© safeguarding public health expert group on innovation in the regulation of healthcare products...
TRANSCRIPT
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Safeguarding public health
Expert Group on Innovation in the Regulation of Healthcare products
Adaptive Licencing workshop at the Wellcome TrustOctober 15, 2012
Slide 2Oct 15, 2012
Adaptive Licencing Workshop at the Wellcome Trust
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Expert Group work programme
• Early Access work
• International/comparative experience
• Clinical trial activity in the UK
• Defining the challenge in regulatory innovation - including Adaptive Licensing and developments in PV
• Mapping projects and initiatives - UK and US (Newdigs)
• Related initiatives- Advanced manufacturing regulation
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Adaptive Licencing Workshop at the Wellcome Trust
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Developments and Action
• Information on flexibilities in existing licensing routes - On internet and with representative bodies- MHRA Paper
• Early access consultation
• EU proposal on Clinical Trials- Wide range of other work under the Growth Review
• Adaptive licensing- Initiatives and thinking on adaptive licensing - Key questions and scoping- A pilot programme of activity on adaptive licensing by Dec
2012
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Safeguarding public health
Early Access
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Adaptive Licencing Workshop at the Wellcome Trust
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Early Access
Scope of the scheme- New medicines in areas of unmet need- Benefit:risk profile of the medicine must be positive- Availability restricted to predefined patient population
Characteristics of the scheme- MHRA provides scientific opinion on the medicine- Medicine could be available for around 1 yr before licence
grantedThe medicine remains unlicensed
- No advertising permitted
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Early Access
Eligible patients- Patients of any age (including children), no CT participants
Eligible drugs- Restricted to any therapeutic area with un-met need
Safety monitoring requirements- ADR reporting requirements will apply, additional
monitoring tbd on a case by case basis
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Adaptive Licencing Workshop at the Wellcome Trust
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Early Access
Pricing- Freedom of pricing for producers of EA drugs but- NHS Trusts decide on purchase of medicine (lower cost
encourages NHS uptake)
Patient consent and liability issues- ‘Active’ patient consent- Effective information dissemination- Manufacturer remains liable for supplying defective product
Additional criteria- Benefit to UK economy- NHS funding for the medicines must be cost effective
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Safeguarding public health
Adaptive Licencing
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Adaptive Licencing Workshop at the Wellcome Trust
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Adaptive Licencing: EU / UK? Existing Legislation or not?
If a UK scheme- Unlicensed use under the professional/legal responsibility
of prescriber- Product for un-met need- Essentially a variant of Early Access
If EU scheme- Centralised product; EU regulation applies- EMA, not UK coordinates licencing decision- European Commission will be the licensing authority
Existing regulation or not?- Essentially a matter of time-frame
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Adaptive Licencing Workshop at the Wellcome Trust
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Adaptive Licencing
3 levels of activity / tripartite structure- Level 1: EU (EMA, CHMP discussions) - Level 2: HMG/MHRA- Level 3: Industry / third sector
Critical role for EU- EU licensing process- European Commission will be the licensing authority
Considerable opportunities for action under current rules- Alternative means long timeframes
Industry must come up with a product/asset- None identified so far – on either side of the Atlantic
Merit in both retrospective and prospective work
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Adaptive Licencing Workshop at the Wellcome Trust
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Adaptive Licencing
Critical issues in regulatory decision making (risk/benefit calculation)
- Evidential levels to apply- Role of RCTs – and use and interpretation of observational data
Industry policy / public health policy- Industry financial/business risks / interests?
Patient / professional / media understanding
Wider system challenges: - Pricing / VBP - Company decisions / management of their development
pipelines and processes
Pilot project by end 2012
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Adaptive Licencing Workshop at the Wellcome Trust
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An “asset” or a product
Likely characteristics:
- break/-through product for as yet un-met need- Perhaps not as “open and shut” as Glivec, but not far off- Likely to be for small(er) patient population
· but not necessarily- For some of the AL ideas, possibly a product with multiple
potential uses- [Probably] something with an identified patient group
· Informed consent etc
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Adaptive Licencing - Forward Look
EU / EMA
- Management Board discussion: March 2013
- CHMP and other EMA committees
- Commission
HMG/MHRA
- Defining the pilot, and the problem(s) it is to solve
- Licensing routes available- Toolbox of options- Structures and roles- Governance framework
needed- Relation and link with
industry/third sector support project
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Safeguarding public health
Conclusions of Expert Group meeting
October 9 2012:
focused on Adaptive Licensing
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Conclusions of EG meeting, Oct 9
• AL to be positioned at EU level within current legislative framework• Tripartite project structure makes sense
• Practical programme of activity by the end of the year• Need to be clear about what questions we are
trying to solve
• Regulation, Clinical Trials, purchasing and R&D strategies within companies all relevant
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Adaptive Licencing Workshop at the Wellcome Trust
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Work and steps ahead
• Commissioned papers:- Pharmacovigilance
• Further consideration: - EMA level work on regulatory challenge of AL- Capacity of CPRD wrt AL
• Pilot project for the end of the year- Retrospective and prospective activity- Identification of potential products