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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Spain

Published: Jun 2013 | Published By: GlobalData

GlobalData, the industry analysis specialist, has released its new report: “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – Spain”. The report is an essential source of information and analysis on Spain’s healthcare, regulatory and reimbursement landscape. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory and reimbursement landscape and the country’s healthcare infrastructure. Most importantly, it provides valuable insights into the trends and segmentation of the Spanish pharmaceutical and medical device markets.

The report is built using data and information sourced from proprietary databases, secondary research and in-house analysis by GlobalData’s team of industry experts.
Spain’s population was 47.1 million in 2012, but it is decreasing due to a negative balance between the birth and death rate, as well as a negative migration balance.

The country’s policymakers are currently faced with the challenge of an increasing unemployment rate due to a lack of clear monetary policies. The pharmaceutical market at the pharmacy retail price was estimated to be worth $24.8 billion in 2012, and is expected to reach $29.4 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 0.6%. The medical devices market was estimated at approximately $7 billion in 2012, and is expected to reach $11.9 billion by 2020 at a CAGR of 4.8%.

Scope

An overview of the pharmaceutical and medical devices markets, comprising size, segmentation and key drivers and barriers
Profiles and SWOT analyses of the major players in the pharmaceutical market, comprising Pfizer, F. Hoffmann-La Roche, Novartis, Sanofi and Eli Lilly; and medical devices market, comprising Abbott Laboratories, F. Hoffmann-La Roche, Medtronics, GE Healthcare and Siemens Healthcare
An insightful review of the country’s reimbursement and regulatory landscape, including details of the healthcare reimbursement process, regulatory agencies and approval processes for new drugs
Detailed analysis of the political and economic environment, including economic indicators, demographics, and healthcare infrastructure and expenditure
An overview of the opportunities for and challenges to growth in the healthcare market

Reasons To Buy

Develop business strategies by understanding the trends shaping and driving Spain’s healthcare market
Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact Spain’s healthcare market in the future
Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing competitors’ performance
Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnership
Identify, understand and capitalize on the opportunities and challenges in Spain’s healthcare market

1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Introduction
2.1 Report Guidance

3 Overview of Pharmaceutical and Medical Device Markets
3.1 Pharmaceutical Market
3.1.1 Market Overview
3.1.2 Pharmaceutical Import and Export
3.1.3 Supply Channels
3.1.4 Market Segments
3.1.5 Major Therapeutic Areas
3.1.6 Major Anatomical Therapeutic Chemical Drug Subgroups According to the Amount Spent on their Purchase by SNS in 2010
3.1.7 Major Players
3.2 Medical Device Market
3.2.1 Market Overview
3.2.2 Overview of Top Five Segments
3.2.3 Diagnostics Market
3.2.4 Major Players
3.3 Market Drivers and Barriers
3.3.1 Market Drivers
3.3.2 Market Barriers

4 Market Access
4.1 Healthcare System
4.2 Reimbursement and Payer Landscape
4.2.1 Reimbursement Process
4.2.2 Overview of Insurance Provider
4.2.3 Patient Share in Healthcare Spending
4.2.4 Prescription Drug Cost Trend
4.2.5 Pricing Policies
4.3 Regulatory Landscape
4.3.1 Overview of Regulatory Agencies
4.3.2 Marketing Authorization Procedure
4.3.3 New Medical Device Approval Process
4.3.4 Licensing Process for Manufacturing of Pharmaceuticals
4.3.5 Licensing Process for Imports and Requirements for the Export of Medicines and Medical Products
4.3.6 Intellectual Property Rights Landscape
4.3.7 Clinical Trial Regulations
4.3.8 Pharmaceutical Advertising Regulations
4.3.9 Pharmacy Regulations
4.3.10 Labeling and Packaging Regulations

