ΣYNΔEΣMOΣ ΦAPMAKEYTIKΩN EΠIXEIPHΣEΩN EΛΛAΔOΣ 2014 HELLENIC ASSOCIATION OF PHARMACEUTICAL COMPANIES THE PHARMACEUTICAL MARKET IN GREECE FACTS AND FIGURES f o u n D At I o n f o r eConoMIC & InDustrIAL reseArCH facts and figures agg.indd 1 N OV E M B E R 2 0 1 5 28/3/16 1:28 PM Contents Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 FOREWORD BY SFEE’S PRESIDENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1.Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 2. Key statistics of Greek pharmaceutical market . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 3.Economic environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 3.1 Macroeconomic indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 4. Demographic trends and health profile of the national population . . . . . . . . . . . . . 4.1 Demographic trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2 Dependency Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3 Causes of death . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 16 19 21 5. Demand side: Health and pharmaceutical expenditure in Greece . . . . . . . . . . . . . . 5.1 Pharmaceutical Expenditure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2 Health Expenditure & Pharmaceutical Expenditure . . . . . . . . . . . . . . . . . . . . . 5.2.1 Comparison with other countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3 Welfare Spending and Public Pharmaceutical Expenditure . . . . . . . . . . . . . . . 5.4 Health Expenditure and Pharmaceutical Expenditure of Households . . . . . . 23 25 28 34 37 40 6.The Supply side: Pharmaceutical Industry and Economy . . . . . . . . . . . . . . . . . . . . . . 6.1Sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.2Production . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.3Employment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.4 External trade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.4 Research and development (R&D) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 46 50 53 55 56 7. Pricing of Pharmaceutical Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1 Pharmaceutical products price structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2 Pharmaceutical Price Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.3 Reimbursement of pharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 59 61 62 8. State’s debt towards pharmaceutical firms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 9. Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 |2| facts and figures agg.indd 2 28/3/16 1:28 PM List of Figures Figure1: GDP (%change) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 2: Unemployment and Inflation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 3: GDP determinants change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 4: Projection of population, Greece, 2015-2050* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 5: Projected shares of the population aged 65+ and 80+ 2015-2050, in Greece, EU-28 and OECD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 6: Evolution of life expectancy at birth in Greece, 1960-2010 . . . . . . . . . . . . . . . . . . . Figure 7: Life expectancy at birth in Greece and in the OECD countries, 2013 . . . . . . . . . . Figure 8: Dependency population ratio EU-27, 2014 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 9: Dependency population ratio in Greece 2010-2050 . . . . . . . . . . . . . . . . . . . . . . . . . Figure 10: Causes of deaths in Greece, 2013 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 11: Health Expenditure & Public Health Expenditure (in mil. €) . . . . . . . . . . . . . . . . Figure 12: Health Expenditure & Public Health Expenditure as a% of GDP, Greece, Eurozone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 13: Public Pharmaceutical Expenditure 2009-2014 (mil. €) . . . . . . . . . . . . . . . . . . . . Figure 14: Per capita Public Pharmaceutical expenditure in Greece, EU and EZ-15, (€) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 15: Total Health Expenditure Components (mil.€) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 16: Total Health Expenditure Components (% GDP) . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 17: Public Health Expenditure Components (bln€) . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 18: Public Health Expenditure Components (% GDP) . . . . . . . . . . . . . . . . . . . . . . . . . Figure 19: Breakdown of NHS hospitals expenditure, 2012-2014( in mil.€) . . . . . . . . . . . . Figure 20: Hospital expenditure evolution, 2012-2014 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 21: Health Expenditure as a percentage of GDP (OECD countries), 2013 . . . . . . . . Figure 22: Average per capita health expenditure evolution, OECD . . . . . . . . . . . . . . . . . . . Figure 23: Health expenditure per capita, $ ΡΡΡ (Purchasing Power Parity) 2013 . . . . . . . Figure 24: Expenditure on health by type of financing (2013) . . . . . . . . . . . . . . . . . . . . . . . . . Figure 25: Distribution of social security expenditures in Greece & EU-28 . . . . . . . . . . . . . Figure 26: Change in Social protection expenditure (2007-2013) . . . . . . . . . . . . . . . . . . . . . . Figure 27: Average health expenditure of households, 2008-2014 . . . . . . . . . . . . . . . . . . . . Figure 28: Breakdown of monthly average household health expenditure, 2008-2014 . . Figure 29: Number of Pharmacies per 100,000 inhabitants, EU 27, 2013 . . . . . . . . . . . . . . Figure 30: Number of Wholesalers, 2013 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 31: Pharmaceutical Sales in values, Greece, 2008-2014 (bln€) . . . . . . . . . . . . . . . . . Figure 32: Pharmaceutical Sales in volume, Greece, 2008-2014, (mil. of packages) . . . . Figure 33: Penetration of pharmaceuticals in European countries (in volume) based on patent status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 34: Pricing in European Countries, 2014 (price per unit, €) . . . . . . . . . . . . . . . . . . . . Figure 35: OTC sales, 2012-2014 (in mil. €) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 36: OTC total sales in various countries, 2014 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 14 15 16 17 17 18 19 20 22 23 24 26 27 29 30 31 31 32 33 34 34 35 36 38 39 40 41 43 44 46 46 47 48 48 49 |3| facts and figures agg.indd 3 28/3/16 1:28 PM Figure 37: Domestic Production of pharmaceutical products, 2000-2014 (mil. €) . . . . . . . Figure 38: Industrial Production Index for Pharmaceutical goods (2010=100) . . . . . . . . . . Figure 39: Turnover Index in Pharmaceutical Industry (2010=100) . . . . . . . . . . . . . . . . . . . Figure 40: Added Value Pharmaceutical Sector Production . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 41: Employment in the production of pharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . Figure 42: Share of employment in the production of pharmaceuticals in the EU (2014) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 43: Pharmaceutical Trade Balance (mil.€) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 44: Number of Clinical Trials, all phases and stages. 2014 . . . . . . . . . . . . . . . . . . . . Figure 45: Drugs Price Index vs Price Index of other Basic Goods (2005=100) . . . . . . . . . . Figure 46: Total State debts evolution towards SfEE member companies’ until 31.12.2014 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 47: State debts evolution towards SfEE member companies’ until 31.12.2014 (Invoices for 2014 only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 50 51 52 53 54 55 56 61 65 65 |4| facts and figures agg.indd 4 28/3/16 1:28 PM List of Tables Table 1: The Greek pharmaceutical market in figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Table 2: Births-Deaths 1931 – 2014 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Table 3: Insured and Uninsured 2014 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Table 4: Causes of Death 2009-2013 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Table 5: Evolution of % contribution of the pharmaceutical industry in public pharmaceutical expenditure (target), 2012-2014 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Table 6: Social Protection Expenditure, ESSPROS system - Greece - EU28 . . . . . . . . . . . . 37 Table 7: Social Protection Expenditure (Helios Program) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Table 8: Pharmacies and Wholesalers in Greece and Europe, 2013-2014 . . . . . . . . . . . . . . 44 Table 9: OTC sales by group in Greece, in mil.€ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Table 10: Share of added value in Manufacturing 2013 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Table 11: Educational employment structure in pharmaceutical production (2014) . . . . . 54 Table 12: Mark-up in the pharmaceutical supply chain. 2014 . . . . . . . . . . . . . . . . . . . . . . . . 59 Table 13: Mark-up for pharmacies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Table 14: Legislative changes re pricing, reimbursement & rebates, 2014 . . . . . . . . . . . . . 63 |5| facts and figures agg.indd 5 28/3/16 1:28 PM facts and figures agg.indd 6 28/3/16 1:28 PM FOREWORD BY SFEE’S PRESIDENT “The Pharmaceutical Market in Greece: Facts & Figures 2014” It is with great pleasure to preface the renewed annual edition ‘The Pharmaceutical Market in Greece: Facts & Figures 2014’, conducted by SFEE’s Data Monitoring Committee in collaboration with the Health Economics Observatory of IOBE. As it has been established during the past years from our association, this report intends to be the most comprehensive overview of key facts and data of the pharmaceutical market in Greece and the wider economic environment in which we are operating, trying to inform both our members and all other stakeholders in the broader health sector. This year’s edition includes not only updates of main data contained in previous editions, but also new information relative to the health sector, while intending to objectively provide an explanation of key trends of last year (2014), compared to the current year. More specifically this year’s edition covers trends regarding the evolution of public and private healthcare expenditure, the shaping of the overall pharmaceutical market, including OTC, the key factors that will affect future trends such as ageing population or dependency ratios and a brief summary of key macroeconomic data that affect the entrepreneurship of the pharmaceutical industry. In an era dominated by Big Data, the need for decision-making and the shaping of a national health policy based on evidence should be the primary focus of all stakeholders, so as to demonstrate and exploit the added value of pharmaceuticals and not simply focus on the costing side while undertaking short term tax-based solutions. We hope you find it useful For the Data Μonitoring Committee For SFEE Konstantinos Kofinas Pascal Apostolides General Secretary President |7| facts and figures agg.indd 7 28/3/16 1:28 PM facts and figures agg.indd 8 28/3/16 1:28 PM THE PHARMACEUTICAL MARKET IN GREECE: FACTS & FIGURES 2014 This edition was composed and reviewed by the research staff of the Health Economics Observatory at IOBE with the active participation of SFEE’s correspondent working group. The Data Monitoring Committee would like to thank Mr. Aggelos Tsakanikas, Assistant Professor at the National Technical University of Athens and Scientific Associate of IOBE, who along with the following IOBE researchers have undertaken the study for this year. Athanasios Athanasiadis, Research Officer of Health Economics Observatory, IOBE Grigoris Pavlou, Research Associate, IOBE We would like also to thank the members of SFEE’s Data Monitoring Committee Pinelopi Karabela, Market Access Specialist, GlaxoSmithKline Markos Katsoulakis, Director, Commercial Operations, MSD Christos Martakos, Corporate Affairs Manager, Pharmaserve Lilly Makis Mpokaris, Business Excellence Director, Sanofi Spyros Bokias, Business Excellence Manager, Menarini Hellas Chrysa Panagopoulou , Market Access Manager, Alcon Laboratories Ελλάς Ioanna Roubou, Head Market Access & Public Affairs Novartis (Hellas) S.A.C.I. Responsible for the general edition was Zefi Vostitsanou, SfEE Scientific & Corporate Affairs Director and for the coordination and processing was Dorina Theodoratou, SfEE, Health Economics & Market Access Officer. Konstantinos Kofinas General Secretary of BoD SFEE and