1.INTERNATIONAL
FORUM on Self-Medication was held, filled to overflowingOn May 10, to celebrate its
20th anniversary, JSMI held an international forum
on self-medication at Tokyo Kaikan, which was packed
to its fullest capacity with some 310 participants
from the competent authorities, academia, business
sectors, mass media and the JSMI member manufacturers.
The forum consisted of two parts, under
the theme "Self-Medication Policy around the World
- What We Can Learn from the World", inviting four
current and former regulators from home and abroad.
Part 1 was for the keynote speeches under the theme
"Self-medication - Current situation and future perspective"
and Part 2 for a panel discussion focused on further
development of self-medication in each region.
JSMI Chairman Ibe, in his welcome address, said that
many industrialized countries look at self-medication
as the key element within their healthcare systems
and that he sincerely wished the forum to provide a
golden opportunity for JSMI to be able to know the
global trend of self-medication, to promote self-medication
in Japan and to eventually revitalize the market of
nonprescription medicines.
Randy P. Juhl, Ph.D.,Vice Chancellor and Professor of
University of Pittsburgh, said as follows:
The general trend towards self-care and the related movement
of drugs from prescription to over-the-counter status
in the US are influenced by a variety of socio-economic
factors.
First, there is an increasing desire on the part of consumers
to take a more active role in their well-being and their
medical care. The access to information through the internet,
the media and other sources both drives the demand for
self-care and facilitates the requisite decision making
encompassed in a model of greater consumer independence.
Second, a large fraction of current-day morbidity and
mortality in the US results from illnesses for which
there are proven preventive measures (e.g.: cardiovascular
disease, cancer). The US health-care system is less adept
at diseases prevention than disease treatment and thus
the self-care mode emerges as an important factor in
maintaining good health through lifestyle modifications
and science-based self-medication. The switch of nicotine
replacement products and the proposed switch of the cholesterol-lowering
statin drugs illustrate this trend.
Third, healthcare costs are consuming an increasing portion
of the gross domestic product to an extent that affects
US global competitiveness. A by-product of measures to
contain these costs is the shift of increasing responsibility,
and costs, to consumers. Because OTC products are, in
general, less expensive than prescription counterparts,
the use of non-prescription drugs is catalyzed by the
pressures to contain healthcare costs. The recent switches
of Claritin and Prilosec into the OTC market serve to
illustrate this point.
Countering these social and economic tendencies which
favor Rx-to-OTC switch is the heightened concern for
safety, fueled by recent high profile reports of unanticipated
adverse effects from drugs in the prescription market.
In addition, the cost of FDA approval of an Rx to OTC
switch must be balanced by the expected return on such
an investment.
James Copping, Principal Administrator, Competitiveness
in Pharmaceuticals Unit, DG Enterprise and Industry,
European Commission, said as follows:
In recent years Europe has witnessed major changes in
the legislative and policy framework governing self-medication
products. The chief cause of these changes has been a
general recognition that Europe would benefit from enhancing
the competitiveness of the self-medication sector, not
only economically but in terms of public health. There
has been a growing demand by patients for a greater say
in their own treatment decisions. Self-medication can
contribute to meeting this demand while easing pressures
on hard pressed medical services.
The focus of this debate has been the recent G10 Medicines
initiative. In 2001 the Commission set up the small high
level group (G10 Medicines) to examine ways to reverse
the decline in the competitiveness of the European-based
industry in line with our public health objectives. As
a consequence of these twin objectives, the Group was
chaired jointly by the then Commissioner for Enterprise,
Mr. Liikanen, and the Commissioner for Health and Consumer
Protection, Mr. Byrne.
The Group concluded that a competitive non-prescription
sector was important "to meet public health objectives
in Member StatesÉ". In particular, the G10 Group recommended:
*
that there should
be data exclusivity incentives to encourage
reclassification;
*
the use of the same trademark
for a product be permitted after reclassification
where there is no risk to public health;
*
there should be no specific
restrictions on advertising of non-prescription
products other than those concerning accuracy
and promotion of rational use of the product;
and
*
lifting of price controls in
those countries that still retain them for
this sector.
