REFERENCE CODE GDHC0054CHR | PUBLICATION DATE OCTOBER 2013
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE -
BRAZIL
Healthcare, Regulatory and Reimbursement Landscape – Brazil 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 –
BRAZIL
Executive Summary
Brazil has Emerged as a Manufacturing Hub for Pharmaceutical and Biotechnology Companies. The Healthcare Market in the Country is Primarily Driven by an Increasing Disease Burden, Affordability, and Access to Primary Care. However, Healthcare Insurance Coverage does not Cover the Total Population and therefore Restricts Market Growth.
The value of the pharmaceutical market in Brazil
amounted to an estimated $XX billion in 2012,
having increased from $XX billion in 2007 at a
Compound Annual Growth Rate (CAGR) of XX%.
This value is expected to reach $XX billion in 2020.
Changing demographics are an important driver for
the market, as the increasing elderly population will
lead to an increase in the incidence of chronic and
other lifestyle-associated diseases. Brazil has
emerged as a global manufacturing hub for
pharmaceutical and biotechnology companies.
Approximately XX% of the country’s Gross
Domestic Product (GDP) comes from the
manufacturing sector. Countries such as India
began to invest heavily in the manufacturing sector
after José Serra, who was the Brazilian Health
Minister in 1997, invited Indian generic companies
to invest in Brazil. In 2013, the government
announced the investment of BRL7 XX billion ($XX
billion) in the health sector. Government programs
such as ‘Brazil without Misery’, a federal program
to combat poverty, will be awarded BRL XX billion
($XX billion), XX% more than was provided in
2012. The decentralized unified healthcare system
(Sistema Único de Saúde, SUS) is one of the
largest public health systems in the world, and
provides medical services to XX–XX% of the
Brazilian population. All of these factors are
expected to drive the growth of the pharmaceutical
market to reach $XX billion in 2020. However, the
absence of complete coverage for all of the
inhabitants of Brazil restricts growth opportunities
in the country.
Pharmaceutical Market, Brazil, Revenue ($bn), 2007–2020
2007 2012* 2015* 2020*
Rev
enue
($bn
)
Year
CAGR (2007–2020): XX%
Source: GlobalData; Febrafarma, 2007; Strozzi and Graeml, 2011 *Estimated figure
The value of the medical device market in Brazil
amounted to an estimated $XX billion in 2012. It is
the largest market in South America, and is
expected to have reached $XX billion by 2020, with
a CAGR of XX% forecast for the 2013–2020
period. In 2012, the main segments of the medical
devices market were ophthalmic devices ($XX
billion), in vitro diagnostics devices ($XX billion),
and diagnostic imaging devices ($XX billion).
Healthcare, Regulatory and Reimbursement Landscape – Brazil 6 © 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 –
BRAZIL
Table of Contents
1 Table of Contents
1 Table of Contents ....................................................................................................................... 6
1.1 List of Tables .................................................................................................................... 10
1.2 List of Figures ................................................................................................................... 15
2 Introduction ............................................................................................................................... 20
2.1 GlobalData Report Guidance ............................................................................................ 20
3 Overview of the Pharmaceutical and Medical Devices Market .................................................. 21
3.1 Pharmaceutical Market ..................................................................................................... 21
3.1.1 Market Overview ........................................................................................................... 21
3.1.2 Pharmaceutical Import and Export ................................................................................ 24
3.1.3 Supply Channels ........................................................................................................... 25
3.1.4 Market Segments .......................................................................................................... 27
3.1.5 Major Disease Areas ..................................................................................................... 32
3.1.6 Major Players ................................................................................................................ 39
3.2 Medical Device Market ...................................................................................................... 90
3.2.1 Market Overview ........................................................................................................... 90
3.2.2 Overview of Leading Five Segments ............................................................................. 93
3.2.3 Diagnostic Market ....................................................................................................... 109
3.2.4 Major Players .............................................................................................................. 111
3.3 Market Drivers and Barriers ............................................................................................ 147
3.3.1 Drivers......................................................................................................................... 147
3.3.2 Barriers ....................................................................................................................... 149
4 Market Access ........................................................................................................................ 151
4.1 Overview of Healthcare System ...................................................................................... 151
4.1.1 Organizational structure .............................................................................................. 151
4.2 Reimbursement and Payer Landscape ........................................................................... 155
4.2.1 Reimbursement Process ............................................................................................. 157
Healthcare, Regulatory and Reimbursement Landscape – Brazil 7 © 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 –
BRAZIL
Table of Contents
4.2.2 Pricing Procedure ........................................................................................................ 161
4.2.3 Overview of Insurance Providers ................................................................................. 163
4.2.4 Patient Share in Healthcare Spending ......................................................................... 171
4.2.5 Drug Price Trend ......................................................................................................... 172
4.2.6 Pricing Policies ............................................................................................................ 173
4.3 Regulatory Landscape .................................................................................................... 175
4.3.1 Overview of Regulatory Agencies................................................................................ 175
4.3.2 New Drug Approval Process ....................................................................................... 183
4.3.3 Generic Drug Approval Process .................................................................................. 187
4.3.4 New Medical Device Approval Process ....................................................................... 190
4.3.5 Licensing Process for Pharmaceutical and Medical Device Manufacturing .................. 194
4.3.6 Licensing Process for Pharmaceutical Exports and Imports ........................................ 195
4.3.7 Intellectual Property Rights.......................................................................................... 197
4.3.8 Clinical Trial Regulations ............................................................................................. 203
4.3.9 Pharmaceutical Advertising Regulations ..................................................................... 205
4.3.10 Pharmacy Regulations ................................................................................................ 206
4.3.11 Labeling and Packaging Regulations .......................................................................... 208
5 Country Analysis ..................................................................................................................... 210
5.1 Political Environment....................................................................................................... 210
5.1.1 Political Structure ........................................................................................................ 210
5.1.2 Analysis of Current Political Environment .................................................................... 212
5.1.3 Healthcare Policy Initiatives ......................................................................................... 214
5.2 Economic Landscape ...................................................................................................... 220
5.3 Economic Indicators ........................................................................................................ 225
5.3.1 Gross Domestic Product ............................................................................................. 225
5.3.2 Gross National Income ................................................................................................ 230
5.3.3 Inflation ....................................................................................................................... 231
Healthcare, Regulatory and Reimbursement Landscape – Brazil 8 © 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 –
BRAZIL
Table of Contents
5.3.4 Currency Exchange Rate ............................................................................................ 234
5.3.5 Foreign Direct Investment ........................................................................................... 235
5.3.6 Foreign Exchange Reserves ....................................................................................... 236
5.3.7 Trade Balance ............................................................................................................. 237
5.3.8 Government Structural Balance................................................................................... 240
5.3.9 Government Net Debt ................................................................................................. 241
5.3.10 Major Industries ........................................................................................................... 242
5.4 Demography ................................................................................................................... 244
5.4.1 Population ................................................................................................................... 244
5.4.2 Education and Literacy ................................................................................................ 261
5.4.3 Employment ................................................................................................................ 263
5.4.4 Disease Burden ........................................................................................................... 264
5.5 Healthcare Infrastructure ................................................................................................. 267
5.5.1 Healthcare Facilities .................................................................................................... 268
5.5.2 Healthcare Parameters ............................................................................................... 276
5.5.3 Environmental Health .................................................................................................. 278
5.5.4 Healthcare Personnel .................................................................................................. 286
5.6 Healthcare Expenditure ................................................................................................... 288
5.6.1 Overview ..................................................................................................................... 288
5.6.2 Major Components of Healthcare Spending ................................................................ 289
5.6.3 Share of Public and Private Sectors ............................................................................ 292
5.6.4 Spending on Pharmaceutical R&D .............................................................................. 293
5.7 Trade Associations ......................................................................................................... 294
5.7.1 ABIMO ........................................................................................................................ 294
5.7.2 ABIMED ...................................................................................................................... 294
5.7.3 Interfarma .................................................................................................................... 295
5.7.4 Abiquifi ........................................................................................................................ 295
Healthcare, Regulatory and Reimbursement Landscape – Brazil 9 © 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 –
BRAZIL
Table of Contents
5.8 Trade Fairs ..................................................................................................................... 296
6 Opportunities and Challenges ................................................................................................. 297
6.1 Opportunities .................................................................................................................. 297
6.2 Challenges ...................................................................................................................... 298
7 Appendix................................................................................................................................. 300
7.1 Abbreviations .................................................................................................................. 300
7.2 Bibliography .................................................................................................................... 313
7.3 Methodology ................................................................................................................... 332
7.3.1 Coverage .................................................................................................................... 332
7.3.2 Secondary Research ................................................................................................... 333
7.3.3 Forecasting ................................................................................................................. 333
7.3.4 Expert Panel Validation ............................................................................................... 333
7.4 Disclaimer ....................................................................................................................... 334
Healthcare, Regulatory and Reimbursement Landscape – Brazil 10 © 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 –
BRAZIL
Table of Contents
1.1 List of Tables
Table 1: Pharmaceutical Industry, Brazil, Revenue ($bn), 2007–2012 ....................................................... 23
Table 2: Pharmaceutical Market, Brazil, Revenue ($bn), Forecast, 2013–2020.......................................... 23
Table 3: Pharmaceutical Market, Brazil, Exports and Imports ($bn), 2007–2012 ........................................ 24
Table 4: Pharmaceutical Market, Brazil, Margin of Preference For Drugs And Medications, 2013 .............. 27
Table 5: Pharmaceutical Market, Brazil, Product Development Partnerships of Biologics, 2013 ................. 31
Table 6: Pharmaceutical Market, Brazil, Proportional Distribution of Types of Cancer by Incidence, 2012 .. 34
Table 7: Pharmaceutical Market, Brazil, Mortality by Type of Cancer (%), 2010 ......................................... 35
Table 8: Pharmaceutical Market, Brazil, Mortality by Major Disease Areas (%), 2010 ................................ 38
