Healthcare, Regulatory and Reimbursement Landscape Venezuela
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E Healthcare, Regulatory and Reimbursement Landscape Venezuela PL M SA Reference Code: GDHC0021CHR Publication Date: December 2012
Despite a High Proportion of the Population being in the Working age Group, Venezuela is Dependent on Skilled Foreign Labor for the Adequate Development of its Oil and Healthcare Sectors Although the Venezuelan Healthcare Market has Significant Growth Potential, its Lack of Patent Protection Laws for Medicines, Lack of Clarity over the Pharmaceutical Regulatory Process, High Level of Corruption, Drug Price Freeze Policy and Lack of Universal Healthcare Coverage E all Negatively Impact the Interest of Foreign Pharmaceutical Investors PL Age Groups, Venezuela, Population Distribution (%), 2006-2020 M SA Source: GlobalData; INE, 2012; US Census Bureau, 2012a *Estimated Figures GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 2 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
Pharmaceutical Market ($bn), Venezuela, 2006-2020 E Source: GlobalData; CIFAR, 2007; RNV, 2012 *Estimated Figures Political Stability in Recent Years has Resulted in the Proper Implementation of Economic Policies and Lack of Clarity and Transparency in the Regulatory System Programs. However, Venezuela’s Overwhelmingly Oil- and Language Barriers in the Drug Approval Process often Based Economy is Vulnerable. Moreover, the Devaluation Attempting to Register New Drugs PL Present a Challenge for Foreign Multinational Companies of the Country’s Currency, Continued Banking Interventions and the Nationalization of Assets in the Petroleum, Alternative Energy and Banking Sectors have Led to a Decline in Foreign Direct Investments M SA Lack of Universal Healthcare Coverage and Skilled Healthcare Personnel, a Shortage of Medicines in Public Pharmacies and a High Level of Private Healthcare Expenditure Leave the Healthcare System of Venezuela with Shaky Foundations GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 3 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
E Country Profile, Venezuela, 2012 Parameter PL Healthcare Market Economic Environment Pharmaceutical Market Stability Country Profile Growth Sub-parameters Pharmaceutical Market Government Initiatives Medical Device Market GDP Growth Medical Device Market Growth Employment M Hospital Beds to Doctors to Population Environmental Health Healthcare Infrastructure Government Initiatives Population Ratio Ratio Overall Public Share Private Share R&D Expenditure Healthcare Expenditure SA Population Working Age Group Elderly Demographics Approval Process Approval Time Government Initiatives Regulatory Environment Political Stability Healthcare Initiatives Economic Policy Political Environment Access Government Initiatives Reimbursement Environment Strong Moderate Weak Source: GlobalData GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 4 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
1 Table of Contents 1 Table of Contents .................................................................................................................................. 5 1.1 List of Tables .................................................................................................................................. 7 1.2 List of Figures ................................................................................................................................. 8 2 Introduction ..........................................................................................................................................10 2.1 Report Guidance............................................................................................................................10 3 Overview of the Pharmaceutical and Medical Devices Market .............................................................11 3.1 Pharmaceutical Market ..................................................................................................................11 3.1.1 Market Overview ...................................................................................................................11 3.1.2 Supply Channels ..................................................................................................................14 3.1.3 Market Segments .................................................................................................................15 3.1.4 Major Disease Areas ............................................................................................................18 3.1.5 Major Players........................................................................................................................19 E 3.2 Medical Device Market ..................................................................................................................45 3.2.1 Market Overview ...................................................................................................................45 3.3 Market Drivers and Barriers ...........................................................................................................45 3.3.1 Drivers ..................................................................................................................................45 3.3.2 Barriers .................................................................................................................................46 4 Market Access ......................................................................................................................................48 4.1.1 4.1.2 4.1.3 4.1.4 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 PL 4.1 Reimbursement and Payer Landscape ..........................................................................................48 Reimbursement Process ......................................................................................................51 Overview of Insurance Providers ..........................................................................................52 Patient Share in Healthcare Spending ..................................................................................53 Price Trend for Medicines .....................................................................................................54 4.2 Regulatory Landscape ...................................................................................................................55 Overview of Regulatory Agencies .........................................................................................55 Registration Procedure for New Drug ...................................................................................55 Medical Device Approval Process ........................................................................................57 Licensing Process for Pharmaceutical Manufacturing ..........................................................57 Licensing Process for Pharmaceutical Exports and Imports .................................................58 Intellectual Property Rights ...................................................................................................58 M 4.2.7 Clinical Trial Regulations ......................................................................................................63 4.2.8 Pharmaceutical Advertising Regulations ..............................................................................65 4.2.9 Pharmacy Regulations .........................................................................................................66 4.2.10 Labeling and Packaging Regulations ...................................................................................67 5 Country Analysis ..................................................................................................................................69 5.1 Political Environment .....................................................................................................................69 5.1.1 Political Structure..................................................................................................................69 5.1.2 Analysis of the Current Political Environment .......................................................................70 SA 5.1.3 Healthcare Policy Initiatives ..................................................................................................71 5.2 Economic Landscape ....................................................................................................................71 5.3 Economic Indicators ......................................................................................................................73 5.3.1 Gross Domestic Product .......................................................................................................73 5.3.2 Gross National Income .........................................................................................................77 5.3.3 Inflation .................................................................................................................................78 5.3.4 Currency Exchange Rate......................................................................................................82 5.3.5 Foreign Direct Investment.....................................................................................................84 5.3.6 Foreign Exchange Reserves ................................................................................................85 5.3.7 Trade Balance ......................................................................................................................86 5.3.8 Government Structural Balance............................................................................................88 5.3.9 Government Gross Debt .......................................................................................................90 5.3.10 Major Industries ....................................................................................................................92 5.4 Demography ..................................................................................................................................93 5.4.1 Population.............................................................................................................................93 5.4.2 Education and Literacy .......................................................................................................112 5.4.3 Employment........................................................................................................................114 5.4.4 Disease Burden ..................................................................................................................116 5.5 Healthcare Infrastructure .............................................................................................................117 5.5.1 Healthcare Facilities ...........................................................................................................117 GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 5 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
5.5.2 Healthcare Parameters .......................................................................................................123 5.5.3 Environmental Health .........................................................................................................125 5.6 Healthcare Expenditure ...............................................................................................................129 5.6.1 Overview.............................................................................................................................129 5.6.2 Share of Public and Private Sectors ...................................................................................130 5.6.3 Spending in Healthcare R&D ..............................................................................................130 5.7 Trade Associations ......................................................................................................................131 5.7.1 Venezuelan Chamber of Medicine ......................................................................................131 5.7.2 Chamber of Pharmaceutical Industry .................................................................................131 5.7.3 Chamber of Non-prescription Medicines ............................................................................131 5.7.4 Venezuelan Association of Distributors of Medical Equipment, Dental Laboratories and Allied ...................................................................................................................................131 5.7.5 Venezuelan Chamber of Pharmacy ....................................................................................131 6 Opportunities and Challenges ............................................................................................................132 6.1 Opportunities ...............................................................................................................................132 E 6.2 Challenges ...................................................................................................................................133 7 Appendix ............................................................................................................................................135 7.1 Abbreviations ...............................................................................................................................135 7.2 Bibliography .................................................................................................................................138 7.3 -Methodology ...............................................................................................................................146 7.3.1 Coverage ............................................................................................................................146 7.3.2 Secondary Research ..........................................................................................................146 7.3.3 7.3.4 7.3.5 PL Forecasting .........................................................................................................................147 Primary Research ...............................................................................................................147 Expert Panel Validation ......................................................................................................147 7.4 Disclaimer ....................................................................................................................................147 M SA GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 6 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
1.1 List of Tables Table 1: Pharmaceutical Market ($bn), Venezuela, 2006-2011 ..............................................................12 Table 2: Pharmaceutical Market ($bn), Venezuela, Forecast, 2012-2020 ..............................................13 Table 3: Drugs Going Off-patent, Revenues ($bn), Global, 2011-2015 ..................................................16 Table 4: Major Products, Pfizer, Global, Revenue ($m), 2011 ................................................................20 Table 5: Late-stage Pipeline, Pfizer, 2012 ..............................................................................................20 Table 6: Major Products, GlaxoSmithKline, Global, Revenue ($m), 2011 ..............................................25 Table 7: Late Stage Pipeline, GlaxoSmithKline, 2012 ............................................................................26 Table 8: Major Products, Sanofi, Global, Revenue ($m), 2011 ...............................................................31 Table 9: Late-stage Pipeline, Sanofi, 2012 .............................................................................................32 Table 10: Major Products, Novartis, Global, Revenue ($m), 2011 ............................................................36 Table 11: Planned Filings, Novartis, 2012-2016 .......................................................................................37 Table 12: Major Products, Groupo Farma, 2012.......................................................................................42 E Table 13: Healthcare Spending, Venezuela, Patient's Share (%), 2005-2010 ..........................................53 Table 14: Price Trend for Medicines and Medical Devices (%), Venezuela, 2008-2011...........................54 Table 15: GDP Per Capita ($), Venezuela, 2006-2011 .............................................................................73 Table 16: GDP Per Capita ($), Venezuela, Forecast, 2012-2020 .............................................................74 Table 17: GDP, Venezuela, Annual Growth (%), 2006-2011 ....................................................................75 Table 18: GDP, Venezuela, Annual Growth (%), Forecast, 2012-2020 ....................................................76 Table 19: Table 20: Table 21: Table 22: Table 23: Table 24: Table 25: Table 26: Table 27: Table 28: Table 29: Table 30: PL GNI Per Capita ($), Venezuela, 2005-2010 ..............................................................................77 Average Consumer Price Index, Venezuela, 2006-2011 ..........................................................78 Average Consumer Price Index, Venezuela, Forecast, 2012-2020 ..........................................79 Average Consumer Price, Venezuela, Annual Change (%), 2006-2011 ...................................80 Average Consumer Price, Venezuela, Annual Change (%), Forecast, 2012-2020 ...................81 Currency Exchange Rate (VEB/$), Venezuela, 2005-2007 ......................................................82 Currency Exchange Rate (VEF/$), Venezuela, 2008-2011.......................................................83 Foreign Direct Investment ($bn), Venezuela, 2005-2010..........................................................84 Foreign Exchange Reserves ($bn), Venezuela, 2006-2011 .....................................................85 Imports of Goods and Services ($bn), Venezuela, 2006-2011 .................................................86 Exports of Goods and Services ($bn), Venezuela, 2006-2011 .................................................87 General Government Structural Balance ($bn), Venezuela, 2006-2011 ...................................88 M Table 31: General Government Structural Balance ($bn), Venezuela, Forecast, 2012-2020 ...................89 Table 32: Government Gross Debt ($bn), Venezuela, 2006-2011 ............................................................90 Table 33: Government Gross Debt ($bn), Venezuela, Forecast, 2012-2020 ............................................91 Table 34: Major Industries, Venezuela, Gross Domestic Product ($bn), 2011 .........................................92 Table 35: Population (m), Venezuela, 2006-2011.....................................................................................94 Table 36: Population (m), Venezuela, Forecast, 2012-2020 .....................................................................95 Table 37: Urban and Rural Population, Venezuela, Share (%), 2005-2010 ..............................................96 Table 38: Age Groups, Venezuela, Population Distribution (%), 2006-2011 ............................................98 SA Table 39: Age Groups, Venezuela, Population Distribution (%), Forecast, 2012-2020.............................99 Table 40: Births (Per 1,000 Population), Venezuela, 2006-2011 ............................................................100 Table 41: Births (Per 1,000 Population), Venezuela, Forecast, 2012-2020 ............................................101 Table 42: Mortality (Per 1,000 Population), Venezuela, 2006-2011........................................................102 Table 43: Mortality (Per 1,000 Population), Venezuela, Forecast, 2012-2020 ........................................103 Table 44: Major Causes of Mortality (Number of Deaths, „000s), Venezuela, 2008 ................................105 Table 45: Children
