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?

• Unfair Competition Law Act (UWG)
• EU Regulation 2017/745 on Medical Devices (MDR)
• German Law on Advertising in the Health Sector (HWG)

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

Medicines

• Freiwillige Selbstkontrolle für die Arzneimittelindustrie eV (FSA):
  • FSA Code of Conduct on Collaboration with Healthcare Professionals
  • FSA Code of Conduct on Collaboration with Patient Organizations
• Arzneimittel und Kooperation im Gesundheitswesen eV (AKG):
  • AKG Code of Conduct for Healthcare Professionals
  • AKG Code of Conduct on Cooperation with Patient Organizations

Medical Devices

• Bundesverband Medizintechnologie e.V. (BVMed): Code of Conduct for Medical Devices
• Verband der Diagnostica-Industrie (VDGH): Code of Conduct for In-vitro-Diagnostics and Medical Devices

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

No specific licenses, approvals, or fees are required for advertising medicines or medical devices to the general public or healthcare professionals in Germany.

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

• Advertising prescription-only medicines to the general public is prohibited.
• Over-the-counter (OTC) medicines may be advertised to the general public with restrictions.

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

Medicines

• Prescription-only medicines may only be advertised to healthcare professionals.
• OTC medicines may not be advertised for certain diseases listed in Section 12 HWG or if they involve psychotropic substances.
• No advertising for unauthorized medicines or off-label uses.
• Comparative advertising is prohibited.
• Advertising gifts or benefits are permitted only to a limited extent.
• Advertisements must avoid misleading information and must be scientifically substantiated.
• Endorsements by scientists, healthcare professionals, or celebrities are prohibited.
• Testimonials or case histories must not be used in a misleading manner.
• Advertising must not target children under 14 years of age.

Medical Devices

• Must comply with Article 7 MDR, national advertising principles, and HWG regulations.
• Claims must not be misleading and must be scientifically substantiated.
• Advertising must not refer to diseases listed in Section 12 HWG.

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

• Claims must be based on reliable scientific evidence.
• References to studies or data must be complete and accurate.
• Only limited gifts or benefits may be provided in connection with promotion.
• No advertising for unauthorized medicines or off-label uses.

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

Medicines

• Pharmaceutical company’s name and place of business
• Medicine name
• Composition
• Therapeutic indications
• Contraindications
• Side effects
• Warnings
• “Prescription only” indication, where applicable
• Compliance with Section 6 HWG for references to scientific publications

Medical Devices

No specific mandatory information is required under the MDR or HWG.

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

Medicines

• Medicine name
• Therapeutic indications
• Warnings
• Advice to consult the package leaflet and healthcare professionals for further information
• Compliance with Section 6 HWG for scientific references

Medical Devices

No specific mandatory information is required, similar to advertisements aimed at healthcare professionals.

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

Medicines

• Claims must be supported by “gold standard” clinical studies: prospective, randomized, controlled, double-blind, statistically analyzed, and published.
• Retrospective analyses, subgroup analyses, meta-analyses, or unpublished data must clearly disclose their limitations.

Medical Devices

• The requirement for gold standard evidence is debated.
• The more specific and defined the claim, the stronger the evidence required, especially for curative or comparative claims.

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

Medicines

• Comparative advertising to the general public is prohibited.
• Comparative advertising to healthcare professionals must:
  • Compare products intended for the same purpose
  • Use objective, relevant, verifiable, and representative features
  • Be supported by reliable scientific evidence, typically head-to-head studies
  • Include disclaimers where direct comparative data is lacking

Medical Devices

• Comparative advertising is permitted to both the public and healthcare professionals.
• Claims must be based on reliable scientific evidence.
• The necessity of head-to-head clinical studies depends on the nature of the claim.

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

• No specific provisions exist, but general advertising restrictions apply.
• Prescription-only medicines require access restrictions (e.g., DocCheck registration).
• Information must be displayed or linked in a clearly visible manner.
• In practice, online advertising is generally limited to OTC medicines and medical devices.

Which bodies oversee compliance with the advertisement provisions, and what are the legal ramifications for noncompliance?

• Enforcement is primarily through civil litigation.
• Competitors and industry or consumer protection associations may initiate proceedings.
• Courts may issue cease-and-desist orders.
• Administrative offence proceedings are rare.
• Arbitration boards decide cases for association members.
• Misleading advertising under Section 3 HWG is rarely pursued criminally.

Are there any future developments in Germany?

No significant changes to the regulatory framework for advertising medicines and medical devices in Germany are anticipated in the near future.

How can OMC help?

• Professional review of marketing and advertising materials with detailed reports
• Support in obtaining authority approvals where required
• Translation of marketing materials by a professional translation agency certified with ISO 17100