Post on 26-Feb-2020
REFERENCE CODE GDHC0070CHR | PUBLICATION DATE SEPTEMBER 2014
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –VENEZUELA
Healthcare, Regulatory and Reimbursement Landscape –Venezuela 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 –VENEZUELA
Executive Summary
Government initiatives and an increasingly elderly population have driven the growth of the healthcare market, but growth depends on the resolution of concerns over inefficient patent protection laws, drug pricing policy, and dependency on imports.
In 2003, the government launched the Inside the
Neighborhood Mission (Misión Barrio Adentro),
which it hoped would increase the efficiency of the
healthcare system (see Section 6.1.3.). In 2009, it
invested VEF28 billion ($XX billion) in an
Autonomous Service of Pharmaceutical
Elaborations (Servicio Autónomo de Elaboraciones
Farmacéuticas, SEFAR) production plant, which
provides medicines at a cheaper rate than private
pharmaceutical manufacturers (MPPCI, 2009).
These initiatives are expected to drive the
Venezuelan pharmaceutical market. Furthermore,
in May 2012, the government launched a chain of
pharmacy stores named National pharmacy
network (Farmapatria) which sell medicines
covering XX% of the most common diseases at a
discount of up to XX% (Venezuela Analysis, 2012;
Arsenal Terapéutico, 2012).
The pharmaceutical market was valued at
approximately $XX billion in 2008 and $XX billion
in 2013, having grown at a Compound Annual
Growth Rate (CAGR) of XX%. It is estimated to
reach $XX billion in 2020 at a CAGR of XX% from
2014 (CIFAR, 2007; CIFAR, 2012). The estimated
drop in the growth rate is due to the frequent
devaluation of the Venezuelan bolívar (from
VEF4.3 per US dollar to VEF6.3 per US dollar in
February 2013) and shortages of drugs in
pharmacies. Due to currency devaluation, the
value of the pharmaceutical market will be less in
US dollar terms than in local currency terms.
In 2008, Venezuela reinstated the “Industrial
Property Law of 1955”, which prevents the patent
of medicines and food. This step will prove to be a
challenge for manufacturers of branded drugs
operating in Venezuela.
In 2003, the government imposed a price
regulation for essential medicines (classified
according to the criteria of the World Health
Organization (WHO)). In November 2011, the Fair
Price Law (Ley de Costos y Precios Justos) was
introduced to regulate the prices of products and
profits (to a maximum of XX%) in the
pharmaceutical industry. These price freezes are
likely to negatively affect pharmaceutical
companies.
The supply of pharmaceuticals is heavily
dependent on imports. The pharmaceutical imports
market grew at a CAGR of XX% from 2008 to 2013
(ITC, 2014). Furthermore, pharmacies face a
shortage of essential medicines due to short
supplies, despite the efforts of the government.
The imports of pharmaceutical products are
anticipated to increase due to the inefficient and
non-favorable domestic healthcare market.
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –VENEZUELA
Executive Summary
The elderly population accounted for XX% of the
total Venezuelan population in 2013, which is
expected to rise to XX% in 2020. The chronic
conditions associated with changes in lifestyle and
increasing population are the primary drivers for
the pharmaceutical market.
Pharmaceutical Market, Venezuela, Revenue ($bn), 2008–2020
2008 2013 2015 2020
Rev
enue
($b
n)
CAGR (2008–2020): XX%
Source: CIFAR, 2007; CIFAR, 2012
The medical device market is mainly dependent on
imported products. The US is the major supplier for
medical devices. However, Cuba, Mexico and
Brazil have replaced some of these US exporters.
Disposable healthcare items such as syringes,
surgical cloths and hospital furniture are
manufactured domestically (US Commercial
Service, 2011).
Lack of clarity and transparency in regulatory system and language barriers in the drug approval application process are challenges for foreign multinational companies when registering new drugs
The Rafael Rangel National Institute of Hygiene
(Instituto Nacional de Higiene Rafael Rangel,
INHRR) is the main regulatory authority for
pharmaceutical products, working under the
guidance of the People’s Power Ministry for Health
(Ministerio del Poder Popular para la Salud,
MPPS). The Pharmaceutical Review Board (Junta
Revisora de Productos Farmacéuticos, JRPF)
works under the INHRR and MPPS. The JRPF is
an advisor to the MPPS on matters related to the
effective and ongoing monitoring of registration,
promotion, dispensing, sale, pharmacovigilance
and clinical trials of drugs (INHRR, 2014a).
According to the established procedures, the time
for the approval of a new drug is XX days. For
generic drugs, it is XX days. However, lack of
clarity in the regulatory system and language
barriers when applications and documents are
required to be submitted in Spanish make the drug
approval process a major challenge for foreign
Multi-National Companies (MNC) (CIFAR, 2014b).
