HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – SPAIN · reference code gdhc0076chr |...
Transcript of HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – SPAIN · reference code gdhc0076chr |...
REFERENCE CODE GDHC0076CHR | PUBLICATION DATE FEBRUARY 2015
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –
SPAIN
Healthcare, Regulatory and Reimbursement Landscape – Spain 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – SPAIN
Executive Summary
The implementation of austerity measures by the Spanish government has negated the effect of drivers such as the increasingly elderly population and free healthcare services, resulting in a decline in the pharmaceutical market.
In 2013, the percentage of elderly in the population
was XX%, and this is expected to reach XX% by
2020 (INE, 2014d). Despite the rise in the elderly
population and the provision of free healthcare, the
Spanish pharmaceutical market has been declining
since 2008 due to the implementation of austerity
measures, such as the promotion of generics and
new pricing policies (BOE, 2011; BOE, 2012a).
In 2011 and 2012, new pricing policies were
implemented such that manufacturers had to price
their product lower than the reference price. The
reference prices for pharmaceutical products in
Spain are based on the indication, rather than the
active molecule. Additionally, the government’s
policy for the promotion of generics mandates that
pharmacists should dispense the cheapest
available drugs (BOE, 2011; BOE, 2012a).
In 2008, the pharmaceutical market was valued at
approximately $XX billion. This declined to $XX
billion in 2013 at a negative Compound Annual
Growth Rate (CAGR) of XX% (in US dollar terms).
It is expected to continue this decline, at a negative
CAGR of XX% during the 2014–2020 period, to
reach an estimated $XX billion by 2020 (AESGP,
2011; AESGP, 2014a).
Pharmaceutical Market, Spain, Revenue ($bn), 2008–2020
2008 2013 2015 2020R
even
ue (
$bn)
CAGR (2008–2020): XX%
Source: AESGP, 2011; AESGP, 2014a
The medical device market was worth
approximately $XX billion in 2008, and increased
to approximately $XX billion by 2013 at a CAGR of
XX%. It is expected to reach $XX billion by 2020.
In 2013, the In Vitro Diagnostics (IVD) and diabetic
care device segments were the largest contributors
to the market, with shares of XX% and XX%
respectively. Other segments with significant
shares were orthopedic devices (XX%),
cardiovascular devices (XX%) and ophthalmic
devices (XX%).
Healthcare, Regulatory and Reimbursement Landscape – Spain 6 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – SPAIN
1 Table of Contents
1 Table of Contents ....................................................................................................................... 6
1.1 List of Tables .................................................................................................................... 10
1.2 List of Figures ................................................................................................................... 15
2 Introduction ............................................................................................................................... 20
2.1 GlobalData Report Guidance ............................................................................................ 20
3 Overview of the Pharmaceutical and Medical Device Markets .................................................. 21
3.1 Pharmaceutical Market ..................................................................................................... 21
3.1.1 Market Overview ........................................................................................................... 21
3.1.2 Pharmaceutical Exports and Imports ............................................................................. 24
3.1.3 Supply Channels ........................................................................................................... 25
3.1.4 Market Segments .......................................................................................................... 27
3.1.5 Overview of Top Five Disease Areas ............................................................................ 33
3.1.6 Major Players ................................................................................................................ 35
3.2 Medical Device Market ...................................................................................................... 78
3.2.1 Market Overview ........................................................................................................... 78
3.2.2 Overview of Top Five Segments.................................................................................... 80
3.2.3 Diagnostic Market ......................................................................................................... 94
3.2.4 Major Players ................................................................................................................ 96
3.3 Market Drivers and Barriers ............................................................................................ 131
3.3.1 Drivers......................................................................................................................... 131
3.3.2 Barriers ....................................................................................................................... 132
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – SPAIN
4 Market Access ........................................................................................................................ 134
4.1 Reimbursement and Payer Landscape ........................................................................... 134
4.1.1 Overview of Healthcare System .................................................................................. 134
4.1.2 Reimbursement Process ............................................................................................. 137
4.1.3 Overview of Insurance Providers ................................................................................. 141
4.1.4 Patient Share in Healthcare Spending ......................................................................... 143
4.1.5 Price Trend in Healthcare Services ............................................................................. 144
4.1.6 Pricing Policies ............................................................................................................ 145
4.2 Regulatory Landscape .................................................................................................... 148
4.2.1 Overview of Regulatory Agencies................................................................................ 148
4.2.2 Market Authorization Procedure for Pharmaceutical Products ..................................... 150
4.2.3 Market Authorization Procedure for Medical Devices .................................................. 166
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing .................. 171
