5o clinical research conference, jim sage
TRANSCRIPT
Clinical Trials: A Potential Growth Engine For Greece
Key Considerations To Attract Clinical Trial Investment
Jim Sage President PhRMA Innovative Forum (PIF) President and Managing Director, Pfizer Hellas
Innovation Forum Greece
Who is the PhRMA Innovation Forum (PIF)
20 world leading R&D pharma companies
Pharmaceutical innovation is a good investment for Greece
Pharmaceutical innovation contributes to better health
Innovation Forum Greece
Mean age at death, Greece, 1995-2010
Pharmaceutical innovation increased longevity in Greece by 0.87 years during the period 1995-2010
Per capita expenditure on cardiovascular hospitalizations would have been $89 (70%) higher in 2003 had new cardiovascular medicines not been introduced in the period 1995–2003.2
$24
-$89 -$100
-$80
-$60
-$40
-$20
$0
$20
$40
Cost of NewMedicines
Hospitalization
$ pe
r Cap
ita
Medicines use yields savings in the HC system
4 www.efpia.eu
Medicine use yields Significant health gains and savings in other parts of healthcare systems
The Pharma Industry has a significant impact on the Greek
Economy
Better Health = More Wealth
The Pharma Industry is a key economic
contributor to Greece
Total Impact total jobs due
to pharma industry
operations in Greece
87.400
Total Impact 3.5% of GDP
€6.2b
Pharma employees in Europe generate 80% more value per employee vs other industries
2005-2015 Inflows of FDI in Greece (million Euros) – Bank of Greece 2016
OECD highlights the low performance of Greece in FDI and recommends actions Only € 0.6b FDI in Greece for 2015
- €5b per year
from Greek economy
Innovation Forum Greece
Improvement in Foreign Direct Investments (FDI) is critical for the recovery of Greek economy
4.78 % of GDP the FDI global average / World Bank
more than € 6 b in Greece before crisis
Pharmaceutical Innovation via Clinical Trials can bring more Foreign Direct Investment and be a significant growth pillar for Greece
Innovation Forum Greece
€31B was invested in clinical trials in Europe, Greece is not attracting
its fair share
Source : EFPIA, The Pharmaceutical industry in figures, 2015 report
Pharma has the highest R & D intensity of any Industry
According to country size, Greece should attract 1.5% of total CT investment in Europe, which means approx. €400 million more
40 75 77 80 85 85 124 158 161 180 197 197 274 305 642 650 765
953 1350 1453
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4564 4868
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5813
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Hung
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Rom
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and
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sAu
stria
Swed
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Italy
Denm
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Belg
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Clinical trials investment brings value to the state, medical community and patients
Innovation Forum Greece
Patients €31B
Clinical trials
State
+ €100M
• Reputation • Resources • Knowledge • Expertise
Access to the newest medicines
Physicians 4.300 jobs €220Μ
Skilled workforce
Medical
Access of patients
Predictable environment
Clinical trial cost
Clinical trial quality
Time to approval
Tax breaks & Incentives for investment
Adoption of innovation & fair pricing
Public -Private partnership
If Ireland and Belgium can why not Greece? What does it take to attract Clinical Trials
COM
MER
CIAL
Innovation Forum Greece
CLIN
ICAL
Unfortunately current conditions in Greece erode the value of
existing investments and limit future ones
No room has been created for innovation
The tax on during business has escalated to
unsustainable levels
The Pharma Industry is < 1/2 the size it was 6 years ago
Evolution of pharmaceutical expenditure 2009-2015
Note: hospital and out-patient spent data are based on annual budget objectives
*: estimation
0
1,000
2,000
3,000
4,000
5,000
6,000
2009 2010 2011 2012 2013 2014 2015
net public pharmaspending
co-payment*
ESY Hospital PharmaMil
lio
n€
Price difference vs EU average
Innovation Forum Greece
-53,0% -15,6%
53,8%
-60,0%
-40,0%
-20,0%
0,0%
20,0%
40,0%
60,0%
ON Patent OFFPatent
Generics
193 177
226
310 320
78
153
202
319
410
220
0
50
100
150
200
250
300
350
400
450
2012 2013 2014 2015 2016€ m. rebates € m. clawback
€ m. Hospital clawback
Claw-back & rebates evolution
IMS Market Analysis , Nov 2015 est.
New Measures will further limit access to innovation and investment in Greece
A similar new product rebate (1/3 the size) in Cyprus led to 20 products not being launched and the eventual removal of the rebate
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Area Measure Implication Reimbursement Criteria 14 Countries/7 HTA Double or triple the time to
launch a product in Greece
New Product Rebate 25% Will Likely prevent most products from launching in Greece
Structural Reform None Will ensure rebates/claw backs remain high and in so doing threaten existing investment
Re-pricing Maintain price protection for Generics
Ensure that there continues to be limited room for innovation
Greece already ranks low in innovation - what’s the right direction for the future?
Innovation Forum Greece
What we can do to maintain and increase investment in Greece
Immediate Removal of new measures which harm innovation and limit Foreign
Investment A transparent evidence based P&R system that recognizes and rewards
innovation A public pharma budget adequate enough to cover patient’s real needs Appropriate investment incentives
Allow clinical trials to be offset against the clawback Tax incentives
Collaborative effort to improve the time required to approve a clinical trial Development of a national multi-year plan for pharmaceuticals to contribute to the
economic growth of Greece done via a public-private partnership
Innovation Forum Greece