Commentary on Article 322. Illegal Medical and Pharmaceutical Activities and the Illegal Issuance or Forgery of Prescriptions or Other Documents Entitling a Person to Obtain Narcotic Drugs or Psychotropic Substances of the Criminal Code of the Republic of Kazakhstan

1. Engaging in medical or pharmaceutical activities by a person who does not have a certificate and (or) a license for this type of activity, if this has resulted, through negligence, in the infliction of moderate bodily harm to a person, —

shall be punishable by a fine of up to two hundred monthly calculation indices or corrective labor in the same amount, or community service for a period of up to two hundred hours, or arrest for a period of up to fifty days, with deprivation of the right to hold certain positions or engage in certain activities for a period of up to two years, or without such deprivation.

2. The same act, if it has resulted, through negligence, in the infliction of grievous bodily harm to a person, —

shall be punishable by a fine of up to three thousand monthly calculation indices or corrective labor in the same amount, or community service for a period of up to eight hundred hours, or restriction of liberty for a period of up to three years, or deprivation of liberty for the same period, with deprivation of the right to hold certain positions or engage in certain activities for a period of up to three years, or without such deprivation.

3. An act provided for in Part One of this Article, if it has resulted, through negligence, in the death of a person, —

shall be punishable by restriction of liberty for a period of up to five years or deprivation of liberty for the same period, with deprivation of the right to hold certain positions or engage in certain activities for a period of up to three years, or without such deprivation.

4. An act provided for in Part One of this Article, if it has resulted, through negligence, in the death of two or more persons, —

shall be punishable by restriction of liberty for a period of three to seven years or deprivation of liberty for the same period, with deprivation of the right to hold certain positions or engage in certain activities for a period of up to three years, or without such deprivation.

5. The illegal issuance or forgery of prescriptions or other documents entitling a person to obtain narcotic drugs or psychotropic substances, —

shall be punishable by a fine of up to five thousand monthly calculation indices or corrective labor in the same amount, or community service for a period of up to one thousand two hundred hours, or restriction of liberty for a period of up to five years, or deprivation of liberty for the same period, with deprivation of the right to hold certain positions or engage in certain activities for a period of up to three years, or without such deprivation.

The public danger of the criminal offense provided for in Article 322 of the Criminal Code (Part 1 constitutes a criminal misdemeanor; Parts 2, 3, 4 and 5 constitute crimes) lies in the fact that it may cause harm to human life and health, and also infringes upon the established procedure in the field of medical provision for the protection of human health.

The object of the criminal offense is public relations focused on compliance with the established rules governing the licensing and certification of medical and pharmaceutical activities. The additional object is public relations guaranteeing the protection of the life and health of citizens.

The objective element of the criminal offense provided for in Parts 1, 2, 3 and 4 of Article 322 of the Criminal Code consists of engaging in medical or pharmaceutical activities by a person who does not have a certificate and (or) a license for this type of activity, where such conduct has resulted, through negligence, in the infliction of moderate bodily harm (Part 1), grievous bodily harm (Part 2), the death of a person (Part 3), or the death of two or more persons (Part 4).

In the Republic of Kazakhstan, the rules relating to the prescription, use, issuance of prescriptions and dispensing of medicinal products containing narcotic drugs, psychotropic substances and precursors for medical purposes are provided for in the Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated January 26, 2015, “On Approval of the Rules for the Medical Use of Narcotic Drugs, Psychotropic Substances and Their Precursors Subject to Control in the Republic of Kazakhstan,” and the Order of the Minister of Health of the Republic of Kazakhstan dated October 2, 2020, “On Approval of the Rules for Issuing, Recording and Storing Prescriptions.”

Medical and pharmaceutical activities are subject to licensing in accordance with the procedure established by the Law of the Republic of Kazakhstan dated May 16, 2014, “On Permits and Notifications.”

According to subparagraph 184) of paragraph 1 of Article 1 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System,” medical activity is the professional activity of individuals who have received technical and vocational, post-secondary, higher and (or) postgraduate medical education, as well as of legal entities, aimed at protecting the health of the population of the Republic of Kazakhstan.

