PharmaceuticalRetailing
Outside of PharmacyFor the overseas readers, we consider it might be advisable to touch
on this controversial, misleading, and sensitive issue from its
historical standpoint to provide them with background.
Under the mounting pre s s u re from both home and abroad for the
i n t roduction of a more liberal distribution (retail) structure for
i m p roved visibility of and access to nonprescription medicines,
Government decided at its regular Cabinet meeting held in Marc h
1996 to initiate investigation into the area of mutual concern and
interest.
The purpose of the investigation was to identify whether there can be
substances (active ingredients) with relatively mild pharmacological
actions to the human body which can be sold without involving health
p rofessionals to provide detailed product information to the
consumer at the point of purchase of nonprescription medicines.
Under the legal framework of the Pharmaceutical Affairs Law (PAL),
p romulgated in 1960 as the nucleus of the pharmaceutical contro l ,
there are five types of business licenses for drug retailing:
1) Yakkyoku (Pharmacy with a pharmacist)
2) Ippan-Hanbai-Gyo (Drugstore with a pharmacist not permitted to
fill prescriptions or dispense)
3) Yakushusho-Hanbai-Gyo (Drugstore without a pharmacist)
4) To k u rei-Hanbai-Gyo (Exceptional license in remote areas with no
pharmacies or drugstores available)
5) Haichi-Hanbai-Gyo (Household distribution but not a peddling
business)
NB: The English translations in the parentheses are loosely
translated equivalents.
Also under the PAL, quasi-drugs (roughly defined
as substances with a mild action to the human
b o d y, other than equipment or instruments, allowed
to claim a certain scope of preventive indications
and effects) can be freely sold outside of pharmacies,
drugstores and aforementioned other designated
drug retail outlets.
In order to assure safety, effectiveness, and quality,
quasi-drugs are kept under a rigid control in the
manufacturing state by the competent authorities.
On the other hand, because of their mild actions, they
can be sold by any person through any retail channel
(convenience stores, grocery outlets, kiosks, etc.)
In the light of the foregoing, addition of quasi-drugs
appeared to be the best compromise most likely
to satisfy the increasingly strong demands of the
conventional retail business sectors while considerably
appeasing pharmacies and drugstores who reacted
with great anxiety to the imminent prospect of
nonprescription medicines on general sale and m o s t
importantly avoiding the pharmaceutical admin-istrative
disruption under the PAL.
After intensive studies and reviews, a total of 15
categories of nonprescription medicines had been
identified to be suitable for shifting their OTC
status to quasi-drug status.
As from April 1, 1999, these quasi-drugs, termed anew
"Newly Designated Quasi-drugs ", have been con-t
r ibuting to activate the sluggish Japanese retail
market as a key player to bring those concerned in
substantial revenues.
In June, Prime Minister Koizumi somewhat briskly
announced a plan to "allow all the medicines with
no safety concern be sold outside of pharmacies by
the end of this year ".
D r. Sakaguchi, Minister of Health, Labour and
Welfare Ministry (MHLW), prudentially r e s p o n d i n g
to the plan, stated "Those medicines whose safety has
been established could be sold outside of pharmacies,
yet, a careful consideration needs to be given to
whether OTC to quasi-drug shifting similar to the
current system be applied or new categorical nam-ing
be conceived ".
In July, the Government sponsored Council for
Regulatory Reform, reflecting these remarks by
both ministers, drafted a proposal saying "It is
desirable to allow the medicines with relatively
mild actions which could be sold by To k u r e i -Hanbai-
Gyo and Haichi-Hanbai-Gyo be sold also
at general retail stores as soon as practical ".
On the other hand, M H LW having formed "Ta s k
Force on the review of the Newly Designated Quasi-d
r u g s "in March this year, has reinforced it by
deploying toxicologists and experts on herbal
medicines so that, by the end of this year, it may
compile and submit a proposal for settling this
pharmaceutical retailing issue fruitlessly disputed
over a long term of years. It is expected that the
proposal may suggest revisions of the PAL as well.
