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EuropaBio Industry Hearing on Tissue Engineering and Advanced Therapies

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As the organisation representing 30 million EU patients affected by rare ... field (the AFM -French Muscular Dystrophy Association and the Italian Telethon, for ex. ... – PowerPoint PPT presentation

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Title: EuropaBio Industry Hearing on Tissue Engineering and Advanced Therapies


1
EuropaBio Industry Hearing on Tissue Engineering
and Advanced Therapies
  • Comments from Patients
  • Fabrizia BIGNAMI
  • Eurordis Therapeutic Development Officer
  • Brussels
  • 9 November 2005

2
Eurordis and the new EC proposal on advanced
therapies
  • As the organisation representing 30 million EU
    patients affected by rare diseases, we have
    always placed considerable hope on the
    advancement of genomic research and on advanced
    therapies. (5 years after the OMP Regulation,
    only less than 10 OMP over the 337 OMP
    designations are advance therapy products)
  • EURORDIS and its members have welcomed the
    Commissions proposal as an appreciated
    recognition of the status of advanced therapies.
    (Eurordis written contribution sent to the EC on
    June 2005)
  • Few well-identified patient groups in the EU are
    at the forefront of innovation in this field (the
    AFM -French Muscular Dystrophy Association and
    the Italian Telethon, for ex.).

3
EURORDIS supports most of the proposed provisions
of the future regulatory framework for advanced
therapies and in particular
  • The compulsory centralised Community marketing
    authorisation, with the intervention of a
    specialised Committee for Advanced Therapies
    (CAT),
  • The recognised need for sufficient flexibility,
  • The recognition of the principles underlying the
    donation of human tissue and cells.
  • ….But we insist that the nature of this donation,
    must be - rather than should be- voluntary
    and unpaid.

4
Some reservations
  • We totally agree that appropriate and long-term
    patient follow-up and post-authorisation
    monitoring are crucial aspects of these products,
  • However we do not agree that the sponsor should
    be directly in charge of these aspects.
  • We do agree that the data collected during any
    clinical study performed after the marketing
    authorisation have to be reported systematically
    by the sponsor, but out of the context of any
    clinical study, we would prefer a Centralised and
    Public Risk Management System to perform these
    tasks.

5
Some reservations
  • Why should the applicant be given the role of
    managing a system allowing complete traceability
    of the patient? We consider this as being
  • A threat to patients privacy
  • An interference with the role of health care
    professionals
  • And a harm for the complete independence of the
    data collection
  • It is a general Public Health Issue which should
    be treated at the MS and EU level and not left to
    the single sponsors initiative.

6
Some reservations
  • Proposal for a EU centralised and highly
    specialised structure, (or network) for Risk
    Management. Already some examples of national
    initiatives- France (RNPV), the Netherlands.
  • Because of its skills, and of its harmonised
    procedures, this structure would allow for a
    better follow-up of these products and the
    constitution of a precious public registry on
    safety and efficacy of advanced therapies
    products.
  • Any new compulsory Risk Management system,
    associated to a MA, while financed by the sponsor
    - at least until the 5-year MA renewal could be
    later continued through public funds and managed
    at European level. (Amgens G-CSF for ex.)
  • This long term follow-up and data collection
    would certainly benefit the development of the
    whole sector and would enhance public support and
    confidence towards advanced therapies.
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