Healthcare & Medical Technologies The Market Study

MARCH 2018

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The information and views set out in this study are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein. The contents of this publication are the sole responsibility of EU Gateway | Business Avenues and can in no way be taken to reflect the views of the European Union. The purpose of this report is to give European companies selected for participation in the EU Gateway | Business Avenues Programme an introductory understanding of the target markets countries and support them in defining their strategy towards those markets. For more information, visit www.eu-gateway.eu.

EU Gateway to the Philippines

Central Management Unit

The Philippines Market Study

March 2018

Submitted to the European Commission on 23 March 2018

Table of Contents

LIST OF FIGURES ...... 6

LIST OF TABLES ...... 7

TABLE OF ABBREVIATIONS ...... 9

1. EXECUTIVE SUMMARY ...... 11

2. WHAT ARE THE CHARACTERISTICS OF THE PHILIPPINES? ...... 17

3. MARKET OVERVIEW & EU ENTRY OPPORTUNITIES IN THE PHILIPPINES ...... 25 3.1 THE PHILIPPINES HEALTHCARE & MEDICAL TECHNOLOGIES SECTOR ...... 25 3.2 ASSISTIVE TECHNOLOGIES ...... 53 3.2.1 Market Overview ...... 53 3.2.2 EU Entry Opportunities ...... 70 3.3 MEDICAL EQUIPMENT ...... 77 3.3.1 Market Overview ...... 77 3.3.2 EU Entry Opportunities ...... 87 3.4 ICT FOR HEALTHCARE ...... 95 3.4.1 Market Overview ...... 95 3.4.2 EU Entry Opportunities ...... 106 3.5 TELEHEALTH AND REMOTE HEALTH MONITORING ...... 114 3.5.1 Market Overview ...... 114 3.5.2 EU Entry Opportunities ...... 127 3.6 NANOMEDICINE ...... 134 3.6.1 Market Overview ...... 134 3.6.2 EU Entry Opportunities ...... 139 3.7 AND LIFE SCIENCES ...... 142 3.7.1 Market Overview ...... 142 3.7.2 EU Entry Opportunities ...... 162 3.8 DENTAL PRODUCTS ...... 169 3.8.1 Market Overview ...... 169 3.8.2 EU Entry Opportunities ...... 180

4. REGULATIONS ...... 186 4.1 GENERAL IMPORT PROCEDURES ...... 186

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4.2 MEDICAL DEVICE IMPORT LICENCE ...... 187 4.3 MEDICAL DEVICE REGULATIONS ...... 188 4.4 GOVERNMENT TENDERS ...... 190 4.5 CONSUMER PROTECTION AND QUALITY STANDARDS ...... 192

5. ANNEX ...... 195 5.1 LIST OF USEFUL CONTACTS ...... 195 5.2 STARTING A BUSINESS IN THE PHILIPPINES ...... 197 5.3 USEFUL STATISTICS ...... 200 5.4 BIBLIOGRAPHY ...... 218

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List of Figures

Figure 1: Map of the Philippines ...... 17 Figure 2: EU-Philippines FDI, Trade in Goods, Services ...... 21 Figure 3: Healthcare system structure and referral system ...... 26 Figure 4: Statistics on medical professionals in the Philippines ...... 30 Figure 5: Philippine healthcare expenditure split ...... 32 Figure 6: Main suppliers of medical and healthcare equipment to the Philippines ...... 34 Figure 7: Required investments for reaching the Philippine Health Facility Development Plan Targets ..... 37 Figure 8: ACHIEVE strategy of the Philippine Health Agenda, 2016-2022 ...... 38 Figure 9: Major private sector players in healthcare industry ...... 39 Figure 10: Supply chain for medical devices to hospitals in the Philippines ...... 47 Figure 11: Population pyramid of the Philippines, 2016 ...... 54 Figure 12: Assistive technologies in the Philippines, 2012-2016 (Market Estimation from Trade Data) ..... 65 Figure 13: Share of imports/exports of assistive technologies (%) by category, 2016 ...... 66 Figure 14: E-wheelchair for Persons with Disabilities by THW ...... 67 Figure 15: Orthopaedics International, Inc. headquarters in the Philippines ...... 68 Figure 16: Indoplas Philippines Inc. plant in Quezon City, Philippines ...... 69 Figure 17: MED-EL’s vibrant soundbridge device ...... 75 Figure 18: Medical devices market by classification ...... 80 Figure 19: Private vs public healthcare expenditure in the Philippines ...... 81 Figure 20: Philab’s warehouse is preparing to send kits to schools all over the country ...... 87 Figure 21: ICT initiatives in the healthcare sector ...... 98 Figure 22: The eHATID LGU mobile application ...... 99 Figure 23: Health Apps - Visualisation ...... 101 Figure 24: Medix EMR Dashboard ...... 106 Figure 25: BPO solutions ...... 108 Figure 26: EMR & EHR Visualisation ...... 109 Figure 27: National Telehealth System Programme...... 115 Figure 28: Number of teleconsultations done by National Telehealth System Programme, 2014 ...... 116 Figure 29: National Telehealth Service Programmes by region as of 2015 ...... 117 Figure 30: RxBox and its components ...... 118 Figure 31: Dr. Damian Reyes Provincial Hospital ...... 121 Figure 32: ASCENT mobile and web application ...... 124 Figure 33: Konsulta MD ...... 125 Figure 34: Lifetrack Medical Systems ...... 126 Figure 35: Medifi landing page ...... 126 Figure 36: MyPocketDoctor App Visualisation ...... 130 Figure 37: Components of LEARNS ...... 132 Figure 38: Visualisation for nanobots used in nanomedicine ...... 134 Figure 39: Current nanotechnology facilities and equipment in the Philippines ...... 135 Figure 40: Examples of nanobot technology for artery cleaning ...... 140 Figure 41: The National Institute of Molecular Biology and Biotechnology (BIOTECH) ...... 144 Figure 42: National Institutes of Health ...... 145 Figure 43: New born Screening Centre – National Institutes of Health (NSC-NIH) ...... 146 Figure 44: Inauguration of the Philippine Genome Centre (PGC) ...... 147 Figure 45: The Core Facility of the Philippine Genome Centre ...... 147

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Figure 46: Biotek-M Dengue Kit ...... 149 Figure 47: St. Luke’s Medical Centre (SLMC) ...... 150 Figure 48: Health Technology Development by research category ...... 157 Figure 49: Pentra 400 chemistry instrument by SBSI...... 161 Figure 50: CliniMACS device by Miltenyi Biotec ...... 167 Figure 51: Dental products market estimations based on import/export data (2012-2016) ...... 173 Figure 52: Share of dental & oral care market imports/exports, 2016 ...... 174 Figure 53: Dental equipment & products trade, 2012-2016 ...... 176 Figure 54: Dental Equipment Trade, 2012-2016 ...... 177 Figure 55: Soniford Maeller’s dental chair model “Happy Doctor” ...... 179 Figure 56: Four main brands represented by ApexMed in the Philippines ...... 180 Figure 57: KaVo’s range of products ...... 183 Figure 58: Interadent laboratory in the Philippines ...... 184

List of Tables

Table 1: Ease of Doing Business in Philippines Ranking (2016-2018) ...... 24 Table 2: Government and private hospitals and bed capacity ...... 27 Table 3: DOH-retained hospitals: occupancy rate and patient load by level, 2011 ...... 29 Table 4: Number of government doctors, nurses, dentists and midwives by region, 2014 ...... 31 Table 5: Healthcare spending statistics among ASEAN countries ...... 33 Table 6: Health technology development by research category ...... 43 Table 7: Number of clinical & non-clinical trials and funding by source ...... 44 Table 8: Household population and Persons with Disability (PWD) by Region, 2010 ...... 55 Table 9: Household population with disability by broad age group, 2010 ...... 56 Table 10: % Distribution of PWDs among households per classification, 2011 ...... 56 Table 11: PhilHealth coverage for assistive technologies ...... 61 Table 12: Assistive Devices and Technologies Market Size in the Philippines Based on Import/Export Data Estimations, 2012-2016 ...... 66 Table 13: Current and projected medical device market, 2016-2021 ...... 77 Table 14: Top 10 exporters of medical equipment to the Philippines ...... 79 Table 15: 6 Top 10 importers of the medical equipment from the Philippines ...... 79 Table 16: Public Tenders for Medical Equipment, February 2018 ...... 92 Table 17: Research of Engineering and Science Education Programme grantee universities in nanotechnology-related areas before 2011 ...... 136 Table 18: Key R&D areas ...... 151 Table 19: R&D priorities for molecular and biotechnology under the HNRDA 2017-2022 ...... 165 Table 20: Number of Government Dentists by Region, 2014 ...... 172 Table 21: Share of dental & oral care market (export/import data estimations), 2016 ...... 174 Table 22: Share of dental & oral care market by category (import/export estimations), 2012-2016 ...... 175 Table 23: Dental equipment & products trade, 2012-2016 ...... 176 Table 24: Dental Equipment Trade, 2012-2016 ...... 177 Table 25: Classification of medical devices by risk category ...... 189 Table 26: Philippine National Health Accounts, 2013-2014...... 200 Table 27: Health Expenditure by Source of Funds, 2013-2014 ...... 200

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Table 28: Government and Private Hospitals Number and Bed Capacity, 2010-2014 ...... 201 Table 29: Number of Government Doctors, Nurses, Dentists and Midwives by Region, 2014 ...... 201 Table 30: Imports of Wadding, gauze, bandages and the like (adhesive) ...... 202 Table 31: Exports of Wadding, gauze, bandages and the like (Adhesive) ...... 202 Table 32: Imports of Wadding, gauze, bandages and the like (non-adhesive) ...... 203 Table 33: Exports of Wadding, gauze, bandages and the like (non-adhesive) ...... 203 Table 34: Imports of Syringes, with or without needles, used in medical, surgical, dental or veterinary sciences ...... 204 Table 35: Exports of Syringes, with or without needles, used in medical, surgical, dental or veterinary sciences ...... 204 Table 36: Imports of Tubular metal needles and needles for sutures, used in medical, surgical, dental or veterinary sciences ...... 205 Table 37: Exports of Tubular metal needles and needles for sutures, used in medical, surgical, dental or veterinary sciences ...... 205 Table 38: Imports of Needles, catheters, cannulae and the like, used in medical, surgical, dental or veterinary sciences (excluding syringes, tubular metal needles and needles for sutures) ..... 206 Table 39: Exports of Needles, catheters, cannulae and the like, used in medical, surgical, dental or veterinary sciences (excluding syringes, tubular metal needles and needles for sutures) ..... 206 Table 40: Imports of Electro-cardiographs ...... 207 Table 41: Exports of Electro-cardiographs ...... 207 Table 42: Imports of Ultrasonic scanning apparatus ...... 208 Table 43: Exports of Ultrasonic scanning apparatus ...... 208 Table 44: Imports of Magnetic resonance imaging apparatus ...... 209 Table 45: Imports of Scintigraphic apparatus ...... 209 Table 46: Imports of Electro-diagnostic apparatus, incl. apparatus for functional exploratory examination or for checking physiological parameters ...... 210 Table 47: Exports of Electro-diagnostic apparatus, incl. apparatus for functional exploratory examination or for checking physiological parameters ...... 210 Table 48: Imports of Ultraviolet or infra-red ray apparatus used in medical, surgical, dental or veterinary sciences ...... 211 Table 49: Exports of Ultraviolet or infra-red ray apparatus used in medical, surgical, dental or veterinary sciences ...... 211 Table 50: Imports of Apparatus based on the use of X-rays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses ...... 212 Table 51: Exports of Apparatus based on the use of X-rays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses ...... 212 Table 52: Imports of Computer tomography apparatus ...... 213 Table 53: Imports of Apparatus based on the use of X-rays for dental uses ...... 213 Table 54: Imports of Apparatus based on the use of X-rays, for medical, surgical or veterinary uses (excluding for dental purposes and computer tomography apparatus) ...... 214 Table 55: Exports of Apparatus based on the use of X-rays, for medical, surgical or veterinary uses (excluding for dental purposes and computer tomography apparatus) ...... 214 Table 56: Imports of X-ray tubes ...... 215 Table 57: Imports of Dental drill engines, whether or not combined on a single base ...... 215 Table 58: Imports of Instruments and appliances used in dental sciences, n.e.s...... 216 Table 59: Exports of Instruments and appliances used in dental sciences, n.e.s...... 216 Table 60: Imports of Instruments and appliances used in medical, surgical or veterinary sciences...... 217 Table 61: Exports of Instruments and appliances used in medical, surgical or veterinary sciences...... 217

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Table of Abbreviations

ADB Asian Development Bank AFTA ASEAN Free Trade Area APLAC Asia Pacific Laboratory Accreditation Cooperation ARMM Autonomous Region in Muslim Mindanao ASCENT Amputee Screening via Cell Phone Networking ASEAN The Association of Southeast Asian Nations BAPI Biotechnology Coalition of the Philippines BIOTECH National Institute of Molecular Biology and Biotechnology BOI Board of Investments BPO Business Processes Outsourcing BPS Bureau of Philippine Standards CAR Cordillera Administrative Region CDRRHR Centre for Device Regulation, Radiation Health, and Research CHITS Community Health Information Tracking System CIPI Certification International Philippines, Inc. CMDN Certificate of Medical Device Notification CPR Certificate of Product Registration DOH Department of Health DOST Department of Science and Technology DTI Department of Trade and Industry eHATID LGU eHealth Tablet for Informed Decision Making of LGUs (Local Government Units) EHR Electronic Health Records EMR Electronic Medical Records HHRDA Harmonised Health R&D Agenda HIMAP Health Informatics Management Association of the Philippines HNRDA Harmonised National Research and Development Agenda IAF International Accreditation Forum ICC Import Commodity Clearance ILAC International Laboratory Accreditation Cooperation ITDI-DOST Industrial Technology Development Institute - Department of Science and Technology LEARNS Leprosy Alert and Response Network System NCR National Capital Region NIH National Institutes of Health NTHC National Telehealth Centre PAB Philippine Accreditation Bureau PAC Pacific Accreditation Cooperation

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PCHRD Philippine Centre for Health Research and Development PDP-Laban Partido Demokratiko Pilipino-Lakas ng Bayan Party PHA Philippine Hospital Association PHAP Pharmaceutical and Healthcare Association of the Philippines PHIE Philippine Health Information Exchange PhilGEPS Philippine Government Electronic Procurement System PhilHealth Philippine Health Insurance Corporation PMA Philippine Medical Association PNS Philippine National Standards PPHA Philippine Public Health Association PPP Private-Public Partnership PREGINET Philippine Research, Education and Government Information Network PWDs Persons with Disabilities SHINE Secured Health Information Network and Exchange SLMC St. Luke’s Medical Centre UNDP United Nations Development Programme UP University of the Philippines WAH Wireless Access for Health

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1. Executive Summary

The Philippines healthcare and medical technologies market is poised for exciting growth, as the demand for quality healthcare is rising on the back of growing per capita income, higher spending on medical care, investments in healthcare facilities and the public-sector reforms. The largest government spending on healthcare so far is being channelled to improve the delivery and access to public healthcare. Meanwhile in the private sector, business expansion and opportunities currently unfolding are causing major local and regional business groups to look more closely at the country and expand their investment plans. The Philippine healthcare and medical technologies sector is rapidly expanding with vibrant and dynamic entry points for European companies.

Assistive Technologies

The global assistive technologies market was estimated at US$ 22.5 billion in 2016 and is anticipated to reach US$ 37.6 billion by 2023. Although North America and Europe are the leading markets for assistive devices, the Asia Pacific region is witnessing the fastest growth rate. Among the emerging economies, the Philippines is primed to become one of the leading destinations for assistive technologies, with its market growth driven by considerable increase in life expectancy, growth in geriatric and disabled population, instances of chronic disease, disability and mobility challenges, as well as changes in lifestyle trends. Advancing technologies, ageing population, growing economy and increasing healthcare spending by individuals and the government are starting to offer robust potential for assistive technology and device companies. The market value for assistive devices has grown by 20.5% between 2015 and 2016.

Medical Equipment

The Philippine medical equipment market is set to benefit from a strong economic performance over the next five years. Modernisation of hospitals and other key health sector development projects, additional health insurance funding together with expanded government as well as private sector spending on healthcare infrastructure, are expected to drive this growth.

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The market is forecast to expand from EUR 387.7 million in 2016 to EUR 603.8 million in 2021, growing at a CAGR of 9.3%. While the market remains heavily import dependent, there are numerous opportunities for European companies to benefit from these favourable market conditions.

ICT for Healthcare

The Philippine eHealth market continues to grow rapidly with the entry of new private sector players and the expansion of government initiatives, which are accelerating the digitalisation of healthcare in the Philippines. The revenue of the eHealth market was estimated at EUR 72.71 million by the end of 2017, and it is expected to reach EUR 106.64 million by 2020, growing at a CAGR of 21.4%. The primary macroeconomic indicators driving this growth are the upheaval of infrastructure in healthcare and a growing number of private healthcare providers, which are bolstering the Information and Communication Technologies (ICT) spending. The largest spending group in health ICT is the healthcare providers segment, including hospitals, clinics and wellness centres, with 88% share in 2015. The private sector, which aims for medical tourism impetus, is the leader in more aggressive adoption of novel ICT solutions while ICT spending in the public sector focuses on developing hardware infrastructure and making the existing health services more accessible. New initiatives are springing up in both private and public sectors, transforming the way healthcare is provided in the Philippines, and offering new entry avenues for European companies.

Telehealth and Remote Health Monitoring

While the Philippines continues to face challenges related to health inequities, arising from geographical isolation and other adversities, telemedicine and remote health monitoring are increasingly recognised as valuable tools to achieve universal healthcare for all Filipinos and improve their access to appropriate health resources. The Philippines is the 96th country in the world to embark on the use of digital and remote health. The country is considered one of the rising stars in the adoption of telemedicine in the South East Asia region. The majority of remote healthcare and health monitoring applications currently utilise mobile technologies given the high penetration rate of mobile devices. The national efforts to drive market segment growth are led

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by the National Telehealth Centre, while the private sector is also active in capitalising on the growing interest in telemedicine and remote health monitoring. A number of companies have already made successful entries with products ranging from referral solutions to full medical consultations. With the growth of tech savvy population, increasing pressures on the healthcare sector, expanding government spending on digitalisation of health infrastructure and focus on quality healthcare provision for remote communities, the country is bound to open up various opportunities for European telemedicine and remote health monitoring technology companies.

Nanotechnology

The nanotechnology market in the Philippines is still very new, but the growing recognition of its utility is driving interest in the country. Presently, utilisation of nanotechnologies is mainly concentrated in government research and development (R&D) institutes and in seven top universities. However, the country is increasingly showing interest to explore potential applications of nanotechnology within the commercial spaces, including those in medical and healthcare sector. The Philippine government has recently recognised the potential of nanotechnology to advance its research capabilities and address many of the persistent challenges in the country and has launched a 10-Year Strategy / Road Map to create a viable nanotechnology industry. The new strategy focuses on six industrial sectors, including the medical field, and the government intends to spend up to EUR 41.4 million on nanotechnology until 2021.

Biotechnology and Life Sciences

Among the South East Asian countries, the Philippines has been one of the more active countries to promote the adoption of and life science innovations for health. The market segment is growing with the proliferation of stem cell treatment, genetics and facilities, increasing R&D activities and the adoption of new, innovative products. The molecular diagnostics market in particular is witnessing rapid growth due to high adoption of molecular diagnostics tests and the advent of innovative cancer and next-generation based diagnostic solutions. In addition to public sector initiatives, the private sector has been particularly active in introducing new products as well as testing services to the Philippine market. In order to

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successfully capitalise on the opportunities presented by the biotechnology and life science technologies in the Philippines, many foreign companies are already exploiting new molecular technologies as strategies for market entry. In order to leverage the economies of scale and simplify the process of product distribution, many companies are also opting for entry into the Philippines via regional distribution agreements. The next five years are expected to witness significant developments in reagent systems and automation as well as introduction of a wide range of new products.

Dental Products

The Philippine dental market has significant growth opportunities, driven by the prevalence of dental problems, rising elderly population and the awareness of dental care, changing lifestyles and increasing affordability of dental practices among Filipino households. Overall, the dental market is expected to reach US$ 2.7 billion by 2019, growing at a CAGR of 10.4%. New government initiatives to improve dental care awareness, increasing spending on physical appearance by Filipinos, advancements in diagnostic and treatment technology, establishment of new clinics along with the rise in dental tourism are expected to add on to the growth of the Philippine dental market over the next five years. Currently, the market is largely dependent on imports with limited domestic manufacturing capabilities, which allows European companies to reap the benefits of the expanding demand for dental products and equipment.

Opportunities

A vibrant and dynamic Philippine healthcare & medical technologies market offers a number of lucrative business opportunities for European companies. Among the most promising avenues for entry are:

Export of Refurbished & New Medical Equipment, Devices and Products

The Philippine market offers a wide range of opportunities to export medical and healthcare devices, equipment and products. While there is a growing demand for high-quality, affordable and accessible healthcare, the country remains a major importer of healthcare and medical equipment and products. Domestic production accounts for less than 3% of the total market and

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it is limited to low level medical furniture and medical consumables. As a result, the market is served primarily by international suppliers. In addition, the market is highly diverse, with various healthcare providers purchasing both refurbished and new products. As the government seeks to increase its national healthcare coverage from 92% to 100% by 2022 with affordable, accessible and quality health system and has launched various initiatives to upgrade its medical and healthcare infrastructure, European companies are bound to find growing business opportunities for equipment and product exports to government healthcare facilities. In addition, the proliferating private sector is also seeking partnerships for refurbishment of new, and upgrading of existing, healthcare facilities across the country.

Healthcare Infrastructure Development

There are also opportunities for European companies to engage in project development, engineering, procurement and design, provision of specialist equipment, machinery and technology, and other supply chain requirements for healthcare infrastructure development. These opportunities are opening up as the government and private sector are expanding and upgrading their portfolios of healthcare facilities. For example, the government is embarking on a campaign to close the gaps for healthcare infrastructure and bed capacity by 2022, with targeted fund requirements of around PHP 228 billion (EUR 46.3 billion). As a result, the government is embarking on a quest to build at least 25 new hospitals, 15,304 new village health stations, 2 mega hospitals, and 2,664 new urban and rural health units in addition to upgrading all Department of Health’s hospitals by 2022. The private sector is also eyeing opportunities to expand the hospital infrastructure portfolio by building new and upgrading existing healthcare facilities. Together with the growing interest in developing new healthcare research fields, such as nanotechnology, biotechnology and life sciences, for which new facilities with quality technologies are needed, the country is a promising destination for European investment.

Collaboration on Research and Development (R&D)

The country is also very active in fostering collaborations between domestic and international players in the healthcare and medical technologies sector. The government and its various agencies remain open for partnerships with the private sector in order to increase the utilisation

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of high-end technologies, accelerate the technology transfer and promote the growth of new healthcare fields, and such opportunities for collaboration have been enshrined in the Harmonised National Research and Development Agenda 2017-2022. Research and development partnerships are particularly encouraged in the fields of nanotechnology, biotechnology and life sciences in order to grow these fields further.

ICT for healthcare and eHealth Technology Provision

Finally, eHealth is rapidly taking off in the Philippines. In an archipelago of more than 7,000 islands, the access to quality, affordable healthcare services remains a challenge to many Filipinos. Divided by many islands, it is difficult to provide an equitable and efficient delivery of medical advice or treatments across the entire country. Aggravating this problem are the shortage of doctors, lack of hospital beds, and unutilised pool of nurses nationwide. Rapid innovations in information and communication technology, however, are rapidly spilling over to the health sector and are helping alleviate these problems, giving rise to the digital healthcare market. The eHealth market continues to grow rapidly with the entry of new private sector players and the expansion of government initiatives, which are accelerating the uptake of digital healthcare and medical technology solutions. The market remains underserved and far from saturated, meaning that there are various opportunities for European ICT companies. From solutions that digitalise and integrate medical and health records to data collection mechanisms, telemedical consultation technologies, wellness apps and eLearning solutions, the ICT and eHealth market is vibrant, and the demand for ICT solutions is high.

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2. What are the characteristics of the Philippines?

The Republic of the Philippines is a sovereign island nation in South East Asia situated in the western Pacific Ocean. It has 7,107 islands spanning more than 300,000 km2 of territory. It is divided into three island groups: Luzon, Visayas, and Mindanao. The climate of the Philippines is tropical and maritime, characterised by relatively high temperature, high humidity and abundant rainfall.

The country has an estimated population of over 100 million and a recorded Gross Domestic Product (GDP) of US$ 310 billion in 2016. The major industries in the Philippines include manufacturing, business process outsourcing, construction and infrastructure.

The Philippines is among the fastest-growing economies in South East Asia, with upgrades to sovereign investment ratings confirming improvements in the country’s macroeconomic fundamentals. The country has a mixed economic system which includes a variety of private freedom combined with centralised economic planning and government regulation.

The country is composed of a unique blend of Malay, Chinese, Spanish, American and

Figure 1: Map of the Philippines Arab ethnic groups. Source: CIA

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More than 100 cultural minority groups are scattered throughout the country. The Philippines lists Filipino and English as its official languages while Spanish, Chinese, Malay, Japanese, Tamil and Arabic languages are also used in the country.

2.1. Political Overview

The Philippines is a republic with a presidential form of government wherein power is equally divided among its three branches: executive, legislative, and judicial. The executive branch is headed by the President, who serves as the Chief of State and Head of Government. The legislative branch is the bicameral congress composed of members of the Senate and the House of Representatives while the judicial branch is headed by the Chief Justice.

The Constitution of the Philippines is the highest law of the land. The Constitution currently in effect was proclaimed on 2nd February, 1987 and popularly known as the 1987 Constitution.

There are a number of political parties in the country’s political system with different ideologies. With this multi-party system, no one party often has a chance of gaining power alone. Thus, elected officers work with each other to form coalition of governments. Currently there are two types of parties in the Philippines, the Major Parties, traditional political parties, and Minor Parties or Party-list Organisations, who bank on the party-list system to win Congressional Seats.

In May 2016, a national election for the executive and legislative positions took place in the country where a total of 18,083 positions were at stake. It was Rodrigo Duterte from the Partido Demokratiko Pilipino-Lakas ng Bayan (PDP-Laban) Party who won the Presidency and became the 16th President of the Philippines, succeeding Benigno S. Aquino III from the Liberal Party.

2.2. Economic Overview

The Philippines’ emergence as a growth leader has been building gradually since the 1990s, following a long period of low growth and political upheaval. The country’s GDP grew by 6.9% in 2016, which is among the fastest in Asia. Meanwhile, the projected GDP growth rate for 2017 and 2018 remain robust at 6.8% and 6.9% respectively, on the back of strong domestic demand,

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infrastructure spending, and recovering exports. The Philippines is classified as a low middle- income nation with a Gross National Income per capita of US$ 3,540.

The country’s service sector represents 58.8% of

The Philippines Government has pursued its GDP and employs more than half of its legislative reforms to enhance the workforce. The major sections of this sector include entrepreneurial environment and develop trade and repair (motor vehicles), real estate, a more vibrant private sector. transportation and communication. Its industrial sector contributes to 30.9% of its GDP and employs about 15% of the country’s workforce. Industrial food processing is among the Philippines’ main manufacturing activities along with the production of cement, glass, chemical products and fertilisers, iron, steel and refined oil products.

The agricultural sector in the country employs about 32% of the labour force but only contributes 10.3% to its GDP. The Philippines is a mineral-rich country with an unexploited mineral wealth of US$ 1.4 trillion.1

The Philippines Government has pursued legislative reforms to enhance the entrepreneurial environment and develop a more vibrant private sector to generate broader-based job growth. Poor infrastructure remains a serious impediment to the country, but its economic growth reflects its efforts in addressing this challenge by developing the infrastructure of the nation with more than 50 infrastructure projects in the pipeline.2

1 Forbes Asia (2015). Trillion-Dollar Philippine Economic Goldmine Emerging From Murky Pit 2 Nikkei Asian Review (2016). Philippines readying 'hundreds' of infrastructure projects

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2.3. Trade Overview

The Philippines has been rather cautious in its Free- trade agreement (FTA) policies compared to some of EU foreign direct investment stock in the Philippines amounted to EUR 6.1 billion in its ASEAN neighbours, having only 7 signed and in- 2015, making the EU the largest investor in effect FTAs. The Philippines is a member of the the Philippines ASEAN Free Trade Area, which plays a key role in the nation’s intra-Asian trade. ASEAN has FTAs with China, India, Japan, South Korea, Australia and New Zealand.

The EU and the Philippines signed a Partnership and Cooperation Agreement3 in 2012. Among areas covered in the agreement are the commitment to promote economic and social progress between two parties and also promote sustainable development, including environmental protection and effective cooperation to combat climate change with emphasis on green technology adoption within the countries. In 2014, the Philippines was a beneficiary of trade preferences granted by the EU under the standard Generalised Scheme of Preferences (GSP). A zero-rate tariff is offered under this scheme for over 6,200 tariff lines as a part of a special incentive arrangement between the EU and Philippines.4

Negotiations for an EU-Philippines Free Trade Agreement were launched on 22 December 2015 and are progressing well.5 The agreement will develop a key aspect of Europe’s overall relationship with the Philippines that is based on the Partnership and Cooperation Agreement signed in 2012. Terms being discussed and negotiated include topics such as rules of origin, trade remedies, sanitary and phyto-sanitary measures, customs and trade facilitation, public procurement, intellectual property, and competition, among others.6

3 European External Action Service (2011). Partnership and Cooperation Agreement “Framework Agreement on partnership and cooperation between the EU and its member states, of the one part, and the Republic of the Philippines, of the other part. 4 http://www.businessmirror.com.ph/doing-ftas-with-the-european-union/ 5 The EU and the Philippines have concluded in February 2017 the second round of trade negotiations. The EU has described the tone of the negotiations to be constructive and positive with various communalities, which may move text-based discussions forward in a number of negotiation areas. 6 http://business.mb.com.ph/2017/04/18/eu-not-prioritizing-second-round-of-fta-talks-with-ph/

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With bilateral trade in goods amounting to EUR 12.8 billion in 2016, the EU ranks as the Philippines' fourth largest trading partner, while the Philippines is the EU's sixth largest trading partner.

EU exports to the Philippines are dominated by machinery (18.9%), transport equipment (16.8%), chemicals (14.1%), food products (13.8%), and electronic components (13.7%). The Philippines’ main exports to the EU are office and telecommunication equipment (45.8%), machinery (13.9%), food products (12%), and optical and photographic instruments (10.5%).7

Figure 2: EU-Philippines FDI, Trade in Goods, Services Source: European Commission

Bilateral trade in services between the EU and the Philippines reached EUR 4.2 billion in 2015, while EU foreign direct investment stock in the Philippines amounted to EUR 6.1 billion for the same year, making the EU the largest investor in the Philippines.

7 European Commission (May 2017). Trade: The Philippines. http://ec.europa.eu/trade/policy/countries-and-regions/countries/philippines/

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The Philippine’s total external trade in goods in 2016 was recorded at US$ 141.514 billion, expanding by 8.9% from US$129.894 billion in 2015. Total import receipts went up by 8.9% to US$ 84.108 billion in 2016 from US$ 71.067 billion in 2015. However, total export receipts decreased by 2.4% from US$ 58.827 billion in 2015 to US$ 57.406 billion in 2016.

The Philippines’ major trading partners are China, Japan, US, Singapore and Hong Kong. Among the EU countries, Germany is the country’s top trading partner, with a total trade of US$ 4.357 billion or 31.8% of the EU’s total trade in 2016.

The top five imported goods from the EU member countries were: Electronic Products - US$ 1.566 billion; Transport Equipment - US$ 1.042 million; Industrial Machinery and Equipment - US$ 684.25 million; Medicinal and Pharmaceutical Products - US$ 561.39 million; and Other Food and Live Animals - US$ 442.24 million.

Since 25 December 2014, the Philippines has enjoyed enhanced trade preferences with the EU under the EU’s Generalised Scheme of Preferences plus (GSP+). Before that, the Philippines was a beneficiary of the standard GSP scheme.

2.4. Market Access

The Philippines has emerged as an attractive market for foreign companies due to its strong economic, democratic and demographic fundamentals. The country offers advantages in the form of manageable inflation, improving public finances, and a strong demographic dividend in a region of high growth.

An agent or distributor arrangement is the most common method in entering the Philippine market. Partnering with a local business is also recommended, as entering the Philippine market presents some challenges to foreign companies. This is due in part to the limited number of family-owned conglomerates that dominate key sectors and, in some cases, create high barriers to entry.

An open economy, the Philippines allows 100% foreign equity in all areas of investment except those reserved for Filipinos under the Philippine Constitution and existing laws, such as private

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lands, mass media, and small-scale mining. The country also supports Build-Operate-Transfer investment schemes that other Asian countries emulate.

Foreign investments are encouraged by the Philippine government to fuel economic growth. According to the National Statistical Coordination Board, the total approved foreign investments in the Philippines for the year 2015 amounted to PHP 245.2 billion (EUR 4.6 billion), an increase of 31.2% from the previous year.

Being the world's third largest English-speaking country, the Filipino workforce is one of the most compelling advantages the country has over any other Asian country.

The Philippines is located right in the heart of Asia – today the region with the fastest economic growth. It is located within four hours’ flying time from major capitals of the region such as Singapore, Beijing, and Bangkok. Sited at the crossroads of the eastern and western business, it is a critical entry point to over 500 million people in the Association of South East Asian Nations (ASEAN) market and a gateway of international shipping and air lanes.

2.5. Business and Competitive Environment

The Philippines slipped by 14 positions from 99th to 113th place in the latest Doing Business Rank report of the World Bank for 2018. In spite of this slipping, the country remains a good place as far as doing business is concerned but it needs to further accelerate its reforms to address tougher competition.

The Philippine government has created a task force composed of various government agencies to streamline processes that will improve the country’s rank in terms of ease of doing business. This includes processes for starting a business, paying taxes as well as social payments.

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Ease of Doing Business in the 2018 2017 2016 Change in Rank (2017- Philippines Rank Rank Rank 2018) Overall rank 113 99 103 - 14

Starting a business 173 171 164 - 2

Dealing with construction permits 101 85 103 - 16

Getting electricity 31 22 30 - 9

Registering property 114 112 109 - 2

Getting credit 142 118 109 - 24

Protecting minority investors 146 137 136 - 9

Paying taxes 105 115 120 - 10

Trading across borders 99 95 93 - 4

Enforcing contracts 149 136 136 - 13

Resolving insolvency 59 56 54 - 3 Table 1: Ease of Doing Business in Philippines Ranking (2016-2018) Source: World Bank

In terms of global competitiveness, the Philippines ranked as the 57th most competitive country in the world (out of around 140 economies) based on the Global Competitiveness Report of the World Economic Forum for 2016.

The country also has the Board of Investments (BOI), an attached agency of Department of Trade and Industry, which assists investors to venture into desirable areas of economic activities in the country.

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3. Market Overview & EU Entry Opportunities in the Philippines

3.1 The Philippines Healthcare & Medical Technologies Sector

The Philippines Healthcare and Medical Technologies market is poised for exciting growth. Increased government spending and contributions from sin taxes are being channelled to improve the delivery and access to public healthcare. In the private sector, business expansion and opportunities currently unfolding have caused major local and regional business groups to look more closely at the country and expand their investment plans in the sector. The dynamic Philippine healthcare sector offers business opportunities for both domestic and international healthcare and medical technologies suppliers. The demand for quality healthcare is rising on the back of growing per capita income, higher spending on medical care, investments in healthcare facilities, public sector reforms, and the proliferation of communicable and non-communicable diseases in the country.8

Healthcare Infrastructure in the Philippines

In general, the healthcare system in the Philippines is structured around the North American model, with a mixed public-private healthcare infrastructure.9 While the leading medical institutions are on par with global medical standards, the facilities in the provinces and villages (barangays) still face some challenges in acquiring systems and equipment for primary healthcare needs. To address this, the Department of Health (DOH) has implemented the Local Investment Plan for Health 2017-2019 that aims to provide financial aid for the delivery of health services, facilities and equipment to the provinces in the country.

8 The country’s tropical climate heightens the incidence of communicable diseases, increasing the need for more health centres, particularly those that specialise in tropical diseases. As across the rest of Asia Pacific, the Philippine population is also ageing and becoming more urban with rises in non-communicable diseases having impact on population health and service delivery capacity. It is anticipated that this trend will have an impact on the proliferation of formal mechanisms to support non-communicable diseases services across the Philippines in the upcoming years. Sources: http://www.pwc.com/gx/en/industries/healthcare/publications/asia-pac-newsletter/assets/pwc-apac-health- industries-newsletter-august2015.pdf & http://asiahealthcaremarketresearch.com/philippines.html 9 https://www.allianzworldwidecare.com/en/support/view/national-healthcare-systems/healthcare-in-philippines/

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Figure 3: Healthcare system structure and referral system Source: Healthcare Market Research Asia

At present, the country’s hospital system is operating at a ratio of one bed per 1,000 Filipinos, which is below the World Health Organisation’s recommendation of 3.3 beds per 1,000 inhabitants.10 It is estimated that the country needs to set up at least 100 new hospitals and upgrade the existing ones with additional bed capacity to achieve the recommended targets by 2022.11 The increasing demand for healthcare services is putting pressures on the healthcare providers to upgrade and expand the health infrastructure network.

According to the Philippine Statistical Yearbook (2015), the country’s bed capacity in 2014 was 98,429 broadly divided between 452 government and 770 private hospitals.12

10 https://www.slideshare.net/FinproRy/philippines-healthcare-61734373 11 http://www.pwc.com/gx/en/industries/healthcare/publications/asia-pac-newsletter/assets/pwc-apac-health-industries-newsletter- august2015.pdf 12 https://psa.gov.ph/sites/default/files/2015%20PSY%20PDF.pdf

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Number of Hospitals Bed Capacity Bed capacity Year per 10,000 Total Government Private Total Government Private population

2010 1,812 730 1,082 98,155 49,372 48,783 10.6

2011 1,819 732 1,087 101,914 51,317 50,597 10.7

2012 1,825 730 1,095 101,366 49,557 51,809 10.5

2013 1,454 542 912 96,796 46,054 50,742 9.9

2014 1,222 452 770 98,429 48,384 50,045 9.9

Table 2: Government and private hospitals and bed capacity Source: Philippine Statistics Authority

As of 2016, the Philippines have reached 67% of the needed bed capacity to meet the medical assistance needs, while 42,856 additional hospital beds were still needed by 2022.13

While health facilities, such as government hospitals, private hospitals and primary health facilities are spread out across the country, 46% of the primary hospitals – fully departmentalised facilities, which are able to handle specialised services – are located in the National Capital Region.14 Some regions in the Philippines have very limited access to more advanced medical treatments and healthcare equipment. This creates opportunities for companies that can provide the needed healthcare facilities and services in the regions outside of Manila. In fact, provincial hospitals are increasing in number to cater to the unmet demand for healthcare service in the countryside and to ease overcrowding in the city hospitals.