It is likely that the Task Force will include in its
agenda items for intensive discussions the following
points:
* A thorough review of the scopes of both non-prescription
medicines and quasi-drugs so as to
establish anew definition and approval/licensing
procedures/standards for both categories:
* A possibility of adding a new category posi-tioned
between nonprescription medicines and
quasi-drugs:
JSMI has been actively involved in these i n i t i a t i v e s
by sending two delegates as a voice of the industry
in order to extend its expertise, experiences and
collaboration.
Studies on Chinese
Medicines and Traditional
Medicines
"Interim Report on Role of Over- T h e - C o u n t e r
(OTC) Medicines in Self-Medication: To encourage
OTC Medicines to be needed, trusted and used with
confidence" (hereinafter referred to as Interim
Report), compiled by Expert Consultation for
Streamlining Procedures to Approval and Examine
OTC Medicines, was released by the MHLW in
November last year.
Under the heading, "Evaluation (approval) of
traditional medicines", Interim Report stated as
follows:
(i) Traditional medicines long used in Japan
These traditional medicines have been handed
down since ancient times in Japan as leading
ingredients for medicines, have been made into
Kampo medicines or used as household medicines,
and have played a major role throughout history.
At Present, most of them are not approved as
medicines in their individual forms, except for
some 30 types, which are approved either in a
"cut" or "ground" form. In order to expand the
range of OTC medicines, it is necessary to conduct
further studies on preserving these traditional
medicines by setting certain standards and taking
other appropriate steps.
(ii) So-called "Western herbs "used as m e d
i c i n e s overseas
Traditional medicines (mainly Western herbs) are
consumed by the public as "s u p p l e m e n t s ". However,
if some herbs are found to have similarities with
medicines in terms of their effects on people 's
bodies and other attributes, future studies will be
required on handling such herbs, with reference to
their usage overseas.
Following the release of Interim Report, late in June,
"The 1st Confab on the approval of herbal medi -c
i n e s (including Western herbs) as nonprescription
m e d i c i n e s "was organized, open to the public, under
the auspices of Director General, Pharmaceutical
and Food Safety Bureau, MHLW.
Yasunori Tsuruta, Councillor for Pharmaceutical
Affairs, gave an opening address, followed by the
introduction of the members of the Confab led by
Hiroshi Saito, Professor Emeritus, To k y o University,
acting as Chairman.
S p e c i f i c a l l y, in reference to the aforementioned
two headings, "Traditional medicines long used
in Japan" and "So-called
used as medicines overseas", discussions were
focused on the approval and licensing procedures for
"Herbal medicines (including Western herbs) as nonprescription
medicines ".
The attending members were unanimous in their
recognition of the urgent necessity of working out
countermeasures for harnessing chaos created by
the quite dubious borderline between medicines
and foodstuffs such as Western herbs including,
among others, Ginkgo biloba and Saint-John 's -w o r t
as well as for preventing possible health hazards
caused by them to consumers.
N o t a b l y, majority of the members were of the
opinion that any products that claim therapeutic
e fficacy should be classified and controlled as
medicines while some said Western herbs might
be possibly used as food depending on new find-ings
to be obtained after further studies on their
properties.
In the subsequent meetings and confabs, as the
conclusion reached, discussions will center around
introducing regulations and rules to control use of
herbs actually contained in the "So-called" health
foods, establishing yardsticks to lay the distinction
between drugs and foodstuffs where herbs are to
be used as medicines, and disseminating information
deemed necessary.
