1.
New Year Greetings for 2005 from Chairman, Sachiaki
IbeAfter the year 2004 closed with
a stunning natural hazards and strong humanitarian
aids on the planet - the unprecedented global catastrophic
earthquakes and tsunamis washed off the coast of
Indonesia, Thailand and other countries. I sincerely
hope the new-year has d a w n e d bright and warm,
having been ushered in by the auspicious news and
events in your country and region.
Chairman
Sachiaki Ibe
On behalf of the JSMI Secretariat and
member manufacturers, may I have the pleasure of extending
our New Year greetings and, at the same time, condolences
on those many innocent citizens who have been suffered
in the havoc worked by Nature which is usually the best
healer.
The pharmaceutical business sector, desperately struggling
for survival in the world's second-largest pharmaceutical
market, has been obliged only to undergo extremely disappointing
years due largely to several adverse factors such as
financial conditions of the health insurance reimbursement
system seriously stiffened by the rapidly graying society
and the ever declining birthrate. Furthermore, the business
sector has been facing an obstinately stagnant growth
in the market and increased competition intensified
by an influx of both foreign capital and industrial
sectors which are totally alien to the pharmaceuticals.
"Statistics on Drug Production compiled by Ministry
of Health, Labour and Welfare" of 2004 showed the
nonprescription medicines production plummeted down
to approximately Japanese YEN 0.7 trillion (roughly
US$7 billion), clearly indicating the market has leveled
off, with a slightly tapering trend, over the past decade.
In the uphill business environment, for helping themselves
to survive, revive, restructure, or counter fiercely
rising competition which has drastically crimped their
profits, domestic manufacturers have begun doing everything
necessary and possible such as divestiture, mergers
and acquisitions, or incorporation of affiliated and/or
subsidiary companies in the light of the imminent enforcement
of the revised Pharmaceutical Affairs Law.
It is my pleasure to retrospect the major activities
undertaken by JSMI nationally last year in the hope
of revitalizing the slack business.
To solidify ourselves under the banner, "Let's
manage our own health by ourselves", in June, we
organized "Strategic Conference for Business Promotion"
(SCBP), setting its goal as "How to revive the
sluggish nonprescription medicines business for peoples
health". SCBP has agreed to place an emphasis on
the industry's concrete stance with high feasibility
to develop new nonprescription medicines offering enlarged
efficacy and indications which not only can play an
important role in the national healthcare system to
curb ever skyrocketing medical expenses but also can
contribute toward promotion of responsible self-medication
by the consumers who take greater charge of their own
health.
To aim at encouraging responsible self-medication among
younger generation, JSMI compiled booklets titled "Self-medication
and Medicines" and presented them to as many as
17,300 junior and senior high schools throughout the
country in the hope that they can be utilized as auxiliary
textbooks on health and physical education. Now preparations
are well under way for editing videotapes designed for
enlightening high school students on self-medication.
I do wish the JSMI's dream that the school curriculum
may include in it the subjects on "Medicines"
and "Self-medication" be crystallized in the
not far-distant future.
As a means to strike root of responsible self-medication
deep into the consciousness of consumers, JSMI convened
Health Forums several times under the co-sponsorship
of Asahi Shimbun, Yomiuri Shimbun Dailies and the Japan
Pharmaceutical Association.
The Japan Pharmaceutical Association and its Regional
Associations co-sponsored with Asahi Shimbun for The
Asahi Health Forums in Tokyo, Chiba and Osaka. On the
other hand, The Yomiuri Self-Medication Lecture selected
some common diseases that nonprescription medicines
can most appropriately treat. JSMI is committed to continuing
to organize moderately and assiduously such health forums
in order to raise the consumers' awareness of both self-medication
and medicines for practicing responsible self-medication.