The following types of medical activities are carried out in the Republic of Kazakhstan: medical care; laboratory diagnostics; pathological and anatomical diagnostics; activities in the field of blood and blood component procurement; activities in the field of sanitary and epidemiological well-being of the population; activities in the field of public health protection; educational and scientific activities in the field of healthcare; examination in the field of healthcare; and other types of activities not prohibited by the Code “On Public Health and the Healthcare System” (Article 64 of the above-mentioned Code).

According to the Law of the Republic of Kazakhstan “On Permits and Notifications,” the following subtypes of medical activities are subject to licensing:

Emergency medical care and (or) medical aviation;

Outpatient and polyclinic care for adults and (or) children in the following specialties: primary healthcare: pre-medical and qualified care; consultative and diagnostic care: diagnostics: radioisotope, radiological, ultrasound, functional and endoscopic; laboratory diagnostics: bacteriological, biochemical and immunological examinations, laboratory diagnostics of the human immunodeficiency virus (HIV diagnostics), general clinical, serological and cytological examinations; obstetrics and gynecology; pediatrics; neonatology; infectious diseases; therapy; neurology; cardiology; rheumatology; gastroenterology; nephrology; pulmonology; endocrinology; allergology and immunology; hematology; occupational pathology; general medical practice; general surgery: thoracic, abdominal and coloproctology; transplantology; cardiac surgery; angiosurgery; plastic surgery; maxillofacial surgery; neurosurgery; otorhinolaryngology; ophthalmology; transfusiology; urology; traumatology and orthopedics; anesthesiology and resuscitation; dermatovenereology (dermatocosmetology); psychiatry: narcology, psychotherapy, sexopathology, medical psychology; phthisiology; oncology; dentistry; traditional medicine: homeopathy, hirudotherapy, manual therapy, reflexotherapy, phytotherapy and treatment using natural-origin remedies; medical rehabilitation and restorative treatment: physiotherapy, massage, therapeutic physical training, balneology; medical genetics; radiation therapy; sports medicine;

Inpatient care and (or) inpatient-replacing care for adults and (or) children in the following specialties: diagnostics: radioisotope, radiological, ultrasound, functional and endoscopic diagnostics, pathological anatomy; laboratory diagnostics: bacteriological, biochemical and immunological examinations, laboratory diagnostics of the human immunodeficiency virus (HIV diagnostics), general clinical, serological and cytological examinations; obstetrics and gynecology; pediatrics; neonatology; infectious diseases; therapy; neuropathology; cardiology; rheumatology; gastroenterology; nephrology; pulmonology; endocrinology; allergology and immunology; hematology; occupational pathology; general medical practice; general surgery: thoracic, abdominal and coloproctology; transplantology; cardiac surgery; plastic surgery; maxillofacial surgery; neurosurgery; otorhinolaryngology; ophthalmology; transfusiology; urology; traumatology and orthopedics; anesthesiology and resuscitation; dermatovenereology (dermatocosmetology); psychiatry: narcology, psychotherapy, sexopathology, medical psychology; phthisiology; oncology; dentistry; traditional medicine: homeopathy, hirudotherapy, manual therapy, reflexotherapy, phytotherapy and treatment using natural-origin remedies; medical rehabilitation and restorative treatment: physiotherapy, massage, therapeutic physical training, balneology; sports medicine; toxicology; perfusiology; radiation therapy;

Procurement, preservation, processing, storage and sale of blood and its components.

Examination of temporary incapacity for work and professional fitness.

Pharmaceutical activity is activity carried out in the field of healthcare involving the production and (or) manufacture and (or) wholesale and (or) retail sale of medicinal products and medical devices, associated with the procurement (acquisition), storage, import, export, transportation, quality control, registration, distribution, use and destruction of medicinal products and medical devices, as well as ensuring their safety, quality and effectiveness (subparagraph 275) of paragraph 1 of Article 1 of the Code “On Public Health and the Healthcare System”).

The following types of pharmaceutical activities are carried out in the Republic of Kazakhstan: production of medicinal products; production of medical devices; manufacture of medicinal preparations; manufacture of medical devices; wholesale sale of medicinal products; wholesale sale of medical devices; retail sale of medicinal products; retail sale of medical devices.

According to the Law of the Republic of Kazakhstan “On Permits and Notifications,” the following subtypes of pharmaceutical activities are subject to licensing:

Production of medicinal products;

Production of medical devices;

Manufacture of medicinal preparations;

Manufacture of medical devices;

Wholesale sale of medicinal products;

Retail sale of medicinal products.

