Generics in Japan.pdf
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1、 1 Generics in Japan Evolving pricing, regulatory, and business environments Reference Code: BI00050-008 Publication Date: January 2012 2 About the author Donald Macarthur is an independent pharmaceutical industry consultant and analytical writer with over 70 major report titles to his name. Coverin
2、g most of the major ex-US countries, his focus is pricing, reimbursement, and market access of prescription medicines, life cycle management, and distribution. He has been visiting Japan regularly for the past 25 years and is recognized as one of the wests leading commentators on its market and indu
3、stry. Disclaimer Copyright 2012 Business Insights Ltd This report is published by Business Insights (the Publisher). This report contains information from reputable sources and although reasonable efforts have been made to publish accurate information, you assume sole responsibility for the selectio
4、n, suitability and use of this report and acknowledge that the Publisher makes no warranties (either express or implied) as to, nor accepts liability for, the accuracy or fitness for a particular purpose of the information or advice contained herein. The Publisher wishes to make it clear that any vi
5、ews or opinions expressed in this report by individual authors or contributors are their personal views and opinions and do not necessarily reflect the views/opinions of the Publisher. 3 Table of Contents About the author 2 Disclaimer 2 Executive summary 11 Organization and funding of Japans healthc
6、are system 11 Regulatory environment 11 Pharmaceutical business environment 12 Generics market 13 Attitudes toward generics 14 Generics industry 15 Generics company strategies and generics defense 15 Market prospects 16 Chapter 1 Organization and funding of Japans healthcare system 18 Summary 18 Int
7、roduction 19 Key actors 20 Health insurance 21 Schemes managed by the government 21 Schemes managed by large companies 22 Schemes managed by the municipalities 22 Health insurance for the elderly 22 Private insurance 23 Healthcare providers 23 Healthcare benefits 24 4 Remuneration of providers 24 Fe
8、e-for-service 24 DPC hospital funding 26 Dispensing fees 28 Patient co-payment 29 Healthcare expenditure 31 Chapter 2 Regulatory environment 34 Summary 34 Intellectual property protection 35 Marketing approval 37 NHI drug tariff 41 NHI price setting 42 NHI price revision processes 44 Biennial revisi
9、on 44 Repricing 46 Long-listed brands 46 Correction premiums 49 Overall impact 52 Generic encouragement measures by government 53 Inconsistent government policies 57 Chapter 3 Pharmaceutical business environment 59 Summary 59 Pharmaceutical market 60 Research-based pharmaceutical industry 62 Generic
10、 industry 64 5 Wholesalers 66 Pharmacies 68 Foreign exchange rates 70 Chapter 4 Generics market 71 Summary 71 Introduction to generics 72 Market size 76 Generic inclusion in NHI drug tariff 78 Introductory pricing of generics 82 Price revision of generics 83 Distribution of generics 85 Chapter 5 Att
11、itudes toward generics 87 Summary 87 Insurers 88 Physicians 88 Hospitals 91 Pharmacists 92 Wholesalers 95 Patients 96 Chapter 6 Generics industry 99 Summary 99 Traditional domestic generic companies 100 Domestic R Korosho). The main advisory body to its minister is the Central Social Insurance Medic
12、al Council (Chuikyo). The entire population is covered by health insurance schemes, managed by large employers, municipalities or the government. They offer a common package of care, known as benefits under National Health Insurance (NHI). There is no family doctor system; patients can select any GP
13、 clinic or hospital outpatient department. Healthcare providers are mainly paid on a fee-for-service basis, with a points-based fee schedule. However, a growing number of hospitals are paid for inpatient care through a prospective diagnostic procedure combination (DPC) system. Under DPC, the payment
14、 a hospital receives for treating a patient with a particular diagnosis is the same regardless of the interventions applied or the cost of drugs administered. As in other countries, healthcare expenditure is rising fast in Japan, reaching a record 36,007bn ($388bn) in FY2009, the equivalent of 10.61
15、% of GDP. One main cost driver is ageing; Japan has the fastest-ageing society in the world. Regardless of setting, and with relatively few exceptions other than welfare recipients, patients are required to pay an age-dependent fixed percentage of their medical costs as a co-insurance under NHI. For
16、 most, the co-insurance rate is 30%. Regulatory environment New drugs benefit from 20 years patent protection. There is a maximum five-year patent term extension to compensate for the period needed for clinical development and regulatory review. There is no limit to the number of patent extensions f
17、or new indications or changes to the manufacturing process. 12 Examination for marketing approval is performed by the Pharmaceuticals and Medical Devices Agency (PMDA). Generics are subject to an abbreviated process with a target review time of 10 months. For inpatients and outpatients alike, only m
18、edicines (brand or generic) listed in the NHI drug tariff can be prescribed, with reimbursement limited to tariff rates. Additions to the NHI drug tariff for new drugs are made four-times a year. The aim is to publish the NHI price within 60 days of regulatory approval. New drugs which represent the
19、 first, second or third entry in the class and are within three years of first entry to the class are priced by similar efficacy comparison. This method sets the price by reference to the NHI cost of an existing product. There are additional premiums for innovativeness, usefulness, pediatric use or
20、small market size. If a new drug is the fourth or later entrant to its class it may be considered to lack novelty and be classified as a “me-too”. These are priced according to the class average price with no possibility of added premiums or foreign adjustment. MHLW attempts, through biennial price
21、revisions, to bring tariff prices closer to market levels. A new reimbursement price is obtained by adding the discount allowance (known as the adjustment zone) 2% of the pre-revision NHI price to the weighted average market price as measured in biennial surveys. Regular across-the-board NHI price c
22、uts on April 1st have been a feature of the market for over 50 years. Pharmaceutical business environment Sales of all prescription medicines in 2010 amounted to 8,873.6bn ($101bn) at NHI prices. Community pharmacies accounted for 50% of the 2009 total, large hospitals for 22.4%, self-dispensing GP
23、clinics for 20%, and medium-small hospitals for 7.6%. Ten of the top-20 pharmaceutical companies by sales in 2010 were of foreign origin. Combined they held a 32.7% market share, almost the same as the top-10 Japanese-origin companies. 13 Over 80 of the 378 firms with products listed in the NHI drug
24、 tariff are generic companies. Forty four of these are members of the Japan Generic Medicines Association (JGA). The Japan Society of Generic Medicines (JSGM), though funded by some generic companies, is an academic body independent of the sector. Almost all distribution of prescription medicines (e
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