GDHC0055CHR-Healthcare, Regulatory and …diseases drugs, Central Nervous System (CNS) drugs, gastrointestinal drugs, and drugs for metabolic disorders. As a part of cost-containment

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE -

GREECE

REFERENCE CODE GDHC0055CHR | PUBLICATION DATE SEPTEMBER 2013

Healthcare, Regulatory and Reimbursement Landscape - Greece 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.


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Executive Summary

The Growing Prevalence of Chronic Ailments and the Increasing Size of the Elderly Population are Boosting Market Growth, but an Unstable Economic Situation, which has Resulted in Lower Reimbursement, Price Cuts Due to Cost-containment Measures, and the Increasing Preference for Generics, is Impeding Market Growth.

The economic crisis and the subsequent policy

changes have affected the growth of Greece’s

pharmaceutical industry. The Greek

pharmaceutical market was valued at $XX billion in

2007, but following the 2009–2012 economic crisis,

net public pharmaceutical expenditure saw a

cumulative decline of $XX billion (€XX billion). This

decline was due to amendments made to the price

of medicines, changes to the reimbursement rates

for Social Security Funds (SSFs), and changes to

the regulation of wholesale and retail margins

(SFEE, 2012).

The pharmaceutical market is expected to increase

during the forecast period (2013 to 2020), driven

by factors such as the growing elderly population’s

associated disease burden. The pharmaceutical

market is expected to grow at a Compound Annual

Growth Rate (CAGR) of XX% from approximately

$XX billion in 2013 to $XX billion in 2020,

dominated by Cardiovascular System (CVS)

diseases drugs, Central Nervous System (CNS)

drugs, gastrointestinal drugs, and drugs for

metabolic disorders.

As a part of cost-containment measures, the

government is focusing on increasing the use of

generics and wants generics to eventually account

for XX% of all medicines used in hospitals (Taylor,

2010). Healthcare reforms in terms of

reimbursement have led to an increase in the co-

payments for certain chronic indications, with rates

ranging from XX% to XX% (SFEE, 2012). As part

of the economic reforms and austerity measures,

nearly XX% of drug prices have been reduced by

XX% (Natz, 2012). These measures, along with

other cost-containment measures, will restrict

market growth.

Pharmaceutical Market, Greece, Revenue ($bn), 2007–2020

2007 2012* 2015* 2020*

Rev

enue

($bn

)

Year

CAGR (2007–2020): XX%

Source: GlobalData; AESGP, 2013 *Estimated figures



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Table of Contents

1 Table of Contents

1 Table of Contents .......................................................................................................................... 7

1.1 List of Tables.......................................................................................................................... 11

1.2 List of Figures ........................................................................................................................ 15

2 Introduction ................................................................................................................................. 20

2.1 Report Guidance .................................................................................................................... 20

3 Overview of Pharmaceutical and Medical Device Markets ........................................................... 21

3.1 Pharmaceutical Market .......................................................................................................... 21

3.1.1 Market Overview ............................................................................................................. 21

3.1.2 Pharmaceutical Imports and Exports .............................................................................. 24

3.1.3 Supply Channels............................................................................................................. 25

3.1.4 Market Segments............................................................................................................ 27

3.1.5 Major Therapeutic Areas................................................................................................. 33

3.1.6 Major Players .................................................................................................................. 35

3.2 Medical Device Market ........................................................................................................... 79

3.2.1 Market Overview ............................................................................................................. 79

3.2.2 Overview of Top Five Segments ..................................................................................... 82

3.2.3 Diagnostics Market ......................................................................................................... 95

3.2.4 Major Players .................................................................................................................. 97

3.3 Market Drivers and Barriers ................................................................................................. 123

3.3.1 Drivers .......................................................................................................................... 123

3.3.2 Barriers ......................................................................................................................... 124



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4 Market Access ........................................................................................................................... 127

4.1 Reimbursement and Payer Landscape ................................................................................ 127

4.1.1 Overview of Healthcare System .................................................................................... 127

4.1.2 Reimbursement Process............................................................................................... 132

4.1.3 Overview of Insurance Provider .................................................................................... 134

4.1.4 Patient Share in Healthcare Spending .......................................................................... 136

4.1.5 Healthcare Price Trends ............................................................................................... 137

4.1.6 Pricing Policies ............................................................................................................. 138

4.2 Regulatory Landscape ......................................................................................................... 139

4.2.1 Overview of Regulatory Agencies ................................................................................. 139

4.2.2 Structure and Organization of the EOF ......................................................................... 139

4.2.3 Marketing Authorization Procedure for Pharmaceutical Products .................................. 140

4.2.4 New Medical Device Approval Process ......................................................................... 152

4.2.5 Licensing Process for Pharmaceutical Manufacturing ................................................... 157

4.2.6 Licensing Process for Pharmaceutical Exports and Imports .......................................... 158

4.2.7 Intellectual Property Rights ........................................................................................... 159

4.2.8 Clinical Trial Regulations .............................................................................................. 161

4.2.9 Pharmaceutical Advertising Regulations ....................................................................... 163

4.2.10 Pharmacy Regulations .................................................................................................. 164

4.2.11 Labeling and Packaging Regulations ............................................................................ 165

5 Country Analysis ....................................................................................................................... 166

5.1 Political Environment ............................................................................................................ 166

5.1.1 Political Structure .......................................................................................................... 166



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5.1.2 Analysis of Current Political Environment ..................................................................... 167

5.1.3 Healthcare Policy Initiatives .......................................................................................... 169

5.2 Economic Landscape ........................................................................................................... 172

5.3 Economic Indicators ............................................................................................................. 176

5.3.1 Gross Domestic Product ............................................................................................... 176

5.3.2 Gross National Income ................................................................................................. 180

5.3.3 Inflation ......................................................................................................................... 181

5.3.4 Currency Exchange Rate .............................................................................................. 185

5.3.5 Foreign Direct Investment ............................................................................................. 186

5.3.6 Foreign Exchange Reserves ......................................................................................... 187

5.3.7 Trade Balance .............................................................................................................. 188

5.3.8 Government Structural Balance .................................................................................... 190

5.3.9 Government Net Debt ................................................................................................... 191

5.3.10 Major Industries ............................................................................................................ 192

5.4 Demographics ...................................................................................................................... 193

5.4.1 Population .................................................................................................................... 193

5.4.2 Education and Literacy ................................................................................................. 208

5.4.3 Employment.................................................................................................................. 210

5.4.4 Disease Burden ............................................................................................................ 212

5.5 Healthcare Infrastructure ...................................................................................................... 217

5.5.2 Healthcare Parameters ................................................................................................. 221

5.5.3 Environmental Health ................................................................................................... 223

5.5.4 Healthcare Personnel ................................................................................................... 225



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5.6 Healthcare Expenditure ........................................................................................................ 229

5.6.1 Overview ...................................................................................................................... 229

5.6.2 Major Components of Healthcare Spending.................................................................. 229

5.6.3 Share of Public and Private Sectors.............................................................................. 230

5.6.4 Health Expenditure by Sector ....................................................................................... 231

5.7 Trade Associations............................................................................................................... 232

5.7.1 Pan Farmakeftikos Association ..................................................................................... 232

5.7.2 Pharmacists’ Co-operative Federation .......................................................................... 232

5.7.3 Hellenic Association of Pharmaceutical Companies ...................................................... 232

5.7.4 Panhellenic Association of Pharmaceutical Wholesalers .............................................. 233

5.7.5 Hellenic Biotech Association ......................................................................................... 233

5.8 Trade Fairs........................................................................................................................... 233

6 Opportunities and Challenges ................................................................................................... 235

6.1 Opportunities........................................................................................................................ 235

6.2 Challenges ........................................................................................................................... 235

7 Appendix ................................................................................................................................... 238

7.1 Abbreviations ....................................................................................................................... 238

7.2 Bibliography ......................................................................................................................... 241

7.3 Methodology ........................................................................................................................ 254

7.3.1 Coverage ...................................................................................................................... 254

7.3.2 Secondary Research .................................................................................................... 255

7.3.3 Forecasting ................................................................................................................... 255

7.3.4 Expert Panel Validation................................................................................................. 255



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7.4 Disclaimer ............................................................................................................................ 256

1.1 List of Tables

Table 1: Pharmaceutical Market, Greece, Revenue ($bn), 2007–2012 ........................................................... 22

Table 2: Pharmaceutical Market, Greece, Revenue ($bn), Forecast, 2013–2020............................................ 23

