GDHC0043CHR Healthcare, Regulatory and Reimbursement … › product › sample-7495061.pdf · Reference Code: GDHC0043CHR Publication Date: March 2013 Healthcare, Regulatory and

Reference Code: GDHC0043CHR Publication Date: March 2013

Healthcare, Regulatory and Reimbursement Landscape

Finland

Healthcare, Regulatory and Reimbursement Landscape Finland

GDHC0043CHR / Published MAR 2013 Page 2

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form

An Efficient three-tier Medical Reimbursement System and the Rising Pharmaceutical Exports Provide the Necessary Impetus for Growth of the Finnish Pharmaceutical Market.

The pharmaceutical market of Finland was estimated at $XX billion in 2007 and is projected to reach approximately $XX billion by 2020 at a Compound Annual Growth Rate (CAGR) of XX%. The key factors driving future growth of the Finnish pharmaceutical market include

An efficient three-tier reimbursement system for medicines helps in sharing the cost of the treatment and reduces the burden of patients. It simplifies the reimbursement process as the reimbursed amount is credited directly in the social security card of the patient at the pharmacy.

Increasing pharmaceutical exports with neighboring countries such as Russia, Switzerland and other European Union (EU) countries. In 2011, Russia accounted for XX% of Finland’s pharmaceutical exports.

During the period 2007–2012, the elderly population grew from XX% to XX% of the total population. Rising elderly population will increase the risk of the associated chronic diseases such as cardiovascular disorders and neoplasm.

Pharmaceutical Market ($bn), Finland, 2007–2020

2007 2012 2015* 2020*

Rev

enue

($bn

)

Year

CAGR (2007−2020): XX%

Source: GlobalData; THL , 2010a *Estimated values

The Finnish medical device market was worth approximately $XX billion in 2007 and is expected to grow to approximately $XX billion by 2020 at a CAGR of XX%. In terms of market share, the main segments in 2012 were ophthalmic devices (with XX%), orthopedic devices (with XX%) and cardiovascular devices (with XX%). With a rapidly growing elderly population and awareness of chronic diseases rising, the medical care and diagnostic markets in Finland are expected to see strong growth in the future.

Medical Device Market ($bn), Finland, 2007–2020

2007 2012 2015* 2020*

Rev

enue

($bn

)

Year

CAGR (2007−2020): XX%

Source: GlobalData, Medical eTrack, [accessed August 29,, 2012] *Estimated values

As a Member of the EU, Finland Shares a Common Regulatory Platform with other Member States, thereby Offering a Strong and Transparent Regulatory System to Facilitate the Approval of Pharmaceutical Products and Medical Devices.

The Finnish Medicines Agency (Lääkealan turvallisuus ja kehittämiskeskus (Fimea)) is the national competent authority for regulating pharmaceuticals in Finland. Fimea operates under the Ministry of Social Affairs and Health. Fimea maintains close cooperation with relevant parties and stakeholders in the pharmaceutical field. Fimea also strengthens its collaboration with the European Medicines Agency (EMA) with regard to the regulatory processes of medicinal products in the EU.

Fimea is expected to process a new drug approval application within 210 days of its receipt. Fimea assess the efficacy, safety and quality of the medicine in question and, if necessary, employs outside experts in the process. The Medicines Act XX/XX is responsible for ensuring the appropriate manufacture and availability of medicinal products in Finland.

Universal Healthcare Coverage, Access to Healthcare Facilities and a National Health Insurance System Make a Finland a Mature Healthcare Market.

The healthcare system in Finland is financed mainly by municipal financing based on general taxation and National Health Insurance (NHI), funded by an earned income insurance component and a medical care insurance component.

The municipality is responsible for providing primary healthcare through health centers that are governed by the municipality or local federation of municipalities, and specialized care is mainly provided by hospitals maintained by the hospital districts.




1 Table of Contents 1 Table of Contents ............................................................................................................................ 4

1.1 List of Tables ............................................................................................................................. 6 1.2 List of Figures............................................................................................................................ 8

2 Introduction ................................................................................................................................... 10 2.1 Report Guidance ..................................................................................................................... 10

3 Overview of Pharmaceutical and Medical Device Market ................................................................. 11 3.1 Pharmaceutical Market ............................................................................................................ 11

3.1.1 Overview ........................................................................................................................ 11 3.1.2 Pharmaceutical Imports and Exports ............................................................................... 14 3.1.3 Supply Channels ............................................................................................................ 17 3.1.4 Market Segment ............................................................................................................. 19 3.1.5 Major Disease Areas....................................................................................................... 23 3.1.6 Major Players ................................................................................................................. 27

3.2 Medical Device Market ............................................................................................................ 58 3.2.1 Overview ........................................................................................................................ 58 3.2.2 Overview of the Top Five Segments ................................................................................ 60 3.2.3 Major Players ................................................................................................................. 73 3.2.4 Market Drivers and Barriers............................................................................................. 94

4 Market Access ............................................................................................................................... 97 4.1 Reimbursement and Payers Landscape ................................................................................... 97

4.1.1 Overview of Healthcare System ...................................................................................... 97 4.1.2 Reimbursement Process ................................................................................................. 99 4.1.3 Overview of Insurance Providers ................................................................................... 101 4.1.4 Patient Share in Healthcare Spending ........................................................................... 103 4.1.5 Healthcare Price Trends ............................................................................................... 104 4.1.6 Pricing Policies ............................................................................................................. 105

4.2 Regulatory Landscape ........................................................................................................... 106 4.2.1 Overview of Regulatory Agencies .................................................................................. 106 4.2.2 New Drug Approval Procedure ...................................................................................... 108 4.2.3 New Medical Device Approval Process .......................................................................... 115 4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing ...................... 120 4.2.5 Licensing Process for Pharmaceutical Exports and Imports ............................................ 120 4.2.6 Intellectual Property Rights ........................................................................................... 121 4.2.7 Clinical Trial Regulations ............................................................................................... 123 4.2.8 Pharmaceutical and Medical Device Advertising Regulations ......................................... 124 4.2.9 Pharmacy Regulations .................................................................................................. 125 4.2.10 Labeling and Packaging Regulations ............................................................................. 125

5 Country Analysis .......................................................................................................................... 127 5.1 Political Environment ............................................................................................................. 127

5.1.1 Political Structure .......................................................................................................... 127 5.1.2 Analysis of Current Political Environment ....................................................................... 127 5.1.3 Healthcare Policy Initiatives........................................................................................... 128

5.2 Economic Landscape ............................................................................................................ 128 5.3 Economic Indicators .............................................................................................................. 129

