REFERENCE CODE GDHC0076CHR PUBLICATION DATE FEBRUARY 2015 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN

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1 REFERENCE CODE GDHC0076CHR PUBLICATION DATE FEBRUARY 2015 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN

2 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 period, to reach an estimated $XX billion by 2020 (AESGP, 2011; AESGP, 2014a). Pharmaceutical Market, Spain, Revenue ($bn), Revenue ($bn) CAGR ( ): 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 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%). 2

3 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction GlobalData Report Guidance Overview of the Pharmaceutical and Medical Device Markets Pharmaceutical Market Market Overview Pharmaceutical Exports and Imports Supply Channels Market Segments Overview of Top Five Disease Areas Major Players Medical Device Market Market Overview Overview of Top Five Segments Diagnostic Market Major Players Market Drivers and Barriers Drivers Barriers

4 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents 4 Market Access Reimbursement and Payer Landscape Overview of Healthcare System Reimbursement Process Overview of Insurance Providers Patient Share in Healthcare Spending Price Trend in Healthcare Services Pricing Policies Regulatory Landscape Overview of Regulatory Agencies Market Authorization Procedure for Pharmaceutical Products Market Authorization Procedure for Medical Devices Licensing Process for Pharmaceutical and Medical Device Manufacturing Licensing Process for Pharmaceutical Exports and Imports Intellectual Property Rights Clinical Trial Regulations Pharmaceutical Advertising Regulations Pharmacy Regulations Labeling and Packaging Regulations Country Analysis Political Environment Political Structure Analysis of the Current Political Environment

5 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents Healthcare Policy Initiatives Economic Landscape Economic Indicators Gross Domestic Product Gross National Income Inflation Currency Exchange Rate Foreign Direct Investment Foreign Exchange Reserves Trade Balance General Government Structural Balance General Government Net Debt Major Industries Demographics Population Education and Literacy Employment Disease Burden Healthcare Infrastructure Healthcare Facilities Healthcare Parameters Environmental Health Healthcare Personnel

6 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents 5.6 Healthcare Expenditure Overview Major Components of Healthcare Spending Public and Private Sector Share Spending in Healthcare, R&D Trade Associations Farmaindustria The Spanish Society of Public Health and Health Services Administration The Spanish Society of Health Informatics Spanish Generic Medicines Association Trade Fairs Opportunities and Challenges Opportunities Challenges Appendix Abbreviations Bibliography Research Methodology Coverage Secondary Research Forecasts Expert Panel Disclaimer

7 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents 1.1 List of Tables Table 1: Pharmaceutical Market, Spain, Revenue ($bn), Table 2: Pharmaceutical Market, Spain, Revenue Forecast ($bn), Table 3: Pharmaceutical Market, Spain, Pharmaceutical Exports and Imports ($bn), Table 4: Pharmaceutical Market, Spain, Pharmaceutical Mark-Ups, Table 5: Pharmaceutical Market, Spain, Generics Market, Drug Consumption by Volume (%), Table 6: Pharmaceutical Market, Spain, Red Biotechnology, Share of Diagnostics Pipeline by Disease Area (%), Table 7: Pharmaceutical Market, Spain, Red Biotechnology, Share of Therapeutics Pipeline by Disease Area (%), Table 8: Over the Counter Pharmaceutical Market, Spain, Share by Segment (%), Table 9: Pharmaceutical Market, Spain, Top Five Therapeutic Areas by Share of Drug Consumption (%), Table 10: Pharmaceutical Market, Pfizer, Major Products, Revenue ($bn) and Annual Growth (%), Table 11: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, Table 12: Pharmaceutical Market, Roche, Global, Major Products, Revenue ($bn) and Annual Growth (%), Table 13: Pharmaceutical Market, Roche, Global, Late-stage Pipeline, Table 14: Pharmaceutical Market, Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), Table 15: Pharmaceutical Market, Novartis, Global, Planned Filings, Table 16: Pharmaceutical Market, Sanofi, Global, Major Products, Revenue ($bn), Table 17: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, Table 18: Pharmaceutical Market, GlaxoSmithKline, Global, Major Products, Revenue ($bn) and Annual Growth (%),

