Pharmaceutical advertising regulation and medical device advertising in Austria

  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 Austria 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 in Austria. 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?

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

1.1 Medicines

The primary legal source is the Medicinal Products Act (Arzneimittelgesetz – AMG). In addition, the Austrian Act Against Unfair Competition (Gesetz gegen den unlauteren Wettbewerb – UWG) must be observed; parallel provisions of the UWG and the AMG are applicable cumulatively.

1.2 Medical devices

The most important legal source regarding medical devices is the Medical Devices Act (Medizinproduktegesetz – MPG). The provisions of the UWG must also be observed when it comes to advertising of medical devices.

2.1 Medicines

The Code of Conduct of the Austrian Pharmaceutical Industry Association (PHARMIG) plays a central role in the determination of the legitimacy of advertising measures. Additionally, the code of conduct of the Association of Austrian Pharmaceutical Manufacturers (IGEPHA) can be named as another self-regulatory code of conduct.

2.2 Medical devices

For medical devices there is the Code of Conduct of the Advocacy of the medical device companies in Austria (Austromed), which, however, does not explicitly contain provisions on advertising of medical devices. Besides, the IGEPHA Code of Conduct also covers some rules regarding the advertising of medical devices.

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?

There are no licenses/approvals/fees required for advertisements of medicines and medical devices.

4. Does the law in Austria 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 (please see below Q5).

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

5.1 Medicines

Advertising may only be carried out for drugs that are authorised for marketing in Austria. Advertising must be objective, must not contain any exaggeration of effects or guarantees of success and must be compatible with the product labelling, instructions for use (IFU) and summary of product characteristics (SmPC).

A general ban on advertising to the general public applies to prescription medicines, non-prescription medicines with names that contain the same fantasy word or the same customary scientific term as a prescription medicine, medicines that are included in the Reimbursement Code of the Austrian Sick Fund, and registered homeopathic drugs.

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 § 53 (1) AMG):

  • Pictorial representations of HCPs or health institutions;
  • Elements which make a medical examination or surgical intervention appear superfluous, in particular by offering remote diagnosis or treatment;
  • Claim of absence of side effects and comparative advertising;
  • Claims that the drug may improve the patient’s normal good health or that it may be harmed if the patient does not take the drug;
  • Addressed mainly or exclusively to children;
  • Recommendation by scientists, HCPs or third parties who may encourage the consumption of medicines due to their high profile;
  • Promotion as a natural product to demonstrate efficacy and safety;
  • Tempting to incorrect self-diagnosis through detailed description or presentation of the anamnesis.

5.2 Medical devices

Medical devices must not be labelled, presented or advertised in a way that is not in accordance with the facts or deceptive. 

A general advertising ban towards the general public applies to prescription medical devices, those intended exclusively for use by HCPs on or for the patient and medical devices that according to their instructions for use may only be used by the consumer in connection with medical treatment.

6. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?

6.1 Medicines

Advertising may in principle only be carried out for drugs that are authorised for marketing in Austria. However, it is possible to advertise medicines that do not have a marketing authorisation in Austria to HCPs at international scientific events that are predominantly attended by participants from abroad.

No premium or financial/material benefit may be granted, offered or promised to persons entitled to prescribe or supply medicines in the course of sales promotions. Excluded are benefits of insignificant value and have relevance for the medical or pharmaceutical practice.

Furthermore, the granting of benefits in kind to persons entitled to prescribe or supply medicines is not permitted with respect to medicines that are included in the Reimbursement Code of the Austrian Sick Fund. 

Restrictions also apply with regard to the distribution of free medical samples. They can only be distributed upon written request by an HCP in the smallest available packaging and with the imprinted statement “unsellable medical sample” (“unverkäufliches Ärztemuster”). Only certain quantities are permitted per doctor.

6.2 Medical devices

HCPs entitled to prescribe or supply medical devices may not be granted, offered or promised any premiums or financial or material advantages. Excluded are those of low value and of no relevance to medical practice.

7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?