While public hospitals in the Philippines tend to place greater emphasis on preventative healthcare, private hospitals concentrate on curative services.

The healthcare facilities industry is dominated by the private sector, which accounts for approximately 63% of the total number of hospitals in the country. Private services are much

13 Philippine Health Agenda 2016-2022 14 http://asiahealthcaremarketresearch.com/philippines.html /

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larger in terms of human, financial and technological resources, but are used by only 30% of the population who can afford them.15 Private facilities are, as a rule, more expensive but are considered to provide better services due to faster processing of results, more advanced equipment and cleaner and less crowded facilities.16 The majority of the private sector expenses are covered by out-of-pocket means, with the remainder being funded through insurance schemes.

Most private sector facilities are situated in urban areas in major cities and deliver services through clinics and private hospitals. Although the private sector is regulated by the DOH and the Philippine Health Insurance Corporation (PhilHealth), health information generated by private providers is generally absent in the information systems of the DOH.

The most prestigious hospitals in the private sector are St. Luke’s Hospital (633 beds), Makati Medical Centre (600 beds), Santo Tomas University Hospital (700 beds), Asian Medical Centre (180 beds), Medical City (393 beds), Cardinal Santos Medical Centre (250 beds), Manila Doctors’ Hospital (300 beds), and Chinese General Hospital (550 beds). Such private sector facilities are highly concentrated in the area.

Although private hospitals outnumber government facilities in all levels, public hospitals are still the healthcare provider of choice by the general population. Approximately 70% of the population are still dependent on public hospitals, most of which are consistently oversubscribed and operating beyond capacity.17

15 http://asiahealthcaremarketresearch.com/philippines.html 16 http://asiahealthcaremarketresearch.com/philippines.html 17 http://asiahealthcaremarketresearch.com/philippines.html

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Level Bed Occupancy Rate Average Annual Patient Load

1 70% 11,403 2 103% 21,837 3 114% 74,632 4 108% 128,294 All 105% 85,213 Table 3: DOH-retained hospitals: occupancy rate and patient load by level, 2011 Source: Hospital Governance Reforms in the Philippines: Four Case studies

Within the public healthcare sector, primary hospitals accommodate most of the population with regards to serious diseases and basic functions. As a result, such hospitals receive more funds from the DOH for maintenance. Under the 2018 National Expenditure Program, the DOH is planning to allot PHP 29 billion (EUR 458.6 million) for its health facilities enhancement programme for all DOH-run hospitals, medical facilities, and drug rehabilitation centres, with priority given to poor provinces in the country.

Health stations in barangays (villages) are designated public health facilities to provide primary care to local communities, such as first aid services, preliminary diagnosis of diseases and other basic health services. Out of 42,000 barangays in the country, however, only 20,241 have health stations.

In the public sector, the biggest hospitals, in terms of authorised bed capacities, are: the Philippine Heart Centre (282 beds), National Kidney Institute (200 beds), the Philippine Children’s Medical Centre (200 beds), Lung Centre (98 beds), National Centre for Mental Health (4,200 beds), San Lazaro Hospital (900 beds), Jose Fabella Memorial Hospital (700 beds), and the Philippine Orthopaedic Centre (700 beds). The Philippine General Hospital (1,300 beds) is considered the best government hospital in terms of facilities and services.

In addition to the requirements for hospital upgrades and the establishment of new health facilities, the Philippines requires a strong focus on skilled manpower as shortage of qualified personnel remains a thorny issue. A major exporter of health workers, many of whom migrate

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abroad in search of better salaries,18 the Philippines has a shortfall of health professionals, particularly in rural and poor areas. At the moment, the country has approximately 1 physician per 1,000 Filipinos. According to the Philippine Medical Association (PMA), of some 130,000 licensed doctors, only 70,000 are active members of the association, serving some 100 million Filipinos. The country is also producing only 2,300 doctors per year, leaving the shortfall of an additional 15,000 doctors to sufficiently meet the health needs of Filipinos, annually.

Figure 4: Statistics on medical professionals in the Philippines Source: MIMS Today

Within the public healthcare sector, the number of medical professionals is considered to be an even more acute issue. In 2014, there were some 3,000 doctors, 1,788 dentists, 6,061 nurses and 17,151 midwives to service the Philippines public health sector.

18 According to the Philippine Medical Association (PMA), some 10,000 doctors have shifted to nursing and have migrated to other countries over the past 10 years.

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Region Doctors Dentists Nurses Midwives NCR 632 509 866 1208 CAR 94 28 227 689 1 162 108 295 994 2 109 71 239 839 3 299 178 585 1638 4-A 235 167 580 1489 4-B 86 55 165 592 5 173 74 271 1048 6 250 125 465 1740 7 257 118 620 1577 8 161 88 290 913 9 92 43 234 671 10 101 50 286 901 11 81 53 126 735 12 118 60 531 981 13 82 36 128 611 ARMM 70 25 153 525 Total 3,002 1,788 6,061 17,151 Table 4: Number of government doctors, nurses, dentists and midwives by region, 2014 Source: Philippine Statistics Authority

At the moment, the five leading causes of morbidity in the Philippines are acute respiratory infections, acute lower respiratory tract infections and pneumonia, bronchitis/bronchiolitis, hypertension and acute water diarrhoea.19 Incidence rates of hypertension and heart diseases, lung and kidney diseases and other respiratory diseases are rising. In response, most hospital improvements concentrate on specialised services for radiology, cardiac, lung and kidney examinations, and pathology. As such, demand for electrocardiographs, computerised tomography scans, x-ray and dialysis machines, and other laboratory instruments is rising.

Health financing sources in the Philippines are national and local governments, insurance (government and private), out-of-pocket means, and funds from the donor agencies.20 Over the years, public sources, such as government and the overseas development agencies have

19 http://asiahealthcaremarketresearch.com/philippines.html 20 http://www.doh.gov.ph/sites/default/files/basic-page/chapter-one.pdf

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consistently contributed around 37% of the total healthcare expenditure, leaving the majority of the costs to be covered via patient’s out-of-pocket means.21

Figure 5: Philippine healthcare expenditure split Source: Healthcare Market Research Asia

The public healthcare coverage is provided in the country by the Philippine Health Insurance Corporation (PhilHealth). Launched in 1995, the National Health Insurance Programme had achieved a 92% coverage of the population by 2016 (92.45 million). The PhilHealth’s mandate is now to increase its coverage to 100% of the population by 2022 and it is expected to drive demand for quality healthcare. The government also aims to promote quality healthcare coverage in addition to simply reaching the mandated 100% of the population.

Recently, the healthcare sector growth has accelerated due to policy measures to increase the healthcare budget, which has led to an increase in the amount of funds available for healthcare facilities upgrades and for financing healthcare spending by the poor. According to BMI Research, the nation’s total healthcare spending is projected to grow by an average of 8% annually, from an estimated US$ 15 billion in 2016 to US$ 20 billion in 2018, and eventually reach US$ 36 billion by 2026.22 Growth is expected to be driven by the government’s spending on its continued efforts to expand universal healthcare. BMI Research predicts that the government’s healthcare

21 In 2014, the share of the public healthcare expenditure has decreased slightly to 34.3%, according to the World Bank data: https://data.worldbank.org/indicator/SH.XPD.PUBL 22 http://healthcareasiamagazine.com/healthcare/news/philippines-healthcare-spend-grow-92-us36b-in-2026

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spending will increase to 44% of the total annual healthcare spending by 2026, from the current levels of 37%.

For 2018, the government has already allocated the highest budget of the health department ever, which, including budgetary support for government corporations, reached PHP 171.09 billion (EUR 2.68 billion). This is a significant increase since 2005 when the budget was only PHP 10 billion (EUR 156.75 million). Around 60% of the fund has been allocated to public health services, improvement of infrastructure and services, decongestion of hospitals and building of a vaccine production facility.23 Around PHP 51.591 billion (EUR 808.67 million) was further allocated for the procurement of drugs, medicines and vaccines, including medical and dental supplies for distribution to government healthcare facilities.24

While the nation’s per capita expenditure is lower than some of its South East Asian neighbours, it is increasing at a steady pace. Per capita healthcare expenditure has recorded more than a 50% increase since 2009, reaching US$ 135 in 2014.

Healthcare Expenditure Per Healthcare Expenditure, ASEAN Member Nation Capita (US$), 2014 Total (% of GDP), 2014 Singapore 2,752 4.9 Brunei 958 2.6 Malaysia 456 4.2 Thailand 360 6.5 Vietnam 142 7.1 Philippines 135 4.7 Indonesia 99 2.8 Cambodia 61 5.7 Laos 33 1.9 Myanmar 20 2.3 Table 5: Healthcare spending statistics among ASEAN countries Source: World Bank

23 https://news.mb.com.ph/2017/09/16/what-doh-plans-to-do-with-its-highest-budget-ever/ 24 https://www.doe.gov.ph/press-releases/legarda-2018-budget-provides-better-health-services-filipinos

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Health & Medical Technologies Provision in the Philippines

As for health & medical equipment, devices and technology, the market is largely dependent on imports with nearly all medical equipment and devices, and more than 65% of medical disposables, arriving from abroad. Local production supplies less than 2% of the healthcare and medical technologies market and it is primarily limited to the manufacturing of low-level supplies. As the majority of healthcare and medical technologies are imported, supplies and other products accompanying their use are likewise supplied via trade with other countries.

Major healthcare and medical technology suppliers to the Philippines are the U.S., Germany, Japan and Singapore. The market, however, is also witnessing a steady entry of other players, such as China and South Korea, the products of which are considered cheaper and more affordable in a price-sensitive market.

Main suppliers to the Philippines

Others United 25% States 29%

Singapore 12% Germany 18% Japan 16%

Figure 6: Main suppliers of medical and healthcare equipment to the Philippines Source: Morulaa HealthTech

For goods imported from the EU, medical equipment and pharmaceutical products top the list. In 2015, the combined import value amounted to EUR 700 million, out of which EUR 412 million went for pharmaceuticals and EUR 287 million for medical equipment.25 The market has seen an

25 https://nordcham.com.ph/european-union-trade-philippines/

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increase from 2013, when the medical equipment exports from the EU amounted to approximately EUR 190 million. Unofficial estimates of 2015 indicated that the total market size for healthcare and medical equipment was around US$ 600 million,26 although the BMI Research reported that the 2016 figures reached only US$ 478.2 million.27

Products with high sales potential for European suppliers are typically high value, low-volume, and high-tech products, such as ultrasound equipment, magnetic resonance imaging, breathing equipment and other radiology and electronic medical devices.

Key Healthcare and Medical Technology Market Developments & Government Initiatives

In recent years, the government has put in motion major initiatives to accelerate the growth of the healthcare sector, including the policies to increase the coverage of health insurance and modernise public sector institutions.

In 2010, the Philippines launched the Universal Healthcare Programme, which aims to ensure that every Filipino receives affordable and quality healthcare benefits. Via the enactment of the National Health Insurance Act of 2013 and the Universal Healthcare Bill, the government aims to provide quality PhilHealth coverage for all Philippine citizens and it has allocated PHP 35 billion (EUR 548.61 million) in 2013 to PhilHealth to accelerate the progress.28

One of the three main thrusts of the Universal Health Care Agenda is the Health Facilities Enhancement Programme, which initiated the government’s commitment to meet the infrastructure and equipment needs of the Philippines. To improve healthcare infrastructure, the government has set a target to upgrade all DOH-controlled hospitals. It has also given the ultimatum for private hospitals to incorporate electronic records and surgical expertise into their practices at the threat of being downgraded to the status of primary healthcare centres. These

26 https://www.slideshare.net/FinproRy/philippines-healthcare-61734373 27 BMI Research (2017). Philippines Medical Devices Report Q4 2017. 28 http://asiahealthcaremarketresearch.com/philippines.html

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developments are likely to drive the demand for information and communication technologies (ICT) and healthcare & medical technology solutions to meet the upgrading requirements.29

In 2012, the government has also introduced the Sin Tax Law,30 which has significantly increased the DOH budget for healthcare provision. Out of the extra revenues collected through the Sin Tax, 85% are earmarked for healthcare, namely to fund universal healthcare, upgrade medical facilities and train doctors. Within the first two years of passing the law, the DOH’s budget increased from US$ 1.25 billion to nearly US$ 2 billion, giving extra thrust for healthcare and medical technology sector growth.31

In 2013, the Philippines, via joint cooperation between the DOH and the Department of Science and Technology (DOST), has also rolled out the “Philippines eHealth Strategic Framework and Plan for 2014-2020”, which aims to utilise ICT in the health sector to support the delivery of health services and manage health systems for greater efficiency and effectiveness. One of the strategic goals of this framework is to establish a unified and coherent health and management information system and to capitalise on ICT to provide better health services to all Filipinos. The Strategic Framework aims to establish national centres for service improvements, upgrade medical equipment for state-sponsored hospitals and the barangay health stations, and implement the national electronic public health information system.32 These initiatives are driving demand for eHealth and ICT solutions across the healthcare sector in the Philippines.

In 2015, the DOH took additional steps to upgrade healthcare facilities by announcing its intentions to modernise at least 20 hospitals at the cost of US$ 20 billion over the course of next decade.33 These plans have been further expanded with the release of the Philippine Health Facility Development Plan 2017-2022 – a designated macro level plan to address the gaps and needs for the upgrading of barangay health stations, rural health units, polyclinics, hospitals and

29 Sin Tax Law increased the taxation of tobacco products and alcohol. https://www.slideshare.net/FinproRy/philippines-healthcare-61734373 30 Sin Tax Law (2012) increased the taxation of tobacco products and alcohol. 31 https://www.slideshare.net/FinproRy/philippines-healthcare-61734373 32 https://nordcham.com.ph/european-union-trade-philippines/ 33 At the moment, there are no clearly defined budget allocation criteria and the Department of Health bases its budget division on presumed needs.

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other healthcare facilities. It is estimated that an additional PHP 228 billion (EUR 46.3 billion) will be needed to achieve these targets.

Figure 7: Required investments for reaching the Philippine Health Facility Development Plan Targets Source: The Philippine Health Facility Development Plan 2017-2022

Among the goals are the plans to upgrade all DOH-hospitals and infirmaries. The government also aims to establish 25 new hospitals, upgrade and/or relocate 263 rural and urban health units to disaster resilient facilities and build 2,664 new ones, in addition to 15,304 new village health stations by 2022.34 Mega hospitals are also expected to be built in Visayas and Mindanao regions.35

To address the shortage of medical professionals, the two-year Public Health Associate Deployment project started in 2015 in 44 provinces, which aims to deploy health professionals to communities with the highest needs. In the upcoming years, the government also aims to hire 2,424 doctors, 39,466 nurses, 1,114 dentists, 3,288 pharmacists, 2,862 medical technologists,

34 http://www.dof.gov.ph/taxreform/index.php/infographics/ 35 Philippine Health Agenda 2016-2022

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911 public health associates and 2,497 universal health care implementers to provide a greater health service coverage across the country.36

Finally, the government has also launched the Philippine Health Agenda Framework 2016-2022, which aims to attain health-related sustainable development goals, provide financial risk protection, better health outcomes and responsiveness of the healthcare system.37 The Philippine Health Agenda is expected to be attainable via the ACHIEVE strategy:

Figure 8: ACHIEVE strategy of the Philippine Health Agenda, 2016-2022 Source: The Philippine Health Agenda 2016-2022

Due to efficiency of the private hospitals, there had been government initiatives to privatise some of its largest hospitals by way of its private-public partnership programme. However, these plans were met with rampant disapproval from the public as the privatisation was seen as a threat to the affordability of health costs for the public. Citizens demanded that the government focused on the provision of quality healthcare at affordable costs instead of privatising its hospitals. As a result, the upcoming developments in the public healthcare sector are likely to focus on modernising and upgrading of the health facilities rather than privatisation initiatives.

36 http://www.dof.gov.ph/taxreform/index.php/infographics/ 37 http://www.doh.gov.ph/philippine_health_agenda

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The private sector is expected to provide approximately 60% of the projected hospital bed needs. This is to be achieved via establishment of new, and expansion of existing hospitals, as well as through the acquisition and consolidation of a number of existing medical businesses.38 Several major conglomerates, such as Ayala, Vitacare and Metro Pacific Investment Corporation have already put forward their plans for aggressive expansion of their hospital portfolios, meaning possible business opportunities for healthcare and medical technology providers in the near future.

For example, the Metro Pacific Investment Corporation has been particularly active in its acquisition of hospitals, with its recent purchases of stakes in De Los Santos General Hospital (51%), Asian Hospital (56.5%) and Colinas Verdes Hospital. The corporation has already announced its intentions to acquire even more healthcare facilities, with particular interest in buying 15 hospitals as well as polyclinic, diagnostic and clinic chains. It also intends to construct 25-30 new hospitals in the next 10 years in order to expand its portfolio in the healthcare sector.39

After breaking into the healthcare sector via its 33% purchase of Mercado General Hospital and acquisition of the large pharmacy chain Generika, Ayala also aims to grow its hospital group further by additional new purchases and building up to 10 new hospitals.40

United Laboratories, via its subsidiary Mount Grace Hospitals, Inc., has further stepped into the healthcare industry through the purchase of VRP Medical Centre and Medical Centre Manila.41

Figure 9: Major private sector players in healthcare industry Source: PwC (2017)

38 The Philippine Health Facility Development Plan 2017-2022 39 https://nordcham.com.ph/european-union-trade-philippines/ 40 https://www.slideshare.net/FinproRy/philippines-healthcare-61734373 41 http://www.pwc.com/gx/en/industries/healthcare/publications/asia-pac-newsletter/assets/pwc-apac-health-industries-newsletter- august2015.pdf

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Several other companies are also considering entering the healthcare facilities industry. Singapore-based Chandler Corporation is in the process of investing in a significant minority stake in Professional Services, Inc., the owner and operator of the Medical City hospitals. Robinsons Land is also considering entering into the healthcare industry through agreements with JB Partners. Further, Mitsubishi Corporation is aiming to set up 10 hospitals in the country by 2020 and the Japanese investors are exploring options to invest in the Philippines health facilities due to the country’s changing demographics.42

With the expanding government initiatives, broadening healthcare system and the active engagement of the private sector in the health infrastructure development, opportunities for healthcare and medical technology providers are expected to grow exponentially in the Philippines.

Key institutions

The Department of Health (DOH) is the main government regulator for healthcare and medical goods, services and facilities. The DOH is mandated by the government to provide national policy direction for healthcare and medical industry, develop and enforce technical standards and guidelines on healthcare provision, regulate the delivery of services and products for public and private healthcare providers, and oversee the overall quality of healthcare in the Philippines.43 The DOH also supervises and regulates the National Health Insurance Corporation, its PhilHealth insurance system, and monitors its financial health. In addition, it is the biggest single healthcare provider in the Philippines, managing 72 hospitals across the country. Through the DOH, the government supervises the biggest public-sector hospitals.

The DOH’s key regulatory agencies for the healthcare and medical technology sector include:

 The Food and Drug Administration (FDA): It regulates and oversees the safety, efficacy, purity and quality of health products in the Philippines. Its Food, Drug and Cosmetic Act remains the key regulation to monitor food, drugs, medical devices, diagnostic reagents,

42 http://www.pwc.com/gx/en/industries/healthcare/publications/asia-pac-newsletter/assets/pwc-apac-health-industries-newsletter- august2015.pdf 43 http://asiahealthcaremarketresearch.com/philippines.html

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cosmetics and household hazardous substances in the country. The FDA was formerly known as the Bureau of Fod and Drugs Administration.

 Health Facilities and Services Regulatory Burea: It sets standards and regulations for health facilities and services in the country and issues permits for construction, operation and maintenance works in the healthcare sector. This bureau was formerly known as the Bureau of Health Facilities.

 The Bureau of Health Devices and Technology: This is a DOH department in charge of developing plans, policies, national objectives, programmes, projects and strategies for regulating health technologies, medical and health devices, radiation devices and facilities, and other health-related technologies.

 The Bureau of Quarantine: The Bureau is in charge of security against the introduction and spread of infectious diseases, emerging disease and public health emergencies of international concern.

In addition to the DOH agencies, Professional Regulations Commission has a mandate to regulate and supervise professional health workers in the country.

The Philippine public health sector also practices the delegation of health services to local government units in order to encourage efficiency. Government units at the provincial, municipal and village levels manage government-owned hospitals and health service units, and lead the implementation of central government priorities. Provincial and district government units manage provincial health offices and provincial public hospitals, whereas city government units are responsible for the provision of local healthcare services and facilities.

Philippine Health Insurance Corporation (PhilHealth) is the designated institution to provide national health insurance to all Filipinos. Since the rolling out of the National Health Insurance Programme, PhilHealth seeks to provide universal health insurance coverage and ensure affordable, acceptable, available, accessible, and quality care services to all Filipinos. It operates the National Health Insurance Programme, which now covers around 8 out of 10 Filipinos.

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Domestic Research and Development (R&D) of Healthcare and Medical Technologies

The healthcare and medical technologies market in the Philippines is largely dependent on foreign companies and imports. Domestic research and development (R&D) remains limited and the private sector contributes the majority of R&D explorations. The current domestic market continues to focus on low-technology devices, components, parts and equipment, and there is an absence of indigenous R&D and medical production capacity.

In total, the Philippines spends approximately 0.11% of its GDP on R&D activities. While data on the share of R&D in the healthcare sector is unavailable, generally this number is lower when compared to regional peers.44 Neighbours, such as Thailand, Vietnam and Indonesia, typically invest close to 2% of their GDP for R&D activities. Foreign companies, on the other hand, are increasingly exploiting the market gaps for advanced technologies and are introducing new technologies to bring innovative solutions to the Philippine market.

In recent years, however, the government has recognised the importance of R&D via establishment of strategic roadmaps for healthcare and medical technology development in the country. This is likely to result in a more vibrant domestic R&D sector with more innovations coming from domestic healthcare players.

In 2013, the former President S. Aquino signed the Republic Act 10532 (Act Institutionalising the Philippine National Health Research System), which became the national integrated framework for health research in the country. The Draft Investment Priorities Plan (2017) by the Department of Trade and Industry has also included R&D projects among preferred activities, which are eligible for incentives.

Most recently, the government has established a Harmonised Health R&D Agenda 2017-2022, which serves as a guide for policy makers, funding and donor agencies and researchers. The research priorities under the agenda’s roadmap for health research in the Philippines include diagnostics, drug discovery and development, functional foods, hospital equipment and

44 World Bank (2016). Research and development expenditure (% of GDP). https://data.worldbank.org/indicator/GB.XPD.RSDV.GD.ZS

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biomedical devices, information and communication technology for health, dengue, nutrition and food quality & safety, disaster risk reduction, climate change adaptation, and genomics/ molecular technology.

The government has also started tracking the domestic medical research since September 2012 via the establishment of the National Philippine Health Research Registry.45 Based on the data from the registry, there were a total of 86 medical technology development projects in 2016, majority of which (84%) focused on drug discovery and development.

Health technology development 2013 2014 2015 2016 research Drug discovery and development 29 39 60 72 Functional foods 2 4 1 1 ICT in health 3 1 0 4 Genomics/Molecular technology 3 2 7 5 Diagnostics 4 1 1 2 Hospital equipment and biomedical devices 0 0 0 2 Others 3 2 3 0 Total 44 49 72 86 Table 6: Health technology development by research category Source: National Philippine Health Research Registry

Between 2013 and 2016, the government’s funding for clinical and non-clinical trials has more than doubled, however, the private sector’s funding for trials is still leading the market.

45 Philippine Health Research Registry. http://registry.healthresearch.ph/index.php?option=com_phocadownload&view=file&id=4&Itemid=164

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Total Total Total No. of Clinical Non-clinical Governmen Privately Year Amount Amount Research Trials Researches t funded funded (in €) (in €) projects 2016 69 47 50 51,563,600 63 909,547,000 116 2015 68 16 14 27,079,300 67 240,821,000 84 2014 82 20 19 12,977,500 82 484,528,000 102 2013 74 39 39 21,704,600 38 139,056,000 113 Total 293 122 122 113,325,000 250 1,773,950,000 415 Table 7: Number of clinical & non-clinical trials and funding by source Source: National Philippine Health Research Registry

A recent study on health governance in the Philippines by Brookings Institution predicts that more investment in medical R&D is likely to be available in the upcoming years as a result of improving regulatory and legislative climate for R&D activities.

Key Associations

Some of the key associations, related to the healthcare and medical technologies market in the Philippines, include:

The Pharmaceutical and Healthcare Association of the Philippines (PHAP) was established in 1946 as the Philippine Wholesale Druggists’ Association. In early 1991, it changed its name to the Pharmaceutical and Healthcare Association of the Philippines to signify a wider representation of participants in the pharmaceutical and healthcare sector. Today, PHAP and its member companies represent the research-based pharmaceutical and healthcare industry. Among its members are generic pharmaceutical companies, pharmaceutical distribution companies, medical device manufacturers, health research companies, over-the-counter pharmaceutical manufacturing companies and pharmaceutical retailers. Membership today encompasses 64 Filipino and international companies. The mission of PHAP is, through its members, to make quality medicines and medical devices available for the Filipino people.

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Philippine Medical Association (PMA) is the medical association of the medical practitioners in the Philippines. Founded 114 years ago, it is the primary voice of Filipino physicians. With more than 80,000 members, it advocates high standards in the medical profession and promotes the expansion and improvement of medical services throughout the country. The association is a member of the World Medical Association, a co-founder of the Confederation of Medical Associations of Asia and Oceania, and a co-founder of Medical Associations of South East Asian Nations.

The Philippine Hospital Association (PHA) is a non-profit, membership organisation of healthcare providers. It provides support to its 2,000 hospital members in pursuit of the Philippines’ health agenda. The organisation provides voice to the public and private sector members in matters affecting hospital management and delivery of health services. Currently in its 67th year, it draws strength from the support of 81 Chapters, nationwide.

Healthcare Information Management Outsourcing Association of the Philippines (HIMOAP), formerly known as the Medical Transcription Industry Association of the Philippines, Inc., is a non- profit industry organisation, which unites healthcare information management (HIM) documentation outsourcing industry players. The association serves the needs of HIM service providers, HIM education and training centres and vendors, and it promotes the Philippines as the destination of choice for quality healthcare information management outsourcing services.

The Philippine Public Health Association (PPHA) is the single largest organisation of public health workers in the Philippines. The PPHA aims to promote and maintain a high standard of public health in the Philippines. Its objectives include the upgrade of the standards and delivery of public health services; promotion and protection of rights and interests of its members; and contribution towards the solutions of public health problems. The PPHA is now servicing 40,000 members across the

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Philippines. The membership includes doctors, nurses, dentists, midwives, medical technologists, sanitary inspectors, medical laboratory aides, dental aides and other professionals and persons engaged in services or work related to public health.

The Private Hospital Association of the Philippines is an industry association that aims to stimulate medical research and encourage scientific activities in the healthcare system. It also advocates for policies that allow for procurement to lower the cost of acquisition of supplies, equipment and medicines. The association is also cooperating with different government agencies, such as the Philippine Health Insurance Corporation (PhilHealth), Department of Health (DOH), and the House of Representatives in advocating for various pending laws that affect the private hospital systems and administration. Around 50% of all private hospitals in the country are connected to this association.

Biotechnology Coalition of the Philippines (BAPI) is a non- profit, multi-sectoral membership association that promotes the safe and responsible use and advancement of modern biotech in the Philippines. Its members are representatives from the academia and science community, farmers’ organisations, industries, church, media and other civil society organisations. It was first organised in 1997 under the auspices of the Department of Trade and Industry to improve the commercial capacity of biotechnology-based products. Since then, BAPI has collaborated with the Department of Trade and Industry for a productivity mission on biotechnology to Singapore, organised an international technomart to facilitate biotechnology transfer to the Philippines and held six local symposia on biotechnology.

Healthcare & Medical technology Purchasing Decisions and Key Sales Channels

Purchasing decisions for both private and public hospitals in the healthcare and medical technology market are based on various criteria, including the international reputation of the manufacturer, the quality and price of the product, reputation of local distributors, availability of after-sales service, and competitive pricing structures. Other factors that influence purchasing decisions are brand, product durability, warranties and availability of training. While decision-

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making processes vary across healthcare sector, most hospitals tend to purchase from local distributors which can guarantee after-sales service.

Figure 10: Supply chain for medical devices to hospitals in the Philippines Source: Orissa International visualisation

For foreign-funded projects, the DOH and other government agencies follow the procurement regulations and procedures of the funding agencies, such as USAID, ADB, CIDA and JICA.46

While the private sector purchases both new and refurbished equipment, the government as a rule considers only new equipment. Private entities make purchases using their own funds (generated from income and investments) whereas the public sector improves hospital facilities or buys hospital equipment with funds from the national budget and foreign funding grants.

The key sales channels for healthcare and medical technology solutions in the Philippines are:

 Distributor/Importer: Distributors and importers represent the main link between exporters from the EU and customers in the Philippines. A key advantage of working with them is that they are usually highly knowledgeable about the Philippine healthcare system and are in touch with the key decision makers for purcahses of new equipment in major private and

46 USAID (U.S. Agency for International Development), ADB (Asian Development Bank), CIDA (Canadian International Development Agency), JICA (Japanese International Cooperation Agency).

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public hospitals. Distributors also take care of, and assist exporters with, compliance with the national market standards. Hospitals also tend to prefer working through local contacts, thus, making local distributors particularly important for selling products to the key end-users’ segment.

 Wholesaler/ Large Retailer: Some types of products, such as orthopaedic appliances and artificial parts of the body (for instance, hearing aids) may be also sold through distributors to wholesalers and large retail chains before reaching end-users. These wholesalers and large retail chains will provide a first-line service to end customers. However, for product-related issues, such as malfunctions and damages, they will call on the distributor.

 End-user: The final option is to supply directly to end-users via online or physical stores. European exporters would have to be certified by the local authorities to do business directly with end-users. This trade channel is especially interesting for assistive devices and technologies, because it can significantly reduce the price of such medical devices for the end-user.

The key buyers of the healthcare and medical technology solutions in the Philippines are:  Private and public hospitals;

 Clinics;

 Nursing and retirement homes;

 Psychiatric institutions;

 Specialist medical practices;

 Homecare market;

 Private dental practices, and jaw and dental surgery departments of hospitals;

 Veterinary practices and clinics.

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Entry Strategies

There are many pathways for European companies to enter the Philippine healthcare and medical technology market. Licensing, franchising, strategic alliances and partnerships for export distribution and project development via distributors/agents, joint ventures, wholly owned subsidiaries and specialised tradeshows are among the available options.

The Philippine business culture, however, puts strong emphasis on personal contact and doing business with people versus companies. Therefore, initial entry steps should prioritise face-to- face meetings for business engagement.

Company size and level of resource commitment is likely to influence the choice of entry mode. Smaller, low resource commitment companies may prefer flexible contractual entry modes, such as exporting and licensing via a distributor/ agent, while larger, high resource commitment companies may consider direct entry modes, such as joint ventures and wholly owned subsidiaries. Although there are many entry points for foreign companies, local distributors/ agents and joint ventures remain the modes of choice for entering the Philippine market.

Given the complexity of the Philippine market, companies looking for direct entry channels are often advised to enter collaborations and joint ventures with local players. Local companies typically have good knowledge of the market and can steer the partnership towards appropriate sales channels. Joint ventures can also expand distribution capacity and local service providers are often critical for revising after-sales repair and maintenance services. Joint ventures may be particularly appealing for companies seeking to gauge their products’ potential in the wider South East Asian market. Taking into consideration the fact that the Philippine government does not require the submission of technology transfer arrangements when entering the joint venture, this option is often considered as an attractive entry mode.

For healthcare & medical equipment and device manufacturers and suppliers, the most common, and often essential, entry point, however, is via the appointment of distributor/ agent. Most hospitals purchase their equipment from distributors with only occasional direct acquisition from suppliers in order to guarantee on time delivery and parts and services warranties. End-users

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often seek information on which company represents a particular supplier to check its track record on delivery, warranty and other services. Hospital administrators/ purchasers also seek the advice from familiar distributors when thinking of acquiring new equipment. Distributors, therefore, are often selective about the products and brands they import and distribute as the quality and performance of a product can affect their standing in the industry.

When collaborating with distributors/ agents, local partners typically handle all aspects of importation, including registration, obtaining a license and getting customs clearance for products. They also help facilitate the product’s entry into the market and assume responsibility for advertising and promotion through sales and dealer networks. It is important to know, though, that distributors in the Philippines prefer exclusive contracts with foreign manufacturers.

Given the importance of partnerships and distributors for entering the market, specialised tradeshows and exhibitions often serve as a springboard for interested international companies to build business relationships. While there are no upcoming tradeshows in the Philippines in the next few months, companies should consider checking regularly the Philippine market for upcoming exhibitions and tradeshows as a gateway for developing business-to-business collaborations.

Challenges & Entry Barriers

While the Philippine market does not have regulatory barriers to the sale or purchase of healthcare and medical technologies of acceptable international standards,47 the country poses some limitations for swift market entry. These risks can be ultimately overcome, but European companies need to exercise a time and resource commitment when entering the market.

47 ISO 13485, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical device industry. Healthcare and medical technologies adhering to these standards face no barriers for selling or purchasing them in the Philippines.

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Firstly, the speed of entry can be slower as paperwork requires many signatures before final approvals are obtained. The country also has a complex judicial system which can prolong the resolution of commercial disputes.48

While European products are generally known to be high quality, they are also costlier. The Philippine market, however, is highly price-sensitive. As a result, exporters may find it difficult to apply their European pricing strategies as distributors and customers may frequently request adjusted pricing and payment terms. The high Euro exchange rate can also sometimes act as a disincentive to buy European products, when compared to cheaper, regional alternatives. However, European technologies are still recognised as having a superior quality, and, thus, are still among the preferable options for healthcare and medical technology purchases.

Equipment depreciation rates also pose an additional market challenge. Hospitals and clinics typically utilise equipment for its entire useful life. It is not uncommon for medical and healthcare facilities to keep high tech equipment for 10-25 years, meaning low turnover rate for technology providers.

The current structure of healthcare and medical facilities may also, to some extent, limit the applicability of specific technology solutions. Low floor height in existing hospitals means that often there is no space to retrofit the piping lines and various technical solutions unless installed to the outer walls. Facilities may, therefore, often opt for solutions which require less space and fewer installation works.

It also to be noted that there is some level of corruption risks present in the country mostly in the form of bribery of government officials. To address this issue, the Philippine Government has put forth major efforts to fight corruption which includes the creation of the Presidential Anti-Corruption Commission in a bid to get rid of corrupt government officials.

48 U.S. Department of Commerce (2017). Philippines Country Commercial Guide. https://www.export.gov/apex/article2?id=Philippines-Market- Challenges

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In addition, the Philippines needs major improvements in transport and logistics infrastructure. The lack of appropriate logistical chains in the country can also impede in-country operations of businesses.

E-Health solution providers may further face difficulties due to lacking internet availability. The Philippines has a low internet penetration, connectivity and speed. Costs, however, are comparable to the European markets. As a result, barriers may exist in scaling up e-health, remote health monitoring and ICT solutions in the Philippine market.

Finally, the VAT is high in the Philippines and may deter some exporters when weighing their comparative options in the South East Asian region. A 12% tax is levied on the sale of all goods and services, including imports of goods in the Philippines. While it can be generally passed on to the buyer/consumer, it also increases the price of the equipment in a price-sensitive market.

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3.2 Assistive Technologies

3.2.1 Market Overview

The global disabled and elderly assistive technologies market was valued at US$ 22.5 billion in 2016 and is anticipated to reach US$ 37.6 billion by 2023.49 Although North America and Europe are the leading markets for assistive devices, the Asia Pacific region is expected to grow at the fastest rate in the coming years. Among the emerging economies, the Philippines is primed to become one of the leading destinations for assistive technologies, with its market growth driven by considerable increase in life expectancy, growth in geriatric and disabled population, instances of chronic disease, disability and mobility challenges, as well as changes in lifestyle trends. Advancing technologies, ageing population, growing economy and increasing healthcare spending by individuals and the government are starting to offer robust growth potential for assistive technology and device companies. Together with the persons with disabilities (PWD), the ageing population forms the primary market for assistive technologies in the country.

End Users I: Aging Population

The Philippines has a population of approximately 101 million. Although it has a relatively young population – approximately 40% of its citizens are between 25-54 years of age – the country is in transition of socio-economic development, demographic shift and epidemiology.

The number of older people is steadily increasing, faster than the growth of the total population. In 2000, the number of senior citizens (60 years old and over) was estimated at 4.6 million, or 6% of the total population. This number had grown to 6.5 million (6.9% of the total population) over the next decade, and it has reached 7.6 million (7.5% of the total population) in 2015.

49 https://www.businesswire.com/news/home/20170824005495/en/Disabled-Elderly-Assistive-Technologies-Market---Global

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Figure 11: Population pyramid of the Philippines, 2016 Source: CIA World Factbook

According to the National Statistics Office, it is estimated that older people will make up around 11.5% of the total population by 2030, making it necessary to address the increasing occurrence of degenerative diseases, disabilities associated with the old age, and other related needs of the older generation. Analysts project that the government has approximately 10 years to find efficient and effective assistive solutions for the ageing population. In addition, the changes in lifestyles of elderly people, with increasing focus on mobility independence, are spurring interest in technologies that expand people’s ability to continue their daily routines and lower the assisted healthcare costs.

End Users II: Persons with Disabilities (PWD)

Together with the growing number of older citizens, PWDs are forming the primary market for assistive medical technologies in the country. Although estimates on the prevalence of disabilities in the Philippines are scant, various sources refer to the most recent 2010 Census by the Philippine Statistics Authority, which indicates the prevalence of PWDs of 1.57%.

Based on the most recent available data (2010 Census by the Philippine Statistics Authority, the 1.57% translates into approximately 1,443,000 documented PWDs in the Philippines.50 The IV-A

50 http://www.aseannews.net/asean-disability-laws-lag-far-behind-daily-realities/

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Calabarzon region accounts for the highest number of PWDs, with 193,000 registered people with disabilities.

