In force
Saudi Fertility Units Law
نظام وحدات الإخصاب والأجنة وعلاج العقم
Regulates fertilization, embryo and infertility treatment units in Saudi Arabia, including licensing, consent, confidentiality, liability and penalties. It has 41 articles and concerns couples, physicians and licensed units.
- Articles
- 41
- In force
- 41
- Amended
- 0
- Issued
- 21/11/1424 AH
Issued by: مرسوم ملكي رقم م/76 بتاريخ 21 / 11 / 1424 · قرار مجلس الوزراء رقم 260 بتاريخ 23 / 9 / 1424
Each article shows the official Arabic text, which is the only legally binding version, followed by our plain-English explanation.
Browse Fertility Units Law by topic
Fertilization and Infertility Treatment Definitions1 articleSharia Rules for Infertility Treatment4 articlesSpousal Consent and Identity Verification3 articlesGenetic Intervention and Embryo Research2 articlesLiability of the Physician and Technician3 articlesPatient Confidentiality, Records and Reports3 articlesFertilization Supervisory Committee4 articlesLicensing of Fertilization Units and Their Levels7 articlesCommittee for Fertilization Violations4 articlesPenalties for Fertilization and Infertility Violations3 articlesLicense Suspension and Grievance Against Penalties4 articlesFinal Provisions of the Fertilization Law3 articles
Articles of the Saudi Fertility Units Law
الباب الأول: أحكام عامةArticles 1–14
- Article 1The article defines the terms of the Fertilization, Embryo and Infertility Treatment Units Law, such as the unit, the supervision committee, infertility, sperm, zygote, embryo, in vitro fertilization (test-tube baby) and micro-injection.
- Article 2The article permits medical intervention to treat infertility caused by reduced fertility or a treatable medical problem on the basis of a medical report, and absolutely prohibits fertilization where inability to have children is established.
- Article 3The article requires fertilization, embryo and infertility treatment units to comply, in carrying on their activity, with the religious rulings issued by the Council of Senior Scholars in the Kingdom.
- Article 4The article requires confirming that a marriage exists before treatment, prohibits fertilizing the wife's egg with the husband's sperm after divorce or death, and obliges the doctor to stop fertilization and insemination when that happens.
- Article 5The article prohibits implanting a fertilized egg from a couple in the uterus of another wife or another woman, insemination with sperm from someone other than the husband, and fertilizing an egg of someone other than the wife.
- Article 6The article requires explicit written consent from both spouses to the method of treatment, after they are informed of all treatment procedures, its risks and the likely results.
- Article 7The article requires at least two specialists of the unit to confirm that the identity and medical record number of both spouses match when collecting samples, fertilizing and transferring the zygote and embryos.
- Article 8The article prohibits interfering with sex cells or genes except to treat hereditary or genetic diseases that may affect the embryo and can be corrected by gene therapy, provided the supervision committee approves it beforehand.
- Article 9The article requires fertilization units to organize sperm, eggs, zygotes and embryos precisely and to take the utmost care against mixing or substituting them, intentionally or not, with the rules left to the Implementing Regulations.
- Article 10The article makes the doctor fully responsible for all damage caused by the doctor's error in treatment.
- Article 11The article makes the doctor, the assistant and the technician each responsible for any negligence, shortcoming or error they commit that leads to the mixing or substitution of sperm, eggs, zygotes or embryos.
- Article 12The article requires a fertility unit to keep patient information absolutely confidential and bars anyone from seeing it except where necessary and with the approval of the Supervisory Committee or the judicial authorities.
- Article 13The article bars fertility units from conducting research on sperm, ova, zygotes and embryos unless the sample owners and the Supervisory Committee have approved, subject to the relevant regulations.
- Article 14The article obliges fertility units to submit an annual report to the Supervisory Committee containing comprehensive statistics and a statement of the cases examined and treated.
الباب الثاني: لجنة الإشراف على أمور الإخصاب والأجنة وعلاج العقمArticles 15–18
- Article 15The article governs the formation of the Supervisory Committee on fertilization, embryo and infertility treatment matters by decision of the Minister, sets its seven members, its seat at the Ministry in Riyadh, and has the Council of Ministers set their remuneration.
- Article 16The article sets membership of the Supervisory Committee at three years, renewable, and provides for appointing a replacement for a member who cannot continue, in the same way as the original appointment.
