Heilmittelwerbegesetz

The Heilmittelwerbegesetz (HWG) is a German federal law that governs advertising for medicines and related remedies. Its primary aim is to protect consumers from misleading or biased claims and to ensure that promotional materials reflect approved indications and safety information.

Scope: The HWG applies to advertising and promotional activities for medicines, including prescription and over-the-counter products, as well as certain therapeutic remedies marketed for human use. It covers advertising directed at both the general public and professionals, but imposes stricter rules on consumer-facing advertising.

Key provisions: Direct advertising of prescription medicines to lay audiences is generally prohibited. Advertising for OTC medicines may be allowed but must be balanced and non-misleading, including accurate statements of indications, contraindications, side effects, and risk information. All claims must be supported by official labeling and approved indications. The law also restricts misleading or exaggerated health claims, testimonials, and inducements.

Advertising content must avoid encouraging self-diagnosis or self-treatment beyond what is appropriate, and it forbids certain promotional tactics such as free samples to the general public or incentives to prescribers that could bias clinical decisions. Comparative advertising is tightly regulated.

Enforcement and penalties: Violations can lead to civil injunctions, fines, and liability under competition or consumer protection law. Enforcement is carried out by the relevant German supervisory authorities at the federal or state level, and cross-border online advertising may fall under EU rules as well.

Relation to other law: The HWG interacts with the Arzneimittelgesetz (AMG) and EU pharmaceutical advertising directives. Revisions have occurred over time to reflect changing medical practice and consumer protection standards.