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Table of Contents
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –VENEZUELA
1 Table of Contents
1 Table of Contents ....................................................................................................................... 6
1.1 List of Tables .................................................................................................................... 10
1.2 List of Figures ................................................................................................................... 13
2 Introduction ............................................................................................................................... 16
2.1 GlobalData Report Guidance ............................................................................................ 16
3 Overview of Pharmaceutical and Medical Device Market .......................................................... 17
3.1 Pharmaceutical Market ..................................................................................................... 17
3.1.1 Market Overview ........................................................................................................... 17
3.1.2 Pharmaceutical Exports and Imports ............................................................................. 20
3.1.3 Supply Channels ........................................................................................................... 22
3.1.4 Market Segments .......................................................................................................... 22
3.1.5 Overview of Major Disease Areas ................................................................................. 24
3.1.6 Major Players ................................................................................................................ 26
3.2 Medical Device Market ...................................................................................................... 63
3.2.1 Market Overview ........................................................................................................... 63
3.3 Market Drivers and Barriers .............................................................................................. 63
3.3.1 Drivers........................................................................................................................... 63
3.3.2 Barriers ......................................................................................................................... 64
4 Market Access .......................................................................................................................... 67
4.1 Reimbursement and Payer Landscape ............................................................................. 67
4.1.1 Overview of Healthcare system ..................................................................................... 67
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –VENEZUELA
4.1.2 Reimbursement Process ............................................................................................... 71
4.1.3 Overview of Insurance Providers ................................................................................... 73
4.1.4 Patient Share in Healthcare Spending ........................................................................... 74
4.1.5 Price Trends in the Healthcare Sector ........................................................................... 75
4.1.6 Pricing Policies .............................................................................................................. 77
4.2 Regulatory Landscape ...................................................................................................... 77
4.2.1 Overview of Regulatory Agencies.................................................................................. 77
4.2.2 Market Authorization Procedure for Pharmaceutical Products ....................................... 78
4.2.3 New Medical Device Approval Process ......................................................................... 80
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing .................... 80
4.2.5 Exports and Imports ...................................................................................................... 81
4.2.6 Intellectual Property Rights............................................................................................ 82
4.2.7 Clinical Trial Regulations ............................................................................................... 90
4.2.8 Pharmaceutical Advertising Regulations ....................................................................... 92
4.2.9 Pharmacy Regulations .................................................................................................. 93
4.2.10 Labeling and Packaging Regulations ............................................................................ 95
5 Country Analysis ....................................................................................................................... 98
5.1 Political Environment......................................................................................................... 98
5.1.1 Political Structure .......................................................................................................... 98
5.1.2 Analysis of Current Political Environment ...................................................................... 99
5.1.3 Healthcare Policy Initiatives ......................................................................................... 101
5.2 Economic Landscape ...................................................................................................... 102
5.3 Economic Indicators ........................................................................................................ 105
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Table of Contents
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –VENEZUELA
5.3.1 Gross Domestic Product ............................................................................................. 105
5.3.2 Gross National Income ................................................................................................ 110
5.3.3 Inflation ....................................................................................................................... 111
5.3.4 Currency Exchange Rate ............................................................................................ 116
5.3.5 Foreign Direct Investment ........................................................................................... 118
5.3.6 Foreign Exchange Reserves ....................................................................................... 119
5.3.7 Trade Balance ............................................................................................................. 121
5.3.8 Government Structural Balance................................................................................... 123
5.3.9 Government Gross Debt ............................................................................................. 124
5.3.10 Major Industries ........................................................................................................... 126
5.4 Demographics ................................................................................................................. 127
5.4.1 Population ................................................................................................................... 127
5.4.2 Education and Literacy ................................................................................................ 147