5 Country Analysis
5.1 Political Environment
5.1.1 Political Structure
5.1.2 Analysis of the Current Political Environment
5.1.3 Healthcare Policy Initiatives
5.2 Economic Landscape
5.3 Economic Indicators
5.3.1 Gross Domestic Product
5.3.2 Gross National Income
5.3.3 Inflation
5.3.4 Currency Exchange Rate
5.3.5 Foreign Direct Investment
5.3.6 Foreign Exchange Reserves
5.3.7 Trade Balance
5.3.8 Government Structural Balance
5.3.9 Government Net Debt
5.3.10 Major Industries
5.4 Demographics
5.4.1 Population
5.4.2 Education and Literacy
5.4.3 Employment
5.4.4 Disease Burden
5.5 Healthcare Infrastructure
5.5.1 Healthcare Facilities
5.5.2 Healthcare Parameters
5.5.3 Environmental Health
5.5.4 Healthcare Personnel
5.6 Healthcare Expenditure
5.6.1 Overview
5.6.2 Major Components of Healthcare Spending
5.6.3 Share of the Public and Private Sectors
5.6.4 Spending in Pharmaceutical R&D
5.6.5 Drug Development Expenditure
5.7 Trade Associations
5.7.1 Farmaindustria
5.7.2 The Medical Association of the Pharmaceutical Industry in Spain
5.7.3 The Spanish Society of Public Health and Health Services Administration
5.7.4 The Spanish Society of Health Information
5.7.5 Spanish Generic Medicines Association (Asociacion Española de Medicamentos Genéricos)
5.8 Trade Fairs

6 Opportunities and Challenges
6.1 Opportunities
6.2 Challenges

7 Appendix
7.1 Abbreviations
7.2 Bibliography
7.3 Methodology
7.3.1 Coverage
7.3.2 Secondary Research
7.3.3 Forecasting
7.3.4 Expert Panel Validation
7.4 Contact Us
7.5 Disclaimer

