The future prospects for clinical
trials in Europe
Richard Torbett
Chief Economist, EFPIA
Importance of Pharma R&D in EU
Europe 2020 strategy, March 2010:
• “The EU […] has a target of investing 3% of GDP in R&D”. “R&D spending in Europe is
below 2% […] mainly as a result of lower levels of private investment.”
• “Europe needs […] to improve the conditions for private sector R&D in the EU.”
COM(2010) 2020, page 10
International clinical trials (mostly phase 2/3) are a pivotal part of the R&D process
Clinical trials for €20Bn every year in the EU (Commissioner for Health)
One-fifth of EU
private R&D is
spent by the
pharmaceutical
Pharma-
Non-
ceuticals
19.2%
clinical
R&D
30%
Phase
M ore than half of
1&4
pharma R&D
trials
is spent on
19%
industry
phase 2 & 3
trials (2009)
Others
80.8%
Phase 2
& 3 trials
50.4%
Phase 1+ 4
Phase 2+ 3
Other R&D
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Clinical Trials going down….
Number of trials in the EU
6000
5000
4000
5109
3000
4687
- 8%
4538
- 3%
4193
- 8%
2009
2010
2000
1000
0
2007
2008
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Just as important:
Science is changing
Personalised Healthcare (or targeted medicine):
•Medicine & «companion» diagnostic
•Co-development adds to complexity of clinical development
•Identification of smaller subset of patients instead of large clinical trials
•Shift in clinical trial designs
•Shift in selecting endpoints, in particular for cancer medicines
•Need for flexibility in the design and architecture of clinical trials
•Need for consideration of entire development process
when discussing clinical trials
•Pharmaceutical Legislation «meets» Medical Device Legislation
4
Commission proposal: a good
start
Industry has been calling for :
•
patient access to therapeutic
breakthroughs without
administrative delay
•
an attractive & harmonised
environment for clinical
development throughout the EU
•
Recognition of the changes in
pharmaceutical development,
such as personalised healthcare
•
Ensuring any changes to the
European framework are relevant &
effective for the next two decades
Proposal delivers a lot and is
a good first fix for today’s
problems:
- Reduced or eliminated
differences in process &
requirements between
MS
- Timelines have been
addressed
- There is more
predictability
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But will it bring more investment?
Issue
Possible way forward
Ethics Committee process
remains at the national
level
Maximise patient safety
and efficiency.
Could create a European
platform for exchange of
best
practice….EUnEthics?
Any COM proposal may take years to adopt and implement so it’s
important to get it as right as possible.
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But will it bring more investment?
Issue
Possible way forward
Will the new system be fit
for the future given
developments in science –
personalised medicines,
orphan drugs etc?
New system needs to be
flexible enough to allow for
novel research methods
and techniques
Any COM proposal may take years to adopt and implement so it’s
important to get it as right as possible.
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Timelines are key to
competitiveness
CT APPROVAL TIMELlNES
EU
Proposal
EU
Old
US
CANADA
CHINA
BRAZIL
ARGENTINA
41 - 75d*
60d
30d
30d
90d
60d
90d
Includes
Ethics
Excludes
Ethics
Reviews
Reviews
It is important to retain the
Commission’s proposed timelines
if the EU is to retain its competitive
position
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The European Access Crisis
needs to be addressed
Source: Innovation and Solidarity in Pharmaceuticals. EU Belgian Presidency Ministerial Conference, 09/2010.
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Conclusions
1. This revision process provides a crucial opportunity to
ensure the EU’s attractiveness for innovative
pharmaceutical R&D for the coming two decades.
2. There is a needs to be enhanced co-operation on ethics
committees if we are to both safe-guard patient safety AND
retain competitive timelines
3. The Commissions ambitions on timelines should not be
diluted
4. Changes in the political and economic environment will
have an impact on the future of clinical trials. Revision
needs to be seen in this broader context. The access crisis
needs to be fixed
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