jornadas #patientinhta · tamas bereczky
TRANSCRIPT
28 April 2017
The European Patients’ Academy (EUPATI)
HTA involvement
What this presentation covers:
Why EUPATI?
What is EUPATI?
What has EUPATI delivered?
EUPATI and HTA guidance
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
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
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
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
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
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
The EUPATI Patient Expert Training Course
The EUPATI National Platforms
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
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
The EUPATI Guidances on the interaction of patients with regulators, HTA bodies,
industry and ethics committees
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
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
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
This is what we want to see happen
This is what we offer in exchange
Two simple basic principles!
Scientific involvement and policy work must go together
If you could learn it, I can learn it, too
Please be in touch! [email protected]