Developing regulatory methodology (DRM): implementing a continuous licensing system for all sectors

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Developing regulatory methodology (DRM)
implementing a continuous licensing system for
all sectors
25 March 2009 Dr Christopher Birkett
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Aims and outcomes

• To help you understand
• the background to the HTAs licensing system and
  why it needed to be changed
• the process by which the HTA reviewed and revised
  its regulatory methods
• the human application sectors contribution to
  the process
• the next steps for licence renewal

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Background

• HTA licensing began in 2006
• Fixed term licences were chosen, mainly to allow
  a smooth transition to the planned successor
  organisation (RATE)
• In October 2007, Ministers announced that HTA
  would remain as a separate regulator
• First HTA licences will expire in July 2009
• There was a need to develop the HTA licence
  renewal process, for all sectors, for 2009

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DRM programme

• Carried out in the 2008/9 business year
• Each sector was considered in parallel, to
• investigate the options for licensing
• develop a proportionate system for renewing
  licences
• Each workstream included a review of how we
• determine an establishments overall risk
• schedule inspections

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Research and stakeholder engagement

• Desk-based research
• What do other regulators do?
• Interviews with individual stakeholders
• Face-to-face
• Telephone
• Email correspondence
• Workshops
• Discussions with key opinion leaders and other
  regulators in Europe

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Suggestions from the HA sector

• Requests for a simple licence renewal process
• The HTA should request only limited additional
  information in order to renew licences
• Large number of suggestions for improving the HTA
  risk matrix

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DRM outcome

• Licence duration is not directly linked to
  regulatory compliance
• Current and new HTA licences will be continuous,
  which avoids unnecessary bureaucracy
• Human application establishments will not need to
  submit additional information other than that
  already required

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Our thanks, to all who contributed
Thank you
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Next steps

• Implementation of continuous licensing will begin
  in the 2009/10 business year
• No need to reapply
• Removal of licence end dates will be done by the
  HTA (licence variations)
• Opportunity to review and amend the standard
  licence conditions
• Replacement licence certificates will be issued

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• Questions

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www.hta.gov.uk