The Group's recommendations have had an impact. The recent revision of pharmaceutical
legislation has included a provision of a year of data exclusivity where there
is evidence of significant clinical benefit from doing so. No additional restrictions
on advertising self-medication medicines and the use of trademarks have been
included. The legislation has been adopted and will come fully into force in
November 2005.
Although there is still work to be done (particularly on pricing) much has been
achieved. We now have a strong framework to support the development of self-medication
in Member States.
Roy Alder, Director, Medicines and Healthcare Products Regulatory Agency, UK
said as follows:
The UK Government has, since 1994, positively encouraged policies which promote
self-care and enabling more people to take care of themselves at home. Over the
past 10 years, more than 200 products have been switched from Prescription-Only
to Over-The-Counter (OTC) status.
It is a fundamental element of the UK Government's plan for the National Health
Service (NHS) to empower both healthcare professionals and the public, and to
give them greater choice and wider access to medicines. The concept of the "expert
patient" is being strongly developed.
Modernising the NHS is about empowering patients, and an important part of this
is to enable them, so far as possible, to manage their own health care. The UK
Government is committed to making more medicines available over the counter -
though patient safety is always the prime consideration in any decision to switch
a medicine to OTC.
There are now a wide range of medicines available OTC in the UK - including nicotine
replacement therapy, emergency hormonal contraception and, most recently, statins.
UK Government policy is positioned firmly within the initiatives taken at European
level, notably the G10 medicines initiative and the recent Review of EU Medicines
legislation. Plans are currently under way in the UK both to continue to programme
of switches of medicines to OTC, and to implement the EU legislation clinical
trials have been undertaken.
The UK sees a competitive and successful OTC market as beneficial to the national
economy, to the pharmaceutical industry and to the public's health.
Tatsuo Kurokawa, Ph.D., Councillor for Pharmaceutical Affairs, Ministry of Health,
Labour and Welfare said as follows:
The competent authorities place an emphasis on securing the best benefits of
patients and populace. In the healthcare administration, safety has priority
over anything else. In the environment surrounding the nonprescription medicines,
drawing a distinction among the roles played by stakeholders, namely, classification
of medicines, distinction between medicines and dietary supplements, establishment
of clear-cut lines of authority and responsibility assumed by consumers, professionals,
and regulators is considered to be a measure that brings forth most efficiently
and quickly the best benefits to patients and consumers. Since the mid-nineties,
people came to feel the Internet more directly and information travels quickly.
This change has been considerably influencing the life and social structure.
The general public have come to have easy access to expert knowledge and to better
understanding and judgement of their own health and diseases. Consequently, there
has rooted a stance among the people to ponder, judge and choose by themselves
as much as possible what are related to themselves. The fact that an increase
in the incidence of diabetes and other ailments has become a national health
concern should be recognized as an environmental change.
Nonprescription medicines
play a role to bring forth the best benefits. It is important for the nonprescription
medicines sector to continue to make every effort to clearly in plain terms appeal
their usefulness for health to the patients and populace. In the seas of information,
it is important to make every effort to get the message, "Our great concern is
your health", crossed to the counterparts. Under the circumstances where the
structure of disease and health issues have undergone a tremendous change, it
will be necessary to review the efforts so far made and to demonstrate "Our recommended
plan for your health" to the consumers. Scientific rationale of combined drugs
and setting of effective quantities of active ingredients are just one example.
Safety and efficacy are prerequisite to nonprescription medicines. I am committed
to working together with all of you in order to cope with these changes.
