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A summary of regulatory activity – a look back and a look forward

A summary of regulatory activity – a look back and a look forward. 21 October 2010 Imogen Swann. Looking back. The European Tissues and Cells Directives.

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A summary of regulatory activity – a look back and a look forward

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  1. A summary of regulatory activity – a look back and a look forward 21 October 2010 Imogen Swann

  2. Looking back

  3. The European Tissues and Cells Directives • The transplantation of human tissues and cells is a strongly expanding field of medicine offering great opportunities for the treatment of as yet incurable diseases. The quality and safety of these substances should be ensured, particularly in order to prevent the transmission of diseases. (Directive 2004/23/EC)

  4. Summary of inspections 2006- 2011/12 13 51 44 90 90 99 0 0 10 45 42 ~41 0 0 2 5 ? ?

  5. Conditions proposed since 2007 • A total of 646 conditions have been proposed to the licences of 117 establishments

  6. Conditions breakdown Of the 646 conditions proposed by the HTA: • 62 were met before the condition was applied • 485 have so far been met satisfactorily

  7. Conditions imposed on site-visit inspection 2008/09 vs 2009/10 2009/10 2008/09

  8. Number of conditions applied following 1st inspection compared to those applied following 2nd inspection (2009)

  9. The business year so far…

  10. The business year so far… • inspections • regulatory policy development • projects • stakeholder engagement

  11. Inspections completed this business year • 47 inspections of main sites/hubs • 13 satellites

  12. Feedback following inspections (2010) What we did well... ‘Flexible to the specific establishment and staff’ ‘Came over as balanced and pragmatic, whilst also being probing with an expectation of high standards’ ‘A very structured day and meetings/interviews conducted in a non-confrontational and professional manner. The exchange of ideas and information was actually very informative and enjoyable’

  13. Feedback following inspections (2010) What we could do better... ‘1 inspector would probably have been sufficient’ ‘Some of the information given was difficult to interpret’ ‘Request for detailed information in preceding 2 weeks was a little 'last minute‘’

  14. Joined up inspections with the MHRA • Some establishments licensed by MHRA and HTA • Establishments either: • procure and test tissues and cells for medicines (sequential licensing) • hold MHRA and full HTA licence due to different types of activities (parallel licensing).

  15. First trial joint inspection - March 2010 • establishment fully licensed by HTA and MHRA • mutually observed inspection, 2 days

  16. Feedback on joint inspections • This was the first joint HTA/MHRA inspection. Our team found the reduced preparatory burden beneficial and it was helpful to have both regulatory present to answer questions and offer advice - particularly relating to the Advanced Therapy Medicinal Product Regulation... • The experience of the joint MHRA/HTA was very positive and highly educational, requiring the minimum investment of time. Therefore continuation of joint inspections, wherever possible, is highly recommended.

  17. Further developments • 1 further trial joint inspection carried out • 2further joint inspections currently planned for the remainder of the year • establishing a rota of suitable establishments • evaluation of trial phase at the end 2010 • more definite protocols for sequential and parallel inspections to be developed

  18. Third party inspections HTA has a statutory responsibility to ensure that third party arrangements are suitable… • piloted four third party inspections • two of the third parties carried out testing on behalf of HTA licensed premises • two of the third parties carried out cord blood procurement on behalf of HTA licensed premises

  19. Findings from inspecting third parties • Over reliance by Designated Individuals on the third party agreement, tended to result in • poor communication between licensed establishments and third parties • limited audit of the third parties’ processes or practices by licensed establishments • some third parties being unaware of the requirement to report adverse event or reactions.

  20. Policy Development • HTLV testing • placenta encapsulation • embryonic stem cell testing • the meaning of ‘single procedure’ re the Tissues and Cells Directives

  21. Current projects • cord blood guidance document • re-write and consolidation of HTA Directions 001/2006, 002/2007, 004/2007 • SOHO V & S project • process review • this conference!

  22. Engagement Advisory committee on the Safety of Blood Tissues and Organs (SaBTO) UK National Stem Cell Network (UKNSCN) European Commission – health directorate (DG Sanco) Cord Blood Establishments MHRA & HFEA Other Competent Authorities

  23. Looking forward

  24. New Directions 003/2010 - highlights • replace 001/2006, 002/2007 & 004/2007 • testing • third party agreements • 24 hour SAEARs • plain English • TPA template http://www.hta.gov.uk/_db/_documents/Third_party_agreement_submission_form.doc Issued on 12 November

  25. HTA cord blood guidance document To be published on HTA website 26 November

  26. Publication of inspection reports • letter sent to all establishments 1 October 2010 • all reports issued from inspections taking place from November 1 2010 to be placed on HTA’s website during January 2011

  27. Introduction of new and streamlined processes • exception reporting, resulting in - concise, focused inspection reports • reduction in the use of conditions to address deficiencies, resulting in - a reduction in administrative processes following an inspection

  28. Organ Donation Directive • working with Department of Health • collaborative working with NHSBT

  29. New fees model for 2011/12 2010/11 licence fees: £5,600 + Cost for satellites £2,800 1 – 3 £3,200 £950 £950 4 – 10 £1,600 £950 £500 11+ £1,100 £500 £500

  30. Final reflections...

  31. "we are all potential donors". “It is necessary to promote information and awareness ...on the donation of tissues, cells and organs based on the theme ‘we are all potential donors’”. (Directive 2004/23/EC)

  32. Q Please tell me to what extent, if at all, you agree or disagree with the following statement? % Strongly agree % Tend to agree % Neither / nor % Tend to disagree % Strongly disagree % Don't know Knowing that there is a regulator for the donation, storage, use and disposal of 17 35 24 8 8 7 human tissue, would make me more confident to donate my organs for transplants 15 34 26 9 8 8 30 5 12 11 7 th th Base: All adults aged 15+ (967), fieldwork dates: 13 - 19 August 2010 Source: Ipsos MORI The effect of having a regulator on the propensity to donate

  33. Regulation Regulation improves standards Increases public confidence Increases donations?

  34. A shared objective... ‘To safeguard human tissues and cells for human application’.

  35. www.hta.gov.uk

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