Healthcare, Regulatory and Reimbursement Landscape. Mexico

Transcription

1 Healthcare, Regulatory and Reimbursement Landscape Mexico Reference Code: GDHC0016CHR Publication Date: August 2012

2 The Large Working Age Population Supports the Economy of the Country by Providing a Readily Available Workforce. however, the Rising Elderly Population will be a Challenge for the Mexican Government as the Demand for Healthcare Services will Increase. The population of Mexico in 2010 was approximately XX million, making it the XXth most populated country in the world (INEGI, 2010a). However, the declining share of the population in the group aged XX-XX years, and the increasing share of the elderly population (XX years and above), represent a demographic as well as a healthcare challenge; the rising elderly population will drive up the government s healthcare expenditure and there will be fewer taxpayers to support it. Mexican labor is generally low skilled and has less schooling than that of developed industrial economies. This scarcity in skilled human capital manifests itself in sluggish labor productivity and low real wages (Library of Congress, 2008). Figure 1 shows the population distribution from 2005, and the forecast population through The Mexican Healthcare Market has High Growth Potential. The Increasing Elderly Population, Prevalence of Non- Communicable Diseases, Improvements in Regulatory Guidelines, Government Support to the Healthcare Sector, and the North American Free Trade Agreement, which Assures its Members Protection of Intellectual Property Rights, Provides the Necessary Impetus for the Growth of the Mexican Pharmaceutical Market. As Figure 2 shows below, the pharmaceutical market in 2005 was valued at approximately $XX billion and is projected to reach approximately $XX billion by 2020, at a CAGR of XX%. Reforms in the General Health Law (Ley General de Salud) and the healthcare sector led to the formalization of the health protection system. Moreover, Seguro Popular led to an increase in the public funds to purchase medicines, and reduced the direct purchase of medicines by the final consumer (War and Gutierrez, 2009). Pharmaceutical Market ($bn), Mexico, Age Groups, Mexico, Population Distribution (%), Population (%) CAGR ( ):XX% CAGR ( ): XX% Revenue ($bn) CAGR ( ): 7% CAGR ( ): XX% * 2020* Year * 2020* Year Source: GlobalData; INEGI, 2012**; US Census Bureau, 2012*** *Estimated Figures **See source entries in the bibliography for full source details ***See source entries in the bibliography for full source details As Figure 1 shows, the population aged XX years and above is increasing at a Compound Annual Growth Rate (CAGR) of XX% between 2005 and The share in population is projected to rise from XX% in 2005 to XX% in The elderly population of Mexico is rising due to higher life expectancy and strong financial support for the elderly population, such as Progresa/Oportunidades and the National Institute of Older Persons (Instituto Nacional de las Personas Adultas Mayores, INAPAM). An increasing elderly population will impose financial and logistical burdens on the healthcare system but will also act as a driver for the growth of the healthcare market (Behrman and Parker, 2011). Source: GlobalData; Daiichi Sankyo, News Release, August 2, 2011; OECD, 2007f *Estimated Figures As Figure 3 shows, the size of the medical device market was approximately $XX billion in The market is projected to reach approximately $XX billion by 2020, at a projected CAGR of XX%. Ophthalmic devices (XX%), nephrology and urology devices (XX%), and orthopedic devices (XX%) were the major segments in the medical device market in The key challenges being faced by the medical device industry in Mexico include the country s dependency on the US for the import of devices, and low expenditure on R&D by the domestic sector. 1 Page 2

3 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction Report Guidance Overview of the Pharmaceutical and Medical Device Market Pharmaceutical Market Market Overview Supply Channels Market Segments Major Disease Areas Major Players Medical Device Market Market Overview Overview of Top Five Segments Major Players Market Drivers and Barriers Drivers Barriers Market Access Reimbursement and Payer Landscape Healthcare System Overview Reimbursement Process Overview of Insurance Providers Patients Share in Healthcare Spending Price Trend in Healthcare Services Pricing Policies Regulatory Landscape Overview of Regulatory Agencies Marketing Authorization Procedure for Pharmaceutical Products New Medical Device Approval Process Licensing Process for Pharmaceutical and Medical Device Manufacturing Licensing Process for Pharmaceutical Exports and Imports Intellectual Property Rights Clinical Trial Regulations Pharmaceutical Advertising Regulations Pharmacy Regulations Labeling and Packaging Regulations Country Analysis Political Environment Political Structure Analysis of the Current Political Environment Healthcare Policy Initiatives Economic Landscape Economic Indicators Gross Domestic Product Gross National Income Inflation Currency Exchange Rate Foreign Direct Investment Foreign Exchange Reserves Trade Balance Government Net Debt External Debt Major Industries Demography Population Education and Literacy Employment Page 5

4 5.4.4 Disease Burden Healthcare Infrastructure Healthcare Facilities Healthcare Parameters Environmental Health Healthcare Personnel Healthcare Expenditure Overview Major Components of Healthcare Spending Share of Public and Private Sectors Spending in Healthcare R&D Trade Associations Mexican Association of Pharmaceutical Research National Association of Pharmaceutical Manufacturers Mexican Association of Pharmaceutical Laboratories National Chamber of the Pharmaceutical Industry Trade Fairs Opportunities and Challenges Opportunities Challenges Appendix Abbreviations Bibliography Methodology Coverage Secondary Research Forecasting Primary Research Expert Panel Validation Contact Us Disclaimer Page 6

