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Issued under the Royal Decree No. M/59 dated 04/11/1426H and its implementing regulation issued by the ministerial resolution No.

4080489 dated 12/01/1439H.

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Regulations of Practicing Healthcare Professions

Kingdom of Saudi Arabia No. 4040489Ministry’s Office (275) Date: 02/01/1439H Attachments:

Ministerial Resolution

The Minister of Health, based on the powers conferred upon him, having examined Law of practicing health care professions issued by the Royal Decree No. (M/59) dated 04/11/1426H, having considered Article No. (43) of law of practicing health care professions stipulates that the Minister of Health shall issue the Law’s implementing regulations and as dictated by the

public interest. The following decisions were taken:

First: Approving the implementing regulations of law of practicing health care professions in the form attached to this resolution.

Second: This resolution shall be effective from the date of its issuance and shall be published in the Official Gazette and the website.

Minister of HealthTawfiq Bin Fawaz Al Rabiah

(Signed)

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Chapter (1)Profession Practice License

Article (1): The following words and expressions – wherever mentioned herein – shall have the meanings stated below, unless the context requires otherwise.Health PractitionerAny person licensed to practice the health professions including the following categories: physicians, dentists, pharmacists, health technicians in radiology, nursing, anesthesiology, laboratory, pharmacy, optics, epidemiology, artificial limbs, physiotherapy, dental care and prosthodontics, computed tomography (CT), nuclear medicine, laser devices and operations, and psychiatrists, social workers, dietitians and specialists of public health, gynecology, first aid, speech and hearing therapy, vocational rehabilitation, occupational therapy, medical physics and other health professions agreed upon between the minister of health, minister of civil service and Saudi Commission for Health Specialties.Minister: Minister of Health Ministry: Ministry of HealthCommission: Saudi Commission for Health SpecialtiesThe Regulation: 1-1 The commission shall update the health professions and issue the list of health practitioner

whenever necessary. It shall submit its recommendations to Minister of Health for approval in order to coordinate with Minister of Civil Service to agree on the same. Noting that, the commission is concerned with approving the health specialties that are considered branches of any health profession.

Article (2):a- It is strictly forbidden to practice any health profession without obtaining a license from the

ministry.b- To practice a health professions, the following conditions have to be met: 1. Obtain the qualification required for the profession from any medical college, college of

pharmacy, college of applied medical sciences, health college or health institute or any other qualifications required for practicing health professions that are recognized by the commission or obtain a certificate from abroad that is recognized by the commission.

2. A practitioner must complete the mandatory internship prescribed by the commission and should be medically fit.

3. Registration in the commission according to the prescribed requirements. 4. Not to be previously convicted in a crime against honor or honesty unless heshe was

rehabilitated.c- Employment in government authorities on health professions jobs is considered a license for

practicing the profession provided that registration in the commission shall be fulfilled.

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The Regulation: 2-1 The health practitioner shall be granted the license by the Ministry of health affairs directorates

in regions and governorates, and the practitioner of alternative medicine is granted the license by the National Center for Complementary and Alternative Medicine.

2-2 A fixed-term license may be granted and the requirements of the Commission shall be fulfilled for the following categories, provided that their qualifications shall be approved:

A- Visiting health practitioners or the like. B- Practitioners hired during the classification process2-3 The alternative medicine may only be exercised under a license from the National Center

for Complementary and Alternative Medicine and according to the specific controls and conditions. In this case, the practitioner of alternative medicine shall be subject to the professional responsibilities set out in this Law, Unauthorized persons shall be referred to the competent authority in accordance with criminal responsibility.

2-4 A compulsory training for the practitioner must have been undertaken under the direct supervision of a licensed practitioner in the same professional field.

2-5 The competent health authority shall be notified by the commission in case of incorrect certificates and documents under which it was hired, so as to be included in the non-hiring and non-licensing list, and the competent health authority shall exclude him and finalizes the deportation procedures for non-Saudis. If the private right is claimed, he shall be referred to the competent authority.

2-6 Obtaining of registration and classification from the Saudi Commission for Health Specialties and approval of the Minister of Education to work in the private health institution by the consultants from university faculty members shall be considered as a license to practice the profession in the private health sector.

2-7 The health practitioners contracted by the medical operating companies to work in government health facilities shall not be appointed until they have been classified and registered by the commission, and their appointment shall be deemed a license to practice the profession.

2-8 The experience requirements for the health practitioners working in government agencies shall be determined in accordance with regulations and rules that are consistent with the health professions regulation and civil service law.

2-9 The regulations relevant to exercising the profession stipulated in the law of private health institutions, Law of Pharmaceutical Preparations and Installations, the Law of Fertilization and Embryology Unit and infertility treatment and their implementing regulations shall be taken into account when licensing health practitioners to work in any of these institutions or establishments. The requirements of qualifications and experience shall be determined in accordance with the commission’s regulations and guidelines issued to determine the criteria for acceptance of qualification and experience.

2-10 A practitioner who has been convicted of any crime against honor or trust shall not be granted a license to exercise the health profession nor shall be renewed unless rehabilitated under a decision of the competent authority.

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Article (3): 1- The healthcare profession’s practicing license term shall be determined by the Implementing

Regulations of this Law. Any practitioner who has been suspended from practicing the profession for two consecutive years– for purposes other than studying or training in the profession– may resume practice only after renewal of the relevant license.

2- Provisions for recruitment, registration and licensing of visiting physicians shall be provided for in the implementing regulations.

The Regulation: 3-1 The license for employees in government authorities shall be valid as long as the health

practitioner is on the medical work, and the renewal of the professional registration shall be considered by the commission at the end of its office.

3-2 The private health institutions employees’ license term shall be equivalent to the professional registration term with the commission. If there is any change in the workplace during the period of professional registration without changing the specialty, the registration shall remain in force.

