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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,


  1. EUnetHTA Plenary Assembly Strategic developments Flora Giorgio DG Health and Consumer

  2. 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

  3. 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 – on-going until October 2015  HTA doers (mainly HTA Agencies) • Two levels in synergy and complementary • Involvement of stakeholders - both @ strategic level and scientific level

  4. 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

  5. EU cooperation in HTA – HOW? • A sustainable Network of HTA Agencies working and learning together to get the evidence needed for national HTA Reports JOINT WORK • Different level of commitments to do and re-use Joint Work

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

  7. EU cooperation in HTA – HOW? II • Assess • Prioritise • Make it happen

  8. 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

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

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

  11. 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

  12. 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 !

  13. 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 €

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