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JSMI
Steering Committee on Pharmaceutical Affairs to Submit
Opinions to the Confab on "So-called "Health Foods
Japan classifies what can be
orally taken as either medicines or foods. Although foods
are much m o r e closely (than medicines) related to the
human daily life, they have been rather loosely (again
than medicines) regulated and controlled. Surprisingly,
it was only in April 2001 that MHLW, as a matter of form,
systematized these two classes as follows:
Over the years,
consumers in Japan have been considerably bewildered and
subjected to fraud by the rampancy of borderline products,
particularly, many dubious products (ostensibly positioning
themselves as foods while quite cunningly making health
claims to the extent of curing cancer and terminal illnesses)
whose safety and efficacy have not in any manner been established by the competent
authorities.
The Internet is glutted with advertisements of
numerous "Neither fish nor fowl "p r o d u c t s ,
presenting a lucrative business to swindlers. With
body consciousness being almost an obsession,
many Japanese women, young and old alike, are
(or hopefully were) taking weight-reducing prod-ucts
manufactured in and brought from China,
s o m e of which were found to contain a variant of
Fenfluramine and N-nitroso fenfluramine (both are
not authorized for use in Japan) which cause
severe liver failure.
It is indeed life 's serious ironies that some women
dying of an ardent desire to slim down actually
died after having taken those slimming products
from China.
Under the circumstances as such, in late April,
Department of Food Safety, Pharmaceutical and
Food Safety Bureau, MHLW organized, open to
the public comments, "The 1st Confab on the control
of 'So-called 'health foods ".
In response to this Confab, in mid-May, JSMI
Steering Committee on Pharmaceutical Aff a i r s
submitted its position paper, the gist of which is
given below:
1: A new legal category of foods, FOSHU, was
introduced by the then Ministry of Health and
Welfare (MHW) in 1991 and is defined as "Foods
for particular use which are allowed to state in the
labeling that people who consume them for
particular health purpose can expect to achieve
specified results by consuming them regularly ".
Being subject to a license system, FOSHU has to
meet criteria of approval almost equal to that
applied to OTC drugs.
The FOSHU labeling is allowed to claim pre-vention
or treatment of life-style related diseases.
On the other hand, there are many "S o - c a l l e d "
health foods which, without being licensed, carry
claims confusingly similar to those of FOSHU.
Interim Report defines OTC medicines as follows:
"People decide on their own to purchase OTC
medicines on the basis of proper information
provided by pharmacists and use at their own
responsibility. OTC medicines improve symptoms
associated with minor illnesses, prevent symptoms
associated with illnesses, improve and upgrade
QOL, facilitate self-checking of health, maintain
and enhance good health, and otherwise promote
hygiene ".
Needless to reiterate, consumers have been
bewildered by the increasingly vague borderline
between OTC medicines and "S o - c a l l e d "h e a l t h
foods. Such consumers 'confusion and bewilderment
have been much intensified with an influx into the
market of foodstuffs in the shapes exactly same as
those of medicines.
In view of such a chaos, JSMI strongly suggests
that processed foods claiming some beneficial
actions based on scientific evidence to the phys-iological
functions be regulated and controlled
under PAL and that such foods be classified anew
as health oriented medicines including, for
example, Newly Designated Quasi-drugs. Thus,
JSMI believes, the distinction between medicines
and foods would become more clear, leading to
assurance of safety of consumers, and alleviation
of confusion generated among consumers.
2: JSMI strongly suggests that OTC medicines
should remain a key player in improving and
preventing symptoms associated with minor illnesses and life-style related diseases, improving
and enhancing QOL, and maintaining and p r o m o t -ing
health.
J S M I 's suggestion might present the following
comparable benefits:
(1) Foods, when some of their nutrients are
purposefully condensed or when such condensed
nutrients are combined, would tend to induce an
excessive intake of nutritionally unbalanced foods,
leading to safety issues. OTC medicines are
mandated to explicitly label directions (dose and
administration).
(2) Foods, when they claim some beneficial
actions to the physiological functions, would tend
to make users harbor false expectations as if they
cure illnesses, often serious ones. OTC medicines
are mandated to correctly claim indications.
