REFERENCE CODE GDHC0072CHR PUBLICATION DATE DECEMBER 2014 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK

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1 REFERENCE CODE GDHC0072CHR PUBLICATION DATE DECEMBER 2014 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK

2 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Executive Summary Increasing demand for medicine and higher healthcare expenditure, as well as government healthcare reforms, will drive the pharmaceutical market. However, governmentinitiated price-cap agreements may restrain growth. The pharmaceutical market in Denmark was valued at $XX billion in 2013, dominated by the antineoplastic, Central Nervous System (CNS) and anti-infective drugs segments. The increasingly elderly population and the corresponding increase in the incidence of chronic diseases such as cancer and CNS diseases will boost future growth. Public healthcare expenditure accounted for an XX% share of total healthcare expenditure in 2013, which is much higher than the average for countries in the Organization for Economic Cooperation and Development (OECD): XX%. Healthcare reforms in 2007 led to a decrease in waiting times for patients, from two months to one, as well as extended free choice, which means that patients have the right to be treated in a private hospital if the waiting time exceeds one month. Increased healthcare expenditure and healthcare reforms will drive the pharmaceutical market. Since 2008, price-cap agreements have been hindering growth. In December 2011, a three-year price-cap agreement on medicines was signed by the Danish Ministry of Health (MoH) and the Danish Association of Pharmaceutical Industry (DAPI) as a continuation of the 2008 agreement. In the new price agreement, the prices of listed medicinal products will be reduced by XX%, effective from January 1, 2013 to the end of The extension of the agreement is a sign of the government s determination to keep the prices of medicinal products down (LIF, 2014a). The pharmaceutical market is expected to grow at a steady rate in the Danish krone but decline in US dollars at a Compound Annual Growth Rate (CAGR) of XX% from $XX billion in 2014 to $XX billion in 2020 (SSI, 2014). Pharmaceutical Market, Denmark, Revenue ($bn), Revenue ($bn) CAGR ( ): XX% Source: SSI,

3 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Table of Contents 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction GlobalData Report Guidance Overview of 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 DENMARK 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 Trends in the Healthcare Sector Pricing Policies Regulatory Landscape Overview of Regulatory Agencies Market Authorization Procedure for Pharmaceutical Products New Medical Device Approval Process Licensing Process for Pharmaceutical and Medical Device Manufacturing Exports and Imports Intellectual Property Rights Clinical Trial Regulations Pharmaceutical Advertising Regulations Pharmacy Regulations Labeling and Packaging Regulations Country Analysis Political Environment Political Structure Current Political Scenario

5 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Table of Contents 5.2 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 Gross Debt Major Industries Demographics Population Education and Literacy Employment Disease Burden Healthcare Infrastructure Healthcare Facilities Healthcare Parameters Environmental Health Healthcare Personnel Healthcare Expenditure

6 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Table of Contents Overview Share of Public and Private Sector Pharmaceutical and Healthcare R&D Expenditure Trade Associations Danish Association of the Pharmaceutical Industry Association of Danish Pharmacies Danish Generic Medicines Industry Association Danish Medical Association Trade Fairs Opportunities and Challenges Opportunities Challenges Appendix Abbreviation Bibliography Research Methodology Coverage Secondary Research Forecasts Expert Panel Disclaimer

