Pharmaceutical Event Disclosure in Russia: Legal Requirements and Compliance

 

September 22, 2026

BRACE Law Firm©

 

The interaction between pharmaceutical companies and physicians extends beyond standard business communication. It represents an intersection of healthcare system interests, corporate objectives, and patient safety. To minimize the risks of unfair promotion of medicinal products and the formation of biased preferences among medical workers, the state implements measures regulating the engagement between the pharmaceutical industry and the medical community.

A key aspect of these requirements is the obligation of pharmaceutical companies to submit event information to the Federal Service for Surveillance in Healthcare (Roszdravnadzor), and to ensure public access by publishing this information on their official websites. For member companies of the Association of International Pharmaceutical Manufacturers (the "AIPM"), this includes a voluntarily assumed obligation to annually disclose information on values transferred to healthcare professionals and healthcare organizations.

The legal framework in this area operates on two levels. On one hand, there are the mandatory provisions of Federal Law No. 61-FZ dated April 12, 2010, On the Circulation of Medicinal Products (the "Law on Circulation of Medicinal Products", the "61-FZ"). On the other hand, self-regulatory instruments play a significant role, primarily the AIPM Code of Practice (the "AIPM Code"). Furthermore, information disclosure constitutes a component of the broader anti-corruption and ethical framework based on the provisions of Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law on Health Protection", the "323-FZ").[1]

This article examines the information a pharmaceutical company must disclose, the timelines and methods for such disclosure, identifies problematic areas in law enforcement, and provides actionable recommendations for structuring compliance procedures.

Legislative Grounds for the Disclosure Obligation

Articles 67.1 and 67.2 of the Law on Circulation of Medicinal Products establish the foundation for regulating the interaction between pharmaceutical companies and medical workers.[2]

Article 67.1 of the Law on Circulation of Medicinal Products imposes restrictions on organizations engaged in the development, production, and (or) sale of medicinal products for medical use, and their representatives, when interacting with medical workers, heads of medical organizations, pharmaceutical workers, and heads of pharmacy organizations. Article 74 of the Law on Health Protection establishes corresponding restrictions for medical and pharmaceutical workers themselves. Our separate article analyzes these restrictions in detail.[3]

Article 67.2 of the Law on Circulation of Medicinal Products sets forth the requirements for organizing and conducting scientific events, and other events aimed at enhancing the professional expertise of medical workers or providing information related to monitoring the safety of medicinal products. Specifically, Part 1 of this provision prohibits obstructing the participation of other organizations that produce or sell medicinal products for medical use with a similar pharmacological mechanism of action, or creating discriminatory conditions for certain participants compared to others, namely:

• allocating disparate speaking time for participants, providing unequal space for exhibiting medicinal product samples or promotional materials on displays or stands, unless such conditions are stipulated in the agreements of these organizations and justified by differing organizational costs incurred by the participants;
• imposing a participation fee for such event participants that exceeds the actual organizational costs and unreasonably restricts the number of attendees.

Parts 2 and 3 of Article 67.2 of the Law on Circulation of Medicinal Products mandate the disclosure of information regarding the conducted events.[4] The legislative intent presumes that publicity and regulatory oversight of events mitigate the likelihood of abuses: submitting event details to the regulator in advance and publishing them in the public domain restricts the opportunity for unfair practices.

It is essential to emphasize that the disclosure regime supplements the general restrictions rather than replacing them. Complying with the disclosure obligation does not legalize an event that substantively violates the prohibitions and requirements of Articles 67.1–67.2 of the Law on Circulation of Medicinal Products. The company must ensure simultaneous compliance with both sets of requirements.

Below, we outline the applicable subjects, conditions, scope, and methods for disclosing event information.

1. Subjects of Disclosure.

First, it is necessary to identify the entities subject to the disclosure obligation. Pursuant to Part 2 of Article 67.2 of the Law on Circulation of Medicinal Products, the following entities must disclose event information:

• organizations engaged in the development, production, and (or) sale of medicinal products for medical use;
• organizations holding the rights to use the trade name of a medicinal product for medical use;
• wholesale organizations distributing medicinal products;
• pharmacy organizations;
• their representatives acting on behalf of these organizations, who organize and (or) finance the events.

In the latter scenario, we believe that an agency relationship within the meaning of Chapter 10 of the Civil Code of the Russian Federation is required, such as a power of attorney, a contract of mandate, or an agency agreement under which the agent acts on behalf of the principal.[5] Entering into any agency agreement does not inherently mandate this conclusion, as an agent may act in their own name. Furthermore, the pharmaceutical company consistently retains its own obligation as the entity financing the event.

In practice, pharmaceutical companies frequently engage specialized event agencies, communication agencies, or professional congress organizers to manage events. This raises the question: which entity bears the disclosure obligation – the customer (the pharmaceutical company) or the contractor (the agency)? Based on a literal interpretation of the statutory provisions, if the agency acts in its own name upon the pharmaceutical company's instructions, but not "on behalf" of the pharmaceutical company in the legal sense of agency, the disclosure obligation remains with the pharmaceutical company as the organizer and (or) the funding source.

