GDHC0054CHR CountryFocus Healthcare, Regulatory and ...

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).



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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



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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



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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



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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



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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



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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



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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



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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



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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



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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



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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



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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



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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



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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



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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.



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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).



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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%




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Table 1: Pharmaceutical Industry, Brazil, Revenue ($bn), 2007–2012 Year 2007 2008 2009 2010 2011 2012*

Revenue


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



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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



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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



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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



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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



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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)



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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)



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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



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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)



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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



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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



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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



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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



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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



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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)



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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)



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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



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Appendix

7.2 Bibliography

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ANVISA (2009a). New rules for labeling of medicines. Agência Nacional de Vigilância

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xQfAmUEZYAky3OQShpuw8QASBYKQaBjk6eP_75Ns0rXrqjpfnwY5eOpaTM25uDfDtXgDB5D

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lOWDfKm7Nes6tdwjTGWN7IERQwFGWGQHrKHqN0sppHkaAdzbUjyLa9vStA94iWktMkjktQW

x5n3UFU8d7oXgsCNtcw4WgWS9bmbnS3HzS5lKpovoULZkkLVCSarMgvtYu-

wPX1stP007Pl9mevIvi6dc-GYzT_o9HImp-tU6JlTYK0M36KoGjA6pbpI3sfbthpjXfcPSdMzI22l-

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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


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


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


http://web.archive.org/web/20120120023736/http://www.anvisa.gov.br/eng/legis/resol/01_03rdc

_e.htm. [Accessed June 10, 2013].



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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

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11-24.



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The World Bank. Available from: http://data.worldbank.org/indicator/EN.ATM.NOXE.KT.CE.




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Appendix

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Appendix

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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).



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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.



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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.

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