Discounts inside pharma patient support programs risk classification as drug advertising in Russia
A patient support program looks like genuine care for the sick: a discount on therapy, assistance with paperwork, and reminders to take medication. For the Federal Antimonopoly Service (FAS), the very same thing can be read differently: as a way to bypass the ban on advertising prescription drugs under the guise of a good cause. A company that thinks it is helping a patient and an antimonopoly authority that sees brand promotion in this initiative are looking at the exact same program from opposite sides.
The Market Access industry has been living with this contradiction for years. Patient Support Programs (PSPs) address a real issue: state coverage often leaves the patient alone with the cost of innovative therapy, making a discount a prerequisite for treatment to even begin. At the same time, every element of such a program, from a social media banner to the sponsor’s name on a website, can be qualified by a regulator as advertising, personal health data, or a tax scheme. Fines and regulatory attention across all these areas have grown since 2024.
Where the Line Between Information and Advertising Lies
Russian law defines advertising as information distributed in any manner, addressed to an indefinite group of persons, and aimed at drawing attention to a product (Art. 3 of Federal Law No. 38-FZ of March 13, 2006 «On Advertising», hereinafter, FL No. 38-FZ). PSPs are formally targeted at patients with a specific diagnosis and prescription, so they do not strictly fall under the definition of an «indefinite group of persons.»
The problem lies elsewhere. Part 8 of Article 24 of FL No. 38-FZ permits advertising of prescription drugs only at medical and pharmaceutical exhibitions, seminars, and conferences, and in specialized publications for doctors and pharmacists. The law says nothing about internet channels, through which PSP platforms typically operate. From this, legal experts conclude that promoting a prescription drug directly to a patient via a website or social network is not permitted under any circumstances, regardless of whether it is termed advertising or informational support.
FAS practice in recent years shows three typical scenarios that trigger scrutiny of these programs.
In the «Motilium» advertising case, the antimonopoly service deemed a claim that the tablets dissolve faster than similar products to be a violation, because no specific comparison criterion was given. For PSPs this means that any phrasing like «the best solution for your diagnosis» or «more effective than similar products» in program materials creates the same risk, even when framed as «educational» text rather than an ad.
In January 2023, FAS fined «Eapteka» over a video on VKontakte. The video promised a discount via a promo code, but the conditions on minimum order value and new-client status stayed hidden from the consumer. The lesson for support programs is simple: every condition for getting a discount needs to be visible before the patient starts registration.
In May 2024, FAS found advertising for the «NaPopravku» service to be non-compliant: it lacked the «Advertising» label and omitted the warning about contraindications and the need to consult a specialist. Both requirements apply directly to any digital PSP channel that mentions a specific drug or medical service.
Beyond advertising law, two other regulators keep watch over PSPs. Roszdravnadzor oversees pharmacovigilance: if a program’s call center receives a report of an adverse drug reaction from a patient and doesn’t pass it on, the company risks suspension of that drug’s registration certificate. The sanction here is more severe than an ordinary fine, because it halts sales. The Federal Tax Service (FTS) checks the accuracy of the documents a PSP helps a patient file for a tax deduction. An error in the payment certificate usually ends in the tax refund being denied to the patient, and the reputational cost in that case falls on the company that ran the program.
| Regulator | Subject of Control | Typical Violation in PSP |
|---|---|---|
| FAS Russia | Distinction between advertising and information | Promotion of a drug disguised as educational content |
| Roskomnadzor | Labeling of online advertising, personal data | Missing erid token; leakage of health data |
| Roszdravnadzor | Pharmacovigilance, circulation of medicines | Late reporting of adverse events |
| FTS Russia | Tax deduction, VAT under the simplified tax system | Errors in payment certificates; unaccounted VAT at a partner pharmacy |
What Changed in 2024-2025 for PSP Operators
Three parallel legislative changes affected the economics and risk profile of patient support programs: liability for health data leaks got tougher, the tax deduction limit for medicines went up, and partner pharmacies on the simplified tax system became partial VAT payers.
| Parameter | Before 2024 | 2024-2025 |
|---|---|---|
| Social tax deduction for drugs (max amount) | 120,000 ₽, refund up to 15,600 ₽ | 150,000 ₽, refund up to 19,500 ₽ (for 2024 expenses onward) |
| Fine for a health data leak (legal entity, 1,000-10,000 subjects) | General provisions of Art. 13.11 of the Administrative Code, no tiering by leak size | 10-15 million ₽ (from May 30, 2025, Art. 13.11 of the Administrative Code as amended by FL No. 420-FZ) |
| VAT for partner pharmacies on the simplified tax system | Exempt from VAT regardless of turnover | 5-7% VAT for annual revenue over 60 million ₽ (from 2025) |
Information about diagnoses and health status falls under special categories of personal data (Art. 10 of Federal Law No. 152-FZ of July 27, 2006). As of May 30, 2025, a leak of such data affecting 1,000 to 10,000 subjects carries a fine of 10 to 15 million rubles for a legal entity. On a repeat violation, the fine becomes turnover-based: 1% to 3% of annual revenue, with a floor of 25 million and a cap of 500 million rubles, where the leak involves special categories of data or biometrics.