Table 3: Pharmaceutical Market, Greece, Imports and Exports ($bn), 2007–2012 .......................................... 24

Table 4: Pharmaceutical Market, Greece, SSF Reimbursement (%), 2010–2012 ........................................... 26

Table 5: Pharmaceutical Market, Greece, Pharmaceutical Supply Chain Mark-ups, 2012 ............................... 26

Table 6: Pharmaceutical Market, Greece, Generic Pharmaceutical Market Share (%), 2007–2012 ................. 28

Table 7: Pharmaceutical Market, Global, Drugs Going Off-patent, Revenue ($m), 2011–2015........................ 29

Table 8: Pharmaceutical Market, Greece, OTC Pharmaceutical Market, Revenue ($m), 2008–2012 .............. 31

Table 9: Pharmaceutical Market, Greece, Major OTC Drug Classes, Revenue ($m), 2011 ............................. 32

Table 10: Pharmaceutical Market, Greece, Major Therapeutic Areas, Revenue Share (%), 2008 ................... 33

Table 11: Sanofi, Global, Major Products, Revenue ($m), 2012 ..................................................................... 36

Table 12: Sanofi, Global, Late-stage Pipeline, 2013 ....................................................................................... 36

Table 13: Novartis, Global, Major Products, Revenue ($m), 2012 ................................................................... 44

Table 14: Novartis, Global, Planned Filings, 2012 to ≥ 2016 ........................................................................... 45

Table 15: Pfizer, Global, Major Products, Revenue ($m), 2012 ...................................................................... 53

Table 16: Pfizer, Global, Late-Stage Pipeline, 2013 ....................................................................................... 54

Table 17: GlaxoSmithKline, Global, Major Products, Revenue ($m), 2012...................................................... 63

Table 18: GlaxoSmithKline, Late-stage Pipeline, 2013 ................................................................................... 64

Table 19: GlaxoSmithKline, Global, Major Products, Revenue ($m), 2012...................................................... 72

Table 20: Roche, Late-stage Pipeline, 2013 ................................................................................................... 73

Table 21: Medical Device Market, Greece, Revenue ($m), 2007–2012 .......................................................... 80



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Table 22: Medical Device Market, Greece, Revenue ($m), Forecast, 2013–2020 ........................................... 81

Table 23: Medical Device Market, Greece, Revenue by Segment ($m), 2013 ................................................. 82

Table 24: Medical Device Market, Greece, In Vitro Diagnostics Market, Revenue ($m), 2007–2012 ............... 84

Table 25: Medical Device Market, Greece, In Vitro Diagnostics Market, Sales Trend for Major Players*

($m), 2011 .................................................................................................................................... 85

Table 26: Medical Device Market, Greece, Cardiovascular Device Market, Revenue ($m), 2007–2012 .......... 87

Table 27: Medical Device Market, Greece, Cardiovascular Device Market, Sales Trend for Major Players

($m)*, 2011 .................................................................................................................................... 87

Table 28: Medical Device Market, Greece, Ophthalmic Device Market, Revenue ($m), 2007–2012 ................ 89

Table 29: Medical Device Market, Greece, Ophthalmic Device Market, Sales Trend for Major Players* ($m),

2011 .............................................................................................................................................. 90

Table 30: Medical Device Market, Greece, Drug Delivery Device Market, Revenue ($m), 2007–2012 ............ 91

Table 31: Medical Device Market, Greece, Drug Delivery Device Market, Sales Trend for Major Players

($m)*, 2011 .................................................................................................................................... 92

Table 32: Medical Device Market, Greece, Diagnostic Imaging Market, Revenue ($m), 2007–2012 ............... 93

Table 33: Medical Device Market, Greece, Diagnostic Imaging Market, Sales Trend for Major Players ($m)*,

2011 .............................................................................................................................................. 94

Table 34: Medical Device Market, Greece, Diagnostics Market, Revenue ($m), 2007–2012 ........................... 95

Table 35: Medical Device Market, Greece, Diagnostic Market, Revenue ($m), Forecast, 2013–2020 ............. 96

Table 36: Medical Device Market, Greece, Major Medical Device Companies, Revenue ($m), 2011 .............. 97

Table 37: Roche, Global, Major Products, Revenues ($m), 2012.................................................................... 98

Table 38: Siemens, Global, Major Products, Revenue ($m), 2012 ................................................................ 105

Table 39: Medtronic, Global, Major Products, Revenue ($m), 2012 .............................................................. 111

Table 40: Abbott, Global, Major Products Classes, Revenue ($m), 2012 ...................................................... 117

Table 41: Abbott, Global, Late-stage Pipeline, 2011 ..................................................................................... 118

Table 42: Healthcare Spending, Greece, Patient's Share (%), 2007–2012 ................................................... 136



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Table 43: Healthcare Consumer Price Index, Greece, Annual Change (%), 2007–2012 ............................... 137

Table 44: Healthcare System, Greece, Patent Application Fees (€) ($),2013 ................................................ 160

Table 45: Disbursements under the EC/ECB/IMF Program ($bn) (€bn) ........................................................ 174

Table 46: Economic Indicators, Greece, Gross Domestic Product per Capita ($’000), 2007–2012 ................ 177

Table 47: Economic Indicators, Greece, Gross Domestic Product per Capita ($’000), Forecast, 2013–2020 177

Table 48: Economic Indicators, Greece, Gross Domestic Product Annual Growth (%), 2007–2012 .............. 178

Table 49: Economic Indicators, Greece, Gross Domestic Product Annual Growth (%), Forecast, 2013–2020179

Table 50: Economic Indicators, Greece, Gross National Income per Capita ($’000), 2007–2012 .................. 180

Table 51: Economic Indicators, Greece, Average Consumer Price Index, 2007–2012 .................................. 181

Table 52: Economic Indicators, Greece, Average Consumer Price Index, Forecast, 2013–2020 ................... 182

Table 53: Economic Indicators, Greece, Average Consumer Price, Annual Change (%), 2007–2012 ........... 183

Table 54: Economic Indicators, Greece, Average Consumer Price, Annual Change (%), Forecast,

2013–2020 ................................................................................................................................... 184

Table 55: Economic Indicators, Greece, Currency Exchange Rate (€/$), 2007–2012 ................................... 185

Table 56: Economic Indicators, Greece, Foreign Direct Investment ($bn), 2007–2012.................................. 186

Table 57: Economic Indicators, Greece, Foreign Exchange Reserves ($bn), 2007–2012 ............................. 187

Table 58: Economic Indicators, Greece, Imports of Goods and Services ($bn), 2007–2012.......................... 188

Table 59: Economic Indicators, Greece, Exports of Goods and Services ($bn), 2007–2012 ......................... 189

Table 60: Economic Indicators, Greece, General Government Structural Balance ($bn), 2007–2012 ........... 190

Table 61: Economic Indicators, Greece, General Government Net Debt ($bn), 2007–2012 .......................... 191

Table 62: Economic Indicators, Greece, Major Industries, Gross Value Added ($bn), 2012 .......................... 193

Table 63: Demographics, Greece, Population (million), 2007–2012 .............................................................. 194

Table 64: Demographics, Greece, Population (million), Forecast, 2013–2020 .............................................. 195

Table 65: Demographics, Greece, Urban and Rural Population, Share (%), 2007–2012 ............................... 196

Table 66: Demographics, Greece, Urban and Rural Population, Share (%), Forecast, 2013–2020 ............... 197



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Table 67: Demographics, Greece, Age Groups, Population Distribution (%), 2007–2012 .............................. 198

Table 68: Demographics, Greece, Age Groups, Population Distribution (%), Forecast, 2013–2020 .............. 199

Table 69: Demographics, Greece, Births (per 1,000 Population), 2007–2012 ............................................... 200

Table 70: Demographics, Greece, Mortality (per 1,000 Population), 2007–2012 ........................................... 201

Table 71: Demographics, Greece, Main Cause of Mortality (%), 2010 .......................................................... 203

Table 72: Demographics, Greece, Children <5 Years, Mortality Rate (per 1,000 Live Births), 2007–2012 ..... 204

Table 73: Demographics, Greece, Immunization Rate (%), 2007–2012 ........................................................ 205

Table 74: Demographics, Greece, Gender Ratio (M/F), 2007–2012 ............................................................. 206

Table 75: Demographics, Greece, Life Expectancy at Birth (Years), 2007–2012 .......................................... 208

