Pharmaceutical advertising regulation and medical device advertising in Slovakia

• The primary legal source is Act No. 147/2001 Coll. on Advertisement, as amended (“Act on Advertisement”), in which the relevant provisions of Directive 2006/114/EC on misleading and comparative advertising and Directive 2001/83/EC establishing a Community code relating to medicinal products for human use are implemented;
• Act No. 264/2022 Coll. on media services and on amendment and supplementation of certain laws (Media Services Act) (“Act on Media Services”) regarding advertising of medicines via  media services in commercial communication;
• Act No. 362/2011 Coll. on Drugs and Medical Devices, as amended (“Act on Medicine”);
• Act No. 187/2021 Coll. On Protection of Competition, as amended;
• Act No. 250/2007 Coll. on Consumer Protection, as amended. 

Yes, the main codes of conducts are the following (note: the list is not exhaustive): 

• EFPIA Code – EU pharmaceutical regulatory law, which represents a collection of ethical rules agreed by EFPIA members for the Promotion of Medicinal Products to HCPs and the interactions with HCPs, HCOs and POs, with the intent of guaranteeing that these activities are conducted while respecting the most stringent ethical principles of professionalism and responsibility. This code applies to all types of communication and interaction (traditional and digital);
• Ethical code of the Pharmaceutical Industry of the Slovak Republic issued by Association of Drug and Health Device Suppliers – main role is to ensure compliance with high standards of medicine and medical devices advertising in general;
• Ethical code of Association of Innovative Pharmaceutical Industry;
• Ethical code of Advertising issued by the Advertising Standards Council– self-regulatory code which lists the ethical principles of advertising in general. 

There are no specific rules for the licensing of advertisement of medicines and medical devices to the general public or healthcare professionals. 

The relevant Slovak regulation stipulates the stricter provisions concerning the advertising of the medicines to the healthcare professionals and general public. 

The medical representative who advertises medicine to healthcare professionals must have professional training and sufficient scientific information in order to provide the most accurate and complete information regarding the advertised medicine. Such training must be arranged by the holder of decision on registration of respective medicine. 

The relevant entities specified in the Act on Medicines are subject to several notification obligations in relation to funds spent on marketing, advertisement, non-monetary considerations, scientific or other educational events.  

Yes. The distinction plays an important role regarding advertisements that are addressed to the general public: while advertising of non-prescription medicines to the general public is permitted under certain conditions, advertising of prescription medicines to the general public is generally prohibited. 

5.1 Medicines 

The advertisement of medication not registered in the Slovak Republic, containing narcotic, psychotropic drugs or supplements, prescription-only and non-prescription medicines covered by health insurance is prohibited, with exception of vaccination campaigns allowed by the Ministry of Health of the Slovak Republic and advertisement towards persons authorised to prescribe medication and issue medicine. 

In general, advertisement of medicine must not be deceptive or obfuscatory, must encourage rational usage of the medicine by providing objective information on characteristics of the medicine and must comply with data stipulated in the SmPC. 

In addition to the above, several restrictions apply to the content of advertising to the general public, the most significant ones being (a complete list can be found in § 8 of the Act on Advertisement): 

• Advertised medication must be unambiguously identified, and it must be obvious that it’s an advertisement and that it is an advertisement for medical product;
• An advertisement must include the name of the medication as well as the name of the medicament, necessary information about correct usage of medication, expressed and comprehensible request for careful reading of the written information for users;
• An advertisement must not include any information that would, for instance: (i) induce the impression that medical examination or medical surgery is unnecessary, (ii) offer determination of diagnosis or method of treatment via correspondence; iii) give the impression that the effects of the medicine are guaranteed, without any side effects; iv) suggests that the good health of a person could be improved by taking the medicine, v) suggests that the good health of a person could be affected by not taking the medicine; vi) is addressed exclusively or mainly to children, vii) contains recommendations from scientists, healthcare professionals, or celebrities, whose popularity could encourage the consumption of medicines; etc.
• An advertisement must include following text: "Traditional herbal medicine intended for indications verified exclusively by long-term use", if the subject of the advertisement is a traditional herbal medicine.
•  An advertisement must not be focused exclusively on children etc. 

5.2 Medical devices 

Only general rules of advertising as stipulated in the Act on Advertisement apply to the advertising of medical devices (i.e. the advertisement must comply with competition rules, advertisement shall not endanger mental and physical health of people or promote violence etc.). Further, also general rules of codes of conduct listed in our answer to Question 2 must be observed (i.e. advertisement must include the name of medical device, advertising of medical devices shall not include data which could lead to false self-assessment of health condition etc.).

6.1 Medicines 

All essential information must be in conformity with the SmPC and the medication must be classified according to the output mode. Further, the advertisement must include the date of issuance or the date of updating thereof. The documentation, as a part of the medication advertisement, must include accurate and up to date information, which is verifiable and sufficient enough for the addressee to come to their own opinion about the therapeutic value of medication. Price offerings, charts or any other materials used for illustration purposes taken over from medical publications, or other scientific resources used in documentation must be truthfully reproduces and true and exact sources must be identified. 

