healthcare, regulatory and reimbursement … · table 33: demographics, venezuela, population...

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.


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.



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).


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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


Table of Contents


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



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.


Country Analysis


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


Country Analysis


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


Appendix


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)


Appendix


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


Appendix


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


Appendix


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)


Appendix


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


Appendix


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]


Appendix


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


Appendix


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


Appendix


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).


Appendix


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.


Appendix


7.4 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any

form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior

permission of the publisher, GlobalData.

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