healthcare, regulatory and reimbursement landscape - israelsample reference code: gdhc0032chr...

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Reference Code: GDHC0032CHR

Publication Date: December 2012

Healthcare, Regulatory and Reimbursement Landscape

Israel

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Healthcare, Regulatory and Reimbursement Landscape - Israel

GDHC0032CHR / Published DEC 2012

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form

The Highest Proportion of the Population is in the

Economically Productive Working age Group and

Government Initiatives have Contributed Significantly to

Israel’s Economic Development

Age Groups, Israel, Population Distribution (%),

2005-2020

Source: GlobalData; CBS, 2012e

*Estimated figures

Factors Such as Technological Advances in the Field of

Medicine, High R&D Expenditure and a Robust Economy

will Boost the Growth of the Israeli Pharmaceutical Market

Pharmaceutical Market, Israel, Revenue ($bn), 2005-2020

Source: GlobalData; Sax, 2005; Pharma Israel, 2011

*Estimated figures

Medical Device Market, Israel, Revenue ($bn), 2006-2020

Source: GlobalData, Medical eTrack [accessed November 19, 2012]

*Estimated figures

Pharmaceutical Players Benefit from Detailed and Well-

Defined Regulatory Filing Procedures, Separate

Departments for the Assessment of Quality and Safety of

Pharmaceutical Products and Ease of Access

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The National Health Insurance Law, Prescription Drug Price

Regulations and Affordable Pharmaceuticals are the

Distinguishing Features of the Israeli Reimbursement

System

Strong Financial Regulations and an Export-Driven Open-

Market Economy has Put Israel on the Path of Economic

Growth, but Strained Political Relationships with

Neighboring Arab Countries and Terrorism Remain Threats

to the Economy

Country Profile, Israel, 2012

Source: GlobalData

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1 Table of Contents

1 Table of Contents .................................................................................................................................. 4 1.1 List of Tables .................................................................................................................................. 5 1.2 List of Figures ................................................................................................................................. 7

2 Introduction ........................................................................................................................................... 9 2.1 Report Guidance ............................................................................................................................. 9

3 Overview of Pharmaceutical and Medical Device Markets ...................................................................10 3.1 Pharmaceutical Market ..................................................................................................................10

3.1.1 Overview of Pharmaceutical Market .....................................................................................10 3.1.2 Market Segment ...................................................................................................................13 3.1.3 Major Disease Areas ............................................................................................................14 3.1.4 Major Players ........................................................................................................................15

3.2 Medical Device Market ..................................................................................................................30 3.2.1 Market Overview ...................................................................................................................30 3.2.2 Overview of the Top Five Segments .....................................................................................32 3.2.3 Major Players ........................................................................................................................43

3.3 Market Drivers and Barriers ...........................................................................................................61 3.3.1 Drivers ..................................................................................................................................61 3.3.2 Barriers .................................................................................................................................62

4 Market Access ......................................................................................................................................63 4.1 Reimbursement and Payer Landscape ..........................................................................................63

4.1.1 Reimbursement Process ......................................................................................................63 4.1.2 Overview of Insurance Providers ..........................................................................................64 4.1.3 Drug Price Trend ..................................................................................................................66 4.1.4 Pricing Policies .....................................................................................................................67

4.2 Regulatory Landscape ...................................................................................................................68 4.2.1 Overview of Regulatory Agencies .........................................................................................68 4.2.2 New Drug Approval Process .................................................................................................69 4.2.3 Licensing Process for Pharmaceutical and Medical Device Manufacturing ..........................69 4.2.4 Licensing Process for Pharmaceutical Exports and Imports .................................................69 4.2.5 Intellectual Property Rights ...................................................................................................70 4.2.6 Clinical Trial Regulations ......................................................................................................71 4.2.7 Pharmaceutical and Medical Devices Advertising Regulations ............................................72 4.2.8 Labeling and Packaging Regulations ...................................................................................73

5 Country Analysis ..................................................................................................................................74 5.1 Political Environment .....................................................................................................................74

5.1.1 Political Structure ..................................................................................................................74 5.1.2 Analysis of Current Political Environment .............................................................................75 5.1.3 Healthcare Policy Initiatives ..................................................................................................76

5.2 Economic Landscape ....................................................................................................................77 5.3 Economic Indicators ......................................................................................................................78

5.3.1 Gross Domestic Product .......................................................................................................78 5.3.2 Gross National Income .........................................................................................................82 5.3.3 Inflation .................................................................................................................................83 5.3.4 Currency Exchange Rate......................................................................................................86 5.3.5 Foreign Direct Investment.....................................................................................................87 5.3.6 Foreign Exchange Reserves ................................................................................................88 5.3.7 Trade Balance ......................................................................................................................89 5.3.8 Government Structural Balance ............................................................................................91 5.3.9 Government Net Debt ...........................................................................................................92 5.3.10 Major Industries ....................................................................................................................94