To safeguard corporate interests in such agreements, we recommend:

• explicitly allocating the disclosure obligation;
• designating the party responsible for the accuracy and completeness of the data;
• incorporating contractual liability (e.g., indemnification for damages and penalties) for breaching these obligations.

However, it is critical to note that even when delegating practical execution to a representative, the pharmaceutical company retains public-law liability before the regulator, as an administrative duty cannot be entirely assigned to a counterparty via a civil law contract. The contractual allocation of duties establishes grounds for recourse claims but does not release the organizer from liability toward the state.

Notably, the disclosure obligation extends beyond events independently organized by the pharmaceutical company. Part 1 of Article 67.2 of the Law on Circulation of Medicinal Products applies to events financed by these organizations and their representatives, and Part 2 of the same article explicitly directs the disclosure obligation to entities organizing and (or) financing the events. Consequently, in our view, a company acting as a sponsor for a conference or congress organized by a professional medical association, educational, or scientific organization must also submit a notification to Roszdravnadzor and publish the information on its official website – regardless of whether the organizer and other sponsors disclose such data. We are not aware of any official guidance permitting a single consolidated notification by the organizer on behalf of all sponsors; therefore, we advise each sponsor to fulfill the obligation independently.

The substantive scope of the rule must also be considered: Chapter 14.1 of the Law on Circulation of Medicinal Products applies to entities circulating medicinal products for medical use. Manufacturers and distributors of medical devices are bound by the restrictions of Article 74 of the 323-FZ; however, we believe the obligation to notify about events under the model of Article 67.2 of the Law on Circulation of Medicinal Products does not extend to them. If a company circulates both medicinal products and medical devices, we recommend adopting a broad interpretation for events with mixed topics and disclosing the information.

2. Scope of Disclosed Information.

The second issue concerns the scope of the information to be disclosed. Based on the interrelated provisions of Parts 1–3 of Article 67.2 of the Law on Circulation of Medicinal Products, the following events require disclosure:

• scientific events (notably, the participant pool for this event type is neither defined nor restricted solely to medical workers);
• events aimed at enhancing the professional expertise of medical workers;
• events focused on providing information related to monitoring the safety of medicinal products.

When determining whether an event qualifies as scientific, companies must refer to the definition of scientific activity provided under Russian Federation law (Article 2 of Federal Law No. 127-FZ dated August 23, 1996, On Science and State Scientific and Technical Policy).[6]

Furthermore, current legislation does not specify the formats for conducting events. In practice, an event may take the form of a roundtable, conference, congress, lecture, seminar, workshop, etc. Regardless of the format, the event information must be disclosed in the statutorily prescribed manner.

Hybrid and fully online events (webinars, online conferences), which have seen a significant increase in market share in recent years, warrant specific attention. The event format does not alter the disclosure obligation. For online events, it is advisable to indicate the hosting platform, the broadcast organizer, and the participants' access method in the "location" field.

The law does not explicitly regulate the necessity to disclose information regarding internal corporate events, such as training sessions for a company's own medical representatives. According to the legislative intent, the disclosure obligation correlates with interactions involving medical workers from third-party organizations; thus, in our view, strictly internal corporate events are exempt from disclosure. However, if external medical workers participate in an internal event (e.g., as invited speakers), the disclosure regime may trigger.

The absence of statutorily defined criteria for categorizing events creates practical ambiguities. Companies must independently classify events based on their substantive content. To mitigate risks, we recommend applying a broad interpretation: in cases of uncertainty regarding the event category, it is prudent to disclose the information.

3. Format and Procedure for Information Disclosure.

The disclosure of event information is executed through two channels:

• by submitting the information to Roszdravnadzor;
• by publishing the information on the company's official website.

The submission of information to Roszdravnadzor is facilitated through the Automated Information System (AIS) "Register of Notifications on Scientific Events" hosted on the authority's official website. To obtain personalized access to the service, companies must submit details regarding the appointment (or removal) of responsible officers to Roszdravnadzor electronically via the email address indicated on the service page (according to the official Roszdravnadzor website: This email address is being protected from spambots. You need JavaScript enabled to view it. [7]), and in hard copy bearing the corporate seal (if applicable[8]) to the following address: 4 Slavyanskaya Square, Bldg. 1, Moscow 109074. The data submission form is provided in Roszdravnadzor Information Letter No. 01I-2001/14 dated December 16, 2014.[9] It includes: details of the pharmaceutical company (name, legal and mailing addresses, OGRN, TIN, full name of the executive), and details of the officer responsible for information disclosure (full name of the authorized employee, position, phone number, email address).

Because the provided form necessitates designating an authorized officer, the head of the organization must issue an order appointing the individual responsible for submitting data to Roszdravnadzor. Depending on the employee's existing duties, amending their job description may be required.