Table 1: Pharmaceutical Market, Spain, Revenue ($bn), 2007–2012
Table 2: Pharmaceutical Market, Spain, Revenue ($bn), Forecast, 2013–2020
Table 3: Pharmaceutical Imports and Exports ($bn), Spain, 2007–2012
Table 4: Share of Generics in the Total Pharmaceuticals Billed to SNS, Spain, 2007–2012
Table 5: Red Biotechnology Pipeline (Number of Development Projects), Spain, 2013
Table 6: OTC Pharmaceutical Market, Spain, Segment Share (%), 2011
Table 7: Major Therapeutic Areas, Spain, Segment Share (% of Total Pharmaceutical Sale in Pharmacies), 2011
Table 8: Major ATC Subgroups, Spain, Amount Spent by SNS for Purchase ($m), 2010
Table 9: Major Products, Pfizer, Global, Revenue ($m), 2012
Table 10: Late-stage Pipeline, Pfizer, 2013
Table 11: Major Products, Roche, Global, Revenue ($m), 2012
Table 12: Late-stage Pipeline, Roche, 2013
Table 13: Major Products, Novartis, Global, Revenue ($m), 2012
Table 14: Planned Filings, Novartis, 2012=2016
Table 15: Major Products, Sanofi, Global, Revenue ($m), 2012
Table 16: Late-stage Pipeline, Sanofi, 2013
Table 17: Major Products, Eli Lilly, Global, Revenue ($bn), 2012
Table 18: Late-stage Pipeline, Eli Lilly, 2010
Table 19: Medical Device Market, Spain, Revenue ($bn), 2007–2012
Table 20: Medical Device Market, Spain, Revenue ($bn), Forecast, 2013–2020
Table 21: Medical Device Market, Spain, Revenue by Segment ($m), 2012
Table 22: In Vitro Diagnostics Market, Spain, Revenue ($m), 2007–2012
Table 23: In Vitro Diagnostics Market, Spain, Sales Trends for Major Players ($m), 2011
Table 24: Diabetic Care Devices Market, Spain, Revenue ($m), 2007–2012
Table 25: Diabetic Care Devices Market, Spain, Sales Trends for Major Players ($m), 2011
Table 26: Orthopedic Devices Market, Spain, Revenue ($m), 2007–2012
Table 27: Orthopedic Devices Market, Spain, Sales Trends for Major Players ($m), 2011
Table 28: Cardiovascular Devices, Spain, Revenue ($m), 2007–2012
Table 29: Cardiovascular Devices Market, Spain, Sales Trends for Major Players ($m), 2011
Table 30: Ophthalmic Devices Market, Spain, Revenue ($m), 2007–2012
Table 31: Ophthalmic Devices Market, Spain, Sales Trends for Major Players* ($m), 2011
Table 32: Diagnostics Market, Spain, Revenue ($m), 2007–2012
Table 33: Diagnostic Market, Spain, Revenue ($m), Forecast, 2013–2020
Table 34: Major Medical Device Companies, Spain, Revenue ($m), 2011
Table 35: Major Products, Siemens, Global, Revenue ($m), 2012
Table 36: Major Products, Roche, Global, Revenue ($m), 2012
Table 37: Major Products, Medtronic, Global, Revenue ($m), 2012
Table 38: Major Product Categories, Abbott, Global, Revenue ($m), 2012
Table 39: Spanish Medicines Pricing and Reimbursement, Stakeholders
Table 40: Contribution Ceiling for Out-Of-Pocket Payment for Pensioners and their Dependents, 2012
Table 41: Out-Of-Pocket Payment (% of Total Healthcare Expenditure), 2007–2012
Table 42: Average Price Change of Prescription Drug (%), Spain, 2007–2012
Table 43: Pricing Process, Spain, 2011
Table 44: GDP Annual Growth (%), Spain, 2007–2012
Table 45: GDP Annual Growth (%), Spain, Forecast, 2013–2020
Table 46: GDP Per Capita ($), Spain, 2007–2012
Table 47: GDP Per Capita ($), Spain, Forecast, 2013–2020
Table 48: GNI Per Capita ($), Spain, 2007–2012
Table 49: Average Consumer Price Index, Spain, 2007–2012
Table 50: Average Consumer Price, Annual Change (%), Spain, 2007–2012
Table 51: Currency Exchange Rate (€/$), Spain, 2007–2012
Table 52: Foreign Direct Investment ($bn), Spain, 2007–2011
Table 53: Foreign Exchange Reserves ($bn), Spain, 2007–2012
Table 54: Exports of Goods and Services ($bn), Spain 2007–2012
Table 55: Imports of Goods and Services ($bn), Spain, 2007–2012
Table 56: General Government Structural Balance ($bn), Spain, 2007–2012