WSMI 6th Asia Pacific Regional Conference was successfully
hosted by our Chinese colleague, CNMA on October 26
~ 29 last year in Beijing, where over three hundred
people from 19 countries and regions, including 84 from
Japan, participated. Taking up this opportunity, I would
like to thank JSMI member companies for sending their
contingent, the second largest after China and also
to thank Ministry of Health, Labour and Welfare (MHLW)
and the Pharmaceutical and Medical Devices Agency (PMDA)
for sending three officials, who kindly disseminated
the recent developments relating to the imminent partial
revisions of the Pharmaceutical Affairs Law (PAL) and
the goals and functions of PMDA, an Independent Administrative
Corporation newly formed in April, 2004 in the wake
of administrative reformative changes. From the Conference,
it might be safely summarized that a recommendation
was made that each country should continue to make every
effort to improve its own social security system so
that self-medication with consumers playing the major
role in it can be framed and practiced with full cooperation
of stakeholders, in particular, healthcare professionals.
As the revision of PAL will be implemented totally from
April this year, a new business license system will
be instituted. The Marketing Authorization may be granted
without the limitation of having factoring with Japan.
The license holder shall be liable for manufacturing
and marketing pharmaceuticals in conformity with the
new administrative framework where, under "General
Supervisor for Manufacturing-Marketing", both "Safety
Supervisor " and "Quality Assurance Supervisor"
shall be as-signed for carrying out each job as specified.
It is strongly requested that the JSMI Committees concerned
see to it that smooth shifting into and adequate compliance
with the regulatory alteration can be ensured at the
JSMI manufacturers' side.
In March, JSMI will celebrate its 20th Anniversary.
With its mission being set forth as "Promotion
of the concept of self-medication to contribute to the
improvement of public health outcomes", JSMI reasserts
its commitment to progress industry initiatives to ensure
the continued progression of sound industry goals aimed
at adequately responding to the needs and voice of all
stakeholders.
2.
Asahi Health Forum and Yomiuri Self-Medication Lectures
in 2004
Health Forums, which are important components of the
JSMI activities to enlighten and empower consumers to
help them through their common health problems, namely,
to promote self-medication, were successfully held under
the sponsor-ship of both Asahi Shimbun and Yomiuri Shimbun
Dailies in Tokyo, Osaka and Chiba during the months
of October and November last year.
The
Asahi Health Forum
The Asahi Health Forum,
conceived five years ago for the purpose of impregnating
the general public with the concept of self-medication,
namely, "To take charge of their own health",
and encouraging consumers to practice self-medication
responsibly by using nonprescription medicines appropriately,
carefully and safely.
The 9th Asahi Health Forum (held in Tokyo on October 23,
Chiba on November 6, and Osaka on November 13 respectively)
was notably featured with installation of Medicine Consultation
Booth in each venue, where the representatives of the
Japan Pharmaceutical Association (JPA) and its Regional
Associations professionally inspired the visitors into
building reliable relationships with "Your Own Pharmacy"
and/or "Your Own Pharmacist".
The Forum subtitled "Medicine Lecture Catered To
Order - Let's do practice self-medication cleverly and
brightly" consisted of two parts: PART I (Speeches)
and PART II (Panel Discussion).
PART I Nobuo Yamamoto
(Vice Chairman, Tokyo Metropolitan Pharmaceutical Association),
Masaaki Yonezawa (Vice Chairman, Chiba Prefecture Pharmaceutical
Association), and Takashi Kodama (Chairman, Osaka Prefecture
Pharmaceutical Association) respectively spoke, under
the title of "Your Own Pharmacist who is Your Partner
in Healthcare", about the significance and merits
of recognizing and respecting self-medication, of responsibly
responding to the everyday health problems by turning
to nonprescription medicines, and of establishing close
rapport with the community pharmacists.
PART II The three panelists
were, in addition to those representatives from the JPA's
Regional Associations, Mayumi Mochizuki (Professor, Department
of Pharmacy, Kitasato University) and Hideaki Hayano (Chairman,
JSMI Public Affairs Committee and Vice President, Consumer
Health Products Division, Eisai Co., Ltd.). Interestingly,
the panel discussions were conducted in a Question &
Answer fashion, where the moderator directed in the preprogrammed
procedure to the panelists various questions which had
been actually sent by the interested consumers.
