Commentary on Article 318. Violation of the Procedure for Conducting Clinical Trials and Applying New Methods and Means of Prevention, Diagnosis, Treatment, and Medical Rehabilitation of the Criminal Code of the Republic of Kazakhstan
1. Excluded by Law of the Republic of Kazakhstan dated July 7, 2020, No. 361-VI.
2. Violation of the procedure for conducting clinical trials and applying new methods and means of prevention, diagnosis, treatment, and medical rehabilitation, committed by an official or resulting in grave consequences —
shall be punishable by a fine in the amount of up to four thousand monthly calculation indices, or corrective labor in the same amount, or community service for a period of up to one thousand hours, or restriction of freedom for a period of up to four years, or imprisonment for the same period, with deprivation of the right to hold certain positions or engage in certain activities for a period of up to five years.
The public danger of the offense provided for in Article 318 of the Criminal Code lies in the violation of the established procedure for conducting medical research and experiments on human beings and, consequently, in the infringement of human life and health.
The object of the offense under consideration is the social relations centered on compliance with the established rules and standards in the field of conducting clinical trials. An additional object is the social relations guaranteeing the protection of the life and health of patients.
The objective side of the offense provided for in Article 318 of the Criminal Code consists in a violation by a medical professional of the procedure for conducting clinical trials and applying new methods and means of prevention, diagnosis, treatment, and medical rehabilitation, committed by an official or resulting in grave consequences.
The disposition of Article 318 of the Criminal Code is blanket in nature and refers to other regulatory legal documents, in particular, Orders of the Minister of Healthcare of the Republic of Kazakhstan dated December 11, 2020, “On Approval of the Rules for Conducting Clinical Trials of Medicinal Products and Medical Devices, Clinical and Laboratory Tests of Medical Devices for In Vitro Diagnostics, Requirements for Clinical Sites, and the Provision of the Public Service for Issuing Permits to Conduct Clinical Trials and/or Tests of Pharmacological and Medicinal Products and Medical Devices,” and dated November 27, 2020, “On Approval of the Rules for the Application of New Methods of Diagnosis, Treatment, and Medical Rehabilitation.”
According to subparagraph 129) of paragraph 1 of Article 1 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System,” a clinical trial is defined as a study involving a human being as a subject, conducted to identify or confirm the safety and effectiveness of means, methods, and technologies for the prevention, diagnosis, and treatment of diseases.
The rules for conducting clinical trials are established by the Order of the Minister of Healthcare of the Republic of Kazakhstan dated December 11, 2020, “On Approval of the Rules for Conducting Clinical Trials of Medicinal Products and Medical Devices, Clinical and Laboratory Tests of Medical Devices for In Vitro Diagnostics, Requirements for Clinical Sites, and the Provision of the Public Service for Issuing Permits to Conduct Clinical Trials and/or Tests of Pharmacological and Medicinal Products and Medical Devices.”
In accordance with Article 227 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System,” biomedical research may be conducted on living humans and animals (research subjects), biological samples from living and deceased humans and animals, as well as on the basis of clinical and epidemiological data and other medical information.
Biomedical research includes fundamental and applied biomedical research. Applied biomedical research includes biomedical experiments, preclinical (non-clinical) studies, clinical trials, and research in the field of public health.
Applied biomedical research may be conducted only if the following requirements are simultaneously met: biomedical research is aimed at obtaining new scientific data and introducing such data into practical healthcare; protection of the interests of the research subject and confidentiality of their medical information are ensured; consent is obtained from the research subject or their legal representative to participate in the research or to use their biological samples and medical information, including for the purpose of populating a biobank for scientific purposes; interventional clinical trials of medicinal products and medical devices are conducted with the permission of the authorized body.
Biomedical research shall be terminated at any stage at the request of a minor participating in the research, their legal representative, the guardian of an incapacitated person, a patient or volunteer, as well as in the event of a threat to the life or health of a volunteer or patient, a minor, or an incapacitated person.
