10 years of SME support SME survey 2015 – Taking stock of the experience gained with the Agency’s SME initiative 10 years after its launch

Presented by Angela-Christina Schmidt on 29 November 2015; Industry Roundtable meeting Corporate Stakeholders Department - Stakeholders & Communication Division

An agency of the European Union

Agenda A. Introduction i.

Survey objectives

ii.

Scope & methodology

iii.

Survey structure

iv.

Respondents’ profile

B. Summary of feedback

1

EMA SME survey 2015

EMA SME Survey 2015

INTRODUCTION

2

EMA SME survey 2015

Survey objectives Evaluate the experience gained from the SME programme at the EMA since it was set up 10 years ago; Elicit direct feedback from SMEs and Stakeholders to better understand current and future challenges faced by SMEs. Identify areas for further development of the Agency’s SME programme that could support innovation in the SME pharmaceutical sector; Tailor our future activities to better meet the needs of SMEs.

What do we aim to achieve? 3

EMA SME survey 2015

Scope & methodology Scope: Services offered by the SME office, current and future challenges faced by SMEs, SME assignment process.

Period: 18 August – 30 Sept 2015

Response rate: 534 unique and valid responses Methodology - Web based survey - 16-17 questions; - Response formats: -

4

EMA SME survey 2015

-

Dichotomous Scale (Yes/ No), 4-point Rating Scale (Great extent– Some extent Minor extent - No); 3-point Rating scale (Very relevant – Relevant – Not relevant) Multiple choice and multiple response, Free text.

Survey structure

Awareness

Overall, Specific services

Experience

Overall, Specific services

Relevance

Overall, Specific services

Respondents’ profile

Satisfaction

Expansion

Overall, Specific services

Overall, Specific services

EMA SME Programme

Challenges

SME assignment process

Current Future 5

EMA SME survey 2015

Measures

Comments

The sample population - Respondents' profile

100%

At least 65% of all respondents have at some point held SME status with the Agency.

The typical profile of this population: • Micro sized; • Autonomous; • From the UK (19%), Germany (12%), France (8%); • Active in the human field;

80%

Are you completing thisprofile survey as: Respondent (n=534) 81%

60% 40% 20%

12%

7%

0%

SME

Organisation representative

Individual

The sample population (n=534) 100%

Healthcare professionals association (human and veterinary)

1%

Non governmental organisation (NGO) or association of NGOs

1%

Other (please specify)

1%

Other private sector (please specify)

1%

Academia or research, or association of academic/research…

60%

2%

National governmental organisation

2%

EU organisation

2%

Industry, trade association or chamber of commerce

82% 80%

40%

4%

Development, production or marketing of medical devices Dev., production, marketing of medical devices

15%

Service provider to pharmaceutical industry Service provider to pharmaceutical industry

20% 9%

19%

Development, production or marketing pharmaceuticals Development, production orofmarketing of

pharmaceuticals

2%

77% 0%

20%

40%

60%

80%

8%

0% 100%

Human health

N=435

Veterinary Human and health veterinary health

N=46

N=43

Other

N=10

The majority of respondents were SMEs operating in the pharmaceutical field, developing products for human use.

EMA SME Survey 2015

SUMMARY OF FEEDBACK

8

EMA SME survey 2015

SME PROGRAMME SERVICES OFFERED BY THE SME OFFICE

9

EMA SME survey 2015

Services offered by the SME Office - Overview

Financial fee incentives (pre-authorisation)

Advanced Therapies incentives

Financial fee incentives (post-authorisation)

Public SME register

Regulatory assistance (pre- and post authorisation

Workshop and training events

SME briefing meetings

SME user guide

Translation assistance

SME newsletter

10

EMA SME survey 2015

SME programme Awareness overall

100%

80%

To what extent are you aware of the Agency’s programme for SMEs? (n=534) 71% are aware of the SME services to at least some extent.