Table 76: Demographics, Greece, Levels of Education, Student Enrollment (‘000), 2010 ............................. 209

Table 77: Demographics, Greece, Unemployment (%), 2007–2012 ............................................................. 211

Table 78: Demographics, Greece, Number of Persons Employed by Industry (‘000), 2011 ........................... 212

Table 79: Demographics, Greece, Hospital Patients Discharged (‘000), 2008 .............................................. 213

Table 80: Demographics, Greece, Cause of Discharge of Male-Patients from Hospital (‘000), 2008 ............. 214

Table 81: Demographics, Greece, Cause of Discharge of Female Patients from Hospitals (‘000), 2008 ....... 215

Table 82: Demographics, Greece, Major Diseases, DALYs (per 100,000 Population), 2009 ......................... 217

Table 83: Healthcare Infrastructure, Greece, Hospitals Establishments, 2007–2012..................................... 217

Table 84: Healthcare Infrastructure, Greece, Hospitals Beds (‘000), 2007–2012 .......................................... 218

Table 85: Healthcare Infrastructure, Greece, Diagnostic Units (per 1,000,000 Population), 2007–2012 ........ 219

Table 86: Healthcare Infrastructure, Greece, Pharmacies (‘000), 2007–2012 ............................................... 220

Table 87: Healthcare Infrastructure, Greece, Hospital Beds (per 1,000 Population), 2007–2012................... 221

Table 88: Healthcare Infrastructure, Greece, Physicians (per 1,000 Population), 2007–2012 ....................... 222

Table 89: Environmental Health, Greece, CO2 Emissions (Million Tons), 2007–2012 ................................... 223

Table 90: Environmental Health, Greece, PM10 Emissions (µgm/m3), 2007–2012 ....................................... 224



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Table 91: Healthcare Personnel, Greece, Doctors (per 1,000 Population), 2007–2012 ................................. 226

Table 92: Healthcare Personnel, Greece, Nurses (per 1,000 Population), 2007–2012 .................................. 227

Table 93: Healthcare Personnel, Greece, Dentists (per 1,000 Population), 2007–2012 ................................ 228

Table 94: Healthcare Expenditure, Greece, Public-Private Share (%), 2007–2012 ....................................... 230

Table 95: Major Healthcare Trade Fairs, Greece, 2013–2014 ...................................................................... 234

1.2 List of Figures

Figure 1: Pharmaceutical Market, Greece, Revenue ($bn), 2007–2012 .......................................................... 22

Figure 2: Pharmaceutical Market, Greece, Revenue ($bn), Forecast, 2013–2020 .......................................... 23

Figure 3: Pharmaceutical Market, Greece, Imports and Exports ($bn), 2007–2012 ......................................... 24

Figure 4: Pharmaceutical Market, Greece, Supply Channels, 2011 ................................................................ 25

Figure 5: Pharmaceutical Market, Greece, Generic Share by Value (%), 2007–2012 ...................................... 28

Figure 6: Pharmaceutical Market, Greece, OTC Pharmaceutical Market, Revenue ($m), 2008–2012 ............. 31

Figure 7: Pharmaceutical Market, Greece, Major OTC Drug Classes, Revenue ($m), 2011 ............................ 32

Figure 8: Pharmaceutical Market, Greece, Major Therapeutic Areas, Revenue Share (%), 2008 .................... 33

Figure 9: Medical Device Market, Greece, Revenue ($m), 2007–2012 ........................................................... 80

Figure 10: Medical Device Market, Greece, Revenue ($m), Forecast, 2013–2020 .......................................... 81

Figure 11: Medical Device Market, Greece, Revenue by Segment ($m), 2013 ............................................... 82

Figure 12: Medical Device Market, Greece, In Vitro Diagnostics Market, Revenue ($m), 2007–2012 .............. 84

Figure 13: Medical Device Market, Greece, In Vitro Diagnostics Market, Sales Trend for Major Players*

($m), 2007–2011 ........................................................................................................................... 85

Figure 14: Medical Device Market, Greece, Cardiovascular Device Market, Revenue ($m), 2007–2012 ......... 86

Figure 15: Medical Device Market, Greece, Cardiovascular Device Market, Sales Trend for Major Players

($m)*, 2007–2011 ......................................................................................................................... 87



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Figure 16: Medical Device Market, Greece, Ophthalmic Device Market, Revenue ($m), 2007–2012 ............... 89

Figure 17: Medical Device Market, Greece, Ophthalmic Device Market, Sales Trend for Major Players*

($m), 2007–2011 .......................................................................................................................... 90

Figure 18: Medical Device Market, Greece, Drug Delivery Device Market, Revenue ($m), 2007–2012 ........... 91

Figure 19: Medical Device Market, Greece, Drug Delivery Device Market, Sales Trend for Major Players

($m)*, 2007–2011 ......................................................................................................................... 92

Figure 20: Medical Device Market, Greece, Diagnostic Imaging Market, Revenue ($m), 2007–2012 .............. 93

Figure 21: Medical Device Market, Greece, Diagnostic Imaging Market, Sales Trend for Major Players

($m)*, 2007–2011 ......................................................................................................................... 94

Figure 22: Medical Device Market, Greece, Diagnostics Market, Revenue ($m), 2007–2012 .......................... 95

Figure 23: Medical Device Market, Greece, Diagnostic Market, Revenue ($m), Forecast, 2013–2020 ............ 96

Figure 24: Medical Device Market, Greece, Major Medical Device Companies, Revenue ($m), 2011 ............. 97

Figure 25: Healthcare Market, Greece, Drivers and Barriers, 2013 ............................................................... 126

Figure 26: Healthcare System, Greece, Overview of Healthcare System, 2010 ............................................ 128

Figure 27: Healthcare System, Greece, Reforms in the Healthcare and Pharmaceutical Sector, 2010–2013 130

Figure 28: Healthcare System, Greece, Reforms in the Healthcare and Pharmaceutical Sector, 2012 .......... 131

Figure 29: Healthcare System, Greece, Financial and Service Flow of the Healthcare System, 2010 ........... 132

Figure 30: Healthcare Spending, Greece, Patient's Share (%), 2007–2012 .................................................. 136

Figure 31: Healthcare Consumer Price Index, Greece, Annual Change (%), 2007–2012 .............................. 137

Figure 32: Healthcare System, EU, Centralized Procedure for Market Authorization, Pre-Submission, 2013 143

Figure 33: Healthcare System, EU, Centralized Procedure, Market Authorization, Pre-Opinion Phase, 2013 145

Figure 34: Healthcare System, EU, Centralized Procedure, Market Authorization, Post-Opinion Phase,

2013 ........................................................................................................................................... 147

Figure 35: Healthcare System, EU, Decentralized Procedure, Market Authorization, 2013 ........................... 149

Figure 36: Healthcare System, EU, Mutual Recognition Procedure, Market Authorization, 2013 ................... 151



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Figure 37: Healthcare System, EU, Conformity Assessment of Class I Medical Devices, 2013 ..................... 153

Figure 38: Healthcare System, EU, Conformity Assessment of Class IIa Medical Devices, 2013 .................. 154

Figure 39: Healthcare System, EU, Conformity Assessment of Class IIb Medical Devices, 2013 .................. 155

Figure 40: Healthcare System, EU, Conformity Assessment of Class III Medical Devices, 2013 ................... 156

Figure 41: Economic Indicators, Greece, Gross Domestic Product per Capita ($’000), 2007–2012 ............... 176

Figure 42: Economic Indicators, Greece, Gross Domestic Product per Capita ($’000), Forecast, 2013–2020 177

Figure 43: Economic Indicators, Greece, Gross Domestic Product Annual Growth (%), 2007–2012 ............. 178

Figure 44: Economic Indicators, Greece, Gross Domestic Product Annual Growth (%), Forecast,

2013–2020 .................................................................................................................................. 179

Figure 45: Economic Indicators, Greece, Gross National Income per Capita ($’000), 2007–2012 ................. 180

Figure 46: Economic Indicators, Greece, Average Consumer Price Index, 2007–2012 ................................. 181

Figure 47: Economic Indicators, Greece, Average Consumer Price Index, Forecast, 2013–2020 ................. 182

Figure 48: Economic Indicators, Greece, Average Consumer Price, Annual Change (%), 2007–2012 .......... 183

Figure 49: Economic Indicators, Greece, Average Consumer Price, Annual Change (%), Forecast,

