Disparagement of generics (dénigrement)

Disparagement of generics refers to the dissemination by a pharmaceutical company of information that discredits the quality, safety or efficacy of competing generic medicinal products, in order to curb their prescription or substitution. It gives rise to civil liability for its author under the rules on unfair competition, on the basis of Article 1240 of the French Civil Code, and, where the author holds a dominant position, may be penalised under Article 102 TFEU and its French law equivalent. It is one of the favoured areas of intervention of the French Competition Authority in the pharmaceutical sector.

Constituent elements

Under civil law, disparagement requires the disclosure of information liable to discredit an identifiable product or undertaking. The Court of Cassation holds that information, even if accurate, constitutes disparagement unless it relates to a subject of general interest, has a sufficient factual basis and is expressed with moderation. In the pharmaceutical sector, messages concerning bioequivalence, excipients, the safety of switching or the reliability of manufacturers are the most exposed, particularly where medical sales representatives relay them to prescribers and pharmacists.

Disparagement as an abuse of a dominant position

The French Competition Authority has on several occasions fined dominant originator companies for disparagement campaigns targeting generics of their product. It holds that such conduct may constitute an abuse of a dominant position where it hinders the entry of generics by playing on the fears of healthcare professionals, and it assesses the campaign as a whole, having regard in particular to whether it is misleading or lacks objectivity. The fines imposed have been substantial, and the Authority may order publication of its decision or of a statement.

Remedies and precautions

A generic manufacturer that falls victim may bring a complaint before the Competition Authority, sue for damages and seek interim relief to bring a manifestly unlawful disturbance to an end. The originator company retains the right to inform healthcare professionals about its product and about the rules on substitution, provided that the information remains objective and consistent with the authorisation documents. A generic manufacturer that discredits the reference medicinal product may also be held liable for disparagement.

Key points

Any communication by a pharmaceutical company about the generics of its product, and even more so any campaign aimed at prescribers, should be reviewed in light of the law on disparagement and on abuse of a dominant position. Companies should confine themselves to the information in the summary of product characteristics and the positions of the health authorities, without extrapolating on the quality of competitors. For the generic manufacturer, preserving the materials disseminated and the testimony of healthcare professionals is the first step in any action.

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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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