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An agency of the European Union
Interaction with patients and consumers
Presented by Nathalie Bere on 15 March 2017 Public engagement department, Stakeholders and Communication Division
Overview of involvement in EMA activities during 2016
Contents
I. Patients and consumers involvement in EMA
II. Types of patients and consumers involvement
III. Key figures in 2016
IV. Conclusion
1
2
I. Patients and consumers involvement in EMA
2000 Patients join COMP as full members
2003 Working group with patients created
2005 Framework of interaction with patient and consumer organisations
2006 Patients and Consumers Working Party (PCWP)created
2014 • Dedicated Patients and Healthcare Professionals Department created
• Revised Framework
Interaction with patients: the EMA journey so far
Ongoing… Systematic inclusion of real life experience in EMA regulatory outputs
1996 Dialogue with HIV patients
1995 EMA created
3
CHMP CAT
PRAC COMP
CHMP- SAWP
CHMP PRAC
Orphan Designation
Scientific Advice Protocol assistance
Paediatric Investigation
Plan
Post Marketing Authorisation
Marketing Authorisation Application Evaluation
COMP PDCO
SAG SAG
Patient input
Patient input
Patient input
Public Summaries of Opinion
Patient input
Package Leaflets (PL) EPAR summaries
Safety Communications
Patient input
Patient input
Patient input
Patient input
Patient input
Package Leaflets (PL) (renewal)
Patient input
Patient input
Opportunities for involvement along the medicine lifecycle at EMA
4
5
Benefits of patient involvement
6
Stages of patient involvement
7
II. Types of representation
Types of representation
8
Management Board (MB)
EMA Scientific Committee(s) Patients representing patients’ organisations
Patients’ and Consumers’ Working Party (PCWP)
EMA consultations
Workshops
Patients representing their organisations
Scientific Advice Procedures Scientific Advisory / ad hoc expert groups
Committee consultations Review of documents
Patients as individual experts
9
III. Key figures in 2016
167 213
307
423
525 551
633
743 770
0
100
200
300
400
500
600
700
800
900
2008 2009 2010 2011 2012 2013 2014 2015 2016
10
Patient and consumer involvement over the years
33 35 46 47 44 55 55 53 60 87
108
175 200
240
333 336 331
433
47 70
86
176
241
163
242
359
277
0
50
100
150
200
250
300
350
400
450
500
2008 2009 2010 2011 2012 2013 2014 2015 2016
MB/ Committee/WP members Individual experts Representatives of their organisations
Involvement as committee/working party members, experts and representatives or organisations 2008-2016
11
Involvement across different activities 2009-2016
3 3 3
13 14 8
13
22
7
19
36
13
28 33
10
37 35
25
76
23 24
82
28 32
0
10
20
30
40
50
60
70
80
90
SA/PA procedures SAG/ad hoc expert meetings Committee consultations
2009 2010 2011 2012 2013 2014 2015 2016
12
13
17
14
3
16
0
2
4
6
8
10
12
14
16
18
Total numberof SAG/Ad-hoc
meetings
Number ofSAG
Number of Ad-hoc
Number ofSAG/Ad-hoc
meetingswhere patientwas present
Number of SAGs/Ad-hoc including patient input
AIDS, 2
Endocrinology, 2
Hematology, 1
Infectious diseases, 1
Mental disorders, 1
Neurology, 3
Oncology, 5
Respiratory, 1
Frequency of therapeutic areas of SAG/Ad-hoc meetings
14
Frequency of therapeutic areas of SA meetings
34 33
0
10
20
30
40
Scientific Advice Protocol Assistance
Number of SA/PA meetings including patient input
15
17
4
14
0
2
4
6
8
10
12
14
16
18
In person Teleconference Written
Distribution of participation type in Scientific Advice and Protocol Assistance
Protocol assistance Scientific advice
27
7
1
0
5
10
15
20
25
30
In person Teleconference Written
16
EMA Scientific Committee consultations in 2016 (examples)
• Risk minimisation measures for HIV PrEP. (CHMP/PRAC)
• Melanoma medicine - educational material (CxMP)
• HIV-1 brochure for individuals/reminder card (PRAC)
• Risk minimisation of medication errors with new diabetes medicine (PRAC)
• Wording (class labelling revision HIV medicines) (CxMP)
17
27
9
32 39 36 33
2
14
41
11
38
70
27
35
91
24
39
95
39
48
80
44 47
71
19
36
58
10
0
10
20
30
40
50
60
70
80
90
100
EPAR PL Safety communication
Review of EPAR, PL and Safety communication
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
18
5
21
26
0
5
10
15
20
25
30
Not-reviewed Reviewed Total number of herbal summaries
Herbal summary review: March - December
Involvement in workshops 2009-2016
3 5
18
44
87
104
115
142
0
20
40
60
80
100
120
140
160
2009 2010 2011 2012 2013 2014 2015 2016
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HIGHLIGHTS
• EMA workshop on extrapolation of efficacy and safety in medicine development across age groups
• EMA multi-stakeholder workshop on Advanced Therapy Products
• DIA Information Day on Medication Errors
• Registries meeting
• Big data workshop
• Workshop on adaptive pathways
EMA workshops & conferences organised in 2016
20
Patient participated in all 22 workshops & conferences organised by
EMA in 2016
HIGHLIGHTS
• Action Duchenne international conference
• DIA Euromeeting, Hamburg, Germany
• ECTRIMS-EMA-EMSP meeting
• IAPO seventh patients congress, London
• ICAN summit, Barcelona
• IMI workshop on patient engagement strategy, Brussels
• IASLC 17th World conference on Lung Cancer, Vienna
• 8th European Conference on Rare Diseases & Orphan
Products, Scotland
Training
• EUPATI Face-To-Face session, Barcelona, Spain
• EURORDIS summer school, Barcelona
21
EMA participation in stakeholder meetings
EMA participated in 16 stakeholder meetings last year
Highlights of the year
• Pilot project to involve patients in CHMP plenary discussions
Completed; report pending
• Elicitation of Benefit/Risk patient preferences
Larger study with myeloma patients
• Enhanced training materials
‘EMA basics’ short videos
Info-sheets
• Topic groups
Social media
Training
Involvement of young people
• Public hearings
Preparations, including dry run
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• Finding suitable patients (e.g. language barrier, availability),
• Ensuring comprehensive, tailored support to facilitate and enhance participation,
• Provide a clear definition of patients role in the different activities to manage expectations
from all angles,
• Managing potential conflicts of interest,
• Representation – how to also gather information from a larger group,
• How to measure the value / impact of patients,
• Process of review of documents needs to be looked at.
23
Challenges
24
IV. Conclusion
• The involvement of PCOs continues to be extremely beneficial,
• Patients are a recognised and integral part of the Agency’s work with opportunities for input along the lifecycle of the medicines development,
• With the passing years, their involvement not only expands, but evolves to ensure it occurs in the most optimal manner possible,
• We will continue to look to enhance and improve involvement wherever feasible,
• We look forward to a continued mutually beneficial collaboration during 2017!
25
Conclusion and way forward
Thank you for your attention
European Medicines Agency 30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
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Nathalie Bere Acknowledgement: Ivan Sebest