Paragraph 6 of Article 227 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System” also defines the categories of persons on whom biomedical research may be conducted only where it cannot be conducted on other persons and where there are scientific grounds to expect that participation in such biomedical research will bring them direct benefits outweighing the risks and inconveniences associated with the biomedical research: minors; pregnant women; incapacitated persons; students, where participation in biomedical research is related to their studies; elderly pensioners requiring outside assistance; military personnel and employees of law enforcement and special state bodies; personnel of medical organizations where biomedical research is conducted; persons held in institutions of the penal enforcement system.
According to subparagraph 121) of paragraph 1 of Article 1 of the aforementioned Code, an interventional study is a study involving a human being as a research subject, in which the physician-researcher, on the basis of an interventional clinical trial protocol that complies with the procedure for conducting clinical trials, prescribes a special intervention to the research subject.
Interventional clinical trials involving such categories of persons as minors, pregnant women, incapacitated persons, students where participation in biomedical research is related to their studies, and elderly pensioners requiring outside assistance may be conducted only for the purpose of studying therapeutic effects (paragraph 6 of Article 227 of the aforementioned Code).
Interventional clinical trials involving such categories of persons as military personnel and employees of law enforcement and special state bodies; personnel of medical organizations where biomedical research is conducted; and persons held in institutions of the penal enforcement system are prohibited.
In turn, a violation of the procedure for conducting clinical trials constitutes a violation of the rules and conditions governing their conduct.
The rules for the application of new methods and means of prevention, diagnosis, treatment, and medical rehabilitation are established by the Order of the Minister of Healthcare of the Republic of Kazakhstan dated November 27, 2020, “On Approval of the Rules for the Application of New Methods of Diagnosis, Treatment, and Medical Rehabilitation.”
Prevention is a set of medical and non-medical measures aimed at preventing the occurrence of diseases, preventing the progression of diseases at their early stages, and controlling complications, organ and tissue damage that have already developed (subparagraph 207) of paragraph 1 of Article 1 of the aforementioned Code).
Accordingly, a violation of the application of new methods and means of prevention should be understood as non-compliance with or failure to perform medical measures aimed at preventing diseases and their progression.
In accordance with subparagraph 98) of paragraph 1 of Article 1 of the aforementioned Code, diagnosis is a set of medical services aimed at establishing the presence or absence of a disease. Consequently, a violation of diagnosis is recognized as the failure to provide a set of medical services aimed at establishing whether a disease is present or absent.
Treatment is a set of medical services aimed at eliminating, arresting, and/or alleviating the course of a disease, as well as preventing its progression (subparagraph 103) of paragraph 1 of Article 1 of the aforementioned Code). Thus, a violation of treatment means the failure to provide a set of medical services aimed at eliminating, arresting, and/or alleviating the course of a disease, as well as preventing its progression.
In accordance with subparagraph 187) of paragraph 1 of Article 1 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System,” medical rehabilitation is a set of medical services aimed at preserving, partially or fully restoring, impaired and/or lost bodily functions of a patient. Consequently, a violation of medical rehabilitation should be understood as non-compliance with the set of medical services aimed at preserving, partially or fully restoring, impaired and/or lost bodily functions of a patient.
Criminal liability for violation of the procedure for conducting clinical trials and applying new methods and means of prevention, diagnosis, treatment, and medical rehabilitation is provided for only in cases where such act is committed by an official or results in grave consequences.
Thus, where a violation of the procedure for conducting clinical trials and applying new methods and means of prevention, diagnosis, treatment, and medical rehabilitation is committed by an official, the composition of the criminal offense, by its construction, is formal in nature. Accordingly, the occurrence of any negative consequences is not required to bring a person to criminal liability; the mere fact of violating the procedure for conducting clinical trials and applying new methods and means of prevention, diagnosis, treatment, and medical rehabilitation is sufficient.
Where a violation of the procedure for conducting clinical trials and applying new methods and means of prevention, diagnosis, treatment, and medical rehabilitation results in grave consequences, the composition of the criminal offense, by its construction, is material in nature. In this regard, the objective side of this act must include three mandatory elements. First, this is a socially dangerous act consisting in a violation of the procedure for conducting clinical trials and applying new methods and means of prevention, diagnosis, treatment, and medical rehabilitation; second, socially dangerous consequences expressed in the occurrence of grave consequences; and third, a causal relationship between the violation of the procedure for conducting clinical trials and applying new methods and means of prevention, diagnosis, treatment, and medical rehabilitation and the consequences specified by law. Thus, the act is considered completed from the moment the socially dangerous consequences occur.
