1.1 patient engagement along the regulatory lifecycle · 1.1 patient engagement along the...
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An agency of the European Union
Patient engagement along the regulatory lifecycle
PCWP meeting September 25, 2018
Presented by Nathalie Bere Public Engagement Department, European Medicines Agency
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Patient involvement along the medicine lifecycle at EMA
Post Marketing procedures
POST AUTHORISATION PRE-SUBMISSION EVALUATION
Marketing Authorisation Evaluation
Patient input
Scientific Advice
Paediatric Investigation
Plans
Orphan designations
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Patient involvement along the medicine lifecycle at EMA
PRE-SUBMISSION
COMP CAT SAWP PDCO
Public Summaries of OD
Scientific Advice
Paediatric Investigation Plans (PIPs)
Orphan designations
- Committee members - Oral Explanations - Written consultations
Scientific Advice procedures
8 13 18 16 19 32 35
76 82
131
0
20
40
60
80
100
120
140
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
No. of patients involved in Scientific Advice, Protocol Assistance, HTA
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Did any of the patient's comments result in further reflection by the coordinators?
3
No 47%
Yes 53%
Did any of the patient's input result in a modification of the final advice letter?
Yes 27%
No 73%
In which aspects of the development plan did the patient give input?
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Patient involvement along the medicine lifecycle at EMA
Marketing Authorisation Evaluation
EVALUATION
Package Leaflets (PL) Medicine Overview
• Committee members (CAT/COMP/PRAC)
• SAG/ad-hoc expert meetings (CHMP/CAT)
• Oral Explanations (CHMP/COMP)
• Written consultations (all committees)
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Patient involvement along the medicine lifecycle at EMA
Post Marketing procedures
POST AUTHORISATION
Package Leaflet (renewal)
Safety Communications
• Committee members (CHMP/PRAC)
• SAG/ad-hoc expert meetings (CHMP/CAT/PRAC)
• Oral Explanations (CHMP/COMP/PRAC)
• Public hearings (PRAC)
• Written consultations (all committees)
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Patients involved in scientific meetings (2017)
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Patients review of documents (2017)
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Patient Involvement in all EMA activities (2008 – 2017)
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Three categories of patient representation
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Flexible engagement methodologies
Expert meeting In writing
Surveys
Preference Elicitation Committee meetings
Conference calls
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Vital support for patients participation
Annual training day
Webpages
One-to-one personalised support Videos; EMA basics
Info-sheets
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Where do the patients come from?
Network of organisations and individual patients:
36 EU organisations representing EU patients / consumers, published on the EMA website - must meet eligibility criteria
440 individuals registered in EMA database
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Application form for patient & consumer organisations
Eligibility criteria to be fulfilled by patient, consumer organisations
Declaration of interests / confidentiality agreement
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Patients and Consumers Working Party (PCWP)
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Monitoring and measuring
• Questionnaires sent to patients who participate
• Proposals for improvements proposed accordingly
• Annual report to EMA Management Board
Feedback • Meeting minutes
• Thank you acknowledgement
• Comments taken into account
Annual reports with
summaries of feedback
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• Engagement with patients:
Brings the everyday aspects of living with a disease into the scientific
discussions and helps bridge the gap between clinical trial data and real world data
Improves transparency and trust
Increases understanding and dissemination of EMA outcomes
• ALL perspectives are crucial and have ultimately resulted in more meaningful
decisions for all concerned.
Importance of engaging with patients in EMA
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Public hearing
13 June 2018
120 Applications (55 speakers / 65 observers) 23 speakers selected, within 21 speaker slots, from 11 EU MS
Getting input from the public to better understand and manage serious and persistent side effects with these antibiotics
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Quinolone/fluoroquinolone Public hearing; outcome
Important information/themes raised: • Symptoms life-changing and wide ranging
• Patients not given enough information about risks
• Healthcare professionals generally unaware of range and severity of possible symptoms
Key proposals gathered during the hearing: • Restrict use
• Improve education for healthcare professionals
• Improve communication and information and encourage further research
• Improve management of side effects
• Consider how certain foods affect patients’ symptoms
Input shaped questions for subsequent expert meetings
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Challenges
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• Finding suitable patients (e.g. language barrier, availability)
• Ensuring training to facilitate and enhance participation
• Managing potential conflicts of interest
• Representativeness
• Avoid missed opportunities
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How to address challenges; Next steps
19
• Finding suitable patients (e.g. language barrier, availability) Increase network of patients and organisations
• Ensuring training to facilitate and enhance participation
Encourage & enhance current training (EMA/EU)
• Managing potential conflicts of interest
Increase understanding and awareness among patient community
• Representativeness Implement complementary methods to gather wider patient data; e.g. further research on
preference elicitation, organise disease specific focus groups, reflection paper
• Avoid missed opportunities
Let us know of any ongoing evaluations which may benefit having patient input
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Any questions? Nathalie Bere
Public Engagement Department
[email protected] www.ema.europa.eu
European Medicines Agency
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5550
Send a question via our website www.ema.europa.eu/contact
Overview of current patient involvement