Healthcare, Regulatory and Reimbursement Landscape Venezuela

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Healthcare, Regulatory and Reimbursement Landscape Venezuela
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Healthcare, Regulatory and Reimbursement Landscape
Venezuela
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  Reference Code: GDHC0021CHR
  Publication Date: December 2012
Despite a High Proportion of the Population being in the
       Working age Group, Venezuela is Dependent on Skilled
       Foreign Labor for the Adequate Development of its Oil and
       Healthcare Sectors

                                                                   Although the Venezuelan Healthcare Market has Significant
                                                                   Growth Potential, its Lack of Patent Protection Laws for
                                                                   Medicines, Lack of Clarity over the Pharmaceutical
                                                                   Regulatory Process, High Level of Corruption, Drug Price
                                                                   Freeze Policy and Lack of Universal Healthcare Coverage

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                                                                   all  Negatively Impact      the   Interest   of  Foreign
                                                                   Pharmaceutical Investors

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         Age Groups, Venezuela, Population Distribution (%),
         2006-2020
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         Source: GlobalData; INE, 2012; US Census Bureau, 2012a
         *Estimated Figures

                                                                                                        GDHC0021CHR / Published DEC 2012
Healthcare, Regulatory and Reimbursement Landscape                                                                                      Page 2
Venezuela                                                              © GlobalData. This report is a licensed product and is not to be copied,
                                                                                                     reproduced, shared or resold in any form
Pharmaceutical Market ($bn), Venezuela, 2006-2020

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         Source: GlobalData; CIFAR, 2007; RNV, 2012
         *Estimated Figures
                                                                   Political Stability in Recent Years has Resulted in the
                                                                   Proper Implementation of Economic Policies and
       Lack of Clarity and Transparency in the Regulatory System
                                                                   Programs. However, Venezuela’s Overwhelmingly Oil-
       and Language Barriers in the Drug Approval Process often
                                                                   Based Economy is Vulnerable. Moreover, the Devaluation

       Attempting to Register New Drugs

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       Present a Challenge for Foreign Multinational Companies
                                                                   of    the   Country’s    Currency,    Continued Banking
                                                                   Interventions and the Nationalization of Assets in the
                                                                   Petroleum, Alternative Energy and Banking Sectors have
                                                                   Led to a Decline in Foreign Direct Investments
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       Lack of Universal Healthcare Coverage and Skilled
       Healthcare Personnel, a Shortage of Medicines in Public
       Pharmacies and a High Level of Private Healthcare
       Expenditure Leave the Healthcare System of Venezuela
       with Shaky Foundations

                                                                                                        GDHC0021CHR / Published DEC 2012
Healthcare, Regulatory and Reimbursement Landscape                                                                                      Page 3
Venezuela                                                              © GlobalData. This report is a licensed product and is not to be copied,
                                                                                                     reproduced, shared or resold in any form
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       Country Profile, Venezuela, 2012

                                              Parameter
                                                          PL
                                          Healthcare Market

                                        Economic Environment
                                                                    Pharmaceutical
                                                                        Market

                                                                        Stability
                                                                                                     Country Profile

                                                                                                   Growth
                                                                                                                Sub-parameters

                                                                                             Pharmaceutical Market

                                                                                             Government Initiatives
                                                                                                                           Medical Device
                                                                                                                              Market

                                                                                                                            GDP Growth
                                                                                                                                                 Medical Device Market
                                                                                                                                                        Growth

                                                                                                                                                        Employment
                             M
                                                                                                   Hospital Beds to     Doctors to Population     Environmental Health
                                       Healthcare Infrastructure Government Initiatives            Population Ratio             Ratio

                                                                         Overall                    Public Share            Private Share             R&D Expenditure
                                        Healthcare Expenditure
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                                                                       Population             Working Age Group                             Elderly
                                            Demographics

                                                                   Approval Process                Approval Time                   Government Initiatives
                                        Regulatory Environment

                                                                    Political Stability       Healthcare Initiatives                  Economic Policy
                                         Political Environment

                                                                                          Access                                   Government Initiatives
                                           Reimbursement
                                           Environment

