REFERENCE CODE GDHC0074CHR PUBLICATION DATE NOVEMBER 2014 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE

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1 REFERENCE CODE GDHC0074CHR PUBLICATION DATE NOVEMBER 2014 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE

2 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Executive Summary Singapore s healthcare market is driven by universal access to health insurance schemes and world-class biomedical sciences research facilities, although the healthcare market is small in comparison to those of other developed countries, due primarily to the limited size of its population. The value of the pharmaceuticals market in Singapore increased from $XXm in 2008 to $XXm in 2013 at a Compound Annual Growth Rate (CAGR) of XX% and is expected to increase further from $XXm in 2014 to $XXm in 2020 at a CAGR of XX% (Tarn et al., 2008; DoS, 2014; EDB, 2014c). Universal healthcare coverage covers XX% of the population. The five types of healthcare insurance plans available are Medisave, MediShield, Medisave-Approved Integrated Shield Plans, MediFund and ElderShield. Singapore is known for its world-class biomedical sciences research facilities for the development of the pharmaceutical and medical device markets at medical technology hubs such as Medtech, Biopolis and Tuas biomedical park. The country has emerged as a regional hub for the manufacture and R&D activities of multinational pharmaceutical companies and offers excellent opportunities for Biomedical Sciences (BMS) companies via a pro-business environment, low unit labor costs, low corporate tax, and strong government support. The BMS industry consists of four sectors: pharmaceuticals, medical technology, biotechnology, and healthcare services. The BMS Industry Partnership Office (IPO) was established in 2010 and includes the National Medical Research Council, Ministry of Health (MoH), A*STAR and the Singapore Economic Development Board (EDB). Singapore is a small country with a total population of approximately XX million as of 2013 (DoS, 2014), which is less than in neighboring countries Indonesia (XX million) and Malaysia (XX million) (IMF, 2014f; IMF, 2014g). Domestic companies have fewer opportunities for permanent establishment due to the limited patient population, which in turn has a negative effect on the revenue generated by domestic companies, ultimately impeding pharmaceutical market growth. Pharmaceutical Market, Singapore, Revenue ($m), Revenue ($m) CAGR ( ): XX% Source: Tarn et al., 2008; DoS, 2014; EDB, 2014c 2

3 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Table of Contents 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction GlobalData Report Guidance Overview of Pharmaceutical and Medical Device Market Pharmaceutical Market Market Overview Pharmaceutical Exports and Imports Supply Channels Market Segments Overview of Major Disease Areas Major Players Medical Device Market Market Overview Market Drivers and Barriers Drivers Barriers Market Access Reimbursement and Payer Landscape Overview of Healthcare System

4 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Table of Contents Reimbursement Process Overview of Insurance Providers Patient Share in Healthcare Spending Price Trends in the Healthcare Sector Pricing Policies Regulatory Landscape Overview of Regulatory Agencies Market Authorization Procedure for Pharmaceutical Products New Medical Device Approval Process Licensing Process for Pharmaceutical and Medical Device Manufacturing Exports and Imports Intellectual Property Rights Clinical Trial Regulations Pharmaceutical Advertising Regulations Pharmacy Regulations Labeling and Packaging Regulations Country Analysis Political Environment Political Structure Analysis of Current Political Environment Healthcare Policy Initiatives Economic Landscape Economic Indicators

5 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Table of Contents Gross Domestic Product Gross National Income Inflation Currency Exchange Rate Foreign Direct Investment Foreign Exchange Reserves Trade Balance Government Structural Balance Government Gross Debt Major Industries Demographics Population Education and Literacy Employment Disease Burden Healthcare Infrastructure Healthcare Facilities Healthcare Parameters Environmental Health Healthcare Personnel Healthcare Expenditure Overview Share of Public and Private Sectors

