Destruction of Medicinal Products and Medical Devices in Russia

 

December 17, 2023

 

The final stage in the circulation of medicinal products (the "Medicinal Products") and medical devices (the "Medical Devices") is their destruction. Over the past few years, the Government of the Russian Federation has updated the destruction rules. This article examines in detail the cases in which medicinal products and medical devices are subject to destruction, the procedure and costs involved, and the potential liability for violating established requirements.

When Must Medicinal Products Be Destroyed?

Chapter 11 of Federal Law No. 61-FZ dated April 12, 2010, On the Circulation of Medicinal Products (the "Law on Circulation of Medicinal Products" or "Law No. 61-FZ") is dedicated to the destruction of medicinal products and essentially contains only one article.

Pursuant to Article 59 of the Law on Circulation of Medicinal Products, the following medicinal products are subject to seizure from circulation and destruction:

• Substandard medicinal products (Medicinal Products that do not comply with the requirements of a pharmacopoeia monograph, regulatory documentation, or a regulatory document);
• Falsified medicinal products (Medicinal Products accompanied by false information about their composition and/or manufacturer);
• Counterfeit medicinal products (Medicinal Products in circulation in violation of civil legislation).

Procedure for the Destruction of Medicinal Products

The rules for destroying falsified, substandard, and counterfeit medicinal products were approved by Government Decree No. 1447 dated September 15, 2020,[1] (the "Decree No. 1447" or the "Destruction Rules") and will remain in effect until January 1, 2027.

Please note that these Destruction Rules do not apply to narcotic drugs and psychotropic medicinal products. Their destruction is carried out in accordance with special legislation of the Russian Federation, which we will consider further.

According to Clause 2 of Decree No. 1447, falsified and substandard medicinal products are subject to seizure and destruction by decision of a federal executive body: Roszdravnadzor (the Federal Service for Surveillance in Healthcare) for medicinal products for human use; Rosselkhoznadzor (the Federal Service for Veterinary and Phytosanitary Surveillance) for medicinal products for veterinary use (the "Authorized Bodies"); the owner of the Medicinal Products; or a court. Counterfeit medicinal products are subject to seizure and destruction only based on a court decision.

Below we consider each ground and the owner's procedure in more detail.

1. Destruction by Decision of Authorized Bodies

If the Authorized Bodies identify the circulation of falsified or substandard medicinal products within Russia, they shall issue a decision requiring the owner to seize and destroy them. The decision to destroy medicinal products must include:

• Information on the medicinal products;
• Grounds for seizure and destruction;
• Deadline for seizure and destruction;
• Information on the owner of the medicinal products;
• Information on the manufacturer of the medicinal products.

Letters identifying falsified or substandard drugs are published on the official websites of the Authorized Bodies. Upon the issuance of such a decision, the owner shall:

• Seize such drugs from circulation, isolate them, and place them in a specially designated area (quarantine zone), or notify the Authorized Body of its disagreement with the decision—within 30 days from the date the decision was issued;
• Destroy the seized medicinal products—within six months from the date the decision was issued.

If the owner of falsified or substandard Medicinal Products fails to comply with the decision and does not report the measures taken, the Authorized Body shall petition a court to compel compliance.

The owner of the medicinal products maintains the right to challenge the destruction decision in an arbitration court. Note that before filing a court petition, the owner must follow a mandatory pre-trial appeal procedure by filing a complaint. This complaint is submitted electronically to the Authorized Body via the State Services Portal. The complaint must be considered within 20 working days from the date of its registration. If the complaint is upheld, the Authorized Body shall revoke the decisions on seizure and destruction. Challenging the decision in court is carried out under the rules of Chapter 24 of the Arbitration Procedure Code of the Russian Federation (APC RF), "Challenging Non-Normative Legal Acts, Decisions, and Actions (Inaction) of Government Bodies." However, judicial practice often does not favor the owner of the Medicinal Products.