The following information must be submitted to Roszdravnadzor (Parts 2 and 3 of Article 67.2 of the Law on Circulation of Medicinal Products):

• date, location, and time of the event;
• plan and program of the event;
• topics scheduled for discussion;
• composition of the participants.

The notification form recommended by Roszdravnadzor,[10] alongside the listed details, requires specifying the event format (seminar, conference, lectures, etc.), the name of the organizer, including sponsors, and the date the notification is submitted. Notably, Roszdravnadzor Letter No. 01I-468/15 dated March 26, 2015,[11] invalidated the participant list formatted as an appendix to the aforementioned letter. In practice, the participant composition is typically described broadly – via categories of specialists (e.g., cardiologists, district therapists) and their projected headcount. This approach, in our view, aligns with the statutory text, which references the composition of participants rather than an itemized name list, while simultaneously preventing the public dissemination of medical workers' personal data without lawful grounds.

Data from the AIS "Register of Notifications on Scientific Events" serves as confirmation of fulfilling the obligation within the statutory deadline. However, in the event of system failures, the most straightforward contingency is to duplicate the disclosure submission via email or postal delivery. To avert liability risks, we advise notifying Roszdravnadzor with proof of delivery and receipt of the message (letter) regarding the technical malfunctions, appending the required disclosure data to it. This will demonstrate that the entity took all necessary measures within its control to comply with the requirements, establishing the absence of corporate guilt under Part 2 of Article 2.1 of the Code of Administrative Offenses of the Russian Federation (the "CAO RF").

The second disclosure method involves publishing the relevant information on the company's official website. It is advisable to create a dedicated website section in Russian ("Notification on Conducting Scientific and Other Events Involving Medical Workers from Third-Party Organizations") to host the pertinent information. The scope of information to be published mirrors the data submitted to Roszdravnadzor. In practice, pharmaceutical companies often replicate the table sent to Roszdravnadzor within this website section. Because the section is publicly accessible, the description of topics and the program must not contain information that could qualify as advertising for prescription medicinal products: such advertising is permitted solely at venues hosting medical or pharmaceutical exhibitions, seminars, conferences, and similar events, or within specialized print publications.[12] Employing neutral phrasing devoid of promotional claims regarding the products is recommended. Additionally, because Part 2 of Article 67.2 of the Law on Circulation of Medicinal Products mandates "ensuring access" to the information, the data must remain on the website at least until the event concludes; deleting it thereafter is ill-advised.

Evidentiary substantiation of the information published on the company website presents a separate challenge. A notarized inspection of the website constitutes the most robust method for proving publication. However, this would require executing a notarized inspection every time modifications are made to the event notification section, inherently entailing supplementary costs. An alternative method for mitigating liability risks involves maintaining a Log for the Publication of Information on Events Involving Medical Workers from Third-Party Organizations, which tracks the publication dates of the relevant data on the official website. The head of the organization must issue an order approving the format of this log and designating the officer responsible for its maintenance (it is advisable to appoint the same individual responsible for submissions to Roszdravnadzor). Time-stamped screenshots saved at regular intervals, alongside content management system audit logs, can serve as supplementary evidence.

4. Disclosure Deadlines.

The information must be submitted to Roszdravnadzor and published on the website no later than two months prior to the event's commencement. This deadline is mandatory: tardy disclosure constitutes independent grounds for liability; Article 19.7.8 of the CAO RF explicitly encompasses not only the failure to submit, but also the untimely submission of mandatory data to Roszdravnadzor.

The statute remains silent on several standard practical scenarios. First, if the decision to conduct or fund an event occurs less than two months before its start, the statutory deadline provides no exceptions: the company must either postpone the event date (or withdraw its funding) or consciously accept the risk of violating the deadline. Second, the framework for disclosing modifications (date postponements, venue changes, substantive program revisions) is undefined. Accordingly, any modifications should be promptly updated in both the AIS and the website, noting the amendment date. If the event is rescheduled to an earlier date, compliance with the two-month threshold relative to the new date must be verified. Third, upon event cancellation, it is advisable to post a corresponding notice on the website and notify Roszdravnadzor to ensure the registry data reflects the actual circumstances.

Notably, the provisions of the Law on Circulation of Medicinal Products merely outline the parameters for disclosing event information, continuing to generate practical ambiguities. Given the regulatory gaps, implementing a robust compliance system within the pharmaceutical company's operations is highly advisable. Recommendations for developing compliance measures are provided below.

Industry Self-Regulation of Disclosure Obligations Under the AIPM Code

Legislative restrictions frequently fail to encompass all operational nuances of pharmaceutical companies and their engagements with the medical community. To provide granular regulation, the industry developed proprietary ethical codes.

