Une révolution médicale en marche : Le Généthon Bioprod d’Evry autorisé à ouvrir la voie des médicaments de thérapie innovante

Michel Berson vient d’obtenir du Ministère de l’Ecologie la levée des derniers blocages qui empêchaient le Généthon Bioprod d’Evry de conduire des essais cliniques de thérapie génique.

A la demande de Michel Berson, la ministre de l’Ecologie, Delphine Batho, vient de signer le décret d’application de la loi n°2011-302 du 22 mars 2011 relatif à la production et la distribution de médicaments de thérapie innovante (MTI).

Ce décret d’application était nécessaire pour permettre à Généthon Bioprod, l’un des principaux centres de R&D de l’Association Française contre les Myopathies, de conduire des essais cliniques sur des traitements innovants dédiés aux maladies rares et notamment neuromusculaires.

Pour la première fois, un laboratoire de recherche sous statut associatif va être reconnu comme un « établissement pharmaceutique » de plein exercice. Une véritable révolution dans ce milieu très fermé du médicament dominé par les grands groupes des industries pharmaceutiques.

Si ce décret avait été rédigé et validé par le Conseil d’Etat et signé par le ministre de la Santé et le ministre de la Défense, il lui restait à être contresigné par la ministre de l’Ecologie.

Michel Berson se félicite de la décision rapide prise par Delphine Batho à la suite de son intervention, qui va permettre à Généthon Bioprod de mettre en production les premiers lots cliniques. Une décision particulièrement attendue par nombre de malades pour qui les thérapies géniques constituent, à terme, un formidable espoir de guérison.

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