5.4.3 Employment ................................................................................................................ 149
5.4.4 Disease Burden ........................................................................................................... 150
5.5 Healthcare Infrastructure ................................................................................................. 152
5.5.1 Healthcare Facilities .................................................................................................... 152
5.5.2 Healthcare Parameters ............................................................................................... 159
5.5.3 Environmental Health .................................................................................................. 161
5.5.4 Healthcare Personnel .................................................................................................. 166
5.6 Healthcare Expenditure ................................................................................................... 167
5.6.1 Overview ..................................................................................................................... 167
5.6.2 Share of Public and Private Sectors ............................................................................ 169
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5.6.3 Major Components of Healthcare Spending ................................................................ 170
5.6.4 Spending in Pharmaceutical R&D ............................................................................... 171
5.7 Trade Associations ......................................................................................................... 171
5.7.1 Venezuelan Chamber of Medicine ............................................................................... 171
5.7.2 Chamber of Pharmaceutical Industry .......................................................................... 171
5.7.3 Chamber of Non-prescription Medicines ...................................................................... 171
5.7.4 Venezuelan Association of Distributors of Medical Equipment, Dental Laboratories and
Related Products ........................................................................................................ 172
5.7.5 Venezuelan Chamber of Pharmacy ............................................................................. 172
6 Opportunities and Challenges ................................................................................................. 173
6.1 Opportunities .................................................................................................................. 173
6.2 Challenges ...................................................................................................................... 174
7 Appendix................................................................................................................................. 176
7.1 Abbreviations .................................................................................................................. 176
7.2 Bibliography .................................................................................................................... 181
7.3 Research Methodology ................................................................................................... 198
7.3.1 Coverage .................................................................................................................... 198
7.3.2 Secondary Research ................................................................................................... 199
7.3.3 Forecasts .................................................................................................................... 199
7.3.4 Expert Panel................................................................................................................ 199
7.4 Disclaimer ....................................................................................................................... 200
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –VENEZUELA
1.1 List of Tables
Table 1: Pharmaceutical Market, Venezuela, Revenue ($bn), 2008–2013 ...................................................... 19
Table 2: Pharmaceutical Market, Venezuela, Revenue Forecast ($bn), 2014–2020 ....................................... 20
Table 3: Pharmaceutical Market, Venezuela, Exports and Imports ($m), 2008–2013 ...................................... 21
Table 4: Pharmaceutical Market, Pfizer, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013
...................................................................................................................................................... 27
Table 5: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2014 .................................................... 28
Table 6: Pharmaceutical Market, GlaxoSmithKline, Global, Major Products, Revenue ($bn) and Annual Growth
(%), 2013 ....................................................................................................................................... 35
Table 7: Pharmaceutical Market, GlaxoSmithKline, Global, Late-Stage Pipeline, 2014 ................................... 36
Table 8: Pharmaceutical Market, Sanofi, Global, Major Products, Revenue ($bn), 2013 ................................. 44
Table 9: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, 2014.................................................... 45
Table 10: Pharmaceutical Market, Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%),
2013 .............................................................................................................................................. 50
Table 11: Pharmaceutical Market, Novartis, Global, Planned Filings, 2014≥2018 ........................................... 51
Table 12: Pharmaceutical Market, Grupo Farma, Major Products, 2014 ......................................................... 60
Table 13: Healthcare Spending, Venezuela, Out-of-Pocket Expenditure (%), 2008–2013 ............................... 75
Table 14: Market Access, Price of Healthcare Products, Venezuela, Change in Average Price of Medicines
(%), 2009–2013 ............................................................................................................................. 76
Table 15: Economic Indicators, Venezuela, Gross Domestic Product per Capita ($), 2008–2013 ................. 106
Table 16: Economic Indicators, Venezuela, Gross Domestic Product per Capita ($), Forecast, 2014–2020 .. 107
Table 17: Economic Indicators, Venezuela, Gross Domestic Product Annual Growth (%), 2008–2013 ......... 108
Table 18: Economic Indicators, Venezuela, Gross Domestic Product Annual Growth (%), Forecast, 2014–2020
.................................................................................................................................................... 109
Table 19: Economic Indicators, Venezuela, Gross National Income per Capita ($), 2008–2013 .................... 111
Table 20: Economic Indicators, Venezuela, Average Consumer Price Index, 2008–2013 ............................. 112
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Table 21: Economic Indicators, Venezuela, Average Consumer Price Index, Forecast, 2014–2020 .............. 113
Table 22: Economic Indicators, Venezuela, Average Consumer Price Index Annual Change (%), 2008–2013
.................................................................................................................................................... 115
Table 23: Economic Indicators, Venezuela, Average Consumer Price Index, Annual Change (%), Forecast,
