1.New
Year Greetings for 2006 from Chairman, Sachiaki Ibe
A Happy New Year to all of you !
At the beginning of the year, may I have the pleasure of extending my New
Year greetings and, at the same time, my sincere appreciation for your full
understanding of and intimate collaboration to the activities of Japan Self-Medication
Industry.
In our country, over the years, the slowdown in economic activity intensified
both by the decrease in population stemming from a sharp decline in the birthrate
and by a rapid arrival of an aging society has become major concerns of the
populace. At the same time, the future outlook of the social security system
which implies an imminent decrease in the national pension and an increase
in the out-of-pocket medical expenses would add to those public concerns.
At this very juncture when the medical security system has been financially
in a state of total collapse, the government has been implementing a structural
reform of the medical services.
As the results of the planned reform, this year will inevitably see a sweeping
review of the medical security system, lowering of medical fees, and a partial
revision of the Drug Tariff, all of which would considerably affect the pharmaceutical
industry as a whole.
On the other hand, since the year before last, Health Sciences Council has
been studying the revision of the pharmaceutical retailing system. Subsequently
a bill to revise the Pharmaceutical Affairs Law proposing new grouping of
nonprescription medicines in accordance with the degrees of their risks,
provision of information, qualifications and responsibilities of those to
be engaged in the sales of medicines, and their recruitment is to be submitted
to the ordinary Diet session this year for passage. Consequently pharmaceutical
manufacturers are obligated to comply with the forthcoming enforcement of
the revised Pharmaceutical Affairs Law by appropriately taking legal countermeasures
to ensure correct and proper use of medicines such as the matters to be indicated
on the outer containers or wrappers and Package Inserts.
With the general public's consciousness toward health being on the rise and
the concept of self-medication being recognized and wide-spread, it is expected
that non-prescription medicines can play an ever increasingly important role
in the treatment of minor ailments.
In 2004, JSMI formed Strategic Alliance Conference for Business Promotion
(SACBP) in its bid to revitalize the sluggish nonprescription medicines business.
SACBP focused its reviews on, among others, enlargement of functions of nonprescription
medicines, development of medicines to prevent life-style related diseases,
promotion of Rx-to-OTC switches, all of which are regarded as the concrete
steps for the materialization of the recommendations explicitly described
in the "Interim Report on Role of Over-The-Counter 'OTC' Medicines in Self-Medication"
prepared by Ministry of Health, Labour and Welfare (MHLW). Notably, "HERB
PROJECT", consisting of interested representatives from the JSMI member manufacturers,
was formed under SACBP in order to explore ways for obtaining approvals for
nonprescription medicines containing Western Herbs
On the other hand, SACBP regularly had meetings with the regulatory agency
and exchanged views and opinions on various issues of mutual interest and
concern.
JSMI plans to file with the MHLW Minister Kawasaki a petition on the matters
conferred with SACBP and discussed within the association.
This year, we will have to make further efforts to ensure each goal an achievement,
to launch nonprescription medicines that can meet the demands of consumers,
and finally to revive the nonprescription medicines market.
As part of activities to promote and enroot in the consumers' mind self-medication,
we will produce and distribute copies of "Self-Medication Handbook" and Videotapes
for enlightenment on self-medication.
In the fall of last year, "The Asahi Health Forum", held in Nagoya and Fukuoka
with full cooperation of the representatives from the respective Regional
Associations of the Japan Pharmaceutical Association, focused on the issues
on the life-style related diseases. On the other hand, "The Yomiuri Self-Medication
Lecture" talked on how to treat common ailments such as a common cold, aches,
and hay fever (pollinosis), using nonprescription medicines. Blessedly, both
events gathered a fairly large audience of citizens, clearly indicating that
consciousness toward both self-medication and correct use of medicines was
being steadily heightened among the general public.
Concerning the activities to promote self-medication, in addition to those
undertaken by JSMI, some prefectures (Tokyo, Aichi, Fukuoka, Shizuoka, Fukushima,
and Nagano) have been enthusiastic for conducting, by the pharmacists retained
by the respective schools, "Education On Medicines" targeting on primary
school pupils. In order to encourage consumers to practice self-medication
responsibly, we should talk competent authorities into incorporating the
"Education On Medicines" into the curriculums.