- Article 17The article governs the Supervisory Committee's quorum of two-thirds of its members, its meetings, the issuing of its decisions by majority of those present and their approval by the Minister, and challenge before the Board of Grievances within 60 days of notification.
- Article 18The article sets the Supervisory Committee's functions: recommending licenses and determining activity level, approving treatment methods, considering research requests, forming technical committees for oversight and complaints, and any task the Law assigns.
الباب الثالث: شروط الترخيص لوحدات الإخصاب والأجنحة وعلاج العقمArticles 19–27
- Article 19The article bars establishing or operating a fertilization, embryo and infertility treatment unit except after obtaining the Ministry's license on the recommendation of the Supervisory Committee.
- Article 20The article sets three licensing levels for fertility units: ovulation induction by injection, then artificial insemination, then IVF, ICSI and micromanipulation, and refers the conditions and qualifications to the Implementing Regulations.
- Article 21The article requires every fertility unit to have all the equipment and facilities needed for each licensing level, according to the specifications set by the Implementing Regulations.
- Article 22The article provides that a fertility unit's license for a given level includes the lower levels before it.
- Article 23The article obliges fertility units to announce the licensed level together with the unit's name on internal and external signs and in its printed materials.
- Article 24The article bars licensing a fertilization, embryo and infertility treatment laboratory unless it is within a licensed fertility unit.
- Article 25The article restricts reproductive techniques requiring laparoscopy or general anesthesia to fertility units inside hospitals or units permitted to perform day surgery.
- Article 26The article makes the medical supervisor in charge of a fertility unit fully responsible for its work, and refers to the Implementing Regulations the supervisor's duties at each level and those of assistant physicians, technicians and technologists.
- Article 27The article obliges fertility units to document all information and procedures, record treatment cycles, their type and results accurately, clearly and honestly, keep them at least 10 years, and present them to the competent authorities on request.
الباب الرابع: لجنة النظر في المخالفاتArticles 28–31
- Article 28The article regulates the committee that considers violations of the fertility law, chaired by a judge, its power to impose penalties other than imprisonment and determine compensation, its seat, its remuneration, and referral of matters warranting imprisonment to the Board of Grievances.
- Article 29The article sets membership of the fertility violations committee at three years, renewable, and provides for appointing a replacement for a member who cannot continue in the same way as the original appointment.
- Article 30The article requires all members of the violations committee to attend for it to meet, and its decisions are issued by majority vote including the chair, whose vote prevails in a tie, failing which the case goes to the Board of Grievances.
- Article 31The article provides that a member of the Bureau of Investigation and Public Prosecution represents the prosecution before the committee that considers violations of the fertility law.
الباب الخامس: العقوباتArticles 32–38
- Article 32The article punishes seven serious violations, such as practicing without a license and insemination by someone other than the husband, with a fine of SAR 200,000 to 500,000, imprisonment of up to five years, or license revocation.
- Article 33A violator of the Law or its Regulations, other than the Article 32 violations, is punished by a warning, a fine of SAR 20,000 to 200,000, imprisonment of up to two years or license revocation, or more than one penalty.
- Article 34The Minister may temporarily suspend a license until the violations committee decides, when caught in the act or evidence points toward guilt, while ensuring patients' treatment continues; a grievance may be filed with the Board of Grievances within 30 days.
- Article 35The article allows a person against whom a penalty decision is issued under the fertility law to file a grievance with the Board of Grievances within 60 days of being notified.
- Article 36The Minister may order a decision revoking or temporarily suspending a license to take effect from its issue date; this does not prevent a grievance before the Board of Grievances, and a grievance does not stay immediate execution.
- Article 37The article bars considering an application for a new license to practice the profession before three years have passed from the date the license revocation decision was issued.
- Article 38The article allows a final penalty decision to include publishing its operative part at the violator's expense in at most three local newspapers, at least one issued where the violator resides or in the nearest region.
الباب السادس: أحكام ختاميةArticles 39–41
- Article 39The article subjects fertility units, in matters the Law does not provide for, to the Law of Practicing the Profession of Human Medicine and Dentistry, the Private Health Institutions Law, the Law of Practicing the Profession of Pharmacy and other related regulations.
- Article 40The article obliges the Minister to issue the Implementing Regulations of the Fertility Units Law within 120 days of its publication, and they are published in the Official Gazette.
- Article 41The Law takes effect 120 days after its publication, and existing units must correct their status within 120 days of its taking effect, after which the Supervisory Committee considers whether their licenses continue.