nd2 APSMI Board of

Directors Meeting

18th October 2012
COEX Intercontinental HotelSeoulToday’s Agenda
1. Confirmation of minutes of 1st APSMI Board of

Directors Meeting, 7th October 2011
2. Membership development
3. Activities and Accounting Report in 2012
4. 9th WSMI AP Regional conference & 1st APSMI GA
5. Activities and the budget in 2013

6. The 2nd APSMI General Assembly Meeting
7. Topics from member associations
8. Announcement
9. Others
2Member Replacement
Board Member, National Association
KPMAMs. Han Byul (Kristeen) Jhung, team leader ofinternational affairs: Succeeded Ms. Heeha Kim
TPMMA
Ms. Sylvia Tsai, Vice Director of OTC Committee,
Succeeded Ms. Iris Wang
TSMIA
Ms. Malinee Uditananda, President,
Succeeded Dr. Noppadon Adjimatera

Board Member, Corporate
Daiichi-Sankyo HC
Mr. Yoshiki Nishii, new President of Daiichi-Sankyo HC
Succeeded Mr. Toshio Takahashi

3Chairperson Election
New Chairperson of APSMI
Ms. Eun Sun Kim
Chairperson of Boryung Pharmaceutical Co. Ltd.
Chairman, OTC Drug Promotion Committee of KPMA
Vice-Chairperson of APSMI

Nominated new Vice- Chairperson
Mr. Seiichi SatoPresident ＆ CEO of Sato Pharmaceutical Co. Ltd.
Vive-Chairman of WSMI, Vice-Chairman of JSMI
Chairperson of APSMI
4APSMI Activities in 2011, 2012

5

APSMI’s Objective
APSMI shall contribute the development ofconsumer healthcare industries, especially
OTC industries in Asia-Pacific region withthe consensus of the members to promote
the responsible Self-Medication in Asia
Pacific region, and with the exchanging
and sharing information

6

Selected Projects

Regulation (including Rx-to-OTC Switching)and Self-Medication were selected as projects
for exchanging and sharing information,and Mutual understanding.

7

Objective of Projects
Promote the development ofconsumer healthcare industries,
especially OTC industry, and revitalize
OTC market through enhancing eachcountry’s Self-Medication andoptimizing OTC regulation in the AsiaPacific region.

8

Expected Outcome of Projects
・Promotion of consumer’s health by carrying
forward Self-Medication
・Improvement and optimization of OTC
regulation in each country
・Quick launch of OTC medicines necessary for
consumers including switch OTCs on themarket
・Improvement of the access to OTC medicinesand revitalization of OTC market
・Reduction of the healthcare expenditurecovered by health insurance

9

Tasks to be Achieved
・Gaining the understanding by healthcare
professionals and health authorities forpromoting Self-Medication and using OTC
medicines including switch OTCs
・Gaining the understanding by each regulatory
authority for the optimization of OTC
regulation
・Consultation with relevant parties including
regulatory authorities for implementationof optimized OTC regulation in Asia-Pacificregion10

Action Plan and Schedule (1)1. Short term (2011-2012)- Advancing – projects-, for “Self-Medication”
and “Regulation”, and sharing the projectresults and mutual understanding within
members- Reporting at 1st APSMI GAM
2. Mid Term (2013-2014)- Pick up common problems & country
specific issue- Starting the challenges for the solution ofproblems picked up from each project- Selection of new projects
11Action Plan and Schedule (2)3. Long term
- Clarifying the significance of OTC
medicines- Achieving the healthy development andactivation of healthcare industries andOTC industries

12

Working Groups for Projects
Chairperson

Board of Directors

ASMI Secretariat (Secretary General)

Working Group for“Regulation” projectGroup Leader: TSMIA*Group members(experts from
Member Associations
Corporate members)

Working Group for“Self-Medication” projectGroup Leader: CNMAGroup members(experts from
Member Associations
Corporate members)*Successor: JSMI, TPMMA
13

Action plan, Regulation PJ
Step I (2011-2012)
Collecting information on OTC regulation-Classification and approval system of OTC in eachcountry-Regulation for OTC marketing, selling and advertisement-Regulation for OTC quality
Summarization and share of the survey results