6 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Table of Contents Major Components of Healthcare Spending Spending in Pharmaceutical Research and Development Trade Associations The Singapore Association of Pharmaceutical Industries The Singapore Medical Association The Society for Emergency Medicine in Singapore The Pharmaceutical Society of Singapore The Healthcare Quality Society of Singapore Trade Fairs Opportunities and Challenges Opportunities Challenges Appendix Abbreviations Bibliography Research Methodology Coverage Secondary Research Forecasts Expert Panel Disclaimer

7 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Table of Contents 1.1 List of Tables Table 1: Pharmaceutical Market, Singapore, Revenue ($m), Table 2: Pharmaceutical Market, Singapore, Revenue Forecast ($m), Table 3: Pharmaceutical Market, Singapore, Exports and Imports ($bn), Table 4: Pharmaceutical Market, Haw Par, Global, Major Products, Table 5: Pharmaceutical Market, SciGen, Global, Major Products, Table 6: Pharmaceutical Market, Pfizer, Global, Major Products, Revenue ($bn) and Annual Growth (%), Table 7: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, Table 8: Pharmaceutical Market, Novartis, Global, Major Products, Revenue ($bn) and Annual Growth (%), Table 9: Pharmaceutical Market, Novartis, Global, Planned Filings, Table 10: Pharmaceutical Market, GlaxoSmithKline, Global, Major Products, Revenue ($bn) and Annual Growth (%), Table 11: Pharmaceutical Market, GlaxoSmithKline, Global, Late-Stage Pipeline, Table 12: Market Access, Singapore, Medisave Wage Contribution (%), Table 13: Market Access, Singapore, MediShield Premium Payment Scheme by Age Group ($), Table 14: Market Access, Singapore, Medisave-Approved Integrated Shield Plans Withdrawal Limit by Age Group ($), Table 15: Market Access, Singapore, Healthcare Spending, Out-of-Pocket Expenditure (%), Table 16: Market Access, Singapore, Price of Pharmaceutical Products, Change in Average Price of Medicines (%), Table 17: Market Access, Singapore, Registration Dossier Format, Table 18: Market Access, Singapore, Registration Dossier Format, Table 19: Market Access, Singapore, Registration Dossier Format, Table 20: Market Access, Singapore, GMP Certificate Fees for Medicinal Products and APIs ($),

8 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Table of Contents Table 21: Market Access, Singapore, Manufacturer s License Fees for Medicinal Products ($), Table 22: Market Access, Singapore, Manufacturer s License Fees for Medicinal Products ($), Table 23: Market Access, Singapore, Wholesale Dealer s License Fees for Medicinal Products ($), Table 24: Market Access, Singapore, Patent Co-operation Treaty (PCT), International Application Process, Table 25: Market Access, Singapore, Patent Filing Fees and Charges SGD ($), Table 26: Market Access, Singapore, Clinical Trial Certificates Issued, Table 27: Market Access, Singapore, Clinical Trials by Therapeutic Area (%), Table 28: Market Access, Singapore, Target Processing Timelines of Clinical Trial, Table 29: Market Access, Singapore, Fees for Advertisement Permit ($), Table 30: Market Access, Singapore, Fees for Advertisement Permit ($), Table 31: Market Access, Singapore, Labeling Requirements, Table 32: Economic Indicators, Singapore, Gross Domestic Product per Capita ($), Table 33: Economic Indicators, Singapore, Gross Domestic Product per Capita ($), Forecast, Table 34: Economic Indicators, Singapore, Gross Domestic Product Annual Growth (%), Table 35: Economic Indicators, Singapore, Gross Domestic Product Annual Growth (%), Forecast, Table 36: Economic Indicators, Singapore, Gross National Income per Capita ($), Table 37: Economic Indicators, Singapore, Consumer Price Index, Table 38: Economic Indicators, Singapore, Average Consumer Price Index, Forecast, Table 39: Economic Indicators, Singapore, Average Consumer Price Index, Annual Change (%), Table 40: Economic Indicators, Singapore, Average Consumer Price Index, Annual Change (%), Forecast, Table 41: Economic Indicators, Singapore, Currency Exchange Rate (SGD/$),

