Revision
of the
Pharmaceutical Affairs Law
- Sweeping Review of OTC Retailing Regulations -
On March 30, General Affairs Division, Pharmaceutical
Affairs Bureau, Ministry of Health, Labour and Welfare
(MHLW) formally announced a plan to conduct a sweeping
review of the regulations that control the retailing
of OTC
drugs, considering some revisions of the Pharmaceutical
Affairs Law (PAL) - the supreme law among a number
of
laws governing the pharmaceutical administration in
Japan
- to be prerequisite to the review.
Reasons for such a reform have been cited as significant
changes of the environment surrounding OTC drugs, an
undeniable gap between the pharmaceutical retailing
regulations in place and a disordered reality, and
an
improvement in the professional skill and quality of
pharmacists anticipated at the juncture when pharmaceutical
curriculum at pharmaceutical colleges is to be
extended from the current 4-year-term to a new 6-yearterm.
In line with these reasons, on April 14, Welfare Science
Council, (an advisory body to MHLW) formed a "Task
Force To Study Pharmaceutical Retailing", which
will study
and review the following various matters in an attempt
to
institute anew a pragmatic system where appropriate
provision of information can be made, accurately reflecting
the degrees of risks potentially imposed by medicines:
Matters to be studied and reviewed (1) Categorization of medicines in
accordance with the degrees of risks potentially imposed
by
them
(2) Methodology of provision of information
required at points of sales of medicines
(i) Contents of necessary information for pro-
vision
(ii) Qualification of those engaged in sales of
medicines and their recruitment
(iii) Methods of provision of information
(Utilization of Information Technologies,
etc.)
(3) Countermeasures against post-sales side effects
(4) Legalization of (1) and (2), and enforcement
thereof
(5) Others (Review of * Tokurei-hanbai-gyo)
* Tokurei-hanbai-gyo or Exceptional business license
which mostly applies to remote areas where there are
no
pharmacies or drugstores available. For such a situation,
a prefectural governor can issue the license, on an
exceptional basis, to an individual who is not a
pharmacist. The license is very specific and restrictive
in terms of the type of drugs handled.
Scheduling
2004
April:
Formed "Task Force To Study Pharmaceutical
Retailing" within Welfare Science Council
to begin debates and analysis of status in quo
concerning provision of information at points of
sales of
medicines:
(Hearing from those concerned, Researches of
systems in foreign countries, and Questionnaire
are to be carried out for debates and analysis.)
Summer: "Task Force" to sort out the findings
of
Hearing, Researches, and Questionnaire and to
chart out the specific direction of study and
review:
Autumn: To form a "Working Group" within "Task
Force" to deliberate, for about a year, specifically
on categorization of medicines and on how to
provide information to consumers at points of sales
of medicines:
"
Working Group" to summarize results of the deliberations
so as to draw a conclusion for submission
to "Task Force":
2005
Autumn: " Task Force",
taking into its consideration the conclusion drawn by "Working Group",
to wrap up its views and opinions for forming its
final opinion on the appropriate revisions of PAL
2006
Ordinary Diet Session: "Task Force", based
on its
final opinion as formed, to submit to the Diet a bill
proposing partial revisions of PAL
Establishment
of Independent Administrative
Corporation, "Institute for Medicines& Medical Devices"
In the wake of administratively reformative
changes brought forth by the new fiscal year
which began as from April 1, the establishment of "
Institute for Medicines & Medical Devices" (IMMD)
is just one example of becoming Independent Administrative
Corporations with the
major aim of reducing overnment controls and
introducing more self-supportingly competitive
climate into conventionally government-led sectors
and areas.
Ministerial Ordinance issued by MHLW on the
same date spells out the goals of IMMD as
follows:
1) To design countermeasures for prompt implementation
against health damages caused either by
drug side effects or by infectious diseases induced
by biological products:
2) To promote research and development of pharmaceutical
as well as pharmacological technologies
which contribute to promotion and maintenance
of the national health: and
To perform such routines as review and examination
which ensure quality, efficacy and safety of
pharmaceuticals so as to improve quality of public
health.