7 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Table of Contents 1.1 List of Tables Table 1: Pharmaceutical Market, Denmark, Revenue ($bn), Table 2: Pharmaceutical Market, Denmark, Revenue Forecast ($bn), Table 3: Pharmaceutical Market, Denmark, Exports and Imports ($m), Table 4: Pharmaceutical Market, Denmark, Distribution Channel Price Margin (%), Table 5: Pharmaceutical Market, Denmark, Over-The-Counter Drugs Market Revenue ($m), Table 6: Pharmaceutical Market, Denmark, Antineoplastic Drug Market, Revenue ($m), Table 7: Pharmaceutical Market, Denmark, Central Nervous System Drug Market, Revenue ($m), Table 8: Pharmaceutical Market, Denmark, Anti-infective Drug Market, Revenue ($m), Table 9: Pharmaceutical Market, Denmark, Respiratory Drug Market, Revenue ($m), Table 10: Pharmaceutical Market, Denmark, Alimentary Tract Drug Market, Revenue ($m), Table 11: Pharmaceutical Market, Takeda, Global, Major Products, Table 12: Pharmaceutical Market, Takeda, Global, Late-Stage Pipeline, Table 13: Pharmaceutical Market, Novo Nordisk, Global, Major Products, Table 14: Pharmaceutical Market, Novo Nordisk, Global, Late-Stage Pipeline, Table 15: Pharmaceutical Market, Lundbeck, Global, Major Products, Table 16: Pharmaceutical Market, Lundbeck, Global, Late-Stage Pipeline, Table 17: Medical Device Market, Denmark, Revenue ($bn), Table 18: Medical Device Market, Denmark, Revenue Forecast ($bn), Table 19: Medical Device Market, Denmark, Revenue by Segment, Table 20: Medical Device Market, Denmark, Ophthalmic Devices Market, Revenue ($m), Table 21: Medical Device Market, Denmark, Ophthalmic Devices Market, Sales Trends for Major Players, Table 22: Medical Device Market, Denmark, In Vitro Diagnostic Market, Revenue ($m),

8 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Table of Contents Table 23: Medical Device Market, Denmark, In Vitro Diagnostic Market, Sales Trends for Major Players, Table 24: Medical Device Market, Denmark, Orthopedic Market, Revenue ($m), Table 25: Medical Device Market, Denmark, Orthopedic Market, Sales Trends for Major Players, Table 26: Medical Device Market, Denmark, Diagnostic Imaging Market, Revenue ($m), Table 27: Medical Device Market, Denmark, Diagnostic Imaging Market, Sales Trends for Major Players, Table 28: Medical Device Market, Denmark, Healthcare IT Market, Revenue ($m), Table 29: Medical Device Market, Denmark, Healthcare IT Market, Sales Trends for Major Players, Table 30: Medical Device Market, Denmark, Diagnostic Market, Revenue ($bn), Table 31: Medical Device Market, Denmark, Diagnostic Market, Revenue Forecast ($bn), Table 32: Medical Device Market, Denmark, Major Medical Device Companies, Revenue, Table 33: Medical Device Market, Roche, Global, Major Products, Table 34: Medical Device Market, Medtronic, Global, Major Products, Table 35: Market Access, Denmark, Reimbursement Threshold, Table 36: Market Access, Denmark, Health Insurance Coverage, Table 37: Healthcare Spending, Denmark, Out-Of-Pocket Expenditure (%), Table 38: Market Access, Denmark, Consumer Price Index Annual Change (%), Table 39: Market Authorisation, Denmark, Stages in Processing of Application, Table 40: Market Authorisation, Denmark, Net Assessment Time and Clock Stop Periods, Table 41: Market Access, Denmark, Prices and Payments for Patents, Error! Bookmark not defined. Table 42: Economic Indicators, Denmark, Gross Domestic Product per Capita ($), Table 43: Economic Indicators, Denmark, Gross Domestic Product per Capita ($), Table 44: Economic Indicators, Denmark, Gross Domestic Product Annual Growth (%),