9 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Table of Contents Table 42: Economic Indicators, Singapore, Foreign Direct Investment ($bn), Table 43: Economic Indicators, Singapore, Foreign Exchange Reserves ($bn), Table 44: Economic Indicators, Singapore, Imports of Goods and Services ($bn), Table 45: Economic Indicators, Singapore, Exports of Goods and Services ($bn), Table 46: Economic Indicators, Singapore, General Government Structural Balance ($bn), Table 47: Economic Indicators, Singapore, General Government Gross Debt ($bn), Table 48: Economic Indicators, Singapore, Major Industries, Industrial Sector, Gross Value Added ($bn), Table 49: Demographics, Singapore, Population (million), Table 50: Demographics, Singapore, Population Forecast (million), Table 51: Demographics, Singapore, Population Distribution by Age Group (%), Table 52: Demographics, Singapore, Population Distribution by Age Group Forecast (%), Table 53: Demographics, Singapore, Births (per 1,000 Population), Table 54: Demographics, Singapore, Mortality (per 1,000 Population), Table 55: Demographics, Singapore, Major Causes of Mortality ( 000), Table 56: Demographics, Singapore, Children Under Five Mortality Rate (per 1,000 Live Births), Table 57: Demographics, Singapore, Immunization Rate (%), Table 58: Demographics, Singapore, Major Causes of Male Mortality (per 1,000 Population), Table 59: Demographics, Singapore, Major Causes of Female Mortality (per 1,000 Population), Table 60: Demographics, Singapore, Gender Ratio (M/F), Table 61: Demographics, Singapore, Life Expectancy at Birth (Years), Table 62: Demographics, Singapore, Student Enrollment by Level of Education (%), Table 63: Demographics, Singapore, Unemployment Rate (%), Table 64: Demographics, Singapore, Major Causes of Patient Discharge (%),

10 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Table of Contents Table 65: Demographics, Singapore, Major Diseases, DALYs (per 100,000 Population), Table 66: Healthcare Infrastructure, Singapore, Hospitals, Table 67: Healthcare Infrastructure, Singapore, Public and Private Hospitals, Table 68: Healthcare Infrastructure, Singapore, Hospitals Beds (per 1,000 Population), Table 69: Healthcare Infrastructure, Singapore, Beds by Type of Hospital, Table 70: Healthcare Infrastructure, Singapore, Number of Physicians (per 10,000 Population), Table 71: Healthcare Infrastructure, Singapore, PM10 (µg/m³), Table 72: Healthcare Infrastructure, Singapore, CO 2 Emissions (Million Metric Tons), Table 73: Healthcare Infrastructure, Singapore, Water Pollutants (Million Metric Tons), Table 74: Healthcare Infrastructure, Singapore, Waste Generated (million Tons), Table 75: Healthcare Infrastructure, Singapore, Waste Handling Methods Share (%), Table 76: Healthcare Infrastructure, Singapore, Waste Recycling Share by Type of Waste (%), Table 77: Healthcare Infrastructure, Singapore, Nurses (per 1,000 Population), Table 78: Healthcare Infrastructure, Singapore, Midwives (per 1,000 Population), Table 79: Healthcare Infrastructure, Singapore, Dentists (per 1,000 Population), Table 80: Healthcare Infrastructure, Singapore, Pharmacists (per 1,000 Population), Table 81: Healthcare Infrastructure, Singapore, Healthcare Expenditure (% of GDP), Table 82: Healthcare Infrastructure, Singapore, Public-Private Share (%), Table 83: Healthcare Infrastructure, Singapore, Share of Expenditure of Major Components of Healthcare Spending (%), Table 84: Healthcare Infrastructure, Singapore, R&D Expenditure ($m), Table 85: Trade Fairs, Singapore, Major Healthcare Trade Fairs,