14Action plan, Self-Medication PJ
Step I (2011-2012)
Survey of Self-Medication status in each member country- OTC market/status of users- Environment for self-medication- Circumstances and cases of self-medication
enlightenment activities
Summarization and share of the survey results

15

Activities in 2012
1. Progress of projects
Survey, Reports by WG
2. 1st APSMI General Assemblywith 9th WSMI Asia-Pacific Regional
Conference, hosted by KPMA
3. Publication of APSMI Country
Report4. Introduce APSMI to non-member
association
5. Communication with WSMI16

9th WSMI AP Regional Conference & APSMI GAM

Theme: Future Horizons for Self-Care
Date: 19th Thursday, 20th Friday, October, 2012
Venue: COEX, Seoul, Korea
Host Association: KPMA17

Results of APSMI Activities
APSMI Country Report

18APSMI Country Report
Self-Medication
Working GroupRegulation
Working Group

Information sharing
Reporting at the 1st APSMI General Assembly

APSMI country report 2012
- Survey report by APSMI Working groups- OTC Market Review in Asia Pacific Region
by Nicholas Hall & company, ASMI, CNMA,JSMICountry Report Index
1. Chairperson’s Foreword
2. Message from Nicholas Hall
3. APSMI Profile and Activities
4. Self-Medication Status SurveyReport
5. Regulation Survey Report
6. Working Group Member
7. OTC market in Asia-Pacific Region
1) Global View
2) Asia Pacific Review
3) Country/ Region Reports

20Regulation Working Group
Current Regulatory Status Survey- Focus Points 1. Registration hurdle of OTC medicines
2. Regulation for OTC marketing, selling
and advertisement
3. Quality and manufacturing control for
OTC medicines
21Regulation Working Group
Items of the Survey

1. OTC classification
2. Example of OTC products
3. License requirement for OTC products
4. Application type of OTC medicines registration
5. Required document of OTC registration
6. Lead time for OTC registration (in month)
7. Problem about OTC classification and approval
8. Advertising channel for OTC products
9. Country's problem about regulation for OTC
marketing, selling and advertisement
10.Quality Standard/Regulation for OTCproducts
11.Country's problem about regulation for OTC
quality and manufacturing control

22

Regulation Working GroupThe Conclusion of Results
1. Registration hurdle of China andThailand is higher than othercountries.
2. Japan does not have an Authority
pre approval system for OTC
Advertisement.
3. Chinese Taipei has a local PIC/S GMP.
On the other hand, Thailand GMP will
be up-graded to PIC/S in 2015.
23

Self-Medication Working Group
Current Self-Medication Status Survey- Focus Points –1. OTC market/status of users
2. Environment for Self-Medication
3. Circumstances and cases of SelfMedication enlightenment activities
24Self-Medication Working Group
Main items of the Survey
1. Recognition of Self-Medications
2. Recognition ratio of OTC Medications
3. Favorable counselor for Health Problems
4. Access to OTC medicines
5. Influence of health care system in each countries
6. Benefits of OTC medicines
7. Promotional activities on Self-Medication
8. Cooperative organization for promotion ofSelf-Medication
9. Multilateral activities to promote theResponsible Self-Medication with otherassociations
25

Self-Medication Working GroupThe Conclusion of a Results
1. There is a difference in degree for recognition of
Self-Medication and OTC medicines.
2. Physician is the largest number of answers for“favorable counselor for health problems”.
Others are Pharmacist and Consumers themselves.
3. National health care system is a one of barriers forpromoting Self-Medication.
4. Advertising by media, event for consumer,
publication of Self-Medication booklets are popularfor “promotional activities on Self-Medication.
26

APSMI Activity Plan For 201327

Action plan, Regulation PJ
Step II (2013)
Investigating and planning action plan for optimization ofOTC regulation throughout Asia-Pacific region-Analyzing problems of each country and pick up
common challenges in the region-Drawing schemes for common challenges andprioritizing them-Breaking down the schemes for each association toachieve challenges in Asia-Pacific region
Meeting with Authorities, other Stakeholders
28