5.3.1 Gross Domestic Product ............................................................................................... 129 5.3.2 Gross National Income.................................................................................................. 133 5.3.3 Inflation ........................................................................................................................ 134 5.3.4 Currency Exchange Rate .............................................................................................. 137 5.3.5 Foreign Direct Investment ............................................................................................. 138 5.3.6 Foreign Exchange Reserves ......................................................................................... 139 5.3.7 Trade Balance .............................................................................................................. 140 5.3.8 Government Structural Balance ..................................................................................... 142 5.3.9 Government Net Debt ................................................................................................... 143 5.3.10 Major Industries ............................................................................................................ 145

5.4 Demography ......................................................................................................................... 146 5.4.1 Population .................................................................................................................... 146 5.4.2 Education and Literacy.................................................................................................. 160 5.4.3 Employment ................................................................................................................. 162 5.4.4 Disease Burden ............................................................................................................ 163




5.5 Healthcare Infrastructure ....................................................................................................... 166 5.5.1 Healthcare Facilities ..................................................................................................... 166 5.5.2 Healthcare Parameters ................................................................................................. 170 5.5.3 Healthcare Personnel ................................................................................................... 173 5.5.4 Environmental Health .................................................................................................... 179

5.6 Healthcare Expenditure ......................................................................................................... 183 5.6.1 Overview ...................................................................................................................... 183 5.6.2 Major Components of Healthcare Spending ................................................................... 184 5.6.3 Share of Public and Private Sector in Healthcare ........................................................... 185 5.6.4 Spending in Pharmaceutical R&D .................................................................................. 186

5.7 Trade Associations ................................................................................................................ 187 5.7.1 Finnish Pharmaceutical Society ..................................................................................... 187 5.7.2 Pharma Industry Finland ............................................................................................... 187 5.7.3 Association of Finnish Pharmacies (AFP) ...................................................................... 187

5.8 Trade Fairs ........................................................................................................................... 188 6 Opportunities and Challenges ...................................................................................................... 189

6.1 Opportunities ......................................................................................................................... 189 6.2 Challenges ............................................................................................................................ 190

7 Appendix ..................................................................................................................................... 192 7.1 Abbreviations ........................................................................................................................ 192 7.2 Bibliography .......................................................................................................................... 194 7.3 Methodology ......................................................................................................................... 198

7.3.1 Coverage ..................................................................................................................... 198 7.3.2 Secondary Research .................................................................................................... 198 7.3.3 Forecasting .................................................................................................................. 199 7.3.4 Primary Research ......................................................................................................... 199 7.3.5 Expert Panel Validation ................................................................................................. 199

7.4 Contact Us ............................................................................................................................ 199 7.5 Disclaimer ............................................................................................................................. 200




1.1 List of Tables Table 1: Pharmaceutical Market ($bn), Finland, 2007–2012.................................................................. 12 Table 2: Pharmaceutical Market ($bn), Finland, Forecast, 2013–2020 .................................................. 13 Table 3: Pharmaceutical Market ($bn), Finland, 2007–2012.................................................................. 14 Table 4: Pharmaceutical Import, Share (%), Finland, 2011 ................................................................... 15 Table 5: Pharmaceutical Export, Share (%), Finland, 2011 ................................................................... 16 Table 6: Retail Price at Pharmacy, Finland, 2002 ................................................................................. 17 Table 7: Generic Pharmaceutical Market ($m), Finland, 2007–2012 ...................................................... 19 Table 8: Over-the-Counter Pharmaceutical Market ($m), Finland, 2007–2012 ....................................... 21 Table 9: Major Segments, Over-the-Counter Pharmaceutical, Finland, Revenue ($m), 2011 .................. 22 Table 10: Major Disease Area, Expenditure ($m), Finland, 2011 ........................................................... 23 Table 11: Major Products, Orion, Global, Revenue ($m), 2011 .............................................................. 27 Table 12: Late-Stage Pipeline, Orion, 2012 .......................................................................................... 28 Table 13: Major Products, Pfizer, Global, Revenue ($m), 2011 ............................................................. 33 Table 14: Late-stage Pipeline, Pfizer, 2012 .......................................................................................... 33 Table 15: Major Products, AstraZeneca, Global, Revenue ($m), 2011 ................................................... 39 Table 16: Late-stage Pipeline, AstraZeneca, 2012 ................................................................................ 40 Table 17: Major Products, Novartis, Global, Revenue ($m), 2011 ......................................................... 45 Table 18: Planned Filings, Novartis, 2012 to ≥2016 .............................................................................. 46 Table 19: Major Products, GlaxoSmithKline, Global, Revenue ($m), 2011 ............................................. 51 Table 20: Late-stage Pipeline, GlaxoSmithKline, 2012 .......................................................................... 52 Table 21: Medical Device Market ($bn), Finland, 2007–2012 ................................................................ 58 Table 22: Medical Device Market ($bn), Finland, Forecast, 2013–2020 ................................................. 59 Table 23: Medical Device Market, Finland, Segments, Revenue ($m), 2012 .......................................... 60 Table 24: Ophthalmic Device Market ($m), Finland, 2007–2012............................................................ 61 Table 25: Sales Trends for Major Players*, Ophthalmic Devices, Finland, 2010..................................... 62 Table 26: Ophthalmic Devices Market ($m), Finland, 2007–2012 .......................................................... 63 Table 27: Sales Trends for Major Players*, Ophthalmic Devices, Finland, 2011..................................... 64 Table 28: In Vitro Diagnostics Devices Market ($m), Finland, 2007–2012 .............................................. 65 Table 29: Sales Trends for Major Players*, In Vitro Diagnostics Devices, Finland, 2010 ........................ 66 Table 30: Wound Care Management Devices ($m), Finland, 2007–2012 .............................................. 67 Table 31: Sales Trends for Major Players*, Nephrology and Urology Devices, Finland, 2006–2010 ........ 68 Table 32: Hospital Supplies Market ($m), Finland, 2007–2012 .............................................................. 69 Table 33: Sales Trends for Major Players*, Orthopedic Devices, Finland, 2010 ..................................... 70 Table 34: Diagnostic Market ($m), Finland, 2007–2012 ........................................................................ 71 Table 35: Diagnostic Market ($m), Forecast, Finland, 2013–2020 ......................................................... 72 Table 36: Major Medical Device Companies, Revenue ($m), Finland, 2010 ........................................... 73 Table 37: Major Segments, Essilor International, Global, Revenue ($m), 2010 ...................................... 74 Table 38: Major Products, Roche, Global, Revenue ($m), 2010 ............................................................ 78 Table 39: Late-stage Pipeline, Roche, 2012 ......................................................................................... 79 Table 40: Major Products, Siemens, Global, Revenue ($m), 2010 ......................................................... 82 Table 41: Major Products, Medtronic, Global, Revenue ($m), 2011 ....................................................... 86 Table 42: Patient Share in Healthcare Spending (% of Total Expenditure), Finland, 2007–2012 ........... 103 Table 43: Healthcare Price Trends (%), Finland, 2007–2012 .............................................................. 104 Table 44: GDP Per Capita ($), Finland, 2007–2012 ............................................................................ 130 Table 45: GDP Per Capita ($), Finland, Forecast, 2013–2020 ............................................................. 131 Table 46: GDP, Annual Growth (%), Finland, 2007–2012 ................................................................... 132 Table 47: GNI Per Capita ($), Finland, 2007–2012 ............................................................................. 133 Table 48: Average Consumer Price Index, Finland, 2007–2012 .......................................................... 134 Table 49: Average Consumer Price Index, Finland, Forecast, 2013–2020 ........................................... 135 Table 50: Average Consumer Price, Finland, Annual Change (%), 2007–2012 .................................... 136 Table 51: Currency Exchange Rate (€/$), Finland, 2007–2012 ........................................................... 137 Table 52: Foreign Direct Investment ($bn), Finland, 2006–2011 ......................................................... 138 Table 53: Foreign Exchange Reserves ($bn), Finland, 2007–2012...................................................... 139 Table 54: Imports of Goods and Services ($bn), Finland, 2007–2012 .................................................. 140 Table 55: Exports of Goods and Services ($bn), Finland, 2007–2012.................................................. 141 Table 56: General Government Structural Balance ($bn), Finland, 2007–2012 .................................... 142 Table 57: General Government Net Debt ($bn), Finland, 2007–2012 .................................................. 143 Table 58: General Government Net Debt ($bn), Finland, Forecast, 2013–2020 ................................... 144 Table 59: Major Industry Sectors, % of GDP, Finland, 2008 ................................................................ 145 Table 60: Population (’000s), Finland, 2007–2012 .............................................................................. 146 Table 61: Population (’000s), Finland, Forecast, 2013–2020 ............................................................... 147 Table 62: Urban and Rural Population, Finland, (%), 2007–2012 ........................................................ 148