Table 9: Pfizer, Global, Major Products, Revenue ($m), 2012 .................................................................... 40
Table 10: Pfizer, Global, Late-stage Pipeline, 2013 ..................................................................................... 41
Table 11: Novartis, Global, Major Products, Revenue ($m), 2012 ................................................................ 53
Table 12: Novartis, Global, Planned Filings, 2012–2016 .............................................................................. 54
Table 13: Sanofi, Global, Major Products, Revenue ($bn), 2012 .................................................................. 62
Table 14: Sanofi, Global, Late-stage Pipeline, 2013 .................................................................................... 63
Table 15: Roche, Global, Major Products, Revenue ($bn), 2012 ................................................................. 69
Table 16: Roche, Global, Late-stage Pipeline, 2013 .................................................................................... 70
Table 17: AstraZeneca, Global, Major Products, Revenue ($bn), 2011 ........................................................ 77
Table 18: AstraZeneca, Global, Late-stage Pipeline, 2012 .......................................................................... 78
Table 19: Medical Device Market, Brazil, Revenue ($bn), 2007–2012 ......................................................... 91
Table 20: Medical Device Market, Brazil, Revenue Forecast ($bn), 2013–2020 ........................................... 92
Table 21: Medical Device Market, Brazil, Revenue by Segment ($bn), 2012................................................ 93
Table 22: Medical Device Market, Brazil, Ophthalmic Devices Market, Revenue ($bn), 2007–2012 ............. 95
Table 23: Medical Device Market, Brazil, Sales Trend for Major Players*, Ophthalmic Devices, 2011 .......... 96
Healthcare, Regulatory and Reimbursement Landscape – Brazil 11 © 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 –
BRAZIL
Table of Contents
Table 24: Medical Device Market, Brazil, In-Vitro Diagnostics Market, Revenue ($bn), 2007–2012 .............. 98
Table 25: Medical Device Market, Brazil, Sales Trend for Major Players*, In-Vitro Diagnostic Devices, 2011
................................................................................................................................................... 99
Table 26: Medical Device Market, Brazil, Diagnostic Imaging Market, Revenue ($bn), 2007–2012 ............ 102
Table 27: Medical Device Market, Brazil, Sales Trends for Major Players*, Diagnostic Imaging Devices, 2011
................................................................................................................................................. 102
Table 28: Medical Device Market, Brazil, Orthopedic Devices Market, Revenue ($bn), 2007–2012............ 104
Table 29: Medical Device Market, Brazil, Sales Trend for Major Players*, Orthopedic Devices, 2011 ........ 105
Table 30: Medical Device Market, Brazil, Cardiovascular Devices Market, Revenue ($bn), 2007–2012 ..... 108
Table 31: Medical Device Market, Brazil, Sales Trend for Major Players*, Cardiovascular Devices, 2011 .. 108
Table 32: Medical Device Market, Brazil, Diagnostics Market, Revenue ($bn), 2007–2012 ........................ 109
Table 33: Medical Device Market, Brazil, Diagnostics Market, Revenue ($bn), Forecast, 2013–2020......... 110
Table 34: Medical Device Market, Brazil, Major Medical Device Companies, Revenue ($m), 2011 ............ 111
Table 35: Siemens, Global, Major Products, Revenue ($m), 2012 ............................................................. 112
Table 36: Roche, Global, Major Products, Revenue ($m), 2012 ................................................................ 125
Table 37: Essilor International, Global, Major Segments, Revenue ($m), 2011 .......................................... 132
Table 38: Philips Healthcare, Global, Major Products, Revenue ($bn), 2012.............................................. 138
Table 39: Healthcare System, Brazil, 2013 ................................................................................................ 152
Table 40: Healthcare System, Brazil, Comparative Analysis of CITEC and CONITEC, 2013 ...................... 159
Table 41: Healthcare System, Brazil, Mean Reduction in Factory Price and Number of Products (%), 2004–
2011.......................................................................................................................................... 163
Table 42: Healthcare Spending, Brazil, Decision-Making Structure of SUS, 2013 ...................................... 165
Table 43: Healthcare Spending, Brazil, Distribution of Health Insurance Beneficiaries (%), 2013 ............... 166
Table 44: Healthcare Spending, Brazil, Private Health Insurance Beneficiaries (million), 2007–2012 ......... 167
Table 45: Healthcare Spending, Brazil, Out-of-Pocket Expenditure (%), 2007–2012 .................................. 171
Healthcare, Regulatory and Reimbursement Landscape – Brazil 12 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –
BRAZIL
Table of Contents
Table 46: Price of Drugs, Brazil, Change in Average Price of Prescription (%), 2007–2011 ....................... 172
Table 47: Pricing Policies, Brazil, 2013 ..................................................................................................... 174
Table 48: Healthcare System, Brazil, Documents Required for Dossier Submission of Clinical Trial, 2013 . 204
Table 49: Economic Landscape, Brazil, BRICS Comparison, 2012 ............................................................ 222
Table 50: Economic Indicators, Brazil, Gross Domestic Product Per Capita ($), 2007–2012 ...................... 226
Table 51: Economic Indicators, Brazil, Gross Domestic Product Per Capita ($), Forecast, 2013–2020 ...... 226
Table 52: Economic Indicators, Brazil, Gross Domestic Product Annual Growth (%), 2007–2012 .............. 227
Table 53: Economic Indicators, Brazil, Gross Domestic Product Annual Growth (%), Forecast, 2013–2020
................................................................................................................................................. 228
Table 54: Economic Indicators, Brazil, Gross Domestic Product, Brazil, Russia, India, China, Annual Growth
(%), 2007–2012 ......................................................................................................................... 229
Table 55: Economic Indicators, Brazil, Gross National Income Per Capita ($), 2007–2012 ........................ 230
Table 56: Economic Indicators, Brazil, Average Consumer Price Index, 2007–2012 .................................. 232
Table 57: Economic Indicators, Brazil, Average Consumer Price Annual Change (%), 2007–2012 ............ 233
Table 58: Economic Indicators, Brazil, Currency Exchange Rate ($/BRL), 2007–2012............................... 234
Table 59: Economic Indicators, Brazil, Foreign Direct Investment ($bn), 2007–2012 ................................. 235
Table 60: Economic Indicators, Brazil, Foreign Exchange Reserves ($bn), 2007–2012 ............................. 236
Table 61: Economic Indicators, Brazil, Trade Balance ($bn), 2007–2012................................................... 237
Table 62: Economic Indicators, Brazil, Imports of Goods and Services ($bn), 2007–2012 ......................... 238
Table 63: Economic Indicators, Brazil, Exports of Goods and Services ($bn), 2007–2012 ......................... 239
Table 64: Economic Indicators, Brazil, General Government Structural Balance ($bn), 2007–2012 ........... 240
Table 65: Economic Indicators, Brazil, General Government Net Debt ($bn), 2007–2012 .......................... 241
Table 66: Economic Indicators, Brazil, Major Industries by Contribution to GDP (%), 2011 ........................ 243
Table 67: Demographics, Brazil, Population (million), 2007–2012.............................................................. 244
Table 68: Demographics, Brazil, Population (million), Forecast, 2013–2020 .............................................. 245
Healthcare, Regulatory and Reimbursement Landscape – Brazil 13 © 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 –
BRAZIL
Table of Contents
Table 69: Demographics, Brazil, Urban and Rural Population Share (%), 2007–2012 ................................ 247
Table 70: Demographics, Brazil, Urban and Rural Population Share (%), Forecast, 2013–2020 ................ 248
Table 71: Demographics, Brazil, Population Distribution by Age Group (%), 2007–2012 ............................ 250
Table 72: Demographics, Brazil, Population Distribution by Age Group (%), Forecast, 2013–2020 ............ 250
Table 73: Demographics, Brazil, (Per 1,000 Population), 2007–2012 ........................................................ 252
Table 74: Demographics, Brazil, Mortality (Per 1,000 Population), 2007–2012 .......................................... 252
Table 75: Demographics, Brazil, Major Causes of Mortality (‘000), 2010.................................................... 254
Table 76: Demographics, Brazil, Children <5 Years Age, Mortality (Per 1,000 Live Births), 2007–2012 ..... 255
Table 77: Demographics, Brazil, Immunization Rate (%), 2007–2012 ........................................................ 256
Table 78: Demographics, Brazil, Major Causes of Mortality per 100,000 Population, 2010 ........................ 258
Table 79: Demographics, Brazil, Gender Ratio (M/F), 2007–2012 ............................................................. 259
Table 80: Demographics, Brazil, Life Expectancy at Birth (Years), 2007–2012 .......................................... 260
Table 81: Demographics, Brazil, Illiteracy (%), 2007–2012 ........................................................................ 262
Table 82: Demographics, Brazil, Employment Rate (%), 2007–2012 ......................................................... 264
Table 83: Demographics, Brazil, Major Diseases, DALY (Per 100,000 Population), 2004 .......................... 265
Table 84: Demographics, Brazil, Major Diseases, In Patients, Jan 2013–May 2013 ................................... 266
Table 85: Healthcare Infrastructure, Brazil, Total Number of Hospitals, 2012 ............................................. 268
Table 86: Healthcare Infrastructure, Brazil, Hospitals Linked to SUS (%), 2013 ......................................... 269
Table 87: Healthcare Infrastructure, Brazil, Hospital Beds (‘000), 2012 ...................................................... 270
Table 88: Healthcare Infrastructure, Brazil, Hospital Beds by Type of Service (‘000), 2013 ........................ 271
Table 89: Healthcare Infrastructure, Brazil, Hospitals Beds by Type of Care (‘000), 2012 .......................... 272
Table 90: Healthcare Infrastructure, Brazil, SUS ICU Beds by Type, 2013 ................................................. 273
Table 91: Healthcare Infrastructure, Brazil, Complementary Services (‘000), 2013 .................................... 274
Table 92: Healthcare Infrastructure, Brazil, Number of Items of Equipment (‘000), 2013 ............................ 275
Healthcare, Regulatory and Reimbursement Landscape – Brazil 14 © 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 –
BRAZIL
Table of Contents
Table 93: Healthcare Infrastructure, Brazil, Beds (Per 1,000 Population), 2007–2012 ................................ 276
Table 94: Healthcare Infrastructure, Brazil, Physicians (per 1,000 Population), 2007–2012 ....................... 277
Table 95: Environmental Health, Brazil, Targets for Carbon Reduction, 2009 ............................................ 279
Table 96: Environmental Health, Brazil, PM10 Emissions (µg/m3), 2007–2012 .......................................... 280
Table 97: Environmental Health, Brazil, N2O Emissions (’000 metric tons), 2007–2012 ............................. 281
Table 98: Environmental Health, Brazil, CO2 Emissions (kilotons), 2007–2012 .......................................... 282
Table 99: Environmental Health, Brazil, Other Greenhouse Gas Emissions (‘000 metric tons), 2007–2012 284
Table 100: Environmental Health, Brazil, Proportion of the Population Using Improved Drinking Water Sources
(%), 2007–2012 ......................................................................................................................... 285
Table 101: Healthcare Personnel, Brazil, Healthcare Personnel (’000), 2013 .............................................. 287
Table 102: Healthcare Expenditure, Brazil, Healthcare Expenditure (% of GDP), 2007–2012 ...................... 288
Table 103: Healthcare Expenditure, Brazil, Household Healthcare Expenditure, Share (%), 2009 ............... 290
Table 104: Healthcare Expenditure, Brazil, General Government Healthcare Expenditure, Share (%), 2009 291
Table 105: Healthcare Expenditure, Brazil, Health Expenditure, Public-Private Share (%), 2007–2012 ........ 292
Table 106: Healthcare Expenditure, Brazil, Pharmaceutical R&D Expenditure, Share (%), 2008.................. 293
Table 107: Healthcare Expenditure, Brazil, Biopharmaceutical R&D Financing in China, India, Brazil and
South Africa, 2013 ..................................................................................................................... 294
Table 108: Major Healthcare Trade Fairs, Brazil, 2013 ................................................................................ 296
Healthcare, Regulatory and Reimbursement Landscape – Brazil 15 © 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 –
BRAZIL
Table of Contents
1.2 List of Figures
Figure 1: Pharmaceutical Industry, Brazil, Revenue ($bn), 2007–2012 ....................................................... 22
Figure 2: Pharmaceutical Market, Brazil, Revenue ($bn), Forecast, 2013–2020.......................................... 23
Figure 3: Pharmaceutical Market, Brazil, Exports and Imports ($bn), 2007–2012 ........................................ 24
Figure 4: Pharmaceutical Market, Brazil, Pharmaceutical Distribution Channel, 2013 ................................. 26
Figure 5: Pharmaceutical Market, Brazil, Mortality by Type of Cancer (%), 2010 ......................................... 34
Figure 6: Pharmaceutical Market, Brazil, Mortality by Major Disease Areas (%), 2010 ................................ 38
Figure 7: Medical Device Market, Brazil, Revenue ($bn), 2007–2012 ......................................................... 91
Figure 8: Medical Device Market, Brazil, Revenue Forecast ($bn), 2013–2020 ........................................... 92
Figure 9: Medical Device Market, Brazil, Revenue by Segment ($bn), 2012................................................ 93
Figure 10: Medical Device Market, Brazil, Ophthalmic Devices Market, Revenue ($bn), 2007–2012 ............. 95
Figure 11: Medical Device Market, Brazil, Sales Trends for Major Players*, Ophthalmic Devices, 2007–2011
................................................................................................................................................... 96
Figure 12: Medical Device Market, Brazil, In-Vitro Diagnostics Market, Revenue ($bn), 2007–2012 .............. 98
Figure 13: Medical Device Market, Brazil, Sales Trend for Major Players*, In-Vitro Diagnostic Devices, 2007–
2011............................................................................................................................................ 99
Figure 14: Medical Device Market, Brazil, Diagnostic Imaging Market, Revenue ($bn), 2007–2012 ............ 101
Figure 15: Medical Device Market, Brazil, Sales Trends for Major Players*, Diagnostic Imaging Devices,
2007–2011 ................................................................................................................................ 102
Figure 16: Medical Device Market, Brazil, Orthopedic Devices Market, Revenue ($bn), 2007–2012............ 104
Figure 17: Medical Device Market, Brazil, Sales Trend for Major Players*, Orthopedic Devices, 2007–2011
................................................................................................................................................. 105
Figure 18: Medical Device Market, Brazil, Cardiovascular Devices Market, Revenue ($bn), 2007–2012 ..... 107
Figure 19: Medical Device Market, Brazil, Sales Trend for Major Players*, Cardiovascular Devices, 2007–