Member of Regulation WG
MemberCNMA

JSMI

NameTitle

Ms. Ruby HE Hong

Representative, CNMA

Ms. Linda SUN Ling

Representative, CNMA

Ms. Ruby SUN Yu

Representative, CNMA

Mr. Kosei Iriyama

International Affair Committee,
JSMI

Mr. Kenji Ukita
KPMA

Ms. Kristeen Jhung

Team Leader of Int'l Affairs
Team, KPMA

TPMMA

Ms. Sylvia Tsai

Vice Director of OTC
Committee, TPMMA

Mr. Yasuhiro Tagashira

Secretary General

TSMIA
APSMI

29

Action plan, Self-Medication PJ
Step II (2013)
Verification of the survey results and planning andimplementation of specific enlightenment activities- Identification of problems common to all countries
and those specific for certain countries/regions- Discussion about actions to solve the commonproblems, regions where actions are taken, cost,
expected outcome, etc.
- Implementation of enlightenment activities (by eachassociation)
Collecting the successful examples of Self-Medication
in member associations
30

Member of Self-medication WG
MemberCNMA

NameMr. James Fan Qun

Title
Executive Director, CNMA

Mr. Wenhu ZHANG
Ms. Ruby Sun

Representative, CNMA

Ms. Nina Liu
Ms. Zheng BoJSMI

Mr. Masatoshi NakamuraMr. Shin Inoue
KPMA

Ms. Kristeen Jhung

TPMMA

Mr. Arthur Su

International Affair
Department, CNMA
International Affair
Committee, JSMI
Leader of International
Affairs Team, KPMA
Assistant Director of OTC
Committee, TPMMA

TSMIA
APSMI

Mr. Yasuhiro Tagashira

Secretary General

Novartis CH

Mr. Rodney Hannington

Head of Marketing, Novartis
31

Other Actions in 2013
More communication within members- What supports members want
- What information members wantMore Contact Stakeholders
e.g. International organization
Authorities
Healthcare Professionals
32

Our Goal
Through the solution of problems
Develop the OTC Market in AP region
through enhancing Self-Medication
by exchanging information, sharing
information and mutual understanding

For saving National Health Cost
33

Account report in 2012
&Proposed Budget in 201334

Account Repot in 2012
IncomeBudgetin US$
71,29520,712in JPY
5,489,715
1,594,858

92,0071US$

7,084,573
77JPY

Income, actualin US$
in JPY
71,295 5,532,872
37,250 2,890,608
10785
108,555 8,424,265
77.6JPY

Item
Note
Office Rental
Phone & Postage
Internet
Equipments
Web HP
Suporting Fee
Equipment
Seal, Stanp, etc.
StationeryConsumable
Ink Tonaer etc.
Printing
Business Card etc.
Travel Fee
WSMI, KPMA, PhAMA etc
Transportation
Shipping Charge
Miscellaneous
Bank Charge etc.
Meeting Fee
APSMI Board Meeting (Oct.)APSMI GAM (Oct.)
Project Cost
Printing
OthersTotal Expenditure
Amount of Carry Over
Total
Exchange Rate
1US$

Budgetin US$
in JPY
4,675
360,000
2,727
210,000
65
5,000
649
50,000260
20,000195
15,000649
50,000758
58,40030,5192,350,000
0091
7,000
12,9871,000,000
12,9871,000,000
12,9871,000,000
6,494
500,000
86,044
6,625,400
5,963
459,173
92,007
7,084,573
77JPY

Expenditure, estimatedin US$
in JPY
4,639
360,000
2,335
181,22200
1,289
100,000
257
20,000
110
8,543
320
24,8304,436
344,200
26,696 2,071,587
1,933
150,000
39
3,050
12,887 1,000,000
12,887 1,000,000
12,887 1,000,000
6,443
500,000
87,158 6,763,432
21,402 1,660,833
108,560 8,424,265
77.6JPY

Item
Annual Due
Carry OverInterest etc.

