gdhc0060chr-healthcare regulatory and reimbursement ...this report is a licensed product and is not...

REFERENCE CODE GDHC0060CHR | PUBLICATION DATE MAY 2014

HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE - PHILIPPINES

Healthcare, Regulatory and Reimbursement Landscape - Philippines 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.


Executive Summary

Although an increasing disease burden and prevailing high pharmaceuticals prices are providing the necessary impetus for the continued growth of the healthcare market in the Philippines, limited access to healthcare facilities and governmental cuts are likely to impede this growth in future.

The value of the pharmaceutical market in the

Philippines amounted to $XX billion in 2013 and is

expected to increase at a Compound Annual

Growth Rate (CAGR) of XX% to reach $XX billion

in 2020 (DTI, 2013). The country has the third

largest pharmaceutical market of the countries in

the Association of Southeast Asian Nations

(ASEAN), after Indonesia and Thailand. Medicine

prices are high in the Philippines in comparison

with other ASEAN countries because most

medicines are imported and branded. According to

the Philippine International Trading Corporation

(PITC), retail drug prices in Malaysia, Indonesia

and Thailand are around XX–XX% lower than in

the Philippines (Senate of Philippines, 2008). The

share of multinational companies in the country is

high, compared with the share of domestic

companies in the total pharmaceutical market. The

leading multinational companies are Pfizer,

GlaxoSmithKline (GSK), Novartis and Merck, and

the leading domestic players are United

Laboratories (Unilab), Johnson and Pascual labs.

The burden of Non-Communicable Diseases

(NCDs) is high in the Philippines. The major NCDs

in the country are cardiovascular disease, cancer,

Chronic Obstructive Pulmonary Disease (COPD)

and diabetes mellitus. In 2008, these four NCDs

accounted for approximately XX% of the total

deaths in the country (Ulep et al., 2013).

The government of the Philippines introduced the

“Universally Accessible Cheaper and Quality

Medicines Act” in 2008 to reduce medicine prices.

The act enables the parallel importation and

compulsory licensing of patented medicines (under

certain conditions) from other countries at lower

prices. In 2009, a XX% price reduction was

imposed on XX drug molecules (XX drug

preparations), including medicines for

hypertension, cancer, diabetes, influenza, arthritis,

hypercholesterolemia, goiters, allergies and

infections (DoH, 2011c). In 2010, the government

of the Philippines forced pharmaceutical

companies in the country to cut the prices of XX

life-saving drugs by XX% in order to reduce retail

drug prices (WSJ, 2010).

Access to healthcare facilities is limited for poor

people, particularly in rural areas. The insufficient

financial and management support provided to the

Botika ng Barangay (BnB) is a major problem,

which directly affects the ability of poor

communities to access affordable and quality

medicines in rural areas.



Executive Summary

This price reduction and limited access to

healthcare facilities is expected to have an adverse

impact upon the growth of the pharmaceutical

market.

Pharmaceutical Market, Philippines, Revenue Forecast ($bn), 2008–2020

2008 2013* 2015 2020

Rev

enue

($bn

)

CAGR (2008–2020): XX%

Source: DTI, 2013; Natrapharm, 2013 *Estimated figure

Well-defined and transparent patent protection and regulatory procedures for pharmaceutical products and medical devices are major features of the healthcare system in the Philippines.

The Food and Drug Administration (FDA), which is

the regulatory authority for pharmaceutical

products and medical devices, is the executive

agency of the Department of Health (DoH). The

DoH is responsible for ensuring access to basic

health services through the provision of standard,

quality healthcare and the regulation of providers

of health goods and services. The FDA authorizes

the approval of medicines and medical devices in

the country. The registration of a patented

pharmaceutical product takes an average 180–270

days (six to nine months), while generic products

take an average 90–180 days (three to six

months). The time taken for drug approval in the

Philippines is comparable to other ASEAN

countries and significantly lower than developed

countries such as the US and the UK. The

Intellectual Property Office (IPO) regulates patent

protection rules and provides 20 years of exclusive

rights to the patent holder.

The FDA also regulates clinical trials for both

pharmaceutical and medical devices. The applicant

must completely disclose all relevant

documentation and information regarding the

product and adhere to the codes of Good

Manufacturing Practice (GMP), good laboratory

practice and good clinical practice.

Insufficient infrastructure, lack of Universal Healthcare (UHC) coverage and high Out-Of-Pocket (OOP) expenditure are barriers for the pharmaceutical market.

Public health insurance provider Philippine Health

Insurance Corporation (PhilHealth) does not cover

the country’s entire population. In the Philippines,

OOP expenditure is high, having increased from

XX% in 2005 to XX% in 2011 (World Bank, 2014a).