2013–2020 .................................................................................................................................. 184

Figure 50: Economic Indicators, Greece, Currency Exchange Rate (€/$), 2007–2012 .................................. 185

Figure 51: Economic Indicators, Greece, Foreign Direct Investment ($bn), 2007–2012 ................................ 186

Figure 52: Economic Indicators, Greece, Foreign Exchange Reserves ($bn), 2007–2012 ............................ 187

Figure 53: Economic Indicators, Greece, Imports of Goods and Services ($bn), 2007–2012 ........................ 188

Figure 54: Economic Indicators, Greece, Exports of Goods and Services ($bn), 2007–2012 ........................ 189

Figure 55: Economic Indicators, Greece, General Government Structural Balance ($bn), 2007–2012 .......... 190

Figure 56: Economic Indicators, Greece, General Government Net Debt ($bn), 2007–2012 ......................... 191

Figure 57: Economic Indicators, Greece, Major Industries, Gross Value Added ($bn), 2012 ......................... 192

Figure 58: Demographics, Greece, Population (million), 2007–2012 ............................................................ 194

Figure 59: Demographics, Greece, Population (million), Forecast, 2013–2020 ............................................. 195



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Figure 60: Demographics, Greece, Urban and Rural Population, Share (%), 2007–2012 .............................. 196

Figure 61: Demographics, Greece, Urban and Rural Population, Share (%), Forecast, 2013–2020 .............. 197

Figure 62: Demographics, Greece, Age Groups, Population Distribution (%), 2007–2012 ............................ 198

Figure 63: Demographics, Greece, Age Groups, Population Distribution (%), Forecast, 2013–2020 ............. 199

Figure 64: Demographics, Greece, Births (per 1,000 Population), 2007–2012 .............................................. 200

Figure 65: Demographics, Greece, Mortality (per 1,000 Population), 2007–2012 .......................................... 201

Figure 66: Demographics, Greece, Main Cause of Mortality (%), 2010 ......................................................... 202

Figure 67: Demographics, Greece, Children <5 Years, Mortality Rate (per 1,000 Live Births), 2007–2012 .... 204

Figure 68: Demographics, Greece, Immunization Rate (%), 2007–2012 ....................................................... 205

Figure 69: Demographics, Greece, Gender Ratio (M/F), 2007–2012 ............................................................ 206

Figure 70: Demographics, Greece, Life Expectancy at Birth (Years), 2007–2012 ......................................... 207

Figure 71: Demographics, Greece, Levels of Education, Student Enrollment (‘000), 2010 ............................ 209

Figure 72: Demographics, Greece, Unemployment (%), 2007–2012 ............................................................ 210

Figure 73: Demographics, Greece, Number of Persons Employed by Industry (‘000), 2011.......................... 211

Figure 74: Demographics, Greece, Hospital Patients Discharged (‘000), 2008 ............................................. 213

Figure 75: Demographics, Greece, Cause of Discharge of Male-Patients from Hospitals (‘000), 2008 .......... 214

Figure 76: Demographics, Greece, Cause of Discharge of Female Patients from Hospitals (‘000), 2008 ...... 215

Figure 77: Demographics, Greece, Major Diseases, DALYs (per 100,000 Population), 2009 ........................ 216

Figure 78: Healthcare Infrastructure, Greece, Hospitals Beds (‘000), 2007–2012 ......................................... 218

Figure 79: Healthcare Infrastructure, Greece, Diagnostic Units (per 1,000,000 Population), 2007–2012 ....... 219

Figure 80: Healthcare Infrastructure, Greece, Pharmacies (‘000), 2007–2012 .............................................. 220

Figure 81: Healthcare Infrastructure, Greece, Hospital Beds (per 1,000 Population), 2007–2012 ................. 221

Figure 82: Healthcare Infrastructure, Greece, Physicians (per 1,000 Population), 2007–2012 ...................... 222

Figure 83: Environmental Health, Greece, CO2 Emissions (Million Tons), 2007–2012 .................................. 223



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Figure 84: Environmental Health, Greece, PM10 Emissions (µgm/m3), 2007–2012 ...................................... 224

Figure 85: Healthcare Personnel, Greece, Doctors (per 1,000 Population), 2007–2012 ................................ 226

Figure 86: Healthcare Personnel, Greece, Nurses (per 1,000 Population), 2007–2012 ................................. 227

Figure 87: Healthcare Personnel, Greece, Dentists (per 1,000 Population), 2007–2012 ............................... 228

Figure 88: Healthcare Expenditure, Greece, Share of Major Components (%), 2011 .................................... 229

Figure 89: Healthcare Expenditure, Greece, Public-Private Share (%), 2007–2012 ...................................... 230

Figure 90: Health Expenditure by Sector, Greece, 2011 ............................................................................... 231

Figure 91: Opportunities and Challenges, Healthcare Market, Greece, 2013 ................................................ 237



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Introduction

2 Introduction

2.1 Report Guidance

Chapter three provides an overview of Greece’s pharmaceutical and medical device markets,

covering size; generic, Over-The-Counter (OTC) and biologic/biosimilar product shares; and

the key drivers and barriers. It also includes profiles of the major players, as well as SWOT

assessments.

Chapter four covers the reimbursement and payer landscape, and includes details of the

reimbursement process, insurance providers, pricing policies and drug price trends in Greece.

It also looks at the regulatory landscape, and gives an overview of the regulatory agencies and

approval processes for new drugs and medical devices. Also covered is the licensing process

for the manufacture, export and import of pharmaceuticals; regulations for pharmaceutical

advertising, labelling, packaging and clinical trials; and an overview of intellectual property

rights.

Chapter five provides detailed analysis of the political and economic environment in Greece,

and analyses economic indicators, demographics, and healthcare infrastructure and

expenditure.

Chapter six provides an overview of the opportunities for and challenges to growth in Greece’s

healthcare market.



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Overview of Pharmaceutical and Medical Device Markets

3.1.2 Pharmaceutical Imports and Exports

Pharmaceutical imports in Greece were valued at approximately $XX billion in 2007, but decreased

to $XX billion in 2011 and further to $XX billion in 2012. Greece mainly imports pharmaceuticals

from Germany, the UK, Netherlands, Cyprus and France. In 2007, pharmaceutical exports were

valued at approximately $XX billion, and decreased to $XX billion in 2011, where they remained in

2012. Approximately XX% of Greece’s exports were within EU countries.

Figure 3: Pharmaceutical Market, Greece, Imports and Exports ($bn), 2007–2012

2007 2008 2009 2010 2011 2012*

Year

Rev

enue

($bn

)

Imports

Exports

Source: GlobalData; ITC, 2011 *Estimated figure

Table 3: Pharmaceutical Market, Greece, Imports and Exports ($bn), 2007–2012

Year 2007 2008 2009 2010 2011 2012*

Pharmaceutical imports

Pharmaceutical exports

Source: GlobalData; ITC, 2011 *Estimated figure



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Overview of Pharmaceutical and Medical Device Markets

3.2.3 Diagnostics Market

In 2007, the diagnostics market was valued at approximately $XXm, which decreased at a negative

CAGR of XX% to $XXm in 2012. One reason for the decrease in the market is the reduced

healthcare expenditure as a result of the stringent austerity measures. It is projected to reach

$XXm by 2020 at a CAGR of XX% from 2013. The main segments driving growth are imaging

devices and IVD, which accounted for a combined share of approximately XX% in 2012, driven by

increased awareness of the early diagnosis of medical conditions and technological advances in

diagnosis techniques.

Figure 22: Medical Device Market, Greece, Diagnostics Market, Revenue ($m), 2007–2012

2007 2008 2009 2010 2011 2012Year

Rev

enue

($m

)

CAGR (2007–2012): -XX%

Source: GlobalData, Medical eTrack [accessed July 6, 2013]

Table 34: Medical Device Market, Greece, Diagnostics Market, Revenue ($m), 2007–2012

Year 2007 2008 2009 2010 2011 2012

Revenue

Source: GlobalData, Medical eTrack [accessed July 6, 2013]



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Country Analysis

5.3.7 Trade Balance

5.3.7.1 Imports of Goods and Services

In 2007, imports of goods and services amounted to approximately $XX billion, and increased

slightly to $XX billion in 2008. In 2009, they fell significantly to $XX billion and continued to decline

to $XX billion in 2010. Imports increased slightly to $XX billion in 2011, and based on data from the

World Bank is estimated to decline slightly to $XX billion in 2012 due to the global economic crisis

and the ensuing decline in domestic consumption.