Note

Total
Exchange Rate

Expenditure

Differencein US$
in JPY043,157
16,5381,295,750
10785
16,548
1,339,692
77.6JPY

Differencein US$
in JPY00-371-28,778-64-5,000
644
50,00000-83-6,457-324-25,170
3,683
285,800-3,588-278,413
1,932
150,000-51-3,950
00000000
1,779
138,032
15,4861,201,660
17,264
1,339,692
77.6JPY

35

Proposed Budget in 2013
IncomeItem
Annual Due
Carry OverInterest etc.

Budget in 2013
in US$
in JPY
71,295 5,561,010
21,292 1,660,833

1US$

7,221,843
78JPY

Estimate in 2012
in US$
in JPY
71,2955,532,872
37,2502,890,608
10785
108,555
8,424,265
77.6JPY

Differencein US$in JPY
028,138-15,958-1,229,775-10-785-15,968
1,202,422
77.6JPY

1US$

Budget in 2013
in US$
in JPY
4,615
360,000
2,945
230,000
64
5,000
1,282
100,000
64
5,000
128
10,000385
30,00054
4,200
26,923 2,100,000
385
30,00038
3,000
12,821 1,000,000
12,821 1,000,000
6,410
500,000
6,410
500,000
75,349 5,877,200
17,239 1,344,643
92,587 7,221,843
77JPY

Expenditure in 2012
in US$
in JPY
4,639
360,000
2,335
181,22200
1,289
100,000
257
20,000
110
8,543
320
24,8304,436
344,200
26,696
2,071,587
1,933150,000
39
3,050
12,8871,000,000
12,8871,000,000
12,8871,000,000
6,443
500,000
87,1586,763,432
21,402
1,660,833
108,560
8,424,265
77.6JPY

Differencein US$
in JPY00629
48,77864
5,000
00-193-15,000
19
1,457
67
5,170
-4,381-340,000
366
28,413-1,546-120,000-1-50
0000-6,443-500,00000-11,421-886,232-4,075-316,190-15,495-1,202,422
77.6JPY

Note
From 2012
Total

Exchange Rate

92,587

Expenditure
Item
Note
Office Rental
Phone & Postage
InternetEquipment
Web HP
Suporting Fee
Equipment
Seal, Stanp, etc.
StationeryConsumable
Ink Tonaer etc.
Printing
Business Card etc.
Travel Fee
WSMI, KPMA, PhAMA etc
Transportation
Shipping Charge
Miscellaneous
Bank Charge etc.
Meeting Fee
APSMI Board Meeting
Other Meeting
Project CostPrinting
OthersTotal Expenditure
Amount of Carry Over
Total
Exchange Rate36

Principle of Annual Due
1. Shared the cost of APSMI activities
by each members
2. The Rule of contribution in Finance isbased on market size
Association Member
Equivalent of 50% WSMI annual fee
in previous year
Corporate Member
US$ 3,00037

Annual Due in 2013
WSMI(CHF)
2010

APSMI(US$)

2011

2011

2012

CNMA

3,770

15,660

1,885

1,885

JSMI

75,39078,33037,69537,695

KPMA

7,540

7,830

3,770

3,770

TPMMA

1,890

1,970

945

945

TSMIA

1,890

1,970

00

27,00027,00071,29571,295

Corporate
Member*Total

90,480105,760

1CHF: equivalent to 1US$(2010)*Nine corporate members
38

3rd APSMI Board of Directors Meeting

Not decide the venue and date now

39

2st APSMI GAM
The 2nd APSMI General Assembly
Meeting will be planned as follows;
Host:
Venue:Date:

TSMIA ( 1st Condidate)
ThailandAutumn 2014

TSMIA is considering the host for the 2nd
GAM with 10th WSMI Asia-Pacific RegionalConference.
40Topics from Members’ Associations
If you have topics, please inform us.
CNMAJSMIKPMA
TPMMA
TSMIA
ASMI
G. P. Farmasi
PhAMAWSMI
41

Others
APSMI secretariat will move in December
New Address
Itopia Iwamotocho 1 Cho-me bldg, 8-15,
1 Cho-me, Iwamotocho, Chiyoda-ku
Tokyo, Japan
After it moves, APSMI will announce
detail, e.g. the new telephone number etc.
42