The paramount instrument in Russia is the AIPM Code of Practice.[13] The AIPM Code does not constitute a normative legal act and lacks the force of law. The AIPM Code binds member companies of the Association of International Pharmaceutical Manufacturers, which unites the premier international pharmaceutical companies operating in the Russian market. For AIPM member companies, its mandates assume a de facto binding nature: breaching its requirements triggers corporate disciplinary measures. Beyond the AIPM Code, individual companies – including Russian manufacturers and non-AIPM members – adopt their own ethical codes and policies governing interactions with healthcare professionals.[14] Generally, these frameworks restrict hospitality at promotional and scientific events to statutory boundaries and proportionality with the meeting's objective.

The AIPM Code operates on the premise that any interaction between a pharmaceutical company and the medical community must remain ethical, transparent, and geared toward delivering objective information on medicinal products, rather than unlawfully incentivizing their prescription or promotion. Specifically concerning events, Section 3.3 of the AIPM Code enshrines a series of foundational principles.

The event's objective must focus on informing healthcare professionals about pharmaceutical products and/or supplying them with scientific or educational information in the healthcare or pharmaceutical sectors.

Companies must neither organize nor finance events held outside the healthcare professionals' country of residence and practice. Exceptions apply when logistical or security considerations warrant an alternative. International scientific congresses and symposia convening multinational participants are deemed justifiable and permissible under this standard.

Events must be conducted in venues and under conditions conducive to achieving the specified scientific and educational objectives.

The utilization of venues publicly associated with entertainment, luxury, or exclusivity is strictly prohibited, irrespective of their official classification. Hosting events in business centers, educational institutions, and other facilities designed for professional and educational gatherings is strongly recommended. Executing an event in a publicly accessible venue requires securing an isolated space or restricting public access to the premises for the event's duration.

The venue selection criteria are detailed in Paragraph 13 of Appendix 3 to the AIPM Code[15] and apply irrespective of the event format (in-person or hybrid). These criteria undergo cumulative evaluation and are segmented into three categories:

• First – Location: The event must convene in or near an established scientific, business, regional, or administrative center. The locale must not be primarily recognized as a resort or tourist destination (exceptions apply for events catering to local resident participants, and for annual professional association events held at the national or international level during off-peak tourist seasons).
• Second – Venue: Business and congress centers, medical and educational institutions, and hotel conference rooms are permitted. Conversely, extravagant venues, 5-star or higher category hotels, facilities primarily designed for leisure, and venues associated with entertainment are strictly prohibited.
• Third – Entertainment Component: The event's scheduling and location must not overlap with major sporting, cultural, or entertainment events that could be leveraged to attract attendees.

A pharmaceutical company's sponsorship of a third-party event must be explicitly and transparently disclosed from the outset (Paragraph 3.3.5 of the AIPM Code). Strict limitations apply to the transfer of various values and other goods.

Specifically, providing stationery of nominal value for note-taking purposes is permitted, provided these items lack pharmaceutical company logos, trade names of pharmaceutical products, or any other product brand identifiers (Paragraph 4 of Appendix 3 to the AIPM Code).

Supplying beverages, snacks, and/or hot meals in a buffet format during the event is allowable if justified by the event's duration, strictly subordinated to the event's primary objective, provided exclusively to event participants (excluding accompanying persons), and kept within reasonable limits.

The term "reasonable limits" denotes the average catering cost for similar events (factoring in duration and attendee volume) hosted by pharmaceutical companies within the specific region or nationwide. AIPM member companies must establish explicit monetary thresholds in their internal corporate policies (Paragraph 3 of Appendix 3 to the AIPM Code).

Organizing or funding entertainment, whether integrated into the event or ancillary to it, is unequivocally prohibited. Leveraging entertainment or sporting activities as inducements to draw healthcare professionals to promotional or scientific events is equally forbidden.

Consequently, the professional and scientific component must constitute the core substance of the event, while hospitality elements must remain strictly auxiliary and subordinate.

The AIPM Code imposes more stringent disclosure requirements on market participants than Russian federal law. We examine these mandates below.

1. Subjects of Disclosure.

Every AIPM member pharmaceutical company bears the disclosure obligation. Within a corporate group, primary disclosure liability rests with the legal entity that executed the contract with the healthcare professional or healthcare organization governing the transfer of values (Paragraph 7.1.3 of the AIPM Code).

2. Scope of Disclosed Information.

The AIPM Code imposes disclosure obligations substantially broader than the statutory duty to simply notify the regulator of an event. These are governed by Section VII of the AIPM Code and Appendix 4 to the Code ("Questions and Answers to Section VII of the AIPM Code of Practice").

The Code requires member companies to disclose data on values transferred to healthcare organizations and healthcare professionals.

To clarify, healthcare organizations encompass any legal entity regardless of its corporate form, individual entrepreneurs operating as a healthcare organization or association, or a medical, pharmaceutical, or scientific organization or association (e.g., a hospital, clinic, foundation, university, or other educational institutions, excluding patient organizations), whose registered office or primary place of business is within the Russian Federation, or which provides services through one or more healthcare professionals.