Table of Contents


1 Table of Contents

1 Table of Contents ....................................................................................................................... 6

1.1 List of Tables ...................................................................................................................... 9

1.2 List of Figures ................................................................................................................... 12

2 Introduction ............................................................................................................................... 16

2.1 GlobalData Report Guidance ............................................................................................ 16

3 Overview of Pharmaceutical and Medical Device Market .......................................................... 17

3.1 Pharmaceutical Market ..................................................................................................... 17

3.1.1 Market Overview ........................................................................................................... 17

3.1.2 Pharmaceutical Exports and Imports ............................................................................. 21

3.1.3 Supply Channels ........................................................................................................... 22

3.1.4 Market Segments .......................................................................................................... 24

3.1.5 Overview of Major Disease Areas ................................................................................. 26

3.1.6 Major Players ................................................................................................................ 28

3.2 Medical Device Market ...................................................................................................... 70

3.2.1 Market Overview ........................................................................................................... 70

3.3 Market Drivers and Barriers .............................................................................................. 70

3.3.1 Drivers........................................................................................................................... 70

3.3.2 Barriers ......................................................................................................................... 71

4 Market Access .......................................................................................................................... 73

4.1 Reimbursement and Payer Landscape ............................................................................. 73

4.1.1 Overview of Healthcare system ..................................................................................... 73

4.1.2 Reimbursement Process ............................................................................................... 74

4.1.3 Overview of Insurance Providers ................................................................................... 78

4.1.4 Patient Share in Healthcare Spending ........................................................................... 82

4.1.5 Price Trends in the Healthcare Sector ........................................................................... 83

4.1.6 Pricing Policies .............................................................................................................. 84


Table of Contents


4.2 Regulatory Landscape ...................................................................................................... 86

4.2.1 Overview of Regulatory Agencies.................................................................................. 86

4.2.2 Market Authorization Procedure for Pharmaceutical Products ....................................... 87

4.2.3 New Medical Device Approval Process ......................................................................... 94

4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing .................... 94

4.2.5 Exports and Imports ...................................................................................................... 95

4.2.6 Intellectual Property Rights............................................................................................ 99

4.2.7 Clinical Trial Regulations ............................................................................................. 102

4.2.8 Pharmaceutical Advertising Regulations ..................................................................... 105

4.2.9 Pharmacy Regulations ................................................................................................ 106

4.2.10 Labeling and Packaging Regulations .......................................................................... 107

5 Country Analysis ..................................................................................................................... 109

5.1 Political Environment....................................................................................................... 109

5.1.1 Political Structure ........................................................................................................ 109

5.1.2 Analysis of Current Political Environment .................................................................... 109

5.1.3 Healthcare Policy Initiatives ......................................................................................... 110

5.2 Economic Landscape ...................................................................................................... 112

5.3 Economic Indicators ........................................................................................................ 115

5.3.1 Gross Domestic Product ............................................................................................. 115

5.3.2 Gross National Income ................................................................................................ 120

5.3.3 Inflation ....................................................................................................................... 121

5.3.4 Currency Exchange Rate ............................................................................................ 123

5.3.5 Foreign Direct Investment ........................................................................................... 124

5.3.6 Foreign Exchange Reserves ....................................................................................... 125

5.3.7 Trade Balance ............................................................................................................. 126

5.3.8 Fiscal Deficit ................................................................................................................ 128

5.3.9 General Government Gross Debt ................................................................................ 129


Table of Contents


5.3.10 External Debt .............................................................................................................. 130

5.3.11 Major Industries ........................................................................................................... 131

5.4 Demographics ................................................................................................................. 133

5.4.1 Population ................................................................................................................... 133

5.4.2 Education and Literacy ................................................................................................ 151

5.4.3 Employment ................................................................................................................ 153

5.4.4 Disease Burden ........................................................................................................... 154

5.5 Healthcare Infrastructure ................................................................................................. 157

5.5.1 Healthcare Facilities .................................................................................................... 157

5.5.2 Healthcare Parameters ............................................................................................... 162

5.5.3 Environmental Health .................................................................................................. 164

5.5.4 Healthcare Personnel .................................................................................................. 167

5.6 Healthcare Expenditure ................................................................................................... 169

5.6.1 Overview ..................................................................................................................... 169

5.6.2 Major Components of Healthcare Spending ................................................................ 170

5.6.3 Share of Public and Private Sector .............................................................................. 171

5.6.4 Spending in Pharmaceutical R&D ............................................................................... 172

5.7 Trade Associations ......................................................................................................... 172

5.7.1 Pharmaceutical and Healthcare Association of the Philippines .................................... 172

5.7.2 The Philippine Pharmaceutical Manufacturers Association.......................................... 172

5.7.3 The Philippine Pharmacist Association ........................................................................ 172

5.7.4 The Philippine Medical Association ............................................................................. 173

5.8 Trade Fairs ..................................................................................................................... 173

6 Opportunities and Challenges ................................................................................................. 174

6.1 Opportunities .................................................................................................................. 174

6.2 Challenges ...................................................................................................................... 175

7 Appendix................................................................................................................................. 176


Table of Contents


7.1 Abbreviations .................................................................................................................. 176

