An agency of the European Union

Overview of EMA’s interaction with patients and consumers during 2015

Nathalie Bere

Stakeholders and Communication Division

Introduction

• Overview of EMA activities where patients, consumers and their organisations have been

involved throughout 2015

• Provides comparison to preceding years

• Will be included within the annual report for 2015, presented to the EMA Management

Board and published on EMA website during 2016

• Consistent high level of interaction and collaboration between EMA and patients and

consumers during 2015

1

2

76

167

213

307

423

525 551

633

687

0

100

200

300

400

500

600

700

800

2007 2008 2009 2010 2011 2012 2013 2014 2015 -

Nov.

Overall number of patient/consumer involvement in EMA

activities

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

CAT SAG SAG

Patient

input

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 Patient involvement along the medicine lifecycle at EMA

4

3 3 2 3 3

14 8 11 13

5

22

7

27

13 18

36

13

24 19

44

33

10

39

28

87

35

25

44

35

104

23 24 18

62

95

0

20

40

60

80

100

120

SAG/ad hoc expert meetings Committee consultations Safety communications SA/PA procedures Workshops

Comparison of involvement in core activities 2009–2015

2009 2010 2011 2012 2013 2014 2015 -Nov.

Activities can be categorised in three different ways:

1. Activities in which patients/consumers are members, alternates or

observers

2. Activities involving individual patient/consumer experts

3. Activities requiring organisation representatives.

5

6

26 33 35 46 47 44

55 55 55

22

87

108

175

200

240

333 336

296

28

47

70 86

176

241

163

242

336

0

50

100

150

200

250

300

350

400

2007 2008 2009 2010 2011 2012 2013 2014 2015 -Nov.

Involvement as committee/WP members, experts and representatives of organisations

2007–2015

Committee/WP members Experts Representatives

Members :

• EMA Management Board (MB)

• Committee for Orphan medicines (COMP)

• Committee for paediatric medicines (PDCO)

• Committee for advanced therapies (CAT)

• Pharmacovigilance Risk Assessment Committee (PRAC)

Individual experts; Examples during 2015:

• Scientific Advice/Protocol Assistance procedures (some with HTAs*)

• Scientific Advisory Group (SAG)/ad-hoc expert meetings

• Committee consultations

• CHMP oral explanations

• Review of package leaflets

• Review of safety communications

• Review of EPAR summaries

* HTA = health technology assessment

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Representatives of organisations; 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

8

EMA Working Party with Patients & Consumers Organisations (PCWP)

The PCWP plays a key role in the interaction between the EMA and PCOs.

• 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.

9

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

PCWP representatives involved in many EU-wide initiatives

• The European Network of Paediatric Research (Enpr-EMA); patient representative member

of the Enpr-EMA coordinating group

• The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance

(ENCePP); PCO representative member of the steering group

• ADVANCE project;

• WEB-RADR

10

• 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

• DIA Info Day on Post-Authorisation Studies

• 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

• ADAPT SMART kick-off meeting

• 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

11

Involvement in EMA workshops/conferences

12

32 39

46

18

46 35

48 60

51

11

43

75

62

79

102 110

89 89

0

20

40

60

80

100

120

2007 2008 2009 2010 2011 2012 2013 2014 2015 -

Oct.

Package leaflets and EPAR summaries sent for

review

EPAR Summaries Package leaflets

Feedback on comments received; EPAR summaries

13

64% of EPARs adjusted due

to feedback by patients

39

25

0

5

10

15

20

25

30

35

40

45

Total amount EPARschecked

Total amount EPARschanged by patient

feedback 29

11

29

20

11

14

1 2

4 1 - What is …

2 - How is it used

3 - How does it work

4 - Benefits

5 - Risks

6 - Why is it introduc

7 - Awaited info

8 - Safety measures

9 - Other info

Eligible organisations: patients/consumers

Topic groups

15

1. Measure impact of patient involvement (2 TC held)

2. Acknowledge and promote visibility of patient input in the Agency’s activities (3 TC

held)

3. Training (2 TC held)

4. Social media (4 TC held, face to face meeting planned)

5. Involvement of young people – children (2 TC held)

Ongoing initiatives

16

• Pilot project to involve patients in CHMP plenary discussions

3 cases so far

• Elicitation of B/R preferences

Pilot study with melanoma / myeloma patients

Larger study planned 1Q 2016

• Enhanced training materials

‘EMA basics’ short videos

Info-sheets

Improvements to webpages dedicated to patients

Conclusion

• The involvement of PCOs continues to be extremely beneficial;

• They 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 continues to expand, but also evolves

ensuring it occurs in the most optimal manner possible

• We will continue to look to enhance and improve involvement wherever needed / feasible

• This interaction allows patients to engage with the EMA to share their real-life experience

and knowledge which ultimately contributes to the quality of the decision-making process

• We look forward to a continued mutually beneficial collaboration during 2016!

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