State authorities do not fall under this definition; consequently, values associated with events organized by state authorities are exempt from disclosure. However, if a professional event proceeds under the patronage and/or support of such state authorities in accordance with an approved event plan, yet healthcare organizations act as the conceptual organizers, the organizational costs must be disclosed as a transfer of values to those healthcare organizations.[16]

Under this instrument, healthcare professionals denote physicians and other medical workers, heads of medical organizations, pharmaceutical workers (including pharmacists), heads of pharmacy organizations, and other specialists whose professional activities involve pharmaceutical products and who possess the authority to prescribe, recommend, purchase, dispense, or administer pharmaceutical products during their practice.

A transfer of values implies a direct or indirect transfer of value in monetary form, in kind, or in any other format connected to the development and sale of strictly prescription medicinal products for medical use (Paragraph 1.2 of the AIPM Code; Question 10 of Appendix 4 to the AIPM Code).

The transfer may be direct (transferred straight to the recipient) or indirect (routed through an intermediary, provided the pharmaceutical company knows or can identify the healthcare organization/healthcare professional benefiting from the transfer).

Categories of Disclosable Value Transfers executed in favor of healthcare organizations and healthcare professionals:

• donations and grants, restricted solely to healthcare organizations (providing gifts to healthcare professionals, including monetary funds, is prohibited under Paragraph 3.5.1 of the Code);
• covering event-related costs (registration fees, sponsorship agreements with healthcare organizations or third parties engaged by them, travel, and accommodation);
• payments for services and consulting (remuneration and out-of-pocket expenses stipulated in the contract are disclosed as two distinct figures);
• values transferred in connection with research and development (disclosed exclusively on an aggregate basis – Paragraph 7.3.6 of the AIPM Code).

The following transfers of values are exempt from the disclosure obligation (Paragraph 7.1.2 of the AIPM Code):

• transfers relating exclusively to over-the-counter (OTC) pharmaceutical products;
• items not specified in Paragraph 7.3 of the AIPM Code, such as articles useful in medical practice, meals and beverages, and pharmaceutical product samples (provided their distribution complies with applicable law and the Code);
• transfers executed as part of ordinary buying and selling activities involving pharmaceutical products between pharmaceutical companies and healthcare organizations.

3. Procedure for Information Disclosure.

Disclosure is executed by publishing the data on the pharmaceutical company’s publicly accessible website, or on the corporate website of the corporate group to which the company belongs (if it lacks a dedicated site).

The information is structured in a standardized table, the format of which is provided in Appendix No. 2 to the AIPM Code. Companies must also publish a methodological note summarizing the procedures used to compile the disclosure and allocate value transfers to each category. The information is published in Russian, and may optionally be disclosed in English at the company's discretion (Paragraph 7.2.6 of the AIPM Code). Documentation substantiating the executed disclosure must be retained for a minimum of five years following the end of the relevant reporting period (Paragraph 7.2.7 of the AIPM Code). Disclosure follows the rules of the national code applicable where the value recipient is physically located, even if the contract was executed by a foreign affiliate within the corporate group (Paragraph 7.2.5 of the AIPM Code).

The AIPM Code provides distinct regimes for disclosing value transfers: individual and aggregate.

Under the 2026 edition of the AIPM Code, pharmaceutical companies maintain the discretion to disclose value transfers either on an individual basis – identifying the specific recipient (healthcare professional or organization) – or on an aggregate basis, strictly conditioned upon compliance with personal data protection legislation.[17] In prior editions of the AIPM Code, individual disclosure functioned as the default standard. Individualized disclosure regarding a healthcare professional is permissible exclusively upon securing their consent: publishing a full name and transferred value amounts on a public website constitutes the dissemination of personal data. We strongly advise companies to proactively secure this consent during the contract negotiation phase with medical workers, ensuring compliance with Federal Law No. 152-FZ dated July 27, 2006, On Personal Data (the "Personal Data Law"). Crucially, effective September 1, 2025, consent for personal data processing must be formalized as a standalone document, detached from any other information or documents confirmed or signed by the data subject; embedding it within a service agreement is therefore impermissible.[18] Consent for the processing of personal data authorized for dissemination must be executed separately from other consents and comply with Article 10.1 of the Personal Data Law. This consent may be procured as an electronic document verified by an electronic signature (Part 4 of Article 9 of the Personal Data Law), facilitating its integration into electronic document management workflows with medical workers.[19] Processing personal data without required written consent triggers administrative liability under Part 2 of Article 13.11 of the CAO RF, imposing corporate fines ranging from 300,000 to 700,000 rubles.[20]

If a healthcare professional grants partial consent (e.g., permitting disclosure of contract remuneration but withholding consent for travel and accommodation expenses), the guidance to Section VII of the Code recommends disclosing all value transfers under that contract on an aggregate basis; identical consent rules govern professionals registered as individual entrepreneurs.[21] Corporate practices vary: certain companies equate partial consent to an outright refusal and report all transfers to such recipients in the aggregate, whereas others individually disclose only those transfers explicitly covered by the consent.[22] If data consolidation or publication relies on overseas corporate group resources, companies must address cross-border personal data transfer mandates (Article 12 of the Personal Data Law) and database localization requirements (Part 5 of Article 18 of the Personal Data Law); due to these constraints, several companies opt strictly for aggregate disclosure concerning healthcare professionals.