8 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents Table 19: Pharmaceutical Market, GlaxoSmithKline, Global, Late-Stage Pipeline, Table 20: Medical Device Market, Spain, Revenue ($bn), Table 21: Medical Device Market, Spain, Revenue Forecast ($bn), Table 22: Medical Device Market, Spain, Top Five Segments, Revenue ($m) and Market Share (%), Table 23: Medical Device Market, Spain, In Vitro Diagnostics Revenue ($m), Table 24: Medical Device Market, Spain, In Vitro Diagnostics, Sales Trend for Major Players, Table 25: Medical Device Market, Spain, Diabetes Care Devices Revenue ($m), Table 26: Medical Device Market, Spain, Diabetes Care Devices, Sales Trend for Major Players, Table 27: Medical Device Market, Spain, Orthopedic Devices Revenue ($m), Table 28: Medical Device Market, Spain, Orthopedic Devices, Sales Trend for Major Players, Table 29: Medical Device Market, Spain, Cardiovascular Devices Market ($m), Table 30: Medical Device Market, Spain, Cardiovascular Devices Market, Sales Trend for Major Players, Table 31: Medical Device Market, Spain, Ophthalmic Devices Revenue ($m), Table 32: Medical Device Market, Spain, Ophthalmic Devices, Sales Trend for Major Players, Table 33: Medical Device Market, Spain, Diagnostic Market, Revenue ($bn), Table 34: Medical Device Market, Spain, Diagnostic Market, Revenue Forecast ($bn), Table 35: Medical Device Market, Spain, Major Medical Device Companies Revenue, Table 36: Medical Device Market, Roche, Global, Major Products, Table 37: Medical Device Market, Medtronic, Global, Major Products, Table 38: Medical Device Market, Abbott, Global, Major Products, Table 39: Medical Device Market, Abbott, Global, Late-Stage Pipeline, Table 40: Healthcare System, Spain, Pharmaceutical Reimbursement Categories, Table 41: Healthcare Spending, Spain, Out-of-Pocket Expenditure (%), Table 42: Market Access, Spain, Change in Average Price of Healthcare Services (%),

9 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents Table 43: Pricing Policies, Spain, Wholesaler and Pharmacist Margin on Drug Price, Table 44: Economic Indicators, Spain, Gross Domestic Product per Capita ($), Table 45: Economic Indicators, Spain, Gross Domestic Product per Capita Forecast ($), Table 46: Economic Indicators, Spain, Gross Domestic Product Annual Growth (%), Table 47: Economic Indicators, Spain, Gross Domestic Product Annual Growth Forecast (%), Table 48: Economic Indicators, Spain, Gross National Income per Capita ($), Table 49: Economic Indicators, Spain, Average Consumer Price Index, Table 50: Economic Indicators, Spain, Average Consumer Price Index Forecast, Table 51: Economic Indicators, Spain, Average Consumer Price Index Annual Change (%), Table 52: Economic Indicators, Spain, Euro to Dollar Currency Exchange Rate, Table 53: Economic Indicators, Spain, Foreign Direct Investment ($bn), Table 54: Economic Indicators, Spain, Foreign Exchange Reserves ($bn), Table 55: Economic Indicators, Spain, Imports of Goods and Services ($bn), Table 56: Economic Indicators, Spain, Exports of Goods and Services ($bn), Table 57: Economic Indicators, Spain, Government Structural Balance ($bn), Table 58: Economic Indicators, Spain, General Government Net Debt (% of GDP), Table 59: Economic Indicators, Spain, General Government Net Debt Forecast (% of GDP), Table 60: Economic Indicators, Spain, Major Industries by Revenue ($bn) and Share (%), Table 61: Demographics, Spain, Population (million), Table 62: Demographics, Spain, Population Forecast (million), Table 63: Demographics, Spain, Population, Urban and Rural Population Share (%), Table 64: Demographics, Spain, Population, Urban and Rural Population Share Forecast (%), Table 65: Demographics, Spain, Population Distribution by Age Group (%), Table 66: Demographics, Spain, Population Distribution by Age Group Forecast (%),