                                                                           Strong                      Moderate                   Weak

       Source: GlobalData

                                                                                                                                                          GDHC0021CHR / Published DEC 2012
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Venezuela                                                                                                                © GlobalData. This report is a licensed product and is not to be copied,
                                                                                                                                                       reproduced, shared or resold in any form
1          Table of Contents
                      1    Table of Contents .................................................................................................................................. 5
                          1.1 List of Tables .................................................................................................................................. 7
                          1.2 List of Figures ................................................................................................................................. 8
                      2    Introduction ..........................................................................................................................................10
                          2.1 Report Guidance............................................................................................................................10
                      3    Overview of the Pharmaceutical and Medical Devices Market .............................................................11
                          3.1 Pharmaceutical Market ..................................................................................................................11
                            3.1.1     Market Overview ...................................................................................................................11
                            3.1.2     Supply Channels ..................................................................................................................14
                            3.1.3     Market Segments .................................................................................................................15
                            3.1.4     Major Disease Areas ............................................................................................................18
                            3.1.5     Major Players........................................................................................................................19

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                          3.2 Medical Device Market ..................................................................................................................45
                            3.2.1     Market Overview ...................................................................................................................45
                          3.3 Market Drivers and Barriers ...........................................................................................................45
                            3.3.1     Drivers ..................................................................................................................................45
                            3.3.2     Barriers .................................................................................................................................46
                      4    Market Access ......................................................................................................................................48

                            4.1.1
                            4.1.2
                            4.1.3
                            4.1.4

                            4.2.1
                            4.2.2
                            4.2.3
                            4.2.4
                            4.2.5
                            4.2.6
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                          4.1 Reimbursement and Payer Landscape ..........................................................................................48
                                      Reimbursement Process ......................................................................................................51
                                      Overview of Insurance Providers ..........................................................................................52
                                      Patient Share in Healthcare Spending ..................................................................................53
                                      Price Trend for Medicines .....................................................................................................54
                          4.2 Regulatory Landscape ...................................................................................................................55
                                      Overview of Regulatory Agencies .........................................................................................55
                                      Registration Procedure for New Drug ...................................................................................55
                                      Medical Device Approval Process ........................................................................................57
                                      Licensing Process for Pharmaceutical Manufacturing ..........................................................57
                                      Licensing Process for Pharmaceutical Exports and Imports .................................................58
                                      Intellectual Property Rights ...................................................................................................58
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                            4.2.7     Clinical Trial Regulations ......................................................................................................63
                            4.2.8     Pharmaceutical Advertising Regulations ..............................................................................65
                            4.2.9     Pharmacy Regulations .........................................................................................................66
                            4.2.10 Labeling and Packaging Regulations ...................................................................................67
                      5    Country Analysis ..................................................................................................................................69
                          5.1 Political Environment .....................................................................................................................69
                            5.1.1     Political Structure..................................................................................................................69
                            5.1.2     Analysis of the Current Political Environment .......................................................................70
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                            5.1.3     Healthcare Policy Initiatives ..................................................................................................71
                          5.2 Economic Landscape ....................................................................................................................71
                          5.3 Economic Indicators ......................................................................................................................73
                            5.3.1     Gross Domestic Product .......................................................................................................73
                            5.3.2     Gross National Income .........................................................................................................77
                            5.3.3     Inflation .................................................................................................................................78
                            5.3.4     Currency Exchange Rate......................................................................................................82
                            5.3.5     Foreign Direct Investment.....................................................................................................84
                            5.3.6     Foreign Exchange Reserves ................................................................................................85
                            5.3.7     Trade Balance ......................................................................................................................86
                            5.3.8     Government Structural Balance............................................................................................88
                            5.3.9     Government Gross Debt .......................................................................................................90
                            5.3.10 Major Industries ....................................................................................................................92
                          5.4 Demography ..................................................................................................................................93
                            5.4.1     Population.............................................................................................................................93
                            5.4.2     Education and Literacy .......................................................................................................112
                            5.4.3     Employment........................................................................................................................114
                            5.4.4     Disease Burden ..................................................................................................................116
                          5.5 Healthcare Infrastructure .............................................................................................................117
                            5.5.1     Healthcare Facilities ...........................................................................................................117

                                                                                                                                                  GDHC0021CHR / Published DEC 2012
Healthcare, Regulatory and Reimbursement Landscape                                                                                                                                Page 5
Venezuela                                                                                                        © GlobalData. This report is a licensed product and is not to be copied,
                                                                                                                                               reproduced, shared or resold in any form
5.5.2   Healthcare Parameters .......................................................................................................123
                        5.5.3   Environmental Health .........................................................................................................125
                      5.6 Healthcare Expenditure ...............................................................................................................129
                        5.6.1   Overview.............................................................................................................................129
                        5.6.2   Share of Public and Private Sectors ...................................................................................130
                        5.6.3   Spending in Healthcare R&D ..............................................................................................130
                      5.7 Trade Associations ......................................................................................................................131
                        5.7.1   Venezuelan Chamber of Medicine ......................................................................................131
                        5.7.2   Chamber of Pharmaceutical Industry .................................................................................131
                        5.7.3   Chamber of Non-prescription Medicines ............................................................................131
                        5.7.4   Venezuelan Association of Distributors of Medical Equipment, Dental Laboratories and
                                Allied ...................................................................................................................................131
                        5.7.5   Venezuelan Chamber of Pharmacy ....................................................................................131
                     6 Opportunities and Challenges ............................................................................................................132
                      6.1 Opportunities ...............................................................................................................................132

