"EUPATI – EU: An overview", held by Eibhlin Mulroe (EUPATI / IPPOSI) at the EUPATI-UK Network Conference on 6 March 2014 in Leeds, UK

1. EUPATI
The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed
of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.
An overview

2. In summary
Who are IPPOSI?
EUPATI Ireland
Why get involved in EUPATI?
What is EUPATI all about!

3. PATIENT’S LEADING THE
DISCUSSION
Eibhlín Mulroe, MBA
CEO, IPPOSI

4. IPPOSI Strategy 2012-2014
4
Our Mission
We expedite
development
of and patient
access to
innovative
therapies
through a
unique
partnership of
Patient
Groups,
Industry and
Science
Vision
Patients in Ireland
have prompt access
to new and
developing
innovative therapies
To deliver on our Vision
Our Strategic Priorities
• Bring a patient perspective
to clinical research in Ireland
• Actively influence policy
that impacts on research
and access to innovative
therapies
• Increase understanding of
the work done by IPPOSI
• Source funding to ensure
IPPOSI’s sustainability

5. Leadership

6. IPPOSI Topics 2013
 Access to innovative treatments
- Clinical Research
- HTA
 Rare Diseases and the Cross Border Directive
 Patient Compliance
Patient-Led
Partnership
Consensus
Building
between
Stakeholders
Inform

7. Secretary General, Department of Health
Annual IPPOSI Roundtable Meeting

8. IPPOSI –patient voice at the table
Rare Diseases

9. National Plan for Rare Diseases
•Launch in May 2014
•DOH officials
•Drawing from Consultation

10. IPPOSI - patient voice at the table
Health Technology
Assessment

11. HTA
 Involving the patient…
 IPPOSI and HTA Agency
Developing a process

12. HTAi
 Patient involvement in HTA: What added value?
 K.M. Facey Health Economics and HTA, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
“there is a need to move from emotive views to finding a way that allows
robust elicitation patients’
perspectives. As happens in the other parts of HTA, a systematic method is
needed, using an explicit analytical approach, and findings need to
scrutinized.”

13. EPF survey on HTA agencies,
decision makers and patients
• Patient involvement in HTA has the most impact in putting
forward patients’ needs in terms of QoL and providing a
real-life context to the use of health technologies; this is
acknowledged by all
• To facilitate patient involvement, HTA agencies and
decision-makers provide access to
• HTA reports/guides/protocols,
• easy-to-read HTA summaries
• – but no training support for patients
Patient organisations need
more capacity to engage on
HTA

14. IPPOSI - patient voice at the table
Clinical Research

15. CLINICAL RESEARCH
in Ireland
“Without a thriving clinical research
culture in Ireland, Irish patients with
severe unmet medical needs will be
deprived of life-saving treatments.”
Report from IPPOSI National Strategic Forum for
Clinical Research
Farmleigh, Dublin, 27 November 2009

16. REPORT INTO THE GENERAL PUBLIC’S ATTITUDES
TOWARDS CLINICAL RESEARCH
Prepared for IPPOSI
by
Drury Research
November 2009

17. Agree v Disagree with Attitudinal
Statements RANKING 1 - 5
26 12 20 12 29 1
50 15 16 5 14
56 14 11 4 14 1
60 17 14 3 5 2
I w ould only participate in
clinical trials if I w as very
sick
I w ould be w illing to supply
personal medical
information for medical
research if it is done in a
confidential manner
I w ould be w illing to donate
blood to be used for clinical
research
I think carrying out clinical
research in I reland w ith the
aim of developing new w ays
to treat many diseases is a
good idea
Strongly agree Agree Neither/nor Disagree Disagree strongly DK
{Base: n=1000, All adults}

18. 2014 EXPANDING OUR CLINICAL TRIALS INFORMATION
CAMPAIGN

19. EUPATI Ireland
The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed
of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.
NLT

