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?

Act No. 147/2001 Coll. on Advertisement: Implements Directive 2006/114/EC (misleading and comparative advertising) and Directive 2001/83/EC (Community code for medicinal products).
Act No. 264/2022 Coll. on Media Services: Governs advertising via media services in commercial communication.
Act No. 362/2011 Coll. on Drugs and Medical Devices: Regulates medicinal products and medical devices.
Act No. 187/2021 Coll. on Protection of Competition: Ensures fair competition practices.
Act No. 250/2007 Coll. on Consumer Protection: Protects consumer rights.

2. Are there any additional legislative frameworks or self-regulatory codes of conduct?

EFPIA Code: Ethical rules for promotion and interactions with healthcare professionals and organizations.
Ethical Code of the Pharmaceutical Industry of the Slovak Republic: Ensures high standards in advertising.
Ethical Code of Association of Innovative Pharmaceutical Industry: Maintains ethical standards in advertising.
Ethical Code of Advertising by the Advertising Standards Council: General principles for ethical advertising.

3. What licenses, approvals, or fees are required for advertising?

No specific licensing requirements for advertising medicines and medical devices.
Advertisers must notify certain expenditures related to marketing and promotional events.
Medical representatives must have professional training and provide accurate information.

4. Does Slovak law govern prescription and over-the-counter medicines differently?

Prescription Medicines: Advertising to the general public is generally prohibited.
Non-Prescription Medicines: Advertising is permitted under specific conditions.

The distinction is crucial for advertisements directed at the general public: while advertising of over-the-counter medicines is allowed under specific conditions, advertising of prescription medicines to the general public is generally prohibited.

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

5.1 Medicines

Prohibited advertisements include unregistered medicines, narcotic or psychotropic drugs, and prescription-only medicines (with certain exceptions such as vaccination campaigns).
Advertisements must not be misleading and must encourage rational use.
Required content includes clear identification as an advertisement, the name of the medicine, correct usage information, and a request to read user information.
Prohibited content includes suggestions that medical examinations are unnecessary, guarantees of no side effects, and advertisements targeting children.

5.2 Medical Devices

General advertising rules apply. Advertising must not endanger health, must comply with competition rules, and must not include misleading information.

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

Medicines

Essential information must align with the Summary of Product Characteristics (SmPC).
The advertisement must include the date of issuance or last update.
Documentation must provide accurate, verifiable, and up-to-date information sufficient for recipients to form their own opinion on therapeutic value.
Any price information or materials from scientific publications must be accurately reproduced with clearly identified sources.
Medical representatives must undergo training and possess sufficient scientific knowledge.
Drug samples may only be provided upon written request from authorized prescribers, limited to two samples of the smallest package per year per drug.
Samples must be labeled “FREE MEDICAL SAMPLE – NOT FOR SALE” and accompanied by the SmPC.
Offering gifts, monetary benefits, or profits to authorized prescribers is prohibited.

Medical Devices

Advertising of medical devices to healthcare professionals is governed by general advertising rules.

7. What is the required information for advertisements directed only at healthcare professionals?

7.1 Medicines

Must conform to the SmPC.
Must include issuance or update dates.
Scientific claims must be accurate and verifiable.

7.2 Medical Devices

General advertising rules apply.

8. What information must be included in public-facing advertisements?

8.1 Medicines

Clear identification that the product is a medicine and an advertisement.
Name of the medicine and active substance.
Essential information for correct use.
Clear instruction to read the package leaflet.
Traditional herbal medicinal products must include the statement: “Traditional herbal medicinal product for use in indications solely based on long-standing use.”
Advertising must align with the SmPC and promote rational use.
Misleading claims are prohibited.
Medical examination or treatment must not be portrayed as unnecessary.
Diagnosis or treatment through correspondence is prohibited.
Guarantees of effect, absence of side effects, or superiority claims are not allowed.
Advertisements must not suggest that health will deteriorate if the medicine is not used.

8.2 Medical Devices

Please refer to the rules outlined under public advertising restrictions for medical devices.

9. Are there constraints on data supporting promotional claims?

Data must be up-to-date.
Data must be identifiable by the average consumer.
Claims must be evidence-based and correctly sourced.

10. Are there rules governing comparative advertising?

Comparative advertising is allowed if it meets criteria under the Act on Advertisement.
Comparisons must be objective.
Products compared must be similar.
Characteristics must be verifiable.

11. Are there special guidelines for internet and social media advertising?

The same rules apply as for other advertising methods.

Prescription-only medicine information may be shared if it is complete and unmodified.

12. Which bodies oversee compliance and what are the legal consequences?

State Institute for Drug Control: Oversees medicine advertisements.
Trade Inspection: Oversees medical device advertisements.
Ministry of Health: Supervises medicine advertising compliance.
Council for Media Services: Supervises media advertisements.
Penalties include fines and advertising bans.

13. Are there any future developments in Slovakia?

No specific future developments are currently known.

How can OMC help?

Professional review of marketing and advertising materials with reports.
Services to obtain authority approvals where required.
Translation of marketing materials by a professional translation agency certified with ISO 17100.