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                      6.2 Challenges ...................................................................................................................................133
                     7 Appendix ............................................................................................................................................135
                      7.1 Abbreviations ...............................................................................................................................135
                      7.2 Bibliography .................................................................................................................................138
                      7.3 -Methodology ...............................................................................................................................146
                        7.3.1   Coverage ............................................................................................................................146
                        7.3.2   Secondary Research ..........................................................................................................146
                        7.3.3
                        7.3.4
                        7.3.5

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                                Forecasting .........................................................................................................................147
                                Primary Research ...............................................................................................................147
                                Expert Panel Validation ......................................................................................................147
                      7.4 Disclaimer ....................................................................................................................................147
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                                                                                                                                               GDHC0021CHR / Published DEC 2012
Healthcare, Regulatory and Reimbursement Landscape                                                                                                                             Page 6
Venezuela                                                                                                     © GlobalData. This report is a licensed product and is not to be copied,
                                                                                                                                            reproduced, shared or resold in any form
1.1     List of Tables
                     Table 1:    Pharmaceutical Market ($bn), Venezuela, 2006-2011 ..............................................................12
                     Table 2:    Pharmaceutical Market ($bn), Venezuela, Forecast, 2012-2020 ..............................................13
                     Table 3:    Drugs Going Off-patent, Revenues ($bn), Global, 2011-2015 ..................................................16
                     Table 4:    Major Products, Pfizer, Global, Revenue ($m), 2011 ................................................................20
                     Table 5:    Late-stage Pipeline, Pfizer, 2012 ..............................................................................................20
                     Table 6:    Major Products, GlaxoSmithKline, Global, Revenue ($m), 2011 ..............................................25
                     Table 7:    Late Stage Pipeline, GlaxoSmithKline, 2012 ............................................................................26
                     Table 8:    Major Products, Sanofi, Global, Revenue ($m), 2011 ...............................................................31
                     Table 9:    Late-stage Pipeline, Sanofi, 2012 .............................................................................................32
                     Table 10:   Major Products, Novartis, Global, Revenue ($m), 2011 ............................................................36
                     Table 11:   Planned Filings, Novartis, 2012-2016 .......................................................................................37
                     Table 12:   Major Products, Groupo Farma, 2012.......................................................................................42