9 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Table of Contents Table 45: Economic Indicators, Denmark, Gross Domestic Product Annual Growth Forecast (%), Table 46: Economic Indicators, Denmark, Gross National Income per Capita ($), Table 47: Economic Indicators, Denmark, Average Consumer Price Index, Table 48: Economic Indicators, Denmark, Average Consumer Price Index Forecast, Table 49: Economic Indicators, Denmark, Average Consumer Price Annual Change (%), Table 50: Economic Indicators, Denmark, Currency Exchange Rate ($/DKK), Table 51: Economic Indicators, Denmark, Foreign Direct Investment ($bn), Table 52: Economic Indicators, Denmark, Forex Reserves ($bn), Table 53: Economic Indicators, Denmark, Import of Goods and Services ($bn), Table 54: Economic Indicators, Denmark, Exports of Goods and Services ($bn), Table 55: Economic Indicators, Denmark, General Government Structural Balance ($bn), Table 56: Economic Indicators, Denmark, General Government Gross Debt (% of GDP), Table 57: Economic Indicators, Denmark, Major Industries, Output ($bn), Table 58: Demographics, Denmark, Population (million), Table 59: Demographics, Denmark, Population Forecast (million), Table 60: Demographics, Denmark, Population, Urban and Rural Population Share (%), Table 61: Demographics, Denmark, Population, Urban and Rural Population Share Forecast (%), Table 62: Demographics, Denmark, Population Distribution by Age Group (%), Table 63: Demographics, Denmark, Population Distribution by Age Group Forecast (%), Table 64: Demographics, Denmark, Births (per 1,000 Population), Table 65: Demographics, Denmark, Mortality (per 1,000 Population), Table 66: Demographics, Denmark, Major Causes of Mortality,

10 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Table of Contents Table 67: Demographics, Denmark, Mortality Rate of Children under Five (per 1,000 Live Births), Table 68: Demographics, Denmark, Immunization Rate (%), Table 69: Demographics, Denmark, Major Causes of Male Mortality, Table 70: Demographics, Denmark, Major Causes of Female Mortality, Table 71: Demographics, Denmark, Gender Ratio (M/F), Table 72: Demographics, Denmark, Life Expectancy at Birth (Years), Table 73: Demographics, Denmark, Student Enrollment by Level of Education (%), Table 74: Demographics, Denmark, Unemployment Rate (%), Table 75: Demographics, Denmark, Major Diseases, Male Hospitalization, Table 76: Demographics, Denmark, Major Diseases, Female Hospitalization, Table 77: Demographics, Denmark, Major Diseases, DALYs (per 100,000 Population), Table 78: Healthcare Infrastructure, Denmark, Hospitals, Table 79: Healthcare Infrastructure, Denmark, Diagnostic Equipment Units (per Million Population), Table 80: Healthcare Infrastructure, Denmark, Hospitals Beds (per 1,000 Population), Table 81: Healthcare Infrastructure, Denmark, Physicians (per 1,000 Population), Table 82: Healthcare Infrastructure, Denmark, CO 2 Emissions (Million Metric Tons), Table 83: Healthcare Infrastructure, Denmark, SO 2 Emissions (Million Metric Tons), Table 84: Healthcare Infrastructure, Denmark, CH 4 Emissions (Million Metric Tons), Table 85: Healthcare Infrastructure, Denmark, CO Emissions (Million Metric Tons), Table 86: Healthcare Infrastructure, Denmark, PM10 (µg/m), Table 87: Healthcare Infrastructure, Denmark, Nurses (per 1,000 Population), Table 88: Healthcare Infrastructure, Denmark, Pharmacist (per 1,000 Population), Table 89: Healthcare Infrastructure, Denmark, Dentists (per 1,000 Population),

11 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Table of Contents Table 90: Healthcare Expenditure, Denmark, Healthcare Expenditure (% of GDP), Table 91: Healthcare Expenditure, Denmark, Public-Private Share (%), Table 92: Healthcare Expenditure, Denmark, Research and Development Expenditure ($bn), Table 93: Healthcare Expenditure, Denmark, Major Healthcare Trade Fairs, List of Figures Figure 1: Pharmaceutical Market, Denmark, Revenue ($bn), Figure 2: Pharmaceutical Market, Denmark, Revenue Forecast ($bn), Figure 3: Pharmaceutical Market, Denmark, Exports and Imports ($m), Figure 4: Pharmaceutical Market, Denmark, Distribution Channels, Figure 5: Pharmaceutical Market, Denmark, Over-The-Counter Drugs Market Revenue ($m), Figure 6: Pharmaceutical Market, Denmark, Antineoplastic Drug Market, Revenue ($m), Figure 7: Pharmaceutical Market, Denmark, Central Nervous System Drug Market, Revenue ($m), Figure 8: Pharmaceutical Market, Denmark, Anti-infective Drug Market, Revenue ($m), Figure 9: Pharmaceutical Market, Denmark, Respiratory Drug Market, Revenue ($m), Figure 10: Pharmaceutical Market, Denmark, Alimentary Tract Drug Market, Revenue ($m), Figure 11: Medical Device Market, Denmark, Revenue ($bn), Figure 12: Medical Device Market, Denmark, Revenue Forecast ($bn), Figure 13: Medical Device Market, Denmark, Revenue by Segment ($m), Figure 14: Medical Device Market, Denmark, Ophthalmic Devices Market, Revenue ($m), Figure 15: Medical Device Market, Denmark, Ophthalmic Devices Market, Sales Trends for Major Players, Figure 16: Medical Device Market, Denmark, In Vitro Diagnostic Market, Revenue ($m),