More specifically, the goals clarify the IMMD
routines which cover the continuation of the following:
- relief of sufferers from adverse drug reactions;
- review and examination of product registration
applications for drugs, medical devices and the
like in accordance with the Pharmaceutical Affairs
Law;
- consultations on the requirements relating to
clinical trials;
- efforts for ensuring safety of drugs.
Additional routines include relief of sufferers from
infectious diseases induced by biological products.
The newly added routines have been conceived
on the ground that health damages may not be
completely prevented even with the state-of-theart
safety measures being properly in place.
Incidentally, judgement of a recipient's eligibility
for due compensation is to be made by the Minister
of MHLW in consultation with Drug and Food
Hygiene Council.
It is planned for IMMD to collect certain amount
of subscription from both manufacturers and
importers of biological products in order to raise
its relief fund.
Noteworthy is that IMMD clearly aims at strengthening
the competitive power of pharmaceutical
companies in international markets, activating
both regional and international markets, and
linking the results of studies such as genome
science to actual development of new pharmaceuticals.
IMMD, in line with such aims and goals, plans to
publicly encourage pharmaceutical companies to
devise and propose R & D themes, among which,
the excellent ones identified as promising high
feasibilities shall be entrusted to the proposers
themselves, and to grant to them the subsequent
achievements as well as the intellectual property
rights generated while it obliges the companies
concerned to pay to IMMD a fixed rate of the
profits earned.
The
JSMI 40th Ordinary General
Assembly held
-The 9th Edition of OTC Encyclopedia issued-
At
the JSMI 40th Ordinary General Assembly held
on May 7, the reports on the business and the
financial statement for the fiscal period of April 1,
2003/March 31, 2004 were unanimously approved,
followed by the approval with unanimity of both
the business programme and the budget for the
current business year.
Notably, each chairman of Pharmaceutical and
Regulatory Affairs Committee, Drug Information
Committee, Public Affairs Committee, International
Affairs Committee, and Steering Committee
on Deregulation of Pharmaceutical
Retailing elucidated the details, using PowerPoint,
on both the various achievements made during the
preceding period and the business initiatives to be
undertaken during the present period.
The major goals of the business programme are (1)
continued efforts to put into practice what are
envisioned in the so-called "Interim Report" ("Interim
Report on Role of Over-The-Counter 'OTC' Medicines in
Self-Medication" issued by
Expert Consultation for Streamlining Procedures
to Approve and Examine OTC Medicines entrusted
by the Ministry of Health, Labour and
Welfare), (2) furtherance of public relations for
promoting public awareness of responsible selfmedication,
(3) active participation in the WSMI
6th Asia Pacific Regional Conference to be hosted
by the China Self-Medication Industry (CSMI),
and (4) preparations for felicitations of the JSMI
20th anniversary.
Individually, Pharmaceutical and Regulatory Affairs
Committee has set up goals, among others, to
promote Rx-to-OTC switching, enlarge the scope
of OTC medicines, review drug approval and
licensing procedures, explore possibilities of
creating new procedures for drug approval and
licensing, increase efforts for ensuring drug safety
in terms of post-marketing surveillance, and draft
approval and licensing standards for single ingredient
herbal medicinal products.
Public Affairs Committee aims at increasingly
encouraging responsible self-medication by way of
partially updating "Self-Medication Handbook",
cultivating those to whom the "Handbook"s are
distributed, editing video tapes teaching how to
practice self-medication, presenting those tapes to
senior high schools throughout the country, and
organizing "Asahi Health Forum (three times a
year) and "Yomiuri Lecture on Self-Medication" (twice
a year). Also the Committee aims at carrying out a campaign
for upgrading the contents of
the Website as well as encouraging consumers to
access to them.
International Affairs Committee places great
emphasis on its collaboration, in response to an
ardent request from CSMI, not only to encourage
the JSMI member companies to send as many
delegates as possible but also to identify speakers
of high calibre so that JSMI can make a great
contribution to the successful WSMI international
event in Beijing.