5.4 Demography ..................................................................................................................................95 5.4.1 Population .............................................................................................................................95 5.4.2 Education and Literacy .......................................................................................................110 5.4.3 Employment ........................................................................................................................112 5.4.4 Disease Burden ..................................................................................................................113 5.4.5 Healthcare Facilities ...........................................................................................................115 5.4.6 Healthcare Parameters .......................................................................................................119 5.4.7 Healthcare Personnel .........................................................................................................120 5.4.8 Environmental Health .........................................................................................................124

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5.5 Healthcare Expenditure ...............................................................................................................127 5.5.1 Major Components of Healthcare Spending .......................................................................128 5.5.2 Share of Public and Private Sector in Healthcare ...............................................................129 5.5.3 Healthcare Expenditure by Financing Agent.......................................................................130 5.5.4 Spending in Science and Technology R&D ........................................................................131

5.6 Trade Associations ......................................................................................................................132 5.6.1 Pharmaceutical Association of Israel ..................................................................................132 5.6.2 Pharma Israel .....................................................................................................................132

5.7 Trade Fairs ..................................................................................................................................133 6 Opportunities and Challenges ............................................................................................................134

6.1 Opportunities ...............................................................................................................................134 6.2 Challenges ...................................................................................................................................135

7 Appendix ............................................................................................................................................136 7.1 Abbreviations ...............................................................................................................................136 7.2 Bibliography .................................................................................................................................137 7.3 Methodology ................................................................................................................................140

7.3.1 Coverage ............................................................................................................................140 7.3.2 Secondary Research ..........................................................................................................140 7.3.3 Forecasting .........................................................................................................................140 7.3.4 Primary Research ...............................................................................................................141 7.3.5 Expert Panel Validation ......................................................................................................141

7.4 Disclaimer ....................................................................................................................................141

1.1 List of Tables

Table 1: Pharmaceutical Market, Israel, Revenue ($bn), 2005-2010 ......................................................11 Table 2: Pharmaceutical Market, Israel, Revenue ($bn), 2011-2020 ......................................................12 Table 3: Major Biotechnology Companies and Products, 2011 ..............................................................13 Table 4: Major Products, Teva, Global, Revenue ($m), 2011 .................................................................15 Table 5: Late-stage Pipeline, Teva, 2012 ...............................................................................................16 Table 6: Major Products, Taro, 2012 ......................................................................................................20 Table 7: Major Products, Dexcel Pharma, 2012 .....................................................................................23 Table 8: Major Products, Rekah Pharmaceutical, 2012 ..........................................................................27 Table 9: Medical Device Market, Israel, Revenue ($m), 2006-2011 .......................................................30 Table 10: Medical Device Market, Israel, Revenue Forecast ($m), 2012-2020 ........................................31 Table 11: Medical Device Market, Israel, Segments, Revenue ($m), 2011 ..............................................32 Table 12: Cardiovascular Devices Market, Israel, Revenue ($m), 2006-2011 ..........................................33 Table 13: Sales Trends for Major Players*, Cardiovascular Devices, Israel, 2011 ...................................34 Table 14: Nephrology and Urology Devices, Israel, Revenue ($m), 2006-2011 .......................................35 Table 15: Sales Trends for Major Players*, Nephrology and Urology Devices, Israel, 2011 ....................36 Table 16: In Vitro Diagnostics Market, Israel, Revenue ($m), 2006-2011 .................................................37 Table 17: Sales Trends for Major Players*, In Vitro Diagnostics Devices, Israel, 2010 ............................38 Table 18: Ophthalmic Devices Market, Israel, Revenue ($m), 2006-2011 ................................................39 Table 19: Sales Trends for Major Players*, Ophthalmic Devices, Israel, 2010 .........................................40 Table 20: Orthopedic Devices Market, Israel, Revenue ($m), 2006-2011 ................................................41 Table 21: Sales Trends for Major Players*, Orthopedic Devices, Israel, 2011 .........................................42 Table 22: Major Medical Device Companies, Israel, Revenues ($m), 2010..............................................43 Table 23: Major Products, Medtronic, Global, Revenue ($m), 2011 .........................................................44 Table 24: Major Products, Boston, Global, Revenue ($m), 2010 ..............................................................49 Table 25: Major Products, Siemens Healthcare, Revenue ($m), 2012 .....................................................51 Table 26: Late-stage Pipeline, Siemens Healthcare, 2012 .......................................................................52 Table 27: Major Product Division, B. Braun, Global, Revenue ($m), 2011 ...............................................55 Table 28: Major Products, Roche, Global Revenues ($m), 2012 ..............................................................58 Table 29: Late-stage Pipeline, Roche, 2012 .............................................................................................58 Table 30: Healthcare Spending, Israel, Patient Share (%), 2005-2010 ....................................................65 Table 31: HMOs, Israel, Co-payment Cap for Chronically Ill Patients (NIS), 2012 ...................................65 Table 32: Drug Price Trends (%), Israel, 2006-2011 ................................................................................66 Table 33: HMOs, Israel, Co-payments for Chronically Ill Patients (NIS) (%), 2012 ...................................67 Table 34: GDP Per Capita ($‟000), Israel, 2006-2011 ..............................................................................78 Table 35: GDP Per Capita ($‟000), Israel, Forecast, 2012-2020 ..............................................................79 Table 36: GDP, Annual Growth (%), Israel, 2006-2011 ............................................................................80 Table 37: GDP, Annual Growth (%), Israel, Forecast, 2012-2020 ............................................................81

