Counterfeit Medical Devices

2023

98% of criminal cases involving unregistered medical products result in a conviction

98% of criminal cases initiated under Art. 238.1 of the Criminal Code of the Russian Federation "Appeal of unregistered medical devices" against suppliers and manufacturers end in a conviction. Such information was shared with Zdrav.Expert on January 21, 2025 by representatives of the Kitsing & Partners Law Office. In 79% of cases, company managers (owner, CEO, commercial director, development director) were prosecuted, and in 21% of cases - sales managers, employees of tender departments.

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According to experts, the initiation of criminal cases under Art. 238.1 of the Criminal Code RUSSIAN FEDERATION for the discrepancy between the characteristics of equipment and the registration dossier is a new trend in Russian legal reality. To help suppliers and manufacturers of media products understand the problem of prosecution under Art. 238.1 of the Criminal Code of the Russian Federation and avoid criminal problems with the law, Kitsing & Partners lawyers conducted a large study of judicial practice on this composition. crimes The authors of the review studied all the sentences discovered in the public domain under Art. 238.1 of the Criminal Code of the Russian Federation for 2015-2023. in part circulation of medical devices and revealed the main trends in law enforcement under this article.

Criminal prosecution against suppliers and manufacturers in 33% of cases begins after inspections. If the Roszdravnadzor fact of the illegality of the circulation of medical products is confirmed, Roszdravnadzor sends the collected materials to law enforcement agencies for a pre-investigation check and a criminal case.

22% of criminal cases were initiated after the goods were accepted by medical institutions, when the hospital staff found that the delivered medical unit did not comply with the stated requirements.

22% of cases against suppliers and manufacturers were initiated at the initiative of law enforcement agencies in the course of investigating crimes related to the illegal circulation of medical devices and medicines.

It is noteworthy that 16% of criminal cases were initiated on the initiative of the market participants themselves. The reason is banal - this is how industry representatives are fighting counterfeit and counterfeit their products.

Just 7% of criminal cases were identified due to complaints from competitors, consumers and excesses related to harm to health. It is noteworthy that as of January 2025, not a single supplier or manufacturer was convicted under paragraph "b" of Part 2 of Art. 238.1 of the Criminal Code of the Russian Federation (consequence in the form of careless infliction of serious harm or death of a person), under Part 3 of Art. 238. 1 of the Criminal Code of the Russian Federation (consequence in the form of death by negligence of two or more persons). This is striking in the context of the fact that initially Art. 238.1 of the Criminal Code of the Russian Federation was introduced, among other things, in order to prevent situations of real harm to the health of citizens from illegal circulation of medical devices, and this has never happened in practice over the 9 years of the existence of the article, noted in Kitsing and Partners.

An analysis of judicial practice showed that when investigating crimes related to the illegal circulation of medical devices, persons who were initially guilty of an illegal act are often not identified - only the last link in the chain of sale of substandard/unregistered/falsified products is brought to criminal responsibility, because it is easier to accuse the supplier under a state contract than the distributor.

During the analysis, it was found that the concept of "unregistered" medical product requires additional explanations from the legislator. In practice, not only products that have never been registered on the territory of the Russian Federation, but even those with a registration certificate, are recognized as unregistered, and not fully corresponding to the documents as part of the KRD (set of registration documents), namely, the operating manual and technical specifications. The investigation usually takes an irreconcilable position on this issue - there are discrepancies with the KRD, which means that the registration certificate does not apply to such a medical product, and therefore it is not registered. According to the authors, the existence of uncertainty in the interpretation of the concept of "unregistered" can lead to unjustified prosecution in the actual absence of public danger of the deed. In addition, the prosecution is inclined to unproven to state that the attracted persons know all the existing legislation in the field of circulation of medical devices, perceiving them as professional market participants with special knowledge by default.

According to the researchers, it is also interesting from the point of view of law enforcement that quite often, when accused of illegal circulation of medical devices, investigators do not pay attention to the volume of the accusation in terms of determining whether the product was unregistered and (or) falsified and (or) poor-quality, and prescribe in the plot of the accusation simultaneously all 3 dispositive signs, unreasonably expanding the scope of the accusation.