11 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Table of Contents 1.2 List of Figures Figure 1: Pharmaceutical Market, Singapore, Revenue ($m), Figure 2: Pharmaceutical Market, Singapore, Revenue Forecast ($m), Figure 3: Pharmaceutical Market, Singapore, Exports and Imports ($bn), Figure 4: Pharmaceutical Market, Singapore, Distribution Channels, Figure 5: Healthcare Market, Singapore, Drivers and Barriers, Figure 6: Market Access, Singapore, Healthcare Insurance System, Figure 7: Market Access, Singapore, Healthcare Financing System, Figure 8: Market Access, Singapore, Healthcare Spending, Out-of-Pocket Expenditure (%), Figure 9: Market Access, Singapore, Price of Pharmaceutical Products, Change in Average Price of Medicines (%), Figure 10: Market Access, Singapore, Structure of the Ministry of Health, Figure 11: Market Access, Singapore, Structure of the Health Sciences Authority, Figure 12: Market Access, Singapore, New Drug Application Types, Figure 13: Market Access, Singapore, New Drug Approval Process, Figure 14: Market Access, Singapore, Licensing Process for Manufacturing, Figure 15: Market Access, Singapore, Licensing Process for Import/Export, Figure 16: Market Access, Singapore, National Patent Approval Process, Figure 17: Market Access, Singapore, PCT National Phase Entry Process, Figure 18: Market Access, Singapore, International Patent Approval Process, Figure 19: Market Access, Singapore, National Trademark Approval Process, Figure 20: Market Access, Singapore, International Trademark Approval Process, Figure 21: Market Access, Singapore, Clinical Trial Certificates Issued, Figure 22: Market Access, Singapore, Clinical Trials by Therapeutic Area (%),

12 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Table of Contents Figure 23: Market Access, Singapore, Clinical Trial Approval Process, Figure 24: Market Access, Singapore, Pharmacy Regulations, Figure 25: Economic Indicators, Singapore, Gross Domestic Product per Capita ($), Figure 26: Economic Indicators, Singapore, Gross Domestic Product per Capita ($), Forecast, Figure 27: Economic Indicators, Singapore, Gross Domestic Product Annual Growth (%), Figure 28: Economic Indicators, Singapore, Gross Domestic Product Annual Growth (%), Forecast, Figure 29: Economic Indicators, Singapore, Gross National Income per Capita ($), Figure 30: Economic Indicators, Singapore, Consumer Price Index, Figure 31: Economic Indicators, Singapore, Average Consumer Price Index, Forecast, Figure 32: Economic Indicators, Singapore, Average Consumer Price Index, Annual Change (%), Figure 33: Economic Indicators, Singapore, Average Consumer Price Index, Annual Change (%), Forecast, Figure 34: Economic Indicators, Singapore, Currency Exchange Rate (SGD/$), Figure 35: Economic Indicators, Singapore, Foreign Direct Investment ($bn), Figure 36: Economic Indicators, Singapore, Foreign Exchange Reserves ($bn), Figure 37: Economic Indicators, Singapore, Imports of Goods and Services ($bn), Figure 38: Economic Indicators, Singapore, Exports of Goods and Services ($bn), Figure 39: Economic Indicators, Singapore, Government Structural Balance ($bn), Figure 40: Economic Indicators, Singapore, General Government Gross Debt ($bn), Figure 41: Economic Indicators, Singapore, Major Industries, Industrial Sector, Gross Value Added ($bn), Figure 42: Demographics, Singapore, Population (million), Figure 43: Demographics, Singapore, Population Forecast (million),