5 1.1 List of Tables Table 1: Pharmaceutical Market, Mexico, Revenue ($bn), Table 2: Pharmaceutical Market, Mexico, Forecast ($bn), Table 3: Drugs Going Off-Patent, Revenues ($bn), Global, Table 4: Major Products, Genomma Lab Internacional, SAB de CV, Table 5: Major Products, Pfizer, Global, Revenue ($m), Table 6: Late Stage Pipeline, Pfizer, Table 7: Major Products, Sanofi, Global, Revenue ($m), Table 8: Late Stage Pipeline, Sanofi, Table 9: Major Products, GlaxoSmithKline, Global, Revenue ($m), Table 10: Late Stage Pipeline, GlaxoSmithKline, Table 11: Major Products, Liomont, Table 12: Medical Device Market ($bn), Mexico, Table 13: Medical Device Market ($bn), Mexico, Forecast, Table 14: Medical Device Market, Mexico, Segments, Revenue ($m), Table 15: Ophthalmic Devices Market ($m), Mexico, Table 16: Sales Trends for Major Players*, Ophthalmic Devices, Mexico, Table 17: Nephrology and Urology Devices Market ($m), Mexico, Table 18: Sales Trends for Major Players*, Nephrology and Urology Devices, Mexico, Table 19: Orthopedic Devices Market ($m), Mexico, Table 20: Sales Trends for Major Players*, Orthopedic Devices, Mexico, Table 21: In Vitro Diagnostics Market ($m), Mexico, Table 22: Sales Trends for Major Players*, In Vitro Diagnostic Devices, Mexico, Table 23: Diagnostic Imaging Market ($m), Mexico, Table 24: Sales Trends for Major Players*, Diagnostic Imaging Market, Mexico, Table 25: Major Medical Device Companies, Mexico, Revenue ($m), Table 26: Major Products, Fresenius Medical, Table 27: Major Products, Roche, Global, Revenue ($m), Table 28: Late Stage Pipeline, F. Hoffmann-La Roche Ltd., Table 29: Major Products, Siemens, Global, Revenue ($m), Table 30: Major Products, Baxter International, Global, Revenue ($m), Table 31: Healthcare Spending, Mexico, Patient's Share (%), Table 32: Price Trend in Healthcare Sector (%), Mexico, Table 33: Regulatory Fee Structure, Pharmaceutical Products, Mexico, Table 34: Regulatory Review Time, Pharmaceutical Products, Mexico, Table 35: Medical Device Approval Timelines, Mexico, Table 36: Regulatory Fee Structure, Medical Devices, Mexico, Table 37: GDP Per Capita ($), Mexico, Table 38: GDP Per Capita ($), Mexico, Forecast, Table 39: GDP, Mexico, Annual Growth (%), Table 40: GDP, Mexico, Annual Growth (%), Forecast, Table 41: GNI Per Capita ($), Mexico, Table 42: Average Consumer Price Index, Mexico, Table 43: Average Consumer Price Index, Mexico, Forecast, Table 44: Average Consumer Price, Mexico, Annual Change (%), Table 45: Average Consumer Price, Mexico, Annual Change (%), Forecast, Table 46: Currency Exchange Rate ($/MXN), Mexico, Table 47: Foreign Direct Investment ($bn), Mexico, Table 48: Foreign Exchange Reserves ($bn), Mexico, Table 49: Imports of Goods and Services ($bn), Mexico, Table 50: Exports of Goods and Services ($bn), Mexico, Table 51: General Government Net Debt ($bn), Mexico, Table 52: General Government Net Debt ($bn), Mexico, Forecast, Table 53: External Debt ($bn), Mexico, Table 54: Major Industries, Mexico, Gross Output ($bn), Table 55: Population (m), Mexico, Table 56: Population (m), Mexico, Forecast, Table 57: Urban and Rural Population, Mexico, Share (%), Table 58: Age Groups, Mexico, Population Distribution (%), Table 59: Age Groups, Mexico, Population Distribution (%), Forecast, Table 60: Births (Per 1,000 Population), Mexico, Table 61: Mortality (Per 1,000 Population), Mexico, Table 62: Major Causes of Mortality ( 000s), Mexico, Page 7