60%

49%

40%

23%

22% 20%

6%

0%

To a great extent

To some extent

To a minor extent

Not at all

SME programme – Awareness of specific services To what extent are you aware of the following support activities provided for SMEs by the Agency? (n=464) 100% 90% 80% 70%

12%

14%

14%

21%

21%

23%

17%

14%

13%

25%

27%

26%

19%

42% 23%

60% 50% 40%

31%

27%

36%

35%

36%

37%

31%

25%

31%

31%

34%

18% 35%

10%

0%

40%

Not at all

30% 20%

22%

Financial fee incentives pre-auth.

29%

28%

Regulatory SME assistance newsletter services (pre- and post)

23% SME user guide

22% Workshop and training events

30%

27%

Financial Public fee SME incentives Register post-auth.

17%

15%

SME Translation briefing assistance meetings

To a minor extent To some extent

18% 10% Advanced Therapies incentives

To a great extent

SME programme – Awareness of specific services 100% 90% 80% 70%

12%

14%

14%

21%

21%

23%

17%

14%

13%

25%

27%

26%

19%

42% 23%

60% 50% 40%

10% 0%

40%

27% Not at all

31%

36%

35%

36%

37%

31%

25%

31%

31%

34%

30% 20%

22%

18% 35%

29%

28%

23%

Regulatory SME user Financial SME assistance newsletter guide fee services incentives pre-auth. (pre- and post)

22% Workshop and training events

30%

27%

Financial Public fee SME incentives Register post-auth.

HIGH AWARENESS FOR 7 / 10 SERVICES More than 50% all respondents are aware to a great or some extent.

17% SME briefing meetings

15% Translation assistance

To a minor extent To some extent

18% 10% Advanced Therapies incentives

To a great extent

SME programme – Awareness of specific services 100% 90% 80% 70%

12%

14%

14%

21%

21%

23%

17%

14%

13%

25%

27%

26%

19%

42% 23%

60% 50% 40%

31%

27%

36%

35%

36%

37%

31%

25%

31%

31%

34% 18% 35%

10% 0%

40%

Not at all

30% 20%

22%

Financial fee incentives pre-auth.

29% Regulatory assistance services (pre- and post)

28% SME newsletter

23% SME user guide

22% Workshop and training events

30%

Financial fee incentives post-auth.

27% Public SME Register

17%

15%

SME Translation briefing assistance meetings

To a minor extent To some extent

18%

To a great extent

10% Advanced Therapies incentives

LIMITED AWARENESS Almost 50% of all respondents are not at all aware of these services or only to a minor extent.

SME programme – Experience with specific services

100%

90% 80%

To what extent have you made use of the following support activities provided for SMEs by the Agency? (n=439) 28%

37%

42%

70% 60%

10%

51%

50% 68%

23%

22%

40%

20%

50%

25%

50%

30%

50%

30%

25%

17%

15%

SME newsletter

SME user guide

22%

14%

11% 17%

22%

16%

11%

21%

19%

14%

20%

0% Public SME Register

Financial Regulatory Financial assistance fee fee incentives incentives services pre-auth. (pre- and post-auth. post)

81%

84%

5% 7% 7%

8% 5%

19%

21% 10%

11% 13% 8%

Workshop Translation SME & training briefing assistance events meetings

Advanced Therapies incentives

100% 90% 80%

28%

37%

42%

70% 60%

10% 0%

51%

50%

68% 23%

22%

40%

20%

50%

25%

50%

30%

50%

30% 17% SME newsletter

25% 15% SME user guide

22%

14% Public SME Register

11% 17%

22% Financial fee incentives pre-auth.

16%

11%

21%

19%

14% Regulator y assistance services (pre- and post)

20% Financial fee incentives post-auth.

81%

84%

5% 7% 7%

8% 5% 3%

19%

21% 10% Workshop & training events

11% 13% 8%

SME Translation briefing assistance meetings

Advanced Therapies incentives

LIMITED USE SMEs registered with the Agency use these services rarely. The same services ranked very lowly in terms of awareness as well.

100% 90% 80%

28%

37%

42%

70% 60%

10% 0%

51%

50%

68% 23%

22%

40%

20%

50%

25%

50%

30%

50%

30% 17% SME newsletter

25% 15% SME user guide

22%

14% Public SME Register

11% 17%

22% Financial fee incentives pre-auth.

16%

11%

21%

19%

14% Regulator y assistance services (pre- and post)

20% Financial fee incentives post-auth.

