Reference price (tarif forfaitaire de responsabilité)

The reference price is the single reimbursement basis applicable to all medicinal products in the same generic group, originator included. Set by the Economic Committee for Health Products, it is in principle introduced where pharmacist substitution remains insufficient in a group of the generics register. The national health insurance system then reimburses each pack on the basis of that tariff, whatever its selling price.

The mechanism

Where the price of the product dispensed exceeds the reference price, the difference is borne by the patient, unless covered by a complementary insurer. Companies are thus encouraged to align the originator’s price with that tariff, failing which patients turn away from the reference medicinal product. The mechanism therefore acts both as a cost-saving tool and as a lever for price convergence within the group.

Interplay with substitution rules

The reference price coexists with other incentives to dispense generic medicinal products. Since 2020, where the patient refuses substitution without medical justification, reimbursement is based on the price of the most expensive generic in the group, and the non-substitutability statement entered by the prescriber must correspond to defined medical situations. These rules produce effects similar to those of the reference price without sharing its nature, since they target the behaviour of the patient and the prescriber rather than the reimbursement basis of the group.

Economic consequences

Introducing a reference price presupposes that generics are actually marketed, and therefore that the patents and certificates protecting the reference medicinal product have expired or are no longer asserted. It accelerates the erosion of the originator’s turnover. In litigation following premature generic entry, this change in tariff is one of the market effects to be reconstructed in order to measure the patent holder’s loss.

Key points

The reference price brings the originator and its generics down to the same reimbursement basis. Groups in the register where substitution is low should be monitored, as they are the first to be affected. For the originator company, the decision whether to align its price should be taken by measuring the effect of the tariff on demand, and that effect must be documented if it results from infringing entry.

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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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