The panel discussion was carried out chaired by Akira Uehara, JSMI Vice Chairman,
focusing on the following three theses:
1: The driving force for Rx-to-OTC switches
i)
In the U.S. and Europe as well, further promotion of self-medication
is ardently expected in the light of the rapidly graying society, medical
care and medical insurance systems that sustain those aging populations,
and furthermore, increased interest of consumers in their own responsibilities.
ii)
Consumers, in particular, by changing their life styles with help of
medicines designed for improvement of life, place a strong emphasis on
prevention of life-style related diseases which accompany the aging. In
this context, consumers expect Rx-to-OTC switches to play a key role.
2: Assurance of safety and enlightenment of consumers - Criteria
for deciding Rx-to-OTC switches
i)
Distribution systems long established in each country should be valued
when deliberation is given as to whether it should be mandatory or not
to seek professional advice at times of purchases of medicines. The first
priority should be "assurance of safety for consumers".
ii)
There are some factors to be taken into consideration in order to materialize
assurance of safety.
A:
Active ingredients which are truly valuable to consumers should be
selected.
B:
Both safety and efficacy of the products are essential. The pharmaceutical
manufacturers should verify them using the state-of-the-art technologies
of medical and pharmaceutical sciencesDTo utilize them, the means to
provide the information shall be established and offered so that consumers
can obtain, at any time they may wish, the information written in such
terms as understandable by and agreeable to general consumers.
C:
ConsumersCas the purchasers of the medicines, shall be fu11y engaged
in the management of their own health based on the correct understanding
of the information on the medicines and in the use of OTC medicines.
To support the consumersCthe manufacturers of the pharmaceuticals should
continue to make every effort to implement an enlightenment campaign
on medicines, targeting at a wide spectrum of people including students
of schools.
3: Dietary Supplements and Healthcare
The legal status of dietary supplements varies considerably from country
to country. It is expected to see exchanges of information and opinions
on herbal medicinal products and dietary supplements henceforth between
Europe and Japan.
Yasunori Tsuruta, JSMI President gave a closing address as follows:
It is significant that the forum has enabled the audience to recognize the institutional
differences between the countries and regions and, in particular, to understand
the different ways of thinking.
In order to practice self-medication, it is prerequisite to supply the pharmaceutical
products which meet the needs of each nation and society. In this context, the
role our industry has to play is extremely important. Our industry is anxious
to learn how self-medication has been practiced in the U.S. and Europe. Likewise,
I would hope that other countries might be able to learn something from Japan.
I am pleased to declare the closing of the forum by commending the forum was
highly informative.
2.FOCAL
POINTS of the revised Pharmaceutical Affairs Law
fully implemented on April 1st, 2005
1:
Sweeping reviews of the Approval
and Licensing Procedures
Introduction of Manufacturing Approval Procedures in line with an international
consistency
with a view to shifting from Manufacturing Approval to Manufacturing/Marketing
Approval
2:
Enhancement of Post Marketing Surveillance
Clarification of the responsibilities for ensuring safety measures to be borne
by the companies
(Legalization of GVP and GQP)
In April
2005, "Sweeping reviews of the Approval and Licensing
Procedures" and "Enhancement of Post Marketing Surveillance"
as specified in the revised Pharmaceutical Affairs Law,
promulgated in 2002, went into effect.
The eye-catchers are the sweeping reviews of the approval
and licensing procedures, namely, a shift from manufacturing
approval to manufacturing/marketing approval, and the
improvement of post marketing surveillance, namely, introduction
of GVP and GQP.
With the implementation of manufacturing/marketing approval
procedures, companies are encouraged to be fully prepared
for the shift from "conventional product liabilities"
to "both manufacturing and distribution responsibilities"
in line with an international consistency.
Other than those amendments, revisions of the procedures
regulating biologically derived pharmaceutical products
and medical devices are one of the main pillars of the
revised pharmaceutical affairs law.