For instance, in one case, a commercial entity petitioned an arbitration court to invalidate a Roszdravnadzor order for the seizure and destruction of a medicinal product. The court established that an expert examination of drug samples revealed non-compliance with regulatory documentation regarding "Packaging" (vials of different types were found in the packages) and "Labeling" (dot markings on vials were of different diameters and located at different distances from the bottom to the top of the dot). The examination results served as the basis for Roszdravnadzor's decision to seize and destroy specific batches of the product. The court stated that medicinal products of the same batch must be produced in a single technological cycle using uniform starting and packaging materials. The court found the Roszdravnadzor destruction decision lawful and justified and denied the petition.[2]

2. By Decision of the Owner of the Medicinal Products

As a rule, medicinal products with an expired shelf life are destroyed by the owner's decision. Legislation does not establish any special requirements for the adoption and documentation of such a decision.

3. By Court Decision

A court decision for destruction is typically issued regarding counterfeit medicinal products. Such a claim is filed by the right holder of the Medicinal Products and is considered through litigation.

Consider an example from judicial practice. In one case, a commercial entity filed a lawsuit in an arbitration court against a Factory to declare a batch of the medicinal product "Cordiamine" produced and released into civil circulation by the Factory as counterfeit, and to compel its seizure and destruction at the Factory's expense. The plaintiff argued it was the developer of the medicinal product and the Marketing Authorization Holder, and therefore production should only occur at its initiative or with its consent. However, the courts disagreed. During the proceedings, it was established that the Factory had performed work to refine production and quality control for the drug. Based on the work performed by the Factory under a contract with the plaintiff, the plaintiff obtained a Marketing Authorization (MA) for the product. In the State Register of Medicinal Products, the Factory was listed as the manufacturer of the finished dosage form and the packer. Subsequently, the Register was amended to list another factory as the manufacturer. The release of the disputed batches into circulation occurred before the registration dossier was amended. The court denied the commercial entity's claim.[3]

Practical Procedure for the Destruction of Medicinal Products

The destruction of medicinal products is carried out by an organization holding a license for the collection, transportation, processing, recycling, neutralization, and disposal of Class I–IV hazardous waste. The owner of substandard medicinal products may independently carry out their destruction if it holds such a license.

The person performing the destruction shall draft an act specifying:

• The date and place of destruction;
• The full names of the individuals involved in the destruction, their workplace, and positions;
• The justification for destruction;
• Information on the destroyed medicinal products (name, dosage form, dosage, units of measurement, batch) and their quantity, container, or packaging;
• The name of the manufacturer;
• Information on the owner;
• The method of destruction.

The act of destruction is drawn up on the day of destruction in a number of copies corresponding to the number of parties, signed by all participants, and certified with a seal. If the owner did not participate in the destruction, a copy of the act or its certified copy must be sent to the owner within five working days via electronic communication.

The owner of the destroyed medicinal products must submit a certified copy of the act to Roszdravnadzor within five working days via electronic communication. Furthermore, as a general rule, information regarding the destruction must be transmitted to the System for Monitoring the Movement of Medicinal Products for Medical Use (the "MDLP System"). This requirement applies to all medicinal products in circulation at the time the decision is made.

Regardless of the grounds for destruction, the owner of the medicinal product shall reimburse all related expenses (Part 3 of Article 57 of Law No. 61-FZ). A person who carries out destruction instead of the owner is entitled to claim damages incurred in connection with the destruction.[4]

Specifics of Destroying Narcotic Drugs and Psychotropic Substances

Federal Law No. 3-FZ dated January 8, 1998, On Narcotic Drugs and Psychotropic Substances (the "Law No. 3-FZ") provides a special procedure for the destruction of narcotic drugs and psychotropic substances.