Chairman of the Strategic Planning – Monitoring of Healthcare Expenditure – Data Monitoring Committee Chairman of the Board & Managing Director, Merck, Greece & Cyprus |9| facts and figures agg.indd 9 28/3/16 1:28 PM 1 Executive Summary The Greek economy in 2014 showed positive growth of 0.8% for the first time after a sixyear recession period (2007-2013) which had resulted in the fall of GDP by 26.3% or by €66 bln. At the same time, the major decline in revenues led to a significant decline in prices, thereby intensifying the recorded deflation, while the unemployment rate was reduced to 26.5% from 27.3% in 2013. With respect to demographic trends, the negative trend in the natural change of the population highlighted by a difference between births and deaths of -21.592 persons for 2014 is expected to continue steadily for the next decades, resulting in an overall reduction of the Greek population until 2050, while significantly changing its age-group composition. In particular, it is expected that people aged over 65 years in Greece in 2050 will almost account for 1/2 of the total population (46.6%), thus deteriorating the dependency ratio and resulting in even greater pressures on the social security system. Public pharmaceutical expenditure followed a downward trend for fifth consecutive year, as the target was reduced at €2 bln from €2.37 bln the previous year, thus, resulting in an overall decrease of 60.8% during the period 2009-2014. As expected, a similar trend has been observed re public pharmaceutical expenditure per capita, as it has been reduced from €456 in 2009 to €183 in 2014 ranking Greece in the bottom among EU countries. At this point, it should be noted that the aforementioned has been proven insufficient as proven by the great contribution of the industry through the mechanisms of rebates and clawback. Specifically, the pharmaceutical industry in 2014, paid €226,4 mil in rebates and €201,8 mil in clawback to cover patient needs, thus contributing with 21.6% of the actual pharmaceutical expenditure compared to 13.9% in 2013 and 9.4% in 2012. Based on the latest available data, health expenditure in Greece reached €15.7 bil in 2013 (8.6% of GDP), out of which €10 bln (5.5% of GDP) accounted for public health expenditure. Expenditure for curative & rehabilitative care services amounting to €9.5 bln followed by pharmaceutical expenditure with €4.6 bln were the main expenditure components, in contrast to ancillary health care services (€833 mil) and health administration (€582.6 mil). Hospital pharmaceutical expenditure amounted to €1.6 bln demonstrating a decline of 9.4% compared to the previous year. The greater reduction in the individual categories comprising hospital expenditure was observed in expenditure for services (-18.2%) and the respective pharmaceutical expenditure (-13.7%). |10| facts and figures agg.indd 10 28/3/16 1:28 PM Total sales of pharmaceutical products in terms of value to wholesalers/pharmacies amounted to €3.88 bln, indicating a fall by 2% compared to 2013, whereas sales to hospitals/ EOPYY demonstrated an increase of 4.5% respectively. On the contrary, in terms of volume (number of packages sold) the latter presented a reduction of 3.6%, whereas sales to pharmacies/wholesalers showed an increase of 2.8%. Penetration rate of patent protected medicinal products in 2014 reached 11.2%, percentage higher than in other European markets (EU average 7%), which can be, however, explained by the significantly lower prices in Greece (52% lower than EU average). Respectively, the share of non-protected medicinal products amounted to 64.2% (off patent 35% and generics 28.7%) higher than the previous years. According to latest available data, over the counter medicinal products (OTC) market size in 2014 amounted to €331 mil., showing an increasing trend compared to previous years, which is in line with the increased self-medication of patients prevailing this period. Production of pharmaceutical products in Greece in value terms was estimated at €857 mil. in 2014, decreased by 2.8% compared to previous year. Overall, when compared to other national manufacturing sectors (24 in total), pharmaceutical industry is ranked 10th, showing a steady contribution in the domestic industrial production for the country. Employment in the manufacturing of pharmaceutical products in Greece was estimated at 13.3 thousand people in 2014, showing an increase of 0.8% compared to 2013. In total, the workforce in the pharmaceutical industry represents 0.4% of total employment in the Greek economy and 3.6% of the respective labor force of the industrial sector, which is higher than the average of EE28 (2.1%). Imports and exports of medicinal products amounted to €2.7 bln and €1.0 bln, respectively in 2014. Compared to last year, imports fell by 2.2% and exports by 0.7%, thus, lowering the pharmaceutical trade deficit at 3.1% or in absolute numbers - €1.6 bln compared to - €1.7 bln in 2013. |11| facts and figures agg.indd 11 28/3/16 1:28 PM 2 Key statistics of Greek pharmaceutical market Table 1: The Greek pharmaceutical market in figures Number of companies(1) Production (2) Employment of pharmaceutical production (3) External trade(4) Parallel Exports (5) Pharmaceutical Sales (6) Public Pharmaceutical Expenditure (7) Public Health Expenditure (8) Price Structure (9) Demographic data(10) Price Change (11) Generics (12) Manufacturers and Importers (2014) Wholesalers (2014) Pharmacists Associations (2014) Domestic Production at ex-factory prices (2014) % change 2013/2014 Value added (2014) Share of value added/Total of manufacturing (2013) Number of employees (production) (2014) Number of employees (production) (2013) % change 2013/2014 Share of employment in production/total of manufacturing (2014) Exports Value (2014) % change 2013/2014 Imports Value (2014) % change 2013/2014 Value terms (2014) To wholesalers / pharmacies (at retail prices) To hospital (at hospital prices) % change sales pharmacies/wholesalers 2013/2014 % change sales hospitals 2013/2014 Expenditure 2009 Expenditure 2014 Clawback 2014 Rebate 2014 Change public pharmaceutical expenditure 2009/2014 Per capita public pharmaceutical expenditure (2014) Public Pharmaceutical Expenditure / Sales of medicinal products (2014) Private pharmaceutical expenditure (2013) Greece (value) (2013) Greece (% of GDP) (2013) European Union (% of GDP) (2013) Ratio of ex-factory price to retail price Life expectancy (2013) Dependency ratio (% population 0-14 years & 65+/ 15-64 years) (2014) % of Uninsured Medicines Price Index 2009/2014 % of total sales (in value terms PPPs) % of total sales (in volume terms) % of total sales (in volume terms) Generics and off-patent (13) Value (2014) OTC (14) Επενδύσεις R&D (14) Estimations (2014) ~106 100 27 € 857 mil. -2.8% €533 mil. 3.1% 13.3 thous. 13.2 thous. 0.8% 3.6% €1,049 mil. -0.7% €2,698 mil. -2.2% €306.7 mil. €3,877 mil. €1,399 mil. -2% 4.5% €5,108 mil. €2,000 mil. €201.8 mil. €226.4 mil. -60.8% €183 37.9% €1,700 mil. €10.021 mil. 5.5% 7.7% 67.4% 81.4 years 51.7% 25.2% -26.5% 15.2% 28.6% 64.2% €331 mil. €100-120 mil. (1) EL.STAT, EOPYY, Panhellenic Association of Pharmaceutical Wholesalers (2) Eurostat 2015, PRODCOM (3) Eurostat, Labour Force Survey, SBS, 2015 (4) Eurostat, International trade, EU Trade Since 1988 By CN8, 2015 (5) EOF, 2015 (6) System of Health Accounts (SHA) 2013, EOPYY 2012-2014, State Budget 20132014, data processing ΙΟΒΕ, SFEE, OECD Health Data 2015, Eurostat 2015 (7) SHA, 2013 (8) M.D 1907/Β/15.7.2014, estimations ΙΟΒΕ & EFPIA 2014 (9) OECD Health Data 2015, Ministry of Labour, Atlas, 2014 (10) Eurostat, Harmonised Indices of Consumer Prices (HICP), 2015 (11) IMS 2014, Midas (12) IMS 2014, Midas (13) AESGP, IMS Hellas Data 2015 (14) EOF,2014 |12| facts and figures agg.indd 12 28/3/16 1:28 PM 3 eConoMIC envIronMent 3 .1 MACROECONOMIC INDICATORS The Greek economy in 2014 exhibited positive growth of 0 .8% after a six-year recession period (2007-2013), which had resulted in a fall of GDP by 26 .3%, that is a loss of €66 bln of national income (from €251 bln to €187 bln), causing significant changes in the production of the economy with a significant number of businesses terminating their function . During the same period, unemployment recorded continuous escalation, reaching its highest levels historically at 27 .5% in 2013 . The major decline in revenues led to a significant decline in prices, thereby intensifying the recorded deflation until 2013 . The recovery in 2014 was fragile due to the exposure of the economy to high uncertainty, with the pre-election period heightening it and suspending the dynamic trend that had been created, primarily due to the strengthening of tourism . figure1: GDP (%change) % change 6.0 4.0 3.5 2.0 0.8 -0.4 0.0 -2.0 -3.9 -4.4 -4.0 -5.4 -6.6 -6.0 -8.9 -8.0 -10.0 2007 2008 2009 2010 201 1 2012 2013 2014 Source: Eurostat, 2015, GDP Chain linked volumes 2010 Source : Eurostat, 2015, GDP Chain linked volumes 2010 |13| facts and figures agg.indd 13 28/3/16 1:28 PM figure 2: unemployment and Inflation Unemployment 30 (%) Inflation (%) 6.0 26.5 5.0 27.5 24.5 4.7 25 4.2 20 4.0 17.9 3.0 15 3.1 3.0 2.0 12.7 8.4 10 9.6 1.3 1.0 1.0 7.8 0.0 5 -0.9 -1.4 0 -1.0 -2.0 2007 2008 2009 2010 Unemployment 201 1 2012 Inflation 2013 2014 Source: Eurostat, 2015 GDP Chain linked volumes The Greek recession period was signified not only by a reduction in GDP by ¼ but also by a restructuring in its components . In particular, until 2007 the Greek economy was mostly based on consumption (public and private), while investments were limited to cyclical fluctuations . Net Exports (exports-imports) usually worked negatively in GDP because of wide trade deficits . From 2008 onwards, the environment is reversed and public and private consumption fell significantly due to the decline in income, thus limiting the growth rate of GDP . 8.0 6.0 4.0 2.0 0.0 -2.0 2.6 2.4 1.0 -2.6 2.0 -0.4 -1.8 -0.1 -4.0 2.9 0.3 -0.7 2.6 -0.9 -6.6 -5.1 -6.0 2.8 3.1 -1.4 -1.1 -7.4 -2.0 -8.0 -5.4 0.2 1.1 -1.5 -1.3 -2.2 -0.2 -0.2 2013 2014 0.9 -3.2 -10.0 -2.8 -12.0 -14.0 2007 2008 Government Consumption 2009 2010 201 1 Private consumption 2012 Investments Net exports |14| facts and figures agg.indd 14 28/3/16 1:28 PM figure 3: GDP determinants change 8.0 6.0 2.6 4.0 2.4 1.0 2.0 0.0 -2.6 -2.0 2.0 -0.4 -1.8 -0.1 -4.0 2.9 0.3 -0.7 2.6 -0.9 -6.6 -5.1 -6.0 2.8 3.1 -1.4 -1.1 -7.4 -2.0 -8.0 -5.4 0.2 1.1 -1.5 -1.3 -2.2 -0.2 -0.2 2013 2014 0.9 -3.2 -10.0 -2.8 -12.0 -14.0 2007 2008 Government Consumption 2009 2010 201 1 Private consumption 2012 Investments Net exports Source: Eurostat, 2015, The numbers show the effective influence of each component in the GDP growth rate In particular, during the period 2010–2012, private consumption declined on average by ~5 .9% which was counterbalanced by the restriction of imports and thus, the strengthening of net exports . From then on and especially in 2014, all GDP components were normalized and in combination with the correction of imbalances in the financial and commercial sectors, there was return to a positive rate of GDP growth (0 .8%) and the turnaround of the primary fiscal deficit and current account deficit into surpluses . As a result, private consumption in 2014 was increased by 0 .9% verifying the positive climate around the Greek economy . |15| facts and figures agg.indd 15 28/3/16 1:28 PM 4 DeMoGrAPHIC trenDs AnD HeALtH ProfILe of tHe nAtIonAL PoPuLAtIon 4 .1 DEMOGRAPHIC TRENDS The number of births in Greece in 2014 amounted to 92,148 persons recording a 2 .1% drop from previous year, while the number of deaths recorded an increase of 1 .17% amounting to 113,740 persons respectively . As such, the natural population change (difference of births - deaths except migration) was negatively affected, resulting in an overall reduction of 21,592 people in the national population . Table 2: Births-Deaths 1931 – 2014 Year 1931 1950 1960 1970 1980 1990 2000 2010 2011 2012 2013 2014 births 199,243 151,134 157,239 144,928 148,134 102,229 103,274 114,766 106,428 100,371 94,134 92,148 Deaths 114,369 53,755 60,563 74,009 87,282 94,152 105,170 109,084 111,099 116,668 111,794 113,740 natural change 84,874 97,379 96,676 70,919 60,852 8,077 -1,896 5,682 -4,671 -16,297 -17,660 -21,592 Source: EL . STAT, 2015 Based on the latest revision from Eurostat, this negative trend in the change of the population is expected to continue until 2050, thus, resulting in both an overall reduction of the population in Greece and a change in its composition, as reflected in Figure 4 . 