13 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Table of Contents Figure 44: Demographics, Singapore, Population Distribution by Age Group (%), Figure 45: Demographics, Singapore, Population Distribution by Age Group Forecast (%), Figure 46: Demographics, Singapore, Births (per 1,000 Population), Figure 47: Demographics, Singapore, Mortality (per 1,000 Population), Figure 48: Demographics, Singapore, Major Causes of Mortality ( 000), Figure 49: Demographics, Singapore, Children Under Five, Mortality Rate (per 1,000 Live Births), Figure 50: Demographics, Singapore, Immunization Rate (%), Figure 51: Demographics, Singapore, Major Causes of Male Mortality (per 1,000 Population), Figure 52: Demographics, Singapore, Major Causes of Female Mortality (per 1,000 Population), Figure 53: Demographics, Singapore, Gender Ratio (M/F), Figure 54: Demographics, Singapore, Life Expectancy at Birth (Years), Figure 55: Demographics, Singapore, Student Enrollment by Level of Education (%), Figure 56: Demographics, Singapore, Unemployment Rate (%), Figure 57: Demographics, Singapore, Major Causes of Patient Discharge (%), Figure 58: Demographics, Singapore, Major Diseases, DALYs (per 100,000 Population), Figure 59: Healthcare Infrastructure, Singapore, Hospitals, Figure 60: Healthcare Infrastructure, Singapore, Public and Private Hospitals, Figure 61: Healthcare Infrastructure, Singapore, Hospitals Beds (per 1,000 Population), Figure 62: Healthcare Infrastructure, Singapore, Beds by Type of Hospital, Figure 63: Healthcare Infrastructure, Singapore, Number of Physicians (per 10,000 Population), Figure 64: Healthcare Infrastructure, Singapore, PM10 (µg/m³), Figure 65: Healthcare Infrastructure, Singapore, CO 2 Emissions (Million Metric Tons), Figure 66: Healthcare Infrastructure, Singapore, Water Pollutants (Million Metric Tons),

14 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Table of Contents Figure 67: Healthcare Infrastructure, Singapore, Waste Generated (million Tons), Figure 68: Healthcare Infrastructure, Singapore, Waste Handling Methods Share (%), Figure 69: Healthcare Infrastructure, Singapore, Waste Recycling Share by Type of Waste (%), Figure 70: Healthcare Infrastructure, Singapore, Nurses (per 1,000 Population), Figure 71: Healthcare Infrastructure, Singapore, Midwives (per 1,000 Population), Figure 72: Healthcare Infrastructure, Singapore, Dentists (per 1,000 Population), Figure 73: Healthcare Infrastructure, Singapore, Pharmacists (per 1,000 Population), Figure 74: Healthcare Infrastructure, Singapore, Healthcare Expenditure (% of GDP), Figure 75: Healthcare Infrastructure, Singapore, Public-Private Share (%), Figure 76: Healthcare Infrastructure, Singapore, Share of Expenditure of Major Components of Healthcare Spending (%), Figure 77: Healthcare Infrastructure, Singapore, R&D Expenditure ($m), Figure 78: Healthcare Market, Singapore, Opportunities and Challenges,

15 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Introduction 2 Introduction 2.1 GlobalData Report Guidance The report begins with an executive summary, which provides an overview of the healthcare market in Singapore and the key factors driving its development. It also includes a snapshot of the country s demographic, regulatory, and reimbursement landscape, as well as its healthcare infrastructure. Chapter three provides an overview of the pharmaceutical and medical device markets in Singapore, covering the following parameters: market size; generic, Over-the-Counter (OTC) and biologic/biosimilar product shares; and key drivers and barriers. It also includes profiles of the major players in the country s healthcare market, as well as SWOT assessments for each player. Chapter four covers the reimbursement and payer landscape and provides details of the reimbursement process, insurance providers, pricing policies and drug price trends in Singapore. It also looks at the regulatory landscape and provides an overview of the regulatory agencies and approval processes for new drugs and medical devices. In addition, this chapter covers the licensing process for the manufacture, export and import of pharmaceuticals; details the regulations in place for pharmaceutical advertising, labeling, packaging, and clinical trials; and provides an overview of the country s legal framework for intellectual property rights. Chapter five provides detailed analysis of the political and economic environment in Singapore, as well as economic indicators, demographics, and healthcare infrastructure and expenditure. Chapter six provides an overview of the opportunities and challenges in the healthcare market. 18