7.2 Bibliography .................................................................................................................... 179

7.3 Research Methodology ................................................................................................... 193

7.3.1 Coverage .................................................................................................................... 193

7.3.2 Secondary Research ................................................................................................... 194

7.3.3 Forecasts .................................................................................................................... 194

7.3.4 Expert Panel................................................................................................................ 194

7.4 Disclaimer ....................................................................................................................... 195

1.1 List of Tables

Table 1: Pharmaceutical Market, Philippines, Revenue ($bn), 2008–2013 ................................................. 19

Table 2: Pharmaceutical Market, Philippines, Revenue Forecast ($bn), 2014–2020 .................................. 20

Table 3: Pharmaceutical Market, Philippines, Exports and Imports ($m), 2008–2013 ................................. 21

Table 4: Pharmaceutical Market, Philippines, Price Distribution of Pharmaceuticals for Multinational

Companies (%), 2008 .................................................................................................................. 23

Table 5: Pfizer, Global, Major Products, Revenue, 2013 ............................................................................ 34

Table 6: Pharmaceutical Market, Global, Late-Stage Pipeline, Pfizer, 2014 ............................................... 35

Table 7: GlaxoSmithKline, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013 ............. 43

Table 8: Pharmaceutical Market, Global, Late-Stage Pipeline, GlaxoSmithKline, 2014 .............................. 44

Table 9: Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013 .......................... 52

Table 10: Pharmaceutical Market, Global, Planned Filings, Novartis, 2014≥2018 ........................................ 53

Table 11: Merck, Global, Major Products, Revenue ($bn) and Annual Growth (%), 2013 ............................. 63

Table 12: Pharmaceutical Market, Global, Late-Stage Pipeline, Merck, 2014............................................... 64

Table 13: Membership in PhilHealth, Philippines, Sector Share (%), 2013 ................................................... 81

Table 14: Benefit Payments from PhilHealth, Philippines, Sector Share (%), 2013 ...................................... 81


Table of Contents


Table 15: Healthcare Spending, Philippines, Out-of-Pocket Expenditure (%), 2008–2013 ............................ 83

Table 16: Price of Healthcare Products, Philippines Change in Average Price of Health Sector (%), 2008–

2013............................................................................................................................................ 84

Table 17: Economic Indicators, Philippines, Gross Domestic Product per Capita ($), 2008–2013 .............. 116

Table 18: Economic Indicators, Philippines, Gross Domestic Product per Capita Forecast ($), 2014–2020 117

Table 19: Economic Indicators, Philippines, Gross Domestic Product Annual Growth (%), 2008–2013 ...... 118

Table 20: Economic Indicators, Philippines, Gross Domestic Product Annual Growth (%), 2014–2020 ...... 119

Table 21: Economic Indicators, Philippines, Gross National Income per Capita ($), 2008–2013 ................. 120

Table 22: Economic Indicators, Philippines, Average Consumer Price Index, 2008–2013 .......................... 121

Table 23: Economic Indicators, Philippines, Average Consumer Price Annual Change (%), 2008–2013 .... 122

Table 24: Economic Indicators, Philippines, Currency Exchange Rate (PHP/$), 2008–2013 ...................... 123

Table 25: Economic Indicators, Philippines, Foreign Direct Investment ($bn), 2008–2013 ......................... 124

Table 26: Economic Indicators, Philippines, Foreign Exchange Reserves ($bn), 2008–2013 ..................... 125

Table 27: Economic Indicators, Philippines, Imports of Goods and Services ($bn), 2008–2013 ................. 126

Table 28: Economic Indicators, Philippines, Exports of Goods and Services ($bn), 2008–2013 ................. 127

Table 29: Economic Indicators, Philippines, Fiscal Deficit (% of GDP), 2008–2012 .................................... 128

Table 30: Economic Indicators, Philippines, General Government Gross Debt (% of GDP), 2008–2013 .... 129

Table 31: Economic Indicators, Philippines, External Debt ($bn), 2008–2013 ............................................ 130

Table 32: Economic Indicators, Philippines, Major Industries, Industrial Sector, Gross Value Added ($bn),

2012–2013 ................................................................................................................................ 132

Table 33: Economic Indicators, Philippines, Major Industries, Service Sector, Gross Value Added ($bn),

2012–2013 ................................................................................................................................ 133

Table 34: Demographics, Philippines, Population (million), 2008–2013 ..................................................... 134

Table 35: Demographics, Philippines, Population Forecast (million), 2014–2020 ....................................... 135

Table 36: Demographics, Philippines, Population, Urban and Rural Population Share (%), 2008–2013 ..... 136


Table of Contents


Table 37: Demographics, Philippines, Population, Urban and Rural Population Forecast Share (%), 2014–

2020.......................................................................................................................................... 137

Table 38: Demographics, Philippines, Population Distribution by Age Group (%), 2008–2013 ................... 138

