Creating conditions for the success of the French industrial advanced therapy sector
Therapie. 2015 Jan-Feb;70(1):69-94.
doi: 10.2515/therapie/2015005.
Epub 2015 Mar 6.
[Article in
English,
French]
Authors
Pierre Noel Lirsac
1
, Olivier Blin
2
, Jérémy Magalon
3
; participants of round table N°5 of Giens XXX:; Pierre Angot
4
, Estelle de Barbeyrac
5
, Pascal Bilbault
6
, Elisabeth Bourg
7
, Odile Damour
8
, Patrick Faure
9
, Nicolas Ferry
10
, Bénédicte Garbil
4
, Jérôme Larghero
11
, Marina Nguon
11
, François Pattou
12
, Stéphane Thumelin
13
, Frank Yates
14
Affiliations
- 1 CELLforCURE, Les Ulis, France.
- 2 Assistance Publique - Hôpitaux de Marseille, Service de Pharmacologie, Marseille, France.
- 3 Assistance Publique - Hôpitaux de Marseille, Laboratoire de Culture et Thérapie Cellulaire, Marseille, France - Unité Inserm 1076 : Endothélium, Pathologies Vasculaires et Cibles Thérapeutiques, Faculté de Pharmacie, Marseille, France.
- 4 Ministère de l'Economie, de l'Industrie et du Numérique, Paris, France.
- 5 Genethon, Evry, France.
- 6 Laboratoire Boehringer-Ingelheim, Reims, France.
- 7 Laboratoire Novartis, Rueil Malmaison, France.
- 8 Hospices Civils de Lyon, Lyon, France.
- 9 SATT Sud Est, Marseille, France.
- 10 ANSM, Saint Denis la Plaine, France.
- 11 Assistance Publique - Hôpitaux de Paris, Paris, France.
- 12 Centre Hospitalier Régional Universitaire, Lille, France.
- 13 Inserm Transfert, Paris, France.
- 14 Sup'Biotech/CEA, Montrouge, France.
Abstract
Although the European Union merely followed the initiatives of the United States and Japan by introducing special regimes for orphan medicinal products, it has introduced a special status for a new category of biological medicinal products, advanced therapy medicinal products (ATMPs), adopting specific associated regulations. European Regulation (which constitutes the highest legal instrument in the hierarchy of European law texts) [EC] No. 1394/2007, published in 2007, uses this term to define somatic cell therapy medicinal products, tissue-engineered products, and gene therapy medicinal products, possibly combined with medical devices. The stated objective was two-fold: both to promote their industrialization and market access, while guaranteeing a high level of health protection for patients. Since publication of the regulation, few marketing authorizations have been granted in Europe, and these have not been accompanied by commercial success. However, certain recent studies show that this is a growing sector and that France remains the leading European nation in terms of clinical trials. This round table brought together a panel of representatives of French public and private protagonists from the advanced therapy sector. The discussions focused on the conditions to ensure the success of translational research and, more generally, the French advanced therapy sector. These enabled a number of obstacles to be identified, which once lifted, by means of recommendations, would facilitate the development and success of this sector.
© 2015 Société Française de Pharmacologie et de Thérapeutique.
MeSH terms
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Biological Products* / classification
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Biomedical Research / legislation & jurisprudence
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Biomedical Research / trends*
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Cell- and Tissue-Based Therapy
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Certification / legislation & jurisprudence
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Clinical Trials as Topic / legislation & jurisprudence
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European Union
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France
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Genetic Therapy / legislation & jurisprudence
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Health Policy
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Humans
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Inventions / economics
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Inventions / trends
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Manufacturing Industry / economics
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Manufacturing Industry / legislation & jurisprudence
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Manufacturing Industry / organization & administration
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Organisms, Genetically Modified
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Orphan Drug Production / legislation & jurisprudence
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Tissue Engineering / legislation & jurisprudence
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Universities / legislation & jurisprudence