2014–2020 .................................................................................................................................. 116
Table 24: Economic Indicators, Venezuela, Currency Exchange Rate (VEF/$), 2008–2013.......................... 117
Table 25: Economic Indicators, Venezuela, Foreign Direct Investment ($m), 2008–2013 ............................. 119
Table 26: Economic Indicators, Venezuela, Foreign Exchange Reserves ($bn), 2008–2013 ........................ 120
Table 27: Economic Indicators, Venezuela, Imports of Goods and Services ($m), 2008–2013...................... 122
Table 28: Economic Indicators, Venezuela, Exports of Goods and Services ($m), 2008–2013 ..................... 123
Table 29: Economic Indicators, Venezuela, General Government Structural Balance ($bn), 2008–2013 ...... 124
Table 30: Economic Indicators, Venezuela, General Government Gross Debt ($bn), 2008–2013 ................. 125
Table 31: Economic Indicators, Venezuela, Major Industries, Industrial Sector, Gross Value Added ($bn),
2008–2009 .................................................................................................................................. 127
Table 32: Demographics, Venezuela, Population (million), 2008–2013 ......................................................... 128
Table 33: Demographics, Venezuela, Population Forecast (million), 2014–2020 .......................................... 129
Table 34: Demographics, Venezuela, Population, Urban and Rural Population Share (%), 2008–2013 ........ 130
Table 35: Demographics, Venezuela, Population, Urban and Rural Population Forecast Share (%), 2014–2020
.................................................................................................................................................... 131
Table 36: Demographics, Venezuela, Population Distribution by Age Group (%), 2008–2013 ....................... 133
Table 37: Demographics, Venezuela, Population Distribution by Age Group Forecast (%), 2014–2020 ........ 134
Table 38: Demographics, Venezuela, Births (per 1,000 Population), 2008–2013 .......................................... 135
Table 39: Demographics, Venezuela, Mortality (per 1,000 Population), 2008–2013 ...................................... 136
Table 40: Demographics, Venezuela, Major Causes of Mortality (‘000), 2008 ............................................... 138
Table 41: Demographics, Venezuela, Children < Five Mortality Rate (per 1,000 Live Births), 2008–2013 ..... 139
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Table 42: Demographics, Venezuela, Immunization Rate (%), 2008–2013 ................................................... 141
Table 43: Demographics, Venezuela, Major Causes of Male Mortality (‘000), 2008 ...................................... 142
Table 44: Demographics, Venezuela, Major Causes of Female Mortality (‘000), 2008 .................................. 143
Table 45: Demographics, Venezuela, Gender Ratio (M/F), 2008–2013 ........................................................ 145
Table 46: Demographics, Venezuela, Life Expectancy at Birth (Years), 2008–2013 ..................................... 146
Table 47: Demographics, Venezuela, Student Enrollment by Level of Education (%), 2008–2013 ................ 148
Table 48: Demographics, Venezuela, Unemployment Rate (%), 2008–2013 ................................................ 150
Table 49: Demographics, Venezuela, Major Diseases, DALYs (per 100,000 Population), 2004 .................... 151
Table 50: Healthcare Infrastructure, Venezuela, Public Hospitals, 2008–2013 .............................................. 154
Table 51: Healthcare Infrastructure, Venezuela, Health System by Level of Care (%), 2010 ......................... 156
Table 52: Healthcare Infrastructure, Venezuela, Urban and Rural Healthcare Facilities, 2008 and 2010 ....... 157
Table 53: Healthcare Infrastructure, Venezuela, Diagnostic Facilities, 2008–2013 ........................................ 159
Table 54: Healthcare Infrastructure, Venezuela, Hospitals Beds (per 1,000 Population), 2008–2013 ............ 160
Table 55: Healthcare Infrastructure, Venezuela, Physicians (per 10,000 Population), 2008–2013 ................ 161
Table 56: Healthcare Infrastructure, Venezuela, Environmental Attributable Deaths per 100,000 Population,
2004 ............................................................................................................................................ 162
Table 57: Healthcare Infrastructure, Venezuela, PM10 (µg/m³), 2008–2013 ................................................. 163
Table 58: Healthcare Infrastructure, Venezuela, CO2 Emissions (Million Metric Tons), 2008–2013 ............... 165
Table 59: Healthcare Infrastructure, Venezuela, Nurses (per 10,000 Population), 2008–2013 ...................... 166
Table 60: Healthcare Infrastructure, Venezuela, Dentists (per 10,000 Population), 2008–2013..................... 167
Table 61: Healthcare Infrastructure, Venezuela, Healthcare Expenditure (% of GDP), 2008–2013 ............... 168
Table 62: Healthcare Infrastructure, Venezuela, Public-Private Share (%), 2008–2013 ................................ 170
Table 63: Healthcare Infrastructure, Venezuela, Major Components of Healthcare Spending (%), 2012 ....... 170
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –VENEZUELA
1.2 List of Figures
Figure 1: Pharmaceutical Market, Venezuela, Revenue ($bn), 2008–2013 ..................................................... 19
Figure 2: Pharmaceutical Market, Venezuela, Revenue Forecast ($bn), 2014–2020 ...................................... 20
Figure 3: Pharmaceutical Market, Venezuela, Exports and Imports ($m), 2008–2013 ..................................... 21
Figure 4: Healthcare Market, Venezuela, Drivers and Barriers, 2014 .............................................................. 66
Figure 5: Market Access, Venezuela, Healthcare System, 2014 ..................................................................... 70
Figure 6: Healthcare Spending, Venezuela, Out-of-Pocket Expenditure (%), 2008–2013................................ 75
Figure 7: Market Access, Price of Healthcare Products, Venezuela, Change in Average Price of Medicines (%),
2009–2013 ................................................................................................................................... 76
Figure 8: Market Access, Approval Process for New Drugs, Venezuela, 2014 ................................................ 79
Figure 9: Market Access, Venezuela, Patent Approval Process, 2014 ............................................................ 85
Figure 10: Market Access, Venezuela, Trademark Approval Process, 2014 ................................................... 89
Figure 11: Market Access, Venezuela, Clinical Trial Approval Process, 2014 ................................................. 91
Figure 12: Economic Indicators, Venezuela, Gross Domestic Product per Capita ($), 2008–2013 ................ 106
Figure 13: Economic Indicators, Venezuela, Gross Domestic Product per Capita ($), Forecast, 2014–2020 . 107
Figure 14: Economic Indicators, Venezuela, Gross Domestic Product Annual Growth (%), 2008–2013 ........ 108
Figure 15: Economic Indicators, Venezuela, Gross Domestic Product Annual Growth (%), Forecast, 2014–
2020 ........................................................................................................................................... 109
Figure 16: Economic Indicators, Venezuela, Gross National Income per Capita ($), 2008–2013 ................... 110
Figure 17: Economic Indicators, Venezuela, Average Consumer Price Index, 2008–2013 ............................ 112
