France defines medical situations in which physicians can exclude generic substitution

The Order provides that, from 1 January 2020, substitution can only be excluded on prescriptions in the following three medical situations:

• Prescriptions of medicines with a narrow therapeutic margin to ensure the stability of the dispensation, when patients are effectively stabilised with a medicine, and excluding treatment adaptation phases.
• Prescriptions for children under six years of age, where no generic medicinal product has a suitable dosage form and the available reference medicinal product allows this administration.
• Prescriptions for patients with a formal contraindication and demonstrated contraindication to an excipient with a known effect present in all available generic medicinal products, when the reference medicinal product does not contain this excipient.

The active ingredients of medicines that may be covered by the first exception are listed in the Annex of the Order: lamotrigine, pregabalin, zonisamide, levetiracetam, topiramate, sodium valproate, everolimus, levothyroxine, mycophenolate mofetil, buprenorphine, azathioprine, cyclosporine and mycophenolate sodium.

In addition, the Order also clarifies that the justification must be indicated on the prescription.

The aforementioned provisions entered into force on 1 January 2020.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, December 2019 Issue (Thomson Reuters).