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Early access to health products in France: Major advances of the French “Conseil stratégique des industries de santé” (CSIS) to be implemented (modalities, regulations, funding) - 23/02/19

Doi : 10.1016/j.therap.2018.12.002 
Nicolas Albin a, , b , Frédéric Chassagnol c, Jean-François Bergmann d

the participants of Giens XXXIV Round Table “Organisational and regulatory aspects”

Lotfi Boudali q, Olivier Blin e, Thibault de Chalus f, Estelle Fruchet g, Mathilde Grande h, Françoise Grudé i, Natalie Hoog-Labouret j, Céline Kauv k, Frédéric Lavie l, Claire Le Jeunne m, Fabrice Meillier n, Brigitte Pouletty-Lefebvre o, Anne-Céline Richard p
e AP–HM, La Timone, 13285 Marseille, France 
f AMGEN France, 92650 Boulogne-Billancourt, France 
g Gilead, 92100 Boulogne-Billancourt, France 
h HAS, 93210 Saint-Denis, France 
i Observatoire de cancer des OMEDIT Bretagne et Pays de la Loire, 49000 Angers, France 
j INCA, 92000 Boulogne-Billancourt, France 
k Takeda France, 92977 Nanterre, France 
l Janssen France, 92787 Issy-les-Moulineaux, France 
m Hôpital Cochin, AP–HP, 75014 Paris, France 
n Les entreprises du médicament, 75017 Paris, France 
o Sanofi, 94250 Gentilly, France 
p Astrazeneca, 92400 Courbevoie, France 
q ANSM, 93285 Saint-Denis, France 

with collaboration

Benjamin Mazaleyrat r, Adrien Monard s
r Roche France, 92650 Boulogne-Billancourt, France 
s Groupe hospitalier mutualiste de Grenoble, institut Daniel Hollard, 8, rue Docteur-Calmette, CS10043, 38028 Grenoble cedex 1, France 

a Groupe hospitalier mutualiste de Grenoble, institut Daniel Hollard, 8, rue Docteur-Calmette, CS10043, 38028 Grenoble cedex 1, France 
b ANSM, 93285 Saint-Denis, France 
c Roche France, 92650 Boulogne-Billancourt, France 
d Hôpital Lariboisière, 75010 Paris, France 

Corresponding author.

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Summary

In a context of perpetual evolution of treatments, access to therapeutic innovation is a major challenge for patients and the various players involved in the procedures of access to medicines. The revolutions in genomic and personalized medicine, artificial intelligence and biotechnology will transform the medicine of tomorrow and the organization of our health system. It is therefore fundamental that France prepares for these changes and supports the development of its companies in these new areas. The recent “Conseil stratégique des industries de santé” launched by Matignon makes it possible to propose a regulatory arsenal conducive to the implementation and diffusion of therapeutic innovations. In this workshop, we present a number of proposals, our approach having remained pragmatic with a permanent concern to be effective in the short term for the patients and to simplify the procedures as much as possible. This was achieved thanks to the participation in this workshop of most of the players involved (industrial companies, “Agence nationale de sécurité du médicament et des produits de santé”, “Haute Autorité de santé”, “Institut national du cancer”, “Les entreprises du médicament”, hospitals, “Observatoire du médicament, des dispositifs médicaux et de l’innovation thérapeutique”…). The main proposals tend to favor the implementation of clinical trials on our territory, especially the early phases, a wider access to innovations by favoring early access programs and setting up a process called “autorisation temporaire d’utilisation d’extension” (ATUext) that make it possible to prescribe a medicinal product even if the latter has a marketing authorisation in another indication. In addition, we propose a conditional reimbursement that will be available based on preliminary data but will require re-evaluation based on consolidated data from clinical trials and/or real-life data. Finally, in order to better carry out these assessments, with a view to access or care, we propose the establishment of partnership agreements with health agencies/hospitals in order to encourage the emergence of field experts, in order to prioritize an ascending expertise closer to patients’ needs and to real life.

Il testo completo di questo articolo è disponibile in PDF.

Keywords : Early access, Innovation, Marketing authorisation, Temporary authorisation for use, Reimbursement, Strategic council for health industries


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 Articles, analyses and proposals from Giens workshops are those of the authors and do not prejudice the proposition of their parent organization.


© 2018  Société française de pharmacologie et de thérapeutique. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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Vol 74 - N° 1

P. 103-117 - Febbraio 2019 Ritorno al numero
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