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Promotion of the Use of Generic Drugs
in Japan
Dec. 5th, 2012 Norihisa Hara, M. D., M. P. H.
Director General of Health Policy Bureau,
Ministry of Health, Labour and Welfare
2
450.0
460.0
470.0
480.0
490.0
500.0
510.0
520.0
( '93) ( '94) ( '95) ( '96) ( '97) ( '98) ( '99) (2000) ( '01) ( '02) ( '03) ( '04) ( '05) ( '06) ( '07) ( '08) ( '09) ( '10)
(trillion yen)
Changes of Gross Domestic Product(GDP) in Japan
Changes of National Medical Expenditure and Drug Costs
6.9 6.7 7.3 7.0 6.7 6.0 6.0 6.1 6.4 6.4 6.9 6.9 7.3 7.1 7.4 7.4 8.0
22.3
0
5
10
15
20
25
30
35
40
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
薬剤費を除く国民医療費
薬剤費
薬剤費比率
Med
ical Expen
ditu
re
(trillion
yen
)
Percen
tage of d
rug co
sts (%)
‘08 ‘09 ‘07
The percentage of the drug costs accounted for national medical expenditure reduced to less than 20%(about 6 trillion yen) in 1999. Then, it tends to increase slightly .
‘06 ‘05 ‘04 ‘03 ‘02 ‘01 2000 ‘99 ‘98 ‘97 ‘96 ‘95 ‘94 ‘93
Percentage of drug costs
Drug costs
National medical expenditure
(except drug costs)
Key features of generic drug
○ Active ingredient, efficacy, dosage and administration, etc. is the same as the original drug.
○ Low cost( Less than 70% of the price of the original drug. There are also generic drugs which are less
than 50%.)
※ May have different additives (Because additives do not affect the efficacy.)
※ Equivalence with the original drug is confirmed by the time of approval. The criteria are
the same as those of the U.S. and Europe
※ If the original drug has registered additional indications, such indications may not be
included in those of generic drugs .
Generic Drugs
○ Dissemination of generic drugs has contributed to the improvement of the financial burden
on patients and health insurance expenditure
○ Effective utilization of limited healthcare resources protects the national healthcare system
4
Promoting the use of generic drugs
Market share of generic drugs: 30% on a volume basis in FY 2012
May, 2007 Programs improve the quality and efficiency of health care and nursing
care services
Jun., 2007 “Honebutono-Houshin 2007”(Structural reform of the Japanese
economy: Basic polices for macroeconomic management)
Action program for the promotion of reassured use of generic drugs
(Oct., 2007)
Quantitative targets
①Stable supply
②Quality assurance
③Provision of information by generic manufacturers
④Improvement of the environment for the use of generic drugs
⑤Health insurance system constraints 5
16.8%18.7%
20.2%
22.8%
5.9% 6.6%7.6%
8.8%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
Sep.'05 Sep.'07 Sep.'09 Sep.'11
Amount base
Money base
Trends in the Market Share of Generic drugs
Unit of measurement: %
Source: Survey by MHLW 9
Volume basis
Value basis
Goal of generic drug use promotion
New drugs
(without generic drug)
19.1%
New drugs
(with generic drug)
34.3%
Generic drugs
22.8%
Other drugs
23.9%
30.0%
Sep 2011
Drug price survey
(amount share)
Mar 2013
Goal
(amount share)
* Other drugs: Drugs approved in or before 1967, Kampo extract preparations, crude drugs, biological preparations
(vaccines, blood preparations), JP drugs
At leas 50% of drugs which can be switched to generic drugs
10
Market share of generic drugs in each countries against off-patent products (volume)
<平成24年8月22日 中央社会保険医療協議会 薬価専門部会資料 より> 8
9
1.Stable Supply • “Manufacture and sale tend to be discontinued immediately after problems such as negative profitability.” • “Sometimes, it takes time from order to delivery.” • “Part of the specifications of the original drug are not manufactured and it hampers substitution to the generic.” • “Small packages are sometimes not available.”
2.Quality Assurance • “I wonder if the dissolution and blood concentration of some generic drugs differ from those of the original drugs.” • “I wonder if there are differences in the type and the amount of impurities from the original drugs.” • “I have an experience of side effects not seen in the original drug.” 3. Concerning provision of information by generic manufacturers • “Detailmen would not make no visits.” • “Lack of pharmaceutical training of detailmen, lack of information” • “Information provision tends to rely on original manufacturers, as we are often told to ‘inquire the original manufacturer about such a matter’.”
Voices from medical work front
Action program for the promotion of reassured use of generic drugs (outline)
・Provision of thorough instruction for stable supply
・Reduction of delivery time
・Buildup of inventory
①Stable supply
・Strengthen the stable supply for medical institutions
②Quality assurance
・Education of the healthcare professionals for better
understanding of the quality of generic drugs
・Tests/analyses and disclosure of their results on the quality of generic drugs ・Expansion of simultaneous vigilance/instruction and disclosure of their results
Task
Government
Generic drug
manufacturers
Task
Government
Generic drug
manufacturers ・Quality tests/analyses and disclosure of their results ・Survey of relevant literatures
10
• Instructions toward improvement of package inserts
• Instructions for upgrading the information provision system of
generic drug manufacturer
・Information provision to healthcare professionals through posting
test data, ADR data, etc. on the website, prompt responses to
requests for reference materials
③Provision of information by generic manufacturer
・Upgrade provision of information by generic drug manufacturer
④Improvement of the environment for more use of generic drugs
・Increase enlightening activities for the general public and
healthcare professionals
・Set-up of prefecture-level councils ・Dissemination and enlightening with posters and pamphlets ・Delivery and publication of “Generic Drug Q&A”
Task
Government
Generic drug
manufacturers
Task
Government
11
・Amendment of additional premiums for generic drugs dispensing practice
・ Revision of regulations facilitating substitution to the generic drugs dispensed at the pharmacy
( such as permission of dispensing an equivalent dosage using different strengths or formulations )
・ Addition of a provision to the physicians’ code of practice an obligation of efforts such as
confirming the patient‘s intention
⑤Medical insurance system constraints
FY 2008
・ Revision of the prescription form: Change to the column “Unchangeable to generic drugs”
・ Additional premiums for generic drugs dispensing practice
・Addition of a provision to the NHI-registered physicians’ and pharmacists’ code of practices an
obligation of efforts to prescribe and dispense generic drugs
FY 2010
FY 2012
・Amendment of additional premiums for generic drugs dispensing practice in terms of the basic fees
at the NHI-registered pharmacies
・Provision of information on generic drugs by utilizing the Drug Information Provision Sheets
・Additional Premiums for Practices that actively use generic drugs in medical institutions without the
DPC system
・Promotion of generic name prescribing so that any generics can be dispensed if the API is the same
・ Revision of the prescription form: The format has been modified so that substitution to generic drugs
can be clarified for individual drugs indicated on each prescription. 12
Future Challenges
In order to promote further use of generic drugs, the Ministry of
Health, Labour and Welfare is creating a Roadmap which
embraces a new target value of generic market share, stable
supply, provision of information relating to the quality and
measures for the health insurance etc. across the related
departments of the Ministry within FY 2012.
13