Improving the regulatory framework Comments from a European perspective

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Improving the regulatory framework---------------
---------------Comments from a European
perspective

• STEVE DEAN
• Chief Executive Officer
• VETERINARY MEDICINES DIRECTORATE

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The key ambition

• The availability of safe and effective
• veterinary medicines

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What does it all mean?

• Availability is essential for the treatment and
  prevention of animal disease.
• A safe medicine means
• Protection of consumers and users of medicines
• Benefit risk analysis is correct for animals
• Disposal and use does not damage the environment
• Effective provides assurance on efficacy of the
  medicine
• Veterinary medicine suggests the product has
  been specifically authorised for safe an
  effective use against animal disease

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and so?

• We can conclude that
• It is desirable for all medicines to have been
  specifically authorised
• This requires extensive reliable data
• Regulation is intended to be protective
• .but not an unacceptable barrier to innovation

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However..

• The animal health industry has relatively low
  attraction for the traditional Pharmaceutical
  Leaders
• The return on investment is modest and high risk
• There are many market sectors that do not justify
  private investment
• Therefore too much regulation will reduce
  innovation and availability

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Therefore

• The system needs considerable flexibility in
  approach
• Needs to be rigorous where this is justified
• Should rely heavily on risk assessment
• Should not assume that human medicine risks are
  the same for veterinary medicine
• Must recognise the financial realities of the
  market place.

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Available tools

• A revised set of European Directives
• HMA strategy Plan
• EMEA Roadmap
• European Technology Platform for Global Animal
  Health (ETPGAH)
• Existing dialogues

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1. European Directives

• Widened Cascade
• Flexible routes to authorisation
• Decentralised procedure
• Scope of Centralised procedure
• Role of CVMP and CMDv
• Risk Assessment issues
• Small animal exemption (Article 4) scheme
• Equine essential products list
• POM exemption list
• Extended protection for fish bee products
• Batch release changes

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European Directives

• ..Some comments and questions

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European Directives The Cascade

• Is this widely used in EU?
• Concerns over adequate control/exceptional use
• Link to Eudrapharm database (yet to be delivered)
• Is it a barrier to innovation?
• Impact of new products?
• Impact on existing products?

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European Directives Flexible routes

• New Decentralised Procedure
• signs are good
• Dealing with the SME
• Not the focus of the Network?
• Predictable outcomes
• Harmonising scientific advice
• Dealing with National sensitivities
• Producing the level playing field
• Science v. market protection

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European Directives Risk assessment issues

• Need to define the Benefit Risk Assessment.
• Equine essential products list
• Why not extend to other minor use or minor
  species?
• Extended market protection for fish bees
• Why not for species innovation too?
• Why not for other minor species?

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2. HMA Strategy Plan

• Sets out the regulators ambitions and offers
  solutions to existing and forthcoming challenges
• Aimed at setting a framework for the Network of
  NCAs including the EMEA
• Sets strategy for important tool development
  (e.g. websites and databases)
• Accepts the reality of the current NCA framework
• Diversity of skill and resource base
• Differing ranges of responsibilities
• Complexity of the national stakeholders and their
  needs
• Ultimate aim is the development of an efficient
  Network

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HMA Strategy Plan progress

• Standing working groups
• Pharmacovigilance (dual Mandate with EMEA)
• CMDv (legal base)
• European Surveillance Strategy
• Tandem Group and IT support group (Telematics)
• Enforcement
• Communication
• Homeopathics

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HMA Strategy Plan progress

• Project working groups
• Benchmarking (quality of assessment work)
• Strategy implementation group
• Website group (communication)
• Training working group (quality of assessment)
• Resource planning in the Network (efficiency)
• Availability of medicines (flexibility)
• Product testing task force (risk based testing)

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Specific HMA-v projects

• Pharmacovigilance (ESS)
• Vaccine Diluents
• Work sharing (Pharmacovigilance/variations)
• Generic products
• e-submissions
• Homeopathics
• Referrals and Arbitration

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3. EMEA ROADMAP

• Focuses on creating a transparent scientific
  based agency and network
• Looks to future technologies and expansion of EU
• Recognises the importance of good telematics and
  efficient use of EU resources
• Acts in parallel to HMA strategy paper

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EMEA ROADMAP

• Has five objectives
• Top quality scientific assessment
• Timely access to safe and effective innovative
  medicines
• Continuous monitoring of medicinal products
• Access to Information
• Specific needs for veterinary medicines

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EMEA ROADMAP

• Specific needs for vmps
• Availability and MUMS
• Antimicrobial resistance
• Environmental safety
• Pharmacovigilance

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EMEA ROADMAP Actions

• Scientific advice and scientific assessment
  quality and consistency
• More rapid access to medicines (no compromise on
  safety)
• Stimulate innovation research
• Incentives for SMEs
• Transparency and Communication
• Telematics

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EMEA ROADMAP Veterinary specifics

• Availability
• Essential products list
• Paper on availability
• Exotic diseases (Bioterrorism)
• Avian Flu
• Blue Tongue
• West Nile Fever
• Transparency
• Eudrapharm database
• Pharmacovigilance
• European Surveillance Strategy

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4. ETPGAH

• Chapter 6 of the SRA deals with Regulatory issues
• Recognises
• Specific needs of the veterinary sector
• Seeks to reduce animal testing
• Recognises the challenges of monographs and
  guidelines
• Covers availability and MUMS
• Calls for a tool to assist Benefit Risk
  assessment.
• Recognises existence of regional and political
  differences across the EU

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ETPGAH

• Seven recommendations for regulation of VMPs
• Identify different drivers for VMPs
• Impact of guidelines and monographs
• Devise a risk based model for benefit risk
  decisions
• Reduction of animal testing
• Identify technical barriers to EU harmonisation
• Define data quality for regulation
• Evaluation of environmental risk assessment
• An action plan is being developed

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5. Existing dialogues

• Generics and Data Protection
• Packaging (Prague outcome)
• Availability
• Level playing field (ERA)
• Better regulation initiative

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. some personal reflections

• Agree with many of the proposals and comments
  made by IFAH.

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. some personal reflections

• Agree with many of the proposals and comments
  made by IFAH.
• 10 year DP for species might be OK for different
  routes of administration

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. some personal reflections

• Agree with many of the proposals and comments
  made by IFAH.
• 10 year DP for species might be OK for different
  routes of administration
• OK with level playing field issue but what about
  the generic applicants confidentiality

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. some personal reflections

• Agree with many of the proposals and comments
  made by IFAH.
• 10 year DP for species might be OK for different
  routes of administration
• OK with level playing field issue but what about
  the generic applicants confidentiality
• Regulation should support innovation but is not
  necessarily about protection of the pioneer

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. some personal reflections

• Agree with many of the proposals and comments
  made by IFAH.
• 10 year DP for species might be OK for different
  routes of administration
• OK with level playing field issue but what about
  the generic applicants confidentiality
• Regulation should support innovation but is not
  necessarily about protection of the pioneer
• The focus should be on what improves availability
  and using proportionate risk assessment risk
  management

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Contact details

• www.vmd.gov.uk
• VMD, Woodham Lane
• New Haw, Addlestone
• Surrey, KT15 3LS
• Tel [phone]
• E-mail s.dean_at_vmd.defra.gsi.gov.uk