Figure 18: Economic Indicators, Venezuela, Average Consumer Price Index, Forecast, 2014–2020 ............ 113
Figure 19: Economic Indicators, Venezuela, Average Consumer Price Index, Annual Change (%), 2008–2013
.................................................................................................................................................. 115
Figure 20: Economic Indicators, Venezuela, Average Consumer Price Index, Annual Change (%), Forecast,
2014–2020 ................................................................................................................................. 116
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Figure 21: Economic Indicators, Venezuela, Currency Exchange Rate (VEF/$), 2008–2013 ........................ 117
Figure 22: Economic Indicators, Venezuela, Foreign Direct Investment ($m), 2008–2013 ............................ 119
Figure 23: Economic Indicators, Venezuela, Foreign Exchange Reserves ($bn), 2008–2013 ....................... 120
Figure 24: Economic Indicators, Venezuela, Imports of Goods and Services ($m), 2008–2013 .................... 121
Figure 25: Economic Indicators, Venezuela, Exports of Goods and Services ($m), 2008–2013 .................... 122
Figure 26: Economic Indicators, Venezuela, Government Structural Balance ($bn), 2008–2013 ................... 124
Figure 27: Economic Indicators, Venezuela, General Government Gross Debt ($bn), 2008–2013 ................ 125
Figure 28: Economic Indicators, Venezuela, Major Industries, Industrial Sector, Gross Value Added ($bn),
2008–2009 ................................................................................................................................. 126
Figure 29: Demographics, Venezuela, Population (million), 2008–2013 ....................................................... 128
Figure 30: Demographics, Venezuela, Population Forecast (million), 2014–2020 ......................................... 129
Figure 31: Demographics, Venezuela, Population, Urban and Rural Population Share (%), 2008–2013 ....... 130
Figure 32: Demographics, Venezuela, Population, Urban and Rural Population Share Forecast (%), 2014–
2020 ........................................................................................................................................... 131
Figure 33: Demographics, Venezuela, Population Distribution by Age Group (%), 2008–2013...................... 133
Figure 34: Demographics, Venezuela, Population Distribution by Age Group Forecast (%), 2014–2020 ....... 134
Figure 35: Demographics, Venezuela, Births (per 1,000 Population), 2008–2013 ......................................... 135
Figure 36: Demographics, Venezuela, Mortality (per 1,000 Population), 2008–2013 ..................................... 136
Figure 37: Demographics, Venezuela, Major Causes of Mortality (‘000), 2008 ............................................. 137
Figure 38: Demographics, Venezuela, Children < Five Mortality Rate (per 1,000 Live Births), 2008–2013 .... 139
Figure 39: Demographics, Venezuela, Immunization Rate (%), 2008–2013 .................................................. 140
Figure 40: Demographics, Venezuela, Major Causes of Male Mortality (‘000), 2008 ..................................... 142
Figure 41: Demographics, Venezuela, Major Causes of Female Mortality (‘000), 2008 ................................. 143
Figure 42: Demographics, Venezuela, Gender Ratio (M/F), 2008–2013 ....................................................... 145
Figure 43: Demographics, Venezuela, Life Expectancy at Birth (Years), 2008–2013 .................................... 146
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Figure 44: Demographics, Venezuela, Student Enrollment by Level of Education (%), 2008–2013 ............... 148
Figure 45: Demographics, Venezuela, Unemployment Rate (%), 2008–2013 ............................................... 149
Figure 46: Demographics, Venezuela, Major Diseases, DALYs (per 100,000 Population), 2004 ................... 151
Figure 47: Healthcare Infrastructure, Venezuela, Public Hospitals, 2008–2013 ............................................ 154
Figure 48: Healthcare Infrastructure, Venezuela, Health System by Level of Care (%), 2010 ........................ 156
Figure 49: Healthcare Infrastructure, Venezuela, Urban and Rural Healthcare Facilities, 2008 and 2010 ...... 157
Figure 50: Healthcare Infrastructure, Venezuela, Diagnostic Facilities, 2008–2013 ...................................... 158
Figure 51: Healthcare Infrastructure, Venezuela, Hospitals Beds (per 1,000 Population), 2008–2013 ........... 159
Figure 52: Healthcare Infrastructure, Venezuela, Physicians (per 10,000 Population), 2008–2013 ............... 160
Figure 53: Healthcare Infrastructure, Venezuela, Environmental Attributable Deaths (per 100,000 Population),
2004 ........................................................................................................................................... 162
Figure 54: Healthcare Infrastructure, Venezuela, PM10 (µg/m³), 2008–2013 ................................................ 163
Figure 55: Healthcare Infrastructure, Venezuela, CO2 Emissions (Million Metric Tons), 2008–2013 .............. 165
Figure 56: Healthcare Infrastructure, Venezuela, Nurses (per 10,000 Population), 2008–2013 ..................... 166
Figure 57: Healthcare Infrastructure, Venezuela, Dentists (per 10,000 Population), 2008–2013 ................... 167
Figure 58: Healthcare Infrastructure, Venezuela, Healthcare Expenditure (% of GDP), 2008–2013 .............. 168
Figure 59: Healthcare Infrastructure, Venezuela, Public-Private Share (%), 2008–2013 ............................... 169
Figure 60: Healthcare Infrastructure, Venezuela, Share of Expenditure of Major Components of Healthcare
Spending (%), 2012 .................................................................................................................... 170
Figure 61: Healthcare Market, Venezuela, Opportunities and Challenges, 2014 ........................................... 175
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HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –VENEZUELA
Introduction
2 Introduction
2.1 GlobalData Report Guidance
The report begins with an executive summary, which provides an overview of the healthcare
market in Venezuela and the key factors driving its development. It also includes a snapshot of
the country’s demographic, regulatory, and reimbursement landscape, as well as its healthcare
infrastructure.
Chapter three provides an overview of the pharmaceutical and medical device markets in
Venezuela, covering the following parameters: market size; generic, Over-the-Counter (OTC)
and biologic/biosimilar product shares; and key drivers and barriers. It also includes profiles of
the major players in the country’s healthcare market, as well as SWOT assessments for each
player.
Chapter four covers the reimbursement and payer landscape and provides details of the
reimbursement process, insurance providers, pricing policies and drug price trends in
Venezuela. It also looks at the regulatory landscape and provides an overview of the regulatory
agencies and approval processes for new drugs and medical devices. In addition, this chapter
covers the licensing process for the manufacture, export and import of pharmaceuticals; details
the regulations in place for pharmaceutical advertising, labeling, packaging, and clinical trials;
and provides an overview of the country’s legal framework for intellectual property rights.
Chapter five provides detailed analysis of the political and economic environment in
Venezuela, as well as economic indicators, demographics, and healthcare infrastructure and
expenditure.