Table 39: Demographics, Philippines, Population Distribution by Age Group Forecast (%), 2008–2013 ..... 139

Table 40: Demographics, Philippines, Births (per 1,000 Population), 2008–2013 ....................................... 140

Table 41: Demographics, Philippines, Mortality (per 1,000 Population), 2008–2013 .................................. 141

Table 42: Demographics, Philippines, Major Causes of Mortality (‘000), 2010 ........................................... 142

Table 43: Demographics, Philippines, Infant Mortality (per 1,000 Live Births), 2008–2013 ......................... 144

Table 44: Demographics, Philippines, Immunization Rate (%), 2008–2013 ................................................ 145

Table 45: Demographics, Philippines, Major Causes of Male Mortality (‘000), 2008 ................................... 146

Table 46: Demographics, Philippines, Major Causes of Female Mortality (‘000), 2008 ............................... 147

Table 47: Demographics, Philippines, Maternal Mortality (per 1,000 Live Births), 2008–2010 .................... 148

Table 48: Demographics, Philippines, Gender Ratio (M:F), 2008–2013 ..................................................... 149

Table 49: Demographics, Philippines, Life Expectancy at Birth (Years), 2008–2013 .................................. 150

Table 50: Demographics, Philippines, Life Expectancy at Birth (Years), 2014–2020 .................................. 151

Table 51: Demographics, Philippines, Student Enrollment by Level of Education (%), 2008–2013 ............. 153

Table 52: Demographics, Philippines, Unemployment Rate (%), 2008–2013 ............................................. 153

Table 53: Demographics, Philippines, Major Diseases, Morbidity (‘000), 2010 ........................................... 155

Table 54: Demographics, Philippines, Major Diseases, DALYs (per 100,000 Population), 2009 ................. 156

Table 55: Healthcare Infrastructure, Philippines, Hospitals, 2008–2013 ..................................................... 158

Table 56: Healthcare Infrastructure, Philippines, Barangay Health Stations, 2008–2013 ............................ 159

Table 57: Healthcare Infrastructure, Philippines, Hospitals by Standard of Care, 2009 .............................. 161

Table 58: Healthcare Infrastructure, Philippines, Diagnostic Equipment (per 100,000 Population), 2007–2009

................................................................................................................................................. 162

Table 59: Healthcare Infrastructure, Philippines, Hospitals Beds (per 10,000 Population), 2008–2013 ....... 163


Table of Contents


Table 60: Environmental Health, Philippines, CO2 Emissions (Million Tons), 2008–2013 ........................... 165

Table 61: Environmental Health, Philippines, PM10 (µgm/m³), 2008–2013 ................................................ 166

Table 62: Healthcare Personnel, Philippines, Registered Healthcare Personnel, 2008–2013 ..................... 168

Table 63: Healthcare Personnel, Philippines, Registered Nurses, 2008–2013 ........................................... 168

Table 64: Healthcare Expenditure, Philippines, Healthcare Expenditure (% of GDP), 2008–2013 .............. 169

Table 65: Healthcare Expenditure, Philippines, Share of Major Components (%), 2011 ............................. 170

Table 66: Healthcare Expenditure, Philippines, Public-Private Share (%), 2008–2013 ............................... 171

Table 67: Major Healthcare Trade Fairs, Philippines, 2014 ........................................................................ 173

1.2 List of Figures

Figure 1: Pharmaceutical Market, Philippines, Revenue ($bn), 2008–2013 ................................................. 19

Figure 2: Pharmaceutical Market, Philippines, Revenue Forecast ($bn), 2014–2020 .................................. 20

Figure 3: Pharmaceutical Market, Philippines, Exports and Imports ($m), 2008–2013 ................................. 21

Figure 4: Pharmaceutical Distribution Channel, Philippines, Distribution Share (%), 2008 ........................... 22

Figure 5: Pharmaceutical Market, Philippines, Price Distribution of Pharmaceuticals for Multinational

Companies (%), 2008 .................................................................................................................. 23

Figure 6: Healthcare Market, Philippines, Drivers and Barriers, 2013 .......................................................... 72

Figure 7: Healthcare System, Philippines, 2014 .......................................................................................... 73

Figure 8: Drug Selection Procedure for Philippine National Drug Formulary, Philippines, 2014 ................... 76

Figure 9: Reimbursement Process, Philippines, 2014 ................................................................................. 77

Figure 10: PhilHealth Milestones, Philippines, 2010...................................................................................... 80

Figure 11: Membership in PhilHealth, Philippines, Sector Share (%), 2013 ................................................... 80

Figure 12: Benefit Payments from PhilHealth, Philippines, Sector Share (%), 2013 ...................................... 81

Figure 13: Healthcare Spending, Philippines, Out-of-Pocket Expenditure (%), 2008–2013 ............................ 83


Table of Contents


Figure 14: Price of Healthcare Products, Philippines, Change in Average Price of Health Sector (%), 2008–

2013............................................................................................................................................ 84