6 Table 63: Children <5 Years Age, Mexico, Mortality (Per 1,000 Live Births), Table 64: Maternal Mortality (Per 100,000 Live Births), Mexico, Table 65: Immunization Rate (%), Mexico, Table 66: Major Causes of Male Mortality ( 000s), Mexico, Table 67: Major Causes of Female Mortality ( 000s), Mexico, Table 68: Gender Ratio (M/F), Mexico, Table 69: Life Expectancy at Birth (Years), Mexico, Table 70: Levels of Education, Mexico, Students Enrollment ( 000s), Table 71: Unemployment Rate (%), Mexico, Table 72: Employees, Mexico, Segment Share (%), Table 73: Major Diseases, Mexico, Hospital Discharges ( 000s), Table 74: Major Diseases, Mexico, DALY (Per 100,000 Population), Table 75: Hospitals, Mexico, Table 76: Public and Private Hospitals, Mexico, Table 77: Hospital by Standard of Care, Mexico, Share (%), Table 78: Public Hospital by Bed Size, Mexico, Table 79: Private Hospital by Bed Size, Mexico, Table 80: Public Hospitals without Coverage Plan, Mexico, Table 81: Public Hospitals with Coverage Plan, Mexico, Table 82: Diagnostic Facilities, Mexico, Diagnostic Devices (Per 100,000 Population), Table 83: Diagnostic Centers, Mexico, Table 84: Hospital Beds (Per 1,000 Population), Mexico, Table 85: Physicians (Per 1,000 Population), Mexico, Table 86: Environmentally Attributable Deaths (Per 100,000 Population), Mexico, Table 87: PM10 (microgram per cubic meter), Mexico, Table 88: CO 2 Emissions (Million Tons), Mexico, Table 89: Sewerage, Mexico, Population Connected (%), Table 90: Waste Generation (Million Tons), Mexico, Table 91: Healthcare Personnel (Per 1,000 Population), Mexico, Table 92: Healthcare Expenditure (% of the GDP), Mexico, Table 93: Public Healthcare Expenditure, Mexico, Share of Major Components (%), Table 94: Healthcare Expenditure, Mexico, Public Private Share (%), Table 95: Public Healthcare R&D Expenditure ($m), Mexico, Table 96: Major Healthcare Trade Fairs, Mexico, Page 8

7 1.2 List of Figures Figure 1: Pharmaceutical Market, Mexico, Revenue ($bn), Figure 2: Pharmaceutical Market, Mexico, Forecast ($bn), Figure 3: Medical Device Market ($bn), Mexico, Figure 4: Medical Device Market ($bn), Mexico, Forecast, Figure 5: Medical Device Market, Mexico, Segments, Revenue ($m), Figure 6: Ophthalmic Devices Market ($m), Mexico, Figure 7: Sales Trends for Major Players*, Ophthalmic Devices, Mexico, Figure 8: Nephrology and Urology Devices Market ($m), Mexico, Figure 9: Sales Trends for Major Players*, Nephrology and Urology Devices, Mexico, Figure 10: Orthopedic Devices Market ($m), Mexico, Figure 11: Sales Trends for Major Players*, Orthopedic Devices, Mexico, Figure 12: In Vitro Diagnostics Market ($m), Mexico, Figure 13: Sales Trends for Major Players*, In Vitro Diagnostic Devices, Mexico, Figure 14: Diagnostic Imaging Market ($m), Mexico, Figure 15: Sales Trends for Major Players*, Diagnostic Imaging Market, Mexico, Figure 16: Major Medical Device Companies, Mexico, Revenue ($m), Figure 17: Drivers and Barriers, Healthcare Market, Mexico, Figure 18: Addition of Drug in Basic Formulary, Mexico, Figure 19: Healthcare Spending, Mexico, Patient's Share (%), Figure 20: Price Trend in Healthcare Sector (%), Mexico, Figure 21: Marketing Authorization Procedure, Mexico, Figure 22: Licensing Process for Manufacturing, Mexico, Figure 23: Patent Approval Process, Mexico, Figure 24: Trademark Approval Process, Mexico, Figure 25: Clinical Trial Regulation Process, Mexico, Figure 26: GDP Per Capita ($), Mexico, Figure 27: GDP Per Capita ($), Mexico, Forecast, Figure 28: GDP, Mexico, Annual Growth (%), Figure 29: GDP, Mexico, Annual Growth (%), Forecast, Figure 30: GNI Per Capita ($), Mexico, Figure 31: Average Consumer Price Index, Mexico, Figure 32: Average Consumer Price Index, Mexico, Forecast, Figure 33: Average Consumer Price, Mexico, Annual Change (%), Figure 34: Average Consumer Price, Mexico, Annual Change (%), Forecast, Figure 35: Currency Exchange Rate ($/MXN), Mexico, Figure 36: Foreign Direct Investment ($bn), Mexico, Figure 37: Foreign Exchange Reserves ($bn), Mexico, Figure 38: Imports of Goods and Services ($bn), Mexico, Figure 39: Exports of Goods and Services ($bn), Mexico, Figure 40: General Government Net Debt ($bn), Mexico, Figure 41: General Government Net Debt ($bn), Mexico, Forecast, Figure 42: External Debt ($bn), Mexico, Figure 43: Major Industries, Mexico, Gross Output ($bn), Figure 44: Population (m), Mexico, Figure 45: Population (m), Mexico, Forecast, Figure 46: Urban and Rural Population, Mexico, Share (%), Figure 47: Age Groups, Mexico, Population Distribution (%), Figure 48: Age Groups, Mexico, Population Distribution (%), Forecast, Figure 49: Births (Per 1,000 Population), Mexico, Figure 50: Mortality (Per 1,000 Population), Mexico, Figure 51: Major Causes of Mortality ( 000s), Mexico, Figure 52: Children <5 Years Age, Mexico, Mortality (Per 1,000 Live Births), Figure 53: Maternal Mortality (Per 100,000 Live Births), Mexico, Figure 54: Immunization Rate (%), Mexico, Figure 55: Major Causes of Male Mortality ( 000s), Mexico, Figure 56: Major Causes of Female Mortality ( 000s), Mexico, Figure 57: Gender Ratio (M/F), Mexico, Figure 58: Life Expectancy at Birth (Years), Mexico, Figure 59: Levels of Education, Mexico, Students Enrollment ( 000s), Figure 60: Unemployment Rate (%), Mexico, Figure 61: Employees, Mexico, Segment Share (%), Page 9

