View
5.921
Download
8
Category
Preview:
DESCRIPTION
US Commercial Service http://www.usatradeonline.gov/
Citation preview
General Medical Indicators (1)
Population 127 million
GDP (01) $4,333 billion
Healthcare Exp. (00) $278 billion
HCE % of GDP (00) 7.9%
# of Hospitals (00) 9,266
# of Clinics (00) 92,824
# of Dental Clinics (00) 63,361
Total # of Beds (00) 1.65 million
General Medical Indicators (2)
Total # of Surgeries approx. 5 million
Average Hospital Stay (00) 39.1 (24.8 for ordinary
hospital)
Life Expectation (00) male: 77.64 female: 84.62
Insurance Coverage 100%
Concept of Operation not for profit
Medical Device Market (00) $18 billion
Pharmaceutical Market (00) $60 billion
Japan’s Healthcare System (1)
Major Characteristics
Universal Healthcare Coverage (achieved in 1961) -health insurance covering the entire population
Free Access - patients can freely choose doctors, clinics, hospitals
Low Co-payment Rate - patient can receive necessary medical care for a small fee (patient are required to pay anywhere 10 and 30% of treatment fee)
Fee-For-Service - reimbursed based on point system
Japan’s Healthcare System (2)
Rapidly Changing Healthcare Environment
Changes in the disease pattern - acute vs. chronic
Aging Society and lower birthrate - the elderly will make upa significant percentage of the total population
Increasing Healthcare Expenditure - Japan’s spending onmedical care continues to increase as Japan becomes a agingsociety
Stagnant Economy - imbalance between the increase ofhealthcare expenditure and the economic growth willincrease further
Rate of Projected Population - over 65
0
5
10
15
20
25
30
2000 2005 2010 2015 2020 2025
Year
Percentage
Japan
USA
France
Germany
UK
Sweden
National Healthcare Expenditure
Source: Ministry of Health, Labor and Welfare (MHLW)
17.5
28.834.7 35.7 36.7 37.3 39.1 37.2
0
100,000
200,000
300,000
400,000
1980 1990 19951996 19971998 1999 2000
Year
100 m
illio
n y
en
0
10
20
30
40
50
Perc
enta
ge
Medical Expenditure
% Medical Expenditure for the Aged (over 70)
Healthcare Reform?
• Past efforts included:- cut reimbursement rates (biannually since 1965)- established a separate insurance system for elderly (1984)- raised co-payment for the elderly (1997)- raised co-payment for ordinary salaried workers (1997)- established a new long-term care insurance system (2000)
• Recent efforts (2002) included- cut reimbursement rates * first time cut on doctor’s technical fee* introduction of foreign reference price on medical devices
- raised co-payment for the elderly- raised co-payment for ordinary salaried workers
Japan Medical Device Market
20
18
1514
12
5
0
2
4
6
8
10
12
14
16
18
20
USA Japan UK France Germany Korea
$US Bill
Medical Device Trade BalancesBetween U.S. and Japan
CY 1998 CY 1999 CY 2000Production 11,507 13,051 13,761Import 6,370 7,319 7,603- from U.S. 4,045 4,870 4,941Export 2,499 3,202 3,362- to U.S. 800 968 949Total Market 15,379 17,169 18,002U.S. Trade Surplus 3,245 3,902 3,992U.S. Share of Import 63.5% 67.0% 65.0%U.S. Share of Market 26.3% 27.0% 27.5%F/X (1 US$/Yen) 131 114 108
$US Million
Source: Ministry of Health, Labor and Welfare (MHLW)
Japan Medical Device Imports
Medical Device Imports in 2000
64%7%
5%
4%
20%
United States Germany Netherl Ireland Others
Source: Ministry of Health, Labor and Welfare (MHLW)
Competitive Products (Japan vs U.S.)