Procuring disclosure consent from a healthcare organization is unnecessary, provided the disclosed data does not constitute state, banking, commercial, or other legally protected secrets under Russian Federation law. If the contract with a healthcare organization restricts or prohibits disclosing value transfers, the AIPM Code advises renegotiating the terms utilizing the provided template "Disclosure Clauses for Contracts with Healthcare Organizations".[23]

Disclosing sponsorship fees paid to technical event organizers warrants specialized scrutiny. If the technical organizer is appointed by the healthcare organization and operates essentially as an intermediary, the sponsorship fee is disclosed as a value transfer to the relevant healthcare organization (the conceptual organizer) – even if the latter receives no direct funds and the benefit is in-kind (e.g., venue rental). The relationship between the technical organizer and the healthcare organization should be documented – ideally via a tripartite agreement or a formal letter from the healthcare organization. Conversely, if the fee goes to an entity organizing the event independently, rather than acting as a broker, the recipient healthcare organization cannot be identified, rendering disclosure inapplicable.[24]

Where individual disclosure is legally blocked, the data is reported on an aggregate basis – categorized by value transfer type, noting the absolute and percentage headcount of recipients alongside the total aggregated value transferred, omitting name-specific identification (Paragraph 7.3.4 of the Code). Value transfers linked to research and development are similarly disclosed exclusively in the aggregate. An indirect transfer of values to a healthcare professional channeled through a healthcare organization is disclosed only once (Paragraph 7.3.5 of the AIPM Code).

The Code does not mandate a uniform template for the methodological note: it must articulate the applied methodologies, detailing the treatment of multi-year contracts, VAT and other tax implications, currency exchange dynamics, and the timing parameters of the value transfers (Paragraph 7.3.7 of the AIPM Code). Because cross-company data comparability is not inherently guaranteed, delivering a coherent and transparent methodological narrative is a prerequisite for accurately interpreting the disclosed metrics.

4. Timelines for Event Information Disclosure by Pharmaceutical Companies.

As a general rule, disclosure must occur annually, with each reporting cycle encompassing a complete calendar year.

The disclosure deadline spans 6 (six) months following the close of the applicable reporting period. The data must remain publicly accessible for a minimum of three years. The guidance accompanying Section VII of the Code designates June 20 to June 30 as the standard annual publication window.[25]

Thus, disclosure under the AIPM Code and disclosure pursuant to Article 67.2 of the Law on Circulation of Medicinal Products serve distinct, albeit related, objectives. Statutory disclosure focuses on the regulator's preemptive oversight of planned event content and parameters, whereas AIPM Code disclosure targets the public transparency of the company's financial ties with the medical community.

Structuring Effective Compliance Procedures

To mitigate risks, pharmaceutical companies must engineer a comprehensive internal control framework, including:

• Drafting an internal policy governing interactions with medical workers and healthcare organizations;
• Designating officers responsible for executing disclosure obligations under both the Law on Circulation of Medicinal Products and the AIPM Code;
• Implementing robust pre-approval protocols for events and associated expenditures;
• Maintaining a centralized registry of contracts with medical workers and tracking transferred values;
• Structuring a system to collect distinct, freestanding consents for personal data processing and dissemination (excluding them from service contracts), and tracking their revocation;
• Exercising rigorous oversight over data preparation and final disclosure;
• Conducting regular compliance training for personnel (primarily targeting medical representatives and marketing teams) on statutory requirements and the AIPM Code;
• Executing periodic internal disclosure audits and establishing a response protocol for Roszdravnadzor inquiries and AIPM grievances;
• Auditing event venues to guarantee alignment with AIPM Code criteria;
• Pinpointing third-party sponsored events that trigger an independent corporate notification obligation toward Roszdravnadzor;
• Embedding disclosure clauses and requirements for submitting documents substantiating the technical organizer's status into contracts with sponsored organizations and technical organizers.

Liability for Breaching Disclosure Requirements

Open sources do not currently reveal published enforcement actions penalizing the failure to submit the data required by Article 67.2 of the Law on Circulation of Medicinal Products to Roszdravnadzor. Nevertheless, compliance with the restrictions set forth in Articles 67.1 and 67.2 of said law is explicitly incorporated into the scope of federal state control (supervision) over the circulation of medicinal products.[26] Furthermore, when instituting the notification form, Roszdravnadzor stated that the resulting database would inform scheduled and unscheduled control and supervisory measures.[27]

Liability for neglecting the notification duty for scientific or other events may arise under Article 19.7.8 of the CAO RF, titled "Failure to Submit Information or Submission of Knowingly Inaccurate Information to the Federal Executive Body Exercising Control and Supervisory Functions in the Healthcare Sector".[28] The sanctions prescribed by this article entail administrative fines ranging from 10,000 to 15,000 rubles for corporate officers, and from 30,000 to 70,000 rubles for legal entities. We contend that the specific failure to publish information on the company's official website falls outside this offense, as it does not constitute submitting data to a federal executive body. However, state control (supervision) audits can flag this breach and issue a remediation order; failing to comply with such an order triggers a distinct administrative liability (Article 19.5 of the CAO RF).

