trends of generic medicines market in japan · japan generic medicines association 15th annual igpa...

Trends of Generic Medicines Market

in Japan

Kenichi Nagano, Director General

Japan Generic Medicines Association

15th Annual IGPA Conference 2012

Kyoto Japan

December 5, 2012

Current Generic Medicines Status in Japan

• Govt set a target of generic market share

in 2007 to bring it to 30% in volume in 5

years.

• The volume share increased about 8%

from 2007 to 2012 to 25.3%.

• Further efforts are still required to reach

30% target within fiscal 2012.(Mar 2013)

• There is also a need to further promote the

use of generics from fiscal 2013.

Copyright © 2012 Japan Generic Medicines Association All Rights Reserved. 2

Evolution of Generic Promotion by Govt

• 2002：Financial Incentives were given to

Physicians and Pharmacists → 4％ up

• 2006：Revision of Prescription Form → a little increase

• 2008：Re-revision of Prescription Form + Dispending

Practice Premium → a little increase

• 2010：Re-enforcement of Dispensing Pharmacy Premium

→ 3％ up

• 2012： New Gx Promotion Measures on the medical

insurance system → 1% up

• Government is considering a new target and action

program ( a new roadmap for promotion of generic

medicines) from fiscal 2013.


2012 New Gx Promotion Measures on the medical

insurance system

1. Valuation of information provision concerning generic medicines utilizing the drug information document

2. Review of additional fees for dispensing practice of generic medicines at pharmacy

3. Promotion of prescription using INN names

4. Change of prescription form


Evolution of Generic Medicines Share

%

5

10

15

20

25

30

02' 03' 04' 05' 06' 07' 08' 09' 10' 11' 12'

12.2

16.4 16.8 17.1 16.9 17.2 17.6

20.3

23.0 23.3

30

4.8 5.2 5.2 5.1 5.7 6.2 6.88.5 9.4 9.6

数量ベース金額ベース

5

政府目標

??

Volume Value

Govt. Target

Source: JGA+ IMS since ‘09

Copyright © 2012 Japan Generic Medicines Association All Rights Reserved.

Estimation of Volume Share by End of 2012

22.4 22.523.1 23.2 23.1 23.2 23.6

24.225.3

30

20

22

24

26

28

30

32

1Q.2010 3Q.2010 1Q.2011 3Q.2011 1Q.2012 4Q. 2012

2Q.2010 4Q.2010 2Q.2011 4Q.2011 2Q.2012 3Q.2012

Source: JGA+ IMS



Source：Website of each company or press reports

Ranking of generics’ manufacturers in Japan

CompanyNet Sales

（bi l l ion yen）Fiscal year Listed/Un l isted Note

1 Nichiiko 77.7 Nov. 2011 Tokyo 1 Market

2 Teva Pharma Japan 70 unlisted （estimation）

3 Sawai 67.6 Mar. 2012 Tokyo 1 Market

4 Towa 48.7 Mar. 2012 Tokyo 1 Market

5 Nipro Pharma 42.5 Mar. 2012 unlisted subsidiary of Nipro Corp.

6 Nippon Chemipha 28.5 Mar. 2012 Tokyo 1 Market

7 Daito 27 May. 2012 Tokyo 1 Market

8 Fuji Seiyaku 21.6 Sep. 2011 Tokyo 1 Market

9 Kobayashi Kako 17.8 Mar. 2012 unlisted (excluding related company)

10 Takata Seiyaku 17.1 Sep. 2011 unlisted

11 Kyowa Yakuhin 16 Mar. 2012 unlisted subsidiary of Lupin

12 Yoshindo 15.2 Apr. 2012 unlisted

13 Nitto Medick 12.7 May. 2011 unlisted

14 Oohara Yakuhin 12.4 Mar. 2012 unlisted

15 Nisshin Seiyaku 12.1 May. 2011 unlisted

16 Kyorin Rimedio 9.6 Mar. 2012 unlisted subsidiary of Kyorin

17 Nippon Generic 8.1 Mar. 2012 unlisted subsidiary of Nippon Chozai

18 Tatsumi Chemical 7 Jun. 2011 unlisted

Cost Reduction Effect by Generic Substitution

for National Medical Expenditure

Volume share Value share

Share of generics 22.8% 8.8%

Off-patent products 34.3% 35.2%


Impact on National Medical Expenditure if all off-patent

products are replaced by all generics

⇒ Total National Medical Expenditure▲1,530 billion yen

(Governmental Expenditure ▲ 400 billion yen) ※Based on (table above), the 2010 national health survey in September

2011 of the MHLW drug prices estimated by Ministry of Finance

National Drug Price Survey by MHLW

in Sept 2011

Actions for Stable Supply of Generics

• Drug Shortage has become a big problem overseas,.

