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

1. 28 April 2017
The European Patients’ Academy
(EUPATI)
HTA involvement

2. What this presentation covers:
 Why EUPATI?
 What is EUPATI?
 What has EUPATI delivered?
 EUPATI and HTA guidance

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. 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. 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. 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. 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. 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. The EUPATI Patient Expert Training
Course

10. The EUPATI
National Platforms

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. 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. The EUPATI Guidances
on the interaction of patients
with regulators, HTA bodies,
industry and ethics committees

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. 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. 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. This is what we want to see happen

18. This is what we offer in exchange

19. Two simple basic principles!
Scientific involvement and
policy work must go together
If you could learn it, I can learn
it, too

20. Please be in touch!
tamas@eupati.eu