Table 61: Hospital Beds (Per 1,000 Population), Venezuela, 2005-2010 ...............................................123 Table 62: Number of Physicians (Per 10,000 Population), Venezuela, 2005-2010 ................................124 Table 63: Environmental Attributable Deaths (Per 100,000 Population), Venezuela, 2004 ....................125 Table 64: PM10 (micrograms per cubic meter), Venezuela, 2005-2010 .................................................126 Table 65: CO2 Emissions (Million Tons), Venezuela, 2005-2010 ...........................................................128 Table 66: Healthcare Expenditure (% of GDP), Venezuela, 2005-2010 .................................................129 Table 67: Healthcare Expenditure, Venezuela, Public-Private Share (%), 2005-2010 ...........................130 1.2 List of Figures Figure 1: Pharmaceutical Market ($bn), Venezuela, 2006-2011 ................................................................12 Figure 2: Pharmaceutical Market ($bn), Venezuela, Forecast, 2012-2020 ................................................13 Figure 3: Distribution Channels, Venezuela, 2011 .....................................................................................14 Figure 4: Drivers and Barriers, Healthcare Market, Venezuela, 2011 ......................................................47 Figure 5: History of the Healthcare System, Venezuela, 2011 .................................................................50 E Figure 6: Healthcare Spending, Venezuela, Patient's Share (%), 2005-2010 ..........................................53 Figure 7: Price Trend for Medicines and Medical Devices (%), Venezuela, 2008-2011 .............................54 Figure 8: Registration Procedure for New Drug, Venezuela, 2012 ............................................................56 Figure 9: Patent Approval Process, Venezuela, 2012..............................................................................60 Figure 10: Trademark Approval Process, Venezuela, 2012 .......................................................................62 Figure 11: Clinical Trial Regulation Process, Venezuela, 2012 .................................................................64 PL Figure 12: Format of Advertisement, Venezuela, 2012 ..............................................................................66 Figure 13: GDP Per Capita ($), Venezuela, 2006-2011 .............................................................................73 Figure 14: GDP Per Capita ($), Venezuela, Forecast, 2012-2020 .............................................................74 Figure 15: GDP, Venezuela, Annual Growth (%), 2006-2011 ....................................................................75 Figure 16: GDP, Venezuela, Annual Growth (%), Forecast, 2012-2020 ....................................................76 Figure 17: GNI Per Capita ($), Venezuela, 2005-2010 ..............................................................................77 Figure 18: Average Consumer Price Index, Venezuela, 2006-2011 ..........................................................78 Figure 19: Average Consumer Price Index, Venezuela, Forecast, 2012-2020 ..........................................79 Figure 20: Average Consumer Price, Venezuela, Annual Change (%), 2006-2011 ...................................80 Figure 21: Average Consumer Price, Venezuela, Annual Change (%), Forecast, 2012-2020 ...................81 Figure 22: Currency Exchange Rate (VEB/$), Venezuela, 2005-2007 ......................................................82 Figure 23: Currency Exchange Rate (VEF/$), Venezuela, 2008-2011 .......................................................83 M Figure 24: Foreign Direct Investment ($bn), Venezuela, 2005-2010..........................................................84 Figure 25: Foreign Exchange Reserves ($bn), Venezuela, 2006-2011 .....................................................85 Figure 26: Imports of Goods and Services ($bn), Venezuela, 2006-2011 .................................................86 Figure 27: Exports of Goods and Services ($bn), Venezuela, 2006-2011 .................................................87 Figure 28: General Government Structural Balance ($bn), Venezuela, 2006-2011 ...................................88 Figure 29: General Government Structural Balance ($bn), Venezuela, Forecast, 2012-2020 ...................89 Figure 30: Government Gross Debt ($bn), Venezuela, 2006-2011 ............................................................90 Figure 31: Government Gross Debt ($bn), Venezuela, Forecast, 2012-2020 ............................................91 SA Figure 32: Major Industries, Venezuela, GDP ($bn), 2011.........................................................................92 Figure 33: Population (m), Venezuela, 2006-2011 .....................................................................................94 Figure 34: Population (m), Venezuela, Forecast, 2012-2020 .....................................................................95 Figure 35: Urban and Rural Population, Venezuela, Share (%), 2005-2010 ..............................................96 Figure 36: Age Groups, Venezuela, Population Distribution (%), 2006-2011.............................................98 Figure 37: Age Groups, Venezuela, Population Distribution (%), Forecast, 2012-2020.............................99 Figure 38: Births (Per 1,000 Population), Venezuela, 2006-2011 ............................................................100 Figure 39: Births (Per 1,000 Population), Venezuela, Forecast, 2012-2020 ............................................101 Figure 40: Mortality (Per 1,000 Population), Venezuela, 2006-2011........................................................102 Figure 41: Mortality (Per 1,000 Population), Venezuela, Forecast, 2012-2020 ........................................103 Figure 42: Major Causes of Mortality (Number of Deaths, „000s), Venezuela, 2008................................104 Figure 43: Children
