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

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€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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Clinical trials investment brings value to the state, medical community and patients

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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

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-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?

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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

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