4.2.5 Licensing Process for Pharmaceutical Exports and Imports ........................................ 174
4.2.6 Intellectual Property Rights.......................................................................................... 176
4.2.7 Clinical Trial Regulations ............................................................................................. 181
4.2.8 Pharmaceutical Advertising Regulations ..................................................................... 183
4.2.9 Pharmacy Regulations ................................................................................................ 188
4.2.10 Labeling and Packaging Regulations .......................................................................... 189
5 Country Analysis ..................................................................................................................... 192
5.1 Political Environment....................................................................................................... 192
5.1.1 Political Structure ........................................................................................................ 192
5.1.2 Analysis of the Current Political Environment .............................................................. 193
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5.1.3 Healthcare Policy Initiatives ......................................................................................... 195
5.2 Economic Landscape ...................................................................................................... 197
5.3 Economic Indicators ........................................................................................................ 201
5.3.1 Gross Domestic Product ............................................................................................. 201
5.3.2 Gross National Income ................................................................................................ 206
5.3.3 Inflation ....................................................................................................................... 207
5.3.4 Currency Exchange Rate ............................................................................................ 210
5.3.5 Foreign Direct Investment ........................................................................................... 211
5.3.6 Foreign Exchange Reserves ....................................................................................... 212
5.3.7 Trade Balance ............................................................................................................. 213
5.3.8 General Government Structural Balance ..................................................................... 215
5.3.9 General Government Net Debt .................................................................................... 216
5.3.10 Major Industries ........................................................................................................... 218
5.4 Demographics ................................................................................................................. 219
5.4.1 Population ................................................................................................................... 219
5.4.2 Education and Literacy ................................................................................................ 237
5.4.3 Employment ................................................................................................................ 241
5.4.4 Disease Burden ........................................................................................................... 242
5.5 Healthcare Infrastructure ................................................................................................. 245
5.5.1 Healthcare Facilities .................................................................................................... 245
5.5.2 Healthcare Parameters ............................................................................................... 250
5.5.3 Environmental Health .................................................................................................. 254
5.5.4 Healthcare Personnel .................................................................................................. 257
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5.6 Healthcare Expenditure ................................................................................................... 260
5.6.1 Overview ..................................................................................................................... 260
5.6.2 Major Components of Healthcare Spending ................................................................ 261
5.6.3 Public and Private Sector Share .................................................................................. 262
5.6.4 Spending in Healthcare, R&D ...................................................................................... 264
5.7 Trade Associations ......................................................................................................... 265
5.7.1 Farmaindustria ............................................................................................................ 265
5.7.2 The Spanish Society of Public Health and Health Services Administration .................. 265
5.7.3 The Spanish Society of Health Informatics .................................................................. 266
5.7.4 Spanish Generic Medicines Association ...................................................................... 266
5.8 Trade Fairs ..................................................................................................................... 267
6 Opportunities and Challenges ................................................................................................. 268
6.1 Opportunities .................................................................................................................. 268
6.2 Challenges ...................................................................................................................... 269
7 Appendix................................................................................................................................. 271
7.1 Abbreviations .................................................................................................................. 271
7.2 Bibliography .................................................................................................................... 276
7.3 Research Methodology ................................................................................................... 294
7.3.1 Coverage .................................................................................................................... 294
7.3.2 Secondary Research ................................................................................................... 295
7.3.3 Forecasts .................................................................................................................... 295
