10 years of SME support · An agency of the European Union 10 years of SME support SME survey 2015 – Taking stock of the experience gained with the Agency’s SME initiative 10

An agency of the European Union

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

Agenda

A. Introduction

i. Survey objectives

ii. Scope & methodology

iii. Survey structure

iv. Respondents’ profile

B. Summary of feedback

1 EMA SME survey 2015

INTRODUCTION

2

EMA SME Survey 2015

EMA SME survey 2015

What do we aim to achieve?

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.

Evaluate the experience gained from the SME programme at the EMA since it was set up 10 years ago;

3

Survey objectives

EMA SME survey 2015

Elicit direct feedback from SMEs and Stakeholders to better understand current and future challenges faced by SMEs.

Period: 18 August – 30 Sept 2015

Scope: Services offered by the SME office, current and

future challenges faced by SMEs, SME assignment process.

4

- Web based survey

- 16-17 questions;

- Response formats:

- 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.

Scope & methodology

EMA SME survey 2015

Response rate: 534 unique and valid responses

Methodology

Respondents’

profile

EMA SME

Programme

5

Survey structure

EMA SME survey 2015

Awareness Overall, Specific services

Challenges

Current

Future

Measures

SME

assignment

process

Experience Overall, Specific services

Relevance Overall, Specific services

Expansion Overall, Specific services

Satisfaction Overall, Specific services

Comments

The sample population - Respondents' profile

81%

12% 7%

0%

20%

40%

60%

80%

100%

SME Organisationrepresentative

Individual

Respondent profile Are you completing this survey as: (n=534)

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;

60%

77%

19%

15%

4%

2%

2%

2%

1%

1%

1%

1%

0% 20% 40% 60% 80% 100%

Development, production or marketing of pharmaceuticals

Service provider to pharmaceutical industry

Development, production or marketing of medical devices

Industry, trade association or chamber of commerce

EU organisation

National governmental organisation

Academia or research, or association of academic/research…

Other private sector (please specify)

Other (please specify)

Non governmental organisation (NGO) or association of NGOs

Healthcare professionals association (human and veterinary)

Development, production or marketing of pharmaceuticals

Service provider to pharmaceutical industry

Dev., production, marketing of medical devices

82%

9% 8%

2%

0%

20%

40%

60%

80%

100%

Human

health

Veterinary

health

Human and

veterinary

health

Other

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

The sample population (n=534)

N=46 N=435 N=43 N=10

SUMMARY OF FEEDBACK

8

EMA SME Survey 2015

EMA SME survey 2015

9

SME PROGRAMME

SERVICES OFFERED BY THE SME OFFICE

EMA SME survey 2015

10

Financial fee incentives (pre-authorisation)

Financial fee incentives (post-authorisation)

Regulatory assistance (pre- and post authorisation

SME briefing meetings

Translation assistance

Advanced Therapies incentives

Public SME register

Workshop and training events

SME user guide

SME newsletter

Services offered by the SME Office - Overview

EMA SME survey 2015

22%

49%

23%

6%

0%

20%

40%

60%

80%

100%

To a great

extent

To some

extent

To a minor

extent

Not at all

SME programme

Awareness overall

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.

http://www.google.co.uk/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwiUwtuvmZ_JAhXH1xQKHSqDB10QjRwIBw&url=http://www.iconsdb.com/white-icons/idea-icon.html&bvm=bv.108194040,d.d2s&psig=AFQjCNHU0NNs7lDT-LdxVgzFhE6dcazTYQ&ust=1448115619129205

SME programme – Awareness of specific services

35% 29% 28% 23% 22%

30% 27% 17% 15% 10%

31% 36% 35% 36% 37% 31% 31%

34%

18% 18%

21% 21% 23% 25% 27% 26%

23% 27%

25% 31%

12% 14% 14% 17% 14% 13% 19% 22%

42% 40%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Not at all

To a minor extent

To some extent

To a great extent

Financial fee

incentives pre-auth.

Regulatory assistance services

(pre- and post)

Financial fee

incentives post-auth.

SME newsletter

SME user guide

Workshop and

training events

Public SME

Register

SME briefing

meetings



To what extent are you aware of the following support activities provided for SMEs by the Agency? (n=464)


35% 29% 28% 23% 22%

30% 27% 17% 15% 10%

31% 36% 35% 36% 37% 31% 31%

34%

18% 18%

21% 21% 23% 25% 27% 26%

23% 27%

25% 31%

12% 14% 14% 17% 14% 13% 19% 22%

42% 40%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Not at all

To a minor extent

To some extent

To a great extent

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

Financial fee



(pre- and post)

Financial fee


SME newsletter

SME user guide

Workshop and

training events

Public SME

Register

SME briefing

meetings




35% 29% 28% 23% 22%

30% 27% 17% 15% 10%

31% 36% 35% 36% 37% 31% 31%

34%

18% 18%

21% 21% 23% 25% 27% 26%

23% 27%

25% 31%

12% 14% 14% 17% 14% 13% 19% 22%

42% 40%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Not at all

To a minor extent

To some extent

To a great extent

Financial fee


Regulatory assistance services (pre- and

post)