8 Figure 62: Major Diseases, Mexico, Hospital Discharges ( 000s), Figure 63: Major Diseases, Mexico, DALY (Per 100,000 Population), Figure 64: Hospitals, Mexico, Figure 65: Public and Private Hospitals, Mexico, Figure 66: Hospital by Standard of Care, Mexico, Share (%), Figure 67: Public Hospital by Bed Size, Mexico, Figure 68: Private Hospital by Bed Size, Mexico, Figure 69: Public Hospitals without Coverage Plan, Mexico, Figure 70: Public Hospitals with Coverage Plan, Mexico, Figure 71: Diagnostic Facilities, Mexico, Diagnostic Devices (Per 100,000 Population), Figure 72: Diagnostic Centers, Mexico, Figure 73: Hospital Beds (Per 1,000 Population), Mexico, Figure 74: Physicians (Per 1,000 Population), Mexico, Figure 75: Environmentally Attributable Deaths (Per 100,000 Population), Mexico, Figure 76: PM10 (microgram per cubic meter), Mexico, Figure 77: CO2 Emissions (Million Tons), Mexico, Figure 78: Sewerage, Mexico, Population Connected (%), Figure 79: Waste Generation (Million Tons), Mexico, Figure 80: Healthcare Personnel (Per 1,000 Population), Mexico, Figure 81: Healthcare Expenditure (% of the GDP), Mexico, Figure 82: Public Healthcare Expenditure, Mexico, Share of Major Components (%), Figure 83: Healthcare Expenditure, Mexico, Public Private Share (%), Figure 84: Public Healthcare R&D Expenditure ($m), Mexico, Figure 85: Opportunities and Challenges, Healthcare Market, Mexico, Page 10

9 2 Introduction 2.1 Report Guidance The report begins with an Executive Summary which gives an overview of the healthcare market of Mexico 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 Mexico. The Overview of the Pharmaceutical and Medical Device Market chapter provides an overview that includes market size; market segmentation by generics, Over-the-Counter (OTC) and biologics/biosimilars products; and the key drivers and barriers for the market. The section also includes profiles of the major players, including a SWOT assessment. The Market Access chapter covers the reimbursement and payer landscape as well as the regulatory landscape. The reimbursement and payer landscape elaborates on the features of the healthcare reimbursement process for Mexico, and 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 overview of the landscape for intellectual property rights are also covered in this chapter. The Country Analysis chapter provides a detailed analysis of the political and economic environment of Mexico. It analyzes the economic indicators, demographics, healthcare infrastructure and healthcare expenditure of Mexico. The Opportunities and Challenges chapter provides an overview of the opportunities and challenges for growth that exist in the healthcare market of Mexico Page 11

10 5.3 Economic Indicators Gross Domestic Product GDP Per Capita Gross Domestic Product (GDP) provides a measure of the size of an economy, related to the monetary value of all production activities. GDP per capita in current prices of Mexico increased from 2005 to 2010 at a CAGR of XX%, as shown in Figure 26 below. The GDP per capita of Mexico is lower than the GDP per capita of total OECD countries. In 2010, the GDP per capita at current price of Mexico was $XX. For the same year, it was $XX for total OECD countries. In 2009, Mexico attained a lower GDP per capita than the previous year, due to: Global demand for exports declining Asset prices falling Decline in remittances and investments (CIA, 2012) Figure 26: GDP Per Capita ($), Mexico, CAGR ( ): XX% GDP Per Capita ($) Year Source: GlobalData; IMF, 2011*; The World Bank, 2012** *See source entries in the bibliography for full source details **See source entries in the bibliography for full source details Table 37: GDP Per Capita ($), Mexico, Year GDP Per Capita Source: GlobalData; IMF, 2011*; The World Bank, 2012** *See source entries in the bibliography for full source details **See source entries in the bibliography for full source details Page 112

11 5.4 Demography Population Mexico is bordered by the US on the north; by the Pacific Ocean on the south and west; by Guatemala, Belize and the Caribbean Sea on the southeast; and by the Gulf of Mexico on the east. Mexico is the fifth largest country in the Americas and the 14th largest independent nation in the world (BMAA Missions, 2011). In 2010, the population of Mexico was approximately XX million and it was the XX th most populated country in the world. There was a steady increase in the population from at a CAGR of XX%, as Figure XX shows. Figure 44: Population (m), Mexico, CAGR ( ):XX% Population (m) Year Source: GlobalData; INEGI, 2012c; US Census Bureau, 2012** ** See source entries in the bibliography for full source details Table 55: Population (m), Mexico, Year Population Source: GlobalData; INEGI, 2012c; US Census Bureau, 2012** ** See source entries in the bibliography for full source details Page 130

