1.Seiichi
Sato, JSMI Vice-Chairman, accepted WSMI Vice-Chairman
for the Asia Pacific Region
With Dr Seung-Pil Yu's (Chairman and CEO of Yuyu Inc., Korea) tendering resignation
of the position of WSMI Vice-Chairman for the Asia Pacific Region, WSMI
Chairman Hans Regenauer offered the Vice-Chairmanship to Seiichi Sato (President & CEO
of Sato Pharmaceutical Co., Ltd.), who has graciously accepted the position.
JSMI has long been committed to promoting "Responsible Self-Medication" by
helping interested consumers obtain sufficient information on nonprescription
medicines, take a more active role in their own health problems and live
a life free from disease or infirmity.
There is evidence that consumers in the Asia Pacific Region can practice
self-medication responsibly. Also there is support showing the consumers
recognize and respect nonprescription medicines.
Seiichi Sato as WSMI Vice-Chairman for the Asia Pacific Region, in collaboration
with the WSMI Member Associations in the region, will devote himself to establishing
a responsible framework in place for self-medication where people, as a whole,
use nonprescription medicines appropriately, carefully, and safely
Mr. Seiichi Sato Educational Background
1982 BS in the Science and Technology Faculty, The Keio University
1985 Master of Business Administration, The Babson College in Massachusetts,
USA
Work Experience
1985 SmithKline Beecham, Canada Branch
1986 Mitsubishi Bank, New York Branch
1986 Sato Pharmaceutical Co., Ltd.
1990 Executive Vice President, Sato Pharmaceutical Co., Ltd.
1995 President and COO, Sato Pharmaceutical Co., Ltd.
1997 Vice-Chairman, JSMI
2000 President and CEO, Sato Pharmaceutical Co., Ltd.
2.The
pharmaceutical market trend of the year 2004The overall market trend
OTC medicines sales at pharmacies and drugstores in the year 2004 (April 2004
~ March 2005) were Japanese YEN (JPY) 1,095.4 billion (approximately US$ 9.488
billion), showing a minus growth of 1.0% as compared with the previous same period.
The OTC medicines market registered an increase in the growth, largely due to
intense heat of the summer, in the therapeutic categories appealing to alleviation
of heat rash, itching, and insect bites. Notably, in March, a rise in the amount
of pollen in the atmosphere from maturing cedar and other trees contributed to
a vigorous growth of the sales of rhinitis remedies, eye lotions and the like
respectively. On the other hand, the market failed to see launching of Rx-to-OTC
switches and blockbustering new OTC products, and hair-growth products, gastrointestinal
remedies, tonics & nutrients and the like registered a considerably large
decline as compared with the previous same period, having resulted in the overall
slack.
In July 2004, as the second deregulatory step in the pharmaceutical retailing,
371 OTC drug products were shifted into the quasi-drugs with new scopes, however,
the total sales of the quasi-drugs (with those 371 items and the newly designated
quasi-drugs shifted in 1999 combined together) at pharmacies and drugstores were
JPY 70.6 billion (approximately US$ 0.612 billion), a minus 0.7% as compared
with the previous same period. The total sales of OTC medicines and quasi-drugs
(newly designated ones and those with new scopes combined) at pharmacies and
drugstores were JPY 1,166 billion (approximately US$ 10.1 billion), a minus growth
of 0.9% as compared with the previous same period, indicating the market was
still sluggish.
The trend in the physical distribution
Among those drugstores whose stocks are listed,
many top-ranking companies continued to increase their sales.
The grouping among them was accelerated, and, consequently
the restructuring of the business sector including mergers
and acquisitions of companies of middle standing continued.
The trend in the pharmaceutical administration In July 2004, the Ministry of Health, Labour and
Welfare (MHLW) implemented the second deregulatory step in
the pharmaceutical retailing whereby 371 OTC drug products
(such as, among others, stomachics, intestinal regulators,
gargles, etc.) were shifted to the "quasi-drug" status
which can be sold at the general retail outlets. The Revised
Pharmaceutical Affairs Law fully went into effect as from April
2005, marking a start of the new pharmaceutical administration.
Enhancement of Post Marketing Surveillance and Shift from Manufacturing
Approval to Manufacturing/Marketing Approval are the major
focal points of the Revised Pharmaceutical Affairs Law.
Household expenses survey According to the household expenses survey conducted
by the Management and Coordination Agency, in the year 2004
(January ~ December), the expenses for medical treatment (the
expenses spent on the products for the maintenance of health
were excluded) per household throughout the country were JPY
22,223 (approximately US$ 192.5), a minus spending of 5.7%
as compared with the previous year.