March last year marked the 20th anniversary of JSMI. For celebration, in
May, JSMI held an international forum under the theme, "Self-Medication Policy
around the World - What We Can Learn from the World", where the keynote speeches
under the theme, "Self-Medication - Current situation and future perspective",
were given by the speakers from the U.S., U.K., European Commission and Japan.
The venue was packed to its fullest capacity with participants from the competent
authorities, academia, business sectors, mass media and the JSMI member manufacturers.
JSMI sent its contingent consisting of 38 people to the WSMI General Assembly
and the AESGP Annual Meeting jointly held in Geneva in June last year. These
international events provided a golden opportunity for all the participants
to recognize the importance of both self-medication and self-care in the
healthcare systems of many countries since the representatives from all stakeholders
worldwide such as industry associations, pharmaceutical companies, regulatory
agencies, healthcare professionals and patient organizations shared their
expertise and experiences relating to the areas of mutual interest and concern.
We at JSMI should continue to commit ourselves to furtherance of self-medication
through not only activating and expanding the nonprescription medicines market
but also making available to consumers the nonprescription medicines that
contribute to increased health benefits of the populace.
May I close my New Year greetings by wishing that you will continue to extend
your guidance and collaboration to me and JSMI.
2.Report
compiled by Task Force To Study Pharmaceutical
Retailing
The report compiled by the Task Force To Study Pharmaceutical Retailing formed
by the Health Sciences Council (An advisory body to the Ministry of Health, Labour
and Welfare) consists of the three major components; (1) The situation currently
surrounding the nonprescription medicines and the pertinent issues to be addressed,
(2) The rationale for the revision of the Pharmaceutical Affairs Law (PAL) and
the conceptual design of the revision, and (3) The concrete particulars of the
revision.
The Ministry of Health, Labour and Welfare (MHLW), upon receipt of the report,
plans to initiate the ground work on drafting a bill that proposes the amendment
of the PAL and to submit the bill to the Diet in March this year provided the
ground work should proceed on schedule. The amendment of the PAL in relation
to the retailing of the nonprescription medicines would be the first one over
the period since the amendment made in 1960.
The gist of the report is as follows: 1: The situation currently surrounding the nonprescription
medicines and the pertinent issues
to be addressed
(1) Characteristics of medicines: Since certain risks are inevitably
associated with all the medicines, it is essential
that information pertinent to the medicines be
appropriately provided. The purchasers of the medicines
should use them correctly only after they have
fully understood the information
(2) Heightened consciousness toward health and
the role to be played by the nonprescription medicines Amid the heightened consciousness
of the populace toward health, there has been
observed a trend showing that consumers do
practice "self-medication" using nonprescription
medicines under the proper advice.
(3) Current pharmaceutical retail
distribution patterns and environmental changes
surrounding medicines: The environmental changes surrounding
medicines include, among others, the increase in
national income, the graying society, the change
of the life-style such as an increase in the number
of night persons, the spread of the Internet, and
the like, all of which are a driving force to urge
easier access to nonprescription medicines. At the
same time, there has been also observed a stronger
wish for a more stabilized life.
(4) Issues to be addressed in the pharmaceutical
retail distribution: At present, the requirements
to provide information by the healthcare professionals
at the points of purchases of medicines have not
necessarily been fully fulfilled. Furthermore,
those engaged in the sales of medicines have obviously
neglected to prioritize sales of "efficacious medicines".
In this context, in order to meet the demands of
the populace, it is a pressing national need to
create an environment where access to efficacious
medicines is materialized. There is an opinion
that to ask healthcare professionals for information
indiscriminately cannot be considered as practically
satisfying diversified needs of the modern society
and that there may be a tendency to neglect to
provide information on the medicines having higher
health risks.
On the other hand, misunderstandings and lack of adequate
knowledge are observed among consumers, therefore,
it is desirable to create an environment where consumers
are encouraged to read without fail labeling before
they use the medicines and to understand how the medicines
are sold.
Concerning the qualifications of the health professionals,
from the standpoint of urging them to provide consumers
with a variety of information corresponding to the
risks and to be willingly called in for consultation,
it is necessary to structure a proper mechanism whereby
the qualifications of those engaged in the sales at
the respectively licensed places of business excepting
pharmacies can be appropriately evaluated.
2: The rationale
for the revision of the PAL and the conceptual design
of the revision
(1) The
rationale of the revision * On the assumption that the
concept of "Self-medication" will continue to penetrate
the whole country, the review of the retail distribution
system shall be conducted in such a manner as will
properly accelerate the penetration thereof.