Chapter six provides an overview of the opportunities and challenges in the healthcare market.
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Country Analysis
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –VENEZUELA
5.6.2 Share of Public and Private Sectors
The share of the public sector in overall healthcare expenditure decreased from approximately
XX% in 2008 to an estimated XX% in 2013. The private sector’s share in the overall healthcare
expenditure increased from XX% in 2008 to an estimated XX% in 2013. The decrease in the public
share from 2008 to 2013 showed the government’s lack of interest in the healthcare sector. The
private sector’s share is higher than the public’s due to high OOP and the low level of public
healthcare coverage.
Figure 59: Healthcare Infrastructure, Venezuela, Public-Private Share (%), 2008–2013
2008 2009 2010 2011 2012 2013*
Hea
lthca
re e
xpen
ditu
re (%
)
PrivatePublic
Source: World Bank, 2014h
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Country Analysis
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –VENEZUELA
Table 62: Healthcare Infrastructure, Venezuela, Public-Private Share (%), 2008–2013
Year 2008 2009 2010 2011 2012 2013*
Public
Private
Source: World Bank, 2014h *Estimated figure
5.6.3 Major Components of Healthcare Spending
Household OOP expenditure accounted for approximately XX% of total healthcare expenditure in
2012, followed by Ministry of Health expenditure (XX%) and social security funds (XX%). The share
of the private insurance was XX% (WHO, 2014d).
Figure 60: Healthcare Infrastructure, Venezuela, Share of Expenditure of Major Components of Healthcare Spending (%), 2012
OOP expenditure
Ministry of Health
Social security fundsPrivate insurance
Source: WHO, 2014d
Table 63: Healthcare Infrastructure, Venezuela, Major Components of Healthcare Spending (%), 2012 Component Share of expenditure
OOP expenditure
Ministry of Health
Social security funds
Private insurance
Source: WHO, 2014d
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Appendix
HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE –VENEZUELA
7 Appendix
7.1 Abbreviations
µg/m³: microgram per cubic meter
AD: Accion Democratica (Democratic Action)
ALK+: Anaplastic Lymphoma Kinase Positive
ANC: Asamblea Nacional Constituyente (National Constituent Assembly)
ASM: Aggressive Systemic Mastocytosis
ATC: Anatomical Therapeutic Chemical
AVEDEM: Asociación Venezolana de Distribuidores de Equipos Médicos, Odontológicos, de
Laboratorios y Afines (Venezuelan Association of Distributors of Medical
Equipment, Dental Laboratories and Related Projects)
BCV: Banco Central de Venezuela (Central Bank of Venezuela)
BRO: Biotechnology Research Organizations
CAGR: Compound Annual Growth Rate
CAMESIP: Cámara de Medicamentos Sin Prescripción (Chamber of Non-prescription
Medicines)
CANAMEGA: National Chamber of Generic and Related Medicine
CAREM: Integración de las Áreas Cardiovascular, Renal y Endocrino-Metabólica
(Integration of Cardiovascular, Renal and Endocrine-Metabolic Areas)
CAT: Centros de Alta Tecnología (High Technology Centers)
CAVEFAR: Camara Venezolana de Farmacia (Venezuelan Chamber of Pharmacy)
CAVEME: Camara Venezolana del Medicamento (Venezuelan Chamber of Medicine)
CDI: Centros de Diagnóstico Integral (Integral Diagnostic Centers)
CDM: Clean Development Mechanism
CEDIMED: Centro de Información de Medicamentos (Drug Information Center)
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CIFAR: Camara de la Industria Farmacéutica (Chamber of Pharmaceutical Industry)
CNE: Consejo Nacional Electoral (National Electoral Council)
CNS: Central Nervous System
CONMED: Consejo Nacional del Medicamento (National Drug Council)
COPD: Chronic Obstructive Pulmonary Disease
COPEI: Comite Organizador Politico por Elecciones Independientes (Organizing
Committee for Independent Political Elections or Christian Democrats)
CPI: Consumer Price Index
CR: La Causa Radical (Radical Cause)
CRL: Complete Response Letter
CT: Computed Tomography
CTN: Comité Terapéutico Nacional (National Drug Committee)
DALY: Disability Adjusted Life Years
DPT: Diphtheria, Pertussis and Tetanus
DRG: Diagnostic Related Groups
EGFR: Epidermal Growth Factor Receptor
EMAP: Emerging Markets and Asia-Pacific
FDA: Food and Drug Administration
FDI: Foreign Direct Investment
Forex: Foreign exchange
GDP: Gross Domestic Product
GMP: Good Manufacturing Practice
GNI: Gross National Income
GSK: GlaxoSmithKline
HeFH: Heterozygous Familial Hypercholesterolemia
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HTA: Health Technology Assessment
IMF: International Monitory Fund
INASS: Nacional de Servicios Sociales (National Institute of Social Services)
INE: Instituto Nacional de Estadistica (Department of Statistics)
INH: Instituto Nacional de Higiene (National Institute of Hygiene)
INHRR: Instituto Nacional de Higiene Rafael Rangel (Rafael Rangel National Institute of
Hygiene)
IPASME: 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)
IPSFA: Instituto de Previsión Social de las Fuerzas Armadas (Social Welfare Institute of
the Armed Forces)
IVSS: Instituto Venezolano de los Seguros Sociales (State Health Directorates and