Figure 54: Public Hospitals, Venezuela, 2005-2010 ................................................................................118 Figure 55: Hospitals by Standard of Care, Venezuela, Share (%), 2010 .................................................119 Figure 56: Ambulatory Facilities, Venezuela, Urban and Rural Share (%), 2010 .....................................120 Figure 57: Hospitals by Bed Size, Venezuela, Share (%), 2010 ..............................................................121 Figure 58: Diagnostic Facilities, Venezuela, 2005-2010 ..........................................................................122 Figure 59: Hospital Beds (Per 1,000 Population), Venezuela, 2005-2010 ...............................................123 Figure 60: Number of Physicians (Per 10,000 Population), Venezuela, 2005-2010 ................................124 Figure 61: Environmental Attributable Deaths (Per 100,000 Population), Venezuela, 2004 ....................125 Figure 62: PM10 (Micrograms Per Cubic Meter), Venezuela, 2005-2010 ................................................126 Figure 63: CO2 Emissions (Million Tons), Venezuela, 2005-2010 ...........................................................128 Figure 64: Healthcare Expenditure (% of GDP), Venezuela, 2005-2010 .................................................129 Figure 65: Healthcare Expenditure, Venezuela, Public-Private Share (%), 2005-2010 ...........................130 Figure 66: Opportunities and Challenges, Healthcare Market, Venezuela, 2012 .....................................134 E PL M SA GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 9 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
2 Introduction 2.1 Report Guidance The report begins with an executive summary which gives an overview of the healthcare market of Venezuela and the key factors driving the market there. The executive summary also gives a snapshot of the demographic, regulatory and reimbursement landscape, as well as the healthcare infrastructure of Venezuela. Chapter three provides an overview of the pharmaceutical and medical device market of Venezuela, including the market size, market segmentation by generics, Over-the-Counter (OTC) and biologics/biosimilar products, and the key drivers and barriers for the market. The section also includes profiles of the major players, with a SWOT assessment. Chapter four covers the reimbursement and payer landscape as well as the regulatory landscape of E Venezuela. The reimbursement and payer landscape elaborates on the features of the healthcare reimbursement process for Venezuela. It includes details of the reimbursement process, the insurance providers, pricing policies and drug price trends in the country. The regulatory landscape section provides an overview of the regulatory agencies and approval processes for new drugs and medical devices. The licensing process for the manufacturing and export/import of pharmaceuticals, the regulations for pharmaceutical advertising, labeling and packaging and clinical trials and an PL overview of the landscape for intellectual property rights are also covered in this chapter. Chapter five provides a detailed analysis of the political and economic environment of Venezuela. It analyses the economic indicators, demographics, healthcare infrastructure and healthcare expenditure of Venezuela. Chapter six provides an overview of the opportunities and challenges for growth that exist in the healthcare market of Venezuela. M SA GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 10 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
3 Overview of the Pharmaceutical and Medical Devices Market 3.1 Pharmaceutical Market 3.1.1 Market Overview E PL M SA GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 11 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
Figure 1: Pharmaceutical Market ($bn), Venezuela, 2006-2011 E PL M Source: GlobalData; CIFAR, 2007; RNV, 2012 Table 1: Pharmaceutical Market ($bn), Venezuela, 2006-2011 Year 2006 2007 2008 2009 2010 2011 Revenue SA Source: GlobalData; CIFAR, 2007; RNV, 2012 GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 12 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
Figure 2: Pharmaceutical Market ($bn), Venezuela, Forecast, 2012-2020 E Table 2: PL Source: GlobalData; CIFAR, 2007; RNV, 2012 Pharmaceutical Market ($bn), Venezuela, Forecast, 2012-2020 M Year 2012 2013 2014 2015 2016 2017 2018 2019 2020 Revenue Source: GlobalData; CIFAR, 2007; RNV, 2012 SA GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 13 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
3.1.2 Supply Channels Figure 3: Distribution Channels, Venezuela, 2011 Public Manufacturer / Private Manufacturer SEFAR E Public Hospitals / Farmapatria / National Wholesaler / Distributor Clinics Pharmacy Network Public Hospitals / Clinics PL Retail Pharmacy Private Hospitals / Clinics Public Hospitals / Clinics Retail Pharmacy M SA Consumer / Patient Source: GlobalData; CIFAR, 2012a GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 14 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
3.1.3 Market Segments 3.1.3.1 Generic Drugs E PL M SA GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 15 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
Table 3 shows the drugs going off patent globally, which will be an opportunity for Venezuelan pharmaceutical manufacturers to export generic drugs into the global market. Table 3: Drugs Going Off-patent, Revenues ($bn), Global, 2011-2015 Company Drug Indication Patent Expiration 2010 Sales ($m) E PL M SA Source: GlobalData, Pharma eTrack [Accessed September 21, 2012] GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 16 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
7 Appendix 7.1 Abbreviations AD : Accion Democratica (Democratic Action) AIDS : Acquired Immunity Deficiency Syndrome AML : Acute Myeloid Leukemia ANC : Asamblea Nacional Constituyente (National Constituent Assembly) ASM : Aggressive Systemic Mastocytosis AVEDEM: Asociación Venezolana de Distribuidores de Equipos Médicos, Odontológicos, de Laboratorios y Afines (Venezuelan Association of Distributors of Medical Equipment, E Dental Laboratories and Allied) BMS : Bristol-Myers Squibb CAGR : Compound Annual Growth Rate CAMESIP: Cámara de Medicamentos Sin Prescripción (Chamber of Non-prescription Medicines) CAREM : CAT CAV CAVEFAR: CAVEME: CDI : : : PL Integración de las Áreas Cardiovascular, Renal y Endocrino-Metabólica (Integration of the Areas Cardiovascular, Renal and Endocrine-Metabolic) Centros de Alta Tecnología (High Technology Centers) Cámara de Aseguradores de Venezuela (Venezuelan Insurance Chamber) Camara Venezolana de Farmacia (Venezuelan Chamber of Pharmacy) Camara Venezolana del Medicamento (Venezuelan Chamber of Medicine) Centros de Diagnóstico Integral (Integral Diagnostic Centers) M CDM : Clean Development Mechanism CDs : Compact Discs CEDIMED: Centro de Información de Medicamentos (Drug Information Center) CIDP : Chronic Inflammatory Demyelinating Polyneuropathy CIFAR : Camara de la Industria Farmacéutica (Chamber of Pharmaceutical Industry) SA CIU : Chronic Idiopathic Urticaria CNE : Consejo Nacional Electoral (National Electoral Council) CNS : Central Nervous System CNV : Choroidal Neovascularization CONMED: Consejo nacional del Medicamento (National Drug Council) COPD : Chronic Obstructive Pulmonary Disease COPEI : Comite Organizador Politico por Elecciones Independientes (Christian Democrats) CPI : Consumer Price Index CR : La Causa Radical (Radical Cause) CRS : Congressional Research Service CT : Computed Tomography Scanner CTN : Comité Terapéutico Nacional (National Drug Committee) DALY : Disability Adjusted Life Years GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 135 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