Figure 53: Economic Indicators, Greece, Imports of Goods and Services ($bn), 2007–2012

2007 2008 2009 2010 2011 2012*

Year

Impo

rts ($

bn)

CAGR (2007–2012): -XX%

Source: GlobalData; The World Bank, 2013e *Estimated figure

Table 58: Economic Indicators, Greece, Imports of Goods and Services ($bn), 2007–2012

Year 2007 2008 2009 2010 2011 2012*

Imports

Source: GlobalData; The World Bank, 2013e *Estimated figure



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Country Analysis

5.6.4 Health Expenditure by Sector

The healthcare sector is financed by sources such as the government, SSFs, OOP payments,

private insurance companies, and non-profit institutions such as the church, In 2011, SSFs and

government funds accounted for approximately XX% and XX% of healthcare expenditure,

respectively. Private payments (OOP) and private insurance accounted for approximately XX% and

XX% of healthcare expenditure.

Figure 90: Health Expenditure by Sector, Greece, 2011

Greek government

funds (excluding SSFs)

SSFs

Private insurance

Private payments

Other expenditure

Source: GlobalData; EL. STAT., 2011c; EL. STAT., 2013h



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Appendix

7 Appendix

7.1 Abbreviations

AIDS: Acquired Immunodeficiency Syndrome

ATC: Anatomical Therapeutic Chemical

BMS: Bristol Myers-Squibb

CAGR: Compound Annual Growth Rate

CE: Conformité Européenne

CHMP: Committee for Medicinal Products for Human use

CMS: Concerned Member State

CNS: Central Nervous System

CO2: Carbon Dioxide

COMP: Committee for Orphan Medicinal Products

COPD: Chronic Obstructive Pulmonary Disease

CPI: Consumer Price Index

CRL: Complete Response Letter

CT: Computed Tomography

CVS: Cardiovascular System

DALY: Disability-Adjusted Life Year

DEPANOM: Public Company for Hospital Buildings (Δημόσια Επιχείρηση Ανέγερσης Νοσηλευτικών

Μονάδων)

DPT: Diphtheria, Pertussis and Tetanus

EC: European Commission

ECB: European Central Bank

EFSF: European Financial Stability Facility



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Appendix

EKEDI: Ethniko Kentro Diaviti (National Centre for Diabetes Mellitus)

EKEPSYE: Hellenic Center of Mental Health and Research

EKEVYL: Research Center for Biomaterials (Ερευνητικό Κέντρο Βιολογικών Υλικών)

EMA: European Medicines Agency

EOF: National Organisation of Medicines (Ethnikos Organismos Farmakon)

EOM: Hellenic Transplant Organization (Εθνικού Οργανισμού Μεταμοσχεύσεων)

EOPYY: National Organization for Healthcare Provision (Εζληθόο Οξγαληζκόο Παξνρήο

Τπεξεζηώλ Τγείαο)

ERT: Ellinikí Radiofonía Tileórasi (Hellenic Broadcasting Corporation)

ESDY: Ethniki Sxoli Dimosias Ygeias (National School of Public Health)

ESY: Ethniko Systima Ygeias (National Health System)

EU: European Union

FDA: Food and Drug Administration

FDI: Foreign Direct Investment

Forex: Foreign exchange

GDP: Gross Domestic Product

GLP: Good Laboratory Practice

GMP: Good Manufacturing Practice

GNI: Gross National Income

GSK: GlaxoSmithKline

HCV: Hepatitis C Virus

HIV: Human Immunodeficiency Virus

IKA: Idrima Koinonikon Asfaliseon (Social Security Institute)

IFET: Institute of Pharmaceutical Research and Technology (Ινστιτούτου Φαρμακευτικής Έρευνας

και Τεχνολογίας)



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Appendix

IMF: International Monetary Fund

IVD: In Vitro Diagnostics

IYP: Institute of Child Health (Ινστιτούτου Υγείας του Παιδιού)

KEELPNO: Hellenic Centre for Disease Control and Prevention (Κέντρο Ελέγχου και Πρόληψης

Νοσημάτων)

MA: Marketing Authorization

MAA: Marketing Authorization Application

MNC: Multinational Company

MRI: Magnetic Resonance Imaging

ND: New Democracy (Néa Dimokratía)

NME: New Molecular Entity

NSCLC: Non-Small-Cell Lung Cancer

OECD: Organization for Economic Co-operation and Development

OKANA: Organization Against Drugs (Οργανισμός Κατά των Ναρκωτικών)

OOP: Out Of Pocket

OTC: Over The Counter

PASTEUR: Hellenic Pasteur Institute

PET: Positron Emission Tomography

RMS: Reference Member State

SEYYP: Body of Inspectors for Health and Welfare Services (Σώμα Επιθεωρητών Υπηρεσιών

Υγείας και Πρόνοιας)

SFEE: Hellenic Association of Pharmaceutical Companies (Panellí̱nios Sýllogos farmakef ̱tikí ̱

orgáno ̱si ̱ epicheirí̱seo ̱n)

SPC: Summary of Product Characteristics



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Appendix

SYRIZA: Coalition of the Radical Left - Unitary Social Front (Synaspismós Rizospastikís Aristerás -

Enotikó Koinonikó Métopo)

UNPD: United Nations Population Division

VAT: Value Added Tax

WHO: World Health Organization

YYKA: Ministry of Health and Social Solidarity (Υπουργείο Υγείας και Κοινωνικής Αλληλεγγύης)

7.2 Bibliography

Abbott (2012). 2012 Annual Report. Abbott. Available from:

http://www.abbottinvestor.com/phoenix.zhtml?c=94004&p=irolproxy&cid=re_annualreprts2011

_abtleftnav_abbottinvestors. [Accessed July 4, 2013].

AESGP (2013). Market Data: Greece. Association of the European Self-Medication Industry.

Available from: http://www.aesgp.eu/facts-figures/market-data/#pharma. [Accessed July 15,

2013].

Andriciuc C (2009). Country Report for Greece. International Diabetes Federation. Available

from: http://www.idf.org/webdata/docs/idf-europe/Country%20report%20GR%20pub.pdf.

Biztradeshows (2013). Medical and pharmaceutical trade shows in Greece. Biztradeshows.

Available from: http://www.biztradeshows.com/greece/. [Accessed July 20, 2013].

CBI (2010). The pharmaceutical products market in the EU. Centre for the Promotion of

Imports (Centrum voor de Bevordering van de Import). Available from:

http://www.cbi.eu/marketinfo/cbi/docs/the_pharmaceutical_products_market_in_the_eu.

[Accessed May 20, 2013].

CIA (2013). The World Factbook. Central Intelligence Agency. Available from:

https://www.cia.gov/library/publications/the-world-factbook/fields/2116.html#top. [Accessed

May 30, 2013].



GREECE

Appendix

CMDh (2011). Decentralized procedure member states’ standard operating procedure. Co-

ordination Group for Mutual Recognition and Decentralized Procedures-Human. Available

from:

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Applica

tion_for_MA/DCP/CMDh-078-2005-Rev3-Clean_2011_09.pdf.

CMDh (2012). Recommendations on submission dates for applicants of the mutual recognition

procedure. Co-ordination Group for Mutual Recognition and Decentralized Procedures-Human.

Available from:

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Applica

tion_for_MA/MRP/CMDh_082_2012_Rev5_2012_10.pdf.

Congressional Research Service (2010a). Greece’s debt crisis: overview, policy responses,

and implications. CRS Report for Congress. Available from:

http://fpc.state.gov/documents/organization/142363.pdf.

Congressional Research Service (2010b). Frequently Asked Questions about IMF Involvement

in the Eurozone Debt Crisis. CRS Report for Congress. Available from:

http://www.fas.org/sgp/crs/row/R41239.pdf.

Deutsche Welle (2012). "Greek buy-back program helps lighten debt load", Deutsche Welle,

December 12, 2012. Available from: http://www.dw.de/greek-buy-back-program-helps-lighten-

debt-load/a-16446284. [Accessed May 30, 2013].

EBF (2012). European Banking Sector: Facts and Figures 2012. European Banking

Federation. Available from: http://www.ebf-fbe.eu/uploads/FF2012.pdf.

EC (2010a). The economic adjustment program for Greece (as of 26 May 2010). European

Commission. Available from:

http://ec.europa.eu/economy_finance/publications/occasional_paper/2010/pdf/ocp61_en.pdf.