3-3 The license renewal shall be issued in accordance with the requirements referred to in Articles (2& 3) of this Law.

3-4 The license shall be deemed cancelled in the following cases: 1- If a period of six months has been elapsed from the date of the license issuance without

actual practice. 2- If the license of the private health institution in which he works is cancelled or the

employment contract of the company by which he was recruited is terminated unless he has been transferred to a licensed health institution, or the licensed physician period of visit is elapsed.

3- If the health practitioner changes his specialty without the approval of the Ministry of Health.

4- If a decision is issued by the competent authority to suspend or cancel the license. 5- Death of the licensee.3-5 Health practitioner must apply for renewal of a license granted before the expiry of at least

one month.3-6 The health practitioner shall be subject to the disciplinary responsibilities set forth in this Law

if he continues to work after the end of the license granted to him. 3-7 Visiting health practitioners are recruited in accordance with the following rules: 1- The visiting health practitioner must have a license to practice the profession in the country

of origin. 2- The recruitment of the visiting health practitioner shall be limited the hospitals and

polyclinics set up for the visiting health practitioner’s area of specialty and potentials. 3- The visiting health practitioner should have rare disciplines or new techniques required in

the Kingdom. 4- The visiting health practitioner should not be sentenced by a legal limit, criminal judgment,

because of medical error or was deported from the Kingdom for reasons related to health professions.

5- Upon determining the visit duration, sufficient time should be taken into account to evaluate the medical procedures undertaken during the visit.

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6- The health facility shall guarantee the payment of compensation stipulated in a final judgment in case of medical error issued by the visiting health practitioner in case of the insurance coverage’s unavailability or insufficiency.

7- A consultant or specialist physician of the private health institution shall be mandated to accompany the visiting physician or health practitioner provided to be of the same specialization or the hospital’s medical director in the absence of physicians or practitioners of the same area of specialty, and shall be mandated by the following tasks:

A- Receive and process patients. B- Sharing the visiting health practitioner in diagnosis, treatment plan and surgical

procedure. C- The cases shall be followed-up by the health practitioner after the departure of the

visiting health practitioner and the necessary measures shall be taken to deal with the complications that may result from the method of treatment or surgery.

8- The visiting health practitioner’s request shall be submitted to the health affairs directorate to which the health institution is affiliated and the following shall be attached therewith:

A- A copy of the visiting health practitioner’s certificates and curriculum vitae. B- The program of the visit includes lectures and workshops to be presented by the visiting

health practitioner. C- An acknowledgement of visiting health practitioner to work according to the regulations

in force in the Kingdom and respect Islamic principles. D- An acknowledgment of the accompanying health practitioner by approving to be

mandated to accompany the visiting health practitioner, as well as agreeing to follow up the sick cases, handling complications and to make his statements before the investigative committees and the competent judicial authorities regarding medical errors resulting from diagnosis, treatment or surgery.

9- A copy of the visiting health practitioner’s certificates and curriculum vitae shall be sent to the commission for evaluation.

10- After the commission approval to recruit the visiting health practitioner, the following shall procedures shall be carried out: A- The approval to recruit the visiting health practitioner shall be granted by the

ministry or the competent health affairs directorate. B- After the arrival of the visiting health practitioner and after finalizing all the procedures

stipulated in this regulation, a temporary license shall be issued to him to work in the private health institution and license expires at the end of the visit.

Article (4):The minister may, as dictated by the public interest, limit granting license to practice any of the professions provided for in this Law to Saudis only. The Regulation:4-1 The license to practice the profession may be restricted to Saudi practitioners for any of the

health professions mentioned in Article 1 of this Law, provided that sufficient number thereof is available in the Kingdom, in a region or for reasons approved by the Minister.

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Chapter (2)Health Practitioner’s Duties

Section (1)General Duties of Health practitioners

Article (5): Health practitioner practices his profession in the interest of the individual and the society within the scope of respecting the human right to life, safety and dignity, taking into consideration the customs and traditions prevailing in the Kingdom, refraining from exploitation.The Regulation:

5-1 The patient’s right should be health practitioner respected in accordance with the Sharia’s principles and the approved medical criteria.

5-2 Health professions practicing code of ethics and other guides approved by the commission apply to health practitioners.

5-3 Health practitioner shall be prohibited to photograph or publish surgeries or remedial procedures unless the following controls are available:

A- Written consent of the patient. B- Approval of the health facility. C- For approved scientific purposes. D- Not to violate public morals and profession ethics.

Article (6):The health practitioner shall be committed to assist the competent authorities in performing their duties to protect public health and to prevent threats in peace and war.

Article (7):A- The health practitioner shall work to develop his knowledge, follow up scientific evolutions

and new discoveries in his area of specialty, and the managements of health establishments shall facilitate his attendance at seminars and courses in accordance with the controls assigned by the Commission.

B- The health practitioner should not practice the methods of diagnosis and treatment that are scientifically unrecognized or prohibited in the Kingdom.

The Regulation:7-1 Knowledge shall be developed by attending conferences, scientific and training seminars,

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lectures, research participation and providing sources of information for health practitioners. This shall be taken into consideration when considering promotions, re-registration or renewal of the license to practice the profession.

7-2 Knowledge advancement controls shall be defined by the commission to the health practitioner and health facilities managements provided to include hours of continuous health education, training accredited hours and the type of courses required in the health practitioner’s area of specialty, and these controls shall be published in the appropriate manner. The health facility shall enable the health practitioner to complete the prescribed hours of continuing education in a manner consistent with the health practitioner’s commitment to patients.

Article (8): The health practitioner who learns or becomes aware of a patient or injured person in a critical condition shall provide all possible assistance or ensure that he receives required care. The Regulation:8-1 The health practitioner shall provide urgent medical care to the patient who requires such

care in accordance with his available potentials without asking his fees in advance. If the patient requires further medical care which cannot be offered by the health practitioner, then the health practitioner shall communicate with the concerned entities to find a way to transport him to the nearest appropriate health facility for treatment.