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                     Table 13:   Healthcare Spending, Venezuela, Patient's Share (%), 2005-2010 ..........................................53
                     Table 14:   Price Trend for Medicines and Medical Devices (%), Venezuela, 2008-2011...........................54
                     Table 15:   GDP Per Capita ($), Venezuela, 2006-2011 .............................................................................73
                     Table 16:   GDP Per Capita ($), Venezuela, Forecast, 2012-2020 .............................................................74
                     Table 17:   GDP, Venezuela, Annual Growth (%), 2006-2011 ....................................................................75
                     Table 18:   GDP, Venezuela, Annual Growth (%), Forecast, 2012-2020 ....................................................76
                     Table 19:
                     Table 20:
                     Table 21:
                     Table 22:
                     Table 23:
                     Table 24:
                     Table 25:
                     Table 26:
                     Table 27:
                     Table 28:
                     Table 29:
                     Table 30:
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                                 GNI Per Capita ($), Venezuela, 2005-2010 ..............................................................................77
                                 Average Consumer Price Index, Venezuela, 2006-2011 ..........................................................78
                                 Average Consumer Price Index, Venezuela, Forecast, 2012-2020 ..........................................79
                                 Average Consumer Price, Venezuela, Annual Change (%), 2006-2011 ...................................80
                                 Average Consumer Price, Venezuela, Annual Change (%), Forecast, 2012-2020 ...................81
                                 Currency Exchange Rate (VEB/$), Venezuela, 2005-2007 ......................................................82
                                 Currency Exchange Rate (VEF/$), Venezuela, 2008-2011.......................................................83
                                 Foreign Direct Investment ($bn), Venezuela, 2005-2010..........................................................84
                                 Foreign Exchange Reserves ($bn), Venezuela, 2006-2011 .....................................................85
                                 Imports of Goods and Services ($bn), Venezuela, 2006-2011 .................................................86
                                 Exports of Goods and Services ($bn), Venezuela, 2006-2011 .................................................87
                                 General Government Structural Balance ($bn), Venezuela, 2006-2011 ...................................88
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                     Table 31:   General Government Structural Balance ($bn), Venezuela, Forecast, 2012-2020 ...................89
                     Table 32:   Government Gross Debt ($bn), Venezuela, 2006-2011 ............................................................90
                     Table 33:   Government Gross Debt ($bn), Venezuela, Forecast, 2012-2020 ............................................91
                     Table 34:   Major Industries, Venezuela, Gross Domestic Product ($bn), 2011 .........................................92
                     Table 35:   Population (m), Venezuela, 2006-2011.....................................................................................94
                     Table 36:   Population (m), Venezuela, Forecast, 2012-2020 .....................................................................95
                     Table 37:   Urban and Rural Population, Venezuela, Share (%), 2005-2010 ..............................................96
                     Table 38:   Age Groups, Venezuela, Population Distribution (%), 2006-2011 ............................................98
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                     Table 39:   Age Groups, Venezuela, Population Distribution (%), Forecast, 2012-2020.............................99
                     Table 40:   Births (Per 1,000 Population), Venezuela, 2006-2011 ............................................................100
                     Table 41:   Births (Per 1,000 Population), Venezuela, Forecast, 2012-2020 ............................................101
                     Table 42:   Mortality (Per 1,000 Population), Venezuela, 2006-2011........................................................102
                     Table 43:   Mortality (Per 1,000 Population), Venezuela, Forecast, 2012-2020 ........................................103
                     Table 44:   Major Causes of Mortality (Number of Deaths, „000s), Venezuela, 2008 ................................105
                     Table 45:   Children
Table 61:    Hospital Beds (Per 1,000 Population), Venezuela, 2005-2010 ...............................................123
                     Table 62:    Number of Physicians (Per 10,000 Population), Venezuela, 2005-2010 ................................124
                     Table 63:    Environmental Attributable Deaths (Per 100,000 Population), Venezuela, 2004 ....................125
                     Table 64:    PM10 (micrograms per cubic meter), Venezuela, 2005-2010 .................................................126
                     Table 65:    CO2 Emissions (Million Tons), Venezuela, 2005-2010 ...........................................................128
                     Table 66:    Healthcare Expenditure (% of GDP), Venezuela, 2005-2010 .................................................129
                     Table 67:    Healthcare Expenditure, Venezuela, Public-Private Share (%), 2005-2010 ...........................130

                     1.2      List of Figures
                     Figure 1: Pharmaceutical Market ($bn), Venezuela, 2006-2011 ................................................................12
                     Figure 2: Pharmaceutical Market ($bn), Venezuela, Forecast, 2012-2020 ................................................13
                     Figure 3: Distribution Channels, Venezuela, 2011 .....................................................................................14
                     Figure 4: Drivers and Barriers, Healthcare Market, Venezuela, 2011 ......................................................47
                     Figure 5: History of the Healthcare System, Venezuela, 2011 .................................................................50

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                     Figure 6: Healthcare Spending, Venezuela, Patient's Share (%), 2005-2010 ..........................................53
                     Figure 7: Price Trend for Medicines and Medical Devices (%), Venezuela, 2008-2011 .............................54
                     Figure 8: Registration Procedure for New Drug, Venezuela, 2012 ............................................................56
                     Figure 9: Patent Approval Process, Venezuela, 2012..............................................................................60
                     Figure 10: Trademark Approval Process, Venezuela, 2012 .......................................................................62
                     Figure 11: Clinical Trial Regulation Process, Venezuela, 2012 .................................................................64