* The new system, with the assurance of safety
being prioritized and due consideration being given
to the convenience of consumers, should be designed
so as to enable consumers to select proper medicines
and to correctly use them.
* Consequently, it is suggested to structure a
proper mechanism whereby adequate consultations
can be readily available and a variety of information
corresponding to the risks can be timely provided.
* The rationale may be summarized as follow:
"Amid the heightened consciousness
of the populace forward health, reflecting
the environmental changes surrounding the
nonprescription medicines, and from the standpoint
of accelerating self-medication, it is desirable
to structure a system, with the assurance
of safety being prioritized and due consideration
being given to the convenience of consumers,
which will facilitate pharmacies and drugstores
to be willingly called in for consultations
from consumers and to provide them with a
variety of information corresponding to the
risks so that consumers will be able to select
proper medicines and to correctly use them."
(2) The
conceptual design * It is reasonable to reclassify
medicines into three groups in accordance with
the respective degrees of risks:
Medicines with particularly high risks,
Medicines with relatively high risks,
Medicines with relatively low risks.
* At the points of sales, since it will become necessary
to provide information corresponding to the risks
and to accept consultations from consumers, the following
framework may be recommended:
- For the
medicines with particularly high risks ÉTo
make it mandatory for pharmacists to proactively
provide information in writing and to willingly
accept consultations from consumers
- For the medicines with relatively high risks
É.. To make it mandatory for health professionals
to make effort to provide information and mandatory to willingly accept consultations
- For the medicines with relatively low risks É To make it mandatory for health
professionals to willingly accept consultations
* Concerning the health professionals other than pharmacists
who are engaged in the sales, it is desirable to make
a system (tests conducted by the prefectural governments)
whereby the qualifications of those engaged in the
sales at the respectively licensed places of business
can be evaluated. It is desirable that such tests
are geared toward practicability in line with the
actual sales of the medicines. Furthermore, it is
desirable to adopt interim measures for the introduction
of the new retail distribution system.
* It is advisable to support the environment for the
pharmaceutical retail outlet through the labeling
in accordance with the respective risks, implementing
guidelines on display, notice to the customers with
posters, etc. with the viewpoint of consumers.
3: The concrete particulars of the revision
(1)
Classification of risks (To be classified by
active ingredients)
Class 1:
Either the active ingredients
whose history in the market place as nonprescription
medicines is brief and whose evaluation of safety as nonprescription medicines
has not been completed
or the active ingredients whose risks as nonprescription medicines are considered
particularly high
Class
2:
The active ingredients
with the risks which on rare occasions cause
health hazards
disrupting normal daily life (possibilities to cause serious health hazards requiring
hospitalization or more medical treatment)
Class
3:
The active ingredients
which may possibly cause a physically bad
condition not so
serious as disrupting normal daily life
(2) Provision
of information corresponding to the risks and
appropriate acceptance of consultations
Group
A Medicines: The medicines containing
Class 1 active ingredients
Intervention
of pharmacists is essential.
It is mandatory to provide information in writing.
It is mandatory to sell the medicines over the counter.
A sale via the Internet is prohibited.
Group
B Medicines: The medicines containing
Class 2 active ingredients
Intervention
of either pharmacists or those qualified
under the new retail distribution
system is essential.
It is mandatory to make effort to provide information in writing.
It is desirable to sell the medicines over the counter.
A sale is permissible with consultation with a pharmacist at mid-night and early
in the
morning by the telephone equipped with TV-type monitor.
Group
C Medicines: The medicines containing
Class 3 active ingredients
Intervention
of either pharmacists or those qualified
under the new retail distribution
system is essential.
Provision of information in writing is not necessary.
A sale over the counter is not necessary.
(Installation of the telephone for consultations from consumers is required.)
* Regarding the display of Group B Medicines,
it is desirable to sell the medicines over
the counter.
However, it is desirable to display and sell
the medicines whose active ingredients are
asterisked (25 active ingredients used in
cold remedies, anti-pyretics and analgesics,
etc.) either over the counter or in such
a manner as will induce pharmacists to proactively
provide information.
* Regardless of the degrees of risks of the
medicines, it is essential to make it mandatory
for the health professionals to willingly
accept consultations from consumers.
