Commentary on Article 323. Handling of Falsified Medicinal Products or Medical Devices of the Criminal Code of the Republic of Kazakhstan
1. The production, manufacture or storage for the purpose of sale, as well as the use or sale of falsified medicinal products or medical devices, if this has resulted in grave consequences, —
shall be punishable by a fine in an amount of up to two thousand monthly calculation indices, or corrective labor in the same amount, or community service for a period of up to six hundred hours, or restriction of liberty for a period of up to two years, or imprisonment for the same period, with confiscation of property, 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 acts committed:
1) by a group of persons by prior conspiracy;
2) repeatedly;
3) on a large scale, —
shall be punishable by a fine in an amount 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 imprisonment for the same period, with confiscation of property, 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. The acts provided for in Parts One or Two of this Article, if committed by a criminal group, —
shall be punishable by imprisonment for a period of five to ten years, with confiscation of property, with deprivation of the right to hold certain positions or engage in certain activities for a period of up to five years or without such deprivation.
The public danger of the crime provided for in Article 323 of the Criminal Code lies in the fact that the handling of falsified medicinal products, medical-purpose products or medical equipment leads to their uncontrolled distribution and use, as a result of which harm is caused to the health of citizens. The use of such medicinal products, as well as the application of medical-purpose products or medical equipment, may cause serious adverse consequences for human health, since falsified products do not undergo the control prescribed for legitimate products during their production and sale.
The object of the crime under consideration is public relations focused on compliance with the established rules governing the circulation of falsified medicinal products or medical devices. The additional object is public relations guaranteeing the protection of the life and health of citizens.
The subject of the crime is falsified medicinal products and falsified medical devices.
A medicinal product is a substance or combination of substances, or a product containing such a substance or combination of substances, that comes into contact with the human body and is intended for the treatment or prevention of human diseases, or for the restoration, correction or modification of physiological functions through pharmacological, immunological or metabolic action, or for the diagnosis of diseases and conditions in humans (Subparagraph 33) of Paragraph 1 of Article 1 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System”).
Medical devices are medical-purpose products and medical equipment (Subparagraph 161) of Paragraph 1 of Article 1 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System”).
In accordance with Subparagraph 108) of Paragraph 1 of Article 1 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System,” as well as Subparagraph 4) of Paragraph 2 of the Rules for the Destruction by Entities in the Sphere of Circulation of Medicinal Products and Medical Devices of Medicinal Products and Medical Devices at Their Disposal That Have Become Unfit for Use, Have Expired, Are Falsified, and Other Medicinal Products and Medical Devices That Do Not Comply with the Requirements of the Legislation of the Republic of Kazakhstan, approved by the Order of the Acting Minister of Healthcare dated October 27, 2020, falsified medicinal products and medical devices are medicinal products and medical devices that have been unlawfully and intentionally supplied with false information concerning their composition or configuration and/or manufacturer, as well as supplies, including records and documents relating to the supply channels used.
The objective side of the crime under consideration consists in the handling of falsified medicinal products or medical devices and is expressed in the production, manufacture, storage for the purpose of sale, use or sale of falsified medicinal products or medical devices.
The circulation of medicinal products is an activity comprising the processes of development, preclinical (non-clinical) studies, testing, clinical trials, expert examination, registration, pharmacovigilance, quality control, production, manufacture, storage, transportation, import and export, dispensing, sale, transfer, use and destruction of medicinal products (Subparagraph 35) of Paragraph 1 of Article 1 of the Code “On Public Health and the Healthcare System”).
The circulation of medical devices includes the design, development, creation of prototypes, technical testing, studies (tests) for assessing the biological effects of medical devices, clinical trials, expert examination of the safety, quality and effectiveness of medical devices, registration, production (manufacture), storage, transportation, sale, installation, commissioning, use (operation), maintenance, repair and disposal of medical devices (Subparagraph 163) of Paragraph 1 of the said Code).
