Hybrid products and registration in the generics register ("répertoire des groupes génériques")

The French supreme administrative Court ("Conseil d'Etat") confirms that only the marketing authorisation may define a pharmaceutical product as generic.

In two recent decisions of 7 July 2021 (Johnson & Johnson, req. no. 437803 and GlaxoSmithKline, req. no. 440747), the French supreme administrative Court ("Conseil d'Etat") confirmed national and European law, as well as long-established case law of the supreme Courts: the identification of a pharmaceutical product as a generic with a view to its registration on the generics register ("répertoire des groupes génériques") falls within the scope of the authority in charge of the marketing authorisation.

In the first case, the French supreme administrative Court ("Conseil d'Etat") recalls that health regulations do not grant the General Director of the French National Agency for Health Products ("Agence nationale de sécurité du medicament et des produits de santé") the power to identify a product as a generic by its registration on the generics register ("répertoire des groupes génériques") since this assessment falls within the sole competence of the authority responsible for issuing the marketing authorization.

The second decision, whose importance is highlighted by its publication by the Court, deals with a specific case, the "respiratory" pharmaceutical products. The High Court annulled the registration of a hybrid product distributed by Mylan France in the generics register ("répertoire des groupes génériques") and the associated price.

The National Agency’s former decisions to register hybrid products on the generics register for substitution ("répertoire des groupes génériques"), was therefore contrary to the law.

The next step will be the implementation of the hybrids register ("répertoire des hybrides") for an effective substitution of hybrids product by pharmacists and the associated discussions with the relevant French authorities!

 

Authored by Charlotte Damiano and Hugo Petit

 

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