16 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Country Analysis Education and Literacy In Singapore, literacy is defined as the ability of a person of XX or above to read and write. In 2012, the literacy rate was XX% (World Bank, 2014e). A high literacy rate contributes to increased awareness about personnel health, community diseases, and healthcare services. In 2013 and 2014, the higher education system in Singapore was ranked second after Finland by the WEF Global Competitiveness Report (WEF, 2014). Education Statistics Digest (ESD) provides basic statistical information on education in Singapore. The country is well-known for life-long learning, provided by world-class educational institutions. In Singapore, school education is divided into the following five levels: Pre-school Primary Secondary Pre-university Post-secondary (MoE, 2014) The distribution of students across the different school and college levels in 2013 is shown in the following figure. Primary schools accounted for the highest share of students with XX%, followed by secondary schools with XX% and polytechnics with XX%. 172

17 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Country Analysis Figure 55: Demographics, Singapore, Student Enrollment by Level of Education (%), 2013 Junior colleges Universities Institute of technical education National institute of education Primary schools Polytechnics Secondary schools, 29.5 Source: DoS, 2014 Table 62: Demographics, Singapore, Student Enrollment by Level of Education (%), 2013 Institutions Number of students Share Primary schools Secondary schools Polytechnics Universities Junior colleges Institute of technical education National institute of education Source: DoS,

18 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Country Analysis Public and Private Hospitals The number of public hospitals in Singapore increased from XX in 2008 to XX in 2013 at a CAGR of XX%, while the number of private hospitals increased at a CAGR of XX% during the same period, from XX in 2008 to XX in 2013 (DoS, 2014). Figure 60: Healthcare Infrastructure, Singapore, Public and Private Hospitals, Hospitals Public Private Source: DoS,

19 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Appendix 7 Appendix 7.1 Abbreviations ACTD: AGC: ALD: ASEAN: ASTR: BFTA: BMRC: BMS: BTI: CAGR: CDA: CDM: CET: CIA: COPD: CPFB: CPI: CPM: CRPNS: CTC: CTD: CTM: ASEAN Common Technical Dossier Attorney General s Chambers Audit and Licensing Division Association of South-East Asian Nations Agency for Science, Technology and Research Belgian Foreign Trade Agency Biomedical Research Council Biomedical Sciences Bioprocessing Technology Institute Compound Annual Growth Rate Centre for Drug Administration Clean Development Mechanism Continuing Education and Training Central Intelligence Agency Chronic Obstructive Pulmonary Disease Central Provident Fund Board Consumer Price Index Chinese Proprietary Medicines Centre for Radiation Protection and Nuclear Science Clinical Trial Certificates Common Technical Document Clinical Trial Materials 211

20 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Appendix DAC: DALY: DoF: DoS: EC: EDB: EMA: EMEA: FDA: FDI: GCP: GDA: GDP: GHTF: GMP: GUD: HIMSS: HOTA: HPB: HPRG: HQSS: HSA: HWPO: IB: Drug Advisory Committee Disability Adjusted Life Year Date of Filing Department of Statistics Ethics Committee Economic Development Board European Medical Agency Europe, Middle East and Africa Food and Drug Administration Foreign Direct Investment Good Clinical Practice Generic Drug Application Good Distribution Practice Global Harmonization Task Force Good Manufacturing Practice Global Urban Development Healthcare Information and Management Systems Society Human Organ Transplant Amendment Health Promotion Board Health Products Regulation Group Healthcare Quality Society of Singapore Health Sciences Authority, Singapore Health and Wellness Program Office International Bureau 212

