Claims of efficacy

Expressions of the efficacy, effect or performance of a product requiring approval must not exceed the scope of the approved indications, whether explicit or implicit, and expressions guaranteeing efficacy or using superlatives are prohibited.

A prescription drug advertisement is false, lacking in fair balance, or otherwise misleading if it contains a representation or suggestion, not approved or permitted for use in the labeling, that the drug is better, more effective, useful in a broader range of conditions or patients, or safer than has been demonstrated by substantial evidence or substantial clinical experience.

No person may label, package, treat, process, sell or advertise a drug in a manner that is false, misleading or deceptive as to its character, value, quantity, composition, merit or safety.

All parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics, and the advertising shall encourage the rational use of the medicinal product by presenting it objectively and without exaggerating its properties and shall not be misleading (Directive 2001/83/EC, Article 87(2) and (3)). The Directive binds Member States as to the result, and what a reviewer applies is the national implementing law. One national implementation has now been read: the German Heilmittelwerbegesetz (HWG). Section 3 HWG makes misleading advertising unlawful and treats as misleading in particular (1) attributing to a medicine a therapeutic efficacy or effects that it does not have, (2) falsely creating the impression that success can be expected with certainty, that no harmful effects occur on intended or prolonged use, or that the advertising is not carried out for competitive purposes, and (3) making untrue or deceptive statements about the composition or properties of the medicine or about the person, training, qualifications or achievements of the manufacturer or inventor. Section 3a HWG prohibits advertising for a medicine that is subject to authorisation and is not authorised, and likewise where the advertising relates to indications or pharmaceutical forms not covered by the authorisation. Section 4(1) HWG requires every advertisement for a medicine to carry the name and registered office of the pharmaceutical company, the name of the medicine, its composition, indications, contraindications, adverse effects, warnings, and for prescription-only medicines the statement 'Verschreibungspflichtig'; section 4(2) requires those particulars to agree with those prescribed for the package leaflet.

An advertisement for a medicinal product with a UK marketing authorisation must comply with the particulars listed in the summary of product characteristics, must encourage rational use by presenting the product objectively without exaggerating its properties, and must not be misleading.

Advertisements for medical services, drugs and medical devices must not contain assertions or guarantees of efficacy or safety, nor state cure rates or effectiveness rates, and the content of a drug advertisement must not be inconsistent with the package insert approved by the drug regulator.

An advertisement about therapeutic goods must be accurate, balanced and not misleading or likely to mislead, must only contain information substantiated by the advertiser before publication, and must not be inconsistent with any indication or intended purpose accepted for the goods' inclusion in the Register.

False or exaggerated advertising about the name, manufacturing method, efficacy or performance of a drug is prohibited, advertising by means of articles, photographs, designs or other implicit methods suggesting efficacy or performance is prohibited, and no advertising of the name, manufacturing method, efficacy or performance may take place before the product has received approval or variation approval or has filed the required notification.

All statements in professional advertising must be consistent with the medicinal product information last approved by Swissmedic and only indications and uses approved by Swissmedic may be advertised; the statements must be accurate, balanced, factually correct, substantiable and not misleading, and must be based on and reflect the current state of scientific knowledge, with the same consistency requirement applying to advertising to the public.