Pharmaceutical advertising regulation and medical device advertising in Slovenia

1.1 Medicines 

• Medicinal Products Act (Zakon o zdravilih)
• Rules on Advertising of Medicines (Pravilnik o oglaševanju zdravil) 

1.2 Medical devices 

• Medical Devices Act (Zakon o medicinskih pripomočkih)
• Rules on Medical Devices (Pravilnik o medicinskih pripomočkih) 

Yes. The main codes in this area are: 

2.1 Medicines 

• The Slovene Code of Medical Ethics (Kodeks zdravniške etike),
• The Code on Cooperation with Healthcare Professionals (Kodeks sodelovanja z zdravstvenimi delavci), the Disclosure code (Kodeks transparentnosti) and
• The Patient Organization Code (Kodeks sodelovanja z združenji bolnikov). 

In 2019, these codes have been merged at a European level into the European Federation of Pharmaceutical Industries and Associations (“ EFPIA”) Code. This change is yet to be reflected in Slovenia. 

The following codes are applicable to advertising of both medicines and medical devices: 

• The Slovene Advertising Code (Slovenski oglaševalski kodeks)
• The Ethical Code of Collaboration between Doctors, The Pharmaceutical Industry and Companies Active in Healthcare (Etični kodeks sodelovanja med zdravniki, farmacevtsko industrijo in podjetji, ki sodelujejo na področju zdravstva). 

No national code exists, however the MedTech Europe Code of Ethical Business Practice applies. The following codes are applicable to advertising of both medicines and medical devices:

• The Slovene Advertising Code (Slovenski oglaševalski kodeks)
• The Ethical Code of Collaboration between Doctors, The Pharmaceutical Industry and Companies Active in Healthcare (Etični kodeks sodelovanja med zdravniki, farmacevtsko industrijo in podjetji, ki sodelujejo na področju zdravstva). 

In the case of medicines, advertising can only be carried out by holders of marketing authorisations for medicines, which need to be obtained from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (“ JAZMP”). 

Marketing authorisation holders must, prior to the commencement of the advertising of medicines, notify the JAZMP of medical sales representatives for the advertising of medicines. The medical sales representatives must be entered into a register with the JAZMP. This applies both to advertising to the general public and to healthcare professionals. 

For the purposes of the EU Reg 2017/745, different types of medical devices are assorted into their corresponding categories. Within each of these categories, a correspondent regulatory framework is in place for the advertising of medical devices. Irrespective of the category to which they pertain, all medical devices must be affixed with a CE marking prior to being advertised. 

Yes, different regimes apply for prescription-only and over-the-counter medicines. 

Any medicinal product that is covered by a marketing authorisation may be advertised to healthcare professionals (healthcare professionals are persons, authorised to prescribe medicines). 

Advertising of prescription-only medicines is allowed only to healthcare professionals. 

Only over-the-counter medicines (those, that are not subject to medical prescription and those, the advertising of which is allowed in the specific marketing authorisation) may be advertised to the general public. 

Pursuant to the Slovene Advertising Code, the advertising of both medicines and medical devices for commonly known diseases must not include scientific terms that are not commonly known. 

5.1 Medicines 

Only over-the-counter medicines for which marketing authorisation has been obtained and the advertising of which is explicitly allowed by the JAZMP in the specific marketing authorisation may be advertised to the general public. Advertising must include mandatory information about the medicine such as name of the medicine, information on application of medicine and explicit advice to discuss the information, or any medication difficulties with their doctor or pharmacist. 

The advertising elements must comply with the summary of the main characteristics of the medicine. The products must be presented objectively, without exaggeration and not in a misleading way. 

The advertising of a medicines must not contain any information that:

• Gives the impression that a medical consultation with a physician or a surgical operation is unnecessary;
• Indicates that the effects of taking the medicine are guaranteed, that the medicine is devoid of adverse reactions or that it is better than, or equivalent to, another medicine or treatment;
• Suggests that the health of a person can be enhanced solely by taking the advertised medicine; Suggests that the health of the person could be affected by not taking the advertised medicine;    Is directed exclusively or principally at children;
• Refers to a recommendation by scientists, health care professionals or other publicly renowned persons who, because of their media influence, could encourage the consumption of a medicine;
• Suggests that the safety or efficacy of the medicinal product is due to its natural origin;            Could lead to erroneous self-diagnosis;
• Uses improper, alarming or misleading terms regarding possibilities of recovery;
• Uses misleading terms, pictorial presentations of changes in the human body caused by disease or injury, or the action of a medicine on the human body.

No samples of medicines may be distributed to end users for promotional purposes.  

5.2 Medical devices 

Only medical devices that comply with the Medical Devices Act may be advertised. An exemption from this applies for advertising of medical devices at fairs or exhibitions if a disclaimer is attached, stating that they are not for sale or to be used until they comply with the law. Medical devices used solely for performing of healthcare services may be advertised only to healthcare professionals. 

The advertising of medical devices may not include information that: 

• Indicates that the effects of using the medical device are guaranteed or equivalent to another treatment;
• Suggests that the health of a person can be enhanced solely by using the advertised medical device;
• Suggests that the health of the person could be affected by not using the advertised medical device;
• Is directed exclusively or principally at children;
• Refers to a recommendation by scientists, health care professionals or other publicly renowned persons who, because of their media influence, could encourage the consumption of a medical device;
• Could lead to erroneous self-diagnosis;
• Uses improper, alarming or misleading terms regarding possibilities of recovery. 

