Generics register (répertoire des groupes génériques)

The generics register is the list, drawn up and published by the French National Agency for Medicines and Health Products Safety (ANSM), that links each reference medicinal product to the generic medicinal products that copy it. It is provided for by the French Public Health Code, Article L. 5121-1 of which defines the generic medicinal product and the generic group. Entry in the register is the key to pharmacist substitution and to many pricing and reimbursement mechanisms.

Composition of the register and entry

Each generic group brings together a reference medicinal product and the products that have the same qualitative and quantitative composition in active substances and the same pharmaceutical form, and whose bioequivalence with it has been demonstrated. The register also lists excipients with known effect, so that prescribers and pharmacists can take them into account. Entry takes place after the marketing authorisation for the generic has been granted, by decision of the agency’s director general, who first informs the marketing authorisation holder of the reference medicinal product. Sixty days elapse between this notice and entry in the register.

Effects of entry

Entry gives pharmacists the right to dispense, by way of substitution, a product from the same group, unless the prescriber has excluded it on justified grounds. It triggers the pricing rules specific to generics, the corresponding reduction in the price of the reference and, where appropriate, the setting of a reference price (tarif forfaitaire de responsabilité) for the group. Biosimilar medicinal products are covered by a separate list, so the register does not cover all copies of a medicinal product.

The register and patents

Entry in the register is without prejudice to intellectual property rights. The Public Health Code provides that the generic may be marketed only after the expiry of the intellectual property rights attached to the reference medicinal product, without entrusting the agency with reviewing those rights. In practice, the notice given to the holder before entry, followed by the generic manufacturer’s pricing and reimbursement steps, are signals that the patent holder monitors, since the courts assess whether infringement is imminent on the basis of a body of evidence of this kind before ordering provisional measures.

Key points

The generics register governs the actual entry of the generic into retail pharmacies. The holder of the reference medicinal product should treat the notice received from the agency as an alert and review without delay the validity and scope of its patents and certificates. For the generic manufacturer, entry in the register offers no guarantee as regards patents, and a freedom-to-operate study must precede any decision to launch at risk.

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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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