National Bereavement Partnership Conference' 31 Oct1 Nov 2005'

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National Bereavement Partnership Conference. 31
Oct1 Nov 2005.
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What we are

• An independent regulator
• Inspiring professional, patient and public
  confidence
• A proportionate regulator inspecting according
  to risk
• Supportive offering clarity and guidance
• Collaborating with other regulators best
  practice and avoid duplication

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What is the HTA aiming for?
To create an effective regulatory framework for
the removal, retention, use and disposal of human
tissue and organs in which the public and
professionals have confidence
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How will we do this?

• By introducing a regulatory system that is
  proportionate to risk
• By consulting widely and listening before
  preparing guidance and advice
• By providing clear guidance and advice keeping
  things as uncomplicated as possible!

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The Givens
The Human Tissue Act 2004 exists!
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The Consultation Process and Beyond

• Consultation on first five 11 July 2005
• Codes of Practice launched
• Four consultation workshops September 2005
• England (2), Wales and
• Northern Ireland 100 attendees
• 116 responses received by 4 October 2005
• close of consultation

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The Consultation Process and Beyond

• HTA will analyse comments November 2005
• and decide on final draft
• To Ministers November 2005
• Parliament December 2005
• Publication Early 2006

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Human Tissue Act and the EUTCD

• We will regulate under both the HT Act and the EU
  Tissues and Cells Directive
• The Human Tissue Authority has decided to issue
  interim licences for storage and also license all
  other areas covered by the HT Act in 2006

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Regulation

• Workstreams
• Licensing
• Pilot methodology
• Standards
• Self assessment
• Designated Individual
• Inspections
• Fees
• EUTCD
• Advice and guidance

• Sectors to be licensed
• Anatomical examinations
• Post mortem examinations
• Removal of PM material
• Storage of PM material
• Storage of anatomical specimens
• Storage of material from a living person
• Public display

Engage external expertise and recruit regulation
team
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Your concerns

• What activities require a licence from HTA?
• Who needs to apply for a licence from HTA?
• How do I apply for a licence?
• When will a licence be required?
• What will happen if I miss the deadline for
  application for a licence?

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Your concerns

• Will my place of work be inspected?
• Who will perform the inspection?
• How much will a licence cost?
• How long will a licence last?
• What will happen if the inspection identifies
  problems in my workplace?

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Future communications

• Forums for communication in your sector
• Upcoming meetings
• How would you like us to keep you informed of our
  work programme?
• Contact Shaun Griffin on 020 7211 3407 or
  shaun.griffin_at_hta.gov.uk

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Contacts

• Sandy Mather, Head of Regulation
• Peter Lemmey, Head of Policy
• Shaun Griffin, Head of Communications
• Colin Pavelin, Head of Resources
• Contact us on 020 7211 3407
• Web www.hta.gov.uk

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www.hta.gov.uk