7.3.4 Expert Panel................................................................................................................ 296
7.4 Disclaimer ....................................................................................................................... 296
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – SPAIN
1.1 List of Tables
Table 1: Pharmaceutical Market, Spain, Revenue ($bn), 2008–2013 ........................................................... 22
Table 2: Pharmaceutical Market, Spain, Revenue Forecast ($bn), 2014–2020 ............................................. 23
Table 3: Pharmaceutical Market, Spain, Pharmaceutical Exports and Imports ($bn), 2008–2013 ................. 25
Table 4: Pharmaceutical Market, Spain, Pharmaceutical Mark-Ups, 2014 .................................................... 26
Table 5: Pharmaceutical Market, Spain, Generics Market, Drug Consumption by Volume (%), 2008–2013 .. 28
Table 6: Pharmaceutical Market, Spain, Red Biotechnology, Share of Diagnostics Pipeline by Disease Area
(%), 2014 ....................................................................................................................................... 30
Table 7: Pharmaceutical Market, Spain, Red Biotechnology, Share of Therapeutics Pipeline by Disease Area
(%), 2014 ....................................................................................................................................... 32
Table 8: Over the Counter Pharmaceutical Market, Spain, Share by Segment (%), 2011 ............................. 33
Table 9: Pharmaceutical Market, Spain, Top Five Therapeutic Areas by Share of Drug Consumption (%),
2013 .............................................................................................................................................. 34
Table 10: Pharmaceutical Market, Pfizer, Major Products, Revenue ($bn) and Annual Growth (%), 2013 ....... 36
Table 11: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2014 .................................................. 37
Table 12: Pharmaceutical Market, Roche, Global, Major Products, Revenue ($bn) and Annual Growth (%),
2013 .............................................................................................................................................. 45
Table 13: Pharmaceutical Market, Roche, Global, Late-stage Pipeline, 2014 ................................................. 46
Table 14: Pharmaceutical Market, Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%),
2013 .............................................................................................................................................. 54
Table 15: Pharmaceutical Market, Novartis, Global, Planned Filings, 2014≥2018 ........................................... 55
Table 16: Pharmaceutical Market, Sanofi, Global, Major Products, Revenue ($bn), 2013 ............................... 64
Table 17: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, 2014 ................................................. 65
Table 18: Pharmaceutical Market, GlaxoSmithKline, Global, Major Products, Revenue ($bn) and Annual
Growth (%), 2013 ........................................................................................................................... 70
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Table 19: Pharmaceutical Market, GlaxoSmithKline, Global, Late-Stage Pipeline, 2014 ................................. 71
Table 20: Medical Device Market, Spain, Revenue ($bn), 2008–2013 ............................................................ 78
Table 21: Medical Device Market, Spain, Revenue Forecast ($bn), 2014–2020 ............................................. 79
Table 22: Medical Device Market, Spain, Top Five Segments, Revenue ($m) and Market Share (%), 2013 ... 81
Table 23: Medical Device Market, Spain, In Vitro Diagnostics Revenue ($m), 2008–2013 .............................. 82
Table 24: Medical Device Market, Spain, In Vitro Diagnostics, Sales Trend for Major Players, 2012 ............... 83
Table 25: Medical Device Market, Spain, Diabetes Care Devices Revenue ($m), 2008–2013 ........................ 85
Table 26: Medical Device Market, Spain, Diabetes Care Devices, Sales Trend for Major Players, 2012 ......... 86
Table 27: Medical Device Market, Spain, Orthopedic Devices Revenue ($m), 2008–2013 ............................. 87
Table 28: Medical Device Market, Spain, Orthopedic Devices, Sales Trend for Major Players, 2012 .............. 88
Table 29: Medical Device Market, Spain, Cardiovascular Devices Market ($m), 2008–2013 ........................... 90
Table 30: Medical Device Market, Spain, Cardiovascular Devices Market, Sales Trend for Major Players, 2012
...................................................................................................................................................... 91
Table 31: Medical Device Market, Spain, Ophthalmic Devices Revenue ($m), 2008–2013 ............................. 92
Table 32: Medical Device Market, Spain, Ophthalmic Devices, Sales Trend for Major Players, 2012 .............. 93
Table 33: Medical Device Market, Spain, Diagnostic Market, Revenue ($bn), 2008–2013 .............................. 94
Table 34: Medical Device Market, Spain, Diagnostic Market, Revenue Forecast ($bn), 2014–2020................ 95
Table 35: Medical Device Market, Spain, Major Medical Device Companies Revenue, 2012 .......................... 96
Table 36: Medical Device Market, Roche, Global, Major Products, 2014 ...................................................... 103
Table 37: Medical Device Market, Medtronic, Global, Major Products, 2013 ................................................. 110
Table 38: Medical Device Market, Abbott, Global, Major Products, 2014 ...................................................... 117
Table 39: Medical Device Market, Abbott, Global, Late-Stage Pipeline, 2014 ............................................... 118
Table 40: Healthcare System, Spain, Pharmaceutical Reimbursement Categories, 2014 ............................. 138
Table 41: Healthcare Spending, Spain, Out-of-Pocket Expenditure (%), 2008–2013 .................................... 143
Table 42: Market Access, Spain, Change in Average Price of Healthcare Services (%), 2008–2013 ............ 144
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Table 43: Pricing Policies, Spain, Wholesaler and Pharmacist Margin on Drug Price, 2010 .......................... 148
Table 44: Economic Indicators, Spain, Gross Domestic Product per Capita ($), 2008–2013 ......................... 202
Table 45: Economic Indicators, Spain, Gross Domestic Product per Capita Forecast ($), 2014–2020 .......... 203
Table 46: Economic Indicators, Spain, Gross Domestic Product Annual Growth (%), 2008–2013 ................. 204
Table 47: Economic Indicators, Spain, Gross Domestic Product Annual Growth Forecast (%), 2014–2020 .. 205
Table 48: Economic Indicators, Spain, Gross National Income per Capita ($), 2008–2013 ........................... 206