21 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Appendix ICH: IDF: IDF: IMF: INN: IPEA: IPOS: IPRP: ISA: ISPOR: ISR: ITA: ITC: KFDA: MAS: MCRC: MDB: MEWR: MHLW: MHRA: MIS: MQA: MRP: MSA: International Conference on Harmonization International Diabetes Federation International Diabetes Federation International Monetary Fund International Non-Proprietary Name Internal Preliminary Examination Authority Intellectual Property Office of Singapore International Preliminary Report on Patentability International Searching Authority International Society for Pharmacoeconomics and Outcomes Research International Search Report International Trade Administration International Trade Centre Korean Food and Drug Administration Monetary Authority of Singapore Medical Clinical Research Committee Medical Devices Bureau Ministry of the Environment and Water Resources Ministry of Health Labor and Welfare Medicines and Healthcare products Regulatory Agency Marketing Institute of Singapore Manufacturing and Quality Audit Mutual Recognition Procedure Medical Savings Account 213

22 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Appendix NDA: NEA: NEA: NHI: NIBR: NPA: NSP: OTC: PAP: PCT: PEDU: PIC/S: PMDA: PRISM: PSS: PUB: QCAC: RIEC: RMS: SAPI: SDA: SDL: SDP: SEMS: New Drug Approval National Environment Agency National Environment Agency National Health Insurance Novartis Institutes for Biomedical Research National Pharmaceutical Administration National Solidarity Party Over-the-Counter People's Action Party Patent Co-operation Treaty Pharmacoeconomics and Drug Utilization Unit Pharmaceutical Inspection Convention/Co-operation Scheme Japanese Pharmaceuticals and Medical Devices Agency Pharmaceutical Regulatory and Information System Pharmaceutical Society of Singapore Public Utilities Board Quality Control Advisory Committee Research, Innovation and Enterprise Council Reference Member State Singapore Association of Pharmaceutical Industries Singapore Democratic Alliance Standard Drug List Singapore Democratic Party Society for Emergency Medicine in Singapore 214

23 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Appendix SFDA: SGCIC: SGGCP: SGH: SMA: SMDR: SPB: SPP: STB: TCM: TGA: TLCC: TTSH: UNFCCC: WHO: WIPO: WONCA: WP: WTS: WTTC: Chinese State Food and Drug Administration Singaporean-German Chamber of Industry and Commerce Singapore Guideline for Good Clinical Practice Singapore General Hospital Singapore Medical Association Singapore Medical Device Register Singapore Pharmacy Board Singapore People's Party Singapore Tourism Board Traditional Chinese Medicine Australian Therapeutic Goods Administration The Legislative Council Commission Tan Tock Seng Hospital United Nations Framework Convention on Climate Change World Health Organization World Intellectual Property Organization World Organization of Family Doctors Workers' Party Workfare Training Support Scheme World Travel and Tourism Council 215

24 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Appendix 7.2 Bibliography 10times (2014). Medical & Pharmaceutical Trade Shows in Singapore. 10times. Available from: [Accessed on November 20, 2014] AGC (2014a). Patents Act. Attorney General s Chambers. Available from: a99fe33f2193%20validtime%3a %20transactiontime%3a ; rec=0;resurl=http%3a%2f%2fstatutes.agc.gov.sg%2faol%2fbrowse%2ftitleresults.w3p%3 Bletter%3DP%3Btype%3DactsAll;whole=yes] [Accessed on November 3, 2014] AGC (2014b). Patents (Amendment) Act Attorney General s Chambers. Available from: e5f6-4c43-81fd- 74c736a77730;rec=0;resUrl=http%3A%2F%2Fstatutes.agc.gov.sg%2Faol%2Fbrowse%2Fyea rresults.w3p%3bpnum%3d1%3btype%3dactssup%3byear%3d2012;whole=yes] [Accessed on November 3, 2014] AGC (2014c). Patents (Amendment) Rules Attorney General s Chambers. Available from: aac2-4a53-8d68-6a5a20738ecb;rec=0;resurl=http%3a%2f%2fstatutes.agc.gov.sg%2faol%2fbrowse%2fyea rresults.w3p%3bpnum%3d1%3btype%3dslgaz%3byear%3d2014;whole=yes [Accessed on November 3, 2014] ASEAN (2014). Country Report of the ASEAN Assessment on the Social Impact of the Global Financial Crisis: Singapore. Available from: Asian Scientist (2013). Adaptive Licensing to Speed up Drug Approvals in Singapore. Asian Scientist. Available from: [Accessed on November 4, 2014] 216

