Pharmaceutical advertising regulation and medical device advertising in the Czech Republic

1.1 Medicines

• Act No. 40/1995 Coll., on Advertising Regulation, as amended (Advertising Act)
• Act No. 378/2007 Coll., on Pharmaceuticals, as amended (Medicines Act)
• Act No. 89/2012 Coll., Civil Code, as amended (Civil Code)

1.2 Medical devices (including in vitro diagnostic medical devices)

• Advertising Act
• Civil Code
• Act No. 375/2022 Coll., on Medical Devices and In Vitro Diagnostic Medical Devices, as amended (Medical Devices Act) 
• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, the Medical Devices Regulation (MDR)
• Regulation (EU) 2017/746 of the European Parliament and of the Council, establishes the European Union framework for in vitro diagnostic medical devices regulation (IVDR)

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 (the European Federation of Pharmaceutical Industries and Associations), 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), which is a Czech member of MedTech Europe.

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 (i.e. a medicine with a valid marketing authorization) and medical devices (including in vitro diagnostic 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 

As set out above, Czech law sets out different rules for advertising of medicine to the general public and to the healthcare professionals. However, there are certain principles which apply in general for any medicine advertising: 

• only medicinal products with a valid marketing authorization may be advertised;
• the advertising must be consistent with the Summary of Product Characteristics (SmPC); and
• the advertising must encourage the rational use of the medicinal product by presenting the product objectively, without exaggerating its properties.

In addition, advertising of medicine must comply with general prohibitions of misleading and unfair commercial practices, including the prohibition of deceptive claims, omission of material information, and practices capable of misleading consumers as to the nature, purpose or performance of the product.

Specifically, with regards to the general public, the advertising of medicines must not:

• involve prescription-only medicines and medicines containing narcotic or psychotropic substances;
• 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 (except for vaccination campaigns 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, healthcare professionals or persons who are not, but who, because of their actual or anticipated social status, could encourage the consumption of medicines;
• indicate that the medicine is a foodstuff or cosmetic product or another consumer product;
• 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 case history, lead to a possible erroneous self-diagnosis;
• refer to recovery in an inappropriate, exaggerated or misleading manner;
• use inappropriate, exaggerated or misleading visual representations of changes in the human body caused by disease or injury or the effect of a medicine on the human body or parts thereof;
• contain any misleading claims regarding composition, therapeutic indications or effects;
• be misleading or create unrealistic expectations about the effects of the medicine;
• encourage its excessive use.

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

The provision of samples of medicines to the general public is prohibited.

5.2 Medical devices

Similarly to the medicine, Czech law sets out different rules for advertising of medical devices to the general public and to the healthcare professionals. However, there are certain principles which apply in general for any medical device advertising:

• only medical devices which can be placed on the market in line with MDR and IVDR can be subject to advertisement. Medical device which does not meet the requirements of the MDR / IVDR can be displayed at trade fairs, exhibitions, demonstrations, or similar events, provided that it is marked in accordance with the MDR / IVDR;
• advertising of medical devices reimbursed in full or in part by public health insurance in the form of a consumer competition based on the quantity of devices prescribed, dispensed, or used is prohibited; and
• advertising of medical devices must not refer in any way to specific public authorities.

In addition, advertising of medical devices must comply with general prohibitions of misleading and unfair commercial practices, including the prohibition of deceptive claims, omission of material information, and practices capable of misleading consumers as to the nature, purpose or performance of the device.

Any advertising must be consistent with the intended purpose of the medical device as defined by the manufacturer and approved under the Regulation MDR or Regulation IVDR. Advertising must not promote uses or indications beyond the device’s approved intended purpose.

As regards the advertising of medical devices  to the general public, the Advertising Act provides that an 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;
• be misleading or create unrealistic expectations about the performance or benefits of the medical device;
• encourage its excessive use.

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.

The same rules apply to advertising of medicine and medical devices on the internet or social media platforms.

6.1 Medicines 

As regards advertising activities towards healthcare professionals, the Advertising Act sets out largely parallel rules for medicinal products and medical devices, although the regime for medicinal products remains more detailed and stricter.

In general, it is prohibited to offer, promise or provide gifts or other benefits in connection with the advertising of medicinal products or medical devices, unless they are of negligible value and related to the professional activities of the healthcare professionals.

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
• at 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 professionals.

Healthcare professionals must not request or accept any of the above 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 authorized 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”.

Medicinal products containing narcotic and psychotropic substances must not be provided as samples. Samples of medicinal products for human use may only be provided upon a written, signed and dated request from the prescribing healthcare professional.

