Pharma R&D and Patents support Health Care & Economy

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Pharma R&D and Patents support Health Care & Economy Konstantinos Μ. Frouzis President of SFEE, V.P & Gen. Manager of Novartis Hellas April 28 th, 2014

Intellectual Property Patents: The vehicle for innovation The pharmaceutical industry has consistently invested in science. In 2011 alone, the industry invested 27.5 billion in R&D in Europe. The rewards are new and better medicines that benefit patients, health outcomes, scientific progress economy and society as a whole. http://www.efpia.eu/topics/innovation/intellectual-property 2

Pharmaceuticals is the most R&D intensive sector in Europe (Source: European Commission EU R&D Scorecard 2012) 3

The Medicine Development Process From 20 years patent protection only 7-8 year commercialization Patent Protection Application Acute Toxicity Studies Pharmacology studies Chronic Toxicity Studies Phase Ι clinical trials Phase ΙΙ clinical trials Phase ΙΙΙ clinical trials Licensing Approval Price Approval Health Technology Assessment & Reimbursement Pharmacovigilance Loss of Patent Exclusivity Introduction of generic 6 month patent extension protection for new indication 0 5 10 15 20 10 year research 3 year regulatory & approval processes 21 years 7-8 years product s commercialization before generic introduction For every 25,000 compounds that begin in a laboratory 25 make it to the point of Clinical Testing, (tested in humans). 5 make it to the market. 1 will recoup what was invested. 4

Pharmaceutical Research & Development From 10.000 compounds only 1 is finally marketed TOTAL Investment $1 bn to $1,2 bn

R&D: Increase in Life Expectancy, 73% From 2000 2009, an improvement in population life expectancy of 1.74 years was seen across 30 OECD countries. Innovative medicines are estimated to have contributed to 73% of this improvement. http://www.efpia.eu/topics/innovation/intellectual-property 6

Positive impact of pharmaceutical innovation Significant increase in life expectancy Improved level of health and longevity (e.g. HIV/AIDS, many cancers, cardiovascular diseases) Significant progress in quality of life (e.g. asthma, diabetes) Much less overall Health Care costs (Hospitalization etc.) Improved treatment lead to more productive population in the country http://www.efpia.eu/topics/innovation/intellectual-property 7

8 Medicines reduce other health costs

2009-2014: -64% drug spend: No new innovative drugs entered in Greece % GDP 2.2% 1.9% 1.8% 1.5% 1.3% 1% GDP (bn) 236 224 209 195 186 187 Equivalents of ~ 350 mio coming from other HC centers to cover extra funding for drugs Diagnostics ~ 70mio: scaled rebate for ALL, insurance prices Private clinics & rehabilitation centers ~ 180mio: DRGs' validation and audit of extra charge, scaled rebate, reduction of the reimbursement level of rehabilitation centers for both daily and extended hospitalization (from 150 & 70 respectively to 120 & 50) Ceilings in prices and amounts of consumables ~ 30 mio: Immediate inaction based on Price Observatory Patients copay 1 /prescriptions ~ 70m Source: European Commission report 2013

Health expenditure per capita in GR is much lower than OECD avg Total HC spent in GR vs OECD : -30% Public HC spent in GR vs OECD : -40% Source: OECD health data 2013 10

OECD avg of Public HC at > 7,5% of GDP while. In GR it contacts dramatically <4,8% of GDP while MoU target is 6% Public HC expenditure as % of GDP 8.00 7.00 6.00 5.00 4.00 3.00 2.00 1.00 Actual 2014 at 4,8% < 6% target missing 2,25 bn for Health 0.00 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Source: OECD Health data 2013 OECD EU AVG for 2013 & 2014 are projections Greece for 2012,2013 & 2014 based on actual social budget OECD EU AVG GREECE 11

Need for more structural reforms on HC system ensuring patients access to innovative medicines a. New medicines Pricing & Reimbursement : Inclusion in RL of ~280 new SKUs (140 new INN), priced in Feb 2014 after 3,5y delays! Correct prices for all medicines according to Law Decrease off patent & Gx prices, and increase their volumes leading to savings for the system and creating room for innovation b. Feasible Pharma targets for 2014, ensuring patients access to drugs EOPYY/SSF 2.2 bil. (currently at 1.919 bil.) Hospitals 650 mil. (currently at 535 mil.) c. Outstanding debts: Outstanding public debt towards pharma companies is at very high levels ~ 1,3 bn. Ensure equal payment treatment among HC providers d. Other Hcare cost centers Drugs account for ~ 17% of total HC Many other cost centers in Hospitals and EOPYY are in comfortable 12

Looking forward: Modernizing our HC system The financial viability of NHS/EOPYY remains very critical The authorities must take immediate action to address the lack of control over consumption and purchasing. Some expenditure categories such as spending with private hospitals or on paraclinic/ diagnostic tests appear to be out of control. The NHS State Hospitals need immediate actions to restore productivity and patients better services. The State should focus on the increasing number of citizens that do not have access to healthcare services and drugs. 13

Thank you for your attention! Annual General Assembly