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                     Figure 12: Format of Advertisement, Venezuela, 2012 ..............................................................................66
                     Figure 13: GDP Per Capita ($), Venezuela, 2006-2011 .............................................................................73
                     Figure 14: GDP Per Capita ($), Venezuela, Forecast, 2012-2020 .............................................................74
                     Figure 15: GDP, Venezuela, Annual Growth (%), 2006-2011 ....................................................................75
                     Figure 16: GDP, Venezuela, Annual Growth (%), Forecast, 2012-2020 ....................................................76
                     Figure 17: GNI Per Capita ($), Venezuela, 2005-2010 ..............................................................................77
                     Figure 18: Average Consumer Price Index, Venezuela, 2006-2011 ..........................................................78
                     Figure 19: Average Consumer Price Index, Venezuela, Forecast, 2012-2020 ..........................................79
                     Figure 20: Average Consumer Price, Venezuela, Annual Change (%), 2006-2011 ...................................80
                     Figure 21: Average Consumer Price, Venezuela, Annual Change (%), Forecast, 2012-2020 ...................81
                     Figure 22: Currency Exchange Rate (VEB/$), Venezuela, 2005-2007 ......................................................82
                     Figure 23: Currency Exchange Rate (VEF/$), Venezuela, 2008-2011 .......................................................83
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                     Figure 24: Foreign Direct Investment ($bn), Venezuela, 2005-2010..........................................................84
                     Figure 25: Foreign Exchange Reserves ($bn), Venezuela, 2006-2011 .....................................................85
                     Figure 26: Imports of Goods and Services ($bn), Venezuela, 2006-2011 .................................................86
                     Figure 27: Exports of Goods and Services ($bn), Venezuela, 2006-2011 .................................................87
                     Figure 28: General Government Structural Balance ($bn), Venezuela, 2006-2011 ...................................88
                     Figure 29: General Government Structural Balance ($bn), Venezuela, Forecast, 2012-2020 ...................89
                     Figure 30: Government Gross Debt ($bn), Venezuela, 2006-2011 ............................................................90
                     Figure 31: Government Gross Debt ($bn), Venezuela, Forecast, 2012-2020 ............................................91
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                     Figure 32: Major Industries, Venezuela, GDP ($bn), 2011.........................................................................92
                     Figure 33: Population (m), Venezuela, 2006-2011 .....................................................................................94
                     Figure 34: Population (m), Venezuela, Forecast, 2012-2020 .....................................................................95
                     Figure 35: Urban and Rural Population, Venezuela, Share (%), 2005-2010 ..............................................96
                     Figure 36: Age Groups, Venezuela, Population Distribution (%), 2006-2011.............................................98
                     Figure 37: Age Groups, Venezuela, Population Distribution (%), Forecast, 2012-2020.............................99
                     Figure 38: Births (Per 1,000 Population), Venezuela, 2006-2011 ............................................................100
                     Figure 39: Births (Per 1,000 Population), Venezuela, Forecast, 2012-2020 ............................................101
                     Figure 40: Mortality (Per 1,000 Population), Venezuela, 2006-2011........................................................102
                     Figure 41: Mortality (Per 1,000 Population), Venezuela, Forecast, 2012-2020 ........................................103
                     Figure 42: Major Causes of Mortality (Number of Deaths, „000s), Venezuela, 2008................................104
                     Figure 43: Children
Figure 54: Public Hospitals, Venezuela, 2005-2010 ................................................................................118
                     Figure 55: Hospitals by Standard of Care, Venezuela, Share (%), 2010 .................................................119
                     Figure 56: Ambulatory Facilities, Venezuela, Urban and Rural Share (%), 2010 .....................................120
                     Figure 57: Hospitals by Bed Size, Venezuela, Share (%), 2010 ..............................................................121
                     Figure 58: Diagnostic Facilities, Venezuela, 2005-2010 ..........................................................................122
                     Figure 59: Hospital Beds (Per 1,000 Population), Venezuela, 2005-2010 ...............................................123
                     Figure 60: Number of Physicians (Per 10,000 Population), Venezuela, 2005-2010 ................................124
                     Figure 61: Environmental Attributable Deaths (Per 100,000 Population), Venezuela, 2004 ....................125
                     Figure 62: PM10 (Micrograms Per Cubic Meter), Venezuela, 2005-2010 ................................................126
                     Figure 63: CO2 Emissions (Million Tons), Venezuela, 2005-2010 ...........................................................128
                     Figure 64: Healthcare Expenditure (% of GDP), Venezuela, 2005-2010 .................................................129
                     Figure 65: Healthcare Expenditure, Venezuela, Public-Private Share (%), 2005-2010 ...........................130
                     Figure 66: Opportunities and Challenges, Healthcare Market, Venezuela, 2012 .....................................134

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                                                                                                                                  GDHC0021CHR / Published DEC 2012
Healthcare, Regulatory and Reimbursement Landscape                                                                                                                Page 9
Venezuela                                                                                        © GlobalData. This report is a licensed product and is not to be copied,
                                                                                                                               reproduced, shared or resold in any form
2       Introduction
                     2.1     Report Guidance
                          The report begins with an executive summary which gives an overview of the healthcare market of
                           Venezuela and the key factors driving the market there. The executive summary also gives a
                           snapshot of the demographic, regulatory and reimbursement landscape, as well as the healthcare
                           infrastructure of Venezuela.
                          Chapter three provides an overview of the pharmaceutical and medical device market of Venezuela,
                           including the market size, market segmentation by generics, Over-the-Counter (OTC) and
                           biologics/biosimilar products, and the key drivers and barriers for the market. The section also
                           includes profiles of the major players, with a SWOT assessment.
                          Chapter four covers the reimbursement and payer landscape as well as the regulatory landscape of

