Strategic developments Flora Giorgio DG Health and Consumer EU - - PowerPoint PPT Presentation

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Strategic developments Flora Giorgio DG Health and Consumer EU - - PowerPoint PPT Presentation

EUnetHTA Plenary Assembly Strategic developments Flora Giorgio DG Health and Consumer EU Objectives in HTA Article 15 Directive 2011/24: Support cooperation between national HTA Authorities Support MS in the provision of objective,


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Strategic developments

EUnetHTA Plenary Assembly

Flora Giorgio DG Health and Consumer

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EU Objectives in HTA Article 15 Directive 2011/24:

  • Support cooperation between national HTA

Authorities

  • Support MS in the provision of objective, reliable,

timely, transparent , comparable and transferable information […] to enable effective exchange of information

  • Avoid duplication of assessments
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EU Cooperation in HTA – where we are

  • HTA Network (art 15 Directive 2011/24)–

strategic level (2 meetings 10/2013 4/2014) MS representatives (mainly MoH); EMA associated

  • EUnetHTA (Joint Action HP)– scientific level –
  • n-going until October 2015  HTA doers (mainly

HTA Agencies)

  • Two levels in synergy and complementary
  • Involvement of stakeholders - both @ strategic

level and scientific level

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EU cooperation in HTA – VISION

  • New phase of cooperation  from "agreeing on "

to "doing and learning together"  PILOTS

  • Up take of joint work in national activities 

MAINSTREAM

  • "Life cycle" approach to health technologies 

More synergies with regulators and payers  DEFRAGMENTATION

  • From "projects" to "permanent" cooperation 

SUSTAINABILITY

HTA Network DRAFT Strategy Paper

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EU cooperation in HTA – HOW?

  • A sustainable Network of HTA Agencies working

and learning together to get the evidence needed for national HTA Reports

  • Different level of commitments to do and re-use

Joint Work

JOINT WORK

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EU cooperation in HTA – HOW? II

  • Joint Work
  • Early Dialogues
  • REA
  • Full HTA
  • Methodology development
  • IT Tools
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EU cooperation in HTA – HOW? II

  • Assess
  • Prioritise
  • Make it happen
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EU cooperation in HTA – Future ?

  • From Project based to permanent structure
  • JA 3 up to 2020 Max
  • post 2020  ?

Joint work – HTA Agencies Coordination work – central Secretariat

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Reflection

  • What’s best done together?
  • What helps you in your national activities ?
  • What are you prepared to invest in ?
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Thank you

Flora.giorgio@ec.europa.eu http://ec.europa.eu/health/technolog y_assessment/policy/index_en.htm

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Secretariat for scientific cooperation in EMA?

  • A “different” EMA
  • A decentralized model (not CHMP)
  • Scientific synergies with regulators fro Pharma
  • New concept to be designed for MD and other

technologies

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Conclusions II

  • Are YOU ready to play your part?
  • National HTA agencies
  • Competent authorities/ payers
  • Technology developers
  • All stakeholders (patients, professionals, academic

bodies, private experts …)

  • "New" cooperation on HTA in Europe can be

reality only if all subscribe and engage in shaping it !

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History about EC activity on HTA

  • Health Programme – Projects
  • EUR-ASSES 1994-1997
  • ECHTA/ECHAI 1999- 2001
  • EUnetHTA 2006-2008
  • FP 7 – Projects
  • 2012 on going
  • Health Programme – Joint Actions
  • EUnetHTA 1 – 2010-2012
  • EUnetHTA 2 – 2012-2015

Total EU Budget over 30 million €