Social Development, Venezuelan Institute of Social Security)
JRPF: Junta Revisora de Productos Farmacéuticos (Pharmaceutical Review Board)
LME: Lista de Medicamentos Esenciales (List of Essential Drugs)
LOS: Ley Orgánica de Salud (Organic Health Law)
LOSSS: Ley Orgánica del Sistema de Seguridad Social (Organic Law for Social Security
System)
MAS: Movimiento al Socialismo (Movement to Socialism)
MDD: Medical Device Directives
MNC: Multi-National Company
MPPS: Ministerio del Poder Popular para la Salud (People’s Power Ministry for Health)
MRI: Magnetic Resonance Imaging
MUD: Mesa de Unidad Democrática (Democratic Unity Table)
PM10: particulate matter with an aerodynamic diameter of less than 10 micrometers
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NDA: New Drug Application
NIBR: Novartis Institutes for Biomedical Research
NSCLC: Non-Small-Cell Long Cancer
OA: Osteoarthritis
OAS: Organization of Americas
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
OOP: Out-of-Pocket Payments
OTC: Over-the-Counter
PAHO: Pan-American Health Organization
PCV: Partido Comunista de Venezuela (Communist Party of Venezuela)
PDVSA: Petróleos de Venezuela (Venezuelan Petroleum)
PJ: Primero Justicia (First Justice)
PNANNA: Programa Nacional de Atención Integral del Niño, Niña y Adolescente (Health
Program of Children and Adolescents)
PPT: Patria Para Todos (Fatherland for All)
PSUV: Partido Socialista Unido de Venezuela (United Socialist Party of Venezuela)
SAPI: Servicio Autónomo de la Propiedad Intelectual (Autonomous Service of Intellectual
Property)
SEFAR: Servicio Autónomo de Elaboraciones Farmacéuticas (Autonomous Service of
Pharmaceutical Elaborations)
SENIAT: Servicio Nacional Integrado de Administración Aduanera y Tributaria (National
Integrated Service for the Administration of Customs Duties and Taxes)
SITME: Sistema de Transacciones con Títulos en Moneda Extranjera (Transaction System
for Foreign Currency Denominated Securities)
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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
UNESCO: United Nations Educational, Scientific and Cultural Organization
UNFCCC: United Nations Framework Convention on Climate Change
UNICEF: United Nations Children’s Fund
UNT: Un Nuevo Tiempo (A New Time)
URMM: Unidad de Recepción de Muestras de Medicamentos (Unit for Reception of Drug
Samples)
VAT: Value Added Tax
VEB: Venezuelan Bolivar Fuerte (Venezuelan Strong Bolivar)
VEF: Venezuelan Bolivar
VP: Voluntad Popular (Popular Will)
WHO: World Health Organization
WIPO: World Intellectual Property Organization
WTO: World Trade Organization
Healthcare, Regulatory and Reimbursement Landscape –Venezuela 181 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
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7.2 Bibliography
AEI (2012). The Deadly World of Fake Drugs. American Enterprise Institute. Available from:
http://www.aei.org/files/2012/02/27/-appendix-a-master-2_170026856632.pdf
Alvarado CH, et al. (2008). Social Change and Health Policy in Venezuela. Social Medicine;
3(2): 95–109
ANCA24 (2011). Venezuela: petrochemical industrial complex causes respiratory diseases in
the population. Environmental, Ecologist and Conservationist News from the Americas.
ANCA24. Available from: http://anca24canada.canalazul24.com/?p=135 [Accessed on July 20,
2014]
Arsenal Terapéutico (2012). Venezuela: Farmapatria vende medicinas a mitad de precio.
Arsenal Terapéutico. Available from:
http://www.arsenalterapeutico.com/2012/05/24/venezuela-farmapatria-vende-medicinas-a-
mitad-de-precio/ [Accessed on July 16, 2014]
AVEDEM (2014). Who We Are. Asociación Venezolana de Distribuidores de Equipos Médicos,
Odontológicos, de Laboratorios y Afines. Available from:
http://www.avedem.com.ve/site/index.php/aboutus [Accessed on July 21, 2014]
Azevedo VF, et al. (2012). Potential Regulatory and Commercial Environment for Biosimilars in
Latin America. Value in Health Regional Issues; 1(2): 228–234
BCV (2010). Informe Económico 2010. Banco Central de Venezuela. Available from:
http://200.74.197.135/upload/publicaciones/infoeco2010.pdf
BCV (2013). Estadísticas Del Sector Externo. Banco Central de Venezuela. Available from:
http://www.bcv.org.ve/Upload/Publicaciones/anuasectorexterno77-12.pdf?id=458
BCV (2014a). International reserves (millions of US$). Banco Central de Venezuela. Available
from: http://www.bcv.org.ve/excel/2_5_2i.xls [Accessed on July 9, 2014]
BCV (2014b). Venezuela: GDP by Economic Activity. Banco Central de Venezuela. Available
from: http://www.bcv.org.ve/blanksite/c2/indicadores.asp [Accessed on July 10, 2014]
BCV (2014c). National Consumer Price Index. Banco Central de Venezuela. Available from:
http://www.bcv.org.ve/c2/indicadores.asp [Accessed on July 10, 2014]
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World Bank (2014a). Urban population (% of total). World Bank. Available from:
http://data.worldbank.org/indicator/SP.URB.TOTL.IN.ZS [Accessed on July 1, 2014]
World Bank (2014b). Death rate crude (per 1,000 population). World Bank. Available from:
http://data.worldbank.org/indicator/SP.DYN.CDRT.IN [Accessed on July 3, 2014]
World Bank (2014c). Immunization, DPT (% of children ages 12–23 months). World Bank.