Advertisements in printed or electronic media or via telecommunication for medicines for which a summary of product characteristics (SmPC) is to be published must contain the essential information about the medicine in accordance with the SmPC in a clearly readable form.

The following information must be included:

  • Name of the drug;
  • Qualitative and quantitative composition of active substances;
  • Fields of application;
  • Contraindications;
  • Personal details of the holder of the authorisation or registration; and
  • Prescription or pharmacy obligation.

Furthermore, all sales documents supplied to HCPs authorised to prescribe or supply medicines must, in addition to the short prescribing information, indicate the date on which the documents were drawn up or last amended.

No premium or financial/material benefit may be granted, offered or promised to persons entitled to prescribe, supply or involved in the use of medicinal products in the course of sales promotions. Excluded are benefits of insignificant value that have relevance for the medical or medical-technical practice. Advertisements that are addressed to HPC may not contradict the instructions for use or other information that has been approved in a conformity assessment procedure.

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

8.1 Medicines

Advertisement for medicines directed to the general public must include at least the following information:

  • Name of the medicine and the scientific name of its active substance (this does not apply in the case of more than one pharmacologically active ingredient);
  • Information essential for the correct use of the medicine; and
  • Clearly visible indication that adverse effects may also be caused and that the instructions for use must therefore be strictly observed or the advice of a doctor or pharmacist sought; in acoustic or audiovisual media the indication must be in acoustic form.

8.2 Medical devices

Advertisement for medical devices directed to the general public must include at least the following information:

  • Name of the medical device;
  • Purpose of the medical device;
  • Information essential for the correct use of the medical device;
  • Clearly visible indication of possible adverse effects; and

If applicable, clearly visible indication that adverse effects may also be caused and that the instructions for use must therefore be strictly observed or the advice of a doctor, pharmacist or dentist sought; in acoustic or audiovisual media the indication must be in acoustic form.

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.)?

Advertising claims (also including retrospective analyses) must be sufficiently scientifically substantiated, and therefore they must be evidence-based.

Scientific information contained in promotional materials must be based on the current state of scientific knowledge. References to “data on file” (unpublished scientific studies, company-internal data, etc.) are not allowed due to the lack of verifiability of the information contained therein.

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

Advertisements directed at the general public must not contain any comparative reference to other medical devices, medications or treatments that represent the advertised product as equivalent or superior. It is forbidden to make individual references, in particular by naming or graphic illustration. The reference to active substances is also prohibited in case the active substance is part of the trade name.

Comparative advertising directed at HCPs is generally permitted. Statements must be up-to-date, verifiable and complete. Quotations, including references, must be reproduced exactly from specialist literature. Furthermore, statements must neither be misleading nor discredit the medical device, the drug or the active substance of a competitor.

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

When advertising on the internet, the general rules apply to both general public and professional advertising.

When operating a website and/or social media page, the rules for service providers according to the E-Commerce Act must be complied with.

Control and supervision of the advertising regulations is the responsibility of the Federal Office for Safety in Healthcare (Bundesamt für Sicherheit und Gesundheitswesen – BASG).

The BASG can request information, carry out on-site inspections and issue various orders and measures to establish a legally compliant state. 

For offences against the advertising provisions, provided that the actions are not subject to criminal sanctions, penalties of EUR 25,000, in the repetition case of EUR 50,000 may be imposed.

Violation of UWG may result in claims for injunctive relief, removal, damages and publication of judgements as well as reimbursement of costs. These claims may be asserted by competitors and certain organisations

13. Any future developments?

  • The EU medical device regulation 2017/745 contains advertising related provisions. Advertisements shall not mislead the user or patient by: 
    • Ascribing functions and properties to the device which the device does not have;
    • Creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have; 
    • Failing to inform on the likely risks associated with the use of the device;
    • Suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
  • Application of the Medical Device Regulation is postponed by one year until 26 May 2021 due to the outbreak of COVID-19.  
Gabriela-Staber-CMS-AT
Gabriela Staber
Partner
Vienna
Jia-Schulz-Cao-CMS-AT
Jia Schulz-Cao
Associate
Vienna