Household Population with Proportion of PWD to the Household Population Region Disability Household Population (in 1,000) (in 1,000) (in %) Philippines 92,098 1,443 1.57 National Capital Region 11,797 167 1.41 (NCR) Cordillera Administrative 1,612 26 1.63 Region (CAR) Region I – Ilocos 4,743 78 1.64 Region II – Cagayan Valley 3,226 56 1.72 Region III – Central Luzon 10,118 139 1.38 Region IV-A – Calabarzon 12,583 193 1.53 Region IV-B – Mimaropa 2,732 50 1.85 Region V – Bicol 5,412 100 1.85 Region VI – Western 7,090 138 1.95 Visayas Region VII – Central Visayas 6,785 109 1.6 Region VIII – Eastern 4,090 72 1.75 Visayas Region IX – Zamboanga 3,398 46 1.35 Peninsula Region X – Northern 4,285 67 1.56 Mindanao Region XI – Davao 4,453 71 1.6 Region XII – Soccsksargen 4,103 59 1.43 Autonomous Region in 3,249 35 1.07 Muslim Mindanao (ARMM) Region XIII - Caraga 2,425 38 1.58 Table 8: Household population and Persons with Disability (PWD) by Region, 2010 Source: National Statistics Office, 2010 Census on Population and Housing

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The highest share of people with PWD status falls within the ages of 5-19, with more males than females qualifying:

Age Group Persons with Disability (in 1,000) by Sex Sex Ratio Total Male Female All Ages 1,443 734 709 104 0-14 272 149 123 121 15-49 578 312 266 117 50-64 274 141 133 106 65 years and over 319 132 187 70 Table 9: Household population with disability by broad age group, 2010 Source: National Statistics Office, 2010 Census on Population and Housing

The Philippine Department of Social Welfare and Development also notes that blindness and visual impairment, together with orthopaedic disabilities, account for the majority of PWD classifications among households, making the assistive devices in these categories particularly relevant for the Philippine PWD population.51

Households with PWDs 302,421 6.77

Households with Hearing Disabilities 27,972 0.63 Households with Visual Disabilities 53,034 1.19 Households with Speech/Communication Disorders 28,259 0.63 Households with Orthopaedic Disabilities 41,551 0.93 Households with Intellectual Disabilities 28,610 0.64 Households with Other Disabilities 77,599 1.74 Table 10: % Distribution of PWDs among households per classification, 2011 Source: SWD Pantawid Palilyang Pilipino (Conditional Cash Transfer, 2011)

51 http://web.nlp.gov.ph/nlp/sites/default/files/20Mar2014/Persons%20with%20Disabilities%20by%20Edgardo%20garcia.pdf

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Existing Infrastructure and Access to Assistive Technologies in the Philippines

The market for elderly & disabled assistive devices and technologies in the Philippines is very new and remains underserved, leaving significant opportunities for companies to cater to the growing customer segment. According to the Philippine Health Insurance Corporation (PhilHealth), around 95% of children with disabilities had unmet needs for assistive devices in 2008. 52 In addition, the limited availability of devices is also leaving significant portions of disabled and elderly adult population underserved.

The most widely used assistive devices are walking aids (including canes), but communication devices feature in second place, according to the World Health Organisation survey,53 ahead of other mobility devices (such as wheelchairs). Although it ranks high in the priority list for required technologies, current use of assistive devices for cognitive support is relatively low, and the devices for both recreation and gardening feature at the bottom of the ratings. These findings by the World Health Organisation reflect the high profile of mobility disabilities and assistive solutions for visual and hearing impairment.

Higher and new technology solutions are not widely known and available in the Philippines. In addition, elderly & disabled people have little involvement in making assistive devices choices and, apart from prosthetics and mobility devices, most of the existing devices are generic and not considered very adaptable to individual’s needs. Affordability also tends to follow socio-economic factors (solutions are more affordable among affluent segments of Filipino society). Walking aids are one of the assistive devices, considered to be of reasonable cost to most across the region.

Based on World Health Organisation’s findings from interviews with respondents in the Philippines, there are several factors that are particularly relevant to end users in making the adoption of assistive devices among communities a success:

52 Philippine Health Insurance Corporation (2016). Philhealth Circular No. 2016-0032 on Guiding Principles for the Z Benefits for Children with Disabilities 53 WHO (2014). Survey of needs for assistive and medical devices for older people in six countries of the WHO Western Pacific Region: China, Japan, Malaysia, the Philippines, the Republic of Korea and Vietnam.

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 Making assistive devices available as close as possible to older people’s communities has been identified as a critical factor for improving adoption rates.

 The importance of embedding device provision within other services and government commitments to older people remain an important factor to spur the growth in purchases.

 Given the relatively high costs of disability and elderly aids in the Philippines, the successful adoption of such devices among communities often hinges on government and/or state agency procurement support and subsidisation to address some of the costs related to assistive device purchases.

 For such settings like Philippines, ensuring items are suitable for local needs and requirements is key to their successful uptake.

 Both reducing regulation and enhanced quality checks remain at the bottom of the ranking lists suggesting that they are not significantly affecting the uptake outcomes in the country.54

The key selling point that existing assistive device companies exhibit in the Philippines is the price with uniqueness, innovation and distinctiveness playing lesser roles. Distributors often offer lower prices to attract more customers and sacrifice more innovative products that may be a more effective means of assistance for an individual. Many manufacturers also overcome stigma associated with disability by offering more “mainstream” products, which do not make users feel as though they inhibit a disability.

Currently, the majority of assistive technologies in the Philippines are imported from abroad with very limited number of local manufacturers. Most assistive devices and technologies are available in the cities, while rural areas lack an effective supply chain.

Retailers and distributors access assistive devices through two means: via an importer or directly purchasing from domestic or foreign manufacturer. Nongovernmental organisations (NGOs) play an important role in distributing assistive devices in the Philippines while community-based

54 WHO (2014). Survey of needs for assistive and medical devices for older people in six countries of the WHO Western Pacific Region: China, Japan, Malaysia, the Philippines, the Republic of Korea and Vietnam.

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rehabilitation programmes often provide, or make, local assistive devices for grasping and house- keeping. Assistive solutions in the Philippines are available, to varying degrees, through a variety of retailers and distributors, including:

 Specialists: specialist and clinic shops, which most often provide services of opticians and audiologists;

 Medical suppliers: medical suppliers and mobility equipment stores, which generally provide aids, such as wheelchairs, walkers, bath seats and grab bars;

 Electronic stores: some specialty electronic and computer stores provide screen reading software, voice recognition systems and modified hardware for disabled people;

 Pharmacy stores: large chain pharmacy stores provide basic assistive devices;

 Hardware stores: hardware stores may provide a bare minimum of assistive devices. Common examples may be adapted kitchen utensils and grab bars for disabled individuals.

Apart from the very basic products, a significant portion of customers purchase such devices through referrals via medical centres, hospitals and clinics, which provide PhilHealth insurance coverage for a number of disabilities.

Repairs market is limited. While repairs are supposed to be carried out by the workshops where devices are made, they are often undertaken by users themselves, or family members.55 This practice in part reflects the lack of available and affordable repair facilities in close proximity to the PWD and elderly communities.

The Philippines has several channels for financing the purchases of assistive devices. Various charitable organisations do play a role in financing and subsidising the purchases, however, the key relevant channels for European companies are:

55 http://www.dinf.ne.jp/doc/english/intl/z15/z15002p2/z1500206.html

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 The Philippine government and/or state agencies, which provide public tendering opportunities for acquiring assistive devices and technologies; they also provide financial assistance to the Filipino residents to obtain personalised devices appropriate to their needs;

 PhilHealth, and other personal insurance plans, which cover individual disability needs, such as assistive devices;

 Out-of-pocket expenses, which come from individuals purchasing assistive devices and technologies.

With the increasing demand for assistive technologies and solutions for disabled & elderly people in the Philippines, the provision of devices and equipment has been recently recognised by the Philippine government as an important measure to achieve. New initiatives have been created to accelerate the market and market access to the end users. Some of the relevant developments include:

 Access to appropriate health and rehabilitation services was included in the Convention on the Rights of Persons with Disabilities, which the Philippines ratified in 2008. Prior to the ratification of the Convention, the country has also enacted the Accessibility Law, which requires buildings to install facilities and devices to enhance the mobility of PWDs. This Act provides for the minimum requirements and standards to make buildings, facilities and utilities for public use accessible to disabled persons, including older persons, who are confined to wheelchair and those who have difficulty in walking or climbing stairs, among others. In addition, the Philippines is a signatory to the UN Standard Rules on the Equalisation of Opportunities for Persons with Disabilities (1993), which urges states to increase the availability of assistive devices (including promotion, production and distribution).56

 To further accelerate the PWD access to appropriate services, technologies and equipment, the Philippine Health Insurance Corporation, PhilHealth, has made PWD coverage available and accessible since 2013.57 It launched the Mobility Orthotics Rehab Prosthetics Help

56 http://www.dinf.ne.jp/doc/english/intl/z15/z15004s2/z1500402.html 57 http://who.int/features/2013/new_leg_philippines/en/

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Package, which improved the funding mechanism of the state for PWDs. The programme provides a PHP 15,000 (EUR 235.12) assistance to a PWD, requiring assistive device (excluding wheelchairs), 85% of which is mandatory for cost of device while the non- mandatory 15% is to cover service costs.58 The coverage encompasses mobility, orthosis, rehabilitation and prosthesis costs together with selected orthopaedic implants for hip arthoplasty, hip fixation, petrochanteric fracture and femoral shaft facture.59 The service has been expanded in 2016 to include the following coverage in contracted hospitals, such as the University of the East Ramon Magsaysay Memorial Medical Centre, University of the Philippines – Philippine General Hospital, Southern Philippines Medical Centre, and Zamboanga Medical Centre: 60

Prosthesis Type Coverage Above knee disarticulation prosthesis PHP 95,000 Hip disarticulation prosthesis PHP 180,000 Below elbow prosthesis PHP 60,000 Above elblow prosthesis PHP 80,000 Van Ness rotationplasty PHP 85,000 Ankle-foot orthoprosthesis PHP 35,000 Knee-ankle-foot orthesis PHP 70,000 Hip-knee-ankle-foot orthosis PHP 104,400 Spinal orthosis for thoracolumbosacral PHP 40,000 Spinal orthosis for lumbosacral PHP 25,000 Spinal orthosis for cervicothoracic PHP 30,000 Table 11: PhilHealth coverage for assistive technologies Source: PhilHealth

 In 2014, the government has also passed the Implementing Rules and Regulations of Execuitve Order 417, or the Economic Independence Programme for PWDs, which offers

58 PhiHealth Circular 0019-2013 & PhilHealth Circular 012-2014 59 PhiHealth Circular 0019-2013 & PhilHealth Circular 012-2014 60 https://www.philhealth.gov.ph/news/2016/prosthesis_package.html

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equal economic opportunities for PWDs and mandates all national government agencies and state-run corporations to allot at least 1% of their annual budgets for programmes that benefit PWDs as well as to provide market and avail at at least 10% of required goods and services from PWDs.61 Increased economic independence achieved by PWDs is expected to open up new channels and greater demand for acquisitions of assistive devices by PWDs.

 In 2015, the Action Framework for the Health and Wellness Programme of Persons with Disabilities was also launched by the Department of Health (DOH), which targets three major objectives, as adapted from the World Health Organisation’s Global Disability Action Plan 2014-2021: 1) the removal of barriers of rehabilitation access to health services and programmes; 2) strengthening and expansion of rehabilitation, assistive technology, and community-based rehabilitation; and 3) strengthening and collection of relevant and internationally comparable data on disability and support for research on disability and related services.

 In April 2016, the first public-private partnership for assistive devices has been made between the Philippine Council for Health Research and Development and Orthopedic International Inc. The partnership has resulted in a locally developed, innovative and affordable knee replacement system suitable for Asians – the Axis Knee System. It is a knee replacement technology, which costs half the price of imported knee implants that cost around PHP 120,000 (EUR 1,880.95).62

 In February 2017, PhilHealth has further announced that it is focusing on the provision of assistive technologies to children with disabilities, including those with hearing, visual, mobility and neuro-developmental disabilities.63 In the same year, the Government has established a legislative agenda to propose an Act Establishing a Disability Support Trust

61 http://www.automotive-fleet.com/channel/global-fleet/news/story/2016/01/philippines-launches-adaptive-mobile-vehicle-for-elderly- disabled.aspx 62 http://www.manilatimes.net/ict-products-among-dosts-contributions-to-health-care/253854/ 63 Philippine Health Insurance Corporation (2016). Philhealth Circular No. 2016-0032 on Guiding Principles for the Z Benefits for Children with Disabilities & PhilHealth Board Resolution No. 2125

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Fund, which intends to support PWDs in rehabilitation services, appropriate assistive device technologies, education, employment, and other disability support services.64

 Under the current laws, the PWDs also enjoy special privileges, such as 20% discount to healthcare services, including medical fees. The discount applies to all public and privately- controlled hospitals and medical centres. PWDs with a valid PWD ID and qualified under PhilHealth may also avail to PHP 15,000 (EUR 251) worth of benefits for securing lower limb prosthesis.65

 In February 2017, UNICEF has further announced that it will build “One-stop shop” for children with disabilities. Four hubs, each worth PHP 10 million (EUR 156,746), will be built nationwide, offering everything from therapy to councelling under one roof. The four centres will be based in Luzon, Visayas and Mindanao. They will be the first of their kind in the country and will provide comprehensive services, such as diagnosis, provision of assistive devices, counceling, therapy, an referral to specialists.66

 The Department of Science and Technology has also released its 2017-2022 Harmonised National Research and Development Agenda, which has put a specific emphasis on the development of assistive devices for PWDs for 2019-2022.

 In March 2017, the Maybank Foundation extended its Reach Independence and Sustainable Entrepreneurship programme in Metro Cebu, targeting 200 beneficiaries.

 To improve the accessibility and mobility of PWDs, new PWD-friendly jeepneys were launched in Quezon City in 2014. The City Optimised Managed Electric Transport (COMET), which now includes a ramp allowing easier entry for PWDs, was developed by a Canadian Valsch Dynamic Mechatronics and Global Electric Transport Philippines, a Filipino mobility solution company. The COMET models are expected to be mass produced in 2018 with over 5,000 COMET models sent out to Philippine roads by 2020.67

64 Philippine Development Plan 2017-2022 65 CBM (2012). The Needs and Availability of Assistive Technologies for Older People in 8 Countries in the Asia Pacific Region. Systematic review commissioned by the WHO. 66 http://lifestyle.inquirer.net/255620/unicef-will-build-one-stop-shop-children-disabilities/ 67 https://www.rappler.com/world/regions/asia-pacific/188264-in-photos-canada-justin-trudeau-electric-jeepneys-manila

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 The Philippine Retirement Authority has recently named Makati as the Most Retirement-and- Ageing-Friendly City in the country for having fully complied with the age-friendly city criteria of the World Health Organisation. Makati City recently increased the bi-annulal allowance of the senior citizens. Other benefits given to the elderly include mobility aids (e.g. walking sticks, quad canes, wheelchair), exemption from color coding, free movies, birthday cakes, free haircut and salon treatments, free massage, and burial assistance. Makati City also has initiated a comprehensive health programme for senior citizens that include regular consultation, laboratory services, dental services, medicines, subsidised hospitalisation, hospice care and home visits for disabled and bedridden cases. The city has also established an Elderly Health Care Office, which, among other things, provides medical support devices, such as crutches and wheelchairs.68

Although many assistive devices remain expensive, the purchases are increasingly made easier through the help and support through the channels of PhilHealth and other insurance providers, non-profit organisations and government funds.

Trade Prospects and Market Segmentation

There is currently not enough national data to determine the extent to which assistive technologies are prevalent in the Philippines. Neither the Government of the Philippines nor the Philippine Statistics Authority separate or differentiate data for medical devices and equipment from assistive technologies.

However, based on the available data from the UN COMTRADE Harmonised Trade System on import and export flows, it is estimated that the market value for assistive technologies has been steadily increasing since 2014, after a slight dip in the previous year. The total market value in 2016 was estimated at around US$ 54,297,085, which is a 20.5% increase since 2015.

68 12th ASEAN and Japan High Level Officials’ Meeting on Caring Societies (October 2014). Philippine Country Report.

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Assistive technologies in the Philippines (market estimation based on trade data) $70,000,000 $60,000,000 $50,000,000 $40,000,000 $30,000,000 $20,000,000 $10,000,000 $0 2012 2013 2014 2015 2016 Value $48,471,901 $61,124,993 $41,758,199 $45,057,716 $54,297,085

Figure 12: Assistive technologies in the Philippines, 2012-2016 (Market Estimation from Trade Data) Source: UN COMTRADE data

The largest share of the assistive technologies and devices has been occupied by the Mechano- Therapy subgroup, which accounted for 43% of the total trade value in 2016, followed by “other appliances which are worn or carried, or implanted in the body” (15%), “Orthopaedic or fracture appliances NES (other than artificial joints) (13%), “Other artificial parts of the body” (8%), and wheelchairs (8%). Neither “orthopaedic joints” nor “artificial parts of the body NES” have recorded sufficient market traction in the Philippines over the period of 2012-2016, based on import and export data.

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SHARE OF IMPORTS/EXPORTS OF ASSISTIVE Other appliances TECHNOLOGIES (%) BY CATEGORY, 2016 which are worn or Invalid carriages; carried or implanted Wheelchairs parts and accessories in the body NES 8% thereof 15% 1% Hearing aids - excluding parts and accessories 5%

Other artificial parts of the body NES 8%

Artificial joints 3%

Mechano Therapy Artificial parts of the Apparatus, Massage body NES Appliances 0% 43% Orthopaedic or fracture appliances NES (Other than artificial joints) Artificial joints Orthopaedic or 13% 0% fracture appliances 4% Figure 13: Share of imports/exports of assistive technologies (%) by category, 2016 Source: UN COMTRADE data

Code Description 2012 2013 2014 2015 2016 HS 8713 Wheelchairs $1,612,421 $2,480,566 $2,923,885 $3,398,334 $4,381,192 HS 871420 Invalid carriages; parts and $1,934,266 $1,351,697 $1,179,164 $2,713,775 $466,698 accessories thereof HS 9019 Mechano Therapy Apparatus, $21,382,125 $33,440,940 $16,134,557 $19,800,952 $23,565,122 Massage Appliances HS 902110 Orthopaedic or fracture $560,690 $1,184,937 $1,036,631 $1,597,325 $2,091,544 appliances HS 902111 Artificial joints $0 $0 $0 $0 $0 HS 902129 Orthopaedic or fracture $2,922,063 $6,171,014 $8,465,389 $5,029,178 $6,881,670 appliances NES (Other than artificial joints) HS 902130 Artificial parts of the body NES $0 $0 $0 $0 $0 HS 902131 Artificial joints $23,728 $155,501 $1,513,097 $1,530,905 $1,804,262 HS 902139 Other artificial parts of the body $5,007,020 $4,688,391 $1,316,817 $1,806,804 $4,551,275 NES HS 902140 Hearing aids - excluding parts $1,777,831 $2,590,874 $5,378,837 $2,863,931 $2,477,097 and accessories HS 902190 Other appliances which are worn $13,251,757 $9,061,073 $3,809,822 $6,316,512 $8,078,225 or carried or implanted in the body NES Total $48,471,901 $61,124,993 $41,758,199 $45,057,716 $54,297,085

Table 12: Assistive Devices and Technologies Market Size in the Philippines Based on Import/Export Data Estimations, 2012-2016 Source: UN COMTRADE

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Local Players

Tahanang Walang Hagdanan is a non-profit rehabilitation and skills training centre that creates opportunities for persons with disability, especially those who are orthopedically handicapped. The organisation was founded by a Belgian nun who was assigned as a volunteer nurse to the Philippines. The centre is located in Cainta Rizal, near East Manila. The organisation has five workshops and six dormitories for trainees who come here for skills training. It is also a rehabilitation and skills training centre with sheltered workshops where people with disabilities are trained to be productive and self-reliant members of society. The centre currently provides livelihoods and education to about 300 orthopaedically handicapped persons and has sheltered close to three thousand over the past four decades. At this rehabilitation and skills training centre, PWDs manufacture wheelchairs, educational toys, bags and assemble packaging items for pharmaceutical companies.

In 2013, the centre has also launched an e-wheelchair for PWDs, that is capable of traveling up to 15-20 km on a single charge of its zero-maintenance lead-acid gel batteries, with a top speed of 15 km/h. It is able to produce approximately 60 units per month and the brand-new e-wheelchair is priced at PHP 50,000 (EUR 832.59). The organisation has been receiving inquiries about motorised wheelchairs for some time, which prompted it to come up with the market solution.

Figure 14: E-wheelchair for Persons with Disabilities by Tahanang Walang Hagdanan Source: Philippines Daily Inquirer

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Orthopaedic International Inc. is a medical device manufacturing company specialising in orthopaedic implants and instruments. The company was formed as a distribution company for Smith & Nephew and has grown since then into an ISO 13485-certified facility that designs, develops and manufactures orthopaedic products, including trauma, spine and joint replacement systems. While in its early years the company carried a full line of orthopaedic products as a local manufacturer and distributor, including compression hip screws, interlocking nails, partial and total hip implants, total knee replacement systems, arthroscopy systems and sports medicine braces, the company has since refocused on affordable orthopaedic solutions. Over the years, the access to high-quality yet affordable orthopaedic solutions in the country remained a challenge as most products were produced for developed healthcare markets, such as North America, Europe and Japan. Thus, the company recognised this gap and redirected its efforts towards designing and manufacturing products for the Philippines and the developing world.

To provide affordable solutions, the company was initially established in 1992 under the name of Orthopaedic Innovations, Inc., in Minneapolis, Minnesota, USA, to develop affordable products and oversee manufacturing operations in the Philippines. Later, local manufacturing operations began in 1995 with the establishment of Orthopaedic Innovations Manufacturing, Inc. (OIMI), based in Cabuyao, Laguna, Philippines.

Figure 15: Orthopaedics International, Inc. headquarters in the Philippines Source: Orthopaedic International, Inc.

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In 1997, R&D was expanded with the creation of a Philippine-based team tasked to develop products more suitable to the Asian market by directly working with surgeons in the region. Over the years, OIMI’s engineers worked with leading Filipino orthopaedic surgeons to design and develop complete implant systems with extensive intellectual property rights. In 2005, all operations were moved to Philippines, with its corporate headquarters now located in Cabuyao, Laguna. OIMI is the only orthopaedic company in the Philippines with a full R&D department and manufacturing plant.

Indoplas Philippines, Inc. is one of the largest medical manufacturers, importers and distributors of plastics, disposable medical equipment and devices in the Philippines. It is the first and only fully Filipino-owned company producing, manufacturing and supplying premium quality medical devices adhering to international standards. Established in 1978 in Espana, Manila, the company focuses on producing medical tubing products, such as catheters, intravenous sets and connecting tubes. Its product lines include diagnostic equipment, latex gloves, pulmonary equipment and supplies, disposable hospital plastic wares, intubation disposable supplies, hospital and homecare furniture, urological disposable supplies, anaesthesia disposable supplies, oxygen supplies and equipment, gauze and non-woven products, laboratory equipment and supplies, orthopaedic supplies and support equipment, and other disposable medical products.

Figure 16: Indoplas Philippines Inc. plant in Quezon City, Philippines Source: www.indoplasphil.com

The company distributes such products domestically and exports them to Australia, Thailand and Singapore. In the Philippines, the company has a production plant, which houses several

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production lines, such as packing machines, high-frequency welding machines, extrusion lines, as well as catheter and ancillary machineries. Today, its production portfolio spans more than 2,000 Stock Keeping Units spread over multiple categories. In addition to its main product lines, the company manufactures a complete line of wheelchairs and disability products as well as elastic bandages.

IWorld Vision Trading Inc. is a medical device importing and distribution company, focusing on optical products. The company was incorporated in January 2009 in Manila, Philippines. The company was established as a wholesaler stock company, taking advantage of the good business location to advance the supply of contact lenses in the domestic and international markets. The company focuses mainly on distribution of products, which are manufactured in South Korea and the USA. With the increasing demand for contact lenses in the Philippines, it expects increased consumption and the expansion of the visual impairment market. The company holds the FDA-approved license to operate and distribute medical devices in the Philippines.

3.2.2 EU Entry Opportunities

The number of older citizens in the Philippines is increasing faster than the growth of the population, meaning that the needs of the older citizens will become more relevant over the years. Given the facts that nearly half (46%) of Filipinos over 60 are experiencing some sort of disability, the number of elderly people is likely to reach 11.5% of the total population by 2030, and that those disabled and the elderly are living longer due to improvements in health, the requirements for more accessible medical and assistive technologies and devices are expected to increase significantly in the upcoming years. The rapidly growing population creates necessity to take measures that will ensure that aging population will remain healthy, active, productive, and autonomous for as long as possible. The government is increasingly recognizing that this can be achieved primarily by increasing the availability, acceptability, and affordability of safe and effective assistive devices. As a result, it creates business opportunities for European companies, which primarily lie in:

 Export of assistive devices

 Export of prosthetics

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 Geriatrics assistive technologies

 Assistive information and communication technologies (ICT) for disabled

Export of Assistive Devices

The Philippine market for assistive technologies is almost entirely reliant on imports. With the growing number of elderly and PWDs, the import opportunities are likely to grow as well. Some of the technologies that may be particularly in demand include mechano therapy apparatuses, wheelchairs and invalid carriages, orthopaedic or fracture appliances, hearing aids and assistive technologies for the visually impaired.

In 2016, the United Nations Development Programme’s (UNDP) Country Office has also issued a procurement notice on the supply of assistive devices for senior citizens. The notice invites interested manufacturers to submit their Expressions of Interest to be shortlisted for the upcoming procurement process to establish Long Term Agreements with UNDP for the supply of assistive devices to various municipalities, cities, and provinces in the Philippines. Assistive devices that according to the UNDP will be in highest demand in the country include: assistive devices to senior citizens with impaired mobility, such as wheelchairs, walkers, cane and crutches; assistive devices to visually impaired persons, such as Braille memo, embossers, players, recorders, and screen readers; and assistive devices to speech impaired and persons with hearing disability, including hearing aids.

In addition, the World Health Organisation’s survey of needs for assistive and medical devices for older people in six countries of the Western Pacific Region, including the Philippines, ranked the assistive devices in terms of priority. The high priority list includes basic items (for seeing, transfer and turning, handrails, etc.). Devices for cognitive assistance was among the top four, probably reflecting growing awareness of the needs of elders with cognitive degeneration. Surprisingly, several items for mobility (e.g. wheelchairs and lower limb prosthetics and orthotics) while deemed very important were placed toward the bottom ranking on the assistive device priority list. This is most likely the result of other assistive devices being a priority for each specific task, ahead of mobility. This serves as a good indication for companies to ensure that assistive devices provision

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is adhering to foundational needs first. Assistive devices for seeing topped the list, yet devices like a walking cane or wheelchair are more routinely available for people in communities.69

Export of Prosthetics

A 2012 study by PhilHealth has also shown that an estimated 30% of people with disabilities in the Philippines could return to work if provided with an assistive device like a prosthesis for a missing limb. While domestic production of prosthetics is almost non-existent, the demand for such assistive devices is growing. European companies have the technological and technical expertise to provide quality products for a growing product sector. However, opportunities should be pursued with the mindset that the Philippine market is very price sensitive. Therefore, prosthesis products, which focus on simplicity and affordability, are likely to be more popular than the high-tech solutions. The increased PhilHealth coverage under 2016 update has also expanded into prosthetics and orthotics fields, meaning that with additional financing options, more customers are likely to opt in for such products.

Geriatrics Assistive Equipment

Additionally, the longevity market is tipped to be one of the biggest growth opportunities in global economy. Worldwide, older consumers are estimated to have a spending power of US$ 15 trillion. In Asia, in general, and the Philippines, in particular, where incomes are rising, and populations are ageing fastest, there is arguably the most to gain from serving the needs of older consumers. Demand is already surging, and the market is relative underserved, leaving many opportunities for assistive device and technology companies.

At the moment, in addition to the ageing Filipino population, there are at least 27,000 foreign retirees from 107 countries that have chosen to live in the Philippines under the Special Resident Retiree Visa, and the number is growing. As a result, there is a significant market potential for retirees and their assistive needs.

69 WHO (2014). Survey of needs for assistive and medical devices for older people in six countries of the WHO Western Pacific Region: China, Japan, Malaysia, the Philippines, the Republic of Korea and Vietnam.

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Although additional capacities are still needed to enable the country to keep pace with the global trends, it is already on the right track in becoming a recognised player in this very new market. If the remaining capacity gaps are addressed, the Philippines could tap the lucrative opportunities presented by a rising demand from the United States and Europe for nursing facilities, given the increasing cost for such services at home, and subsequent needs for assistive devices.

The country has a built-in advantage with its location, weather and the Filipinos’ fluency in English, which most of the other countries offering the same service do not possess. New nursing homes are already springing up across the country. For example, a nursing home for Germans has been put up in Iloilo while nursing homes for foreign retirees will soon rise in Cebu and Metro Manila. More nursing facilities are expected to be built over the next several years while demand is seen to expand exponentially. The total number of beds in private institutions quintupled in the last three years and about 80% of the bed capacity is now occupied by Filipino residents. The increase is a strong indicator that there is also a need for geriatric services and devices for the local market.70

The Philippine geriatric market has the potential to contribute PHP 9.6 billion (EUR 150.48 million), annually, to the economy if it could build about 10,000 private rooms in nursing homes by 2022, together with the required equipment, devices and technology. The government has announced that geriatric health is among its top priorities and it has already approved the guidelines on the Standards of Care for Older Person in all Health Care Settings which will be considered in accrediting licensed healthcare facilities. With only 10 operators of private elderly care facilities that have a total number of 25 assisted-living facilities, most of them in Metro Manila, Calabarzon, Cebu, Tagaytay and Iloilo, there are opportunities for expanding these kinds of facilities in the country. With the number of beds in private geriatric care facilities multiplying tenfold in the last five years, and the Philippine cost for nursing bed at PHP 80,000 (EUR 1,254) per month, compared to PHP 210,000 (EUR 3,292) in Germany, there is a lot of scope for expansion. Companies serving the elderly & disabled assistive device market can find

70 http://business.inquirer.net/181469/tap-growing-geriatric-care-mart-ph-urged

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multiple opportunities to offer their devices to such institutions, as well as private individuals residing there.71

Assistive Information and Communication Technologies for Disabled

European companies with assistive ICT may also find promising market avenues in the Philippines. As online freelance work is becoming a prominent feature of the Philippine economy (around 100,000 Filipinos are doing online freelance work) and the country is poised to be a regional leader in ICT Business Process Outsourcing, there are significant opportunities to cater to the PWD market with solutions that enable their productivity through ICT. ICT assistive technologies, such as speech-enabled software, screen readers, video to speech converters and ICT physical-accessibility solutions are among possible product categories for the Philippine market. One of the local companies, Grayscale Marketing, is already tapping these opportunities by training and hiring PWDs as well as developing PWD-friendly ICT assistive solutions.

European Players

MED-EL GmbH

Established in 1989, the Austrian MED-EL is a leading manufacturer of medical devices for the treatment of hearing loss. The company develops and manufactures hearing implant solutions and other medical devices, including implantable hearing systems, such as middle ear implants, electric acoustic stimulation hearing systems, speech processors, therapy devices, cochlear implant systems and the world’s first active bone conduction implant. The company’s products are used by prelingually and postlingually deafened adults and children worldwide. Since its founding more than 20 years ago, MED-EL has continuously expanded globally and it now sells its products in over 100 countries via its more than 30 offices.

71 http://www.malaya.com.ph/business-news/business/seniors%E2%80%99care-industry-hit-p96b-%E2%80%9922

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MED-EL started its operations in the Philippines after the incorporation of its local subsidiary, MED-EL Philippines, in Muntinlupa in 1997, which also serves as the company’s Asia-Pacific Regional Headquarters.72 While developing many hearing loss solutions for the local market, MED-EL is most famous for its cochlear implants. After 20 years of the Philippine business, MED- EL’s technologies benefited some 500 deaf and hearing-impaired persons in the country.

The company has managed to achieve greater local recognition, and the subsequent market traction, via its collaboration with local organisations, which support PWDs, and its philanthropic activities. When MED-EL first started in the Philippines, it gave out four hearing implants for free. In 2005, it gave out three additional implants to celebrate the firm’s growing presence in the Philippines. The next year, it also donated two Vibrant Soundbridge devices for three middle ear implant operations held at the Philippine General Hospital and the University of Santo Tomas Hospital.73 The company has maintained its social commitment since then as it continues to give two free cochlear implants at the end of every year.

Figure 17: MED-EL’s vibrant soundbridge device Source: www.medel.com

The conception of the National Ear and Hearing Health Care Programme in 2013 has further marked the beginning of the healthy relationship between MED-EL Philippines and the Philippine Government, and the strengthening of the company’s presence in the country. Recognised for its activities to assist hearing-impaired persons, the company has been supported by the Philippine Charity Sweepstakes Office, which donated funds for operations of indigent deaf children. With

72 http://www.earthlingorgeous.com/2012/11/medical-breakthrough-filipinos-hearing-today.html 73 https://businessmirror.com.ph/digital-technology-fights-deafness-in-the-philippines/

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the help of this office’s funds, the company has been able to socialise the cost of the implants and grow its domestic business lines. The company has also expanded its presence in the Philippines via a network of local distributors of medical supplies.

Smith & Nephew Plc

Founded in 1856, S&N is a British multinational medical equipment manufacturing company, headquartered in London, UK. It is an international producer of advanced wound management, arthroscopy, trauma and clinical therapy, and orthopaedic reconstruction products. The company supports healthcare professionals in more than 100 countries and it offers its products through distributors and local representatives. Its sales in 2016 reached more than US$ 4.6 billion. Its orthopaedics division is a leading provider of joint reconstruction, trauma and clinical therapy products. It has entered the Philippine market by establishing a partnership with a local distributor, namely RBGM Medical Express Sales, Inc., which remains its exclusive domestic distributor for the orthopaedic reconstruction products.

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3.3 Medical Equipment

3.3.1 Market Overview

The Philippine medical equipment market is set to benefit from a strong economic performance over the next five years. Modernisation of hospitals and other key health sector development projects, together with expanded government as well as private sector spending on health, are expected to drive this growth. According to BMI Research, the market is forecast to expand from US$ 478.2 million (EUR 387.7 million) in 2016 to US$ 744.7 million (EUR 603.8 million) in 2021, growing at a Compound Annual Growth Rate (CAGR) of 9.3%. Further investment in the health sector and additional health insurance funding will additionally support this high market growth.74

Total (Local Per Capita (Local Year Total (USDmn) Per Capita (USD) Currency mn) Currency) 2016 478.2 4.6 22,093.5 213.8 2017 500.2 4.8 25,108.3 239.3 2018 544.5 5.1 27,633.5 259.4 2019 598.8 5.5 30,460.0 281.8 2020 666.8 6.1 33,754.0 307.7 2021 744.7 6.7 37,507.9 337.0 Table 13: Current and projected medical device market, 2016-2021 Source: National Sources/ BMI Research 2018

The Philippine medical equipment market is heavily import dependent due to limited domestic production, comprising mainly consumables, medical furniture, spare parts, prototype units, and disposable medical supplies.75

The market is expected to remain dependent on imports as local production has not expanded significantly in the past several years. In 2018, stronger import performance is anticipated by the BMI Research, rising on the back of increased budgetary allocations for health in the 2018 budget, ongoing health sector development projects and local currency stabilisation. Imports of medical

74 BMI Research (2018). Philippines Medical Devices Report Q1 2018 75 http://www.businesswire.com/news/home/20151006006406/en/Research-Markets-Philippines-Medical-Device-Market-2015 & https://healthcaresea.wordpress.com/2014/05/01/91/

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equipment and devices have increased by 0.6% y-o-y in Q317 to US$ 111.9 million, and by 9.8% to US$ 439.9 million in the year ending September 2017.

Exports, on the other hand, are forecast to underperform due to constrained domestic production, growing regional competition and an easing of economic growth in developed markets, such as Japan, which is the leading export destination. Exports decreased by 15.5% y-o-y in Q317, to US$ 59.4 million. In the 12 months to September 2017, exports fell by 18.8% to US$ 255.4 million.

The major medical device exporting countries to the Philippines are Singapore, the U.S. and Germany.76 Developed markets perform well in the Philippines with high-value, low-volume medical equipment, such as ultrasound and magnetic imaging, breathing, and other radiology and electronic medical equipment. Buyer preference for Western-manufactured equipment is often justified by product technology and quality, access to warranty, parts and service, and available training for equipment handling.

The Philippine market is very price sensitive, which explains the growing presence of inexpensive equipment from China, South Korea and Taiwan. Hospitals with limited budgets tend to source medical equipment largely from these countries, while those with larger budgets focus on acquiring more developed, higher-end technologies from Western markets.77

Source Markets Value imported in 2016 (USD Share in Philippine imports (%) thousand) Singapore 44,150 18.2 USA 41,456 17.1 Germany 39,140 16.2 China 24,084 10 Japan 17,957 7.4 Netherlands 12,784 5.3 Republic of Korea 10,317 4.3 Malaysia 9,270 3.8

76 http://www.fpacctradexpo.com/us-trade-opportunities.html 77 http://www.fpacctradexpo.com/us-trade-opportunities.html

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Source Markets Value imported in 2016 (USD Share in Philippine imports (%) thousand) Hong Kong, China 8,856 3.7 France 4,028 1.7 Table 14: Top 10 exporters of medical equipment to the Philippines Source: ITC Trade Map

Import Countries Value export in 2016 (USD Share in Philippine exports (%) thousand) Japan 60,526 27.8 USA 32,829 15.1 Thailand 17,237 7.9 Belgium 16,309 7.5 Mexico 15,582 7.1 Canada 14,532 6.7 Taiwan 8,677 4 Republic of Korea 8,145 3.7 Indonesia 6,920 3.2 Australia 6,137 2.8 Table 15: 6 Top 10 importers of the medical equipment from the Philippines Source: ITC Trade Map

According to import analysis, approximately 94% of the wound dressing products rely on imports from Belgium and China, whereas 82% of catheters, surgical gloves and protective equipment are imported from the Malaysian market. Terumo, a Japanese company, has the syringe devices manufactured locally and, therefore, the demand for imports is relatively low. Over 98% of the auxiliary devices, such as hearing aids and pacemakers reach the Philippines from Hong Kong and Switzerland. Dental medical equipment, such as dental x-rays and dental treatment chairs are primarily sourced from China and Singapore while the artificial joint technologies are mostly imported from Taiwan.78

78 http://philmedical.com/post/14/industry-facts.html

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The market for medical equipment is dominated by diagnostic imaging products, which account for 36% of the total market value, followed by medical consumables (22%), and other medical devices (21%). Auxiliary devices, dental products and orthopaedics & implants account for 9%, 9%, and 3% of the market share, respectively.

Other 21% Diagnostic Imaging Orthopedics & 36% Implants 3%

Dental Products 9%

Auxiliary Devices 9%

Medical Consumables 22% Diagnostic Imaging Medical Consumables Auxiliary Devices Dental Products Orthopedics & Implants Other

Figure 18: Medical devices market by classification Source: Asia Healthcare Market Research

The Philippines healthcare industry, and, subsequently, the medical equipment market, is dominated by the private sector. There are approximately 1,700 licensed hospitals in the country, of which more than 60% are privately owned.

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Figure 19: Private vs public healthcare expenditure in the Philippines Source: Morulaa HealthTech

Industry growth for medical devices is seen predominantly at privately-owned hospitals and health facilities, such as St. Luke’s and the Asian Hospital and Medical Centre. Other well-known private hospitals in the Philippines, which accelerate the medical equipment market growth, are Makati Medical Centre, Medical City, Cardinal Santos Medical Centre, and Metropolitan Hospital. These facilities are concentrated in urban areas and possess sufficient funding to procure new and high- end medical devices.