2011.......................................................................................................................................... 108
Figure 20: Medical Device Market, Brazil, Diagnostics Market, Revenue ($bn), 2007–2012 ........................ 109
Healthcare, Regulatory and Reimbursement Landscape – Brazil 16 © 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 –
BRAZIL
Table of Contents
Figure 21: Medical Device Market, Brazil, Diagnostics Market, Revenue ($bn), Forecast, 2013–2020......... 110
Figure 22: Medical Device Market, Brazil, Major Medical Device Companies, Revenue ($m), 2011 ............ 111
Figure 23: Healthcare Market, Brazil, Drivers and Barriers, 2013 ................................................................ 150
Figure 24: Healthcare System, Brazil, Financing Flows, 2013 ..................................................................... 154
Figure 25: Healthcare System, Brazil, Reimbursement System, 2013 ......................................................... 157
Figure 26: Healthcare System, Brazil, Reimbursement Process, 2013 ........................................................ 161
Figure 27: Healthcare System, Brazil, Flowchart for Classification of Drugs into Categories, 2013 .............. 162
Figure 28: Healthcare Spending, Brazil, Health Insurance Providers, 2013 ................................................. 164
Figure 29: Healthcare Spending, Brazil, Distribution of Health Insurance Beneficiaries (%), 2013 ............... 165
Figure 30: Healthcare Spending, Brazil, Private Health Insurance Beneficiaries (million), 2007–2012 ......... 166
Figure 31: Healthcare System, Brazil, Organization Structure of ANS, 2013 ............................................... 168
Figure 32: Healthcare Spending, Brazil, Out-of-Pocket Expenditure (%), 2007–2012 .................................. 171
Figure 33: Price of Drugs, Brazil, Change in Average Price of Drugs (%), 2007–2011 ................................ 172
Figure 34: Healthcare System, Brazil, Ministry of Health Organizational Structure, 2013 ............................. 177
Figure 35: Healthcare System, Brazil, ANVISA Old Organizational Structure, 2013 .................................... 179
Figure 36: Healthcare System, Brazil, Roles and Responsibilities of Regulatory Bodies, 2013 .................... 183
Figure 37: Healthcare System, Brazil, New Drug Approval Stages, 2013 .................................................... 184
Figure 38: Healthcare System, Brazil, New Drug Approval Process, 2013 .................................................. 186
Figure 39: Healthcare System, Brazil, Generic Drug Approval Process, 2013 ............................................. 188
Figure 40: Healthcare System, Brazil, Similar Drug (Biosimilar) Approval Process, 2013 ............................ 189
Figure 41: Healthcare System, Brazil, New Medical Device Approval Process, 2013 .................................. 191
Figure 42: Economic Indicators, Brazil, Gross Domestic Product Per Capita ($), 2007–2012 ...................... 225
Figure 43: Economic Indicators, Brazil, Gross Domestic Product Per Capita ($), Forecast, 2013–2020 ...... 226
Figure 44: Economic Indicators, Brazil, Gross Domestic Product Annual Growth (%), 2007–2012 .............. 227
Healthcare, Regulatory and Reimbursement Landscape – Brazil 17 © 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 –
BRAZIL
Table of Contents
Figure 45: Economic Indicators, Brazil, Gross Domestic Product Annual Growth (%), Forecast, 2013–2020 228
Figure 46: Economic Indicators, Brazil, Gross National Income Per Capita ($), 2007–2012 ........................ 230
Figure 47: Economic Indicators, Brazil, Average Consumer Price Index, 2007–2012 ................................. 232
Figure 48: Economic Indicators, Brazil, Average Consumer Price Annual Change (%), 2007–2012 ............ 233
Figure 49: Economic Indicators, Brazil, Currency Exchange Rate ($/BRL), 2007–2012............................... 234
Figure 50: Economic Indicators, Brazil, Foreign Direct Investment ($bn), 2007–2012 ................................. 235
Figure 51: Economic Indicators, Brazil, Foreign Exchange Reserves ($bn), 2007–2012 ............................. 236
Figure 52: Economic Indicators, Brazil, Trade Balance ($bn), 2007–2012................................................... 237
Figure 53: Economic Indicators, Brazil, Imports of Goods and Services ($bn), 2007–2012238
Figure 54: Economic Indicators, Brazil, Exports of Goods and Services ($bn), 2007–2012 ......................... 239
Figure 55: Economic Indicators, Brazil, General Government Structural Balance ($bn), 2007–2012 ........... 240
Figure 56: Economic Indicators, Brazil, General Government Net Debt ($bn), 2007–2012 .......................... 241
Figure 57: Economic Indicators, Brazil, Major Industries by % Contribution to GDP, 2011 .......................... 242
Figure 58: Demographics, Brazil, Population (million), 2007–2012.............................................................. 244
Figure 59: Demographics, Brazil, Population (million), Forecast, 2013–2020 .............................................. 245
Figure 60: Demographics, Brazil, Urban and Rural Population Share (%), 2007–2012 ................................ 247
Figure 61: Demographics, Brazil, Urban and Rural Population Share (%), Forecast, 2013–2020 ................ 248
Figure 62: Demographics, Brazil, Population Distribution by Age Group (%), 2007–2012 ............................ 249
Figure 63: Demographics, Brazil, Population Distribution by Age Group (%), Forecast, 2013–2020 ............ 250
Figure 64: Demographics, Brazil, Births (Per 1,000 Population), 2007–2012............................................... 251
Figure 65: Demographics, Brazil, Mortality (Per 1,000 Population), 2007–2012 .......................................... 252
Figure 66: Demographics, Brazil, Major Causes of Mortality (‘000), 2010.................................................... 253
Figure 67: Demographics, Brazil, Children <5 Years Age, Mortality (Per 1,000 Live Births), 2007–2012 ..... 255
Figure 68: Demographics, Brazil, Immunization Rate (%), 2007–2012 ........................................................ 256
Healthcare, Regulatory and Reimbursement Landscape – Brazil 18 © 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 –
BRAZIL
Table of Contents
Figure 69: Demographics, Brazil, Major Causes of Mortality per 100,000 Population, 2010 ........................ 257
Figure 70: Demographics, Brazil, Gender Ratio (M/F), 2007–2012 ............................................................. 259
Figure 71: Demographics, Brazil, Life Expectancy at Birth (Years), 2007–2012 .......................................... 260
Figure 72: Demographics, Brazil, Illiteracy (%), 2007–2012 ........................................................................ 262
Figure 73: Demographics, Brazil, Employment Rate (%), 2007–2012 ......................................................... 263
Figure 74: Demographics, Brazil, Major Diseases, DALY (Per 100,000 Population), 2004 .......................... 264
Figure 75: Healthcare Infrastructure, Brazil, Flow of Funds to Hospitals, 2008 ............................................ 267
Figure 76: Healthcare Infrastructure, Brazil, Hospitals Linked to SUS (%), 2013 ......................................... 268
Figure 77: Healthcare Infrastructure, Brazil, Hospital Beds (‘000), 2007–2012 ............................................ 270
Figure 78: Healthcare Infrastructure, Brazil, Hospital Beds by Type of Service (‘000), 2013 ........................ 271
Figure 79: Healthcare Infrastructure, Brazil, Hospitals Beds by Type of Care (‘000), 2012 .......................... 272
Figure 80: Healthcare Infrastructure, Brazil, SUS ICU Beds by Type, 2013 ................................................. 273
Figure 81: Healthcare Infrastructure, Brazil, Complementary Services (‘000), 2013 .................................... 274
Figure 82: Healthcare Infrastructure, Brazil, Number of Items of Equipment (‘000), 2013 ............................ 275
Figure 83: Healthcare Infrastructure, Brazil, Beds (Per 1,000 Population), 2007–2012 ................................ 276
Figure 84: Healthcare Infrastructure, Brazil, Physicians (per 1,000 Population), 2007–2012 ....................... 277
Figure 85: Environmental Health, Brazil, PM10 Emissions (µg/m3), 2007–2012 .......................................... 280
Figure 86: Environmental Health, Brazil, N2O Emissions (‘000 metric tons), 2007–2012 ............................. 281
Figure 87: Environmental Health, Brazil, CO2Emissions (kilotons), 2007–2012 ........................................... 282
Figure 88: Environmental Health, Brazil, Other Greenhouse Gas Emissions (‘000 metric tons), 2007–2012 284
Figure 89: Environmental Health, Brazil, Proportion of the Population Using Improved Drinking Water Sources
(%), 2007–2012 ......................................................................................................................... 285
Figure 90: Healthcare Personnel, Brazil, Healthcare Personnel (’000), 2013 .............................................. 286
Figure 91: Healthcare Expenditure, Brazil, Healthcare Expenditure (% of GDP), 2007–2012 ...................... 288
Figure 92: Healthcare Expenditure, Brazil, Household Healthcare Expenditure, Share (%), 2009 .............. 289
Healthcare, Regulatory and Reimbursement Landscape – Brazil 19 © 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 –
BRAZIL
Table of Contents
Figure 93: Healthcare Expenditure, Brazil, General Government Healthcare Expenditure, Share (%), 2009 291
Figure 94: Healthcare Expenditure, Brazil, Health Expenditure, Public-Private Share (%), 2007–2012 ........ 292
Figure 95: Healthcare Expenditure, Brazil, Pharmaceutical R&D Expenditure, Components Share (%), 2008
................................................................................................................................................. 293
Figure 96: Healthcare Market, Brazil, Opportunities and Challenges, 2013 ................................................. 299
Healthcare, Regulatory and Reimbursement Landscape – Brazil 20 © 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 –
BRAZIL
Introduction
2 Introduction
2.1 GlobalData Report Guidance
Chapter begins with an executive summary, which gives an overview of Brazil’s healthcare
market and the key driving factors. It also gives a snapshot of the demographic, regulatory, and
reimbursement landscape and the healthcare infrastructure.
Chapter three provides an overview of Brazil’s pharmaceutical and medical device markets,
covering size; generic, Over-The-Counter (OTC) and biologic/biosimilar product shares; and
the key drivers and barriers. 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 Brazil. 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 Brazil, and
analyses economic indicators, demographics, and healthcare infrastructure and expenditure.
Chapter six provides an overview of the opportunities for and challenges to growth in Brazil’s
healthcare market.
Healthcare, Regulatory and Reimbursement Landscape – Brazil 21 © 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 –
BRAZIL
Overview of the Pharmaceutical and Medical Devices Market
3 Overview of the Pharmaceutical and Medical Devices Market
3.1 Pharmaceutical Market
3.1.1 Market Overview
Brazil is one of the most attractive and promising pharmaceutical markets. All major global
pharmaceutical companies have operations based in Brazil. The value of the pharmaceutical
market reached $XX billion in 2012, increasing from $XX billion in 2007, at a Compound Annual
Growth Rate (CAGR) of XX% between 2007 and 2012, and is expected to have reached $XX
billion by 2020.
Changing demographics are a key driver of the Brazil pharmaceutical market. A rise in the
population of elderly citizens is likely to increase the incidence of chronic and lifestyle diseases
which, when combined with the availability of universal healthcare and advancements in
pharmaceutical and medical technology, is likely to drive demand for healthcare services in future.
The market for generic drugs is also registering rapid growth in Brazil. Almost the entire generic
produce in the country is procured by the state public healthcare set-up. Government initiatives
have been responsible for an increase in the usage and availability of generics. The People’s
Pharmacy program (Farmácia Popular) is one such initiative undertaken by the Brazilian
government. In 2013, the government has announced the investment of BRL7 XX billion ($XX
billion) in the country’s health sector. Government programs such as “Brazil without Misery”, a
federal program to combat poverty, will receive BRL XX billion ($XX billion), XX% more than in
2012.
Approximately XX% of the pharmaceutical companies in Brazil are domestic, and this number has
been increasing since the Generic Law was introduced in 1999 (US Commercial Service,
Department of Commerce, 2012). Multinational Companies (MNCs) are, however, generating
higher revenues than domestic companies. The major MNCs operating in the Brazilian
pharmaceutical market are Pfizer Inc. (Pfizer), Sanofi, Novartis, and F. Hoffmann-La Roche Ltd
(Roche).
Healthcare, Regulatory and Reimbursement Landscape – Brazil 22 © 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 –
BRAZIL
Overview of the Pharmaceutical and Medical Devices Market
Brazil has emerged as a manufacturing hub for global pharmaceutical and biotechnology
companies. Approximately XX% of the country’s Gross Domestic Product (GDP) is accounted for
by the manufacturing sector. Countries like India began investing heavily in the manufacturing
sector after José Serra (Brazilian Health Minister, 1997) invited Indian generic companies to invest
in Brazil.
Trade plays a key role in the growth of the pharmaceutical market in Brazil, which is the third
largest exporter of high-tech industrial products in the world. According to the Industry Association
Pharmaceutical Chemicals and Raw Material of Brazil (Associação Brasileira da Indústria
Farmoquímica e de Insumos Farmacêuticos, Abiquifi), Brazil’s pharmaceutical trade deficit in 2012
amounted to $XX billion, indicating a XX% increase from $XX billion in 2011. Brazil is the only
Brazil, Russia, India and China (BRIC) country with a healthcare system. Brazil’s commitment to
the provision of primary treatment to almost all inhabitants and services, such as organ transplants
and free Human Immunodeficiency Virus (HIV) care, has lead to a sharp increase in imported
product costs. Of the total amount of raw material imported, approximately XX% of raw materials
are imported for the manufacturing of generic drugs (US Commercial Service, Department of
Commerce, 2012).
Figure 1: Pharmaceutical Industry, Brazil, Revenue ($bn), 2007–2012
2007 2008 2009 2010 2011 2012*
Rev
enue
($bn
)
Year
CAGR (2007-2012): XX%
Source: GlobalData; Febrafarma, 2007; Strozzi and Graeml, 2011 *Estimated figure
Healthcare, Regulatory and Reimbursement Landscape – Brazil 23 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –
BRAZIL
Overview of the Pharmaceutical and Medical Devices Market
Table 1: Pharmaceutical Industry, Brazil, Revenue ($bn), 2007–2012 Year 2007 2008 2009 2010 2011 2012*
Revenue
Source: GlobalData; Febrafarma, 2007; Strozzi and Graeml, 2011 *Estimated figure
Figure 2: Pharmaceutical Market, Brazil, Revenue ($bn), Forecast, 2013–2020
2013 2014 2015 2016 2017 2018 2019 2020
Rev
enue
($bn
)
Year
CAGR (2013-2020): XX%
Source: GlobalData; Febrafarma, 2007; Strozzi and Graeml, 2011
Table 2: Pharmaceutical Market, Brazil, Revenue ($bn), Forecast, 2013–2020 Year 2013 2014 2015 2016 2017 2018 2019 2020
Revenue
Source: GlobalData; Febrafarma, 2007; Strozzi and Graeml, 2011
Healthcare, Regulatory and Reimbursement Landscape – Brazil 241 © 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 –
BRAZIL
Country Analysis
5.3.9 Government Net Debt
Gross debt comprises all liabilities that require payment or payments of interest and/or principal by
the debtor to the creditor at a date or dates in the future. This includes debt liabilities in the form of
Special Drawing Rights (SDRs), currency and deposits, loans, insurance, pensions and
standardized guarantee schemes, and other accounts payable.
Data from IMF suggests that the government net debt of Brazil increased at a CAGR of XX%
between 2007 and 2012. The general government net debt increased from $XX billion in 2007 to
$XX billion in 2012.
