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Actors and Networks database

The evolving field of gene and cell therapy is supported by a large community of academic, clinical, translational, regulatory and patient organisations. The Actors and Networks database maps these stakeholders in Europe and beyond, their activities, and resources they have produced. 

EuroGCT has developed and compiled this database for those interested in identifying the actors involved at each stage of the pathways bringing gene and cell therapies from lab to clinic. Coming from an academic perspective, our focus is to map information that has not been mapped elsewhere. This includes documenting the various types of interconnected regulators, patient groups actively involved along the pathways, and non-profit organisations devoted to therapy development. In its first iteration, this database does not yet include commercial partners and service providers.

Additional complementary work by other organisations on GCT stakeholders mapping can be found here.

A scientific paper on actors has also been published in Humanities and Social Sciences Communications. You can find its lay summary here.

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French Ministry of Higher Education and Research (Ministère de l’Enseignement supérieur et de la Recherche) (MESR)

Region/Country:  
  • Countries in the EU/EEA
  • France

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for Research
  • Competent Authorities for GMO
  • Competent Authorities for Animals

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Translational Research

Additional information

The Ministry of Higher Education and Research receives declarations of preservation and preparation for scientific purposes of tissues and cells from the human body for the needs of research programmes, as well as requests for authorisation for preservation and preparation with a view to their transfer for scientific use. In addition, any contained use of Genetically Modified Organism is subject to a request for authorisation or a declaration to the Ministry. Finally, the Ministry receives applications for authorisation to import/export human body parts and products for scientific purposes. / In the field of animal experimentation, the Ministry evaluates and authorises animal experimentation projects both prospectively and retrospectively. It ensures compliance with national and European regulations. It carries out the statistical tasks required by Directive 2010/63/EU, collecting and analysing data on the use of animals for scientific purposes. It also promotes the 3Rs principles (Replacement, Reduction, Refinement) to limit and improve the use of animals in research, while encouraging the development of alternative methods. Finally, it works with ethics committees and national and European authorities to ensure the responsible and controlled use of animals for scientific purposes.

French National Agency for the Safety of Medicine and Health Products (Agence nationale de sécurité du médicament et des produits de santé) (ANSM)

Region/Country:  
  • Countries in the EU/EEA
  • France

Type of Actor:

  • Regulators
  • Medicines Agencies
  • National Medicines Agencies
  • Medical Devices Entities
  • Medical Device Authorities
  • National Medical Device Authorities
  • Other National competent authorities
  • Competent Authorities for Tissues and Cells
  • Competent Authorities for Blood and Blood Components
  • Competent Authorities for Research
  • Research Funding Authorities
  • National Research Funding Authorities
  • Competent Authorities for GMO

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Manufacturing
  • Commercialisation

Additional information

The ANSM ensures the safety of health products, especially medicinal products and medical devices, throughout their life cycle. It is informed of research involving humans and authorises clinical trials. The ANSM also authorises ‘cell therapy preparations’ and advanced therapy medicinal products falling within the scope of the hospital exemption, and establishments carrying out activities related to these preparations and medicines. It is also promoting academic research on the safety of use of medicines by funding calls for projects towards research organisms, health research facilities and establishments, but also by creating Public Interest Groups (GIP), for instance, between the State, the HAS (High authority for Health), and the Institute for sanitary watch (InVS).

French National Commission for the protection of animals used for scientific purposes (Commission nationale pour la protection des animaux utilisés à des fins scientifiques) (CNEA)

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for Animals

Development Stage:

  • Fundamental Research

Additional information

The National Commission for the Protection of Animals Used for Scientific Purposes (Commission nationale pour la protection des animaux utilisés à des fins scientifiques), also known as the National Commission for Animal Experiments (Commission Nationale de l'Expérimentation Animale – CNEA), is an advisory body reporting to the Minister for Agriculture and the Minister for Research. It issues opinions on any changes to legislation or regulations relating to animal experimentation and is involved in approving training courses for designers, applicators and caretakers. It may also be called upon by the Ministers of Agriculture and Research, as well as by the Minister of Defence and the Minister of Health, on matters relating to its area of competence. It is composed of representatives of research, health and industry, as well as representatives from several ministries (Health, Research, Armed Forces, Industry).

Resources

Commission nationale pour la protection des animaux utilisés à des fins scientifiques (dite CNEA) (in French): https://www.enseignementsup-recherche.gouv.fr/fr/commission-nationale-pour-la-protection-des-animaux-utilises-des-fins-scientifiques-dite-cnea-84416

French National Commission on Informatics and Liberty (Commission Nationale de l'Informatique et des Libertés) (CNIL)

Region/Country:  
  • Countries in the EU/EEA
  • France

Type of Actor:

  • Regulators
  • Data Authorities
  • National Data Authorities
  • Other National competent authorities
  • Competent Authorities for Research

Development Stage:

  • Fundamental Research
  • Clinical Research
  • Translational Research
  • Health Data

Additional information

The CNIL issues reference methodologies, some of which are designed for health data in the context of research. For research protocols that do not fit one of the existing reference methodologies, a favourable opinion from the CNIL is required before undertaking research involving humans, including clinical trials.