12 11 10 9 8 7 6 5 4 3 2 1 0 11.0 10.7 40% 10.1 9.6 33.9% 9.1 30.5% 30% 25% 25.6% 20.7% 35% % population mil.people figure 4: Projection of population, Greece, 2015-2050* 20% 21.9% 15% 10% 5% 0% 2015 2020 2030 Total population 2040 2050 Population aged 65 years and over Source: Eurostat, Population Projections, 2014, data processing ΙΟΒΕ *Not included the possible legalization of migration from 2015 onwards |16| facts and figures agg.indd 16 28/3/16 1:28 PM Explicitly, while in 2015 the percentage of people aged 65+ years in Greece is estimated at 20 .7% of the total population, it is expected to cover 1/3 in 2050 . Simultaneously, the proportion of over 80 years of age is estimated to double to 12 .7%, in contrast to EU and OECD averages . figure 5: Projected shares of the population aged 65+ and 80+ 2015-2050, in Greece, % of total eu-28 andpopulation oeCD 40.0% % of total population 33.9% 35.0% 40.0% 30.0% 33.9% 35.0% 25.0% 20.7% 30.0% 20.0% 25.0% 20.7% 15.0% 20.0% 10.0% 15.0% 5.0% 10.0% 0.0% 5.0% Greece 28.1% 18.9% 25.3% 28.1% 16.4% 25.3% 12.7% 18.9% 16.4% 6.1% 10.9% 12.7% 5.3% 6.1% EU28 OECD +65 EU28 0.0% Greece +80 EU28 Greece +65 9.5% 4.4% OECD EU28 2015 OECD 10.9% 4.4% 5.3% Greece 9.5% OECD +80 2015 Source: OECD, Historical Population Data and Projections Database, 2015, processing data IOBE Life expectancy in Greece has increased considerably over the last 50 years, as it can be proven from the respective increase from 72 years in 1960 to 79 .8 years in 2010 (Figure 6), due to technological advances, improvement in the provision of healthcare services, contribution of R&D and innovation of new drugs and therapies . figure 6: evolution of life expectancy at birth in Greece, 1960-2010 85.0 81.6 80.7 85.0 80.0 80.0 75.0 75.0 70.0 65.0 70.0 60.0 65.0 77.1 73.8 72.0 73.8 72.0 68 68 1960 78.2 75.3 75.3 77.1 74.8 72.6 78.2 77.1 81.6 79.8 77.1 69.9 74.8 72.6 69.9 1970 1980 1990 2000 60.0 Source: OECD, Health 1960Data 2015, *United 1970 Nations estimation 1980 1990 |17| facts and figures agg.indd 17 80.7 79.8 2000 2010 Greece 2010 Greece 2015-2020* OECD 2015-2020* OECD 28/3/16 1:28 PM According to OECD data, life expectancy in Greece reached 81 .4 years in 2013, which is higher than the respective average of 80 .4 years . The highest life expectancy was recorded in Japan, Spain, Switzerland and France (Figure 7) . figure 7: Life expectancy at birth in Greece and in the oeCD countries, 2013 Japan Spain Switzerland Italy France Australia Israel Iceland Sweden Luxemburg Norway Korea New Zealand The Netherlands Greece Austria U.K. Ireland Finland Germany Portugal Belgium avg OECD Slovenia Denmark USA Chile Chezh Rep. Estonia Poland Turkey Slovakia Hungary Mexico 83.4 83.2 82.9 82.8 82.3 82.2 82.1 82.1 82.0 81.9 81.8 81.8 81.4 81.4 81.4 81.2 81.1 81.1 81.1 80.9 80.8 80.7 80.4 80.4 80.4 78.8 78.8 78.3 77.3 77.1 76.6 76.5 75.7 74.6 70.0 72.0 74.0 76.0 78.0 80.0 82.0 84.0 86.0 Source: OECD, Health Data 2015 |18| facts and figures agg.indd 18 28/3/16 1:28 PM 44 .2 DEPENDENCY RATIO The demographic changes directly affect population’s dependency ratio . In Greece, nearly half of the population is dependent on the other half, and this proportion is expected to grow, signaling deterioration and increased pressure on social security systems, following the general tendency that currently exists in the developed countries1 . In particular, in 2014 Greece’s dependency ratio reaches 51 .7 and is close to the EU-27 average (51 .8) and the average of OECD countries (51 .9) (Figure 8) . figure 8: Dependency population ratio eu-27, 2014 57.9 57.9 56.5 55.5 54.4 54.4 54.2 53.3 52.6 52.1 51.9 51.9 51.8 51.7 51.1 51.0 50.7 49.5 48.8 48.6 48.2 47.3 46.4 45.8 45.2 44.9 44.2 43.3 Sweden France Finland Denmark U.K. Italy Belgium Ireland Netherlands Estonia Germany avg OECD EU-27 Greece Portugal Latvia Spain Bulgaria Austria Czech Republic Luxembourg Hungary Slovenia Malta Lithuania Cyprus Romania Poland Slovakia 40.5 35 40 45 50 55 60 65 70 Source: OECD, Health Data 2015 1 . Dependency population ratio shows the number of dependents (aged 0-14 and over the age of 65) to the total active population (aged 15-64) . A high ratio means that the overall economy faces a greater burden in supporting the ageing population . This indicator is on an upward trend in advanced economies, reflecting rising life expectancy and declining birth rates . |19| facts and figures agg.indd 19 28/3/16 1:28 PM According to United Nations estimations it is expected to amount 81 .8% by 2050, as only in the age group 65+ the dependency ratio is expected to increase to 30% compared to 19 .5% in 2015 . figure 9: Dependency population ratio in Greece 2010-2050 35 81.8 30 80 70.9 30 25 20 15 49.7 18.6 59.2 55.0 52.2 27.3 70 60 23.3 50 20.5 19.5 90 40 30 10 20 5 10 0 0 2010 2015 2020 2030 Dependency ratio % 2040 2050 Dependency ratio % (65+) Source: United Nations, Population projections Additionally, the uninsured consisted 25 .2% of the total population in 2014 . One can observe significant differences depending on the social security fund they belong to . The highest percentage of uninsured was found in IKA with 37 .3% of the total uninsured population, followed by ETAA with 20 .4%, whereas OGA and the Civil Servants’ Sickness Insurance Fund (OPAD) had the lowest percentage, with 9 .8% and 5 .3% respectively . table 3: Insured and uninsured 2014 social security funds IKA uninsured Insured total % uninsured/total 1,989.749 3,340.740 5,330.489 37.3% oGA 161,326 1,484.014 1,645.340 9.8% oAee 160,537 855,159 1,015.696 15.8% oPAD 68,882 1,238.558 1,307.440 5.3% etAA 36,479 142,187 178,666 20.4% esAA 29,150 120,125 149,275 19.5% oikos nautou 28,823 132,521 161,344 17.9% ote. 19,220 108,267 127,487 15.1% rest 30,077 243,850 273,927 11.0% total 2,494.166 7,421.571 9,951.737 25.2% Source: Ministry of Labour, Atlas, 2014 |20| facts and figures agg.indd 20 28/3/16 1:28 PM 4.3 Causes of death During the period 2009-2013, an increase in the number of deaths by 3.25% is recorded with cancer being the cause of death with the most significant increase (1,512 patients more, 5.5% vs. last year). According to Table 4 “other causes” recorded the greatest increase by 26.3% and in particular, deaths due to diseases of the digestive system and diseases of the genitourinary system which were the most frequent. Table 4: Causes of Death 2009-2013 1 Diseases of the circulatory system (of which) 2009 48,453 2013 46,342 Heart disease 31,976 30,212 Cerebrovascular diseases 15,493 14,996 Other circulatory system diseases 984 1,134 2 Neoplasms 27,345 28,857 3 Diseases of the respiratory system 10,770 10,924 4 Violent deaths (of which) 3,868 3,473 Accidents related to transport 1,647 1096 Other accidents 1663 1624 Suicides 391 533 Homicides 167 158 Other violence * 0 62 5 Infectious and parasitic diseases 6 Other Causes 1,183 1,105 16,697 21,093 1,404 1,759 Endocrine and metabolic diseases, nutrional deficiencies and immonity Diseases of blood and blood-forming organs 211 481 Mental disorders 109 137 Diseases of the nervous system and sense organs 1,517 1,830 Diseases of the digestive system 2,585 3,049 Diseases of the genitourinary system 1,859 2,106 Complications of pregnancy, childbirh and the puerperium 4 0 Diseases of the skin and subcutaneous tissue 35 28 Diseases of the musculoskeletal system and connective tissue 426 371 Congenital anomalies 214 195 Certain conditions originating in the perinatal period 172 158 Symptoms, signs and indefinable conditions 8,161 10,979 108,316 111,794 TOTAL DEATHS Source: EL.STAT., 2015, data processing IOBE *Pursuant to the 9th Revision of the International Statistical Classification of Diseases, Injuries and Causes of Death (ICD-9) the following are included: cases when it is stated that an investigation by a medical or legal authority has not determined whether the injuries are accidental, suicidal or homicidal; deaths caused by injuries inflicted by law-enforcing agents (including military) on duty in the course of attempting to enforce the Law; deaths caused by injuries during war operations. |21| facts and figures agg.indd 21 28/3/16 1:28 PM The basic cause of death were diseases of the circulatory system with 41 .5% (heart diseases with 65%) followed by neoplasms with 25 .8% and diseases of the respiratory system with 9 .8%, as shown in Figure 10 . figure 10: Causes of deaths in Greece, 2013 18,9% 3,1% 41,5% 1,0% 9,8% 25,8% Diseases of the circulatory system Diseases of the respiratory system Violent deaths Neoplasms Infectious and parasitic diseases Other causes Source: EL .STAT, 2015 data processing IOBE |22| facts and figures agg.indd 22 28/3/16 1:28 PM 5 DeMAnD sIDe: HeALtH AnD PHArMACeutICAL exPenDIture In GreeCe In 2013 total health expenditure2 in Greece amounted to €15 .8 bln from which public expenditure amounted to €10 bln . During the period 2009-2013, the reduction in total health expenditure and subsequently in public health expenditure accounted for 31 .9% and 37 .8% respectively following the downward trend of GDP . figure 11: Health expenditure & Public Health expenditure (in mil. €) health exp. mil.euro 25,000 23,177 20,000 22,269 19,599 15,000 16,098 17,106 15,777 15,582 13,188 10,000 11,408 10,021 5,000 0 2009 2010 201 1 Current health expenditure 2012 2013 Current public health expenditure Source: System of Health Accounts (SHA) 2013, data processing IOBE More precisely, total health expenditure as a percentage of GDP in 2009 accounted for 9 .8%, whereas in 2013 for 8 .6%3, proportion lower than both the EU average (9 .8%) and the respective Eurozone average (available data for 17 countries, 10 .2%) . What is important to note is that the percentage of health expenditure in countries with similar economic problems is higher than in Greece and specifically, in Portugal and Italy it accounts for 9% and 8 .8% respectively . Correspondingly, public health expenditure in Greece accounted for 2 . The Hellenic Statistical Authority (ELSTAT) publishes statistical data for the Funding on Health Expenditures at national level based on the new System of Health Accounts manual SHA 2011 of the OECD, against SHA 1 .0 that used for earlier data . The data have been revised based on the new methodology for the period 2009-2013 . 3 . It should be noted that according to OECD data the percentage of health expenditure is 9 .2%, and has calculated with the old methodology SHA 1 .0, while 8 .6% correspond to the new SHA methodology 2011 |23| facts and figures agg.indd 23 28/3/16 1:28 PM 5 .5% of GDP in 2013 compared to 7 .8% in the EU and 8 .0% in the Eurozone, with Portugal and Italy standing at 6% and 6 .8% respectively . figure 12: Health expenditure & Public Health expenditure as a% of GDP, Greece, eurozone 12% 10% 9.8% 9.6% 9.8% 9.8% 9.6% 9.4% 9.6% 8.8% 9.8% 8.6% 8% 7.7% 6% 6.8% 7.6% 7.5% 6.9% 6.3% 7.5% 5.9% 7.7% 5.5% 4% 2% 0% 2009 2010 201 1 2012 2013 Current Health Expenditure (%GDP)-Greece Current Public Expenditure (%GDP)-Greece Current Health Expenditure (%GDP)-EU Current Public Expenditure (%GDP)-EU Source: System of Health Accounts (SHA) 2013, EL .STAT, 2015, data processing IOBE The pharmaceutical market is only a subset of the total health expenditure . However, due to the fact that the fiscal adjustment program has focused on the contraction of the pharmaceutical expenditure alone, its analysis is of significance . For a more complete understanding of the individual costs of pharmaceutical spending, it is necessary to clarify certain components, as presented below . |24| facts and figures agg.indd 24 28/3/16 1:28 PM 5 .1 PHARMACEUTICAL ExPENDITURE Data on “pharmaceutical expenditure” are often confused with data on “total pharmaceutical sales” released by the National Organization for Medicines (EOF). EOF records sales of medicinal products from pharmaceutical companies to hospitals, wholesalers and pharmacies, on a monthly basis . On the other hand, according to the OECD’s International Classification of Health Accounts, with which Greek statistics have been harmonized, pharmaceutical spending is the total expenditure for medicinal products prescribed for outpatient care (non-hospital treatment) . Therefore, pharmaceutical expenditure is only a fraction of total pharmaceutical sales. More precisely, pharmaceutical sales are composed of: (a) Public pharmaceutical expenditure which is incurred by social insurance funds (part is reimbursed to public funds, as it is inclusive of VAT 6 .5% and mandatory discounts/ rebates/ clawbacks from pharmacists and pharmaceutical companies); (b) Hospital sales from pharmaceutical products (invoiced at hospital price = wholesaler price minus 8 .74% - rebates); (c) Sales of pharmaceutical products that are re-exported (parallel exports); (d) Sales of pharmaceutical products to Greek citizens or tourists at their own cost; (e) Patient’s copayment, which does not put burden on social security funds . Regarding point (b), it should be noted that pharmaceutical sales to hospitals are included in hospital expenditure, so they should be excluded from the analysis to avoid double-counting . Regarding points (c) and (d), it should be noted that these sales are not part of public pharmaceutical expenditure; on the contrary, they generate revenue to the government, in the form of VAT, income tax, payroll tax, social security contributions, etc . Public pharmaceutical expenditure is the final amount Social Security Funds have to spend to cover population needs, after deduction of rebates and clawback . In 2014, the respective target was set at €2 billion compared to €5 .1 bln in 2009, resulting in an overall decrease of 60 .8% the period 2009-2014 . |25| facts and figures agg.indd 25 28/3/16 1:28 PM figure 13: Public Pharmaceutical expenditure 2009-2014 (mil. €) mil.euro 70% 6,000 92 78 4,000 250 5,108 2,000 4,522 50% 78 193 153 177 3,750 2,880 2,371 204 226 2,000 30% 10% 0 -10% -11.5% -2,000 -26.6% -30% -43.6% -4,000 -50% -53.6% -60.8% -6,000 -70% 2009 2010 Net Public Pharmaceutical Expenditure 2011 Rebates 2012 clawback 2013 2014 % Cumulative change since 2009 Source: System of Health Accounts (SHA) 2013, EOPYY 2012, State Budget 2014: Executive Summary, data processing IOBE . * Midterm Fiscal Strategy forecasts, ** forecasts Note: Data for refunds / rebates (rebates) from pharmaceutical companies are only available for the years 2009-2013 The reduction in public pharmaceutical expenditure from 2012 onwards has been proven greater than appropriate, leaving the state unable to meet patients’ needs and thus, transposing a significant part of the economic burden to the private sector and specifically to the pharmaceutical industry . In particular, as shown in Table 5, the proportion with which pharmaceutical companies participate in the coverage of the actual public pharmaceutical expenditure, through clawback & rebates, is growing exponentially year by year, reaching 21 .5% in 2014 from 9 .4% in 2012 . |26| facts and figures agg.indd 26 28/3/16 1:28 PM table 5: evolution of % contribution of the pharmaceutical industry in public pharmaceutical expenditure (target), 2012-2014 Pharmaceutical % participation of expenditure industry in pharma (b) expenditure Year Industry Rebates Industry Clawback Total (a) 2012 €193 mil . €78 mil . €271 mil . €2,880 mil . 9 .4% 2013 €177 mil . €153 mil . €330 mil . €2,371 mil . 13 .9% 2014 €226 mil . € 204 mil . €430 mil . €2,000 mil . 21 .5% * Mandatory discounts such as simulation hospital price (8 .74%), mandatory hospital discounts (5%) etc, are not included here . As expected, similar downward trend was observed for public pharmaceutical expenditure per capita, where spending has been reduced from €456 per capita in 2009 to €183 in 2014 (Figure 14) . This is compared with both the Eurozone (17 countries data available) and the EU averages (22 countries data available) evolution of the respective per capita expenditure that also follow a declining trend but at a smoother rate . Specifically, in 2013 the average public pharmaceutical spending per capita the EU average was reduced to €260 from € 284 originally in 2009 and respectively the Eurozone average to €295 in 2013 from €323 in 2009 . figure 14: Per capita Public Pharmaceutical expenditure in Greece, eu and eZ-15, (€) 500 456 450 404 400 350 300 250 337 300 323 323 311 284 286 276 295 265 260 257 200 216 150 183 100 50 2009 2010 201 1 2012 Greece EU (22) 2013 2014 EZ (17) Source: System of Health Accounts (SHA) 2013, EOPYY 2014, State Budget 2014: Executive Summary, OECD Health Data 2015, Eurostat, data processing IOBE . |27| facts and figures agg.indd 27 28/3/16 1:28 PM 5.2 Health Expenditure & Pharmaceutical Expenditure Health expenditure, according to the new SHA methodology 2011 is comprised of the respective expenditure for: Care Services, Rehabilitation • HC.1 Hospitals (public and private) •H C.2 Residential. Long-term care facilities • HC.3 Providers of ambulatory health care Ancillary Health Care Services • HC.4 Providers of ancillary services (eg. clinical diagnostic imaging and laboratory services, patient transport and emergency rescue services) Products Supply for Outpatient Patients • HC.5 Retailers and other providers of medical goods (pharmaceuticals, vision glasses, hearing aids, orthopedic belts and accessories Other Medical Products, Healthcare Management etc • HC.6 Preventive Care Services & Public Health • HC.7 Healthcare Management & Social Security Funds •H C.9 Non-specialized services by type Note that in the present analysis, the category “Retailers and other providers of medical goods (HC.5)” has been separated to “Pharmaceuticals” (HC.5.1)4 and “Other Medical Products” (HC.5.2), so as to have a deeper description of the pharmaceutical spending. In 2013, expenditure for Curative, Rehabilitative & Long-term care services amounted to € 9.5 bln accounting for the greater proportion of total healthcare spending, followed by total pharmaceutical expenditure with €4.6 bln, ancillary health care services with € 833 million and expenditure for healthcare management (€ 582,6 million.). 4. This category contains OTC and high-cost products (L.3816/2010). |28| facts and figures agg.indd 28 28/3/16 1:28 PM figure 15: total Health expenditure Components (mil.€) mil. 16,000.0 13,950.2 14,000.0 13,468.0 Curative,Rehabilitative and Long term care (HC.1, HC.2, HC.3) 12,000.0 10,783.3 10,157.8 10,000.0 8,000.0 Medical Goods (HC.5.1) Pharmaceuticals 9,485.7 Ancillary Services (HC.4) Healthcare Management (HC.6-HC.0) 6,880.1 Medical Goods (HC.5.2) Other medical products 6,000.0 4,619.6 4,000.0 2,000.0 - 1,081.7 833.1 715.5 549.5 2009 2010 2011 2012 582.6 255.6 2013 Source: System of Health Accounts (SHA) 2013, EL .STAT ., 2015, data processing IOBE The categories refer to the HP classification of individual categories according to the SHA The following figure depicts health expenditure components as a percentage of GDP (note that during 2009-2013 national income has significantly decreased (-23 .2% or €55 bln)) . Expenditure for Curative, Rehabilitative and Long Term care services correspond to 5 .2% of % total GDP in 2013, while pharmaceutical expenditure to 2 .5% in 2013 . 7.0% 5.9% 6.0% 6.0% 5.2% 5.2% 5.2% Curative,Rehabilitative and Long term care (HC.1, HC.2, HC.3) 5.0% Medical Goods (HC.5.1) Pharmaceuticals 4.0% 3.0% Ancillary Services (HC.4) 2.9% Healthcare Management (HC.6-HC.0) 2.5% Medical Goods (HC.5.2) Other medical products 2.0% 1.0% 0.5% 0.4% 0.4% 0.5% 0.5% 2009 2010 2011 2012 2013 0.3% 0.0% 0.3% 0.1% 0.2% |29| facts and figures agg.indd 29 28/3/16 1:28 PM 2009 2010 2011 2012 2013 figure 16: total Health expenditure Components (% GDP) % total 7.0% 5.9% 6.0% 6.0% 5.2% 5.2% 5.2% Curative,Rehabilitative and Long term care (HC.1, HC.2, HC.3) 5.0% Medical Goods (HC.5.1) Pharmaceuticals 4.0% 3.0% Ancillary Services (HC.4) 2.9% Healthcare Management (HC.6-HC.0) 2.5% Medical Goods (HC.5.2) Other medical products 2.0% 1.0% 0.5% 0.4% 0.4% 0.5% 0.5% 2009 2010 2011 2012 2013 0.3% 0.0% 0.3% 0.1% 0.2% Source: System of Health Accounts (SHA) 2014, EL .STAT, 2015, data processing IOBE Figures 17 and 18 depict the respective components as part of public health expenditure alone . Public expenditure for Curative, Rehabilitative and Long Term care services and public pharmaceutical care remain the most significant fragments, although they have been reduced from €8 .9 bln in 2009 to €5 .9 in 2013 and from €5 .5 bln to €2 .9 bln in 2013 respectively . As a percentage of GDP, long-term care faced a small reduction from 3 .7% in 2009 to 3 .3% in 2013, in contrast to public pharmaceutical expenditure which fell significantly to 1 .6% of GDP compared to 2 .3% in 2009 . Other components of public health expenditure as % of GDP remained stable during the respective period . |30| facts and figures agg.indd 30 28/3/16 1:28 PM figure 17: Public Health expenditure Components (bln€) mil. 10,000.0 8,887.8 9,000.0 mil. 10,000.0 8,000.0 8,887.8 8,807.4 8,807.4 9,000.0 7,000.0 5,944.4 5,543.8 7,000.0 5,000.0 6,000.0 4,000.0 6,432.2 6,351.5 8,000.0 6,000.0 6,432.2 6,351.5 5,944.4 5,543.8 2,919.1 5,000.0 3,000.0 497.1 647.8 634.4 384.5 - 489.1 171.1 2009 647.8 634.4 384.5 - Ancillary Services (HC.4) 2,919.1 3,000.0 1,000.0 1,000.0 Medical Goods (HC.5.1) Pharmaceuticals Curative,Rehabilitative and Long termHealthcare care (HC.1, HC.2, HC.3) Management (HC.6-HC.0) Medical Goods (HC.5.1) Pharmaceuticals Ancillary Services (HC.4) Healthcare MedicalManagement Goods (HC.5.2) (HC.6-HC.0) Other medical products 4,000.0 2,000.0 2,000.0 Curative,Rehabilitative and Long term care (HC.1, HC.2, HC.3) 2010 2011 2012 Source: System of Health Accounts (SHA) 2013, EL .STAT, 2015 2009 2010 2011 2012 Medical Goods (HC.5.2) Other medical products 2013 497.1 489.1 171.1 2013 % figure 4.5%18: Public Health expenditure Components (% GDP) % 4.0% 3.7% Curative,Rehabilitative and Long term care (HC.1, HC.2, HC.3) 3.9% 4.5% 3.5% 4.0% 3.7% 3.9% 3.3% 3.3% 3.1% 3.0% 3.5% 3.3% 2.3% 2.5% 3.3% 3.1% 2.5% Healthcare MedicalManagement Goods (HC.5.2) (HC.6-HC.0) Other medical products Ancillary Services (HC.4) 3.0% 2.0% Medical Goods (HC.5.1) Pharmaceuticals Curative,Rehabilitative and Long Management termHealthcare care (HC.1, HC.2, HC.3) (HC.6-HC.0) Medical Goods (HC.5.1) Ancillary Services (HC.4) Pharmaceuticals 1.6% 2.3% Medical Goods (HC.5.2) Other medical products 1.5% 2.0% 1.6% 1.0% 1.5% 0.5% 1.0% 0.0% 0.5% 0.0% 0.3% 0.3% 0.1% 0.3% 0.3% 0.2% 2009 0.3% 0.3% 0.2% 2009 2010 2010 2011 2012 2011 2012 2013 0.3% 0.3% 0.1% 2013 Source: System of Health Accounts (SHA) 2013, EL .STAT, 2015 |31| facts and figures agg.indd 31 28/3/16 1:28 PM Reduction in public health expenditure in Greece can also be reflected in the evolution of hospital expenditure . It is noteworthy that during the period 2012-2014, hospital pharmaceutical expenditure was reduced by 20 .6%, thus reaching in €1 .6 bln from €2 .04 bln . figure 19: breakdown of nHs hospitals expenditure, 2012-2014( in mil.€) 2500 2,500 2,038 2000 1500 1000 500 200 505 163 62 368 740 2,000 1,786 185 440 154 61 331 1,618 215 1,500 360 134 62 316 1,000 500 615 531 0 2012 Medicines Orthopedical materials Services Total 2013 2014 Medical Supplies Chemical Reactors Outsourcing/ other expenses Source: Ministry of Health This reduction was not allocated equally among the different cost-centers of hospital spending . Specifically, during 2012-2014, the greatest reduction was marked in expenditure for services and medicines reaching 28% followed by the reduction in expenditure for chemical reactors (18%) and expenditure of medical supplies (14%) . According to Figure 20, medicines currently represent 32 .8% from 36 .3% in 2012 while services represent 22 .2% from 24 .8% respectively of the hospital expenditure budget . On the contrary, medical supplies and outsourcing exhibited an upward trend to 19 .5% and 13 .3% respectively . |32| facts and figures agg.indd 32 28/3/16 1:28 PM figure 20: Hospital expenditure evolution, 2012-2014 100% 32.8% 36.3% Medicines 90% 80% Services 70% 60% 50% 22.3% 24.8% Medical Supplies 19.5% 18.1% Consumables 40% 30% 13.3% 20% 9.8% 10% 8.0% 8.3% 3.0% 3.8% 0% 2012 2013 Reagents Orthopedics 2014 Source: Ministry of Health, data processing IOBE-SFEE |33| facts and figures agg.indd 33 28/3/16 1:28 PM 5 .2 .1 COMPARISON WITH OTHER COUNTRIES Health expenditure as a percentage of GDP in Greece in 2013 accounted for 8 .6% which is lower than the average of OECD countries (8 .9%) but also from countries with economic crisis like Portugal (9%), Spain (8 .9%) and Italy (8 .8%) . It should be noted here that 8 .6% corresponds to the new SHA methodology 2011 (see Appendix) . According to data from the OECD, appreciated with the old methodology SHA 1 .0, health expenditure rate is 9 .2% . figure 21: Health expenditure as a percentage of GDP (oeCD countries), 2013 USA USA TheThe Switzerland Switzerland Germany Germany Sweden Sweden France France Denmark Denmark Canada Canada (1)(1) Belgium Belgium Japan Japan Austria Austria New New Zealand Zealand Portugal Portugal (1)(1) Spain Spain (2)(2) Norway Norway AvgAvg OECD OECD ItalyItaly Australia Australia (2)(2) Slovenia Slovenia Iceland Iceland Greece Greece Finland Finland UKUK Ireland Ireland (2)(2) Slovakia Slovakia Israel Israel (1)(1) Hungary Hungary Chile Chile Chezh Chezh Rep. Rep. Korea Korea Luxemburg Luxemburg Poland Poland Mexico Mexico Estonia Estonia Turkey Turkey % GDP % 18GDP 18 16 16 14 14 12 12 10 10 8 8 6 6 4 4 2 2 0 0 Source: OECD, Health Data 2015, SHA, 2013, (1) Preliminary estimations, (2) Data 2012 Additionally, during the period 2009-2013 per capita health expenditure in Greece decreased by 7 .2%, which accounted for the greater reduction among OECD countries, as shown in the figure below . 