Pharmacist substitution

Substitution is the power granted to pharmacists to dispense, in place of the prescribed product, another product from the same generic group. It is provided for by Article L. 5125-23 of the French Public Health Code and is the main driver of the uptake of generic medicinal products in France. Biological medicinal products follow their own rules, discussed under interchangeability of biosimilars.

Conditions for substitution

• The prescribed product and the dispensed product belong to the same group in the generics register.
• The prescriber has not excluded substitution by an express statement on the prescription.
• Substitution does not result in higher expenditure for the national health insurance than dispensing the most expensive generic in the group would have entailed.
• The pharmacist records on the prescription the name of the product dispensed.

The « non-substitutable » statement and the patient’s refusal

Since 2020, prescribers may no longer add the exclusion statement freely. It must correspond to one of the medical situations laid down by ministerial order, such as a narrow therapeutic index, the absence of a form suitable for children or a formal contraindication to an excipient with known effect, and must be justified on the prescription. A patient who refuses the generic without medical justification loses the benefit of direct billing to the insurer (tiers payant), and reimbursement is calculated on the basis of the price of the generics in the group.

Substitution, patents and pharmaceutical company communications

Substitution makes the entry of a generic rapid and massive. The harm caused to the patent holder by infringing marketing is therefore hard to reverse, since market share lost in retail pharmacies is difficult to recover and the price cut on the reference is rarely undone. This hard-to-repair nature of the damage underpins applications for provisional measures. Conversely, communications by a pharmaceutical company aimed at dissuading prescribers and pharmacists from substituting are scrutinised under the rules on disparagement of generics.

Key points

Substitution turns the authorisation of a generic into an immediate loss of volume for the reference medicinal product. Patent holders should act before entry in the register or as soon as it occurs, because action taken once substitution has actually begun does little to repair the damage. For pharmaceutical companies, any communication about the « non-substitutable » statement must remain strictly objective and based on the authorisation documents.

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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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