Pharmaceutical advertising regulation and medical device advertising in Slovakia

  1. 1. Which laws are applicable regarding advertising of medicines and medical devices?
  2. 2. Are there any other legal regimes such as self-regulatory codes of conduct that govern the advertising of medicines and medical devices?
  3. 3. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?
  4. 4. Does the law in Slovakia regulate the advertising of prescription-only and over-the-counter medicines differently?
  5. 5. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?
  6. 6. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?
  7. 7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?
  8. 8. What information must appear in advertisements directed to the general public for medicines and medical devices?
  9. 9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?
  10. 10. Are there specific rules for comparative advertisement of medicines and medical devices?
  11. 11. Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?
  12. 12. Please describe the enforcement mechanism. Which bodies monitor compliance with the advertisement provisions and what are the legal consequences (e.g. penalties) for non-compliance?
  13. 13. Any future developments in Slovakia?

1. Which laws are applicable regarding advertising of medicines and medical devices?

  • The primary legal source is Act No. 147/2001 Coll. on Advertisement, as amended (“Act on Advertisement”);
  • Act No. 308/2000 Coll. On Broadcasting and Retransmission, as amended (“Act on Broadcasting”);
  •  Act No. 362/2011 Coll. on Drugs and Medical Devices, as amended (“Act on Medicine”);
  • Act No. 136/2001 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.

3. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?

3.1 The general public

There are no specific rules for the licencing of advertisement of medicines and medical devices to the general public.

3.2 Healthcare professionals

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. Further, the holder of the decision on registration of medicine must make available a sample of any advertisement produced by his business alongside with declaration on persons it is designated for and date of the beginning of its usage.

Moreover, the holders of decision on registration of medicine are obliged to notify the Ministry of Health on the amount of expenses spent for marketing, advertisement and non-monetary considerations provided to providers of healthcare services. Furthermore, the holders of decision on registration of medicine must notify the National Health Information Centre on healthcare professionals who attended scientific or other educational events funded by the persons advertising their product.

4. Does the law in Slovakia regulate the advertising of prescription-only and over-the-counter medicines differently?

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. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?

5.1 Medicines

The advertisement of medication not registered in the Slovak Republic, containing narcotic, psychotropic drugs or supplements, prescription-only and over-the-counter 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;
  • 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: (i) induce the impression that medical examination or medical surgery is unnecessary, (ii) offer determination of diagnosis or method of treatment via correspondence;
  • 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. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?

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 Act on Advertisement prohibits offering or any kind of gifts, monetary benefits or profits to the person authorised to prescribe or issue medication. Further several restrictions also apply to provision of samples of medicine and organisation of scientific 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. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?

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. What information must appear in advertisements directed to the general public for medicines and medical devices?

8.1 Medicines

Advertised medication must be unambiguously identified, and it must be obvious that it’s an advertisement. Further, 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.

8.2 Medical devices

Please see our answers to Question 4 above.

9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?

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.

10. Are there specific rules for comparative advertisement of medicines and medical devices?

In general, comparative advertising is admissible if it complies with 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.

11. Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?

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.

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.

Penalties include prohibition of advertising and a monetary penalty amounting up to EUR 166 000.

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 Broadcasting and Retransmission supervises the broadcasted advertisement, among the sanctions it may impose include a fine or a broadcast of a notification on its breach of law etc.

13. Any future developments in Slovakia?

The EU Medical Device Regulation 745/2017 will come into force in May 2021; it contains advertising-related provisions.

Portrait of Petra Čorba Stark
Petra Čorba Stark
Partner
Bratislava
Portrait of Soňa Hanková
Soňa Hanková
Partner
Bratislava