Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Which laws apply when it comes to promoting medicines and medical devices?

Applicable Laws

• Law on Advertising No. 270/96-ВР (3 July 1996):
  • Article 21: Rules for advertising medicines and medical devices.
• Law on Medicines No. 123/96-ВР (4 April 1996):
  • Article 26: Specific regulations for advertising and promoting prescription (Rx) and over-the-counter (OTC) medicines.
• Ministry of Health Order No. 422 (6 June 2012):
  • Criteria for including OTC medicines in the list of medicines prohibited from advertising.
• Order No. 1295 (18 July 2023):
  • Prohibition List of OTC medicines (effective from 1 March 2024).
• Fundamentals of the Health Care Legislation of Ukraine No. 2801-XII (4 November 1992).
• Consumer’s Rights Protection Law No. 1023-XII (12 May 1991).
• Law on Protection Against Unfair Competition No. 236/96-BP (7 June 1996).

New Version of the Medicines Law

• Will align Ukrainian legislation with EU regulations, particularly Directive 2001/83/EC.
• Differentiates between advertising to the general public and promotion to healthcare professionals.
• Scheduled to take effect 2.5 years after the end of martial law in Ukraine.

2. Are there any additional legislative frameworks, such as self-regulatory codes of conduct, that control the advertising of pharmaceuticals and medical devices?

Current Situation

• No single market-wide self-regulatory code specifically for the advertising of medicines and medical devices in Ukraine.
• Association of Pharmaceutical Research and Development (APRAD): Code of Pharmaceutical Marketing Practices provides professional ethics rules for its members.

Future Developments

• 2023 Amendments to the Law on Advertising promote the development of self-regulation in advertising through codes for creating and distributing advertisements, including those related to medicines and medical devices.

3. What licenses, approvals, or fees (if any) are required for advertising medications and medical devices to the general public and healthcare professionals?

Requirements

• OTC Medicines: Can be advertised if approved for use in Ukraine by the Ministry of Health (MoH).
• Medical Devices: Must pass the Ukrainian national conformity assessment procedure in accordance with the Technical Regulation on medical devices (Resolution of the Cabinet of Ministers No. 753, 2 October 2013).
• Rx Medicines: Promotional materials may be communicated to healthcare professionals, including those for unapproved medicines in development stages.

Optional Approval

• Antimonopoly Committee of Ukraine (AMCU): Businesses may request an analysis of advertisements to ensure compliance with fair business practices.
• Administrative fee for violations: UAH 5,440 (approximately €150).

4. Does Ukrainian law govern the advertisement of prescription and over-the-counter medications differently?

• Ukrainian legislation distinguishes between advertising medicines to the general public and to healthcare professionals, as well as between prescription (Rx) and over-the-counter (OTC) medicines.
• When targeting the general public, only OTC medicines not listed in the Prohibition List may be advertised.
• Advertising of Rx medicines and prohibited OTC medicines to the general public is explicitly prohibited.
• Both OTC and Rx medicines may be communicated to healthcare professionals under conditions outlined in Article 26(3) of the Medicines Law.
• Advertising to healthcare professionals usually takes the form of “information about medicines” disseminated through professional publications or medical events.
• The updated Medicines Law defines such communication as “promotion” and introduces additional regulatory requirements, effective 2.5 years after the end of martial law.

5. What are the primary limits on promoting drugs and medical devices to the public?

Under Article 21 of the Law on Advertising, advertising aimed at the general public must not include:

• References to therapeutic effects for incurable or difficult-to-cure diseases.
• Statements implying that consultation with a doctor is unnecessary.
• Claims guaranteeing therapeutic effects.
• Images depicting bodily changes caused by illness or injury.
• Claims suggesting that failure to use the product could worsen health or cause illness.
• Statements promoting self-diagnosis or self-treatment.
• References implying the product is the most effective, harmless, or free of side effects.
• Mentions of individual cases of successful use.
• Recommendations or endorsements from healthcare professionals, scientists, or institutions.
• Testimonials, appreciation letters, or personal stories.
• Images or mentions of celebrities, fictional characters, or authoritative organizations.
• Misleading information on content, origin, effectiveness, or patent protection.
• Statements equating medicines with food, cosmetics, or consumer products, or attributing safety to natural origin.
• Use of doctors or individuals imitating healthcare professionals in a misleading manner.

These requirements were recently revised and will take effect 2.5 years after the end of martial law.

6. What are the primary limits on promoting drugs and medical devices to healthcare professionals?

Current Law

No specific restrictions apply beyond general prohibitions.

New Medicines Law

• Prohibits material incentives tied to prescription frequency.
• Bans bonuses, cash refunds, or participation in games or contests linked to prescriptions.
• Requires accurate and up-to-date information for healthcare professionals.

7. What is the required information for advertisements directed only at healthcare professionals for medicines and medical devices?

Ukrainian legislation does not define specific rules for OTC medicines and medical devices targeted exclusively at healthcare professionals.

For prescription (Rx) medicines, promotional materials should include the product name, characteristics, and potential side effects in line with general requirements.

Such materials often state that they provide information rather than advertising.

The new Medicines Law requires promotion only of authorized products, objective presentation, avoidance of exaggeration, and accuracy of information.

8. What information must be included in public-facing advertisements for drugs and medical devices?

• Objective information about the product.
• Clear indication that the content is an advertisement.
• Warnings to consult a doctor before use.
• Recommendation to read the patient information leaflet.
• Mandatory notice: “Self-treatment may be harmful to your health,” occupying at least 15% of the advertisement space or duration.

9. Are there any constraints on the data used to support promotional claims?

Ukrainian advertising law does not specify requirements for scientific data in advertisements.

General Provisions

• No specific requirements or restrictions for scientific data.
• General prohibitions apply to misleading information.
• References to individual cases or guaranteed effects are prohibited.

10. Are there any rules governing comparative advertising of drugs and medical devices?

General Rules

• Comparative advertising must be objective.
• Must be based on true information.
• Only similar products may be compared.
• Competitors must not be discredited.

11. Are there special guidelines for advertising drugs and medical devices on the internet or social media?

There are no specific Ukrainian regulations for online or social media advertising of medicines and medical devices.

General Compliance

• Advertisements must comply with general advertising laws.
• Rules on spam and consumer consent apply.
• Prior written consent is required for mass communications.

12. Which bodies oversee compliance and what are the legal ramifications for noncompliance?

Enforcement Mechanisms

• Immediate cessation of violations upon notification.
• Suspension of non-compliant advertisements.
• Imposition of fines on advertisers, producers, or distributors.

Monitoring and Oversight

• State Service of Ukraine on Food Safety and Consumer Protection: Ensures consumer rights protection.
• Antimonopoly Committee of Ukraine (AMCU): Prevents unfair competition, investigates misleading information, trade dress violations, and unfair comparative advertising.

Penalties

• Fines up to five times the value of distributed advertising if consumer rights are infringed.
• Fines up to 5% of the previous year’s revenue for competition law violations.

13. Are there any future developments in Ukraine?

New Medicines Law

• Alignment with EU Directive 2001/83/EC.
• Entry into force 2.5 years after the end of martial law.
• Possible expedited implementation proposed by the Ministry of Health.
• Introduction of specific advertising and promotion provisions focused on rational use and preventing misleading practices.

How can OMC help?

• OMC offers professional review of marketing and advertising materials and provides reports.
• We offer services to obtain authority approvals where required.
• We offer translation of marketing materials as a professional translation agency certified with ISO 17100.