The Russian Government has launched a pilot program running from August 17, 2020, to June 30, 2021, to implement pre-trial administrative appeals of decisions, actions, and omissions of regulatory and supervisory authorities and their officials.

Under this pilot framework, corporate entities and individuals may voluntarily submit administrative complaints through the Integrated Portal of State and Municipal Services (Gosuslugi).

The pilot program encompasses the following categories of federal state control and regulatory oversight:

• Fire safety supervision;

• Quality and safety control of medical activities;

• Regulatory oversight of the circulation of pharmaceuticals;

• Regulatory control over the circulation of medical devices;

• Industrial safety supervision;

• Energy sector supervision;

• Safety supervision of hydraulic structures.

Notably, this scope explicitly includes federal state oversight of pharmaceutical circulation and state control over medical devices, directly affecting the Life Sciences sector.

Previously, Russian Government Decree No. 438, dated April 3, 2020, suspended scheduled inspections regarding the state control of the quality and safety of medical activities for the duration of 2020. Authorities conduct inspections under Federal Law No. 294-FZ "On the Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Exercise of State Control (Supervision) and Municipal Control" subject to the exemptions outlined in the aforementioned Government Decree. However, regulatory bodies retain the power to execute enforcement measures if an imminent threat to human life or health arises.

Consequently, market participants operating within the pharmaceutical and medical device sectors are unlikely to participate heavily in the online appeal pilot program before the end of 2020.

The Ministry of Emergency Situations (EMERCOM), the Federal Service for Surveillance in Healthcare (Roszdravnadzor), and the Federal Service for Environmental, Technological, and Nuclear Supervision (Rostechnadzor) will adjudicate these complaints, alongside other competent regulatory authorities overseeing life sciences and medical technology.

Under the pilot framework, aggrieved parties may appeal against:

• Decisions authorizing scheduled or unscheduled inspections;

• Regulatory enforcement orders to remedy violations;

• Statutory measures aimed at preventing or halting harm;

• Actions or omissions by officials of the respective regulatory or supervisory authority.

Specifically, scrutinized legal entities or individual entrepreneurs operating in the pharmaceutical or medical device industries must submit complaints through their corporate accounts on the Federal State Information System (the Integrated Portal of State and Municipal Services), authenticating the submission via an enhanced qualified electronic signature.

The petition may include a motion to stay the enforcement of the challenged regulatory decision. The competent authority must review this motion within two working days of submission. Following the review of the administrative complaint, the authorized government body may deny the appeal, vacate the challenged decision, or overturn the decision and independently issue a new ruling. Furthermore, reviewing authorities possess the power to declare the actions or omissions of regulatory officials unlawful and issue a binding decision on the merits, including ordering specific performance where necessary.

Crucially, the currently effective Federal Law No. 294-FZ guarantees scrutinized parties the right to challenge the actions or omissions of state and municipal control officials that infringe upon the rights of a legal entity or individual entrepreneur during an inspection. Parties may pursue these remedies through administrative or judicial channels, including the right to seek damages under the Civil Code of the Russian Federation. The statute obligates regulatory authorities to prove the legal and factual basis of their actions upon challenge. However, Federal Law No. 294-FZ lacks a detailed procedural framework for such appeals, merely stipulating that petitions challenging the actions or omissions of regulatory bodies or their officials shall be adjudicated in accordance with the legislation of the Russian Federation.

Furthermore, Federal Law No. 248-FZ "On State Control (Supervision) and Municipal Control in the Russian Federation" takes effect on July 1, 2021. Similar to Federal Law No. 294-FZ, this statutory instrument shifts the burden of proof to the regulatory body, requiring it to demonstrate the legality and validity of the challenged decision. However, the new statute outlines the procedural mechanism for appealing regulatory actions with significantly greater specificity, codifying certain provisions tested during the pilot program.

A critical statutory development introduced by Federal Law No. 248-FZ is the institution of mandatory pre-trial administrative appeals for regulatory decisions, actions, and omissions, effective January 1, 2023. From this date forward, corporate entities must exhaust administrative remedies before pursuing judicial review of regulatory enforcement actions or official omissions, except in cases involving individual citizens.

Federal Law No. 248-FZ also codifies the procedure for filing complaints via the Integrated Portal of State and Municipal Services and regional state service portals upon the entry into force of its core provisions. The statute prescribes a 30-calendar-day window from the date the aggrieved party discovered or should have discovered the violation of its rights to appeal a regulatory decision, while reducing the filing window to 10 working days for challenging enforcement remedies (orders to remedy violations). Mirroring the Government's pilot decree, Federal Law No. 248-FZ permits motions to stay the challenged decision, mandating an identical two-day review period. The authority must adjudicate the underlying administrative complaint within 20 working days from its formal registration.

Another novel compliance requirement under Federal Law No. 248-FZ is the strict prohibition against profane, abusive language, or threats to the life, health, or property of regulatory officials and their families within the complaint. Authorized representatives may file the appeal on behalf of the scrutinized entity. Significantly, upon the enactment of this legislation, applicants may append supporting positions from the Presidential Commissioner for Entrepreneurs' Rights or regional ombudsmen. The reviewing authority must then issue a formal response addressing the ombudsman's stated position.

The head of the respective territorial body or a superior authority reviews complaints against decisions issued by a territorial regulatory unit. Concurrently, a superior authority hears complaints targeting the actions or omissions of the head or deputy head of a territorial unit. In the absence of a territorial branch, or where an entity challenges decisions rendered by the central apparatus of a regulatory body, the agency's chief executive adjudicates the matter.

The authorized body publishes its final administrative decision directly in the scrutinized entity's personal account on the Integrated Portal of State and Municipal Services.

The Ministry of Economic Development of the Russian Federation is mandated to evaluate the pilot program's outcomes by March 1, 2021.

Accordingly, given the enactment of Federal Law No. 248-FZ—the provisions of which transition into full effect immediately following the pilot's conclusion—strong indications suggest that authorities expect a high rate of efficiency from the pre-trial online appeal framework.

Nevertheless, the current Government Decree No. 438 lacks substantive procedural mechanisms governing appeals against territorial or central regulatory bodies, and fails to establish clear filing windows or adjudication timelines. These procedural safeguards will formally manifest only upon the effective date of Federal Law No. 248-FZ.

Blunting the impact of these omissions, the Government has instructed an interagency working group within the Ministry of Economic Development to approve methodical recommendations for the pilot's execution. These guidelines will likely clarify the mechanics of filing complaints during the pilot phase, or the participating regulatory and supervisory authorities themselves may directly provide the necessary clarifications regarding administrative appeal workflows.