• Imaging Diagnostic equipment• Therapeutic and Surgical Equipment• Biophenomena Measuring and Monitoring Systems• Home Therapeutic Equipment• Others (Dialyzers, Endoscopes, Hemodialysis Apparatus, etc.)
• Pacemakers• Advanced Interventional Cardiology Products such as stents• Orthopedic Implants• Laser Surgical Equipment• Cardiac Valve Prothesis• Others (MRI, CT, etc.)
Japan
U.S.
U.S. Medical Device Firms in Japan
• 3M Healthcare• Allergan• Bausch & Lomb• Baxter• Boston Scientific• Edwards Lifesciences
• General Electric (GE)• Guidant• Johnson & Johnson• Kodak• Medtronic• St. Jude Medical
American Chamber of Commerce in Japan (ACCJ), Medial Device Subcommittee has 46 member firms
Medical Device Regulation System
Japanese LawPharmaceutical Affairs Law (PAL) ----- enforced by the Ministry of Health, Labor and Welfare (MHLW). Necessary Governmental Authorizations• Manufacturing (or import) approval ("Shonin") which guarantees the safety and efficacy of the device. (approx. 2,500-3,000 submissions per year) • Manufacturing ( or import) license ("Kyoka") of a device, which the Japanese manufacturer and importer hold. (in 2002: manufacturing license - 2,709 / import license - 1,282)• Reimbursement listing approval
How to Register Your Products
Pros• Simple• Less expensive• No direct involvement with the
Japanese authorities
Cons• The manufacturer often is
limited to one importer• Change of importer forces the
manufacturer to reapply for shonin from the beginning
• Dependency on the importer increases
Pros• Option to work with multiple
importers who may have different strenghts
• No reapplication for shonin upon change of importer
• The ability to focus fully on marketing your product
Cons• Expensive
Ask Your Importer to Apply Use In-country Care Taker
Application Categories
(1) Devices which do not require approval (2) “Me-too Devices” which are equivalent to already-
approved devices in Japan (Time Clock: 4 months)(3) “Improved Devices” which do not have new
characteristics as much as the devices to be reexamined but are not substantially equivalent to already-approved devices in Japan (Time Clock: 12 months)
(4) “New Devices” which are different in use, function or technology from already-approved devices in Japan (Time Clock: 12 months)
Risk Categories of Medical Devices
Categories Categories of medicaldevices according to risk
Approval Clinical Trial
Class I
Medical devices that are believed to poseextremely little risk to the human body even ifthey failExamples: In vitro diagnostic devices, steelsupplies, x-ray film, dental prosthetic supplies
-----
Not necessary
Class II
Medical devices that are believed to poserelatively little risk to the human body even ifthey failExamples: MRI, electromanometers,electronic endoscopes, digestive catheters,ultrasonic diagnostic equipment, and dentalalloys
In principle, not necessary
Class III
Medical devices that are believed to poserelatively high risk to the human body if theyfailExamples: dialyzers, artificial bones,respirators, and balloon catheters
Sometimes, necessary
Class IV
Medical devices that are highly invasive uponthe patient and may directly endanger thepatient's life if they failExamples: pacemakers, artificial heartvalves, and stents
Necessary
In principle, necessary
Note: The products shown as examples are classified according to international categories. Minister of Health, Labor and Welfare has thefinal authority to classify products according to definitions under the law.
