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

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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

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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

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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

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• 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

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・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.

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