As the analysis of judicial practice showed, 73% of the accused choose a guilty plea strategy, and only 27% are ready to fight.

As for specific arguments within the framework of positions on non-recognition of guilt, the following can be distinguished among the most typical:

• "the accused simply performed his official duties - responsibility for the crime must be borne by another person - for example, another employee or head of a company, or persons from other companies";
• "the quality of medical products sold was similar and even better than that of the required medical product";
• "the accused did not know that the supplied products were unregistered, substandard or falsified";
• "there were no claims from the state customer, and the medical device was used in a medical facility without causing harm to anyone";
• "there was a provocation of crime by law enforcement and there was pressure."

These arguments are not perceived by the court, since they are aimed either at shifting the guilt to another person, or appeal to the ignorance of the person brought to justice, but do not confirm the legality of the defendant's behavior.

According to the authors of the review, perhaps the most alarming judicial legal position in cases under Art. 238.1 of the Criminal Code of the Russian Federation was reflected in the Cassation Ruling of the Second Court of Cassation of General Jurisdiction of 11.05.2023 No. 77-1230/2023. The decision gave the "green light" to the law enforcement officer to impute the aggregate of Art. 159 of the Criminal Code of the Russian Federation and Art. 238.1 of the Criminal Code of the Russian Federation.

Most medical devices are sold within the framework of public procurement, and this circumstance gives law enforcement officers the opportunity to qualify the supplier's actions not only under Art. 238.1 of the Criminal Code, but also under Art. 159 of the Criminal Code. The logic of the court is as follows: fraud consists of two mandatory components - theft of someone else's property and deception, if the products do not correspond to the registration certificate, then, therefore, false information was provided, and this indicates that there was a deception on the part of the supplier. At the same time, the money was received, and no proper compensation was provided, because the supplied equipment is unregistered, which means that it is prohibited for circulation - such actions of the supplier can be regarded as theft. The maximum punishment under Art. 159 of the Criminal Code reaches 10 years in prison. The accusation of fraud increases the risks of choosing a preventive measure in the form of detention, and also increases the chances of getting a real term of imprisonment instead of a conditional one, experts explained.

Art. 238.1 of the Criminal Code of the Russian Federation provides for a maximum punishment of up to 12 years in prison, but in practice the sanctions did not come close to such a period - the most severe punishment ever imposed in practice under Art. 238.1 of the Criminal Code of the Russian Federation, is considered a sanction in the form of 3 years of real imprisonment with serving a sentence in a colony-settlement and with a fine of 500,000 rubles.

If we consider the totality of Art. 238.1 of the Criminal Code of the Russian Federation and Art. 159 of the Criminal Code of the Russian Federation, then the maximum sentence that the researchers managed to find is 7 years of real imprisonment with a fine of 500,000 rubles and with the deprivation of the right to engage in activities related to the production, manufacture and sale of medical devices for a period of 3 years.

When imputing exclusively Art. 238.1 of the Criminal Code of the Russian Federation in 74% of cases, the accused received a suspended sentence, 16% of such criminal cases ended in fines and only 7% of the accused received real terms. When the totality of Art. 238.1 of the Criminal Code of the Russian Federation and Art. 159 of the Criminal Code of the Russian Federation, the pattern of sentencing changed significantly: in 57% of cases, real imprisonment was imposed, in 28% - conditional, and in 14% - a fine.

700 thousand fake medical gowns worth 70 million rubles were found in Perm

In the Perm Territory, the prosecutor's office approved the indictment in a criminal case against a group of persons accused of producing and selling falsified medical devices and fraud. The press service of the supervisory authority announced this on April 10, 2023. Read more here.

2022

Roszdravnadzor revealed fake and defective medical devices worth 535 million rubles

At the end of 2022, the Federal Service for Supervision of Healthcare (Roszdravnadzor) identified more than 400 thousand fake, poor-quality or unregistered medical devices totaling 535 million rubles. This is stated in the report, which the department published in April 2023.