Figure 56: Economic Indicators, Brazil, General Government Net Debt ($bn), 2007–2012
2007 2008 2009 2010 2011 2012
Net
deb
t ($b
n)
Year
CAGR (2007–2012): XX%
Source: GlobalData; IMF, 2013a
Table 65: Economic Indicators, Brazil, General Government Net Debt ($bn), 2007–2012 Year 2007 2008 2009 2010 2011 2012
Net debt
Source: GlobalData; IMF, 2013a
Healthcare, Regulatory and Reimbursement Landscape – Brazil 242 © 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 –
BRAZIL
Country Analysis
5.3.10 Major Industries
In 2011, services accounted for more than XX% of the Brazilian economy. The highlights of the
service sector were public administration, health, and education, which accounted for
approximately XX% of the country’s GDP. The second biggest contributors were manufacturing
and other services which contributed approximately XX% of the country’s GDP. The growth of the
real volume of salaries, along with an increase in consumption credit, increased sales of retail trade
of goods faster than the industrial output and accounted for XX% of GDP.
Figure 57: Economic Indicators, Brazil, Major Industries by % Contribution to GDP, 2011
Public administration, health
and education
Manufacturing
Other services
Retail
Real estate and rentals
Financial services, insurance,
supplementary welfare schemes
and related services
Construction
Agriculture
Transport, warehousing and
postal services
Mining
Information services Generation and distibution of
electricity, gas and water
Source: GlobalData; IBGE, 2011b
Healthcare, Regulatory and Reimbursement Landscape – Brazil 243 © 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 –
BRAZIL
Country Analysis
Table 66: Economic Indicators, Brazil, Major Industries by Contribution to GDP (%), 2011
Sector Contribution to GDP
Public administration, health and education
Manufacturing
Other services
Retail
Real estate and rentals
Financial services, insurance, supplementary welfare schemes and related services
Construction
Agriculture
Transport, warehousing and postal services
Mining
Information services
Generation and distribution of electricity, gas and water
Source: GlobalData; IBGE, 2011b
Healthcare, Regulatory and Reimbursement Landscape – Brazil 300 © 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 –
BRAZIL
Appendix
7 Appendix
7.1 Abbreviations
ABIMED: Associação Brasileira da Indústria de alta Tecnologia de Equipamentos, Produtos
e Suprimentos Médico-Hospitalares (Brazilian Association of High Technology
Equipment, Products and Medical-Hospital Supplies)
ABIMO: Associação Brasileira da Indústria de Artigos e Equipamentos Médicos,
Odontológicos, Hospitalares e de Laboratórios (Brazilian Association of Industry of
Medical, Dental and Hospital Articles and Equipment)
Abiquifi: Associação Brasileira da Indústria Farmoquímica e de Insumos Farmacêuticos
(Industry Association of Pharmaceutical Chemicals and Pharmaceutical Raw
Materials)
ACS: Acute Coronary Syndrome
ADME: Absorption, Distribution, Metabolism, Excretion and Toxicity
AIDS: Acquired Immune Deficiency Syndrome
ANDA: Abbreviated New Drug Application
ANS: Agência Nacional de Saúde Suplementar (National Health Agency)
ANVISA: Agência Nacional de Vigilância Sanitária (National Health Vigilance Agency)
API: Active Pharmaceutical Ingredient
APLAN: Assessoria De Planejamento (Planning Advisor)
ASCEC: Assessoria De Comunicação, Eventos E Cerimonial (Communication Consultants,
and Ceremonial Events)
ASEGI: Assessoria De Segurança Institucional (Institutional Security Advisory)
AUDIT: Auditoria Interna (Internal Audit)
BACE: Beta-secretase
BCB: Banco Central do Brasil (Brazil Central Bank)
BCG: Bacille Calmette Guerin
Healthcare, Regulatory and Reimbursement Landscape – Brazil 301 © 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 –
BRAZIL
Appendix
BGM: Blood Glucose Monitoring
BHU: Basic Health Unit
BNDES: Brazilian Development Bank
BRATS: Brazilian Bulletin of Health Technology Assessment
BRIC: Brazil, Russia, India, China
BRICS: Brazil, Russia, India, China, South Africa
B/W: Black and White
CA: Competent Authority
CAGR: Compound Annual Growth Rate
CAGED: Cadastro Geral de Empregados e Desempregados (General Register of the
Employed and Unemployed)
CAMSS: Câmara de Saúde Suplementar (House of Health Insurance)
CAP: Coeficiente de Adequação de Preços (Coefficient of Price Adjustment)
CEANS: Comissão de Ética (Ethics Committee)
CIB: Bipartite Interagency Commission
CISET: Secretaria de Controle Interno (Secretariat of Internal Control)
CIT: Conselho Intergestores Tripartite (Brazilian Tripartite Council)
CITEC: Comissão de Incorporação de Tecnologias do Ministério da Saúde (National
Commission for Technology Incorporation)
CMED: Câmara De Regulação Do Mercado De Medicamentos (Chamber of Market
Regulation of Drugs)
CMS: Centers for Medicare and Medicaid Services
CNS: Conselho Nacional de Saúde (National Health Council)
CNES: Cadastro Nacional de Estabelecimentos de Saúde (National Register of Health
Facilities)
Healthcare, Regulatory and Reimbursement Landscape – Brazil 302 © 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 –
BRAZIL
Appendix
CO2: Carbon Dioxide
CONASEMS: Conselho Nacional de Secretarios Municipais de Saude (National Council of
Municipal Health)
CONASS: National Council of Health Secretaries
CONITEC: Comissão Nacional de Incorporação de Tecnologias (National Commission for the
Incorporation of Technologies)
CONSU: Conselho de Saúde Suplementar (Supplementary Health Council)
COPD: Chronic Obstructive Pulmonary Disease
CORGE: Corregedoria (Magistrate)
CPhI: International Exhibition on Pharmaceutical Ingredients and Intermediates
CPI: Consumer Price Index
CRL: Complete Response Letter
CRM: Cardiac Rhythm Management
CRO: Clinical Research Organization
CR: Controlled Release
CRPC: Castrate-Resistant Prostate Cancer
CRT: Cardiac Resynchronization Therapy
CT: Computed Tomography
cTnI: Cardiac Troponin
CTV: Vaccine Technology Complex
CVD: Cardiovascular Disease
DALY: Disability-Adjusted Life Year
DCB: Brazilian Common Denomination
DEM: Democratas (Democrats)
DICOL: Diretoria Colegiada (Board of Directors)
Healthcare, Regulatory and Reimbursement Landscape – Brazil 303 © 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 –
BRAZIL
Appendix
DIDES: Diretoria de Desenvolvimento Setorial (Director of Sector Development)
DIFIS: Diretoria de Fiscalização (Supervisory Board)
Digesa: Diretoria de Gestão (Board of Management)
DIOP: Diretoria de Normas e Habilitação das Operadoras (Board of Standards and
Qualification of Operators)
DIPRO: Diretoria de Normas e Habilitação das Operadoras (Board of Standards and
Qualification of Products)
DOTS: Directly Observed Treatment-Short
DOU: Diário Oficial da União (Federal Register)
DTP: Diphtheria, Tetanus, Pertussis
EC: European Commission
EGFR: Epidermal Growth Factor Receptor
EMA: European Medicines Agency
EMS: Emergency Medical Services
Essilor: Essilor International
EU: European Union
FDA: Food and Drug Administration
FDI: Foreign Direct Investment
FDIC: Infrastructure Debentures and Receivables Investment Funds
FINEP: The Financiadora de Estudos e Projetos (Financier of Studies and Projects)
Fiocruz: Oswaldo Cruz Foundation
FOSSL: Fiber Optic Shape Sensing and Localization
FP: Factory Price
GADIP: Gabinete Do Diretor - Presidente (Office of the Director)
GCP: Good Clinical Practice
Healthcare, Regulatory and Reimbursement Landscape – Brazil 304 © 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 –
BRAZIL
Appendix
GDP: Gross Domestic Product
GeMM: Genetically Modified Models
GENT: Dimension Vista Gentamicin
GGALI: Gerência - Geral De Alimentos (General Management of Food)
GGCOS: Gerência - Geral De Cosméticos (General Management of Cosmetics)
GGGAF: Gerência - Geral De Gestão Administrativa E Financeira (General Management of
Administrative and Financial Management)
GGIMP: Gerência - Geral De Inspeção E Controle De Insumos, Medicamentos E Produtos
(General Management and Control of Inspection of Raw Materials, Products and
Drugs)
GGLAS: Gerência - Geral De Laboratórios De Saúde Pública (General Management of
Public Health Laboratories)
GGMED: Gerência - Geral De Medicamentos (General Management of Medicines)
GGPAF: Gerência - Geral De Portos, Aeroportos, Fronteiras E Recintos Alfandegados
(General Management of Ports, Airports, and Borders)
GGPRO: Gerência Geral De Monitoramento E Fiscalização De Propaganda, De
Publicidade, De Promoção E De Informação De Produtos Sujeitos A Vigilância
Sanitária (General Management of Monitoring and Supervision of Advertising,
Advertising, Promotion and Information Products Subject To Health Surveillance)
GGRHU: Gerência - Geral De Gestão De Recursos Humanos (General Management of
Human Resources Management)
GGSAN: Gerência - Geral De Saneantes (General Sanitary Management)
GGSTO: Gerência - Geral De Sangue, Outros Tecidos, Células E Órgãos (General
Management - Blood, Other Tissues, Cells and Organs)
GGTES: Gerência - Geral De Tecnologia Em Serviços De Saúde (General Management of
Technology In Health Services)
Healthcare, Regulatory and Reimbursement Landscape – Brazil 305 © 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 –
BRAZIL
Appendix
GGTIN: Gerência - Geral De Gestão De Tecnologia Da Informação (General Management
Information Technology)
GGTOX: Gerência - Geral De Toxicologia (General Management of Toxicology)
GGTPS: Gerência - Geral De Tecnologia De Produtos Para A Saúde (General
Management Technology Health Products)
GHG: Greenhouse Gas
GITE: Grupos e Indicações Terapêuticas Especificadas (Groups and Specified
Therapeutic Indications)
GLP: Good Laboratory Practices
GMP: Good Manufacturing Practice
GNI: Gross National Income
GPDTA: Gerência De Produtos Derivados Do Tabaco (Management of Tobacco Products)
GRU: Guide Gathering Union
HepB3: Hepatitis B
HER2: Human Epidermal Growth Factor Receptor 2
HFC: Hydroflourocarbons
Hib3: Haemophilus Influenza
HIV: Human Immunodeficiency Virus
HMO: Health Maintenance Organization
HTA: Health Technology Assessment
IBGE: Instituto Brasileiro de Geografia e Estatística (Brazilian Institute of Geography and
Statistics)
ICD: Implantable Cardioverter Defibrillator
ICU: Intensive Care Unit
IDEA: International Design Excellence Award
Healthcare, Regulatory and Reimbursement Landscape – Brazil 306 © 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 –
BRAZIL
Appendix
IDEC: Instituto Brasileiro de Defesa do Consumidor (Brazilian Institute for Consumer
Defense)
IDMC: Independent Data Monitoring Committee
IDSA: Industrial Designers Society of America
IHME: The Institute for Health Metrics and Evaluation
IMF: International Monetary Fund
INCA: Nacional Instituto de Cancerologia (Brazilian National Cancer Institute)
INCQS: Instituto Nacional de Controle de Qualidade em Saúde (National Institute for
Quality Control in Health)
INPC: Índice Nacional de Preços ao Consumidor (National Consumer Price Index)
INPI: Instituto Nacional da Propriedade Industrial (National Institute of Industrial
Property)
IOL: Intraocular Lens
IPCA: Índice Nacional de Preços ao Consumidor Amplo (Extended National Consumer
Price Index)
ISAAC: International Study of Asthma and Allergies in Childhood
ISI: Import Substitution Industrialization
ISPOR: International Society for Pharmacoeconomics and Outcomes
IT: Information Technology
IVD: In Vitro Diagnostics
IVUS: Intravascular Ultrasound Systems
JV: Joint Venture
kt: kiloton
LACENS: Rede de Laboratórios Centrais dos Estados (States Central Laboratories Network)
LI: Non-Automatic License
Healthcare, Regulatory and Reimbursement Landscape – Brazil 307 © 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 –
BRAZIL
Appendix
LOGIN: National Register of Legal Entities
MCV: Meningococcal vaccine
MI: Myocardial Infarction
MIT: Massachusetts Institute of Technology
MMV: Medicines for Malaria Venture
MNC: Multinational Companies
MoH: Ministry of Health
MRI: Magnetic Resonance Imaging
