European Union

Advertising regulation in European Union

Regulator: European Commission / EMA ／ Basis: 指令 2001/83/EC 第 VIII 編

Claims of efficacyAll 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.
Comparative advertisingAdvertising of a medicinal product to the general public must not contain any material that suggests that the effects of taking the medicine are better than, or equivalent to, those of another treatment or medicinal product (Directive 2001/83/EC, Article 90(b)), and all advertising must comply with the summary of product characteristics and must not be misleading (Article 87(2)-(3)). The text of Directive 2006/114/EC on misleading and comparative advertising has now been obtained and read. Article 1 states its purpose as protecting traders against misleading advertising and laying down the conditions under which comparative advertising is permitted, so its protective addressees are traders. Article 2(c) defines comparative advertising as any advertising which explicitly or by implication identifies a competitor or goods or services offered by a competitor. Article 4 permits comparative advertising, as far as the comparison is concerned, only where all of the following are met: (a) it is not misleading within Articles 2(b), 3 and 8(1) of that Directive or Articles 6 and 7 of Directive 2005/29/EC; (b) it compares goods or services meeting the same needs or intended for the same purpose; (c) it objectively compares one or more material, relevant, verifiable and representative features, which may include price; (d) it does not discredit or denigrate the marks, names, goods, services, activities or circumstances of a competitor; (e) for products with a designation of origin, it relates to products with the same designation; (f) it does not take unfair advantage of the reputation of a competitor's mark or name or of a competing product's designation of origin; (g) it does not present goods or services as imitations or replicas of goods or services bearing a protected trade mark or trade name; and (h) it does not create confusion among traders, between the advertiser and a competitor, or between their marks, names, distinguishing marks, goods or services. Article 7 requires Member States to empower courts or administrative authorities to require the advertiser to furnish evidence of the accuracy of factual claims, in a short period of time in the case of comparative advertising, and to consider factual claims inaccurate if that evidence is not furnished or is deemed insufficient.
Safety informationAdvertising to persons qualified to prescribe or supply must include essential information compatible with the summary of product characteristics and the supply classification of the product, and all information contained in promotional documentation must be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product.
Direct-to-consumerMember States must prohibit advertising to the general public of medicinal products that are available on medical prescription only or that contain substances defined as psychotropic or narcotic by international convention, while medicinal products that by virtue of their composition and purpose are intended and designed for use without the intervention of a medical practitioner may be advertised to the general public.
Materials for HCPsAny advertising to persons qualified to prescribe or supply must include essential information compatible with the summary of product characteristics and the supply classification, documentation transmitted as part of promotion must state the date on which it was drawn up or last revised, and quotations, tables and other illustrative matter taken from medical journals or other scientific works must be faithfully reproduced with the precise sources indicated.
Pre-clearanceMember States must ensure that there are adequate and effective methods to monitor the advertising of medicinal products, and such methods may be based on a system of prior vetting (Directive 2001/83/EC, Article 97(1)); the marketing authorisation holder must keep available for, or communicate to, the authorities or bodies responsible for monitoring advertising a sample of all advertisements emanating from its undertaking together with a statement indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination (Article 98(2)). Because prior vetting is an option and not an obligation, whether it applies depends on national law, and examples in both directions have now been checked in national sources. France operates prior vetting: the ANSM states that for all medicines, whether or not subject to medical prescription, the whole body of promotional documents intended for health professionals and for the public is subject to a contrôle a priori by the ANSM, that is, before any dissemination, and that where the criteria are met the application results in a prior authorisation called a visa de publicité, while failure to meet them leads to refusal. By contrast the German Heilmittelwerbegesetz contains no prior-vetting provision at all; control under that Act operates after the fact through the criminal penalty in section 14, the administrative fine in section 15 and competition-law remedies.
Digital and socialDirective 2001/83/EC defines advertising of medicinal products in Article 86(1) as any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products, without limitation as to medium, and Articles 86 to 100 contain no provision specific to digital or social media.
EnforcementMember States must confer upon the courts or administrative authorities powers to order the cessation of misleading advertising, or to order the prohibition of its publication where publication is imminent, even without proof of actual loss or damage or of intention or negligence on the part of the advertiser, and must determine the penalties for infringement of the national provisions adopted in execution of Title VIII (Directive 2001/83/EC, Articles 97(2)-(4) and 99). Equivalent powers appear in Article 5 of Directive 2006/114/EC: paragraph 1 requires adequate and effective means to combat misleading advertising and to enforce compliance with the provisions on comparative advertising, including legal provisions under which persons or organisations with a legitimate interest may take legal action or bring the advertising before a competent administrative authority; paragraph 3 requires powers to order cessation or prohibition even without proof of loss, intention or negligence, under an accelerated procedure with interim or definitive effect; paragraph 4 permits powers to require publication of the decision in whole or in part and of a corrective statement; and paragraph 6 requires reasons always to be given where the powers are exercised exclusively by an administrative authority, together with provision for judicial review. The level of penalties is set by each Member State, not by EU law. One national implementation has now been read: under the German Heilmittelwerbegesetz, section 14 punishes a breach of the prohibition on misleading advertising in section 3 with imprisonment of up to one year or a fine; section 15(1) makes breaches of sections 3a, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 regulatory offences; section 15(2) makes a negligent breach of section 3 a regulatory offence; and section 15(3) sets the administrative fine at up to 50,000 euro for a section 15(1) offence and up to 20,000 euro for a section 15(2) offence. Section 16 permits confiscation of the advertising material concerned.

Every cell carries a summary, a source and a date checked. Topics whose source has not been verified are left marked “not researched” rather than filled with plausible text. Directives and statutes bind as to the result; what applies in practice is national implementing law. This is a research aid, not legal advice.