Transcript and “healthy life expectancy”

ENHANCING MUTUAL STAKEHOLDER BENEFITS
IN SELF-CARE MEDICINE REGISTRATION
APSMI
PANEL MEMBERS
Moderator
TSMIA:
Dr. Noppadon Adjimatera
Participants from APSMI member associations
JSMI:
Mr. Motohito Nishizawa
TPMMA:
Ms. Sylvia Tsai
TSMIA: Dr. Noppadon Adjimatera
APSMI:
Mr. Yasuhiro Tagashira
SET THE SCENE FOR DISCUSSION
Prospective of self-care regulation
(declaration in 1st self-CARER in 2014)
To expedite the launch of high-quality OTC
medicines for Asian consumers
1.
Active ingredients of OTC medicines must have the experience/evidence of safe and efficacious use in
prescription or OTC medicines, and the safety and efficacy of OTC medicines must be confirmed. Considering the
lower level of risk in OTC medicines, the assessment process for OTC approval should be different from the
assessment process of new ethical medicines.
2.
The Investigation of the registration requirements should be conducted to optimize the data required for OTC
medicines approval in each country, and avoid the unnecessary repetition of data generation to support the
registration, particularly clinical studies.
3.
OTC medicines which active ingredients are listed in the monograph and/or have the experience/evidence of use
in other countries, which active ingredients have evidences of safety and efficacy, and which active ingredients
do not exceed the dosage and application in other countries, should be regarded as the “well-established OTC
medicines” and the minimum approval requirements should be adopted by the regulatory authority (e.g. ANDA
or generic drug application, instead of NDA or new drug application).
4.
The appropriate use of Brand names in OTC medicines should be authorized, given it help in communicating the
characteristics of OTC medicines, and avoiding the misapplication use.
5.
Tabular list of ingredients/dosages approved for OTC medicines in each country (Asian version monograph)
should be established, and health authorities should explore the harmonization possibility to allow the common
classifications, ingredient, doses etc. in OTC medicines within Asia.
6.
Efforts should be made to achieve optimization of OTC approval assessment through interaction between
regulatory authorities of individual countries, and ultimately the cooperation between authorities in driving the
regulatory optimization or harmonization in OTC registration across Asia.
DISCUSSION POINTS
What is the level of self-care
awareness in your country? –all 4
countries
DISCUSSION POINTS
What is current status of OTC registration
/regulation in your country, after the
st
1 RTD meeting in Phuket in 2014? Any new
regulation or changes? - all 4 countries
DISCUSSION POINTS
What is the top priority that country should
work to get full benefit of self-care? – all 4
countries + APSMI
DISCUSSION POINTS
What is the role of “APSMI/industry” and
“government” help drive the self-care
policy? – APSMI
BACK UP SLIDES - TAIWAN
10
In developing
• Consumers are with high health consciousness: 84% of general public in
Taiwan are willing to maintain regular self health care.
• High National Health Insurance (NHI) coverage, low self-medication (34%)
• Different expectation for self-care/ self-medication among stakeholders
OTC
5.5%
Rx
1995
2000
2005
94.5%
2014
11
• Completed monograph revisions:
• Newly add 3 categories:
• Anti- hemorrhoids preparation (draft version)
• Anti-Acne preparation (draft version)
• Topical steroid preparation (draft version)
• Revision on the current monograph:
• Ophthalmic preparation (Final version)
• TFDA showed its determination in Rx-to-OTC switch in Jan 
been strongly against by the physician association
• Complete the review for 6 ingredients for Rx-to-OTC (to be
published to industry by end of Oct)
• Host an International OTC workshop
• Introduce best practice from other markets to Taiwan stakeholders
• Set up a plate form for stakeholder communication
12
• Continue the efforts in establish switch mechanism and cases
• Strengthen the role of community pharmacists
• Get alignment within stakeholders to drive consumer empowerment
Back up slides - Japan
Global Trend of Aged
(figures for 2011 and later are estimated value.)
Before the WW II, Infectious diseases killed
young and aged. After the WW II,
Life-style diseases gave us more heavy burden.
From 2004 MHLW Year book
Gap between “life expectancy”
and “healthy life expectancy”
(Year)
Men
9.13 years
Women
12.68 years
Life
expectancy
Healthy life expectancy
(Period when their daily life is not restricted)
Gap between life expectancy and healthy life
expectancy
Source: A survey conducted by Ministry of Health, Labour and Welfare (2000)
Increased medical expenses
could rise over 400 billion
US$ soon.
40.0
(Trillion yen)
35.0
Apr. 1961
*$1= JPY102.3
12
37.8
国民皆保険制度実施以降
10
30.0
8
25.0
20.0
6
15.0
4
10.0
2
0.0
1954
1955
1956
1957
1958
1959
1960
1961
1962
1963
1964
1965
1966
1967
1968
1969
1970
1971
1972
1973
1974
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
5.0
Medical cost (insurance fees and
医療費（保険料・患者負担）
payments from patients)
0
Medical cost (national and local
Ratio to the national income
医療費（国庫と地方の公費）
国民所得比
government expenditures)
Source: Survey by Ministry of Health, Labour and Welfare
(%)
Self-Medication could contribute
to solve the health issues
(Grand Design for OTC Industry by2025)
Vision for OTC Industry
(3 Principles in 2025）
• Self-Medication and Self-Care contribute the
nation for its Healthy Active Longevities
• “Community Health Station” works well for
the implementation of Self-Medication and
Self-Care
• In ASEAN and other countries, the Japanmodel is utilized for the Healthy Active
Longevities
Recently approved Ingredients in
the Pharmacist Intervention Required
Medicines (Switched OTC or Direct OTC) in
Japan
Year
Ingredient
2010
Epinastine Hydrochloride ; Becrometazone propionate (nasal spray)
2011
Clotrimazole * ; Mixture of dried-extract of red vine leaf (Flaven TM) ;
Oxymethazoline hydrochloride (nasal spray) ;
Acitazanolast hydrate (eye drops) ; Mequitazine
2012
<new dosage> ;
Ibuprofen + Scopolamine butylbromide ; Pemirolast pottasium
Neticonazole hydrochloride ; Ibuprofen <new dosage> ;
Fexofenadine hydrochloride ; Pemirolast potassium * ;
Ketotifen fumarate + Naphazoline hydrochloride (nasal spray) ;
2013
Cetirizine hydrochloride ; Ethyl icosapentate
Pemirolast pottasium ; Evastine ; Tranilast ; Trimebutine maleate
2014
Chasteberry extract ; Alminoprofen
20