Adaptive Licensing UK

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Adaptive Licensing UK
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Content

• What is adaptive licensing?
• Draft criteria for pilot candidate selection
• EMA Road Map 2015 and work programme 2012
• UK perspective
• Summary of workshop agreements

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What is adaptive licensing (AL)?

• Adaptive licensing is a prospectively planned
  customised approach to regulation based on
  iterative assessment of benefits, risks and
  uncertainties.
• Adapted from Eichler et al. Nature CPT, 91 3,
  426-437.

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AL Aims

• To increase the efficiency of the biomedical
  innovation paradigm by streamlining of
  development, regulation and market access for
  selected products.
• To balance timely access for patients with the
  need to provide adequate evolving information on
  benefits and risks.

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AL Key features

• Judicious authorisation based on early
  risk/benefit assessment in agreed restricted
  population. Followed by iterations of prompt
  label adaptations informed by data from
  monitoring of real-life effectiveness and
  safety.
• All stakeholders contribute to a prospective
  development plan and input into the design of the
  confirmatory trials.
• Customised drug- and disease- specific licensing
  pathways that may utilise existing regulatory
  mechanisms.
• Managed market entry controlling patient-access
  with re-imbursement conditional on data
  collection on safety and efficacy. With the
  opportunity to inform value assessment.

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Draft criteria for pilot candidate selection

1. A willing commercial participant.
2. A robust case for why existing regulatory
   pathways not suitable. For example unmet clinical
   need.
3. Anticipated acceptable risk/benefit profile in
   the target disease area with reasonable
   certainty.
4. Sufficient numbers of patients that can be
   recruited in the UK or opportunity for EU
   collaboration.
5. Appropriate data collection mechanisms. For
   example robust trial networks in the specific
   disease area with clinicians that are interested
   in participating in research.
6. If possible, existing patient support mechanisms.
   
7. AL route anticipated to reduce time to market and
   development costs.

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The UK perspective

• Strategy for life sciences
• A group of experts drawn from government,
  regulators, the NHS, industry, and the academic
  and third sector communities will meet quarterly
  to discuss healthcare regulation issues,
  including the development of new initiatives and
  innovations.
• The Ministerial (Biopharmaceutical) Industry
  Strategy Group Innovative Technology Forum will
  be responsible for ensuring the delivery of these
  initiatives, and will provide an annual report to
  DH and BIS ministers. This will set out measures
  of performance such as the use of conditional
  authorisation pathways, and uptake of the Early
  Access Scheme, alongside next steps proposals
  for further regulatory innovation.
• UK stakeholder workshop 2nd April 2012, Welcome
  Trust.

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April 2012 Workshop agreement

• There are a number of issues with the current
  innovation ecosystem which may need different
  solutions for different medicines.
• Adaptive licensing is an interesting proposition
  that is worth further exploration.
• A working party should be established with
  membership drawn from key stakeholders. Their
  activity should be guided by an independent
  advisory group.
• The UK could be a potential site for an adaptive
  licensing pilot and an expression of interest
  should be submitted to the EMA.
• The timelines should be established and a project
  plan developed.
• Collaborative links to continue with the NEWDIGS
  consortium.