New
Year Greetings for 2004 from Chairman,
Sachiaki Ibe
Trusting
that our dear colleagues both at home and abroad as
well as all the parties and persons concerned greeted the first morning of the new year in good health and
condition, I have, as is quite customary with us, the
pleasure of extending my New Year g reetings, by way
of firstly retrospecting on the last year and secondly
sharing with all of you the plans JSMI harbours for
implementation this year.
Chairman
Sachiaki Ibe
1: Activities undertaken nationally for promotion of
responsible self-medication
On September 29, JSMI Website (in the Japanese language,
for the time being) was completely renewed by adding
anew "Medicines Retrieval Function". This Retrieval
Function, instrumented in collaboration with Nonpre
scription Medicines Database Center, enables
consumers to retrieve approximately 3,500 items
of nonprescription medicines from products' names,
therapeutic categories, manufacturers' names, and symptoms.
Further, it allows consumers to read a package insert
of each drug item.
Addition of more data and public relations to raise
consumers' awareness towards this renewed cyberspace
gateway to nonprescription medicines which need to be
properly used for responsible self-medication are the
two areas planned for immediate imple-mentation.
The momentum, encouragingly generated at the WSMI 14th
General Assembly and 5th Asia Pacific Regional Conference
hosted by JSMI in November 2002, for striking root of
responsible self-medication deep into the consciousness
of consumers has never faltered over the period since
these international events.
On the contrary, JSMI made every effort to increase
the number of Health Forum, in addition to the Asahi
Shimbun Health Forum held twice a year, spring and autumn,
by newly co-hosting with the Yomiuri Shimbun dailies
the First Yomiuri Self-Medication Symposium in autumn,
focusing on "Obesity". All the participants had their
"Degree of Obesity" (A Body Mass Index or BMI which
is a formula in which a person's body weight in kilograms
is divided by the square of his or her height in meters)
measured to alert themselves to the potential danger
of overweight or obesity.
The Symposium designed to allow the participants to
gain their knowledge by "actual experience" was well
accepted as compared to the conventional lecture-type
symposia where participants tend to passively listen
to lectures or talks which flow very much like one-way
traffic.
This year's plan calls for co-hosting four events with
both the Asahi Shimbun and Yomiuri Shimbun dailies.
2: Activities to be undertaken internationally for promotion
of responsible self-medication
Our colleagues in the People's Republic of China, Chinese
Self-Medication Industry (CSMI), at the very juncture
when their name was changed from China Nonprescription
Medicines Association (CNMA) to CSMI, volunteered ~
needless to mention, was warmly and unanimously endorsed
by the WSMI Member Associations ~ to host the WSMI 6th
Asia Pacific Regional Conference in Beijing from October
26 through 29 this year.
Although China is not separated from Japan by a narrow
streak of water, much of what is today considered traditional
in Japanese culture, arts and crafts was inherited from
China, defying the geographical tyranny of distance.
The corollary to this is that Chinese and Japanese cultures
have a great deal in common.
Now, CSMI's First Announcement with a highly challenging
title, "From the Past to the Future: Public Health,
Regulatory and Industrial Opportunities on Responsible
Self-Medication" has introduced Diaoyutai State Guesthouse
in Beijing ~ which is unquestionably a most prestigious
garden-villa complex flavoured with the timehonoured
wisdom and, at the same time, equipped with advanced
ideas and facilities ~ as the conference venue.
To reciprocate the then CNMA's great support extended
to the WSMI international events in 2002, we are committed
to developing the contribution that JSMI can make to
CSMI. I would hereby encourage the JSMI member manufacturers
to send their delegates as many as possible to China
which is firmly positioned as the world's fastest-growing
major economy and has become an increasingly important
source of demand for exports from Asia and the rest
of the world.
3 : Suggestions and recommendations to "Interim Report"
from the industry
In November 2002, "Expert Consultation for Streamlining
Procedures to Approve and Examine OTC Medicines" (an
advisory task force for the Ministry of Health, Labour
and Welfare) publicized "Interim Report on Role of
Over- The -Counter (OTC) Medicines to be needed, trusted
and used with confidence" (commonly termed "Interim
Report").