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                           Venezuela. The reimbursement and payer landscape elaborates on the features of the healthcare
                           reimbursement process for Venezuela. It includes details of the reimbursement process, the
                           insurance providers, pricing policies and drug price trends in the country. The regulatory landscape
                           section provides an overview of the regulatory agencies and approval processes for new drugs and
                           medical devices. The licensing process for the manufacturing and export/import of pharmaceuticals,
                           the regulations for pharmaceutical advertising, labeling and packaging and clinical trials and an

                     

                     
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                           overview of the landscape for intellectual property rights are also covered in this chapter.
                           Chapter five provides a detailed analysis of the political and economic environment of Venezuela. It
                           analyses the economic indicators, demographics, healthcare infrastructure and healthcare
                           expenditure of Venezuela.
                           Chapter six provides an overview of the opportunities and challenges for growth that exist in the
                           healthcare market of Venezuela.
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                                                                                                                   GDHC0021CHR / Published DEC 2012
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Venezuela                                                                         © GlobalData. This report is a licensed product and is not to be copied,
                                                                                                                reproduced, shared or resold in any form
3       Overview of the Pharmaceutical and Medical Devices Market
                     3.1     Pharmaceutical Market
                     3.1.1     Market Overview

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                                                                                                 GDHC0021CHR / Published DEC 2012
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Venezuela                                                       © GlobalData. This report is a licensed product and is not to be copied,
                                                                                              reproduced, shared or resold in any form
Figure 1: Pharmaceutical Market ($bn), Venezuela, 2006-2011

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                       Source: GlobalData; CIFAR, 2007; RNV, 2012

                       Table 1:      Pharmaceutical Market ($bn), Venezuela, 2006-2011
                       Year                            2006         2007   2008           2009            2010            2011
                       Revenue
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                       Source: GlobalData; CIFAR, 2007; RNV, 2012

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Venezuela                                                                     © GlobalData. This report is a licensed product and is not to be copied,
                                                                                                            reproduced, shared or resold in any form
Figure 2: Pharmaceutical Market ($bn), Venezuela, Forecast, 2012-2020

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                       Table 2:
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                       Source: GlobalData; CIFAR, 2007; RNV, 2012

                                     Pharmaceutical Market ($bn), Venezuela, Forecast, 2012-2020
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                       Year                 2012       2013         2014   2015   2016       2017       2018        2019       2020
                       Revenue
                       Source: GlobalData; CIFAR, 2007; RNV, 2012
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                                                                                                                    GDHC0021CHR / Published DEC 2012
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Venezuela                                                                          © GlobalData. This report is a licensed product and is not to be copied,
                                                                                                                 reproduced, shared or resold in any form
3.1.2       Supply Channels

                       Figure 3: Distribution Channels, Venezuela, 2011

                                                                 Public Manufacturer /
                                                                                                                     Private Manufacturer
                                                                        SEFAR

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                                                  Public Hospitals /          Farmapatria / National
                                                                                                                                 Wholesaler / Distributor
                                                       Clinics                 Pharmacy Network

                             Public Hospitals /
                                  Clinics                   PL
                                                         Retail Pharmacy
                                                                                         Private Hospitals /
                                                                                               Clinics
                                                                                                                      Public Hospitals /
                                                                                                                           Clinics
                                                                                                                                                     Retail Pharmacy
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                                                                                         Consumer / Patient

                       Source: GlobalData; CIFAR, 2012a

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Venezuela                                                                                                      © GlobalData. This report is a licensed product and is not to be copied,
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3.1.3     Market Segments
                     3.1.3.1    Generic Drugs

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                                                                                       GDHC0021CHR / Published DEC 2012
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Venezuela                                             © GlobalData. This report is a licensed product and is not to be copied,
                                                                                    reproduced, shared or resold in any form
Table 3 shows the drugs going off patent globally, which will be an opportunity for Venezuelan
                     pharmaceutical manufacturers to export generic drugs into the global market.