In most cases, representatives of Roszdravnadzor identified fakes, of which 296 thousand copies were found in 2022. The second and third places in the list under consideration were taken by poor-quality and not passed the mandatory registration of medical devices - 100 thousand and 42 thousand units were discovered in 2022, respectively. According to official information, all indicated violations were recorded within the framework of 400 inspections, which were carried out with the cooperation of Roszdravnadzor with the Ministry of Internal Affairs, the Investigative Committee, as well as the prosecutor's office and the FSB.

Roszdravnadzor revealed more than 400 thousand fake, poor-quality or unregistered medical devices

It is reported that in just 2022, Roszdravnadzor received 1,176 reports about the adverse consequences of the use of medical devices. At the same time, in 8 cases it was about deaths, and in 136 - about the threat to the health and life of patients. 1020 appeals to Roszdravnadzor, that is, most of them in 2022 were related to imported medical devices. In 156 cases, it was about the products of domestic manufacturers.

According to the materials of Roszdravnadzor, in 2022, more than 3 thousand medical devices were registered for the first time in the Russian Federation. In parallel with this, 3.3 thousand dossiers were amended. In 2022, violations were identified in 608 medical institutions. At the same time, during the inspections, 514 protocols were drawn up in the amount of 4.7 million rubles. Joint inspections of Roszdravnadzor with law enforcement agencies in this direction showed that illegal drugs totaling 7.8 million rubles were stored in hospitals and other medical institutions.^[1]

Mishustin approved the rules for the seizure and destruction of falsified and poor-quality medical devices

In February 2022, Prime Minister Mikhail Mishustin signed a decree approving new rules for the withdrawal from circulation and destruction of falsified medical devices, poor-quality medical devices and counterfeit medical devices. The document will enter into force on September 1, 2022 and will be valid for six years.

The key innovation in the rules is the procedure for Roszdravnadzor to seize falsified and poor-quality medical devices. The rules establish the procedure for the owner to make an independent decision on the withdrawal from circulation of relevant medical products. The destruction of falsified or poor-quality medical devices is entrusted to their owner, subject to compliance with the requirements of legislation on health and environmental protection.

Mikhail Mishustin approved the rules for the seizure and destruction of falsified and poor-quality medical devices

According to the authors of the initiative, the adopted resolution will increase the effectiveness of the existing mechanisms for the implementation of federal state control over the circulation of medical devices, increase the level of coordination of the supervisory authority - Roszdravnadzor - with manufacturers or authorized representatives of manufacturers of medical devices, sellers and suppliers of medical devices or persons performing the functions of a foreign manufacturer.

The implementation of the resolution will allow participants in the circulation of medical devices to minimize the financial risks associated with the identification of medical devices in circulation in violation of the law.

The decision of Roszdravnadzor can be appealed by the manufacturer or owner, whose medical device was found to be falsified or poor quality.

The new rules will replace the 2020 document on the destruction of seized falsified, poor-quality and counterfeit medical products.^[2]"

2021: Russia adopted a law on the operational seizure of poor-quality medical devices

On June 9, 2021, the State Duma adopted in the third (final) reading a bill on the operational withdrawal of poor-quality medical devices. The changes will be spelled out in the law "On the basics of protecting the health of citizens in the Russian Federation."

The document obliges owners of falsified, poor-quality or counterfeit medical devices to bear the costs associated not only with the destruction of such medical devices, as happened before, but also with their prompt withdrawal from circulation.

The Duma adopted a law on the operational seizure of falsified medical devices

Poor-quality and falsified medical devices can be withdrawn from circulation and destroyed on the basis of a decision by their owner, Roszdravnadzor or a court decision. Counterfeit medical products will be subject to seizure and destruction only by a court decision.

The new regulations also oblige owners of falsified, poor-quality or counterfeit medical devices to reimburse the costs associated with the withdrawal of such medical devices from circulation.

Before the adoption of these amendments, the legislation of the Russian Federation did not determine the procedure for the seizure of medical counterfeit by Roszdravnadzor. In this regard, the document proposes to establish mandatory requirements, the assessment of compliance with which is carried out within the framework of state control over the circulation of medical products.