Those questions included, among others, "What is
Self-Medication?" "How different are medicines
from dietary supplements?", "Where can I seek
advice about medicines?", "How properly should
I use eye drops?", "How should I store medicines?",
"Does a painkiller cure the stomachache?", "Is
it safe to let children take medicines that have no specific
Directions for Use for Children?", "Is it true
that nonprescription medicines are also eligible for medical
expense deduction?", "What are precautions for
taking medicines and medicines concomitantly or medicines
and foods concomitantly?", "Do more expensive
medicines work more effectively ? " , "When
I have forgotten to take my antihypertensive, what am
I supposed to do?" and the like.
Hayano encouraged the audience to visit and make effective
use of not only the "How to responsibly practice
self-medication" column on the JSMI Website but also
a wide spectrum of information carried on many Websites
run by the JSMI member manufacturers.
Each of the three venues gathered a relatively large attendance
of some 100 interested consumers, many of whom contributed
to the JSMI Secretariat favorable comments that those
answers and explanations given by the panelists in consumer
friendly terms were highly valuable and useful for clearly
understanding many questions and concerns they usually
harbour in relation to medicines.
The
Yomiuri Self-Medication Lecture
On
November 14, the 3rd Yomiuri Self-Medication Lecture,
subtitled "Taking preventive measures against a common
cold - a symbol of a chilly winter - before it gets worse",
was held in the Tokyo Head Office of the Yomiuri Shimbun
Dailies, where over 300 people gathered.
Like the Asahi Health Forum, the Yomiuri Self-Medication
Lecture consisted of three parts; PART I (Keynote speeches),
PART II (Panel Discussion) and PART III (Lecture).
PART I The first keynote
speech, given by Dr. Atsushi Nagai (Vice President, Tokyo
Women's Medical College Hospital) covered a topic stimulatingly
titled "How to discern a common cold from influenza
and other similar diseases". The speech was very
comprehensive as it elucidated the symptoms accompanied
by a common cold, influenza, and pneumonia, the knack
of discerning one from others, the trend of influenza
anticipated to be rampant this year, and the basic knowledge
about bird flu and Severe Acute Respiratory Syndrome (better
known as SARS).
The second keynote speech, titled "Wise selection
of a well balanced assortment of vegetables for the prevention
of a common cold" and given by Dr. Kiyoko Yoshida
(Professor, Kagawa Nutrition University) strongly appealed
to the female audience as it gave a useful suggestion
that vegetables such as, among others, "Spinach"
and "Broccoli" rich in Vitamin C and Carotene
should be constantly taken throughout the year for the
prevention of a common cold and that hot food served in
the pot would enable all the family members to effortlessly
increase intake of vegetables which tend to be less sufficiently
ingested these days.
PART II The panelists
were Dr. Nagai, Professor Yoshida, Michiko Hori (former
Managing Director, the Japan Pharmaceutical Association)
and Hiroshi
Ohtsuki (JSMI Vice-Chairman and President, Consumer Healthcare
Company, Takeda Pharmaceutical Co., Ltd.). The Panel Discussion
titled "Self-Medication for preventing a common cold
from getting worse" was moderated by Teruo Matsuda
(former Executive Announcer at Japan Broadcasting Corporation)
domestically known for his talented chairmanship at forums
dealing with medical issues and affairs.
Matsuda skillfully threw questions not at the panelists
but at the floor so that the audience itself was unconsciously
intoxicated with its answering each question by raising
either one of the two round fans which said either YES
or NO. Those questions included, among others, "Am
I liable to catch cold?" "When you have caught cold,
do you have a bath as is usual?", "Does your
cold begin showing the same symptoms?", "Do
you always take the same medicine for your cold?",
"Do you read without fail the information carried
in the package insert concerning the side effects of the
cold remedies?" and the like. The effort to get the
floor actively involved in the panel discussion proved
to be a success as it produced lively discussions, during
which important messages on responsible self-medication
and preventive measures against a common cold were smoothly
conveyed to the target attendees.