12 5.6.2 Major Components of Healthcare Spending In 2010, curative care services had the highest share of total public healthcare expenditure, approximately XX%. Curative care services in Mexico include curative care inpatient and outpatient services, medical and basic diagnostic services, dental care and specialized medical services. Other major components in healthcare spending were health insurance, medical goods supply, generation of resources, preventive and public healthcare services and ancillary healthcare services. Expenditure on healthcare insurance by government had the second highest share, XX%. Figure XX shows the complete breakdown. Figure 82: Public Healthcare Expenditure, Mexico, Share of Major Components (%), 2010 Ancillary healthcare services XX% Preventive and public healthcare services XX% Generation of resources XX% Medical goods supplied to outpatients XX% Curative care services XX% Health insurance administration XX% Source: SINAIS, 2009* *See source entries in the bibliography for full source details Table 93: Public Healthcare Expenditure, Mexico, Share of Major Components (%), 2010 Major Component Curative care services Health insurance administration Medical goods supplied to outpatients Generation of resources Preventive and public Healthcare services Ancillary healthcare services Source: SINAIS, 2009* *See source entries in the bibliography for full source details Share Page 171

13 7 Appendix 7.1 Abbreviations ACTA : Anti-Counterfeiting Trade Agreement AIDS : Acquired Immune Deficiency Syndrome AMELAF : Asociación Mexicana de Laboratorios Farmacéuticos (Mexican Association of Pharmaceutical Laboratories) AMIIF : Asociación Mexicana de Industrias de Investigación Farmacéutica (Mexican Association of Pharmaceutical Research) ANAFAM : Asociación Nacional de Fabricantes de Medicamentos (National Association of Pharmaceutical Manufacturers) APEC : Asia Pacific Economic Cooperation APV : Arranque Parejo en la Vida (Start in Life Program) BRIC : Brazil, Russia, India and China BRT : Bus Rapid Transit CAGR : Compound Annual Growth Rate CANIFARMA: Cámara Nacional de la Industria Farmacéutica (National Chamber of the Pharmaceutical Industry) CCNPMIS : Comisión Coordinadora para la Negociación de Precios de Medicamentos y otros Insumos para la Salud (Coordinating Committee for the Negotiation of Prices Medicines and other Health Supplies) CDM : Clean Development Mechanism CIA : Central Intelligence Agency CIDET : Centro de Innovación y Desarrollo Tecnológico (Center for Innovation and Technological Development) CIS : Centro Integral de Servicios (Center for Integrated Services) CMN : Comité de Moléculas Nuevas (New Molecule Committee) CNS : Central Nervous System CMS : Centers for Medicare and Medicaid Services COEVAL : Consejo Nacional de Evaluación de la Política de Desarrollo Social (National Council on Evaluation of Social Development Policy) Cofepris : Creación de la Comisión Federal para la Protección contra Riesgos Sanitarios (Creation of the Federal Commission for Protection against Health Risks) COPD : Chronic Obstructive Pulmonary Disease CPI : Consumer Price Index CRS : Congressional Research Service CT : Computed Tomography DALY : Disability Adjusted Life Year DHHS : Department of Health and Human Services DPT : Diphtheria, Pertussis and Tetanus ESRD : End Stage Renal Disease EU : European Union FCL : Flexible Credit Line FDI : Foreign Direct Investment FIFARMA : Latin American Federation of Pharmaceutical Industry Page 178

14 Forex : Foreign Exchange Reserves GCI : Global Competitiveness Index GCP : Good Clinical Practice GDP : Gross Domestic Product GLP : Good Laboratory Practice GMP : Good Manufacturing Practice GNI : Gross National Income HD : Hemodialysis HIMFG : Hospital Infantil de Mexico Federico Gomez HIV : Human Immunodeficiency Virus IBS : Irritable bowel syndrome IFPMA : International Federation of Pharmaceutical Manufacturers IMF : International Monetary Fund IMPI : Instituto Mexicano de la Propiedad Industrial (Mexican Institute of Industrial Property) IMSS : Instituto Mexicano del Seguro Social (Mexican Social Security Institute) INAPAM : Instituto Nacional de las Personas Adultas Mayores (National Institute of Older Persons) INEGI : Instituto Nacional de Estadística y Geografía INSP : Instituto Nacional de Salud Publica ISSSTE : Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (Institute of Security and Social Services for State Workers) KNC : Kraevoy Nefrologicheskiy Center LAES : Latin American Economic System LAIA : Latin American Integration Association LDL : Low Density Lipid LGEEPA : Ley General de Equilibrio Ecológico y Protección Ambiental (General Law of Ecological Balance and Environmental Protection) LGPGIR : Programa Nacional para la Prevención y Gestión Integral de los Residuos MOITI : Massachusetts Office of International Trade and Investment MRI : Magnetic Resonance Imaging MXN : Mexican Peso NAFTA : North American Free Trade Agreement NRC : National Research Council NTCP : National Tuberculosis Control Program ODM : Objetivos de Desarrollo del Milenio (Millennium Development Goal) OECD : Organisation for Economic Co-operation and Development OOP : Out-of-Pocket OTC : Over-the-Counter PAN : Partido Acción Nacional (National Action Party) PRD : Partido de la Revolución Democrática (Party of the Democratic Revolution) PD : Peritoneal Dialysis PDHSA : Programa de Derechos Humanos del Sector Ambiental (Human Rights Program of the Environmental Sector) Page 179

