosecuting violations before the Criminal Court, which, in turn, handles cases arising from the application of the Human Organ Donation Law. The Criminal Court may double the penalties in cases of repeat violations. Anyone who has been issued a penalty decision has the right to appeal it before the Administrative Court in accordance with the provisions of the Law of Procedures Before the Board of Grievances. Anyone who has suffered harm as a result of any violations specified in the Human Organ Donation Law or its executive regulations has the right to claim compensation for the damage before the competent court.