10 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents Table 67: Demographics, Spain, Births (per 1,000 Population), Table 68: Demographics, Spain, Mortality (per 1,000 Population), Table 69: Demographics, Spain, Major Causes of Mortality, Table 70: Demographics, Spain, Children <5 Years Age, Mortality Rate (%), Table 71: Demographics, Spain, Immunization Rate (%), Table 72: Demographics, Spain, Major Causes of Male Mortality, Table 73: Demographics, Spain, Major Causes of Female Mortality, Table 74: Demographics, Spain, Gender Ratio (Male to Female), Table 75: Demographics, Spain, Life Expectancy at Birth (Years), Table 76: Demographics, Spain, Students Enrolled at Different Levels in Non-university Courses (%), Table 77: Demographics, Spain, Students Enrolled at Different Levels in University Courses (%), Table 78: Demographics, Spain, Unemployment Rate (%), Table 79: Demographics, Spain, Distribution of Employment by Sectors (%), Table 80: Demographics, Spain, Number of Hospital Admissions and Diseases Diagnosed, Table 81: Demographics, Spain, Major Diseases, Disability-Adjusted Life Years (per 100,000 Population), Table 82: Healthcare Infrastructure, Spain, Number of Hospitals, Table 83: Healthcare Infrastructure, Spain, Number of Hospitals by Type of Treatment, Table 84: Healthcare Infrastructure, Spain, Number of Hospitals by Sector, Table 85: Healthcare Infrastructure, Spain, Diagnostic Units (per 1,000,000 Population), Table 86: Healthcare Infrastructure, Spain, Hospital Beds (per 1,000 Population), Table 87: Healthcare Infrastructure, Spain, Number of Hospital Beds by Sector, Table 88: Healthcare Infrastructure, Spain, Hospital Beds by type of treatment,

11 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents Table 89: Healthcare Infrastructure, Spain, Doctors (per 100,000 Population), Table 90: Healthcare Infrastructure, Spain, PM10 (µg/m 3 ), Table 91: Healthcare Infrastructure, Spain, CO 2 Emissions (Million Metric Tons), Table 92: Healthcare Infrastructure, Spain, Nurses (per 1,000 Population), Table 93: Healthcare Infrastructure, Spain, Pharmacists (per 1,000 Population), Table 94: Healthcare Infrastructure, Spain, Dentists (per 1,000 Population), Table 95: Healthcare Expenditure, Spain, Healthcare Expenditure (% of GDP), Table 96: Healthcare Expenditure, Spain, Major Components of Healthcare Expenditure (%), Table 97: Healthcare Expenditure, Spain, Healthcare Expenditure, Public-Private Share (%), Table 98: Healthcare Expenditure, Spain, Research and Development Expenditure by Field (%), Table 99: Healthcare Expenditure, Spain, Major Healthcare Trade Fairs,

