Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Which laws apply when it comes to promoting medicines and medical devices?

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)

2. Are there any additional legislative frameworks, such as self-regulatory codes of conduct, that control the advertising of pharmaceuticals and medical devices?

2.1 Medicines

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

Note: These codes are merged at the European level into the EFPIA Code, but the change is yet to reflect in Slovenia.

Codes Applicable to Both Medicines and Medical Devices

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

2.2 Medical Devices

• MedTech Europe Code of Ethical Business Practice

3. What licenses, approvals, or fees are required for advertising medications and medical devices to the general public and healthcare professionals?

Medicines

Advertising of medicines is exclusively permitted for holders of marketing authorizations obtained from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP).

Prior to commencing advertising, marketing authorization holders must notify the JAZMP of their medical sales representatives who will be involved in medicine advertising.

Medical sales representatives must be registered with the JAZMP for both general public and healthcare professional advertising.

Medical Devices

Under EU Regulation 2017/745, different categories of medical devices are classified, each subject to specific regulatory frameworks for advertising.

All medical devices, regardless of category, must bear a CE marking before they can be advertised.

This ensures compliance with regulatory standards and requirements for the marketing of medical devices within the European Union.

4. Does Austrian law govern the advertisement of prescription and over-the-counter medications differently?

• Prescription-Only Medicines: Advertising allowed only to healthcare professionals.
• Over-the-Counter Medicines: May be advertised to the general public if explicitly allowed in the marketing authorisation.

5. What are the primary limits on promoting drugs and medical devices to the public?

5.1 Medicines

Only over-the-counter medicines obtained with marketing authorization and explicitly allowed for advertising by JAZMP may be promoted to the general public.

Advertising must include mandatory information such as the medicine's name, application details, and explicit advice to discuss any concerns with a doctor or pharmacist.

Advertisements must align with the summary of the main characteristics of the medicine.

Products must be presented objectively, without exaggeration, and non-misleadingly.

Advertising for medicines must not include:

• Suggestions that medical consultation or surgery is unnecessary
• Claims of guaranteed effects, absence of adverse reactions, or superiority over other medicines or treatments
• Implications that a person's health can solely improve by taking the advertised medicine, or that their health could deteriorate by not taking it
• Targeting exclusively or primarily at children
• References to endorsements by scientists or healthcare professionals that could influence consumption
• Claims of safety or efficacy solely based on natural origin
• Potential for erroneous self-diagnosis
• Use of improper, alarming, or misleading terms regarding recovery possibilities

Distribution of medicine samples to end users for promotional purposes is prohibited.

5.2 Medical Devices

Only medical devices compliant with the Medical Devices Act may be advertised.

Exceptions include devices showcased at fairs or exhibitions, accompanied by a disclaimer indicating they are not for sale or use until compliant with regulations.

Devices used solely for healthcare services may only be advertised to healthcare professionals.

Advertising of medical devices must not include:

• Claims of guaranteed effects or equivalence to other treatments
• Suggestions that a person's health can solely improve by using the advertised device, or that their health could decline by not using it
• Targeting exclusively or primarily at children
• References to endorsements by scientists or healthcare professionals that could influence consumption
• Potential for erroneous self-diagnosis
• Use of improper, alarming, or misleading terms regarding recovery possibilities

6. What are the primary limits on promoting drugs and medical devices to healthcare professionals?

When advertising medicines and medical devices to healthcare professionals, no gifts, pecuniary advantages, or benefits in kind may be provided, offered, or promised unless they are of a small amount and intended for use in medical or pharmaceutical activities.

This is in accordance with the Slovene Code of Medical Ethics, which prohibits medical doctors from participating in the advertising of medicines or medical devices.

6.1 Medicines

• Medicines covered by marketing authorization may be advertised through scientific publications or directly to inform healthcare professionals about safe and correct administration
• Advertising to healthcare professionals working within public healthcare services must occur during preparation time, not patient interaction time
• Advertising includes informing professionals about medicine characteristics, sponsoring promotional meetings, sponsoring scientific conferences, and distributing medicine samples
• Inducing prescription through financial or material benefits is considered advertising and only permissible if of small value and for medical or pharmaceutical use

6.2 Medical Devices

• General advertising rules applicable to the public also apply
• Medical devices intended solely for healthcare professionals may only be advertised directly to those professionals

7. What is the required information for advertisements directed only at healthcare professionals?

7.1 Medicines

• Name of the medicine
• Essential information consistent with the summary of product characteristics, including ingredients, therapeutic indications, administration methods, and summary of side effects
• Date of collection or last modification of the information

Advertising must be accurate, balanced, fair, objective, and sufficiently comprehensive to allow healthcare professionals to form their own opinion about the medicine's therapeutic value.

Claims regarding side effects must be supported by available evidence or clinical experience.

Informational materials must be clearly labeled as “for expert public.”

7.2 Medical Devices

Samples of medical devices must be clearly labeled as “sample.”

Please also refer to the provisions outlined in section 6.2 above.

8. What information must be included in public-facing advertisements for drugs and medical devices?

8.1 Medicines

• Clear presentation that the product is a medicine
• Name of the medicine
• Essential information for correct use
• Clearly visible warning: “Carefully read instructions before use! Before use, consult a doctor or pharmacist regarding risks and side effects.”

8.2 Medical Devices

Samples of medical devices must be distinctly labeled as “sample.”

For further details, please refer to section 5.2 regarding medical device advertising regulations.

9. Are there any constraints on the data used to support promotional claims?

According to the EFPIA Code, advertisements that reference published studies must provide clear references.

Quotations from medical and scientific literature must be accurately reproduced.

Claims made in advertising must be substantiated and promptly provided upon reasonable request from healthcare professionals.

10. Are there any rules governing comparative advertising of drugs and medical devices?

• General Public: Prohibited from suggesting that one medicine is better or equivalent to another
• Healthcare Professionals: Permitted if based on relevant and comparable aspects and not misleading or disparaging

11. Are there special guidelines for advertising drugs and medical devices on the internet or social media?

No specific provisions apply. General advertising rules apply equally.

12. Which bodies oversee compliance and what are the legal ramifications for noncompliance?

The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) is the responsible authority for enforcement.

JAZMP is empowered to enforce EU Regulations 2017/745 and 2017/246.

JAZMP inspectors may act based on notifications, anonymous reports, and information found in media and online sources.

Medicines – Fines:

• EUR 800–4,000 for failure to notify JAZMP of expert staff before advertising
• EUR 8,000–120,000 for presenting non-medicinal products as medicinal or violating advertising rules

Medical Devices – Fines:

• EUR 15,000–150,000 for advertising in violation of rules or misleading properties

Decisions by JAZMP may be appealed in court.

13. Are there any future developments in Slovenia?

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

How can OMC help?

• Professional review of marketing and advertising materials and reports
• Services to obtain authority approvals where required
• Translation of marketing materials by a professional translation agency certified with ISO 17100