French National Committee for Ethical Reflection on Animal Experimentation (Comité National de Réflexion Éthique sur l'Expérimentation Animale) (CNREEA)

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for Animals

Development Stage:

  • Fundamental Research

Additional information

Reporting to the National Commission for the Protection of Animals Used for Scientific Purposes (CNEA), the National Committee for Ethical Reflection on Animal Experimentation (Comité National de Réflexion Éthique sur l'Expérimentation Animale – CNREEA) is a consultative body responsible for promoting ethical reflection on the use of animals for scientific purposes in France. It ensures that ethical principles are applied and helps to draw up recommendations and guidance for good practice in the field of animal experimentation for those involved in the sector (CNEA, C2EA ethics committees, user establishments, veterinary services). It also draws up annual reports on the activities of the ethics committees on animal experimentation (C2EA) in order to formulate its recommendations.

French National Institute of Industrial Property (Institut National de la Propriété Industrielle) (INPI)

Region/Country:  
  • Countries in the EU/EEA
  • France

Type of Actor:

  • Regulators
  • Patent Offices
  • National Patent Offices

Development Stage:

  • Fundamental Research

French National Network of Ethics Committees for Animal Experimentation (Réseau national des comités d'éthique en expérimentation animale) (National Network C2EA / Réseau National C2EA)

Region/Country:  
  • Countries in the EU/EEA
  • France

Type of Actor:

  • Regulators
  • Other National competent authorities
  • Competent Authorities for Animals

Development Stage:

  • Fundamental Research

Additional information

The National Network of Ethics Committees for Animal Experimentation (Réseau national des comités d'éthique en expérimentation animale – National Network C2EA) is a coordinating body that brings together all the Ethics Committees for Animal Experimentation (Comités d’éthique en expérimentation animale – C2EA) in France. Its aim is to harmonise ethical assessment practices for projects involving animals for scientific purposes, by encouraging the exchange of information and best practice between committees.

Resources

Institutional framework for the ethical supervision and protection of animals used for scientific purposes in France, including a complete organisational chart (In French): https://www.sbea-c2ea.fr/lanimal-dans-la-recherche/

French National Research Agency (Agence Nationale de la Recherche) (ANR)

Region/Country:  
  • Countries in the EU/EEA
  • France
Website:  

Type of Actor:

  • Research Funding Authorities
  • National Research Funding Authorities

Development Stage:

  • Fundamental Research
  • Translational Research
  • Clinical Research

Additional information

The French National Research Agency (ANR) is a public administrative institution under the authority of the French Ministry of Higher Education, Research and Innovation. The agency funds project-based research carried out by public operators cooperating with each other or with private companies. It was founded in 2005 to promote French project-based research and to stimulate innovation by promoting the emergence of collaborative multidisciplinary projects and encouraging collaboration between the public and private sectors.

French National Union of Health Insurance Funds (Union Nationale des Caisses d'Assurance Maladie) (UNCAM)

Type of Actor:

  • Regulators
  • Payers

Development Stage:

  • Commercialisation

Additional information

The UNCAM is the French body that brings together representatives of the general and agricultural social security schemes. Its role is to co-ordinate the work of the national funds in managing the health insurance system, and to establish partnerships with healthcare professionals and complementary social protection bodies. It is also responsible for managing the agreement policy, defining the scope of services eligible for reimbursement and setting the rate at which care is covered. In the case of medicines, it is responsible for setting reimbursement rates.

French Public Investment Bank (Banque publique d’investissement) (BPI)

Region/Country:  
  • Countries in the EU/EEA
  • France

Type of Actor:

  • Research Funding Authorities
  • National Research Funding Authorities

Development Stage:

  • Fundamental Research
  • Translational Research
  • Clinical Research

Additional information

Since 2013, Bpifrance has become the one stop shop for entrepreneurs with a vastly comprehensive toolbox offered in the field to customers through 50 local branches. BPI is also the French agency for innovation, delivering massive programs to innovative entrepreneurs. Bpifrance is a financial institution, with private culture, serving the collective interest. In the health sector, Bpifrance supports by investing, funding and helping Health innovation businesses. In 2018, 503 businesses in the health sector have benefitted from 158 M€ of innovation funds.

Resources

Innovation and Health: do you know what Bpifrance is doing?: https://www.bpifrance.fr/nos-actualites/innovation-et-sante-connaissez-vous-les-actions-de-bpifrance (In French)
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