France clarifies situations in which physicians and pharmacists can exclude generic substitution

The Order of 12 November 2019 listed three medical situations in which substitution could be excluded by physicians. The Implementing Order goes further and gives pharmacists the possibility to exclude substitution even when the physician does not exclude generic substitution on the prescription, for prescriptions of medicines with a narrow therapeutic margin, when they deem it necessary to ensure the stability of dispensation, when patients are effectively stabilised with a medicine, and excluding treatment adaptation phases.

As with physicians, the pharmacist's ability to exclude substitution is limited to the list of active ingredients of medicines listed in the Annex of the Order of 12 November 2019.

Contrary to physicians, pharmacists must mention the exclusion on the prescription in handwritten form (using a specific mention), for each medicinal product to which it applies. They must also inform the prescribing physician of their decision.

These new provisions entered into force on 6 February 2020.

This post was originally co-authored by Eveline Van Keymeulen.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, March 2020 Issue (Thomson Reuters).