An Inaugural Address by
the JSMI New Chairman Ibe At the reception held on May
7 in commemo-ration of the JSMI 39th Ordinary General
A s s e m b l y, the following were announced that
Hachizaemon Kazama, President, Tsumura & Co., stepped
down as Chairman after having successfully performed
his responsibilities for two years and that Sachiaki
Ibe, President , Zeria Pharmaceutical Co., Ltd.,
was elected Chairman.
Sachiaki Ibe, Chairman
Japan Self-Medication Industry
In his inaugural address saying that the General Assembly
was a time to focus on the future and that it also served
as an opportune time to reflect on the past years, Chairman
Ibe said as follows:
In the 21st century where demographics see rapidly aging
population, the common goal or wish of the people is to
enjoy longevity in good health rather than uselessly live
long being confined to bed for a long time.
WHO encourages people to value "Healthy span of life"-
a thought -provoking measurement of longevity in good
health and condition -rather than the mere average span
of life conventionally considered as a yardstick of longevity.
Ever increasing awareness by the empowered consumers towards
their own health keeps encouraging the nonprescription
medicines to change the paradigm so as to develop products
suitable for self-medication to prevent occurrences of
lifestyle-related diseases as well as to improve quality
of life or QOL.
On the other hand, in November last year, the Ministry
of Health, Labour and Welfare (MHLW) i s s u e d "Interim
Report on Roles of Over- T h e -Counter (OTC) Medicines
in Self-Medication".
As the sub-title of the Interim Report says, " To encourage
OTC medicines to be needed, trusted and used with confidence",
the Interim Report clearly sets a goal for the industry
to target as it signals a visionary new direction for
nonprescrip-tion medicines and responsible self-medication
in Japan.
More specifically, in addition to the conventional roles
played by OTC medicines, most notably the Interim Report
says "The existing scope of OTC medicines should be expanded
to include preven-tion of symptom occurrences associated
with lifestyle-related diseases, and improvement and upgrading
of QOL".
All in all, the Interim Report was favourably welcomed
as the momentum for promoting responsible self-medication
in Japan.
The WSMI 14th General Assembly and 5th Asia Pacific Regional
Conference (jointly called Tokyo Conference), with the
objective, "To assess how to best meet increasing consumer
healthcare expecta-tions through responsible self-medication",
were held in November last year in Tokyo, under the strong
leadership of both the then WSMI Chair-man Uehara and
PAJ Chairman Kazama.
Among major learnings, there was meaningful recognition,
"For promoting self-medication, each of the stakeholders
- government, consumers, physicians, pharmacists, and
industry - should jointly as well as individually perform
its role".
Taking up this occasion, the management and staff at JSMI
wish very much to extend their heartfelt thanks not only
to the International Planning Committee members for their
inestimable help and cooperation continuously extended
over the years but also to all the participants, whose
enthusiasm made the Tokyo Conference a great success.
It is my great pleasure to outline our strategic programme
to implement the priorities, emphasiz-ing, inter alia,
two major goals set in the JSMI Business Programme of
the fiscal year 2003:
(1) Consciousness towards self-medication should be fostered
and rooted as early as in the childhood by way of providing
correct information on the medicines.
In this context, JSMI plans to prepare textbooks designed
as curriculums for pharmaceutical education of junior
and senior high school students throughout the country.
(2) Without labouring the importance of dissemi-nation
of information on nonprescription medicines to physicians
and pharmacists, JSMI plans to implement sweeping changes
of its Website so that not only healthcare professionals
but also the general public may reap the benefits of easier
access to and retrieval of information needed right on
target.
In a bid to familiarize consumers with the concept of
self-medication, our association has decided to shift
our representation from classical "Proprie-tary" to clear
"Self-Medication". Proprietary Association of Japan (PAJ)
is now Japan Self-Medication Industry (JSMI) with its
newly designed logo or wordmark.
While our association as PAJ has made certain progress
in bringing the concept of self-medication forward in
the domestic healthcare agenda, the newborn JSMI has a
very long way to go on many fronts both nationally and
internationally.