                       Table 3:      Drugs Going Off-patent, Revenues ($bn), Global, 2011-2015
                       Company              Drug         Indication             Patent Expiration                          2010 Sales ($m)

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                       Source: GlobalData, Pharma eTrack [Accessed September 21, 2012]

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Venezuela                                                                                  © GlobalData. This report is a licensed product and is not to be copied,
                                                                                                                         reproduced, shared or resold in any form
7       Appendix
                     7.1     Abbreviations
                     AD        :        Accion Democratica (Democratic Action)

                     AIDS      :        Acquired Immunity Deficiency Syndrome
                     AML       :        Acute Myeloid Leukemia
                     ANC       :        Asamblea Nacional Constituyente (National Constituent Assembly)
                     ASM       :        Aggressive Systemic Mastocytosis

                     AVEDEM:            Asociación Venezolana de Distribuidores de Equipos Médicos, Odontológicos, de
                                        Laboratorios y Afines (Venezuelan Association of Distributors of Medical Equipment,

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                                        Dental Laboratories and Allied)
                     BMS       :        Bristol-Myers Squibb
                     CAGR      :        Compound Annual Growth Rate

                     CAMESIP:           Cámara de Medicamentos Sin Prescripción (Chamber of Non-prescription Medicines)
                     CAREM :

                     CAT
                     CAV
                     CAVEFAR:

                     CAVEME:
                     CDI
                               :
                               :

                               :
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                                        Integración de las Áreas Cardiovascular, Renal y Endocrino-Metabólica (Integration of
                                        the Areas Cardiovascular, Renal and Endocrine-Metabolic)
                                        Centros de Alta Tecnología (High Technology Centers)
                                        Cámara de Aseguradores de Venezuela (Venezuelan Insurance Chamber)
                                        Camara Venezolana de Farmacia (Venezuelan Chamber of Pharmacy)

                                        Camara Venezolana del Medicamento (Venezuelan Chamber of Medicine)
                                        Centros de Diagnóstico Integral (Integral Diagnostic Centers)
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                     CDM       :        Clean Development Mechanism
                     CDs       :        Compact Discs
                     CEDIMED:           Centro de Información de Medicamentos (Drug Information Center)

                     CIDP      :        Chronic Inflammatory Demyelinating Polyneuropathy
                     CIFAR :            Camara de la Industria Farmacéutica (Chamber of Pharmaceutical Industry)
SA

                     CIU       :        Chronic Idiopathic Urticaria
                     CNE       :        Consejo Nacional Electoral (National Electoral Council)
                     CNS       :        Central Nervous System
                     CNV       :        Choroidal Neovascularization

                     CONMED:            Consejo nacional del Medicamento (National Drug Council)
                     COPD      :        Chronic Obstructive Pulmonary Disease
                     COPEI :            Comite Organizador Politico por Elecciones Independientes (Christian Democrats)
                     CPI       :        Consumer Price Index
                     CR        :        La Causa Radical (Radical Cause)
                     CRS       :        Congressional Research Service
                     CT        :        Computed Tomography Scanner
                     CTN       :        Comité Terapéutico Nacional (National Drug Committee)
                     DALY      :        Disability Adjusted Life Years

                                                                                                                    GDHC0021CHR / Published DEC 2012
Healthcare, Regulatory and Reimbursement Landscape                                                                                                Page 135
Venezuela                                                                          © GlobalData. This report is a licensed product and is not to be copied,
                                                                                                                 reproduced, shared or resold in any form
DEA       :        Drug Enforcement Administration
                     DHHS      :        Department of Health and Human Services
                     EU        :        European Union

                     FDI       :        Foreign Direct Investments
                     FTA       :        Free Trade Agreement
                     GCI       :        Global Competitiveness Index
                     GDP       :        Gross Domestic Product
                     GNI       :        Gross National Income
                     GSK       :        GlaxoSmithKline

                                                                                 E
                     HCC       :        Hepatocellular Carcinoma
                     IMF       :        International Monitory Fund
                     Inass     :        Nacional de Servicios Sociales (National Institute of Social Services)
                     INE       :        Instituto Nacional de Estadistica (Department of Statistics)
                     INH

                     INHRR :

                     IPASME :

                     IPSFA
                               :

                               :
                                                     PL
                                        Instituto Nacional de Higiene (National Institute of Hygiene)

                                        Instituto Nacional de Higiene Rafael Rangel (National Institute of Hygiene Rafael
                                        Rangel)
                                        Instituto de Previsión y Asistencia Social del Ministerio de Educación, Cultura y
                                        Deportes (Institute of Welfare and Social Assistance, Ministry of Education, Culture and
                                        Sports)
                                        Instituto de Previsión Social de las Fuerzas Armadas (Social Welfare Institute of the
                                        Armed Forces)
                             M
                     IVSS      :        Instituto Venezolano de los Seguros Sociales (State Health Directorates and Social
                                        Development, the Venezuelan Institute of Social Security)
                     JRPF      :        Junta Revisora de Productos Farmacéuticos (Pharmaceutical Review Board)
                     JV        :        Joint Venture