According to Paragraph 1 of Article 231 of the said Code, the production of medicinal products and medical devices means pharmaceutical activity comprising a set of all operations necessary for the serial production of medicinal products and medical devices, associated with the procurement of raw materials, materials, semi-finished products, equipment and components, and the technological process, including the performance of one of its stages, storage and sale of the manufactured products, as well as all types of accompanying control.
It should be noted that the production of medicinal products on the territory of the Republic of Kazakhstan is carried out by entities operating in the sphere of circulation of medicinal products and medical devices in accordance with the Good Manufacturing Practice (GMP) of the Republic of Kazakhstan and/or the Eurasian Economic Union and on the basis of a license obtained in accordance with the procedure established by the legislation of the Republic of Kazakhstan (Paragraph 2 of Article 231 of the said Code).
In accordance with the Rules for the Manufacture of Medicinal Preparations and Medical Devices by Entities in the Sphere of Circulation of Medicinal Products and Medical Devices Holding a License for the Manufacture of Medicinal Preparations and Medical Devices, approved by the Order of the Minister of Healthcare of the Republic of Kazakhstan dated December 20, 2020, the manufacture of medicinal preparations means pharmaceutical activity associated with the manufacture of medicinal preparations in pharmacies, the procurement of pharmaceutical substances (active pharmaceutical substances) for pharmaceutical use, storage, quality control, labeling and sale of the manufactured medicinal preparations.
The manufacture of medical devices means pharmaceutical activity associated with the manufacture of medical devices in pharmacies, medical device stores and optical stores.
The manufacture of medicinal preparations and medical devices is carried out by entities operating in the sphere of circulation of medicinal products and medical devices that hold a license for the manufacture of medicinal preparations and medical devices, in accordance with the procedure determined by the authorized body. Manufactured medicinal preparations are subject to internal pharmacy quality control in accordance with the procedure determined by the authorized body (Article 232 of the said Code).
In accordance with Paragraph 4 of Article 231 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System,” the production of medicinal products and medical devices is prohibited in the following cases: 1) production of medicinal products and medical devices that have not undergone state registration in the Republic of Kazakhstan, with the exception of medicinal products and medical devices intended for conducting expert examination during their state registration, adjustment and commissioning of equipment and technological processes, preclinical (non-clinical) and clinical trials, contract manufacturing and production of medicinal products and medical devices for export, as well as advanced therapy medicinal products manufactured for individual use with the use of autologous biological materials of the patient or a donor selected specifically for that patient; 2) without a license for the right to manufacture medicinal products and medical devices; 3) in violation of Good Manufacturing Practice and the rules for the manufacture of medical devices.
Thus, the production of falsified medicinal products and medical devices means intentional actions associated with the totality of all operations necessary for the serial production of medicinal products and medical devices, as a result of which they acquire the characteristics of genuine medical products.
The manufacture of falsified medicinal products and medical devices means intentional actions associated with the manufacture of medicinal products and medical devices, as a result of which they acquire the characteristics of genuine medical products.
It should be noted that, when proving the objective side, it is necessary to refer to the regulatory legal acts governing the production and manufacture of medicinal products or medical devices.
To store means to preserve or keep something somewhere in safety and in an intact condition.
Unlawful storage should be understood as any intentional actions associated with the possession of falsified medicinal products and medical devices by the offender without the appropriate authorization, regardless of the location (on one's person, in a hiding place, premises, vehicle or other locations) and the duration of storage.
The duration of storage (one day or one year) does not affect the qualification of the crime. The storage of falsified medicinal products and medical devices accepted for safekeeping from another person is also considered unlawful.
Sale means the sale of finished products and goods. At the same time, sale should also be understood to include other methods of their realization or transfer (gifting, exchange, etc.).
Thus, the sale of falsified medicinal products and medical devices means their sale through wholesale supply or retail purchase and sale, barter transactions, as well as their transfer through gratuitous alienation.
To use means to consume, apply in practice in some way, or adapt. The use of falsified medicinal products should be understood as the totality of methods of using them for their intended purpose.