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

From the perspective of Czech law, several additional aspects should be taken into account:

• Interactions with healthcare professionals might also be assessed under the antibribery rules;
• Members of industry associations are subject to transparency and disclosure obligations (including disclosure of certain benefits provided to healthcare professionals) and are bound by self-regulatory codes that are often stricter than statutory rules, especially regarding hospitality limits, sponsorship and congress support.
• Since MDR and IVDR became fully applicable, supervisory authorities have been paying closer attention to whether promotional claims for medical devices are fully consistent with the device’s intended purpose and the underlying clinical evaluation documentation.
• The Czech supervisory authority, SIDC, has recently focused more closely on advertising addressed to healthcare professionals, especially in cases where promotional claims are “borderline” and could give the impression that the device has effects comparable to those of a medicinal product. Such claims may trigger increased regulatory scrutiny and potential enforcement action.

6.2 Medical devices (including in vitro diagnostic medical devices)

As set out above, the rules applicable to medicinal products under the Advertising Act largely apply to medical devices as well.

As regards samples of medical devices, these can be provided to healthcare professionals only in quantities necessary to allow them to test the medical device in accordance with its intended purpose. Each sample must be visibly labelled “Not for sale sample” or “Free sample”.

In addition, the provision of samples must not serve as an indirect financial incentive or circumvention of the prohibition on benefits. The quantity and frequency of supplied samples should be objectively justifiable and proportionate to the legitimate need for professional evaluation of the device.

Where advertising to professionals is intended as a reminder of a medical device, it shall not contain any information other than the name or trademark of the 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, safety and effectiveness of a particular medical device; data taken from professional publications or the trade press must be accurately reproduced and the source must be acknowledged. 

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, including dosage, method of administration, main contraindications, warnings, and potential side effects in a scope suitable for laypersons;
• contain a clear and, in the case of a printed advertisement, easily legible invitation to read carefully the package leaflet.

8.2 Medical devices (including in vitro diagnostic 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 substance of 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, the source of the information must be clearly indicated, the data must be accurately reproduced, and the interpretation must be consistent with the SmPC.

As regards the advertisement of medical devices, the law requires that with respect to professionals, the data must be sufficient, demonstrable, objective and scientifically valid to allow professionals to form an independent opinion on the clinical benefit, safety and efficacy of the medical device. 

Data taken from peer-reviewed publications or the trade press must be accurately reproduced and the source must be acknowledged, and promotional claims may not exaggerate the benefits or misrepresent the safety profile.

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

Comparative advertisement must fully comply with the approved summary of product characteristics (SmPC) for medicines, or with the intended purpose and safety information for medical devices, and may not include misleading, unverified, or promotional claims outside these limits. 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;
• if the comparison of medicines or medical devices is based on scientific evidence or data consistent with the SmPC (for medicines) or with peer-reviewed/validated clinical data (for medical devices); promotional claims must not extrapolate beyond these data;
• if any comparative claims are supported by sources that are accessible and verifiable, the references must be clearly indicated in the advertisement.

Same aforementioned rules apply to advertising on the Internet and other forms and carriers of advertising.

For prescription-only medicines, online advertising is permitted only if access is restricted to healthcare professionals authorised to prescribe or dispense these medicines. 

It is permitted to distribute information on prescription-only medicines, provided that this information is:

• accessible only to healthcare professionals;
• represented by a depiction of packaging, and
• includes full-scope and accurate information from the leaflet or summary of the product characteristic (SmPC) as approved in the marketing authorization.

It is prohibited to advertise medicines online with information modified solely 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).

Access to advertising aimed at the professional public must be ensured in such a way that it is primarily visited by professionals. This may include requiring visitors to declare their professional status and acknowledging the definition of a healthcare professional, while providing appropriate warnings regarding the risks for persons who are not professionals when accessing a site intended primarily for professionals.

Similar rules apply for the advertisement of medical devices.

In the Czech Republic, the State Institute for Drug Control (SIDC) is the primary supervisory body responsible for monitoring the advertising of medicines and medical devices in compliance with the Advertising Act, with the exception of advertising done via TV or radio broadcast, which falls under the competence of the Council for Radio and Television Broadcasting (RRTV).

The SIDC has the authority to impose administrative fines of up to CZK 5,000,000 (approx. EUR 190,000) for non-compliance. In addition, the SIDC can issue warnings, require the cessation of misleading or unlawful advertising.

In extreme cases, criminal liability may also apply for offences such as endangering public health or misleading consumers.

SIDC may conduct inspections or request documentation to verify advertising practices.

Discussions are currently underway regarding potential changes to advertising regulations. Although the legislative process began last year, a change of government in the interim has made it challenging to anticipate the future direction of the amendment. The current Minister of Health has expressed the view that an update to the advertising framework is necessary and has indicated his willingness to support such reforms. The proposed changes are expected to focus primarily on improving the quality and clarity of information about medicines and medical devices communicated to patients. In addition, there are ongoing initiatives at the EU level, such as the proposed regulations on green claims and environmental sustainability marketing, which could indirectly affect advertising practices of pharmaceutical and medtech companies.