12 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents 1.2 List of Figures Figure 1: Pharmaceutical Market, Spain, Revenue ($bn), Figure 2: Pharmaceutical Market, Spain, Revenue Forecast ($bn), Figure 3: Pharmaceutical Market, Spain, Pharmaceutical Exports and Imports ($bn), Figure 4: Pharmaceutical Market, Spain, Supply Channel, Figure 5: Pharmaceutical Market, Spain, Generics Market, Drug Consumption by Volume (%), Figure 6: Pharmaceutical Market, Spain, Red Biotechnology, Share of Diagnostics Pipeline by Disease Area (%), Figure 7: Pharmaceutical Market, Spain, Red Biotechnology, Share of Therapeutics Pipeline by Disease Area, Figure 8: OTC Pharmaceutical Market, Spain, Segment Share (%), Figure 9: Medical Device Market, Spain, Revenue ($bn), Figure 10: Medical Device Market, Spain, Revenue Forecast ($bn), Figure 11: Medical Device Market, Spain, Top Five Segments, Revenue ($m), Figure 12: Medical Device Market, Spain, In Vitro Diagnostics Revenue ($m), Figure 13: Medical Device Market, Spain, In Vitro Diagnostics, Sales Trend for Major Players, Revenue ($m), Figure 14: Medical Device Market, Spain, Diabetes Care Devices Revenue ($m), Figure 15: Medical Device Market, Spain, Diabetes Care Devices, Sales Trend for Major Players, Revenue ($m), Figure 16: Medical Device Market, Spain, Orthopedic Devices Revenue ($m), Figure 17: Medical Device Market, Spain, Orthopedic Devices, Sales Trend for Major Players, Revenue ($m), Figure 18: Medical Device Market, Spain, Cardiovascular Devices Market ($m), Figure 19: Medical Device Market, Spain, Cardiovascular Devices Market, Sales Trend for Major Players, Revenue ($m),

13 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents Figure 20: Medical Device Market, Spain, Ophthalmic Devices Revenue ($m), Figure 21: Medical Device Market, Spain, Ophthalmic Devices, Sales Trend for Major Players, Revenue ($m), Figure 22: Medical Device Market, Spain, Diagnostic Market, Revenue ($bn), Figure 23: Medical Device Market, Spain, Diagnostic Market, Revenue Forecast ($bn), Figure 24: Medical Device Market, Spain, Major Medical Device Companies, Revenue ($m), Figure 25: Healthcare Market, Spain, Drivers and Barriers, Figure 26: Healthcare System, Spain, Organization of the Spanish National Health System, Figure 27: Healthcare System, Spain, Health Technology Assessment Process, Figure 28: Healthcare Spending, Spain, Out-of-Pocket Expenditure (%), Figure 29: Market Access, Spain, Change in Average Price of Healthcare Services (%), Figure 30: Regulatory Landscape, Spain, AEMPS Organization, Figure 31: Market Authorization, Spain, National Procedure, Figure 32: Market Authorization, Spain, Centralized Procedure, Pre-Submission, Figure 33: Market Authorization, Spain, Centralized Procedure, Pre-Opinion Phase, Figure 34: Market Authorization, Spain, Centralized Procedure, Post-Opinion Phase, Figure 35: Market Authorization, Spain, Decentralized Procedure, Figure 36: Market Authorization, Spain, Mutual Recognition Procedure, Figure 37: Market Authorization, Spain, Conformity Assessment of Class I Medical Devices, Figure 38: Market Authorization, Spain, Conformity Assessment of Class IIa Medical Devices, Figure 39: Market Authorization, Spain, Conformity Assessment of Class IIb Medical Devices, Figure 40: Market Authorization, Spain, Conformity Assessment of Class III Medical Devices, Figure 41: Economic Indicators, Spain, Gross Domestic Product per Capita ($), Figure 42: Economic Indicators, Spain, Gross Domestic Product per Capita Forecast ($), Figure 43: Economic Indicators, Spain, Gross Domestic Product Annual Growth (%),