Table 63: Age Groups, Finland, Population Distribution (%), 2007–2012 ............................................. 149 Table 64: Births (Per 1,000 Population), Finland, 2007–2012 .............................................................. 150 Table 65: Births (Per 1,000 Population), Finland, 2013–2020 .............................................................. 151 Table 66: Mortality (Per 1,000 Population), Finland, 2007–2012 ......................................................... 152 Table 67: Mortality (Per 1,000 Population), Finland, 2013–2020 ......................................................... 153 Table 68: Major Causes of Mortality, Finland, 2010 ............................................................................ 154 Table 69: Infant Mortality (Per 1,000 Live Births), Finland, 2007–2012 ................................................ 155 Table 70: Major Causes of Male Mortality (%), Finland, 2011 .............................................................. 156 Table 71: Major Causes of Female Mortality (Per 10,000 Population), Finland, 2011 ........................... 157 Table 72: Gender Ratio (M/F), Finland, 2007–2012 ............................................................................ 158 Table 73: Life Expectancy at Birth (Years), Finland, 2007–2012 ......................................................... 159 Table 74: Education Qualifications, Number of Student (%), Finland, 2010 .......................................... 160 Table 75: Education Qualifications, Qualification Achieved (%), Finland, 2010 .................................... 161 Table 76: Unemployment Rate (%), Finland, 2007–2012 .................................................................... 162 Table 77: Major Diagnostic Diseases Areas (Per 1,000 Population), Finland, 2008 .............................. 164 Table 78: Major Diseases, Finland, DALYs (Per 100,000 Population), 2004 ........................................ 165 Table 79: Hospitals, Finland, 2007–2012 ........................................................................................... 166 Table 80: Public Hospitals, Finland, 2007–2012 ................................................................................. 167 Table 81: Non-public Hospitals, Finland, 2007–2012 .......................................................................... 168 Table 82: General Hospitals, Finland, 2007–2012 .............................................................................. 169 Table 83: Hospital Beds (Per 1,000 Population), Finland, 2007–2012 ................................................. 170 Table 84: Long Term, Acute Care and Psychiatric Care, Hospital Beds, Finland, 2007–2012 ............... 171 Table 85: Long Term, Acute Care and Psychiatric Care, Hospital Beds, Finland, 2007–2012 ............... 172 Table 86: Physicians (Per 1,000 Population), Finland, 2007–2012 ...................................................... 173 Table 87: Dentists (Per 1,000 Population), Finland, 2007–2012 .......................................................... 174 Table 88: Pharmacists (Per 1,000 Population), Finland, 2007–2012 .................................................... 175 Table 89: Pharmacies, Finland, 2007–2012 ....................................................................................... 176 Table 90: Head Dispenser (Per 1,000 Population), Finland, 2007–2012 .............................................. 177 Table 91: Nurses (Per 1,000 Population), Finland, 2007–2012 ............................................................ 178 Table 92: PM10 Emissions, Finland (µg/m3), 2007–2012 .................................................................... 179 Table 93: CO2, Finland, Emissions (Million Tons), 2007–2012 ............................................................ 180 Table 94: SO2, Finland, Emission (‘000 Tons), 2007–2012 ................................................................. 181 Table 95: NOx, Finland, Emissions (‘000 Tons), 2007–2012................................................................ 182 Table 96: Healthcare Expenditure (% of GDP), Finland, 2005–2010 ................................................... 183 Table 97: Healthcare Expenditure, Finland, Share of Major Components (%), 2010............................. 184 Table 98: Healthcare Expenditure, Finland, Public–Private Share (%), 2007–2012 .............................. 185 Table 99: Pharmaceutical R&D Expenditure ($m), Finland, 2007–2012 ............................................... 186 Table 100: Major Healthcare Trade Fairs, Finland, 2012–2013 ........................................................... 188




1.2 List of Figures Figure 1: Pharmaceutical Market ($bn), Finland, 2007–2012 ................................................................ 12 Figure 2: Pharmaceutical Market ($bn), Finland, Forecast, 2013–2020 ................................................. 13 Figure 3: Pharmaceutical Import and Export ($bn), Finland, 2007–2012 ................................................ 14 Figure 4: Pharmaceutical Import, Share (%), Finland, 2011 .................................................................. 15 Figure 5: Pharmaceutical Export, Share (%), Finland, 2011 .................................................................. 16 Figure 6: Pharmaceutical Distribution Channel, Finland, 2012............................................................... 18 Figure 7: Generic Pharmaceutical Market ($m), Finland, 2007–2012..................................................... 19 Figure 8: Over-the-Counter Pharmaceutical Market ($m), Finland, 2007–2012 ...................................... 21 Figure 9: Major Segments, Over-the-Counter Pharmaceutical, Finland, Revenue ($m), 2011................. 22 Figure 10: Major Disease Area, Expenditure ($m), Finland, 2011 .......................................................... 23 Figure 11: Antineoplastic and Immunomodulating Agents, Average Expenditure Per Physician,(%), 2011

