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.

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

Medicines

For medicines, the primary legal framework is governed by the Medicinal Products Act (Arzneimittelgesetz – AMG) in Austria. Additionally, the Austrian Act Against Unfair Competition (Gesetz gegen den unlauteren Wettbewerb – UWG) applies, and both sets of provisions must be adhered to concurrently.

Medical Devices

Regarding medical devices, the key legislation is the Medical Devices Act (Medizinproduktegesetz 2021 – MPG 2021). Similarly, advertising of medical devices must comply with the provisions of the Act Against Unfair Competition (UWG).

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

Medicines

• The Code of Conduct of the Austrian Pharmaceutical Industry Association (PHARMIG) is central in determining the legitimacy of advertising measures.
• The code of conduct of the Association of Austrian Pharmaceutical Manufacturers (IGEPHA) provides further guidelines.

Medical Devices

• The Code of Conduct of the Advocacy of the medical device companies in Austria (Austromed) exists, but it does not explicitly address provisions on advertising of medical devices.
• The IGEPHA Code of Conduct does cover some rules regarding the advertising of medical devices.

What licenses, approvals, or fees (if any) are required for advertising medications and medical devices to the general public and healthcare professionals?

Advertisements for drugs and medical devices do not require any licences, permissions, or fees.

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

Advertising of non-prescription drugs to the general public is allowed under specific conditions, whereas advertising of prescription medicines to the general public is generally prohibited. This distinction is based on the potential risks associated with prescription medicines and the need for healthcare professional oversight in their use, compared to non-prescription drugs, which are deemed safe for self-administration without medical supervision.

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

Medicines

• Authorization Requirement: Advertising is only permitted for drugs authorized for marketing in Austria.
• Objectivity: Advertisements must be objective, without exaggerating effects or guaranteeing success, and must align with product labeling, instructions for use (IFU), and summary of product characteristics (SmPC).
• General Public Advertising Ban: Prescription medicines, certain non-prescription medicines, medicines in the Reimbursement Code of the Austrian Sick Fund, and registered homeopathic drugs cannot be advertised to the general public.
• Content Restrictions: Limitations apply to pictorial representations of healthcare professionals, claims of absence of side effects, claims of improving normal good health, recommendations by high-profile individuals, promotion as a natural product, and detailed descriptions encouraging incorrect self-diagnosis.

Medical Devices

• Accuracy and Non-deception: Medical devices must not be labeled, presented, or advertised in a deceptive manner, including ascribing functions or properties the device does not have or creating false impressions.
• Advertising Ban for Certain Devices: A general advertising ban applies to prescription medical devices, devices exclusively for use by healthcare professionals, and those usable only in connection with medical treatment by consumers.
• Additional Content Restrictions: Advertisements must not suggest superiority to other treatments, target children, make medical treatments appear unnecessary, refer to convalescence certificates, or use pictorial representations of changes in the human body.

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

Medicines

• Authorization Requirement: Advertising is generally allowed only for medicines authorized for marketing in Austria, with limited exceptions for international scientific events.
• No Premiums or Financial Benefits: No premium or financial/material benefit may be granted, offered, or promised, except benefits of insignificant value relevant to medical or pharmaceutical practice.
• Restrictions on Benefits in Kind: Benefits in kind are prohibited for medicines included in the Reimbursement Code of the Austrian Sick Fund.
• Distribution of Free Medical Samples: Samples may only be provided upon written request, in the smallest available packaging, marked “unsellable medical sample” (“unverkäufliches Ärztemuster”), and within permitted quantity limits.

Medical Devices

• No premiums or financial/material advantages may be granted, except for items of low value and no relevance to medical practice.

What is the required information for advertisements directed only at healthcare professionals for medicines and medical devices?

Medicines

• Name of the drug
• Qualitative and quantitative composition of active substances
• Fields of application
• Contraindications
• Personal details of the holder of the authorization or registration
• Prescription or pharmacy obligation
• Date on sales documents

Medical Devices

The Medical Devices Act (MPG 2021) does not specify any mandatory information for advertisements directed at healthcare professionals.

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

Medicines

• Product name
• Active ingredient (unless multiple)
• Essential usage information
• Clear statement that the medicine can have side effects and that instructions should be followed or professional advice sought

Medical Devices

• Device name
• Intended use
• Essential usage information
• Potential side effects and safety precautions
• Recommendation to consult a qualified healthcare professional where appropriate

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

Scientific claims must be supported by solid evidence based on the latest scientific knowledge. References to unpublished research, such as “data on file,” are not permitted.

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

General Public

• Comparative references representing products as equivalent or superior are forbidden.
• Individual references or graphic illustrations are prohibited.
• Reference to active substances is prohibited if the substance is part of the trade name.

Healthcare Professionals

• Comparative advertising is generally permitted.
• Statements must be up-to-date, verifiable, and complete.
• Quotations must be reproduced exactly from specialist literature.
• Advertising must not be misleading or discredit competitors.

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

The same general criteria apply to online advertising as to other forms. Website and social media operators must comply with the requirements of the E-Commerce Act.

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

Monitoring Body

The Federal Office for Safety in Healthcare (Bundesamt für Sicherheit und Gesundheitswesen – BASG) is responsible for control and supervision.

Enforcement Actions

The BASG may request information, conduct inspections, and issue measures to ensure compliance.

Penalties

• EUR 25,000 for a first offense
• EUR 50,000 for repeat offenses
• Additional claims under the Act Against Unfair Competition (UWG), including injunctions, damages, publication of judgments, and cost reimbursement

Are there any future developments in Austria?

The EU is expected to enact special laws on green advertising, which will also impact pharmaceutical and medical device businesses engaged in environmental advertising.

How can OMC help?

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