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Jornadas #PatientInHTA · Tamas Bereczky

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Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017

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Jornadas #PatientInHTA · Tamas Bereczky

  1. 1. 28 April 2017 The European Patients’ Academy (EUPATI) HTA involvement
  2. 2. What this presentation covers:  Why EUPATI?  What is EUPATI?  What has EUPATI delivered?  EUPATI and HTA guidance
  3. 3. Health research & policy is changing at a fast pace Innovation transforms the lives of patients with serious, lifelong conditions:  Molecular targets/pathways  Genome sequencing,  Translational research  Personalized medicine • Small trial populations • Biomarkers, companion diagnostics  Need for post-marketing data  Health Technology Assessment, QoL, endpoints, comparators  BUT long term pressure on health budgets – here to stay Window of opportunity  trial design  relationship between researchers, regulators, industry, patients 3
  4. 4. Public Research Ethics Committees Competent authorities Policy makers /Research Policy HTA agencies & committees Research subject Info provider Advisor Reviewer Co-researcher Driving force Clinical Research Patients have a key role in all aspects of health-related research Trial protocol design, informed consent, ethical review, marketing authorization, value assessment, health policy
  5. 5. Patient involvement in practice within the R&D life cycle Source: Geissler, Ryll, Leto, Uhlenhopp – www.eupati.eu Source: Geissler, Ryll, Uhlenhopp, Leto (2016): www.eupati.eu
  6. 6. Public Research Ethics Committees Competent authorities Policy makers /Research Policy HTA agencies & committees Research subject Info provider Advisor Reviewer Co-researcher Driving force Clinical Research Patients have a key role in all aspects of health-related research Trial protocol design, informed consent, ethical review, marketing authorization, value assessment, health policy
  7. 7. EUPATI: Paradigm shift in empowering patients on medicines R&D  Launched Feb 2012 as a public private partnership, 33 consortium members, Funded by Innovative Medicines Initiative  has developed and disseminate objective, credible, correct and up-to-date public knowledge about medicines R&D  is building competencies & expert capacity among patients and the public,  has been a game changer and driver of patient engagement in R&D  Continues as a permanent educational programme
  8. 8. EUPATI Patient Experts Training Course -- for expert patients EUPATI is developing education targeted at different levels EUPATI Educational Toolbox -- for patient advocates EUPATI Internet Library -- for the health-interested public English French German Spanish Polish Italian Russian (Rumanian) (Portuguese) English 1.Discovery of Medicines 2.Pre-clinical Development 3.Clinical Development 4.Clinical Trials 5.Regulatory Affairs, Drug Safety, Pharmaco- vigilance 6.Health Technology Assessment
  9. 9. The EUPATI Patient Expert Training Course
  10. 10. The EUPATI National Platforms
  11. 11. 18+ EUPATI National Platforms EUPATI National Platforms...  bring all stakeholders together in countries  address educational needs in R&D  disseminate EUPATI’s training material to patient organisations National platforms set up in AT, FR, DE, IE, IT, LU, MT, PL, ES, CH, UK, DK, SK, PT Additional platform initiatives ongoing NO, GR, RO, SRB, SE
  12. 12. What are ENPs doing? ENP social media campaigns ENP learning webinars ENP workshops & conferences ENP MoUs with partners ENPs on the TV ENPs in the papers
  13. 13. The EUPATI Guidances on the interaction of patients with regulators, HTA bodies, industry and ethics committees
  14. 14. EUPATI Guidances for patient involvement and interaction – Why?  Patients & patient organisations to be involved more widely • include early & post-approval stages, not confined to clinical development  Overarching guidance on meaningful and ethical interaction is missing in many areas, especially in R&D, causing insecurity • Existing codes/regulations hold mostly legal & ethical content, i.e. collaboration, communication, funding -- do not cover patient involvement in R&D • e.g. EFPIA, EATG code, PCWP framework, ECAB, EMA framework, HTAi  Language needs to be more directive towards patient involvement • Clear default statement that collaboration is allowed unless expressly forbidden
  15. 15. EUPATI Guidances to support the interaction with patient organisations in R&D EUPATI has developed guidances for the interaction of patient organisations with stakeholders  in industry-led R&D  in HTA bodies  in regulatory processes  in ethics committees Available for download at  EUPATI.eu > Resources > Guidances
  16. 16. Guidance on interaction between patients and HTA bodies  Definition of terms  Definition of rationale  Reference to frames and examples used  Basic tenets: • Relevance • Fairness • Equity • Legitimacy • Capacity building  Practical guidance for HTA bodies on what to do and how  Practical guidance for POs on what to do and how
  17. 17. This is what we want to see happen
  18. 18. This is what we offer in exchange
  19. 19. Two simple basic principles! Scientific involvement and policy work must go together If you could learn it, I can learn it, too
  20. 20. Please be in touch! tamas@eupati.eu

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