Of the major thirteen steps for improvement proposed
in the "Interim Report", the OTC drug industry delightfully
observed its suggestions and recommendations were reflected into the revision to reduce the number of class of nonprescription
medicines from six to four at filing an application
for registration. This revision should be considered
as a great improvement as it considerably alleviates
the burden of an applicant when preparing an application
dossier.
The industry is fully committed to continuing to make
further suggestions and recommendations both to expedite
Rx-to-OTC switches and to enlarge the scope of nonprescription
medicines so that they can manage prophylaxis of lifestyle
related diseases.
Recent movements of OTC medicines retailing deregulation
(part of which were featured in JSMI Newsletters Nos.
56 and 57) were: "Working Group" of "Task Force on the
selection of medicines presenting no major safety issues"
(Chaired by Hiroshi Saito, Professor Emeritus, Tokyo
University) selected approximately 350 items of nonprescription
medicines in the 15 categories such as, among others,
Digestives, Intestinal regulators, etc. as OTC medicines
that "present no safety concerns".
It is very likely that those items will be sold outside
of pharmacies, drugstores and other conventionally
authorized retail outlets, providing more convenience
in terms of visibility, accessibility and availability
of medicines to the consumers.
Under the legal framework of the Pharmaceutical Affairs
Law, it is mandatory that all the medicines are sold
"face-to-face", in other words, retailers are obliged
to have licensed pharmacists physically present.
H o w e v e r, rapidly increasing emergence of "e-commerce"
(sales of medicines via the Internet) and sales of medicines
via "Videophone" (a totally unprecedented retailing
practice where a discount retailer sells drugs at midnight
and in the early morning while using videophones linking
its outlets to pharmacists) has begun presenting a serious
issue for the industry as well as the competent authorities
to tackle as promptly as practical.
Such phenomena, depending on how they develop, could
inevitably affect the way the drug information is provided
at time of purchase and sale of OTC drugs.
However drastically the social and economical environment
may change, the necessity to educate and enlighten consumers
on the importance of "To manage your own health by yourself"
or Responsible Self-Medication shall remain unchanged.
JSMI is fully committed to ensuring the continued growth
of the OTC drug industry through promoting responsible
self-medication. Taking up this occasion, on behalf
of the management and staffs at JSMI, I would like to
make a fresh determination that we work closely with
all of you in 2004.
Collaboration
for the WSMI 6th Asia Pacific Regional Conference- Beijing,
People's Republic of China
On January 9 when the JSMI 137th Board of Directors
Meeting was held in Tokyo, JSMI extended its very warm
welcome to Mr. Albert Yeung, Senior Advisor to China
Self-Medication Industry (CSMI).
As was partly covered in the JSMI Chairman's New Year
Greetings, CSMI will be hosting the WSMI 6th Asia Pacific
Regional Conference in Beijing from October 26 through
29 this year.
Considering the Board of Directors Meeting as a golden
opportunity for Mr. Yeung to make his personal appearance
to encourage the JSMI member companies to attend the
Conference, JSMI gladly managed to find a slot for him
to make a brief presentation immediately after the Board
Meeting adjourned.
There is a worldwide trend for people to take greater
charge of their own health. The Wo r l d Health Organization
(WHO) clearly stated this was a most desirable trend
in the Alma-Ata Declaration in 1978 which endorsed the
goal of health for all by the year 2000, with primary
health care being the key to attaining it.
Professor Zhang He-Yong, President, CSMI remarked in
his greetings in the CSMI First Announcement as follows:
"People everywhere are becoming more aware of the importance
of health, and the opportunity they have for self-care.
Many factors - social, economic and political - are
encouraging people to take more responsibility for their
own healthcare, and in this self-medication has an important
place. Government interest and regulatory development
in self-medication are therefore high on the agenda
in many countries.
"China is no exception to the global trend, and has
made rapid strides in medicines classification and regulation
in recent years.