Breaches of the AIPM Code disclosure mandates do not attract coercive state enforcement. Nonetheless, AIPM members and other stakeholders may file grievances against any pharmaceutical manufacturer operating in the Russian market, citing specific Code violations. If the dispute remains unresolved voluntarily, a Special Task Force may adjudicate the grievance, though its decision is subject to appeal.

Upon reviewing the petition and confirming a violation, the Special Task Force may issue a recommendation demanding corrective action and imposing the following sanctions (in any combination):

• mandate that the offending company's personnel complete AIPM Code online training;
• formally notify the offending company's global headquarters regarding the breach;
• in instances of severe violations, levy a fine up to the threshold of the annual AIPM membership fee;
• for severe or recurrent breaches, publicly disclose the violation – naming the offending company – on the AIPM website for a 3-month term;
• recommend to the AIPM General Assembly that the offending company be expelled from the Association.[29]

Fines and expulsion apply exclusively to AIPM member companies. The Association's website generally publishes Special Task Force rulings in an anonymized format, unless public shaming forms part of the assigned sanction.

While lacking state-coercive force, the reputational fallout for a multinational pharmaceutical company often inflicts far greater damage than a nominal administrative fine.

The provisions of the Law on Circulation of Medicinal Products mandate the disclosure of information concerning scientific and other events involving medical workers, including events orchestrated by third parties but funded by the pharmaceutical company. Nevertheless, several disclosure variables remain poorly regulated, spanning from the classification of an event as "scientific" to granular procedural mechanics.

The AIPM Code imposes broader disclosure criteria, engineered primarily to ensure the financial transparency of the company's relationship with the medical community. In the 2026 edition, companies retain the discretion to choose between individual and aggregate disclosure; however, individualized reporting on healthcare professionals still hinges on securing their consent, executed in strict accordance with the personal data legislation frameworks enforced since September 1, 2025.

For AIPM member companies, the integrated adherence to both regimes (statutory and corporate) constitutes the gold standard for proper disclosure practices.

To mitigate adverse risk exposure, we recommend that pharmaceutical companies deploy the following compliance measures:

• Formalize internal disclosure procedures. Issue an executive order designating the responsible officer, approve the publication log format, and amend job descriptions where necessary.
• Apply a broad interpretive standard to event classification. If ambiguity surrounds the event category, opt for disclosure, as the penalties for non-submission outweigh the costs of over-reporting.
• Secure a buffer for the two-month deadline. Maintain a robust event calendar and guarantee proactive data submission, archiving proof of timely delivery. If event or funding decisions arise within the two-month window, actively evaluate rescheduling.
• Ensure reliable substantiation of website publications. Maintain a publication log, archive time-stamped screenshots, and rely on a notarized website inspection when confronting elevated risk profiles.
• Implement a rapid-response protocol for technical outages. If AIS submission fails, replicate the data submission via email and dispatch a registered letter with return receipt to report the technical malfunction.
• Allocate contractual duties with precision. When retaining organizers and agencies, explicitly hardwire disclosure liabilities into the agreements while retaining executive oversight. Pinpoint third-party sponsored events that trigger an independent corporate notification mandate.
• Integrate AIPM Code mandates into the broader compliance architecture. For Association members, ensure dual-track compliance encompassing statutory disclosure and Code requirements, including the annual reporting of value transfers, the procurement of distinct consents for personal data processing and dissemination, and strict adherence to hospitality limits and contracting rules with medical workers.
• Audit the substance of public-facing website sections. Prohibit the injection of promotional content regarding prescription drugs into event sections, and block the unlawful dissemination of participants' personal data.
• Execute routine personnel training for AIPM members. Ensure staff fluency regarding statutory mandates and the AIPM Code to drastically curtail the risk of inadvertent violations.

A holistic approach to information disclosure, synthesizing strict statutory compliance with self-regulatory standards, empowers a pharmaceutical company to neutralize both administrative and reputational risks, while cultivating a transparent, high-trust paradigm with the medical community and the regulator.