20. EUPATI Ireland
National Liason Team
The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed
of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.
Mr. Peter Kelly, Irish Chronic Pain Association
Ms Siobhan Gaynor, Molecular Medicine Ireland and ICRIN
Ms Sinead Duffy, Bayer Healthcare

21. EUPATI Ireland
The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed
of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.
HTA Training Day with National Agency and Patients
January 2014
OUTCOMEREPORTAVAILABLEON
ipposi.ie
Katie Murphy @KatieMurphy1989 Jan 24
@EibhlinMulroe @ipposi thanks for organising a
great,informative session! Looking forward to
forming some action points & moving forward �
Dmitri Wall @DmitriWall Jan 24
At another great @IPPOSI
conference where the NCPE are
discussing health technology
assessment

23. EUPATI
The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed
of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.
The backdrop to the setting up of EUPATI

24. Medical landscape is transforming
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
24

25. Patients as partners of research:
More needs to be done!
Rare cancers will never be a priority unless the patients make it
one. Patients themselves must therefore play a larger role in
driving forward the search for therapies. They are able to see
connections that have eluded scientists.
“ „

26. Patient advocates have a key role in
building new environment for R&D
 Patient organisations have unique insights into
„real life“ and „real needs“ of patients:
• Gaps  research priorities
• Clinical trial design
• Quality of Life measurement
• Real-world access to therapies
• „Value“
• Patient-centered research policy
Training essential to get expertise to contribute to
medicines research & development (R&D) Research subject
Info provider
Advisor
ReviewerReviewer
Co-researcherCo-researcher
Driving forceDriving force
PatientPartner FP7 Project (2010),
www.patientpartner-europe.eu
With more than 200
cancers and >6000 rare
diseases, we need
many qualified patient
experts!

27. Addressing public scrutiny and
distrust of research…
 Only 6-12% of cancer patients
participate in clinical studies
 75% of Phase II-IV studies delayed due to
slow patient recruitment
 Bad image one reason for
delayed generation of
meaningful clinical data
?
Europe has a lot of safeguards
in medicines R&D – but public
image lagging behind

28. Patient advocates working with
regulators…
EMA track record since 2005…
Patients‘ and Consumers‘ Working
Party (PCWP, 34 POs)
Full members of MA Management
Board, COMP (rare diseases), PDCO
(pediatric), CAT (advanced therapies)
Assessment of EPARs,
Package leaflets, safety information
Ad-hoc support in CHMP:
Product assessment, guidelines,
Pharmacovigilance WG, protocol assistance
Speakers and participants at
EMA conferences/workshops .....
AND AT THE NATIONAL LEVEL
... Patient involvement ‚by accident‘
Patient organisations need
more qualified advocates to
engage with regulators

29. Having a patient (advocate) in every
Research Ethics Committee…
• 9.400 EU applications for
clinical studies/year
• 5.000 clinical studies initiated
in EU/year
– 25% multinational
= ~1250 studies/year
– 4.5 Member States on
average per
multinational study
– Single opinion per
country assumed
– For 1250 multinational
studies, more than
5.000 ethics panels with
35.000 panelists needed
Sources: Impact on Clinical Research of European Legislation (ICREL),
Final Report, Feb. 2009, and Rokus de Zeeuw 2010
If patients are to be involved in
RECs on a broad level, we need
more patients who understand
how trials work

30. Patient advocates through
IPPOSI in Ireland working with…
 Irish Medicines Board
 Health Information and Quality Authority
 Department of Health Steering Group on Rare Diseases
 Health Service Executive Patient Forum
 National Centre for Pharmacoeconomics (HTA)
Patient organisations needmore qualified advocates toengage with regulators

31. Patients want a seat at the table.
Currently, there are many empty seats.
This is why we have
established the
European Patients‘ Academy (EUPATI).

32. http://www.patientsacademy.eu – info@patientsacademy.eu
European Patients’ Academy
on Therapeutic Innovation
The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed
of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.