"Increasingly, the world is looking at China
with interest and confidence, as China opens a new chapter
in its rich history. The Chinese Self-Medication Industry
(CSMI) association is therefore proud to host the WSMI
6th Asia Pacific Regional Conference, between October
26th - 29th 2004, in Beijing, China.
"The rich conference programme will commence with an
overview of health policy in China, and the role of
self-medication. This will be followed by a review of
the social, market and regulatory situation in China,
providing an overview of the very latest developments
for overseas delegates".
In line with the CSMI President's greetings, Mr. Yeung,
in his presentation, put emphasis on the fact that a
full support of the Chinese competent authorities has
been extended to, among others, the unique availability
of Diaoyutai State Guesthouse, Beijing, as the lodging
accommodations as well as the Conference venue.
Needless to explain, Diaoyutai State Guesthouse is by
far the prestigious and most ideal place, where the
six-way talks were held last year, therefore, Mr. Yeung,
in anticipation of a great demand for the rooms, strongly
recommended that reservations be made as soon as practical.
In response to the great zeal shown not only by CSMI
but also by Mr. Yeung, who, JSMI firmly believed, achieved
a great deal as a Public Relations Ambassador entrusted
by CSMI, the JSMI Secretariat circulated to
its member manufacturers "REGISTRATION FORM" and
"APPLICATION FORM FOR HOTEL ACCOMMODATION and TOURS" attached to the CSMI First Announcement, encouraging
them to participate in the Conference in the hope that
a larger attendance would lead to a more remarkable
success of the Conference.
OTC
Retailing Deregulation- Shifting into Quasi-drugs Regarded
as Solution
On December 16, 2003, at its
4th meeting, "Working Group" of "Task Force on the selection
of medicines presenting no major safety issues" (Chaired
by Hiroshi Saito, Professor Emeritus, Tokyo University)
compiled and submitted its report to the Ministry of Health,
Labour and Welfare (MHLW).
MHLW, having based its arguments on the report, issued
its final policy with specifics shown below:
(1) "Working Group", after having scrutinized nonprescription
medicines (13,000 item belonging to 85 categories), selected
approximately 350 items belonging to 15 categories.
The majority of those items shall be shifted to quasi-drugs
without undergoing reformulation and partial changes to
their contents.
(2) These items shall be allowed to be sold at general
retail outlets on condition that precautions for use,
warnings, directions, etc. are printed on the outer containers
or wrappers of the items.
(3) The procedures for the said shifting shall be "regarded
as having been appropriately and duly performed" without
needing to file specific applications thereof. The shifting
shall be completed in approximately six months.
The JSMI Website has been updated since the issuance of
its final policy by MHLW on December 16 and, at present,
carries Report NO.4, "On preparations for shifting to
quasi-drugs".
As of the end of January, there has been published no
official announcement as yet concerning the products (brand)
names while the JSMI Website is ready for carrying the
particulars to be announced by MHLW.
JSMI has been requested by MHLW to design and submit drafts
of labelling (in plain terms and suggested printing type)
on the outer containers or wrappers of the items in each
category.
Report
Compiled on"Access to OTC at Midnight and in the Early
Morning"
Ministry of Health, Labour and Welfare (MHLW), having
formed a panel of pharmaceutical experts in October last
year, held meetings six times in order to intensively
discuss whether it is legal or illegal to allow selling
nonprescription (OTC) medicines at midnight and in the
early morning when pharmacists are not physically present
at retail outlets while using videophones linking retail
outlets to pharmacists.
On January 22, the panel compiled and released a final
report which calls for authorizing such sales from April
on condition that the following requirements are met.
As legal formalities, the Cabinet Order having relevance
to the issue needs to be revised as accordingly prior
to the commencement of the videophone-based OTC drug sales.
Additionally, the report remarks that those
requirements are subject to review for possible modifications
one year after the enforcement thereof.
1: The time zone specified as "At midnight and in the
early morning" shall be:
From 10 p.m. through 6 a.m.
2: The scope of medicines shall be:
Nonprescription medicines to the exclusion of Specified
Drugs, Poisonous drugs, and Powerful drugs.
