Pharmaceutical advertising regulation and medical device advertising in the Czech Republic

The main law applicable for advertising in general, inclusive for medicines and medical devices, is Act No. 40/1995 Coll., on the Regulation of Advertising, as amended (the “Advertising Act”) and Act No. 89/2012 Coll., the Civil Code, as amended (the “Civil Code”).

In addition to the above legal regulations, the State Institute for Drug Control (“SIDC”) issues instructions / explanations which provide more details of the rules set out in law.

There are also several associations which associate manufacturers / suppliers of medicines or medical devices. Such associations usually have their internal codes of conduct which are binding upon the members of such associations.

2.1 Medicines

In relation to medicines, the most active in the Czech Republic are the Association of Innovative Pharmaceutical Industry (AIFP), which is a Czech member of EFPIA, and Czech Association of Pharmaceutical Companies, which is a member of Medicines for Europe and associates generic and biosimilar pharma companies in the Czech Republic.

2.2 Medical devices

In relation to medical devices , the most active in the Czech Republic is Czech Association of Suppliers of Medical Devices (CzechMed). 

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

In general, only a registered medicine and medical devices which fulfil requirements of the respective European legislation can be subject to advertisement in the Czech Republic.

Yes, the law in the Czech Republic regulates the advertising of prescription-only and over-the-counter medicines differently.

The main distinction is that in relation to a general public, only the over-the-counter-medicines (which do not contain narcotic or psychotropic substance) can be advertised.

In relation to the healthcare professional, all registered medicines, i.e. including both over-the-counter and prescription-only medicines, can be advertised.

5.1 Medicines

Advertising of medicines to the general public must not involve prescription-only medicines and medicines containing narcotic or psychotropic substances. The provision of samples of medicines to the general public shall be prohibited.

Furthermore, advertising of medicines aimed at the general public must not:

• give an impression that consultation with a doctor, medical intervention or treatment is unnecessary, in particular, by offering diagnosis or distance treatment,
• indicate that the effects of the administration of the relevant medicine are guaranteed, not associated with undesirable effects or are better or equivalent to those of another treatment or other medicine;
• imply that the use of a medicine will improve the health of the person using it;
• imply that the non-use of a medicine may adversely affect the health of persons, with the exception of vaccination actions approved by the Ministry of Health;
• be aimed exclusively at persons under the age of 15;
• recommend a medicine by reference to the advice of scientists, health professionals or persons who are not, but who, by virtue of their actual or anticipated social status, could encourage the consumption of medicines;
• indicate that the medicine is a food or cosmetic product or another consumer good;
• imply that the safety or efficacy of the medicine is only guaranteed because of its natural origin;
• by describing or describing in detail the specific course of a particular case, lead to a possible erroneous self-diagnosis;
• point out the possibility of healing in an inappropriate, excessive or misleading manner;
• use in an inappropriate, exaggerated or misleading way a representation of changes in the human body caused by a disease or injury or the effect of a medicine on the human body or parts thereof.

Where advertising to the general public is intended as a reminder of a medicine, it shall not contain any information other than the name of the medicine as specified in the marketing authorisation, or its international non-proprietary name or trademark.

5.2 Medical devices

With the effectiveness as of 26 May 2021, Czech law regulates advertising of medical devices similarly to the regulation of medicine. As regards the advertising of medical devices (including in vitro diagnostic medical devices) to the general public, the Advertising Act sets out that the advertisement must not: 

• give the impression that medical advice, intervention or treatment is not necessary, especially by offering a diagnosis or offering treatment at a distance;
• imply that the clinical effectiveness of a medical device is guaranteed, superior or equivalent to that of another treatment or another medical, or that the use of the medical device is not associated with risks;
• suggest that the health of persons may be adversely affected by the non-use of a medical device;
• be directed exclusively at persons under 15 years of age;
• recommend a medical device with reference to the recommendations of scientists, medical professionals or persons who are not such professionals but who, by virtue of their actual or presumed social status, could support the use of the medical device;
• refer to the performance of clinical trials or other processes that are a condition for the placing on the market of a medical device;
• imply that the safety or efficacy of a medical device is guaranteed only by its natural origin;
• lead to possible misdiagnosis by describing or detailing the specific course of a particular case;
• imply in an inappropriate, exaggerated or misleading manner the possibility of cure;
• use inappropriate, exaggerated or misleading representations of changes to the human body caused by disease or injury or by the action of a medical device on the human body or parts thereof.

Where advertising to the general public is intended as a reminder of a medical device, it shall not contain any information other than the name of the medical device or its trademark. 

Advertising for medical devices must not refer in any way to specific public authorities.

6.1 Medicines

As regards advertising activities towards healthcare professionals, the Advertising Act sets out similar rules for medicines and medical devices. In general, it is prohibited to offer, promise or provide gifts or other benefits, unless they are of negligible value and are related to the professional activities they carry out. 

The extent of the free hospitality and accommodation provided:

• at a meeting attended by experts to promote the prescription, sale, supply or consumption or use of medicines and medical devices, or a meeting of experts held for professional or scientific purposes, must be proportionate, secondary to the main purpose of the meeting, and not extend to persons other than the healthcare professional.