Article (9): A- Healthcare shall always be in the interest of patients, and the health practitioner shall do his best to all patients. B- A health practitioner may not, except in emergencies, practice an act beyond his specialty or potentials.The Regulations:9-1 The health practitioner shall not practice any medical procedure that does not achieve the

desired benefit to the patient, even if there is no harm pertaining thereof, such as prescription of unnecessary drugs or examinations or to the patient’s referral to inpatient section if his condition was not at risk.

9-2 The health practitioner is obliged to work in accordance with the medical powers “privileges” and the job description given to him according to the commission’s classification and registration.

9-3 The employer shall highlight the powers in writing and comply therewith.

Article (10):A- A health practitioner is strictly forbidden- save as in cases prescribed by the implementing

regulation- from advertising or promoting himself directly or by mediation. B- A health practitioner is prohibited from indicating on signs, cards, prescriptions or

advertisements, academic titles or specialties he has not obtained in accordance with relevant rules.

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The Regulations: 10-1 Without prejudice to the provisions of article 31 of the Law of private health institutions and

its executive regulations, a health practitioner shall refrain from promotion and advertising by various means, such as promoting himself or making advertisements of a commercial nature that are not based on scientific grounds or contrary to the profession’s ethics.

Article (11): A health practitioner, upon examination of a patient suspected to have incurred a crime related injury or to have an infectious disease, shall immediately notify the competent security and health authorities.The Minister shall issue a decision designating diseases that must be reported, the authorities to be notified and procedures that must be followed in this respect.The Regulation: 11-1 A health practitioner, upon examination of a patient suspected of being criminally injured,

shall prepare a detailed report covering the expected length of recovery and a precise injury description signed by two physicians accredited by the health establishment.

11-2 The competent authority in the Ministry shall designate the communicable diseases to be reported, the competent authority to be notified, and establish the appropriate preventive and curative rules and procedures. The Minister shall issue a decision, and the same shall be updated periodically provided to be available to all health practitioners.

11-3 The health practitioner shall comply with the decisions and instructions governing the reporting of infectious diseases and notification shall be reported to the competent authorities directly or through the facility employing the health practitioner.

Article (12):A health practitioner may not practice more than one healthcare profession, nor may he practice any other profession the practice that conflicts with healthcare professions. He is prohibited to request, accept or take a commission or reward, and also he is strictly forbidden to receive any benefit in return for promoting or strictly prescribing certain medications, or equipment or directing patients to a particular pharmacy, hospital, laboratory or the like. The Regulation:12-1 A health practitioner may not exercise more than one health profession even if he has

qualified to do so.12-2 A health practitioner is prohibited to obtain any material or in-kind benefit from pharmaceutical

or medical equipment companies for the purpose of promotion or marketing, and to force the patient towards a specific product or service against the patient.

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Article (13):A health practitioner may not, in non-emergency situations, conduct examinations, treatment in return or free of charge in pharmacies or places not designated for such purpose.

Article (14):A health practitioner is prohibited from: A- Employ unlicensed healthcare professionals or provide assistance to any person illegally

practicing a healthcare profession.B- Retain drugs and vaccinations in the workplace contrary to instructions issued by the

Ministry, except for pharmaceutical facilities.C- Sell drugs to patients, except in pharmaceutical facilities, or sell medication samples under

any circumstances.D- Facilitate a patient’s access to any undue or unlawful privilege or benefit, whether material

or otherwise.E- Accommodate patients in places other than those designated for this purpose, except in

emergencies.F- Use diagnosis or treatment equipment prohibited in the Kingdom.

The Regulation:14-1 A health practitioner is prohibited from issuing incorrect or exaggerated reports in order to

give the patient sick leave, health certificate or any other benefit. 14-2 A health practitioner may retain unexpired drugs which are not assigned for sale or first

aid provided to be properly maintained and stored in his workplace to be dispensed free of charge in emergency cases.

14-3 A health practitioner is prohibited from using unauthorized diagnosis or treatment equipment.

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Section (2)Duties of health practitioner toward patients

Article (15):A health practitioner shall exert due diligence in diagnosis, utilizing appropriate technical methods and any specialists or assistants the case may require and provide the patient, upon his request, with reports on his condition and test results, taking into account accuracy and objectivity in this regard.The Regulation:15-1 In this vein, the regulations governing the issuance of medical reports on sick leave,

fitness, reports relevant to criminal injuries, death certificates and other official reports shall be complied with.

15-2 The health practitioner, who is aware of the lack of means or specialties required for diagnosing and treating the case, use due care regarding the patient referral to facilities where necessary capabilities are available.

Article (16):A health practitioner may, other than in serious or emergency cases, apologize for the treatment

of a patient for professional or acceptable personal reasons.16-1 An apology based on differences of religion, color, sex or race is not acceptable.16-2 A health practitioner may, before apologizing for follow-up treatment, ensure that the

patient is not harmed and inform the competent authority to ensure the continuation of the treatment plan.

Article (17):An attending health practitioner shall, if he sees a need for a second opinion, alert the patient or his family thereof and shall agree to seek assistance from other healthcare professionals if so requested by the patient or his family. The heath practitioner may propose names of health practitioners he deems fit for consultation. If the attending health practitioner decides that there is no need to consult another health practitioner or disagrees with his opinion upon consultation, he shall have the right to discontinue treatment, with no obligation to give justification therefor. 17-1 A health practitioner shall introduce himself to the patient, his specialty and scientific

degree upon launching treatment.17-2 If the patient’s diagnosis or treatment requires other specialties or diagnosis means, the

health practitioner shall clarify thereof and the grounds for doing so.