(3) Foods are not subjected to any advertising
code. The absence or less effective enforcement of
advertising practice control tends to make consumers
harbor excessive expectations. OTC medicines are
regulated by PAL and "Standards for Appropriate
Advertisements of P h a r m a c e u t i c a l s "prepared by
the then MHW in 1980.
(4) It is commonly accepted that foods are safe to
take. Such acceptance tends to lead to an excessive
intake of them. OTC medicines provide p r e c a u -
tions for use based on scientific evidence or sub-stantiation.
(5) Post Marketing Surveillance, in particular, its
vital component, Adverse Drug Reaction reporting
system ensures prompt and proper steps to be
taken through pharmacies or drugstores in case of
contingencies such as health hazards linked to use
of OTC medicines.
(6) Application of Good Manufacturing Practice
(GMP) and its validation ensure stable manufacture
and supply of quality OTC medicines whose s p e c -ifications
are spelled out and registered with the
regulatory bodies.
3: In the absence of a legitimate category or de-finition,
the term "Health foods ", has come into
common use to the extent of being mixed up with
dietary/food supplements which likewise have no
categorically clear status. All in all, all of these foods
are the culprit of the chaotic "healthcare "product
segment.
In order not only to restore consumers 'confidence
and trust but also to purify muddy water staled in
one of the fastest - g r o w i n g |if not the fastest-g
r o w i ng |segments of the healthcare market, im-p
l e m e n t a t i o n of a rigorous controlling mechanism is
urgently needed.
New
Formation of WSMI Sub-committee
So far, International Affairs Committee has been
supported by its plural sub-committees; Asian Aff a i r s
Sub-committee, Overseas News Sub-committee and
Newsletter Sub-committee.
As an additional international arm, WSMI Sub-committee
was formed in January this year after
the Board of Directors Meeting unanimously c o n -curred
with and approved a plan to create a new arm
specifically conceived for further cultivating and
consolidating international relationships with
WSMI and its member associations around the
world.
The plan appears to be quite timely as JSMI is still
in a state of deep emotion and excitement about
the WSMI 14th General Assembly and 5th Asia
Pacific Regional Conference held in November
last year in Tokyo, where there was clearly d e m o n -strated
a strong tendency to make progress with a
concerted effort in bringing the concept of re-sponsible
self-medication further forward in the
healthcare agenda although we still have a long
way to go in many parts of the world.
Middle and long-term goals of the newly born
WSMI Sub-committee are active and proactive
interactions with the WSMI member associations,
inter alia, with those in Southeast Asia where
many reliable sources expect some of the major
changes are likely to occur, setting great hopes on
continued economic growth in the foreseeable
future.
At the very juncture when China Nonprescription
Medicines Association (CNMA) has been granted
concurrence by WSMI to host the WSMI 6th Asia
Pacific Regional Conference in Beijing in October
next year, WSMI Sub-committee does welcome
this conference as a golden opportunity to share its
experiences and expertise gained in the To k y o
Conference 2002 and to extend its fullest co-operation
to CNMA for ensuring dynamic and
healthy promotion of responsible self-medication
not only in China but also in the region as a whole.
"Information is power ", so is often said. In a sea
of information obtained and disseminated via
numerous means and media, selection of really
valuable pieces of information and conveyance
thereof should be one of the major roles WSMI
Sub-committee is expected to play so that infor-mation
becomes literally a most powerful weapon
which will enable the industry to cope with the
ever changing business environment.
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Dissatisfaction
with OTC Medicines -
As little as 10.8%
~ Results of Consumer Survey ~
As part of its regular
campaign to promote responsible self-medication, JSMI
conducted a consumer opinion survey on OTC medicines by
means of a questionnaire in an advertorial in the Asahi
Shimbun dailies in early May this year.
In the survey, as usual, readers were asked about their
concern over or awareness of health, counter-measures
for an increased medical expenditure, questions, complaints,
expectations and the like about OTC medicines.
Some of these questions and answers are shown
below:
