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REFERENCE CODE GDHC0062CHR | PUBLICATION DATE JUNE 2014 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)
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Page 1: HEALTHCARE, REGULATORY AND REIMBURSEMENT … · Table 4: Pharmaceutical Device Market, Republic of China (Taiwan), Market Segments of Newly Emerging Biotech Industry, Share (%), 2009

REFERENCE CODE GDHC0062CHR | PUBLICATION DATE JUNE 2014

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF

CHINA (TAIWAN)

Page 2: HEALTHCARE, REGULATORY AND REIMBURSEMENT … · Table 4: Pharmaceutical Device Market, Republic of China (Taiwan), Market Segments of Newly Emerging Biotech Industry, Share (%), 2009

Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

Executive Summary

Taiwan’s increasing elderly population and declining birth rate pose a demographic challenge for its government. Good access to health insurance, a growing healthcare burden and government initiatives are expected to drive market growth, although periodic price cuts present a major challenge.

In 2013, the number of people above the age of XX

years accounted for XX% of Taiwan’s total

population (NDC, 2013b). This is increasing

significantly and given the association between

elderly populations and increased prevalence of all

kinds of disease, it is associated with a growing

disease burden for Taiwan’s healthcare system.

Medical expenditure for chronic diseases has also

increased, although the government is attempting

to reduce the financial burden this presents

through comprehensive healthcare reforms. The

overall population increased slightly between 2008

and 2013 from XX to XX million, mainly due to a

rising life expectancy. However, the birth rate

decreased at a negative Compound Annual

Growth Rate (CAGR) of XX% between 2008 and

2013 (National Statistics R.O.C., 2012; NDC,

2013b).

In 2013, although Taiwan’s pharmaceutical market

was smaller compared to Japan’s, China’s, India’s

and South Korea’s, totaling $XX billion, its per-

capita expenditure on medicines was significantly

higher, being $XX in 2013. The pharmaceutical

market grew at a CAGR of XX% from 2008 to

2013. The Taiwanese government is taking various

steps to ensure investment and growth in the

pharmaceutical industry. In line with the Act for the

Development of Biotech and New Pharmaceuticals

Industry introduced in 2007, the Taiwanese

government provides incentives for new

pharmaceutical companies to establish themselves

in Taiwan, such as a reduction in income tax.

However, the country’s Global Budget Payment

System was implemented in 2002, following which

the price of National Health Insurance (NHI)-

funded drugs reduced seven times, impacting both

domestic companies and their foreign

counterparts. The Office of the US Trade

Representative estimates that on average,

pharmaceutical prices in Taiwan are XX% of the

price of the equivalent product in the US (USTR,

2013). The continual price cuts are a major

challenge for the growth of the pharmaceutical

market.

Pharmaceutical Market, Republic of China (Taiwan), Revenue ($bn), 2008–2020

2008 2013* 2015 2020

Rev

enue

($bn

)

CAGR (2008–2020): XX%

Source: Chen, 2010; MOEAIDB, 2013; Australian Trade Commission, 2013 *Estimated figure

Page 3: HEALTHCARE, REGULATORY AND REIMBURSEMENT … · Table 4: Pharmaceutical Device Market, Republic of China (Taiwan), Market Segments of Newly Emerging Biotech Industry, Share (%), 2009

Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 5 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Table of Contents

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

1 Table of Contents

1 Table of Contents ....................................................................................................................... 5

1.1 List of Tables ...................................................................................................................... 9

1.2 List of Figures ................................................................................................................... 15

2 Introduction ............................................................................................................................... 21

2.1 GlobalData Report Guidance ............................................................................................ 21

3 Overview of the Pharmaceutical and Medical Device Markets .................................................. 22

3.1 Pharmaceutical Market ..................................................................................................... 22

3.1.1 Market Overview ........................................................................................................... 22

3.1.2 Pharmaceutical Exports and Imports ............................................................................. 24

3.1.3 Supply Channels ........................................................................................................... 26

3.1.4 Market Segments .......................................................................................................... 26

3.1.5 Overview of Top Five Disease Areas ............................................................................ 30

3.1.6 Major Players ................................................................................................................ 32

3.2 Medical Device Market ...................................................................................................... 69

3.2.1 Market Overview ........................................................................................................... 69

3.2.2 Overview of Top Five Segments.................................................................................... 71

3.2.3 Diagnostic market ......................................................................................................... 84

3.2.4 Major Players ................................................................................................................ 87

3.3 Market Drivers and Barriers ............................................................................................ 117

3.3.1 Drivers......................................................................................................................... 117

3.3.2 Barriers ....................................................................................................................... 118

Page 4: HEALTHCARE, REGULATORY AND REIMBURSEMENT … · Table 4: Pharmaceutical Device Market, Republic of China (Taiwan), Market Segments of Newly Emerging Biotech Industry, Share (%), 2009

Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 6 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Table of Contents

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

4 Market Access ........................................................................................................................ 120

4.1 Reimbursement and Payer Landscape ........................................................................... 120

4.1.1 Overview of Healthcare System .................................................................................. 120

4.1.2 Reimbursement Process ............................................................................................. 122

4.1.3 Overview of Insurance Providers ................................................................................. 125

4.1.4 Patient Share in Healthcare Spending ......................................................................... 130

4.1.5 Price Trend in Healthcare Services ............................................................................. 132

4.1.6 Pricing Policies ............................................................................................................ 133

4.2 Regulatory Landscape .................................................................................................... 134

4.2.1 Overview of Regulatory Agencies................................................................................ 134

4.2.2 Market Authorization Procedure for Pharmaceutical Products ..................................... 136

4.2.3 Market Authorization Procedure for Medical Devices .................................................. 141

4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing .................. 144

4.2.5 Licensing Process for Pharmaceutical Exports and Imports ........................................ 147

4.2.6 Intellectual Property Rights.......................................................................................... 148

4.2.7 Clinical Trial Regulations ............................................................................................. 151

4.2.8 Pharmaceutical Advertising Regulations ..................................................................... 153

4.2.9 Pharmacy Regulations ................................................................................................ 154

4.2.10 Labeling and Packaging Regulations .......................................................................... 155

5 Country Analysis ..................................................................................................................... 156

5.1 Political Environment....................................................................................................... 156

5.1.1 Political Structure ........................................................................................................ 156

5.1.2 Analysis of the Current Political Environment .............................................................. 157

Page 5: HEALTHCARE, REGULATORY AND REIMBURSEMENT … · Table 4: Pharmaceutical Device Market, Republic of China (Taiwan), Market Segments of Newly Emerging Biotech Industry, Share (%), 2009

Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 7 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Table of Contents

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

5.1.3 Healthcare Policy Initiatives ......................................................................................... 158

5.2 Economic Landscape ...................................................................................................... 159

5.3 Economic Indicators ........................................................................................................ 161

5.3.1 Gross Domestic Product ............................................................................................. 161

5.3.2 National Income per Capita ......................................................................................... 165

5.3.3 Inflation ....................................................................................................................... 166

5.3.4 Currency Exchange Rate ............................................................................................ 170

5.3.5 Foreign Direct Investment ........................................................................................... 172

5.3.6 Foreign Exchange Reserves ....................................................................................... 174

5.3.7 Trade Balance ............................................................................................................. 175

5.3.8 Government Structural Balance................................................................................... 178

5.3.9 General Government Gross Debt ................................................................................ 180

5.3.10 Major Industries ........................................................................................................... 182

5.4 Demographics ................................................................................................................. 184

5.4.1 Population ................................................................................................................... 184

5.4.2 Education and Literacy ................................................................................................ 201

5.4.3 Employment ................................................................................................................ 203

5.4.4 Disease Burden ........................................................................................................... 205

5.5 Healthcare Infrastructure ................................................................................................. 207

5.5.1 Healthcare Facilities .................................................................................................... 207

5.5.2 Healthcare Parameters ............................................................................................... 218

5.5.3 Environmental Health .................................................................................................. 220

5.5.4 Healthcare Personnel .................................................................................................. 225

Page 6: HEALTHCARE, REGULATORY AND REIMBURSEMENT … · Table 4: Pharmaceutical Device Market, Republic of China (Taiwan), Market Segments of Newly Emerging Biotech Industry, Share (%), 2009

Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 8 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Table of Contents

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

5.6 Healthcare Expenditure ................................................................................................... 229

5.6.1 Overview ..................................................................................................................... 229

5.6.2 Major Components of Healthcare Spending ................................................................ 230

5.6.3 Public and Private Sector Share .................................................................................. 232

5.6.4 Spending in Pharmaceutical R&D ............................................................................... 234

5.7 Trade Associations ......................................................................................................... 235

5.7.1 Taiwan Medical and Biotech Industry Association ....................................................... 235

5.7.2 Taiwan Public Health Association................................................................................ 235

5.7.3 Taiwan Medical Association ........................................................................................ 235

5.7.4 Taiwan Generic Pharmaceutical Association ............................................................... 235

5.8 Trade Fairs ..................................................................................................................... 236

6 Opportunities and Challenges ................................................................................................. 237

6.1 Opportunities .................................................................................................................. 237

6.2 Challenges ...................................................................................................................... 238

7 Appendix................................................................................................................................. 240

7.1 Abbreviations .................................................................................................................. 240

7.2 Bibliography .................................................................................................................... 245

7.3 Research Methodology ................................................................................................... 260

7.3.1 Coverage .................................................................................................................... 260

7.3.2 Secondary Research ................................................................................................... 261

7.3.3 Forecasts .................................................................................................................... 261

7.3.4 Expert Panel................................................................................................................ 261

7.4 Disclaimer ....................................................................................................................... 262

Page 7: HEALTHCARE, REGULATORY AND REIMBURSEMENT … · Table 4: Pharmaceutical Device Market, Republic of China (Taiwan), Market Segments of Newly Emerging Biotech Industry, Share (%), 2009

Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 9 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Table of Contents

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

1.1 List of Tables

Table 1: Pharmaceutical Market, Republic of China (Taiwan), Revenue ($bn), 2008–2013............................. 23

Table 2: Pharmaceutical Market, Republic of China (Taiwan), Revenue Forecast ($bn), 2014–2020 .............. 24

Table 3: Pharmaceutical Market, Republic of China (Taiwan), Population, Exports and Imports ($m), 2008–

2013............................................................................................................................................ 25

Table 4: Pharmaceutical Device Market, Republic of China (Taiwan), Market Segments of Newly Emerging

Biotech Industry, Share (%), 2009 ............................................................................................... 29

Table 5: Pharmaceutical Device Market, Republic of China (Taiwan), Top Five Therapeutic Areas, Total

Expenditure on Personal Health Care, 2012 ................................................................................ 30

Table 6: Pfizer, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013 .................................. 33

Table 7: Pharmaceutical Market, Global, Late-Stage Pipeline, Pfizer, 2014 .................................................... 34

Table 8: Sanofi, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013 ................................. 42

Table 9: Sanofi, Global, Late-Stage Pipeline, 2013 ........................................................................................ 43

Table 10: GlaxoSmithKline, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013................ 51

Table 11: Pharmaceutical Market, Global, Late-Stage Pipeline, GlaxoSmithKline, 2014 ................................. 52

Table 12: Major Products, China Chemical & Pharmaceutical, 2013............................................................... 64

Table 13: Medical Device Market, Republic of China (Taiwan), Revenue ($bn), 2008–2013 ........................... 70

Table 14: Medical Device Market, Republic of China (Taiwan), Revenue Forecast ($bn), 2014–2020 ............ 71

Table 15: Medical Device Market, Republic of China (Taiwan), Nephrology and Urology Devices Market ($m),

2008–2013 .................................................................................................................................. 73

Table 16: Medical Device Market, Republic of China (Taiwan), Nephrology and Urology Devices Market, Sales

Trend for Major Players, 2012 ..................................................................................................... 74

Table 17: Medical Device Market, Republic of China (Taiwan), Ophthalmic Devices Market ($m), 2008–2013 75

Table 18: Medical Device Market, Republic of China (Taiwan), Ophthalmic Devices Market, Sales Trend for

Major Players, 2012 .................................................................................................................... 76

Page 8: HEALTHCARE, REGULATORY AND REIMBURSEMENT … · Table 4: Pharmaceutical Device Market, Republic of China (Taiwan), Market Segments of Newly Emerging Biotech Industry, Share (%), 2009

Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 10 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

Table 19: Medical Device Market, Republic of China (Taiwan), In Vitro Diagnostics Device Market ($m), 2008–

2013............................................................................................................................................ 78

Table 20: Medical Device Market, Republic of China (Taiwan), In Vitro Diagnostics Device Market, Sales Trend

for Major Players, 2012 ............................................................................................................... 79

Table 21: Medical Device Market, Republic of China (Taiwan), Cardiovascular Devices Market ($m), 2008–

2013............................................................................................................................................ 80

Table 22: Medical Device Market, Republic of China (Taiwan), Cardiovascular Devices Market, Sales Trend for

Major Players, 2012 .................................................................................................................... 81

Table 23: Medical Device Market, Republic of China (Taiwan), Orthopedic Device Market, Revenue ($m),

2008–2013 .................................................................................................................................. 83

Table 24: Medical Device Market, Republic of China (Taiwan), Orthopedic Device Market, Sales Trend for

Major Players, 2012 .................................................................................................................... 84

Table 25: Medical Device Market, Republic of China (Taiwan), Diagnostic Market, Revenue ($bn), 2008–2013

................................................................................................................................................... 85

Table 26: Medical Device Market, Republic of China (Taiwan), Diagnostic Market, Revenue Forecast ($bn),

2014–2020 .................................................................................................................................. 86

Table 27: Major Products, Baxter International, Global, Revenue ($m) and Annual Growth (%), 2013 ............ 88

Table 28: Major Products, Fresenius Medical Care, 2013............................................................................... 94

Table 29: Medtronic, Global, Major Products Classes, 2014 ......................................................................... 111

Table 30: Healthcare System, Republic of China (Taiwan), NHI Premium Formulas, 2014 ........................... 128

Table 31: Healthcare System, Republic of China (Taiwan), Basic Outpatient Care Co-payments, 2014 ........ 129

Table 32: Healthcare System, Republic of China (Taiwan), Basic Outpatient Care Co-payments, 2014 ........ 130

Table 33: Healthcare Spending, Republic of China (Taiwan), Out-of-Pocket Expenditure as Share of Total

Healthcare Expenditure (%), 2008–2013 ................................................................................... 131

Table 34: Price of Prescription Drugs, Republic of China (Taiwan), Medical Care Services Price Trend (%),

2008–2013 ................................................................................................................................ 133

Page 9: HEALTHCARE, REGULATORY AND REIMBURSEMENT … · Table 4: Pharmaceutical Device Market, Republic of China (Taiwan), Market Segments of Newly Emerging Biotech Industry, Share (%), 2009

Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 11 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

Table 35: Healthcare System, Republic of China (Taiwan), Registration Fee Structure for New Drug

Application ($), 2012 ................................................................................................................. 140

Table 36: Healthcare System, Republic of China (Taiwan), Regulatory Requirements for Medical Devices,

2013.......................................................................................................................................... 141

Table 37: Market Access, Republic of China (Taiwan), Trademark Fees ($), 2014 ....................................... 149

Table 38: Market Access, Republic of China (Taiwan), Trademark Fees, 2012............................................. 151

Table 39: Economic Indicators, Republic of China (Taiwan), Gross Domestic Product per Capita ($), 2008–

2013.......................................................................................................................................... 162

Table 40: Economic Indicators, Republic of China (Taiwan), Gross Domestic Product per Capita Forecast ($),

2014–2020 ................................................................................................................................ 162

Table 41: Economic Indicators, Republic of China (Taiwan), Gross Domestic Product Annual Growth (%),

2008–2013 ................................................................................................................................ 164

Table 42: Economic Indicators, Republic of China (Taiwan), Gross Domestic Product Annual Growth Forecast

(%), 2014–2020 ......................................................................................................................... 165

Table 43: Economic Indicators, Republic of China (Taiwan), National Income per Capita ($), 2008–2013..... 166

Table 44: Economic Indicators, Republic of China (Taiwan), Average Consumer Price Index, 2008–2013.... 167

Table 45: Economic Indicators, Republic of China (Taiwan), Average Consumer Price Index Forecast, 2014–

2020.......................................................................................................................................... 168

Table 46: Economic Indicators, Republic of China (Taiwan), Average Consumer Price Annual Change (%),

2008–2013 ................................................................................................................................ 170

Table 47: Economic Indicators, Republic of China (Taiwan), Currency Exchange Rate (TWD/$), 2008–2013

................................................................................................................................................. 171

Table 48: Economic Indicators, Republic of China (Taiwan), Foreign Direct Investment ($bn), 2008–2013 ... 173

Table 49: Economic Indicators, Republic of China (Taiwan), Foreign Exchange Reserves ($bn), 2008–2013

................................................................................................................................................. 175

Table 50: Economic Indicators, Republic of China (Taiwan), Imports of Goods and Services ($bn), 2008–2013

................................................................................................................................................. 176

Page 10: HEALTHCARE, REGULATORY AND REIMBURSEMENT … · Table 4: Pharmaceutical Device Market, Republic of China (Taiwan), Market Segments of Newly Emerging Biotech Industry, Share (%), 2009

Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 12 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

Table 51: Economic Indicators, Republic of China (Taiwan), Exports of Goods and Services ($bn), 2008–2013

................................................................................................................................................. 178

Table 52: Economic Indicators, Republic of China (Taiwan), Government Structural Balance ($bn), 2008–2013

................................................................................................................................................. 179

Table 53: Economic Indicators, Republic of China (Taiwan), General Government Gross Debt (% of GDP),

2008–2013 ................................................................................................................................ 180

Table 54: Economic Indicators, Republic of China (Taiwan), General Government Gross Debt Forecast (% of

GDP), 2014–2020 ..................................................................................................................... 181

Table 55: Economic Indicators, Republic of China (Taiwan), Major Industries, Gross Domestic Product by

Industry ($bn), 2012 .................................................................................................................. 183

Table 56: Demographics, Republic of China (Taiwan), Population (million), 2008–2013 ............................... 185

Table 57: Demographics, Republic of China (Taiwan), Population Forecast (million), 2014–2020 ................. 186

Table 58: Demographics, Republic of China (Taiwan), Urban–Rural Population (%), 2008–2013 ................. 187

Table 59: Demographics, Republic of China (Taiwan), Population Distribution by Age Group (%), 2008–2013

................................................................................................................................................. 189

Table 60: Demographics, Republic of China (Taiwan), Population Distribution by Age Group Forecast (%),

2014–2020 ................................................................................................................................ 189

Table 61: Demographics, Republic of China (Taiwan), Births (per 1,000 Population), 2008–2013 ................ 191

Table 62: Demographics, Republic of China (Taiwan), Mortality (per 1,000 Population), 2008–2013 ............ 192

Table 63: Demographics, Republic of China (Taiwan), Major Causes of Mortality (per 100,000 Population),

2012.......................................................................................................................................... 194

Table 64: Demographics, Republic of China (Taiwan), Children <5 Years Age, Infant Mortality Rate (per 1,000

Live Births), 2008–2013 ............................................................................................................. 196

Table 65: Demographics, Republic of China (Taiwan), Immunization Rate (%), 2012 ................................... 197

Table 66: Demographics, Republic of China (Taiwan), Gender Ratio (M/F), 2008–2013 ............................... 199

Table 67: Demographics, Republic of China (Taiwan), Life Expectancy at Birth (Years), 2008–2013 ............ 201

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Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 13 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

Table 68: Demographics, Republic of China (Taiwan), Student Net Enrollment by Level of Education (%), 2013

................................................................................................................................................. 203

Table 69: Demographics, Republic of China (Taiwan), Unemployment Rate (%), 2008–2013 ....................... 204

Table 70: Demographics, Republic of China (Taiwan), Employment by Sector (%), 2012 ............................. 205

Table 71: Demographics, Republic of China (Taiwan), Personal Health Expenditure by Disease (%), 2012 .. 206

Table 72: Demographics, Republic of China (Taiwan), Male Personal Health Expenditure per Capita by

Disease ($), 2012 ...................................................................................................................... 206

Table 73: Demographics, Republic of China (Taiwan), Female Personal Health Expenditure per Capita by

Diseases ($), 2012 .................................................................................................................... 207

Table 74: Healthcare Infrastructure, Republic of China (Taiwan), Hospitals, 2008–2013 ............................... 208

Table 75: Healthcare Infrastructure, Republic of China (Taiwan), Public and Private Hospitals, 2008–2013 .. 210

Table 76: Healthcare Infrastructure, Republic of China (Taiwan), Public Hospitals, Share by Ownership and

Number of Facilities, 2012 ......................................................................................................... 210

Table 77: Healthcare Infrastructure, Republic of China (Taiwan), Private Hospitals, Share by Ownership and

Number of Facilities, 2012 ......................................................................................................... 211

Table 78: Healthcare Infrastructure, Republic of China (Taiwan), Hospitals by Standard of Care, Contracted by

NHIA, 2008–2013 ...................................................................................................................... 212

Table 79: Healthcare Infrastructure, Republic of China (Taiwan), Hospitals by Services Rendered, 2012 ..... 213

Table 80: Healthcare Infrastructure, Republic of China (Taiwan), Beds by Type of Hospital, 2008–2013 ...... 215

Table 81: Healthcare Infrastructure, Republic of China (Taiwan), Beds by Specialty, 2012 ........................... 216

Table 82: Healthcare Infrastructure, Republic of China (Taiwan), Diagnostic Units, 2008–2013 .................... 217

Table 83: Healthcare Infrastructure, Republic of China (Taiwan), Hospital Beds (per 1,000 Population), 2008–

2013.......................................................................................................................................... 219

Table 84: Healthcare Infrastructure, Republic of China (Taiwan), Doctors (per 1,000 Population), 2008–2013

................................................................................................................................................. 220

Table 85: Healthcare Infrastructure, Republic of China (Taiwan), PM10 (µg/m3), 2008–2013 ....................... 222

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Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 14 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

Table 86: Healthcare Infrastructure, Republic of China (Taiwan), CO2 Emissions (million tons), 2008–2013 . 224

Table 87: Healthcare Infrastructure, Republic of China (Taiwan), Nurses (per 1,000 Population), 2008–2013

................................................................................................................................................. 226

Table 88: Healthcare Infrastructure, Republic of China (Taiwan), Pharmacists (per 1,000 Population), 2008–

2013.......................................................................................................................................... 227

Table 89: Healthcare Infrastructure, Republic of China (Taiwan), Dentists (per 1,000 Population), 2008–2013

................................................................................................................................................. 228

Table 90: Healthcare Expenditure, Republic of China (Taiwan), Healthcare Expenditure (% of GDP), 2008–

2013.......................................................................................................................................... 230

Table 91: Healthcare Expenditure, Republic of China (Taiwan), Primary Healthcare Expenditure, Current

Health Expenditure by Provider (%), 2011 ................................................................................. 231

Table 92: Healthcare Expenditure, Republic of China (Taiwan), Primary Healthcare Expenditure, Current

Health Expenditure by Mode of Production (%), 2011 ................................................................ 232

Table 93: Healthcare Expenditure, Republic of China (Taiwan), Healthcare Expenditure, Public–Private Share

(%), 2008–2013 ......................................................................................................................... 233

Table 94: Healthcare Expenditure, Republic of China (Taiwan), Pharmaceutical R&D Expenditure, 2008–2013

................................................................................................................................................. 234

Table 95: Healthcare Expenditure, Republic of China (Taiwan), Major Healthcare Trade Fairs, 2014 ........... 236

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Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 15 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

1.2 List of Figures

Figure 1: Pharmaceutical Market, Republic of China (Taiwan), Revenue ($bn), 2008–2013 ........................... 23

Figure 2: Pharmaceutical Market, Republic of China (Taiwan), Revenue Forecast ($bn), 2014–2020 ............. 24

Figure 3: Pharmaceutical Market, Republic of China (Taiwan), Population, Exports and Imports ($m), 2008–

2013............................................................................................................................................ 25

Figure 4: Pharmaceutical Market, Republic of China (Taiwan), Market Segments of Newly Emerging Biotech

Industry, Share (%), 2009 ............................................................................................................ 29

Figure 5: Medical Device Market, Republic of China (Taiwan), Revenue ($bn), 2008–2013 ............................ 70

Figure 6: Medical Device Market, Republic of China (Taiwan), Revenue Forecast ($bn), 2014–2020 ............. 71

Figure 7: Medical Device Market, Republic of China (Taiwan), Nephrology and Urology Devices Market ($m),

2008–2013 .................................................................................................................................. 72

Figure 8: Medical Device Market, Republic of China (Taiwan), Nephrology and Urology Devices Market, Sales

Trend for Major Players, Revenue* ($m), 2008–2012 .................................................................. 73

Figure 9: Medical Device Market, Republic of China (Taiwan), Ophthalmic Devices Market ($m), 2008–2013 75

Figure 10: Medical Device Market, Republic of China (Taiwan), Ophthalmic Devices Market, Sales Trend for

Major Players, Revenue ($m), 2008–2012 ................................................................................... 76

Figure 11: Medical Device Market, Republic of China (Taiwan), In Vitro Diagnostics Device Market ($m), 2008–

2013............................................................................................................................................ 77

Figure 12: Medical Device Market, Republic of China (Taiwan), In Vitro Diagnostics Device Market, Sales

Trend for Major Players, Revenue ($m), 2008–2012 .................................................................... 78

Figure 13: Medical Device Market, Republic of China (Taiwan), Cardiovascular Devices Market ($m), 2008–

2013............................................................................................................................................ 80

Figure 14: Medical Device Market, Republic of China (Taiwan), Cardiovascular Devices Market, Sales Trend

for Major Players, Revenue ($m), 2008–2012 .............................................................................. 81

Figure 15: Medical Device Market, Republic of China (Taiwan), Orthopedic Device Market, Revenue ($m),

2008–2013 .................................................................................................................................. 82

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Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 16 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

Figure 16: Medical Device Market, Republic of China (Taiwan), Orthopedic Device Market, Sales Trend for

Major Players, Revenue ($m), 2008–2012 ................................................................................... 83

Figure 17: Medical Device Market, Republic of China (Taiwan), Diagnostic Market, Revenue ($bn), 2008–2013

................................................................................................................................................... 85

Figure 18: Medical Device Market, Republic of China (Taiwan), Diagnostic Market, Revenue Forecast ($bn),

2014–2020 .................................................................................................................................. 86

Figure 19: Healthcare Market, Republic of China (Taiwan), Drivers and Barriers, 2013 ................................ 119

Figure 20: Healthcare System, Republic of China (Taiwan), Financial Flow in the Healthcare System, 2013 121

Figure 21: Healthcare System, Republic of China (Taiwan), Evolution of the Healthcare System, 1950–2013

................................................................................................................................................. 122

Figure 22: Healthcare System, Republic of China (Taiwan), Reimbursement Process, 2008 ........................ 124

Figure 23: Market Access, Republic of China (Taiwan), Process for Coverage and Reimbursement of Medical

Devices, 2014 ........................................................................................................................... 125

Figure 24: Healthcare System, Republic of China (Taiwan), Premium Collection under Second-Generation NHI

System, 2014 ............................................................................................................................ 128

Figure 25: Healthcare Spending, Republic of China (Taiwan), Out-of-Pocket Expenditure as Share of Total

Healthcare Expenditure (%), 2008–2013 ................................................................................... 131

Figure 26: Price of Prescription Drugs, Republic of China (Taiwan), Medical Care Services Price Trend (%),

2008–2013 ................................................................................................................................ 133

Figure 27: Market Access, Republic of China (Taiwan), Organization Structure of CDE, 2014 ...................... 136

Figure 28: Market Access, Republic of China (Taiwan), Marketing Authorization Procedure for New Drugs,

2014.......................................................................................................................................... 138

Figure 29: Market Access, Republic of China (Taiwan), New Drug Evaluation Process, 2013 ....................... 139

Figure 30: Market Access, Republic of China (Taiwan), HTA Process for New Drug Listing Application with the

NHIA, 2013 ............................................................................................................................... 140

Figure 31: Market Access, Republic of China (Taiwan), Marketing Authorization Procedure for Medical

Devices, 2013 ........................................................................................................................... 144

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Figure 32: Market Access, Republic of China (Taiwan), Clinical Trial Regulation Process for an IND, 2013 .. 153

Figure 33: Economic Indicators, Republic of China (Taiwan), Gross Domestic Product per Capita ($), 2008–

2013.......................................................................................................................................... 161

Figure 34: Economic Indicators, Republic of China (Taiwan), Gross Domestic Product per Capita Forecast ($),

2014–2020 ................................................................................................................................ 162

Figure 35: Economic Indicators, Republic of China (Taiwan), Gross Domestic Product Annual Growth (%),

2008–2013 ................................................................................................................................ 163

Figure 36: Economic Indicators, Republic of China (Taiwan), Gross Domestic Product Annual Growth Forecast

(%), 2014–2020 ......................................................................................................................... 164

Figure 37: Economic Indicators, Republic of China (Taiwan), National Income per Capita ($), 2008–2013 ... 165

Figure 38: Economic Indicators, Republic of China (Taiwan), Average Consumer Price Index, 2008–2013 .. 167

Figure 39: Economic Indicators, Republic of China (Taiwan), Average Consumer Price Index Forecast, 2014–

2020.......................................................................................................................................... 168

Figure 40: Economic Indicators, Republic of China (Taiwan), Average Consumer Price Annual Change (%),

2008–2013 ................................................................................................................................ 169

Figure 41: Economic Indicators, Republic of China (Taiwan), Currency Exchange Rate (TWD/$), 2008–2013

................................................................................................................................................. 171

Figure 42: Economic Indicators, Republic of China (Taiwan), Foreign Direct Investment ($bn), 2008–2013 .. 173

Figure 43: Economic Indicators, Republic of China (Taiwan), Foreign Exchange Reserves ($bn), 2008–2013

................................................................................................................................................. 174

Figure 44: Economic Indicators, Republic of China (Taiwan), Imports of Goods and Services ($bn), 2008–2013

................................................................................................................................................. 176

Figure 45: Economic Indicators, Republic of China (Taiwan), Exports of Goods and Services ($bn), 2008–2013

................................................................................................................................................. 177

Figure 46: Economic Indicators, Republic of China (Taiwan), Government Structural Balance ($bn), 2008–

2013.......................................................................................................................................... 179

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Figure 47: Economic Indicators, Republic of China (Taiwan), General Government Gross Debt (% of GDP),

2008–2013 ................................................................................................................................ 180

Figure 48: Economic Indicators, Republic of China (Taiwan), General Government Gross Debt Forecast (% of

GDP), 2014–2020 ..................................................................................................................... 181

Figure 49: Economic Indicators, Republic of China (Taiwan), Major Industries, Gross Domestic Product by

Industry ($bn), 2012 .................................................................................................................. 183

Figure 50: Demographics, Republic of China (Taiwan), Population (million), 2008–2013 .............................. 185

Figure 51: Demographics, Republic of China (Taiwan), Population Forecast (million), 2014–2020 ............... 186

Figure 52: Demographics, Republic of China (Taiwan), Urban–Rural Population (%), 2008–2013 ................ 187

Figure 53: Demographics, Republic of China (Taiwan), Population Distribution by Age Group (%), 2008–2013

................................................................................................................................................. 188

Figure 54: Demographics, Republic of China (Taiwan), Population Distribution by Age Group Forecast (%),

2014–2020 ................................................................................................................................ 189

Figure 55: Demographics, Republic of China (Taiwan), Births (per 1,000 Population), 2008–2013 ............... 191

Figure 56: Demographics, Republic of China (Taiwan), Mortality (per 1,000 Population), 2008–2013 ........... 192

Figure 57: Demographics, Republic of China (Taiwan), Major Causes of Mortality (per 100,000 Population),

2012.......................................................................................................................................... 194

Figure 58: Demographics, Republic of China (Taiwan), Children <5 Years Age, Infant Mortality Rate (per 1,000

Live Births), 2008–2013 ............................................................................................................. 195

Figure 59: Demographics, Republic of China (Taiwan), Immunization Rate (%), 2012 .................................. 197

Figure 60: Demographics, Republic of China (Taiwan), Gender Ratio (M/F), 2008–2013.............................. 199

Figure 61: Demographics, Republic of China (Taiwan), Life Expectancy at Birth (Years), 2008–2013 ........... 200

Figure 62: Demographics, Republic of China (Taiwan), Student Net Enrollment by Level of Education (%),

2013.......................................................................................................................................... 202

Figure 63: Demographics, Republic of China (Taiwan), Unemployment Rate (%), 2008–2013 ..................... 204

Figure 64: Demographics, Republic of China (Taiwan), Personal Health Expenditure by Disease (%), 2012 205

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Figure 65: Healthcare Infrastructure, Republic of China (Taiwan), Hospitals, 2008–2013 ............................. 208

Figure 66: Healthcare Infrastructure, Republic of China (Taiwan), Public and Private Hospitals, 2008–2013 209

Figure 67: Healthcare Infrastructure, Republic of China (Taiwan), Public Hospitals, Share by Ownership (%),

2012.......................................................................................................................................... 210

Figure 68: Healthcare Infrastructure, Republic of China (Taiwan), Private Hospitals, Share by Ownership (%),

2012.......................................................................................................................................... 211

Figure 69: Healthcare Infrastructure, Republic of China (Taiwan), Hospitals by Standard of Care, Contracted

by NHIA, 2008–2013 ................................................................................................................. 212

Figure 70: Healthcare Infrastructure, Republic of China (Taiwan), Hospitals by Services Rendered (%), 2012

................................................................................................................................................. 213

Figure 71: Healthcare Infrastructure, Republic of China (Taiwan), Beds by Type of Hospital, 2008–2013 ..... 214

Figure 72: Healthcare Infrastructure, Republic of China (Taiwan), Beds by Specialty, 2012 .......................... 215

Figure 73: Healthcare Infrastructure, Republic of China (Taiwan), Diagnostic Units, 2008–2013 ................... 217

Figure 74: Healthcare Infrastructure, Republic of China (Taiwan), Hospital Beds (per 1,000 Population), 2008–

2013.......................................................................................................................................... 218

Figure 75: Healthcare Infrastructure, Republic of China (Taiwan), Doctors (per 1,000 Population), 2008–2013

................................................................................................................................................. 219

Figure 76: Healthcare Infrastructure, Republic of China (Taiwan), PM10 (µg/m3), 2008–2013 ...................... 222

Figure 77: Healthcare Infrastructure, Republic of China (Taiwan), CO2 emissions (million tons), 2008–2013 224

Figure 78: Healthcare Infrastructure, Republic of China (Taiwan), Nurses (per 1,000 Population), 2008–2013

................................................................................................................................................. 226

Figure 79: Healthcare Infrastructure, Republic of China (Taiwan), Pharmacists (per 1,000 Population), 2008–

2013.......................................................................................................................................... 227

Figure 80: Healthcare Infrastructure, Republic of China (Taiwan), Dentists (per 1,000 Population), 2008–2013

................................................................................................................................................. 228

Figure 81: Healthcare Expenditure, Republic of China (Taiwan), Healthcare Expenditure (% of GDP), 2008–

2013.......................................................................................................................................... 229

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Figure 82: Healthcare Expenditure, Republic of China (Taiwan), Primary Healthcare Expenditure, Current

Health Expenditure by Provider, Share (%), 2011 ...................................................................... 230

Figure 83: Healthcare Expenditure, Republic of China (Taiwan), Primary Healthcare Expenditure, Current

Health Expenditure by Mode of Production (%), 2011 ................................................................ 231

Figure 84: Healthcare Expenditure, Republic of China (Taiwan), Healthcare Expenditure, Public–Private Share

(%), 2008–2013 ......................................................................................................................... 233

Figure 85: Healthcare Expenditure, Republic of China (Taiwan), Pharmaceutical R&D Expenditure ($m), 2008–

2013.......................................................................................................................................... 234

Figure 86: Healthcare Market, Republic of China (Taiwan), Opportunities and Challenges, 2013 ................. 239

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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

Introduction

2 Introduction

2.1 GlobalData Report Guidance

The report begins with an executive summary, which gives an overview of the Republic of

China’s (Taiwan) healthcare market and its key driving factors. It also gives a snapshot of the

demographic, regulatory, and reimbursement landscape and healthcare infrastructure in

Taiwan.

Chapter three provides an overview of Taiwan’s pharmaceutical and medical device markets,

covering market size; the market shares of generic, Over-The-Counter (OTC) and

biologic/biosimilar products; and the key drivers and barriers for the overall market. It also

includes profiles of the major players, as well as SWOT assessments.

Chapter four covers the reimbursement and payer landscape, and includes details of the

reimbursement process, insurance providers, pricing policies and drug price trends in Taiwan.

It also looks at the regulatory landscape, and gives an overview of the regulatory agencies and

approval processes for new drugs and medical devices. Also covered is the licensing process

for the manufacture, export and import of pharmaceuticals; regulations for pharmaceutical

advertising, labeling, packaging and clinical trials; and an overview of intellectual property

rights.

Chapter five provides detailed analysis of the political and economic environment in Taiwan,

and analyses economic indicators, demographics, and healthcare infrastructure and

expenditure.

Chapter six provides an overview of the opportunities for and challenges to growth in Taiwan’s

healthcare market.

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Overview of the Pharmaceutical and Medical Device Markets

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3 Overview of the Pharmaceutical and Medical Device Markets

3.1 Pharmaceutical Market

3.1.1 Market Overview

In 2013, the pharmaceutical market of the Republic of China (Taiwan) was valued at an estimated

$XX billion, having grown at a Compound Annual Growth Rate (CAGR) of XX% from 2008. It is

projected to reach $XX billion in 2020. Although Taiwan has a smaller market compared to Japan,

China, India and South Korea, its per-capita pharmaceutical market was worth approximately $XX

in 2013. Domestic Taiwanese pharmaceutical companies sell most of their products to the local

market and the National Health Insurance Administration (NHIA) is the biggest buyer of

pharmaceuticals in Taiwan.

The Taiwanese pharmaceutical sector is divided into three sub-sectors: Active Pharmaceutical

Ingredients (API), Western medicine and Traditional Chinese Medicine (TCM) (Hu, 2009). The

Taiwanese government is aggressively supporting R&D into Western medicines and applications

into TCM drugs. In 2011, the production value of APIs was approximately $XX billion, while

formulated drugs were valued at $XX billion and TCMs were valued at $XX billion (Department of

Investment Services, 2012).

The level of domestic consumption of pharmaceuticals is higher than the level of exports for

pharmaceutical goods in Taiwan. In 2012, domestic demand for pharmaceuticals was

approximately XX%, while only XX% of the pharmaceutical goods were exported (MOEAIDB,

2013).

The Global Budget Payment System was introduced in Taiwan in 2001, after which the price paid

by the NHIA for drugs fell six times by 2010. This has had a negative impact on both domestic

companies and foreign players. The seventh cut in drug prices occurred in December 2011, under

the country’s National Health Insurance (NHI) policy (USTR, 2013). These price-cutting policies

and the reimbursement environment in general are posing a significant challenge to the growth of

the country’s pharmaceutical market as they are discouraging future investment and interest due to

low returns.

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Overview of the Pharmaceutical and Medical Device Markets

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

However, the Taiwanese government is taking various steps to ensure investment and growth for

the country’s pharmaceutical industry. According to the Act for the Development of Biotech and

New Pharmaceuticals Industry (2007) the government is providing incentives for new

pharmaceutical companies to establish themselves in Taiwan, such as a reduction of income tax to

a maximum of XX% (Department of Investment Services, 2013a).

Figure 1: Pharmaceutical Market, Republic of China (Taiwan), Revenue ($bn), 2008–2013

2008 2009 2010 2011 2012 2013*

Rev

enue

($bn

)

CAGR (2008–2013): XX%

Source: Chen, 2010; MOEAIDB, 2013; Australian Trade Commission, 2013 *Estimated figure

Table 1: Pharmaceutical Market, Republic of China (Taiwan), Revenue ($bn), 2008–2013

Year 2008 2009 2010 2011 2012 2013*

Revenue

Source: Chen, 2010; MOEAIDB, 2013; Australian Trade Commission, 2013 *Estimated figure

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Country Analysis

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

5.3 Economic Indicators

5.3.1 Gross Domestic Product

5.3.1.1 GDP per Capita

GDP, which refers to the market value of all goods and services produced within a country in a

given period, is often considered an indicator of a country’s standard of living. In 2013, GDP per

capita in Taiwan was $XX, having grown at a CAGR of XX% from 2008.

Since then the GDP has showed an increasing trend (IMF, 2014a). The International Monetary

Fund (IMF) expects the GDP per capita to reach $XX in 2014 and $XX in 2019. Based on IMF

data, the GDP per capita is forecast to reach an estimated $XX in 2020 (IMF, 2014a).

Figure 33: Economic Indicators, Republic of China (Taiwan), Gross Domestic Product per Capita ($), 2008–2013

2008 2009 2010 2011 2012 2013

GD

P p

er c

apita

($)

CAGR (2008–2013): XX%

Source: IMF, 2014a

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Country Analysis

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5.5.1.3 Hospitals by Type of Services

Western medicine hospitals are classified into psychiatric, specialty, ordinary, general and chronic

care hospitals. There are more general hospitals than any other type of hospital. Some of the most

popular specialty hospitals are: Show Chwan Memorial Hospital, Potz General Hospital, Kaohsiung

Veterans General Hospital, and Chi-Shan Hospital.

Figure 70: Healthcare Infrastructure, Republic of China (Taiwan), Hospitals by Services Rendered (%), 2012

Ordinary hospitalsGeneral hospitals

Psychiatric hospitals

Chronic care Specialty hospitals

Source: MoHW, 2013c

Table 79: Healthcare Infrastructure, Republic of China (Taiwan), Hospitals by Services Rendered, 2012

Type of hospital Share (%) Number of facilities

Ordinary hospitals

General hospitals

Psychiatric hospitals

Chronic care

Specialty hospitals

Source: MoHW, 2013c

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Appendix

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7 Appendix

7.1 Abbreviations

µg/m3: micrograms per cubic meter

µm: micrometers

AC: Advisory Committee

ADHD: Attention Deficit Hyperactivity Disorder

ALK: Anaplastic Lymphoma Kinase

ANDA: Abbreviated New Drug Application

API: Active Pharmaceutical Ingredients

ASEAN: Association of Southeast Asian Nations

BACE: Beta Secretase

BNHI: Bureau of NHI

BoPA: Bureau of Pharmaceutical Affairs

CAGR: Compound Annual Growth Rate

CCPC: China Chemical & Pharmaceutical Co.

CDC: Centers for Disease Control

CDE: Center for Drug Evaluation

CDI: Clostridium difficile Infection

CE: Conformité Européenne

CKD: Chronic Kidney Disease

CMO: Contract Manufacturing Outsourcing

CNS: Central Nervous System

CO2: Carbon Dioxide

COPD: Chronic Obstructive Pulmonary Disease

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Appendix

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CPI: Consumer Price Index

CPP: Certificate of Pharmaceutical Product

CPS: Counts Per Second

CRAMS: Contract Research and Manufacturing services

CRL: Complete Response Letter

CRO: Contract Research Outsourcing

CT: Computed Tomography

CTIL: Clinical Trial Import License

CTP: Community Transformation Programme

DBC: Drug Benefit Committee

DEHP: Diethylhexyl phthalate

DET: Drug Expenditure Target

DoH: Department of Health

DPP: Democratic Progressive Party

DTaP–Hib–IPV: Diptheria, Tetanus and Pertussis–Haemophilus influenzae type b–Inactivated

PolioVirus

DTwP: Diphtheria, Tetanus toxoid with whole-cell Pertussis

E-beam: Electron beam

ECFA: Economic Cooperation Framework Agreement

EMA: European Medicines Agency

EMAP: Emerging Markets Asia-Pacific

ENT: Ear, Nose and Throat

EPA: Environmental Protection Administration

ESRD: End-Stage Renal Disease

EU: European Union

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Appendix

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FDA: Food and Drug Administration

FDI: Foreign Direct Investments

FEIBA: Factor eight inhibitor bypassing activity

Forex: Foreign exchange

GCP: Good Clinical Practice

GCRC: General Clinical Research Center

GDP: Gross Domestic Product

GLP: Good Laboratory Practice

GMP: Good Manufacturing Practice

GNI: Gross National Income

GSK: GlaxoSmithKline

HD: Hemodialysis

HepB: Hepatitis B vaccine

HIPAA: Health Insurance Portability & Accountability Act

HIV: Human Immunodeficiency Virus

HTA: Health Technology Assessment

ICD: Implantable Cardioverter-Defibrillator

ICH-GCP: International Conference on Harmonization–Good Clinical Practice

IDEA: International Design Excellence Awards

IDSA: Industrial Designers Society of America

iFOBT: immunochemical-based Fecal Occult Blood Test

IGIV: Immune Globulin Intravenous

IMF: International Monetary Fund

iMPRO: Integrated Medicinal Products Review Office

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IND: Investigational New Drug

IRB: Institutional Review Board

IPR: Intellectual Property Rights

IVD: In-vitro diagnostics

JE: Japanese encephalitis vaccine

JIRB: Joint Institutional Review Board

KMT: Kuomintang (Nationalist Party)

LIS: Laboratory Information System

ml: milliliters

MMR: Measles, mumps and rubella combination vaccine

MNC: Multinational Company

MoHW: Ministry of Health and Welfare

MRI: Magnetic Resonance Imaging

NCE: New Chemical Entities

NDA: New Drug Application

NHE: National Health Expenditure

NHI: National Health Insurance

NHIA: National Health Insurance Administration

NME: New Molecular Entities

NRPB: National Research Program for Biopharmaceuticals

NSAID: Non-Steroidal Anti-Inflammatory Drugs

OB: Originator Brand

OECD: Organization for Economic Co-operation and Development

OEM: Original Equipment Manufacturing

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OOP: Out-of-Pocket

OTC: Over-The-Counter

PACS: Picture Archiving Communication Systems

PBRS: Pharmaceutical Benefit and Reimbursement Scheme

PCV: Pneumococcal Conjugate Vaccine

PIP: Peak Inspiratory Pressure

PM10: Particulate Matter with a diameter of ≤10µm

PUD: Peptic Ulcer Disease

QC: Quality Control

QIV: Quadrivalent

QSD: Quality Systems Documentation

R&D: Research and Development

RRC: Research Review Committee

SDR: Special Drawing Rights

TAITRA: Taiwan External Trade Development Council

TB: Tuberculosis

TCM: Traditional Chinese Medicine

TEPA: Taiwan Environmental Protection Agency

TFDA: Taiwan Food and Drug Administration

TGPA: Taiwan Generic Pharmaceutical Association

TIPO: Taiwan Intellectual Property Office

TJCHA: Taiwan Joint Commission on Hospital Accreditation

TUR: Trans-Urethral

UN: United Nations

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UNFCCC: United Nations Framework Convention on Climate Change

UNICEF: United Nations Children's Fund

VACRS: Vocational Assistance Commission for Retired Servicemen

VAR: Varicella Vaccine

WIPO: World Intellectual Property Organization

WTO: World Trade Organization

7.2 Bibliography

10times (2014). Medical and pharmaceutical trade shows in Taiwan. 10times. Available from:

http://10times.com/taiwan/tradeshows. [Accessed on April 25, 2014].

Australian Trade Commission (2013). Health and Biotechnology: Trade Opportunities in the

Asian Century. Australian Trade Commission. Available from:

http://www.austrade.gov.au/ArticleDocuments/1418/Asian-Century-2013-Health-and-

Biotechnology-Melbourne.pdf.aspx [Accessed on April 27, 2014].

Baxter (2013). Annual report 2013. Baxter. Available from:

http://www.baxter.com/downloads/investors/reports_and_financials/annual_report/2013/2013_

baxter_form10-K.pdf.

Branigan T (2012). “Taiwan offers baby bonus to fix plummeting birth rate”, The Guardian,

January 23, 2012. Available from: http://www.theguardian.com/world/2012/jan/23/taiwan-low-

birth-rate. [Accessed on March 27, 2014].

Bureau of Foreign Trade (2014a). Import Regulation codes instruction. Bureau of Foreign

Trade. Available from: https://fbfh.trade.gov.tw/rich/text/fhj/asp/FHJP150Q.asp

[Accessed on March 27, 2014].

Bureau of Foreign Trade (2014b). Notes of import regulations. Bureau of Foreign Trade.

Available from:

http://www.trade.gov.tw/english/Pages/Detail.aspx?nodeID=101&pid=309889&dl_DateRange=

all&txt_SD=&txt_ED=&txt_Keyword=&Pageid=1 [Accessed on March 27, 2014].

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Appendix

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7.3 Research Methodology

GlobalData’s dedicated research and analysis teams consist of experienced professionals with

advanced statistical expertise and marketing, market research and consulting backgrounds in the

pharmaceutical industry.

GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk )

and Strategic and Competitive Intelligence Professionals (www.scip.org ).

All GlobalData databases are continuously updated and revised. The following research

methodology is followed for all databases and reports.

7.3.1 Coverage

The objective of updating GlobalData’s coverage is to ensure that it represents the most up-to-date

vision of the industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company,

association and competitor sources.

Company coverage is based on three key factors: revenue; products; and media attention,

innovation and market potential.

The estimated revenue of all major companies, including private and governmental, are gathered

and used to prioritize coverage.

Companies that are making the news or are of particular interest due to their innovative approach

are prioritized.

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).

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Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 261 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Appendix

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

7.3.2 Secondary Research

The research process begins with extensive secondary research using internal and external

sources to gather qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and

US Securities and Exchanges Commission (SEC) filings

Industry trade journals, scientific journals and other technical literature

Internal proprietary databases

Relevant patent and regulatory databases

National government documents, statistical databases and market reports

Procedure registries

News articles, press releases and web-casts specific to the companies operating in the market

The CountryFocus reports are largely based on secondary research and use reliable and

authoritative sources such as the IMF, the World Bank, OECD, WHO, UNICEF, UNStats, BEA,

MHLW and NHS, among others.

7.3.3 Forecasts

The CountryFocus reports use the data available from the secondary sources to forecast and

validate the future trends for a country’s healthcare market, as well as parameters related to the

economy and healthcare infrastructure and expenditure.

7.3.4 Expert Panel

GlobalData uses a panel of experts to cross-verify its databases and forecasts.

GlobalData’s expert panel comprises marketing managers, product specialists, international sales

managers from pharmaceutical companies, academics from research universities, consultants from

venture capital funds, and distributors/suppliers of pharmaceuticals and supplies.

Historic data and forecasts are relayed to GlobalData’s expert panel and adjusted in accordance

with their feedback.

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Healthcare, Regulatory and Reimbursement Landscape – Republic of China (Taiwan) 262 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

Appendix

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE – REPUBLIC OF CHINA (TAIWAN)

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.


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