81%

84%

5% 7% 7%

8% 5% 3%

19%

21% 10% Workshop & training events

11% 13% 8%

SME Translation briefing assistance meetings

Advanced Therapies incentives

USED BY ~100%... ... of those companies to whom the translation service is applicable!

100% 90% 80%

28%

37%

42%

70% 60%

10% 0%

51%

50%

68% 23%

22%

40%

20%

50%

25%

50%

30%

50%

30% 17% SME newsletter

25%

22%

15% SME user guide

14% Public SME Register

11% 17%

22% Financial fee incentives pre-auth.

16%

11%

21%

19%

14% Regulator y assistance services (pre- and post)

20% Financial fee incentives post-auth.

USED MOST SMEs registered with the Agency use these services the most. The same services ranked quite high in terms of awareness as well.

81%

84%

5% 7% 7%

8% 5% 3%

19%

21% 10% Workshop & training events

11% 13% 8% SME briefing meetings

Translation assistance

Advanced Therapies incentives

SME programme Relevance overall

100%

80%

Overall, how relevant has the SME programme been for your organisation? (n=438) 78% indicate that the SME services have been relevant or very relevant.

60%

47% 40%

31%

20%

11%

11%

Not relevant

Not applicable yet

0%

Very relevant

Relevant

SME programme – Relevance of specific services How relevant were the following specific activities? (n=422) 100% 90%

16%

22%

20%

23%

22%

80% 70% 60%

35%

54%

20%

0%

Not relevant

Financial fee incentives pre-auth.

53%

41%

30%

Relevant 25%

53%

41% 26%

10%

44%

51% 46%

49%

38%

36%

40% 30%

28%

60%

25%

50%

28%

Regulatory SME SME user assistance newsletter guide services (pre- and post)

27%

26%

Workshop Financial fee and training incentives postevents auth.

19% Public SME Register

22%

25%

SME Translation briefing assistance meetings

Very relevant 15% Advanced Therapies incentives

1.

3.

2.

22%

20%

3.

100% 90%

16%

23%

22%

80% 70% 60%

35%

54%

20%

0%

Not relevant

Regulatory assistance services (pre- and post)

41%

30%

Relevant

41% 26%

Financial fee incentives pre-auth.

53%

25%

53%

10%

44%

51% 46%

49%

38%

36%

40% 30%

28%

60%

25%

50%

28%

SME newsletter

SME user guide

27%

26%

Workshop and training events

Financial fee incentives post-auth.

MOST RELEVANT Respondents find these services the most relevant. Awareness for these services was high.

19%

22%

Public SME Register

SME briefing meetings

25% Translation assistance

Very relevant 15% Advanced Therapies incentives

100% 90%

16%

22%

20%

23%

22%

80% 70% 60%

35%

54%

20%

0%

Not relevant

Regulator y assistance services (pre- and post)

41%

30%

Relevant

41% 26%

Financial fee incentives pre-auth.

53%

25%

53%

10%

44%

51% 46%

49%

38%

36%

40% 30%

28%

60%

25%

50%

28%

SME newsletter

SME user guide

27%

26%

Workshop and training events

Financial fee incentives post-auth.

19%

22%

Public SME Register

SME briefing meetings

25% Translation assistance

Very relevant 15% Advanced Therapies incentives

LEAST RELEVANT … however respondents were least aware of this service and have consequently almost never used it. 91% of all respondents who have made use of this service to at least some extent, rated it relevant (35%) or very relevant (57%).

SME programme – Relevance of specific services Respondents who have made use of a particular service to at least some extent, consistently rate that respective service very highly (>89%) in terms of relevance. 100%

2%

1%

6%

90% 90% 80%

19%

35%

11%

8%

5%

35%

54%

48%

60%

3%

3%

51%

53%

7%

24%

33%

70%

9%

42%

Not relevant

50% 40%

Relevant

79% 64%

30%

67%

61%

20%

57%

41%

41%

51%

46%

44%

SME user guide

SME newsletter

n= 153

n= 182

10% 0%

Financial fee incentives pre-auth. n= 148

Financial Regulatory SME Translation fee assistance briefing assistance incentives services meetings post-auth. (pre-& post) n= 136

n= 130

n= 80

n= 50

Advanced Therapies incentives

Public SME Register

Workshop and training events

n= 54

n= 136

n= 117

Very relevant

SME PROGRAMME FUTURE SERVICES

24

EMA SME survey 2015

SME programme Expansion overall Does the Agency need to expand its programme to support SMEs? (n=421) 100% 80%

64% favour an expansion of the SME programme to at least some extent.