12 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Table of Contents Figure 17: Medical Device Market, Denmark, In Vitro Diagnostic Market, Sales Trends for Major Players, Figure 18: Medical Device Market, Denmark, Orthopedic Market, Revenue ($m), Figure 19: Medical Device Market, Denmark, Orthopedic Market, Sales Trends for Major Players, Figure 20: Medical Device Market, Denmark, Diagnostic Imaging Market, Revenue ($m), Figure 21: Medical Device Market, Denmark, Diagnostic Imaging Market, Sales Trends for Major Players, Figure 22: Medical Device Market, Denmark, Healthcare IT Market, Revenue ($m), Figure 23: Medical Device Market, Denmark, Healthcare IT Market, Sales Trends for Major Players, Figure 24: Medical Device Market, Denmark, Diagnostic Market, Revenue ($bn), Figure 25: Medical Device Market, Denmark, Diagnostic Market, Revenue Forecast ($bn), Figure 26: Medical Device Market, Denmark, Major Medical Device Companies, Revenue ($m), Figure 27: Healthcare Market, Denmark, Drivers and Barriers, Figure 28: Market Access, Denmark, Healthcare System Financing, Figure 29: Market Access, Denmark, Healthcare System Key Players, Figure 30: Healthcare Spending, Denmark, Out-Of-Pocket Expenditure (%), Figure 31: Market Access, Denmark, Consumer Price Index Annual Change (%), Figure 32: Market Access, Denmark, Regulatory Agencies, Figure 33: Market Authorisation, Denmark, National Procedure, Figure 34: Market Authorization, Denmark, Centralized Process: Pre-submission Phase, Figure 35: Market Authorization, Denmark, Centralized Process: Pre-opinion Phase, Figure 36: Market Authorization, Denmark, Centralized Process: Post-opinion Phase, Figure 37: Market Authorization, Denmark, Decentralized Procedure,

13 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Table of Contents Figure 38: Market Authorization, Denmark, Mutual Recognition Procedure, Figure 39: Market Authorization, Denmark, Conformity Assessment of Class I Medical Devices, EU, Figure 40: Market Authorization, Denmark, Conformity Assessment of Class IIa Medical Devices, EU, Figure 41: Market Authorization, Denmark, Conformity Assessment of Class IIb Medical Devices, EU, Figure 42: Market Authorization, Denmark, Conformity Assessment of Class III Medical Devices, EU, Figure 43: Economic Indicators, Denmark, Gross Domestic Product per Capita ($), Figure 44: Economic Indicators, Denmark, Gross Domestic Product per Capita Forecast ($), Figure 45: Economic Indicators, Denmark, Gross Domestic Product Annual Growth (%), Figure 46: Economic Indicators, Denmark, Gross Domestic Product Annual Growth Forecast (%), Figure 47: Economic Indicators, Denmark, Gross National Income per Capita ($), Figure 48: Economic Indicators, Denmark, Average Consumer Price Index, Figure 49: Economic Indicators, Denmark, Average Consumer Price Index Forecast, Figure 50: Economic Indicators, Denmark, Average Consumer Price Annual Change (%), Figure 51: Economic Indicators, Denmark, Currency Exchange Rate ($/DKK), Figure 52: Economic Indicators, Denmark, Foreign Direct Investment ($bn), Figure 53: Economic Indicators, Denmark, Forex Reserves ($bn), Figure 54: Economic Indicators, Denmark, Imports of Goods and Services ($bn), Figure 55: Economic Indicators, Denmark, Exports of Goods and Services ($bn), Figure 56: Economic Indicators, Denmark, General Government Structural Balance ($bn), Figure 57: Economic Indicators, Denmark, General Government Gross Debt (% of GDP), Figure 58: Economic Indicators, Denmark, Major Industries, Output ($bn), Figure 59: Demographics, Denmark, Population (million), Figure 60: Demographics, Denmark, Population Forecast (million), Figure 61: Demographics, Denmark, Population, Urban and Rural Population Share (%),