March next year will greet the 20th anniversary.
The Ordinary General Assembly has served as a
golden opportunity for JSMI to formally announce
a plan, although in embryo at present, to celebrate
the event which shall be capitalized as a momentum
for penetrating the significant concept of
responsible self-medication and the role played by
nonprescription medicines in promoting elfmedication
among consumers, mass media, the
competent authorities concerned and the ndustries
involved.
Following
suit of the Ordinary General Assembly, the 30th General
Assembly of JSMI Information
Service (a body affiliated to JSMI) was held.
Most notably, an introduction was made to the 9th
edition of the "OTC Encyclopedia" up-dated
and
published in late April.
As the name speaks for itself, the series of this
directory has been utilized as an encyclopedia of
nonprescription medicines.
The latest edition contains 2,848 items of both
OTC medicines and Newly Designated Quasidrugs
manufactured and distributed by the JSMI
member companies, together with summaries of
package inserts of those products classified by
therapeutic categories.
The 9th edition features anew "All About
Additives" and "Q & A On Medicines" (Tabulation
of some 30 questions most frequently raised by
consumers to <Questions or Comments ?> Section
of the manufacturers and the respective answers),
all of which greatly facilitate consumers to consult
the directory.
Consumers'
Spending on Medicines
decreased
On February 10, the Management and Coordination
Ministry (MCM) released a report on the
findings of its survey on housekeeping expenses
for the year 2003.
Spending per household per year on medicines" was YEN 20,929 (approximately US$190) and that
on "foods and supplements for maintenance of
health" was YEN 12,208 (approximately US$
110).
The comparison of the 2003 figures with those of
2002 clearly indicates that consumers tended to
spend more on "health foods" rather than on
"
medicines" for maintaining and promoting their
own health:
Incidentally,
MCM gives definitions of "medicines" and "foods
and supplements for maintenance of health" respectively as shown below:
MEDICINES: Both "Drugs" and "Quasi-drugs" as
defined in the Article 2 of the harmaceutical
Affairs Law.
Those medicines purchased on extramural dispensing
based on the physicians' prescriptions are
also categorized into the above mentioned therapeutic
categories.
OTHER MEDICINES include both drugs and
quasi-drugs which do not belong to any one of the
above mentioned therapeutic categories (COLD
REMEDIES ~ OTHER EPIDERMAL DRUGS).
FOODS AND SUPPLEMENTS FOR MAINTENANCE
OF HEALTH: Foods taken as nutritional
supplements for maintaining and promoting
health, in the shapes similar to ordinary drugs such
as tablets, capsules, granules, powders, pills,
liquids (extracts) and the like.
Consumer
Awareness of "
Self-Medication"
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 on
December 13, 2003 in relation to the Asahi Health Forum
held under the title, "Self-Medication to be
practiced together by married couples".
The latest similar survey had been conducted in May 2002,
where the responses to the question, "How well
do you know the term, "Self-Medication" ?,
had been as follows:
The December 2003 results were as follows:
Awareness of "Self-Medication",
therefore, seems to have improved some 10% as compared
to the 2002
survey to slightly over 60% when the top three results
are added up.
Other questions and answers thereto were as follows:
(1) How do you treat yourself when you feel unwell ?
(2) What do you want to know about OTC
drugs ?
(3) How do you assess Consulting Function ?
Regarding "What do you require of Consulting Function ?", 275 respondents
expressed respectively wishes
and/or improvements, major details of which are as follows:
(4) Are you interested in the issue on pharmaceutical retailing deregulation
which will allow OTC drugs to
be sold in convenience stores ?
(5) Why are you interested in the issue ?
(6) If and when OTC drugs are allowed to be sold in convenience stores, how
do you intend to buy your
OTC drugs ?
A total of 590 out of the
statistically eligible 1,000 respondents expressed their
recommendations
and
grievances about OTC drugs. These will be analyzed and
tabulated into "Report of the 27th Survey on
Consumer Awareness of OTC drugs" in due course of
time and be distributed to the JSMI member
companies.