Figure 15: Food and Drug Administration Structure, Philippines, 2014 .......................................................... 87

Figure 16: Approval Process of New Drugs and Medical Devices, Philippines, 2014 ..................................... 90

Figure 17: Approval Process of Generic Drugs, Philippines, 2014................................................................. 93

Figure 18: Bureau of Health Devices and Technology Structure, Philippines, 2014 ....................................... 94

Figure 19: Licensing Process for Manufacture of Pharmaceuticals and Medical Devices, Philippines, 2014 .. 95

Figure 20: Patent Approval Process, Philippines, 2014 ............................................................................... 100

Figure 21: Trademark Approval Process, Philippines, 2014 ........................................................................ 101

Figure 22: Clinical Trial Approval Process, Philippines, 2014 ...................................................................... 104

Figure 23: Procedure for Opening a Retail Pharmacy, Philippines, 2014 .................................................... 107

Figure 24: Healthcare Policy Initiatives, Philippines, Major Healthcare Reforms, 1999–2010 ...................... 112

Figure 25: Economic Indicators, Philippines, Gross Domestic Product per Capita ($), 2008–2013 .............. 116

Figure 26: Economic Indicators, Philippines, Gross Domestic Product per Capita Forecast ($), 2014–2020 117

Figure 27: Economic Indicators, Philippines, Gross Domestic Product Annual Growth (%), 2008–2013 ...... 118

Figure 28: Economic Indicators, Philippines, Gross Domestic Product Annual Growth Forecast (%), 2014–

2020.......................................................................................................................................... 119

Figure 29: Economic Indicators, Philippines, Gross National Income per Capita ($), 2008–2013 ................. 120

Figure 30: Economic Indicators, Philippines, Average Consumer Price Index, 2008–2013 .......................... 121

Figure 31: Economic Indicators, Philippines, Average Consumer Price Annual Change (%), 2008–2013 .... 122

Figure 32: Economic Indicators, Philippines, Currency Exchange Rate (PHP/$), 2008–2013 ...................... 123

Figure 33: Economic Indicators, Philippines, Foreign Direct Investment ($bn), 2008–2013 ......................... 124

Figure 34: Economic Indicators, Philippines, Foreign Exchange Reserves ($bn), 2008–2013 ..................... 125

Figure 35: Economic Indicators, Philippines, Imports of Goods and Services ($bn), 2008–2013 ................. 126

Figure 36: Economic Indicators, Philippines, Exports of Goods and Services ($bn), 2008–2013 ................. 127


Table of Contents


Figure 37: Economic Indicators, Philippines, Fiscal Deficit (% of GDP), 2008–2012 .................................... 128

Figure 38: Economic Indicators, Philippines, General Government Gross Debt (% of GDP), 2008–2013 .... 129

Figure 39: Economic Indicators, Philippines, External Debt ($bn), 2008–2013 ............................................ 130

Figure 40: Economic Indicators, Philippines, Major Industries, Industrial Sector, Gross Value Added ($bn),

2012–2013 ................................................................................................................................ 131

Figure 41: Economic Indicators, Philippines, Major Industries, Service Sector, Gross Value Added ($bn),

2012–2013 ................................................................................................................................ 132

Figure 42: Demographics, Philippines, Population (million), 2008–2013 ..................................................... 134

Figure 43: Demographics, Philippines, Population Forecast (million), 2014–2020 ....................................... 135

Figure 44: Demographics, Philippines, Population, Urban and Rural Population Share (%), 2008–2013 ..... 136

Figure 45: Demographics, Philippines, Population, Urban and Rural Population Share Forecast (%), 2014–

2020.......................................................................................................................................... 137

Figure 46: Demographics, Philippines, Population Distribution by Age Group (%), 2008–2013 ................... 138

Figure 47: Demographics, Philippines, Population Distribution by Age Group Forecast (%), 2014–2020 ..... 139

Figure 48: Demographics, Philippines, Births (per 1,000 Population), 2008–2013 ....................................... 140

Figure 49: Demographics, Philippines, Mortality (per 1,000 Population), 2008–2013 .................................. 141

Figure 50: Demographics, Philippines, Major Causes of Mortality (‘000), 2010 ........................................... 142

Figure 51: Demographics, Philippines, Infant Mortality (per 1,000 Live Births), 2008–2013 ......................... 143

Figure 52: Demographics, Philippines, Immunization Rate (%), 2008–2013 ................................................ 145

Figure 53: Demographics, Philippines, Major Causes of Male Mortality (‘000), 2008 ................................... 146

Figure 54: Demographics, Philippines, Major Causes of Female Mortality (‘000), 2008 ............................... 147

Figure 55: Demographics, Philippines, Maternal Mortality (per 1,000 Live Births), 2008–2010 .................... 148

Figure 56: Demographics, Philippines, Gender Ratio (M:F), 2008–2013 ..................................................... 149

