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

19

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

22

• 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