While the private sector purchases both new and refurbished equipment, the government-owned facilities as a rule purchase only new equipment. Limited budgets of the public and government- owned facilities sometimes constrain the extent to which they can invest in equipment upgrades and new technology purchases, however, the newly approved budget for 2018 shows increased spending plans on upgrades of public healthcare infrastructure. Although growth in the medical device and equipment industry is still being led by the private sector, public sector facilities are expected to spend increasingly more on acquiring new, more advanced technologies in the next few years.79

79 http://medicaldesign.com/prototyping/world-market-europe-and-asia-show-signs-recovery

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The demand for medical equipment and devices continues to vary significantly by region, with the capital and the surrounding areas providing the best prospects for growth. With a relatively wealthy growing middle-class populace in the Manila/Quezon regions, new technologies and devices remain in demand. Elsewhere, many hospitals lack adequate equipment and, therefore, spending in those areas is likely to focus on acquiring basic medical equipment and devices. Remote areas also tend to primarily purchase refurbished equipment to satisfy the healthcare needs. To date, about 55% of all medical equipment supplied to hospitals and clinics is refurbished equipment.80

Purchasing decisions for both public and private hospitals are based on various criteria, but the international reputation of the manufacturer, availability of reputed local distributors, which provide after sales support, competitive pricing structure, service warranties, and training programmes for medical personnel are among the key determinants for a successful purchase of medical equipment and devices.

Public hospitals currently tend to put greater emphasis on preventative healthcare, while private hospitals concentrate on curative services. These trends are also reflected in the purchase orders of medical equipment.

The regulations of the Philippine medical device industry are in compliance with the norms of the United States. The medical device market is primarily regulated by the Bureau of Food and Drug Administration, which was created to oversee the efficacy, quality, safety, and purity of health products. The bureau regulates the trade and distribution of medical device products as well as the approval of medical device establishments - whether a distributor, importer, wholesaler, exporter, or manufacturer. In order to have products sold efficiently in the Philippines, it is important for companies to find a good dealer. According to local regulations, all dealers and all foreign medical devices must be registered with the bureau.

80 https://books.google.co.uk/books?id=SvtlAwAAQBAJ&pg=PA99&lpg=PA99&dq=Philippines+medical+equipment+and+instruments&source= bl&ots=qCpC-LWIla&sig=9V5MQ9cFdahiaSgzRdtKyWK6-M0&hl=en&sa=X&ved=0ahUKEwjg4uSO3cLWAhVoCMAKHVrVDoA4ChDoAQha MAc#v=onepage&q=Philippines%20medical%20equipment%20and%20instruments&f=false

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Given the fact that Manila is currently the most important market location in the country, the majority of dealers have established their business presence there. The logistics and infrastructure for the sale of medical equipment in remote areas are often constrained. Therefore, the medical device dealership in these regions is limited to a small number of players, which have a national network in service and can provide the economies of scale. Additionally, in areas outside Manila, the direct sales approach is often ineffective and not recommended. Hospital buyers tend to purchase medical devices and products from known dealers; therefore, credibility is a key factor for a successful entry into the medical device distribution and sales outside Manila.81 Among other mandated areas, the Food, Drug and Cosmetic Act regulates medical devices in the Philippines.82

Some of the most recent developments in the Philippines point to increasing opportunities for medical equipment manufacturers and suppliers in the country:

 The 2018 government budget will be positive for the healthcare sector and medical device market. The budget proposes a signfiicant increase in funds allocated to the Department of Health to finance the expansion of the country’s health insurance and upgrade medical facilities. This increase in public healthcare expenditure will address the key impediments to healthcare access in the Philippines and will reinforce commercial opportunities for medical device companies.

 In the private sector, the two leading hospital developers, namely Metro Pacific Investments Corporation and QualiMed Heath Network (a partnership between Ayala Land Inc./AlLI Capital and Daniel Mercado Memorial Hospital), continue to expand either through acquisitions of existing facilities or construction and development of new hospital projects. This is likely to result in positive outcomes for medical equipment suppliers as demand for furbishing new facilities increases.

81 https://healthcaresea.wordpress.com/2014/05/01/91/ 82 https://www.mddionline.com/asean-countries-could-be-next-emerging-medtech-markets

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Local Players

East Lane Corporation is a Philippine distributor of hospital supplies and equipment. Established in 1994, the company has been operating for more than 20 years, and it mainly caters to the hospitals, the medical supply dealers, and the homecare market. The company distributes its products primarily in the Metro Manila region and other major cities across the country. Initially, East Lane Corporation’s product lines consisted primarily of ostomy products. However, the company has expanded since to promote a diverse range of medical devices. Currently, the company distributes products of the following brands: RÜSCH, Smith & Nephew, Maxter, Tuta, Venoplus, MED-EL, Dynatec, the LMA, and most recently, Alcare Stoma appliances.

Bataan Manufacturing Inc. is a Philippine manufacturer, distributor and importer of hospital and medical equipment, such as hospital beds, wheelchairs, operating tables, and other related products and hospital furniture. The company started its operations in 1950 as a small shop of dental equipment. In less than two years after its founding, Bataan Manufacturing expanded its operations by adding hospital and medical equipment, thus, enabling it to enhance its product range. The company started to increase and maintain a number of regular clients as a result of its relatively high product quality and competitive pricing structures.

After 25 years of operations, the company has propelled into its present status as the pioneer of the domestic medical manufacturing industry. The Department of health has issued the company a Certificate of Supplier Accreditation, thereby making the company one of the few reliable suppliers of hospital and medical equipment to government hospitals in the Philippines. At present, Bataan Manufacturing remains one of the leading domestic manufacturers and suppliers of medical products in the Philippines. The company is based in Manila City and its client list includes 22 private hospitals, 12 government hospitals and other agencies in the healthcare industry.

Fairbright Enterprises Incorporated is a leading domestic distributor and supplier of healthcare and medical equipment. Founded in 1978, the company has continuously grown its representation of diverse range of products in response to the changing requirements of the Philippine market. Today, Fairbright provides products to both private and public hospitals across

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the country. It services the fields of cardiology, pulmonary, physiology, neurology, advanced wound care, rehabilitation medicine, sports medicine, fitness, orthopaedics, hemo and peritoneal dialysis, clinical and industrial laboratory medicine. As a response to the increasing pre-hospital medical care, the company has also expanded its coverage to serve the industrial, occupational safety, and emergency medicine markets as well. Its line of business covers both the In-Hospital and Pre-Hospital market segments. The company is currently representing manufacturers from Europe and the U.S. and it maintains a strong after-sales and technical support division to support its clients.

Aso Philippines, Inc. was founded in 1993 and it is the local manufacturer of medical tapes. It remains the source factory for most of the Asian and European sales volume. The 3,000 m2 factory employs more than 125 people, with a capability of running three shifts. Total production capacity is 100 million adhesive bandage strips monthly with room for expansion. Its products are ethylene oxide sterilised onsite with all conversion and sterilisation equipment designed and built in Japan and the U.S. Aso Philippines is an ISO 9001 and ISO 13485 certified company and has a Conformité Européenne (CE) mark for sterile bandages in Europe. Those certifications, combined with the U.S. FDA registration, make this factory capable of exporting its production lines to any marketplace globally. With a regional presence, a flexible manufacturing facility at the Mactan Economic Processing Zone in Cebu, Philippines, and a customer centre/commercial office in Hong Kong, Aso Philippines is strategically positioned to service the Asia-Pacific region.

Indoplas Philippines, Inc. is the only fully Filipino-owned company producing and supplying premium quality medical devices adhering to international standards. The company was established in 1978 and commenced its operations in Espana, Manila. Indoplas concentrated initially on producing medical products, such as catheters, intravenous sets and connecting tubes for the domestic market and export to Australia, Thailand and Singapore. The company currently provides institutional and home care products, medical equipment, consumer products, home care/commercial buildings lifter solutions, automotive lifter solutions and indovet systems. Its plant in the Philippines is self-contained and it houses several production lines, such as packing machines, high-frequency welding machines, extrusion lines as well as advanced catheter and

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ancillary machineries. Its product portfolio spans more than 2,000 Stock Keeping Units spread over multiple categories.

Technomed International, Inc. is a medical and hospital equipment distributer, located in San Juan City, Philippines. The company was founded in 1985 from a division of Medecor Philippines, Inc., which ceased its operations of medical equipment to concentrate on real estate property. After a division buy-out, the medical equipment segment was named Technomed International, Inc. and started its operations by continuing business relationships with foreign suppliers. Over the years, the company forged numerous partnerships with international medical device brands to mainstream medical technologies and services in the Philippines. Among its suppliers are KLS Martin, Puritan Bennett, SORENSEN, Elcon, ATOM, Welch Allyin, GE Healthcare, Mindaray and Lisa Lasers, B. Braun, JIHUA, ZONDAN, COMPASS, BenQ, Eschman, and Philips Imaging Systems. The company is one of the top importers of medical equipment, supplies and furniture to the Philippine market and an exclusive distributor of various manufacturers worldwide.

Philab Industries designs and builds medical and science laboratories for medical research facilities in the Philippines. The company is among those at the forefront of the private sector, which is helping to bring modern healthcare science systems and technologies to the country. In the past 5 decades, it has been involved in building and supplying medical facilities for hospitals, clinics and educational research laboratories. More recently, it has been supplying scientific equipment to more than 38,000 schools in the Philippines and has now gone into the medical self-diagnosis technology sector, in the form of the country’s first dengue self-help kit.

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Figure 20: Philab’s warehouse is preparing to send kits to schools all over the country Source: Inquirer.net 2017

3.3.2 EU Entry Opportunities

The Philippine government is strengthening its healthcare sector and its goal is to develop health infrastructure, implement immunisation programs, and provide quality innovative medicines and medical equipment and devices in the country. This creates opportunities for healthcare related European firms that can offer products and technology that will support these healthcare goals. In addition, the market is almost entirely dependent on imports of medical equipment and devices and local production is limited to prototype unit, spare parts and disposables which further offer opportunities for qualified European firms. The most imported products into the Philippines are: actocardiograph systems, blood analytical equipment, catheters, chemical analysis instruments, computerised tomography scan system, dental implants and dental accessories, diagnostics, dialysers, electrocardiogram equipment, ear, nose and throat treatment equipment, imaging and radiograph equipment, mobile x-ray units, magnetic resonance imaging systems, needles, orthopaedic implants, processors, seals, surgical instruments, sutures, ultrasound scanners,

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ultrasound systems, wound healing products, and x-ray systems.83 Demand for these technologies is expected to remain given the expanding healthcare sector in the Philippines.

Additional opportunities for European companies exist in the following areas:

 Radiography devices

 Provision of equipment replacement & enhancement

 Provision of equipment and devices for cancer centres

 Provision of refurbished/used equipment provision

 Provision of equipment for new healthcare infrastruture projects

 Government tenders

Radiography Devices

General radiography devices and aids are in high demand in the Philippines. High incident rates of lung diseases, heart diseases, kidney diseases, hypertension, and other respiratory diseases prompt hospitals to make enhancements for medical equipment, thus, increasing the demand for general radiography devices like linear accelerators, electro-cardiographs, ultrasonic scanning machines (ultrasound), magnetic resonance imaging, x-ray and radiation equipment, breathing appliances, electrocardiogram equipment, dialysis machines, and computed tomography apparatuses.

Provision of Equipment Replacement & Enhancement

There is also a market demand for medical equipment replacement. The Philippine Health Insurance Corp’s (PhilHealth) mandate to increase its coverage from 92% to 100% of the population is expected to drive demand for quality healthcare that is both affordable and accessible. In anticipation of the surge in demand for healthcare services, the Philippines has

83 http://www.morulaa.com/medical-device/philippines-healthcare-market-an-overview-morulaa/

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launched an ambitious programme to develop and upgrade its healthcare facilities to ensure equitable access to healthcare across the country.

For 2018, the DOH has secured a healthcare budget of PHP 171.09 billion (EUR 2.68 billion), of which around PHP 29 billion (EUR 454.56 million) are expected to be allocated for the enhancement of health facilities and PHP 6.8 billion (EUR 106.59 million) will be provided for the purchase of hospital equipment. The proposed health facilities enhancement programme budget is likely to be used to build 1,497 barangay health stations and improve 353 hospitals, which may fuel growth in the medical technologies sector. 85% of the income from the new tax increases on alcohol and tobacco is also earmarked for healthcare, namely to fund universal healthcare, upgrade medical facilities and train doctors and nurses. As the Philippines is almost entirely reliant on imports of medical devices, abundant opportunities are available for medical device companies to meet the country’s growing demand.

25 public hospitals listed under the Public-Private Partnership (PPP) programme are expected to benefit from the modernisation. Some requirements of the hospitals under the PPP programme are linear accelerators for eight cancer centres, dialysis units, various imaging equipment, and devices for treating kidney, heart, respiratory, and diabetes diseases. The first beneficiary is the Philippine Orthopaedic Hospital, which PPP hopes to transform into the country’s primary centre for bone and joint diseases on par with global standards. To achieve this, the requirements are for more efficient healthcare services, new technology and equipment replacement.

Provision of Equipment for Cancer Centres

The Department of Health has also recently disclosed its plans to establish up to 8 cancer centres in various hospitals across the Philippines. The new centres are expected to have linear accelerators, treatment planning systems, computerised tomography stimulators and brachytherapy units. The strategy to establish new centres provides entry opportunities for European companies with the technological solutions for cancer treatment.84

84 http://www.fpacctradexpo.com/us-trade-opportunities.html

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Provision of Refurbished/Used Equipment

There is a growing demand for refurbished medical equipment in the Philippines. While public and government-owned hospitals tend to purchase only new equipment, the private sector is divided between the market segments of new and refurbished medical equipment. Private hospitals and clinics outside metropolitan Manila often tend to purchase used and refurbished equipment, such as x-rays, cardiology and surgery devices, given their limited budgets. To date, approximately 55% of all medical equipment supplied to hospitals and clinics are refurbished. With the growing demand for extensive healthcare coverage outside the main urban centres, European companies may find opportunities to tap into this emerging market segment.

Provision of Equipment for New Healthcare Infrastructure Projects

Over the last few years, a number of private sector companies and individuals have also invested in hospital development across the Philippines. Several investment companies have acquired stakes in the healthcare sector, providing much-needed capital for facilities to upgrade and modernise equipment. Real estate developers have also partnered with known healthcare providers to construct health and wellness centres in and around communities that they are building, to attract customers, thus, also providing demand for medical equipment and devices.

Existing hospital groups, such as Metro Pacific Group and Ayala Corp, are on an expansion binge either through acquisitions of existing facilities or construction of new hospital projects, which is likely to provide new opportunities for purchases of quality medical equipment. For example, Conglomerate Metro Pacific Group, which is a strategic partner of Singapore’s sovereign wealth fund, is actively looking for more investments in the Philippine healthcare sector. The conglomerate is seeking to acquire about 15 more hospitals to achieve the benchmark of 5,000 beds. The company in 2016 said it would invest in 10 to 15 hospitals to add around 2,000 more beds and expand existing medical facilities by another 700 to 800 beds to increase its presence in the sector across the country.

The Qualimed Hospital Network, a network of healthcare facilities owned by the Ayala Corp, is also expanding. The company plans to expand its portfolio to 10 hospitals by 2020, and it is

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considering locations, such as Davao, Cebu, Cavite, Balintawak, and Arca South. In the short term, it is also planning to build a 200 to 300-room hospital in Balintawak in the northern part of Metro Manila, and another similarly-sized hospital in Arca South in the southern part of Metro Manila. The upcoming hospital and health facilities modernisation and construction projects are likely to drive demand for new medical equipment. Qualified European companies are well positioned to build partnerships with these industry groups and export their products for new healthcare facilities.

In 2017, the Philippine Board of Investment’s Investment Priorities Plan preferred list of activities included the establishment and operation of general and specialty hospitals, and other medical/healthcare facilities, including drug rehabilitation centres, which means that the healthcare sector is expected to witness increasing demand for new facilities as well as equipment/technologies to cater to this demand.

Procurement and Tenders

Providers of medical equipment may also find opportunities to bid for public tenders. All current public tenders can be found at the Philippine Government Electronic Procurement System, or PhilGEPS, which is the single, centralised electronic portal for centralised information on government procurement. The PhilGEPS website provides guidance on participating in a government bid (www.philgeps.gov.ph). Some of the current opportunities for European companies are listed in the table below, however, interested companies should check the portal regularly as the public tenders are updated frequently. The public tender values generally range from PHP 100,000 (EUR 1,567.60) to PHP 75,000,000 (EUR 1.2 million).

Procuring Entity Title Budget for Closing Contract date Luis Hora Memorial Regional Bid for supply, delivery, and installation of PHP 74,673,000 27 Feb 2018 Hospital medical, radiology, laboratory and biomedical waste equipment Barangay Quintin Salas Jaro, Purchase of medical equipment (stretcher & PHP 150,000 7 Feb 2018 Iloilo City wheelchair) Bicol Medical Centre Autoclave machine PHP 960,000 2 Feb 2018 National Centre for Mental Supply and delivery of dental supplies PHP 724,421.3 16 Feb 2018 Health CY2018

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Procuring Entity Title Budget for Closing Contract date Municipality of New Corella, Supply and delivery of medical equipment PHP 146,500 6 Feb 2018 Davao Del Norte City of Valenzuela ECG Portable Machine & Thermal paper PHP 65,875 1 Feb 2018 City of Antipolo, Rizal Purchase of medical and dental equipment PHP 121,800 1 Feb 2018 Province of Cotabato Supply and delivery of medical equipment PHP 331,600 5 Feb 2018 for the use of Office of the Provincial Veterinarian, Amas, Kidapawan City Province of Cotabato Supply and delivery of dental equipment for PHP 2,560,000 5 Feb 2018 Provincial Health Office, Amas, Kidapawan City Barangay Bagong Silangan, Medical and dental supplies and equipment PHP 1,552,279.3 5 Feb 2018 Quezon City Bataan General Hospital 2018 4th Public Bidding – Medical equipment PHP 4,550,000 21 Feb 2018 Vicente Sotto Memorial Medical Supply and delivery of medical surgical PHP 20 Feb 2018 Centre – Region VII dental supplies 205,689,901.64 Bataan General Hospital 2018 5th Public Bidding – Medical Equipment PHP 1,212,000 21 Feb 2018 Barangay Cuanos, Minglanilla, Purchase of birthing equipment PHP 100,000 13 Feb 2018 Cebu Municipality of Bacarra, Ilocos Procurement of regular supplies of medical PHP 1,000,000 1 Feb 2018 Norte and dental supply Narlac State University Medical equipment – APP 2018 (1st Qtr) PHP 139,800 1 Feb 2018 Municipality of Labo, Camarines Bidding for medical equipment PHP 1,188,714 13 Feb 2018 Norte Province of Davao Occidental Supply and delivery of various medical PHP 100,000,000 8 Feb 2018 equipment City of Iligan, Lanao Del Norte Procurement of medical equipment PHP 8,000,000 7 Feb 2018 Municipality of Masinloc, Procurement of automated external PHP 900,000 12 Feb 2018 Zambales defibrillator (AED) for MDRRM 24/7 Emergency Response Operation Bataan General Hospital 2018 1st Public Bidding – Medical equipment PHP 10,080,000 6 Feb 2018 Municipality of Siocon Procurement of dental supplies, RHU Siocon PHP 102,740 9 Feb 2018 Barangay Apas, Cebu City Purchase of one unit Cardiac Monitor for PHP 155,000 7 Feb 2018 ambulance Mayor Hilarion A. Ramiro Sr. Calibration service PHP 1,500,000 7 Feb 2018 Regional Training & Teaching Hospital Province of Benguet Purchase of 1 unit of anaesthesia machine PHP 1,300,000 5 Feb 2018 with integrated ventilator and monitor for use of Northern Benguet district hospitals – rebid Valenzuela Medical Centre Procurement of ECG Machine PHP 100,000 1 Feb 2018 Table 16: Public Tenders for Medical Equipment, February 2018 Source: PhilGEPS

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European Players

Smith & Nephew Plc (S&N)

Founded in 1856, Smith & Nephew is a British multinational medical equipment manufacturing company, headquartered in London, UK. It is an international producer of advanced wound management, arthroscopy, trauma and clinical therapy, and orthopaedic reconstruction products. The company supports healthcare professionals in more than 100 countries and it offers its products through distributors and local representatives. Its sales in 2016 reached more than US$ 4.6 billion. In the Philippines, it distributes its advanced wound management products via exclusive distributor East Lane Corporation, endoscopy products via Endomed Trading Inc., and orthopaedic reconstruction and ENT products via RBGM Medical Express Sales Inc.

Philips

Philips is a Dutch technology company headquartered in Amsterdam with primary divisions focused on electronics, healthcare and lighting. Founded in 1891, it is one of the largest electronics companies in the world and it employs around 105,000 people across more than 60 countries, with sales in over 100 countries. The company is a market leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care products. Its healthcare products include computerised tomography scans; clinical informatics, such as cardiology and enterprise imaging informatics; imaging systems, including cardio/vascular x-ray, fluoroscopy, magnetic resonance imaging, mammography, mobile C-arms, nuclear medicine, radiology, and others; diagnostic monitoring; defibrillators; and other consumer products. In 2015, Philips’ sales exceeded EUR 24.2 billion, driven by above 4% growth in the HealthTech portfolio.85

The company operates in the Philippines primarily via its network of domestic distributors. In 2014, the company has also partnered with World Citi Inc. to develop a new, modern Philippine Orthopaedic Centre. The PHP 5.7 billion (EUR 113 million) build-operate-transfer project was awarded to Megawide-World Citi consortium through a public-private partnership (PPP) scheme. Philips was expected to bring in medical facilities to the new Philippine Orthopaedic Centre.

85 https://www.philips.co.uk/a-w/about/news/archive/standard/news/press/2015/philips-fourth-quarter-results-2015.html

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However, due to persistent delays in awarding of the Certificate of Possession, and other permits, Megawide-World Citi consortium terminated the contract with the DOH in 2015. In March 2016, it was reported that DOH has again deferred the modernisation of the Orthopaedic Centre as no companies appeared to take the PPP deal.86

Intersurgical

Established in the UK in 1982, Intersurgical is a leading European designer, manufacturer and supplier of a wide range of medical devices for respiratory support. The company designs, manufactures and supplies respiratory care products for airway management, anaesthesia, critical care, and oxygen and aerosol solutions. Based in Wokingham, UK, it services clients domestically and internationally, and provides flexible patient solutions for the use within the hospital environment and in-home care. All of its products are designed and manufactured to meet the requirements of relevant ISO, British and European Standards. Intersurgical is operating worldwide via its global network of subsidiary offices and distributor network. In the Philippines, its local subsidiary, Intersurgical (Philippines) Inc. is the domestic distributor and supplier of the Intersurgical devices, such as breathing circuit adapters, household humidifiers, laryngeal mask artificial airway systems, bacteria filters, breathing bags, masks, ventilators and filters. The local subsidiary holds the distribution and operation licenses from the Philippine FDA.

Italray Srl

Italray Srl was founded in 1974. The Italian company’s business lines include the manufacturing of medical, surgical, ophthalmic and veterinary instruments and apparatus. Its core business focus is, however, medical imaging with a specialisation on the manufacturing of x-ray systems. The company’s activities range from product development, manufacturing to commercialisation, installation and after sales service. The company sells its products in more than 50 countries around the world. The company started selling its products in the Philippines via a dedicated distributor network.

86 http://news.abs-cbn.com/business/11/17/15/megawide-terminates-ph-orthopedic-center-modernization-contract & http://newsinfo.inquirer.net/776885/doh-defers-orthopedic-center-upgrade-no-deal-takers-under-ppp

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3.4 ICT for Healthcare

3.4.1 Market Overview

Access to healthcare services remains a challenge for many Filipinos. Divided by many islands, it is difficult to provide an equitable and efficient delivery of medical advices or treatments across the entire country. Aggravating this problem are the shortage of doctors, lack of hospital beds, and unutilised pool of nurses nationwide. However, the rapid innovations in information and communications technology (ICT) are spilling over to the health sector and are helping alleviate these problems, giving rise to the digital healthcare market.

The Philippine eHealth market continues to grow rapidly with the entry of new private sector players and the expansion of the government initiatives, which are accelerating the digitalisation of healthcare in the Philippines. According to Statista research, the revenue in the eHealth market amounted to US$ 90 million (EUR 72.71 million) by the end of 2017, and it is expected to reach US$ 132 million (EUR 106.64 million) by 2020, growing at a compound annual growth rate (CAGR) of 21.4%.87 These significant growth projections point to abundant opportunities for European ICT providers.

ICT Infrastructure in Healthcare

The primary macroeconomic indicators driving growth in the country are the upheaval of infrastructure in healthcare and a growing number of private hospitals. These indicators are likely to bolster the ICT spending growth in the Philippine healthcare market.

The largest spending group in health ICT is the healthcare providers market, including hospitals, clinics and wellness centres, with 88% share in 2015.88 Although spending on hardware continues to dominate the sector with 79% share of the total healthcare ICT market, services and software spending are fast growing fields.

87 https://www.statista.com/outlook/312/123/ehealth/philippines# 88 https://www.idc.com/getdoc.jsp?containerId=prAP41037816

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The private healthcare sector, which aims for medical tourism impetus, is the leader when it comes to more aggressive adoption of ICT. Meanwhile, spending on information technologies in the public health sector focuses more on developing hardware infrastructure and making the existing health services more accessible.89 Initiatives, however, are springing up in both private and public sectors, transforming the way healthcare is provided.

Software for Electronic Health Records (EHRs) and Electronic Medical Records (EMR) is still relatively new in the Philippines. However, this is rapidly changing. Research agencies, such as Frost & Sullivan, predict sustained growth in this market segment in the region. Currently, hospitals in the Philippines, such as Makati Medical Centre, St. Luke’s Medical Centre and the Medical City are already adopting the use of Electronic Medical Records and Electronic Health Records, allowing them to create and share digitised patient records. The Department of Health (DOH) has also taken steps to push electronic health and medical record adoption. Locally developed software includes the Free Feathers EHR and Serious MD.

With the rise of digital health worldwide, the Healthcare Information Management (HIM) outsourcing industry is also growing exponentially in the Philippines. From purely medical transcription, the service has now evolved to healthcare information management outsourcing, which includes medical coding, medical billing and eClaims processing, help desk/scheduling/appointment setting, discharge management, medical records analytics, clinical abstraction, accounting, utilisation review, pharmacy benefits management, document and electronic health & medical record management business. Global trends show high-growth opportunity for HIM outsourced services as countries, such as the US, UK and Canada require more outsourced services to cater to the domestic demand. Possessing a rather healthy level of confidence in the Philippines’ e-health capabilities, the Health Informatics Management Association of the Philippines is seeking to capture 5% of the global healthcare Business Processes Outsourcing (BPO) market by 2020 – suggesting a rather ambitious target, but also opportunities for various stakeholders.

89 https://www.export.gov/article?id=Philippines-Information-and-Communications-Technology & https://www.idc.com/getdoc.jsp?containerId=prAP41037816

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Healthcare ICT Initiatives in the Philippines

The Philippine government, through the DOH, has recognised the importance of ICT to the facilitation and implementation of its healthcare sector agendas. As a result, DOH partners with all stakeholders in the sector to develop and improve upon its electronic programmes and data.

The involvement of stakeholders – civil society groups, health-promoting non-governmental institutions, faith-based organisations, private sponsors, and international groups – play a huge role in managing ICT for healthcare in the Philippines.

The development of the eHealth initiatives is currently guided by the Philippines e-Health Strategic Framework and Plan 2014-2020. Like many countries in the world, the Philippines is advancing towards greater digitalisation of its healthcare systems and services via e-Health initiatives, and the strategic framework anticipates the accelerated growth in, and sustained focus on, the following areas:

 Enhanced interoperability of existing Health Information Systems. One of the goals of this framework is to establish unified and coherent health and management information systems, and to capitalise on ICT to reach and provide better healthcare services and support. According to the framework, Health Information Systems for all government hospitals and rural healthcare providers under the mainland provinces of Cavite, Laguna, Batangas, Rizal and Quezon are aimed to become interoperable by 2018. Various efforts (discussed below) have already been initiated to achieve this goal, which are likely to continue at least until 2020.

 Increased healthcare accessibility through the expansion of telemedicine programmes. Pilot telemedicine programmes have been implemented by the National Telemedicine Centre, National Institute for Health and the University of the Philippines since 2014. In early 2015, the Department of Health has also collaborated with SMC SKY Medical Group to implement a mobile technology to facilitate telemedicine, which linked Sta. Cruz District Hospital, Torijos Municipal Hospital and Dr. Damian Reyes Provincial Hospital together. As one of the priorities in the e-Health Strategic Plan, telemedicine is receiving

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interest from both the private and public sectors. It is expected that that telemedicine will remain a priority area given the government’s aim to achieve universal healthcare provision to all Filipinos.

 Improved efficiency via adoption of new IT solutions. The Startegic Plan also aims to improve the efficiency of healthcare provision via smart solutions. Technological initiatives, such as Surveillance in Post Extreme Emergencies and Disasters, which facilitiates reporting of dire health cases to the Health Emergency Management Staff, were developed by the Department of Health in 2015. The government also targeted to roll out e-Claims systems to all hospitals and clinics as well as to 101 million Filipinos by December 2016.

Over the past several years the government and several research agencies have launched multiple initiatives to accelerate the growth of ICT utilisation in healthcare.

Government Initiatives

The government has been active in promoting ICT implementation in healthcare primarily via its three main initiatives: eHealth Philippines, eHATID LGU and Hospital Advisor (discussed below).

eHatid eHealth LGU PH

Hospital Advisor

Information and Communication Technology for HealthCare

Figure 21: ICT initiatives in the healthcare sector

eHealth Philippines (eHealth PH) has been launched in February 2012 as an online community resource hosted by the Department of Health. The eHealth PH includes an interactive forum

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wherein readers can post questions or contribute to discussion boards about health-related concerns. It also calls on experts to submit blog posts, which will be reviewed for possible publication in their feature section: Community News.

The eHealth Tablet for Informed Decision Making of LGUs project is also featured on eHealth. The project was developed by the Philippine Council for Health Research and Development of the Department of Science and Technology (DOST), and led by the Ateneo De Manila University. The project generates an Electronic Medical Record that provides summaries of reports from the Department of Health and the Philippine Health Insurance Corporation (PhilHealth). The project deployed the application and tablet devices to 450 selected cities and municipalities nationwide between 2014 and 2015. The electronic medical record can also be generated using the mobile app, which accompanied the distributed tablets.

Figure 22: The eHealth Tablet for Informed Decision Making of LGUs mobile application Source: Ateneo de Manila University

Finally, in December 2015, the Department of Health has also launched its own Hospital Advisor page in its quest for Universal Healthcare. The website was co-funded by the UK Government through the British Embassy in Manila. It assists patients with getting access to a wide assortment of hospitals and healthcare facilities. It also provides useful information on the quality of service, specialisations, infrastructure, and health personnel of a particular healthcare provider to help the patient make the right choice.

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Another initiative to utilise ICT for healthcare was launched by the partnership of the DOST, the Philippine Health Insurance Corporation, (PhilHealth), and the Department of Health. The partnership gave birth to the Philippine Health Information Exchange (PHIE), a government initiative that aims to promote efficient health information management with the end goal of improving upon the services of the agencies involved in the project. PHIE has become the driver for encouraging frontline primary healthcare centres to automate. Whereas still in its infancy, the PHIE promises to ensure seamless health information transfer to allow continuity of care and administrative efficiency. The Advanced Science and Technology Institute – hosted by the DOST – and the Information and Communications Technology Office will be managing the technical support for the Department of Health - PhilHealth Harmonised Data Warehouse Platform. This system will be directly and simultaneously handled by PhilHeath and the Department of Health.

PhilHealth is turning out to be an important driver for ICT development in the Philippines. PhilHealth, which runs the country’s social insurance program, provides a sizeable amount of money to primary care government facilities and it requires the submission of electronic information from primary care facilities through the PHIE system. Those who already have EMRs are boosting their systems, while those who have no EMRs are considering various systems that are available to them. According to PhilHealth information, the company has given the deadline of March 2017 for primary healthcare facilities to upgrade their systems. With around 2,500 government-funded health facilities in the municipalities, around 1,000 of them are using one form of EMR or another from one of 6 EMR providers. National Telehealth Centre covers around 200, and the Department of Health itself covers over 1,000.90

90 http://www.opengovasia.com/articles/7423-exclusive---pioneering-ict-based-healthcare-solutions-at-the-national-telehealth-center-philippines (2017)

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Figure 23: Health Apps - Visualisation Source: imedicalapps.com (2017)

In addition, as connected devices become increasingly ubiquitous in the region, many companies are developing innovative eHealth applications to address the healthcare needs. Many health apps have sprung up in recent years in the Philippines, from apps that keep track of important health indicators, such as sugar or cholesterol levels, to fitness apps and apps on CPR education. These private sector apps are further improving the awareness of the ICT applications in healthcare. Some of the popular Philippine apps for health include:

 eMDI: a mobile application, developed by ThinkBIT Solutions, that offers syndicated news for its users across all medical specialties and medical & health information. The app targets doctors, aspiring doctors, and other health professionals who want to be the first to know the latest information about their field of work or interest, or want to receive information that can aid them in their day-to-day operations. The app is also available for people who want to learn about the latest information on certain health issues that they are concerned with.

 Aide: the app, also developed by ThinkBIT Solutions, features an extensive database of doctors and medical practitioners and enables its users to easily search and book the nearest medical care, based on their requirements and need.

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 Healthscore: An app, developed by Arcanys, is a quiz about the user’s health habits. After answering questions about diet and lifestyle, users subscribe to receive push alerts about the commitments they have made to live in a healthy way.

 Spine Tests: an app, developed by Arcanys, is an iOS application to determine a patient’s Spinal angle & blockages by following the spine on an image of the patient’s back taken with the app. It takes the “before” and “after” image of a patient’s chiropractic sessions with calculations for the doctor’s analysis.

 LowCal: Cardinal Santos Medical Centre and Voyager Innovations, a subsidiary of wireless services company Smart Communications, in 2013 launched the country’s first hospital- backed preventive healthcare application, which helps users manage their nutrition intake and allows patients to transact with the medical centre more easily.

 Hx Factfinder: a mobile app, developed at the Hackathon for Health in July 2016, connects primary health institutions, mostly maternal and child health facilities, with the larger health institutions, like city hospitals.

 PhilHealth ACR (All Case Rates): in order to keep up with the mobile app trend and be able to provide its clientele with easy benefit information access anytime and anywhere, the Philippine Health Insurance Corporation (PhilHealth) has created in February 2017 its own application. The application provides a facility to search for PhilHealth’s compensable illnesses and procedures, along with its benefit rates under the All Case Rates mechanism.91

 Dario: in July 2016, the Israeli company, Labstyle Innovations Corporation, announced that it was looking to expand the distribution of their flagship product – Dario – to the Philippines. Dario is the world’s first personalised smart metre that combines an all-in-one glucose metre with a mobile app that can help monitor a user’s blood glucose levels. The device itself is a compact glucose metre that connects directly to any smartphone. The product also comes with its own lacing device and a set of disposable test strips.92

91 https://www.philhealth.gov.ph/news/2017/acr_app.html 92 https://www.iccp.ph/israeli-company-introduces-app-for-diabetics/

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 Nambal: an app, created in August 2017, which provides an electronic medical record platform with both a doctor-facing and patient-facing portal, so that both parties can access crucial medical information at any time. The app can be used to chat with your doctor, find a doctor, set apointments, and upload lab results and prescriptions.93

 HealthCloud MD, HealthCloud Patient, and HealthCloud Health Maintenance Organisation: an app platform , created by the Philippine company, LiFeData, in partnership with Globe Telecom, which manages health data – medical records, checkup schedules, and other information pertaining to patient’s health.94

 St. Luke’s MedConnect: with the aim to provide the public with an easier access to healthcare services, St. Luke’s Medical Centre launched its first mobile application in 2015. The app includes features, such as requesting for a doctor’s appointment, accessing one’s laboratory results, reserving a room, paying hospital bills online, scheduling executive checkups, and reading about essential information, such as health tips and information about various diseases.95

 Practo: Asia’s largest healthcare platform announced in 2016 its entry into the Philippine market to bring its products – Practo Search and Practo Ray – to the region. Using Practo, consumers are able to search through over thousands of verified doctors across all 17 cities in the Greater Manila area.96

 Maria Health: a platform, which allows users search through, compare and purchase available heath insurance plans. The company has partnered with top health maintenance organisations in the Philippines, including PhilCare, AsianLife, MaxiCare, MediCard and Lifeline.97

93 https://stories.makesense.org/en/nambal-innovation-philippine-startup/ 94 http://www.stefdelacruz.com/2013/10/lifecloud-philippine-health-app-platform.html 95 http://www.philstar.com/health-and-family/2015/01/30/1418393/hospital-brings-healthcare-services-your-mobile-phone 96 http://astig.ph/practo-health-app-lets-you-search-for-doctors-in-the-philippines/ 97 https://mariahealth.ph/

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 Nestlé Wellness: Nestlé Philippines has launched its Wellness app, a mobile initiative designed to help users of Apple devices to readily access Nutrition, Health and Wellness information that can be applied to daily life.98

 Fit in 15: a fitness and health app that combines workouts with nutritious meal plans.99

 Sali: the app, which aims to universalise CPR education and training. It connects the user to a network of fellow life-savers who can provide auxiliary support.100

Local Players

Several local players have already tapped into the Philippine healthcare ICT market. Among those are:

Smart Communications (Smart) is a major Philippine wireless communications and digital services provider. The company is a fully-owned subsidiary of PLDT Inc. Philippines’ leading telecommunications and digital services company, which has recently invested in the Philippine mHealth solutions – “the practice of medicine and public health supported by wireless communication devices such as mobile phones and tablet computers.”101 Smart’s three main projects in mHealth are SHINE, ASCENT and WAH.

SHINE (Secured Health Information Network and Exchange) is Smart’s flagship mHealth project. The project was launched in 2011 to address the Philippines’ need for an integrated health management exchange system that would connect individuals, communities, and private and public health service providers. SHINE’s key goal is to raise efficiency and effectiveness of healthcare facilities through the innovative use of mobile and ICT technologies. In its nature, SHINE is a hosted electronic health information and referral system, which can be accessed by a Java-capable phone or a computer with internet connectivity.

98 http://pana.com.ph/nestle-launches-wellness-app-for-ios/ 99 http://asianjournal.com/lifestyle/filipino-develops-app-to-simply-fitness-and-health/ 100 https://www.rappler.com/move-ph/163149-ateneo-student-cpr-app-global-recognition 101 https://smart.com.ph/About/community-partnership/kabalikat/kabalikat-sa-kalusugan

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In February 2013, Smart has also signed a Memorandum of Understanding with the Ateneo de Manila University and Ateneo Java Wireless Competency Centre with the aim of improving the existing SHINE architecture based on the national eHealth Framework.

Smart has also developed WAH (Wireless Access for Health), a multi-sectoral, public-private partnership that involves equipping rural health clinics with netbooks and wireless broadband connectivity. WAH supports the computerisation of patients’ medical records using an information system for barangay health centres and the transmission of vital information to health authorities. In its nature, WAH allows to enter key personal and medical data directly into clinics’ databases using netbooks and PCs. For example, in four rural health centres in Tarlac, patient-handling has become paperless.