The list of grave consequences is established in subparagraph 4) of Article 3 of the Criminal Code. From this list of grave consequences, the following may be identified as applicable to the criminal offense under consideration: the death of a person; the death of two or more persons; suicide of the victim or their close relative(s); infliction of grievous bodily harm; infliction of grievous bodily harm on two or more persons; mass illness, infection, radiation exposure, or poisoning of people; deterioration in the health of the population and the environment; occurrence of an unwanted pregnancy; infliction of large or particularly large damage; and other consequences indicating the gravity of the harm caused.
The subjective side of the offense provided for in Article 318 of the Criminal Code is characterized by an intentional form of guilt (direct or indirect intent), since the medical professional or official is aware that they are violating the procedure for conducting clinical trials and applying new methods and means of prevention, diagnosis, treatment, and medical rehabilitation and wishes to do so, or consciously allows such violation, or is indifferent to it.
The mental attitude toward the consequences of the committed act must be characterized by negligence. If there is an intentional form of guilt in relation to grave consequences that entail a greater degree of public danger, the actions of the medical professional must be classified under the relevant article of the Criminal Code provided for in Chapter 1, “Criminal Offenses Against the Person.”
Motive and purpose in relation to the offense under examination are optional elements of the subjective side and, accordingly, do not affect its legal classification. Motives may vary and must be taken into account when imposing punishment.
The subject of the criminal offense is special — a medical professional or an official.
In accordance with subparagraph 154) of paragraph 1 of Article 1 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System,” a medical professional is an individual who has professional medical education and engages in medical activities.
The categories of persons who qualify as officials, as applicable to the offense under consideration, are established in Articles 31, 37, and 54 of Chapter 5, “State Control and Supervision in the Field of Healthcare,” of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System.” Thus, officials exercising state control in the field of the provision of medical services (care) are: the Chief State Medical Inspector of the Republic of Kazakhstan and/or their deputy; chief state medical inspectors of the respective administrative-territorial units and their deputies, appointed by the head of the state body in the field of the provision of medical services (care); specialists of the state body in the field of the provision of medical services (care).
Officials exercising state control and supervision in the field of sanitary and epidemiological welfare of the population are: the Chief State Sanitary Doctor of the Republic of Kazakhstan and/or their deputy; chief state sanitary doctors of the respective administrative-territorial units (in transport), and their deputies, appointed by the head of the state body in the field of sanitary and epidemiological welfare of the population; specialists of the state body in the field of sanitary and epidemiological welfare of the population; chief state sanitary doctors and their deputies, heads and specialists of structural subdivisions of the Ministry of Defense of the Republic of Kazakhstan, national security and internal affairs bodies, and the Department of Presidential Affairs, exercising activities in the field of sanitary and epidemiological welfare of the population.
Officials exercising state control in the field of circulation of medicinal products and medical devices are: the Chief State Pharmaceutical Inspector of the Republic of Kazakhstan and/or their deputy; state pharmaceutical inspectors of structural subdivisions of the state body in the field of circulation of medicinal products and medical devices; chief state pharmaceutical inspectors in the respective territories, appointed by the head of the state body in the field of circulation of medicinal products and medical devices; state pharmaceutical inspectors of territorial subdivisions of the state body in the field of circulation of medicinal products and medical devices.
At the same time, it should be noted that medical professionals conducting clinical trials or applying new means of prevention, diagnosis, treatment, and medical rehabilitation, and who are also officials, may be held criminally liable in their capacity as officials only if their unlawful actions are of an organizational and administrative nature (the right to issue orders and instructions binding on subordinate employees, and to apply incentives and disciplinary sanctions to subordinates) or of an administrative and economic nature (the right to manage and dispose of property recorded on the balance sheet of an organization).
The act provided for in Part 2 of Article 318 of the Criminal Code is classified as a criminal offense of medium gravity.
Commentary of 2021 to the Criminal Code of the Republic of Kazakhstan by Isidor Shamilovich Borchashvili, Honored Figure of Kazakhstan, Doctor of Law, Professor, Academician of the National Academy of Natural Sciences of Kazakhstan, 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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