These types of activities are considered illegal if carried out by persons who do not have a certificate and (or) a license for the specified type of activity.

In accordance with Resolution of the Government of the Republic of Kazakhstan dated December 9, 2014, “On Certain Issues of Licensing Activities Related to the Circulation of Narcotic Drugs, Psychotropic Substances and Precursors,” the authorized body in the field of healthcare is the licensing authority for activities related to the circulation of narcotic drugs, psychotropic substances and precursors within the healthcare system (paragraph 1).

According to Resolution of the Government of the Republic of Kazakhstan dated October 23, 2018, “On Certain Issues of Licensing Medical and Pharmaceutical Activities,” the licensing authorities for medical activities, with the exception of forensic medical, forensic narcological and forensic psychiatric examinations, are the territorial divisions of the department of the state body in the field of medical services (care) (subparagraph 1) of paragraph 1).

The licensing authorities for such types of pharmaceutical activities as the production of medicinal products; production of medical devices; manufacture of medicinal preparations; manufacture of medical devices; wholesale sale of medicinal products; retail sale of medicinal products, as well as activities related to the circulation of narcotic drugs, psychotropic substances and precursors in the field of healthcare, are the territorial divisions of the department of the state body in the field of circulation of medicinal products and medical devices (subparagraph 2) of paragraph 1).

In accordance with subparagraph 89) of paragraph 1 of Article 1 of the Code “On Public Health and the Healthcare System,” the authorized body in the field of healthcare is the central executive body responsible for management and intersectoral coordination in the areas of protecting the health of citizens of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiological well-being of the population, circulation of medicinal products and medical devices, and the quality of medical services (care).

In accordance with the Law of the Republic of Kazakhstan dated May 16, 2014, “On Permits and Notifications,” a license is a first-category permit issued by a licensing authority to an individual or legal entity to carry out a licensed type of activity or a subtype of a licensed type of activity associated with a high level of danger.

Licensing is a set of measures related to the issuance and reissuance of a license and (or) appendices to a license and a duplicate of a license and (or) appendices to a license, the exercise of permit control, suspension, resumption and termination of the validity of a license and (or) appendices to a license.

According to subparagraph 83) of paragraph 1 of Article 1 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System,” a specialist certificate in the field of healthcare is a document of the established form confirming the qualifications of an individual and their readiness to engage in professional activities in the field of healthcare, including readiness for clinical or pharmaceutical practice, or activities in the field of sanitary and epidemiological well-being of the population.

Certification of a specialist in the field of healthcare is a procedure for determining whether the qualifications of an individual comply with the qualification requirements established by the sectoral qualifications framework and professional standards in the field of healthcare, as well as determining their readiness to engage in professional activities in the field of healthcare, including clinical or pharmaceutical practice, or activities in the field of sanitary and epidemiological well-being of the population (subparagraph 82) of paragraph 1 of Article 1 of the above-mentioned Code).

A person who does not have a certificate and (or) a license is understood to be a person who has not obtained the relevant certificate and (or) license (for any reason), or who has engaged in medical or pharmaceutical activities after the expiration of the license, or whose certificate and (or) license has been obtained in the name of another person, and so forth.

By its structure, the composition of the criminal offense is material. Accordingly, the objective element of the offense includes three mandatory features. First, this is a socially dangerous act consisting of engaging in medical or pharmaceutical activities by a person who does not have a certificate and (or) a license for this type of activity; second, socially dangerous consequences expressed in causing harm to human life and health; and third, a causal relationship between the violations and the consequences specified in the law. Accordingly, the act is considered completed from the moment socially dangerous consequences occur.

Article 322 of the Criminal Code provides for liability for the following socially dangerous consequences resulting from engaging in medical or pharmaceutical activities by a person who does not have a certificate and (or) a license for this type of activity: under Part 1 — for negligently causing moderate bodily harm; under Part 2 — for negligently causing grievous bodily harm; under Part 3 — for negligently causing the death of a person; under Part 4 — for negligently causing the death of two or more persons.

The time, place, method, circumstances, instruments and means of committing the criminal offense are irrelevant when qualifying an act provided for in Article 322 of the Criminal Code.