Finally, dubbed ASCENT (Amputee Screening via Cellphone Networking) is the mobile app, which allows health workers to record patient data of an amputee and take photos of the amputations using a mobile phone or tablet. By connecting to the internet, data are then sent to a website where Physicians for Peace doctors can view and organise the patient records and even provide recommendations online.

MEC Networks Corporation is a distribution company that provides value added ICT and physical security products, solutions and services in the Philippines. Since its inception in 1995, MEC has designed, set-up and deployed an array of ICT solutions, technologies and infrastructure for a broad range of clients in banking, hospitality, retail, healthcare, construction, and other industry sectors. The company is distributing products from many top brands in the fields of networking, communications, wireless infrastructure, IP surveillance, and other network- related essentials.

Medix is a software company offering cloud-based clinic management solutions to healthcare practitioners, helping them improve their clinic operations. Aside from Integrated Clinic Management and Confidential Charting, Medix also provides a thorough and highly secure record system for practitioners. The company started in early 2012, when the electronic record industry in the Philippines was still a nascent one.

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Figure 24: Medix EMR Dashboard Source: Tech in Asia (2014)

The company started out as a service for dentists and dental practitioners, focused on enabling them to manage their patients and patient records on tablet devices. The app highlighted connectivity as its main feature – making patient records accessible across clinics and offices through the cloud. This meant patients no longer had to fill out new forms when they were referred to others, which improved the accuracy of records and patient history. With its initial focus on dental practices, Medix’s app enabled dentists to directly input dental records onscreen, without relying on paper-based cards. More recently, mClinica, a pharmaceutical industry and mobile healthcare provider, has acquired a stake in Medix, and the company has started offering its platform for medical doctors.

3.4.2 EU Entry Opportunities

The most promising opportunities for European companies to enter the Philippine healthcare ICT market lie in the following areas:

 Enhanced connectivity technologies

 Business Process Outsourcing (BPO) solutions

 Electronic Medical Records (EMR) & Electronic Health Records (EHR)

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 Training for health professionals on ICT tools

 Security solutions for healthcare ICT systems

 Platforms to promote transparency

 Adoption of emerging disruptive technologies

Enhanced Connectivity Technologies

With about 100 million Filipinos spread across 7,000 islands, the fragmented geographical nature of the Philippines is driving the adoption of standardised and interoperable health information systems. This trend is likely to benefit companies with technological solutions that enhance connectivity between patients and medical professionals, and offer opportunities for collaboration with the government and other Philippine agencies. Given the strategic e-health framework, the government is keen to collaborate with the private sector to improve its ICT infrastructure and healthcare reach across the country. Companies with solutions that require low-levels of training and tech support, but offer significant efficacy gains, are likely to be particularly in demand.

Business Process Outsourcing (BPO) Solutions

The Health Informatics Management Association of the Philippines (HIMAP) is seeking to capture 5% of the global healthcare BPO market by 2020. In the upcoming years, the demand for BPO services is likely to grow in the medical industry as players in this sector optimise, automate and outsource their operations. This translates into a healthy amount of opportunities for companies with expertise in BPO, especially in the healthcare sector.

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Figure 25: BPO solutions Source: PLP Group 2015

The Health Information Management Services industry is one of the most promising and fastest growing industries in the Information Technology and Business Process Management sector. In 2015, the country’s health information management service industry employed 100,000 people and generated US$ 1.9 billion in revenues.102

The Health Information Management services now include medical transcription, medical coding, medical billing and claims processing, help/desk/scheduling/appointment setting, discharge management, medical records analytics, clinical abstraction, accounting, utilisation review, pharmacy benefits management, and document management, to name a few. The Philippine Government and the DOST are already working closely with the HIMAP to step up the value chain insofar as the Health Information Management services industry is concerned. In 2013, the DOST-ICT Office and HIMAP have also signed a Memorandum of Understanding to continuously support the industry through implementing programmes on research, talent development, domestic and international marketing and branding, and industry building to achieve national

102 http://www.philstar.com/business/2016/09/12/1622740/healthcare-revenues-reach-1.9-b-2015

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development goals of generating employment and investments. As the demand for providing Health Information Management services continues to grow, the Philippines is well-placed to take advantage of these opportunities and cement its global leadership position through private sector investments. European companies can take advantage of the positive sector environment to enter the BPO and Health Information Management services markets via the Philippines.

Electronic Medical Records (EMR) & Electronic Health Records (EHR)

According to the Government’s Development Plan 2017-2022, the government is seeking to invest heavily in eHealth and data collection mechanisms in order to improve healthcare provision and access, and address the data gaps. The use of EMRs (clinical and administrative) in all health facilities will become a requirement for licensing and contracting of health facilities and drug outlets. Performance monitoring units are also expected to be established to track the progress of reforms and medical audits, and to oversee third-party monitoring.103

Figure 26: EMR & EHR Visualisation Source: Healthcare Informatics Magazine 2016

As a result, it is likely that the Philippines will experience an increasing demand for services in record digitalisation and EMR standardisation. There are many opportunities for companies with

103 Philippine Development Plan 2017-2022

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required expertise to provide both consulting and process optimisation services as well as the provision of the effective EMR & EHR technology.

Training for Health Professionals on ICT Tools

As the ICT technologies are becoming part of the healthcare infrastructure in the Philippines, there is an increasing demand to train current and future health professionals on the usage of the ICT tools and appropriate ICT systems in the healthcare sector. In the transition of healthcare to digital form, the industry is likely to experience a generational gap with senior doctors requiring education and training on ICT usage. This offers opportunities for European companies with ICT training packages to provide their software products to the Philippine medical market.

Security Solutions for Healthcare ICT Systems

IBM X-Force Research – Cyber Security Intelligence Index 2015 reported that the industry with the most cyber-attacks in 2015 was healthcare. As the public and private healthcare providers are digitalising their systems, concerns over data privacy and security are likely to emerge. Therefore, opportunities for developing secure solutions for healthcare are rising. For example, EHRs with strong safety measures and protocol are among the rising needs in the healthcare sector.104

Platforms that Promote Transparency

Another emerging trend in the Philippines is platforms that meaningfully assemble data from analytics or enable marketplaces. One such platform is mClinica, which harnesses the information it collects from pharmacies to generate actionable insights. At US$ 6.3 million, mClinica’s recent Series A attracted a wide mix of institutional investors outside of the Philippines. Another platform, Maria Health, is a health insurance marketplace that also aggregates individuals and small enterprises to offer them better rates. MedGrocer also combines both analytics and marketplaces by administering, augmenting, and analysing corporate medicine benefit programmes to promote

104 https://seriousmd.com/blog/the-filipino-healthcare-providers-guide-to-ehr-pros-and-cons/

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disease management and cost efficiency. At the same time, MedGrocer provides choice and pricing transparency through its ePharmacy. European companies can find venues for entry by focusing on such platforms that promote transparency and interoperability in the healthcare sector.

Adoption of Emerging Disruptive Technologies

There are currently several emerging disruptive technologies that could significantly affect the future of healthcare, including Big Data, Cloud, Internet of Things, Artificial Intelligence, and other IT developments. As the healthcare ICT market is gaining traction in the Philippines, and more companies enter the market, these developments can contribute to competitive advantage, profitability, sustainability, and market success, if utilised properly. AI, machine-learning and automated conversational user experience front ends could be important developments in delivering aspects of the healthcare value chain at large scale and low cost. For example, patient feedback and tracking could be automated, to allow for precious human resources to be designated to higher level tasks; healthcare equipment and resources could be optimised through intelligent enterprise resource planning solutions. Innovative models like Caregiver Asia also create platforms for mobilising spare talent to meet needs of patients, and these models could be in demand given the shortage of medical professionals in the public health sector in the Philippines.

In addition, the government has put an emphasis in its eHealth Strategic Framework 2014-2020 on the enhancement of efficiency via adoption of new IT solutions. It has already engaged in initiatives, such as the aforementioned Surveillance in Post Extreme Emergencies and Disasters, and it is keen to explore other disruptive technologies that enhance efficiency and efficacy of the healthcare sector. Companies with advanced ICT solutions may find demand for cooperation on enhancing IT infrastructure.

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European Players

Siemens Healthineers

Siemens Healthineers is a medical technology company registered and headquartered in Germany. It is a subsidiary of a prominent German conglomerate, Siemens AG, the largest industrial manufacturing company in Europe. Until recently, the company was largely known as Siemens Healthcare and was renamed to Siemens Healthineers in 2016. Siemens Healthineers maintains four offices in the Philippines, namely, in Manila, Davao, Cebu Iloilo and a satellite office in San Fernandino. The company employs more than 100 Filipinos around half of which are engineers.

In September 2017, Siemens Healthineers held a meeting with representatives of the Philippine media, where it revealed its exploration in the field of digital transformation to make healthcare more affordable and accessible. The company has also introduced its Digital Ecosystem portfolio during the 16th Hospital Management Asia event in Manila, Philippines, in 2017 and it has declared its efforts to digitise the health industry in the Philippines. Its Digital Ecosystem relies on Teamplay, a cloud-based network. Teamplay makes it possible to assess the capacity utilisation of imaging devices, the various work sequences, and individual examinations in an easily accessible and understandable manner. The network also has a protocol function which makes it simple to combine, process and analyse protocols. Teamplay also has a Usage and Dose offering which helps prepare large volumes of incoming data on a single platform so that analysis can be performed very fast. Using Digital Ecosystem, hospitals can improve hospital work sequences and employee workloads. The Digital Ecosystem also brings together additional platforms, such as Personal Education Plat (PEPconnect) and LifeNet. PEPconnect provides access to training courses with around 7,000 learning activities, available in seven languages. LifeNet, meanwhile, is a web-based customer portal for managing the fleet of Siemens Healthineers systems at clinical facilities. The new Digital Ecosystem is likely to be implemented in several facilities in the Philippines either later this year, or early next year.

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Technidata

The French company Technidata is a major player in the field of software solutions for clinical laboratories and biorepositories. The company’s solutions serve organisations from the small single-discipline private laboratory to large multi-site and multi-disciplinary state-owned institutions. Developed in full compliance with the ISO 9001/ISO 13485 quality standards, Technidata software products are distributed in more than 25 countries worldwide and cover all the clinical laboratory disciplines: Biochemistry, Immunology, Virology, Microbiology, Blood Banking, Histology/Cytology, Genetics, and Biobanking. The company has over 40 years of experience in the field of laboratory management. It has established its regional headquarters for Asia-Pacific in Manila, Philippines, and it distributes its products via its partner network.

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3.5 Telehealth and Remote Health Monitoring

3.5.1 Market Overview

An archipelago of more than 7,000 islands, the Philippines has many areas with limited accessibility. As the country continues to face persistent health inequities, arising from geographical isolation and other social adversities,105 telemedicine and remote health monitoring are increasingly recognised in the Philippines as valuable tools to achieve universal healthcare for all Filipinos and improve their access to appropriate healthcare resources. Currently, the Philippines is the 96th country in the world to embark on the use of digital and remote health to overcome physical distance and the lack of clinical resources across the country.106

Although there are no specific details about the Philippine telemedicine and remote health monitoring market size, the Asia-Pacific region is estimated to have earned US$ 239.1 million in 2014, and the sector is estimated to reach US$ 421.6 million in 2019.107 The Philippines is considered one of the rising stars in the initiation of telemedicine in the South East Asian region. With increasing government spending on healthcare, digitalisation of health infrastructure and focus on providing healthcare to remote communities, the country is bound to open up various opportunities for European companies.

The majority of remote healthcare and monitoring applications in the Philippines currently utilise mobile technologies (text messaging, telephone calls, smartphone interfacing, etc.) given the low penetration of computer access. As of 2010, only 13 out of 100 Filipino households had computer access (vs. 65/100 for Malaysia).108 On the other hand, the Philippines has around 116.8 million mobile subscribers with a penetration rate of 116%. The penetration is forecasted to reach 119.8% by 2020. Broadband for wireless subscriptions also accounts for 80% of all subscriptions,

105 http://www.gmanetwork.com/news/scitech/content/92466/texting-voip-help-enhance-rp-s-healthcare-system/story/ 106 http://newsbytes.ph/2014/11/27/marinduque-is-first-lgu-in-ph-to-launch-interactive-telemedicine-system/ 107 www.asiabiznews.net 108 https://www.slideshare.net/denseymour/electronic-medical-records-emr-in-the-philippines

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and smartphone ownership is increasing rapidly (current smartphone penetration is estimated at around 40%).109 As a result, stakeholders involved in the remote health sector primarily seek, and utilise, solutions that have the capacities to reach remote populations via existing, and most prevalent, channels.

In the Philippines, the telehealth and remote health monitoring initiatives are primarily driven by the National Telehealth Centre (NTHC). The centre partners with various government and non- government institutions in the areas of eMedicine, eRecords, eSurveillance, eLearning and eHealth to drive the remote health monitoring and telemedicine sectors forward. Established in 1998, as a means for the University of the Philippines-Manila (UP-Manila) to reach out across the 7,000 islands and find new ways of supporting health professionals and communities beyond the conventional physical face-to-face activities, the centre has pioneered remote healthcare and monitoring applications in the Philippines via several initiatives.110

Figure 27: National Telehealth System Programme Source: National Telehealth Centre

Firstly, the NTHC pioneered telehealth in the Philippines in 2004 via its National Telehealth Service Programme, which connects patients in remote rural areas with clinical specialists in their

109 https://www.export.gov/article?id=Philippines-Information-and-Communications-Technology 110 http://www.opengovasia.com/articles/7423-exclusive---pioneering-ict-based-healthcare-solutions-at-the-national-telehealth-center-philippines

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region, or to the Philippine General Hospital through information and communications technologies. Under the National Telehealth Service Programme, physicians in remote and rural areas are able to send SMS or e-mail teleconsults to specialists in tertiary hospitals and receive additional expert support.

The centre’s initial set-up was slow to take off as the system was deemed too complex, requiring constant tech support. However, this has changed after doctors shifted to SMS referrals that made use of simpler technology with less need for tech support. The centre’s telehealth system has been increasingly growing since then as more doctors have been shifting towards text messaging referrals. Its community-based approach in delivering eHealth solutions has gathered momentum in recent years as the lack of doctors, nurses and other health workers in underserved areas has become more severe. As of December 2014, the National Telehealth Service Programme has conducted over 2,640 teleconsultations.

Figure 28: Number of teleconsultations done by National Telehealth System Programme, 2014 Source: National Telehealth Centre

According to the National Telehealth Centre, the National Telehealth Service Programme has already expanded to three telehealth centres and has identified 416 telemedicine sites across the Philippines for provision of telehealth activities. Telemedicine consultation for health centres in the Cordillera Administrative Region (CAR) are conducted by specialists from the Baguio General Hospital and Medical Centre while those in Eastern Visayas are handled by Eastern Visayas Regional Medical Centre. Meanwhile, the Philippine General Hospital is still in charge of telemedicine consultation for the rest of the country.

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Figure 29: National Telehealth Service Programmes by region as of 2015 Source: National Telehealth Centre

Related to the telemedicine aspect is also the revolutionary RxBox of the National Telehealth Centre – a Filipino-made telemedicine device designed to offer better access to life-saving healthcare services in isolated and disadvantaged communities nationwide. The RxBox is a multi- functional, locally-manufactured, medical grade telemedicine device, used by health workers to perform basic physiologic measurements. The custom-made device has ports on the side where sensors, such as blood pressure monitor, electrocardiogram, pulse oximeter, fetal heart monitor, maternal tocometer, and a temperature sensor, are attached. A touchscreen Android tablet serves as the interface, and the data is transmitted via internet, through SMS, or over TV white screen (Super Wi-Fi) spectrum technology. RxBox has been integrated with the Community Health Information Tracking System (CHITS) to offer open-source electronic medical record and enhance the remote health provision capabilities and efficacy. The RxBox aims to reduce the overall cost of healthcare by enabling health workers to diagnose, monitor and treat patients within

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the rural health facility via remote consultations and diagnosis. As of 2017, 143 official sites and 77 volunteer sites across Philippines have already received the RxBox units.111

Moving forward, the RxBox is being pitched to private companies, especially start-ups, to unburden the National Telehealth Centre from its maintenance and sustainability plans. Under the proposed business setup, the private entity would mass produce and commercialise the device, in exchange for a royalty to be paid to the university.

Figure 30: RxBox and its components Source: National Telehealth Centre

Another telemedical innovation initiated by the National Telehealth Centre is the CHITS – an electronic medical record system to improve tracking and patient care, and faculty level health information management system at the primary Rural Health Unit level. Originally, an SMS-based child injury surveillance program, CHITS has since evolved to include other clinical modules. It has been recently re-launched as an mHealth solution, and as a suite of health apps (web- based CHITS, mobile reporting tool for fieldwork and local government unit dashboard).

111 https://rxbox.chits.ph/what_is_rxbox/rxbox-sites/

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Recognised for its efficacy, the system has been already adopted by over 200 rural health units. It has also won two international and five Philippine national awards in the last decade.112

Both telehealth and CHITS have also paved way for another iteration of CHITS, called Real-time CHITS. The National Telehealth Centre linked CHITS and mobile phones to release real-time community health information tracking system, as part of the UNICEF-funded project, which was implemented in a few towns in Mindanao, southern Philippines. The Real-Time CHITS includes additional modules in pre-natal care, post-partum care, new-born screening and immunisation. Public health workers, such as midwives, were trained in using cell phones and computers to document and report health data. The National Telehealth Centre linked them to a single database and allowed real-time monitoring of maternal and child health indicators, displaying the data in a local government health dashboard.

Apart from these projects, several other agencies have been pushing remote health provision and monitoring in the Philippines via following initiatives:

 Mag-Ina (Mother & Child) Telereferral System has been implemented in Quezon City and has seen encouraging results for better maternal and healthcare. The system drew relevant maternal data from the CHITS Electronic Medical Records, alerted the hospitals of the referral of a high-risk pregnant mother, and notified the primary care clinic where the patient originated of the outcomes of the care received.113

 Three years ago, the Department of Health, together with Novartis Healthcare and Metahelix, have also developed the Leprosy Alert and Response Network System (LEARNS), the country’s first mobile phone-based leprosy referral system. LEARNS enables health workers in rural areas to refer possible leprosy patients to specialists in urban health facilities by simply sending a picture of the skin lesion and patient details through their mobile phone.

112 http://www.opengovasia.com/articles/7423-exclusive---pioneering-ict-based-healthcare-solutions-at-the-national-telehealth-center-philippines (2017) 113 http://www.opengovasia.com/articles/7423-exclusive---pioneering-ict-based-healthcare-solutions-at-the-national-telehealth-center-philippines (2017)

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 The Philippine government has also tapped the private sector in further developing its eHealth projects. Together with Qualcomm Wireless Reach, the government released its project Wireless Access for Health (WAH), which leverages the high penetration of mobile devices in the Philippines, low-cost tablets and smartphones, and open-source platform in order to improve healthcare by reducing the time required for reporting and improving access to accurate and relevant patient information for clinicians and government decision makers. The project has expanded the CHITS Electronic Medical Records platform to be compatible with the Philippine Field Health Service Information System. It now allows health workers to track patient data, generate reports, and record outbreaks. According to the latest available data on WAH, the platform has been adopted so far by 153 clinics in 116 cities and municipalities and served more than 8,460 patients per day.114 It has also trained 3,066 clinicians, conducted over 6,561,270 patient consultations since its establishment and recorded 1,832,073 patient records.

 In 2014, the island of Marinduque has also become the first local government unit to launch an interactive telemedicine system in the country.115 The launch of the telemedicine system was initiated at the newly inaugurated Dr. Damian J. Reyes Provincial Hospital in Boac and the project was conducted under the Private-Public Partnership with SMC Sky Medical Group, where the Department of Health provided PHP 10 million (EUR 198,520) for the installation of the satellite equipment. If successful, the implementation of the telemedicine system is expected to be replicated in other parts of the country. Initially, three hospitals have been linked to each other through the telemedicine system, which are the St. Cruz District Hospital, Torijos Municipal Hospital and Dr. Damian Reyes Provincial Hospital. The Marinduque local government unit is now aiming to become a telehealth centre of the Philippines.116

114 https://wah.ph/?page_id=134 115 http://newsbytes.ph/2014/11/27/marinduque-is-first-lgu-in-ph-to-launch-interactive-telemedicine-system/ 116 http://business.inquirer.net/210155/ph-healthcare-industry-set-for-growth

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Figure 31: Dr. Damian Reyes Provincial Hospital Source: ugnayan.com

 In 2016, the Philippine healthcare facilities have additionally shifted gears to telemedicine through PREGINET, the Philippine Research, Education and Government Information Network. The new system allows doctors and medical practitioners to diagnose and examine patients in far-flung communities via telemedicine, which runs through PREGINET, managed by the Advanced Science and Technology Institute.117 The telemedicine solution utilises videoconferencing facilities, high-definition cameras and computers to remotely consult with doctors or diagnose patients.

As a result of PREGINET efforts to accelerate the adoption of telemedicine in the Philippines, the first Philippine Telemedicine Network Symposium was also conducted in July 2016. The event aimed at developing a national medical network community through telemedicine. The symposium was attended by doctors, nurses and IT engineers from several hospitals, which have already started, or are planning to start, implementing telehealth solutions, including St. Luke’s Medical Centre, Philippine General Hospital, National Kidney and Transplant Institute, Baguio General Hospital, University of Cebu Medical Centre, Davao Doctors Hospital, Aborian Medical Centre, and the Veterans Memorial Medical Centre.118 PREGINET is currently the only research and education network in the Philippines with links

117 http://pregi.net/uncategorized/ph-healthcare-facilities-shift-gears-to-telemedicine-through-preginet/ 118 http://pregi.net/uncategorized/ph-healthcare-facilities-shift-gears-to-telemedicine-through-preginet/

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to international research and education networks, such as the Trans-Eurasia Information Network and Asia –Pacific Advanced Network.

 In May 2017, the Department of Health together with the local government of the Province of Marinduque has further signed a Memorandum of Agreement with two government medical centres, namely, the Batangas Medical Centre and the East Avenue Medical Centre, to provide expanded healthcare delivery systems through telemedicine.

In addition to the government and public-sector initiatives, the private sector has been active in capitalising on the growing interest in telemedicine and remote health monitoring. Several companies have already entered the Philippine market with products ranging from referral solutions to full medical consultations via multiple information and communications channels, including mobile, telephone and internet-based solutions. These entries are further pointing to the growing international interest in the Philippine telehealth and remote health monitoring market. Some of the recent entries include:

 KonsultaMD, which is a health hotline service composed of licensed Filipino doctors who provide 24/7 immediate medical information and advisory. Developed by Globe Telehealth, the service provides telephone triage; lab and diagnostic results; health coaching and nutrition counceling; permissible medication; and information on primary conditions like cough, fever, urinary tract infections, allergies, maternity, and pediatrics. Globe has also released Globe HealthCloud, an end-to-end web-based health ICT solution that provides real-time, secure, and expedient access to health information. In addition, it has tapped the services of international think-tank, ACCESS Health Interational, and Philippine National AIDS Council to enable fast and efficient access to maternal and child care services, as well as to create mobile campaigns on HIV counceling, testing, and life-saving treatments.

 Medifi has also entered the Philippine market via its app that allows consultation between doctors and patients through a variety of activities, such as video conferencing, chat messaging, medical imaging, and medical profiling.

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 Telegria Project, which was borne out of the partnership between the Asian Institute of Management – Dr. Stephen Zuellig Centre for Asian Business Transformation and ACCESS Health International, is another telemedicine project that focuses on the elderly population, dubbed as “telegeriatrics”, with the ICT platform provided by ClickMedix. Its features include electronic medical records, medical imaging, and referral to health specialists. Its pilot imlementation was in Quezon City and Las Piñas City in Metro Manila.

 SynapseHealth Solutions, Inc. has further entered the Philippine market via its mobile telehealth and information resource system for community health workers and health, emergency, and disaster information using mobile technology.

 Moreover, ACCESS Health International, an international think tank and consulting group, has launched the mHealth project e-AKAP that aims to improve maternal and child care in the country through training of community health workers via a mobile application and tablet. It was piloted in 2014 on some 100 health workers covering 6,000 households in Caloocan City.

 ePharmacy is also closely associated to telehealth and MedGrocer is one of the organisations that ventured into this field. It is funded by Ayala Healthcare Holdings, Inc. to use online technology in the delivery of drugs to various communities at lower prices.

With the growth of tech savvy population and the increasing pressures on the healthcare sector, more companies are showing interest to cater to the Philippine market demand for telehealth and remote health solutions.

The market of telemedicine and remote health monitoring does not have formalisation as a modality of care in the Philippines yet. However, several bills have been proposed over the years, and the latest bill aiming to establish telehealth centres in every hospital across the country is currently pending at the committee level in the 17th Congress.119 Should the bill be passed into the law, it will provide additional stimulus for the telehealth market growth.

119 For example, in 2012, Congressman Joseph E. Abaya filed a bill to push for the “Telehealth Act of 2012” (also known as House Bill 6336), which would regulate telehealth in the Philippines and set standards for its safe and ethical practice. The bill is still under review on the Congress floor. It has been around four years since the filing of the bill, however, no immediate action has been done to facilitate its passage into law.

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Local Players

Smart Communications is a telecommunications and digital services provider in the Philippines. The company has recently entered into the eHealth market by investing in mHealth – healthcare provision supported by the use of mobile phones and tablet computers. Smart’s three main projects in mHealth are Secure Health Information Network and Exchange (SHINE), Amputee Screening via Cell Phone Networking (ASCENT) and WAH (see more details on these products in 3.4 ICT in Health – Local Players – Smart Communications).

Figure 32: ASCENT mobile and web application Source: smart.com.ph

In the telehealth and remote health monitoring sub-sector, the company has launched ASCENT. This project was launched in collaboration with Physicians for Peace Philippines (a Philippine subsidiary of the international non-profit medical training organisation). ASCENT is a mobile and web application allowing real-time evaluation and advice on prosthesis use to amputees in remote communities. Smart’s website describes that trained heath workers use ASCENT to interview and record data from amputees during medical missions, including photos of the amputee, sent via Smart mobile broadband to a website that can be accessed by volunteer doctors from Physicians for Peace Philippines.

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KonsultaMD is a venture started by the Philippine telco Globe Telecom, via its subsidiary Yondu and content provider Salud Interactiva.

Figure 33: Konsulta MD Source: ww.konsulta.md

KonsultaMD is a 24/7 telemedicine hotline manned by licensed doctors in the country. It provides medical assessment and advice to members, including basic healthcare and medication over the phone. The service works through subscriptions: prepaid or contract mobile account holders can pay a minimal monthly fee, which covers up to four additional family members. Members can text or call about their medical concerns, and licensed practitioners will provide advice to either diagnose or refer the patient to a practitioner or specialist when necessary.

Lifetrack Medical Systems is a Philippine enterprise, which aims to address the shortage of radiologists in the country by providing tele-radiology services in order to enable access to X-ray facilities remotely. Funded by Kickstarter in late 2015, along with other institutional investors, Lifetrack’s cloud-based platform matches hospital residents with experienced radiologists, who help evaluate medical images and provide reports. Being a cloud-based solution, the radiology professionals can be located anywhere in the country or the world. Beyond crowdsourcing radiology to capable professionals, the solution also enables local radiologists to further their careers by providing access to scans from abroad, thus helping improve their skills.

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Figure 34: Lifetrack Medical Systems Source: lifetrackmed.com

Medifi is a cloud-based web app that allows remote doctor and patient consultation through its set of telehealth features, which include video conferencing, chat messaging, a personal medical profile and journal, and medical image management that enable patients to consult with doctors from the comfort of home.

Figure 35: Medifi landing page Source: medifi.com

Doctors who have used Medifi see it as a good way to vet patients and shorten long lines at the waiting room, particularly those that do not require on-site examination.120 The medical fields where Medifi aims to play a major role are those where physical examination is not required, including psychiatric care departments of major hospitals in Manila. Currently on public beta mode, Medifi is run by a team of eight people. The Manila-based start-up is currently self-funded at US$ 500,000 and has started raising funds for marketing efforts in 2015. Medifi currently has 10 doctors from both the Philippines and the U.S. using its service.

120 https://sg.news.yahoo.com/philippines-medifi-enables-telehealth-consultation-doctors-patients-103000736.html

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3.5.2 EU Entry Opportunities

Telehealth and Remote Health Monitoring have the potential to revolutionise the way that healthcare is provided in the Philippines. As the burden of disease, primarily non-communicable disease, continues to grow and the population ages, the cost of healthcare is expected to rise further. Solutions that reduce healthcare costs are expected to grow in demand in the Philippines. The Government of the Philippines has also committed itself to provide 100% healthcare coverage to Filipinos. However, its limited budget is pushing the government to seek alternative solutions to physical healthcare provision. Given the relative concentration of medical practitioners in urban areas, the government is increasingly leaning towards solutions that help outsource medical processes between rural and urban locations and improve the efficacy, accuracy and efficiency of healthcare provision. As a result, there are growing opportunities for European companies to enter the Philippine healthcare market via remote health solutions. Some of the viable entry points lie in:

 Mobile health solutions

 Telehealth services

 Segmentation to address market gaps

 Test-bedding

 Wearables

Mobile Solutions

An exciting development in the country is the rapidly maturing wireless cellular network with value- added services. The Philippines is the texting capital of the world and is home to more than 300 million daily messages. It is also a large laboratory for SMS and wireless internet-based applications. With a wide mobile penetration rate, mobile telehealth solutions are a protocol waiting for a health informatics and telemedicine application. With the recent proliferation of health apps in the domestic market, mobile solutions are proving to be the preferable medium for healthcare provision for many Filipinos. As a result, primary care and specialist referral services,

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remote patient monitoring and patient medical health information access via mobile channels are some of the solutions that may offer lucrative opportunities for European companies.

Telehealth Services

With a population of 101 million, persistent healthcare accessibility issues and a growing number of Filipinos having access to ICT technologies, there is a growing demand for telehealth services. While some domestic and international companies have already entered the market, the telehealth segment is nowhere close to reaching market saturation. The European healthcare system, defined by quality and efficiency, is well situated to complement the Philippine healthcare market via outsourced telemedicine solutions. European companies may find good opportunities to enter this growing market. General medical teleconsultation and teleradiology are among the fields in demand.

Segmentation to Address Market Gaps

From an undifferentiated and fragmented provider market, startups are attempting to innovate on business models to address the needs and price points of specific market segments. For example, KonsultaMD offers 24/7 phone access to doctor consultations for just US$ 1.2 per month. It delivers brief and affordable doctor consultations to the mass market that aren’t worth consumers spending half a day in traffic and the waiting room. KonsultaMD’s membership grew 10x from 10,000 subscribers after its August 2015 launch to 100,000 subscribers by the end of 2016. Another player, Medifi, addresses a similar pain point, but targeting a more affluent market through video consultations and value-added services.

Test-bedding

In the Philippines, personal health management is an emerging area that is steadily acquiring popularity among the urban population, in which individuals take care of their own health via the use of web and mobile applications. The applications enable individuals to have access to their own health records and relevant data, as well as facilitate their health promotion activities and wellness. This creates opportunities for healthcare ICT players to leverage on this shift, making

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the Philippines a suitable testbed and launch-pad to reach the greater South East Asian region. Technologies that enable remote consultation and diagnosis are already being test-bedded locally via research institutions and government-led initiatives. Vendors, healthcare providers, and governments are working through public-private partnerships to pilot various technologies like telemedicine, home monitoring, patient engagement solutions, and disease management platforms to generate evidence of their impact on the health system.

Wearables

Wearables are starting to penetrate the Philippines consumer market as well, capturing and tracking how people live and manage their condition. Consumers and providers integrate information from multiple devices seamlessly to create a comprehensive view of the individuals and their health conditions. Wearables are now becoming popular beyond fitness consumer groups as specialist medical (bio-sensing) wearables are becoming more affordable.

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European Players

Mediaxes A/S

Denmark-based Mediaxes A/S was established in 2006 as a medical consultancy company with a core idea to provide fast and accurate medical advice over the internet to private individuals, employees, clients of municipalities and insurance companies. Until now, its medical group has handled more than 30,000 medical visitations and claims for health insurance customers with Topdanmark, Skadia and Doctorservice/Alpha Group Insurance.

Figure 36: MyPocketDoctor App Visualisation Source: www.mypocketdoctor.com

The company has entered the Philippine telemedicine market in May 2016 with the introduction of the MyPocketDoctor mobile app, which offers 24/7 medical consultation services to Filipinos. The app aims to solve long hospital queues that many Filipinos experience when going to the doctor. Touted as the first telemedicine app in the country, MyPocketDoctor can be downloaded through the Apple App Store or Google Play. User can also request for a consultation by sending a mobile text message. Prepaid cards are used to pay for the medical consultation, which costs PHP 450 (EUR 7).

According to Dr. Nicky Montoya, president of MediCard Philippines, a leading healthcare maintenance organisation provider, the app is being considered a game changer, especially to a

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country like the Philippines where the concept of getting medical advice via a mobile phone is new.121 Mediaxes announced that it has chosen to establish a telemedicine hub in the Philippines due to availability of high quality nurses and doctors in the country, high level of education and mobile literacy, and the strategic location of the Philippines for expansion to the wider ASEAN region.122

Novartis AG

Novartis AG is a multinational pharmaceutical corporation, the world’s second largest pharmaceutical company with the second largest market share in Europe, and a manufacturer of pharmaceutical products. The company operates in 140 countries with headquarters in Basel, Switzerland.

In January 2014, the company has cooperated with the Department of Health and the local information technology company Metahelix to launch the first mobile phone-based leprosy referral system, the Leprosy Alert and Response Network System (LEARNS). The mobile-based system is intended to help fight pockets of leprosy cases in some municipalities (particularly in Regions I, VII and XII) in the post-elimination phase. Aside from case finding, LEARNS also provides disease surveillance, adverse reaction reporting, treatment outcome reporting, message broadcasting, patient education, and report generation capabilities. The system is currently being piloted in Iloilo province, with the local government providing funding for health personnel training and public awareness advocacy. The Iloilo government expects to expand the LEARNS coverage to 18 more municipalities. The funding for LEARNS development was provided by the Novartis Foundation and the Philippine Centre for Health Research and Development, an attached agency of the Department of Science and Technology (DOST). In August 2017, Novartis has also partnered with the Philippine Heart Association to provide its members with free online access to Continuing Medical Education on Heart Failure management.

121 https://www.medicardphils.com/the-doctor-is-always-in-with-medicards-my-pocket-doctor/ 122 http://www.bworldonline.com/content.php?section=Corporate&title=new-app-hopes-to-be-&145uber-of-medicine&8217&id=128740

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Figure 37: Components of LEARNS Source: DOH-Novartis Leprosy Task Force 2014

SES S.A.

SES S.A. is a communications satellite owner and operator, based in Luxembourg. SES operates more than 50 active and occasional use geostationary communications satellites. Via its subsidiary, SES TechCom Services, it has developed Satmed, a satellite-based eHealth communications platform used in particular for provision of eHealth to remote, resource-poor areas of emerging and developing countries. The company aims to provide services to non-governmental organisations that provide healthcare, education or health management services; government organisations, which support regional development programmes and humanitarian organisations; and institutions, such as medical universities, hospitals and health management institutions.

Satmed is in a pilot phase for the design and evolution of the platform, with satellite terminal equipment and the software deployed to partner organisations, including Nongovernmental Organisations (NGOs), hospitals, medical universities, and other healthcare providers that are active in Bangladesh, Benin, Eritrea, Guinea, Niger, the Philippines and Sierra Leone. For its pilot phase, Satmed is funded by the Luxembourg government.

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In the Philippines, Satmed was first implemented in 2005. In conjunction with German Doctors, the Buda Community Healthcare Centre on the island of Mindanao is the only medical point of contact for more than 200,000 people living in remote villages within 100 km of the Centre. Satmed has been deployed at the Centre as a mobile health information management system to collect and analyse patient data. The initial focus is on using Satmed to support rolling clinics. Portable devices, such as tablets, are used to collect patient data. Which is then processed, aggregated and synchronised on Satmed’s cloud platform. Satmed also provides communication with doctors and medical experts around the world via video conferencing, and training of local medical professional. In addition, Satmed’s text messaging facility allows doctors to keep tabs on large group of patients living in remote villages whose main form of contact with the outside world is via mobile phones.

Medgate

Founded in 1999, the Swiss company Medgate is Europe’s largest telemedicine centre operated by physicians. The company is the leading provider of telemedical services in Switzerland, having up to 5,000 patient contacts per day. Medgate has conducted around 6.6 million teleconsultations since the Medgate Telemedicine Centre opened its doors in 2000.

Early in 2016, Medgate started its operations in the Philippines. The Philippines is already the third country outside Switzerland where the successful telemedicine concept of Medgate takes root, after the opening of the Abu Dhabi Telemedicine Centre in the UAE in 2014 and the Telemedicine Centre ReadyCare in Australia in 2015. At Medgate Philippines, 25 doctors and 8 telemedical assistants provide advice and diagnosis around the clock, 365 days a year, for patients with acute and general medical questions. Patients are treated according to the high- quality guidelines as developed and implemented by Medgate Switzerland. Doctors can also provide their patients with medication prescriptions and a certificate of inability to work, if necessary. The Medgate concept has established itself over the last 16 years in Switzerland and it is attracting a lot of attention abroad. A further expansion is therefore planned and negotiations for further countries are already underway.

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3.6 Nanomedicine

3.6.1 Market Overview

Figure 38: Visualisation for nanobots used in nanomedicine Source: World Science Festival 2014

The global nanomedicine and nanotechnology healthcare market is expected to be worth US$ 528 billion by 2019, thus, presenting various opportunities for healthcare providers, medical technology suppliers, manufacturers and research institutions worldwide. Presently, opportunities in the nanotechnology market in the Philippines are mainly related to research and development R&D. The country is increasingly interested to explore potential applications of nanotechnology, including those in the medical and healthcare sectors, thus providing first-mover advantages for interested companies.

Although still at its early stages, the Philippine nanotechnology infrastructure is steadily growing, and the country has acquired some of the nanotechnology equipment for utilisation in R&D activities. Between 1994 and 1999, some of the research universities have become the beneficiaries of the US$ 20 million (EUR 16.16 million) Department of Science and Technology (DOST) project called the Engineering and Science Education Programme, which was funded by the World Bank. The project has upgraded the R&D facilities of several Philippine universities with state-of-the-art technologies and equipment and benefited them with some nanotechnology

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facilities. Additional acquisitions are also expected under the Philippine 10-Year Strategy/ Road Map to create a viable nanotechnology industry:

Figure 39: Current nanotechnology facilities and equipment in the Philippines Source: Industrial technology Development Institute

Currently, research on nanotechnology applications is concentrated in government R&D institutes and in seven top universities. The main areas of research in terms of number of projects are in biology and chemistry.