As for the medicines other than active ingredients
, it has been suggested that their risks
be classified as follows:
KAMPO
(Chinese medicine preparations):
Class
2
Natural
drug preparations: (Some products
Class
2
Class 3)
Disinfectants:
Class
2
Insecticides
(Those corresponding to powerful drugs
Class
2
Class 1)
OTC
In-vitro Diagnostic Agents
Class
2
As for the distribution patterns, it has been suggested that the business
licenses, excepting pharmacies, for selling the medicines to consumers be
reorganized into two license, namely, "Business license for selling in the
shops" and "Business license for the household distribution".
3.JSMI
events relating to health promotion
As part of publicity campaign to deepen
the understandings of consumers on "Self-medication",
every year, JSMI has been holding seminars and forums
on health in collaboration with the major newspaper companies.
During the current fiscal year, those living in Fukuoka,
Nagoya and Tokyo actively participated in the annual
events held in these respective areas, the particulars
of which are summarized below:
The
10th Asahi Health Forum In Fukuoka on October
16 and in Nagoya on November 12, 2005
Theme: Stop the lifestyle-related diseases !
Let's retain our youthfulness !
PART
I: Keynote Speech
Theme:
"Pathological anatomy of the lifestyle-related diseases"
Speaker: Yoshio Ikeda, President, The Japan Society of Prevention of Lifestyle-Related
Diseases
The speaker, elucidating how the complication of obesity, high blood pressure,
hyperlipidemia, diabetes, and the like associated with the desultory lifestyles
can, by adversely affecting each other, result in so-called metabolic syndrome
which tends to cause arteriosclerosis, stressed the importance of keeping one's
eye on one's lifestyle.
PART
II: Panel Discussions
Theme: "The knacks
for practicing self-medication"
Panelists: (At the Fukuoka
venue)
Yoshio Ikeda:
President, The Japan Society
of Prevention of Lifestyle-Related Diseases
Mayumi Mochizuki:
Professor, School of Pharmaceutical Sciences,
Kitasato
University
Keiko Morita:
Vice-chairperson, Fukuoka Pharmaceutical
Association
Masaji Ooe:
Vice-chairman, JSMI
Moderator
Isao Tanabe:
Editorial writer, The Asahi Shimbun Dailies
Panelists: (At the Nagoya venue)
Yoshio Ikeda:
President,
The Japan Society of Prevention of Lifestyle-Related
Diseases
Mayumi Mochizuki:
Professor, School of Pharmaceutical
Sciences, Kitasato University
Taeko Kajioka:
Assistant Professor, Department
of Health Science , Faculty of
Psychosomatic Psychological and Physical Science,
Aichi-Gakuin
University
Mitsuji Higuchi:
Vice-chairman, Aichi Prefecture
Pharmaceutical Association
Masaji Ooe:
Vice-chairman, JSMI
Moderator
Isao Tanabe:
Editorial writer, The
Asahi Shimbun Dailies
The panel discussions held at both venues saw lively
exchanges of discussions as to the role and expectations
of nonprescription medicines in the climate where consumers
do practice self-medication responsibly for the management
of their own health. It was strongly suggested that consumers
have their family pharmacists, as health advisers, with
whom they can readily consult.
JSMI Vice-chairman, Ooe, explained how the JSMI member manufacturers are tackling
the lifestyle-related diseases and encouraged the attendees to utilize the JSMI
Website which carries information on the correct use of the medicines, news on
newly launched products, and "How to retrieve medicines".
The explanations in plain and consumer-friendly language were given by the respective
panelists on the three themes, "The lifestyle-related diseases viewed from various
perspectives", "How to check the lifestyle-related diseases", and "The lifestyle-related
disease, the future outlook of medicines, and toward self-medication".
The finale of PART II was a physical exercise, which can be handily performed
at home for keeping a healthy body, enjoyed by all the audience, to a melody
accompaniment.
The details of the event were reported on the December 24 Asahi Shimbun Dailies
countrywide.
The
5th Yomiuri Self-Medication Lecture On December 4, 2005,
Sunday, the Lecture was held in the Tokyo Head Office
of the Yomiuri Shimbun Dailies.