14 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Table of Contents Figure 62: Demographics, Denmark, Population, Urban and Rural Population Share Forecast (%), Figure 63: Demographics, Denmark, Population Distribution by Age Group (%), Figure 64: Demographics, Denmark, Population Distribution by Age Group Forecast (%), Figure 65: Demographics, Denmark, Births (per 1,000 Population), Figure 66: Demographics, Denmark, Mortality (per 1,000 Population), Figure 67: Demographics, Denmark, Major Causes of Mortality, Figure 68: Demographics, Denmark, Mortality Rate of Children under Five (per 1,000 Live Births), Figure 69: Demographics, Denmark, Immunization Rate (%), Figure 70: Demographics, Denmark, Major Causes of Male Mortality, Figure 71: Demographics, Denmark, Major Causes of Female Mortality, Figure 72: Demographics, Denmark, Gender Ratio (M/F), Figure 73: Demographics, Denmark, Life Expectancy at Birth (Years), Figure 74: Demographics, Denmark, Student Enrollment by Level of Education (%), Figure 75: Demographics, Denmark, Unemployment Rate (%), Figure 76: Demographics, Denmark, Major Diseases, Male Hospitalization, Figure 77: Demographics, Denmark, Major Diseases, Female Hospitalization, Figure 78: Demographics, Denmark, Major Diseases, DALYs (per 100,000 Population), Figure 79: Healthcare Infrastructure, Denmark, Hospitals, Figure 80: Healthcare Infrastructure, Denmark, Diagnostic Equipment Units (per Million Population), Figure 81: Healthcare Infrastructure, Denmark, Hospitals Beds (per 1,000 Population), Figure 82: Healthcare Infrastructure, Denmark, Physicians (per 1,000 Population), Figure 83: Healthcare Infrastructure, Denmark, CO 2 Emissions (Million Metric Tons),

15 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Table of Contents Figure 84: Healthcare Infrastructure, Denmark, SO 2 Emissions (Million Metric Tons), Figure 85: Healthcare Infrastructure, Denmark, CH 4 Emissions (Million Metric Tons), Figure 86: Healthcare Infrastructure, Denmark, CO Emissions (Million Metric Tons), Figure 87: Healthcare Infrastructure, Denmark, PM10 (µg/m), Figure 88: Healthcare Infrastructure, Denmark, Nurses (per 1,000 Population), Figure 89: Healthcare Infrastructure, Denmark, Pharmacist (per 1,000 Population), Figure 90: Healthcare Infrastructure, Denmark, Dentists (per 1,000 Population), Figure 91: Healthcare Expenditure, Denmark, Healthcare Expenditure (% of GDP), Figure 92: Healthcare Expenditure, Denmark, Public-Private Share (%), Figure 93: Healthcare Expenditure, Denmark, Research and Development Expenditure ($bn), Figure 94: Healthcare Market, Denmark, Opportunities and Challenges,