60%

43% 40%

21% 20%

12%

16%

9%

0%

Yes, to a Yes, to some Yes, to a great extent extent minor extent 25

EMA SME survey 2015

No

No awareness of current programme

SME programme – Expansion of specific services 100% 90%

Does the Agency need to expand specific activities in the EMA programme to support SMEs? (n=414) 20%

80% 70%

17%

60%

27%

14%

27%

14%

21%

24%

25%

26%

50% 50% 40%

39%

34%

34%

36%

34%

20%

0%

24%

25%

Regulatory Financial assistance fee services incentives (pre- and pre-auth. post)

25% Financial fee incentives post-auth.

21%

32%

26%

35%

39%

19%

14%

Workshop SME and briefing training meetings events

32%

31%

42%

29%

26% 11%

14%

11%

9%

Translation assistance

SME user guide

SME newsletter

No Yes, to a minor extent

27% 23%

30%

10%

33%

28%

22% 8%

Advanced Public Therapies SME incentives Register

Yes, to some extent Yes, to a great extent

100% 90%

20%

80% 70%

17%

60%

27%

14%

27%

14%

21%

24%

25%

26%

50% 50% 40%

39%

34%

34%

36%

34%

20%

0%

24%

25%

Regulatory Financial assistance fee services incentives (pre- and pre-auth. post)

25% Financial fee incentives post-auth.

21%

32%

35%

39%

19% Workshop and training events

14% SME briefing meetings

32%

31%

14%

11%

Translation assistance

SME user guide

42%

29%

26%

9%

11%

SME newsletter

EXPANSION SUGGESTED More than 50% of all respondents indicate that existing services should be expanded to at least some extent.

Advanced Therapies incentives

No Yes, to a minor extent

27%

26%

23%

30%

10%

33%

28%

22% 8% Public SME Register

Yes, to some extent Yes, to a great extent

Current & future challenges

28

EMA SME survey 2015

Challenges faced by SMEs – Current (n=373)

• Finding funding and the relevant expertise needed to move things forward.

100% 80% 60%

• The cost of compliance with the current regulations is too high.

82% *

• Lack of funds to develop quickly products pipeline, slow approval route, bureaucratic drawbacks.

47%

40%

8%

29

• The main challenges for SMEs are the difficulties to be competitive in front of the bigger companies.

22%

20%

0%

SAMPLE COMMENTS

Regulatory requirements

EMA SME survey 2015

Funding & finance

5%

Competition & Information, globalisation communication & networking

(*) Themes reflect >=5% of all responses)

• Different national interpretations of regulation. To be more European we have to be more 1 Europe.

• Too much paperwork in every direction.

Challenges faced by SMEs – Current (n=373)

100% 80% 60%

82% * 47%

3%

40%

8% 0%

30

Regulatory requirements

EMA SME survey 2015

Funding & finance

2% 27%

22%

20%

Lack of harmonisation

5%

Competition & Information, globalisation communication & networking

(*) Themes reflect >=5% of all responses)

15% Regulatory requirements

Administrative burden Regulatory complexity Regulatory costs

Challenges faced by SMEs – Current

100%

Emerging themes:

80% 60%

1. Market access (4%) 2. Recruitment, education, training (2%)

82% * 47%

40% 22%

20%

8% 0%

31

Regulatory requirements

EMA SME survey 2015

Funding & finance

5%

Competition & Information, globalisation communication & networking

Challenges faced by SMEs – 5 years (n=373)

100% 80%

89% *

60%

2%

44%

9%

40%

17%

20%

0%

32

Lack of harmonisation

Regulatory requirements

EMA SME survey 2015

Funding & finance

14% 13%

Competition & globalisation

8% Info., comm. & networking

7% Market access

(*) Themes reflect >=5% of all responses)