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References

1. Articles 74, 75 of Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation; Article 13.3 of Federal Law No. 273-FZ dated December 25, 2008, On Anti-Corruption.
2. Chapter 14.1 of Federal Law No. 61-FZ dated April 12, 2010, On the Circulation of Medicinal Products (introduced by Federal Law No. 317-FZ dated November 25, 2013; as amended on December 29, 2025).
3. Source: https://brace-lf.com/informaciya/farmatsevticheskoe-i-meditsinskoe-pravo/ogranicheniya-pri-vzaimodejstvii-farmatsevticheskikh-kompanij-i-vrachej.
4. Parts 2, 3 of Article 67.2 of the 61-FZ.
5. Paragraph 1 of Article 182, Paragraph 1 of Article 971, Paragraph 1, Subparagraph 1 of Article 1005 of the Civil Code of the Russian Federation.
6. Article 2 of Federal Law No. 127-FZ dated August 23, 1996, On Science and State Scientific and Technical Policy. This concept does not serve as a specific criterion for the purposes of Article 67.2 of the 61-FZ and may only be utilized as a guideline.
7. Automated Information System "Register of Notifications on Scientific Events" // Official website of Roszdravnadzor. URL: https://roszdravnadzor.gov.ru/services/events (accessed: September 17, 2026).
8. Paragraph 5 of Article 2 of Federal Law No. 14-FZ dated February 8, 1998, On Limited Liability Companies, Paragraph 7 of Article 2 of Federal Law No. 208-FZ dated December 26, 1995, On Joint-Stock Companies (as amended by Federal Law No. 82-FZ dated April 6, 2015).
9. Roszdravnadzor Letter No. 01I-2001/14 dated December 16, 2014, On Informing Roszdravnadzor About Conducting Scientific and Other Events.
10. Roszdravnadzor Letter No. 16I-1595/13 dated December 25, 2013, On Informing Roszdravnadzor About Conducting Scientific and Other Events (as amended by Roszdravnadzor Letter No. 01I-468/15 dated March 26, 2015).
11. Roszdravnadzor Letter No. 01I-468/15 dated March 26, 2015, On Informing Roszdravnadzor About Conducting Scientific and Other Events.
12. Part 8 of Article 24 of Federal Law No. 38-FZ dated March 13, 2006, On Advertising.
13. AIPM Code of Practice (as amended on April 9, 2026, approved by the AIPM General Assembly on April 9, 2026). URL: https://lk.aipm.org/uploads/rus/code/code_of_practice_2026.pdf.
14. See, for example: Code of Ethics of the Pharmaceutical Company AKRIKHIN, Code of Ethics of SANTO Member of Polpharma Group, Menarini Code of Conduct.
15. Paragraph 3.3.4 of the AIPM Code; Paragraph 13 of Appendix 3 to the AIPM Code; Event Venues // Official website of the AIPM. URL: https://aipm.org/location.
16. Question 27 of Appendix 4 to the AIPM Code, Questions and Answers to Section VII of the AIPM Code of Practice.
17. Paragraph 7.3.1 of the AIPM Code of Practice (2026 edition, approved by the AIPM General Assembly on April 9, 2026).
18. Part 1 of Article 9 of Federal Law No. 152-FZ dated July 27, 2006, On Personal Data (as amended by Federal Law No. 156-FZ dated June 24, 2025, effective September 1, 2025); Article 10.1 of Federal Law No. 152-FZ; Roskomnadzor Order No. 18 dated February 24, 2021, On Approval of Requirements for the Content of Consent to the Processing of Personal Data Authorized by the Personal Data Subject for Disseminatio.
19. Part 4 of Article 9 of Federal Law No. 152-FZ; Electronic Document Management with Healthcare Professionals (handbook), prepared based on the project results of AIPM member companies (concept update date - February 27, 2024).
20. Part 2 of Article 13.11 of the CAO RF (as amended by Federal Law No. 589-FZ dated December 12, 2023).
21. Questions 20, 21 of Appendix 4 to the AIPM Code.
22. See, for example, the methodological notes of LLC Novo Nordisk (version 6.0 dated June 30, 2021), Servier Russia (2019), LLC AstraZeneca Pharmaceuticals (2016 data), and LLC Pierre Fabre (revision date June 30, 2023).
23. Question 26 of Appendix 4 to the AIPM Code.
24. Questions 23–25 of Appendix 4 to the AIPM Code.
25. Paragraphs 7.2.1, 7.2.2 of the AIPM Code; Question 7 of Appendix 4 to the AIPM Code.
26. Subparagraph "b" of Paragraph 2 of the Regulation on Federal State Control (Supervision) in the Sphere of Circulation of Medicinal Products, approved by Decree of the Government of the Russian Federation No. 1049 dated June 29, 2021 (as amended on November 15, 2025).
27. Roszdravnadzor Letter No. 16I-1595/13 dated December 25, 2013, On Informing Roszdravnadzor About Conducting Scientific and Other Events.
28. Article 19.7.8 of the CAO RF (introduced by Federal Law No. 317-FZ dated November 25, 2013).
29. Paragraphs 1.2, 1.3, 6.1, 7.1–7.3 of Appendix 1 to the AIPM Code, Procedure for Considering Statements and Disputes on Violation of the AIPM Code of Practice.