16 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Introduction 2 Introduction 2.1 GlobalData Report Guidance The report begins with an executive summary, which gives an overview of Denmark s 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 Denmark s pharmaceutical and medical device markets, covering the market size and generic, Over-The-Counter (OTC) and biologic/biosimilar product segment shares, as well as the market s key drivers and barriers. It also includes SWOT assessments and profiles of the major market players. Chapter four analyzes the reimbursement and payer landscape, covering the reimbursement process, insurance providers, pricing policies and drug price trends in Denmark. It also looks at the regulatory landscape and provides an overview of the regulatory agencies and approval processes for new drugs and medical devices. Also covered are the licensing processes for the manufacture, export and import of pharmaceuticals and the regulations in place for pharmaceutical advertising, labeling, packaging and clinical trials. An overview of intellectual property rights is also provided. Chapter five analyzes the political and economic environment in Denmark, covering economic indicators, demographics, and healthcare infrastructure and expenditure. Chapter six provides an overview of the opportunities for and challenges facing the growth of Denmark s healthcare market. 19

17 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Overview of Pharmaceutical and Medical Device Markets 3.2 Medical Device Market Market Overview Denmark s medical device market is growing due to the increasingly elderly population and subsequent increase in the demand for healthcare products, services and new technologies. It was valued at $XX billion in 2008 and grew at a CAGR of XX% to reach $XX billion The market is expected to reach $XX billion by Figure 11: Medical Device Market, Denmark, Revenue ($bn), CAGR ( ): XX% Revenue ($bn) Source: GlobalData, Medical etrack [Accessed on September 9, 2014] Table 17: Medical Device Market, Denmark, Revenue ($bn), Year Revenue Source: GlobalData, Medical etrack [Accessed on September 9, 2014] 63

18 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Appendix 7 Appendix 7.1 Abbreviation µg/m: ANDA: API: BCG: CA: CAGR: CESP: CH 4 : CHMP: CI&T: CMS: CNS: COMP: COPD: COSAT: CPI: CPS: CRDM: CRL: CT: CTR: CVD: microgram per meter Abbreviated New Drug Application Active Pharmaceutical Ingredient Bacillus Calmette-Guerin Conformity Assessment Compound Annual Growth Rate Common European Submission Platform Methane Committee for Medicinal Products for Human Use Center for Innovation and Technologies Concerned Member State Central Nervous System Committee for Orphan Medicinal Products Chronic Obstructive Pulmonary Disease Corporate Office of Science and Technology Consumer Price Index Counts per Second Cardiac Rhythm Disease Management Complete Response Letter Computed Tomography Central Reimbursement Register Cardiovascular Disease 232

19 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Appendix DACEHTA: DALY: DAPI: DCE: DGMIA: DHMA: DKK: DKPTO: DMA: DPA: DPT: EEA: EFPIA: EGA: EMA: ENT: EO: EPA: EPO: EUnetHTA: FDA: FDAAA: FDI: FOL: Danish Centre for Health Technology Assessment Disability-Adjusted Life Year Danish Association of Pharmaceutical Industry Danish Council of Ethics Danish Generic Medicine Industry association Danish Health and Medicines Authority Danish krone Danish Patent and Trademark Office Danish Medical Association Danish Pharmacy Act Diphtheria, Pertussis, and Tetanus European Economic Area European Federation of Pharmaceutical Industry Association European Generic Medicines Association European Medicines Agency Ear, Nose and Throat Executive Order Environment Protection Agency European Patent Office European Network for Health Technology Assessment Food and Drug Administration Food and Drug Administration Amendments Act Foreign Direct Investment Folic Acid 233

20 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Appendix Forex: GCP: GDP: GLP: GMO: GMP: GNI: GP: gred: ICH: IMF: IVD: LIF: LoQ: MA: MAA: MAH: MDD: MD&D: MII: MNC: MoH: MP AG: MRI: Foreign exchange Good Clinical Practice Gross Domestic Product Good Laboratory Practice Genetically Modified Organism Good Manufacturing Practice Gross National Income General Practitioner Genentech Research and Early Development International Conference on Harmonization International Monetary Fund In Vitro Diagnostics Lägemiddelindustriforeningen (Danish Association of the Pharmaceutical Industry) List of Questions Marketing Authorization Market Authorization Application Market Authorization Holder Medical Device Directive Medical Device and Diagnostic Medical Imaging Information Multi-National Company Ministry of Health Molecular Partners AG Magnetic Resonance Imaging 234