• On the medical insurance system in Japan, supply

obligation of all the registered prescription drugs is

imposed on the pharmaceutical companies, in case of a

discontinuation it requires certain procedures. (No drug

marketer is allowed to discontinue with its own decision

alone.)

• However, request for stable supply of generics from

medical professionals is strong in Japan

• JGA has been actively working to provide a stable

supply and launched new campaign in March 2012.


Requirements from the Govt for

Stable Supply of Generics

As for compliance with the stable supply of

generics, MHLW has set three requirements for

generic medicines companies in 2006:

① At least five-year supply continuity, ensuring the

inventory of the finished products and securing raw

materials

② Establishment of a sales system in all prefectures.

Information provision to the ordering customers.

③ Establishment of a system to make a quick and

appropriate response and to resolve complaints

10 Copyright © 2012 Japan Generic Medicines Association All Rights Reserved.

Summary Procedure for Discontinuation of a listed

Drug and Stop Supply

11

Japan Medical

Association (JMA)

Pharmaceutical

manufacturers MHLW

transitional

measures period

②To be

reported

③ result of

review

①Application in

advance of a

discontinuation

⑥ Request for the cancel-

lation of the listed drug

price

④ notification

of result

medical

institutions

⑦ Notification of

transitional measures

⑤ Information

provision

⑧ Cancellation of

the listed drug price


Actions Taken So Far by JGA：Stable Supply

Stable Supply

Shortening of time of

delivery to wholesalers

depending on situation:

・delivery next day

・delivery the same day

Secure Inventory

Distributor Inventory

Manufacturer Inventory

each 1 month

Prevention of

Stock-out

Goal

achievement

Goal

achievement

The number of stock-outs

have been decreased 2008：14companies, 34 cases

2011： 8companies, 11cases

12 Copyright Japan Generic Medicines Association

13

New Approach for Stable Supply（2012～）

Further

Promotion

of stable

supply

Appoint product

inventory managers

(each company) &

Organize the

Inventory Managers’

Coordinating

Committee（JGA）

Manage by

Stable Supply

Manual

（each member

company）

Ensure Stable

Supply of the

APIs

(each company)

Publicize drug

shortage information

（JGA homepage）


① Organization of Inventory Manager’s

Coordinating Committee

• Register inventory managers to JGA

• Hold manager’s meetings regularly for sharing

information related to stable supply of generics

• Promote networking among the managers in order

to have close coordination

• When the problem occurs in terms of the stable

supply in particular, with respect to smooth supply

of replacements, the managers shall act as a point

of contact when involved companies form a

cooperative group.


② Stable supply manual －１

• JGA requests all member companies to prepare “Stable

Supply Manual”

• JGA presents the member companies the requirements

to be specified in “Stable Supply Manual“

• Member companies create their “Stable Supply Manual",

and establish their own stable supply systems.

• JGA monitor creation of “Stable Supply Manual” and its

operation of each member company

• JGA will respond to inquiries from members and advise

depending on the results of monitoring


② Stable supply manual －２

Contents to be specified

• Definition of Responsibility and Assignment of Jobs

• Compilation of Information and Coordination of Departments

• Inventory Control and Formation

• Actions to be taken when drug registration contents are

changed

• Actions to be taken for maintenance, renewal, newly-building

and/or expansion of production-facilities

• Setup and Control of Corresponding Levels

• Security to obtain stable supply of APIs

• Security to obtain secondary sources

• Points to consider to contract out to other manufacturers

• Listing of products to be handled at most care

• Actions to be taken when shortages happen

16 Copyright © 2012 Japan Generic Medicines Association All Rights Reserved.

③ Measures to Secure Stable Supply of

Raw Materials Such As APIs

JGA asked member companies to take the following

measures from the fact that because of environmental

issues, etc., controls on both domestic and international

manufacturing plants have become severer, and stable

supply of API has become difficult.

• Close coordination with in-country caretaker and API

manufacturer and appropriate change control

• Secure a second source as needs arise.

• Take extra care when contracting with suppliers of APIs

• Audit of API manufacturing sites based on GMP audit

manual


18

Provision of Supply

Information by JGA

website started (from

H.24.7.1)

This measure is modeled

after the U.S. FDA Drug

Shortage Program

④ Provision of Supply Information


Conclusions

• Govt started out the generic-promotion policy in 2007.

• As the results, generic medicines’ sales volume is

growing more than before.

• But it is necessary to have more promotional measures

to reach 30% by March 2013.

• JGA is making its efforts to achieve the target and also

started new action for stable supply of generics this year.

• Govt started new promotion scheme of generics on

medical insurance system. The 1st Q. grew, but the

market shows unpredictable condition for the future.

• Govt is considering some new promotion schemes from

fiscal 2012 and new target and will publicize soon.


Thank you for your attention


ＥＮＤ

trends of generic medicines market in japan · japan generic medicines association 15th annual igpa...

Documents