As JSMI Chairman, I am committed to fulfilling my responsibilities
to ensure the continued growth of the industry and to
promote self-medication in our country under the banner,
"To encourage OTC medicines to be needed, trusted and
used with confidence" as proclaimed in the MHLW Interim
Report.
May I cordially request you to continue to extend your
expertise and to share your experiences as I do look forward
to working with many of you, domestically and internationally,
in many areas of mutual interest and concern.
From PAJ
to JSMI
As
was reported in PAJ Newsletter, NO. 52, August 8, 2002,
following the concurrence and approval at the PAJ Annual
General Assembly held in May 2001, "Self-Medication
Promotion Conference" was formed in July 2001 with the
aim of elaborating a strategy to promote responsible
self-medication.
Action Plans for Implementation, consisting of four
major areas (Pharmaceutical administration, Interactions
with consumers, Interactions between related business
sectors, Globalization) were also explained in the said
issue.
As it had become more and more apparent that the original
name of our association, Proprietary Association of
Japan or PAJ, was perhaps no longer most understandable
to our partners, under the Action Plans, a project was
established to create a new name and logotypes for the
association.
A new name, Japan Self-Medication Industry or JSMI,
together with new logotypes were approved at the General
Assembly held on May 7 as appro-priate tools for establishing
us as the representative of modern self-care and self-medication
industry.
The new logotypes are available in two patterns: Japan
Self-Medication Industry and JSMI.
The colour is royal purple which, as its name suggests,
has been traditionally valued as a colour of nobility
or royalty.
Needless to mention, the name in the Japanese language
remains unchanged as it has long been impregnated among
the consumers and other major stakeholders.
@
Simplification
of OTC Product Registration
Procedures
Nonprescription medicines
are defined as drugs which have a relatively mild action
and a high m a rgin of safety if used correctly within
a fixed range of directions and dosage.
They can be purchased directly from pharmacies, drugstores,
and other designated retail outlets and used freely in
responsible self-medication by the consumers.
For any drug, both Rx and OTC, to be registered and marketed
in Japan, it is mandatory to obtain both SHONIN and KYOKA.
SHONIN or Approval is official confirmation that the particular
item in question is registered as a drug with its safety
and efficacy established. SHONIN is granted to an individual
or legal person.
KYOKA or License certifies that the company is qualified
as an applicant, meeting both personal requirements (the
company representative is not a drug addict or insolvent
or the like, for example) and structural/operational requirements
(the applicant's plant facilities, management of production
process or quality control system, are in conformity with
the standards set by the competent authorities, for example).
KYOKA is granted to a manufacturing plant or business
office.
SHONIN and KYOKA are to be obtained in tandem, so to speak.
Currently there are six (6) classes of application for
OTC product registration and data required for SHONIN
differ from type to type.
"Expert Committee for
Streamlining Procedures to Approve and Examine OTC Medicines",
formed within Pharmaceutical and Food Safety Bureau, Ministry
of Health, Labour and Welfare, strongly suggested last
year that data required for product registration of OTC
drugs should be reasonably minimized by reducing redundant
animal experiments and by utilizing the results of clinical
trials obtained for Rx.
In response to the suggestion, MHLW drafted a plan to
simplify and narrow the scope of data to be attached to
an application dossier.
Incidentally the six classes of application for OTC product
registration may be summarized as follows:
Class 1: Drugs which contain active ingredients which
have been used neither in Rx nor in OTCs;
Class 2: Drugs which contain active ingredients, other
those in Class 1, which have not been used as active ingredients
in already approved OTCs;
Class 3: Drugs which consist of active ingredients which
have been used in already approved OTCs but which have
not been used in the therapeutic category in question
and drugs which are different from already approved OTCs
in the therapeutic category in question in terms of combinations
of active ingredients, or indications & effects, or administration
& dosage;
Class 4: After completion of Post Marketing Surveillance
on safety during use of drugs in any one of Classes 1,
2, and 3, drugs which are applied for approval as drugs
containing either the active ingredients specified in
Classes 1, 2, and 3 but which have differences in combination
of active ingredients used in already approved OTCs;
Class 5: Drugs, belonging to the therapeutic categories
with the Approval Standards (loosely similar to the U.S.