21 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Appendix MSO: NAP: NBH: OECD: OEM: OOP: OTC: PCR: PM10: POM: PPP: pred: PRV: QC: R&D: RLI: RMS: SBS: SEC: SFDA: SME: SO 2 : SPC: SSI: Medtronic Singapore Operations National Allocation Plan National Board of Health Organization for Economic Co-operation and Development Original Equipment Manufacturer Out-of-Pocket Over-The-Counter Polymerase Chain Reaction Particulate Matter with a diameter of less than 10 micrometers Prescription-Only Medicine Pharmacy Purchasing Price pharma Research and Early Development Swedish Patent Office Quality Control Research and Development Roche Laboratories Inc. Reference Member State Short-Bowel Syndrome Scientific Ethical Committee Chinese State Food and Drug Administration Small and Medium Entrepreneurs Sulfur dioxide Summary of Product Characteristics Statens Serum Institute 235

22 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Appendix TB: UNFCCC: VAT: VHI: VNAR: WHO: Tuberculosis United Nations Framework Convention on Climate Change Value Added Tax Voluntary Health Insurance Variable New Antigen Receptor World Health Organization 236

23 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Appendix 7.2 Bibliography 10times (2014). Medical & Pharmaceutical Trade shows in Denmark. 10times. Available from: [Accessed on August 26, 2014] ADP (2014). About Association of Danish Pharmacies. Association of Danish Pharmacies. Available from: sh%20%20%20nyt%20apotekerforeningen%20dk.ash [Accessed on September 8, 2014] CMDh (2013). Recommendation for submission date for applicants of the mutual recognition procedure. Co-ordination Group for Mutual Recognition and Decentralization Procedure. Available from: tion_for_ma/mrp/cmdh_082_2005_rev.06_2013_11.pdf CMDh (2014). Recommendation for submission date for applicants of the mutual recognition procedure. Co-ordination Group for Mutual Recognition and Decentralization Procedure. Available from: tion_for_ma/dcp/cmdh_078_2005_rev05_01_2014_clean_a.pdf DAPI (2014). Price Cap Agreement. Danish Association of Pharmaceutical Industry. Available from: DCE (2014). The history and spheres of work of the council. Danish Council of Ethics. Available from: [Accessed on September 5, 2014] DMCEB (2014). From coal, oil and gas to energy. Danish Ministry of Climate, Energy and Building. Available from: [Accessed on September 12, 2014] DD (2014). The Danish judicial system. Danmarks Domstole. Available from: dicialsystem.aspx [Accessed on September 7, 2014] 237

24 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Appendix World Bank (2014f). Mortality rate, infant (per 1,000 live births). World Bank. Available from: [Accessed on August 17, 2014] World Bank (2014g). School enrollment, preprimary (% gross). World Bank. Available from: [Accessed on August 17, 2014] World Bank (2014h). School enrollment, primary (% gross). World Bank. Available from: [Accessed on August 17, 2014] World Bank (2014i). School enrollment, secondary (% gross). World Bank. Available from: [Accessed on August 17, 2014] World Bank (2014j). School enrollment, tertiary (% gross). World Bank. Available from: [Accessed on August 17, 2014] World Bank (2014k). Health expenditure, total (% of GDP). World Bank. Available from: [Accessed on August 20, 2014] World Bank (2014l). CO2 emissions (kt). World Bank. Available from: [Accessed on August 20, 2014] World Bank (2014m). PM10, country level (micrograms per cubic meter). World Bank. [Accessed on August 20, 2014] World Bank (2014n). Health expenditure, public (% of total health expenditure). World Bank. Available from: [Accessed on August 20, 2014] World Bank (2014o). Immunization, measles (% of children ages months). World Bank. Available from: [Accessed on August 17, 2014] World Bank (2014p). Immunization, DPT (% of children ages months). World Bank. Available from: [Accessed on August 17, 2014] World Health Organization (2009). Disability Adjusted Life Years. World Health Organization. Available from: [Accessed on August 20, 2014] 248

25 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Appendix 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. 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). 249

26 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Appendix 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 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. 250

27 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE DENMARK Appendix 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. 251