The breakdown for the major therapeutic categories was: Cold
remedies = JPY 2,235 (US$ 19.4), minus 9.7% as compared with
the previous year; Gastrointestinal remedies = JPY 1,216 (US$
10.5), minus 1.2%; and Nutrients = JPY 6,146 (US$ 53.2), minus
10.6%.
The expenses for the products for healthcare including so-called
health foods were JPY 15,038 (US$ 130.3), plus 13.7%, a significant
rise over the previous same period.
The expenses for medical treatment included the costs of prescription
medicines dispensed at the pharmacies outside of the medical
institutions where physicians issued the prescriptions.
The sales trends of the major therapeutic
categories
Health drinks and Mini-drinks
The sales were JPY 97.05 billion (approximately
US$ 0.841 billion), minus 4.7% as compared with the previous
same period. In addition to the sluggish market, the second
deregulatory step in the pharmaceutical retailing was responsible
for the minus growth in the period.
Nutrients and Tonics other than health
drinks and mini-drinks The sales were JPY 203.45 billion (US$ 1.762 billion),
minus 3.0% as compared with the previous same period.
The breakdown by therapeutic categories was: Nutrients and
Tonics = JPY 73.0 billion (US$ 0.632), plus 2.7%; Multi-vitamins
= JPY 29.45 billion (US$ 0.255), zero percent; Vitamin E Preparations
= JPY 14.65 billion (US$ 0.127 billion), minus 12.8%; Vitamin
B1 Preparations = JPY 43.05 billion (US$ 0.373 billion), minus
5.0%; Vitamin C Preparations = JPY 15.55 billion (US$ 0.135
billion), minus 12.4%; Calcium Preparations = JPY 5.45 billion
(US$ 47 million), minus 7.6%.
The products which clearly claimed therapeutic efficacy and/or
indications such as "For neuralgia and arthritis" , "For
urinary discomforts", and the like satisfactorily increased
their sales.
With an increase in the number of the middle- and advance-aged,
the products specifically targeting at those age group were
well accepted.
Gastrointestinal remedies The sales were JPY 66.45 billion (US$ 0.576 billion),
minus 3.8%, as compared with the previous same period, showing
a constant decline. Over the past two to three years, the trend
was that multi-symptom remedies, stomachics and Kampo medicines
for regulating the stomach condition all showed a sluggish
rise. On the other hand, H2 blockers whose efficacy on a stomachache
has been relatively well recognized and stomachics for a hangover
which can be easily purchased at convenience stores and the
similar retail outlets recorded a stabilized growth.
Cold remedies and medicines related to
a common cold The total sales of the cold remedies (Multi-symptoms
cold remedies, Anti-tussives and expectorants, Rhinitis remedies,
Oral cavity drugs, and Gargles) were JPY 203.3 billion (US$
1.761 billion), registering a very slight increase of 0.8%
as compared with the previous same period. While in the first
half of the period, the influenza which was most rampant during
the past 11 years and the record rise in the amount of pollen
contributed to a considerable increase in the sales, the slower
growth in the latter half of the period offset the better performance,
having resulted in the minimal growth as a whole.
Only the rhinitis remedies, with the sales of JPY 32.9 billion
(US$ 0.285 billion), plus 16.3%, registered a bigger growth
as compared with the previous same period. Multi-symptoms cold
remedies that have a 60% share in the market recorded the sales
of JPY 112.95 billion (US$ 0.978 billion), minus 0.5%. The
sales of Gargles (JPY 10.55 billion, US$ 91 million, minus
0.9%), Anti-tussives and expectorants (JPY 34.85 billion, US$
0.302 billion, minus 4.8%) and Oral cavity drugs (JPY 12.05
billion, US$ 0.104 billion, minus 4.0%) all saw poor records.
Anti-pyretics and analgesics The sales were JPY 47.5 billion (US$ 0.411 billion),
minus 4.0%. The products containing Ibuprofen continued to
grow as in the past years.
Eye drops The sales were JPY 67.5 billion (US$ 0.585 billion),
plus 9.3%, showing an increase two consecutive years. A rise
in the amount of pollen in the spring season in 2005 generated
the expansion of the market as the sales of Anti-allergic ophthalmologic
drugs and Eye washing solution respectively increased. Artificial
tears carrying claims such as "Refreshingness", "Moistened
sensation" and "Alleviation of discomforts when wearing
contact lenses" in addition to the conventional indications, "Eye
strain" and "Blurred vision", showed a yearly
increase, sustaining the growth of the market. The future outlook
of the market is that as the eye drop market becomes more segmentary,
will become more important the merchandising strategy that
can meet diversified consumer demand.