14 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents Figure 44: Economic Indicators, Spain, Gross Domestic Product Annual Growth Forecast (%), Figure 45: Economic Indicators, Spain, Gross National Income per Capita ($), Figure 46: Economic Indicators, Spain, Average Consumer Price Index, Figure 47: Economic Indicators, Spain, Average Consumer Price Index Forecast, Figure 48: Economic Indicators, Spain, Average Consumer Price Index Annual Change (%), Figure 49: Economic Indicators, Spain, Euro to Dollar Currency Exchange Rate, Figure 50: Economic Indicators, Spain, Foreign Direct Investment ($bn), Figure 51: Economic Indicators, Spain, Foreign Exchange Reserves ($bn), Figure 52: Economic Indicators, Spain, Imports of Goods and Services ($bn), Figure 53: Economic Indicators, Spain, Exports of Goods and Services ($bn), Figure 54: Economic Indicators, Spain, Government Structural Balance ($bn), Figure 55: Economic Indicators, Spain, General Government Net Debt (% of GDP), Figure 56: Economic Indicators, Spain, General Government Net Debt Forecast (% of GDP), Figure 57: Economic Indicators, Spain, Major Industries by Revenue ($bn), Figure 58: Demographics, Spain, Population (million), Figure 59: Demographics, Spain, Population Forecast (million), Figure 60: Demographics, Spain, Population, Urban and Rural Population Share (%), Figure 61: Demographics, Spain, Population, Urban and Rural Population Share Forecast (%), Figure 62: Demographics, Spain, Population Distribution by Age Group (%), Figure 63: Demographics, Spain, Population Distribution by Age Group Forecast (%), Figure 64: Demographics, Spain, Births (per 1,000 Population), Figure 65: Demographics, Spain, Mortality (per 1,000 Population), Figure 66: Demographics, Spain, Major Causes of Mortality, Figure 67: Demographics, Spain, Children <5 Years Age, Mortality Rate (%),

15 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents Figure 68: Demographics, Spain, Immunization Rate (%), Figure 69: Demographics, Spain, Major Causes of Male Mortality, Figure 70: Demographics, Spain, Major Causes of Female Mortality, Figure 71: Demographics, Spain, Gender Ratio (Male to Female), Figure 72: Demographics, Spain, Life Expectancy at Birth (Years), Figure 73: Demographics, Spain, Students Enrolled at Different Levels in Non-university Courses (%), Figure 74: Demographics, Spain, Students Enrolled at Different Levels in University Courses (%), Figure 75: Demographics, Spain, Unemployment Rate (%), Figure 76: Demographics, Spain, Distribution of Employment by Sector (%), Figure 77: Demographics, Spain, Number of Hospital Admissions and Diseases Diagnosed, Figure 78: Demographics, Spain, Major Diseases, Disability-Adjusted Life Years (per 100,000 Population), Figure 79: Healthcare Infrastructure, Spain, Number of Hospitals, Figure 80: Healthcare Infrastructure, Spain, Number of Hospitals by Type of Treatment, Figure 81: Healthcare Infrastructure, Spain, Number of Hospitals by Sector, Figure 82: Healthcare Infrastructure, Spain, Diagnostic Units (per 1,000,000 Population), Figure 83: Healthcare Infrastructure, Spain, Hospital Beds (per 1,000 Population), Figure 84: Healthcare Infrastructure, Spain, Number of Hospital Beds by Sector, Figure 85: Healthcare Infrastructure, Spain, Hospital Beds by Type of Treatment Provided, Figure 86: Healthcare Infrastructure, Spain, Doctors (per 100,000 Population), Figure 87: Healthcare Infrastructure, Spain, PM10 (µg/m 3 ), Figure 88: Healthcare Infrastructure, Spain, CO 2 Emissions (Million Metric Tons), Figure 89: Healthcare Infrastructure, Spain, Nurses (per 1,000 Population),

16 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Table of Contents Figure 90: Healthcare Infrastructure, Spain, Pharmacists (per 1,000 Population), Figure 91: Healthcare Infrastructure, Spain, Dentists (per 1,000 Population), Figure 92: Healthcare Expenditure, Spain, Healthcare Expenditure (% of GDP), Figure 93: Healthcare Expenditure, Spain, Major Components of Healthcare Expenditure (%), Figure 94: Healthcare Expenditure, Spain, Healthcare Expenditure, Public-Private Share (%), Figure 95: Healthcare Expenditure, Spain, Research and Development Expenditure by Field (%), Figure 96: Healthcare Market, Spain, Opportunities and Challenges,