THE
GIST of newly introduced measures based on the
revisions of
the Pharmaceutical Affairs Law
*
l Designation
of prescription (only) medicines
*
l Guidelines on the
utilization of registry for drug substances
(Drug Master-File)
*
l Survey on GMP compliance
*
l Procedures, to
be initiated by medical institutions/physicians,
to conduct
clinical trials on drugs
*
l Procedures to file reports on adverse drug
reactions directly from
medical institutions
*
l Additional safety measures reflecting the
characteristics of biologically
derived pharmaceutical products
The above gist is considered either to be relevant to
or to affect nonprescription medicines.
At the JSMI 143rd Board of Directors Meeting held on
January 14, the attendees unanimously elected Yasunori
Tsuruta, former Councillor for Pharmaceutical Affairs,
Ministry of Health, Labour and Welfare, to the presidency.
Tsuruta released an inaugural address as follows:
It is my great honour that I have been elected to the
second JSMI President after Mr. Shinji Nitta, the first
President and now Honorary Adviser. Being sensible of
my heavy responsibilities, I will do my best to fulfill
my duties and, in this context, may I cordially request
all of you here to support me.
Taking up this occasion, I wish to commend the past chairmen
and the first President for their contributions to the
development of both the OTC industry and JSMI.
Today, the OTC industry in Japan finds itself positioned
in the environment where the aging has been rapidly progressing
at the speed unparalleled in the globe. Curtailment of
medical expenses has resulted in sluggishness in the
prescription medicines sector alike, which in turn happens
to be with the nonprescription medicines on the tapering
path. On the other hand, however, it is in the pharmaceutical
area that new and advanced technologies can be expected
to emerge and international harmonization can make great
progress. There has not been any period in the past such
as the past several years which witnessed the topics
and issues on nonprescription medicines were so hotly
discussed in the framework of regulatory affairs. I believe
this phenomenon clearly indicates that the awareness
of the general public towards their own health is quite
high. In other words, this shows an optimistic aspect
of potential growth of the business notwithstanding the
lingering severe circumstances surrounding the nonprescription
medicines sector. In this sense, I am glad to tell myself
that my new assignment is really challenging and exciting.
Promotion of self-medication
will, I believe, enhance recognition by the populace
of the role played by the nonprescription medicines
and social contributions made by them. Although
I will not deny the importance of creating new
nonprescription medicines through Rx-to-OTC switches,
I want to attract your attention to the many products
which have been used for a long period of time
and valued by the consumers. I do want to pour
my efforts into promoting and utilizing such products
which might be called a national asset.
Now allow me to mention some tasks JSMI has to tackle
right now: Facilitation of smooth enforcement of
the revised Pharmaceutical Affairs Law from this
April, compliance with the revisions of the retailing
regulations on nonprescription medicines; Steady
materialization of the Recommendations given in the
"Interim Report on Role of Over-The-Counter "OTC"
Medicines in Self-Medication" compiled by "Expert
Consultation for Streamlining Procedures to Approve
and Examine OTC Medicines" issued in 2002; And full
support for ensuring a success of the 15th WSMI General
Assembly slated for June in Switzerland.
In the capacity of the JSMI President, I am determined
to wrestle with various tasks and issues, fully supporting
the Chairman Ibe. Needless to mention here, the activities
of the JSMI member manufacturers are the pillars
of the JSMI various activities, part of which is
shouldered by the JSMI Secretariat represented by
its President.
May I close my address by wishing
that all the member companies continue to devote
themselves in furtherance of responsible self-medication
and to extend their support and collaboration to
the Secretariat as much as they have done so far.
4.Development
of new pharmaceutical products containing Western
herbs
Strategic Alliance Conference for Business Promotion
(SACBP), since its establishment in June 2004, has
been discussing the issue, "Enlargement of functions
of OTCs", focusing on development of new Rx-to-OTC
switches, OTCs with new indications, OTCs in new therapeutic
areas, and the like. SACBP has recently arrived at
a conclusion that, "without submission of an actual
application dossier for a product approval", creation
of OTCs in a new genre would never be materialized.