Figure 57: Demographics, Philippines, Life Expectancy at Birth (Years), 2008–2013 .................................. 150

Figure 58: Demographics, Philippines, Life Expectancy at Birth (Years), 2014–2020 .................................. 151


Table of Contents


Figure 59: Demographics, Philippines, Student Enrollment by Level of Education (%), 2008–2013 ............. 152

Figure 60: Demographics, Philippines, Unemployment Rate (%), 2008–2013 ............................................. 153

Figure 61: Demographics, Philippines, Major Diseases, Morbidity (‘000), 2010 ........................................... 154

Figure 62: Demographics, Philippines, Major Diseases, DALYs (per 100,000 Population), 2009 ................. 156

Figure 63: Healthcare Infrastructure, Philippines, Hospitals, 2008–2013 ..................................................... 158

Figure 64: Healthcare Infrastructure, Philippines, Barangay Health Stations, 2008–2013 ............................ 159

Figure 65: Healthcare Infrastructure, Philippines, Hospitals by Standard of Care, 2009 .............................. 160

Figure 66: Healthcare Infrastructure, Philippines, Diagnostic Equipment (per 100,000 Population), 2007–2009

................................................................................................................................................. 162

Figure 67: Healthcare Infrastructure, Philippines, Hospitals Beds (per 10,000 Population), 2008–2013 ....... 163

Figure 68: Environmental Health, Philippines, CO2 Emissions (Million Tons), 2008–2013 ........................... 165

Figure 69: Environmental Health, Philippines, PM10 (µgm/m³), 2008–2013 ................................................ 166

Figure 70: Healthcare Personnel, Philippines, Registered Healthcare Personnel, 2008–2013 ..................... 167

Figure 71: Healthcare Personnel, Philippines, Registered Nurses, 2008–2013 ........................................... 168

Figure 72: Healthcare Expenditure, Philippines, Healthcare Expenditure (% of GDP), 2008–2013 .............. 169

Figure 73: Healthcare Expenditure, Philippines, Share of Major Components (%), 2011 ............................. 170

Figure 74: Healthcare Expenditure, Philippines, Public-Private Share (%), 2008–2013 ............................... 171

Figure 75: Healthcare Market, Philippines, Opportunities and Challenges, 2013 ......................................... 175



Introduction

2 Introduction

2.1 GlobalData Report Guidance

The report begins with an executive summary, which provides an overview of the healthcare

market in the Philippines and the key factors driving its development. It also includes a

snapshot of the country’s demographic, regulatory, and reimbursement landscape, as well as

its healthcare infrastructure.

Chapter three provides an overview of the pharmaceutical and medical device markets in the

Philippines, covering the parameters of: market size; generic, Over-The-Counter (OTC) and

biologic/biosimilar product shares; and key drivers and barriers. It also includes profiles for

major players in the country’s healthcare market, as well as SWOT assessments for each.

Chapter four covers the reimbursement and payer landscape, and provides details of the

reimbursement process, insurance providers, pricing policies and drug price trends in the

Philippines. It also looks at the regulatory landscape and provides an overview of the

regulatory agencies and approval processes for new drugs and medical devices. In addition,

this chapter covers the licensing process for the manufacture, export and import of

pharmaceuticals; details the regulations in place for pharmaceutical advertising, labeling,

packaging, and clinical trials; and provides an overview of the country’s legal framework for

intellectual property rights.

Chapter five provides detailed analysis of the political and economic environment in the

Philippines, as well as economic indicators, demographics, and healthcare infrastructure and

expenditure.

Chapter six provides an overview of the opportunities for and challenges facing the growth of

the healthcare market.


Overview of Pharmaceutical and Medical Device Market


3.1.2 Pharmaceutical Exports and Imports

The value of pharmaceutical exports in the Philippines amounted to approximately $XXm in 2008,

which increased to approximately $XXm in 2012. In 2008, the value of pharmaceutical imports

amounted to an estimated $XXm, which increased to approximately $XXm in 2012. The country’s

major trading partners were Vietnam, Myanmar and Thailand.

Figure 3: Pharmaceutical Market, Philippines, Exports and Imports ($m), 2008–2013

2008 2009 2010 2011 2012 2013*

Rev

enue

($m

)

ExportsImports

Source: ITC, 2012 *Estimated figure

Table 3: Pharmaceutical Market, Philippines, Exports and Imports ($m), 2008–2013 Year 2008 2009 2010 2011 2012 2013*

Exports

Imports

Source: ITC, 2012 *Estimated figure


Country Analysis


5.3.2 Gross National Income

The GNI per capita for the Philippines increased from $XX in 2008 to $XX in 2012 (World Bank,

2014b). GNI increased at a CAGR of XX% between 2008 and 2013.

