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Safeguarding Tissues & Cells for Human Application

Safeguarding Tissues & Cells for Human Application. Implications of regulations on Tissue banks Keith Smith. Safeguarding – Against What?. Unethical removal and exploitation of “Freely” donated human material. Removal and use without informed consent. Safeguarding – For What Reasons?.

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Safeguarding Tissues & Cells for Human Application

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  1. Safeguarding Tissues & Cells for Human Application Implications of regulations on Tissue banks Keith Smith

  2. Safeguarding – Against What? Unethical removal and exploitation of “Freely” donated human material Removal and use without informed consent

  3. Safeguarding – For What Reasons? Safety and well-being of patients Reputation of the tissue & cell banking sector Future Supply of safe starting/raw material for clinical development and ATMPs

  4. Does Cell & Tissue Banking need Regulating? Yes – Why? Because of real physical and emotional risks for donors, donor’s families & particularly for recipients of tissues and cells

  5. Risk – Some Examples Tendon Replacement – Sepsis, Amputation, Death Removal & use of tissue without consent HCV Transmission through HPC

  6. Risk – What Scale? In the first 6 months of 2010 NHSBT has provided: 2200 + Tissue grafts of all types for use in surgery 1800 + Doses of HPC for transplantation How many SEARs? – NHSBT Ca 12-15 pa

  7. Types of Regulation? Self Regulation – Internal Policies and oversight Voluntary Regulation – Professional Standards & Accreditation schemes State Regulation – Mandatory Standards & Licensing

  8. Implications? COST ! COST of Licensing – NHSBT Ca £400 K p.a. COST of Compliance ?? – Considerably more? Statutory Standards are the same for all, large & small

  9. Implications? Finding a Suitable Designated Individual Establishing Suitable Governance Arrangements Preparing for and responding to inspections

  10. Implications? Disjointed regulation and unclear links with other legislation – BSQR, Medicinal products. Single set of European Directives enacted through different legislation in UK unlike other EU states.

  11. Implications? Reporting of Serious Adverse Events & Reactions (SEARs) • Finding outAssessing the Clinical ImpactFiling the report - Timeliness Alerts – Use of the CAS system.

  12. TQSR – What have we gained? Minimum standards of best practice & a level playing field Confidence? Legal rights and protection Better placed to support UK clinical R&D using tissue & cells and ATMPs Controls over imported material – Commercial Interests

  13. TQSR – What has the patient gained? Clear legal accountability Assurance of systematic improvement in quality & safety of tissue and cell grafts Independent oversight of the supply of tissues & cells - Confidence

  14. TQSR – What have we lost? Flexibility? Proportionality? Freedom from bureaucracy? Clinical Interest? Low cost provision?

  15. Last Words With all the safeguards in place one thing we must safeguard is the actual provision of sufficient tissues and cells to meet the growing UK demand and in particular the means for local supply.

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