Table 57: General Government Structural Balance ($bn), Spain, Forecast, 2013–2020
Table 58: General Government Net Debt ($bn), Spain, 2007–2012
Table 59: General Government Net Debt ($bn), Spain, Forecast, 2013–2020
Table 60: Major Product Industries, Spain, Revenue ($bn), 2010–2011
Table 61: Major Service Industries, Spain, Revenue ($bn), 2010
Table 62: Population (million), Spain, 2007–2012
Table 63: Population (million), Spain, Forecast, 2013–2020
Table 64: Urban and Rural Population, Spain, Share (%), 2007–2012
Table 65: Urban and Rural Population, Spain, Share (%), Forecast, 2013–2020
Table 66: Age Groups, Population Distribution (%), Spain, 2007–2012
Table 67: Age Groups, Population Distribution (%), Spain, Forecast, 2013–2020
Table 68: Births (Per 1,000 Population), Spain, 2007–2012
Table 69: Crude Mortality Rate (Per 1,000 Population), Spain, 2007–2012
Table 70: Number of Deaths in Children Below Five Years, Infant Mortality Rate and Under Five Mortality Rate, Spain, 2007–2012
Table 71: Major Causes of Mortality, Spain, 2011
Table 72: Major Causes of Male Mortality, Spain, 2011
Table 73: Major Causes of Female Mortality, Spain, 2011
Table 74: Immunization Coverage among One-Year-Olds (%), Spain, 2007 and 2011
Table 75: Gender Ratio (M/F), Spain, 2007–2013
Table 76: Gender Ratio (M/F), Spain, 2011
Table 77: Life Expectancy at Birth (Years), Female and Male, Spain, 2007–2012
Table 78: Life Expectancy at Birth (Years), Male and Female, Spain, Forecast, 2013–2020
Table 79: Life Expectancy at Age 65 (Years), Female and Male, Spain, 2007–2012
Table 80: Life Expectancy at Age 65 (Years), Male and Female, Spain, Forecast, 2013–2020
Table 81: Students Enrolled at Different Levels in Non-university Courses (%), 2011–2012
Table 82: Students Enrolled at Different Levels in University Courses during Academic Year (%), 2011–2012
Table 83: Employment Rate (% of Population of 16–64 Year-olds), Spain, 2007–2012
Table 84: Employment by Economic Sector, Share (%), Spain, 2012
Table 85: Number of Hospital Admissions (‘000), Spain, 2011
Table 86: Major Diseases, Spain, DALY (Per 100,000 Population), 2004
Table 87: Number of Hospitals, Spain, 2007–2012
Table 88: Public and Private Hospitals, Share (%), Spain, 2007–2012
Table 89: Hospitals by Type of Service, Spain, 2007–2012
Table 90: Hospitals by Number of Beds, Spain, 2007–2012
Table 91: Hospital Beds (‘000), Spain, 2007–2012
Table 92: Public and Private Hospital Beds, Share(%), Spain, 2007–2012
Table 93: Beds by Type of Care (‘000), Spain, 2007–2012
Table 94: Hospitals by Standard of Care, Spain, Share (%), 2010
Table 95: Diagnostic Faclilities in Hospitals, Spain, 2007–2012
Table 96: Physicians (Per 1,000 Population), Spain, 2007–2012
Table 97: General Practitioners (Per 100,000 Population), Spain, 2007–2012
Table 98: Hospitals (Per 100,000 Population), Spain, 2007–2012
Table 99: Hospital Beds (Per 100,000 Population), Spain, 2007–2012
Table 100: Nitrogen Oxide Emission (Thousand Tons), Spain, 2007–2012
Table 101: Sulfur Oxide Emission (Thousand Tons), Spain, 2007–2012
Table 102: PM10 (Thousand Tons), Spain, 2007–2012
Table 103: Carbon Dioxide Emission (Million Tons), Spain, 2007–2012
Table 104: Nurses (Per 100,000 Population), Spain, 2007–2012
Table 105: Pharmacists (Per 100,000 Population), Spain, 2007–2012
Table 106: Dentists (Per 100,000 Population), Spain, 2007–2012
Table 107: Healthcare Expenditure (% of GDP), Spain, 2007–2012
Table 108: Major Components of Healthcare Expenditure (%), Spain, 2007–2010
Table 109: Healthcare Expenditure, Spain, Public–Private Share (%), 2007–2012
Table 110: Pharmaceutical R&D Expenditure ($bn), Spain, 2007–2012
Table 111: Pharmaceutical R&D Expenditure ($m, %), Spain, 2011
Table 112: Major Healthcare Trade Fairs, Spain, 2013–2015

