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
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EMA SME survey 2015
EMA SME Survey 2015
INTRODUCTION
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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: -
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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
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EMA SME survey 2015
SME PROGRAMME SERVICES OFFERED BY THE SME OFFICE
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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
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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
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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
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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
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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]
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