Until the release of the new government roadmap for nanotechnology industry in 2011, the Engineering and Science Education Programme funding grantees have engaged in nanotechnology-related research primarily in the following fields:

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Area Institution123 Funding Source

Quantum dots or nanoparticle research AdMU, UPD PCASTRD Molecular-imprinted polymers for AdMU, UPD, UPLB, UST PCASTRD, NSRI, UST, CHED-COE separations and sensor devices Thin film electrochemical and optical AdMU, DLSU, UPD, UST, UPLB PCASTRD, NSRI, UST, CHED-COE sensors Dendrimers, organic synthesis DLSU DLSU Nanostructured systems: ultrathin films, monolayers, membranes and vesicles, AdMU, UPD, UST, UPLB (Biotech) PCASTRD, NRCP, DOST, CHED-COE etc. Molecular modelling AdMU, MSU-IIT, UPLB PCASTRD, CHED-COE General areas of materials research MIRDC, ITDI, SCRDC DOST Table 17: Research of Engineering and Science Education Programme grantee universities in nanotechnology-related areas before 2011 Source: Enriquez, E. P. (2001). Nanotechnology: Dream or Reality for the Philippines

The Philippine government has recognised the potential of nanotechnology to advance its research capabilities and address many of the persistent challenges in the country. In 2011, it launched a 10-Year Strategy/ Road Map to create a viable nanotechnology industry. The new strategy focuses on six industrial sectors, including the semiconductor, information technology, energy, agriculture, environmental protection and medical industries.

Under the road map, the Department of Science and Technology is intending to spend up to PHP 2.5 billion (EUR 41.4 million) until 2021 on nanotechnology research, with an initial PHP 60 million (EUR 997,000) being allocated for the first batch of projects. The amount is expected to increase in the coming years as more projects are evaluated and approved. Up to date, agricultural projects have received the highest number of funding for nano-research, but the government is seeking to balance the funding for projects in other research areas, such as medical research on nanotechnologies.

123 AdMU: Ateneo de Manila University, DLSU: De La Salle University, ITDI: Industrial Technology Development Institute (DOST), MSU-IIT : Mindanao State University-Iligan Institute of technology, MIRDC: Metals Industry Research and Development Centre (DOST), SCRDC: Surfaces and Coatings Research and Development Centre, UPD: University of the Philippines-Diliman, UPLB: University of Philippines- Los Baños, UST: University of Santo Tomas, NSRI: Natural Science Research Institute, NRCP: National Research Council of the Philippines, CHED-COE: Commission on Higher Education-Centre of Excellence Programme.

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Under the road map, the field of nanotechnology in healthcare is increasingly recognised as a strategic research area, which is believed to have significant benefits for development of medicines, improvement of capabilities of early detection and prevention, efficacy of diagnostics, treatment solutions and follow-ups on diseases. According to the Nanotechnology Road Map, the plans to accelerate nanomedical research and development include:

 In the next 3 to 10 years, research is expected to focus on ex-vivo and in vitro diagnostic and imaging protocols for early and sensitive detection of tuberculosis, malaria, cancer and cardiovascular diseases using nanostructures and lab-on-chips, and ethnobiology that harvests and investigates natural nanostructures from endemic flora, fauna, and non-living sources for drug properties, bioactive pigments, biomarkers and structural colour.

 In 5 years, the programme is expected to be geared towards miniaturisation and deployment of optical and chemical diagnostic kits into field extension of diagnostic research to other priority areas, such as filariasis, schistosomiasis, leprosy, sexually transmitted diseases, and re-emerging infections, as well as towards the development of efficient drug delivery systems from the library of medications covered by the Cheaper Medicine Bill.

 Top research efforts in the next 10 years are expected to cover the development of bioactive nanostructures (targeted drugs) from ethnobiology, the deployment of diagnostic kits to other priority areas, and the whole-animal multimode imaging and clinical stages of developed nanodrugs from ethnobiology.124

The Road Map also aims to introduce nanotechnology in all science and engineering courses, pave the way for acquisitions of basic equipment to illustrate nanostructures, and upgrading of laboratories for nanoparticle measurements and nanotechnology risk assessment.

Projects, which are evaluated under the new nanotechnology strategy, must have direct benefit to the Philippines. Current healthcare and medical projects under evaluation include the areas of in vitro diagnostics.

124 http://dost.gov.ph/index.php/knowledge-resources/news/38-2009-news/366-dost-outlines-nanotechnology-roadmap

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Although there are no domestic commercialised applications of nanotechnology in the medical and healthcare fields yet, the Philippines is exploring such potential via its R&D activities. For example, the PVA-chitosan nanofibrous membrane for drug delivery is being explored at the University of Santo Tomas, the adoption of nanotubes for cancer diagnosis and detection is researched at the University of the Philippines Diliman and the research on nanofibrous membrane for tissue engineering is taking place at the Industrial Technology Development Institute.

In early 2016, the National Tuberculosis Reference Laboratory of the Research Institute for Tropical Medicine has also collaborated with the National Institute of Molecular Biology and Biotechnology of the University of Philippines Los Baños, the Alocija Nano-Biosensors Lab of the Michigan State University, and the Provincial Government of Bohol to conduct a workshop on the applications of nanotechnology in tuberculosis detection. The workshop has become the key driver for the establishment of the very first development centre for medical nanotechnology in the Philippines in July 2017.125

The Philippines currently has no specific regulation on nanotechnology, but the Road Map for Nanotechnology Industry serves as the general policy guideline at the national level.

Local Players

There are currently no commercial entities engaged in the nanomedicine market in the Philippines. The field remains at the research and development stages, primarily focused on expanding awareness of the utilisation of nanotechnologies in the medical fields. There are several research institutions, which have started conducting pilot research projects. These research centres remain the key domestic players in the field of nanomedicine:

The Centre for Nanotechnology Application in Agriculture, Forestry and Industry is a nanotechnology facility, located at the University of the Philippines Los Baños. The facility

125 https://uplb.edu.ph/component/k2/807-uplb-launches-nanotech-facility

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provides nanotechnology-based services as well as an enabling environment for interdisciplinary and collaborative R&D on nanotechnology applications in agriculture, forestry, healthcare, and other industries.

ITDI-DOST NanoLab is one of the very few public nanotechnology research laboratories in the country. Established in 2012 by the Department of Science and Technology (DOST), and located at the Industrial Technology Development Institute (ITDI), the NanoLab has opened its laboratory to the public in 2015. The laboratory offers world-class equipment and devices meant to provide nanotechnology-related technical services. The NanoLab is housed at the Department of Material Sciences of ITDI, where a high-resolution field-emission transmission electron microscope, the very first in the Philippines, is located.

3.6.2 EU Entry Opportunities

Although the opportunities in the Philippines to enter the nanomedicine market are limited, several avenues exist for European companies with the right expertise and technological solutions.

 Collaboration on Research and Development

 Upgrading of existing nanotechnology infrastructure

Collaboration on Research and Development

The Department of Science and Technology is reported to be open for partnerships with the private sector in order to increase the utilisation of nanotechnology across the Philippines. As a result, opportunities for collaboration with local research institutes exist for European companies engaged in nanotechnology research. Collaboration is most likely to be successful in those projects that are considered as beneficial for the Philippines. Key nanotechnology areas in healthcare that are thought to be of most potential benefit include nano-diagnostics (in vitro, ex vivo), nano-diagnostics (in vivo), nano-imaging and nano-probes (in vivo), cancer treatment, and biosensors.

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Figure 40: Examples of nanobot technology for artery cleaning

Given the government’s wishes to establish new cancer research centres, the collaboration on nanotechnology application for cancer treatment may be among the most direct avenues to engage the Philippine nanotechnology sector. Given the level of clogging-related illnesses among Filipinos, nanobots, which can unclog arteries and thereby prevent heart-attacks are also among the areas in demand.

Upgrading Existing Nanotechnology Infrastructure

Increasing developments in nanotechnology require newer tools and methodologies for research. Given the government’s plan to accelerate the nanotechnology research in the upcoming years, there is a major need to upgrade many of the existing facilities and provide additional advanced equipment.

Scanning probe microscopes, x-ray photoelectron spectrometers, secondary ion mass spectrometer, and electron microscopes are among the technologies in demand. As the government accelerates funding for nanotechnology research, opportunities are likely to open up for companies with nanotechnology solutions to upgrade existing facilities to international standards and provide new nanotechnologies for Philippine research facilities.

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European Players

The field of nanotechnology is very new in the Philippines and no European companies have entered the nanomedicine market yet. Even though there is a broad consensus among interested parties that the future of nanotechnology, in general, and nanomedicine, in particular, may be bright for the Philippines, investors are still deterred by the initial R&D costs of developing new nanotechnologies, securing or licensing existing nanotechnology and commercialising it. The lacking domestic nano-infrastructure is still considered as a significant entry barrier for many international companies.

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3.7 Biotechnology and Life Sciences

3.7.1 Market Overview

The Biotechnology and Life Sciences Technologies market in the Philippines is growing with the proliferation of stem cell treatment, genetics and genomics facilities, increasing research and development (R&D) activities and the adoption of new, innovative products. The molecular diagnostics market, in particular, is witnessing rapid growth due to high adoption of molecular diagnostics tests for infectious diseases applications and the advent of innovative cancer and next-generation sequencing based diagnostic solutions. The field in the Philippines has huge potential as the country is starting to show widespread adoption of the technologies and the distributors are showing great enthusiasm.

Multinational companies have not only identified South East Asia as a market for future growth but have significantly invested in R&D efforts to cater to the Asian population. Genomic studies on the Asian population in disease areas like oncology for targeted therapies, infectious diseases, genetic disorders and pharmacogenomics are constantly on the rise, with active efforts from pharmaceutical and in vitro diagnostic device companies to offer innovative solutions.

Among the South East Asian countries, the Philippines has been one of the more active countries to promote adoption of biotechnologies and life science innovations for health. The rise of the private healthcare sector in the Philippines, with the improvement of socio-economic conditions and the growth of a wealthy middle class, together with the expansion of ageing population and the geriatrics services, have also triggered the quest for affordable and quality healthcare across the region. The next five years are expected to witness significant developments in reagent systems and automation, as well as the introduction of a wide range of new products. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of cost-effective and automated systems with amplification methods.

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There are several key market drivers for this market segment:

 The rise in Out-of-pocket payments and demand for quality healthcare are increasing the public healthcare spending while the growing public awareness about preventive health is driving the increases in test volume in healthcare settings;

 High incidence of communicable and non-communicable diseases is increasing the opportunity for diagnostic tests, and, thus, improvements in diagnostic facilities. In particular, increasing prevalence of infectious diseases and the upsurge in several chronic disease incidents are leading to greater demand for point of care diagnostic technologies;

 Focus on preventive healthcare, voluntary diagnositc tests, and payer initiatives to reduce long-term healthcare costs by early stage diagnostics are driving demand for innovations and personalised health diagnostics solutions;

 Growing geriatric population base along with rising incidences of infecious diseases are acting as a high impact rendering factor for molecular diagnostics field. Elderly people, prone to suffer from several diseases, require continuous monitoring as well as diagnostic tests for various diseases. Multifactorial applications of molecular diagnostics in therapeutic monitoring, detection of predisposition to disease, patient stratification, drug regimen selection and others are expected to drive the market growth further;

 Technological advancements, including target specific polimerase chain reaction with high throughput capacity, have escalated the level of disease diagnosis in less time as compared to conventional methods, and these developments will favor molecular diagnosis segment as well as biotechnology market growth in the Philippines; further public awareness about several diseases, diagnosis and prevention are also stimulating demand for diagnostic tests;

 The cancer diagnostics market is on the verge of explosion. During the next five years, the cancer diagnostics market is promising to be an exciting, dynamic and rapidly expanding field. Anticipated technological breakthroughs will create numerous opportunities for determining genetic predisposition, detecting specific tumours and monitoring biological response to cancer therapy. The rise in geriatric population will further compound the growing demand for malignancy assays and the rapid market expansion.

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Growing Domestic Biotechnology, Genetics and Genomics Infrastructure

Recognising the growing demand for biotechnology, genetics and genomics, the Philippines has taken important steps to accelerate domestic infrastructure for biotechnology and life sciences development in healthcare settings.

The Philippines’ early efforts to promote national biotechnology capability have started with the establishment of the National Institute of Molecular Biology and Biotechnology (BIOTECH) at the University of the Philippines Los Bãnos.

Figure 41: The National Institute of Molecular Biology and Biotechnology (BIOTECH)

In 1990, the Philippines has also become the first ASEAN country to initiate a biotechnology regulatory system and to establish the National Committee on Biosafety of the Philippines, which has become a model for ASEAN Member States seeking to engage in genetic engineering activities. Although the initial efforts have been predominantly focused on agricultural biotechnology crops, the country in 1995 expanded its focus by replicating the BIOTECH concept with varying specialisations in three other campuses under the University of the Philippines (UP) System, including:

 UP Diliman Campus with the focus on industrial biotechnology;

 UP Visayas with the focus on marine biotechnology; and

 UP Manila with the focus on human health.

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Further to the creation of the UP-Manila Health Biotechnology Hub, the government has in 1998 also established the National Institutes of Health under the UP Manila to carry out policy on health R&D.

Figure 42: National Institutes of Health Source: University of the Philippines Manila

The National Institutes of Health has become the coordinating and integrating body of the existing health research institutes in UP Manila, such as the Institute of Ophthalmology, the Institute of Socio-Biomedical Research, the Institute of Biotechnology and Molecular Biology for Health, the Institute of Human Genetics, and the Institute of Clinical Epidemiology. The National Institutes of Health currently remains the national health research centre with the responsibility for biomedical and public health research.

Many genetic tests and services are currently available from, and delivered by, the Institute of Human Genetics in partnership with the Department of Health and other government and private institutions. The institute currently provides cytogenetics, molecular genetics, biochemical genetics and new born screening clinical and testing services.

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Figure 43: New born Screening Centre – National Institutes of Health (NSC-NIH) Source: Institute of Human Genetics

The Molecular Genetics Unit of the Institute of Human Genetics also conducts interdisciplinary research in collaboration with both local and international academic clinicians and scientists, who study the genetics of monogenic and complex genetic conditions in the Filipino population. By using molecular genetics techniques, new diagnosis tools are applied for the conditions seen in the clinics to understand how these genes cause disease.126 The Molecular Genetics Laboratory is also currently focusing on molecular-based testing for the common genetic conditions, such as cancer, cardiovascular diseases and X-Lined Dystonia Parkinsonism as well as those genetic disorders, which are part of the new born screening programme. It is currently the largest provider of genetics services in the Philippines.

Biotechnology and life sciences infrastructure has been further strengthened with the establishment of the Philippine Genome Centre, which is conducting R&D activities on health diagnostics, therapeutics, DNA forensics and drug discovery. The establishment of the centre has also marked the beginning of genomics R&D in the Philippines.

126 http://onlinelibrary.wiley.com/doi/10.1002/mgg3.247/full

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Figure 44: Inauguration of the Philippine Genome Centre (PGC) Source: Department of Science and Technology

Today, the centre has two core facilities – the DNA Sequencing Core Facility and the Bioinformatics Core Facility, both of which were opened with the PHP 100 million (EUR 1.57 million) grant from the Philippine Council for Industry, Energy and Emerging Technology Research and Development.

Figure 45: The Bioinformatics Core Facility of the Philippine Genome Centre Source: PhilStar Global

As the Philippine Genome Centre is investing heavily in the next-generation sequencing equipment, capable of high throughput sequencing and genotyping, the current DNA Sequencing Core Facility has the capacity to offer a full range of DNA sequencing, including the for identifying single nucleotide polymorphisms, somatic mutations, copy number and structural variations, as well as targeted re-sequencing and exome sequencing for selected

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regions. Since 2012, the centre has served more than 100 clients from different sectors. The first two grants received by the centre were for dengue diagnostic testing and Influenza A virus subtype (H1N1) surveillance.

The Philippine Genome Centre’s Health Programme’s main objective is to apply genomics for the promotion of Filipino health and the prevention and management of public health problems. Its current research projects focus on the development of diagnostic kits for early diagnosis of infectious diseases, such as dengue, tuberculosis, chikungunya, leptospirosis, malaria, schistosomiasis and salmonella, and non-communicable diseases, including diabetes, cardiovascular diseases and colorectal cancer. In addition, it aims to develop the genome web library for H1N1 for early diagnosis for disease outbreaks. The centre’s research also covers in- depth the study of specific genes sequencing assays for diseases. Several study groups have been created for specific diseases with genetics and genomics as the focus area. Collaborations among geneticists, endocrinologists, cardiologists, haematologists, neurologists and otorhinolaryngologists from different institutions and research centres are ongoing, which aim to utilise biotechnology for disease prevention and management.127

One of the results of domestic collaboration in genome R&D between the UP-Manila National Institutes of Health, Philippine Genome Centre and the Department of Science and Technology, is the locally produced Biotek-M, a confirmatory test for dengue diagnosis, which is as accurate as the currently available Polymerase Chain Reaction technology, yet less costly. The kit saves resources for both hospital and patients as it allows less administration for suspected dengue cases.128

127 http://onlinelibrary.wiley.com/doi/10.1002/mgg3.247/full 128 http://www.healthresearch.ph/index.php/component/content/article/32-shared-stories/349-philippine-gov-t-supports-5-health-technologies-for- nationwide-rollout?Itemid=101

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Figure 46: Biotek-M Dengue Kit Source: https://biotekmaqua.wordpress.com/about/

Further to the establishment of Philippine Genome Centre, the Philippine Biomedical Device Innovation Consortium was also formed in 2015. The Consortium is tasked with exploring the market for potential of the Philippine-based biomedical device industry and developing Philippine capacities to develop biomedical devices.129 The consortium now aims to consolidate, design and implement activities that will support the biomedical device innovation ecosystem.130 Some of the deliverables include monitoring the inventory of available technologies, identification of gaps in biomedical device innovation and generation of a lab to market roadmap for the Hospital Equipment and Biomedical Devices priority area under the National Unified Health Research Agenda.

Private Sector Initiatives in Biotechnology, Genetics and Genomics

The private sector, including both healthcare actors and the private companies, has been particularly active in introducing new products as well as testing services to the Philippine market.

For example, in 1995 St. Luke’s Medical Centre (SLMC) established the Research and Biotechnology Group, which aims to utilise biotechnology for disease treatment.

129 https://www.pressreader.com/philippines/manila-bulletin/20150324/282076275360944 130 http://www.pchrd.dost.gov.ph/index.php/news/4379-pbdic-to-pave-the-way-in-developing-biomed-devices-and-products-in-rp

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Figure 47: St. Luke’s Medical Centre (SLMC)

Via its Research and Biotechnology Group, the SLMC remains the highest ranking medical centre for research productivity and currently holds the record for having the highest number of clinical trials in the Philippines (246 clinical trials), with 29 international and 15 local linkages, partnerships and collaborations.

The SLMC’s present capabilities include the centre for clinical trials, contract research services, biobanking, biomedical engineering research centre, electron microscopy and virology sequencing techniques, molecular cytogenetics and genomics, tissue and cell biology, drug discovery and molecular assay development.131 The Research and Biotechnology Group has also been the first in the Philippines to develop a serologic detection test for dengue.132 In addition, the following molecular tests and technologies under testing stages are available at SLMC:

St. Luke’s Medical Centre’s R&D Categories

Molecular tests available at SLMC Dengue serological detections assay Chikungunya virus detection BRAFv600e molecular test for determining aggressiveness of thyroid cancer Test for leukaemia: cytogenetics and fluorescence hybridisation (FISH) Test for Alzheimer’s dementia APO E Genotyping text

Identification of unknown microbial infections by DNA sequencing

131 https://www.stlukes.com.ph/about-us/researchbiotechnology 132 https://www.stlukes.com.ph/about-us/researchbiotechnology

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St. Luke’s Medical Centre’s R&D Categories

Tests undergoing further testing Molecular biomarker for colon cancer, through Microsatellite Instability (MSI) testing and optimisation Genetic testing for Chronic Myelogenous Leukaemia (CML) Analytic chemistry technique for gene expression imaging in PET Scan Tapid point-of-care strip test for detection of dengue infections Detection test for Zika and other mosquito-borne viruses Cancer: colon, stomach, liver, nasopharyngeal carcinoma, Non-Hodgkin’s Current areas of research Lymphoma Digestive diseases: liver disease, H.pyroli infection Infectious diseases: Dengue, Hepatitis, Japanese Encephalitis, Chikungunya,

Rotavirus, and Influenza viruses Antimicrobial resistance Hematologic (blood) disorders: leukaemia and thalassemia Neurologic disorders: stroke and dementia Stem cell research: ocular surfaces diseases Metabolic disorders: diabetes mellitus Cardiovascular diseases: Oschemic Health Disease (OHD) Pulmonary disorders Drug discovery from natural products Table 18: Key R&D areas Source: St Luke’s Medical Centre

The private sector has also witnessed the establishment of the privately-owned Genomics Institute of Asia, which is the first institution in Asia to conduct next generation genomic sequencing.133 In the past, the institute has successfully conducted full genome sequencing of different rice varieties for the International Rice Research Institute and the Philippine Rice Institute. In 2013, the institute launched the first domestic testing of breast cancer mutations, BRCA1 and BRCA2, prevalent among Filipino women.

In order to successfully capitalise on the opportunities presented by the biotechnology and life science technologies in the Philippines, many foreign companies are already exploiting new

133 http://business.inquirer.net/222326/philab-poised-breakthroughs

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molecular technologies as strategies for entering the market. To illustrate the dynamic opportunities in the country, some of the recent market developments are provided below:

 In December 2017, Eone-Diagnomics Genome Centre signed an agreement with cord blood service provider Cordlife to offer its Gen Screen non-invasive prenatal test in the Philippines and Indonesia through Cordlife’s existing sales network. This genome centre said it anticipates expanding this relationship later to include additional Asian countries and its other products, such as the direct-to-consumer genetic test Gene2me and the ophthalmology genetic test Myeyegene. Earlier in 2017, the centre partnered with Chinese genetic analysis company GPBio to develop and expand consumer and clinical genomic services in Asian markets.134

 In addition, Streck company has signed a distribution agreement in July 2017 for its cell stabilisation, molecular, and core products with the Philippines-based life sciences product distribution firm Golden Bat Far East. Cell stabilisation products covered in the deal include Streck’s Cyto-Chex BCT, a blood collection tube for the preservation of whole blood speciments for immunophenotyping by flow cytometry; Cell-free DNA BCT, a direct-draw blood collection tube that stabilises nucleated blood cells and prevents the release of genomic DNA; Cell-Free RNA BCT, a blood collection tube with a preservative that stabilises circulating ribonucleic acid in plasma and prevents the release of non-target background ribonucleic acid from blood cells during sample processing and storage; and Cell-Free DNA Urine Preserve, a liquid reagent that stabilises cell-free DNA in urine. Streck’s molecular products include its ARM-D kits for the detection of antibiotic resistance genes by multiplex real-time polymerase chain reaction and the not-yet-launched real-time polymerase chain reaction instrument Zulu RT. The firms’s core product portfolio includes control products that test the performance and limits of instruments and reagents.135

 Further to the aforementioned distribution agreements, the Welcome Trust Sanger Institute has also announced that its Centre for Genomic Pathogen Surveillance has been selected to

134 https://www.genomeweb.com/molecular-diagnostics/eone-diagnomics-cordlife-ink-nipt-deal 135 https://www.genomeweb.com/business-news/streck-golden-bat-far-east-sign-distribution-deal

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house a global research unit to monitor antibiotic-resistant bacteria across the world. The initiative, funded with a GBP 6.8 million grant from the UK’s National Institute of Health Research, will cooperate with national laboratories in the Philippines as well as India, Nigeria and Colombia to provide surveillance data for bacterial pathogens using whole-genome sequencing. The Welcome Trust Sanger Institute will provide resources and training in genomic methods to the Philippine national labs to enhance local capacity, while local labs will feed in data into the national and international surveillance for monitoring and spotting the emergence of bacterial-resistance.136

 Moreover, Philab Industries has announced in December 2016 that it was working on 18 low-cost, self-test kits for the early detection of diseases, which would be available through the Department of Health (DOH). Earlier, the company has delivered 1 million dengue self- test kits to the regional offices of the DOH, the largest DOH’s order to date for dengue nonstructural protein 1 rapid diagnostic self-test kits.137

 Finally, the US-based molecular diagnostics company Biocept has struck a deal with life science distributor HarlePhil Venture Inc. in August 2016 to get Biocept’s Target Selector liquid biopsy assays into the Philippine market. The deal marked the first distribution agreement of Biocept in South East Asia and represented a key milestone in its goal of expanding the distribution of its proprietary testing services into international markets. Under the agreement, Biocept will do all diagnostic testing services while HarlePhil will be responsible for sales, marketing, distribution, and reimbursement of the company’s liquid biopsy platform. The partnership came as life science technologies are starting to receive growing interest in Asia.138

In order to leverage the economies of scale and simplify the process of product registration, licensing and distribution in the region, many companies are also opting for entry into SE Asia, and, in turn, the Philippine market, via regional distribution agreements. Over the past two years,

136 https://www.genomeweb.com/sequencing/sanger-institute-wins-grant-antibiotic-resistance-surveillance 137 https://businessmirror.com.ph/philab-working-on-17-low-cost-self-test-kits-to-detect-diseases-early/ 138 https://www.genomeweb.com/molecular-diagnostics/biocept-signs-distribution-deal-its-tests-philippines

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there have been a number of agreements between foreign companies and regional distributors to cover multiple markets, including the Philippines:

 For example, the Clearbridge Health subsidiary, SAM Laboratory, has become in November 2017 the exlusive provider of NanoString Technologies’ Prosigna breast cancer prognostic gene signature assay to patients in the Philippines, Malaysia, Indonesia and Singapore.139

 In August 2017, NantHealth has also signed a distribution agreement for its cancer molecular profiling service GPS Cancer with Asia Genomics, which covers the Philippine, Singaporean, Malaysian, Thai and Vietnamese markets. GPS Cancer integrates whole- genome sequencing, whole-transcriptome sequencing, and quantitative proteomics to provide oncologists with a molecular profile of a patient’s specific cancer.140

 In July 2017, Asia Genomics has also partnered with Silicon Valley-based CellMax Life to immediately introduce CellMax Life’s multi-biomarker precision oncology blood and saliva tests to the Philippines, Vietnam, Malaysia, Thailand and Singapore. The advanced diagnostic testing is expected to reduce cancer mortality through personalised, precision cancer risk assessment and screening.141 Whereas Dovetail Genomics, an advanced informatics for genomic solutions firm, has signed a distribution agreement with Tree Code for its genome assembly services in the Philippines, Singapore, Malaysia, Thailand, Vietnam, Indonesia and Myanmar.142

 In May 2017, EKF Diagnostics has also expanded the distribution of its Procalcitonic LiqioColor Test into South East Asia, where it is working closely with three major distributors covering the Philippines, Indonesia and Vietnam to introduce this test into hospitals. The test is a marker for bacterial infection and sepsis, and it is now widely recognised as an important adjunct marker in sepsis diagnosis which aids in the differentiation between viral and bacterial infections.143

139 https://www.genomeweb.com/microarrays-multiplexing/clearbridge-health-nanostring-ink-distribution-agreement-asia 140 https://www.genomeweb.com/business-news/nanthealth-signs-distribution-deal-gps-cancer-southeast-asia 141 https://cellmaxlife.com/cellmax-cancer-testing-now-available-throughout-southeast-asia-through-asia-genomics/ 142 https://www.genomeweb.com/sequencing/dovetail-genomics-signs-distribution-deal-southeast-asia 143 https://www.genomeweb.com/columns/brief-week-sequenom-perkinelmer-quest-diagnostics-and-more

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 Imagene Labs and LifeNome have finally formed a partnership in May 2016 to develop and market personalised genomic wellness services in South East Asia. The deal joins Singapore-based Imagene’s genetic testing facilities with LifeNome’s proprietary informatics platform in order to provide tailored genomic guidance on nutrition, fitness, skin care and other wellness topics to customers in the Philippines, Singapore, Vietnam, Malaysia, Thailand and Indonesia. The platform leverages information on thousands of genetic variations and delivers actionable insights to individuals. The partnership also brings the computational technologies, state-of-the-art genetic testing, interactive consumer engagement apps and expert services to South East Asia.144

Stem Cell Treatments

In addition to genomics and genetics R&D and product distribution, stem cell treatment is another innovative technology, which is gaining momentum in the country. Although the practice is not yet fully authorised for widespread application in health services and the accreditation system is heavily regulated by the Department of Health and the Food and Drug Administration (FDA), there is a growing number of accredited facilities in the country. The number of licensed facilities to provide stem cell treatment has increased from 4 in 2013 to 7 in 2016.145

As of August 2016, the licensed facilities are the Medical City (Institute of Personalised Medicine), the Asian Stem Cell Institute, Makati Medical Centre (Cellular Therapeutics Centre), Lung Centre of the Philippines (Molecular Diagnostics and Cellular Therapeutics Laboratory), St. Luke’s Medical Centre (Global City’s Stem Cell Centre), St. Luke’s Medical Centre (Quezon City’s Centre for Stem Cell Research and Bone Marrow Transplant Centre) and National Kidney and Transplant Institute (Molecular and Cellular Therapeutics Laboratory).146

144 https://www.genomeweb.com/molecular-diagnostics/imagene-lifenome-partner-offer-genomic-wellness-services-se-asia 145 http://kickerdaily.com/posts/2016/01/doh-4-health-facilities-in-ph-authorized-to-give-stem-cell-services/ 146 Department of Health (August 2016). Health Facilities and Services Regulatory Bureau Health Advisory on Stem Cells. Administrative Order No. 2013-0012.

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The stem cell treatments currently allowed in the country include hematopoietic stem cell transplantation, corneal resurfacing with limbal stem cells, and skin regeneration with epidermal stem cells.147 The Department of Health also notes that the majority of stem cell therapies, such as treatment of malignancies, blood disorders, degenerative diseases, metabolic diseases and immune cell therapy are still under clinical evaluation and study.148 However, as these areas progress, new opportunities are likely to rise in the country.

Biotechnology and Life Science Technology R&D Priority Areas in the Philippines

The importance of genomics and molecular technologies has also been recognised under the National Unified Health Research Agenda 2011-2016, which identified the use of information in the human genome in the design of vaccines, therapeutics and diagnostic devices and products for treatment of cardiovascular diseases, infectious diseases, such as tuberculosis, dengue and influenza, cancer (particularly breast, lung, liver, cervical and colon cancer), diabetes and neurodegenerative diseases. The agenda had previously focused on the following priorities for technology development between 2011-2016:

 Omics Technology:

▪ Biomarker identification via genomics, trasncriptonics, proteomics and metabolomics;

▪ Host-pathogenomics.

 Adult Stem Cells:

▪ Mesenchymal, cord, induced pluripotent stem cells.

 Biologics:

▪ Vehicles, biologics and small molecules.

147 Department of Health (August 2016). Health Facilities and Services Regulatory Bureau Health Advisory on Stem Cells. Administrative Order No. 2013-0012. 148 http://news.abs-cbn.com/lifestyle/10/24/12/doctors-dont-promise-cure-stem-cell-therapy

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Between 2013-2016, 17 genomics and molecular technology research projects have been registered under the National Philippine Health Research Registry.

No. of Genomics/Molecular Technology vs Total No. of Health Technology Projects by Year

72

60

39 29

7 5 3 2

2013 2014 2015 2016

No. of Genomics/ Molecular technology Research Projects Total Health Technology projects

Figure 48: Health Technology Development by research category Source: National Philippine Health Research Registry

In 2017, the Department of Science and Technology has further released the new Harmonised National Research and Development Agenda 2017-2022 (HNRDA), which also emphasised the need to develop molecular and genomics technologies. Among the molecular technologies for health, the HNRDA is expected to prioritise during the period of 2017-2022 the utilisation of molecular technology platforms in advancing local technologies for the development of personalised medicines, diagnostics and therapeutics. The R&D efforts are likely to focus on:

 Priority diseases based on the top causes of mortality and morbidity, malignant neoplasms, pneumonia and other chronic respiratory diseases;

 Prevalent emerging and re-emerging infectious diseases;

 Neurological, neurodegenerative and mental health conditions;

 Disease conditions of special interest to the Philippines, such as X-linked Dystonia- Parkinsonism Syndrome; and

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 Other applications and topics of national interest or significance.

Specific topics for genomics and molecular technologies under HNRDA 2017-2022 include:

 Omics technologies for health and wellness;

 Bioinformatics and systems biology;

 Novel techniques for therapeutics;

 Biobanking, data mining and population studies for human health, ethnicity and forensic applications.

Local Players

Philab Industries is a diversified scientific and research company and a Philippine pioneer in designing, equipping and building medical and science laboratories for medical research facilities in the Philippines. Founded in 1959, Philab is the only supplier of genomic services and equipment in the country. The company offers general lab, microscopy and packaging supplies and services for medical, pharmaceutical, educational and clinical applications, including chemical analysis and diagnostic products. It also engineers, plans, designs and develops scientific, medical and lab facilities, advances the research of genomics and genome sequencing in the country, and offers cancer and cardiovascular diseases screening tests. In the field of research, Philab caters researches to molecular biology, genomics, new-born screening, material and life sciences. Its clientele ranges from discerning customers to multi-million-dollar companies.

In 2015, the company has advanced the genomics R&D by establishing the Philab + Genomics Unit, in order to offer genetic screening, molecular diagnostics and genomic sequencing services for medical cases. It also funded the establishment and operations of the Genomics Institute of Asia in 2013.149

149 https://www.pressreader.com/philippines/manila-bulletin/20160815/282162175614128

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The company aims to become a genome sequencing provider, offering genomic services to ordinary Filipinos and to the rest of Asia.150 It is also eyeing Clark and Angeles, Pampanga, as the potential locations for its planned business-to-customers genomics facility. It envisions the facility as the first and largest next generation sequencing facility in Asia. The company has a goal to provide the capacity of 18,000 whole genome sequences that can be then confidentially shared with medical researchers. The new facility was expected to be launched in 2017, but delays are likely to postpone the launch until some time in 2018.

Among its largest contracts, Philab was awarded by the Department of Health (DOH) an initial PHP 88.6 million (EUR 18 million) contract to deliver 1 million dengue NSr (non-buffer) rapid diagnostic self-test kits – the largest DOH order to date for dengue self-test kits. The company is also currently developing 17 new, rapid-diagnostic self-test kits for additional DOH requirements and eventual entry into the business-to-customer market. To date, Philab has aggregated ongoing PHP 3.19 billion (EUR 648.4 million) contracts with the Department of Education, the Department of Health and the National Institutes of Health through to 2018.151 Philab and the Medical City have also inked a partnership in 2016 to revolutionise health management in the Philippines through genomics wellness solutions. Such partnership will materialise with Philab determining a patient’s probable disease and the Medical City designing the correct wellness programme.

PHIX Genomics is a Philippine clinical genomics diagnostic company. Established in 2017, the company aims to be the first commercial company to launch a clinical lab for the development of a Filipino-specific genome database. PHIX Genomics anticipates its offering, via its own lab facilities and via licensing agreements with established global leaders in clinical genomic diagnostics, to encompass a menu of tests, including, but not limited to, cancer profiling, pharmacogenomics, new-born screening, non-invasive pregnancy diagnostic, inherited diseases, infectious diseases and personal genomics.

150 http://www.manilatimes.net/genomics-inc-eyes-ph-hub-by-mid-2017/285475/ 151 https://businessmirror.com.ph/philab-working-on-17-low-cost-self-test-kits-to-detect-diseases-early/

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Building on biomedical research programmes, such as the Human Genome Project, and subsequent genomics R&D, PHIX Genomics anticipates applying state-of-the-art genomics, bioinformatics and digital imaging technologies to generate the high resolution comprehensive diagnostic reporting.

Amylex Biotechnology Philippines, Inc. is a leading Philippine biotechnology firm dedicated to delivering therapeutics and diagnostics that tackle some of the most prevalent diseases. Its lead product, Betaclear, is to be developed into a clinical service operation for the treatment of Alzheimer’s disease through a novel disease-modifying approach. The technology is based on a proprietary approach using nanomolecular robotics. The company was formalised to run through clinical trials and the commercialisation process in 2011.

Manila HealthTek, Inc. is a private R&D company with a molecular diagnostic technology pipeline and a clinical molecular diagnostic laboratory. As a first ever university spin-off from the University of the Philippines, it is developing and manufacturing portable diagnostic kits for the diagnosis of selected infectious diseases in the region. The company partners with hospitals, laboratories, industries and research institutes to further develop its offering and promote its products. At the moment, the company has three marketable products, including the Biotek-M LAMP Heater, the Biotek-M Dengue Aqua Kit and Easyview LED Transilluminator.

Scientific Biotech Specialties Inc (SBSI) is a Philippine distribution company focusing on in- vitro diagnostics testing. SBSI has been operating for about 18 years in the Philippine diagnostics market and has been one of the leading local diagnostics companies for hospitals and free- standing laboratories in the fields of haematology, immunology and clinical chemistry.

The headquarters of SBSI, which provides products and after-sales support to North Luzon, South Luzon and the National Capital Region, is based in Metro Manila. Its Visayas operations are based in Cebu City and Iloilo City. The Mindanao operations are based in Davao City and Cagayan de Oro City. Operationally, the company is divided into three departments: sales, service and logistics. SBSI’s products are mainly laboratory instruments (semi-automated to fully- automated) and their corresponding consumables. The in-vitro diagnostics market segments in

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which the company is actively present are immunochemistry, haematology, coagulation, clinical chemistry, serology, immunohematology, microbiology, molecular biology and some other specialised segments. SBSI is currently the market leader for electrophoresis testing in the Philippines and one of the leading players in Clinical Haematology and Coagulation.152 With its introduction of the National Institutes of Health-approved G-6PD confirmation test through its Pentra 400 chemistry instrument, it is now posing itself as a strong challenger in the medium- sized market in clinical chemistry.

Figure 49: Pentra 400 chemistry instrument by SBSI Source: Scientific Biotech Specialties Inc.

152 http://www.sbsi.com.ph/about-us.html

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3.7.2 EU Entry Opportunities

The Biotechnology and Life Sciences market in the Philippines is gradually opening up with the expansion of R&D activities and new facilities. There are several entry opportunities for European companies to enter the growing Philippine market:

 Provision of biotechnology and life science products and technology

 Technologies for genome database development

 Collaboration on research and development (R&D)

Provision of Biotechnology and Life Science Products and Technology

According to the Department of Science and Technology, the government is committed to provide help on infrastructure development and the acquisition of technologies that will sustain scientific and analytical processes comprising genome-based research.153 In addition, the government has prioritised the development of genomics and molecular technologies under the HNRDA 2017- 2022. Given the increase in the Philippine Government’s commitment to support the development of biotechnology and life sciences technologies, it is likely that European companies may find increasing demand for products and technological solutions that support such government targets. Technologies that help domestic R&D efforts in genomics, genetics and stem cell treatment research are expected to receive the greatest interest. In addition, the government’s research priorities for 2017-2022 on molecular technology platforms include the R&D of omics technologies, bioinformatics and systems biology, novel techniques for therapeutics, biobanking and data mining. Thus, companies wishing to provide equipment for molecular and biotechnological R&D are likely to find the greatest entry avenues by focusing on those research priority areas.