17 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. 20

18 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Overview of the Pharmaceutical and Medical Device Markets 3.2 Medical Device Market 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 It is expected to reach $XX billion in Figure 9: Medical Device Market, Spain, Revenue ($bn), CAGR ( ): XX% Revenue ($bn) Source: GlobalData, Medical etrack [Accessed on December 3, 2014] Table 20: Medical Device Market, Spain, Revenue ($bn), Year Revenue Source: GlobalData, Medical etrack [Accessed on December 3, 2014] 78

19 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Country Analysis 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 Chemicals Motor vehicles Aerospace R & D services Pharmaceuticals Source: INE, Press release, November 14, 2013 IT related activities Scientific and technical activities Table 98: Healthcare Expenditure, Spain, Research and Development Expenditure by Field (%), 2012 Field R&D services Scientific and technical activities IT related activities Pharmaceuticals Aerospace Motor vehicles Chemicals Source: INE, press release, November 14, 2013 Share 264

20 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Appendix 7 Appendix 7.1 Abbreviations AC: ACL: AEC: AEMPS: Autonomous Community Anterior Cruciate Ligament Association of Community Nursing (Asociación de Enfermería Comunitaria) Spanish Agency for Medicines and Healthcare Products (Agencia Espanola del Medicamento y Productos Sanitarios) AES: AESEG: AJS: ALK+: AMAS: Association of Health Economics (Asociación de Economía de la Salud) Spanish Generic Medicines Association (Asociacion Española de Medicamentos) Association of Health Lawyers (Asociación de Juristas de la Salud) Anaplastic Lymphoma Kinase Positive Madrid Association of Health Administration (Asociación Madrileña de Administración Sanitaria) AMC: CA: CAGR: CC-CEIC: Asset Management Company Conformity Assessment Compound Annual Growth Rate Co-ordinating Center of the Research Ethics Committee (Centro Coordinador de los Comités Éticos de Investigación Clínica) CE: CEIC: CHMP: CIPM: Conformité Européenne Research Ethics Committee (Comité Ético de Investigación Clínica) Committee for Medicinal Products for Human Use Interministerial Commission on Pharmaceutical Prices (Comisión Interministerial de Precios de los Medicamentos) CMDh Co-ordination group for Mutual recognition and Decentralised procedures human 271

21 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Appendix CMH/CODEM Committee for Medicinal Products for Human Use (Comité de Medicamentos de Uso Humano) CMHS: CMS: CNS: CODEM: COMP: COPD: CPI: CRDM: CRL: CT: CT/NG CVS: DALY: DGFPS: Safety Committee for Medicinal products for Human Use Centers for Medicare and Medicaid Services Central Nervous System Comité de Medicamentos de Uso Humano Committee for Orphan Medicinal Products Chronic Obstructive Pulmonary Disease Consumer Price Index Cardiac Rhythm Disease Management Complete Response Letter Computed Tomography Chlamydia Trachomatis/Neisseria Gonorrhoeae Cardiovascular System Disability-Adjusted Life Year Directorate General of Pharmacy and Health Products (Dirección General de Farmacia y Productos Sanitarios) DPT: DRG: ecr: EFP: Diphtheria, Pertussis and Tetanus Diagnostic Related Groups electronic Clinical Records Advertisable Over-The-Counter Drugs (Especialidades Farmaceuticas Publicitarias) EMA: EMAP: European Medicines Agency Emerging Markets and Asia-Pacific 272