Financial fee


SME newsletter

SME user guide

Workshop and

training events

Public SME

Register

SME briefing

meetings



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

Financial fee



(pre- and post)

Financial fee


SME newsletter

SME user guide

Workshop & training

events

Public SME

Register

SME briefing

meetings



17% 15% 14% 22%

14% 20%

10% 8% 7%

30% 25% 22% 17%

21% 19% 21%

13% 7%

5%

25%

23% 22% 11% 16% 11%

19%

11%

5% 8%

28% 37% 42%

50% 50% 51% 50%

68%

81% 84%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

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

17% 15% 14% 22%

14% 20%

10% 8% 7% 3%

30% 25% 22% 17%

21% 19% 21%

13% 7%

5%

25%

23% 22% 11% 16% 11%

19%

11%

5% 8%

28% 37% 42%

50% 50% 51% 50%

68%

81% 84%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Financial fee


Regulatory

assistance services (pre- and

post)

Financial fee


SME newsletter

SME user guide

Workshop & training

events

Public SME

Register

SME briefing

meetings



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

17% 15% 14% 22%

14% 20%

10% 8% 7% 3%

30% 25% 22% 17%

21% 19% 21%

13% 7%

5%

25%

23% 22% 11% 16% 11%

19%

11%

5% 8%

28% 37% 42%

50% 50% 51% 50%

68%

81% 84%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Financial fee


Regulatory


post)

Financial fee


SME newsletter

SME user guide

Workshop & training

events

Public SME

Register

SME briefing

meetings



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

17% 15% 14% 22%

14% 20%

10% 8% 7% 3%

30% 25% 22% 17%

21% 19% 21%

13% 7%

5%

25%

23% 22% 11% 16% 11%

19%

11%

5% 8%

28% 37% 42%

50% 50% 51% 50%

68%

81% 84%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Financial fee


Regulatory


post)

Financial fee


SME newsletter

SME user guide

Workshop & training

events

Public SME

Register

SME briefing

meetings



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

31%

47%

11% 11%

0%

20%

40%

60%

80%

100%

Very relevant Relevant Not relevant Not applicable

yet

SME programme

Relevance overall

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.

SME programme – Relevance of specific services


(pre- and post)

Financial fee


SME newsletter

SME user guide

Workshop and

training events

Public SME

Register

SME briefing

meetings



49% 53%

26%

41%

27% 26% 19% 22% 25%

15%

35% 25%

54% 36%

51%

46% 53% 41% 30%

25%

16% 22% 20% 23% 22%

28% 28% 38%

44%

60%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Not relevant

Relevant

Very relevant

Financial fee


How relevant were the following specific activities? (n=422)

Financial fee



post)

Financial fee


SME newsletter

SME user guide

Workshop and

training events

Public SME

Register

SME briefing

meetings



49% 53%

26%

41%

27% 26% 19% 22% 25%

15%

35% 25%

54% 36%

51%

46% 53% 41% 30%

25%

16% 22% 20% 23% 22%

28% 28% 38%

44%

60%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Not relevant

Relevant

Very relevant

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

1. 2. 3. 3.

Financial fee


Regulatory


post)

Financial fee


SME newsletter

SME user guide

Workshop and

training events

Public SME

Register

SME briefing

meetings



49% 53%

26%

41%

27% 26% 19% 22% 25%

15%

35% 25%

54% 36%

51%

46% 53% 41% 30%

25%

16% 22% 20% 23% 22%

28% 28% 38%

44%

60%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Not relevant

Relevant

Very relevant

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

Financial fee



(pre-& post)

Financial fee


SME newsletter

SME user guide

Workshop and

training events

Public SME

Register

SME briefing

meetings



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.

79%

64% 61%

41%

67% 57%

41% 51% 46% 44%

19% 35% 33%

48%

24%

35% 54% 42% 51% 53%

2% 1% 6% 11% 9% 8% 5% 7%

3% 3%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Not relevant

Relevant

Very

relevant

90%

n= 117 n= 153 n= 148 n= 136 n= 130 n= 80 n= 50 n= 136 n= 182 n= 54

24

SME PROGRAMME

FUTURE SERVICES

EMA SME survey 2015

21%

43%

12% 16%

9%

0%

20%

40%

60%

80%

100%

Yes, to a

great extent

Yes, to some

extent

Yes, to a

minor extent

No No

awareness of

current

programme

SME programme

Expansion overall

Does the Agency need to expand its programme to support SMEs? (n=421)

EMA SME survey 2015 25

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

24% 25% 25% 19% 14% 14% 11% 9% 11% 8%

39% 34% 34%

36% 34%

32% 31% 29% 26%

22%

17% 14% 14% 24%

26% 21% 26% 27%

23% 28%

20% 27% 27%

21% 25%

33% 32% 35% 39% 42%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

No

Yes, to a

minor extent

Yes, to some

extent

Yes, to a great

extent

SME programme – Expansion of specific services

Financial fee



(pre- and post)