8.48.4 0.80.8 0.90.9 1.51.5 1 1 2.22.2 1 1 1.71.7 1.31.3 1.71.7 1.71.7 3.33.3 2 2 2.82.8 2.32.3 -2.3 -2.3 5.45.4 3.23.2 3.43.4 0.50.5 3.63.6 0.30.3 6.76.7 0.50.5 3.23.2 0.50.5 3.43.4 0.60.6 11.3 11.3 -0.1 -0.1 -0.2 -0.2 -0.3 -0.3 -0.8 -0.8 1.31.3 5.35.3 3.53.5 -1.6 -1.6 -1.6 -1.6 -3.3 -3.3 -4.3 -4.3 -0.4 -0.4 -4 -4 -7.2 -7.2 15 15 10 10 5 5 0 0 -5 -5 -10 -10 5.45.4 figure 22: Average per capita health expenditure evolution, oeCD 2005-2009 2005-2009 2009-2013 2009-2013 Source: OECD, Health Statistics 2015 |34| facts and figures agg.indd 34 28/3/16 1:28 PM Total health expenditure per capita (Figure 23), expressed in $ PPP5, in Greece was 28% lower than the EU average . This was mainly due to the reduction in public health expenditure per capita which was 39 .4% lower than EU countries, in contrast to private health expenditure per capita which was the 3rd highest among EU countries and 8th among OECD countries (33 .7% Greece 22 .6%, 26 .6% EU & OECD) . Figure 23: Health expenditure per capita, $ ΡΡΡ (Purchasing Power Parity) 2013 USA Switzerland Norway Netherlands Sweden Germany Denmark Austria Luxembourg 2012 Canada Belgium France Australia 2012 Japan Iceland Ireland 2012 OECD Finland New Zealand EU* UK Italy Spain 2012 Slovenia Portugal Israel Greece Korea Czech Republic Slovakia Hungary Chile Estonia Poland Mexico Turkey 8,713 4,197 6,325 4,178 2,084 5,862 4,981 882 5,131 4,495 636 4,904 4,126 779 4,819 3,677 1,141 4,553 3,841 713 4,553 3,469 1,084 4,371 3,608 763 4,351 3,074 1,277 4,256 3,31 1 944 4,124 3,247 877 3,866 2,614 1,251 3,713 3,090 623 3,677 2,968 709 3,663 2,509 1,154 3,453 2,536 918 3,442 2,583 859 3,328 2,656 672 3,298 2,558 745 3,235 2,802 561 3,077 2,381 696 2,928 2,099 829 2,51 1 1,783 728 2,482 1,639 843 2,428 1,444 950 1,551 798 2,366 2,366 1,551 2,275 1,2721,003 2,040 1,716 324 2,010 1,492 519 1,719 1, 111 608 1,623 749 874 1,542 1,198 344 1,530 1,081 447 1,048536 513 941 737 204 - 2,000 4,000 6,000 Total 8,000 Public 10,000 12,000 4,516 14,000 16,000 18,000 Private Source: OECD Health Statistics 2015 * The EU refers to the average of 21 EU countries, due to unavailability of data for other countries 5 . Purchasing Power Parity |35| facts and figures agg.indd 35 28/3/16 1:28 PM The following figure demonstrates the breakdown of health expenditure by type of financing in each country . In Greece, 25% of expenditure is financed by the general government, while adding social security funds contribution increases the proportion of state funding to approximately 65 .5% . Figure 24: Expenditure on health by type of financing (2013 figure 24: expenditure on health by type of financing (2013) UK Denmark Sweden Italy Norway New Zealand Canada Australia Ireland Spain Portugal Finland Iceland Chile Austria Greece Mexico T urkey Switzerland Belgium Korea Esthonia Japan Poland Hungary Luxembourg Netherlands Slovakia Germany Czech Republic France Slovenia USA 86.6 84.3 84.1 77.0 74.1 72.0 69.2 67.6 67.4 67.0 64.8 60.8 52.5 41.8 4.3 31.3 25.0 22.4 20.5 18.8 11.4 11.1 11.0 10.5 9.6 8.8 8.6 7.2 6.7 6.6 6.0 4.0 3.2 34.9 0 10 General Government 20 3.5 9.9 1.9 13.7 0.1 0.6 14.8 0.5 0.4 1.0 21.7 0.4 10.8 14.6 2.6 7.8 4.9 12.6 1.9 1.5 13.2 14.3 3.6 8.9 19.9 2.1 0.1 13.4 16.9 0.4 4.7 5.8 22.1 0.4 1.25.6 28.0 3.6 14.2 2.1 19.3 1.5 28.2 17.8 20.9 44.9 40.5 28.7 33.0 5.0 3.0 6.5 66.7 72.7 61.0 55.8 74.0 80.4 67.6 69.7 78.2 74.7 67.8 Social Security 12.3 4.6 40 50 Private insurance - 44.7 7.2 44.8 1.5 0.1 17.4 30.7 4.2 57.9 47.2 66.4 30 ) 4.0 2.7 4.7 16.9 25.8 4.1 17.9 36.9 0.2 21.8 0.2 0.7 0.2 1.7 23.6 4.5 28.1 1.2 4.6 11.6 5.9 5.3 1.2 2.5 23.3 0.9 9.3 13.5 1.0 0.2 14.7 13.9 15.2 60 70 80 Private out-of pocket 12.6 90 6.7 0.6 1.2 100 Other Source: OECD Health Statistics 2015 |36| facts and figures agg.indd 36 28/3/16 1:28 PM 5.3 Welfare Spending and Public Pharmaceutical Expenditure Table 6 represents welfare spending6 in Greece comparative to EE-28 average for the period 2008 -2012 (latest available data). Pension and sickness benefits cover the highest share with 72.7% of total spending in Greece and 67.2% respectively in EE-28. It should be noted though that pension benefits in EE-28 represent a significantly smaller proportion of 40.6% of total spending compared to 51.3% in Greece. Differences are noted in other categories as well with disability costs and family allowances exhibiting the greatest differences (7.4% vs. 4.5% (GRE) and 7.8% vs 5.5% respectively) (Figure 25). Table 6: Social Protection Expenditure, ESSPROS system - Greece - EU28 GREECE Categories (%of total) Sickness/ Health care Disability Old age Survivors Family/Children Unemployment Housing Social exclusion Total expenditure (mil.€) ΕΕ-28 Categories (%of total) Sickness/ Health care Disability Old age Survivors Family/Children Unemployment Housing Social exclusion Total expenditure (mil.€) 2008 2009 2010 2011 2012 Change %11/12 29.0 4.7 42.4 8.3 6.3 5.1 2.0 2.2 59,204 29.1 4.7 41.4 8.2 6.7 5.9 1.8 2.1 63,249 29.2 4.7 42.3 7.8 6.4 6.1 1.4 2.2 62,550 25.9 4.9 44.0 8.1 6.2 7.4 1.3 2.3 60,165 21.4 4.5 51.3 8.0 5.5 6.3 0.8 2.1 57,954 -20.2% -11.1% 12.3% -4.9% -14.8% -18.0% -36.4% -9.1% -3.7% 2008 2009 2010 2011 2012 Change %11/12 29.6 29.6 29.5 29.6 29.6 7.8 7.6 7.5 7.5 7.4 40.0 39.4 39.7 40.1 40.6 6.1 5.9 5.8 5.7 5.6 8.2 8.1 8.1 8.0 7.8 4.9 6.0 5.8 5.5 5.4 2.0 2.0 2.1 2.1 2.1 1.4 1.5 1.5 1.5 1.5 3,212,438 3,345,567 3,474,912 3,550,706 3,673,484 3.4% 2.3% 4.8% 1.7% 1.4% 1.3% 3.4% 1.7% 3.5% Source: Eurostat, 2015, EL.STAT, 2015, processing data IOBE 6. According to the classification system ESSPROS developed by Eurostat, expenditure, which is mainly incurred by social security funds, is broken down into the following categories: Sickness, Disability, Old age, Survivors, Family/Children, Unemployment, Housing and Social exclusion. In Greece, recording of public spending in these categories was done by EL.STAT. |37| facts and figures agg.indd 37 28/3/16 1:28 PM figure 25: Distribution of social security expenditures in Greece & eu-28 % 60 51.3 50 40.6 40 29.6 30 21.4 20 10 4.5 8 7.4 5.6 5.5 7.8 6.3 5.4 0.8 2.1 2.1 1.5 0 Greece EU-28 Source: Eurostat, 2015, EL .STAT, 2015, processing data IOBE In 2014, welfare spending according to data from the Ministry of Labor (Helios program) amounted to €27 .7 bln of which €22 .5 bln corresponded to pensions, €3 .2 bln for death benefits and €1 .7 bln for disability benefits . table 7: social Protection expenditure (Helios Program) €billion Old age 22 .573 .138 .582 Death 3 .295 .325 .605 Disability 1 .721 .633 .199 Uninsured old age (OGA) 133 .267 .854 Without category 12 .904 .583 total 27.736.269.822 Source: Ministry of Labor (Helios program) During the period 2007-2008 & 2009-2010 an increase in social spending by 2% on average was recorded in both Greece and OECD countries, which was then followed during the periods 2009-2010 & 2012-2013 by a reduction of 0 .8% vs . 25% respectively . In the figure below, data for 34 OECD countries, during the same study periods are shown . |38| facts and figures agg.indd 38 28/3/16 1:28 PM figure 26: ChangeBetween in social protection expenditure (2007-2013) 2007-08 and 2009-10 Between 2009-10 and 2012-13 -0.7 -0.1 -0.9 Mexico Korea Chile T urkey Israel Iceland Estonia Slovak Republic Canada Switzerland Australia United States Poland Czech Republic Hungary OECD-34 Ireland New Zealand Japan Norway Greece Luxembourg United Kingdom Slovenia Netherlands Portugal Germany Spain Austria Italy Sweden Finland Belgium Denmark France 1.0 1.4 1.5 2.2 0.0 -0.20.4 -0.8 2.7 -2.4 5.8 -0.8 -0.9 -0.9 3.2 1.7 2.1 1.5 0.5 0.3 2.9 -0.9 1.7 0.7 2.5 -1.9 0.4 -0.2 2.5 -1.6 5.2 0.6 2.9 0.0 2.8 2.3 -0.3 -0.8 -0.6 -0.1 2.0 2.7 2.9 0.8 3.3 2.2 -1.3 0.9 2.6 0.2 2.2 0.7 4.3 -0.8 2.4 2.4 -0.6 0.3 1.6 4.6 1.1 3.8 2.9 2.5 -2.0 -1.0 0.0 1.0 2.0 0.7 0.4 0.5 3.0 4.0 5.0 6.0 Source: OECD, Society at a Glance, 2014 |39| facts and figures agg.indd 39 28/3/16 1:28 PM 5 .4 HEALTH ExPENDITURE AND PHARMACEUTICAL ExPENDITURE OF HOUSEHOLDS In absolute terms, average monthly healthcare spending7 was reduced by 21% from €134 .4 in 2009 to €105 .8 in 2014 . However, this accounted for 7 .2% of total household spending compared to 6 .5% in 2009, indicating the reduced purchasing power of households and the increased participation of patients in healthcare spending . figure 27: Average health expenditure of households, 2008-2014 euro % Total Expenditure 7.5 7.2 160 140 142.1 120 100 134.3 6.7 6.5 80 6.9 124.4 6.4 114.6 6.3 104.7 104.4 7 105.8 6.5 6.4 60 40 6 20 5.5 0 2008 2009 2010 Health Expenditure ( ) 2011 2012 2013 2014 Health Expenditure as a % of Total Expenditures Source: EL .STAT . 2015, data processing IOBE As shown in Figure 28 during the economic crisis period there was a shift of household expenditure mainly to pharmaceutical and hospital care . Specifically, from the €105 .8 monthly health expenditure per household 33 .3% refers to pharmaceuticals, 29 .3% to hospital services, 15% to dental services and 10 .8% to other medical services . 7 . Household Budget Survey, which is conducted annually by the ELSTAT, provides information for the composition of total household spending, according to various socioeconomic characteristics of each household . |40| facts and figures agg.indd 40 28/3/16 1:28 PM figure 28: breakdown of monthly average household health expenditure, 2008-2014 100% 1,5% 2,6% 1,5% 2,3% 1,5% 3,3% 1,4% 2,3% 1,5% 1,7% 90% 9,7% 9,3% 9,2% 8,5% 8,7% 2,3% 1,5% 7,8% 14,3% 11,7% 10,8% 20,1% 18,0% 16,1% 15,0% 80% 17,3% 70% 18,8% 60% 26,7% 50% 23,3% 29,4% 27,9% 27,4% 40% 30% 29,3% 20,0% 23,3% 17,5% 20% 10% 19,2% 22,1% 22,1% 2009 2010 2011 27,4% 32,4% 33,3% 2012 2013 2014 0% Pharmaceutical products Dental services Paramedical services Other medical products Hospital services Medical services Therapeutic appliances and equipment Source: EL .STAT . 2015, data processing IOBE |41| facts and figures agg.indd 41 28/3/16 1:28 PM 6 The Supply side: Pharmaceutical Industry and Economy Production and distribution of pharmaceuticals is one of the most dynamic sectors of the Greek economy. In 2014, according to Eurostat, approximately 13.3 thousand people were employed in the manufacturing of medicinal products (employees of the wholesale sector are not included), making the pharmaceutical industry a vital factor for growth in Greece. The supply chain for pharmaceutical products is comprised of pharmaceutical companies (both manufacturers and importers), wholesalers (both storage and distribution) and pharmacies. All medicinal products are distributed through wholesalers to pharmacies, except products for hospital use only which are provided through sales to hospitals. Direct sales to pharmacies are permitted, as long as pharmacies accept the respective payment policies of the companies. In some occasions, doctors or pharmaceutical companies are allowed to supply patients directly upon approval by the Social Insurance Fund. ~ 56 Multinational & ~ 50 National Pharma companies 100 Wholesalers 27 Pharmacist cooperations Pharmacies of Hospitals 28 EOPYY pharmacies 11.000 pharmacies Source: ΕL.STAT. EOPYY, PanHellenic Association of Pharmaceutical Wholesalers The wholesale segment of the market is comprised by private wholesalers and pharmacist cooperatives. 