.......................................................................................................................................... 25 Figure 12: Medical Device Market ($bn), Finland, 2007–2012 ............................................................... 58 Figure 13: Medical Device Market ($bn), Finland, Forecast, 2013–2020 ................................................ 59 Figure 14: Medical Device Market, Finland, Segments, Revenue ($m), 2012 ......................................... 60 Figure 15: Ophthalmic Device Market ($m), Finland, 2007–2012 .......................................................... 61 Figure 16: Sales Trends for Major Players*, Ophthalmic Devices, Finland, 2006–2010 .......................... 62 Figure 17: Orthopedic Devices Market ($m), Finland, 2007–2012 ......................................................... 63 Figure 18: Sales Trends for Major Players*, Orthopedic Devices, Finland, 2006–2011........................... 64 Figure 19: In Vitro Diagnostics Devices Market ($m), Finland, 2007–2012............................................. 65 Figure 20: Sales Trends for Major Players*, In Vitro Diagnostics Devices, Finland, 2006–2010 .............. 66 Figure 21: Wound Care Management Devices ($m), Finland, 2007–2012 ............................................. 67 Figure 22: Sales Trends for Major Players*, Wound Care Management Devices, Finland, 2006–2010 ... 68 Figure 23: Hospital Supplies Market ($m), Finland, 2007–2012 ............................................................. 69 Figure 24: Sales Trends for Major Players*, Hospital Supplies, Finland, 2006–2010 .............................. 70 Figure 25: Diagnostic Market ($m), Finland, 2007–2012 ....................................................................... 71 Figure 26: Diagnostic Market ($m), Forecast, Finland, 2013–2020 ........................................................ 72 Figure 27: Major Medical Device Companies, Revenue ($m), Finland, 2010.......................................... 73 Figure 28: Drivers and Barriers, Healthcare Market, Finland, 2012 ........................................................ 96 Figure 29: Overview of Healthcare System, Finland, 2008 .................................................................... 98 Figure 30: Reimbursement Process, Finland, 2008 ............................................................................ 100 Figure 31: Patient Share in Healthcare Spending (% of Total Expenditure), Finland, 2007–2012.......... 103 Figure 32: Healthcare Price Trends (%), Finland, 2007–2012 ............................................................. 104 Figure 33: Organizational Chart, Fimea, Finland, 2012 ....................................................................... 107 Figure 34: Centralized Procedure, Pre-submission, EU, 2011 ............................................................. 109 Figure 35: Centralized Procedure, Market Authorization, Pre-opinion Phase, EU, 2012 ....................... 110 Figure 36: Centralized Procedure, Market Authorization, Post-opinion Phase, EU, 2012 ...................... 111 Figure 37: Decentralized Procedure, EU, 2011 ................................................................................... 113 Figure 38: Mutual Recognition Procedure, EU, 2011 .......................................................................... 114 Figure 39: Conformity Assessment of Class I Medical Devices, EU, 2012 ........................................... 116 Figure 40: Conformity Assessment of Class IIa Medical Devices, EU, 2012 ........................................ 117 Figure 41: Conformity Assessment of Class IIb Medical Devices, EU, 2012 ........................................ 118 Figure 42: Conformity Assessment of Class III Medical Devices, EU, 2012 ......................................... 119 Figure 43: GDP Per Capita ($), Finland, 2007–2012 ........................................................................... 130 Figure 44: GDP Per Capita ($), Finland, Forecast, 2013–2020 ............................................................ 131 Figure 45: GDP, Annual Growth (%), Finland, 2007–2012 .................................................................. 132 Figure 46: GNI Per Capita ($), Finland, 2007–2012 ............................................................................ 133 Figure 47: Average Consumer Price Index, Finland, 2007–2012 ......................................................... 134 Figure 48: Average Consumer Price Index, Finland, Forecast, 2013–2020 .......................................... 135 Figure 49: Average Consumer Price, Finland, Annual Change (%), 2007–2012 ................................... 136 Figure 50: Currency Exchange Rate (€/$), Finland, 2007–2012 .......................................................... 137 Figure 51: Foreign Direct Investment ($bn), Finland, 2006–2011 ........................................................ 138 Figure 52: Foreign Exchange Reserves ($bn), Finland, 2007–2012 .................................................... 139 Figure 53: Imports of Goods and Services ($bn), Finland, 2007–2012 ................................................. 140 Figure 54: Exports of Goods and Services ($bn), Finland, 2007–2012 ................................................ 141 Figure 55: General Government Structural Balance ($bn), Finland, 2007–2012 ................................... 142 Figure 56: General Government Net Debt ($bn), Finland, 2007–2012 ................................................. 143 Figure 57: General Government Net Debt ($bn), Finland, Forecast, 2013–2020 .................................. 144 Figure 58: Major Industry Sectors, % of GDP, Finland, 2008 ............................................................... 145 Figure 59: Population (‘000s), Finland, 2007–2012 ............................................................................. 146 Figure 60: Population (’000s), Finland, Forecast, 2013–2020 .............................................................. 147