Article (18): A health practitioner shall be committed to, after explaining the therapeutic or surgical condition

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and implications thereof, alert the patient or his family to the necessity of following the instructions provided and warn them of the seriousness of the consequences of failing to follow said instructions.A physician may, in cases of incurable or life threatening diseases, decide, as his conscience dictated, whether it is appropriate to inform the patient or his family of the fact of his disease, unless prohibited to do so by the patient or if the patient designates a person to be exclusively informed. The Regulation:18-1 A health practitioner shall explain to the patient, his family or a person designated by the

patient the possible side effects pertaining to the therapeutic or surgery procedure.18-2 A health practitioner shall not divulge the patient’s medical secrets the details of his

medical condition except to the patient himself, his family or a person designated by the patient.

Article (19): No medical intervention may be performed except with the consent of the patient, his representative or guardian if the patient is legally incompetent. As an exception, a health practitioner must in cases of accidents, emergencies or critical cases requiring immediate or urgent medical intervention to save the patient’s life or an organ thereof or to avert severe damage that might result from delay, where the timely consent of the patient, his representative or guardian is unattainable– intervene without waiting for such consent. Under no circumstances may the life of a terminally ill patient be terminated even if so requested by the patient or his family.The Regulation:19-1 The consent of the rational and adult patient must be obtained, whether a man or a woman,

or his representative or if the patient is legally incompetent prior to any medical intervention in accordance with the content of the Royal Decree No. M/2428/4 dated 29/07/1404H based on the decision of Council of Senior Scholars No. 119 dated 26/05/1404.

Article (20):A physician assigned to conduct a medical examination on a deceased body may not report death except after ascertaining the cause of death, based on his medical expertise.The physician however, may not provide such report if the death is suspected to be caused by a criminal act. In such case, he must immediately notify the competent authorities.The Regulation:20-1 A thorough medical examination shall be conducted by the physician, prior establishing

the death, to ensure that the body vital functions are stooped through clinical examination and other technical means. A death report may only be issued after ascertaining by the technical means and death time shall be recorded.

20-2 When traces of injury or toxicity were suspected, the physician shall: A- Notify the responsible department in the health facility in which he is employed, which in

turn notifies the competent security authorities in an official manner.

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B- Confirm injuries under a medical report delivered to the competent security authorities. C- A physical examination, at the time of body revisit, shall be carried out by the forensic

physician, when summoned, and if he deemed that the autopsy is required to prove the cause of death, he shall request the security authorities to issue an order of autopsy while retaining all evidences related to the deceased such as clothes, ballistics and the like.

Article (21): A health practitioner shall maintain the confidentiality of information obtained in the course of his practice and may not disclose it except in the following cases: A- If disclosure is for the following purposes:

1- Reporting a case of death resulting from a criminal act or to prevent the commission of a crime; in which case, disclosure may only be made to the competent authorities.

2- Reporting communicable or epidemic diseases. 3- A practitioner rebuts accusations pertaining to his competence or practicing of his

profession made by the patient or his family. B- If the patient agreed in writing to disclose the secret, or if disclosure to the patient’s family

is useful for his treatment. C- If so ordered by a judicial authority.

Article (22):A physician shall be strictly prohibited to abort a pregnant woman unless it is necessary to save her life. However, abortion may be carried out if pregnancy has not completed four months and conclusively established that the continuation of such pregnancy will have serious consequences on the mother’s health, based on a decision by a medical committee formed in accordance with terms and conditions specified in the Implementing Regulations of this Law.The Regulation:22-1 the decision of Council of Senior Scholars No. 140 dated 20/06/1407H includes the

following controls: 1- Pregnancy may not be aborted in all its stages except for legitimate justification and

within very narrow limits. 2- If the pregnancy is in the first phase, which is forty days, and if it’s abortion by a legitimate

interest or limiting expected harm, abortion may be valid. However, abortion during this period for fear of hardship in raising children or fear of being unable to pay for their living, education, for their future or parents are satisfied with their number of children, then abortion is impermissible.

3- Abortion shall be impermissible if it is a clinging substance or embryo until a reliable medical committee decides that the continuation of such pregnancy will have serious consequences on the mother’s health, therefore, abortion may be valid after exhausting all means to avoid such risks.

4- After the pregnancy enters in the 3rd phase and after completion of four months, abortion is impermissible until determined by collection of specialists that keeping the fetus in the mother’s uterus causes her death after exhausting all the means to save his life. Rather, it

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is permissible to abort the fetus under these conditions in order to prevent harm and bring benefit.

22-2 A committee comprises not less than three consultants or specialists provided to include consultant or specialist for the disease for which pregnancy is recommended to be aborted shall be formed by the director of the hospital, or his designee, in which the birth department is located. The Committee shall prepare a report indicating the type of confirmed risk that threatens the mother’s health if the pregnancy continues and is signed by all the members of the Committee and then authenticated by the director of the hospital or his designee. In the case of abortion recommended, the patient and her husband or guardian shall be informed and their prior written approval shall be recorded.

22-3 Abortion drugs may not be dispensed or facilitating to be dispensed, nor may any other health practitioner be allowed to do so for the purpose of performing an abortion that is legally impermissible.

Article (23): A- A pharmacist is prohibited to:

1- Be a responsible manager of more than one pharmaceutical facility. 2- Prescribe any drugs without a medical prescription issued by a physician licensed to

practice in the Kingdom, excluding thereof medications specified by the Ministry. 3- Dispense drugs contravening those stated in the prescription without the approval

of the issuing physician. A pharmacist may, under the approval of the patient, dispense generically equivalent drugs without consulting the physician, excluding drugs specified by the Ministry.

4- Repeat prescriptions unless so stated therein, except for drugs specified by the Ministry. 5- Dispense medication if he suspects an error in the prescription; in which case, he shall

seek clarification from the prescribing physician.B- A pharmaceutical technician may only dispense a prescription under the supervision of a

licensed pharmacist.