Table 49: Economic Indicators, Spain, Average Consumer Price Index, 2008–2013 .................................... 207
Table 50: Economic Indicators, Spain, Average Consumer Price Index Forecast, 2014–2020 ...................... 208
Table 51: Economic Indicators, Spain, Average Consumer Price Index Annual Change (%), 2008–2013 ..... 209
Table 52: Economic Indicators, Spain, Euro to Dollar Currency Exchange Rate, 2008–2013 ........................ 210
Table 53: Economic Indicators, Spain, Foreign Direct Investment ($bn), 2008–2013 .................................... 211
Table 54: Economic Indicators, Spain, Foreign Exchange Reserves ($bn), 2008–2013 ................................ 212
Table 55: Economic Indicators, Spain, Imports of Goods and Services ($bn), 2008–2013 ............................ 214
Table 56: Economic Indicators, Spain, Exports of Goods and Services ($bn), 2008–2013 ............................ 214
Table 57: Economic Indicators, Spain, Government Structural Balance ($bn), 2008–2013 ........................... 215
Table 58: Economic Indicators, Spain, General Government Net Debt (% of GDP), 2008–2013 ................... 216
Table 59: Economic Indicators, Spain, General Government Net Debt Forecast (% of GDP), 2014–2020 .... 217
Table 60: Economic Indicators, Spain, Major Industries by Revenue ($bn) and Share (%), 2013 .................. 219
Table 61: Demographics, Spain, Population (million), 2008–2013 ................................................................ 220
Table 62: Demographics, Spain, Population Forecast (million), 2014–2020 ................................................. 221
Table 63: Demographics, Spain, Population, Urban and Rural Population Share (%), 2008–2013 ................ 222
Table 64: Demographics, Spain, Population, Urban and Rural Population Share Forecast (%), 2014–2020 . 223
Table 65: Demographics, Spain, Population Distribution by Age Group (%), 2008–2013 .............................. 225
Table 66: Demographics, Spain, Population Distribution by Age Group Forecast (%), 2014–2020................ 225
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Table 67: Demographics, Spain, Births (per 1,000 Population), 2008–2013 ................................................. 226
Table 68: Demographics, Spain, Mortality (per 1,000 Population), 2008–2013 ............................................. 227
Table 69: Demographics, Spain, Major Causes of Mortality, 2012 ................................................................ 229
Table 70: Demographics, Spain, Children <5 Years Age, Mortality Rate (%), 2008–2013 ............................. 230
Table 71: Demographics, Spain, Immunization Rate (%), 2008–2013 .......................................................... 231
Table 72: Demographics, Spain, Major Causes of Male Mortality, 2012 ....................................................... 233
Table 73: Demographics, Spain, Major Causes of Female Mortality, 2012 ................................................... 234
Table 74: Demographics, Spain, Gender Ratio (Male to Female), 2008–2013.............................................. 235
Table 75: Demographics, Spain, Life Expectancy at Birth (Years), 2008–2013 ............................................. 236
Table 76: Demographics, Spain, Students Enrolled at Different Levels in Non-university Courses (%), 2012–
2013 ............................................................................................................................................ 239
Table 77: Demographics, Spain, Students Enrolled at Different Levels in University Courses (%), 2012–2013
.................................................................................................................................................... 240
Table 78: Demographics, Spain, Unemployment Rate (%), 2008–2013 ....................................................... 241
Table 79: Demographics, Spain, Distribution of Employment by Sectors (%), 2013 ...................................... 242
Table 80: Demographics, Spain, Number of Hospital Admissions and Diseases Diagnosed, 2012 ............... 243
Table 81: Demographics, Spain, Major Diseases, Disability-Adjusted Life Years (per 100,000 Population),
2004 ............................................................................................................................................ 245
Table 82: Healthcare Infrastructure, Spain, Number of Hospitals, 2008–2013 .............................................. 246
Table 83: Healthcare Infrastructure, Spain, Number of Hospitals by Type of Treatment, 2008–2013 ............ 247
Table 84: Healthcare Infrastructure, Spain, Number of Hospitals by Sector, 2008–2013 ............................... 248
Table 85: Healthcare Infrastructure, Spain, Diagnostic Units (per 1,000,000 Population), 2008–2013 .......... 249
Table 86: Healthcare Infrastructure, Spain, Hospital Beds (per 1,000 Population), 2008–2013 ..................... 250
Table 87: Healthcare Infrastructure, Spain, Number of Hospital Beds by Sector, 2008–2013 ....................... 251
Table 88: Healthcare Infrastructure, Spain, Hospital Beds by type of treatment, 2008–2013......................... 252
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Table 89: Healthcare Infrastructure, Spain, Doctors (per 100,000 Population), 2008–2013........................... 253
Table 90: Healthcare Infrastructure, Spain, PM10 (µg/m3), 2008–2013 ........................................................ 255
Table 91: Healthcare Infrastructure, Spain, CO2 Emissions (Million Metric Tons), 2008–2013 ...................... 257
Table 92: Healthcare Infrastructure, Spain, Nurses (per 1,000 Population), 2008–2013 ............................... 258
Table 93: Healthcare Infrastructure, Spain, Pharmacists (per 1,000 Population), 2008–2013 ....................... 259
Table 94: Healthcare Infrastructure, Spain, Dentists (per 1,000 Population), 2008–2013 .............................. 260
Table 95: Healthcare Expenditure, Spain, Healthcare Expenditure (% of GDP), 2008–2013 ......................... 261
Table 96: Healthcare Expenditure, Spain, Major Components of Healthcare Expenditure (%), 2008-2013.... 262
Table 97: Healthcare Expenditure, Spain, Healthcare Expenditure, Public-Private Share (%), 2008–2013 ... 263
Table 98: Healthcare Expenditure, Spain, Research and Development Expenditure by Field (%), 2012 ....... 264
Table 99: Healthcare Expenditure, Spain, Major Healthcare Trade Fairs, 2015 ............................................ 267
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1.2 List of Figures
Figure 1: Pharmaceutical Market, Spain, Revenue ($bn), 2008–2013 .......................................................... 22
Figure 2: Pharmaceutical Market, Spain, Revenue Forecast ($bn), 2014–2020 ........................................... 23
Figure 3: Pharmaceutical Market, Spain, Pharmaceutical Exports and Imports ($bn), 2008–2013 ................ 24
Figure 4: Pharmaceutical Market, Spain, Supply Channel, 2010 .................................................................. 26
