Russian Government decided to conduct from August 17, 2020, to June 30, 2021, an experiment on pre-trial appeal against decisions of control (supervisory) bodies, as well as actions (inaction) of their officials through the voluntary filing of complaints through the Single portal of public servants.
The experiment concerns the following types of federal-state control (supervision):
• fire supervision;
• quality control and safety of medical activities;
• supervision in the field of medicinal products circulation;
• control over the circulation of medical devices;
• supervision in the field of industrial safety;
• energy supervision;
• supervision over safety of hydraulic structures.
The list includes federal state supervision in the field of medicinal products circulation and state control over the circulation of medical devices.
We remind that earlier in the decree of the Government of Russia dated April 3, 2020 N 438 it was established that in 2020 scheduled inspections are not carried out in the implementation of state quality control and safety of medical activities. Inspections following Federal Law N 294-FZ of December 26, 2008 “On the Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Exercise of State Control (Supervision) and Municipal Control” are carried out subject to the exceptions specified in the above-mentioned resolution of the Government of Russia. At the same time, control measures can still be carried out in the event of a threat to the life and health of citizens.
In this regard, it can be assumed that until the end of 2020, participation in the experiment of the online appeal of controlled persons operating in the field of circulation of medicinal products and or medical devices will not be particularly active.
Complaints will be considered by the Ministry of Emergency Situations, the Federal Service for Supervision in Healthcare and the Federal Service for Environmental, Technological and Nuclear Supervision, as well as authorities for supervision in the field of circulation of medicines and medical devices (Federal Service on Surveillance in Healthcare).
As part of the experiment, it will be possible to appeal against:
• decision on the appointment of a scheduled or unscheduled inspection;
• an order to eliminate violations;
• measures to prevent causing harm or to stop causing it;
• actions (inaction) of officials of the control (supervisory) body.
In particular, a legal entity or individual entrepreneur carrying out activities in the field of circulation of medicines or medical devices, which are controlled persons, file a complaint by using a personal account in the Federal State Information System “Unified Portal of State and Municipal Services (Functions)” by signing it with an enhanced qualified electronic signature.
The submitted complaint may contain a petition to suspend the execution of the appealed decision of the control (supervisory) body, which is subject to consideration within 2 working days from the date of filing the complaint. Based on the results of consideration of the submitted complaint, the authorized authority may decide to dismiss the complaint, to cancel the contested decision, to cancel the contested decision with the adoption of a new decision independently. Also, the authorities considering the complaint are empowered to recognize the actions (inaction) of officials of the control (supervisory) bodies as illegal and make a decision on the merits, including the implementation of certain actions, if necessary.
It is important to note that the current Federal Law of December 26, 2008, N 294-FZ establishes the rights of the inspected persons to appeal against actions (inaction) of officials of the state control (supervision) body, the municipal control body, which entailed a violation of the rights of a legal entity, an individual entrepreneur during an inspection, in administrative and (or) judicial procedure with the right to demand compensation for harm (compensation for losses) in accordance with the Civil Code of the Russian Federation. It is stipulated that during the inspection, the inspection bodies are obliged to prove the validity of their actions when they are appealed by the inspected legal entities and individual entrepreneurs. However, this law does not regulate in detail the issue of the procedure for such an appeal, but it determines that an application for appealing the actions (inaction) of a state control (supervision) body or a municipal control body or their officials is subject to consideration in the manner prescribed by the legislation of the Russian Federation.
It is important to note that from July 1, 2021, the Federal Law of July 31, 2020, N 248-FZ “On State Control (Supervision) and Municipal Control in the Russian Federation” will come into force. The new law, similar to the Federal Law of December 26, 2008, N 294-FZ, imposes the duty of proving the legality and validity of the decision taken on the control (supervisory) body whose decision is being appealed. However, the new law defines in more detail the procedure for appealing against the actions of control and supervisory authorities with the consolidation of some provisions related to the conduct of the experiment.
An important novelty is an introduction by Federal Law N 248-FZ of July 31, 2020, from January 1, 2023, of a mandatory pre-trial appeal against decisions and actions (inaction) of control bodies. In particular from the indicated date, a judicial appeal against decisions of the control (supervisory) body, actions (inaction) of its officials is possible only after their pre-trial appeal, with the exception of cases of citizens applying to court.
Also, Federal Law N 248-FZ of July 31, 2020 (from the date of entry into force of its main provisions) establishes the procedure for filing complaints using the Unified Portal of State and Municipal Services and (or) regional portals of state and municipal services. The deadline for filing a complaint against the decision of the body is 30 calendar days from the day when the controlled person learned or should have learned about the violation of his rights, while the time limit for appealing the order will be 10 working days. Also, Federal Law N 248-FZ of July 31, 2020, contains provisions similar to the resolution of the Russian Government on conducting an experiment on the possibility of filing a petition to suspend the appealed decision with similar two-day consideration. The term for consideration of a complaint should be no more than 20 (twenty) working days from the date of its registration.
An additional innovation of the Federal Law N 248-FZ of July 31, 2020, is the prohibition on the content in the complaint of obscene or offensive language, threats to the life, health, and property of officials of the control (supervisory) body or their family members. The filing of a complaint can be carried out by the authorized representative of the controlled person. It is important to note that with the entry into force of the specified normative legal act, the position of the Commissioner under the President of the Russian Federation for the protection of the rights of entrepreneurs, his public representative, authorized to protect the rights of entrepreneurs in the subject of the Russian Federation, related to the subject of the complaint, may be attached to the complaint. Upon receiving the position of the Commissioner under the President of the Russian Federation for the protection of the rights of entrepreneurs or a public representative authorized to protect the rights of entrepreneurs in the subject of the Russian Federation, the body considering the complaint will have to prepare a response to the expressed position.
A complaint against a decision of a territorial body of a control (supervisory) body is considered by the head of this territorial body or by a higher authority; a complaint against the actions (inaction) of the head of the territorial body of the control (supervisory) body is considered by the higher body. In the absence of a territorial body of the control (supervisory) body and in the event of an appeal against decisions made by its central office of the authority, the complaint is considered by the head of this control (supervisory) body.
The decision of the body authorized to consider the complaint is posted in the personal account of the controlled person on the Unified portal of state and municipal services.
The Ministry of Economic Development of the Russian Federation was instructed to evaluate the results of the experiment being carried out by March 1, 2021.
Thus, taking into account the fact that the Federal Law of July 31, 2020 N 248-FZ has been adopted, the provisions of which come into force immediately after the end of the experiment, there is reason to believe that there are forecasts for the high efficiency of the experiment on pre-trial online appeal against decisions of control bodies.
However, the current Government Decree N 438 of April 3, 2020 does not actually contain provisions on the procedure for appealing against decisions of territorial control (supervisory) bodies and decisions of the central offices of such bodies, does not establish the deadline for filing complaints, as well as the timeframe for their consideration. These provisions come into force precisely with the commencement of the provisions of Federal Law N 248-FZ dated July 31, 2020.
In this regard, there is reason to believe that some questions regarding participation in the experiment remain unresolved. At the same time, the Government instructed the interdepartmental working group of the Ministry of Economic Development of Russia, created to ensure the conduct of the experiment, to approve methodological recommendations for conducting the experiment. It is likely that these methodological recommendations can concretize the issues related to filing complaints within the framework of the experiment, or specifying and/or providing clarifications regarding the procedure for appealing can be assigned directly to the control (supervisory) bodies participating in the experiment.
August 21, 2020
Associate Anna Ivanova
BRACE Law Firm ©