The Regulation: 23-1 A pharmacist appointed to manage any pharmaceutical facility must comply with

the professional duties and responsibilities specified by that institution under Law of Pharmaceutical Preparations and Installations and its implementing regulations.

23-2 A- The prescription must be in accordance with the conditions specified by the Ministry and professionally recognized.

B- Regarding the prescriptions of narcotic drugs and psychotropic substances, drugs dispensing procedures and controls adopted by the Ministry shall be adhered to and in accordance with the Law of combating narcotic drugs and psychotropic substances and its implementing regulation.

C- Over the counter drugs shall be excluded from drugs dispensing identified by the Saudi Guide for Over the Counter Drugs.

23-3 A pharmacist may dispense prescriptions both quantitative and qualitative, whether they are ready or accurately installed, and may not be contravened without the approval

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prescribing physician. a pharmacist may dispense similar alternatives of medicines both quantitative and qualitative and registered with the FDA without reference to the physician provided to be equal or less expensive with taking the patient’s approval and medicines with a narrow therapeutic area shall be excluded thereof.

23-4 A pharmacist may refill the prescription of chronic disease medicines if prescribed except for the drugs listed in the table attached to the Law of combating narcotic drugs and psychotropic substances, and the psychiatric drugs specified in the Saudi Drug Guide and its respective annexes issued by Saudi Food and Drug Authority.

23-5 Pharmaceutical technicians and pharmaceutical students who work under training are prohibited from selling or dispensing pharmaceutical preparations without the pharmacist’s supervision, and does not relieve them of liability.

23-6 A pharmacist may apologize for the payment or sale of drugs in the following cases: A- If the prescription contains an error, then he should clarify the error from the prescribing

physician. B- If the prescription contains drug is not valid for use, he should clarify the error from the

prescribing physician.

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Section (3)Professional Courtesy

Article (24):The relationship between health practitioners shall be on the basis of cooperation and mutual trust.It is prohibited for a health practitioner to conspire against colleagues, detract from their professional or moral standing or spread rumors against them; nor may a health practitioner, directly or indirectly, solicit or dissuade patients treated by a colleague or coworker.

Article (25): A health practitioner replaces a colleague in the treatment of a patient shall refrain from exploiting this situation for his personal benefit and shall stand above anything that may discredit the practice of his profession.The Regulation:

25-1 A health practitioner substituting a colleague in treating a patient shall review the patient’s file and procedures initiated or recommended by his former colleague and complete the procedures required by the patient’s condition, and the same shall be recorded in his file.

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Chapter (3)Professional Liability

Section (1) Civil Liability1

Article (26):The compliance of a health practitioner governed by this Law is a commitment to exert due diligence consistent with recognized scientific principles.

Article (27):Any healthcare profession health practitioner who commits malpractice causing harm to a patient shall be liable for indemnification. The Sharia Medical Panel provided for in this Law shall determine the amount of such indemnification. The following shall be deemed malpractice: 1. In treatment or provide follow-up. 2. Lack of knowledge and skills that can be expected in others in the profession. 3. Performing experimental and un-presented surgery on a person, in violation of relevant

rules. 4. Conduct experiments or scientifically non-accredited research on patients. 5. Administer medications to patients on experimental basis. 6. Use medical instruments or equipment without adequate knowledge of their use, or failing

1 (1 ) Civil liability is defined as a breach of the physician commitment under the law, and this violation results in damage to another person, and this damage requires compensation and reparation. The compliance in the physician’s job arises from the laws regulating the medical profession, in addition to the medical charter between the physician and the patient, where the physician shall be committed to exert the necessary due care and provide the necessary treatment for the patient. If the physician commits any medical error and this error results in harm to the patient, then the physician bears civil liability (tortious or contractual). The physician is obliged to reparation of the damage by means of material compensation. The compensation is determined by the Sharia Health Authority, which is the judicial body competent to consider medical errors. Knowing that the blood money or retribution is defined by legitimate principles, but compensation is left to the discretion of the medical authority. Civil liability: A penalty for damage to private interests where the liability of the official to compensate the damage is sufficient to protect thereof based on a request of the interested party who is entitled to waive or reconcile thereof.Civil liability shall be defined as any error causing harm to third parties which committing the violator with compensation, breach the law provisions or non-compliance with the contract terms, and this means that the physician shall be held accountable in a civilian capacity if error, damage and casual relationship are founded in his act, i.e. damage caused to the patient has to be a direct result of his error. (2) A medical error is legally defined as physician’s any violation or deviation from behavior regarding medical rules and principles dictated by science or theoretically and practically recognized at the time of execution of the medical work or the breach of duties of caution, consideration and vigilance dictated by Law and physician’s profession duties, where serious consequences pertaining to his acts while his potentials and duties impose on him to be vigilant and careful in his behavior so as not to cause harm to the patient.

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to take appropriate preclusions to prevent damage arising from such use. 7. Lack of providing adequate monitoring or supervision. 8. Absence of consult anyone the consultation of which is necessitated by the condition of

a patient.Any provision limiting the liability of a healthcare professional or holding him accountable shall be deemed invalid.

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Section (2)Criminal Liability 2

Article (28):Without prejudice to any severe punishment set forth in other Laws, a person shall be sentenced to imprisonment of no more than six months and a fine not exceeding one hundred thousand riyals, or either punishment: 1- Practice health profession without a license.2- Provide misleading statements or use unlawful methods pertaining thereon his obtaining a

license to practice a health profession. 3- Utilize means of advertising that would lead the public to believe in his eligibility to practice

a health profession, contrary to fact. 4- Unlawfully claiming a title usually associated with health practitioners.5- Possess tools or equipment usually used in the practice of health professions without having

a license to practice such professions or a legitimate reason for such possession.6- Abstained to treat a patient without an acceptable reason. 7- Breach provisions of Articles 7(b), 9, 11, 14(a) and (f), 19, 20, 22, 23, 24 and 27(3) of this Law.8- Trade in human organs or performing human organ transplant knowing that the organ in

question has been obtained by means of trade

Article (29): Any person violating provisions of Articles 10, 12 and 13 and paragraphs (b), (c), (d) and (e) of Article 14 of this Law, shall be subject to a fine not exceeding fifty thousand riyals.