PART III Lastly, a lecture
specifically titled "Are you sure you aren't wrong
in selecting cold remedies?" was given by Hori, who
strongly recommended the audience to have "Your own
pharmacist" to whom information on a family make-up
and a family member, if any, who is allergic to some cold
remedies should be provided. "Your own pharmacist",
thus armed with necessary knowledge, would be of a great
help to you when selecting a proper cold remedy to use.
3.Meeting
Held on Good Vigilance Practice (GVP)
On November 17, 2004, PMS Sub-Committee (Under the Drug
Information Committee of JSMI) organized a study session,
"Let's Study on Prototype of Good Vigilance Practice
for Nonprescription Medicines". The session was held
in collaboration with Japan Direct-Selling Pharmaceutical
Manufacturers Association, Japan Kampo-Medicine Manufacturers
Association and Council of Household Medicines Manufacturers,
and gathered over three hundred audiences at the venue,
Josui Kaikan Hall in Tokyo.
The session was featured with two keynote speeches; firstly,
"What GVP aims at achieving and what is expected
of the pharmaceutical manufacturers" by Deputy Director,
Safety Division, Pharmaceutical and Food Safety Bureau,
Ministry of Health, Labour and Welfare (MHLW) and secondly,
"Survey on GVP in the sector of the Group 2 Medicines
Manufacturing and Marketing License Holder" by Deputy
Director, Health and Safety Department, Welfare and Health
Bureau, Tokyo Metropolitan Government.
The keynote speeches were followed by the explanations
of Prototype of GVP given by the PMS Sub-Committee members.
The explanations were followed by Question & Answer
Session which saw brisk exchanges of not only questions
and answers but also views and opinions.
The paradigm shift from "Approval for Manu-facture"
to "Marketing Authorization" is note-worthy
in the revision of PAL. Any person who wishes to market
medicines may file an application for "Marketing
Authorization", provided he meets the requirements
set forth by the competent authorities. It would be safe
to say that "Marketing Authorization" is loosely
equivalent to the marketing authorization commonly employed
in the major countries in the European Union.
Copies of the study materials (including the handout and
templates, prototype GVP rules in each factory in CD-ROM)
distributed at the meeting are now available for YEN 2,000
per set. At the website http://www.jsmi.jp (in Japanese
only), you may get an application form.
4.
Four New Active Ingredients Approved for Nonprescription
Medicines
On December 10, 2004, Nonprescription Medicines Working
Group, Council on Pharmaceuticals and Foodstuffs Sanitation,
arrived at a conclusion, after deliberation and review
of the following four active ingredients, that all of
them be granted approvals for Rx-to-OTC switches and Direct
OTC respectively.
The former - Rx-to-OTC switch - includes two ingredients
for H2 blockers, namely, Roxatidine Acetate Hydrochloride
(Teikoku Zoki Seiyaku Co., Ltd.) and Nizatidine (Zeria
Pharmaceutical Co., Ltd.) and one ingredient for allergic
rhinitis, namely, Ketotifen Fumarate (Ciba-Geigy Japan).
(The names in the parentheses are the manufacturers who
filed applications in question.)
In consideration of the possibilities of the consumers'
misjudging serious diseases, at the meetings of the Working
Group, it was specifically pointed out that labeling and
packaging should be designed in such a manner that the
consumers could easily understand those matters printed
on labeling and packaging providing vital information
such as precautions for use.
Ketotifen Fumarate to be switched for allergic rhinitis
is the first case in the spray dose form.