In addition, cancer incidence has also gone up significantly in the Philippines and the cancer diagnostics market segment is on the verge of explosion, as the researchers approach major

153 https://www.technologynetworks.com/genomics/news/philippine-govt-boosts-genomebased-research-205338

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technological breakthroughs in tumour diagnostics and therapy, discover new specific antigens and unlock the mystery of the genetic basis of the disease. During the next five years, the cancer diagnostics market is promising to be exciting, dynamic and rapidly expanding field. Anticipated technological breakthroughs will create numerous opportunities for determining genetic predisposition, detecting specific tumours, and monitoring biological response to cancer therapy. The rise in geriatric population will further compound the growing demand for malignancy assays and the rapid market expansion. Under the new product development opportunities with potentially significant market appeal, genetic disorders, such as non-invasive prenatal testing, as well as oncogenes and biochemical markers have great attraction in the Philippine market. On the technology front, conventional polymerase chain reaction technology is being upgraded with multiplexing capabilities and introduction of automated solutions to cater to high volumes. Next-Generation Sequencing solutions are also gradually making inroads into the country.

New segments that are gaining traction in the Philippine in vitro diagnostic device marketplace also include a point of care technologies, that is exponentially increasing adoption in home care segments and low to moderate uptake in hospitals that offer short transactivator and quick treatment decisions in cases like cardiac care. There are also opportunities for new analysers and regents’ kits as well as decentralised testing products/technologies.

Technologies for Genome Database Development

In addition, European companies may find opportunities to provide their products for genome database development. The Programme Director of the DNA Sequencing Core Facility at the Philippine Genome Centre, Dr. Cynthia P. Saloma, has identified the need in the Philippines for the development of Filipinised personal medicine through a database of Filipino genome sequence variations. This, according to Saloma, would significantly improve the country’s ability to respond to epidemics and pandemics, and forecast emerging and re-emerging infections like

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AH1N1, AHF5N, SARS and tuberculosis.154 As a result, the demand for technologies that enable the Philippines to develop genome databases are likely to rise in demand.

Collaboration on Research and Development

Finally, there is significant opportunity for interested European companies to collaborate with the government, its research agencies, other research institutions and the private sector on R&D activities to further genomics, genetics, stem cell and other biotechnology and life sciences development in the country. Cooperation with domestic players can give European companies access to resources in terms of research and development for new biotechnology applications as well as entry points for commercialisation of their products in the domestic Philippine market.

Some of the collaborations, such as the one between German FIZ (Frankfurt Innovation Centre), local biotech company BioSmart and the Philippine Genome Centre, as well as the one between Philab and Medical City, are already taking place. Other opportunities for European companies are likely to be available as local research institutions are keen to collaborate with international partners. Some of the R&D fields where collaborations may be viable are delineated under the HNRDA 2017-2022 and point to both shorter and longer-term opportunities:

Priorities for 2018 Omics technologies for health and Omics research programs on neurological/ neurodegenerative/ wellness mental health conditions (susceptibility and drug response) Validation of candidate genomic markers on susceptibility and drug response for cardiovascular diseases and Type 2 Diabetes Mellitus (T2DM) Human host and viral markers of Dengue severity (knowledge generation on pathophysiological and molecular mechanisms of dengue severity) Nutrigenomics Development of computational approaches and formulation of Bioinformatics and systems biology bioinformatics pipeline to study Filipino genomes Data mining for lung and breast cancer tissues

154 https://www.enterpriseinnovation.net/article/philippine-genome-center-big-step-health-and-agri-research-1630239239

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Priorities for 2018

Novel technologies for therapeutics Development of molecular vehicles for targeted drug delivery Biobanking, data mining and Development of forensic methods used in criminal investigations, population studies for human health, kinship analysis and victim identification ethnicity and forensic applications Studies on Filipino DNA markers for forensic applications Characterisation of Filipino Genomic Variations (22 regional groups

and 24 ethno-linguistics groups – sample collection) Establishment of biobanking resource of Filipino samples and their

associated data (genomic, proteomic, etc.) Omics technologies for health and Validation of candidate genomic markers on susceptibility and drug wellness response for neurodegenerative/ mental health diseases Omics research programmes on rare diseases in the Filipino

population (susceptibility and drug response) Omics research programs on human host and infectious disease

markers of susceptibility, severity and therapeutic response Nutrigenomics Development of the national capability for bioinformatics, Bioinformatics and systems biology chemioinformatics, and big data analytics for the medical and health sciences Validation and testing of computational approaches and formulation

of bioinformatics pipelines to study Filipino genome Validation, pre-clinical and clinical testing of molecular vehicles for Novel technologies for therapeutics targeted drug delivery Biobanking, data mining and Validation of use of molecular technologies for forensics for the use population studies for human health, in criminal investigations, kinship studies and victim identification ethnicity and forensic applications Validation of Filipino DNA markers for forensic applications

Data mining of Filipino Genomic Variations Management of biobanking resource of Filipino samples and their

associated data (genomic, proteomic, etc.) Table 19: R&D priorities for molecular and biotechnology under the HNRDA 2017-2022 Source: HNRDA 2017-2022

The Joint Health Research Initiative between the UK Medical Research Council and the Philippine Council for Health and Research Development (PCHRD) has also recently launched the second call for high quality 3-year collaborative research projects focusing on communicable and non- communicable diseases, relevant to the Philippines. The initiative builds on the previous call

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launched in 2015 through which 6 proposals addressing research needs in infectious diseases were funded. Areas of particular research interest include, but are not limited to:

 Genomics and molecular technologies for novel biomarket identification, with a focus on host and pathogen omics and host-pathogen interactions;

 Diagnostics for development of cost effective, rapid diagnostic tools, utilising off-patent/ lapsed and/or novel technologies.

 Development of cost-effective biomedical devices for diagnosing, treatment, and/or management of T2DM among Filipinos.

The UK Medical Research Council is expected to provide up to GBP 2 million for successful UK applicants while the PCHRD will provide up to GBP 1.25 million for successful Filipino applicants. It is expected that the initiative will support around 6 joint projects.155

European Players

Miltenyi Biotec

Miltenyi Biotec is a global biotechnology company, based in Cologne, Germany. It is a global provider of biomedical research and cellular therapy products for cell isolation, flow cytometry, sample separation, cell separation and sorting, cell culture, molecular analysis and clinical applications. Since its founding in 1989, the company has focused on advancing cellular therapy treatments worldwide. Currently, it has more than 1,400 employees in more than 25 countries in North America, Europe and Asia Pacific. Miltenyi Biotec also provides support to customers through an extensive distributor network covering dozens of additional countries.

155 http://region2.healthresearch.ph/index.php/8-news/173-call-for-concept-proposals-uk-philippines-joint-health-research-initiative%202

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Figure 50: CliniMACS device by Miltenyi Biotec Source: Miltenyi Biotec

In the Philippines, the company promotes its products via a network of distributors. Among its significant sales, the company supplied the CliniMACS – the device which allows laboratories to isolate hundreds of millions of cells with more than 90% purity – to the Cellular Therapeutics Centre of Makati Medical Centre.156

ZenTech

ZenTech is a Belgian biotechnology company, specialising in diagnostics of pathologies occurring in the early life stages, from birth to adolescence, and in the diagnostics of chronic diseases affecting both children and adults. The company has particular expertise in the development, production and marketing of in-vitro diagnostics kits, specifically developed for new born screening and paediatric use.

The company has been targeting Asia, and more specifically the ASEAN region, since 2006 as the first market to sell its products. After incorporating ZenTech Biotechnology Asia in Singapore in 2013, the company has established its branch office in Vietnam and continued to develop commercial activities in other ASEAN countries. ZenTech has then entered the Philippine market after winning the contract to furnish 1 million tests for a genetic disorder Maple Syrup Urine

156 http://www.philstar.com/health-and-family/2014/11/18/1392839/real-deal-stem-cell-therapy-philippines

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Disease. Nowadays, four centralised laboratories in different regions across the country are routinely working with ZenTech’s automated systems.157

Frankfurt Biotechnology Innovation Centre GmbH (FIZ)

Established in 2002, FIZ is a German biotechnology innovation centre jointly owned by the State of Hesse, the City of Frankfurt and the Frankfurt am Main Chamber of Commerce and Industry. It offers bespoke research infrastructure and working conditions for small and medium-sized biotechnology enterprises. Over time, it has become an important breeding ground for joint projects and interdisciplinary networks. Being active in facilitating national and international collaborations between companies in the life sciences industry, FIZ in 2017 has entered into partnership with the Philippine Genome Centre and a local biotech company, GeoSmart, to carry out a large-scale profiling of the Philippine cancer patients. The centre’s DNA Sequencing and Bioinformatics Facility plans to offer its sequencing and bioinformatics services to clinicians at rates accessible to Filipino citizens. The sequencing data will then be processed through GeoSmart and FIZ database networks in order to construct a nationwide database of cancer research, diagnosis and treatment.

157 http://win-health.org/zentech-biotechnology-of-liege-science-park-in-belgium-is-now-incorporated-in-asia/

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3.8 Dental Products

3.8.1 Market Overview

The growth in the dental care market of Philippines has been spurred in the past decade by the rising elderly population, changing lifestyles, which include long working hours, dependence on packaged food and increased consumption of tobacco and liquor leading to oral problems, increased healthcare expenditure by the government as well as households.158 Growing popularity of dentist as a profession has also led to more students opting for dental studies, which has further led to an increase in the number of private clinics being established in the country. Moreover, the establishment of new clinics is generating demand for dental equipment while rising number of dental patients in the country is fuelling the demand for dental consumables. Overall, the dental market is expected to reach US$ 2.7 billion by 2019, growing at a compound annual growth rate (CAGR) of 10.4%.159

Rising awareness regarding oral health, government initiatives, increased spending on physical appearance by Filipinos, advancements in diagnostic and treatment technology, establishment of new clinics along with rising dental tourism in the Philippines are expected to add on to the growth of the Philippine dental market over the next five years, opening up new, budding opportunities for European companies.

Dental Care in the Philippines

The Philippine market for dental care has significant growth opportunities, driven by the prevalence of dental problems, the rising awareness of dental care, and increasing affordability of dental practices among households. The National Monitoring and Evaluation Dental Survey, conducted by the Department of Health (DOH) in 2011, notes that approximately 87% of Filipinos

158 https://businessmirror.com.ph/the-future-of-dental-industry/ 159 Ken Research Pvt Ltd (2016). Philippines Dental Care Market Growth to 2019.

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(83 million people) are suffering from dental caries, such as tooth decay, while about 48% have gum diseases.160 The Decayed, Missing, Filed Teeth Index places the Philippines as second worst among the 21 World Health Organisation’s Western Pacific countries, fuelling a large potential customer base.

According to the 2011 National Oral Health Survey, around 97.1% of 6-year-olds in public elementary schools also suffer from tooth decay, and more than 4 out of 5 children manifest symptoms of dentinogenic infection.161 Studies have also shown that 98% of children aged three to five have dental caries or cavities, and 74% of 12-year-olds suffer from gingivitis.162 Furthermore, based on the Department of Health statistics of 2011, 77%, or approximately 7 out of every 10 Filipinos, have never been to a dentist due to the high costs associated with dental practices. Dental caries and periodontal diseases are significantly more prevalent in rural areas, primarily because the dental network is concentrated in urban settings. This leaves significant gaps in the dental network coverage, which can be exploited by the private sector.

Moreover, as the disposable incomes rise among households, and the costs associated to dental care decrease due to technological advancements, more Filipinos are considering dental care as part of their regular health check-ups. As a result, private sector is increasingly eyeing opportunities in the Philippines to cater to the growing customer base by establishing new clinics, marketing dental care products, and selling dental equipment to the growing number of dental practices across the country.

Dental market is being further boosted by ageing population and the increases in denture wearers. According to the study by GlaxoSmithKline, the Philippines, with around 9 million denture wearers, is the country with one of the highest total number of denture wearers in Asia, which further fuels dental service demand among the ageing Filipinos.163

160 http://www.doh.gov.ph/oral-health-program 161 http://www.doh.gov.ph/dental-health-program 162 https://www.rappler.com/brandrap/stories/83854-oral-health-more-attention-ph 163 The 2014 study by GSK, which has provided these results, has no comparable statistics on China. http://news.abs- cbn.com/lifestyle/05/29/15/how-ph-ranks-dental-health

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Although the public awareness about curative and preventive dental care is growing across both urban and rural regions, regular check-ups and preventive dental care are more common in urban areas. Dental practice visits in rural regions are typically prompted by pain and curative dental practice dominates such areas. The government has been recently active in promoting public education, guidance and training concerning preventive dentistry and regular teeth maintenance nationwide through primary schools and health centres, which is increasing public interest in proper dental hygiene and regular dental visits.

Dental Care Infrastructure

The dental care infrastructure is distributed unevenly across the Philippines. The majority of dental facilities are located in urban centres, while rural populations typically have limited accessibility to dental practices. There are approximately 751 licensed dental clinics in the Philippines.164 According to the Global Clinic Rating, the top 10 dental clinics in the Philippines are: Tooth & Go Dental Clinic (Paranaque City), Sacred Heart Dental Clinic (Caloocan), Gerochi Dental & Implant Centre (Makati City), iDent Dental Centre (Makati City), Dalisay Dental Clinic (Malolos), Northern Dental Specialists (Angeles City), Navales Dental (Makati Dental), Louie’s Dental Clinic (Quezon City), One Dental Care (Antipolo), Martinez Dental Clinic (Malolos).165

According to Philippine Dental Association, the total number of registered dental professionals currently stands at 10,649 registered members, which translates into a ratio of one dentist per every 9,727 Filipinos. In 2014, there were approximately 1,788 dentists in the public healthcare system. Given the available statistics, the Philippines dentistry sector is dominated by the private sector which accounts for 83.3%, in terms of available dentists. Government dentists, which offer subsidised, or free, check-ups account for 16.7%.

Based on the latest available data, the National Capital Region (NCR) is leading with the highest number of government dentists (509 dentists, or 28.4% of the total number of government dentists

164 https://gcr.org/top/dental/ph 165 http://blog.gcr.org/20160923philippines-top-10-dental-clinic-rankings-2016/

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in 2014). The lowest number of government dentists was recorded in Autonomous Region in Muslim Mindanao (ARMM) (25 dentists) and Cordillera Administrative Region (CAR) (28 dentists).

Region Dentists NCR 509 CAR 28 1 108 2 71 3 178 4-A 167 4-B 55 5 74 6 125 7 118 8 88 9 43 10 50 11 53 12 60 13 36 ARMM 25 Total 1,788 Table 20: Number of Government Dentists by Region, 2014 Source: Philippine Statistics Authority

Dental & Oral Care Market

The Philippines is largely dependent on imports of dental equipment and consumables. Countries, such as China, Germany, Singapore, Japan, the U.S., and South Korea are leading the dental market imports into the Philippines. China, in particular, has been the largest importing market for dental equipment and consumables for the Philippines. The availability of reasonable quality products at lower prices has made it a particularly attractive import partner.

The local manufacturing industry is very small, and mainly limited to sterilisers, incubators and dental furniture.

The dental and oral care market typically generates the majority of revenues from the fee charged by the clinics for diagnosis and treatment of dental problems. The rising number of dental issues

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being faced by the Filipinos alongside the rising trend of dental tourism has enabled this market segment to dominate over the subsector revenues during 2009-2014. Over the same period, the Philippine dental care services have received a strong CAGR of 14.7%, owing to a number of factors, such as the increasing population of elderly people, rise in healthcare expenditure and improving awareness about dental care. These trends, in turn, are also spurring growth in the dental products market sub-segment.

The total dental & oral care equipment and products market, based on import/export data estimations, has been steadily rising over the past several years, accumulating to a total of nearly US$ 126 million in 2016.

Dental products market estimations based on import/export data (2012-2016) $140,000,000 $120,000,000 $100,000,000 $80,000,000 $60,000,000 $40,000,000 $20,000,000 $0 2012 2013 2014 2015 2016 Total value $33,541,195 $74,811,852 $101,271,138 $90,449,544 $125,904,920

Figure 51: Dental products market estimations based on import/export data of dental products (2012-2016) Source: UN COMTRADE

The market has been largely dominated by oral and dental hygiene products, which accounted for 70% of the total trade value in 2016. Dental fittings occupy 13.6% of market share, followed by pharmaceutical goods (8.5%) and dental instruments and appliances (3.7%). The majority of dental market categories have experienced a steady growth between 2012 and 2016.

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Total Dental & Oral Care Market in 2016 Oral and dental hygiene products, $88,183,801

Dental furniture; $1,164,495

Pharmaceutical goods, $10,716,883 Apparatus based on X-rays; $754,949 Modelling pastes; Dental fittings; Dental instruments and $3,332,939 $17,085,497 appliances, $4,666,356 Figure 52: Share of dental & oral care market imports/exports, 2016 Source: UN COMTRADE

Category Percentage Total Value Oral and dental hygiene products 70.0% $88,183,801 Pharmaceutical goods 8.5% $10,716,883 Modelling pastes 2.6% $3,332,939 Dental instruments and appliances 3.7% $4,666,356 Dental fittings 13.6% $17,085,497 Apparatus based on X-rays 0.6% $754,949 Dental furniture 0.9% $1,164,495 Total 100.0% $125,904,920 Table 21: Share of dental & oral care market (export/import data estimations), 2016 Source: UN COMTRADE

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Code Description 2012 2013 2014 2015 2016

HS Chairs; dentists', barbers' or similar chairs $461,014 $524,700 $1,382,566 $850,852 $1,164,495 940210 having rotating as well as both reclining and elevating movements, and parts thereof

HS Apparatus based on the X-rays; including $114,257 $116,073 $402,898 $527,724 $754,949 902213 radiography or radiotherapy apparatus; for dental uses; excluding computed tomography apparatus

HS Dental fittings; other than artificial teeth $2,922,063 $6,171,014 $8,465,389 $5,029,178 $6,881,670 902129

HS Dental fittings artificial teeth $14,857,588 $8,906,521 $10,892,268 $12,051,304 $10,203,827 902121

HS Dental instruments and appliances; other than $3,476,535 $2,904,873 $2,329,958 $4,229,956 $3,928,275 901849 dental drill engines

HS Dental instruments and appliances; dental $46,337 $249,889 $285,646 $512,447 $738,081 901841 drill engines, whether or not combined on a single base with other dental equipment

HS Modelling pastes; preparations known as $1,879,849 $2,153,327 $2,294,027 $4,016,772 $3,332,939 340700 dental wax, put up in sets, in packings for retail sale or in plates, horseshoe shapes, sticks or similar forms, other preparations for use in dentistry

HS Pharmaceutical goods; dental cements and $4,056,786 $3,913,806 $930,875 $1,080,739 $2,214,561 300640 other dental fillings, bone reconstruction cements

HS Pharmaceutical goods; sterile surgical catgut, $2,169,201 $2,393,675 $872,363 $4,602,749 $8,502,322 300610 suture materials, tissue adhesives, laminaria, laminaria tents, absorbable surgical or dental haemostatics, and surgical or dental adhesion barriers

HS Oral or dental hygiene preparations other $3,351,321 $2,205,115 $4,396,166 $6,332,659 $10,240,495 330690 than dentifrices

HS Oral or dental hygiene preparations yarn used $206,244 $235,823 $297,081 $571,136 $1,309,053 330620 to clean between the teeth (dental floss)

HS Oral or dental hygiene preparations; $46,725,565 $45,037,036 $68,721,901 $50,644,028 $76,634,253 330610 dentrifices

Total $33,541,195 $74,811,852 $101,271,138 $90,449,544 $125,904,920 Table 22: Share of dental & oral care market by category (import/export data estimations), 2012-2016 Source: UN COMTRADE

Dental equipment and products imports/exports value has reached nearly US$ 38 million, while dental equipment alone accounted for approximately US$ 6.59 million in 2016.

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Dental Equipment & Products Trade, 2012-2016 £45,000,000.00

£30,000,000.00

£15,000,000.00

£0.00 2012 2013 2014 2015 2016 Total $29,983,630 $27,333,878 $27,855,990 $32,901,721 $37,721,119

Figure 53: Dental equipment & products trade, 2012-2016 Source: UN COMTRADE

Code Description 2012 2013 2014 2015 2016

Chairs; dentists', barbers' or similar chairs having HS rotating as well as both reclining and elevating $461,014 $524,700 $1,382,566 $850,852 $1,164,495 940210 movements, and parts thereof Apparatus based on the X-rays; including HS radiography or radiotherapy apparatus; for dental $114,257 $116,073 $402,898 $527,724 $754,949 902213 uses; excluding computed tomography apparatus HS Dental instruments and appliances; other than $3,476,535 $2,904,873 $2,329,958 $4,229,956 $3,928,275 901849 dental drill engines Dental instruments and appliances; dental drill HS engines, whether or not combined on a single base $46,337 $249,889 $285,646 $512,447 $738,081 901841 with other dental equipment Pharmaceutical goods; sterile surgical catgut, suture materials, tissue adhesives, laminaria, HS laminaria tents, absorbable surgical or dental $2,169,201 $2,393,675 $872,363 $4,602,749 $8,502,322 300610 haemostatics, and surgical or dental adhesion barriers HS Pharmaceutical goods; dental cements and other $4,056,786 $3,913,806 $930,875 $1,080,739 $2,214,561 300640 dental fillings, bone reconstruction cements Modelling pastes; preparations known as dental HS wax, put up in sets, in packings for retail sale or in $1,879,849 $2,153,327 $2,294,027 $4,016,772 $3,332,939 340700 plates, horseshoe shapes, sticks or similar forms, other preparations for use in dentistry HS Dental fittings; other than artificial teeth $2,922,063 $6,171,014 $8,465,389 $5,029,178 $6,881,670 902129 HS Dental fittings artificial teeth $14,857,588 $8,906,521 $10,892,268 $12,051,304 $10,203,827 902121 Total $29,983,630 $27,333,878 $27,855,990 $32,901,721 $37,721,119 Table 23: Dental equipment & products trade, 2012-2016 Source: UN COMTRADE

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Dental Equipment Trade (2012-2016) $7,000,000 $6,000,000 $5,000,000 $4,000,000 $3,000,000 $2,000,000 $1,000,000 $0 2012 2013 2014 2015 2016 Total $4,098,143 $3,795,535 $4,401,068 $6,120,979 $6,585,800

Figure 54: Dental Equipment Trade, 2012-2016 Source: UN COMTRADE

Code Description 2012 2013 2014 2015 2016

HS Chairs; dentists', barbers' or similar chairs having rotating $461,014 $524,700 $1,382,566 $850,852 $1,164,495 940210 as well as both reclining and elevating movements, and parts thereof

HS Apparatus based on the X-rays; including radiography or $114,257 $116,073 $402,898 $527,724 $754,949 902213 radiotherapy apparatus; for dental uses; excluding computed tomography apparatus

HS Dental instruments and appliances; other than dental drill $3,476,535 $2,904,873 $2,329,958 $4,229,956 $3,928,275 901849 engines

HS Dental instruments and appliances; dental drill engines, $46,337 $249,889 $285,646 $512,447 $738,081 901841 whether or not combined on a single base with other dental equipment

Total $4,098,143 $3,795,535 $4,401,068 $6,120,979 $6,585,800 Table 24: Dental Equipment Trade, 2012-2016 Source: UN COMTRADE

Government Initiatives to Accelerate Dental Care in the Philippines

In recent years, there have been several initiatives, which targeted the greater utilisation of oral and dental healthcare in the Philippines. In 2007, the Department of Health formulated the Guidelines in the Implementation of Oral Health Programme for Public Health Services (AO 2007- 2017), which aimed to reduce the prevalence rate of dental caries by 85% and periodontal disease up to 60% by the end of 2016. The programme sought to achieve these targets by providing

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preventive, curative and promotive dental healthcare to Filipinos through a lifecycle approach whereby Filipinos are engaged at every stage of their lives.

In 2010, the Government also proposed a bill to create a dental unit for each of the 2,266 rural health units as part of the human resources development. In 2010, there were 881 rural health dentists in Plantilla of the DOH, distributed across 12 regions.166 By providing for one dentist position per each of the 2,266 rural health units, the DOH aims to achieve wider dental coverage across the country.167 In 2014, the number of DOH’s dentists had increased to 1,788 dentists. These initiatives are spurring the rise of dental profession and, subsequently, the establishment of new dental clinics. Given the dominance of imported dental equipment and products in the Philippines, and the limited domestic production, foreign suppliers are expected to fill in the equipment demand within the expanding dental practice network.

Local Players

Soniford Maeller Corp was established in 1982 to manufacture and sell dental equipment. Based in Taguig, the company manufactures medical, surgical and dental furniture and fixtures. Its three main product lines include dental chairs, dental equipment and dental supplies. In its first decade, Soniford Maeller has successfully developed and moved into production of the high-speed control box AIR FLOW, the portable chairs FINA and NEW FINA, as well as the dental units CHAIRMOUNT and SEIKI for domestic consumption. A strategic partnership with a Japanese company has further led Soniford Maeller to develop a micro motor control box BRAVO. In the succeeding decades, the company continued to invest heavily in the R&D of new technologies and designs in dental equipment, and has introduced a number of new product lines, such as CONCEPT, ADVANCE, FOCUS, and HAPPY DOCTOR.

166 The number of dentists within the DOH system had increased to 1788 by 2014. 167 H.B. No. 411 (2010).

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Figure 55: Soniford Maeller’s dental chair model “Happy Doctor” Source: Soniford Maeller

It has also introduced a model ACROSS, a luxury class dental chair, for the export market. More recently, Soniford Maeller has gained reputation both internationally and locally for the quality of its products and the company entered into a strategic joint venture with a foreign company to produce x-ray machines. Manufacturing of its product lines is completely done in its 3,000 m2 facility, located 20 km south of Manila.

JAGAS Dental Trading is a medical and dental trading company headquartered in Paranaque City, with additional offices in Cebu, Iloilo and Davao cities. It specialises on the provision of a large selection of dental equipment, including dental chairs and dental chair parts, dental accessories and equipment, dental x-ray machine units, dental instruments and supplies. The company represents a wide range of brands and its products are imported directly from the U.S., Japan, South Korea and China. The company started its operations in 1995, focusing initially on the U.S.-Philippine export market. In 1999, the company expanded its operations in the Philippines to offer equipment maintenance and make-over services, such as remodelling, repainting, re-upholster, restoration, and replacement of defective parts.

ApexMed is a dental, medical and surgical instrument and product provider, based in Metro Manila, Philippines. The company started its operations with the commitment in providing high-

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quality products and equipment to serve the specific needs of medical professionals and specialists. Currently, AmexMed is representing four brands, namely, AlphaBiotec, OrthoPli USA, Monitex and Geislich, and provides tools, such as implants, bio-material, pliers and cutters, imaging devices and surgical kits for medical and dental industries in the Philippines.

Figure 56: Four main brands represented by ApexMed in the Philippines Source: ApexMed

Forbes Dental Prosthetic, Inc. is a Philippines-based dental equipment and supplies manufacturer, based in Makati, Philippines. The company was founded in 2010. In December 2016, the Board of Investments has approved its application for a project to produce 3,260 export- quality crown pieces for the global market. In its application to the Board of Investment, Forbes said it would employ additional 11 personnel to further boost the production of the crown pieces it currently supplies to a United States-based dental firm, which provides the crown moulds to Forbes complete with instructions and customer specifications.

3.8.2 EU Entry Opportunities

The market for dental products and equipment is expected to grow in the upcoming years, thus, presenting various opportunities for European manufacturers and suppliers. The key drivers for the market growth include a rise in cases of dental conditions, adoption of innovative technologies, greater oral care awareness, expanding dental clinic network, and growing cosmetic dentistry. Some of the entry opportunities are:

 Efficiency and effectiveness optimising equipment

 Cosmetic dentistry products

 Dental fittings and artificial teeth

 Equipment upgrades for new dental clinics

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Efficiency and Effectiveness Optimizing Equipment

Implementation of high-end technology, such as imaging and radiology, is likely to be limited to private clinics with greater budgets for new equipment. Widespread adoption of advanced dental devices in the Philippines would be possible only if the same quality were available at lower cost, a challenge for a market defined by high equipment costs. Opportunities in the Philippine market, therefore, lie primarily in improving the present equipment by bringing in new technological innovations that would improve dental surgical procedures and allow for more efficient and effective treatment, while limiting the acquisition costs.

Dental lasers are used for variety of purposes, such as for removal of dental caries, whitening, and root canal procedures, and, hence, are likely to be in demand as effectiveness-enhancing technology. The demand for computer-aided design & manufacturing (CAD/CAM) systems is also expected to increase as these systems reduce the time for procedures, improve diagnosis and treatment outcomes. Other devices as well as higher quality surgical instruments that improve the quality of dental procedures, effectiveness and efficiency are also likely to find success in the domestic Philippine market.

A certain demand, however, for high-tech dental equipment is also likely to rise together with the growth of new, private dentist clinics. As the private medical sector generally has more flexibility to invest in higher-end equipment, these new clinics may require Western-quality products to satisfy the demands of the growing urban middle-class.

Cosmetic Dentistry Products and Equipment

One of the growing trends among more affluent Filipinos is cosmetic dental work. The trend is becoming popular in major cities, especially among public figures and wealthier people. As a result, urban dental clinics may find themselves in demand of upgrading their equipment with cosmetic dentistry devices in order to cater for this growing customer segment. Some of the products in demand may be interdental cleaning and snoring devices, crowns, bridges, implants, braces, and other products as well as teeth whitening, veneering, and composite bonding equipment and products. This leads to possible business opportunities for European cosmetic

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dental equipment manufacturers and suppliers to provide affordable, yet higher quality products to service the growing field of cosmetic dentistry.

Dental Fittings and Artificial Teeth

As the Philippines’ population of elderly people is steadily increasing and growing faster than the total population, the dental market is faced with additional service opportunities, namely, the provision of dental fittings and artificial teeth. Its 9 million denture wearers also make the Philippines the country with the highest number of denture wearers in Asia. While the country mostly imports these products from abroad, European companies, which provide quality dental fittings and artificial teeth, are likely to find opportunities in the Philippines.

Equipment Upgrades for New Dental Clinics

The number of private dental clinics in the Philippines is increasing. In addition, the Government has also proposed a bill to create a dental unit for each of the 2,266 rural health units as part of the human resources development. While in 2010 there were only 881 rural health dentists in the Plantilla of the Department of Health, distributed across 12 regions, an additional 1,385 dentist units were required to achieve the government’s plan.168

As a result of the development of new dental clinics, both private and public dental units will require new equipment for their services. European dental equipment and dental surgery products manufacturers may find lucrative opportunities to cooperate with the government in upgrading the rural units and helping new clinics procure the devices for their dental practices. Equipment, including amalgams, cements, plasters, dental chairs, dental hand instruments, dental surgery instruments, drills and sterilisers may be particularly sought after.

168 The number of dentists within the DOH system had increased to 1788 by 2014.

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European Players

Kaltenbach & Voigt (KaVo)

Founded in 1909, KaVo is a German dental products manufacturer with a comprehensive array of dental products, ranging from dental instruments to state-of-the-art dental practice equipment. KaVo’s core business lines are structured around the fields of dental instruments, dental equipment, imaging and diagnostics, laboratory, and dental education.

With over 100 years of operations, it has registered more than 2,000 patents for dental products and equipment. The company’s range of products includes turbines, handpieces and contra- angle handpieces, diagnostics, laser therapy, surgical interventions, treatment units as multimedia, and dental x-ray technologies, among others. As a manufacturer of medical devices, KaVo is certified according to EN ISO 9001, EN ISO 13485 and the directive 93/42 EWG. The company is present worldwide with over 3,000 employees and 18 subsidiaries around the globe. It produces its products in four locations.

Figure 57: KaVo’s range of products Source: Kaltenbach & Voigt

The company has established its presence in the Philippines via partnership with its exclusive domestic distributor, the New Citizen’s Dental Supply. KaVo has also established its presence in the region via subsidiary companies in Malaysia, Singapore, Taiwan, Thailand, South Korea and China.

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InteraDent Zahntechnik GmbH (InteraDent)

InteraDent is a German leading manufacturer, supplier and provider of low-cost dental prosthetics meeting the high-quality standards of the German market. The company was founded in 1984 and it is based in Lübeck, Germany, with additional laboratories in Berlin, Leipzig, and Chemnitz, Germany; and Manila, Philippines. InteraDent operates as a subsidiary of EDP European Dental Partners Holding GmbH. The company is one of the pioneers of medical dental care at affordable prices. As early as 1985 InteraDent set up its own master laboratory in Manila, Philippines – one of the first laboratories in the world to be certified by TÜV-CERT according to ISO 9001.

Figure 58: Interadent laboratory in the Philippines Source: Google Maps

The entry into the Philippine market started with the establishment of the local subsidiary, InteraDent Zahntechnik Phils., Inc. Today, InteraDent handles over 60,000 orders for dental prostheses per year and it is one of Germany’s largest dental laboratories. Among its manufactured products are the custom made dental products, such as milling and precision attachments, crowns and bridges, full and partial dentures, chrome-cobalt frames and other precision works. InteraDent is the only significant player in Germany with its own presence in Asia, enabling the company to ensure consistently high quality at lower prices. The price differential to the patient of InteraDent’s products vs. a German based dental lab is between 30% and 60%.

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Fona Dental

Fona Dental is a Slovakian dental equipment company. With headquarters in Bratislava, Slovakia, the company has a production site for 2D and 3D imaging systems, software intraoral X-rays, phosphor plat scanners and sterilisers in Assago, Italy, and a production site for FONA 1000 and 2000 treatment centre lines in Guangzhou, China. The company provides its products via a global network of sales representatives and technical service teams. It sells its products in the Philippines via its designated distribution partner, Golden Peak Sales Corporation. Among its Philippine portfolio are its products Stellaris 3D, FONA XPan 3d Plus, FONA XPan 3D, FONA Art Plus/Art Plus C, FONA XPan DG/XPan DG Plus and FONA XPan/XPan Ceph.

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4. Regulations

4.1 General Import Procedures

All articles, when imported to the Philippines, are subject to duty upon each importation, even though previously exported there except as otherwise specifically provided for in the Tariff and Customs Code. Importation begins when the carrying vessel or aircraft enters the jurisdiction of the Philippines with the intention to unlade therein. Importation is deemed terminated upon payment of the relevant duties, taxes and other charges, either related to the imported articles, or to the charges and taxes related to the entry into the Philippines. Duties are usually calculated ad valorem, and specified in the Philippines Customs Code. For the calculation of import duties, the Philippines currently use the system of value based on the price of domestic consumption. Import taxes vary from 3 to 50% according to the product.

Certificate of Listing

Importers can apply for a Certificate of Listing that is issued to a medical device intended for research, clinical trial, exhibit, donation, etc. and that is not intended for sale in the Philippines. The requirements for the Certificate of Listing include:

 Notarised Application Form169

 Notarised letter to the Director, Centre for Device Regulation, Radiation Health and Research, stating that the medical device will be used solely for personal use, research, analysis, exhibit, or is being donated by a certain organisation and is not intended for sale.

 Certificate of Product Notification or Certificate of Product Registration or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency in the country where the device will come from.

169 http://www.fda.gov.ph/attachments/article/175544/FInal%20Draft%20of%20the%20New%20Sets%20of%20guidelines%20for%20the %20Registration%20of%20Medical%20Device%20Products,%20edited%2019June2014.pdf

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 For a donated medical device, a certified true copy of the deed of donation and deed of acceptance.

 Copy of bill of lading, proforma invoice, or official receipt of purchase.

4.2 Medical Device Import Licence

A company importing medical devices into the Philippines is required to have a License to Operate and a Certificate of Product Registration. If the company complies with the requirements and passed the inspection, a license to operate will be issued. The company is given sixty days to comply with all the deficiencies. Non-compliance will result to temporary stoppage of the selling of medical devices.

Companies with a valid license to operate as a medical device distributor/ importer/wholesaler can file an application for product registration. The application will be reviewed and evaluated in accordance with the requirements. All complying applications will be issued a certificate of product registration. All non-complying applications will be issued a notice of deficiency. Each company is given a non-extendable ninety (90) days compliance period. All those who will not be able to comply will be disapproved but will be given a period of sixty (60) days to file for re-application and comply with all the deficiencies. In the case that after this period the application did not satisfactorily comply with all the requirements, the application will be disapproved, and the company needs to file again for an initial application.

The Centre for Device Regulation, Radiation Health, and Research (CDRRHR) under the Food and Drug Administration (FDA) is the recommending office for approval of the certificate of product registration.

Foreign suppliers usually appoint a licensed distributor to represent their interests in the Philippines. Usually, distributors handle all aspects of importation from registration of the products, to obtaining a license and a clearance. Distributors become responsible for the equipment (capability, safety, market performance, and after-sales service) and, thus, prefer exclusive contracts with foreign suppliers.

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The average tariff rate for Medical equipment is 3% plus a 12% value-added tax. The VAT is based on the valuation determined by the Bureau of Customs for the application of customs duties, plus those duties themselves, excise taxes, and other charges (i.e., charges on imports prior to release from customs custody, demurrage fees, including insurance and commissions). The Bureau of Customs is responsible for customs valuation, classification, and clearance functions.

4.3 Medical Device Regulations

The FDA, formerly the Bureau of Food and Drugs, was created under the Department of Health to license, monitor, and regulate the flow of food, drugs, cosmetics, medical devices, and household hazardous waste in the Philippines.

The Department of Health defines medical device in the Philippines as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:170

 diagnosis, prevention, monitoring, treatment or alleviation of disease,

 diagnosis, monitoring, treatment, alleviation of or compensation for an injury

 investigation, replacement, modification or support of the anatomy or of a physiological process,

 supporting or sustaining life

 control of conception

 disinfection of medical devices

 providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body;

170 http://www.doh.gov.ph/node/1242

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 and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

CDRRHR is the FDA arm created to oversee the regulation of medical equipment and devices.

The classification system of medical devices in the Philippines is categorised as Class A, B, C, and D, where class A is the classification for the low risk medical devices and class D for the highest risk medical devices. The CDRRHR is authorised to reclassify certain devices when the level of risk of the device is changed by a certain incident in the manufacture, distribution or use of the device upon proper consultation with the advisory committee set forth by the FDA. The classification is based on the intended purpose of the medical device, mode of operation and the user, and also the device technologies. The table below provides a broad overview of the classification system with some examples:

Risk Level Device Examples Class A Low Bandages/ Wheelchairs/ Face masks/ Cotton balls Class B Low – Mid Contact lenses/ dental crowns/ Hearing aids Class C Mid – High X-ray machines/ Lung ventilators/ Hip implants Class D High Pacemakers/ Heart stents/ Breast implants Table 25: Classification of medical devices by risk category Source: http://asean.org/storage/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf

Further guidelines on medical device classification are also available under the ASEAN Medical Device Directive.171

A foreign company must provide complete documentation for its equipment to the distributor who will register them. Complete and correct documentation determines the outcome of registration and the length of registration process. Further information on the required documentation for

171 http://asean.org/storage/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf

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different classes of medical devices is available here: Guidelines for the Registration of Medical Device Products (19 June 2014).172

Companies wishing to export their medical devices to the Philippines should also review the list of devices, which are subject to registration, under the FDA Memorandum Circular 2014-005. They can review the list here.173

4.4 Government Tenders

The Philippine Government Electronic Procurement System174 (PhilGEPS) is the single, centralised electronic portal that serves as the primary and definitive source of information on government procurement in the Philippines. Government agencies, as well as suppliers, contractors, manufacturers, distributors and consultants, are mandated to register and use the system in the conduct of procurement of goods, civil works and consulting services. PhilGEPS makes available information on all government procurement and bid opportunities, allows obtaining bid documents electronically, gives access to government agencies’ annual procurement plans, uploads product catalogue advertisements, sends automatic notifications for new opportunities and lets suppliers print their own PhilGEPS Certificate of Registration.