100 wholesalers and 27 pharmacist cooperatives operated in the domestic market, based on data from the PanHellenic Association of Pharmaceutical Wholesalers in 2014. |42| facts and figures agg.indd 42 28/3/16 1:28 PM Based on the number of licenses, there are more than 11 .000 pharmacies . With a pharmacy density of 99 pharmacies per 100,000 inhabitants, Greece comes first among the EU-28 average of 31 pharmacies per 100,000 inhabitants . figure 29: number of Pharmacies per 100,000 inhabitants, eu 27, 2013 99 Greece Bulgaria Cyprus Malta Spain Lithuania Belgium Ireland Latvia Slovakia Estonia France Romania EU-Average Poland Italy Portugal Germany Hungary Chezh Rep. Croatia UK Luxemburg Finland Austria Slovenia Sweden Netherlands Denmark 56 54 51 46 45 45 40 37 36 36 35 32 31 30 30 28 26 25 25 24 22 18 15 15 15 13 12 6 0 20 40 60 80 100 120 Source: ABDA, German Pharmacies, Figures Data Facts 2013-2014 In 2013, (latest data available), the number of wholesalers in Greece reached 100, which is rather high in contrast to other European countries . It is worth noting that every full-line wholesaler in Greece is a separate entity in contrast to European practices, where full-line wholesalers can operate warehouses with many branches (Table 8) . |43| facts and figures agg.indd 43 28/3/16 1:28 PM figure 30: number of Wholesalers, 2013 200 180 180 160 150 140 120 141 113 100 100 80 54 60 42 27 26 23 21 40 20 13 13 13 12 11 8 6 5 5 3 3 3 2 0 Source: GIRP, 2013-2014 table 8: Pharmacies and Wholesalers in Greece and europe, 2013-2014 Country Austria Belgium Bulgaria France Germany Denmark Switzerland** Greece Estonia UK Ireland Spain Italy Croatia Cyprus Latvia** Lithuania** Luxembourg Hungary Netherlands Poland Portugal Romania Slovakia Slovenia Sweden Czech Rep . Finland Pharmacies* 2014 1,303 4,998 3,652 22,655 20,921 314 1,744 11,000 469 14,186 1,701 21,458 18,102 1,111 477 783 1,383 91 2,334 1,981 11,297 2,885 7,932 1,935 321 1,303 2,450 818 full-line wholesalers** 7 8 3 17 13 2 4 100 4 9 2 42 52 Μ/Δ Μ/Δ 3 3 3 7 5 10 46 7 2 9 3 4 2 Wholesalers** 2013 23 27 21 180 113 6 8 100 2 54 11 150 N/A 13 N/A 3 42 3 12 13 141 26 13 N/A 3 5 N/A 5 ratio Warehouses per Wholesaler 3 .3 3 .8 7 .0 10 .6 8 .7 3 .0 2 .0 1 .0 0 .5 6 .0 3 .5 3 .6 1 .0 14 .0 1 .0 1 .7 2 .6 13 .0 0 .6 1 .9 0 .3 1 .7 5 .3 2 .5 ΠSource: *PGEU, 2014 **GIRP, 2013 (Data refer to EU-27 countries, except Cyprus and Malta) . N/A: Not Available |44| facts and figures agg.indd 44 28/3/16 1:28 PM EOPYY Pharmacies The majority of high cost drugs belonging in L .3816 / 2010 list are provided exclusively by EOPYY pharmacies or hospital pharmacies . Based on the ministerial decree published in Government Gazette 64/Β΄/16-01-2014, the list of high-cost, serious diseases pharmaceutical products that fall under the provisions of L .3816/2010 was split into two distinct lists . The first list relates to pharmaceutical products that are only available for hospital use (1A), while the second list includes those pharmaceuticals, which their use begins in the hospital and can be continued externally . EOPYY initially operated five pharmacies in Attica and one in Thessaloniki . Currently, 28 EOPYY pharmacies are in operation . In areas where EOPYY pharmacies do not exist, the insured can obtain the respective medicines from EOPYY’s local health units, after placing an order . Products that are exclusively available for hospital use are sold from EOPYY at hospital price, reduced by 5%, while those in the second list are subject to the prices as regulated by the Ministry of Health . |45| facts and figures agg.indd 45 28/3/16 1:28 PM 6 .1 SALES8 Sales of medicinal products to pharmacies/wholesalers amounted to €3 .88 bln in 2014, exhibiting a reduction of 2% compared to previous year . On the contrary, sales to hospitals presented an increase of 4 .5% respectively . Approximately, 73 .5% of total sales were supplied to wholesalers and private pharmacies9, while the remaining 26 .5% of sales to hospitals & EOPYY pharmacies . It is worth noting that the market has recorded an overall decrease of 44 .6% in sales compared to 2009 . figure 31: Pharmaceutical sales in values, Greece, 2008-2014 (bln€) bil. euro 8 7 6 7.00 6.55 6.03 5 5.56 4.61 4 3.96 3 3.88 2 1 1.47 1.47 1.31 1.36 1.20 1.34 1.40 0 2008 2009 2010 201 1 2012 2013 2014 Pharmacies/Wholesalers Source: EOF 2015 (Pharmacies/Wholesalers at retail prices and Hospitals at hospital prices) figure 32: Pharmaceutical sales in volume, Greece, 2008-2014, (mil. of packages) mil. packages 600 500 566.5 562.5 521.2 512.4 400 479.4 484.6 493.2 300 200 469.0 465.8 434.3 424.3 394.8 404.6 416.1 97.5 96.8 86.9 88.1 84.5 80.0 77.1 2012 farmacies 2013 Total 2014 100 0 2008 2009 2010 Pharmacies/Wholesalers 201 1 Hospitals/EOPYY Source: EOF 2015 *Possible smaller packaging replacements 8 . Total pharmaceutical sales recorded monthly by the National Organization of Medicines (EOF) and include pharmaceutical sales by pharmaceutical companies to hospitals (at hospital prices) and Wholesalers / Pharmacies (at retail prices) . Sales also recorded in terms of number of packages . 9 . Parallel exports in 2014 were €306 .7 mil . and are included here . |46| facts and figures agg.indd 46 28/3/16 1:28 PM Pharmaceutical products can be classified according to their patent protection status . According to IMS, the penetration rate of patent protected medicinal products reaches 11 .2%, which is higher than in other European markets (7%) but can be justified by their significantly lower prices compared to other EU countries (0 .82 € per unit on average compared to 1 .72€) . Respectively, the market share of non-protected pharmaceutical products amounted to 64 .2% (off-patent 35 .0% & generics 28 .7%) showing an upward trend compared to previous years (Figure 33), while a large margin in terms of price is not recorded between them . figure 33: Penetration of pharmaceuticals in european countries (in volume) based on patent status 100% 90% 24.6% 20.2% 14.3% 8.6% 5.9% 14.3% 17.9% 7.9% 4.7% 12.4% 80% 37.7% 70% 60% 28.7% 41.7% 50.4% 52.8% 73.1% 49.5% 66.1% 50.5% 57.1% 50% 40% 30% 30.7% 20% 10% 46.2% 35.5% 26.7% 28.9% 29.1% 24.3% 13.3% 24.5% 23.5% 11.2% 7.4% 8.6% 9.7% 7.7% 7.1% 7.3% 8.2% 4.7% 7.0% Greece Italy Spain France Germany Ireland Portugal Belgium UK A vg EU 0% on-patent of f-patent Generics Others Source: IMS, 09/2014 Note: Includes only retail sales for all countries |47| facts and figures agg.indd 47 28/3/16 1:28 PM figure 34: Pricing in european Countries, 2014 (price per unit, €) 4.00 3.50 3.00 2.50 4.00 3.50 3.00 2.50 2.00 2.00 1.50 1.00 0.50 - Spain France Germany Ireland Portugal Belgium 1.50On-patent Greece 0.82 0.73 1.08 1.79 3.55 2.54 0.80 2.06 1.02 1.72 Of f-patent 0.29 0.30 0.23 0.30 0.59 0.39 0.23 0.28 0.27 0.31 0.21 0.14 0.12 0.17 0.14 0.19 0.13 0.17 0.10 0.13 1.00Generics Italy UK A vg EU 0.50Source: IMS, 09/2014 Note: only retail sales are included - Greece Spaindata,France Germany Ireland Portugal Belgium UK A vg EU Based on latest Italy available in 2014 the over-the-counter (OTC) market amounted to On-patent 0.82 mil.euro 0.73 1.08 1.79 3.55 2.54 0.80 2.06 1.02 1.72 mil.euro €331 mil, showing higher levels than previous years . Analyzing, the number of packages Of f-patent 0.30 0.23 0.30 0.59 0.39 0.23 0.28 331 0.27 0.31 0.29 120 sales 350 sold in the market for 2014, there is an increase of 14 .9% compared to 2013 reaching Generics 0.14 0.12 0.17 0.14 0.19 0.13 0.17 0.10 0.13 0.21 292.3 of 95 .9 mil packages . 300 100 258.4 250 figure 35: otC sales, 2012-2014 (in mil. €) 200 83.5 78.2 150 mil.euro 60 mil.euro 331 350 100 300 50 250 0 200 150 80 95.9 120 292.3 100 258.4 2012 2013 83.5 Value 78.2 95.92014 V olume 80 40 20 0 60 40 100 20 50 0 0 2012 2013 Value 2014 V olume Source: AESGP, 2015, IMS, 2015 Note: Depending on the source of information used, there may be deviations over EOFs’ sales data . |48| facts and figures agg.indd 48 28/3/16 1:28 PM figure 36: otC total sales in various countries, 2014 Germany 6,502 Brazil 6,200 Poland 2,734 Italy 2,429 Mexico 1,541 UK 1,344 Ukraine 999 Spain 997 Austria 774 Netherlands 741 Switzerland 642 Belgium 623 Sweden 575 Argentina 471 Hungary 387 Greece 331 Finland 261 Portugal 212 New Zealand 211 166 Denmark Lithuania 75 Latvia 59 Croatia 54 Estonia 46 urkeyT 44 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 Source: AESGP, 2015 *Note: Different definition of OTC in Greece and other European counties OTC share in Greece is among the lowest compared with the rest of Europe . However, it should be noted that the respective market share depends largely on the range of nonprescription medicines included in each country . In 2014, vitamins and minerals (23%) had the greatest share of the market followed by analgesics (20 .2%) and cold remedies (19 .9%) . table 9: otC sales by group in Greece, in mil.€ otC groups Cough and cold Analgesics Digestives Skin treatment Vitamins and minerals Others total 2012 54 .5 56 .3 17 .3 24 49 .8 56 .5 258.4 2013 60 .1 58 .9 20 .6 27 62 .1 63 .6 292.3 2014 66 67 24 28 .5 76 .2 69 .3 331 %13/14 9 .8% 13 .8% 16 .5% 5 .6% 22 .7% 9 .0% 13.2% % of total, 2014 19 .9% 20 .2% 7 .3% 8 .6% 23 .0% 20 .9% 100% Source: AESGP, 2015, data processing IOBE |49| facts and figures agg.indd 49 28/3/16 1:28 PM 6 .2 PRODUCTION According to Prodcom database (Eurostat) in terms of value (ex-factory prices), pharmaceutical production in Greece was estimated at €857 mil in 2014, approximately 2 .8% lower than in 2013 . figure 37: Domestic Production of pharmaceutical products, 2000-2014 (mil. €) 1,000 mil.euro mil.euro 900 802 800 677 700 600 500 337 400 372 431 450 890 866 918 907 881 825 857 71 1 515 300 200 100 - 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 201 1 2012 2013 2014 source: Eurostat 2015, PRODCOM Database . *Any changes based upon review of data from Eurostat Figure 38 below shows the evolution of production index for the pharmaceutical industry . In particular, the index declined in the first half of 2014, which was then partially compensated by the increase in the second half of the year . figure 38: Industrial Production Index for Pharmaceutical goods (2010=100) 106 103 104 103 103 104 101 102 99 100 98 96 94 94 q1 q2 97 97 q2 q3 95 93 94 92 90 88 86 q3 2012 q4 q1 q2 q3 2013 q4 q1 q4 2014 Source: EL .STAT, 2015, seasonally adjusted and adjusted data by working days |50| facts and figures agg.indd 50 28/3/16 1:28 PM The diagram below shows the evolution of turnover index in the pharmaceutical industry, as a proportion of the turnover in both the domestic market as a whole but also as exports to Eurozone and non-Eurozone countries . figure 39: turnover Index in Pharmaceutical Industry (2010=100) 250 194 200 171 151 118 100 144 140 150 116 103 166 153 111 114 115 151 151 147 111 107 105 111 98 87 89 89 88 85 86 90 88 88 85 85 82 81 84 q1 q2 q3 q4 q1 q2 q3 q4 q1 q2 q3 q4 103 50 0 2012 2013 Index of turnover-Domestic market 2014 Index non-domestic turnover-Euro area market Index non-domestic turnover- non Euro area market Source: EL .STAT, 2015, seasonally adjusted and adjusted data by working days The importance of the pharmaceutical industry in the years of recession can be represented in the figure below . The added value of the pharmaceutical sector as part of total manufacturing for the country is stabilized near 3% after a recessive period during 2005-2008, despite the economic crisis . When compared with other national manufacturing industries, the pharmaceutical sector is ranked 10th in 2014 (Table 10) . % 5.0% mil. (2010) 1,000 4.6% 900 800 700 4.5% 4.0% 805 3.8% 3.4% 746 672 600 500 3.4% 2.8% 624 505 400 4.0% 3.2% 3.0% 2.9% 3.1% 3.0% 616 519 507 474 3.5% 533 2.5% 2.0% 300 1.5% 200 1.0% 100 0.5% 0 0.0% 2005 2006 2007 2008 Value added mil. 2009 2010 |51| 201 1 2012 2013 (2010=100) Share of pharmaceutical sector in total manufacturing facts and figures agg.indd 51 28/3/16 1:28 PM figure 40: Added value Pharmaceutical sector Production % 5.0% mil. (2010) 1,000 4.6% 900 800 700 4.5% 4.0% 805 3.8% 3.4% 746 672 600 500 3.4% 2.8% 624 505 400 4.0% 3.2% 3.0% 2.9% 3.1% 3.0% 616 519 507 474 3.5% 533 2.5% 2.0% 300 1.5% 200 1.0% 100 0.5% 0 0.0% 2005 2006 2007 2008 V alue added mil. 2009 2010 201 1 2012 2013 (2010=100) Share of pharmaceutical sector in total manufacturing Source: Eurostat,2015, data processing IOBE table 10: share of added value in Manufacturing 2013 Manufacturing C 10: Manufacture of food products C 19: Manufacture of coke and refined petroleum products C 24: Manufacture of basic metals C: 33: Repair and installation of machinery and equipment C 25 Manufacture of fabricated metal products . except machinery and equipment C 23: Manufacture of other non-metallic mineral products C 11: Manufacture of beverages C 20: Manufacture of chemicals and chemical products C 28: Manufacture of machinery and equipment n .e .c C 21: Manufacture of basic pharmaceutical products and pharmaceutical preparations C 18: Printing and reproduction of recorded media C 14: Manufacture of textiles . wearing apparel C 17: Manufacture of paper and paper products C 27: Manufacture of electrical equipment C 26: Manufacture of computer . electronic and optical products C: 32: Other manufacturing C 12: Manufacture of tobacco products C 13: Manufacture of textiles C 22: Manufacture of rubber and plastic products C 31: Manufacture of furniture C 30: Manufacture of other transport equipment C 29: Manufacture of motor vehicles . trailers and semi-trailers C 15: leather and related products share in total Manufacturing 2014 26 .1% 10 .4% 10 .0% 7 .4% 6 .7% 5 .1% 4 .3% 4 .2% 3 .3% 3.1% 2 .3% 2 .3% 2 .2% 1 .7% 1 .7% 1 .7% 1 .7% 1 .3% 1 .3% 1 .3% 1 .0% 0 .5% 0 .3% Source: Eurostat (last data11/11/2015), data processing ΙΟΒΕ, 2015 * C 21: Manufacture of basic pharmaceutical products and pharmaceutical preparations include only the companies active in the production of medicines and pharmaceutical preparations . In C 21 manufacturing companies are not included firms that belong to subsector 46 .46 Wholesale of pharmaceutical products . |52| facts and figures agg.indd 52 28/3/16 1:28 PM 66 .3 EMPLOYMENT The European pharmaceutical industry is a high-tech sector offering employment to 690 .000 people (estimations EFPIA Facts & Figures, 2014) . According to Eurostat, in 2014 13 .3 thousands people were employed in the manufacturing of pharmaceutical products in Greece, demonstrating a slight increase 0 .8% higher compared to the previous year . figure 41: employment in the production of pharmaceuticals thousands people 15.0 14.0 13.7 3.0% 14.0 13.2 13.3 2.2% 13.0 2.0% 1.0% 12.0 0.8% 0.0% 11.0 -1.0% 10.0 -2.0% 9.0 -3.0% 8.0 -4.0% 7.0 -5.0% 6.0 -6.0% -5.7% 5.0 201 1 2012 2013 Employment in the pharmaceutical production sector -7.0% 2014 % change Source: Eurostat . 