Article (30): Any violation for which this Law or its Implementing Regulations contains no provisions shall be punishable by a fine not exceeding twenty thousand riyals.

2 Criminal liability is a breach of a legal or professional duty or obligation when act or omission to act contrary to the criminal or medical rules and provisions set forth in the legal regulations. In order for this to happen, a criminal intent is required by the physician, which is to say that he has to be aware of the damage that may be caused by his action, but he has done so deliberately.The criminal liability would be established on the physician when he convicted an act constitute crimes in the Law, such as illegal abortion, willful harm to patient, decline to provide treatment or first-aid in emergencies and the like.

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Section (3) Disciplinary Liability 3

Article (31)Without prejudice to provisions of criminal or civil liability, a health practitioner who defaults in performing any duty provided for in this Law, violates relevant codes of practice or acts contrary to professional conduct or ethics, shall be accountable and subject to disciplinary measures.

Article (32):Disciplinary penalties for professional violations shall be as follows: 1- Warning 2- A fine not exceeding ten thousand riyals. 3- Health profession license practicing cancellation, strike him off the roll of licensees. In

case of license cancellation, reapplication for a new license may not be filed before the lapse of two years from the date of cancellation.

3 Disciplinary Liability means the physician’s accountability for violation of his professional behavior provided by career code of conduct of honesty, devotion and other.Disciplinary liability is committing an act that would constitute deviation from the profession duties requirements.

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Chapter (4)Investigation and Trail

Article (33):A- A panel entitled the Sharia Medical Panel shall be formed as follows: 1. A judge of a grade not lower than Grade (A) designated by the Minister of Justice, as a

Chairman. 2. A legal adviser designated by the Minister. 3. A faculty member from a college of medicine designated by the Minister of Higher

Education. In provinces not having a college of medicine, an alternative member of health facilities in the province shall be designated by the Minister.

4. A faculty member from a college of pharmacy designated by the Minister of Higher Education. In provinces not having a college of pharmacy, an alternative member of health facilities in the province shall be designated by the Minister.

5. Two competent and experienced physicians chosen by the Minister. 6. A competent and experienced pharmacist chosen by the Minister.B- Participation of the two members referred to in paragraphs 4 and 6 shall be limited to

cases relating to pharmacy.C- The competent minister shall designate a substitute member to replace an absent

member.D- This Panel shall have a secretary designated by the Minister.E- The Panel may seek the assistance of one or more experts on cases under review.F- The seat of this Panel shall be in Ministry of Health in Riyadh; other panels may be set up

in provinces designated pursuant to a decision by the Minister.G- TheImplementingRegulationsshallspecifythemembershipofficeofsaidPaneland

shall regulate its proceedings.

The Regulation: 33-1 Membership office in Sharia Medical Panel shall be three years renewal.33-2 The Panel shall seek assistance of an expert or more, if deemed necessary, to show an

opinion on a technical matter relating to the case before it or at the request of one of the opponents on his own account.

33-3 The expert shall provide the Panes his opinion in a written report and listen to him at one or more sessions, and the fees paid to the expert for sessions attended by him shall be estimated in an amount equivalent to the remuneration paid to the Panel member for each session.

33-4 The secretary shall be experienced, highly qualified and with university degree enabling him to understand the issued presented.

33-5 Sharia Medical Panel’s secretary shall check the transactions received from the Sharia

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Health Panel’s secretariat, ensures the completion of the medical files, prepares the case for presentation to the Sharia Health Panel, register sessions minutes and panel’s decisions, and confirm the opponents’ attendance, absence and their requests in the minutes.

Article (34):The Sharia Health Panel shall have the following jurisdictions:1- Consider claims of medical malpractice in cases brought before it regarding private rights

(blood money, indemnity or retribution).42- Consider cases of medical malpractice leading to death, damage of an organ or loss of total

or partial use thereof, even in the absence of a claim for a private right.

Article (35):The Sharia Medical Panel shall be convened in the presence of all the members and shall pass its decisions by a majority vote, provided the majority includes the judge. Decisions of this Panel may be appealed before the Board of Grievances within sixty days from the date of notification thereof. The Regulation: 35-1 The person who is harmed by the alleged medical error and his heirs may claim his special

right no matter what amount he has before the Sharia health panel considering the case.35-2 The secretary shall attend the sessions and handle the minutes under the chairman

supervision. The minutes shall include the names of the panel chairman, members, public prosecutor, and date and time and venue of the session, names of litigants and their attorneys, statements, requests, summary of their pleadings, evidences and submitted documents, and all the proceedings take effects in the session. The minutes shall be signed by the chairman and participating members on each page.

35-3 The panel shall hear the general prosecutor’s claim and plaintiff’s claim, and each party shall have the right to give feedbacks on the other party’s statements, then the panel lodges offences to the defendant and request his answer. If the defendant denies the offenses attributed to him or refrained from replying, the panel shall consider the evidences and take the necessary actions thereon and each of the litigants shall request to hear witnesses and consider their evidences. Each of litigants may provide the panel any matters relating to the case in writing to be included in the case file.

35-4 The panel shall give its decision with the defendant’s acquittal or conviction and impose the punishment, in both cases, the panel shall decide on the claim submitted by the plaintiff, the panel’s decision shall be substantiated and supported by all facts or the merit of its decision to the relevant provisions.

4 Blood money means the money to be paid by the offender to the victim or his pardons as compensation for the crime he committed whether crime or offence. However, the jurists have termed (blood money) on indemnification paid by the offender instead of the committed crime, and retribution termed on indemnification paid by the offender instead of wounds.Retribution is an amount estimated as much as what is missing from the body organs. Indemnification means what is given to a person instead of what he has lost.

