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.
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
Translation assistance
Advanced Therapies incentives
To what extent are you aware of the following support activities provided for SMEs by the Agency? (n=464)
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
HIGH AWARENESS FOR 7 / 10 SERVICES More than 50% all respondents are aware to a great or some 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
Translation assistance
Advanced Therapies incentives
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
Translation assistance
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
Financial fee
incentives pre-auth.
Regulatory assistance services
(pre- and post)
Financial fee
incentives post-auth.
SME newsletter
SME user guide
Workshop & training
events
Public SME
Register
SME briefing
meetings
Translation assistance
Advanced Therapies incentives
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
incentives pre-auth.
Regulatory
assistance services (pre- and
post)
Financial fee
incentives post-auth.
SME newsletter
SME user guide
Workshop & training
events
Public SME
Register
SME briefing
meetings
Translation assistance
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.
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
incentives pre-auth.
Regulatory
assistance services (pre- and
post)
Financial fee
incentives post-auth.
SME newsletter
SME user guide
Workshop & training
events
Public SME
Register
SME briefing
meetings
Translation assistance
Advanced Therapies incentives
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
incentives pre-auth.
Regulatory
assistance services (pre- and
post)
Financial fee
incentives post-auth.
SME newsletter
SME user guide
Workshop & training
events
Public SME
Register
SME briefing
meetings
Translation assistance
Advanced Therapies incentives
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
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
Translation assistance
Advanced Therapies incentives
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
incentives pre-auth.
How relevant were the following specific activities? (n=422)
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
Translation assistance
Advanced Therapies incentives
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
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
Translation assistance
Advanced Therapies incentives
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
incentives pre-auth.
Regulatory assistance services
(pre-& post)
Financial fee
incentives post-auth.
SME newsletter
SME user guide
Workshop and
training events
Public SME
Register
SME briefing
meetings
Translation assistance
Advanced Therapies incentives
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
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
Translation assistance
Advanced Therapies incentives
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
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
Translation assistance
Advanced Therapies incentives
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
Regulatory requirements
Competition & globalisation
Information, communication & networking
82% *
(*) Themes reflect >=5% of all responses)
47%
15%
27%
Regulatory costs
Regulatory complexity
Administrative burden
Lack of harmonisation
2% 3%
Regulatory requirements
31
Challenges faced by SMEs – Current
EMA SME survey 2015
22%
8% 5%
0%
20%
40%
60%
80%
100%
Funding & finance
Regulatory requirements
Competition & globalisation
Information, communication & networking
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
Regulatory requirements
Competition & globalisation
89% *
(*) Themes reflect >=5% of all responses)
44%
Info., comm. &
networking
Market access
19%
14%
Regulatory complexity
Administrative burden
Regulatory costs
Lack of harmonisation
9%
2%
Regulatory requirements
17% 13%
8% 7%
0%
20%
40%
60%
80%
100%
33
Challenges faced by SMEs – 5 years
EMA SME survey 2015
Funding & finance
Regulatory requirements
Competition & globalisation
Info., comm. &
networking
89% *
(*) Themes reflect >=5% of all responses)
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
Information, communication & networking
Regulatory requirements
Funding & finance
76% *
(*) Themes reflect >=5% of all responses)
42%
27%
7% 17%
9%
Increase regulatory support
Lower regulatory cost
Reduce regulatory burden
Reduce admin. burden
9%
2% 5%
Harmonise
Regulatory requirements
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
Information, communication & networking
Regulatory requirements
Funding & finance
76% *
(*) Themes reflect >=5% of all responses)
42%
27%
7% 13%
8%
Improve access to information & communication
Provide training
Broaden networking opportunities
3%
3% Engage SMEs and stakeholders
Information, communication & networking
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
Information, communication & networking
Regulatory requirements
Funding & finance
76% *
(*) Themes reflect >=5% of all responses)
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
Further information
Follow us on @EMA_News
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