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Table 38: GNI Per Capita ($‟000), Israel, 2006-2011 ................................................................................82 Table 39: Average Consumer Price Index, Israel, 2006-2011 ..................................................................83 Table 40: Average Consumer Price Index, Israel, Forecast, 2012-2020 ..................................................84 Table 41: Average Consumer Price, Israel, Annual Change (%), 2006-2011 ...........................................85 Table 42: Currency Exchange Rate (NIS/$), Israel, 2006-2011 ................................................................86 Table 43: Foreign Direct Investment ($bn), Israel, 2006-2011 ..................................................................87 Table 44: Foreign Exchange Reserves ($bn), Israel, 2006-2011..............................................................88 Table 45: Imports of Goods and Services ($bn), Israel, 2006-2011 ..........................................................89 Table 46: Exports of Goods and Services ($bn), Israel, 2006-2011 .........................................................90 Table 47: General Government Structural Balance ($bn), Israel, 2005-2010 ...........................................91 Table 48: General Government Net Debt ($bn), Israel, 2005-2010 ..........................................................92 Table 49: General Government Net Debt ($bn), Israel, Forecast, 2011-2020 ..........................................93 Table 50: Major Industry Sectors, Net Domestic Product ($bn), Israel, 2010 ...........................................94 Table 51: Population („000), Israel, 2006-2011 .........................................................................................95 Table 52: Population („000), Israel, Forecast, 2012-2020 .........................................................................96 Table 53: Urban and Rural Population, Israel, Share (%), 2005-2010 ......................................................97 Table 54: Age Groups, Israel, Population Distribution (%), 2005-2010 .....................................................98 Table 55: Births (Per 1,000 Population), Israel, 2005-2010 ......................................................................99 Table 56: Births (Per 1,000 Population), Israel, Forecast, 2011-2020 ....................................................100 Table 57: Mortality (Per 1,000 Population), Israel, 2006-2011 ................................................................101 Table 58: Mortality (Per 1,000 Population), Israel, Forecast, 2012-2020 ................................................102 Table 59: Major Causes of Mortality (Per 100,000 Population), Israel, 2009 ..........................................103 Table 60: Infant Mortality (Per 1,000 Live Births), Israel, 2006-2011 ......................................................104 Table 61: Immunization Rate for MMR, DPT, Hib, HBV (%), Israel, 2005-2010 .....................................105 Table 62: Major Causes of Male Mortality (Per 10,0000 Population), Israel, 2009 .................................106 Table 63: Major Causes of Female Mortality (Per 100,000 Population), Israel, 2009 .............................107 Table 64: Gender Ratio (M/F), Israel, 2005-2010 ...................................................................................108 Table 65: Life Expectancy at Birth (Years), Israel, 2005-2010 ................................................................109 Table 66: National Expenditure, Israel, Education and Literacy (% of GDP), 2005-2010 .......................110 Table 67: National Expenditure, Israel, Level of Education (%), 2007 ....................................................111 Table 68: Unemployment Rate (%), Israel, 2005-2010 ...........................................................................112 Table 69: Most Frequently Diagnosed Diseases („000), Israel, 2009 ......................................................113 Table 70: Major Diseases, Israel, DALYs (Per 100,000 Population), 2004 .............................................114 Table 71: Total Number of Hospitals, Israel, 2005-2010 .........................................................................115 Table 72: Public and Private Hospitals, Israel, 2005-2010 .....................................................................116 Table 73: Types of Hospital, Israel, 2008-2010 ......................................................................................117 Table 74: Long-term Care Hospitals, Israel, 2008-2010 .........................................................................118 Table 75: Hospital Beds (Per 1,000 Population), Israel, 2005-2010 .......................................................119 Table 76: Doctors (Per 1,000 Population), Israel, 2005-2010 .................................................................120 Table 77: Dentists (Per 1,000 Population), Israel, 2006-2011 ................................................................121 Table 78: Nurses (Per 1,000 Population), Israel, 2006-2011 ..................................................................122 Table 79: Pharmacists (Per 1,000 Population), Israel, 2006-2011 ..........................................................123 Table 80: PM10 (µg/m