Figure 5: Pharmaceutical Market, Spain, Generics Market, Drug Consumption by Volume (%), 2008–2013 . 28
Figure 6: Pharmaceutical Market, Spain, Red Biotechnology, Share of Diagnostics Pipeline by Disease Area
(%), 2014 ..................................................................................................................................... 30
Figure 7: Pharmaceutical Market, Spain, Red Biotechnology, Share of Therapeutics Pipeline by Disease
Area, 2014 ................................................................................................................................... 31
Figure 8: OTC Pharmaceutical Market, Spain, Segment Share (%), 2011 .................................................... 33
Figure 9: Medical Device Market, Spain, Revenue ($bn), 2008–2013 .......................................................... 78
Figure 10: Medical Device Market, Spain, Revenue Forecast ($bn), 2014–2020 ............................................ 79
Figure 11: Medical Device Market, Spain, Top Five Segments, Revenue ($m), 2013 ..................................... 80
Figure 12: Medical Device Market, Spain, In Vitro Diagnostics Revenue ($m), 2008–2013 ............................ 82
Figure 13: Medical Device Market, Spain, In Vitro Diagnostics, Sales Trend for Major Players, Revenue ($m),
2008–2012 ................................................................................................................................... 83
Figure 14: Medical Device Market, Spain, Diabetes Care Devices Revenue ($m), 2008–2013 ....................... 84
Figure 15: Medical Device Market, Spain, Diabetes Care Devices, Sales Trend for Major Players, Revenue
($m), 2008–2012 .......................................................................................................................... 85
Figure 16: Medical Device Market, Spain, Orthopedic Devices Revenue ($m), 2008–2013 ............................ 87
Figure 17: Medical Device Market, Spain, Orthopedic Devices, Sales Trend for Major Players, Revenue ($m),
2008–2012 ................................................................................................................................... 88
Figure 18: Medical Device Market, Spain, Cardiovascular Devices Market ($m), 2008–2013 ......................... 89
Figure 19: Medical Device Market, Spain, Cardiovascular Devices Market, Sales Trend for Major Players,
Revenue ($m), 2008–2012 ........................................................................................................... 90
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Figure 20: Medical Device Market, Spain, Ophthalmic Devices Revenue ($m), 2008–2013 ........................... 92
Figure 21: Medical Device Market, Spain, Ophthalmic Devices, Sales Trend for Major Players, Revenue ($m),
2008–2012 ................................................................................................................................... 93
Figure 22: Medical Device Market, Spain, Diagnostic Market, Revenue ($bn), 2008–2013............................. 94
Figure 23: Medical Device Market, Spain, Diagnostic Market, Revenue Forecast ($bn), 2014–2020 .............. 95
Figure 24: Medical Device Market, Spain, Major Medical Device Companies, Revenue ($m), 2012 ............... 96
Figure 25: Healthcare Market, Spain, Drivers and Barriers, 2014 ................................................................. 133
Figure 26: Healthcare System, Spain, Organization of the Spanish National Health System, 2014............... 134
Figure 27: Healthcare System, Spain, Health Technology Assessment Process, 2014 ................................ 140
Figure 28: Healthcare Spending, Spain, Out-of-Pocket Expenditure (%), 2008–2013 ................................... 143
Figure 29: Market Access, Spain, Change in Average Price of Healthcare Services (%), 2008–2013 ........... 144
Figure 30: Regulatory Landscape, Spain, AEMPS Organization, 2014 ........................................................ 150
Figure 31: Market Authorization, Spain, National Procedure, 2014 .............................................................. 154
Figure 32: Market Authorization, Spain, Centralized Procedure, Pre-Submission, 2014 ............................... 157
Figure 33: Market Authorization, Spain, Centralized Procedure, Pre-Opinion Phase, 2014 .......................... 159
Figure 34: Market Authorization, Spain, Centralized Procedure, Post-Opinion Phase, 2014 ......................... 161
Figure 35: Market Authorization, Spain, Decentralized Procedure, 2014 ...................................................... 163
Figure 36: Market Authorization, Spain, Mutual Recognition Procedure, 2014 ............................................. 165
Figure 37: Market Authorization, Spain, Conformity Assessment of Class I Medical Devices, 2014 .............. 167
Figure 38: Market Authorization, Spain, Conformity Assessment of Class IIa Medical Devices, 2014 ........... 168
Figure 39: Market Authorization, Spain, Conformity Assessment of Class IIb Medical Devices, 2014 ........... 169
Figure 40: Market Authorization, Spain, Conformity Assessment of Class III Medical Devices, 2014 ............ 170
Figure 41: Economic Indicators, Spain, Gross Domestic Product per Capita ($), 2008–2013 ....................... 202
Figure 42: Economic Indicators, Spain, Gross Domestic Product per Capita Forecast ($), 2014–2020 ......... 203
Figure 43: Economic Indicators, Spain, Gross Domestic Product Annual Growth (%), 2008–2013 ............... 204
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Figure 44: Economic Indicators, Spain, Gross Domestic Product Annual Growth Forecast (%), 2014–2020 . 205
Figure 45: Economic Indicators, Spain, Gross National Income per Capita ($), 2008–2013 .......................... 206
Figure 46: Economic Indicators, Spain, Average Consumer Price Index, 2008–2013 ................................... 207
Figure 47: Economic Indicators, Spain, Average Consumer Price Index Forecast, 2014–2020 .................... 208
Figure 48: Economic Indicators, Spain, Average Consumer Price Index Annual Change (%), 2008–2013.... 209
Figure 49: Economic Indicators, Spain, Euro to Dollar Currency Exchange Rate, 2008–2013 ...................... 210
Figure 50: Economic Indicators, Spain, Foreign Direct Investment ($bn), 2008–2013 .................................. 211
Figure 51: Economic Indicators, Spain, Foreign Exchange Reserves ($bn), 2008–2013 .............................. 212
Figure 52: Economic Indicators, Spain, Imports of Goods and Services ($bn), 2008–2013 .......................... 213
Figure 53: Economic Indicators, Spain, Exports of Goods and Services ($bn), 2008–2013 .......................... 214
Figure 54: Economic Indicators, Spain, Government Structural Balance ($bn), 2008–2013.......................... 215
Figure 55: Economic Indicators, Spain, General Government Net Debt (% of GDP), 2008–2013 ................. 216
Figure 56: Economic Indicators, Spain, General Government Net Debt Forecast (% of GDP), 2014–2020 ... 217
