1. Patient engagement at the EMA
27 November 2018
Patient engagement at the EMA
IAPO Congress, 25 May 2018
Latin American Patient Academy
Presented by Nathalie Bere
Public Engagement Department

2. The European Medicines Agency (EMA)
27 November 2018

4. Patient engagement at EMA; our experience

5. Interaction with patients: a progressive journey…
27 November 2018
Interaction with patients: a progressive journey…
Public Hearings
Involving young people
Patient & Consumer Working Party (PCWP)
Dialogue with patients
Working group with patients
1996
2003
2006
2017
1995
2000
2005
2014
Ongoing…
EMA created
Patients become Committee members
Framework of interaction with patient & consumer organisations
Public Engagement Department
Systematic inclusion of patient input along medicine lifecycle

6. Increasing involvement in EMA activities
27 November 2018
Increasing involvement in EMA activities

7. Involvement along the entire medicine regulatory lifecycle6

8. Different ways to engage:
Members of EMA Management Board
Members of EMA Committees
Representing the patient community
Patients and Consumers Working Party (PCWP)
EMA consultations
Workshops
Representing their own organisation
Scientific Advice procedures
Expert meetings
Committee consultations
Review of documents
Patients as individual experts

9. Learn by experience!
Be flexible!

10. Engagement methodologies; a menu of options
One size does not fit all!
Surveys
Face to Face
Preference Elicitation
Committee meetings
In writing

11. Support and training is vital!
Webpages
Annual
training day
Info-sheets
One-to-one
personalised support
Videos; EMA basics

12. Who do we engage with?
Any organisation representing EU patients or consumers (must meet eligibility criteria : application form on EMA website)
Any individual patient or carer can register to work with the EMA (application form on EMA website)

14. Patients and Consumers Working Party (PCWP)
Platform for dialogue and exchange between the EMA and patient organisations
Representation from 20 organisations, EMA committees & Management Board
Four plenary meetings per year, and consulted as and when needed

15. Wider Engagement; share practices and promote multi-stakeholder discussions
EMA cross-agency departments
Healthcare professionals; GPs, pharmacists, nurses..
National Competent Authorities
EMA/FDA exchange
Patient initiatives

16. 70% of comments led to changes
Feedback
Meeting minutes/report
Thank you acknowledgement
Show when input is taken into account
Review of documents
70% of comments led to changes
Monitoring and measuring
Questionnaires sent to patients and assessors who participate
Leads to proposals for improvement
Continuous monitoring
Demonstrate value

17. Example of value of input ; Scientific Advice procedures
2017: 90 responses

18. Patient input changed final advice in 26% of cases
Patient input impacted final advice in 43% of cases

19. Examples
Safety reporting: selection of Black Triangle based on recommendations by patients and consumers (PCWP)
Expert meeting on use of retinoids: Patient representatives provided useful information on current use and awareness of Pregnancy Prevention Plans. They suggested that stronger, simpler and clearer messages and use of reminders and digital technology to improve compliance, especially considering the younger population
Scientific Advice : Patient representative highlighted the burden of lung (re-) biopsy procedures and advised to limit them to strictly required cases
Committee Expert meeting: Patient representatives highlighted that some non statistically significant differences in endpoints can be life-changing for Duchenne patients in daily activities.

20. Scientific Advice assessor
Feedback
Deputy Executive Director: “Over the past 20 years, I have seen many changes at the Agency, in particular the Agency’s interactions with civil society representatives, which have evolved and strengthened over time”
“The PCWP in its ten years of existence has been a catalyst for a profound culture change at EMA and to some extent at national agencies”.
PCWP Patient co-chair
“I have found this experience extremely interesting and enriching and I am very honoured to have been able to take part”
Patient involved
“This patient provided exceptionally valuable and knowledgeable input and participated in discussions at a very differentiated level”
Scientific Advice assessor
“I felt that the patients opinions and information are taken seriously for further decisions”
Patient involved
“Members of the scientific team have been very helpful to phone me and to explain the procedures”
Patient involved

21. Challenges Patients availability and language barriers
Ensuring support to enhance participation
Providing a clear definition of patients role to manage expectations
Handling potential conflicts of interest
Representation – how to also gather information from larger groups
How to demonstrate the value / impact of patients

22. Summary messages Engaging with patients;
brings everyday aspects of living with a disease into scientific discussions
helps bridge the gap between clinical trial data and real world data
increases transparency, awareness and understanding
Initiate engagement in a stepwise approach; learn together what format works best;
Ensure engagement is mutually beneficial
Engaging with patients leads to more meaningful outcomes for everyone!

23. Questions? Nathalie Bere Patient Engagement
Public Engagement Department
European Medicines Agency
30 Churchill Place • Canary Wharf • London E14 5EU • UK
Telephone +44 (0)
Send a question via our website