Figure 1: Pharmaceutical Market, Spain, Revenue ($bn), 2007–2012
Figure 2: Pharmaceutical Market, Spain, Revenue ($bn), Forecast, 2013–2020
Figure 3: Pharmaceutical Imports and Exports ($bn), Spain, 2007–2012
Figure 4: Share of Generics in the Total Pharmaceuticals Billed to SNS, Spain, 2007–2012
Figure 5: Red Biotechnology Pipeline (Number of Development Projects), Spain, 2013
Figure 6: OTC Pharmaceutical Market, Spain, Segment Share (%), 2011
Figure 7: Major Therapeutic Areas, Spain, Segment Share (% of Total Pharmaceutical Sale in Pharmacies), 2011
Figure 8: Major ATC Subgroups, Spain, Amount Spent by SNS for Purchase ($m), 2010
Figure 9: Medical Device Market, Spain, Revenue ($bn), 2007–2012
Figure 10: Medical Device Market, Spain, Revenue ($bn), Forecast, 2013–2020
Figure 11: Medical Device Market, Spain, Revenue by Segment ($m), 2012
Figure 12: In Vitro Diagnostics Market, Spain, Revenue ($m), 2007–2012
Figure 13: In Vitro Diagnostics Market, Spain, Sales Trends for Major Players* ($m), 2007–2011
Figure 14: Diabetic Care Devices Market, Spain, Revenue ($m), 2007–2012
Figure 15: Diabetic Care Devices Market, Spain, Sales Trends for Major Players* ($m), 2007–2011
Figure 16: Orthopedic Devices Market, Spain, Revenue ($m), 2007–2012
Figure 17: Orthopedic Devices Market, Spain, Sales Trends for Major Players* ($m), 2007–2011
Figure 18: Cardiovascular Devices, Spain, Revenue ($m), 2007–2012
Figure 19: Cardiovascular Devices Market, Spain, Sales Trends for Major Players* ($m), 2007–2011
Figure 20: Ophthalmic Devices Market, Spain, Revenue ($m), 2007–2012
Figure 21: Ophthalmic Devices Market, Spain, Sales Trends for Major Players* ($m), 2007–2011
Figure 22: Diagnostics Market, Spain, Revenue ($m), 2007–2012
Figure 23: Diagnostic Market, Spain, Revenue ($m), Forecast, 2013–2020
Figure 24: Major Medical Device Companies, Spain, Revenue ($m), 2011
Figure 25: Drivers and Barriers, Healthcare Market, Spain, 2012
Figure 26: Evolution of SNS, Spain, 2012
Figure 27: Organization of Healthcare, Spain, 2012
Figure 28: Decision-making Process for the Inclusion of Medical Products and Pharmaceuticals in the SNS National Catalogue, Spain, 2009
Figure 29: Reimbursement Process, Spain, 2012
Figure 30: Spanish Pharmaceutical System, 2011
Figure 31: Roles of DGFPS and Interministerial Commission in Spain, 2011
Figure 32: Out-Of-Pocket Payment (% of Total Healthcare Expenditure), 2007–2012
Figure 33: Average Price Change of Prescription Drug (%), Spain, 2007–2012
Figure 34: Pricing of Pharmaceutical Products, Spain, 2011
Figure 35: AEMPS Structure, Spain, 2013
Figure 36: National Procedure, Pre-Submission, Spain, 2011
Figure 37: Centralized Procedure for Marketing Authorization, EU, Pre-Submission, 2013
Figure 38: Centralized Procedure, EU, Marketing Authorization, Pre-Opinion Phase, 2013
Figure 39: Centralized Procedure, EU, Marketing Authorization, Post-Opinion Phase, 2013
Figure 40: Decentralized Procedure, EU, Marketing Authorization, 2013
Figure 41: Mutual Recognition Procedure, EU, Marketing Authorization, 2013
Figure 42: Conformity Assessment of Class I Medical Devices, EU, 2013
Figure 43: Conformity Assessment of Class IIa Medical Devices, EU, 2013
Figure 44: Conformity Assessment of Class IIb Medical Devices, EU, 2013
Figure 45: Conformity Assessment of Class III Medical Devices, EU, 2013
Figure 46: GDP Annual Growth (%), Spain, 2007–2012
Figure 47: GDP Annual Growth (%), Spain, Forecast, 2013–2020
Figure 48: GDP Per Capita ($), Spain, 2007–2012
Figure 49: GDP Per Capita ($), Spain, Forecast, 2013–2020
Figure 50: GNI Per Capita ($), Spain, 2007–2012
Figure 51: Average Consumer Price Index, Spain, 2007–2012
Figure 52: Average Consumer Price, Annual Change (%), Spain, 2007–2012
Figure 53: Currency Exchange Rate (€/$), Spain, 2007–2012
Figure 54: Foreign Direct Investment ($bn), Spain, 2007–2011
Figure 55: Foreign Exchange Reserves ($bn), Spain, 2007–2012
Figure 56: Exports of Goods and Services ($bn), Spain, 2007–2012