New Device
Submission to Prefecural Government
Evaluation and Licensing Div., MHLW
Pharmaceuticals and Medical Devices Evaluation Center (PMDEC)
Me-too DeviceImproved DeviceEvaluation by PMDEC Evaluation by JAAME
PresentationPresentation
Expert Discussion Expert Discussion
Pharmaceuticals and Medical Devices Evaluation Center (PMDEC)
Equivalency Investigation
Evaluation and Licensing Div., MHLW
PAFCS
Evaluation and Licensing Div., MHLW
Prefecural Government
Approval
Pharmaceutical Affairs Law Revision - Key Points
(1) review of the approval system and enhancement of past marketing safety measures
* Introduction of a classification system corresponding to the risk of medical devices
- three categories by risk to the human body (extremely low, low and high)
* A third party certification system for low risk medical devices
(2) review of the safety measures regarding medical devices; and
(3) enhancement of safety measures for biological products
Pharmaceutical Affairs Law Revision - Revision Schedule
July 2002 Pharmaceutical Affairs Law Amendment (PAL)passed the Diet
Fall 2002 Bill on new Administrative Agency to be submitted toextraordinary session of the Diet
April 2003 Revised PAL on biological products to be enacted
April 2004 New Independent Administrative Corporation to beestablished
April 2005 Full enforcement of revised PAL
Review of Categories and Safety Measures Concerning Medical Devices
CurrentPharmaceutical
Affairs LawRevision plan
Internationalcategories
Current status andreview plan
Categories of medicaldevices according to risk
Distributionregulations
Manufacturingregulations
Risk
Distributionregulations
Primarydistributionregulations
Class IMedical devices that are believed topose extremely little risk to the humanbody even if they fail
Extre
mel
y lo
w
Distributor's notificationis not required
Approval formarketingauthorization is notrequired
Notification fordistribution
is not necessary
Approval ofmanufacturing isnot necessary
Class IIMedical devices that are believed topose relatively little risk to the humanbody even if they fail
Low
Distributor's Notificationis required*
Imple-mentationof third-partycertificationsystem
Class III
Medical devices that are believed topose relatively high risk to the humanbody if they fail
Class IV
Medical devices that are highlyinvasive upon the patient and maydirectly endanger the patient's life ifthey fail
Notification systemfor distribution
Minister'sapproval formanufacturing
High
Implementationof license
system fordistribution
Minister'sapproval for marketingauthorization
New Independent Administrative Agency
Drug Manufacturers
Medical Device Manufacturers
JAAME
Medical devices’equivalency investigation
PMDEC
Review of drugs and medical devices
OPSRDrug’s equivalency investigation. Clinical trial consultation. Reliability inspections. GCP, GLP and GPMSP inspections
MHLW CouncilReport of review results Consultation
Recommendation
Inquiry, instructionand answer
Inquiry, instructionand answer
Application
Approval
Current System Proposed New System
Drug and Medical DeviceManufacturers
New Independent Administrative Institution
Review of drugs and medical devices (including clinical trial consultation and inspections)
MHLW CouncilConsultation
Recommendation
Report of review results
Application Inquiry, instructionand answer
Approval
Certification by a third party for low-risk medical devices
Medical Device Reimbursement
A1 Covered under technical fee: Product reimbursement is included in thetechnical fee. Products are usually a low-end, inexpensive nature suchas sutures and other supplies.
A2 Covered under technical fee: Product itself gives technical fees. A2products include high-end and expensive diagnostic equipment such asMRI, CT, etc.
B Existing products (single use products): There is an existing technicalfee and also existing device category.
C1 New products (single use products) used with current existingtechnology: There is an existing technical fee, but no existing devicecategory.
C2 New products with no existing technology: This category is forbreakthrough technologies.
Seriously, Japan is a tough market
• Cost contamination pressure• Over-regulation • High-costs of doing business• Protectionism• Unique and complex market culture• Competitive Japanese firms
Approaching the Market
• Trade Shows- Modern Hospital Show- Hospex- Japan Dental Show- and more
• Academic Conference and Exhibition
• Healthcare Consultants• The U.S. Commercial Service
Programs
Market Information in English
• Our market research reports http://www.usatrade.gov
• Japan External Trade Organization's (JETRO)http://www.jetro.go.jp
• Japan Pharmaceutical Manufacturers Association (JPMA)http://www.jpma.or.jp
• Ministry of Health, Labor and Welfare (MHLW)http://www.mhlw.go.jp/english/index.html
• Japan Association for the Advancement of Medical Equipment (JAAME)http://www.jaame.or.jp/english/index.html
Recommended