2015 Employment in the pharmaceutical sector represents 0 .4% of total employment of the Greek economy, while this share increases to 3 .6% with regards to employment in the industrial sector overall . Both shares are higher than the respective average in Europe . It is worth noting that Ireland has the highest share in Europe, representing 13 .3% of total industrial employment . |53| facts and figures agg.indd 53 28/3/16 1:28 PM figure 42: share of employment in the production of pharmaceuticals in the eu (2014) % economy % industry 1.8% 16.0% 1.6% 14.0% 1.4% 12.0% 1.2% 10.0% 1.0% 8.0% 0.8% 6.0% 0.6% 3.6% 0.4% 4.0% 2.1% 2.0% 0.0% 0.0% Ireland Slovenia Denmark Malta Belgium Croatia Hungary Austria UK France Spain Greece Bulgaria Italy Cyprus EU-28 Czech Rep. Germany Poland Latvia Sweden Netherlands Finland Portugal Romania Slovakia 0.2% % economy (left axis) % Industry (right axis) Source: Eurostat . Labour Force Survey . 2015 According to the International Standard Classification of Education, in the manufacturing sector of medicinal products, the majority of employees 61 .3% (8 .128 people) have university education (level 5) which indicates the high educational training of the industry . table 11: educational employment structure in pharmaceutical production (2014) 1-Primary education or first stage of basic education 2-Lower secondary or second stage of basic education 3-(Upper) secondary education 4-Post-secondary non-tertiary education 5-First stage of tertiary education 6-Second stage of tertiary education Total sector 21 total economy Number of Percentage Percentage persons total Industry Percentage 563 4 .2% 13 .6% 15 .9% 383 2 .9% 9 .8% 13 .9% 3 .285 24 .8% 33 .5% 41 .7% 227 1 .7% 9 .0% 8 .9% 8 .128 61 .3% 32 .5% 19 .3% 666 5 .0% 1 .0% 0 .2% 13 .252 100 .0% 100 .0% 100 .0% Source: EL .STAT . (ISCED . International Standard Classification of Education – Unesco) |54| facts and figures agg.indd 54 28/3/16 1:28 PM 6 .4 ExTERNAL TRADE The pharmaceutical industry is also an important driver for the country’s external trade . Imports and exports of medicinal products amounted to €2 .7 bln and €1 .0 bln respectively in 2014 . This is translated to a reduction of 2 .2% in imports and 0 .7% in exports respectively compared to previous year, thus lowering the pharmaceutical trade deficit by 3 .1% at €1 .65 bln compared to €1 .7 bln in 2013 . It is worth mentioning that based on data from the Panhellenic Exporters Association in 2014 medicinal products are the second export product in value terms after mineral oils in Greece . figure 43: Pharmaceutical trade balance (mil.€) 5,000 4,000 3,770.1 4,025.4 3,571.2 3,275.4 3,000 2,941.4 2,759.0 2,698.2 1,056.1 1,048.7 -1,702.9 -1,649.5 2013 2014 mil. 2,000 1,000 892.9 971.0 1,043.4 921.1 969.2 0 -1,000 -2,000 -3,000 -2,877.2 -3,054.4 2008 2009 -2,527.8 -2,354.3 2010 2011 -1,972.1 -4,000 Trade Balance Imports 2012 Exports Source: Eurostat. 2015. International trade. EU Trade Since 1988 By CN8. 2015. data processing ΙΟΒΕ |55| facts and figures agg.indd 55 28/3/16 1:28 PM 6 .4 RESEARCH AND DEVELOPMENT (R&D) Greece was ranked in the last places among EU countries in the R&D investment list, spending €100-120 mil according to EOF estimations . With respect to the number of clinical studies conducted in 2014, irrespective of phases, it was found that 1 .778 clinical studies took place in Greece, which is similar to that in countries such as Romania and far less than countries more research intensive, such as Germany, France and United Kingdom . figure 44: number of Clinical trials, all phases and stages. 2014 number of studies 410 581 618 640 659 667 1,016 1,183 1,205 1,213 1,778 1,737 2,039 2,568 2,591 2,853 3,978 3,484 4,095 4,005 2,000 5,917 4,000 4,980 7,349 6,000 6,142 8,000 10,565 10,000 7,837 13,025 12,000 12,418 14,000 - Source: Clinical trials .gov . 2014 |56| facts and figures agg.indd 56 28/3/16 1:28 PM 7 Pricing of Pharmaceutical Products Prices of medicinal products in Greece are set based on an international price referencing (IPR) system. Specifically, as set by the Law 4213, Chapter 4, art.22, prices for medicinal products are set based on the average of the 3 lowest prices of the EU member-states. The above provisions are specified by ministerial decisions. During 2014 there were significant changes in pricing and profit margins for pharmacists as reflected in Tables 12 & 13. Ministerial decision GG1907/Β/15.7.2014, as described below, sets the provisions under which pricing of pharmaceutical products is currently set out. Any intermediate provisions published within this year are presented in Table 14. In order for a medicinal product to be priced for the first time, it needs to have been priced in at least three EU member-countries. Only orphan medicinal products may be priced even if prices are available in only two other EU countries. Maximum wholesaler price (ex-factory) of on-patent products is based on the average of the three lowest prices of the EU member-states which publish reliable data. Respectively, the maximum wholesale price of off-patent products is automatically reduced either to 50% of the last price the product held under patent protection or to the average of the three lowest prices of the EU member-states, respecting the lowest between the two. Generic prices are set to 65% of the price of the respective reference medicinal product. For the medicinal products for which there is no generic in the market during the last twelve months, based on EOPYY sales, the average of the three lowest prices in the Member States of the European Union is exclusively used. When a generic product becomes available in the market (with sales), its price is reduced by 50%, even if the resulting price is lower than the average of the three lowest prices in the EU Member States. The latter is valid for all medicinal products for which patent protection has expired after 01.01.2012, including the respective generics (market authorization after 01.01.2012 & LOE after 01.01.2012). For those products with loss of exclusivity before 01.01.2012, horizontal price reductions are applied as defined by the respective ministerial decree. Similarly, for generics authorized prior to 01.01.2012. For medicinal products that are exclusively produced in Greece and/ or have Greek patent rights, price is set based on invoice / tariff which contain production and packaging costs, as well as administration - distribution – dissemination costs and research and development costs. Prices are revisited regularly downwards each time a price bulletin is issued. Products excluded from repricing are any products belonging in the negative list and OTC list. Exceptionally, for reasons of safeguarding public health and for covering adequately patient needs, blood products are exempted from repricing. Finally, the latter may not be priced lower than the average of the three lowest. |57| facts and figures agg.indd 57 28/3/16 1:28 PM Price definitions Maximum Wholesale Price: Maximum Wholesale Price of Medicinal Products is the price at which medicinal products are sold to pharmacies . This price includes the gross profit margin of the wholesaler, which is calculated as a percentage on the maximum price of the ex-factory . Gross profit margin (mark-up) a) for all medicinal products reimbursed by social security funds is set as a percentage of 4 .9% on the maximum net ex-factory price (up to €200) and 1,5% on the maximum net ex-factory price (>€200) b) for non-prescription medicinal products (OTC) as a percentage of 7 .8% on the maximum net ex-factory price and c) for medicinal products that belong to par .2, art .2, L3816/2010 as a percentage of 2% on hospital price . The latter is called as Special Wholesaler Price . Maximum retail Price: Maximum Retail Price of Medicinal Products is the price at which medicinal products are sold by pharmacies to consumers, and it is defined by the wholesale price, adding the lawful profit margin of the pharmacy as set out in the respective ministerial decree and the applicable Value Added Tax (VAT 6 .5%) . In particular, for pharmacies the mark up is determined as follows: a) 35% on the wholesale price for non-prescription medicinal products (OTC) b) 35% on the wholesale price for non-reimbursed prescription products c) for reimbursed products (see Table 6) and for products with price > €3 .000 is set a percentage of 2% . ex-factory price: The maximum producer’s price (ex-factory) is the sale price by the marketing authorization holders (MAHs) to wholesalers and is calculated based on the wholesale price reduced a) for prescription medicinal products which are not reimbursed by the Social Insurance Funds by 4 .67%, b) for prescription nonreimbursed medicinal products by 5 .12% and c) for non-prescription (OTC) medicinal products by 7 .24% . Maximum Hospital Price: Maximum Hospital Price of Medicinal Products is the price at which medicinal products are sold by the Marketing Authorization Holders to the State, State hospitals, Social Care Units, public law legal entities referred to in par . 1 of Article 37 of Law 3918/2011, pharmacies of private clinics with over 60 beds and EOPYY pharmacies . The maximum hospital price shall be determined on the basis of the ex-factory price reduced by 8,74% . |58| facts and figures agg.indd 58 28/3/16 1:28 PM 7.1 Pharmaceutical products price structureProfit margins of wholesalers vary depending on the reimbursement status of each product that is, on whether the product belongs in the positive, negative, OTC list or if they fall under L.3816/2011 provisions and its relative wholesaler price. For medicines belonging in the positive list (and therefore reimbursed by the social security funds) profit margins and the price structure are set as follows: Table 12: Mark-up in the pharmaceutical supply chain. 