DEA : Drug Enforcement Administration DHHS : Department of Health and Human Services EU : European Union FDI : Foreign Direct Investments FTA : Free Trade Agreement GCI : Global Competitiveness Index GDP : Gross Domestic Product GNI : Gross National Income GSK : GlaxoSmithKline E HCC : Hepatocellular Carcinoma IMF : International Monitory Fund Inass : Nacional de Servicios Sociales (National Institute of Social Services) INE : Instituto Nacional de Estadistica (Department of Statistics) INH INHRR : IPASME : IPSFA : : PL Instituto Nacional de Higiene (National Institute of Hygiene) Instituto Nacional de Higiene Rafael Rangel (National Institute of Hygiene Rafael Rangel) Instituto de Previsión y Asistencia Social del Ministerio de Educación, Cultura y Deportes (Institute of Welfare and Social Assistance, Ministry of Education, Culture and Sports) Instituto de Previsión Social de las Fuerzas Armadas (Social Welfare Institute of the Armed Forces) M IVSS : Instituto Venezolano de los Seguros Sociales (State Health Directorates and Social Development, the Venezuelan Institute of Social Security) JRPF : Junta Revisora de Productos Farmacéuticos (Pharmaceutical Review Board) JV : Joint Venture LME : Lista de Medicamentos Esenciales (List of Essential Drugs) SA LOS : Ley Orgánica de Salud (Organic Health Law) LOSSS : Ley Orgánica del Sistema de Seguridad Social (Law for Social Security System) MAS : Movimiento al Socialismo (Movement to Socialism) MCIT : Ministerio de Comercio, Industria y Turismo (Ministry of Commerce, Industry and Tourism) ME : Macular Edema MNCs : Multinational Companies MPPS : Ministerio del Poder Popular para la Salud (Ministry for People's Power for Health) MRI : Magnetic Resonance Imaging Machine MUD : Mesa de Unidad Democrática (Democratic Unity Table) N/A : Not Applicable NIBR : Novartis Institutes for Biomedical Research NIDWMR: Novartis Institute for Medical Research in the Developing World GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 136 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
NMEs : New Molecular Entities NRC : National Research Council NTDs : Neglected Tropical Diseases NVGH : Novartis Vaccine Institute for Global Health OHH : Obese Hypogonadotropic Hypogonadism OICEMP : Oficina de Inscripcion Control de Equipos Medicos y Para Medicos (Office of Registration and Control for Medical and Paramedical Equipment and Supplies) OPEC : Organization of the Petroleum Exporting Countries OTC : Over-the-Counter E PAHO/WHO: Pan-American Health Organization PCV : Partido Comunista de Venezuela (Communist Party of Venezuela) PD-LID : Parkinson‟s Disease L-dopa Induced Dyskinesia PDVSA : Petróleos de Venezuela PJ PNANNA: PPT PSUV R&D SAPI : : : : : PL Primero Justicia (First Justice) Programa Nacional de Atención Integral del Niño, Niña y Adolescente (Health Program of Children and Adolescents) Patria Para Todos (Fatherland for All) Partido Socialista Unido de Venezuela (United Socialist Party of Venezuela) Research and Development Servicio Autónomo de la Propiedad Intelectual (Autonomous Service of Intellectual Property) M SEFAR : Servicio Autónomo de Elaboraciones Farmacéuticas (Autonomous Service of Pharmaceutical Elaborations) SITME : Sistema de Transacciones con Títulos en Moneda Extranjera (Transaction System for Foreign Currency Denominated Securities) SJIA : Systemic-onset Juvenile Idiopathic Arthritis SA SPNS : Sistema Público Nacional de Salud (National Public Health System) SRI : Salas de Rehabilitación Integral (Integral Rehabilitation Facilities) TRIPS : Trade Related Aspects of Intellectual Property Rights TSU : Therapeutic Strategic Units UNESCO: United Nations Educational, Scientific and Cultural Organization UNFCCC: United Nations Framework Convention on Climate Change UNT : Un Nuevo Tiempo (A New Time) URMM : Unidad de Recepción de Muestras de Medicamentos (Reception of Unit Drug Samples) USAID : US Agency for International Development VAT : Value Added Tax VEF : Venezuelan Bolivar Furete (Strong Bolivar) VP : Voluntad Popular (Popular Will) WHO : World Health Organization GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 137 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
WIPO : World Intellectual Property Organization WTO : World Trade Organization 7.2 Bibliography Alvarado, CH et al. (2008). Social Change and Health Policy in Venezuela. Social Medicine; 3 (2): 95-109. American Enterprise Institute (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. 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 September 18, 2012]. E Arsenal Terapeutico (2012). Venezuela: Farmapatria vende medicinas a mitad de precio. Arsenal Teraputico. Available from: http://www.arsenalterapeutico.com/2012/05/24/venezuela-farmapatria- vende-medicinas-a-mitad-de-precio/. [Accessed on June 28, 2012]. Asamblea Nacional (2012). Strengthen the production of generic drugs. Asamblea Nacional. Available from: PL http://www.asambleanacional.gob.ve/index.php?option=com_content&view=article&id=38764%3Afort aleceran-la-produccion-de-medicamentos-genericos- &catid=332%3Aparlamentarias&Itemid=247&lang=es. [Accessed on June 28, 2012]. Banco Central de Venezuela (2010). Informe Económico 2010. Banco Central de Venezuela. Available from: http://200.74.197.135/upload/publicaciones/infoeco2010.pdf. Banco Central de Venezuela (2012a). Indicadores. Banco Central de Venezuela. Available from: http://www.bcv.org.ve/blanksite/c2/indicadores.asp. [Accessed on June 12, 2012]. Banco Central de Venezuela (2012b) via El Universal. Venezuelan domestic debt smashes 13-year record. El Universal. Available from: http://www.eluniversal.com/economia/120818/venezuelan- M domestic-debt-smashes-13-year-record. [Accessed on September 12, 2012]. Bonvecchio A, et al. (2011). The health system of Venezuela. Salud Pública de México. 53 (Suppl. 