15 PECC : Programa Especial de Cambio Climático (Special Climate Change Program) PEMEX : Petróleos Mexicanos (Petroleum Company) PhRMA : Pharmaceutical Research and Manufacturers of America PIR : Precio Internacional de Referencia (International Reference Price) PM10 : Particulate Matter PMVP : Precio Máximo de Venta al Público (Maximum Sales Price to the Public) PNCC : National Program for Cancer Control PRI : Partido Revolucionario Institucional (Institutional Revolutionary Party) PRVP : Precio de Referencia para Venta al Público (Reference Price for Sales to the Public) PT : Partido del Trabajo (Labour Party) PVEM : Partido Verde Ecologista de México (Green Ecological Party of Mexico) R&D : Research and DevelopmentSalud Salud : Secretaria de Salud (Ministry of Health) SDR : Special Drawing Rights SE : Secretaria de Economía (Ministry of Economy) SECOFI : Secretaría de Comercio y Fomento Industrial (Ministry of Commerce and Industrial Development) SEMAR : Secretaría de Marina Armada de México (Ministry of the Navy) SEMARNAP : Secretaría de Medio Ambiente, Recursos Naturales y Pesca (Ministry of Environment, Natural Resources, and Fisheries) SEP : Secretaría de Educación Pública (Secretariat of Public Education) SG&A : Selling, General and Administrative SINAIS : Sistema Nacional de Información en Salud SNS : Sistema Nacional de Salud (National Health System) SPPS : Subsecretaria de Prevención y Promoción de la Salud STD : Sexual Transmitted Diseases TRIFE : Tribunal Federal Electoral (Federal Electoral Tribunal) TRIPS : Trade Related Aspects of Intellectual Property Rights UNCTAD : United Nations Conference on Trade and Development UNEME : Unidades Médicas de Especialidad (Specialty Medical Units) UNFCCC : United Nations Framework Convention on Climate Change USAID : US Agency for International Development WENR : World Education News Review WHO : World Health Organization WIPO : World Intellectual Property Organization WTO : World Trade Organization Page 180

16 7.2 Bibliography Arredondo A, et al. (2007). Economic Burden of Expected Epidemiological Changes in Diseases Related to Tobacco, Mexico. Revista de Saúde Pública; 41(4): Asociación Nacional de Fabricantes de Medicamentos (2011) via El Economista,Generic Drugs, Available from: [Accessed February 9, 2012]. Asociación Nacional de Fabricantes de Medicamentos (2011) via El Universal Generic Drugs Available from: [Accessed February 9, 2012]. Bank of Mexico (2012). Currency Exchange Rate. Bank of Mexico. Available from: [Accessed January 11, 2012]. Barber SL (2007). Family Planning Advice and Postpartum Contraceptive Use Among Low-Income Women in Mexico. International Family Planning Perspectives; 33(1):6-12. Behrman JR and Parker SW (2011). The Impact of the PROGRESA/Oportunidades Conditional Cash Transfer Program on Health and Related Outcomes for the Aging in Mexico. Population Ageing Research Center Working Paper Series, WPS BMAA Missions (2011). Population. BMAA Missions. Available from: [Accessed January 18, 2012] California Environmental Protection Agency (2003). PM10. California Environmental Protection Agency. Available from: [Accessed January 11, 2012]. Central Intelligence Agency (2012). GDP Per Capita. Central Intelligence Agency. Available from: [Accessed January 9, 2012]. Congressional Research Service (2010). Economic Landscape. Congressional Research Service. Available from: [Accessed January 11, 2012]. Creación de la Comisión Federal para la Protección contra Riesgos Sanitarios (2012). Marketing Authorization Procedure for Pharmaceutical Products. Creación de la Comisión Federal para la Protección contra Riesgos Sanitarios. Available from: [Accessed February 14, 2012]. Creación de la Comisión Federal para la Protección contra Riesgos Sanitarios (2012). Labeling and Packaging Regulations. Creación de la Comisión Federal para la Protección contra Riesgos Sanitarios. Available from: agefirstrow=31&&view={3faec755-a2bb-46c9-85d5-88abc9ea38f0}&initialtabid=ribbon%2elistitem&visibilitycontext=wsstabpersistence. [Accessed February 15, 2012]. Cuevas A, et al. (2005). Foreign Direct Investment in Mexico since the Approval of NAFTA. World Bank Economic Review; 19(3): Generic and Biosimilars Initiative Journal (2010). Biologics/Biosimilars. Generic and Biosimilars Initiative Journal. Available from: [Accessed February 11, 2012]. Huck JD (2008). Mexico: A Global Studies Handbook. ABC-CILO, Inc. Santa Barbara, California, CA. The Heritage Foundation (2012). Economic Landscape. The Heritage Foundation. Available from: [Accessed February 2, 2012]. International Diabetes Federation (2006). Biologics/Biosimilars. International Diabetes Federation. Available from: [Accessed February 16, 2012]. Page 181