2014 Wholesalers (over ex-factory) Pharmacies Reimbursed Products up to 200€ Reimbursed Products > 200.01€ OTC Negative list products 4.9% 1.5% 7.8% 5.4% Table 13 Table 13 35% 35% Source: Ministerial Decision Νο. 3457.2014 (Gazette of Government Β 64) Για τα φαρμακεία το ποσοστό μικτού κέρδους (mark-up) για όλα τα αποζημιούμενα φάρμακα από τους ΦΚΑ σύμφωνα με το κάτωθι πίνακα. Table 13: Mark-up for pharmacies Wholesale price (€) 0-50 50.01-100 100.01-150 150.01-200 200.01-300 300.01-400 400.01-500 500.01-600 600.01-700 700.01-800 800.01-900 900.01-1000 1000.01-1250 1250.01-1500 1500.01-1750 1750.01-2000 2000.01-2250 2250.01-2500 2500.01-2750 2750.01-3000 Percentage mark-up pharmacies 30.00% 20.00% 16.00% 14.00% 12.00% 10.00% 9.00% 8.00% 7.00% 6.50% 6.00% 5.50% 5.00% 4.25% 3.75% 3.25% 3.00% 2.75% 2.50% 2.25% Source: M.D. (1907/Β/15.7.2014) |59| facts and figures agg.indd 59 28/3/16 1:28 PM Mark-up margins mentioned above are the maximum margins allowed in the case of OTC products for both wholesalers and pharmacists, and they are allowed to voluntarily reduce them and offer these products in lower prices as long as it is recorded in the respective invoice. Additionally, these margins are applied to all reimbursed products sold in private pharmacies including products belonging in the L.3816/2010 list. When the latter are directly sold by private pharmacies and the respective cost is not reimbursed by EOPYY or any other SSF, pharmacist margin is set based on the table above and for products with wholesaler price greater than €3.000 this changes to 2%. According to the price structure of medicinal products, the current rate of 6.0% VAT and the respective profit rates in the supply chain based on wholesale prices (IMS elements 03/2015), the weighted average percentage of the final value attributable to the manufacturer lays at 67.8%, wholesaler at 3.4% and pharmacist to 22.8% |60| facts and figures agg.indd 60 28/3/16 1:28 PM 7 .2 PHARMACEUTICAL PRICE INDEx The prices of medicinal products in Greece followed a slightly upward trend until 2009, however, significantly lower than the rate of inflation . Pricing reforms introduced from 2009 onwards led to an overall decline of 26 .5% in the pharmaceutical price index until 2013 . figure 45: Drugs Price Index vs Price Index of other basic Goods (2005=100) 150 140 136.7 130 121.6 120 111.3 110 108.9 100 90 80 74.7 70 60 2005 2006 2007 2008 2009 2010 201 1 2012 Harmonised Index of Consumer Prices Pharmaceutical products Health Medical services; paramedical services 2013 Hospital services Source: Eurostat . 2015 |61| facts and figures agg.indd 61 28/3/16 1:28 PM 7.3. Reimbursement of pharmaceuticals Regarding the reimbursement of medicinal products, the most important legislative changes during 2014 are summarized below: According to Law 4249, Article 127 (GG 73 / 03.24.2014), Social Security Funds reimburse patent protected medicinal products that have received market authorization in Greece after 1.1.2012, if they are reimbursed by Social Security Funds in 2/3 of EU Member - States or in at least 12 EU member- states after an health technology assessment evaluation, provided full compliance with the Community EC Directive 89/105 / EG Directive on transparency. The Minister of Health has the authority to exempt medicinal products which are characterized as essential to the life risk coverage of patients or orphan drugs, only when covered by international clinical protocols. New generics are automatically included in the list if the reference medicinal products (off patent) are also included. The positive list is prepared by EOF and after approval from the Minister of Health it is published in Government Gazette. Following either price revision or after price setting of new medicinal products, the positive list and the corresponding reference values must be reviewed within 30 days (GG64 / 01.16.2014). For the setting up, the revision and the completion of the reimbursement list, the system of Anatomical Therapeutic Chemical Classification (Anatomic Therapeutic Chemical classification - ATC) from World Health Organization (WHO) is used and a reference pricing system by therapeutic category is applied. The reference price is calculated for each available strength and/or pack size in each cluster. As defined in the ministerial decision published in GG1144 / 05.06.2014, the reference price is calculated as the weighted average of the lowest cost of daily treatment generics that account for 20% of market sales during the last six months prior to the calculation of prices. Sales are based on EOPYY expenditure. In cases where a patient chooses a medicinal product with retail price equal to the reimbursement price, then he pays the statutory co-payment (0%, 10%, or 25%). In cases, where the patient decides to choose a product where retail price is greater than the reimbursement price, then he must pay the set co-payment and additionally the full difference between these prices. Finally, when the retail price is lower than the reimbursement price, up to 50% of the difference between them is deducted from the set co-pay. Based on the ministerial decision published in GG1276/20.05.2014, the maximum amount a patient can pay on top of the set co-pay cannot exceed € 50 per pack. Finally, all pharmaceutical products belonging in L.3816 / 2010 list are fully reimbursed by SSFs and are available to patients without co-payment. It should be noted that based on a later ministerial decision (GG2243/18.08.2014), in cases where a medicinal product with no generic presence is chosen, and its retail price is greater than the reimbursement price, patient must pay 50% of the difference between the prices on top of the set co-pay and the remaining 50% is paid by pharmaceutical companies in the form of a rebate, starting from 15.09.2014 onwards. |62| facts and figures agg.indd 62 28/3/16 1:28 PM Table 14: Legislative changes re pricing, reimbursement & rebates, 2014 Ημερομηνία Gazette / Ministerial Decision 16.1.2014 21.01.2014 07.02.2014 06.05.2014 MD 3457 - GG 64/Β MD 3594 - GG 18 MD 12449 - GG 256/Β MD 38733 & MD 38714 20.05.2014 04.06.2014 - GG 1144/Β MD 43066 - GG 1277/Β MD 45001 - GG 1435/Β 10.06.2014 02.07.2014 15.07.2014 24.07.2014 31.12.2014 MD 49515 - GG 1530/Β MD 58430 - GG 1805/B MD 61771 – GG 1907/B MD 65470 - GG 2013/Β MD 112654 - GG 3677 16.1.2014 13.02.2014 07.03.2014 24.03.2014 26.03.2014 06.05.2014 MD 3457 - GG 64/Β MD 14228 - GG 329/Β MD 21261 - GG 572/B Law 4249 - GG 73/Α MD 22405 - GG 740/Β MD 38733 & MD 38714 10.05.2014 - GG 1144/Β Law 4262 - GG 114/Α 14.05.2014 14.05.2014 20.05.2014 20.05.2014 06.06.2014 11.07.2014 21.07.2014 30.07.2014 29.08.2014 16.12.2014 16.1.2014 17.02.2014 10.05.2014 23.05.2014 18.08.2014 18.08.2014 31.12.2014 Law PRICING Pricing Provisions Pricing Provisions Pricing Provisions – amendment of GG64B Pricing & supply provisions for OTC Pricing Provisions & L.3816/2010 list Supply & administration provisions for medicinal products Pricing Provisions Pricing Provisions Pricing Provisions Pricing Provisions Pricing Provisions REIMBURSEMENT Pricing Provisions, article 14 Revision of reimbursement list Approval of reimbursement list Reorganization of Greek Police (article 127) Approval of reimbursement positive list Pricing Provisions – Amendment of article 14, GG 64B Authorisation for economic activity and other provisions (article 54) MD 38907 - GG 1222/Β Updated OTC list Law 4263 - GG 117/Α Midterm Fiscal Term Strategy 2015-2018 MD 43066 - GG 1277/Β Approval of Reimbursement list MD 43063 & MD 43063 - GG 1277/Β Cap to co-payment-50€/package MD 49516 - GG 1511/B Provisions for the prescription and reimbursement of oncological medicinal products MD 60490 - GG 1894/B Approval of reimbursement list MD 62836 - GG 1981/Β Updated OTC list MD 66788 - GG 2083/Β OTC List MD 74288 - GG 2336 Reimbursement list MD 108477 - GG 3376/Β Reimbursement list REBATES MD 3457GG 64/Β Pricing Provisions Law 4238/2014 - GG 38/Α Article 52 Offsetting state debts with rebates & clawback Law 4262 - GG 114/Α Supplementation of Article 54 - calculation of clawback MD 41767 / GG1322 Offsetting of second half 2013 EOPYY, hospitals and MAHs MD 70519 & MD 70520 - GG 2243/Β Rebate & Claw back MD 70522 - GG 2247/Β Rebate MD 6931 - GG 3676/B Modification of Ministerial Decision 50-50 |63| facts and figures agg.indd 63 28/3/16 1:28 PM 8 State’s debt towards pharmaceutical firms The Hellenic Association of Pharmaceutical Companies (SFEE) collects and records data related to State’s debts of its member companies (on a voluntary basis). Below an overview of total receipts, sales invoices and debts until 31.12.2014 only for the pharmaceutical industry (end date of data collection 31.12.14) are presented. The data collected refer to invoices in the period described above. Data for sales, receipts and outstanding debts re NHS hospitals, EOPYY, Military hospitals, judicial hospitals, private entities and IFET are requested. However, comparable data from all companies refer to outstanding debts from NHS, EOPYY and military hospitals, which also constitute the largest part of health expenditure. Specifically, findings show that: • The total amount of sales of SfEE member-companies to the State during the period 01.01.2013 to 31.12.2014 amounted to €1.943 mil., while respective receipts amounted to €1.314 mil. (Note: The aforementioned amounts are part of the total, as they involve only companies – members that they have sent detailed data of sales-receipts). • The total amount of outstanding debts from the State re invoices until 31.12.2014 amounted to €789.9 mil. It should be noted that any debts remaining unsettled before 31.12.2012 are also included here (estimated to €31.9 mil). If broken down to each stakeholder, €496.1 mil account for EOPYY, €276 mil for NHS Hospitals and €17.7 mil for Military Hospitals. (These amounts include also companies which sent aggregated data). • The settlement of state debts for 2013 is almost completed (94.86% paid back). • Despite the downward trend shown in Figures 46 & 47, only 40.1% of state debts for 2014 have been paid back. In particular, 56% of NHS hospitals debts and 30.2% of EOPYY debts have been settled for 2014. It becomes evident that pharmaceutical companies are significantly behind in settling state debts both standalone and comparative to other providers such as pharmacies, private clinics, diagnostic centres, etc. A stable repayment policy must be established directly so as to avoid inability of pharmaceutical companies to support both the market and their businesses. |64| facts and figures agg.indd 64 28/3/16 1:28 PM figure 46: total state debts evolution towards sfee member companies’ until 31.12.2014 700 700 600 600 500 500 550 550 415 415 597 597 450 450 573 573 455 455 568 568 598 598 648 648 632 632 633 633 627 627 608 608 496 496 430 430 429 429 400 400 348 348 368 368 376 376 343 343 300 300 295 295 276 276 200 200 100 100 30 30 23 23 22 22 22 22 23 23 21 21 24 24 25 25 24 24 21 21 18 18 0 0 EOPYY EOPYY Source: SFEE ESY ESY Military Military figure 47: state debts evolution towards sfee member companies’ until 31.12.2014 (Invoices for 2014 only) 600 600 482 482 500 500 560 560 493 493 260 260 300 300 165 165 200 200 0 0 546 546 362 362 400 400 100 100 519 519 50 50 2 2 45 45 Source: SFEE 100 100 90 4 90 4 145 145 7 7 200 200 190 190 10 10 EOPYY EOPYY 259 259 210 210 202 202 12 12 12 12 ESY ESY 16 16 274 274 18 18 249 249 17 17 214 214 204 204 17 17 15 15 Military Military |65| facts and figures agg.indd 65 28/3/16 1:28 PM 9 Appendix Based on article 6 of the European Regulation (EU) 1338/2008 of the European parliament re matters of public health and the respective under voting Implementation Regulation and in cooperation from OECD & WHO the new compilation of SHA data was created. As such, ELSTAT was obliged to communicate SHA data to Eurostat and to International Organizations (OECD and World Health Organization) according to the new SHA 2011 and a revision was done from 2009-2013. Transition table from SHA 1.0 to SHA 2011 codes System of Health Accounts SHA 1.0 Funding Sectors (HF) System of Health Accounts SHA 2011 HF.1.2 General Government (excl. Social Security Funds) Social Security Funds (SSFs) HF.2.2 Private Voluntary Insurance Schemes HF.2.1 HF.2.3 Private Households Out-of pocket Expenditures HF.3.1 HF.2.4 Non Profit Institutions Financing Schemes HF.2.2 HF.2.5 Corporation Financing Schemes HF.2.3 HF.1.1 HF.3 HF.0 System of Health Accounts SHA 1.0 HP.1 HP.2 HP.3.1-3.4. HP.3.6 Rest of the World HF.1.1 HF.1.2 HF.4 n.e.c Health care providers (HP) Hospitals (public and private) Residential. Long-term care facilities HF.0 System of Health Accounts SHA 2011 HP.1 HP.2 Providers of ambulatory health care HP.3 Providers of ancillary services HP.4 HP.4 Retailers and other providers of medical goods HP.5 HP.5 HP.6 HP.7 Providers of preventive care Providers of health care system administration and financing Rest of Economy HP.9 Rest of the World HP.9 HP.0 n.e.c HP.0 HP.3.5. HP.3.9 HP.6 HP.7 HP.8 Codification at the category of health care activities (HC-health care) remains unchanged between SHA 2011 & SHA 1.0. |66| facts and figures agg.indd 66 28/3/16 1:28 PM NOTES facts and figures agg.indd 67 28/3/16 1:28 PM NOTES facts and figures agg.indd 68 28/3/16 1:28 PM
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