Figure 61: Urban and Rural Population, Finland, (%), 2007–2012 ....................................................... 148 Figure 62: Age Groups, Finland, Population Distribution (%), 2007–2012 ............................................ 149 Figure 63: Births (Per 1,000 Population), Finland, 2007–2012............................................................. 150 Figure 64: Births (Per 1,000 Population), Finland, 2013–2020............................................................. 151 Figure 65: Mortality (Per 1,000 Population), Finland, 2007–2012 ........................................................ 152 Figure 66: Mortality (Per 1,000 Population), Finland, 2013–2020 ........................................................ 153 Figure 67: Major Causes of Mortality, Finland, 2010 ........................................................................... 154 Figure 68: Infant Mortality (Per 1,000 Live Births), Finland, 2007–2012 ............................................... 155 Figure 69: Major Causes of Male Mortality (%), Finland, 2011............................................................. 156 Figure 70: Major Causes of Female Mortality (Per 10,000 Population), Finland, 2011 .......................... 157 Figure 71: Gender Ratio (M/F), Finland, 2007–2012 ........................................................................... 158 Figure 72: Life Expectancy at Birth (Years), Finland, 2007–2012 ........................................................ 159 Figure 73: Education Qualifications, Number of Student (%), Finland, 2010 ........................................ 160 Figure 74: Education Qualifications, Qualification Achieved (%), Finland, 2010 ................................... 161 Figure 75: Unemployment Rate (%), Finland, 2007–2012 ................................................................... 162 Figure 76: Major Diagnostic Diseases Areas (Per 1,000 Population), Finland, 2008............................. 163 Figure 77: Major Diseases, Finland, DALYs (Per 100,000 Population), 2004 ....................................... 165 Figure 78: Hospitals, Finland, 2007–2012 .......................................................................................... 166 Figure 79: Public Hospitals, Finland, 2007–2012 ................................................................................ 167 Figure 80: Non-public Hospitals, Finland, 2007–2012 ......................................................................... 168 Figure 81: General Hospitals, Finland, 2007–2012 ............................................................................. 169 Figure 82: Hospital Beds (Per 1,000 Population), Finland, 2007–2012 ................................................ 170 Figure 83: Long Term, Acute Care and Psychiatric Care, Hospital Beds, Finland, 2007–2012.............. 171 Figure 84: Diagnostic Units (Per Million Population), Finland, 2007–2012 ........................................... 172 Figure 85: Physicians (Per 1,000 Population), Finland, 2007–2012 ..................................................... 173 Figure 86: Dentists (Per 1,000 Population), Finland, 2007–2012 ......................................................... 174 Figure 87: Pharmacists (Per 1,000 Population), Finland, 2007–2012................................................... 175 Figure 88: Pharmacies, Finland, 2007–2012 ...................................................................................... 176 Figure 89: Head Dispenser (Per 1,000 Population), Finland, 2007–2012 ............................................. 177 Figure 90: Nurses (Per 1,000 Population), Finland, 2007–2012 .......................................................... 178 Figure 91: PM10 Emissions, Finland (µg/m3), 2007–2012 ................................................................... 179 Figure 92: CO2, Finland, Emissions (Million Tons), 2007–2012 ........................................................... 180 Figure 93: SO2, Finland, Emission (‘000 Tons), 2007–2012 ................................................................ 181 Figure 94: NOx, Finland, Emissions (‘000 Tons), 2007–2012 .............................................................. 182 Figure 95: Healthcare Expenditure (% of GDP), Finland, 2005–2010 .................................................. 183 Figure 96: Healthcare Expenditure, Finland, Share of Major Components (%), 2010 ........................... 184 Figure 97: Healthcare Expenditure, Finland, Public–Private Share (%), 2007–2012 ............................. 185 Figure 98: Pharmaceutical R&D Expenditure ($m), Finland, 2007–2012.............................................. 186 Figure 99: Opportunities and Challenges, Healthcare Market, Finland, 2012 ....................................... 191




2 Introduction 2.1 Report Guidance The report begins with an executive summary that provides an overview of Finland’s healthcare

market and the key factors driving growth. It also gives a snapshot of the country’s healthcare infrastructure and demographic, regulatory and reimbursement landscapes.

Chapter three gives an overview of Finland’s pharmaceutical and medical device markets, including size; segmentation by product type (generic, Over-the-Counter (OTC) and biologic/biosimilar); and their key drivers and barriers. It also includes profiles and SWOT assessments of each of the major players for both markets.

Chapter four covers the reimbursement and payer landscape and the regulations governing the Polish healthcare market. The reimbursement and payer landscape section elaborates on the features of the healthcare reimbursement process, including details of insurance providers, pricing policies and drug pricing trends. The regulatory landscape section gives an overview of the regulatory agencies and approval processes for new drugs and medical devices. The chapter also covers the licensing process for the manufacture, export and import of pharmaceuticals; regulations for pharmaceutical advertising, labeling, packaging and clinical trials; and gives an overview of the intellectual property rights landscape.

Chapter five provides a detailed analysis of Finland’s political and economic environment in terms of economic indicators, demographics, healthcare infrastructure and healthcare expenditure.

Chapter six provides an overview of the opportunities for and challenges to growth in Finland’s healthcare market.




3 Overview of Pharmaceutical and Medical Device Market 3.1 Pharmaceutical Market 3.1.1 Overview Finland was the 16th largest European Union (EU) market for pharmaceutical products in 2007, accounting for approximately XX% of the EU total market. Finland was also the XXth largest producer of pharmaceutical products in the EU, accounting for around XX% of the total EU production of pharmaceuticals in 2007 (CBI, 2010).

Between 2007 and 2012, Finland’s pharmaceutical expenditure increased at a Compound Annual Growth Rate (CAGR) of XX%, and was worth $XX billion in 2012. The pharmaceutical market declined and was valued $XX billion in 2009 from $XX billion in 2008, due to the depreciation of the Euro against the US Dollar (THL, 2010a). Pharmaceutical expenditure has grown in Finland over the past decade, and is the fastest growing component of total health expenditure. The trend of increase in pharmaceutical expenditure is common in countries with well-developed healthcare systems both within and outside Europe.

Most pharmaceutical companies operating in Finland are members of the association called Pharma Industry Finland (PIF). In 2012, XX companies were the members of PIF. The member companies of PIF account for XX% of the pharmaceutical market. In 2011, the Finnish pharmaceutical industry employs about XX people in Research and Development (R&D), marketing authorization administration, marketing and production jobs. During 2000–2011, the number of personnel working in the pharmaceutical industry decreased at a CAGR of XX%. The number of jobs in pharmaceutical production in Finland decreased over the past few years because industrial manufacturing of medicines mostly takes place outside Europe (PIF, 2012).




Figure 1: Pharmaceutical Market ($bn), Finland, 2007–2012

2007 2008 2009 2010 2011* 2012*

Mar

ket (

$bn)

Year

CAGR (2007–2012): XX%CAGR (2007–2012): XX%

Source: GlobalData; THL, 2010a *Estimated value

Table 1: Pharmaceutical Market ($bn), Finland, 2007–2012

Year 2007 2008 2009 2010 2011* 2012*

Revenue

Source: GlobalData; THL, 2010a *Estimated value




Figure 2: Pharmaceutical Market ($bn), Finland, Forecast, 2013–2020

2013 2014 2015 2016 2017 2018 2019 2020

Mar

ket (

$bn)

Year

CAGR (2013–2020): XX%

Source: GlobalData; THL, 2010a

Table 2: Pharmaceutical Market ($bn), Finland, Forecast, 2013–2020 Year 2013 2014 2015 2016 2017 2018 2019 2020

Revenue

Source: GlobalData; THL, 2010a




3.1.2.1 Imports

In 2008, Finland was the 18th largest importer of pharmaceutical products in the EU, accounting for XX% of total EU imports.

In 2008, Germany was the leading supplier of pharmaceutical products to Finland, accounting for XX% of its total imports, followed by Belgium (with XX%) and Sweden (with XX%). The contribution of developing countries in supplying pharmaceutical products to Finland is very small. In 2008, approximately all of Finland’s imports of pharmaceutical products consisted of packed pharmaceutical products.

In 2011, XX% of Finland’s imports were sourced from EU countries, XX% from Switzerland and the remaining XX% from the rest of the world (PIF, 2011b).

Figure 4: Pharmaceutical Import, Share (%), Finland, 2011

EU countries

Rest of the world

Switerland

Source: GlobalData; PIF, 2011b

Table 4: Pharmaceutical Import, Share (%), Finland, 2011 Destination Share (%)

EU countries

Other countries

Switzerland

Source: GlobalData; PIF, 2011b




3.1.2.2 Exports

In 2008, Finland was the XXth largest exporter within the EU, accounting for XX% of total EU exports. In 2011, Russia was the leading destination for pharmaceutical exports from Finland; XX% of Finland’s exports were destined for Russia, XX% for EU countries, XX% for Switzerland and the remaining XX% were constituted by the rest of the world (PIF, 2011c).