Figure 57: Imports of Goods and Services ($bn), Spain, 2007–2012
Figure 58: General Government Structural Balance ($bn), Spain, 2007–2012
Figure 59: General Government Structural Balance ($bn), Spain, Forecast, 2013–2020
Figure 60: General Government Net Debt ($bn), Spain, 2007–2012
Figure 61: General Government Net Debt ($bn), Spain, Forecast, 2013–2020
Figure 62: Major Product Industries, Spain, Revenue ($bn), 2010–2011
Figure 63: Major Service Industries, Spain, Revenue ($bn), 2010
Figure 64: Population (million), Spain, 2007–2012
Figure 65: Population (million), Spain, Forecast, 2013–2020
Figure 66: Urban and Rural Population, Spain, Share (%), 2007–2012
Figure 67: Urban and Rural Population, Spain, Share (%), Forecast, 2013–2020
Figure 68: Age Groups, Population Distribution (%), Spain, 2007–2012
Figure 69: Age Groups, Population Distribution (%), Spain, Forecast, 2013–2020
Figure 70: Births (per 1,000 Population) Spain, 2007–2012
Figure 71: Crude Mortality Rate (Per 1,000 Population), Spain, 2007–2012
Figure 72: Infant Mortality and Under Five Mortality (Per 1,000 Live Births), Spain, 2007–2012
Figure 73: Major Causes of Mortality, Spain, 2011
Figure 74: Major Causes of Male Mortality, Spain, 2011
Figure 75: Major Causes of Female Mortality, Spain, 2011
Figure 76: Immunization Coverage among One-Year-Olds (%), Spain, 2007 and 2011
Figure 77: Gender Ratio (M/F), Spain, 2007–2012
Figure 78: Gender Ratio (M/F), Spain, 2011
Figure 79: Life Expectancy at Birth (Years), Female and Male, Spain, 2007–2012
Figure 80: Life Expectancy at Birth (Years), Female and Male, Spain, Forecast, 2013–2020
Figure 81: Life Expectancy at Age 65 (Years), Female and Male, Spain, 2007–2012
Figure 82: Life Expectancy at Age 65 (Years), Female and Male, Spain, Forecast, 2013–2020
Figure 83: Students Enrolled at Different Levels in Non-university Courses (%), 2011–2012
Figure 84: Students Enrolled at Different Levels in University Courses during Academic Year (%), 2011–2012
Figure 85: Employment Rate (% of Population of 16–64 Year-olds), Spain, 2007–2012
Figure 86: Employment by Economic Sector, Share (%), Spain, 2012
Figure 87: Number of Hospital Admissions (‘000), Spain, 2011
Figure 88: Major Diseases, Spain, DALY (Per 100,000 Population), 2004
Figure 89: Number of Hospitals, Spain, 2007–2012
Figure 90: Public and Private Hospitals, Share (%), Spain, 2007–2012
Figure 91: Hospitals by Type of Service, Spain, 2007–2012
Figure 92: Hospitals by Number of Beds, Spain, 2007–2012
Figure 93: Hospital Beds (‘000), Spain, 2007–2012
Figure 94: Public and Private Hospital Beds, Share(%), Spain, 2007–2012
Figure 95: Beds by Type of Care (‘000), Spain, 2007–2012
Figure 96: Hospitals by Standard of Care, Spain, Share (%), 2010
Figure 97: Diagnostic Faclilities in Hospitals, Spain, 2007–2012
Figure 98: Physicians (Per 1,000 Population), Spain, 2007–2012
Figure 99: General Practitioners (Per 100,000 Population), Spain, 2007–2012
Figure 100: Hospitals (Per 100,000 Population), Spain, 2007–2012
Figure 101: Hospital Beds (Per 100,000 Population), Spain, 2007–2012
Figure 102: Nitrogen Oxide Emission (Thousand Tons), Spain, 2007–2012
Figure 103: Sulfur Oxide Emission (Thousand Tons), Spain, 2007–2012
Figure 104: PM10 (Thousand Tons), Spain, 2007–2012
Figure 105: Carbon Dioxide Emission (Million Tons), Spain, 2007–2012
Figure 106: Nurses (Per 100,000 Population), Spain, 2007–2012
Figure 107: Pharmacists (Per 100,000 Population), Spain, 2007–2012
Figure 108: Dentists (Per 100,000 Population), Spain, 2007–2012
Figure 109: Healthcare Expenditure (% of GDP), Spain, 2007–2012
Figure 110: Major Components of Healthcare Expenditure (%), Spain, 2007–2010
Figure 111: Healthcare Expenditure, Spain, Public–Private Share (%), 2007–2012
Figure 112: Pharmaceutical R&D Expenditure ($bn), Spain, 2007–2012
Figure 113: Pharmaceutical R&D Expenditure ($m, %), Spain, 2011
Figure 114: Opportunities and Challenges, Healthcare Market, Spain, 2012

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