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An agency of the European Union
Interaction with patients and consumers
Nathalie Bere, Patients and Healthcare professionals Dept, Stakeholders and Communication Division
Overview of involvement in EMA activities during 2015
1
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
2
Patient and consumer involvement over the years..
76
167 213
307
423
525 551
633
742
0
100
200
300
400
500
600
700
800
2007 2008 2009 2010 2011 2012 2013 2014 2015
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
Categories of patient participation:
• Management Board
• EMA Scientific Committee(s)
Patients representing patients’ organisations
• Patients’ and Consumers’ Working Party (PCWP)
• EMA consultations
• Workshops
Patients representing their organisations
• Scientific Advice / Protocol Assistance Procedures • Scientific Advisory / ad hoc expert Groups • Scientific committee consultations • Review of documents
Patients as individual experts
5
26 33 35 46 47 44 55 55 53
22
87 108
175 200
240
333 336 331
28 47
70 86
176
241
163
242
358
0
50
100
150
200
250
300
350
400
2007 2008 2009 2010 2011 2012 2013 2014 2015
Comparison of involvement as committee/WP members, experts and representatives of organisations
2007–2015
MB/ Committee/WP members Individual experts Representatives of their organisations
6
3 3 3 2 3
13 14 8 11
5 13
22
7
27 18 19
36
13
24
44
28 33
10
39
87
37 35
25
44
104
76
23 24 19
115
0102030405060708090
100110120
SA/PA procedures SAG/ad hoc expertmeetings
Committeeconsultations
Safety communications Workshops
2009 2010 2011 2012 2013 2014 2015
Comparison of involvement across different activities
The revised framework of interaction ; Action Plan
• Maintain the network of patients and consumers organisations • Establish a pool of experts:
– Continue to identify patients/consumers through network – Identify gaps in expertise – Publish a call for expression of interests
• Promote participation at key milestones during lifecycle of medicines:
– Ensure early involvement in development of medicines – Patients involvement in benefit/risk evaluation at CHMP; develop
processes to capture patients’ input
• Build capacity: – Explore means to increase awareness on medicines evaluation – Gather feedback and streamline provision of EMA training – Conduct a reflection on providing further support to enable patient involvement
PCWP
• Monitor and increase transparency on involvement of patients, consumers and organisations in EMA:
– Establish system for regular collection of quantitative and qualitative data for monitoring and reporting purposes
– Explore methodologies to measure the impact of patients’ involvement on regulatory outcomes – Acknowledge and promote visibility of patient/consumer organisations input provided in Agency
activities
Eligible organisations: patients/consumers
Patients representing patients’ organisations
Members of :
• EMA Management Board (MB)
• Committee for Orphan medicines (COMP)
• Committee for paediatric medicines (PDCO)
• Committee for advanced therapies (CAT)
• Pharmacovigilance Risk Assessment Committee (PRAC)
9
Patients representing their organisations
EMA Working Party with Patients & Consumers Organisations (PCWP)
• 19 members and 16 alternates representing PCOs;
• 6 members from the EMA Scientific Committees;
• 1 member from the EMA secretariat;
• Observers from the CMD-h, HCPWP and MB.
10
Five PCWP meetings; • one plenary meeting, • two joint meetings with the HCPWP
(including a dedicated session on “Biosimilars” and a workshop on “Risk minimisation tools”)
• one with all eligible organisations • one-day training session
11
Patients also contribute to EU-wide initiatives where EMA is involved such as:
• Enpr-EMA - European Network of Paediatric Research at the European Medicines Agency
• ENCePP - European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
• WEB-RADR - Recognising Adverse Drug Reactions
Patients representing their organisations (Cont.)