Narcotic drugs and psychotropic substances (the "Narcotics and Psychotropic Substances") are destroyed in the following cases:

• The shelf life has expired;
• The Narcotics and Psychotropic Substances were subjected to chemical or physical influence rendering them unsuitable and impossible to restore or reprocess;
• Unused narcotics were received from the relatives of deceased patients;
• It is difficult to determine whether the preparation is a narcotic or psychotropic medicinal product;
• Confiscated Narcotics and Psychotropic Substances cannot be used for medical, scientific, or other purposes, as well as in other cases provided for by the legislation of the Russian Federation (Part 2 of Article 29 of Law No. 3-FZ).

The destruction procedure is regulated by Government Decree No. 647 dated June 18, 1999,[5] and Ministry of Health Order No. 1004n dated October 22, 2021 (the "Order No. 1004n").[6] Below is an overview of the main rules for destroying Narcotics and Psychotropic Substances used in medical practice.

Destruction is carried out as items accumulate, but at least once per quarter. The necessity of destruction is justified by a responsible person appointed by the organization's head. Only state unitary enterprises and state institutions (or municipal enterprises and institutions when providing medical care within municipal healthcare systems) are authorized to perform this operation, provided they hold a license for the circulation of narcotic drugs and psychotropic substances with the specific activity "destruction of narcotic drugs and psychotropic substances."

The transfer of narcotic drugs and psychotropic substances to such enterprises is carried out based on a contract and a transfer and acceptance act. Destruction is performed by a commission at specially equipped sites (landfills) or in specially prepared premises. Destruction methods are regulated by Order No. 1004n.

The commission performing the destruction shall draft an act specifying:

• The date and place of drafting;
• The workplace, position, and full names of the participants;
• The grounds for destruction;
• Information on the name and quantity of the destroyed Narcotics and Psychotropic Substances, as well as the container or packaging in which they were stored;
• The method of destruction.

The number of copies of the act depends on the number of parties involved. The act may be drafted as an electronic document signed with electronic signatures.

Destruction of Medical Devices: Cases and Grounds

The destruction of Medical Devices is carried out according to rules similar to those for medicinal products.

In accordance with Part 18 of Article 38 of Federal Law No. 323-FZ, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law No. 323-FZ"), the following are subject to seizure from circulation and destruction:

• Falsified medical devices (Medical Devices accompanied by false information about their characteristics or manufacturer);
• Substandard medical devices (Medical Devices that do not comply with safety and efficiency requirements, labeling requirements, or regulatory, technical, and operational documentation, and which cannot be safely used for their intended purpose as established by the manufacturer);
• Counterfeit medical devices (Medical Devices in circulation in violation of civil legislation).

The rules for the seizure and destruction of falsified, substandard, and counterfeit medical devices were approved by Government Decree No. 145 dated February 10, 2022,[7] (the "Decree No. 145").

Pursuant to Clause 3 of Decree No. 145, falsified and substandard Medical Devices are subject to seizure based on a decision by Roszdravnadzor, the owner, or a court. Counterfeit Medical Devices are subject to seizure and destruction by court decision.

1. Destruction of Medical Devices by Decision of Roszdravnadzor

If Roszdravnadzor or its territorial bodies identify falsified or substandard medical devices during federal state control (surveillance) over the circulation of medical devices, they shall issue a decision to seize and destroy said devices.

The Roszdravnadzor decision must specify:

• The name of the Medical Device, including the batch, lot, and quantity, as well as identification features used to declare it substandard or falsified;
• The date and number of the state registration of the medical device;
• Details of the documents drafted based on the state control (surveillance) results;
• Information on the owner;
• Information on the manufacturer;
• The deadline for seizure and destruction.

The decision is posted on the official Roszdravnadzor website as information letters within three working days of its adoption. The manufacturer or owner may challenge the decision. Appeals are made:

• Through pre-trial proceedings by filing a complaint with Roszdravnadzor before the established destruction deadline;
• In court under the rules of Chapter 24 of the APC RF.