3), Israel, 2005-2010 ............................................................................................124

Table 81: CO2 Emissions („000 Tons), Israel, 2005-2010 .......................................................................125 Table 82: NOx, CO, SO2 Emissions (Tons), Israel, 2005-2010 ................................................................126 Table 83: Healthcare Expenditure (% of GDP), Israel, 2005-2010 .........................................................127 Table 84: Healthcare Expenditure, Israel, Types of Services (%), 2008 .................................................128 Table 85: Healthcare Expenditure, Israel, Public-Private Share (%), 2005-2010....................................129 Table 86: Healthcare Expenditure, Israel, Financing Agent (%), 2008 ...................................................130 Table 87: R&D Expenditure, Israel, Science and Technology ($bn), 2005-2010 ....................................131 Table 88: Major Healthcare Trade Fairs, Israel, 2013-2014 ...................................................................133

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1.2 List of Figures

Figure 1: Pharmaceutical Market, Israel, Revenue ($bn), 2005-2010 ......................................................11 Figure 2: Pharmaceutical Market, Israel, Revenue, Forecast ($bn), 2011-2020 ........................................12 Figure 3: Medical Device Market, Israel, Revenue ($m), 2006-2011 .........................................................30 Figure 4: Medical Device Market, Israel, Revenue Forecast ($m), 2012 --2020 ........................................31 Figure 5: Medical Device Market, Israel, Segments, Revenue ($m), 2011 ................................................32 Figure 6: Cardiovascular Devices Market, Israel, Revenue ($m), 2006-2011 ............................................33 Figure 7: Sales Trends for Major Players*, Cardiovascular Devices, Israel, 2006-2011 ............................34 Figure 8: Nephrology and Urology Devices, Israel, Revenue ($m), 2006-2011 .........................................35 Figure 9: Sales Trends for Major Players*, Nephrology and Urology Devices, Israel, 2006-2011 .............36 Figure 10: In Vitro Diagnostics Market, Israel, Revenue ($m), 2006-2011 .................................................37 Figure 11: Sales Trends for Major Players*, In Vitro Diagnostics Devices, Israel, 2006-2010 ...................38 Figure 12: Ophthalmic Devices Market, Israel, Revenue ($m), 2006-2011 ................................................39 Figure 13: Sales Trends for Major Players*, Ophthalmic Devices, Israel, 2006-2010 ................................40 Figure 14: Orthopedic Devices Market, Israel, Revenue ($m), 2006-2011 ................................................41 Figure 15: Sales Trends for Major Players*, Orthopedic Devices, Israel, 2006-2011 ................................42 Figure 16: Major Medical Device Companies, Israel, Revenues ($m), 2010..............................................43 Figure 17: Drivers and Barriers, Healthcare Market, Israel, 2012 ..............................................................62 Figure 18: Overview of Healthcare System, Israel, 2012 ...........................................................................64 Figure 19: Healthcare Spending, Israel, Patient Share (%), 2005-2010 ....................................................65 Figure 20: Drug Price Trends (%), Israel, 2006-2011 ................................................................................66 Figure 21: Overview of Regulatory Bodies, Israel, 2012 ............................................................................68 Figure 22: GDP Per Capita ($‟000), Israel, 2006-2011 ..............................................................................78 Figure 23: GDP Per Capita ($‟000), Israel, Forecast, 2012-2020 ..............................................................79 Figure 24: GDP, Annual Growth (%), Israel, 2006-2011 ............................................................................80 Figure 25: GDP, Annual Growth (%), Israel, Forecast, 2012-2020 ............................................................81 Figure 26: GNI Per Capita ($‟000), Israel, 2006-2011 ................................................................................82 Figure 27: Average Consumer Price Index, Israel, 2006-2011 ..................................................................83 Figure 28: Average Consumer Price Index, Israel, Forecast, 2012-2020 ..................................................84 Figure 29: Average Consumer Price, Israel, Annual Change (%), 2006-2011 ...........................................85 Figure 30: Currency Exchange Rate (ILS/$), Israel, 2006-2011 ................................................................86 Figure 31: Foreign Direct Investment ($bn), Israel, 2006-2011 ..................................................................87 Figure 32: Foreign Exchange Reserves ($bn), Israel, 2006-2011 ..............................................................88 Figure 33: Imports of Goods and Services ($bn), Israel, 2006-2011 ..........................................................89 Figure 34: Exports of Goods and Services ($bn), Israel, 2006-2011 .........................................................90 Figure 35: General Government Structural Balance ($bn), Israel, 2005-2010 ...........................................91 Figure 36: General Government Net Debt ($bn), Israel, 2005-2010 ..........................................................92 Figure 37: General Government Net Debt ($bn), Israel, Forecast, 2011-2020 ..........................................93 Figure 38: Major Industry Sectors, Net Domestic Product ($bn), Israel, 2010 ...........................................94 Figure 39: Population (000‟s), Israel, 2006-2011 .......................................................................................95 Figure 40: Population (000‟s), Israel, Forecast, 2012-2020 .......................................................................96 Figure 41: Urban and Rural Population, Israel, Share (%), 2005-2010 ......................................................97 Figure 42: Age Groups, Israel, Population Distribution (%), 2005-2010 .....................................................98 Figure 43: Births (Per 1,000 Population), Israel, 2005-2010 ......................................................................99 Figure 44: Births (Per 1,000 Population), Israel, Forecast, 2011-2020 ....................................................100 Figure 45: Mortality (Per 1,000 Population), Israel, 2006-2011 ................................................................101 Figure 46: Mortality (Per 1,000 Population), Israel, Forecast, 2012-2020 ................................................102 Figure 47: Major Causes of Mortality (Per 100,000 Population), Israel, 2009 ..........................................103 Figure 48: Infant Mortality (Per 1,000 Live Births), Israel, 2006-2011 ......................................................104 Figure 49: Immunization Rate for MMR, DPT, Hib, HBV (%), Israel, 2005-2010 .....................................105 Figure 50: Major Causes of Male Mortality (Per 100,000 Population), Israel, 2009 .................................106 Figure 51: Major Causes of Female Mortality (Per 10,0000 Population), Israel, 2009 .............................107 Figure 52: Gender Ratio (M/F), Israel, 2005-2010 ...................................................................................108 Figure 53: Life Expectancy at Birth (Years), Israel, 2005-2010 ................................................................109 Figure 54: National Expenditure, Israel, Education and Literacy (% of GDP), 2005-2010 .......................110 Figure 55: National Expenditure, Israel, Level of Education (%), 2007 ....................................................111 Figure 56: Unemployment Rate (%), Israel, 2005-2010 ...........................................................................112 Figure 57: Most Frequently Diagnosed Diseases („000), Israel, 2009 ......................................................113 Figure 58: Major Diseases, Israel, DALYs (Per 100,000 Population), 2004 .............................................114 Figure 59: Total Number of Hospitals, Israel, 2005-2010 .........................................................................115 Figure 60: Public and Private Hospitals, Israel, 2005-2010......................................................................116

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Figure 61: Types of Hospital, Israel, 2008-2010 ......................................................................................117 Figure 62: Long-term Care Hospitals, Israel, 2008-2010 .........................................................................118 Figure 63: Hospital Beds (Per 1,000 Population), Israel, 2005-2010 .......................................................119 Figure 64: Doctors (Per 1,000 Population), Israel, 2005-2010 .................................................................120 Figure 65: Dentists (Per 1,000 Population), Israel, 2006-2011 ................................................................121 Figure 66: Nurses (Per 1,000 Population), Israel, 2006-2011 ..................................................................122 Figure 67: Pharmacists (Per 1,000 Population), Israel, 2006-2011 ..........................................................123 Figure 68: PM10 (µg/m

3), Israel, 2005-2010 ............................................................................................124

Figure 69: CO2 Emissions („000 Tons), Israel, 2005-2010 .......................................................................125 Figure 70: NOx, CO, SOX Emissions (Tons), Israel, 2005-2010 ...............................................................126 Figure 71: Healthcare Expenditure (% of GDP), Israel, 2005-2010 .........................................................127 Figure 72: Healthcare Expenditure, Israel, Types of Services (%), 2008 .................................................128 Figure 73: Healthcare Expenditure, Israel, Public-Private Share (%), 2005-2010 ....................................129 Figure 74: Healthcare Expenditure, Israel, Financing Agent (%), 2008 ...................................................130 Figure 75: R&D Expenditure, Israel, Science and Technology ($bn), 2005-2010 ....................................131 Figure 76: Opportunities and Challenges, Healthcare Market, Israel, 2012 .............................................135

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2 Introduction

2.1 Report Guidance

The report begins with an executive summary which gives an overview of Israel‟s healthcare market

and the key factors driving growth. It also gives a snapshot of the healthcare infrastructure and the

demographic, regulatory and reimbursement landscapes.