Under the theme, "Can you hear the message from your
own body ? Isn't that sneezing a symptom of the hay fever
? The allergies that are stealthily attacking you.",
PART I, Keynote Speech, under the title, "Before the
cedar pollen season sets in - The basic knowledge of
allergies", was given by Dr. Yasuyuki Sano, Director,
Allergy and Respiratory Tract Internal Medicine, Social
Welfare Corporation, Doai Memorial Hospital. Dr. Sano
talked in depth on the basic knowledge on the causes
and kinds of allergic diseases that keep increasing over
the years and on the pathologies of and treatments for
asthma, which is the typical allergic disease. He also
discussed in plain and consumer-friendly language the
most common symptoms of pollinoses, their medical treatments
and preventive measures.
PART
II: Panel Discussions
PART II, Panel
Discussion, under the theme, "Let our family begin
! The basic knowledge of allergy", was carried
out with the following panelists and moderator:
Panelists:
Yasuyuki
Sano:
Director,
Allergy and Respiratory Tract Internal Medicine,
Social Welfare
Corporation, Doai Memorial Hospital
Nobuko Awano:
Managing Director, Tokyo
Prefecture Pharmaceutical Association
Kunio Yamada:
Vice-chairman, JSMI
Moderator
Teruo Matsuda:
Former Executive Announcer
at NHK (Japan Broadcasting Corporation)
Those questions previously raised by the readers of
the Yomiuri Shimbun Dailies were answered by the
panelists
respectively. On the other hand, the audience itself
was unconsciously intoxicated with its answering each
question on its own health by raising either one of
the two round fans which said either YES or NO.
In addition, how to practice self-medication was
intensively discussed by each and all panelists
from their own professional viewpoints, with each
panelist emphasizing that, in order to protect
one's own health, self-medication should be responsibly
practiced by improving one's lifestyles and appropriately
using nonprescription medicines before any diseases
become worse.
JSMI Vice-chairman, Yamada, explained the JSMI
Website and the provision by the pharmaceutical
manufacturers and the pharmaceutical associations
of the information on the medicines.
PART III, Lecture on Appropriate
Use of Nonprescription Medicines, under the theme,
"How to appropriately use nonprescription medicines
in order to comfortably spend the cedar pollen season",
was given by Nobuko Awano, Managing Director, Tokyo
Prefecture Pharmaceutical Association, whose comprehensive
lecture covered the points as to how to carefully
select nonprescription medicines such as nasal spray,
antiallergics, and eye lotion to alleviate symptoms
of pollinoses, and how to safely use them. Awano
also stressed the importance of building rapport
with family pharmacists for various consultations.
The foregoing is to be featured on the Yomiuri Shimbun
Dailies countrywide around the end of January 2006.
4.JSMI
Herbal Medicinal Products Committee to give lecture
on Japanese Traditional Medicines to Regulators
from ASEAN
Japanese International Corporation
of Welfare Services (JICWELS*) organized its 21st lecture
for the regulators responsible for pharmaceutical administration
in Asia.
Recently, the eligibility required of the regulators
has been rigidified so that only the officials high in
rank responsible for the pharmaceutical administration
in the countries belonging to Association of Southeast
Asian Nations (ASEAN) and its neighboring nations were
able to attend the lecture.
This year, seven regulators from the seven countries
- Cambodia, Indonesia, Laos, Myanmar, the Philippines,
Thailand and Viet Nam - were invited to the lecture which
was held from November 9, Wednesday through December
9, Friday.
JSMI Herbal Medicinal Products Committee has been taking
charge of the class, "Traditional Medicines in Japan" and
gave its lecture on November 29.
The lecture covered a wide spectrum of topics such as,
firstly, a brief explanation on the outline of the pharmaceutical
administration in Japan and on the dual definitions of
"KAMPO" as pharmacotherapy (the use of medicines) and physiotherapy
(treatments), and, secondly, detailed explanations on the
history, classification, identification, analytical methods,
business climate, differences between synthetic medicines
and many other specifics relating to herbal medicinal products
and natural drugs.
JICWELS*
On July 7, 1983, being granted authorization from the
then Ministry of Health and Welfare (now the Ministry
of Health, Labour and Welfare) as a corporate juridical
person, JICWELS was institutionalized with the purposes
of making a contribution to the international developments
of healthcare and welfare.
It has been promoting various plans to help developing
countries grow through undertaking lectures for regulators
from the developing countries, accepting the WHO fellowship,
training domestic healthcare professionals, planning
and conducting various R & D, exchanging information
and conducting public relations. (Translated into English
from the JICWELS Web site).