22 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Appendix ENT: FDA: FFPC: Forex: FROB: Ear, Nose and Throat Food and Drug Administration Fiscal and Financial Policy Council Foreign exchange Fund for Orderly Restructuring of Banks (Fondo De Reestructuración Ordenada Bancaria) GDP: GLP: GMP: GNI: GSK: HBV: HCV: HeFH: HIPATIA: HOM: HPV: HTA: IMSERSO: Gross Domestic Product Good Laboratory Practice Good Manufacturing Practice Gross National Income GlaxoSmithKline Hepatitis B Virus Hepatitis C Virus Heterozygous Familial Hypercholesterolemia Andalusian Public Health Association (Asociación Andaluza de Salud Pública) Hospital Only Medicines Human Papillomavirus Health Technology Assessment Instituto de Mayores y Servicios Sociales (National Institute of Health Management) INGESA: INSALUD: IPC: IPR: Instituto Nacional de Gestión Sanitaria (National Institute of Health Management) Instituto Nacional de la Salud (National Institute of Health) Interministerial Pricing Committee Intellectual Property Rights 273

23 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Appendix ISCIII: ISFAS: ITB: IVD: MA: MDD: MESS: MHLW: MOU: MRI: MSO: MSPS: MSSSI: Instituto de Salud Carlos III Social Institute for the Armed Forces (Instituto Social de las Fuerzas Armadas) Inter-Territorial Board In Vitro Diagnostics Marketing Authorization Medical Device Directives Ministry of Employment and Social Security Ministry of Health, Labour and Welfare Memorandum of Understanding Magnetic Resonance Imaging Medtronic Singapore Operations Ministerio de Sanidad Política Social (Ministry of Health and Social Policy) 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: NDA: NIBR: non-efp: OA: OEPM: OOP: OTC: General Justice Mutual Company (Mutualidad General Judicial, MUGEJU) New Drug Application Novartis Institutes for Biomedical Research non-advertizable OTC Osteoarthritis Oficina Espanola de Patentes y Marcas Out-Of-Pocket Over-The-Counter 274

24 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Appendix PCR: PM10: pred: PSOE: QC: QRD: REAP: RMS: RP: SAREB: Polymerase Chain Reactions Particulate Matter with an aerodynamic diameter of less than 10 micrometers pharma Research and Early Development Partido Socialista Obrero Español (Spanish Socialist Workers Party) Quality Control Quality Review of Documents Group Spanish Network of Primary Care (Red Española de Atención Primaria) Reference Member State Reference Pricing Company for the Management of Assets proceeding from Restructuring of the Banking System (Sociedad de Gestión de Activos procedentes de la Reestructuración Bancaria) SCSP: SEE: SEEP: Society of Public Health Canaria (Sociedad Canaria de Salud Pública) Spanish Society of Epidemiology 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) 275

25 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Appendix SSPCiB: Society of Public Health Catalunya i Balears (Societat de Salut Publica de Catalunya i de Balears) TCRC: UNICEF: VAT: Translational and Clinical Research Center United Nations Children s Fund Value Added Tax WHO : World Health Organization 7.2 Bibliography 10times (2014). Medical and Pharmaceutical Trade Shows in South Africa. 10times. Available from: [Accessed on November 11, 2014]. Abbott (2013) Investor Relations. Abbott. Available from: [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: 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: AEMPS (2012a). Presentación del Comité de Seguridad de Medicamentos de Uso Humano (CSMH). Agencia Española de Medicamentos y Productos Sanitarios. Available from: [Accessed on November 21, 2014]. 276

26 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Appendix World Bank (2014f). PM10 country level (micrograms per cubic meter). World Bank. Available from: [Accessed on October 17, 2014]. World Bank (2014g). CO2 emissions (metric tons per capita). World Bank. Available from: [Accessed on October 17, 2014]. World Bank (2014h). Out-of-pocket health expenditure (% of private expenditure on health). World Bank. Available from: [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 ( and Strategic and Competitive Intelligence Professionals ( All GlobalData databases are continuously updated and revised. The following research methodology is followed for all databases and reports 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. 294

27 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Appendix 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) 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 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. 295

28 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SPAIN Appendix 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. 296