OTC Monographs), only whose dose forms are different from
those specified in the Approval Standards;
Class 6: Drugs which conform to the Approval Standards
or drugs which do not fall into any one of the Classes
1 through 5;
Now the MHLW plan sketches to sort six classes into four.
The gist of the four classes appears as follows:
New Class 1: Drugs which contain new active ingredients;
(So-called Direct OTC)
New Class 2: Drugs which contain active ingre-dients,
other than those used in New class 1, which have not been
used as active ingredients in already approved OTCs; (So-called
Switch OTCs)
New Class 3: Drugs consisting of active ingre-dients which
have been used in already approved OTCs; (So-called drugs
with new indications & e ffects or with new combinations
of active ingredients)
New Class 4: Drugs loosely equivalent to the current Classes
4, 5, and 6;
While data required for New Class 1 remain same, a major
point of simplification is exemption of "Acceleration
Test Data" for New Classes 2, 3 and 4.
Acceleration Test takes at least six months to generate
the required stability data, therefore, exemption of Acceleration
Test Data would considerably shorten the period taken
for the preparations of application dossiers, eventually
enabling manufacturers to launch their products much faster.
The proposed "convergence" further means that the requirements
for the current Classes 4 and 5 would lessen to only those
applicable to Class 6 in terms of "Data on origin and
use in foreign countries", "Data on ADME" and most notably
"Data on results of clinical trials".
Public comments or opinions are sought for submission
to MHLW by June 20, which would be incorporated into revised
requirements which are going into effect from October
this year.
(Data from Yakuji Nippo)
High Consumers'
Spending on Health
While continued negative growth of nonprescrip-tion medicines
has been responsible for painting a bleak picture in the
healthcare business sector, total annual medical expenditure
per household has been staying at the high level of Japanese
Yen 140,000 (approximately US$1,170) over a couple of
years.
Similarly high spending at the level of Yen 10,000 (approximately
US$83) has been observed in the category of "s o - c a
l l e d "health foods and dietary supplements over the
past two to three years.
On April 1, 1999, 15 categories were shifted from nonprescription
to quasi-drug status for free sale outside of pharmacies
and drugstores.
These products, called "Newly designated quasi-d r u g
s "as opposed to the conventionally termed "Quasi-drugs
", have been steadily expanding their share in the food-oriented
market.
On the other hand, the nonprescription medicines sector
has been stagnant particularly in pharma-cies, drugstores
and other legally designated retail outlets except some
chain drugstores.
"Family Budget Inquiry "conducted
in 2002 by Statistics Bureau, Ministry of Management and
Coordination indicated an increase of Yen 290 (approximately
US$2.4) over the previous year in the annual medical expenditure
per household, showing also an increase of 2.9% in the
pharma-ceutical spending.
Annual expenditure per household on "s o - c a l l e d
" health foods and dietary supplements showed a sharp
upward swing from Yen 6,620 (approxi-mately US$55) in
1995 to the level of Yen 11,000 (approximately US$92)
in 2001 and Yen 10,000 (approximately US$83) in 2002.
Despite the stagnancy in the OTC area, consumers ' spending
on promotion and maintenance of their own health keeps
increasing, providing a bright future perspective in the
healthcare related market as a whole.
Since 1993, an average monthly spending per household
keeps declining to reach Yen 306,129 (approximately US$2,550)
in 2002, therefore, an increase in the total expenditure
on pharmaceu-ticals, "so-called" health foods and dietary
supplements deserves special mention here.
TA B L E "Annual expenditure per household on pharmaceuticals
by major therapeutic categories" clearly tells spending
on "Other therapeutic cate-gories" attracts much more
attention than the three most commonly used categories
(Common c old reme-dies, Gastrointestinal remedies and
Nutrients).