The specific features of the subjective element of the criminal offense provided for in Parts 1, 2, 3 and 4 of Article 322 of the Criminal Code consist in the fact that the person's mental attitude toward the very act of engaging in medical or pharmaceutical activities without the required certificate and (or) license is characterized by indirect intent, whereby the person is aware of the socially dangerous nature of their actions (inaction), foresees the possibility of adverse consequences, does not desire their occurrence but consciously allows them to occur or is indifferent to them. At the same time, when qualifying the act under consideration, it must be taken into account that the mere fact of engaging in medical or pharmaceutical activities by such a person does not constitute a criminally punishable act.

With regard to the consequences, the offense under consideration is characterized by guilt in the form of negligence, since the legislator has expressly indicated this in the disposition of the Article (Part 4 of Article 19 of the Criminal Code).

In general, the subjective element of the act under consideration is characterized by the negligent form of guilt.

Since the criminal offense under consideration is negligent, its motives and purposes apply not to the act as a whole, but only to the fact of illegal engagement in medical or pharmaceutical activities. Nevertheless, they are of significant practical importance when determining the degree of public danger of the offense and imposing punishment. Establishing the motive and purpose of an act consisting of engaging in medical or pharmaceutical activities without the required certificate and (or) license enables law enforcement authorities to determine the person's attitude toward public interests and their own life values.

The subject of the criminal offense under Parts 1, 2, 3 and 4 of Article 322 of the Criminal Code is an individual who has reached the age of sixteen and does not have the relevant certificate and (or) license to engage in medical or pharmaceutical activities. Such a person may have a medical education or may have no such education.

In Part 5 of Article 322 of the Criminal Code, the legislator has provided for an independent corpus delicti in the form of the illegal issuance or forgery of prescriptions or other documents entitling a person to obtain narcotic drugs or psychotropic substances.

The object of the crime is public relations focused on compliance with the established rules for issuing prescriptions or other documents entitling a person to obtain narcotic drugs or psychotropic substances. The additional object is public relations ensuring the health of citizens.

The subject matter of the crime under Part 5 of Article 322 of the Criminal Code consists of prescriptions and other documents entitling a person to obtain narcotic drugs or psychotropic substances.

A prescription is a written instruction issued by a physician on a prescribed form and containing all the necessary details, directing a pharmacy to dispense a medicinal product or preparation containing a narcotic or psychotropic substance, specifying its composition, dosage and method of administration to the patient.

Other documents entitling a person to obtain narcotic drugs or psychotropic substances include certificates, referrals issued by medical institutions, licenses to engage in certain types of activities related to the circulation of narcotic drugs or psychotropic substances, extracts from a patient's medical history, consignment notes, applications submitted by medical institutions for obtaining such drugs and substances, and so forth.

The objective element of the crime provided for in Part 5 of Article 322 of the Criminal Code is expressed in the illegal issuance or forgery of prescriptions or other documents entitling a person to obtain narcotic drugs or psychotropic substances.

The illegal issuance of prescriptions entitling a person to obtain narcotic drugs or psychotropic substances should be understood as their preparation and issuance without medical indications, that is, where the person to whom the prescription is issued does not suffer from a disease that requires treatment with such preparations.

The issuance of other documents shall be considered illegal in cases where there are no substantive grounds for their issuance or where the rules governing their issuance have been violated.

Forgery may be carried out in two ways: falsification and the production of an entirely forged document. Falsification may be material, where amendments distorting the contents of an authentic document (prescription) are introduced (erasures, additions, corrections to the text, alteration of the date, quantity, dosage of the medicinal product, surname of the person to whom the prescription was issued, and so forth), or intellectual, where an entirely fictitious prescription or document is created (production of the form itself, forgery of a seal or signature).

According to paragraph 19 of the Rules for the Medical Use of Narcotic Drugs, Psychotropic Substances and Precursors Subject to Control in the Republic of Kazakhstan, approved by Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated January 26, 2015, prescriptions for patients for medicinal products containing narcotic drugs, psychotropic substances and their precursors listed in Tables II, III and IV of the List shall be issued in Latin on the basis of a standard assessment of the patient's condition by paramedics, midwives, physicians of healthcare organizations or physicians conducting independent medical practice, where appropriate medical indications exist, and shall be certified by their signature, personal seal (if available), and the stamp and seal of the healthcare organization (if available).