17 Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (2010). Public Insurance. Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado. Available from: [Accessed February 15, 2012]. Instituto Mexicano de la Propiedad Industrial (2011). Patents. Instituto Mexicano de la Propiedad Industrial. Available from: [Accessed February 16, 2012]. Instituto Nacional de Estadistica y Geografia (2010a). Population. Instituto Nacional de Estadistica y Geografia. Available from: [Accessed January 16, 2012]. Instituto Mexicano del Seguro Social (2010). Public Insurance. Instituto Mexicano del Seguro Social. Available from: [Accessed February 17, 2012]. Instituto Nacional de Estadistica y Geografia (2011a). Foreign Direct Investment. Instituto Nacional de Estadistica y Geografia. Available from: D [Accessed January 17, 2012]. Instituto Nacional de Estadistica y Geografia (2011b). Imports of Goods and Services. Instituto Nacional de Estadistica y Geografia. Available from: D [Accessed January 18, 2012]. Instituto Nacional de Estadistica y Geografia (2011c). Exports of Goods and Services. Instituto Nacional de Estadistica y Geografia. Available from: D [Accessed January 16, 2012]. Instituto Nacional de Estadistica y Geografia (2011d). Education and Literacy. Instituto Nacional de Estadistica y Geografia. Available from: 011/mexatg_2011.pdf. [Accessed January 17, 2012]. Instituto Nacional de Estadistica y Geografia (2011e). Employment. Instituto Nacional de Estadistica y Geografia. Available from: 011/mexatg_2011.pdf. [Accessed January 17, 2012]. Instituto Nacional de Estadistica y Geografia (2011f). Population. Instituto Nacional de Estadistica y Geografia. Available from: 3A%2F%2Fwww.inegi.org.mx%2Fest%2Fcontenidos%2Fproyectos%2Fccpv%2Fcpv2010%2Fdefaul t.aspx%3f_file%3dcpv2010_panorama.pdf&ei=fvb_t4saemagraedkpgibg&usg=afqjcngu3enc M4Zyr4XgqzHScppapncUwg&sig2=urSF1JrsUhP6JxBnCGZsHw. [Accessed January 18, 2012]. Instituto Nacional de Estadistica y Geografia (2012a). Distribution by Age Group. Instituto Nacional de Estadistica y Geografia. Available from: 3A%2F%2Fwww.inegi.org.mx%2Fest%2Fcontenidos%2Fproyectos%2Fccpv%2Fcpv2010%2Fdefaul t.aspx%3f_file%3dcpv2010_panorama.pdf&ei=fvb_t4saemagraedkpgibg&usg=afqjcngu3enc M4Zyr4XgqzHScppapncUwg&sig2=urSF1JrsUhP6JxBnCGZsHw. [Accessed January 18, 2012]. Instituto Nacional de Estadistica y Geografia (2012b). Mortality Rate. Instituto Nacional de Estadistica y Geografia. Available from: 1/Aeeum11_1.pdf. [Accessed January 19, 2012]. Instituto Nacional de Estadistica y Geografia (2012c). Population. Instituto Nacional de Estadistica y Geografia. Available from: Page 182

18 1/Aeeum11_1.pdf. [Accessed January 19, 2012]. Instituto Nacional de Estadistica y Geografia (2012). Birth Rate. Instituto Nacional de Estadistica y Geografia. Available from: 1/Aeeum11_1.pdf. [Accessed January 18, 2012]. Instituto Nacional de Estadistica y Geografia (2012). Birth Rate. Instituto Nacional de Estadistica y Geografia. Available from: _wa15q155ogmteb45a3mceu45.xml&Titulo=Nacimientos. [Accessed January 18, 2012]. Instituto Nacional de Estadistica y Geografia (2012). Gender Ratio. Instituto Nacional de Estadistica y Geografia. Available from: 1/Aeeum11_1.pdf. [Accessed January 19, 2012]. Instituto Nacional de Estadistica y Geografia (2012). Mortality Rate. Instituto Nacional de Estadistica y Geografia. Available from: _wa15q155ogmteb45a3mceu45.xml&Titulo=Defunciones%20generales%20hombres [Accessed January 19, 2012]. Instituto Nacional de Estadistica y Geografia (2012). Price Trend in Healthcare Services. Instituto Nacional de Estadistica y Geografia. Available from: ecios%20al%20consumidor&st=%cdndice%20nacional%20de%20precios%20al%20consumidor, %20clasificaci%F3n%20objeto%20del%20gasto%20%A0. [Accessed February 20, 2012]. Instituto Nacional de Salud Publica (2012). Healthcare Policy Initiatives. Instituto Nacional de Salud Publica. Available from: [Accessed February 20, 2012]. International Monetary Fund (2011a). Economic Landscape. International Monetary Fund. Available from: [Accessed February 20, 2012]. International Monetary Fund (2011). Annual Change in Consumer Price. International Monetary Fund. Available from: [Accessed January 17, 2012]. International Monetary Fund (2011). Annual Growth of GDP. International Monetary Fund. Available from: [Accessed January 18, 2012]. International Monetary Fund (2011). Consumer Price Index. International Monetary Fund. Available from: [Accessed January 18, 2012]. International Monetary Fund (2011). GDP Per Capita. International Monetary Fund. Available from: [Accessed January 18, 2012]. International Monetary Fund (2011). Government Net Debt. International Monetary Fund. Available from: [Accessed January 19, 2012]. International Monetary Fund (2011). Government Structural Balance. International Monetary Fund. Available from: [Accessed January 18, 2012]. International Asset Management (2008). New Mexican marketing authorisation and data exclusivity regulations. International Asset Management. Available from: [Accessed July 12, 2012] Page 183