Chapter three gives an overview of Israel‟s pharmaceutical and medical device markets, covering

size; segmentation by product type (generic, Over-The-Counter (OTC) and biologic/biosimilar); and

the key drivers and barriers. It also includes profiles and SWOT assessments of each of the major

players.

Chapter four covers the reimbursement and payer landscape and the regulations governing the

Israeli healthcare market. The reimbursement and payer landscape section elaborates on the

features of the healthcare reimbursement process, including details of insurance providers, pricing

policies and drug pricing trends. The regulatory landscape section gives an overview of the regulatory

agencies and approval processes for new drugs and medical devices. The chapter also covers the

licensing process for the manufacture, export and import of pharmaceuticals; regulations for

pharmaceutical advertising, labeling, packaging and clinical trials; and gives an overview of the

intellectual property rights landscape.

Chapter five provides detailed analysis of Israel‟s political and economic environment in terms of

economic indicators, demographics, healthcare infrastructure and healthcare expenditure.

Chapter six provides an overview of the opportunities for and challenges to growth in Israel‟s

healthcare market.

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GDHC0032CHR / Published DEC 2012 Page 63


4 Market Access

4.1 Reimbursement and Payer Landscape

4.1.1 Reimbursement Process

4.1.1.1 Ministry of Health

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4.1.1.2 National Insurance Institute

Figure 18: Overview of Healthcare System, Israel, 2012

Source: GlobalData, based on information from HiT, 2009

4.1.2 Overview of Insurance Providers

4.1.2.1 National Health Insurance

4.1.2.2 Voluntary Health Insurance

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Patient Share in Healthcare Spending

Figure 19: Healthcare Spending, Israel, Patient Share (%), 2005-2010

Source: Globaldata; CBS, 2012b

Table 30: Healthcare Spending, Israel, Patient Share (%), 2005-2010

Year 2005 2006 2007 2008 2009 2010

Source: GlobalData; CBS, 2012b

Co-payment - discounts and exemptions for drug purchases

Table 31: HMOs, Israel, Co-payment Cap for Chronically Ill Patients (NIS), 2012

Clalit Maccabi Meuhedet Leumit

Source: GlobalData; MOH, 2012a

* Monthly

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4.2 Regulatory Landscape

4.2.1 Overview of Regulatory Agencies

4.2.1.1 Pharmaceutical Division

4.2.1.2 Medical Registration Division

4.2.1.3 Institute for Standardization and Control of Pharmaceuticals

Figure 21: Overview of Regulatory Bodies, Israel, 2012

Source: GlobalData, based on information from MoH, 2012

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4.2.2 New Drug Approval Process

Key Stages

4.2.3 Licensing Process for Pharmaceutical and Medical Device Manufacturing

4.2.4 Licensing Process for Pharmaceutical Exports and Imports

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7 Appendix

7.1 Abbreviations

API: Active Pharmaceutical Ingredient

BOI: Bank of Israel

CAGR: Compound Annual Growth Rate

cGMP: current Good Manufacturing Practice

CO: Carbon Monoxide

COPD: Chronic Obstructive Pulmonary Disease

CPI: Consumer Price Index

CT: Computed Tomography

DALY: Disability-Adjusted Life Year

DPT: Diphtheria, Pertussis and Tetanus

FDA: Food and Drug Administration

FDI: Foreign Direct Investment

GDP: Gross Domestic Product

GMP: Good Manufacturing Practice

GNI: Gross National Income

HBV: Hepatitis B Virus

Hib: Haemophilus influenzae type b

HMO: Health Maintenance Organization

ISCP: Institute for Standardization and Control of Pharmaceuticals

MMR: Measles, Mumps, and Rubella

MS: Multiple Sclerosis

NCE: New Chemical Entity

NHI: National Health Insurance

NII: National Insurance Institute

NO2: Nitrogen Dioxide

NOx: Nitrogen Oxide

OTC: Over-The-Counter

PET: Positron Emission Tomography

RRMS: Relapsing Remitting Multiple Sclerosis

SO2: Sulfur Dioxide

SOx: Sulfur Oxide

VHI: Voluntary Health Insurance

WHO: World Health Organization

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7.2 Bibliography

Aharoni E (2012). “Israelis overpay for OTC drugs”, Globes, January 19, 2012. Available from:

http://www.globes.co.il/serveen/globes/docview.asp?did=1000717290&fid=1725. [Accessed

September 25, 2012].

