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 are applicable laws regarding advertising of medicines and medical devices in the Czech Republic?

In the Czech Republic, the primary legal frameworks governing the advertising of medicines and medical devices are:

• Act No. 40/1995 Coll., on the Regulation of Advertising (the “Advertising Act”): This law regulates all forms of advertising, including those for medicines and medical devices.
• Act No. 89/2012 Coll., the Civil Code (the “Civil Code”): This law includes provisions relevant to advertising practices, ensuring that they comply with general civil law principles.

2. Are there any self-regulatory codes of conduct?

State Institute for Drug Control (SIDC)

The SIDC provides additional instructions and explanations detailing the rules set out in the Advertising Act, offering more specific guidance on compliance.

Industry Associations and Codes of Conduct

2.1 Medicines

• Association of Innovative Pharmaceutical Industry (AIFP): This association is the Czech member of the European Federation of Pharmaceutical Industries and Associations (EFPIA). It sets out internal codes of conduct for its members, focusing on ethical advertising practices.
• Czech Association of Pharmaceutical Companies: This association represents generic and biosimilar pharmaceutical companies in the Czech Republic and is a member of Medicines for Europe. It also provides its members with internal guidelines for advertising.

2.2 Medical Devices

• Czech Association of Suppliers of Medical Devices (CzechMed): This association is the Czech member of MedTech Europe and provides a code of conduct for its members, ensuring ethical promotion of medical devices.

3. What are the Licenses/Approvals/Fees for advertising medicines and medical devices?

There are no specific licenses, approvals, or fees required for advertising medicines or medical devices to either the general public or healthcare professionals in the Czech Republic.

General Requirements:

Only registered medicines and medical devices that meet the requirements of respective European legislation can be advertised.

4. What is the difference in regulation: prescription-only vs. over-the-counter medicines?

Prescription-only Medicines

• General Public: Advertising prescription-only medicines to the general public is prohibited.
• Healthcare Professionals: Advertising to healthcare professionals is permitted for all registered medicines, including prescription-only medicines.

Over-the-Counter Medicines

• General Public: Advertising is permitted for OTC medicines that do not contain narcotic or psychotropic substances.
• Healthcare Professionals: Advertising is allowed for both OTC and prescription-only medicines.

5. What are the restrictions on advertising medicines and medical devices to the general public?

5.1 Medicines

Prohibitions

• Prescription-only medicines cannot be advertised to the general public.
• Medicines containing narcotic or psychotropic substances cannot be advertised.
• Providing samples of medicines to the general public is prohibited.

Content Restrictions

• Advertisements must not suggest that consulting a doctor or undergoing medical treatment is unnecessary, nor offer diagnoses or treatments at a distance.
• Claims that the effects of the medicine are guaranteed, without side effects, or superior to other treatments are prohibited.
• Advertisements must not imply that using the medicine will improve health or that not using it will adversely affect health, except for approved vaccination campaigns.
• Advertising must not target individuals under 15 years of age exclusively.
• Recommendations by scientists, health professionals, or other influential persons are not allowed.
• Advertisements must not suggest that a medicine is a food, cosmetic product, or another consumer good.
• Claims must not imply that safety or efficacy is guaranteed solely due to natural origin.
• Specific case descriptions that could lead to self-diagnosis are not allowed.
• Advertisements must not exaggerate or mislead regarding the potential for healing.
• Inappropriate, exaggerated, or misleading depictions of changes in the human body caused by disease or the effect of the medicine are prohibited.

Reminder Advertisements

• These must contain only the name of the medicine as per the marketing authorization, its international non-proprietary name, or trademark.

5.2 Medical Devices

Content Restrictions

• Advertisements must not suggest that medical advice, intervention, or treatment is unnecessary, nor offer diagnoses or treatments at a distance.
• Claims that the clinical effectiveness of a device is guaranteed or superior to other treatments or devices, or that use of the device is risk-free, are prohibited.
• Advertisements must not imply that health will suffer without using the device.
• Advertising must not be directed exclusively at individuals under 15 years of age.
• Recommendations by scientists, health professionals, or other influential persons are not allowed.
• Claims about the performance of clinical trials as a basis for marketing the device are not allowed.
• Advertising must not imply that safety or efficacy is guaranteed solely due to natural origin.
• Specific case descriptions that could lead to misdiagnosis are not allowed.
• Advertisements must not exaggerate or mislead regarding the potential for cure.
• Inappropriate, exaggerated, or misleading depictions of changes in the human body caused by disease or the effect of the device are prohibited.

Reminder Advertisements

• These must contain only the name of the medical device or its trademark.

Authority References

• Advertisements must not refer in any way to specific public authorities.

6. Which are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?

6.1 Medicines

Prohibitions

• Offering, promising, or providing gifts or benefits is prohibited unless they are of negligible value and related to professional activities.
• Hospitality and accommodation provided during professional or scientific meetings must be proportionate and secondary to the main purpose of the meeting.
• Healthcare professionals must not seek or accept prohibited benefits.