Figure 29: Economic Indicators, Philippines, Gross National Income per Capita ($), 2008–2013

2008 2009 2010 2011 2012 2013*

GN

I per

cap

ita (

$)

CAGR (2008–2013): XX%

Source: World Bank, 2014b *Estimated figure

Table 21: Economic Indicators, Philippines, Gross National Income per Capita ($), 2008–2013 Year 2008 2009 2010 2011 2012 2013*

GNI per capita

Source: World Bank, 2014b *Estimated figure


Country Analysis


5.6.2 Major Components of Healthcare Spending

In the Philippines, private OOP expenditure accounted for approximately XX% of total healthcare

expenditure in 2011, followed by local government expenditure with XX% and national government

expenditure with XX%. The share of HMOs was approximately XX% (NSCB, 2013e).

In 2007, general government spending on health was equivalent to approximately XX% of GDP,

significantly lower than in other Asian countries such as Vietnam (XX%) and Thailand (XX%)

(Manasan, 2011).

Figure 73: Healthcare Expenditure, Philippines, Share of Major Components (%), 2011

Private OOP

Local government

National government

NHIP

HMOsOther

Source: NSCB, 2013e

Table 65: Healthcare Expenditure, Philippines, Share of Major Components (%), 2011

Major component Expenditure

Private OOP

Local government

National government

National Health Insurance Program

Health Maintenance Organizations

Others

Source: NSCB, 2013e


Appendix


7 Appendix

7.1 Abbreviations

µgm: micrometer

AIDS: Acquired Immune Deficiency Syndrome

ALK: Anaplastic Lymphoma Kinase

APEC: Asia-Pacific Economic Cooperation

ASEAN: Association of Southeast Asian Nations

AusAID: Australian Agency for International Development

BHDT: Bureau of Health Devices and Technology

BHS: Barangay Health Station

BnB: Botika ng Barangay

BNB: Botika ng Bayan

BPO: Business Process Outsourcing

CAGR: Compound Annual Growth Rate

CDM: Clean Development Mechanism

CER: Certified Emission Reduction

CNS: Central Nervous System

CO2: carbon dioxide

COPD: Chronic Obstructive Pulmonary Disease

CPI: Consumer Price Index

CPR: Certificate of Product Registration

CRL: Complete Response Letter

CT: Computed Tomography

DALY: Disability Adjusted Life Year


Appendix


DoH: Department of Health

DRG: Diagnostic Related Group

DTI: Department of Trade and Industry

DTP: Diphtheria, Tetanus and Pertussis

ED: Export Declaration

EDPMS: Essential Drug Price Monitoring System

EMAP: Emerging Markets Asia-Pacific

ERB: Ethical Review Board

ERC: Ethical Review Committee

ESRD: End Stage Renal Disease

EXPONET: Export Assistance Network

FDA: Food and Drug Administration

FDI: Foreign Direct Investment

Forex: Foreign exchange

GDP: Gross Domestic Product

GMP: Good Manufacturing Practices

GNI: Gross National Income

GSIS: Government Service Insurance System

HACCP: Hazard Analysis Critical Control Points

HCMV: Human Cytomegalovirus

HIV: Human immunodeficiency virus

HMO: Health Maintenance Organizations

HTA: Health Technology Assessment

ICC: Import Commodity Clearances


Appendix


IPO: Intellectual Property Office

IRRI: International Rice Research Institute

LGU: Local Government Unit

LOD: Letter of Denial

LTO: License to Operate

MDD: Medical Device Directive

MDG: Millennium Development Goal

MILF: Moro Islamic Liberation Front

MNLF: Moro National Liberation Front

MRI: Magnetic Resonance Imaging

NCD: Non-Communicable Disease

NDA: New Drug Application

NFC: National Formulary Committee

NGO: Non-Government Organization

NHIP: National Health Insurance Program

NIBR: Novartis Institute for Biomedical Research

NSCLC:Non-Small Cell Lung Carcinoma

OOP: Out-Of-Pocket

OR: Official Receipt

OTC: Over-The-Counter

PD: Pharmacodynamics

PDP: Partido Demokratiko Pilipino (Democratic Party of the Philippines)

PET: Positron Emission Tomography

PHAP: Pharmaceutical and Healthcare Association of the Philippines


Appendix


PITC: Philippine International Trading Corporation

PK: Pharmacokinetics

PMA: Philippine Medical Association

PNDF: Philippine National Drug Formulary

PPAD: Policy Planning and Advocacy Division

PPha: Philippine Pharmacist Association

R&D: Research and Development

RSN: Routing Slip Number

SEC: Securities and Exchange Commission

UHC: Universal Healthcare

UNFPA: United Nations Population Fund

UNICEF: United Nations Children’s Fund

USP: US Pharmacopoeia

VAT: Value Added Tax

WHO: World Health Organization

WTO: World Trade Organization

7.2 Bibliography

ABS-CBN (2014). 36 biggest BPO firms in Philippines. ABS-CBN News, January 1, 2014.

Available from: http://www.abs-cbnnews.com/business/01/01/14/36-biggest-bpo-firms-

philippines [Accessed March 27, 2014]

ADB (2013). Key Indicators for Asia and the Pacific. Asian Development Bank. Available from:

http://www.adb.org/ki2013/StatTrends.html [Accessed March 27, 2014].