25 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Appendix World Bank (2014f). PM10, country level (micrograms per cubic meter). World Bank. Available from: [Accessed on November 18, 2014] World Bank (2014g). CO2 emissions (kt). World Bank. Available from: [Accessed on November 18, 2014] World Bank (2014h). Organic water pollutant (BOD) emissions (kg per day). World Bank. Available from: [Accessed on November 18, 2014] World Bank (2014i). Health expenditure, total (% of GDP). World Bank. Available from: [Accessed on November 19, 2014] World Bank (2014j). Health expenditure, public (% of total health expenditure). World Bank. Available from: [Accessed on November 19, 2014] WTTC (2011). Singapore Economic Impact Report. World Travel and Tourism Council. Available from: [Accessed on October 18, 2014] 233

26 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Appendix 7.3 Research Methodology GlobalData s dedicated research and analysis teams consist of experienced professionals with advanced statistical expertise and marketing, market research and consulting backgrounds in the pharmaceutical industry. GlobalData adheres to the codes of practice of the Market Research Society ( and Strategic and Competitive Intelligence Professionals ( All GlobalData databases are continuously updated and revised. The following research methodology is followed for all databases and reports Coverage The objective of updating GlobalData s coverage is to ensure that it represents the most up-to-date vision of the industry possible. Changes to the industry taxonomy are built on the basis of extensive research of company, association and competitor sources. Company coverage is based on three key factors: revenue; products; and media attention, innovation and market potential. The estimated revenue of all major companies, including private and governmental, are gathered and used to prioritize coverage. Companies that are making the news or are of particular interest due to their innovative approach are prioritized. GlobalData aims to cover all major news events and deals in the pharmaceutical industry, updated on a daily basis. The coverage is further streamlined and strengthened with additional input from GlobalData s expert panel (see below). 234

27 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Appendix Secondary Research The research process begins with extensive secondary research using internal and external sources to gather qualitative and quantitative information relating to each market. The secondary research sources that are typically referred to include, but are not limited to: Company websites, annual reports, financial reports, broker reports, investor presentations and SEC filings Industry trade journals, scientific journals and other technical literature Internal proprietary databases Relevant patent and regulatory databases National government documents, statistical databases and market reports Procedure registries News articles, press releases and web-casts specific to the companies operating in the market The CountryFocus reports are largely based on secondary research and use reliable and authoritative sources such as the IMF, the World Bank, OECD, WHO, UNICEF, UNStats, BEA, MHLW and NHS, among others Forecasts The CountryFocus reports use the data available from the secondary sources to forecast and validate the future trends for a country s healthcare market, as well as parameters related to the economy and healthcare infrastructure and expenditure Expert Panel GlobalData uses a panel of experts to cross-verify its databases and forecasts. GlobalData s expert panel comprises marketing managers, product specialists, international sales managers from pharmaceutical companies, academics from research universities, consultants from venture capital funds, and distributors/suppliers of pharmaceuticals and supplies. Historical data and forecasts are relayed to GlobalData s expert panel and adjusted in accordance with their feedback. 235

28 HEALTHCARE, REGULATORY AND REIMBURSEMENT LANDSCAPE SINGAPORE Appendix 7.4 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData. 236