Epidermal analgesics and anti-inflammatory
drugs The sales were JPY 73.25 billion (IS$ 0.434 billion),
minus 1.3%.
Epidermal drugs The sales were JPY 86.35 billion (US$ 0.748 billion),
plus 0.9%, showing an increase two consecutive years. The breakdown
was: Products for dermatitis for external use = JPY 39.25 billion
(US$ 0.34 billion), plus 2.2%; Antiseptics = JPY 17.5 billion
(US$ 0.152 billion), plus 2.0%; Epidermal drugs for common
skin problems = JPY 16.15 billion (US$ 0.14 billion), minus
6.6%, and Epidermal analgesics = JPY 13.45 billion (US$ 0.117
billion), plus 5.9%. The temperatures higher than usual favorably
affected the sales of Products for dermatitis for external
use and Epidermal analgesics.
On the other hand, the higher temperatures and more precipitation
than usual during autumn and winter when the seasonal demand
for Epidermal drugs for common skin problems was brisk adversely
affected the sales of Cream for dried skin.
Athlete's foot products The sales were JPY 26.0 billion (US$ 0.225 billion),
minus 5.6%, presenting a striking contrast to the 2003's performance
of plus 7.8% as compared with the previous same period. The
summer of 2004, which was featured by intense heat but by fewer
precipitation, generated only one condition, "High temperatures" but
not two conditions, "High temperatures and High moisture",
considered to be ideal for ringworm to propagate and increase.
All in all, the summer weather resulted in the poor sales.
The sales of "Rx-to-OTC switched products", on the
other hand, kept steadily growing every year, with the year
2004 having registered a tremendous increase of 36.9% as compared
with the previous same period.
Market
share by therapeutic categories
(Figures
of 2003)
Multi-symptoms cold remedies
10.8 % ( 10.7 %)
Health drinks and Mini-drinks
9.2 % ( 9.7 %)
Epidermal drugs
8.3 % ( 8.1 %)
Epidermal analgesics and anti-inflammatory
drugs
7.0 % ( 7.0 %)
Nutrients and Tonics
7.0 % ( 6.7 %)
Eye drops
6.5 % ( 5.8 %)
Gastrointestinal remedies
6.4 % ( 6.5%)
Anti-pyretics and analgesics
4.5 % ( 4.7%)
Anti-tussives and expectorants
3.3 % ( 3.5 %)
Others
32.9 % ( 33.0 %)
The market
trend of quasi-drugs The total sales of quasi-drugs
(the newly designated quasi-drugs and the quasi-drugs with
new scopes combined) were JPY 149.95 billion (US$ 1.299
billion), minus 1.0% as compared with the previous same
period, were the total of sales recorded at convenience
stores, super markets, and home centers. The decline of
Health drinks that have a large share in the market dealt
a blow to the growth of this area.
47 % and 53% of the products were sold at pharmacies/drugstores and general retail
outlets respectively, indicating more than a half of the products were sold at
the general retail stores
Courtesy: INTAGE Inc.
For further information, please contact the following:
1-41-1, Hommachi, Higashi-Kurume-Shi, Tokyo 203-8601, Japan
TEL: +81 - 424 - 76 - 5177 FAX: +81 - 424 - 76 - 5198
URL: http://www.intage.co.jp/english/index.html
3.Self-Medication
Handbook
Toward the end of September, the Public
Affairs Committee, as part of its annual campaign of
public relations, printed 220,000 of a pamphlet for consumers
entitled "Self-Medication Handbook" and distributed
them to 47 prefectural pharmaceutical authorities, Consumer
Centers, and Public Health Centers in the cities designated
by the Cabinet Order. The Committee prepared and distributed
these copies in its bid to support various events annually
held throughout the country corresponding to the "Week
of Medicines and Health" which started from October
17.
The contents of the pamphlet were partially modified so as to include anew two
sections, namely, the one titled "Pharmaceuticals ? Medicines ? Drugs ?" to
elucidate dietary supplements in relation to pharmaceutical products and the
other to guide
the readers to "The ABC of Emergency Measures".
4.Seminars
on implementing fair advertising practices of OTC
medicines
The seminars have been annually
held at the two venues in Tokyo and Osaka for the purposes
of promoting proper advertising practices of OTC medicines.
