Advertising of medicinal products

Under Article L. 5122-1 of the French Public Health Code, advertising of medicinal products means any form of information, including door-to-door canvassing, prospecting or inducement designed to promote the prescription, supply, sale or consumption of medicinal products. This regime transposes Title VIII of Directive 2001/83/EC. Excluded, in particular, are correspondence answering a specific question about a medicinal product, information relating to human health that makes no reference, even indirect, to a medicinal product, and labelling and the package leaflet.

Conditions of lawfulness

Only a medicinal product that has a marketing authorisation or a registration may be advertised. Advertising must present the medicinal product objectively, encourage its rational use, comply with the information in the summary of product characteristics and not be misleading. Advertising to the general public is allowed only for medicinal products that are not subject to medical prescription and are not reimbursable, subject to exceptions, in particular for certain vaccination campaigns. Advertising to healthcare professionals is subject to specific content requirements, including the reproduction of the product’s essential information.

Prior control

In France, all advertising for a medicinal product, whether aimed at the public or at healthcare professionals, requires prior approval (visa) from the ANSM. The agency may refuse, suspend or withdraw this approval and impose financial penalties, and the dissemination of unauthorised advertising is also a criminal offence. A charter concluded between the public authorities and the pharmaceutical industry also governs the activity of medical sales representatives with prescribers.

Disputes between competitors

Pharmaceutical advertising is a frequent source of disputes between companies. Comparative advertising is permitted under the general law, provided it relates to essential and verifiable characteristics of the products, and use of a competitor’s trade mark is lawful only within that framework. Messages calling into question the quality or safety of a competitor’s products expose their author to an action for disparagement, or even to competition law proceedings where they target the entry of a generic, as illustrated by disparagement of generics. Administrative approval does not shield the advertiser from court proceedings brought by a competitor.

Key points

Advertising for a medicinal product requires a marketing authorisation, content consistent with the summary of product characteristics and, in France, prior approval from the ANSM. Advertising to the general public remains the exception. Each promotional item should be reviewed against the summary of product characteristics, and the studies relied on should be retained, since they will be requested in any dispute with a competitor.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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