The latter - Direct OTC - is Minoxidil (Taisho Pharmaceuticals
Co., Ltd.), which is contained in the hair-growing agent
for female and is subjected to re-examination for four
years after the approval. There were preceding direct
OTC products of Minoxidil from same company supplied only
for men but not for women.
The regulations call for classifying these products with
those four active ingredients as Designated Drugs. These
classified drugs are limited to be distributed by pharmacist,
then the Yakushusho-hanbai-gyo (Drugstore without a pharmacist)
is not permitted to sell them.
5.
The Actual Use Trial (AUT) Study Particulars for the Second
Pilot Study Determined
The particulars for conducting the second pilot study
of the Actual Use Trial (AUT) have been mapped out. The
study was designed for the purpose of verifying whether
a new clinical trial method can be established as a substitute
for the ordinary clinical trials required to be conducted
for certain filings of OTCs Market Authorizations.
The newly determined particulars for the second study
are as follows:
1: PURPOSE of AUT
To verify whether AUT can be a feasible and appropriate
method for evaluating both efficacy and safety of a nonprescription
medicine as compared with "the clinical trials"
which are ordinarily conducted with interventions of physicians.
Additionally, studies will be made in order to identify
how well the consumers understand the labeling and package
inserts of the medicines in question.
2:
PROTOCOL of AUT
(1)
Medicines used: Four cold remedies containing
Ibuprofen, currently on the market
(2)
Number of pharmacy involved and number
of case to be collected:
Number of pharmacy involved: 20 pharmacies located
in Tokyo Metropolis
Number of case to be collected: 300 cases (15 cases
per pharmacy)
3: MAJOR TIMETABLE
(1)
Meeting of Ethics Review Committee December 22,
2004
(2)
Meeting for explanations to pharmacies December
25, 2004
(3)
Duration of conducting AUT From early January
2005 to the end of March 2005
(4)
Tabulation of the results of AUT By the beginning
of May 2005
(5)
Release of the final report Mid-May
2005
(Release planned for May 10, 2005 in conjunction
with the JSMI 20th Anniversary)
6.The
JSMI 20th Anniversary to be Celebrated on May 10
"Project
20", an ad hoc planning committee for the 20th anniversary
of JSMI, submitted its draft celebration programme to
the JSMI 142nd Board of Directors Meeting held on October
7, 2004 and was duly granted the approval.
The gist of the programme is as follows:
DATE:
May 10, 2005 (Tuesday)
VENUE: Rose Room, Tokyo Kaikan, 9th Floor, Tokyo
SESSION 1
14:10 ~ 15:00 Keynote Speeches
Theme: "Current Situation and Future Outlook
of Measures for Promoting OTCs"
Speakers:
*Regulator from FDA (to be named)
*Regulator from EMEA or NHS of UK (to be named)
*Representative from MHLW, Japan (to be named)
SESSION 2
15:15 ~ 16:45 Panel Discussion
Theme: "Promotion of Self-Medication and Utilization
of OTCs"
(The theme includes, among others, the following
topics:
Risks involved in the use of OTCs and Provision
of information thereof & The method of provision,
Accessibility and availability of OTCs, Enlargement
of the scope of OTCs, Development of Rx-to-OTC switches,
Correct understanding of the situation surrounding
Dietary Supplements, Clear differentiation between
OTCs and Dietary Supplements, The role to be played
by OTCs under the Health Insurance System, etc.)
Panelists:
*Chair - JSMI Representative (to be named)
*Regulator from FDA (to be named)
*Regulator from EMEA or NHS of UK (to be named)
*Representative from MHLW, Japan (to be named)
Audience:
*JSMI member manufacturers
*Constituency (Japan Pharmaceutical Association,
SMAC, etc.)
*Competent Authorities
*News media, The press, etc.Notably, "Project
20" has decided to look into the feasibility
of the following:
1) Compilation of the JSMI twenty-year history (Production
of CD, Carrying on Website)
2) Proposal for compiling a Data Book on OTCs