6.2 Medical devices

Healthcare professionals shall not seek or accept any of the aforementioned prohibited benefits in connection with advertising of any medicine or medical device.

Samples of medicinal products for human use may only be provided in exceptional cases to persons authorised to prescribe them, in a limited number per calendar year, each sample shall correspond to the smallest package of medicine and marked “Not for sale” or “Free sample”. Preparations containing narcotic and psychotropic substances must not be provided. Samples of medicinal products for human use may only be provided at the written request of the prescribing person, signed and dated.

Samples of medical devices can be provided to healthcare professionals only in the quantities necessary to test the medical device in accordance with the intended purpose of use. The sample of the medical device needs to be visibly labelled “Not for sale sample” or “Free sample”. 

Where advertising to professionals is intended as a reminder of a medicine or a medical device, it shall not contain any information other than the name or trademark of the medicine or medical device.

Advertising for medical devices must not refer in any way to specific public authorities.

7.1 Medicines

The advertisement of medicines directed only to healthcare professionals shall contain:

• accurate, up-to-date, verifiable and sufficiently complete data to enable professionals to form their own views on the therapeutic value of a medicine. Data taken from professional publications or professional publications must be accurately reproduced and their source indicated;
• 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 authorisation;
• information on the method of reimbursement from public health insurance funds.

The sales representative must, at each visit made to advertise a medicine, provide the healthcare professional with a summary of the product characteristics of each medicine advertised and information on the pricing of these medicines.

7.2 Medical devices

The advertisement of medical devices directed only to healthcare professionals shall contain:

• sufficient, verifiable and objective data to enable professionals to form their own opinion on the clinical merits of a particular medical device; data taken from professional publications or the trade press must be accurately reproduced and the source must be acknowledged;
• essential information contained in the instructions for use of the medical device, if it must be enclosed to the device.

8.1 Medicines

The advertisement of medicines directed to the general public must:

• be formulated in such a way as to make it clear that the product is a human medicinal product;
• contain the name of the medicine as specified in the marketing authorisation. If a medicine contains only one active substance, the advertising shall include the common name of that medicinal product;
• contain the information necessary for the correct use of the medicine;
• contain a clear and, in the case of a printed advertisement, easily legible invitation to read carefully the package leaflet.

8.2 Medical devices

The advertisement of medical devices directed to the general public must:

• be formulated in such a way as to make it clear that the product is a medical device;
• contain the trade name of the medical device;
• state the intended purpose of the medical device; and
• contain a clear and, in the case of a printed advertisement, easily legible invitation to read carefully the instructions for use of the medical device and the information relating to its safe use, where they are required to be enclosed to the medical device.

See response to question 7.

All information included in the advertisement of medicine must be in compliance with the information in the summary of product characteristics. Within the advertisement, it is only possible to include results of clinical trials, which were taken into account in the summary of product characteristics or if they confirm or precise the information in the summary of product characteristics.

In the advertisement of medicines towards healthcare professionals, it is possible to include information from scientific publications. In such a case it is necessary to include the source of such information and the information must be in line with the summary of product characteristics.

Comparative advertisement of medicines and medical devices is permitted only if it is directed to healthcare professionals who are authorised to prescribe or dispense them.

There are no other specific rules for comparative advertisement of medicines and medical devices. The general provisions applicable under the Civil Code shall apply.

Comparative advertising is permitted in terms of making comparisons in the following cases:

• if it is not misleading;
• if it only compares goods or services which satisfy the same need or which are intended for the same purpose;
• if it objectively compares one or several relevant, important, verifiable and typical properties of goods or services, including price;
• if it compares goods with a designation of origin only to goods of the same designation;
• if it does not disparage a competitor, its position, its activities or its results, or their identification, or unfairly benefits therefrom; and
• if it does not offer goods or services as an imitation or copy of goods or services identified by a trademark of a competitor or by the competitor’s name.

Same aforementioned rules apply to advertising on the Internet and other forms and carriers of advertising. In addition, it is permitted to distribute information on prescription-only medicines, provided that this information is accessible only to those who seek it and such advertised medicine is represented by a depiction of packaging and full-scope and accurate information from the leaflet or summary of the product characteristic as agreed in the process in the process of registration.

It is prohibited to advertise medicines online with information modified only for promotional purposes. This position was also confirmed by the judgment of the ECJ in Case C-316/09 (MSD Sharp & Dohme GmbH v Merckle GmbH).

With the exception of the above, it is necessary to ensure access to advertising aimed at the professional public in such a way as to ensure that they are mainly visited by professionals, at least by declaring that they are professionals, by acknowledging the definition of a professional and by acknowledging the risks to which a person other than a professional is exposed when accessing a website intended primarily for professionals. 

Similar rules apply for the advertisement of medical devices.

The “SIDC” is the supervisory body for the advertising of medicines and medical devices in compliance with the Advertising Act (with the exception of advertising done via TV or radio broadcast). 

The SIDC may impose a financial sanction up to CZK 5,000,000 (approx. EUR 190,000) for non-compliance.

In extreme cases, criminal law liability may also arise. 

At the moment, we are not aware of any specific future developments concerning regulation of advertisement of medicines or medical devices in the Czech Republic. However, there is an initiative on the EU level concerning green claims which may have impact on advertising activities of pharma and medtech companies