2): 275-286. Borell B (2010). The Counterfeiter. The Scientist. Available from: http://www.the- scientist.com/?articles.view/articleNo/28743/title/The-Counterfeiter/flagPost/47872/. [Accessed on September 7, 2012]. SA Borges MS (2010). Psychological and Societal Dimensions of Asthma: Asthma Care in Resource- Poor Settings. Presentation at World Allergy Organization International Scientific Conference. Dubai, UAE. Cámara de Aseguradores de Venezuela (2012) via Latin America Herald Tribune. Private Health Care Under Stress in Venezuela as Patients Abandon State Health Service. Cámara de Aseguradores de Venezuela. Available from: http://www.laht.com/article.asp?CategoryId=10717&ArticleId=322153. [Accessed on June 26, 2012]. Camara de la Industria Farmaceutica (2007). Behavior of the Pharmaceutical Market in Venezuela. Camara de la Industria Farmaceutica. Available from: http://www.cifar.org.ve/info_interes/Cierre_delMercado_farmaceutico_2007.pdf. Camara de la Industria Farmaceutica (2011) via VenamCham. Drug production in Venezuela. Camara de la Industria Farmaceutica. Available from: http://www.venamcham.org/index.php?option=com_content&view=article&id=744:comite-de-salud- produccion-de-medicamentos-en-venezuela&catid=8:comite-al-dia. [Accessed on May 4, 2012]. Camara de la Industria Farmaceutica (2012a) via Codigo. Pharmaceutical industry reported irregularities in the supply of medicines. Camara de la Industria Farmaceutica. Available from: http://www.codigovenezuela.com/2012/02/economia/industria-farmaceutica-reporta-irregularidades- en-el-abastecimiento-de-medicamentos. [Accessed on June 29, 2012]. GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 138 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
Camara de la Industria Farmaceutica (2012b) via El Nacional. Drug prices were up 30.6%. Camara de la Industria Farmaceutica. Available from: http://www.el-nacional.com/noticia/28719/18/Precios- de-los-medicamentos-subieron-306-por-ciento-.html. [Accessed on June 29, 2012] Camara de la Industria Farmaceutica (2012c). Lista de Medicamentos Esenciales (LPM) para Venezuela, publicada en Gaceta Oficial NO 37.586 de fecha 06 de diciembre de 2002. Camara de la Industria Farmaceutica. Available from: http://www.cifar.org.ve/lista_medicamentos.htm. [Accessed on June 27, 2012]. Camara de la Industria Farmaceutica (2012d). Instructivo Para el Registro Nacional de Productos Famaceúticos. Camara de la Industria Farmaceutica. Available from: http://www.cifar.org.ve/legislaciones/inst_registro_farmaceutica.htm. [Accessed on June 27, 2012]. Camara de la Industria Farmaceutica (2012f). Law Practice of Pharmacy. Camara de la Industria Farmaceutica. Available from: http://www.cifar.org.ve/legislaciones/ley_farmacia.htm. [Accessed on June 14, 2012]. E Camara de la Industria Farmaceutica (2012e). Pharmaceutical Advertising Regulations. Camara de la Industria Farmaceutica. Available from: http://www.cifar.org.ve/legislaciones/normas_publicidad.htm. [Accessed on May 4, 2012]. Camara de Medicamentos Sin Prescripcion (2012). Norma de Etiquetas y Empaques. Camara de Medicamentos Sin Prescripcion. Available from: http://www.camesip.org/documentos/norma-de- etiqueta-y-empaque-inh.pdf. PL Cámara Venezolana de Medicamentos (2012) via Producto. Se Desacelera el Pulso Producto. Available from: http://www3.producto.com.ve/articulo.php?art=169&edi=23&ediant=. [Accessed on June 19, 2012]. Camara Venezolana del Medicamento (2010). Mercado Farmacéutico Venezolano. Camara Venezolana del Medicamento. Available from: http://www.caveme.org/documentos/Estadisticas%202010.pdf. Cancel, D (2007). In Venezuela, two public-health systems grow apart. The Lancet; 370 (9586): 473- 474. M Central Intelligence Agency (2012). Venezuela. The World Factbook. Available from: https://www.cia.gov/library/publications/the-world- factbook/rankorder/2119rank.html?countryName=Venezuela&countryCode=ve®ionCode=soa&ran k=45#ve. [Accessed on April 26, 2012]. Congressional Research Service (2009). Venezuela: Political Conditions and US Policy. Congressional Research Service. Available from: http://www.fas.org/sgp/crs/row/RL32488.pdf. SA Department of Foreign Affairs and Trade, Australia (2012). Venezuela country brief. Department of Foreign Affairs and Trade. Available from: http://www.dfat.gov.au/geo/venezuela/venezuela_country_brief.html. [Accessed on June 7, 2012]. Dutch Ministry of Economic Affairs, Agriculture and Innovation (2012). Venezuela: farmaceutische producten en gezondheidszorg, kwartaal-2012. Dutch Ministry of Economic Affairs, Agriculture and Innovation. Available from: http://www.agentschapnl.nl/onderwerp/venezuela-farmaceutische- producten-en-gezondheidszorg-kwartaal-i-2012. [Accessed on June 27, 2012]. Export Development Canada (2011). Venezuela: Economics. Export Development Canada. Available from: http://www.edc.ca/EN/country-info/Documents/venezuela.pdf. Fundación Escuela de Gerencia Social (FEGS) (2007). Urban-Rural Share. Fundación Escuela de Gerencia Social. Available from: http://www.gerenciasocial.org.ve/bsocial/bs_06/bs_06_marco_referencial.htm. [Accessed on April 26, 2012]. Gaceta Oficial, Venezuela (2007). Population. Gaceta Oficial, Venezuela. Available from: http://www.cvc.com.ve/portal/Leyes%20y%20Acuerdos/LEYPARAPROTECCIONDELASFAMILIAS.p df. GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 139 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
Global Forum for Health Research (2009). The 2009 report card on financing research and development for health. Global Forum for Health Research. Available from: http://announcementsfiles.cohred.org/gfhr_pub/assoc/chapter+10.pdf. GLOBOCAN (2008). GLOBOCAN 2008 FACT STATS: Venezuela. GLOBOCAN. Available from: http://globocan.iarc.fr/factsheet.asp. [Accessed on September 18, 2012]. Instituto de Prevision Social de la Fuerza Armada Nacional (IPSFA) (2012). Management of Welfare and Social Security. Instituto de Prevision Social de la Fuerza Armada Nacional. Available from: http://www.ipsfa.mil.ve/html/preguntas.faq.content.php. [Accessed on June 6, 2012]. Instituto Nacional de Estadistica (2012a). Population. Instituto Nacional de Estadistica. Available from: http://www.ine.gov.ve/documentos/Demografia/CensodePoblacionyVivienda/ppt/Resultados_Censo2 011.pdf. E Instituto Nacional de Estadistica (2012b). Population. Instituto Nacional de Estadistica. Available from: http://www.ine.gov.ve/documentos/Demografia/CensodePoblacionyVivienda/html/PobSexoSegunCe nso1873-2001.html. [Accessed on April 19, 2012]. Instituto Nacional de Estadistica (2012c). Population. Instituto Nacional de Estadistica. Available PL from: http://www.ine.gob.ve/documentos/Demografia/CrecimientoDemografico/html/CrecDemof.html. [Accessed