Our role

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Our role

• 15 February 2006
• Sandy Mather

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Aims

• To explain the HTAs ethos as a regulator
• To outline a timetable for licensing the storage
  of tissue for human application
• To explain our emerging approach to licensing
• Self assessment/compliance reporting
• Role of designated individual
• Definition of suitability of premises
• To share learning from the pilot

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Setting the scene

• Human Tissue Authority - members
• 17 (including the Chair)
• Lay majority
• Professional representatives
• Human Tissue Authority staff
• 17 (including Chief Officer)
• Four directorates regulation, policy,
  communication and resources
• Working groups professional and lay
  representatives
• Range of expertise
• Regulation, transplantation, storage,
  import/export, research, pathology, public
  display, emergency licensing
• Time-limited focussed on key outputs

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The HTAs regulatory aim

• 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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Licensing under the Human Tissue Act

• The Act regulates removal, storage and use of
  human tissue material that has come from a
  human body and consists of, or includes, human
  cells

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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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How we will 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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Regulation activities 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

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Regulation workstreams

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

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Human Tissue Act and the EUTCD

• We will regulate under both the HT Act and the
  EUTCD
• The Human Tissue Authority will license in two
  phases
• under the Human Tissue Act from 7 April 2006
• using detailed regulatory requirements for EUTCD
  when known (20062007)

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Milestones

• Programme planning approach
• Phase 1a (up to Apr 2006)
• Phase 1b (Apr - Sept 2006)
• Phase 2 (Sep 2006 Mar 2007)
• Phase 3 (Apr 2007 Mar 2008)

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Milestones

• Phase 1a up to Apr 2006
• Commence relevant parts of the Act for storage of
  tissue for human application
• Publish licensing standards for all sectors on
  the website
• Draft Codes of Practice to DH and then Ministers
  and on the website
• Transplant timetable announced
• Phase 1b Apr - Sept 2006
• Regulatory timetable - training for DIs, fees,
  inspections, TD2 finalised
• Final Codes of Practice (approved by Parliament)
  published on website

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Human Tissue Act and EUTCD timetable

• Phase 1a
• Workshops Sep - Dec 2005
• Pilots Jan 2006
• De-brief workshop for pilot sites Jan 2006
• Refine standards, guidance and web site Feb
  2006
• Commence HT Act and invite applications Mar
  2006
• Issue short term licences Apr 2006
• Phase 1b
• Evaluate self assessment/compliance reports
  Apr/May 2006
• Issue licence offers Apr/May 2006
• Issue substantive licences May/Jun 2006

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How will we license?

• Engage sector workshops
• High level requirements outcomes
• Self-assessment/compliance reporting
• HTA evaluate evidence in SA/compliance report
• Inspection every 2 years (EUTCD)

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What is self-assessment/compliance reporting?

• Purpose
• Evaluates application
• Suitability for a licence
• Applicant evaluates progress against a
  regulators standards
• Engenders change
• Drives up standards
• Regulator evaluates applicants evidence and
  determines suitability
• Advantages
• Empowers regulated sector
• Identifies areas for improvement
• Implements changes to achieve them

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Self-assessment/compliance report how this is
measured

• Assessment/compliance report is summarised
• Quantitatively
• Qualitatively
• Self-assessment/compliance report is evaluated by
  the regulator
• Regulator awards a score based on an evaluation
  of the available information about an applicant
• Regulator allocates a final score taking account
  of the applicants self-assessment score.

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Inspection

• Inspection process includes site visits and
  desk-based evaluation of information
• Site visits
• carried out prudently to benefit both applicant
  and the regulator
• gather additional visual and aural evidence
• test compliance with standards
• test validity of risk assessment and evidence
  provided

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Role of designated individual - 1

• Must be the applicant for a licence or consent to
  it
• Must be a suitable person to supervise the
  activity authorised by the licence
• Must secure that
• other people to whom the licence applies are
  suitable
• suitable practices are used
• there is compliance with licence conditions

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Role of designated individual - 2

• Securing compliance with licence conditions
• Licence conditions can be statutory, standard and
  additional
• Examples of statutory licence conditions the
  givens
• The licensed activity must only take place on the
  premises specified in the licence
• Supervise activities carried on under a licence
• Record information as required by HTA (direction
  making powers)
• Keep records specified by HTA as required by HTA
• Provide copies of records or extracts to HTA as
  may be specified
• Pay fees to the Authority in respect of its costs
  in superintending compliance with the terms of
  licences

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Role of designated individual - 3

• Additional specific licence conditions
• Require compliance where a standard is not being
  met
• Can be supportive to improve standards
• Written using the SMART principle
• Simple
• Measurable
• Achievable
• Relevant
• Time bound

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Suitability of premises - 1

• Pre-conditions to the grant of a licence
• the Authority must be satisfied that the
  premises are suitable for the activity to be
  authorised by the licence
• Define suitable

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Suitability of premises - 2

• One activity per licence
• A licence must specify the premises where the
  activity is to be carried out
• A licence cannot authorise licensed activity on
  premises at different places
• One person (DI) supervises the activities under
  a licence

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Evaluating suitability

• Standards based approach
• Consent
• Governance and Quality Systems
• Premises, Facilities and Equipment
• Disposal
• The role of Designated Individual
• Guidance about role and responsibilities
• Apply to HTA
• Education and training workshops and e-learning

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The pilot

• 12 volunteers
• Representatives from England, N Ireland, Scotland
  and Wales
• They store bone, eye, bone marrow, heart valves
  and skin
• Some have been accredited by MHRA
• On-line piloting finished 20 Jan 2006
• Final de-brief workshop with pilot sites 25 Jan
  2006
• Standards revised Feb 2006

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Human Tissue Act and EUTCD summary of time line

• Phase 1a
• Workshops Sep - Dec 2005
• Pilots Jan 2006
• De-brief workshop for pilot sites Jan 2006
• Refine standards, guidance and web site Feb
  2006
• Commence HT Act and invite applications Mar
  2006
• Issue short term licences Apr 2006
• Phase 1b
• Evaluate self assessment/compliance reports
  Apr/May 2006
• Issue licence offers Apr/May 2006
• Issue substantive licences May/Jun 2006

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Were the aims of the session achieved?

• To explain the HTAs ethos as a regulator
• To outline a timetable for licensing the storage
  of tissue for human application
• To explain our emerging approach to licensing
• Self assessment/compliance reporting
• Role of designated individual
• Definition of suitability of premises
• To share learning from the pilot

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www.hta.gov.uk