19 Jasso GL, et al. (2010). Tendency of the Consumption and Weighted Average Price in Regard to the Cost of Anti-infective Drugs in a Pediatric Hospital. Boletín médico del Hospital Infantil de México; 67(1): Latin American Network Information Center (2011). Analysis of the Current Political Environment. Latin American Network Information Center. Available from: [Accessed February 21, 2012]. Leenen I, et al. (2008). Effectiveness of a Mexican Health Education Program in a Poverty-Stricken Rural Area of Guatemala. Journal OF Cross-Cultural Psychology; 39(2): Library of Congress Federal Research Division (2008). Economic Landscape. Library of Congress Federal Research Division. Available from: [Accessed January 20, 2012]. Massachusetts Office of International Trade and Investment (2011a). Healthcare Facilities. Massachusetts Office of International Trade and Investment. Available from: [Accessed January 23, 2012]. Massachusetts Office of International Trade and Investment (2011b). Pharmaceutical Market. Massachusetts Office of International Trade and Investment. Available from: [Accessed February 22, 2012]. Massachusetts Office of International Trade and Investment (2011c). Biologics/Biosimilars. Massachusetts Office of International Trade and Investment. Available from: [Accessed February 22, 2012]. MyBio (2012). Biologics/Biosimilars. MyBio. Available from: [Accessed June 21, 2012]. National Cancer Institute (2011). Cancer. National Cancer Institute. Available from: [Accessed February 22, 2012]. Núñez EO, et al. (2009). Participación social en salud:la experiencia del programa de salud maternal Arranque Parejo en la Vida. Salud Pública de México; 51(2): Objetivos de Desarrollo del Milenio (2012). Healthcare Policy Initiatives. Objetivos de Desarrollo del Milenio. Available from: [Accessed February 22, 2012]. Organisation for Economic Co-operation and Development (2005). Healthcare Facilities. Organisation for Economic Co-operation and Development. Available from: [Accessed January 23, 2012]. Organisation for Economic Co-operation and Development (2007a). Supply Channel. Organisation for Economic Co-operation and Development. Available from: [Accessed February 27, 2012]. Organisation for Economic Co-operation and Development (2007b). Generic Drugs. Organisation for Economic Co-operation and Development. Available from: [Accessed February 23, 2012]. Organisation for Economic Co-operation and Development (2007c). Over-the-Counter. Organisation for Economic Co-operation and Development. Available from: [Accessed February 27, 2012]. Organisation for Economic Co-operation and Development (2007d). Public Insurance. Organisation for Economic Co-operation and Development. Available from: [Accessed February 22, 2012]. Organisation for Economic Co-operation and Development (2007e).Pricing Policies. Organisation for Economic Co-operation and Development. Available from: [Accessed February 27, 2012]. Organisation for Economic Co-operation and Development (2007f). Pharmaceutical Market. Organisation for Economic Co-operation and Development. Available from: [Accessed February 27, 2012]. Page 184

20 Organisation for Economic Co-operation and Development (2011a). Public Insurance. Organisation for Economic Co-operation and Development. Available from: [Accessed February 22, 2012]. Organisation for Economic Co-operation and Development (2011). Diagnostic Facilities. Organisation for Economic Co-operation and Development. Available from: [Accessed January 30, 2012]. Organisation for Economic Co-operation and Development (2011). Doctors to Population Ratio. Organisation for Economic Co-operation and Development. Available from: [Accessed January 30, 2012]. Organisation for Economic Co-operation and Development (2011). Healthcare Personnel. Organisation for Economic Co-operation and Development. Available from: [Accessed January 30, 2012]. Organisation for Economic Co-operation and Development (2011). Healthcare Expenditure. Organisation for Economic Co-operation and Development. Available from: [Accessed January 30, 2012]. Organisation for Economic Co-operation and Development (2011). Healthcare Expenditure of Public and Private Sectors. Organisation for Economic Co-operation and Development. Available from: [Accessed January 30, 2012]. Organisation for Economic Co-operation and Development (2011). Hospital Beds to Population Ratio. Organisation for Economic Co-operation and Development. Available from: [Accessed January 30, 2012]. Organisation for Economic Co-operation and Development (2012). Health Status by Gender and Age. Organisation for Economic Co-operation and Development. Available from: [Accessed January 30, 2012]. Organisation for Economic Co-operation and Development (2012). Healthcare facilities. Organisation for Economic Co-operation and Development. Available from: [Accessed January 30, 2012]. Organisation for Economic Co-operation and Development (2012). Life Expectancy. Organisation for Economic Co-operation and Development. Available from: [Accessed January, 2012]. Organisation for Economic Co-operation and Development (2012). Major Industries. Organisation for Economic Co-operation and Development. Available from: [Accessed January 31, 2012]. Organisation for Economic Co-operation and Development (2012). Public and Private Hospitals. Organisation for Economic Co-operation and Development. Available from: [Accessed January 31, 2012]. Pagan JA, et al. (2006). Self-medication and Health Insurance Coverage in Mexico. Health Policy; 75(2): Possani LD (2003). The past, present, and future of biotechnology in Mexico, Nature Biotechnology; 21(1): Presidencia de la Republica (2012a). Analysis of the Current Political Environment. Presidencia de la Republica. Available from: [Accessed February 27, 2012]. Presidencia de la Republica (2012b). Pharmaceutical Advertising Regulations. Presidencia de la Republica. Available from: [Accessed February 27, 2012]. Page 185