When advertising both medicines and medical devices to healthcare professionals, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised unless they are of a small amount and intended for use in medical or pharmaceutical activity. Pursuant to the Slovene Code of Medical Ethics, medical doctors may not participate in advertising medicines or medical devices. 

6.1 Medicines 

Medicines covered by a marketing authorisation may be advertised to healthcare professionals in scientific publications or directly where that is necessary to inform the healthcare professionals about the safe and correct administration of medicines. If the healthcare professionals work within public healthcare services, the advertising may only take place during the time dedicated to preparation for work and not in the time dedicated to being spent with patients. Note that informing healthcare professionals about characteristics and effects of medicines, sponsorship and organisation of promotional meetings, sponsorship of scientific conferences attended by healthcare professionals authorised to prescribe medicines and distribution of samples of medicines is also deemed as advertising. Additionally, inducing persons to prescribe medicines by way of promising or giving any financial or material benefits is deemed as advertising. Such benefits are not allowed unless they are of a small amount (as defined in the Decree on restrictions and duties of public employees as regards acceptance of gifts – note that amendments in regulation of gifts are expected) and intended for use in medical or pharmaceutical activity. 

6.2 Medical devices 

The provisions for advertising to the general public apply. In addition, medical devices intended for use only by healthcare professionals may only be advertised to healthcare professionals. 

7.1 Medicines

Any promotional materials targeted at healthcare professionals must include:

• Name of the medicine;
• Essential information, consistent with the summary of product characteristics (including ingredients, therapeutic indications, mode of administering, summary of side effects) and
• The date of when this information was collected or last modified;

Advertising must be accurate, balanced, fair, objective and sufficiently complete to enable the healthcare professionals to form his/her own opinion of the therapeutic value of the medicine concerned. It must be based on an up-to-date evaluation and must not mislead by distortion, exaggeration, undue emphasis, omission or in any other way. Advertising claims about side effects must reflect available evidence or be capable of substantiation by clinical experience. 

The marketing authorisation holder must ensure that any advertising to healthcare professionals only targets and reaches the persons authorised to prescribe medicines. Informational materials intended for healthcare professionals should be labelled “for expert public”. 

7.2 Medical devices 

If samples of medical devices are distributed, a sample must be labelled as “sample” 

Please also see answer in point 6.2 above.  

8.1 Medicines 

In advertising materials, medical products need to be unambiguously presented as medicines. 

Advertising must include:

• Name of the medicine;
• Information necessary for the correct use of the medicine;
• Visible graphic, written or spoken warning: “Carefully read instructions before use! Before use, consult a doctor or a pharmacist about risks and side effects.” 

8.2 Medical devices 

If samples of medical devices are distributed, a sample must be labelled as “sample”

Please also see answer in point 5.2 above.  

Pursuant to the EFPIA Code, when advertising refers to published studies, clear references must be given. Quotations from medical and scientific literature must be faithfully reproduced. Advertising claims must be capable of substantiation which must be promptly provided in response to reasonable requests from healthcare professionals. 

When advertising medicines to the general public, advertising that indicates that a medicine is better or equivalent to other medicine or treatment is prohibited. 

Comparative advertisement of medicines to healthcare professionals is generally permitted, however it must be based on relevant and comparable aspects of medicines and must not be misleading or disparaging. 

No, the general rules apply. 

The responsible authority for enforcement in this field is the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (“ JAZMP”). JAZMP is a national competent authority recognised by the European Medicines Agency and has competency to address enforcement issues in relation to regulations 2017/745 and 2017/246. 

Alongside regular inspections, the inspecting officers of the JAZMP can act on the basis of notifications, anonymous reports and information available in the media and online. In case of minor violations for which extenuating circumstances have been found, the JAZMP may decide to issue a warning. If the JAZMP deems the violation to be serious, it is authorised to issue the following fines. 

Regarding medicines:

• A fine of between EUR 800 and EUR 4,000 may be imposed on a legal entity that fails to notify the JAZMP of the list of expert staff members to be entered in the register of medical sales representatives prior to the commencement of the activity of medicinal product advertising;
• A fine of between EUR 8,000 and EUR 120,000 may be imposed on a legal entity if:
  • It advertises and markets products presented as having properties for treating or preventing disease in human beings if they are not covered by the Medicinal Products Act as medicinal products; or
  • It presents to patients and customers products that are not covered as medicinal products as having properties for treating or preventing disease in human beings; or
  • It advertises advanced therapy medicinal products prepared on a non-routine basis, their preparation or therapeutic use; or
  • It violates the abovementioned rules on advertising to either general public or healthcare professionals. 

Regarding medical devices:

• A fine of between EUR 15,000 and EUR 150,000 may be imposed on a legal entity if:
  • It advertises a medical device contrary to the abovementioned rules; or
  • It advertises the properties and modes of use of medical devices in a deceptive way.

An appeal against the JAZMP’s decision may be brought before the court. 

No developments regarding advertising of medicines are anticipated in the near future.