Available from: http://data.worldbank.org/indicator/SH.IMM.IDPT [Accessed on July 4, 2014]
World Bank (2014d). Immunization, measles (% of children ages 12–23 months). World Bank.
Available from: http://data.worldbank.org/indicator/SH.IMM.MEAS [Accessed on July 4, 2014]
World Bank (2014e). PM10, country level (micrograms per cubic meter). World Bank. Available
from: http://data.worldbank.org/indicator/EN.ATM.PM10.MC.M3 [Accessed on July 4, 2014]
World Bank (2014f). CO2 emissions (kt). World Bank. Available from:
http://data.worldbank.org/indicator/EN.ATM.CO2E.KT [Accessed on July 4, 2014]
World Bank (2014g). Health expenditure, total (% of GDP). World Bank. Available from:
http://data.worldbank.org/indicator/SH.XPD.TOTL.ZS [Accessed on July 4, 2014]
World Bank (2014h). Health expenditure, public (% of total health expenditure). World Bank.
Available from: http://data.worldbank.org/indicator/SH.XPD.PUBL.ZS [Accessed on July 4,
2014]
World Bank (2014i). Incidence of tuberculosis (per 100,1000 people). World Bank. Available
from: http://data.worldbank.org/indicator/SH.TBS.INCD [Accessed on July 19, 2014]
World Bank (2014i). Out-of-pocket health expenditure (% of private expenditure on health).
World Bank. Available from: http://data.worldbank.org/indicator/SH.XPD.OOPC.ZS [Accessed
on July 7, 2014]
World Bank (2014j). Gross National Income. World Bank. Available from:
http://data.worldbank.org/indicator/NY.GNP.PCAP.CD [Accessed on July 8, 2014]
World Bank (2014l). Labor force, total. World Bank. Available from:
http://data.worldbank.org/indicator/SL.TLF.TOTL.IN [Accessed on July 12, 2014]
World Bank (2014m). Labor force, participation rate, total (% of total population ages 15+).
World
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Bank. Available from:
http://data.worldbank.org/indicator/SL.TLF.CACT.ZS/countries/1W?display=default [Accessed
on
July 12, 2014]
World Bank (2014n). Literacy rate, adult total (% of people ages 15 and above). World Bank.
Available from: http://data.worldbank.org/indicator/SE.ADT.LITR.ZS [Accessed on July 12,
2014]
World Economic Forum (2014). The Global Competitiveness Report. World Economic Forum.
Available from: http://www3.weforum.org/docs/WEF_GlobalCompetitivenessReport_2013-
14.pdf
Healthcare, Regulatory and Reimbursement Landscape –Venezuela 198 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
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7.3 Research Methodology
GlobalData’s dedicated research and analysis teams consist of experienced professionals with
advanced statistical expertise and marketing, market research and consulting backgrounds in the
pharmaceutical industry.
GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and
Strategic and Competitive Intelligence Professionals (www.scip.org).
All GlobalData databases are continuously updated and revised. The following research
methodology is followed for all databases and reports.
7.3.1 Coverage
The objective of updating GlobalData’s coverage is to ensure that it represents the most up-to-date
vision of the industry possible.
Changes to the industry taxonomy are built on the basis of extensive research of company,
association and competitor sources.
Company coverage is based on three key factors: revenue; products; and media attention,
innovation and market potential.
The estimated revenue of all major companies, including private and governmental, are gathered
and used to prioritize coverage.
Companies that are making the news or are of particular interest due to their innovative approach
are prioritized.
GlobalData aims to cover all major news events and deals in the pharmaceutical industry, updated
on a daily basis.
The coverage is further streamlined and strengthened with additional input from GlobalData’s
expert panel (see below).
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7.3.2 Secondary Research
The research process begins with extensive secondary research using internal and external
sources to gather qualitative and quantitative information relating to each market.
The secondary research sources that are typically referred to include, but are not limited to:
Company websites, annual reports, financial reports, broker reports, investor presentations and
SEC filings
Industry trade journals, scientific journals and other technical literature
Internal proprietary databases
Relevant patent and regulatory databases
National government documents, statistical databases and market reports
Procedure registries
News articles, press releases and web-casts specific to the companies operating in the market
The CountryFocus reports are largely based on secondary research and use reliable and
authoritative sources such as the IMF, the World Bank, OECD, WHO, UNICEF, UNStats, BEA,
MHLW and NHS, among others.
7.3.3 Forecasts
The CountryFocus reports use the data available from the secondary sources to forecast and
validate the future trends for a country’s healthcare market, as well as parameters related to the
economy and healthcare infrastructure and expenditure.
7.3.4 Expert Panel
GlobalData uses a panel of experts to cross-verify its databases and forecasts.
GlobalData’s expert panel comprises marketing managers, product specialists, international sales
managers from pharmaceutical companies, academics from research universities, consultants from
venture capital funds, and distributors/suppliers of pharmaceuticals and supplies.
Historical data and forecasts are relayed to GlobalData’s expert panel and adjusted in accordance
with their feedback.
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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.