Figure 57: Economic Indicators, Spain, Major Industries by Revenue ($bn), 2013 ....................................... 218
Figure 58: Demographics, Spain, Population (million), 2008–2013 .............................................................. 220
Figure 59: Demographics, Spain, Population Forecast (million), 2014–2020 ................................................ 221
Figure 60: Demographics, Spain, Population, Urban and Rural Population Share (%), 2008–2013 .............. 222
Figure 61: Demographics, Spain, Population, Urban and Rural Population Share Forecast (%), 2014–2020 223
Figure 62: Demographics, Spain, Population Distribution by Age Group (%), 2008–2013 ............................ 224
Figure 63: Demographics, Spain, Population Distribution by Age Group Forecast (%), 2014–2020 .............. 225
Figure 64: Demographics, Spain, Births (per 1,000 Population), 2008–2013 ................................................ 226
Figure 65: Demographics, Spain, Mortality (per 1,000 Population), 2008–2013............................................ 227
Figure 66: Demographics, Spain, Major Causes of Mortality, 2012 .............................................................. 228
Figure 67: Demographics, Spain, Children <5 Years Age, Mortality Rate (%), 2008–2013 ........................... 230
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Figure 68: Demographics, Spain, Immunization Rate (%), 2008–2013 ......................................................... 231
Figure 69: Demographics, Spain, Major Causes of Male Mortality, 2012 ...................................................... 232
Figure 70: Demographics, Spain, Major Causes of Female Mortality, 2012 .................................................. 233
Figure 71: Demographics, Spain, Gender Ratio (Male to Female), 2008–2013 ............................................ 235
Figure 72: Demographics, Spain, Life Expectancy at Birth (Years), 2008–2013 ........................................... 236
Figure 73: Demographics, Spain, Students Enrolled at Different Levels in Non-university Courses (%), 2012–
2013 ........................................................................................................................................... 238
Figure 74: Demographics, Spain, Students Enrolled at Different Levels in University Courses (%), 2012–2013
.................................................................................................................................................. 240
Figure 75: Demographics, Spain, Unemployment Rate (%), 2008–2013 ...................................................... 241
Figure 76: Demographics, Spain, Distribution of Employment by Sector (%), 2013 ...................................... 242
Figure 77: Demographics, Spain, Number of Hospital Admissions and Diseases Diagnosed, 2012 .............. 243
Figure 78: Demographics, Spain, Major Diseases, Disability-Adjusted Life Years (per 100,000 Population),
2004 ........................................................................................................................................... 244
Figure 79: Healthcare Infrastructure, Spain, Number of Hospitals, 2008–2013 ............................................. 246
Figure 80: Healthcare Infrastructure, Spain, Number of Hospitals by Type of Treatment, 2008–2013 ........... 247
Figure 81: Healthcare Infrastructure, Spain, Number of Hospitals by Sector, 2008–2013 ............................. 248
Figure 82: Healthcare Infrastructure, Spain, Diagnostic Units (per 1,000,000 Population), 2008–2013 ......... 249
Figure 83: Healthcare Infrastructure, Spain, Hospital Beds (per 1,000 Population), 2008–2013 ................... 250
Figure 84: Healthcare Infrastructure, Spain, Number of Hospital Beds by Sector, 2008–2013 ...................... 251
Figure 85: Healthcare Infrastructure, Spain, Hospital Beds by Type of Treatment Provided, 2008–2013 ...... 252
Figure 86: Healthcare Infrastructure, Spain, Doctors (per 100,000 Population), 2008–2013 ......................... 253
Figure 87: Healthcare Infrastructure, Spain, PM10 (µg/m3), 2008–2013 ....................................................... 255
Figure 88: Healthcare Infrastructure, Spain, CO2 Emissions (Million Metric Tons), 2008–2013 ..................... 256
Figure 89: Healthcare Infrastructure, Spain, Nurses (per 1,000 Population), 2008–2013 .............................. 257
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Table of Contents
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – SPAIN
Figure 90: Healthcare Infrastructure, Spain, Pharmacists (per 1,000 Population), 2008–2013 ...................... 258
Figure 91: Healthcare Infrastructure, Spain, Dentists (per 1,000 Population), 2008–2013 ............................ 259
Figure 92: Healthcare Expenditure, Spain, Healthcare Expenditure (% of GDP), 2008–2013 ....................... 260
Figure 93: Healthcare Expenditure, Spain, Major Components of Healthcare Expenditure (%), 2008–2013 . 261
Figure 94: Healthcare Expenditure, Spain, Healthcare Expenditure, Public-Private Share (%), 2008–2013 .. 263
Figure 95: Healthcare Expenditure, Spain, Research and Development Expenditure by Field (%), 2012 ...... 264
Figure 96: Healthcare Market, Spain, Opportunities and Challenges, 2014 .................................................. 270
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – SPAIN
Introduction
2 Introduction
2.1 GlobalData Report Guidance
Chapter starts with an executive summary, which gives an overview of the healthcare market
and its key driving factors. It also gives a snapshot of the demographic, regulatory and
reimbursement landscape and healthcare infrastructure.
Chapter three provides an overview of the pharmaceutical and medical device markets,
covering market size, Over-The-Counter (OTC) products, biologic/biosimilar products and the
market shares of generics, as well as the key drivers and barriers for the market as a whole. 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. 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, labeling, packaging and clinical trials; and an overview of intellectual property
rights.
Chapter five provides detailed analysis of the political and economic environment, and
analyses economic indicators, demographics, and healthcare infrastructure and expenditure.
Chapter six provides an overview of the opportunities for and challenges to growth in the
healthcare market.
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Overview of the Pharmaceutical and Medical Device Markets
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – SPAIN
3.2 Medical Device Market
3.2.1 Market Overview
The market for medical devices is large, due to the increasingly elderly population and the
subsequent increase in the demand for healthcare products and services. The medical device
market was valued at approximately $XX billion in 2008 and grew at a CAGR of XX% to $XX billion
in 2013. It is expected to reach $XX billion in 2020.