ASEAN (2012a). ASEAN Labeling Requirements: Issues on Country Specific Requirements.

Association of Southeast Asian Nations. Available from:

portal.bpfk.gov.my/view_file.cfm?fileid=126 [Accessed March 24, 2014]


Appendix


ASEAN (2012b). Country report of the ASEAN Assessment on the Social Impact of the Global

Financial Crisis: The Philippines. Association of Southeast Asian Nations. Available from:

http://www.aseansec.org/wp-content/uploads/2013/07/Philippines.pdf

Alcantara N (2014). “Philippine economy continues to grow despite adversities”. eTurboNews,

February 17, 2014. Available from: http://www.eturbonews.com/42851/philippine-economy-

continues-grow-despite-adversities [Accessed March 24, 2014].

BSP (2013). SDDS: External Debt. Central Bank of Philippines (Bangko Sentral ng Pilipinas).

Available from: http://www.bsp.gov.ph/statistics/sdds/extdebt.htm [Accessed March 17, 2014]

BSP (2014). Foreign Direct Investments Post Higher Net Inflows in October 2013; Ten-Month

Level Reaches US$3.4 Billion. Central Bank of Philippines (Bangko Sentral ng Pilipinas).

Available from: http://www.bsp.gov.ph/publications/media.asp?id=3345 [Accessed March 17,

2014]

Danguilan, RA (2008). The burden of kidney disease in the Philippines, ABS-CBN News, July

29, 2008. Available from: http://www.abs-cbnnews.com/node/14995 [Accessed March 20,

2013]

DoH (2011a). New Medical Device Approval Process. Department of Health. Available from:

http://www.doh.gov.ph/bhdt [Accessed January, 2014]

DoH (2011b). Healthcare Policy Initiatives. Department of Health. Available from:

http://www.doh.gov.ph/content/how-was-enc-protocol-developed [Accessed January, 2012]

DoH (2011c). Pricing Policies. Department of Health. Available from:

http://www.doh.gov.ph/node/1332 [Accessed March 17, 2014]

DoH (2011d). Universal Health Care (UHC) and Access to Medicines. Department of Health.

Available from: http://uhmis2.doh.gov.ph/doh_ncpam/index.php/2011-07-23-13-45-53/2011-07-

19-07-11-04/ncpam?id=10 [Accessed May, 2012]

DoH (2012). THE Philippine Health System at a Glance. Department of Health. Available from:

http://www.doh.gov.ph/sites/default/files/3%20Chapter1.pdf

DoH (2013). Maternal Deaths By Main Cause. Department of Health. Available from:

http://www.doh.gov.ph/kp/statistics/maternal_deaths.html [Accessed March 17, 2014]


Appendix


UNICEF (2013). UNICEF: Extreme Risks for Pregnant Women and Newborn Babies in

Developing Countries. United Nations Children's Fund. Available from:

https://www.google.co.in/search?q=UNICEF&ie=utf-8&oe=utf-8&aq=t&rls=org.mozilla:en-

US:official&client=firefox-a&gfe_rd=cr&ei=snFaU-63A8_M8geAiIDYDw [Accessed March 17,

2014]

WHO (2011). Causes of Mortality. World Health Organization. Available from:

http://apps.who.int/ghodata/?vid=10011 [Accessed February 28, 2014]

7.3 Research Methodology

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

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

pharmaceutical industry.

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

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

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

methodology is followed for all databases and reports.

7.3.1 Coverage

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

vision of the industry possible.

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

association and competitor sources.

Company coverage is based on three key factors: revenue; products; and media attention,

innovation and market potential.

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

gathered and used to prioritize coverage.

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

approach are prioritized.

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

on a daily basis.


Appendix


The coverage is further streamlined and strengthened with additional input from GlobalData’s

expert panel (see below).

7.3.2 Secondary Research

The research process begins with extensive secondary research using internal and external

sources to gather qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

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

SEC filings

Industry trade journals, scientific journals and other technical literature

Internal proprietary databases

Relevant patent and regulatory databases

National government documents, statistical databases and market reports

Procedure registries

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

The CountryFocus reports are largely based on secondary research and use reliable and

authoritative sources such as the IMF, the World Bank, OECD, WHO, UNICEF, UNStats, BEA,

MHLW and NHS, among others.

7.3.3 Forecasts

The CountryFocus reports use the data available from the secondary sources to forecast and

validate the future trends for a country’s healthcare market, as well as parameters related to the

economy and healthcare infrastructure and expenditure.

7.3.4 Expert Panel

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

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

managers from pharmaceutical companies, academics from research universities, consultants from

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


Appendix


Historic data and forecasts are relayed to GlobalData’s expert panel 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.

gdhc0060chr-healthcare regulatory and reimbursement ...this report is a licensed product and is not...

Documents