3: Kind and properties of the technology of communications
shall be:
Videophones and other technology of communications capable
of properly performing collection and provision of information
on the medicines by way of transmitting animations and
voices (Videophones, etc. capable of enabling pharmacists
to properly discern complexion and natural physical movements
of customers, to judge the necessity to advise them to
see a doctor, and to confirm the medicines as directed
by pharmacists are handed over to them)
4: Proper supervision by pharmacists physically present
at retail outlets during "Normal Ti m e Zone":
Retailers are obliged to have pharmacists physically present
on a full-time basis during ordinary operating hours outside
the time zone when videophones, etc. are used (hereinafter
referred to as "Normal time zone") in order to ensure
proper management on the spot such as control of pharmaceuticals
and supervision of store clerks.
5: Limits on the time zone when videophones, etc. are
used in each business day:
The time zone when videophones, etc. are used shall not
exceed ordinary operating hours where pharmacists are
physically present on a full-time basis in each business
day.
6: Mandatory utilization of videophones, etc.:
At each sale of medicines, provision of information by
pharmacists to customers shall be made at each and every
retail outlet, with videophones, etc. as specified in
the above Item 3 being utilized without fail.
Further, at each and every retail outlet, a staff
shall be designated for ensuring the above mentioned provision
of information is appropriately done. The staff shall
be responsible for encouraging customers to utilize
videophones, etc. and ensuring the medicines
to be handed over to customers are those directed by pharmacists.
7: Keeping records:
Proprietors of each and every retail outlet shall keep
records of the following items and retain them for one
year:
(1) Date and time of sale
(2) Names of medicines sold and symptoms worthy of mention
(3) Names of store clerks involved in the sale
(4) Names of pharmacists involved in provision of information
via utilization of videophones, etc.
8: Establishment of systems enabling pharmacists to go
to their stores to cope with complaints from customers
of side effects:
(1) Designation of pharmacists (supervising pharmacists
and pharmacists at standby centers included) at each and
every store
Establishment of practical countermeasures at each and
every store
(2) Preparation and keeping, at each and every store as
well as standby centers, of the lists of nearby medical
institutions capable of handling, even at midnight and
in the early morning, emergencies attributable to side
effects
9: Control and supervision by pharmacists of pharmaceuticals
and store clerks:
Pharmacists (supervising pharmacists and pharmacists
at standby centers included) shall make the rounds of
retail outlets at least once at midnight and in the early
morning.
Store clerks shall report to standby centers what drugs
have been sold, how drugs are displayed, etc.
Proprietors of each and every retail outlet shall retain
the reports of the rounds together with the reports as
specified in the above Item 7.
10: A sufficient number of pharmacists for customers'
education on compliance and provision of information:
(1) A system shall be established whereby a sufficient
number of pharmacists are secured so that the Item 6 can
be fulfilled and customers' education on compliance as
well as provision of information can be properly performed.
(2) Pharmacists at standby centers shall be physically
present, in principle, at least once a week during "Normal
Time Zone", at the videophone-based retail outlets and
provide with them education on compliance and information.
11: Videophone-based sales within the same prefectures:
Retail outlets and standby centers shall be located in
the same prefectures.
12: Filing notifications with local public bodies:
Proprietors intending to begin videophonebased sales
of medicines shall file with the respective local public
bodies notifications describing the following items:
(1) Time zone, during ordinary operating hours, for conducting
videophone-based sales at midnight and in the early morning
(2) Locations of standby centers, and locations and names
of the retail outlets with which pharmacists at standby
centers provide instructions on medicines via videophones,
etc.
(3) Names of pharmacists working at standby centers, and
reports on their working concurrently with other retail
outlets
JSMI, in the capacity of an observer, has been invited
to the panel meetings, where, although they do not necessarily
address the sale at midnight and in the early morning,
the following two noteworthy opinions were given:
(1) It might be advisable to improve Package Inserts and
Labeling on the outer containers or wrappers so as to
be more easily understood by consumers.
(2) It might be advisable to educate consumers to read
carefully Package Inserts.