NADAV: Núcleo De Assessoramento Em Descentralização Das Ações De Vigilância
Sanitária (Asistance Nucleus Decentralization of Health Surveillance)
NAINT: Núcleo De Assessoramento Em Assuntos Internacionais (Advisory Centre for
International Affairs)
NCI: National Cancer Institute
NDA: New Drug Application
NDP: National Drug Policy
NEPEC: Núcleo De Educação, Pesquisa E Conhecimento (Center for Education, Research
and Knowledge)
NERD: Non-Erosive Reflux Disease
NGO: Non-Governmental Organization
NHL: Non-Hodgkin's Lymphoma
NIBR: Novartis Institutes for Biomedical Research
NIP: National Immunization Program
NME: New Molecular Entity
NSCLC: Non-Small-Cell Lung Cancer
Healthcare, Regulatory and Reimbursement Landscape – Brazil 308 © 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 –
BRAZIL
Appendix
NUREM: Núcleo De Assessoramento Econômico Em Regulação (Center For Economic
Advisory In Regulation)
NUVIG: Núcleo De Gestão Do Sistema Nacional De Notificação E Investigação Em
Vigilância Sanitária (Core Management System Notification and National Research
In Health Surveillance)
OECD: Organization for Economic Co-operation and Development
ORG. VINC.: Órgãos Vinculados (Linked Bodies)
OSA: Obstructive Sleep Apnea
OTC: Over-the-Counter
OUVID: Ouvidoria (Ombudsman)
P/E: Price/Earnings
PAB: Proportion of live births protected
PAC: Programa de Aceleração do Crescimento (Growth Acceleration Program)
PACS: Picture Archiving Communication Systems
PAHO: Pan-American Health Organization
PAH: Pfizer Animal Health
PCdoB: Partido Comunista do Brasil (Communist Party of Brazil)
PCR: Polymerase Chain Reaction
PDP: Product Development Partnership
PDT: Partido Democratico Trabalhista (Democratic Labor Party)
PET: Positron Emission Tomography
PFC: Perfluorocarbons
PFCL: Per Fluro Carbon Liquids
PIP: Peak Inspiratory Pressure
PISA: Program for International Student Assessment
Healthcare, Regulatory and Reimbursement Landscape – Brazil 309 © 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 –
BRAZIL
Appendix
PMDB: Partido do Movimento Democratico Brasileiro (Brazilian Democratic Movement
Party)
PMMA: Polymethyl Methacrylate
PNASS: Programa Nacional de Avaliação de Serviços de Saúde (National Program to
Evaluate Health Services)
PNAD: Pesquisa Nacional por Amostra de Domicílio (National Household Sample Survey)
POC: Proof-of-Concept
Pol: Polio vaccine
PP: Partido Progressista (Progressive Party)
PPCOR: Corregedoria (Internal Affairs)
PR: Partido da Republica (Republic Party)
PRES: Presidência (Presidency)
PROCR: Procuradoria (Attorney)
PROG. Procuradoria Federal junto à ANS (Federal Prosecutor with the ANS)
PROVAB: Programa De Valorização Do Profissional De Atenção Básica (The Professional
Enhancement Program In Primary Care)
PSB: Partido Socialista Brasileiro (Brazilian Socialist Party)
PSD: Partido Social Democrático (Social Democratic Party)
PSDB: Partido da Social Democracia Brasileira (Party of Brazilian Social Democracy)
PSE: School Health Program
PSOL: Partido Socialismo e Liberdade (Socialism and Freedom Party)
PT: Partido dos Trabalhadores (Workers' Party)
PTA: Percutaneous Transluminal Angioplasty
PTB: Partido Trabalhista Brasileiro (Brazilian Labor Party)
PTCA: Percutaneous Transluminal Coronary Angioplasty
Healthcare, Regulatory and Reimbursement Landscape – Brazil 310 © 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 –
BRAZIL
Appendix
PUD: Peptic Ulcer Disease
PV: Partido Verde (Green Party)
PVD: Peripheral Vascular Disease
QS: Quality System
RA: Rheumatoid Arthritis
rBLH-BR: Rede Brasileira de Bancos de Leite Humano (Brazilian Network of Human Milk
Banks)
R&D: Research and Development
Reblas: Rede Brasileira de Laboratórios Analíticos em Saúde (Brazilian Network of
Analytical Laboratories for Health)
RAIS: Relação Anual de Informações Sociais (Annual List of Social Information)
REMUME: Relação Municipal de Medicamentos Essenciais (Municipal Essential Medicines
Lists)
RENAME: Relação Nacional de Medicamentos Essencia (National Essential Drugs List)
RIS: Radiology Information System
RNA: Ribonucleic Acid
Roche: F. Hoffmann-La Roche Ltd
ROW: Rest of World
RSV: Respiratory Syncytial Virus
SAS: Secretaria de Atenção à Saúde (Department of Health Care)
SAMU: Serviço De Atendimento Móvel De Urgência (Service Mobile Emergency)
SCTIE: Secretaria de Ciência, Tecnologia e Insumos Estratégicos (Secretariat for Science,
Technology and Strategic Inputs)
SDR: Special Drawing Rights
SE: Secretário Executivo (Executive Secretary)
Healthcare, Regulatory and Reimbursement Landscape – Brazil 311 © 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 –
BRAZIL
Appendix
SECEX: Secretaria de Comércio Exterior (Brazilian Foreign Trade Secretariat)
SECOL: Secretaria Executiva Da Diretoria Colegiada (Executive Secretariat Board of
Collegiate)
SEGER: Secretatia-Geral (General Secretariat)
SESA: Secretaria Estadual de Saúde (Special Secretariat of Indigenous Health)
SELIC: Sistema Especial de Liquidação e Custodia (Special System of Clearance and
Custody)
SGEP: Secretaria de Gestão Estratégica e Participativa (Office of Strategic and
Participative Management)
SGTES: Secretaria de Gestão do Trabalho e da Educação na Saúde (Office of Labor
Management and Health Education)
SINAEMO: Sindicato da Indústria de Artigos e Equipamentos Odontológicos, Médicos e
Hospitalares do Estado de São Paulo (São Paulo state dental, medical and
hospital articles and equipment industry union)
SISCOMEX: Sistema Integrado de Comércio Exterior (Integrated Foreign Trade System)
SNGPC: Sistema Nacional de Gerenciamento de Produtos Controlados (National
Management System of Controlled Products)
SNIPC: Sistema Nacional de Índices de Preços ao Consumidor (National System of
Consumer Price Indexes)
SNVS: Sistema Nacional de Vigilância Sanitária (National Health Surveillance System)
SR: Structured Reporting
STD: Sexually Transmitted Disease
SUS: Sistema Único de Saúde (Unified Health System)
SVS: Secretaria de Vigilância em Saúde (Secretariat of Health Surveillance)
TB: Tuberculosis
TCU: Tribunal de Contas da União (Brazilian Court of Audit)
Healthcare, Regulatory and Reimbursement Landscape – Brazil 312 © 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 –
BRAZIL
Appendix
TTR-FAP: Transthyretin Familial Amyloid Polyneuropathy
UFES: Universidade Federal do Espírito Santo (Federal University of Espírito Santo)
UNA-SUS: Open University of SUS
UNDP: United Nations Development Program
UNESCO: United Nations Educational, Scientific and Cultural Organization
UNFCCC: United Nations Framework Convention on Climate Change
UNICEF: United Nations Children's Fund
USAID: United States Agency for International Development
µgs/m3: micrograms per cubic meter
VAN: Value Added Network
VSE: Vigilância Sanitária Estadual (State Health Surveillance Office)
WHO: World Health Organization
WSJ: Wall Street Journal
WTO: World Trade Organization
Healthcare, Regulatory and Reimbursement Landscape – Brazil 313 © 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 –
BRAZIL
Appendix
7.2 Bibliography
Abiquifi (2012). Info 2012. Brazilian Association of Pharmaceutical Chemicals and
Pharmaceutical. Available from: http://www.abiquifi.org.br/mercado_estatisticas.html.
[Accessed June 14, 2013].
ANS (2013a). Tempo assist management presentation - 2Q13. Agência Nacional de Saúde
Suplementar. Available from:
http://ri.tempoassist.com.br/tempoassist/web/conteudo_en.asp?idioma=1&conta=44&tipo=370
68. [Accessed June 1, 2013].
ANS (2013b). Data and sector indicators. Agência Nacional de Saúde Suplementar. Available
from: http://www.ans.gov.br/materiais-para-pesquisas/perfil-do-setor/dados-e-indicadores-do-
setor. [Accessed June 3, 2013].
ANS (2013c). Organization chart, structure and roles in the national health agency. Agência
Nacional de Saúde Suplementar. Available from: http://www.ans.gov.br/index.php/aans/quem-
somos/organograma. [Accessed June 3, 2013].
ANVISA (2008). RDC 39, June 5, 2008. Agência Nacional de Vigilância Sanitária. Available
from: http://www.anvisa.gov.br/medicamentos/pesquisa/legis/rdc39_08.pdf.
ANVISA (2009a). New rules for labeling of medicines. Agência Nacional de Vigilância
Sanitária. Available from:
http://portal.anvisa.gov.br/wps/portal/anvisa/anvisa/home/medicamentos/!ut/p/c5/rZDLdrJAEISf
xQfAmUEZYAky3OQShpuw8QASBYKQaBjk6eP_75Ns0rXrqjpfnwY5eOpaTM25uDfDtXgDB5D
j485QzK3oQAixuoOWIXhYCHxoUARScIDbY9g-
RmvpFtqK1PXKmLlLxlyNbFxyXrzIdsLWRREZnTAe_ah97jXPRpWMEj0giu1pTRasnqzsWxb0-
V8vyX9I_O__8-E3o8Bf-gh45tDXIAO5eEwMXjL3BoKGLarQIpGp-1DfCIgH0R9-5GcW-
lOWDfKm7Nes6tdwjTGWN7IERQwFGWGQHrKHqN0sppHkaAdzbUjyLa9vStA94iWktMkjktQW
x5n3UFU8d7oXgsCNtcw4WgWS9bmbnS3HzS5lKpovoULZkkLVCSarMgvtYu-
wPX1stP007Pl9mevIvi6dc-GYzT_o9HImp-tU6JlTYK0M36KoGjA6pbpI3sfbthpjXfcPSdMzI22l-
FU8--
8fROJQL_MBnruxk4ZydE39FXJmVp5EJbFSbSArMPaTg6nJkIQkpqxWXy_NqSI!/dl3/d3/L2dBI
SEvZ0FBIS9nQSEh/?pcid=9e5863004700f526bf51bfdbccd7064e. [Accessed June 3, 2013].
Healthcare, Regulatory and Reimbursement Landscape – Brazil 314 © 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 –
BRAZIL
Appendix
ANVISA (2009b). Resolution – RDC no. 47, of September 8, 2009. Agência Nacional de
Vigilância Sanitária. Available from:
http://xa.yimg.com/kq/groups/2299115/1607259243/name/RDC_47.09_english.pdf.
ANVISA (2010a). Manual Para Regularização De Equipamentos Médicos Na Anvisa. Agência
Nacional de Vigilância Sanitária. Available from:
http://portal.anvisa.gov.br/wps/wcm/connect/991239804745928e9ae1de3fbc4c6735/manual_E
quipMed_Anvisa_abr_10.pdf?MOD=AJPERES.
ANVISA (2010b). Brazil: Antibiotics to be sold with prescription only. Library of Congress.
Agência Nacional de Vigilância Sanitária. Available from:
http://www.loc.gov/lawweb/servlet/lloc_news?disp3_l205402356_text. [Accessed June 10,
2013].
ANVISA (2012a). Compras públicas de medicamentos. Agência Nacional de Vigilância
Sanitária. Available from: http://www.tce.ro.gov.br/arquivos//Downloads/IEP-Curso-27-04-12-
11-28-06.ppt. [Accessed June 12, 2013].
ANVISA (2012b). Nova estrutura organizacional da Anvisa. Agência Nacional de Vigilância
Sanitária. Available from:
http://portal.anvisa.gov.br/wps/wcm/connect/50ecec004c86fc509f17df93d95c4045/1.Nova+Est
rutura+Organizacional+da+Anvisa.pdf?MOD=AJPERES.
ANVISA (2012c). Registration of medicines. Agência Nacional de Vigilância Sanitária.
Available from:
http://web.archive.org/web/20120402011913/http://www.anvisa.gov.br/eng/drugs/registration.ht
m. [Accessed June 10, 2013].
ANVISA (2012d). Resolution - RDC nº 25, December 9, 1999. Agência Nacional de Vigilância
Sanitária. Available from:
http://web.archive.org/web/20120302050750/http://www.anvisa.gov.br/legis/resol/25_99rdc_ing
.htm. [Accessed June 10, 2013].
ANVISA (2012e). Resolution - RDC nº 01, of January 6, 2003. Agência Nacional de Vigilância
Sanitária. Available from:
http://web.archive.org/web/20120120023736/http://www.anvisa.gov.br/eng/legis/resol/01_03rdc
_e.htm. [Accessed June 10, 2013].
Healthcare, Regulatory and Reimbursement Landscape – Brazil 315 © 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 –
BRAZIL
Appendix
ANVISA (2012f). Law 9.294, of July 2, 1996. Agência Nacional de Vigilância Sanitária.
Available from:
http://web.archive.org/web/20120109173014/http://www.anvisa.gov.br/eng/tobacco/law_9294.h
tm. [Accessed June 14, 2013].
ANVISA (2013a). Efeitos da resolução CMED nº 02/04 no processo de análise de preços de
novos medicamentos. Agência Nacional de Vigilância Sanitária. Available from:
http://portal.anvisa.gov.br/wps/wcm/connect/31cbde804e311d5694ddb7c09d49251b/trabalho+
balan%C3%A7o+resol+2.final.15.Jan.2013.pdf?MOD=AJPERES.
ANVISA, via Regulatory Focus (2013b). “Brazil to Expedite Review and Approval Process,
Recognize Foreign Audits and Inspections”, Regulatory Focus, March 25, 2013. Available
from: http://www.raps.org/focus-online/news/news-article-view/article/3072/brazil-to-expedite-
review-and-approval-process-recognize-foreign-audits-and-ins.aspx. [Accessed on June 24,
2013].