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35-5 The plaintiff has the right to submit a very summary procedure to the chairman of Sharia Health Panel, during the proceedings or after it has directly referred to the panel, prohibiting his opponent from traveling, and the judge the chairman shall issue a prohibition decision if justified.

35-6 The relevant parties shall be notified to be summoned before the panel or the competent committee in the time and place determined by them, and in the case of the absence of the plaintiff or the attorney in the hearing venue and date despite being formally notified, the panel shall set another date, and in the event that the plaintiff or his attorney fails to attend the second date, the panel shall continue considering the public right and no longer purse the plaintiff claim and prosecution documents shall be sent back to the entity from which the claim was received.

35-7 In the event the defendant fails to attend despite of being formally notified with the hearing date and venue, the panel shall adjourn the proceedings to a subsequent hearing, in which the defendant is notified, if he did not appeared, the claim shall be adjudicated by the panel and the judgment shall be deemed in all cases pronounced. If the defendant is a resident outside the Kingdom of the Member States of the Arab-Riyadh Agreement on Judicial Cooperation, then he shall be notified in accordance with the procedures provided for in Article VI of the Convention. If the defendant is not a member of the States, he shall be notified by the Ministry of Foreign Affairs.

35-8 The prevailing party of the public or private right shall take the legal procedures to implement the final decision issued it its favor after being notified thereof and the Sharia Health Panel or the Medical Offenses Committees shall have no relation to the implementation of the decisions issued by these committees.

35-9 Each Sharia Health Panel shall have a full time secretariat formed of a physician and a qualified administrative body, in accordance with the stipulated in the Royal Decree Telegram No. (7/B/15229) dated 04/08/1422H.

Article (36): Public Prosecution shall be represented before the Sharia Medical Panel by officers designated pursuant to a decision by the Minister.The Regulation:36-1 The Public Prosecutor shall be paid for the sessions he attends an amount equivalent to

the remuneration paid to the member of the Panel for each session.

Article (37):The public right claim shall not be heard after a period of one year elapsed since the date of knowledge of the relevant medical malpractice, and the implementing regulation shall specify the controls pertaining to said knowledge. The Regulation:37-1 Knowledge of the medical malpractice shall be established from the date of submitting

the report prepared by competent investigator in accordance with Article (40) and its implementing regulations.

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Article (38):Except for jurisdiction stipulated for the Sharia Medical Panel, violations arising from implementation of this Law shall be considered by committees formed pursuant to a decision by the competent minister, provided that each committee includes a legal specialist and a healthcare professional of Saudi nationality. Decisions issued by said committees shall be approved by the competent minister and may be appealed before the Board of Grievances within sixty days from the date of notification thereof. The Implementing Regulations shall specify committee proceduresThe Regulation: 38-1 Work procedures of the Medical Offenses Committees in accordance with work procedures

of Sharia Medical Panel.38-2 The sessions of these committees shall be convened at the headquarters assigned thereto

and their decision shall be issued by majority vote. In the event of an equality of votes, the chairman shall have the casting vote.

38-3 The decisions of these committees may only be implemented after they have acquired the final status after the expiry of the specified grievance period or after a final judgment has been issued by the Board of Grievances.

Article (39): The Minister may suspend a health practitioner from practicing for a period he deems appropriate, should there be evidence or presumptions indicating a violation punishable, if proven, by license revocation. If there is a probability that such suspension will adversely affect relevant patients, the Minister shall take appropriate measures to ensure that said patients will continue to receive necessary healthcare. A health practitioner may appeal the suspension decision before the Board of Grievances within thirty days from the date of notification thereof.The Regulation:39-1 The director of competent health affairs, the executive directors of the medical cities and

specialized hospitals or the Assistant Agency for Compliance shall propose a temporary suspension for the health practitioner if the investigation reveals evidences or presumptions indicating a violation which deserves license revocation, if established.

Article (40): The Implementing Regulations shall provide for rules and procedures necessary for considering and deciding violations and cases arising from the implementation of this Law. The Regulation:40-1 The competent authorities shall take into account the gradual penalty in determining the

appropriate punishment in accordance with the offence degree of seriousness and the extent of its recurrence.

40-2 Any person who has suffered harm from the medical malpractice set forth in this Law or to his heirs in case of death the right to apply to health facility where the malpractice occurred or

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the relevant director of health affairs with investigation application. The complaint submitted by the harmed person, his designee, guardian or heirs due to medical malpractice shall be deemed as a claim for his private right. An investigation of medical malpractice may be requested even if there is no claim of a private right.

40-3 The competent health authority may order an investigation as soon as the complaint is submitted by the plaintiff. The person responsible for the investigation may postpone the defendant’s travel and persons whom are required to be heard in the investigation for thirty days to complete the investigation. If the investigation requires an additional period, an extension application shall be submitted to the director of the competent health affairs or the executive directors of the medical cities and specialized hospitals for another 30 days. The plaintiff may submit an application to the investigator to submit thereof to the chairman of the Sharia Health Panel.

40-4 The investigation shall be carried out by experienced and competent specialists selected by the competent authority of the Ministry or selected by the competent director of health affairs or the executive directors of the medical cities and specialized hospitals.

40-5 The investigator in charge shall notify the litigants of the day and hour of carrying out the investigation and the investigation procedures and venue a sufficient time before the investigation to be held.

40-6 When the defendant who has committed a medical malpractice appeared for the first time in the investigation, the investigator must record all his personal data and be notified of the violations attributed to him. The defendant’s statements shall be recorded in the minutes and he may be confronted with other related persons or plaintiffs, then the defendant shall sign on his statements after being recited to him.

40-7 The investigation shall be carried out in an environment which the defendant’s will to make his statements is being influenced, and the litigants may provide the investigator during the proceedings the requests they consider to be made.