The medical representative must undergo training and must have sufficient scientific knowledge to be able to provide the most accurate and complete information about the drug they are promoting. 

Drug samples can be provided by the holder of the drug registration decision only upon written request to a person authorized to prescribe drugs, and only to the extent of two samples of the smallest packaging of the registered drug per year, labeled "FREE MEDICAL SAMPLE - NOT FOR SALE," and accompanied by a summary of the product characteristics. 

The Act on Advertisement further prohibits offering or any kind of gifts, monetary benefits or profits to the person authorised to prescribe or issue medication. Several other restrictions also apply to provision of samples of medicine and organisation of promotional events. 

6.2 Medical devices 

Only general rules on advertising apply to the advertising of medical devices (please see our answers to question 4 above). 

7.1 Medicines 

Please see our answer in point 6.1 above. 

7.2 Medical devices 

Only general rules on advertising apply to the advertising of medical devices (please see our answers to Question 4 above).

8.1 Medicines 

Advertised medication must be unambiguously identified, and it must be obvious that it’s an advertisement. Advertisement must include the name of medication as well as the name of the medicament, necessary information about correct usage of medication, expressed and comprehensible request for careful reading of the written information for users.

In more detail, advertising in general

1. must be consistent in every part with the data stated in the summary of product characteristics,
2. must promote the rational use of the drug by objectively informing about the drug's characteristics without exaggerating,
3. must not be misleading.

Further, any advertisement of drugs intended for the public must

1. be compiled in such a way as to make it clear that the information is an advertisement and to clearly identify the product being advertised as a medicine,
2. contain the name of the drug and the name of the active substance,
3. essential information for proper use,
4. an explicit and understandable invitation to carefully read the instructions for proper use of the drug contained in the written information for drug users, which is included with the drug,
5. the text: 'Traditional herbal medicinal product for use in indications solely based on long-standing use,' if the advertisement is for a traditional herbal medicinal product."

In more detail, it is prohibited for advertising of medicines intended to the general public to:

1. give the impression that medical examination or treatment is unnecessary,
2. offer diagnosis or treatment by correspondence,
3. give the impression that the effects of the medicine are guaranteed and are not accompanied by any side effects, or are better or the same as the effects of another medicine or treatment,
4. suggests that the good health status of a person could be affected by not taking the medicine; etc. 

8.2 Medical devices 

Please see our answers to Question 4 above. 

Scientific data used in the advertisement must be up-to-date, clearly identifiable by the average customer mostly by stating the source and relevant time information. All the information must be evidence-based. 

In general, comparative advertising is admissible if it complies with list of restrictions stipulated in the Act on Advertisement (e.g. it is not deceptive, does not cause confusion between companies, compares products or services, which satisfy the same needs or are used for the same purpose etc.). 

The comparative advertisement is allowed in advertisements for the general public as well as for healthcare professionals. The advertisement must objectively compare products used for the same purposes or needs and at the same time compare at least one of specific, typical, essential and verifiable characteristics of products (medications). The price can be the subject of comparison as well. We recommend to review the statutory list for compliance check of the comparative advertisement rules before any commencement of such type of advertisement. 

There are no specific rules for advertisement of medicines and medical devices on the internet/in social media posting. The same restrictions must be applied as in the case of any other advertising method. The codes of conduct listed in our answer to Question 2 must be observed. 

According to the statement of the State Institute for Drug Control, 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. Any other modification or selection of data shall be considered as promotion of the medicinal product. 

Additionally, A hyperlink is a reference in the advertising text to another information source. The referenced sources are part of the advertising content and can be used only if they meet the requirements of the Act on advertisement.

Monitoring of compliance in the advertisement of medicine and medical devices sector is carried out by several public bodies, which include: 

• The State Institute for Drug Control supervise the advertisement of medications pursuant to the Act on Advertisement. The State Institute for Drug Control reviews the propagation of advertising based on notifications of medication advertisements, delivered by the propagator along with the information of target group and the commencement date of the advertising campaign.
• The Trade Inspection should supervise the advertising of medical devices.
• Penalties include prohibition of advertising and a monetary penalty amounting up to EUR 166 000 for medicine and up to EUR 99 600 for medical devices.
• Further, the Ministry of Health also supervises compliance with respective provisions of the Act on Medicine (some of these also briefly touch upon the subject of advertising). If the Ministry of Health identifies breaches, it may impose a fine amounting to up to EUR 25 000.
• Moreover, the Council for Media Services supervises the media. advertisement, among the sanctions it may impose include a fine or a broadcast of a notification on its breach of law etc. 

At the moment, we are not aware of any specific future developments concerning regulation of advertisement of medicines or medical devices in the Slovak Republic.