By its structure, the corpus delicti is material. In this regard, the objective side of this act includes three mandatory elements: a socially dangerous act consisting in the production, manufacture or storage for the purpose of sale, as well as the use or sale of falsified medicinal products or medical devices; socially dangerous consequences expressed in causing harm to human life and health; and a causal link between the violations and the consequences specified in the law. Accordingly, the act is deemed completed from the moment socially dangerous consequences occur. The socially dangerous consequence provided for in the Article under consideration is the occurrence of grave consequences.
The concept of “grave consequences,” provided for as a qualifying element of Article 323 of the Criminal Code, is contained in Subparagraph 4) of Article 3 of the Criminal Code.
The subjective side is characterized by indirect intent, that is, the person is aware of the public danger of their unlawful actions involving the production, manufacture or storage for the purpose of sale, as well as the use or sale of falsified medicinal products or medical devices, foresees the probability or inevitability of socially dangerous consequences and consciously allows them to occur. When deciding whether there was intent to unlawfully store such products for the purpose of sale, it is necessary to proceed from the totality of evidence indicating that these falsified medicinal products and medical devices were actually prepared for sale (for example, the discovery of the said products and devices in large quantities that exclude the possibility of their use solely for personal consumption, the presence of tools or equipment for their manufacture or packaging, the establishment of the fact that the offender does not use them personally, etc.).
The subject of the crime under consideration is a sane individual who has reached the age of sixteen.
Part 2 of Article 323 of the Criminal Code provides for the following qualifying elements: commission by a group of persons by prior conspiracy; repeated commission; commission on a large scale.
In accordance with Article 31 of the Criminal Code, a crime is recognized as having been committed by a group of persons by prior conspiracy if it involved persons who had agreed in advance to commit the crime jointly. With regard to Article 323 of the Criminal Code, this means that the conspiracy to commit the acts specified in the Article under consideration must take place before the commencement of the crime. The possibility of suddenly arising intent is also recognized.
In accordance with the Regulatory Resolution of the Supreme Court of the Republic of Kazakhstan dated December 25, 2006, “On the Qualification of Repeated Criminal Offenses and the Aggregation of Criminal Offenses,” repeated commission presupposes the commission by the same person of several criminal offenses provided for by the same Article or the same Part of an Article of the Special Part of the Criminal Code.
At the same time, a criminal offense shall not be considered repeated if the person has been convicted or released from criminal liability on lawful grounds for a previously committed criminal offense. Thus, the production, manufacture or storage for the purpose of sale, as well as the use or sale of falsified medicinal products or medical devices, is recognized as having been committed repeatedly in cases where the person has previously committed one or more criminal offenses provided for by Article 323 of the Criminal Code.
For the purposes of the Article under consideration, a large scale is recognized as the value of medicinal products and medical devices in respect of which falsification has been committed exceeding one thousand monthly calculation indices (Subparagraph 38) of Article 3 of the Criminal Code). This indicator may change in connection with changes in the amount of the monthly calculation index by decision of the authorized state bodies in the field of economic policy.
Part 3 of Article 323 of the Criminal Code provides for a particularly qualifying element — commission of the crime by a criminal group. The concept of a criminal group is defined in Subparagraph 24) of Article 3 and Part 3 of Article 31 of the Criminal Code of the Republic of Kazakhstan.
The concepts of an organized group, criminal organization, criminal community, transnational organized group, transnational criminal organization, transnational criminal community, terrorist group, extremist group, gang and illegal paramilitary formation are contained in Subparagraphs 23), 35), 34), 33), 31), 40), 7) and 18) of Article 3 of the Criminal Code.
The act provided for in Part 1 of Article 323 of the Criminal Code is classified as a minor offense.
The act provided for in Part 2 of Article 323 of the Criminal Code is classified as an offense of medium gravity.
The act provided for in Part 3 of Article 323 of the Criminal Code is classified as a serious crime.
Commentary of 2021 on the Criminal Code of the Republic of Kazakhstan 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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