For a PSP this points to a clear conclusion: a program’s call center, which collects a patient’s diagnosis and medical history, is processing high-risk personal data. The scale of the potential fine turns the question of «who is the data operator» into a central element of the program’s legal setup. A company can no longer treat this as a formality.
Online advertising labeling is its own separate source of fines. It has nothing to do with medical subject matter directly, but it applies to any PSP banner on social media. Part 16 of Article 14.3 of the Administrative Code fines the placement of advertising without an erid token (a unique creative-identifier tag in the online advertising tracking system) or with errors in how it is displayed. For legal entities the fine runs from 200,000 to 500,000 rubles per identified creative.
The rise in the social tax deduction works in the program’s favor. For 2024 expenses onward, a patient can claim back up to 19,500 rubles in personal income tax when buying medicine on a doctor’s prescription issued on Form No. 107-1/u with a clinic’s stamp. A PSP operator that helps a patient properly complete this prescription and payment certificate is providing advice on the patient’s rights as a taxpayer. Advertising a specific drug plays no part in that.
The VAT change concerns mainly the partner pharmacies through which a PSP dispenses discounted medicine. From 2025, a pharmacy on the simplified tax system with annual revenue over 60 million rubles becomes a VAT payer at a rate of 5% (for revenue up to 250 million) or 7% (up to 450 million). This changes the calculation of the final price for the patient and calls for revisiting the discount mechanics wherever they were set without accounting for the pharmacy’s new tax burden.
Principles That Reduce Risk for PSPs
The international pharmaceutical industry worked out an approach to patient programs long ago, one noticeably stricter than the baseline set by Russian advertising law alone. These principles aren’t tied to a specific edition of an industry code, but they come up repeatedly in reviews of FAS cases as the test that separates a program from a promotion.
Physician as intermediary. Information about the program reaches the patient through the treating physician. Targeted social media advertising that names a brand doesn’t fit this role.
Medical necessity. The discount covers the gap between the cost of therapy and compulsory health insurance (CHI) coverage. A bonus for purchase volume belongs to a different, marketing logic that doesn’t suit a PSP.
Transparency of terms. The patient sees who is funding the program and what data about them is being collected, before registration.
Clean educational content. Materials on injection technique or managing side effects don’t carry the drug’s trade name outside restricted sections meant for participants already enrolled.
Data minimization. The call center collects only the health information the program needs, and doesn’t keep it longer than the personal data policy allows.
Written or qualified electronic consent to process health data (Part 2, Art. 10 of Federal Law No. 152-FZ) remains a mandatory condition for launching a program, regardless of who acts as the data operator: the pharmaceutical company itself or a separate PSP provider.
Action Plan
The five steps below turn the principles above into concrete tasks for a team that has already launched a program or is preparing to launch one.
Split up the roles inside the program. Determine who acts as the operator of the patient’s personal data: the manufacturer, a separate PSP provider, or a medical organization. Direct manufacturer access to patients’ diagnoses raises the risk both under FL No. 152-FZ and for reputation.
Route the channel through the physician. Information about the program should reach the patient through the treating physician or the pharmacy. Targeted advertising naming a specific drug doesn’t fit this purpose.
Check every digital creative for labeling. A banner, social post, or mailing that mentions the program needs an erid token, an «Advertising» label (where it is advertising), and the advertiser’s details. Missing any of these elements leads to a fine under Part 16, Article 14.3 of the Administrative Code.
Set up adverse-event reporting. Train the PSP call center staff to pass on reports of adverse drug reactions to the company’s pharmacovigilance unit within the deadline set by internal policy, usually no more than 24 hours from the initial contact.
Recalculate the program’s tax model. Account for the higher 150,000-ruble deduction limit when advising patients under Form No. 107-1/u, and for the new VAT rate at partner pharmacies on the simplified tax system with revenue over 60 million rubles, so the discount doesn’t lose its economic point once the pharmacy’s tax is paid.
A patient support program stays a legitimate tool for as long as medical necessity stands behind every part of it. A company that can show a regulator a transparent framework of consents, labeling, and adverse-event reporting gets through an audit by FAS or Roskomnadzor without consequences for the business.
Regulatory Framework:
1. Order of the Ministry of Health of the Russian Federation No. 1094n of November 24, 2021
2. Federal Law No. 38-FZ of March 13, 2006 «On Advertising» (Art. 3, Art. 24)
3. Federal Law No. 152-FZ of July 27, 2006 «On Personal Data» (Art. 10)
4. Federal Law No. 61-FZ of April 12, 2010 «On Circulation of Medicines» (Art. 67.1)
5. Code of Administrative Offenses of the Russian Federation, Art. 13.11, Art. 14.3 (as amended by Federal Law No. 420-FZ of November 30, 2024)
6. Tax Code of the Russian Federation, Art. 145, Art. 219, Art. 346.11 (as amended by Federal Law No. 176-FZ of July 12, 2024)