Figure 5: Pharmaceutical Export, Share (%), Finland, 2011

Russia

EU Countries

Rest of the world

Switzerland

Source: GlobalData; PIF, 2011c

Table 5: Pharmaceutical Export, Share (%), Finland, 2011 Destination Share (%)

Russia

EU countries

Switzerland

Rest of the world

Source: GlobalData; PIF, 2011c




7 Appendix 7.1 Abbreviations AD: Alzheimer’s disease

AFP: Association of Finnish Pharmacies

ANDA: Abbreviated New Drug Administration

API: Active Pharmaceutical Ingredient

BBMRI: Biobanking and Biomolecular Resources Research Infrastructure

BKA: Bundeskartellamt

BMS: Bristol-Myers Squibb

CAGR: Compound Annual Growth Rate

CE: Conformité Européene

CGMs: Continuous Glucose Monitors

CHMP: Committee for Medicinal Products:

CMS: Centers for Medicare & Medicaid Services

CNS: Central Nervous System

COPD: Chronic Obstructive Pulmonary Disease

CPI: Consumer Price Index

CRO: Clinical Research Organization

CSO: Central Statistical Office

CT: Computed Tomography

CTD: Common Technical Document

CVIS: Cardiovascular Imaging Systems

CZT: Cadmium Zinc Telluride

DALY: Disability-Adjusted Life Year

DBS: Deep Brain Stimulation

DRA: Deficit Reduction Act

DRG: Diagnostic Related Groups

DRL: Dr. Reddy’s Laboratories

EATRIS: European Advanced Translational Research InfraStructure in Medicine

EEA: European Economic Area

EMA: European Medication Association

EMA: European Medicines Agency

EMR: Electronic Medical Record

EU: European Union

FDA: Food and Drug Administration

FDI: Foreign Direct Investment

FHA: Finnish Heart Association




GDP: Gross Domestic Product

GLP: Good Laboratory Practice

GMP: Good Manufacturing Practice

GNI: Gross National Income

GTU: Gene Transfer Unit

HCV: Hepatitis C Virus

HCV: Hepatitis C Virus

HILA: Lääkkeiden hintalautakunta

HIV: Human Immunodeficiency Virus

HTA: Health Technology Assessment

HUS: Helsinki and Uusimaa

ICD: Implantable Cardioverter Defibrillator

IDMC: Independent Data-Monitoring Committee

IMI: Innovative Medicines Imitative

IP: Intellectual Property

IT: Information Technology

MDD: Medical Device Directives

MENA: Middle East and North Africa region

MMV: Medicines for Malaria Venture

MRI: Magnetic Resonance Imaging

MS: Multiple Sclerosis

MSAH: Ministry of Social Affairs and Health

MSO: Medtronic Singapore Operations

NAM: National Agency for Medicines

NAM: National Agency of Medicine

NBPR: National Board of Patents and Registration

NHI: National Health Insurance

NHI: National Health Insurance

NIBR: Novartis Institutes for Biomedical Research

NME: New Molecular Entities

OECD: Organisation for Economic Co-operation and Development

OMS: Orbotech Medical Solutions

OTC: Over-the-Counter

P/E: Price/Earnings

P/E: Price/Earnings

PACS: Picture Archiving and Communication System

PCR: Polymerase Chain Reaction




PD: Parkinson’s disease

PET: Positron Emission Tomography

PIF: Pharma Industry Finland

PL: Product Leaflet

R&D: Research and Development

R&D: Research and Development

RIS: Radiology Information System

RMS: Reference Member State

SDR: Special Drawing Rights

SPC: Summaryies of Product Characteristics

ug/m3: Microgram per Meter cube

VAT: Value Added Tax

VEGF: Vascular Endothelial Growth Factor

WHO: World Health Organization

7.2 Bibliography Association of the European Self-Medication Industry (AESGP) (2012). European self-medication

pharmaceutical market. Association of the European Self-Medication Industry. Available from: http://www.aesgp.eu/facts-figures/market-data/#sm. [Accessed November 9, 2012].

Biz Trade Shows (2013). Medical & Pharmaceutical Trade Shows in Finland. Biz Trade Shows. Available from: http://www.biztradeshows.com/finland/finland-tradeshows.mp?industry=medical-pharma. [Accessed November 17, 2012].

CBI (2010). The pharmaceutical products market in the Finland. Centre for the Promotion of Imports. Available from: http://www.cbi.eu/marketintel/The%20pharmaceutical%20products%20market%20in%20Finland/163930. [Accessed November 17, 2012].

CIA (2013). The World Factbook. Centeral Intelligence Agency. Available from: https://www.cia.gov/library/publications/the-world-factbook/geos/fi.htmlhttps://www.cia.gov/library/publications/the-world-factbook/geos/fi.html. [Accessed Nov 17, 2012].

Co-ordination Group for Mutual Recognition and Decentralized Procedures-Human (CMDh) (2011). Decentralized procedure member states’ standard operating procedure. Heads of Medicine Agency. Available from: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/DCP/CMDh-078-2005-Rev3-Clean_2011_09.pdf.

Co-ordination Group for Mutual Recognition and Decentralized Procedures-Human (CMDh) (2012). Recommendations on submission dates for applicants of the mutual recognition procedure. Heads of Medicine Agency. Available from: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/MRP/CMDh_082_2012_Rev5_2012_10.pdf.

EFPIA (2012). E-Library: Publication. European Federation of Pharmaceutical Industry and Association. Available from: http://www.efpia.eu/articles/facts-figures [Accessed November 7, 2012].

European Medicines Agency (EMA) (2012). Centralized procedure. European Medicines Agency. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000278.jsp&mid=WC0b01ac05800b5ca1. [Accessed December 18, 2013].




Eurostat (2012). GDP per capita in the Member States ranged from 45% to 274% of the EU27 average in 2011. Eurostat. Available from: http://epp.eurostat.ec.europa.eu/cache/ITY_PUBLIC/2-20062012-AP/EN/2-20062012-AP-EN.PDF.

Fimea (2007). Clinical Trials on Medicinal Products in Human Subjects. Finnish Medical Agency. Available from: http://www.fimea.fi/download/17457_Clinical_trials_regulation_1_2007_.pdf.

Fimea (2010). Labelling and package leaflets for medicinal products. Finnish Medical Agency. Available from: http://www.fimea.fi/download/17165_Fimea_M_1_2010_Laakevalmisteen_myyntipaallysmerkinnat_ja_pakkausseloste_EN_uusi.pdf

Fimea (2011). The Statutes of Finland. Fimea. Available from: http://www.fimea.fi/instancedata/prime_product_julkaisu/fimea/embeds/fimeawwwstructure/20733_Fimea_decree_on_fees_2012_lopullinen.pdf.