ANVISA (2013c). Operating permit - AFE / medicines and pharmaceutical. Agência Nacional
de Vigilância Sanitária. Available from:
http://portal.anvisa.gov.br/wps/portal/anvisa/anvisa/regulado/!ut/p/c5/rZHJkqJAAES_pT8Aq9jh
SEtZFkiByGLVhQBbBZWlxZbl68eZe_dcOvP4IiMjMgEHLzf5szrnj6pt8hvYA65lS2ytFX0DIdTel5
BglWrq1ofYFl-cfcuhL_0nnYI9VLLdZerIfJ3Dyxw6EbrCXt8Ono1mz3Z87-
JP1M7lBxpmL7KGPp4kapMJGqaYrLbIQspQIPYGHMCrol4Mh3oBF5osyTI0DEWVNVWTJJBS
po3F2Xm3UZiN4faLJXK0P6wcN1wSiuzmuBSZtuemdKKTs8qCanf5qE0c8Z7c9r7-
pYzMybneRKe7i3Xsmd5o19zGeYm6_h5kF9Jek9u0KYW-
aErd361EtSNNmdNEFYhJGqFLlXwn08aCnUUNqqTr6uCw5EP1xZE1WeEO2yRqU3V1LU_exI
olvj-
MUo_iWsj7Og7ObWz0GzMZ5mrmAeufoUfH9HM8HowA89eW_Ie1_33xl8NvZEHAANezBEvG
2sUi9GVPggTpBnRdJBmOCKJffOvnLvlXu-i6rY-gq-
NnbRIhf_kPEMvzCA!!/dl3/d3/L2dBISEvZ0FBIS9nQSEh/?pcid=4ada698046023b6293799f400
49c9226. [Accessed on June 24, 2013].
AstraZeneca (2012). Annual Report 2012. AstraZeneca. Available from:
http://www.astrazeneca-
annualreports.com/2012/documents/eng_download_centre/annual_report.pdf.
Healthcare, Regulatory and Reimbursement Landscape – Brazil 316 © 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 –
BRAZIL
Appendix
Bahia LR et al. (2011). The costs of type 2 diabetes mellitus outpatient care in the Brazilian
public health system. National Center for Biotechnology Information, US National Library of
Medicine. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21839888. [Accessed June 10,
2013].
Banco Espirito Santo (2012). International support kit of opportunities. Banco Espirito Santo.
Available from: http://www.bes.pt/siteBES/cms.aspx?plg=6512ff17-fbb6-44fc-8136-
8c7623a82905. [Accessed June 2, 2013].
Barrucho LG (2013). “Spending grows, but health model still lives contradiction in Brazil”. BBC
Brazil, April 2, 2013. Available from:
http://www.bbc.co.uk/portuguese/noticias/2013/04/130402_saude_gastos_publicos_lgb.shtml.
[Accessed May 30, 2013].
BCB (2012). Infrastructure in Brazil, projects, financing instruments, opportunities. Banco
Central do Brasil. Available from:
http://www.fazenda.gov.br/portugues/documentos/2013/Book-AAE--Web-Final.pdf.
BCB (2013a). Review of COPOM meetings and short-term interest rates. Banco Central do
Brasil. Available from: http://www.bcb.gov.br/?INTEREST. [Accessed June 14, 2013].
BCB (2013b). International reserves in the Banco Central do Brasil. Banco Central do Brasil.
Available from: http://www.bcb.gov.br/?indicators. [Accessed June 24, 2013].
Biztradeshows (2013). Medical & pharmaceutical trade shows in Brazil. Biztradeshows.
Available from: http://www.biztradeshows.com/brazil/brazil-tradeshows.mp?industry=medical-
pharma. [Accessed June 28, 2013].
Bloom DE, et al. (2011). Population aging: facts, challenges, and responses. Harvard Initiative
for Global Health, PDGA Working Paper No. 71. Available from:
http://www.hsph.harvard.edu/pgda/WorkingPapers/2011/PGDA_WP_71.pdf.
BRICS (2013). BRICS Joint Statistical Publication 2013. Statistics South Africa. Available from:
http://www.statssa.gov.za/news_archive/Docs/FINAL_BRICS%20PUBLICATION_PRINT_23%
20MARCH%202013_Reworked.pdf.
Healthcare, Regulatory and Reimbursement Landscape – Brazil 317 © 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 –
BRAZIL
Appendix
Caring for Diabetes (2004). Diabetes care in Brasil. Caring for Diabetes. Available from:
http://www.caringfordiabetes.com/Global/LatinAmerica/Diabetes_Brazil.cfm. [Accessed June
18, 2013].
Chakma J, et al. (2013). Life sciences venture capital in emerging markets. Nature
Biotechnology; 31: 195–201.
CNES (2013a). Panorama dos hospitais de entidades beneficentes sem fins lucrativos.
Cadastro Nacional de Estabelecimentos de Saúde via Senado Federal Brasil. Available from:
http://www.senado.gov.br/comissoes/cas/ap/AP20130319_AnaPaulaSilvaCavalcante.pdf.
CNES (2013b). Health sector in Brazil. Cadastro Nacional de Estabelecimentos de Saúde via
IHF. Available from: http://www.ihf-fih.org/content/search?SearchText=brazil. [Accessed June
15, 2013].
Couttolenc B and Dmytraczenko T (2013). UNICO studies series 2 Brazil’s primary care
strategy. The World Bank. Available from: http://www-
wds.worldbank.org/external/default/WDSContentServer/WDSP/IB/2013/01/31/000425962_201
30131142856/Rendered/PDF/749570NWP0BRAZ00Box374316B00PUBLIC0.pdf.
CRS (2013). Brazil-US relations, February 27, 2013. Congressional Research Service.
Available from: http://www.fas.org/sgp/crs/row/RL33456.pdf.
Datafolha, via MercoPress (2013). “Brazil’s Dilma seems unbeatable 18 months ahead of the
presidential election”, MercoPress, March 27, 2013. Available from:
http://en.mercopress.com/2013/03/27/brazil-s-dilma-seems-unbeatable-18-months-ahead-of-
the-presidential-election. [Accessed May 31, 2013].
DATASUS (2008). Doenças respiratórias crônicas. Pan American Health Organization.
Available from:
http://www.paho.org/bra/index.php?option=com_content&view=article&id=581&Itemid=539.
[Accessed July 2, 2013].
Essilor (2011). Annual Report 2011. Essilor. Available from:
http://www.essilor.com/rapportactivite2011/en/pdf/RA_ESSILOR_2011_UK.pdf.
Healthcare, Regulatory and Reimbursement Landscape – Brazil 318 © 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 –
BRAZIL
Appendix
Export.gov (2012). Medical Equipment. Export.gov. Available from:
http://export.gov/brazil/static/CC_BR_DoingBusiness_CCG_PDF_Chap4_MedicalEquip_Latest
_eg_br_062841.pdf.
FBH (2012a). Hospitais no país. Federação Brasileira de Hospitais. Available from:
http://fbh.com.br/2011/06/06/hospitais-no-pais/. [Accessed June 19, 2013].
FBH (2012b). Leitos de Hospitais. Federação Brasileira de Hospitais. Available from:
http://fbh.com.br/2011/06/06/leitos-de-hospitais/. [Accessed June 14, 2013].
FBH (2012c). Leitos por tipo. Federação Brasileira de Hospitais. Available from:
http://fbh.com.br/2011/06/06/leitos-por-tipo/. [Accessed June 15, 2013].
FBH (2012d). Saúde no Brasil tem a maior carga tributária da economia. Federação Brasileira
de Hospitais. Available from: http://fbh.com.br/2012/08/16/saude-no-brasil-tem-a-maior-carga-
tributaria-da-economia/. [Accessed June 14, 2013].
Febrafarma (2007). The pharmaceutical industry in Brazil and the use of traceability supply
chain information. Febrafarma. Available from:
http://www.dainf.ct.utfpr.edu.br/~graeml/publica/artigos/download/Euroma2007_Pharmaceutica
lIndustryTraceabilityInformation.pdf.
Fenafar (2013). Federal budget 2013 provides 11.9% more for health and education.
Federação Nacional dos Farmacêuticos. Available from:
http://www.fenafar.org.br/portal/sus/64-sus/1677-orcamento-federal-de-2013-preve-119-a-
mais-para-saude-e-educacao.html. [Accessed June 29, 2013].
Fick J and Cowley M (2013). ”Brazil's real closes sharply stronger on central bank
intervention”, The Wall Street Journal, August 23, 2013. Available from:
http://online.wsj.com/article/BT-CO-20130823-710092.html. [Accessed August 30, 2013].
Flanders Investment & Trade (2011). The pharmaceutical industry in Brazil. Flanders
Investment & Trade. Available from:
http://www.flanderstrade.be/site/wwwnl.nsf/vattachments/Nieuwsbrief/$File/PharmaBrazil2011.
pdf.
Healthcare, Regulatory and Reimbursement Landscape – Brazil 319 © 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 –
BRAZIL
Appendix
Frayssinet F (2011). World Health Day-Brazil: First map of clusters of antibiotic resistance.
Inter Press Service. Available from: http://www.ipsnews.net/2011/04/world-health-day-brazil-
first-map-of-clusters-of-antibiotic-resistance/. [Accessed June 29, 2013].
Gomez EJ (2013). Dilma's Education Dilemma. Americas Quarterly. Available from:
http://www.americasquarterly.org/gomez. [Accessed June 30, 2013].
Hudson RA (1997). Brazil: A Country Study. Washington: GPO for the Library of Congress.
Available from: http://countrystudies.us/brazil/. [Accessed June 28, 2013].
IBGE (2008). Pesquisa de Inovação Tecnológica 2008. Instituto Brasileiro de Geografia e
Estatística. Available from:
http://www.ibge.gov.br/home/estatistica/economia/industria/pintec/2008/defaultpdf_esforcos.sh
tm. [Accessed June 29, 2013].
IBGE (2009). Financiamiento del sistema único de salud de Brasil. Instituto Brasileiro de
Geografia e Estatística via PAHO. Available from:
http://www.paho.org/hq/index.php?option=com_content&view=article&id=7391%3Afinancing-
health-care-systems-macroeconomic-and-fiscal-implications-of-financing-universal-health-
coverage&catid=1937%3Ahss020106--workshops%2C-consultations%2C-and-
&Itemid=2092&lang=es. [Accessed June 4, 2013].
IBGE (2010a). Censo Demografico. Instituto Brasileiro de Geografia e Estatística. Available
from:
http://www.ibge.gov.br/home/estatistica/populacao/censo2010/caracteristicas_da_populacao/r
esultados_do_universo.pdf.
IBGE (2010b). Tabela 3 - População residente, total e respectiva distribuição percentual, por
situação do domicílio e grupos de idade, segundo as Grandes Regiões e as classes de
tamanho da população dos municípios. Instituto Brasileiro de Geografia e Estatística. Available
from:
http://www.ibge.gov.br/english/estatistica/populacao/censo2010/indicadores_sociais_municipai
s/tabelas_pdf/tab3.pdf.
IBGE (2010c). Distribuição da população por sexo, segundo os grupos de idade. Instituto
Brasileiro de Geografia e Estatística. Available from:
http://www.censo2010.ibge.gov.br/sinopse/webservice/. [Accessed June 22, 2013].
Healthcare, Regulatory and Reimbursement Landscape – Brazil 320 © 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 –
BRAZIL
Appendix
IBGE (2010d). Mortalidade do adulto no Brasil: taxas de mortalidade segundo o sexo, as
causas e as regiões, 2010. Instituto Brasileiro de Geografia e Estatística. Available from:
http://portalsaude.saude.gov.br/portalsaude/arquivos/pdf/2013/Fev/21/saudebrasil2011_parte1
_cap7.pdf.
IBGE (2010e). Sinopse do, censo demografico. Instituto Brasileiro de Geografia e Estatística.
Available from: http://www.ibge.gov.br/home/estatistica/populacao/censo2010/sinopse.pdf.
IBGE (2011a). 2010 Municipal social indicators: incidence of poverty is higher in medium size
municipalities. Instituto Brasileiro de Geografia e Estatística. Available from:
http://saladeimprensa.ibge.gov.br/en/noticias?view=noticia&id=1&busca=1&idnoticia=2019.
[Accessed June 24, 2013].
IBGE (2011b). International Support Kit of Opportunities. Instituto Brasileiro de Geografia e
Estatística. Available from: http://www.bes.pt/sitebes/cms.aspx?plg=0b2b331e-1f32-4384-
a5ac-994e6ae7f3b5. [Accessed June 2, 2013].
IBGE (2011c). Variação (%) Acumulada por item - IPCA julho de 1994 a novembro de 2011.
Instituto Brasileiro de Geografia e Estatística. Available from:
http://www.ibge.gov.br/home/estatistica/indicadores/precos/inpc_ipca/ipca-
inpc_201111_3.shtm. [Accessed June 31, 2013].
IBGE (2012). In 2011, life expectancy at birth was 74.08 years. Instituto Brasileiro de Geografia
e Estatística. Available from:
http://saladeimprensa.ibge.gov.br/en/noticias?view=noticia&id=1&busca=1&idnoticia=2271.
[Accessed June 10, 2013].
IBGE (2013a). Banco de dados agregados. Instituto Brasileiro de Geografia e Estatística.
Available from:
http://www.sidra.ibge.gov.br/bda/emprego/default.asp?t=4&z=t&o=16&u1=26674&u2=26674&u
3=26674&u4=26674&u5=26674&u6=26674. [Accessed June 11, 2013]..
IBGE (2013b). Em 2012, PIB cresce 0,9% e totaliza BRL4,403 trilhões. Instituto Brasileiro de
Geografia e Estatística. Instituto Brasileiro de Geografia e Estatística. Available from:
http://saladeimprensa.ibge.gov.br/noticias?view=noticia&id=1&busca=1&idnoticia=2329.
