Pharma 2026: HWG, EU 1924/2006 and EmpCo — The Triple Advertising Regulation

The pharmaceutical industry is subject to triple advertising regulation: the German Medicinal Products Act (HWG) for medicinal products, the EU Health Claims Regulation 1924/2006 for foodstuffs, and EmpCo for environmental claims. These three regulations overlap particularly in the case of natural cosmetics and food supplements.

HWG (Heilmittelwerbegesetz): Advertising for prescription drugs is only permitted to professionals. For over-the-counter drugs, advertising claims must be scientifically substantiated. Prohibited statements include: “eliminates pain”, “cures”, and specific healing results. Section 11 of the HWG prohibits any misleading advertising in the healthcare sector — emotional adjectives such as “loving care” are problematic.

EU Health Claims Regulation 1924/2006: A list of approved health claims for foodstuffs applies (example: “Vitamin C contributes to the normal function of the immune system”). Own health claims are prohibited; only listed claims are allowed.

EmpCo: If pharmaceutical products are advertised as “sustainable”, “carbon neutral” or “plant-based”, the EmpCo rules apply in addition. This is practically always relevant for natural cosmetics.

Reformulation examples: ❌ “Natural pain therapy” → ✓ “Phytopharmaceutical (plant extract Boswellia 200 mg, clinical study XYZ 2024, efficacy proof BfArM)”. ❌ “Climate-neutral care” → ✓ “Care series with Scope 1 reduction of -52 % since 2019 (ISO 14064 certified), COSMOS Natural certified”.

Specific risks in the pharmaceutical sector: Fines can reach six figures here (BfArM, supervisory authorities). Criminal charges are possible (§ 95 AMG). Reputation: Pharmaceutical scandals spread disproportionately quickly.

Conclusion: In the pharmaceutical sector, a compliance check must be carried out BEFORE any advertising. AI tools can only be rough pre-filters here; final approval must come from lawyers experienced in HWG.