EC (2010b). The economic adjustment program for Greece second review – autumn 2010.

European Commission. Available from:

http://ec.europa.eu/economy_finance/publications/occasional_paper/2010/pdf/ocp72_en.pdf



GREECE

Appendix

EC (2011). Greece and the euro. European Commission. Available from:

http://ec.europa.eu/economy_finance/euro/countries/greece_en.htm. [Accessed May 30, 2013].

EC (2012). Industrial Performance Scoreboard and Member States' Competitiveness

Performance and Policies. European Commission. Available from:

http://ec.europa.eu/enterprise/policies/industrial-competitiveness/monitoring-member-

states/files/ms_comp_report_2012_en.pdf.

EC (2013). Cardiovascular Diseases. European Commission. Available from:

http://ec.europa.eu/health-eu/health_problems/cardiovascular_diseases/index_en.htm.

[Accessed February 25, 2013].

EC (2013a). The Second Economic Adjustment Programme for Greece – update on progress

and challenges. European Commission. Available from:

http://ec.europa.eu/economy_finance/publications/occasional_paper/2013/pdf/presentation_el_

convergence_report_17_may_2013_en.pdf.

EC (2013b). VAT rates applied in the member states of the European Union. European

Commission. Available from:

http://ec.europa.eu/taxation_customs/resources/documents/taxation/vat/how_vat_works/rates/v

at_rates_en.pdf.

Economou C (2010). Greece: Health system review. Health Systems in Transition; 12(7): 1–

180.

EFGCP (2012). The EFGCP Report on The Procedure for the Ethical Review of Protocols for

Clinical Research Projects in Europe and Beyond. European Forum for Good Clinical Practice

(EFGCP). Available from:

http://www.efgcp.eu/Downloads/EFGCPReportFiles/EFGCP%20ECs%20Report%202012%20-

%20Question%2003%20Updated.pdf.

EFPIA (2009). The Pharmaceutical Industry in Figures. European Federation of

Pharmaceutical Industries and Associations (EFPIA). Available from:

http://www.efpia.eu/uploads/Modules/Documents/figures_2011_final-20110610-014-en-v1.pdf.



GREECE

Appendix

EFPIA (2012). The Pharmaceutical Industry in Figures. European Federation of

Pharmaceutical Industries and Associations (EFPIA). Available from:

http://www.efpia.eu/uploads/Modules/Documents/efpia_figures_2012_final-20120622-003-en-

v1.pdf.

EFSF (2013a). Frequently asked questions. Available from:

http://www.efsf.europa.eu/attachments/EFSF%20FAQ%2015052013.pdf.

EFSF (2013b). Lending Operations. European Financial Stability Facility. Available from:

http://www.efsf.europa.eu/about/operations/index.htm. [Accessed May 31, 2013].

Ekathimerini (2013a). "Council of State president to be new caretaker PM [UPDATE]",

Ekathimerini, May 16, 2012. Available from:

http://ekathimerini.com/4dcgi/_w_articles_wsite1_1_16/05/2012_442401. [Accessed June 12,

2013].

Ekathimerini (2013b). "PM gambles on closure of state broadcaster ERT", Ekathimerini, June

11, 2013. Available from:

http://www.ekathimerini.com/4dcgi/_w_articles_wsite1_1_11/06/2013_503960. [Accessed July

12, 2013].

Ekathimerini (2013c). "Greece coalition partner pulls out ministers in wake of ERT debacle

[update]", Ekathimerini, June 21, 2013. Available from:

http://www.ekathimerini.com/4dcgi/_w_articles_wsite1_1_21/06/2013_505319.[Accessed July

12, 2013].

Ekathimerini (2013d). "PM hails choice of TAP as 'putting Greece on pipeline map' [UPDATE]",

Ekathimerini, June 28, 2013. Available from:

http://www.ekathimerini.com/4dcgi/_w_articles_wsite2_1_28/06/2013_506302. [Accessed July

12, 2013].

EL. STAT. (2010a). Statistical Themes: Deaths - Absolute numbers and rates (Years 1932-

2010). Hellenic Statistical Authority. Available from:

http://www.statistics.gr/portal/page/portal/ESYE/PAGE-

themes?p_param=A1605&r_param=SPO09&y_param=2010_00&mytabs=0. [Accessed May

16, 2013].



GREECE

Appendix

EL. STAT (2010b). Statistical Themes: Deaths in Greece by age and cause (Years 2000-




16, 2013].

EL. STAT (2010c). Statistical Themes: Education. Available from:

http://www.statistics.gr/portal/page/portal/ESYE/PAGE-themes?p_param=A1401. [Accessed

May 16, 2013].

EL. STAT (2010d). Statistical Themes: Public Health. Available from:


themes?p_param=A2103&r_param=SHE12&y_param=2008_00&mytabs=0. [Accessed May

18, 2013].

EL. STAT (2011a). Statistical Themes: Population projections-Total population (Years 2007-




16, 2013].

EL. STAT (2011b). Statistical Themes: Population projections - Assumptions (Years 2007-




16, 2013].

EL. STAT (2011c). Health Expenditures –System of Health Accounts 2009-2011 (Preliminary

estimates). Available from:

http://www.statistics.gr/portal/page/portal/ESYE/BUCKET/A2103/PressReleases/A2103_SHE3

5_DT_AN_00_2011_01_F_EN.pdf. [Accessed on June 5, 2013].

EL. STAT (2012). Greece in figures, 2012. Available from:

http://www.statistics.gr/portal/page/portal/ESYE/BUCKET/General/ELLAS_IN_NUMBERS_EN.

pdf. [Accessed May 27, 2013].



GREECE

Appendix

EL. STAT (2013a). Statistics Themes: Inflation-Consumer Price Index (CPI) -National Index-

Cum., 2012. Hellenic Statistical Authority. Available from:


themes?p_param=A1701&r_param=DKT87&y_param=2012_00&mytabs=0.[Accessed June

20, 2013].

EL. STAT (2013b). Statistical Themes: Main Aggregates (Per Capita figures) - 2012. Hellenic

Statistical Authority. Available from: http://www.statistics.gr/portal/page/portal/ESYE/PAGE-

themes?p_param=A0702&r_param=SEL33&y_param=2012_00&mytabs=0. [Accessed May

22, 2013].

EL. STAT (2013c). Statistical Themes: Annual national accounts: Gross value added by

Industry - 2012. Hellenic Statistical Authority. Available from:


themes?p_param=A0702&r_param=SEL12&y_param=2012_00&mytabs=0. [Accessed May

27, 2013].

EL. STAT (2013d). Statistical Themes: Public health > Hospitals and local health centres

(beds, staff, equipment). Hellenic Statistical Authority. Available from:

http://www.statistics.gr/portal/page/portal/ESYE/PAGE-themes?p_param=A2103. [Accessed

May 16, 2013].

EL. STAT (2013e). Statistical Themes: Public health > Hospitals and local health centres

(beds, staff, equipment). Hellenic Statistical Authority. Available from:


themes?p_param=A2103&breadcrump_parameter=SHE06. [Accessed May 6, 2013].

EL. STAT (2013f). Statistical Themes: Public health > Doctors and dentists. Hellenic Statistical

Authority. Available from: http://www.statistics.gr/portal/page/portal/ESYE/PAGE-

themes?p_param=A2103&breadcrump_parameter=SHE09. [Accessed on June 5, 2013].

EL. STAT (2013g). Statistical Themes: Environmental Accounts > NAMEA - Air Emissions.

Hellenic Statistical Authority. Available from:


themes?p_param=A1502&r_param=SOP08&y_param=2009_00&mytabs=0. [Accessed June

6, 2013].



GREECE

Appendix

EL. STAT (2013h). Public health > System of Health Accounts - 2011. Hellenic Statistical

Authority. Available from:

http://www.statistics.gr/portal/page/portal/ESYE/BUCKET/A2103/PressReleases/A2103_SHE3

5_DT_AN_00_2011_01_F_EN.pdf.

EMA (2012). Centralized procedure. European Medicines Agency. Available from:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_lis

ting_000278.jsp&mid=WC0b01ac05800b5ca1. [Accessed June 18, 2013].

EOF (2013a). Organization-Information. National Organisation for Medicines. Available from:

http://www.eof.gr/web/guest/organization;jsessionid=d868da71f46c6e97aaa6c63ea2f8.

[Accessed July 1, 2013].