Not only pharmaceutical manufacturers but also TV stations,
Newspapers, Advertising agencies, Advertising production
companies are encouraged to attend the seminars where
are provided useful pieces of information such as lectures
on the specific issues of mutual interest and concern,
recent developments in the pharmaceutical regulatory
affairs relating to advertising practices and case study
of the advertisements questioned at the Advertising Review
Board (ARB).
Pharmaceutical products which are closely related to protection of human life
and health have particular features that are different from characteristics of
other commodities consequently the pharmaceutical advertisements are stringently
required to pursue and maintain the ethics that are different from those of other
commodities. Furthermore, restrictions are imposed on what the pharmaceutical
advertisements can say. The advertisements of OTC medicines play an important
role in providing information that urges consumers to properly use OTC medicines,
therefore, the pharmaceutical advertisements should not allure consumers to carelessly
use the medications and especially should not mislead consumers into misuse.
From such viewpoints, JSMI has formed the said ARB, which conducts once every
two months voluntary reviews of the OTC medicines advertisements in whole. The
ARB, consisting of independent third-party experts for securing opinions from
the unbiased standpoint, reviews the OTC medicines advertisements carried or
run in TV, newspapers and magazines. The reviews are carried out in the light
of the Pharmaceutical Affairs Law (PAL) and the Industry Self-Imposed Advertising
Standards (SIAS).
The advertisements judged at the reviews to be violating the PAL and SIAS are
directly referred back to the manufacturers in question for remedying thereof.
At the same time, for ensuring thorough comprehension of the issues in question
by all those involved, ARB has been issuing "ARB Report" which covers
the details of each and every voluntary review. Japan Advertising Review Organization,
Inc. accredits JSMI and ARB with their fair and impartial reviews of pharmaceutical
advertisements. JSMI and ARB, through the ARB activities including advertising
seminars once every year, are committed to continuing the campaign to help those
concerned deepen understanding of the OTC medicines advertisements and improve
their quality.
The above gist is considered either to be relevant to
or to affect OTC medicines.
5.Consumer
Awareness Survey
Report of the 29th Consumer Awareness Survey on OTC Medicines
As part of its regular campaign to
promote responsible self-medication, JSMI conducted a
consumer opinion survey on the consumer awareness of
self-medication by means of a questionnaire in an advertorial
in the Asahi Shimbun dailies on December 24, 2004. The
survey also covered how deeply consumers are interested
in the pharmaceutical retailing system currently under
deliberation and how well they understand the matters
indicated on the Package Inserts.
BREAKDOWN
OF THE RESPONDENTS
(A)
Gender and Age
The
1,000 respondents consisted of approximately equal
number of male (52.5 %) and
female (47.5 %).
(B)
Occupation
"Salaried employees" showed
the largest percentage, 33.2%, followed by "Jobless
and Others", 28.7% and "Housewives",
(27.1%).
RESULTS
OF THE SURVEY
(1)
Awareness of Self-Medication
The term, "Self-Medication" is
defined as self-diagnosis and self-treatment of minor
illnesses or injuries by use of OTC medicines available
without professional supervision.
Do you know this term ?
1: Yes, I know it pretty well.
2: Yes, I know it to some extent.
3: I have only heard the term.
4: No, I don't know it.
Awareness
of the concept of "Self-Medication" indicated
by 1 (5.9 %) and 2 (24.2 %) combined was 30.1
%.
Awareness of both the concept and the term of "Self-Medication" indicated
by 1, 2, and 3 (33.6 %) combined was 63.7 %.
Thus, the total awareness exceeded 60% of the respondents, leaving the "No,
I don't know" respondents at 36.3 %.
(2)
Usage of the Package Inserts
Package Inserts are attached to OTC
medicines for urging consumers to read them carefully
and to use the products correctly.
How do you read and keep the Package Inserts ?
1: I keep them together with the medicines.
2: I keep them together with other Package Inserts.
3: I immediately throw them away after having read them first of all.
4: I throw them away without reading.
5: Others
"I keep
them together with the medicines" (70.6
%) and "I keep them together with other
Package Inserts" (6.1 %) combined were 76.7
%, indicating that the great majority of the
respondents keep the Package Inserts. Those respondents
who "throw away" represented 21.8 %,
with "I immediately throw them away after
having read them first of all" (19.5 %)
and "I throw them away without reading" (2.3
%) combined.
(3)
Understandability of the Package Inserts
The Package Inserts of OTC medicines,
as compared with those made several years ago, have
been devised to improve their readability.