These measures, according to the developers of the bill, will allow participants in the appeal of medical devices to minimize the financial risks associated with the identification of medical devices in circulation in violation of the law. 

The Government of the Russian Federation will have to approve the procedure for the seizure of medical products in circulation in violation of the law.

The Ministry of Health of the Russian Federation has developed amendments to federal law on behalf of Deputy Prime Minister Tatyana Golikova. It was assumed that Roszdravnadzor would receive the authority to recover through the court compensation for the costs of withdrawing and storing poor-quality or falsified medical devices.^[3]

2020: Reduction of fines issued by Roszdravnadzor for defective and gray medical devices by 13 times, to 6.5 million rubles

The fines issued by Roszdravnadzor for defective and gray medical devices by the end of 2020 decreased by more than 13 times and amounted to 6.5 million rubles. In 2019, the total amount of penalties for the supply of unregistered and substandard products was measured at 87 million rubles.

According to the "City News Agency" Moscow"with reference to the deputy head of the department for organizing state control and registration of medical devices of Roszdravnadzor Maria Migeeva, according to the results of control and supervisory measures in the field of circulation of medical devices in 2020, 1,184 orders were issued to legal entities to eliminate the identified violations, 769 protocols were drawn up on administrative offenses under Art. 6.28 (violation of the established rules in the field of circulation of medical products) and 6.33 of the Administrative Code (circulation of poor-quality, falsified, counterfeit or unregistered medical products).

Fines issued by Roszdravnadzor for defective and gray medical devices for 2020 decreased by 13 times

According to Roszdravnadzor, a total of 1,183 inspections of legal entities were carried out in 2020, including 99 planned and 1,084 unscheduled.

In Moscow and the Moscow region, during inspections at the end of 2020, 62 companies were found to have 29 items of expired medical products, one poor quality and 10 unregistered. For control, 184 types of medical devices were selected with a total volume of more than 4.7 thousand units.

In particular, unregistered medical devices were identified at the Dental Revue 2020 exhibition, expired Phase-5NR ventilators were identified during joint actions with the Office of Economic Security to Counter Corruption of the Ministry of Internal Affairs of the Russian Federation at one of the warehouses in Ramensky, Moscow Region. In addition, a factory for the production of counterfeit personal protective equipment was closed in the Samara region.^[4]

2019: A batch of dental implants worth 3.1 million rubles detained at Sheremetyevo

At the end of March 2019, customs officers at Sheremetyevo airport detained a passenger who was trying to transfer more than 2 thousand undeclared dental products from Seoul.

As a result of the customs inspection, 2 thousand 219 dental items were found: scanner markers and analogues of implants, the press service of the department told the Moscow agency.

Employees of the Sheremetyevo customs stopped an attempt to import more than 2 thousand undeclared dental products from Korea into the Russian Federation

When conducting a fluoroscopy of luggage presented by a 32-year-old South Korean citizen, the inspector drew attention to a large number of homogeneous metal objects.

The young man, from whom undeclared objects were seized, stated that these products are demonstration and intended for exhibition. Men estimated the goods at less than $200, however, according to the customs service, the cost of the cargo exceeds 3.1 million rubles.

Since medical products are included in a single list of products, the movement of which through the customs border of the EAEU is carried out with a declaration of compliance, employees of the department issued protocols under Part 1 of Art. 16.2 of the Code of Administrative Offenses ("Non-declaration of goods subject to declaration according to the established form") and Art. 16.3 ("Non-compliance with prohibitions and restrictions").

Vademec notes that attempts to transfer undeclared medical products from Seoul have previously been thwarted at Sheremetyevo Airport. In July 2017, customs officers stopped an attempt by a 45-year-old South Korean citizen to import 1030 mezzanines (cosmetic injection products) into Russia for a total amount of more than 2 million rubles.

According to the World Health Organization, a tenth of medical products that are in circulation are either falsified or poor-quality (data at the beginning of 2019).^[5]

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