The herbs used in the foreign countries as OTCs would
be classified as "CLASS 1" in Japan, if and when applied
for an approval, for the reason that there have been
no precedents. In addition, such an application would
be required to submit massive substantiation. SACBP
has further agreed to explore ways for obtaining approvals
for OTCs in the new areas so far untouched in Japan.
With the concurrence on the exploration granted by
the 145th Board of Directors Meeting held on April
18, a notice "On Development of Pharmaceuticals using
Western herbs" was already circulated among the member
manufacturers.
The notice details the formation of "HERB PROJECT" (consisting
of representative members from Pharmaceutical & Regulatory
Affairs Committee, Products Safety Committee, Herbal
Medicinal Products Committee, and International Affairs
Committee) under SACBP, which will conduct surveys
on the actual use of herbs as a single ingredient of
OTCs in Germany, Italy, United Kingdom, France and
USA (used as dietary supplements). The findings of
the surveys will be compiled into a table, based on
which the development will progress. Notably, what
"HERB PROJECT" plans to tackle is an entirely new initiative
to expedite early approvals or to expedite "making
ground rules which will enable to obtain approvals
for enlarged functions of OTCs".
5.VIDEOTAPES
for enlightenment on Self-Medication now available
Public
Affairs Committee, as part of its campaign for enlightenment
on self-medication, has recently edited two kinds of
videotapes and distributed them to the parties concerned.
The
first videotape is;
"What
is Self-Medication ? : Your health management
and nonprescription medicines" intended to
be used for senior high school students
The contents in the videotape are
designed to enable high school students understand
the basic concept of self-medication and the correct
use of nonprescription medicines so that students
are motivated to practice self-medication. The
videotape is intended to be utilized for health,
physical education, health guidance, and ordinary
curriculums at the schools. The Committee expects
the videotape contributes considerably to enlightenment
on self-medication together with those booklets
titled "Self-Medication and Medicines" produced
in last summer for use by senior high school teachers
throughout the country.
The 20-minute videotape has the following contents:;
l
Health Management and Self-Medication
An introduction to the concept of
self-medication which properly uses nonprescription
medicines based on one's own decision, utilizing
one's information and knowledge to cope with the
social changes relating the health management
l
Nonprescription Medicines and Self-Medication
To share basic knowledge such as
the classification between prescription and nonprescription
medicines, and adverse drug reactions; How to practice
self-medication by properly using nonprescription
medicines primarily based on one's own decision
drawn from a variety of health information and,
if circumstances require, on the proper advice
of the healthcare professionals
l
Correct Use of Medicines
With a check list of YES or NO,
to review actual experiences of the viewers so
as to teach them how to correctly use medicines
l
Reports on the actual purchases of medicines
at pharmacies
To have senior high
school students who have less experiences in purchasing
medicines by themselves go to pharmacies to purchase
medicines talking to pharmacists and submit the
reports of their firsthand experiences at pharmacies
The Committee distributed the videotapes together with
copies of the "Guidebook for Teachers" which includes a
suggested curriculum plan and materials for teachers to
use to 1,000 schools throughout the country at the beginning
of March in the hope these enlightening aids can be used
from the new school term.
The Committee plans to deliver the similar materials to
additional 500 senior high schools also next year.
The second videotape is titled as follows;
"How
to correctly and wisely practice Self-Medication
: Nonprescription
medicines that maintain your health" intended
to be used for the consumers
This is a revised version of the first one
with a partial revision made such as a change
from "Reports
on the actual purchases of medicines at pharmacies"
to "Reports on interviews with one's family pharmacy
and pharmacist".
Also at the beginning
of March, the Committee distributed them to 250
Consumer Centers and 150 regional pharmaceutical
associations through Japan Pharmaceutical Association,
so that they can be utilized at the assemblies
for the consumers hosted by the regional pharmaceutical
associations. A plan calls for providing the videotapes
to health centers next year for enhancing the consciousness
on self-medication among the consumers. The JSMI
member manufacturers are encouraged to fully utilize
those videotapes on such occasions as presentations
on their products.