It should be noted that when a prescription is issued for a medicinal product containing narcotic drugs, psychotropic substances and their precursors listed in Tables II, III and IV of the List within the framework of the guaranteed volume of free medical care at the outpatient level, an additional prescription for free dispensing is issued in addition to the prescription form. The prescriptions issued are registered in the register of prescriptions issued for obtaining medicinal products free of charge. In this case, in addition to the prescribing physician, the prescription for a narcotic medicinal product must also be signed by the chief physician or their deputy.

The illegal issuance or forgery of prescriptions or other documents entitling a person to obtain narcotic drugs or psychotropic substances is fully covered by the disposition of Part 5 of Article 322 of the Criminal Code and does not require additional qualification under Article 385 of the Criminal Code, “Forgery, Manufacture or Sale of Forged Documents, Stamps, Seals, Forms, State Postage Marks and State Awards.” However, where the above actions are associated with the theft of prescriptions or other documents entitling a person to obtain narcotic drugs or psychotropic substances, the act should be qualified under the cumulative application of Part 5 of Article 322 of the Criminal Code and Part 3 of Article 384 of the Criminal Code, “Illegal Seizure, Theft, Destruction, Damage or Concealment of Documents, Stamps and Seals.”

If a medical worker illegally issues a prescription or forges it and acquires narcotic drugs or psychotropic substances, the actions of the medical worker should be qualified under the cumulative application of Part 5 of Article 322 of the Criminal Code and Article 297 of the Criminal Code, “Illegal Manufacture, Processing, Acquisition, Storage, Transportation for the Purpose of Sale, Dispatch or Sale of Narcotic Drugs, Psychotropic Substances and Their Analogues.”

The composition of the crime under consideration is formal. Criminal liability arises from the moment of the illegal issuance or forgery of a prescription or other document entitling a person to obtain narcotic drugs or psychotropic substances, regardless of whether the person has succeeded in using the document for its intended purpose.

The subjective element of the criminal offense provided for in Part 5 of Article 322 of the Criminal Code is expressed in direct intent.

The guilty person is aware that they are illegally issuing or forging a prescription or other documents entitling a person to obtain narcotic drugs or psychotropic substances and desires to do so.

The subject of the illegal issuance or forgery of prescriptions or other documents entitling a person to obtain narcotic drugs or psychotropic substances is special, namely, a person vested with the authority to issue them. In relation to prescriptions, such persons are physicians, paramedics, midwives and heads of medical institutions. In relation to other documents, they are officials authorized to issue them. At the same time, it should be taken into account that the subject of forgery may be any sane individual who has reached the age of sixteen.

Where the act under analysis is committed by an official, the composition of the offense under consideration competes with Article 369 of the Criminal Code, “Official Forgery.” The distinction between these offenses should be made according to the generic object of the act under consideration. In Part 5 of Article 322 of the Criminal Code, the generic object is public relations aimed at protecting the life and health of citizens, whereas in Article 369 of the Criminal Code, it is public relations ensuring the normal functioning of public service. In addition, the principal distinction between the offenses is based on the subject matter of the offense. The subject matter of the offense provided for in Part 5 of Article 322 of the Criminal Code consists of prescriptions and only those documents that entitle a person to obtain narcotic drugs or psychotropic substances. The subject matter of the criminal offense provided for in Article 369 of the Criminal Code consists of various official documents. Thus, Part 5 of Article 322 of the Criminal Code constitutes a special rule in relation to Article 369 of the Criminal Code.

The act provided for in Part 1 of Article 322 of the Criminal Code is classified as a criminal misdemeanor.

The acts provided for in Parts 2, 3 and 5 of Article 322 of the Criminal Code are classified as crimes of medium gravity.

The act provided for in Part 4 of Article 322 of the Criminal Code is classified as a serious crime.

Commentary to the Criminal Code of the Republic of Kazakhstan, 2021, by Isidor Shamilovich Borchashvili, Honored Figure of Kazakhstan, Doctor of Law, Professor, Academician of the Kazakhstan National Academy of Natural Sciences, Member of the Scientific Advisory Councils under the Constitutional Council of the Republic of Kazakhstan and the Supreme Court of the Republic of Kazakhstan, Member of the Working Group on Reform of the Law Enforcement System under the Security Council of the Republic of Kazakhstan, Honored Employee of the Ministry of Internal Affairs of the Republic of Kazakhstan.

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