Sample Provision

• Samples of medicinal products can be provided only in exceptional cases and must be limited to the smallest package.
• Samples must be marked “Not for sale” or “Free sample”.
• Samples containing narcotic and psychotropic substances are not permitted.
• Samples can only be provided upon a written request from the prescribing healthcare professional, signed and dated.

Reminder Advertisements

• These must contain only the name or trademark of the medicine.

6.2 Medical Devices

Prohibitions and Requirements

• Offering, promising, or providing gifts or benefits is prohibited unless they are of negligible value and related to professional activities.
• Hospitality and accommodation provided during professional or scientific meetings must be proportionate and secondary to the main purpose of the meeting.
• Healthcare professionals must not seek or accept prohibited benefits.

Sample Provision

• Samples of medical devices can be provided only in quantities necessary for testing the device according to its intended use.
• Samples must be labeled “Not for sale sample” or “Free sample”.

Reminder Advertisements

• These must contain only the name or trademark of the medical device.

Authority References

• Advertisements must not refer in any way to specific public authorities.

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

7.1 Medicines

• Accurate, up-to-date, verifiable, and complete data to enable professionals to form their own views on the therapeutic value of a medicine.
• Essential information according to the approved summary of product characteristics, including the date of approval or last revision.
• Information on the method of dispensing the medicine pursuant to the marketing authorization.
• Information on reimbursement from public health insurance funds.
• A summary of the product characteristics and pricing information provided by sales representatives during visits.

7.2 Medical Devices

• Sufficient, verifiable, and objective data to enable professionals to form their own opinion on the clinical merits, safety, and effectiveness of a medical device.
• Accurate reproduction of data taken from professional publications or the trade press, with the source acknowledged.

8. What are the advertising requirements for medicines and medical devices?

8.1 Medicines

Product Identification

• The advertisement must clearly indicate that the product is a human medicinal product.
• The name of the medicine as specified in the marketing authorization must be included. If the medicine contains only one active substance, the common name of that substance must also be included.

Usage Information

• Essential information for the correct use of the medicine must be provided.

Invitation to Read

• A clear and easily legible invitation to read the package leaflet carefully must be included in printed advertisements.

8.2 Medical Devices

Product Identification

• The advertisement must clearly indicate that the product is a medical device.
• The trade name of the medical device must be included.

Intended Purpose

• The advertisement must state the substance of the intended purpose of the medical device.

Invitation to Read

• A clear and easily legible invitation to read the instructions for use and the information relating to the safe use of the medical device must be included, where such instructions are required to be enclosed with the device.

9. What are the requirements for scientific data in advertisements for medicinal and medical device products?

9.1 Medicines

• All information in the advertisement must be consistent with the summary of product characteristics.
• Results from clinical trials included in the summary of product characteristics or that confirm or specify its information can be included.
• For healthcare professionals, advertisements can include information from scientific publications, provided the source is cited, and the information aligns with the summary of product characteristics.

9.2 Medical Devices

• Advertisements to healthcare professionals must include sufficient, demonstrable, and objective data to form an opinion on the clinical benefit, safety, and efficacy of a medical device.
• Data from peer-reviewed publications or the trade press must be accurately reproduced with the source acknowledged.

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

Permissible Audience

Comparative advertising is permitted only if directed to healthcare professionals who are authorized to prescribe or dispense the products.

General Conditions

• The comparison must not be misleading.
• It must compare goods or services that satisfy the same need or are intended for the same purpose.
• The comparison must be objective, covering one or more relevant, important, verifiable, and typical properties of the goods or services, including price.
• It must not disparage a competitor or unfairly benefit from their reputation.
• The advertisement must not suggest the goods or services are an imitation or copy of those identified by a competitor’s trademark or name.

11. How to advertise medicines and medical devices on the internet and social media?

The same rules apply to advertising on the internet and social media as in other media. Additionally:

Access Restrictions for Prescription-only Medicines

• Information on prescription-only medicines must be accessible only to those who seek it and must include a depiction of packaging and full, accurate information from the leaflet or summary of product characteristics.

No Modifications for Promotion

• It is prohibited to modify information for promotional purposes online.

Access for Professional Audiences

• Access to advertisements aimed at healthcare professionals must ensure that only professionals, or those acknowledging they are professionals and aware of associated risks, can view them.

12. Which are the enforcement mechanisms and legal consequences?

Supervisory Body

The State Institute for Drug Control (SIDC) is the primary body overseeing compliance with advertising regulations for medicines and medical devices, except for TV and radio broadcasts.

Penalties

The SIDC can impose financial penalties up to CZK 5,000,000 (approximately EUR 190,000) for non-compliance.

In extreme cases, criminal liability may arise.

13. Are there any future developments in Czech Republic?

There are no specific future developments regarding the regulation of advertisements for medicines and medical devices in the Czech Republic at the moment.

However, an EU-level initiative concerning green claims may impact advertising activities for pharmaceutical and medical technology companies.

How can OMC help?

• OMC offers professional review of your 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.