Likewise, TABLE "Annual expenditure per household on 'so-called'
health foods and dietary supplements" vividly illustrates
noteworthiness of these stuffs.
In this context, medicines for prevention of lifestyle-related
diseases such as, for example,
Annual
expenditure per household on "so-called "
(UNIT: Japanese Yen)
Year
ME
T
A
B
C
D
E
F
1195
119,684
22,075
2,870
1,407
6,869
848
2,675
7,406
1996
124,996
21,445
2,688
1,379
6,613
850
2,703
7,212
1997
131,004
22,636
2,841
1,407
7,026
936
3,015
7,412
1998
135,859
22,963
2,730
1,373
6,847
877
3,146
7,989
1999
137,704
23,768
2,944
1,292
7,006
967
3,311
8,249
2000
137,371
23,579
2,722
1,239
7,019
888
3,057
8,653
2001
140,304
23,571
2,593
1,283
6,951
859
2,862
9,024
2002
140,594
24,252
2,654
1,341
6,729
859
2,736
9,933
ME = Total Medical Expenditure, T
= Total spending on pharmaceuticals, A = Common cold remedies,
B = Gastrointestinal remedies, C = Nutrients, D = Epidermal
drugs, E = Other topical application, F = Other therapeutic
categories Annual expenditure per household on pharmaceuticals
by major therapeutic categories
Annual
expenditure per household on "so-called " health foods and dietary supplements
1995
6,620
1996
7,229
1997
7,011
1998
7,989
1999
8,237
2000
8,388
2001
11,585
2002
10,631
(UNIT: Japanese Yen)
smokig cessation products
are considered as having a high potential of growth.
By changing conceptual paradigm so as to place "Self-care"
above "Self-medication", it is encour-aged that we commit
to challenge ourselves in the future so that we can demonstrate
examples of expanding self-medication beyond the conven-tional
boundary for the healthcare benefit of the consumers.
(Data from Yakkyoku Shimbun)
@
Report of
the 25th Survey on Consumer
Awareness of OTC Drugs
In early December last
year, the then Proprietary Association of Japan, now Japan
Self-Medication Industry, conducted a consumer opinion
survey on issues related to self-medication.
The survey was carried out by means of a question-naire
for readers contained in an advertisement in the Asahi
Shimbun, one of the national daily n e w s -papers.
In this survey, readers or consumers were asked about
the management of their own health, utili-zation of "family
pharmacy", their opinions concern-ing explanations given
by staff members at "Client Consulting Office" of the
manufacturers regarding their products, and the degree
of satisfaction with such explanations.
Outline of
the survey Among the readers of the Asahi Shimbun,
881 (approximately 36% male and 64% female) were sampled
at random from 2,657 who had responded to the questionnaire.
The respondents consisted of "salaried workers" (35.8%),
followed by "h o u s e w i v e s" (31.8%) and "others
and those without occupation" (17.6%).
Questions (1) How do you regularly manage to
control your own health ? (Multiple replies are eligible.)
(2) Self-Medication is defined as "Taking care of or treating
minor illnesses or injuries with nonpre-scription or over-the-counter
(OTC) medicines". Do you hear this term more often than
before ?
(3) Do you have your "family doctor" who is ready and
willing to listen to your health-related problems ?
(4) Do you have your "family pharmacy" that is ready and
willing to listen to your health-related problems ?
(5) To those who have answered, against Question 4, either
"No, I don't have any one but I intend to have one" or
"No, I don't have any one and do not intend to have one
even from now on" Why don't you have your "family pharmacy"
?
( M u l t i p le replies are eligible.)
(6) Many manufacturers have"Client Consulting O ffice"
in charge of handling the questions or comments from the
consumers.
Have you ever contacted that function ?
Question 1:
How do you usually manage to control
your own health ? Question 2:
Do you hear the term, "Self-Medication",
more often than before ?
Question 3:
Do you have your "family doctor"
? Question 4:
Do you have your "family pharmacy"? Question 5:
Why don't you have your "family
pharmacy" ? Question 6:
Have you ever contacted that function
?