Amitai Y (2012). The Equivalent Drug and the System Sustainability: The Israeli Experience. The

Israeli Ambulatory Pediatric Association, 2nd

International Congress on Primary Care Pediatrics,

Prague, May 11, 2012. Available from: http://www.fimp.org/conferenza/praga2012/doc/AMITAI.pdf.

Central Bureau of Statistics (CBS) (2011a). OECD Health at a Glance 2011: Key findings for Israel.

Central Bureau of Statistics. Available from:

http://www.health.gov.il/English/News_and_Events/Spokespersons_Messages/Pages/23112011_2e.

aspx. [Accessed August 21, 2012].

Central Bureau of Statistics (CBS) (2011b). Women and men in Israel 1990-2009. Central Bureau of

Statistics. Available from: http://www1.cbs.gov.il/www/statistical/mw2011_e.pdf

Central Bureau of Statistics (2012a). Persons Reporting Myocardial Infarction, By Sex and Socio-

Demographic Characteristics. Central Bureau of Statistics. Available from:

http://www1.cbs.gov.il/reader/cw_usr_view_SHTML?ID=598. [Accessed August 21, 2012].

Central Bureau of Statistics (2012b). National Expenditure on Health 1962-2010. Central Bureau of

Statistics. Available from: http://www1.cbs.gov.il/publications11/briut10/pdf/intro_e.pdf.

Central Bureau of Statistics (2012c). National Accounts (Data from 1995) Exports of Goods and

Services at Constant and Current Prices. Central Bureau of Statistics. Available from:

http://www1.cbs.gov.il/ts/ID015a2ae60a0ec9/databank/series_func_e_v1.html?level_1=22&level_2=5

&level_3=1. [Accessed August 21, 2012].

Central Bureau of Statistics (2012d). Net Domestic Product and National Income, By Industry.

Central Bureau of Statistics. Available from: http://www1.cbs.gov.il/shnaton63/st14_03.pdf.

Central Bureau of Statistics (2012e). Israel in Figures. Central Bureau of Statistics. Available from:

http://www1.cbs.gov.il/reader/publications/israel_fig_e.htm. [Accessed July 21, 2012].

Central Bureau of Statistics (2012f). Deaths and Mortality Rates, By Cause and Population Group.

Central Bureau of Statistics. Available from: http://www1.cbs.gov.il/shnaton63/st03_30x.pdf.

Central Bureau of Statistics (2012g). Immunization Coverage of Two-Year-Olds. Central Bureau of

Statistics. Available from: http://www1.cbs.gov.il/shnaton63/st06_12.pdf.

Central Bureau of Statistics (2012h). Health---Mortality Rates, By Causes of Death---Data by Select

Causes. Central Bureau of Statistics. Available from:

http://www1.cbs.gov.il/ts/IDca0b9d75a5112c/databank/series_func_e_v1.html?level_1=4&level_2=2&

level_3=1. [Accessed July 21, 2012].

Central Bureau of Statistics (2012i). National Expenditure on Education in 2007-2010. Central Bureau

of Statistics. Available from: http://www1.cbs.gov.il/www/hodaot2011n/08_11_186e.pdf.

Central Bureau of Statistics (2012j). Chronic Diseases. Central Bureau of Statistics. Available from:

http://www1.cbs.gov.il/reader/cw_usr_view_SHTML?ID=598. [Accessed July 21, 2012].

Central Bureau of Statistics (2012k). Hospitals, By Type and Ownership. Central Bureau of Statistics.

Available from: http://www1.cbs.gov.il/shnaton63/st06_06.pdf.

Central Bureau of Statistics (2012m). National Expenditure on Health. Central Bureau of Statistics.

Available from: http://www1.cbs.gov.il/reader/cw_usr_view_SHTML?ID=589. [Accessed July 21,

2012].

Central Bureau of Statistics (2012n). Indices - Percent Change between two selected periods.

Central Bureau of Statistics.

http://www1.cbs.gov.il/reader/?Years_1=2005&Months_1=12&Years_2=2006&Months_2=12&MIval=

%2Fprices_db%2FCompare_TwoPeriods_E.html&Radio1=5_3&DataType=Ind&Subjects=38&MyCod

e=11121280&Separated=11121280&MultMin=198301&MultMax=201208&DateMin=01%2F1983&Da

teMax=08%2F2012. [Accessed September 22, 2012].