Figure 9: Medical Device Market, Spain, Revenue ($bn), 2008–2013
2008 2009 2010 2011 2012 2013
Rev
enue
($bn
)
CAGR (2008–2013): XX%
Source: GlobalData, Medical eTrack [Accessed on December 3, 2014]
Table 20: Medical Device Market, Spain, Revenue ($bn), 2008–2013 Year 2008 2009 2010 2011 2012 2013
Revenue
Source: GlobalData, Medical eTrack [Accessed on December 3, 2014]
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Country Analysis
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – SPAIN
5.6.4 Spending in Healthcare, R&D
Gross domestic expenditure on R&D is divided into two sectors: the business sector and public
administration. In 2012, R&D activities were financed mostly by the business sector (XX%),
followed by public administration (XX%). In 2012, R&D expenditure was €XXm ($XXm) (INE, press
release, November 14, 2013).
The expenditure on R&D was highest in the field of R&D services, which accounted for XX% of the
funds, followed by scientific and technical activities, which accounted for XX%. R&D expenditure
was lowest in motor vehicles (XX%) and chemicals (XX%) (INE, press release, November 14,
2013).
Figure 95: Healthcare Expenditure, Spain, Research and Development Expenditure by Field (%), 2012
R & D services
Scientific and technical activitiesIT related activities
Pharmaceuticals
Aerospace
Motor vehiclesChemicals
Source: INE, Press release, November 14, 2013
Table 98: Healthcare Expenditure, Spain, Research and Development Expenditure by Field (%), 2012 Field Share
R&D services
Scientific and technical activities
IT related activities
Pharmaceuticals
Aerospace
Motor vehicles
Chemicals
Source: INE, press release, November 14, 2013
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Appendix
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7 Appendix
7.1 Abbreviations
AC: Autonomous Community
ACL: Anterior Cruciate Ligament
AEC: Association of Community Nursing (Asociación de Enfermería Comunitaria)
AEMPS: Spanish Agency for Medicines and Healthcare Products
(Agencia Espanola del Medicamento y Productos Sanitarios)
AES: Association of Health Economics (Asociación de Economía de la Salud)
AESEG: Spanish Generic Medicines Association (Asociacion Española de Medicamentos)
AJS: Association of Health Lawyers (Asociación de Juristas de la Salud)
ALK+: Anaplastic Lymphoma Kinase Positive
AMAS: Madrid Association of Health Administration
(Asociación Madrileña de Administración Sanitaria)
AMC: Asset Management Company
CA: Conformity Assessment
CAGR: Compound Annual Growth Rate
CC-CEIC: Co-ordinating Center of the Research Ethics Committee
(Centro Coordinador de los Comités Éticos de Investigación Clínica)
CE: Conformité Européenne
CEIC: Research Ethics Committee (Comité Ético de Investigación Clínica)
CHMP: Committee for Medicinal Products for Human Use
CIPM: Interministerial Commission on Pharmaceutical Prices
(Comisión Interministerial de Precios de los Medicamentos)
CMDh Co-ordination group for Mutual recognition and Decentralised procedures – human
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CMH/CODEM Committee for Medicinal Products for Human Use
(Comité de Medicamentos de Uso Humano)
CMHS: Safety Committee for Medicinal products for Human Use
CMS: Centers for Medicare and Medicaid Services
CNS: Central Nervous System
CODEM: Comité de Medicamentos de Uso Humano
COMP: Committee for Orphan Medicinal Products
COPD: Chronic Obstructive Pulmonary Disease
CPI: Consumer Price Index
CRDM: Cardiac Rhythm Disease Management
CRL: Complete Response Letter
CT: Computed Tomography
CT/NG Chlamydia Trachomatis/Neisseria Gonorrhoeae
CVS: Cardiovascular System
DALY: Disability-Adjusted Life Year
DGFPS: Directorate General of Pharmacy and Health Products
(Dirección General de Farmacia y Productos Sanitarios)
DPT: Diphtheria, Pertussis and Tetanus
DRG: Diagnostic Related Groups
eCR: electronic Clinical Records
EFP: Advertisable Over-The-Counter Drugs
(Especialidades Farmaceuticas Publicitarias)
EMA: European Medicines Agency
EMAP: Emerging Markets and Asia-Pacific
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Appendix
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ENT: Ear, Nose and Throat
FDA: Food and Drug Administration
FFPC: Fiscal and Financial Policy Council
Forex: Foreign exchange
FROB: Fund for Orderly Restructuring of Banks
(Fondo De Reestructuración Ordenada Bancaria)
GDP: Gross Domestic Product
GLP: Good Laboratory Practice
GMP: Good Manufacturing Practice
GNI: Gross National Income
GSK: GlaxoSmithKline
HBV: Hepatitis B Virus
HCV: Hepatitis C Virus
HeFH: Heterozygous Familial Hypercholesterolemia
HIPATIA: Andalusian Public Health Association (Asociación Andaluza de Salud Pública)
HOM: Hospital Only Medicines
HPV: Human Papillomavirus
HTA: Health Technology Assessment
IMSERSO: Instituto de Mayores y Servicios Sociales
(National Institute of Health Management)
INGESA: Instituto Nacional de Gestión Sanitaria (National Institute of Health Management)
INSALUD: Instituto Nacional de la Salud (National Institute of Health)
IPC: Interministerial Pricing Committee
IPR: Intellectual Property Rights
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Appendix
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ISCIII: Instituto de Salud Carlos III
ISFAS: Social Institute for the Armed Forces (Instituto Social de las Fuerzas Armadas)
ITB: Inter-Territorial Board
IVD: In Vitro Diagnostics
MA: Marketing Authorization
MDD: Medical Device Directives
MESS: Ministry of Employment and Social Security
MHLW: Ministry of Health, Labour and Welfare
