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Accès aux médicaments non encore commercialisés : c’est simple ?

Accès aux médicaments non encore commercialisés : c’est simple ?

Publiée le mardi 13 juillet 2021 à 05h45 dans Actu Juridique

Il existe une procédure spécifique permettant aux patients atteints d’une maladie grave ou rare d’accéder à des médicaments non encore commercialisés. Cette procédure vient d’être modifiée pour faciliter encore plus l’accès à ces médicaments. Explications.


Un accès aux médicaments non encore commercialisés facilité

Jusqu’à présent, 6 mécanismes différents coexistaient pour permettre aux patients atteints d’une maladie grave ou rare d’accéder à des médicaments non encore commercialisés.

Le gouvernement a décidé de simplifier et d’unifier ces mécanismes pour permettre aux patients d’avoir le plus rapidement possible accès aux médicaments présumés innovants et aux thérapeutiques qui leur sont indispensables.

Voici les nouveautés à retenir :

  • les étapes de la procédure sont raccourcies ;
  • dans un délai de 3 mois à compter de la recevabilité du dossier, le laboratoire sait désormais si son produit obtient une autorisation d’accès précoce ; il doit ensuite le mettre à disposition des patients dans un délai de 2 mois ;
  • création d’un recueil obligatoire de données observationnelles pour renforcer les connaissances sur le médicament utilisé et s'assurer de son intérêt pour les malades ;
  • mise en place d’un guichet unique, via le portail SESAME, pour rendre plus fluides les étapes de la procédure d’accès aux soins pour les patients.

Source :

  • Décret n° 2021-869 du 30 juin 2021 relatif aux autorisations d'accès précoce et compassionnel de certains médicaments
  • https://ansm.sante.fr/actualites/reforme-de-lacces-derogatoire-aux-medicaments-renforcer-lacces-aux-traitements-innovants-pour-les-patients-en-impasse-therapeutique

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Plus d’informations ?

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  • Sotorec
    267 bd. du Docteur Charles Barnier
    83000 Toulon
  • 04 94 09 17 02
  • +33494895133

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