Pharmaceutical system : Republic of Korea [fact sheet]

583.4 Agency that Sets Price Ministry of Health and Welfare YES Pharmaceutical System REPUBLIC OF KOREA SOCIOECONOMICS 1 Population 49 263 000 Life Expectancy at Birth 82 years 15%Percentage of Children Aged below 15 Years No. of Physicians No. of Pharmacists Hospital Beds Doctor Consultations 22.4 per 10 000 population 1.28 per 1000 population 10.3 per 1000 population 14.6 per capitaHUMAN RESOURCES 2 HEALTH EXPENDITURE 2 2530.6 Total Health Expenditure / Capita (PPP) Total Health Expenditure as a Share of GDP Public vs Private Share of Total Health Expenditure 54.1% 45.9% Public Private Composition of Total Health Expenditure PHARMACEUTICAL EXPENDITURE 2 Total Pharmaceutical Expenditure / Capita (PPP) 23.1% Pharmaceutical Expenditure as a Share of Total Health Expenditure / Capita Public vs Private Share of Total Pharmaceutical Expenditure 41.6% Private 58.4% Public PHARMACEUTICAL REGULATION Pharmaceutical Legislation National Medicines Policy National Medicine Policy Plan Regulatory Authority for Pharmaceuticals Ministry of Food and Drug Safety 7.4% PRICING Pricing Regulation in the Public Sector Pricing Regulation in the Private Sector NO Price Negotiations? YES Free Pricing? NO External Price Referencing? YES Internal Price Referencing? NO VAT on Medicines 10% PROCUREMENT / REIMBURSEMENT Body Responsible for Selection of Products for Public Procurement/Reimbursement Health Insurance and Review and Assessment Service National Evidence-based Healthcare Collaborating Agency Body Responsible for Health Technology Assessment 39 847 No. of Registered Medicines No data available No. of Products on Essential Medicines List No data available No. of Products on Procurement List 17 798 No. of Products on Reimbursement List 17% Percentage of Adults Aged over 60 Years Pharmaceutical Affairs Act 34 321.6 GDP / Capita (PPP) 36.1% Out-of-Pocket 42.9% Social Health Insurance 4% Other Private 5.8% Private Prepaid Plans 11.2% General Government Pharmaceutical System Flowchart MARKET AUTHORIZATION / LICENSING NEW MEDICINE National Regulatory Authority PHARMACEUTICAL SAFETY BUREAU, MINISTRY OF FOOD AND DRUG SAFETY REFERENCES PROCUREMENT SELECTION 1 World health statistics (2015) [online database]. Geneva: World Health Organization (http://www.who.int/gho/publications/world_health_statistics/2015/en/, accessed 25 November 2016). 2 Health at a glance: Asia/ Pacic (2016). Paris: The Organisation for Economic Co-operation and Development and World Health Organization (http://www.oecd.org/health/health-at-a-glance-asia-pacic-23054964.htm, accessed 2 December 2016). HEALTH INSURANCE REVIEW AND ASSESSMENT SERVICE AND PHARMACEUTICAL BENEFIT REVIEW COMMITTEE TASKS Drug approval and registration CRITERIA Quality, safety, efcacy and information on production and sale in origin country (for imported products) REGULATIONS Pharmaceutical Affairs Act PURPOSE Decision on which medicines are to be included and not in the Positive List for reimbursement by the National Health Insurance Service, reviewed by the National Health Insurance Policy Deliberation Committee (NHIPDC) CRITERIA Clinical and cost effectiveness, and budget impact Public and private hospitals, clinics and pharmacies employing medical tenders and competitive bids CLIENTS PRICING AND REIMBURSEMENT Medicine prices are regulated if such costs are reimbursed by the National Health Insurance Service. For pharmaceuticals in the Positive List Reimbursement ceilings for new products are determined through negotiations between the National Health Insurance Service and the manufacturer, reviewed by the NHIPDC and announced by the Minister of Health and Welfare. Pharmaceutical Benet Review Committee sets listed price for essential drugs if price negotiation fails. The prices are reviewed by NHIPDC and announced by the Minister of Health and Welfare. Reimbursement ceiling price for generic products and off-patent drugs is 53.55% of the innovator product's price, pursuant to the regulations of the Ministry of Health and Welfare. Zero margin policy is applied in order for the reimbursement to be based on actual transaction price. For pharmaceuticals not in the Positive List Payment is out of pocket. DISTRIBUTION All public and private hospitals, clinics and pharmacies are legally obliged to subscribe as providers. WPR/2017/DHS/007 ©World Health Organization 2017 Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO licence.