EOF (2013b). Organization-Information. National Organisation for Medicines. Available from:

http://www.eof.gr/web/guest/structure. [Accessed July 1, 2013].

EOF (2013c). Organization-Information. National Organisation for Medicines. Available from:

http://www.eof.gr/assets/Checklist_new_application_final.doc. [Accessed July 1, 2013].

EOF (2013d). Inspections: Procedures for granting licenses, certificates, etc. and change

declaration: Required documents A. Medicinal Products for Human Use. National Organisation

for Medicines. Available from:

http://www.eof.gr/web/guest/various?p_p_id=62_INSTANCE_QbU6&p_p_lifecycle=0&p_p_stat

e=maximized&p_p_mode=view&p_p_col_id=column-

1&p_p_col_count=1&_62_INSTANCE_QbU6_struts_action=%2Fjournal_articles%2Fview&_62

_INSTANCE_QbU6_groupId=12225&_62_INSTANCE_QbU6_articleId=16809&_62_INSTANC

E_QbU6_version=1.0. [Accessed July 1, 2013].

EPO (2013). EU unitary patent. European Patent Office. Available from:

http://www.epo.org/law-practice/unitary/unitary-patent.html. [Accessed July 20, 2013].

GaBI (2012). European uptake of biosimilars. Generics and Biosimilars Initiative. Available

from: http://gabionline.net/layout/set/print/content/view/full/2085. [Accessed July 12, 2013].

GSK (2012). 2012 Annual Report. GSK. Available from:

http://www.gsk.com/content/dam/gsk/globals/documents/pdf/GSK-Annual-Report-2012.pdf.



GREECE

Appendix

IKA (2013). IKA: Overview. Social Insurance Institute. Available from:

http://www.ika.gr/en/home.cfm. [Accessed June 21, 2013].

IMF (2013). World Economic Outlook Database [database], April 2013. Available from:

http://www.imf.org/external/pubs/ft/weo/2013/01/weodata/download.aspx. [Accessed May 22,

2013].

IOBE (2009). Annual Report 2009: Greek Pharmaceutical Market. IOBE. Available from:

http://www.sfee.gr/files/story/The_Pharmaceutical_Market_in_Greece_Annual_Report_Executi

ve%20Summary_2009.pdf.

ISPOR (2008). Greece -Reimbursement Process. International Society for

Pharmacoeconomics and Outcomes Research. Available from:

http://www.ispor.org/htaroadmaps/Greece.asp. [Accessed June 21, 2013].

ITC (2011). Trade Performance HS: Exports and imports of Greece - 30 Pharmaceutical

products (2011, in USD thousands). International Trade Centre (ITC). Available from:

http://legacy.intracen.org/appli1/TradeCom/TP_TP_CI_HS4.aspx?IN=30&RP=300&YR=2011&

TY=T. [Accessed July 10, 2013].

Kanellopoulos CN and Gregou M (2006). Managed Migration and the Labour Market – The

HEALTH SECTOR, May 2006. European Migration Network. Available from:

http://emn.intrasoft-intl.com/Downloads/prepareShowFiles.do?directoryID=71. [Accessed June

10, 2013].

Krikos Zois (2013). About IMD. Krikos Zois. Available from:

http://www.krikoszois.gr/en/AboutMD. [Accessed June 23, 2013].

Lojsch HD, et al. (2011). The size and composition of government debt in the Euro area.

Occasional Paper Series, 132, October 2011. European Central Bank. Available from:

http://www.ecb.europa.eu/pub/pdf/scpops/ecbocp132.pdf.

McMahon A (2012). The potential benefits of a traceability solution for surgical trays in the Irish

Health Service. Available from: https://www.cs.tcd.ie/postgraduate/health-

informatics/assets/pdfs/Alana%20McMahon_MSc%20Health%20Informatics%202012.pdf



GREECE

Appendix

Medtronic (2012). 2012 Annual Report. Medtronic. Available from:

http://www.medtronic.com/wcm/groups/mdtcom_sg/@mdt/@corp/documents/documents/ar12_

annual_report_final.pdf

Ministry of Finance (2011). MEDIUM TERM FISCAL STRATEGY 2012-2015. Ministry of

Finance. Available from: http://www.minfin.gr/content-

api/f/binaryChannel/minfin/datastore/8d/78/0e/8d780e3337a1e1cb20d1a1707686d7399be4913

a/application/pdf/MTFS.pdf.

Ministry of Foreign Affairs (2013). Government and Politics. Ministry of Foreign Affairs.

Available from: http://www.mfa.gr/usa/en/about-greece/government-and-politics/. [Accessed

June 11, 2013].

Ministry of Health (2013). National Action Plans. Ministry of Health. Available from:

http://www.moh.gov.gr/articles/health/domes-kai-draseis-gia-thn-ygeia/ethnika-sxedia-

drashs/95-ethnika-sxedia-drashs. [Accessed June 11, 2013].

Natz A (2012). Pharmaceutical pricing: Impact of the Greek pricing decisions on other Member

States and the Transparency Directive. Boussias Conferences. European Confederation of

Pharmaceutical Entrepreneurs. Available from:

http://healthcareconference.boussiasconferences.gr/files/_presscorner/_2012/dr_alexander_na

tz_FT_healthcare_in_greece.pdf.

Novartis (2012). Annual Report 2012. Novartis. Available from:

http://www.novartis.com/newsroom/corporate-publications/annual-report-2012.shtml.

[Accessed June 20, 2013].

OANDA (2012). Historical exchange rates. OANDA. Available from:

http://www.oanda.com/currency/historical-rates/. [Accessed January 18, 2013].

OBI (2008). OBI Presentation. OBI. Available from:

http://www.obi.gr/OBI/Portals/0/ImagesAndFiles/vm2/OBI_PROFILE_2008.pdf.

OBI (2013). FAQs: Patents and Utility Models. OBI. Available from:

http://www.obi.gr/obi/Default.aspx?tabid=266. [Accessed June 25, 2013].

OECD (2011a). Health at a Glance 2011: OECD Indicators. Organisation for Economic Co-

operation and Development. Available from: http://www.oecd.org/health/49716427.pdf.



GREECE

Appendix

OECD (2011b). Health at a Glance 2011: OECD Family Database. Organisation for Economic

Co-operation and Development. Available from:

http://www.oecd.org/els/family/CO1.2%20Life%20expectancy%20at%20birth%20-

%20updated%20081212.pdf

OECD (2011c), Health at a Glance 2011(Nurses): OECD Indicators. Organisation for

Economic Co-operation and Development. Available from:

http://dx.doi.org/10.1787/health_glance-2011-26-en. [Accessed June 12, 2013].

OECD (2012a). Obesity update 2012. Organisation for Economic Co-operation and

Development. Available from: http://www.oecd.org/health/49716427.pdf.

OECD (2012b). Health: Hospital beds Density per 1000 population. Organisation for Economic

Co-operation and Development. Available from: http://www.oecd-ilibrary.org/social-issues-

migration-health/hospital-beds_20758480-table5. [Accessed June 5, 2013].

OECD (2012c). OECD Health Data 2012 -Frequently Requested Data. Organisation for

Economic Co-operation and Development. Available from: http://www.oecd.org/els/health-

systems/oecdhealthdata2012-frequentlyrequesteddata.htm. [Accessed June 5, 2013].

Pfizer (2012). Appendix A 2012 Financial Report. Pfizer. Available from:

http://www.pfizer.com/files/annualreport/2012/financial/financial2012.pdf

Roche (2012). Annual Report. Roche. Available from:

http://www.roche.com/investors/annual_reports.htm [Accessed on July 4, 2013].

Sanofi (2013). Form 20-F. Sanofi. Available from: http://en.sanofi.com/Images/31972_20-

F_2012.pdf.

SFEE (2012). The Pharmaceutical Market in Greece: Facts & Figures 2012. Hellenic

Association of Pharmaceutical Companies. Available from:

http://www.sfee.gr/files/story/Facts%20%20Figures_Brochure_ENG_F_FINAL_17-4.pdf.

SFEE (2013a). Pharmaceutical Legislation: Ministerial Decision. DYG3A/oik.7789. Hellenic

Association of Pharmaceutical Companies. Available from:

http://www.sfee.gr/files/story/NEW_Ministerial%20Decision_Pricing_DYG3_a_oik%2097018_2

012.pdf.