Fimea (2012a). Medicines Decree. Fimea. Available from: http://www.fimea.fi/download/18579_Laakeasetus_englanniksi_paivitetty_5_2011.pdf

Fimea (2012b). Medicine act. Fimea. Available from: http://www.fimea.fi/download/18580_Laakelaki_englanniksi_paivitetty_5_2011.pdf

Health System in Transition (HiT) (2008). Finland health system review. World Health Organization. Available from: http://www.euro.who.int/__data/assets/pdf_file/0007/80692/E91937.pdf.

IMF (2012). World Economic Outlook. International Monetary Foundation. Available from: http://www.imf.org/external/pubs/ft/weo/2012/02/weodata/weorept.aspx?pr.x=69&pr.y=9&sy=2007&ey=2017&scsm=1&ssd=1&sort=country&ds=.&br=1&c=172&s=NGDP_R%2CNGDP_RPCH%2CNGDP%2CNGDPD%2CNGDP_D%2CNGDPRPC%2CNGDPPC%2CNGDPDPC%2CNGAP_NPGDP%2CPPPGDP%2CPPPPC%2CPPPSH%2CPPPEX%2CNID_NGDP%2CNGSD_NGDP%2CPCPI%2CPCPIPCH%2CPCPIE%2CPCPIEPCH%2CTM_RPCH%2CTMG_RPCH%2CTX_RPCH%2CTXG_RPCH%2CTXGO%2CTMGO%2CLUR%2CLE%2CLP%2CGGR%2CGGR_NGDP%2CGGX%2CGGX_NGDP%2CGGXCNL%2CGGXCNL_NGDP%2CGGSB%2CGGSB_NPGDP%2CGGXONLB%2CGGXONLB_NGDP%2CGGXWDN%2CGGXWDN_NGDP%2CGGXWDG%2CGGXWDG_NGDP%2CNGDP_FY%2CBCA%2CBCA_NGDPD&grp=0&a= [Accessed November 29, 2012].

Invest in Finland (2013). Why Finland. Invest in Finland. Available from: http://www.investinfinland.fi/why-finland/5. [Accessed Nov 17, 2012].

Kela (2011a). Reimbursements of medicine expenses: Number of recipients and prescription data. Kela. Available from: http://raportit.kela.fi/ibi_apps/WFServlet?IBIF_ex=NIT137AL&YKIELI=E. [Accessed Nov 9, 2012].

Kela (2011b). Statistical Yearbook of the Social Insurance Institution. Kela. Available from: http://www.kela.fi/it/kelasto/kelasto.nsf/NET/131112113750TL/$File/Vk_11.pdf?OpenElement.

Kela (2011c). Top 10 prescription categories. Kela. Available from: http://raportit.kela.fi/ibi_apps/WFServlet?IBIF_ex=NIT056CL&YKIELI=E. [Accessed November 9, 2012].

Kela (2012a). Funding. Kela. Available from: http://www.kela.fi/in/internet/english.nsf/NET/080808143901HS. [Accessed November 5, 2012].

Kela (2012a). Reimbursements for medicine expenses. Kela. Available from: http://www.kela.fi/in/internet/english.nsf/NET/131003131216MH?OpenDocument. [Accessed November 5, 2012].

National Public Health Institute, National Research and Development Centre for Welfare and Health, Ministry of Social Affairs and Health (2006). Health in Finland. Available from: http://circumpolarhealth.org/library/Health-in-Finland.pdf.

NBPR (2012a). Processing of applications at the National Board of Patents and Registration. National Board of Patents and Registration of Finland. National Board of Patents and Registration of Finland. Available from: http://www.prh.fi/en/patentit/hakusuomi/kasittely.html. [Accessed November 5, 2012].




NBPR (2012b). Application procedure. National Board of Patents and Registration of Finland. Available from: http://www.prh.fi/en/tavaramerkit/hakemus/hakemusnenettely.html [Accessed Nov 5, 2012].

OANDA (2012). Historic Currency Exchange Rate. OANDA. Available from: http://www.oanda.com/currency/historical-rates/. [Accessed on November 3, 2012].

OECD (2010). Economic Survey of Finland, 2010. Available from: http://www.oecd.org/economy/surveys/44897180.pdf.

OECD (2012a). OECD Stat Extracts. Organization for Economic Co-operation and Development. Available from: http://stats.oecd.org/. [Accessed on July 20, 2012]

OECD (2012b). OECD Health Data 2012 - Frequently Requested Data. Organization for Economic Co-operation and Development. Available from: http://www.oecd.org/els/healthpoliciesanddata/oecdhealthdata2012-frequentlyrequesteddata.htm. [Accessed on July 18, 2012].

Pharma Industry Finland (2011a). Pharmaceutical exports and imports. Pharma Industry Finland. Available from: http://www.pif.fi/Tiedostot/05%20Import%20and%20export.pdf.

Pharma Industry Finland (2011b). Pharmaceutical imports from Finland. Pharma Industry Finland. Available from: http://www.pif.fi/Tiedostot/07%20Import%20by%20country.pdf.

Pharma Industry Finland (2011c). Pharmaceutical exports from Finland. Pharma Industry Finland. Available from: http://www.pif.fi/Tiedostot/06%20Export%20by%20country.pdf.

Pharma Industry Finland (2012). Members of Pharma Industry Finland PIF. Pharma Industry Finland. Available from: http://www.pif.fi/frontpage/operations/member_companies. [Accessed on November 17, 2012].

Pharma Industry Finland (2013). Medicine prices are made of many elements. Pharma Industry Finland. Available from: http://www.pif.fi/frontpage/pharmaceutical_industry/medicine_prices. [Accessed on November 17, 2012].

PhRMA (2013). Open Letter to the Public from John J. Castellani. PhRMA. Available from: http://www.phrma.org/issues/open-letter-public-john-j-castellani. [Accessed on November 17, 2012].

Siemens (2011). The Company Siemens 2011. Available from: http://www.siemens.com/press/pool/de/homepage/the_company_2011.pdf.

Statistics Finland (2012a). Prices and cost. Statistics Finland. Available from: http://www.stat.fi/tup/suoluk/suoluk_hinnat_en.html. [Accessed on November 5, 2012].

Statistics Finland (2012b). Trade. Statistics Finland. Available from: http://www.stat.fi/tup/suoluk/suoluk_kotimaankauppa_en.html [Accessed on November 5, 2012].

Statistics Finland (2012c). National Account. Statistics Finland. Available from: http://tilastokeskus.fi/tup/suoluk/suoluk_kansantalous_en.html [Accessed on November 5, 2012].

Statistics Finland (2012d). Population. Statistics Finland. Available from: http://tilastokeskus.fi/tup/suoluk/suoluk_vaesto_en.html [Accessed on November 5, 2012].