33. Key stakeholders of the
Patients’ Academy

34. Audiences: advocacy leaders
and the public at large
EUPATI Certificate Training Programme
Academic Modular Certificate Programme
Patient Ambassadors in committees, R&D teams, …
Patient Journalists raising awareness
Patient Trainers for patient communities & networks
100
patient
advocates
12.000
patient
advocates
100.000
individuals
EUPATI Educational Toolbox
 Educational tools for patient advocates
 Variety of distributable formats: Paper-based booklets,
presentations, eLearning, webinars, videos etc.
EUPATI Internet Library
 Patients & lay public at large, e.g. on specific aspects of
the development process of medicines for patients with
low (health) literacy.
 Wiki, YouTube, films and/or cartoons

35. Topics of EUPATI Training Courses
(which will also be covered in web library – more info
later today)
Topic areas:
nDiscovery of Medicines & Planning of Medicine Development
nNon-Clinical Testing and Pharmaceutical Development
nExploratory and Confirmatory Clinical Development
nClinical Trials
nRegulatory Affairs, Medicinal Product Safety, Pharmacovigilance
and Pharmaco-epidemiology
nHTA principles and practices
+Patients‘rolesand
responsibilities
35
…and NOT:
develop indication-
or therapy-specific
information!

36. Patients' Academy: up, running and real. Workshop,
5 Sept 2012 and National Liaisons Workshop in March
2013. Warsaw next in April, 2014!
Patients' Academy: up, running and real. Workshop,
5 Sept 2012 and National Liaisons Workshop in March
2013. Warsaw next in April, 2014!
 100 participants from 24
countries
 Majority patient advocates
 12 countries building
national platforms
 100 participants from 24
countries
 Majority patient advocates
 12 countries building
national platforms
36

37. AT
BE
CH
DE
ES
FR
IT
IE
LUX
MT
PL
UK
National EUPATI “National Liaison
Teams” and “National Platforms”
 Initiated by “trio” of patient orgs, academia, industry
 Patient LEAD and
• make sure EUPATI understands educational
needs in R&D on national level
• disseminate EUPATI’s existing training material
and information on the national level
• raise public awareness & interest about EUPATI
• identify training faculty, logistics and financial
support on the national level
Budget of 9k available to all 12 NLTs to begin work.

38. EUPATI: A paradigm shift in empowering
patients on medicines R&D
 Launched Feb ’12, runs for 5 years,
30 consortium members,
PPP of EU Commission and EFPIA
 will develop and disseminate
objective, credible, correct knowledge
about medicines R&D
 will build competencies
& expert capacity among patients
& public
 will facilitate patient involvement in R&D
to support industry, academia, authorities
and ethics committees

39.  EUPATI platform complete with training courses,
education, information material in multiple
languages
 Good practice guidelines on patient involvement
available and in use
 Public conferences and regional workshops will
lead to an extensive expert network established.
 12 National Platforms established in 12 countries
 Robust strategy on sustainability and political
buy-in
EUPATI by 2017:
Where we want to be.

40. EUPATI can make the difference.
creating the tipping point for patient
engagement in medicines R&D
It‘s for all of us to make it happen.

41. EUPATI NATIONAL LIAISON TEAM UK
GET INVOLVED!
Irene Oldfather, Life Changes Trust Programme Director, Health and
Social Care Alliance Scotland www.alliance-scotland.org.uk
Dr Sue Pavitt, Reader in Applied Health Research, Leeds Institute of
Health Sciences, University of Leeds
http://www.leeds.ac.uk/lihs/
Bella Starling PhD, Director of Public Programmes, Nowgen,
Manchester Academic Health Sciences Centre. www.nowgen.org.uk
Kay Warner, Project Manager, GlaxoSmithKline
http://www.gsk.com/

42. Get to know us!
Web:
www.patientsacademy.eu
Twitter: @eupatients
as well as:

43. For further information: emulroe@ipposi.ie
Sign up for newsletter info@ipposi.ie
Twitter @EibhlinMulroe
@ipposi
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