on April 19, 2012]. Instituto Nacional de Estadistica (2012d). Distribution by Age Groups. Instituto Nacional de Estadistica. Available from: http://www.ine.gov.ve/documentos/Demografia/SituacionDinamica/Proyecciones/html/PoblacionEdad .html. [Accessed on April 19, 2012]. Instituto Nacional de Estadistica (2012e). Birth rate. Instituto Nacional de Estadistica. Available from: http://www.ine.gob.ve/documentos/Demografia/SituacionDinamica/Indicadores/html/indicadores_dem ograficos.html. [Accessed on April 20, 2012]. Instituto Nacional de Estadistica (2012f). Employment. Instituto Nacional de Estadistica. Available M from: http://www.ine.gov.ve/index.php?option=com_content&view=category&id=103&Itemid=40#. [Accessed on April 20, 2012]. Instituto Nacional de Estadistica (2012g). Población total, por sexo al 30 de Junio, 1990-2015 (base Censo, 2001). Instituto Nacional de Estadistica. Available from: http://www.ine.gov.ve/documentos/Demografia/SituacionDinamica/Proyecciones/html/PoblacionSexo .html. [Accessed on April 20, 2012]. SA Instituto Nacional de Estadistica (2012h). Life Expectancy. Instituto Nacional de Estadistica. Available from: http://www.ine.gob.ve/documentos/Demografia/CrecimientoDemografico/html/CrecDemof.html. [Accessed on April 20, 2012]. Instituto Nacional de Estadistica (2012i). Mortality rate. Instituto Nacional de Estadistica. Available from: http://www.ine.gob.ve/documentos/Demografia/SituacionDinamica/Indicadores/html/indicadores_dem ograficos.html. [Accessed on April 20, 2012]. Instituto Nacional de Estadistica (2012j). Population. Instituto Nacional de Estadistica. Available from: http://www.ine.gob.ve/documentos/Demografia/CrecimientoDemografico/html/CrecDemof.html. [Accessed on April 19, 2012]. Instituto Nacional de Estadistica (2012k). Pobreza por línea de ingreso, 1er semestre 1997 - 2do semestre 2011. Instituto Nacional de Estadistica. Available from: http://www.ine.gov.ve/index.php?option=com_content&view=category&id=104&Itemid=45# . [Accessed on April 19, 2012]. Instituto Nacional de Estadistica (2012l). FOB value of imports, by country, 1998-2011. Instituto Nacional de Estadistica. Available from: http://www.ine.gov.ve/index.php?option=com_content&view=category&id=48&Itemid=33#. [Accessed on April 20, 2012]. GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 140 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
Instituto Nacional de Estadistica (2012m). Indicadores Básicos de Salud, 1990-2011. Instituto Nacional de Estadistica. Available from: http://www.ine.gov.ve/documentos/Social/Salud/pdf/Indicadores_Basicos_Salud.pdf. Instituto Nacional de Estadistica (2012n). Indicadores Educativos, 2000/01-2010/11. Instituto Nacional de Estadistica. Available from: http://www.ine.gov.ve/documentos/Social/Educacion/pdf/IndicadoresEducativos2000-2011.pdf. Instituto Nacional de Estadistica (2012o). Valor FOB de las exportaciones No Petroleras efectuadas por Venezuela 2005 - Mayo 2012. Instituto Nacional de Estadistica. Available from: http://www.ine.gov.ve/documentos/Economia/ComercioExteriorComentarios/html/CuadroComercioEx port.php?cuadro=1&tipo=E. [Accessed on September 21, 2012]. Instituto Nacional de Higiene Rafael Rangel (2012a). Antecedentes del INHRR. Instituto Nacional de Higiene. Available from: http://www.inhrr.gob.ve/instituto/instituto.html. [Accessed on June 13, 2012]. E Instituto Nacional de Higiene Rafael Rangel (2012b). Instructivo de llenado F-RCDM-023 Solicitud Para el registro nacional de productos farmacéuticos. Instituto Nacional de Higiene. Available from: http://www.inhrr.gob.ve/ef/pdf/INSTRUCTIVO_DE_LLENADO_F-RCDM-023.pdf. Instituto Nacional de Higiene Rafael Rangel (2012c). Clinical Trial Regulation. Instituto Nacional de Higiene. Available from: http://www.inhrr.gob.ve/ef/pdf/F-RCDM-011_SAPC_Instructivo.pdf. PL International Crisis Group (2011). Health Status by Gender and Age. International Crisis Group. Available from: http://www.crisisgroup.org/en/regions/latin-america-caribbean/andes/venezuela/038- violence-and-politics-in-venezuela.aspx?alt_lang=es. [Accessed on April 18, 2012]. International Diabetes Federation (2012). South And Central America (SACA). International Diabetes Federation. International Diabetes Federation. Available from: http://www.idf.org/diabetesatlas/5e/south-and-central-america. [Accessed on September 20, 2012]. International Monetary Fund (2012). World Economic Outlook 2012. International Monetary Fund. Available from: http://www.imf.org/external/pubs/ft/weo/2012/01/weodata/weorept.aspx?sy=2000&ey=2017&scsm=1 &ssd=1&sort=country&ds=.&br=1&pr1.x=31&pr1.y=5&c=299&s=NGDP_R%2CNGDP_RPCH%2CN M GDP%2CNGDPD%2CNGDP_D%2CNGDPRPC%2CNGDPPC%2CNGDPDPC%2CPPPGDP%2CP PPPC%2CPPPSH%2CPPPEX%2CNID_NGDP%2CNGSD_NGDP%2CPCPI%2CPCPIPCH%2CPC PIE%2CPCPIEPCH%2CTM_RPCH%2CTMG_RPCH%2CTX_RPCH%2CTXG_RPCH%2CTXGO%2 CTMGO%2CLUR%2CLP%2CGGR%2CGGR_NGDP%2CGGX%2CGGX_NGDP%2CGGXCNL%2C GGXCNL_NGDP%2CGGSB%2CGGXONLB%2CGGXONLB_NGDP%2CGGXWDG%2CGGXWDG_ NGDP%2CNGDP_FY%2CBCA%2CBCA_NGDPD&grp=0&a=. [Accessed on June 11, 2012]. SA International Trade Administration (2008). Medical Device Regulatory Requirements for Venezuela. International Trade Administration. Available from: http://www.ita.doc.gov/td/health/Venezuela%202008%20Med%20Dev%20Reg%20Requirements.pdf. Isaacs A (2009). The Food Sovereignty Movement in Venezuela. Venezuela Analysis. Available from: http://venezuelanalysis.com/analysis/4952. [Accessed on July 3, 2012]. La Prensa (2012). Clima para negocios en América Latina vuelve a su mejor nivel . La Prensa. Available from: http://www.laprensa.com.ni/2012/05/16/activos/101653/imprimir. [Accessed on June 8, 2012]. Legatum Institute (2011). The 2011 Legatum Prosperity Index. Legatum Institute. Available from: http://www.prosperity.com/country.aspx?id=VE. [Accessed on September 20, 2012]. El Congreso de la República de Venezuela (1956). Patents. Ley de Propiedad Industrial. Available from: http://www.mho.com.ve/biblioteca/Ley%20de%20Propiedad%20Industrial%20de%201956.pdf. Library of Congress - Federal Research Division (2005). Population. Library of Congress - Federal Research Division. Available from: http://lcweb2.loc.gov/frd/cs/profiles/Venezuela.pdf. Lopez (2005). Formulario Terapéutico Nacional. Dermatología Venezolana; 43 (2): 42. Ministerio de Comercio, Industria y Turismo (2012). Venezuela exonera de impuestos importaciones que favorecen sector de la salud. Ministerio de Comercio, Industria y Turismo. Ministerio de GDHC0021CHR / Published DEC 2012 Healthcare, Regulatory and Reimbursement Landscape Page 141 Venezuela © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form
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