As a general rule, eligible bidders should be at least 60% Filipino Equity. The exception however is that foreign bidders are eligible to participate when provided for under treaty or international agreement; when the foreign supplier is a citizen, corporation, association of a country, the laws or regulations of which grant reciprocal rights or privileges to citizens, corporations, associations of the Philippines; when the goods sought to be procured are not available from local suppliers; or when there is a need to prevent situations that defeat competition or restrain trade.

172 http://www.fda.gov.ph/attachments/article/175544/FInal%20Draft%20of%20the%20New%20Sets%20of%20guidelines%20for%20the%20 Registration%20of%20Medical%20Device%20Products,%20edited%2019June2014.pdf 173 http://www.fda.gov.ph/attachments/article/146828/FMC2014-005%20- %20Updated%20List%20of%20Medical%20Devices%20required%20to%20be%20Registered%20Prior%20to%20Sale,%20Distribution%20 and%20Use.pdf 174 https://philgeps.gov.ph/

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Government Procurement

The national government, its departments, bureaus, offices and agencies, including state universities and colleges, government-owned and/or-controlled corporations, government financial institutions and local government units are in charge of procuring their own good services. To promote transparency and efficiency, information and communications technology shall be utilised in the conduct of procurement procedures. Procuring entities are required to post all procurement opportunities, results of bidding and related information in the PhilGEPS bulletin board.

The Procuring Entity or its duly authorised representative, in order to promote economy and efficiency, may resort to any of the following methods of procurement:

 Competitive Bidding - a method of procurement which is open to participation by any interested party and which consists of the following processes: advertisement, pre-bid conference, eligibility screening of prospective bidders, receipt and opening of bids, evaluation of bids, post-qualification, and award of contract. This is the usual method of procurement by government entities.

 Limited Source Bidding, otherwise known as Selective Bidding – a method of procurement that involves direct invitation to bid by the procuring entity from a set of preselected suppliers or consultants with known experience and proven capability relative to the requirements of a particular contract.

 Direct Contracting, otherwise known as Single Source Procurement – a method of procurement that does not require elaborate bidding documents because the supplier is simply asked to submit a price quotation or a pro-forma invoice together with the conditions of sale, which may be accepted immediately or after some negotiations.

 Repeat Order – a method of procurement that involves a direct procurement of goods from the previous winning bidder, whenever there is a need to replenish goods procured under a contract previously awarded through competitive bidding.

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 Shopping – a method of procurement whereby the procuring entity simply requests for the submission of price quotations for readily available off-the-shelf goods or ordinary/regular equipment to be procured directly from suppliers of known qualification.

 Negotiated Procurement – a method of procurement whereby the procuring entity directly negotiates a contract with a technically, legally and financially capable supplier, contractor or consultant.

4.5 Consumer Protection and Quality Standards

The Consumer Act of the Philippines is the policy of the State that protects the interests of the consumer, promotes his general welfare and, establishes standards of conduct for business and industry. The Department of Health is the implementing and regulating agency under the Consumer Act for food, drugs, cosmetics and medical devices.

Any consumer product offered for importation into the Philippines shall be refused if such product:

 Fails to comply with an applicable consumer and product quality and safety standard.

 Is or has been determined injurious, unsafe and dangerous.

 Is substandard and has material defect.

Two separate bureaus under the Department of Trade and Industry, namely the Bureau of Philippine Standards (BPS) and the Philippine Accreditation Bureau (PAB), oversee quality standards and accreditation in the country.

The BPS develops, promulgates, implements, and promotes standardisation activities as mandated by Republic Act No. 4109 (Standards Law) and Republic Act No. 7394 (Consumer Act of the Philippines). The BPS maintains its certification to ISO 9001 from Certification International Philippines, Inc.

The PAB, formerly Philippine Accreditation Office, is responsible for the accreditation of conformity assessment bodies in the Philippines.

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Standards Development

The BPS formulates Philippine National Standards or adopts relevant international or foreign standards to help industries produce quality products or services and raise productivity. These standards also help consumers evaluate product performance and safety. Some of these include the family of international standards on Quality Management System (ISO 9000), Environmental Management System (ISO 14000), and Quality System for Calibration and Testing Laboratories (ISO 17025) that apply to both the manufacturing and services sectors. The Philippines is a member to the International Organisation for Standardisation or ISO, the world's largest developer of voluntary international standards, composed of 161 member countries which are national standards bodies around the world. ISO develops international standards on quality, safety and efficiency of products, services, and systems from technology to food safety, agriculture and healthcare.

Product Testing

BPS offers third-party testing of electrical, electronic, chemical, mechanical, calibration, and consumer products through its BPS Testing Centre to verify conformity to Philippine National Standards requirements that support the Philippine Standard (PS) and Import Commodity Clearance (ICC) product certification schemes.

Labelling and Marking

To guide the consumers in the purchase of products, including electrical, and electronics, consumer and chemical and construction and building materials, consumers are encouraged to look for the PS and ICC marks on the product or, if not feasible because of the nature and/ or size of the product, on its accompanying packaging.

Product Certification

The BPS implements mandatory product certification schemes for certain products divided into categories, namely, building and construction, electrical and electronics, chemical and consumer products. The BPS subjects these products under its list of Philippine National Standards for

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mandatory certification to inspection and testing methods prior to distribution and sale in the Philippine market with the necessary PS or ICC marks.

Accreditation

The PAB is responsible for the accreditation of conformity assessment bodies in the Philippines. It is recognised internationally with its membership to the International Accreditation Forum (IAF), International Laboratory Accreditation Cooperation (ILAC), Pacific Accreditation Cooperation (PAC), Asia Pacific Laboratory Accreditation Cooperation (APLAC). PAB is also a signatory to the Multilateral Recognition Arrangement for Quality Management System and Environmental Management System of PAC and IAF; and Mutual Recognition Arrangement for testing and calibration of APLAC and ILAC.

Quality Standard for Medical Devices

All importers and distributors of medical devices in the Philippines are required to submit a Government certificate attesting to the status of the manufacturer‘s competency and reliability of the personnel and facilities or Quality Systems Certificate of approval or compliance certificate with ISO 9000 series or ISO 13485. For imported medical devices, the certificate shall be duly authenticated by the territorial Philippine Consulate.

The certificate of medical device notification and certificate of medical device registration are documents issued by the CDRRHR for the importation and distribution of medical devices in the Philippines.

 Certificate of Medical Device Notification – refers to the authorisation issued to a medical device that complies with all the requirements for the import and distribution of Class A medical devices in the Philippines.

 Certificate of Medical Device Registration– refers to the authorisation issued to a medical device that complies with all the requirements for the import and distribution of Class B, C, and D medical devices in the Philippines.

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5. Annex

5.1 List of Useful Contacts

Department of Health San Lazaro Compound, Tayuman, Sta. Cruz, Manila Philippines 1003 Tel: +632 651 7800 Fax: +632 711 6744 Website: http://www.doh.gov.ph/

Department of Science and Technology (DOST) DOST Building, Gen. Santos Avenue Bicutan, Taguig City Metro Manila 1631 Philippines Tel: +632 837 2071 to 82 Fax: +632 837 2937 Website: http://www.dost.gov.ph

Philippine Medical Association (PMA) PMA Bldg., North Avenue, Quezon City, Philippines, 1105 Tel: +632 929 7361 Fax: +632 929 6951 Website: www.philippinemedicalassociation.org

Pharmaceutical & Healthcare Association of the Philippines (PHAP) Unit 502 One Corporate Plaza, 845 Pasay Road, Makati City Philippines, 1254 Tel: +632 865 5600 Fax: +632 816 0618 Website: www.phap.org.ph

Philippine Hospital Association (PHA) 14 Kamias Road, Quezon City, Metro Manila, Philippines 1102 Tel: +632 922 7674 Website: www.pha.org.ph

Philippine Association of Medical Device Regulatory Affairs Professionals (PAMDRAP) Block 3 Lot 9, Alabang-Zapote Road, Veraville Townhomes Pamplona Tres, Las Pinas, Metro Manila, Philippines 1740 Tel: +632 9475 248322 Website: www.pamdrap.org

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National Telehealth Center (NTHC) University of the Philippines Manila 3rd Floor IT Complex, Philippine General Hospital Taft Avenue Ermita Manila, Philippines 1000 Tel: +632 509 1003 Website: www.telehealth.ph

Philippine Council for Health Research and Development (PCHRD) Saliksik Building, DOST Compound, Gen. Santos Ave. Bicutan Taguig City 1631 Philippines Tel: +632 837 7537 Fax: +632 837 2924 Website: www.pchrd.dost.gov.ph/

Healthcare Information Management Outsourcing Association of the Philippines (HIMOAP) IBPAP Office, C2 Building, Bonifacio Highstreet Central 28th Street corner 7th Avenue, Bonifacio Global City Taguig City, Philippines 1630 Tel: +632 817 2727 Website: www.himoap.com

Health Informatics Management Association of the Philippines (HIMAP) BPAP Office, C2 Building, Bonifacio Highstreet Central 28th Street corner 7th Avenue, Bonifacio Global City,Taguig City Philippines Tel: +632 817 2727 loc. 117 Website: http://himap.ph/

Philippine Dental Association Ayala Avenue Corner Kamagong Street, Makati Philippines Tel: +632 899 6332 Website: www.philippinedentalassociation.info

Philippine Heart Association (PHA) Suite 1108, 11th Flr. East Tower, PSE Centre, Exchange Road Ortigas Center, Pasig City, Philippines Tel: +63 2 470 5525, 470 5528 Website: www.philheart.org

Philippine Health Insurance Corporation (PhilHealth) Citystate Centre, 709 Shaw Blvd.,1603 Pasig City, Philippines Tel: +632 441 7444 Website: www.philhealth.gov.ph

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5.2 Starting a Business in the Philippines

Why the Philippines?

The Philippines has emerged as an attractive market for foreign companies due to its strong economic, democratic and demographic fundamentals. Moreover, the country, with its strategic location, is a gateway to the dynamic Asian market.

Finding a Distributor in the Philippines

An agent or distributor arrangement is the most common method in entering the Philippine market. Partnering with a local business is also recommended, as entering the Philippine market presents some challenges to foreign companies. This is due in part to a limited number of family-owned conglomerates that dominate key sectors and, in some cases, create high barriers to entry.

Philippines-based trade associations, chambers of commerce, and foreign commercial offices within EU Member State embassies are all good places to start the search for a distributor in the country. International business consultants with experience in helping foreign companies can also prove invaluable by facilitating introductions to qualified distributors. It is always best to meet a prospective distributor in person, and to check references.

Registering your business

The SEC, the Securities and Exchange Commission, is the government agency responsible for the registration, licensing, regulation, and supervision of all corporations and partnerships organised in the Philippines, including foreign corporations licensed to engage in business or to establish branch offices in the Philippines. Registration with the SEC grants the entity with the corporate franchise or juridical personality to operate and transact business in the Philippines.

The processing and approval of the papers generally take around 15 working days from official acceptance of the application.

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A majority of the directors must be residents of the Philippines. The number of directors must be at least five but not more than 15. Hence, if there are five directors, at least three must be residents.

At least 25% of the authorised capital stock of a domestic corporation must be subscribed and at least 25% of the subscription must be paid. However, subscriptions by alien individuals or foreign entities must generally be fully paid, except in cases where the law provides for the specific amount of paid-up capital.

Government Agencies

The government of the Philippines provides support and assistance to help businesses grow in the country. European companies looking to set up, operate and establish a business in the Philippines will find it easier with assistance from the following government agencies:

 The Philippine Board of Investments, an attached agency of the Department of Trade and Industry, is the lead government agency responsible for the promotion of investments in the Philippines. Taking the lead in the promotion of investments, the board assists Filipino and foreign investors to venture and prosper in desirable areas of economic activities. It assists businesses with the following services:

▪ Advisory, Actualisation and Aftercare

▪ Industry Updates and Information

▪ Marketing & Promotions

▪ Incentives

▪ Policy Advocacy

 The Philippine Economic Zone Authority is attached to the Department of Trade and Industry and is tasked to promote investments, extend assistance, register, grant incentives to and facilitate the business operations of investors in export-oriented manufacturing and service facilities inside selected areas throughout the country. It oversees and administers incentives to developers/operators of, and locators in, world-class, ready-to-occupy, environmentally-friendly, secured and competitively priced Special Economic Zones.

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Business Locations

The urban centres of Metro Manila, Metro Cebu, and Davao City, as well as the government- owned and private special economic zones, are magnets of economic activities. The Philippine Assistance Programme is helping in the acceleration of regional development by sponsoring projects in Calabarzon (Cavite, Laguna, Batangas, Rizal, and Quezon Provinces), Iloilo, Samar, the Iligan-Cagayan de Oro corridor, and General Santos. The Calabarzon Project has resulted in the proliferation of privately-owned industrial estates to address the needs of foreign investors.

The Subic Naval Base in Olongapo City, the Clark Air Base in Angeles City, and other former US military bases with excellent infrastructure were converted into special economic zones. The Bases Conversion Development Authority succeeded in taking over these installations and implementing its master plans for these areas.

Investors’ interest in these areas has been tremendous and is perceived to be sustainable over the next five to ten years. The main factors for increased investors’ interest in these areas include fiscal incentives, full administration support for the development of these areas, strategic location, and excellent infrastructure, particularly the presence of an excellent harbour and international airports that meet global standards in both Subic and Clark.

Recently, the government has taken significant strides in promoting the country as an attractive information technology destination. As of January 2015, it has created 209 IT Parks and Centres which have been proclaimed as IT Ecozones by the President of the Philippines and are now registered with the Philippine Economic Zone Authority. The digitisation and improvements in information and communications technologies (ICT) have also disrupted the healthcare sector with the healthcare IT industry expected to reach US$ 60 million by 2019. These developments are opening up new, strategic business opportunities in major hospitals and clinics across the country to implement ICT solutions.

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5.3 Useful Statistics

Indicator 2013 2014 Growth Rate

Total Health Expenditure (in million pesos, at current prices) 530,283.2 585,307.3 10.4

Total Health Expenditure (in million pesos, at constant 2006 prices) 395,733.7 419,575.1 6.0

Per Capita Health Expenditure (in pesos, at current prices) 5,400.0 5,858.9 8.5

Per Capita Health Expenditure (in pesos, at constant 2006 prices) 4,029.9 4,200.0 4.2

Population (in millions) 98.2 99.9 1.7

Gross Domestic Product (GDP, in billion pesos, at current prices) 11,538.4 12,645.1 9.6

Gross National Income (GNI, in billion pesos, at current prices) 14,019.0 15,306.0 9.2

Total Health Expenditure as % of GDP 4.6 4.6 0.7

Total Health Expenditure as % of GNI 3.8 3.8 1.1 Table 26: Philippine National Health Accounts, 2013-2014 Source: Philippine Statistics Authority Unit: Philippine Peso (PHP)

Source of Funds 2013 2014 Growth Rate GOVERNMENT 103,467.5 101,137.2 -2.3 National Government 66,915.1 61,815.7 -7.6 Local Government 36,552.4 39,321.5 7.6 SOCIAL INSURANCE 60,373.1 83,323.6 38.0 National Health Insurance Program 60,299.4 83,280.9 38.1 Employees' Compensation 73.6 42.7 -42.0 PRIVATE SOURCES 359,207.4 395,343.2 10.1 Private Out-of-Pocket 296,501.6 326,786.6 10.2 Private Insurance 9,228.4 10,111.1 9.6 Health Maintenance Organisations 36,814.3 40,443.1 9.9 PRIVATE ESTABLISHMENTS 11,752.0 12,819.3 9.1 Private Schools 4,911.1 5,183.2 5.5 REST OF THE WORLD 7,235.2 5,503.2 -23.9 Grants 7,235.2 5,503.2 -23.9 ALL SOURCES 530,283.2 585,307.3 10.4 Table 27: Health Expenditure by Source of Funds, 2013-2014 Source: Philippine Statistics Authority Unit: Philippine Peso (PHP) Millions

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Number of Hospitals Bed Capacity Bed capacity Year per 10,000 population Total Government Private Total Government Private

2010 1,812 730 1,082 98,155 49,372 48,783 10.6 2011 1,819 732 1,087 101,914 51,317 50,597 10.7 2012 1,825 730 1,095 101,366 49,557 51,809 10.5 2013 1,454 542 912 96,796 46,054 50,742 9.9 2014 1,222 452 770 98,429 48,384 50,045 9.9 Table 28: Government and Private Hospitals Number and Bed Capacity, 2010-2014 Source: Philippine Statistics Authority

Region Doctors Dentists Nurses Midwives

NCR 632 509 866 1,208

CAR 94 28 227 689 1 162 108 295 994 2 109 71 239 839 3 299 178 585 1,638 4-A 235 167 580 1,489 4-B 86 55 165 592 5 173 74 271 1,048 6 250 125 465 1,740 7 257 118 620 1,577 8 161 88 290 913 9 92 43 234 671 10 101 50 286 901 11 81 53 126 735 12 118 60 531 981 13 82 36 128 611 ARMM 70 25 153 525

Total 3,002 1,788 6,061 17,151

Table 29: Number of Government Doctors, Nurses, Dentists and Midwives by Region, 2014 Source: Philippine Statistics Authority

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Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016

World 14,477 15,341 13,818 18,914 33,260

Japan 2,297 2,376 2,463 1,830 7,502

China 2,528 4,739 3,656 5,615 7,368

Thailand 1,630 1,414 1,133 2,123 4,865

Viet Nam 4,479 3,411 2,894 3,275 4,145

Singapore 1,186 756 884 1,152 2,141

United States of America 236 340 284 701 1,283

Malaysia 672 388 504 659 1,202

Hong Kong, China 87 138 200 224 865

India 132 130 154 149 715

United Kingdom 29 242 581 1,122 406 Table 30: Imports of Wadding, gauze, bandages and the like (adhesive) Source: Trade Map Unit: US Dollar thousand

Exported Exported Exported Exported Exported Importers value in 2012 value in 2013 value in 2014 value in 2015 value in 2016

World 3,459 4,721 6,920 7,728 8,458

Japan 1,180 2,874 4,068 4,380 4,358

Hong Kong, China 453 237 749 1,098 979

Netherlands 147 6 378 459 681

Singapore 165 227 296 432 401

Australia 85 25 72 276 393

United States of America 527 155 294 146 302

Malaysia 168 61 156 229 285

Lebanon 0 0 0 0 215

Nigeria 0 0 0 0 212

Korea, Republic of 219 265 386 302 211 Table 31: Exports of Wadding, gauze, bandages and the like (Adhesive) Source: Trade Map Unit: US Dollar thousand

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Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016

World 7,349 7,174 6,766 9,233 16,553

China 1,176 1,749 2,148 2,846 5,087

Thailand 1,404 1,213 1,012 1,897 4,333

Japan 1,581 1,286 578 430 1,359

Malaysia 662 375 504 645 1,202

United States of America 85 221 162 371 823

Singapore 1,186 710 763 841 691

Hong Kong, China 6 12 53 57 667

France 1 6 42 432 402

Taipei, Chinese 39 82 22 117 386

Netherlands 61 0 2 2 353 Table 32: Imports of Wadding, gauze, bandages and the like (non-adhesive) Source: Trade Map Unit: US Dollar thousand

Exported Exported Exported Exported Exported Importers value in 2012 value in 2013 value in 2014 value in 2015 value in 2016

World 3,107 3,758 5,239 6,524 7,955

Japan 1,180 2,874 4,068 4,380 4,358

Hong Kong, China 393 82 174 615 866

Netherlands 147 6 74 181 632

Singapore 90 58 195 376 365

Australia 84 25 61 189 329

United States of America 499 155 294 146 302

Malaysia 81 0 39 177 266

Lebanon 0 0 0 0 215

Nigeria 0 0 0 0 212

Korea, Republic of 219 0 53 195 159 Table 33: Exports of Wadding, gauze, bandages and the like (non-adhesive) Source: Trade Map Unit: US Dollar thousand

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Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 7,015 9,440 13,002 15,265 12,295

Singapore 3,515 3,986 6,034 6,494 3,730

China 1,550 2,239 3,280 4,263 3,616

United States of America 262 946 625 1,141 970

Spain 0 44 511 652 817

Japan 891 956 968 1,247 751

Germany 50 62 138 215 571

Korea, Republic of 92 182 350 226 471

United Kingdom 4 7 210 249 194

India 94 219 94 29 182

Taipei, Chinese 25 16 183 80 180 Table 34: Imports of Syringes, with or without needles, used in medical, surgical, dental or veterinary sciences Source: Trade Map Unit: US Dollar thousand

Exported Exported Exported Exported Exported Importers value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 110,005 145,603 256,200 264,146 131,375

Japan 4,834 21,187 105,474 55,996 32,179

Thailand 5,263 8,957 19,238 90,444 16,747

Mexico 4,433 5,872 5,797 6,213 15,574

Canada 6,555 4,085 2,468 1,639 11,726

Belgium 24,962 31,986 53,662 22,973 11,336

United States of America 27,036 16,628 7,790 7,169 8,006

Indonesia 6,904 19,961 23,746 25,798 6,919

Taipei, Chinese 7,348 7,384 11,681 9,709 6,883

Australia 6,315 5,276 5,177 12,803 5,953

Saudi Arabia 3,300 3,113 2,334 2,799 2,806 Table 35: Exports of Syringes, with or without needles, used in medical, surgical, dental or veterinary sciences Source: Trade Map Unit: US Dollar thousand

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Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 730 1,820 1,606 1,511 4,957

Singapore 275 852 775 546 2,352

Japan 64 133 14 158 762

China 109 219 341 133 578

United States of America 18 16 44 12 251

Thailand 128 237 145 143 217

Belgium 0 163 36 214 204

Malaysia 64 72 79 99 96

India 0 0 8 41 69

France 4 1 0 2 64

Korea, Republic of 43 17 43 20 60 Table 36: Imports of Tubular metal needles and needles for sutures, used in medical, surgical, dental or veterinary sciences Source: Trade Map Unit: US Dollar thousand

Exported Exported Exported Exported Exported Importers value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 3,232 14,567 42,625 42,891 10,022

United States of America 1 406 906 3,194 4,731

Belgium 3,167 1,241 13,593 36,831 3,492

Saudi Arabia 0 0 0 19 639

Japan 62 12,787 27,335 1,900 544

Argentina 0 0 0 0 298

Thailand 0 0 20 367 127

United Arab Emirates 0 0 0 0 84

Brazil 0 51 727 422 80

India 0 0 0 15 9

Canada 0 6 3 0 7 Table 37: Exports of Tubular metal needles and needles for sutures, used in medical, surgical, dental or veterinary sciences Source: Trade Map Unit: US Dollar thousand

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Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 22,661 22,390 27,711 34,690 47,400

Singapore 6,975 7,433 6,865 10,071 10,183

Netherlands 4,396 2,863 3,961 8,458 9,380

United States of America 2,302 1,651 3,408 3,916 6,704

China 1,745 1,726 2,635 3,387 4,969

Malaysia 1,587 1,918 2,965 2,456 4,364

Japan 1,027 2,269 705 655 2,900

Taipei, Chinese 1,043 844 1,367 1,206 1,848

India 584 995 779 912 1,210

Germany 864 1,175 1,450 606 1,120

Korea, Republic of 205 244 160 104 1,079 Table 38: Imports of Needles, catheters, cannulae and the like, used in medical, surgical, dental or veterinary sciences (excluding syringes, tubular metal needles and needles for sutures) Source: Trade Map Unit: US Dollar thousand

Exported Exported Exported Exported Exported Importers value in 2012 value in 2013 value in 2014 value in 2015 value in 2016

World 122,955 62,431 35,700 26,016 36,784

Japan 80,445 17,478 25,864 16,541 22,698

United States of America 233 17 218 2,296 2,940

Canada 324 80 0 56 2,496

Hong Kong, China 1,073 330 23 0 2,186

Taipei, Chinese 7,278 8,803 808 53 1,785

Belgium 1,273 1,783 0 0 1,481

Korea, Republic of 1,210 506 8,537 4,001 712

Turkey 0 0 0 263 525

Argentina 266 0 0 0 356

Viet Nam 424 398 152 150 321 Table 39: Exports of Needles, catheters, cannulae and the like, used in medical, surgical, dental or veterinary sciences (excluding syringes, tubular metal needles and needles for sutures) Source: Trade Map Unit: US Dollar thousand

Healthcare & Medical Technologies - Philippines Market Study - Page 206 of 227

Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 2,389 2,609 3,222 3,387 3,607

Bulgaria 0 22 769 1,065 1,217

Singapore 306 648 1,046 581 932

China 180 338 471 255 287

Hong Kong, China 41 37 77 347 286

United States of America 317 397 216 373 182

Germany 572 109 99 250 179

Japan 237 202 131 275 164

Malaysia 74 606 277 0 119

India 4 24 17 53 59

Canada 0 0 0 23 55 Table 40: Imports of Electro-cardiographs Source: Trade Map Unit: US Dollar thousand

Exported Exported Exported Exported Exported Importers value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 95 17 282 99 1,119

Malaysia 0 0 0 16 836

Netherlands 0 0 0 0 181

Singapore 0 8 89 4 102

China 0 0 109 17 1

Korea, Republic of 0 0 13 0 0

Belgium 0 2 0 0 0

Brazil 33 0 0 0 0

Costa Rica 0 2 3 47 0

Italy 0 0 8 0 0

Japan 51 0 4 1 0 Table 41: Exports of Electro-cardiographs Source: Trade Map Unit: US Dollar thousand

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Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 11,902 15,107 12,302 11,729 19,955

Korea, Republic of 4,120 5,004 4,751 2,501 5,762

United States of America 2,344 3,222 2,266 4,019 2,817

Germany 606 293 161 48 2,700

China 925 1,140 1,576 1,693 1,956

Singapore 877 1,254 714 562 1,883

Japan 2,533 2,324 855 1,174 1,810

Hong Kong, China 73 549 391 811 828

Norway 0 146 396 78 671

Israel 0 575 687 0 410

Thailand 0 0 75 3 266 Table 42: Imports of Ultrasonic scanning apparatus Source: Trade Map Unit: US Dollar thousand

Exported Exported Exported Exported Exported Importers value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 240 2,141 4,306 1,826 1,955

United States of America 26 1,230 1,800 788 1,016

Germany 0 723 1,913 894 832

Singapore 19 26 41 64 49

Japan 0 0 6 0 22

Korea, Republic of 0 0 39 8 10

Malaysia 0 0 0 0 8

Taipei, Chinese 0 0 0 12 8

Australia 0 85 179 60 7

Canada 0 0 62 0 3

Brazil 1 0 0 0 0 Table 43: Exports of Ultrasonic scanning apparatus Source: Trade Map Unit: US Dollar thousand

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Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 3,614 3,281 1,520 4,310 10,058

United States of America 0 299 9 540 2,274

Hong Kong, China 1,020 0 0 818 2,147

China 579 1,224 6 1,579 2,128

Netherlands 779 328 325 2 1,577

Germany 78 633 113 3 848

Japan 442 0 711 1,166 788

Singapore 658 779 354 171 137

Bulgaria 0 0 0 0 100

Denmark 0 0 0 0 50

India 0 0 0 1 8 Table 44: Imports of Magnetic resonance imaging apparatus Source: Trade Map Unit: US Dollar thousand

Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 410 496 428 1,079 1,373

Hong Kong, China 0 170 9 64 998

Israel 0 0 0 173 142

Denmark 0 0 0 125 103

Germany 24 5 0 2 66

France 38 0 0 20 29

Korea, Republic of 0 0 0 14 18

United States of America 334 12 0 204 9

Singapore 0 6 0 22 6

Netherlands 0 0 0 0 2

Argentina 0 0 0 142 0 Table 45: Imports of Scintigraphic apparatus Source: Trade Map Unit: US Dollar thousand

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Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 9,078 7,139 6,400 9,310 19,625 United States of America 1,948 2,274 1,628 3,367 8,832 Germany 1,935 521 129 369 2,206 Singapore 1,507 630 660 1,157 1,589 Japan 2,074 62 737 1,090 1,502 Korea, Republic of 177 76 119 311 1,226 Hong Kong, China 49 424 333 883 988 France 161 14 7 97 846 China 498 2,023 2,354 897 456 Denmark 124 105 87 89 441 Finland 0 0 0 1 429 Table 46: Imports of Electro-diagnostic apparatus, incl. apparatus for functional exploratory examination or for checking physiological parameters (excluding electro-cardiographs, ultrasonic scanning apparatus, magnetic resonance imaging apparatus and scintigraphic apparatus) Source: Trade Map Unit: US Dollar thousand

Exported Exported Exported Exported Exported Importers value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 230 1,873 2,916 2,434 1,916 United States of America 205 52 0 99 1,095 Germany 6 68 63 0 218 Italy 0 1,598 1,978 1,581 198 Japan 0 3 324 195 86 Poland 0 0 0 260 84 Korea, Republic of 0 0 0 0 45 Singapore 4 28 8 8 41 Australia 0 85 20 0 38 Latvia 0 0 30 33 25 Austria 0 0 10 0 17 Table 47: Exports of Electro-diagnostic apparatus, incl. apparatus for functional exploratory examination or for checking physiological parameters (excluding electro-cardiographs, ultrasonic scanning apparatus, magnetic resonance imaging apparatus and scintigraphic apparatus) Source: Trade Map Unit: US Dollar thousand

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Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016

World 831 677 840 457 612

Japan 140 580 54 208 296

United States of America 182 22 268 217 168

Korea, Republic of 3 6 8 0 50

Hong Kong, China 0 0 6 3 48

Hungary 0 0 0 0 16

Turkey 0 0 1 5 9

China 47 28 128 0 4

Germany 0 24 0 2 4

Viet Nam 0 0 0 0 4

United Kingdom 435 0 4 5 4 Table 48: Imports of Ultraviolet or infra-red ray apparatus used in medical, surgical, dental or veterinary sciences Source: Trade Map Unit: US Dollar thousand

Exported Exported Exported Exported Exported Importers value in 2012 value in 2013 value in 2014 value in 2015 value in 2016

World 48,943 42,177 39,319 12,855 13,062

United States of America 34,718 32,081 31,117 10,185 8,035

Germany 9,402 3,565 3,671 1,081 2,667

Malaysia 81 723 1,392 829 1,290

Japan 351 198 468 68 327

Mongolia 0 13 0 0 203

Canada 477 869 544 67 190

Korea, Republic of 0 8 95 68 135

Singapore 89 242 321 126 120

Australia 2,300 3,170 940 431 68

Thailand 0 5 0 0 14 Table 49: Exports of Ultraviolet or infra-red ray apparatus used in medical, surgical, dental or veterinary sciences Source: Trade Map Unit: US Dollar thousand

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Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016

World 33,740 35,512 41,396 57,096 78,674 United States of America 5,109 6,925 6,966 19,485 22,899 Japan 3,826 7,790 5,575 7,938 11,918 China 4,171 7,179 4,201 7,117 11,442 Singapore 4,027 2,969 4,436 4,089 7,009 Germany 7,672 4,399 6,074 6,816 6,681 Korea, Republic of 1,869 1,362 2,222 3,468 4,528 Switzerland 447 451 23 199 2,142 United Kingdom 628 8 547 334 1,982 Hong Kong, China 373 218 185 1,277 1,537 Thailand 26 28 72 648 1,230 Table 50: Imports of Apparatus based on the use of X-rays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses Source: Trade Map Unit: US Dollar thousand

Exported Exported Exported Exported Exported Importers value in 2012 value in 2013 value in 2014 value in 2015 value in 2016

World 4,568 2,310 18,613 32,795 28,408 United States of America 731 615 2,567 9,585 8,613 Japan 881 47 7,543 8,639 7,603 Netherlands 585 0 2,109 5,659 4,752 China 412 142 2,467 3,712 3,825 Korea, Republic of 134 20 1,004 872 854 India 118 20 537 526 589 Singapore 31 688 658 648 430 Canada 21 39 67 164 226 Germany 0 6 252 117 223 Viet Nam 632 0 63 227 195 Table 51: Exports of Apparatus based on the use of X-rays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses Source: Trade Map Unit: US Dollar thousand

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Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 2,891 6,995 4,992 5,338 17,406

United States of America 294 1,337 708 127 5,615

China 2,062 4,799 1,538 2,563 5,326

Japan 51 845 1,632 1,244 5,084

Germany 469 0 306 1,280 836

India 0 0 0 0 345

Israel 0 0 346 0 179

Australia 0 6 0 0 21

Korea, Republic of 0 0 0 30 0

Denmark 0 0 0 56 0

Taipei, Chinese 0 0 0 38 0 Table 52: Imports of Computer tomography apparatus Source: Trade Map Unit: US Dollar thousand

Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 114 116 403 526 551

Korea, Republic of 67 63 306 349 233

Italy 36 41 40 130 123

Japan 9 12 20 28 81

France 0 0 0 14 59

Poland 0 0 0 0 35

Canada 0 0 0 0 14

India 0 0 0 0 4

China 2 0 6 0 1

Germany 0 0 28 0 0

Netherlands 0 0 0 1 0 Table 53: Imports of Apparatus based on the use of X-rays for dental uses Source: Trade Map Unit: US Dollar thousand

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Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 7,274 8,106 9,035 16,305 25,542

United States of America 468 1,543 719 8,874 12,998

Germany 3,446 1,499 2,644 2,107 2,452

Japan 1,581 2,139 771 1,249 1,958

Korea, Republic of 120 361 465 1,300 1,787

United Kingdom 2 0 0 135 1,321

China 21 556 100 519 1,285

Singapore 630 424 136 29 844

Spain 123 116 721 89 606

Belgium 57 180 153 353 573

India 159 265 38 144 483 Table 54: Imports of Apparatus based on the use of X-rays, for medical, surgical or veterinary uses (excluding for dental purposes and computer tomography apparatus) Source: Trade Map Unit: US Dollar thousand

Exported Exported Exported Exported Exported Importers value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 0 13 0 7,032 4,980

United States of America 0 0 0 5,740 4,552

Korea, Republic of 0 0 0 190 173

Canada 0 0 0 85 130

Singapore 0 0 0 94 53

Germany 0 0 0 37 38

Australia 0 0 0 886 33

Malaysia 0 0 0 0 1

India 0 13 0 0 0 Table 55: Exports of Apparatus based on the use of X-rays, for medical, surgical or veterinary uses (excluding for dental purposes and computer tomography apparatus) Source: Trade Map Unit: US Dollar thousand

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Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 1,017 532 1,158 967 936

United States of America 353 146 471 353 440

Singapore 555 238 587 511 244

India 0 0 16 10 89

United Kingdom 0 0 12 37 68

Australia 0 0 0 4 24

Netherlands 0 0 0 19 17

Korea, Republic of 3 33 7 0 12

Italy 0 0 0 0 10

France 0 15 23 0 7

Taipei, Chinese 0 0 0 0 7 Table 56: Imports of X-ray tubes Source: Trade Map Unit: US Dollar thousand

Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016

World 41 134 283 512 615

Germany 1 13 82 162 233

Hong Kong, China 6 55 32 202 222

Austria 0 0 0 15 45

Japan 0 0 0 17 25

Korea, Republic of 0 0 23 30 24

Switzerland 0 12 95 3 20

Singapore 3 0 0 0 13

Australia 0 0 0 0 12

United States of America 13 15 0 3 11

China 13 2 10 63 7 Table 57: Imports of Dental drill engines, whether or not combined on a single base with other dental equipment Source: Trade Map Unit: US Dollar thousand

Healthcare & Medical Technologies - Philippines Market Study - Page 215 of 227

Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 3,242 2,860 2,255 3,880 3,514

Switzerland 329 287 307 464 848

United States of America 147 238 161 258 590

Germany 278 658 247 389 572

Canada 0 0 2 47 234

Hong Kong, China 427 344 251 608 220

Pakistan 33 9 33 19 220

China 89 116 239 1,361 182

Singapore 612 766 629 27 129

Japan 255 286 103 28 74

Korea, Republic of 13 1 51 79 70 Table 58: Imports of Instruments and appliances used in dental sciences, n.e.s. Source: Trade Map Unit: US Dollar thousand

Exported Exported Exported Exported Exported Importers value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 235 45 75 350 415

Japan 233 44 75 344 397

Germany 0 0 0 3 15

Netherlands 0 0 0 0 2

United Kingdom 0 0 0 0 1

Australia 0 1 0 0 0

Hong Kong, China 1 0 0 0 0

Lebanon 0 0 0 2 0

Pakistan 0 0 0 0 0

Singapore 0 0 0 0 0

United States of America 1 0 0 0 0 Table 59: Exports of Instruments and appliances used in dental sciences, n.e.s. Source: Trade Map Unit: US Dollar thousand

Healthcare & Medical Technologies - Philippines Market Study - Page 216 of 227

Imported Imported Imported Imported Imported Exporters value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 64,093 71,235 74,660 95,853 111,397

Germany 16,823 20,638 21,261 22,446 29,460

Singapore 6,929 6,026 10,046 16,815 23,023

United States of America 10,900 12,946 9,151 14,238 14,703

China 4,962 6,528 7,632 8,664 9,637

Japan 5,985 6,813 8,238 5,905 8,660

Malaysia 4,714 4,622 3,954 6,083 4,314

France 2,719 2,515 1,033 1,483 2,889

Hong Kong, China 2,502 727 2,031 1,830 2,482

Costa Rica 215 82 64 668 1,952

Korea, Republic of 637 1,603 1,200 1,470 1,523 Table 60: Imports of Instruments and appliances used in medical, surgical or veterinary sciences, n.e.s. Source: Trade Map Unit: US Dollar thousand

Exported Exported Exported Exported Exported Importers value in 2012 value in 2013 value in 2014 value in 2015 value in 2016 World 14,515 11,203 3,233 168,640 20,575

United States of America 176 733 587 7,583 7,006

Korea, Republic of 1,614 258 750 154,945 6,340

Japan 11,678 8,057 406 1,609 3,478

Germany 20 1,601 1,086 1,821 1,983

Singapore 22 98 50 395 522

Hong Kong, China 0 0 4 1,069 460

Malaysia 2 0 124 226 375

Canada 0 4 6 98 93

Thailand 9 3 10 36 71

Australia 0 205 23 319 41 Table 61: Exports of Instruments and appliances used in medical, surgical or veterinary sciences, n.e.s. Source: Trade Map Unit: US Dollar thousand

Healthcare & Medical Technologies - Philippines Market Study - Page 217 of 227

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