[Accessed June 10, 2013].
Healthcare, Regulatory and Reimbursement Landscape – Brazil 321 © 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 –
BRAZIL
Appendix
IBGE (2013c). Consumer Price Index - IPCA and INPC. Instituto Brasileiro de Geografia e
Estatística. Instituto Brasileiro de Geografia e Estatística. Available from:
http://www.ibge.gov.br/english/estatistica/indicadores/precos/inpc_ipca/ipca-
inpc_201304_1.shtm. [Accessed June 12, 2013].
IBGE (2013d). via Envolverde, Brasil quer aumentar o número de médicos por habitante. Isto
basta? Instituto Brasileiro de Geografia e Estatística. Available from:
http://envolverde.com.br/saude/brasil-saude/brasil-quer-aumentar-o-numero-de-medicos-por-
habitante-isto-basta/. [Accessed June 12, 2013].
Ibope, via MercoPress (2013). “Brazil’s Dilma seems unbeatable 18 months ahead of the
presidential election”, MercoPress, March 27, 2013. Available from:
http://en.mercopress.com/2013/03/27/brazil-s-dilma-seems-unbeatable-18-months-ahead-of-
the-presidential-election. [Accessed May 31, 2013].
IFPMA (2011). The pharmaceutical industry and global health: facts and figures. International
Federation of Pharmaceutical Manufacturers. Available from:
http://www.ifpma.org/fileadmin/content/Publication/2011/2011_The_Pharmaceutical_Industry_a
nd_Global_Health_low_ver2.pdf.
IHME (2010). GBD profile: Brazil. The Institute for Health Metrics and Evaluation. Available
from: http://www.healthmetricsandevaluation.org/sites/default/files/country-
profiles/GBD%20Country%20Report%20-%20Brazil.pdf.
IMF (2013a). World Economic Outlook Database, April 2013 [database]. Available from:
http://www.imf.org/external/pubs/ft/weo/2013/01/weodata/weorept.aspx?pr.x=77&pr.y=15&sy=
2007&ey=2018&scsm=1&ssd=1&sort=country&ds=.&br=1&c=223&s=NGDP_R%2CNGDP_RP
CH%2CNGDP%2CNGDPD%2CNGDP_D%2CNGDPRPC%2CNGDPPC%2CNGDPDPC%2C
PPPGDP%2CPPPPC%2CPPPSH%2CPPPEX%2CNID_NGDP%2CNGSD_NGDP%2CPCPI%
2CPCPIPCH%2CPCPIE%2CPCPIEPCH%2CTM_RPCH%2CTMG_RPCH%2CTX_RPCH%2C
TXG_RPCH%2CTXGO%2CTMGO%2CLUR%2CLP%2CGGR%2CGGR_NGDP%2CGGX%2C
GGX_NGDP%2CGGXCNL%2CGGXCNL_NGDP%2CGGSB%2CGGSB_NPGDP%2CGGXON
LB%2CGGXONLB_NGDP%2CGGXWDN%2CGGXWDN_NGDP%2CGGXWDG%2CGGXWD
G_NGDP%2CNGDP_FY%2CBCA%2CBCA_NGDPD&grp=0&a=. [Accessed June 18, 2013].
Healthcare, Regulatory and Reimbursement Landscape – Brazil 322 © 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 –
BRAZIL
Appendix
IMF (2013b). Regional Economic Outlook: Western Hemisphere, May 2013. International
Monetary Fund. Available from:
http://www.imf.org/external/pubs/ft/reo/2013/whd/eng/pdf/wreo0513.pdf.
IMF (2013c). World Economic Outlook Database, April 2013 [database]. Available from:
http://www.imf.org/external/pubs/ft/weo/2013/01/weodata/weorept.aspx?pr.x=91&pr.y=5&sy=2
007&ey=2012&scsm=1&ssd=1&sort=country&ds=.&br=1&c=223%2C924%2C922%2C534&s=
NGDP_RPCH&grp=0&a=. [Accessed May 27, 2013].
Imprensa Nacional (2013). Official Gazette (Diario oficial da uniao). Imprensa Nacional.
Available from:
http://www.in.gov.br/visualiza/index.jsp?data=15/04/2013&jornal=1&pagina=68&totalArquivos=
148. [Accessed June 9, 2013].
INCA (2012). Incidence of cancer in Brazil. Instituto Nacional de Câncer. Available from:
http://translate.google.co.in/translate?hl=en&sl=pt&u=http://www.inca.gov.br/estimativa/2012/in
dex.asp%3FID%3D5&prev=/search%3Fq%3DBrasil%2BTipo%2Bde%2Bneoplasias%2Bmaior
%2B%2525%26hl%3Den%26noj%3D1%26biw%3D1366%26bih%3D677. [Accessed June 15,
2013].
ISAAC (2007). Chronic respiratory diseases. The International Study of Asthma and Allergies
in Childhood via PAHO. Available from:
http://new.paho.org/bra/index.php?option=com_content&task=view&id=581&Itemid=539.
[Accessed June 17, 2013].
ISPOR (2008). Pharmacoeconomics and outcomes research in Latin America - Argentina,
Brazil, Chile, Colombia, and Mexico. International Society for Pharmacoeconomics and
Outcomes Research. Available from:
http://www.ispor.org/news/articles/oct08/latinamericape.asp. [Accessed May 28, 2013].
ITA (2002). Medical device regulatory requirements for Brazil. International Trade
Administration, US Department of Commerce. Available from:
http://www.ita.doc.gov/td/health/brazilregs.pdf.
Itaú BBA (2013). Brazil scenario review. Itaú BBA. Available from:
http://www.itau.com.br/itaubba-en/economic-analysis/publications/brazil-scenario-review/lower-
growth-and-a-weaker-currency. [Accessed June 28, 2013].
Healthcare, Regulatory and Reimbursement Landscape – Brazil 323 © 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 –
BRAZIL
Appendix
La Forgia GM and Couttolenc BF (2008). Health care, development and fiscal policy in Brazil.
Brazilian National Treasury – Ministry of Finance. Available from:
http://www.pedrojucamaciel.com/Health%20Care%20System%20and%20Fiscal%20Policy%20
in%20Brazil1.ppt.pdf.
La Rovere EL and AS Pereira (2007). Brazil & climate change: a country profile. SciDev.Net.
Available from: http://www.scidev.net/global/policy-brief/brazil-climate-change-a-country-
profile.html. [Accessed June 22, 2013].
Magalhaes JL and Borschiver S (2012). Amoxicillin and Ampicillin - Import trends and
increasing use in Brazil. Chemistry Today; 30(5): 91–98.
Martins E (2013). New middle class is the protagonist in the performance of OTC drugs. Guia
Da Farmacia. Available from: http://www.guiadafarmacia.com.br/mips-2013/nova-classe-
media-e-protagonista-no-desempenho-dos-mips. [Accessed June 30, 2013].
MercoPress (2012). “Brazil applies 25% tariff increase on 100 imported goods; another 100 list
in the making”, MercoPress, September 5, 2012. Available from:
http://en.mercopress.com/2012/09/05/brazil-applies-25-tariff-increase-on-100-imported-goods-
another-100-list-in-the-making. [Accessed May 31, 2013].
Ministry of Environment (2010). FIP in Brazil. Ministry of Environment. Available from:
http://www.climateinvestmentfunds.org/cif/sites/climateinvestmentfunds.org/files/Brazil%20FIP
%20PresentationPilot%20Country%207%20Nov.pdf.
MoH (2005). Experiências exitosas em residências multiprofissionais em saúde no uso
racional de medicamentos. Ministry of Health. Available from:
http://portalsaude.saude.gov.br/portalsaude/arquivos/Oficina5.pdf.
MoH (2011a). Estrutura organizacional. Ministry of Health. Available from:
http://portalsaude.saude.gov.br/portalsaude/arquivos/pdf/2012/Mai/16/organograma_Dec_753
0_vs1.pdf.
MoH (2011b). O que muda da antiga CITEC para a atual CONITEC no processo de
incorporação de tecnologias no SUS. Ministry of Health. Available from:
http://portal.saude.gov.br/portal/arquivos/pdf/O_que_muda_da_CITEC_para_CONITEC2.pdf.
Healthcare, Regulatory and Reimbursement Landscape – Brazil 324 © 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 –
BRAZIL
Appendix
MoH (2011c). Ministry of Health. Available from:
http://portal.saude.gov.br/portal/arquivos/pdf/FluxosimpificadoCONITEC.pdf.
MoH (2011d). Evidências aplicadas a processos de registro, autorização de preço e
incorporação de novos medicamentos no SUS. Ministry of Health. Available from:
http://portal.saude.gov.br/portal/arquivos/pdf/CONITECEstudosCMEDXCONITEC.pdf.
MoH (2011e). Basic data and indicators - Brazil – 2011. Ministry of Health. Available from:
http://tabnet.datasus.gov.br/cgi/idb2011/matriz.htm#mort. [Accessed June 10, 2013].
MoH (2012a). Estratégia para Incentivo da Produção de Fármacos no Brasil. Ministry of
Health. Available from: http://www.ipd-
farma.org.br/uploads/paginas/file/palestras/6_ENIFarMed/Kellen%20Rezende.pdf.
MoH (2012b). Investment in cancer treatment grows 26%. Ministry of Health. Available from:
http://www.blog.saude.gov.br/investimento-em-tratamento-do-cancer-cresce-26/. [Accessed
June 8, 2013].
MoH (2013). Ministry of Health will invest R $ 35 billion by 2016. Ministry of Health. Available
from: http://portalsaude.saude.gov.br/portalsaude/noticia/10405/162/ministerio-da-saude-
vaiinvestir-r$-35-bi-ate-2016.html. [Accessed June 9, 2013].
MoH (2013b). DATASUS. Ministry of Health. Available from:
http://tabnet.datasus.gov.br/cgi/tabcgi.exe?sih/cnv/nruf.def. [Accessed June 9, 2013].
Novartis (2012). Annual report 2012. Novartis. Available from:
http://www.novartis.com/downloads/investors/reports/novartis-annual-report-2012-en.pdf.
OANDA (2013). Historical exchange rates. OANDA Corporation. Available from:
http://www.oanda.com/currency/historical-rates/. [Accessed June 9, 2013].
Obashoro-John O (2011). Global aging issues: The Nigerian situation. The Journal of Aging in
Emerging Economies; December 2011. Available from:
http://www.kent.edu:8014/sociology/resources/jaee/upload/obashoro.pdf.
Odnir Finotti, Pró Genéricos (2012). Interview with Odnir Finotti, Executive President, Pró
Genéricos. Pharma Boardroom. Available from:
http://www.pharmaboardroom.com/article/interview-with-odnir-finotti-executive-president-pr-
gen-ricos. [Accessed June 10, 2013].
Healthcare, Regulatory and Reimbursement Landscape – Brazil 325 © 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 –
BRAZIL
Appendix
OECD (2010). Brazil. Organization for Economic Cooperation and Development. Available
from: http://www.oecdbetterlifeindex.org/countries/brazil/. [Accessed June 9, 2013].
Olivier JGJ, et al. (2011). Long-term trend in global CO2 emissions; 2011 report. The PBL
Netherlands Environmental Assessment Agency. Available from:
http://www.pbl.nl/en/publications/2011/long-term-trend-in-global-co2-emissions-2011-report.
[Accessed June 5, 2013].
PAHO (2008a). Monitoring and analysis of health systems change/reform. Pan American
Health Organization. Available from:
http://new.paho.org/hq/dmdocuments/2010/Health_System_Profile-Brazil_2008.pdf.
PAHO (2008b). Chronic respiratory diseases. Ministry of Health via PAHO. Available from:
http://new.paho.org/bra/index.php?option=com_content&view=article&id=581&Itemid=539.
Accessed June 18, 2013].
PAHO (2010). Basic indicator browser - Country indicator profile. Pan American Health
Organization. Available from: http://ais.paho.org/phip/viz/indicatorprofilebydomain.asp.
[Accessed June 5, 2013].
Pearson S (2013). ”Brazil raises rates for fourth time since April”, The Financial Times, August
29, 2013. Available from: http://www.ft.com/intl/cms/s/0/5f347c50-1037-11e3-99e0-
00144feabdc0.html. [Accessed August 30, 2013].
Pfizer (2012). Annual report 2012. Pfizer. Available from:
http://www.pfizer.com/files/annualreport/2012/financial/financial2012.pdf.
Pfizer (2013). Pipeline 2013. Pfizer. Available from:
http://www.pfizer.com/sites/default/files/product-pipeline/pipeline_2013_0228.pdf.
Philips Healthcare (2012). Annual report 2012. Philips Healthcare. Available from:
http://www.annualreport2012.philips.com/downloads/index.aspx. [Accessed June 5, 2013].
PhRMA (2009). Pharmaceutical Research and Manufacturers of America Special 301
Submission 2009. Pharmaceutical Research and Manufacturers of America. Available from:
http://phrma.org/sites/default/files/pdf/phrma_special_301_submission_20092.pdf.
Healthcare, Regulatory and Reimbursement Landscape – Brazil 326 © 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 –
BRAZIL
Appendix
Piotto RF, et.al (2012). Independent predictors of prolonged mechanical ventilation after
coronary artery bypass surgery. Revista Brasileira de Cirurgia Cardiovascular; 27(4): 520–
528..