Do you think the Package Inserts currently used are easy to understand ?
1: Easy to understand
2: Understandable to some extent
3: A little bit hard to understand
4: Hard to understand
Those respondents
who answered "Easy to understand" represented
84.8 % with "Easy to understand" (17.0
%) and "Understandable to some extent" (67.8
%) combined, indicating that the great majority
of the respondents understand the Package Inserts.
On the other hand, those respondents who answered "Not
understandable" represented 15.0 % with "A
little bit hard to understand" (11.4 %)
and "Hard to understand" (3.6 %) combined.
(4)
Matters on the Package Inserts hard to understand
To those respondents who answered 3
(A little bit hard to understand) or 4 (Hard to understand),
what are the matters hard to understand ?
The letters are too small and illegible
63
Illustrations and designs easy to understand at a glance are needed
4
Hard to understand the explanations full of technical terms
33
The explanations are lengthy
19
Hard to understand ingredients and/or indications
13
Hard to understand dosage and/or when to take
13
Insufficient explanations on side effects
9
Too sparingly folded to read
1
Quality of papers is poor
1
The matters need to be printed on the containers/wrappers
1
The matters need to be printed on the outer containers/wrappers
1
To those 150
respondents who answered either "A little
bit hard to understand" or "Hard to
understand", a question, "What are
the matters hard to understand ?", was raised
and 135 specifically answered.
A total of 67 respondents, namely, 63 (The letters are too small and
illegible) and 4 (Illustrations and designs easy to understand at a glance
are needed), representing almost a half of the respondents, thought the
designs of the Package Inserts were poor. There were also many respondents,
namely, 33 (Hard to understand the explanations full of technical terms)
and 19 (The explanations are lengthy) who wanted the expressions to be
improved. Other major matters felt to be improved were "Hard to
understand ingredients and/or indications" (13 respondents), "Hard
to understand dosage and/or when to take" (13 respondents), and "Insufficient
explanations on side effects" (9 respondents).
(5)
Awareness of Relaxation of Restrictions on Pharmaceutical
Retailing
At present, relaxation of restrictions
on pharmaceutical retailing has been under deliberation
within the Ministry of Health, Labour and Welfare.
Are you familiar with this issue ?
1: Yes, I am.
2: Although I am not, I feel an interest in it.
3: No, I am not.
Those who "are
familiar with" (62.2 %) indicated that the
awareness exceeded 60 % of the respondents while
the "Although I am not, I feel an interest
in it" respondents and the "No, I am
not" respondents represented more than 20
% and approximately 10 % of the respondents respectively.
(6)
Retailing system of OTC medicines
To those respondents who answered either "Yes,
I am." or "Although I am not, I feel an interest
in it.", in relation to (5) Awareness of Deregulation,
a question, "How would you like OTC medicines
be retailed ?", was specifically raised.
1: They should most preferably be sold only, as they are now, at pharmacies
and drugstores where professionals of medicines are available.
2: Some of them might be most preferably sold at convenience stores and general
stores as well where professionals of medicines are not available.
3: All of them might be most preferably sold at convenience stores and general
stores as well where professionals of medicines are not available.
To those respondents
(83.3 %) of both "Yes, I am" (62.2
%) and "Although I am not, I feel an interest
in it" (26.1 %), a specific question, "How
would like OTC medicines be retailed ?",
was raised.
More than 30 % of the respondents answered "OTC medicines should
be most preferably sold, as they are now, at pharmacies and drugstores
where professionals of medicines are available" while 61.7 % representing "Some
of them might be most preferably sold at convenience stores and general
stores as well where professionals of medicines are not available" (52.4
%) and "All of them might be most preferably sold at convenience
stores and general stores as well where professionals of medicines are
not available" (9.3 %) expressed pros for sales of OTC medicines
at stores other than pharmacies.
(7)
Naming of OTC medicines
OTC medicines currently sold at pharmacies
and drugstores have many different names.
What nomenclature would you like to recommend for them if unification becomes
necessary ?
1: Medicines for general public
2: Marketable medicines
3: Medicines for general use
4: OTC medicines
5: OTC drugs (An abbreviation for Over-The-Counter drugs)
6: No specific idea for naming
7: No need to unify
8: Others
Of the five
(1 ~ 5), the top preference was 2 (36.8 %), followed
by 3 (30.8 %), 1 (14.1 %), 4 (9.4 %) , and 5
(1.6 %), indicating the term, "OTC drugs",
to be least popular.