Financial fee


SME newsletter

SME user guide

Workshop and

training events

Public SME

Register

SME briefing

meetings



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

50%

24% 25% 25% 19% 14% 14% 11% 9% 11% 8%

39% 34% 34%

36% 34%

32% 31% 29% 26%

22%

17% 14% 14% 24%

26% 21% 26% 27%

23% 28%

20% 27% 27%

21% 25%

33% 32% 35% 39% 42%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

No

Yes, to a

minor extent

Yes, to someextent

Yes, to a great

extent

Financial fee



post)

Financial fee


SME newsletter

SME user guide

Workshop and

training events

Public SME

Register

SME briefing

meetings



50%

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

28

Current & future challenges

EMA SME survey 2015

22%

8% 5%

0%

20%

40%

60%

80%

100%

29

Challenges faced by SMEs – Current (n=373)

EMA SME survey 2015

Funding & finance

Regulatory requirements

Competition & globalisation

Information, communication & networking

82% *

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

47%

• Finding funding and the relevant

expertise needed to move things

forward.

• The cost of compliance with the

current regulations is too high.

• Lack of funds to develop quickly

products pipeline, slow approval

route, bureaucratic drawbacks.

• The main challenges for SMEs are

the difficulties to be competitive in

front of the bigger companies.

• Different national interpretations

of regulation. To be more

European we have to be more 1

Europe.

• Too much paperwork in every

direction.

SAMPLE COMMENTS

22%

8% 5%

0%

20%

40%

60%

80%

100%

30

Challenges faced by SMEs – Current (n=373)

EMA SME survey 2015

Funding & finance




82% *


47%

15%

27%

Regulatory costs

Regulatory complexity

Administrative burden

Lack of harmonisation

2% 3%


31

Challenges faced by SMEs – Current

EMA SME survey 2015

22%

8% 5%

0%

20%

40%

60%

80%

100%

Funding & finance




82% *

47%

Emerging themes:

1. Market access

(4%)

2. Recruitment,

education,

training (2%)

17% 13%

8% 7%

0%

20%

40%

60%

80%

100%

32

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

EMA SME survey 2015

Funding & finance



89% *


44%

Info., comm. &

networking

Market access

19%

14%

Regulatory complexity

Administrative burden

Regulatory costs

Lack of harmonisation

9%

2%


17% 13%

8% 7%

0%

20%

40%

60%

80%

100%

33

Challenges faced by SMEs – 5 years

EMA SME survey 2015

Funding & finance



Info., comm. &

networking

89% *


44%

Market access

Emerging

themes:

1. Market access

(7%)

2. Recruitment,

education,

training (4%)

0%

20%

40%

60%

80%

100%

34

Measures

EMA SME survey 2015



Funding & finance

76% *


42%

27%

7% 17%

9%

Increase regulatory support

Lower regulatory cost

Reduce regulatory burden

Reduce admin. burden

9%

2% 5%

Harmonise


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

0%

20%

40%

60%

80%

100%

35

Measures

EMA SME survey 2015



Funding & finance

76% *


42%

27%

7% 13%

8%

Improve access to information & communication

Provide training

Broaden networking opportunities

3%

3% Engage SMEs and stakeholders


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

0%

20%

40%

60%

80%

100%

36

Measures

EMA SME survey 2015



Funding & finance

76% *


42%

27%

7%

Emerging themes:

1. Market access:

Early dialogue with HTA: Parallel

SA/EMA HTA.

2. Recruitment, education,

training

Improve access to information;

Offer more training and

workshops.

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

37

SME assignment process and incentives

EMA SME survey 2015

44% 35% 33% 38%

47% 37%

52% 59% 58% 48% 41%

49%

4% 6% 7% 12% 10% 13%

1% 2% 2% 2%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Very poor

Poor

Good

Very good

SME assignment – Satisfaction with initial assignments

and renewals

Initial assignment:

Timelines

Initial assignment: Contact with SME Office

Renewal: Timelines

Initial Assignment:

Guidance

Renewal: Contact with SME Office

Renewal: Guidance

Please rate the Agency’s SME registration process. (n=307)

85%

44% 35% 33% 38%

47% 37%

52% 59% 58% 48% 41%

49%

4% 6% 7% 12% 10% 13%

1% 2% 2% 2%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Very poor

Poor

Good

Very good

Initial assignment:

Timelines

Initial assignment: Contact with SME Office

Renewal: Timelines

Initial Assignment: Guidance

Renewal: Contact

with SME Office

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.

85%

COMMENTS SME Survey 2015

40 EMA SME survey 2015

48%

31%

Allow for longer

SME status validity

32%

21%

Technical issues with the

declaration form

69%

Positive feedback on the

SME office services and

staff

63%

• 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.

• Keep doing this !!!

• A very worthwhile service which is

very much appreciated by those

with whom I have worked.

• SME status needs to be renewed

annually, it would be good if this

could be done less frequently.

• 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)

SAMPLE COMMENTS

Thank you for your attention

[email protected]

Further information

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Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555

Send a question via our website www.ema.europa.eu/contact

Documents

10 years of SME support · An agency of the European Union 10 years of SME support SME survey 2015 – Taking stock of the experience gained with the Agency’s SME initiative 10