GREECE

Appendix

SFEE (2013b). Translation of the Ministerial Decision No. DYG3a/G.P. 85037/10 entitled:

"Terms, conditions and procedure for granting temporary approval for early access to

medicines for human use (“compassionate use”)". Hellenic Association of Pharmaceutical

Companies. Available from: http://www.sfee.gr/en/node/7675. [Accessed July 1, 2013].

SFEE (2013c). Code of Ethics. Hellenic Association of Pharmaceutical Companies. Available

from: http://www.sfee.gr/en/node/2717. [Accessed June 9, 2013].

Stanger O, et al. (2009). Homocysteine, folate and vitamin B12 in neuropsychiatric diseases:

review and treatment recommendations. Expert Reviews in Neurotherapy; 9(9): 1393–1412.

Taylor L (2010). “Greek firms blame govt as drug access reaches breaking point”,

Pharmatimes, December 21, 2010. Available from: http://www.pharmatimes.com/Article/13-03-

12/Greek_firms_blame_govt_as_drug_access_reaches_breaking_point.aspx. [Accessed June

24, 2013].

Taylor L (2012). “Greece: drops pharma clawback plan", Pharmatimes, October 19, 2012.

Available from: http://www.pharmatimes.com/article/12-10-

19/Greece_drops_pharma_clawback_plan.aspx. [Accessed June 24, 2013].

Transparency International (2012). Money, politics, power: corruption risks in Europe.

Transparency International. Available from:

http://www.transparency.org/whatwedo/pub/money_politics_and_power_corruption_risks_in_e

urope. [Accessed July 13, 2013].

The World Bank (2013a). Out-of-pocket health expenditure (% of total expenditure on health).

The World Bank. Available from: http://data.worldbank.org/indicator/SH.XPD.OOPC.TO.ZS.

[Accessed May 16, 2013].

The World Bank (2013b). Gross domestic product 2011. Available from:

http://databank.worldbank.org/databank/download/GDP.pdf. [Accessed May 30, 2013].

The World Bank (2013c). Foreign direct investment, net inflows (BoP, current US$). The World

Bank. Available from: http://data.worldbank.org/indicator/BX.KLT.DINV.CD.WD. [Accessed

May 27, 2013].



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The World Bank (2013d). Total reserves (includes gold, current US$). The World Bank.

Available from: http://data.worldbank.org/indicator/FI.RES.TOTL.CD. [Accessed on May 27th,

2013].

The World Bank (2013e). Imports of goods and services (BoP, current US$). The World Bank.

Available from: http://data.worldbank.org/indicator/BM.GSR.GNFS.CD. [Accessed May 27,

2013].

The World Bank (2013f). Exports of goods and services (current US$). The World Bank.

Available from: http://data.worldbank.org/indicator/NE.EXP.GNFS.CD. [Accessed May 27,

2013].

The World Bank (2013g). Urban population (% of total). The World Bank. Available from:

http://data.worldbank.org/indicator/SP.URB.TOTL.IN.ZS. [Accessed May 16, 2013].

The World Bank (2013h). Birth rate, crude (per 1,000 people). The World Bank. Available from:

http://data.worldbank.org/indicator/SP.DYN.CBRT.IN. [Accessed May 16, 2013].

The World Bank (2013i). Death rate, crude (per 1,000 people). The World Bank. Available

from: http://data.worldbank.org/indicator/SP.DYN.CDRT.IN. [Accessed May 16, 2013].

The World Bank (2013j). Maternal mortality ratio (modeled estimate, per 100,000 live births).

The World Bank. Available from: http://data.worldbank.org/indicator/SH.STA.MMRT. [Accessed

May 16, 2013].

The World Bank (2013k). Mortality rate, under-5 (per 1,000 live births). The World Bank.

Available from: http://data.worldbank.org/indicator/SH.DYN.MORT. [Accessed May 16, 2013].

The World Bank (2013l). Immunization, measles (% of children ages 12-23 months). The World

Bank. Available from: http://data.worldbank.org/indicator/SH.IMM.MEAS. [Accessed May 16,

2013].

The World Bank (2013m). Unemployment, total (% of total labor force). The World Bank.

Available from: http://data.worldbank.org/indicator/SL.UEM.TOTL.ZS. [Accessed May 16,

2013].

The World Bank (2013n). PM10, country level (micrograms per cubic meter). The World Bank.

Available from: http://data.worldbank.org/indicator/EN.ATM.PM10.MC.M3. [Accessed June 4,

2013].



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The World Bank (2013o). Health expenditure, public (% of total health expenditure). The World

Bank. Available from: http://data.worldbank.org/indicator/SH.XPD.PUBL. [Accessed June 4,

2013].

The World Bank (2013p). Central government debt, total (% of GDP). The World Bank.

Available from: http://data.worldbank.org/indicator/GC.DOD.TOTL.GD.ZS. [Accessed on May

22, 2013].

US Census Bureau (2013). Mid-year Population by Five Year Age Groups and Sex - Custom

Region - Greece. United States Census Bureau. Available from:

http://www.census.gov/population/international/data/idb/region.php?N=%20Results%20&T=10

&A=separate&RT=0&Y=2007,2008,2009,2010,2011,2012,2013,2014,2015,2016,2017,2018,20

19,2020&R=-1&C=GR. [Accessed May 16, 2013].

Vardica A and Kontozamanis V (2007). Pharmaceutical Pricing and Reimbursement

Information-Greece Pharma Profile June 2007.Gesundheit Österreich GmbH,

Geschäftsbereich ÖBIG/ WHO Regional Office for Europe. Available from:

https://ppri.goeg.at/Downloads/Results/Greece_PPRI_2007.pdf.

WHO (2009). Global burden of disease. World Health Organization. Available from:

http://www.who.int/healthinfo/global_burden_disease/en/. [Accessed January 13, 2013].

WHO (2011). Global Atlas on cardiovascular disease prevention and control. World Health

Organisation. Available from:

http://whqlibdoc.who.int/publications/2011/9789241564373_eng.pdf.

WIPO (2013). Greece Law No. 2239/1994 on Trademarks. World Intellectual Property

Organization. Available from: http://www.wipo.int/wipolex/en/text.jsp?file_id=127593.

[Accessed June 20, 2013].



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7.3 Methodology

GlobalData’s dedicated research and analysis teams consist of experienced professionals with

advanced statistical expertise and marketing, market research and consulting backgrounds in the

pharmaceutical industry.

GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and

the Strategic and Competitive Intelligence Professionals (www.scip.org).

All GlobalData databases are continuously updated and revised. The following research

methodology is followed for all databases and reports.

7.3.1 Coverage

The objective of updating GlobalData’s coverage is to ensure that it represents the most up to date

vision of the industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company,

association and competitor sources.

Company coverage is based on three key factors: revenue, products and media

attention/innovation/market potential.

The estimated revenue of all major companies, including private and governmental, are

gathered and used to prioritize coverage.

Companies which are making the news or which are of particular interest due to their

innovative approach are prioritized.

GlobalData aims to cover all major news events and deals in the pharmaceutical industry, updated

on a daily basis.

The coverage is further streamlined and strengthened with additional inputs from GlobalData’s

expert panel (see below).



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7.3.2 Secondary Research

The research process begins with exhaustive secondary research on internal and external sources

being carried out to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and

US Securities and Exchanges Commission (SEC) filings

Industry trade journals, scientific journals and other technical literature

Internal proprietary databases

Relevant patent and regulatory databases

National government documents, statistical databases and market reports

Procedure registries

News articles, press releases and web-casts specific to the companies operating in the market.

The country reports are largely based on secondary research and make use of reliable and

authoritative sources such as the IMF, the World Bank, OECD, WHO, UNICEF, UNStats, MHLW,

NHS, and BEA, among others.

7.3.3 Forecasting

For the country reports, GlobalData uses the data available from reliable and authoritative

secondary sources to forecast the future trends for the healthcare market for the country, as well as

the parameters related to the economy and healthcare infrastructure and expenditure of the

country. The trends are further validated through the secondary sources.

7.3.4 Expert Panel Validation

GlobalData uses a panel of experts to cross verify its databases and forecasts.

GlobalData’s expert panel comprises marketing managers, product specialists, international sales

managers from pharmaceutical companies; academics from research universities, consultants from

venture capital funds, and distributors/suppliers of pharmaceuticals and supplies.

Historic data and forecasts are relayed to GlobalData’s expert panel for feedback and adjusted in

accordance with their feedback.



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7.4 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any

form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior

permission of the publisher, GlobalData.