Examples during 2015: • Committee/EMA consultations
• Pharmacovigilance legislation forum
• Patient registries
• EMA policy on proactive publication of and access to clinical-trial data
• Pandemic preparedness
• WEB-RADR stakeholders survey
• Ad-hoc observers attending PCWP meetings
• Working groups
• Workshops
• Workshop on biosimilars
• Science, Medicines, Health: Patients at the heart of future innovation conference
• Duchene (DMD) workshop
• Workshop on chordoma as a model for very rare cancers
• Webinar: Implementation of EMA policy on publication of clinical data
• EMA workshop on the development of new medicines for the treatment of ulcerative colitis and Crohn’s disease
• Workshop on haemophilia registries
• Implement. policy on access to clinical data
• Follow-up stakeholder meeting on the implementation of EMA policy on publication of clinical data
• 9th Stakeholder Platform meeting
• Joint EFGCP-DIA-EMA paediatric conference
• Lunchtime talk and debate: 'Involving young people in the evaluation of medicines for children‘
• EMA workshop on shortages
• Anticoagulants workshop
• Workshop to clarify concept/demonstrating of significant benefit of orphan medicines
• EMA 20th anniversary event: The view from the sharp end: what patients and healthcare professionals can do for us
• IMI ADVANCE project
12
Involvement in EMA workshops/conferences
Medicines’ development:
• Participation in scientific advice/protocol assistance procedures
Benefit/risk evaluations:
• Participation in scientific advisory / ad-hoc expert group meetings (SAGs) convened by CHMP or PRAC
• Respond to ad-hoc consultations on assessment of medicines from all Committees
• Review information on medicines: Package leaflets, EPAR summaries, safety communications (Q&As) and soon herbal summaries
Patients as individual experts
14
32 39
46
18
46 35
48 60 57
11
43
75 62
79
102 110
89
108
0
20
40
60
80
100
120
2007 2008 2009 2010 2011 2012 2013 2014 2015
Package leaflets and EPAR summaries sent for review
EPAR Summaries Package leaflets
84% 82% 78% 78% 83%
100%
81% 80% 82% 82% 91%
44%
66%
89% 89% 86% 90%
66%
0%10%20%30%40%50%60%70%80%90%
100%
2007 2008 2009 2010 2011 2012 2013 2014 2015
Percentage of package leaflets and EPAR summaries reviewed
EPAR Summaries Package leaflets
Feedback on comments received; EPAR summaries
15
62% of EPARs adjusted due to feedback by patients
47
33
05
101520253035404550
Total amount EPARschecked
Total amount EPARschanged by patient
feedback
Ongoing initiatives
• Pilot project to involve patients in CHMP plenary discussions
3 cases so far; ongoing
• Elicitation of B/R preferences
Pilot study with melanoma / myeloma patients
Expanded study 2016
• Enhanced training materials
‘EMA basics’ short videos
Info-sheets
Improvements to webpages dedicated to patients
• Topic groups
Measure impact/value of patient involvement
Acknowledge and promote visibility of patient input in the Agency’s activities
Training and support to patients
Social media
Involvement of young people
16
Continued to raise awareness
Participation in conferences
17
• EATG stakeholders meeting, Brussels • Giving patients a voice - Federal Joint Committee,
Berlin • PROTECT Final Symposium, EMA • Eurordis rare disease day media event • LSE conference - Pharmaceutical Policy: Pricing,
access and reimbursement, London • EFPIA 50 year anniversary of EU pharmaceutical
legislation, Brussels • Newcastle University – Workshop: Participants not
subjects – engaging patients and families in paediatric clinical research
• DIA Euromeeting-Paris • Melanoma (MPNE) 2015 conference - Brussels • Myeloma Patients Europe annual meeting -
Dubrovnik
• University of Copenhagen: Patient Involvement in medicines development and approvals
• Eurordis summer school - Barcelona • EUPATI Advisory Board meeting - Berlin • CIRS patient Engagement workshop - UK • EUPATI training course for patients - Barcelona • WONCA conference - Istanbul • ISPOR roundtable - Milan • FT global pharmaceutical and Biotechnology
conference - London • EUnetHTA-EMA meeting - Copenhagen • Invitation to participate and advise on workshop
on stem cell therapies and gene therapies (Genetic Alliance UK/Wellcome Trust - Medical Research Council Cambridge Stem Cell Institute)
• Joint EMA-EBE (European Biopharmaceutical Enterprises) seminar
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 2016!
18