Statistics Finland (2012e). Health. Statistics Finland. Available from: http://www.stat.fi/tup/suoluk/suoluk_terveys_en.html [Accessed on November 5, 2012].

Statistics Finland (2012f). Education. Statistics Finland. Available from: http://www.stat.fi/tup/suoluk/suoluk_koulutus_en.html [Accessed on November 5, 2012].

Statistics Finland (2012g). Labour market. Statistics Finland. Available from: http://www.stat.fi/tup/suoluk/suoluk_koulutus_en.html [Accessed on November 5, 2012].

Statistics Finland (2012h). Labour market. Statistics Finland. Available from: http://www.stat.fi/tup/suoluk/suoluk_alue_en.html [Accessed on November 5, 2012].

The Association of Finnish Pharmacies (2011). The Association of Finnish Pharmacies 2011. The Association of Finnish Pharmacies. Available from: http://www.apteekkariliitto.fi/media/pdf/annual_review_2012.pdf




The News (2012). Spurious drugs cause over half-a-million deaths each year. The News. Available from: http://www.thenews.com.pk/Todays-News-2-90776-Spurious-drugs-cause-over-half-a-million-deaths-each-year. [Accessed on November 17, 2012].

The World Bank (2012a). GNI per capita, Atlas method (current US$). The World Bank. Available from: http://data.worldbank.org/indicator/NY.GNP.PCAP.CD. [Accessed on November 3, 2012]

The World Bank (2012b). Foreign direct investment, net inflows (BoP, current US$). The World Bank. Available from: http://data.worldbank.org/indicator/BX.KLT.DINV.CD.WD. [Accessed on November 19, 2012].

The World Bank (2012c). Total reserves (includes gold, current US$). The World Bank. Available from: http://data.worldbank.org/indicator/FI.RES.TOTL.CD. [Accessed on November 3, 2012].

The World Bank (2012d). Mortality rate, infant (per 1,000 live births). The World Bank. Available from: http://data.worldbank.org/indicator/SP.DYN.IMRT.IN. [Accessed on November 3, 2012]

The World Bank (2012e). PM10, country level (micrograms per cubic meter). The World Bank. Available from: http://data.worldbank.org/indicator/EN.ATM.PM10.MC.M3. [Accessed on November 19, 2012].

The World Bank (2012f). Urban population (% of total). Available from: http://data.worldbank.org/indicator/SP.URB.TOTL.IN.ZS/countries/1W-FI?display=graph. [Accessed on November 19, 2012].

THL (2010a). Health Expenditure and Financing 2010. Terveyden ja Hyvinvoinnin (National Institute of Health and Welfare). Available from: http://www.thl.fi/en_US/web/en/statistics/topics/health_expenditure. [Accessed Nov 7, 2012].

THL (2010b). Facts about Social Welfare and Health Care in Finland 2010. Terveyden ja Hyvinvoinnin (National Institute of Health and Welfare). Available from: http://www.stakes.fi/tilastot/tilastotiedotteet/tasku/facts2010.pdf

United Nations Conference on Trade and Development (UNCTD) (2012). World Investment Report. Available from: http://unctad.org/en/PublicationsLibrary/wir2012_embargoed_en.pdf

University of Helsinki (2011), Finland initiates European biomedical research infrastructures construction with 5 M funding for 2011. University of Helsinki. Available from: http://notes.helsinki.fi/halvi/tiedotus/pressrelease.nsf/e1e392ad852e72f5c225680000404fa8/1608cc301259ab1dc225781d004d906a?OpenDocument. [Accessed November 17, 2012].

Valvira (2012). Registration. Valvira, National Supervisory Authority of Welfare and Health. Available from: http://www.valvira.fi/en/licensing/medical_devices/registration. [Accessed on December 13, 2012].

World Health Organization (WHO) (2009). Global Burden of Disease. World Health Organization. Available from: http://www.who.int/healthinfo/global_burden_disease/en/. [Accessed on December 13, 2012].




7.3 Methodology GlobalData’s dedicated research and analysis teams consist of experienced professionals with advanced statistical expertise and marketing, market research and consulting backgrounds in the pharmaceutical industry.

GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the Strategic and Competitive Intelligence Professionals (www.scip.org).

All GlobalData databases are continuously updated and revised. The following research methodology is followed for all databases and reports.

7.3.1 Coverage The objective of updating GlobalData’s coverage is to ensure that it represents the most up to date vision of the industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company, association and competitor sources.

Company coverage is based on three key factors: revenues, products and media attention/innovation/market potential.

The estimated revenues of all major companies, including private and governmental, are gathered and used to prioritize coverage.

Companies which are making the news or which are of particular interest due to their innovative approach are prioritized.

GlobalData aims to cover all major news events and deals in the pharmaceutical industry, updated on a daily basis.

The coverage is further streamlined and strengthened with additional inputs from GlobalData’s expert panel (see below).

7.3.2 Secondary Research The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to, the following.

Company websites, annual reports, financial reports, broker reports, investor presentations and US Securities and Exchanges Commission (SEC) filings

Industry trade journals, scientific journals and other technical literature

Internal and external 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

Country reports are largely based on secondary research and make use of reliable and authoritative sources such as the IMF, the World Bank, OECD, WHO, UNICEF, UNStats, MHLW, NHS, and BEA, among others.




7.3.3 Forecasting For country reports, GlobalData uses the data available from reliable and authoritative secondary sources to forecast the future trends for the healthcare market for the country, as well as the parameters related to the economy and healthcare infrastructure and expenditure of the country. The trends are further validated through the secondary sources.

7.3.4 Primary Research GlobalData conducts hundreds of primary interviews a year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions.

It provides first-hand information on the market size, market trends, growth trends, competitive landscape and future outlook of a market.

It helps in validating and strengthening secondary research findings.

It develops the analysis team’s expertise and market understanding.

Primary research involves email correspondence and telephone interviews as well as face-to-face interviews for each market, category, segment and sub-segment across the geographies covered.

The participants who typically take part in such a process include, but are not limited to, the following:

Industry participants: Chief Executive Officers (CEOs), Vice Presidents (VPs), marketing/product managers, market intelligence managers and national sales managers.

Hospital stores, pharmacies, distributors and paramedics.

Outside experts: investment bankers, valuation experts, research analysts specializing in specific pharmaceutical markets.

Key Opinion Leaders (KOLs): Physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of pharmaceuticals.

7.3.5 Expert Panel Validation GlobalData uses a panel of experts to cross verify its databases and forecasts.

GlobalData’s expert panel comprises marketing managers, product specialists, international sales managers from pharmaceutical companies; academics from research universities, KOLs from hospitals, consultants from venture capital funds, and distributors/suppliers of pharmaceuticals and supplies.

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




7.5 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.

Documents

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