Portal Brasil (2010a). Health technology. Available from:
http://www.brasil.gov.br/sobre/science-and-technology/health-technology/the-pharmaceutical-
industry/br_model1?set_language=en. [Accessed June 3, 2013].
Portal Brasil (2010b). Domestic goals. Available from: http://www.brasil.gov.br/cop-
english/overview/what-brazil-is-doing/domestic-goals/br_model1?set_language=en. [Accessed
June 19, 2013].
Portal Brasil (2010c). Single Health System (SUS). Available from:
http://www.brasil.gov.br/sobre/saude/atendimento. [Accessed June 19, 2013].
Portal do Planalto (1996). Regulates the rights and obligations relating to industrial property.
Available from: http://www.planalto.gov.br/ccivil_03/Leis/L9279.htm. [Accessed June 3, 2013].
Presidency of the Republic (2012). Complementary Act No. 141 of 13 January 2012. Available
from: http://www.planalto.gov.br/ccivil_03/leis/lcp/Lcp141.htm. [Accessed on June 4, 2013].
Rapoza K (2013). ”Brazil growth surprises to the upside”, Forbes, August 30, 2013. Available
from: http://www.forbes.com/sites/kenrapoza/2013/08/30/brazil-growth-surprises-to-the-
upside/. [Accessed August 30, 2013].
Reuters (2013). ”Brazil real to hold above 2.2/dlr as US economy recovers-gov't source”,
Thomson Reuters, July 8, 2013. Available from:
http://www.reuters.com/article/2013/07/08/brazil-currency-source-idUSL1N0FE0HW20130708.
[Accessed June July 3, 2013].
Rio Negócios (2013). Bionovis defines factory and has vouched for biological. Rio Negócios.
Available from: http://rio-negocios.com/bionovis-define-fabrica-e-tem-aval-para-biologicos/.
[Accessed June 4, 2013].
Roche (2012). Annual report 2012. Roche. Available from:
http://www.roche.com/investors/annual_reports.htm. [Accessed July 4, 2013].
Healthcare, Regulatory and Reimbursement Landscape – Brazil 327 © 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 –
BRAZIL
Appendix
Roche (2013). Pipeline 2013. Roche. Available from:
http://www.roche.com/research_and_development/pipeline/roche_pharma_pipeline.htm.
[Accessed July 4, 2013].
Romero S (2013). “After protests, brazilian president’s popularity plummets”. New York Times,
June 29, 2013. Available from: http://www.nytimes.com/2013/06/30/world/americas/after-
protests-brazilian-presidents-popularity-plummets.html?_r=0. [Accessed June July 3, 2013].
Sanofi (2012). Annual Report 2012. Sanofi. Available from:
http://en.sanofi.com/Images/31972_20-F_2012_V2.pdf.
Sanofi (2013). Pipeline 2013. Sanofi. Available from:
http://en.sanofi.com/rd/rd_portfolio/rd_portfolio.aspx. [Accessed July 5, 2013].
Siemens (2012). Annual Report 2012. Siemens. Available from:
http://www.siemens.com/investor/pool/en/investor_relations/siemens_ar_2012.pdf.
Simões A (2013). “Venda de medicamentos fracionados patina na falta de informação”, Jornal
de Londrina, March 27, 2013. Available from:
http://www.jornaldelondrina.com.br/online/conteudo.phtml?id=1357406. [Accessed June 15,
2013].
Siqueira H (2013). Global project wants to reduce cardiovascular mortality. S/A Estado de
Minas. Available from:
http://sites.uai.com.br/app/noticia/saudeplena/noticias/2013/04/24/noticia_saudeplena,143155/
projeto-global-quer-reduzir-mortalidade-por-doencas-cardiovasculares.shtml. [Accessed June
30, 2013].
Standard & Poors (2013). Infrastructure in Brazil, projects, financing instruments, opportunities.
Standard & Poors. Available from:
http://www.fazenda.gov.br/portugues/documentos/2013/Book-AAE--Web-Final.pdf.
Strozzi VH and Graeml AR (2011). The use of traceability information throughout the Brazilian
pharmaceutical industry’s supply chain. Gestão da Produção, Operações e Sistemas; 6(1):
11-24.
Healthcare, Regulatory and Reimbursement Landscape – Brazil 328 © 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 –
BRAZIL
Appendix
TCU (2011). Relatório De Auditoria, Ações de vigilância sanitária de medicamentos. Tribunal
De Contas Da União. Available from:
http://portal2.tcu.gov.br/portal/page/portal/TCU/comunidades/programas_governo/areas_atuac
ao/saude/idSisdoc_2860777v2-49%2B-%2BInstrucao_Processo_01723820063%20(.pdf.
The Global Times (2013). “Brazilian president announces spending increase on health,
education”, The Global Times, July 11, 2013. Available from:
http://www.globaltimes.cn/content/795387.shtml#.UeUspNKB9c0. [Accessed June 6, 2013].
The World Bank (2013a). Total reserves (includes gold, current US. The World Bank. Available
from: http://data.worldbank.org/indicator/FI.RES.TOTL.CD. [Accessed June 21, 2013].
The World Bank (2013b). Imports of goods and services (current US$). The World Bank.
Available http://data.worldbank.org/indicator/NE.IMP.GNFS.CD. [Accessed June 20, 2013].
The World Bank (2013c). Employment to population ratio, 15+, total (%). The World Bank.
Available from: http://data.worldbank.org/indicator/SL.EMP.TOTL.SP.ZS. [Accessed June 20,
2013].
The World Bank (2013d). Exports of goods and services (current US$). The World Bank.
Available http://data.worldbank.org/indicator/NE.EXP.GNFS.CD. [Accessed June 17, 2013].
The World Bank (2013e). GNI per capita, Atlas method (US$). The World Bank. Available from:
http://data.worldbank.org/indicator/NY.GNP.PCAP.CD. [Accessed May 27, 2013].
The World Bank (2013f). Rural population. The World Bank. Available from:
http://data.worldbank.org/indicator/SP.RUR.TOTL?display=default. [Accessed May 27, 2013].
The World Bank (2013g). Urban population. The World Bank. Available from:
http://data.worldbank.org/indicator/SP.URB.TOTL/countries/1W-BR?display=default.
[Accessed May 27, 2013].
The World Bank (2013h). PM10, country level (micrograms per cubic meter). The World Bank.
Available from: http://data.worldbank.org/indicator/EN.ATM.PM10.MC.M3. [Accessed May 27,
2013].
The World Bank (2013i). Nitrous oxide emissions (thousand metric tons of CO2 equivalent).
The World Bank. Available from: http://data.worldbank.org/indicator/EN.ATM.NOXE.KT.CE.
[Accessed May 31, 2013].
Healthcare, Regulatory and Reimbursement Landscape – Brazil 329 © 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 –
BRAZIL
Appendix
The World Bank (2013j). CO2 emissions (kt). The World Bank. Available from:
http://data.worldbank.org/indicator/EN.ATM.CO2E.KT. [Accessed May 29, 2013].
The World Bank (2013k). Other greenhouse gas emissions, HFC, PFC and SF6 (thousand
metric tons of CO2 equivalent). The World Bank. Available from:
http://search.worldbank.org/data?qterm=Sulfur%20Oxide&language=EN. [Accessed May 29,
2013].
The World Bank (2013l). Health expenditure, total (% of GDP). The World Bank. Available
from: http://data.worldbank.org/indicator/SH.XPD.TOTL.ZS. [Accessed May 30, 2013].
The World Bank (2013n). Net trade in goods and services (BoP, current US$). The World
Bank. Available from: http://data.worldbank.org/indicator/BN.GSR.GNFS.CD. [Accessed May
30, 2013].
The World Bank (2013o). Hospital beds (per 1,000 people). The World Bank. Available from:
http://data.worldbank.org/indicator/SH.MED.BEDS.ZS. [Accessed May 30, 2013].
The World Bank (2013p). Physicians (per 1,000 people). The World Bank. Available from:
http://data.worldbank.org/indicator/SH.MED.PHYS.ZS. [Accessed May 31, 2013].
The World Bank (2013q). Health expenditure, public (% of total health expenditure). The World
Bank. Available from: http://data.worldbank.org/indicator/SH.XPD.PUBL?page=1. [Accessed
May 31, 2013].
The World Bank (2013r). Out of pocket health expenditure (% of total expenditure on health).
The World Bank. Available from: http://data.worldbank.org/indicator/SH.XPD.OOPC.TO.ZS.
[Accessed May 29, 2013].
The World Bank (2013s). Foreign direct investment, net inflows (BoP, current US$). The World
Bank. Available from:
http://data.worldbank.org/indicator/BX.KLT.DINV.CD.WD?display=default. [Accessed July 25,
2013].
The World Bank (2013t). Birth rate, crude (per 1,000 people). The World Bank. Available from:
http://data.worldbank.org/indicator/SP.DYN.CBRT.IN. [Accessed July 25, 2013].
The World Bank (2013u). Death rate, crude (per 1,000 people). The World Bank. Available
from: http://data.worldbank.org/indicator/SP.DYN.CDRT.IN. [Accessed July 25, 2013].
Healthcare, Regulatory and Reimbursement Landscape – Brazil 330 © 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 –
BRAZIL
Appendix
The World Bank (2013v). Mortality rate, under-5 (per 1,000 live births). The World Bank.
Available from: http://data.worldbank.org/indicator/SH.DYN.MORT. [Accessed July 25, 2013].
The World Bank (2013w). GDP (current US$). The World Bank. Available from:
http://data.worldbank.org/indicator/NY.GDP.MKTP.CD. [Accessed July 25, 2013].
Transparency International (2012). Transparency International Corruption Perceptions Index
2012. Transparency International. Available from: http://www.transparency.org/cpi2012/results.
[Accessed July 5, 2013].
UNESCO (2013). Water in a changing World. United Nations Organization for Education,
Science and Culture. Available from:
http://www.unesco.org/new/fileadmin/MULTIMEDIA/HQ/SC/pdf/WWDR3_Facts_and_Figures.p
df.
UNICEF (2013). Brazil reduces infant mortality. United Nations Children's Fund. Available from:
http://portalsaude.saude.gov.br/portalsaude/noticia/11141/162/brasil-reduz-taxa-de-
mortalidade-infantil.html. [Accessed July 25, 2013].
United Nations Statistics Division (2013). Proportion of the population using improved drinking
water sources, total. United Nations Statistics Division. Available from:
http://data.un.org/Data.aspx?q=drinking+water&d=MDG&f=seriesRowID%3a665#MDG
[Accessed June 24, 2013].
US Commercial Service, Department of Commerce (2012). Doing business in Brazil: 2013
country commercial guide for US companies. US Commercial Service, Department of
Commerce. Available from:
http://export.gov/brazil/build/groups/public/@eg_br/documents/webcontent/eg_br_034878.pdf.
Wellcome Trust (2009). Opinion formers’ conference on counterfeit medicines: perspectives
and action. Wellcome Trust, American Pharmaceutical Group, London. Available from:
http://www.wellcome.ac.uk/stellent/groups/corporatesite/@policy_communications/documents/
web_document/WTX057518.pdf.
WHO (2003). Substandard and counterfeit medicines, Fact sheet N 275. World Health
Organization. Available from: http://www.who.int/mediacentre/factsheets/2003/fs275/en/.
[Accessed May 2, 2013].
Healthcare, Regulatory and Reimbursement Landscape – Brazil 331 © 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 –
BRAZIL
Appendix
WHO (2006). Fact sheet on chronic respiratory diseases in Brazil. World Health Organization.
Available from:
http://www.who.int/respiratory/gard/events/FINAL%20Q&A%20GARD%20Brazil%2003_10_06.
pdf.
WHO (2009). Global tuberculosis control. World Health Organization. Available from:
http://www.tbrieder.org/publications/books_english/rm24392.pdf. [Accessed June 24, 2013].
WHO (2010). Growing threat from counterfeit medicines. Bulletin of the World Health
Organization; 88(4): 241–320.
WHO (2012). Global tuberculosis report 2012. World Health Organization. Available from:
http://apps.who.int/iris/bitstream/10665/75938/1/9789241564502_eng.pdf.
WHO (2013). WHO vaccine-preventable diseases: monitoring system. 2013 global summary.
World Health Organization. Available from:
http://apps.who.int/immunization_monitoring/globalsummary/countries?countrycriteria%5Bcoun
try%5D%5B%5D=BRA. [Accessed June 28, 2013].
Winterstein P and Magalhaes L (2013). “Brazil Central Bank Has Done 'Good Job' With
Inflation –Analyst”. The Wall Street Journal. Available from: http://online.wsj.com/article/BT-
CO-20130830-711958.html?mod=googlenews_wsj. [Accessed August 30, 2013].
Wirtz V, et al. (2010). Trends in antibiotic utilization in eight Latin American countries, 1997–
2007. Revista Panamericana de Salud Pública; 27(3): 219–225.
Healthcare, Regulatory and Reimbursement Landscape – Brazil 332 © 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 –
BRAZIL
Appendix
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: revenue, products and media
attention/innovation/market potential.
The estimated revenue 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).
Healthcare, Regulatory and Reimbursement Landscape – Brazil 333 © 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 –
BRAZIL
Appendix
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:
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 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 the 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 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, 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.
Healthcare, Regulatory and Reimbursement Landscape – Brazil 334 © 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 –
BRAZIL
Appendix
7.4 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any
form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior
permission of the publisher, GlobalData.