19% Regulatory requirements

Regulatory costs

Administrative burden Regulatory complexity

Challenges faced by SMEs – 5 years

100% 80%

Emerging themes:

89% *

60% 44% 40%

17%

20%

0%

33

Regulatory requirements

EMA SME survey 2015

Funding & finance

13%

Competition & globalisation

8% Info., comm. & networking

7% Market access

(*) Themes reflect >=5% of all responses)

1. Market access (7%) 2. Recruitment, education, training (4%)

Measures In your opinion, what measures could the Agency introduce to address these challenges? (n=373) 100% 80%

76% *

60%

2%

42% 40%

34

9%

27%

9%

20% 0%

5%

7% Regulatory requirements

EMA SME survey 2015

Information, communication & networking

Funding & finance

(*) Themes reflect >=5% of all responses)

17% Regulatory requirements

Reduce admin. burden Harmonise

Reduce regulatory burden Lower regulatory cost Increase regulatory support

Measures In your opinion, what measures could the Agency introduce to address these challenges?? (n=373) 100% 80%

76% *

60%

3%

42% 40%

3% 27%

8%

20% 0%

35

7% Regulatory requirements

EMA SME survey 2015

Information, communication & networking

Funding & finance

(*) Themes reflect >=5% of all responses)

13% Information, communication & networking

Broaden networking opportunities Engage SMEs and stakeholders Provide training Improve access to information & communication

Measures In your opinion, what measures could the Agency introduce to address these challenges?? (n=373) 100%

76% *

42% 40%

 

27%

20%

7% Regulatory requirements

EMA SME survey 2015

Information, communication & networking

Early dialogue with HTA: Parallel SA/EMA HTA.

2. Recruitment, education, training

60%

36

1. Market access: 

80%

0%

Emerging themes:

Funding & finance

(*) Themes reflect >=5% of all responses)

Improve access to information; Offer more training and workshops.

SME assignment process and incentives

37

EMA SME survey 2015

SME assignment – Satisfaction with initial assignments and renewals Please rate the Agency’s SME registration process. (n=307) 100%

4%

6%

1% 7%

2%

2%

2%

12%

10%

13%

52%

59%

58%

48%

90%

85%

80% 70% 60%

41% 49%

Very poor

50% Poor

40% 30% 20%

44%

35%

10%

33%

38%

47%

Good 37%

0% Initial assignment: Contact with SME Office

Initial assignment: Timelines

Initial Assignment: Guidance

Renewal: Timelines

Renewal: Contact with SME Office

Renewal: Guidance

Very good

100%

4%

6%

1% 7%

2%

2%

2%

12%

10%

13%

52%

59%

58%

48%

90%

85%

80% 70% 60%

41% 49%

50%

Poor

40%

Good

30%

20%

44%

35%

33%

Initial assignment: Timelines

Initial Assignment : Guidance

10% 0%

Very poor

Initial assignment: Contact with SME Office

38%

Renewal: Timelines

47%

Renewal: Contact with SME Office

37%

Renewal: Guidance

RENEWALS While still being ranked as good or very good by more than 85% of all respondents, overall renewals have received lower satisfaction scores than initial assignments.

Very good

SME Survey 2015

COMMENTS 40

EMA SME survey 2015

SAMPLE COMMENTS

21%

• Thank you for your very appreciated support to SMEs . • Personnel at EMA´s SME Office and Innovation Task Force have done an excellent job at helping us and addressing our questions.

69%

48%

• Keep doing this !!! • A very worthwhile service which is very much appreciated by those with whom I have worked.

63%

• SME status needs to be renewed annually, it would be good if this could be done less frequently.

Positive feedback on the SME office services and staff

• Completing the renewal form takes ages. It could be made quicker if we could just update the previous years information rather than insert it all from scratch. • The template for SME application and renewal is not working well when it comes to Electronic submission.

(n= 114)

Technical issues with the declaration form

31% 32%

Allow for longer SME status validity

Thank you for your attention Further information [email protected]

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

Follow us on

@EMA_News