It should be noted that attempts to challenge Roszdravnadzor information letters are not always successful. Some courts believe that Roszdravnadzor information letters do not constitute a normative legal act, as they are informative and do not violate the applicant's rights.[8]

If the owner fails to comply with the Roszdravnadzor decision or fails to report the measures taken or its disagreement, Roszdravnadzor may petition a court to compel the owner to comply.

2. Destruction by Decision of the Owner of the Medical Device

In the absence of a decision by Roszdravnadzor or a court, the owner may decide to seize and destroy a medical device if there is evidence it is substandard or falsified. The owner must immediately notify the manufacturer (or its authorized representative) and Roszdravnadzor.

The manufacturer may submit a reasoned objection to the owner and Roszdravnadzor within 30 working days. The owner must consider the objection within 30 working days and provide its reasoned position. Based on this review, the owner may change its decision, in which case it must notify Roszdravnadzor.

A falsified or substandard medical device may be destroyed no earlier than 60 working days after the decision is sent to the manufacturer and Roszdravnadzor, even if no objection is received from the manufacturer.

3. By Court Decision

As with medicinal products, counterfeit medical devices are most often destroyed by court decision.

Procedure for the Destruction of Medical Devices

The destruction of falsified, substandard, or counterfeit medical devices must comply with environmental protection, health protection, and sanitary and epidemiological welfare legislation.

Decree No. 145 does not explicitly require the person performing the destruction to hold a license. In our view, the destruction should be carried out by an organization licensed for the collection, transportation, processing, recycling, neutralization, and disposal of Class I–IV hazardous waste.

An act of destruction must be drafted specifying:

• Information on the organization or individual entrepreneur that performed the destruction;
• The grounds for destruction (court decision, Roszdravnadzor decision, or owner's decision, citing document details);
• The names of the medical devices, batches, lots, quantities, packaging information, and other identification features;
• Information on the manufacturer;
• Information on the owner;
• The date, place, and method of destruction.

After destruction, the owner of the Medical Device must notify Roszdravnadzor within five working days, attaching the act of destruction.

The owner shall reimburse all expenses related to the seizure and destruction of falsified, substandard, and counterfeit medical devices.

Liability for Violating the Rules for the Destruction of Medicinal Products and Medical Devices

Owners of medicinal products and medical devices may be held administratively liable for violating destruction rules:

• Under Part 4 of Article 14.1 of the CAO RF (Carrying out entrepreneurial activity in gross violation of the requirements and conditions provided for by a special permit (license)). Fines for officials range from 5,000 to 10,000 rubles; for individual entrepreneurs, from 4,000 to 8,000 rubles or administrative suspension of activity for up to 90 days; for legal entities, from 100,000 to 200,000 rubles or administrative suspension of activity for up to 90 days.
• Under Part 3 of Article 19.20 of the CAO RF (Carrying out activity not related to profit-making in gross violation of the requirements and conditions provided for by a special permit (license)). Fines for officials range from 20,000 to 30,000 rubles; for legal entities, from 150,000 to 250,000 rubles or administrative suspension of activity for up to 90 days.

Liability under these provisions arises because compliance with the rules for the circulation of medicinal products and medical devices is a licensing requirement for pharmaceutical activities.

To illustrate, Rosselkhoznadzor petitioned an arbitration court to hold an individual entrepreneur administratively liable under Part 4 of Article 14.1 of the CAO RF. The authority argued that during an inspection, it discovered an expired veterinary medicinal product that had not been destroyed within the statutory timeframe and had been stored in a quarantine zone for over six months. The court ruled that the violations of the Destruction Rules constituted a gross violation of pharmaceutical activities. The court found the entrepreneur guilty but, noting that the offense was a first-time violation and caused no harm to life, health, or the environment, replaced the fine with a warning.[9]

Practically, there are also cases of liability under Article 14.43 of the CAO RF (Violation by a manufacturer, performer, or seller of the requirements of technical regulations). Fines for officials range from 10,000 to 20,000 rubles; for individual entrepreneurs, from 20,000 to 30,000 rubles; for legal entities, from 100,000 to 300,000 rubles.