MOU: Memorandum of Understanding
MRI: Magnetic Resonance Imaging
MSO: Medtronic Singapore Operations
MSPS: Ministerio de Sanidad Política Social (Ministry of Health and Social Policy)
MSSSI: Ministerio de Sanidad, Servicios Sociales e Igualdad
(Ministry of Health, Social Services and Equality)
MUFACE: Mutual Fund for State Civil Servants
(La Mutualidad General de Funcionarios Civiles del Estado, MUFACE
MUGEJU: General Justice Mutual Company (Mutualidad General Judicial, MUGEJU)
NDA: New Drug Application
NIBR: Novartis Institutes for Biomedical Research
non-EFP: non-advertizable OTC
OA: Osteoarthritis
OEPM: Oficina Espanola de Patentes y Marcas
OOP: Out-Of-Pocket
OTC: Over-The-Counter
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PCR: Polymerase Chain Reactions
PM10: Particulate Matter with an aerodynamic diameter of less than 10 micrometers
pRED: pharma Research and Early Development
PSOE: Partido Socialista Obrero Español (Spanish Socialist Workers’ Party)
QC: Quality Control
QRD: Quality Review of Documents Group
REAP: Spanish Network of Primary Care (Red Española de Atención Primaria)
RMS: Reference Member State
RP: Reference Pricing
SAREB: Company for the Management of Assets proceeding from Restructuring of the
Banking System
(Sociedad de Gestión de Activos procedentes de la Reestructuración Bancaria)
SCSP: Society of Public Health Canaria (Sociedad Canaria de Salud Pública)
SEE: Spanish Society of Epidemiology
SEEP: Spanish Society of Psychiatric Epidemiology
(Sociedad Española de Epidemiología Psiquiatrita)
SEIS: The Spanish Society of Health Informatics
(Sociedad Española De Informática de la Salud)
SESA: Spanish Society of Environmental Health
(Sociedad Española de Sanidad Ambiental)
SESPAS: Spanish Society of Public Health and Health Services Administration
(The Sociedad Espanola de Salud Pública y Administración Sanitaria)
SNS: National Health System (Sistema Nacional de Salud)
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SSPCiB: Society of Public Health Catalunya i Balears
(Societat de Salut Publica de Catalunya i de Balears)
TCRC: Translational and Clinical Research Center
UNICEF: United Nations Children’s Fund
VAT: Value Added Tax
WHO : World Health Organization
7.2 Bibliography
10times (2014). Medical and Pharmaceutical Trade Shows in South Africa. 10times. Available
from: http://10times.com/southafrica/medical-pharma/tradeshows [Accessed on November 11,
2014].
Abbott (2013). 2013 Investor Relations. Abbott. Available from:
http://www.abbottinvestor.com/phoenix.zhtml?c=94004&p=irol-irhome [Accessed on
September 12, 2014]
Abbott (2014). Abbott initiates absorb iv trial to evaluate quality of life and cost savings of
dissolving heart device. Abbott. Available from: http://abbott.mediaroom.com/2014-09-15-
Abbott-Initiates-ABSORB-IV-Trial-to-Evaluate-Quality-of-Life-and-Cost-Savings-of-Dissolving-
Heart-Device [Accessed on September 12, 2014]
AEMPS (2010). How are medicines and medical devices regulated in Spain? Agencia
Española de Medicamentos y Productos Sanitarios. Available from:
http://www.aemps.gob.es/en/publicaciones/publica/regulacion_med-PS/docs/folleto-
regulacion_Med-PS.pdf.
AEMPS (2012a). Presentación del Comité de Seguridad de Medicamentos de Uso Humano
(CSMH). Agencia Española de Medicamentos y Productos Sanitarios. Available from:
http://www.aemps.gob.es/en/laAEMPS/estructura/csmh/presentacion.htm. [Accessed on
November 21, 2014].
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Appendix
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World Bank (2014f). PM10 country level (micrograms per cubic meter). World Bank. Available
from: http://data.worldbank.org/indicator/EN.ATM.PM10.MC.M3 [Accessed on October 17,
2014].
World Bank (2014g). CO2 emissions (metric tons per capita). World Bank. Available from:
http://data.worldbank.org/indicator/EN.ATM.CO2E.PC [Accessed on October 17, 2014].
World Bank (2014h). Out-of-pocket health expenditure (% of private expenditure on health).
World Bank. Available from: http://data.worldbank.org/indicator/SH.XPD.OOPC.ZS [Accessed
on November 14, 2014].
7.3 Research 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
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 and market potential.
The estimated revenue of all major companies, including private and governmental, are gathered
and used to prioritize coverage.
Companies that are making the news or are of particular interest due to their innovative approach
are prioritized.
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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 input from GlobalData’s
expert panel (see below).
7.3.2 Secondary Research
The research process begins with extensive secondary research using internal and external
sources to gather 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
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 CountryFocus reports are largely based on secondary research and use reliable and
authoritative sources such as the IMF, the World Bank, OECD, WHO, UNICEF, UNStats, BEA,
MHLW and NHS, among others.
7.3.3 Forecasts
The CountryFocus reports use the data available from the secondary sources to forecast and
validate the future trends for a country’s healthcare market, as well as parameters related to the
economy and healthcare infrastructure and expenditure.
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7.3.4 Expert Panel
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 and adjusted in accordance
with their feedback.
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.