Article 31 bis of the Social Security Financing Bill (PLFSS) for 2023 provides for the possibility for pharmacists to substitute certain medical devices.
Unlike medicinal products, for which substitution has become a principle that is difficult to derogate from, there is no substitution regime for medical devices.
In this context, an option to substitute a medical device similar to the one prescribed had exceptionally been opened to pharmacists during the health crisis (it has been terminated in 2021).
Considering that “this measure [put in place during the state of health emergency] has proven its usefulness“, the Government has proposed the creation of a permanent regime for the substitution of medical devices by pharmacists.
Under what conditions will a medical device be substitutable?
Article 31 bis of the PLFSS for 2023 inserts an article L. 5125-23-3 into the Public Health Code. This article defines the four conditions that give rise to the right to substitute a medical device with a comparable product:
- The product appears on a list established by ministerial order after the opinion of the High Authority of Health (HAS);
- Any conditions set by the said list must be respected. These conditions may concern:
- substitution (for example, only for the initiation of treatment);
- and/or information of the prescriber and the patient at the time of this substitution.
- The prescriber has not excluded the possibility of substitution (express and justified mention on the prescription);
- If the prescribed product is listed on the LPPR, the substitution must not result in additional expenditure for the health insurance system that is higher than the expenditure that would have been incurred if the prescribed product had been dispensed.
How much leeway do prescribers have?
Article 31 bis of the PLFSS implies that the prescriber could exclude substitution if “the patient’s medical situation” justifies it.
This “flexibility” contrasts with the regime applicable to the medicinal product, which only allows the prescriber to exclude substitution if (i) the medicinal product has a narrow therapeutic margin (MTE), or (ii) no generic has a galenic form suitable for children, or (iii) the patient has a formal and proven contraindication to an excipient (for more information, see our article of February 6, 2020).
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