                     LME       :        Lista de Medicamentos Esenciales (List of Essential Drugs)
SA

                     LOS       :        Ley Orgánica de Salud (Organic Health Law)
                     LOSSS :            Ley Orgánica del Sistema de Seguridad Social (Law for Social Security System)
                     MAS       :        Movimiento al Socialismo (Movement to Socialism)
                     MCIT      :        Ministerio de Comercio, Industria y Turismo (Ministry of Commerce, Industry and
                                        Tourism)
                     ME        :        Macular Edema
                     MNCs      :        Multinational Companies
                     MPPS      :        Ministerio del Poder Popular para la Salud (Ministry for People's Power for Health)
                     MRI       :        Magnetic Resonance Imaging Machine
                     MUD       :        Mesa de Unidad Democrática (Democratic Unity Table)
                     N/A       :        Not Applicable
                     NIBR      :        Novartis Institutes for Biomedical Research
                     NIDWMR:            Novartis Institute for Medical Research in the Developing World

                                                                                                                     GDHC0021CHR / Published DEC 2012
Healthcare, Regulatory and Reimbursement Landscape                                                                                                 Page 136
Venezuela                                                                           © GlobalData. This report is a licensed product and is not to be copied,
                                                                                                                  reproduced, shared or resold in any form
NMEs      :        New Molecular Entities
                     NRC       :        National Research Council
                     NTDs      :        Neglected Tropical Diseases

                     NVGH      :        Novartis Vaccine Institute for Global Health
                     OHH       :        Obese Hypogonadotropic Hypogonadism
                     OICEMP :           Oficina de Inscripcion Control de Equipos Medicos y Para Medicos (Office of
                                        Registration and Control for Medical and Paramedical Equipment and Supplies)
                     OPEC      :        Organization of the Petroleum Exporting Countries
                     OTC       :        Over-the-Counter

                                                                                  E
                     PAHO/WHO:          Pan-American Health Organization
                     PCV       :        Partido Comunista de Venezuela (Communist Party of Venezuela)
                     PD-LID :           Parkinson‟s Disease L-dopa Induced Dyskinesia
                     PDVSA :            Petróleos de Venezuela
                     PJ

                     PNANNA:

                     PPT
                     PSUV
                     R&D
                     SAPI
                               :

                               :
                               :
                               :
                               :
                                                     PL
                                        Primero Justicia (First Justice)

                                        Programa Nacional de Atención Integral del Niño, Niña y Adolescente (Health Program
                                        of Children and Adolescents)
                                        Patria Para Todos (Fatherland for All)
                                        Partido Socialista Unido de Venezuela (United Socialist Party of Venezuela)
                                        Research and Development
                                        Servicio Autónomo de la Propiedad Intelectual (Autonomous Service of Intellectual
                                        Property)
                             M
                     SEFAR :            Servicio Autónomo de Elaboraciones Farmacéuticas (Autonomous Service of
                                        Pharmaceutical Elaborations)
                     SITME :            Sistema de Transacciones con Títulos en Moneda Extranjera (Transaction System for
                                        Foreign Currency Denominated Securities)
                     SJIA      :        Systemic-onset Juvenile Idiopathic Arthritis
SA

                     SPNS      :        Sistema Público Nacional de Salud (National Public Health System)
                     SRI       :        Salas de Rehabilitación Integral (Integral Rehabilitation Facilities)
                     TRIPS     :        Trade Related Aspects of Intellectual Property Rights
                     TSU       :        Therapeutic Strategic Units
                     UNESCO:            United Nations Educational, Scientific and Cultural Organization

                     UNFCCC:            United Nations Framework Convention on Climate Change
                     UNT       :        Un Nuevo Tiempo (A New Time)
                     URMM :             Unidad de Recepción de Muestras de Medicamentos (Reception of Unit Drug Samples)
                     USAID :            US Agency for International Development
                     VAT       :        Value Added Tax
                     VEF       :        Venezuelan Bolivar Furete (Strong Bolivar)

                     VP        :        Voluntad Popular (Popular Will)
                     WHO       :        World Health Organization

                                                                                                                        GDHC0021CHR / Published DEC 2012
Healthcare, Regulatory and Reimbursement Landscape                                                                                                    Page 137
Venezuela                                                                              © GlobalData. This report is a licensed product and is not to be copied,
                                                                                                                     reproduced, shared or resold in any form
WIPO      :        World Intellectual Property Organization
                     WTO       :        World Trade Organization

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                                                                                                                  reproduced, shared or resold in any form
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