In one case, an unscheduled inspection of a Children's Clinic regarding medicinal product circulation revealed a violation of the destruction procedure. Specifically, a single dose of an expired DTP vaccine was destroyed by a commission of clinic employees. Roszdravnadzor issued a decree holding the Clinic liable under Part 1 of Article 14.43 of the CAO RF with a fine of 150,000 rubles, arguing the Clinic destroyed the drug without a license for Class I–IV hazardous waste management. The Clinic petitioned a court to revoke the decree. The court found no grounds for revocation but reduced the fine to 50,000 rubles.[10]

Regarding the destruction of Narcotics and Psychotropic Substances, in the absence of a criminal offense, Article 6.16 of the CAO RF applies (Violation of the rules for the circulation of narcotic drugs, psychotropic substances, and their precursors). Fines for legal entities range from 200,000 to 400,000 rubles or administrative suspension of activity for up to 90 days, with or without confiscation of the substances.

In one instance, law enforcement discovered that a Hospital failed to specify the container and packaging of Narcotics and Psychotropic Substances in a destruction act, violating Law No. 3-FZ and Decree No. 647. The destruction was confirmed by testimony. The court qualified the Hospital's actions under Part 1 of Article 6.16 of the CAO RF as a violation of destruction rules and imposed a fine of 100,000 rubles.[11]

In summary, under Russian law, the destruction of medicinal products and medical devices occurs when they are found to be falsified, substandard, or counterfeit, and is intended to prevent threats to public life and health. To minimize liability risks, entities in the circulation sphere must monitor reports of such products and strictly adhere to destruction rules.

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References

[1] Government Decree No. 1447 dated September 15, 2020, On Approval of the Rules for the Destruction of Seized Falsified Medicinal Products, Substandard Medicinal Products, and Counterfeit Medicinal Products.

[2] Ruling of the Supreme Court of the Russian Federation dated September 15, 2014, in Case No. 305-KG14-401.

[3] Ruling of the Supreme Court of the Russian Federation dated December 28, 2020, No. 305-ES20-20112.

[4] Decision of the Arbitration Court of the Nizhny Novgorod Region dated October 5, 2022, in Case No. A43-1694/2022.

[5] Government Decree No. 647 dated June 18, 1999, On the Procedure for the Further Use or Destruction of Narcotic Drugs, Psychotropic Substances and Their Precursors, Plants Containing Narcotic Drugs or Psychotropic Substances or Their Precursors, or Their Parts Containing Narcotic Drugs or Psychotropic Substances or Their Precursors, as Well as Instruments and Equipment That Were Confiscated or Seized from Illegal Circulation or the Further Use of Which Is Deemed Inexpedient.

[6] Order of the Ministry of Health of Russia dated October 22, 2021, No. 1004n, On Approval of Instructions for the Destruction of Narcotic Drugs and Psychotropic Substances Included in Schedules II and III of the List of Narcotic Drugs, Psychotropic Substances and Their Precursors Subject to Control in the Russian Federation, the Further Use of Which in Medical Practice Is Deemed Inexpedient.

[7] Government Decree No. 145 dated February 10, 2022, On Approval of the Rules for the Seizure from Circulation and Destruction of Falsified Medical Devices, Substandard Medical Devices, and Counterfeit Medical Devices.

[8] Ruling of the Supreme Court of the Russian Federation dated May 17, 2022, No. 305-ES22-8241 in Case No. A40-46962/2021.

[9] Decision of the Arbitration Court of the Irkutsk Region dated June 8, 2021, in Case No. A19-7996/2021.

[10] Resolution of the Arbitration Court of the Central District dated June 17, 2021, No. F10-2573/2021 in Case No. A68-7402/2020.

[11] Resolution of the Muravlenko City Court of the Yamalo-Nenets Autonomous Okrug dated September 11, 2023, in Case No. 5-104/2023.