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Central Bureau of Statistics (2012o). National Expenditure on Health, By Operating Sector, Type of

Expenditure and service. Central Bureau of Statistics.

http://www.cbs.gov.il/publications11/briut10/pdf/t04.pdf.

Central Bureau of Statistics (2012p). National Accounts (Data from 1995) ---Imports of Goods and

Services---At Constant and Current Prices. Central Bureau of Statistics. Available from:

http://www1.cbs.gov.il/ts/IDca0b9d75a5112c/databank/series_func_e_v1.html?level_1=22&level_2=6


Central Bureau of Statistics (2012q). Environment, Greenhouse Gases, Greenhouse Gas Emissions

Precursors by Source. Central Bureau of Statistics. Available from:



Central Bureau of Statistics (2012r). Environment, Greenhouse Gases, Direct Greenhouse Gas

Emissions by Source, Co2 Equivalent Central Bureau of Statistics. Available from:



Health System in Transition (2009). Israel Health system in review. Available from:

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SAMPLE




7.3 Methodology

GlobalData‟s dedicated research and analysis teams consist of experienced professionals with advanced

statistical expertise and marketing, market research and consulting backgrounds in the pharmaceutical

industry.

GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the

Strategic and Competitive Intelligence Professionals (www.scip.org).

All GlobalData databases are continuously updated and revised. The following research methodology is

followed for all databases and reports.

7.3.1 Coverage

The objective of updating GlobalData‟s coverage is to ensure that it represents the most up to date vision

of the industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company, association

and competitor sources.

Company coverage is based on three key factors: revenues, products and media

attention/innovation/market potential.

The estimated revenues of all major companies, including private and governmental, are gathered

and used to prioritize coverage.

Companies which are making the news or which are of particular interest due to their innovative

approach are prioritized.

GlobalData aims to cover all major news events and deals in the pharmaceutical industry, updated on a

daily basis.

The coverage is further streamlined and strengthened with additional inputs from GlobalData‟s expert

panel (see below).

7.3.2 Secondary Research

The research process begins with exhaustive secondary research on internal and external sources being

carried out to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to, the following.

Company websites, annual reports, financial reports, broker reports, investor presentations and US

Securities and Exchanges Commission (SEC) filings.

Industry trade journals, scientific journals and other technical literature.

Internal and external proprietary databases.

Relevant patent and regulatory databases.

National government documents, statistical databases and market reports.

Procedure registries.

News articles, press releases and web-casts specific to the companies operating in the market.

Country reports are largely based on secondary research and make use of reliable and authoritative

sources such as the IMF, the World Bank, OECD, WHO, UNICEF, UNStats, MHLW, NHS, and BEA,

among others.

7.3.3 Forecasting

For country reports, GlobalData uses the data available from reliable and authoritative secondary sources

to forecast the future trends for the healthcare market for the country, as well as the parameters related to

the economy and healthcare infrastructure and expenditure of the country. The trends are further

validated through the secondary sources.

http://www.mrs.org.uk/

http://www.scip.org/

SAMPLE




7.3.4 Primary Research

GlobalData conducts hundreds of primary interviews a year with industry participants and commentators

in order to validate its data and analysis. A typical research interview fulfills the following functions.

It provides first-hand information on the market size, market trends, growth trends, competitive

landscape and future outlook of a market.

It helps in validating and strengthening secondary research findings.

It develops the analysis team‟s expertise and market understanding.

Primary research involves email correspondence and telephone interviews as well as face-to-face

interviews for each market, category, segment and sub-segment across the geographies covered.

The participants who typically take part in such a process include, but are not limited to, the following.

Industry participants: Chief Executive Officers (CEOs), Vice Presidents (VPs), marketing/product

managers, market intelligence managers and national sales managers.

Hospital stores, pharmacies, distributors and paramedics.

Outside experts: investment bankers, valuation experts, research analysts specializing in specific

pharmaceutical markets.

Key Opinion Leaders (KOLs): Physicians and surgeons specializing in different therapeutic areas

corresponding to different kinds of pharmaceuticals.

7.3.5 Expert Panel Validation

GlobalData uses a panel of experts to cross verify its databases and forecasts.

GlobalData‟s expert panel comprises marketing managers, product specialists, international sales

managers from pharmaceutical companies; academics from research universities, KOLs from hospitals,

consultants from venture capital funds, and distributors/suppliers of pharmaceuticals and supplies.

Historic data and forecasts are relayed to GlobalData‟s expert panel for feedback and adjusted in

accordance with their feedback.

7.4 Disclaimer

All Rights Reserved.

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

any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of

the publisher, GlobalData.

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