40-8 The investigator shall hear the statements of all those directly related to the subject of investigation’s medical malpractices and shall hear the witnesses’ statements who are asked by the litigants to make their statements. The investigator shall record in the minutes the full data of each witness and each witness shall be heard individually. Witnesses may be confronted one another and with the litigants and each of them shall sign on his statements.

40-9 The investigator in charge may engage specialists to express their opinions to any matter related to the investigation and his report shall be submitted in writing at the time specified by the investigator. The investigator may replace it with another if the report is not submitted on time and any of the litigants may submit a report from another specialist in an advisory capacity.

40-10 All concerned parties shall submit data, documents, medical files and reports, x-ray reports and analysis to the investigator when requested.

40-11 The investigation’s all proceedings and findings shall be deemed top secret which must not be disclosed by the investigators, others concerned with the investigation or who are summoned therein given their profession or job. Anyone who breaches this shall be accountable.

40-12 The Investigator shall, after the completion of the investigation, prepare a report containing the facts investigated, evidences or presumptions and findings with attributing each violation,

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if any, to the relevant provision and recommending referral of the case to the competent health authority or the competent health violations committee based on the grounds provided that the committees or the Sharia health panels shall be the jurisdiction to adjudicate the cases raised.

40-13 Upon the case referral to the Sharia health panel or any competent health violations committees, the investigator shall handed over all the investigation’s documents include medical files, x-ray reports and etc., to the secretariat of the Sharia health panel or the committee referred thereto and a copy to the competent public prosecutor. The secretariat shall ensure that the requirements to consider the claim and the addresses of all parties thereto in a special register and that a hearing is scheduled to be considered and notifying the litigants and all parties concerned to appear before the Sharia Health Panel or the competent committee well in advance of a meeting. The health practitioner’s employer shall prepare the registered address for notification and the employer shall hand over the notification to the health practitioner in a formal and proven manner.

40-14 The secretariat of the Sharia health panel or the competent committees a separate file for each case.

40-15 The panel and the competent committees shall hear and record the statements of the concerned parties, they may rely on the findings of the preliminary investigation raised thereto, provided all of which shall be in Arabic language, if any of the parties is not Arabic speaker, he shall notify the committee to be escorted by a reliable interpreter, or approve the use of a member of the committee in this regard.

Article (41): Subscription to cooperative insurance against medical malpractice shall be mandatory for all physicians and dentists of public and private health institutions. These facilities and institutions shall guarantee payment of compensations rendered by final judgments against their staff in case of lack or insufficiency of insurance coverage, and they shall have the right of recourse against those found liable, for reimbursement. Said mandatory cooperative insurance may include other categories of health practitioners pursuant to a resolution by the Council of Ministers upon a proposal by the Minister of Health.The Regulation:41-1 All physicians and dentists are subjected to cooperative insurance against medical

malpractices regardless their level of income and duration of employment of those who have a professional registration in the commission.

41-2 Each physician or dentist is committed to conclude an insurance policy against medical malpractices with one of the insurance companies licensed to work in the Kingdom of Saudi Arabia.

41-3 The physician or dentist shall pay the premiums to the insurance company he chooses for this purpose in accordance with the agreement entered into with it.

41-4 The relevant employer must take the necessary action to obligate the physician or dentist to subscribe in insurance against medial malpractices.

41-5 The insurance company shall issue a certificate to the insured doctor or dentist stating that he is insured to submit it to the competent authority upon licensing to work or the license renewal.

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41-6 The insurance coverage benefits include the value of the claim for a private right resulting from a medical malpractice under this Law.

41-7 The health insurance coverage includes all compensations arising from medical malpractices occurred during the period of insurance coverage. The date of issuing the final judgment shall not detract from the right to pay compensation resulting from medical malpractice during the period of insurance coverage.

41-8 The insurance coverage ends with the death of the beneficiary, termination or cancellation of the term of the policy, or termination of the employment contract with the insured or ceasing/ suspension from practicing the health professions.

41-9 The Insured may change the insurance company contracted to provide insurance coverage, provided that he shall send a letter to the insurance company at least one month before the date of cancellation. The rest of the insurance premium shall be calculated on a relative basis agreed thereupon in the policy.

41-10 In case of lack of insurance coverage for the payment of compensations rendered by final judgments on the health practitioner or insufficiency of insurance coverage guaranteed by the health practitioner to pay the said compensations, then the health institution to which the health practitioner if affiliated, whether public or private, shall be the guarantor of the payment of such compensation and the holder of the private right shall be entitled to claim the compensation awarded to him by a final judgment in case of lack of insurance coverage and with the difference between the insurance coverage value and sentenced compensations if the insurance coverage insufficient for the payment of all compensations, in this case, the health institution shall have the right to recourse against the health practitioner for reimbursement.

41-11 If a health practitioner has a working relationship with more than one institution, then the joint liability lies with the institution where the medical malpractice occurred.

41-12 The health institution shall be bound by the acts committed by the physician-in-training, and the health institution shall be jointly liable to third parties for any of this trainee’s malpractices.

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Chapter (5)Concluding Provisions

Article (42): This Law shall supersede the Law of Practicing Medicine and Dentistry Professions issued by Royal Decree No. (M/3) dated 21/02/1409H, as also repeal the Law of Practicing Pharmacy and Trading in Medicines and Medical Preparations issued by Royal Decree No. (M/18) dated 18/03/1398H and any provisions conflicting therewith.

Article (43): The Implementing Regulations of this Law shall be issued by the Minister, which shall be published in the Official Gazette. The Minister shall also issue decisions and directives necessary for the implementation of this Law.

Article (44): This Law shall be published in the Official Gazette, and shall be deemed to take effect sixty days from publication date. 44-1 These Implementing Regulations shall be published in the Official Gazette and the ministry

website and shall come into effect from publication date.

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