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The Fair Competition Code
of
the Medical Devices Industry in Japan
Notice:
This English Version of the Japanese
original of "The Fair Competition Code Concerning Restriction on
Premium Offers in the Medical Devices Industry" is published to meet
the needs of non - Japanese speaking readers.
When and if any discrepancy arises between the Japanese original and its
English translation, the former shall be considered as the proper meaning.
No part of this publication may be reproduced, stored, in a retrieval
system, or transmitted, in any form or by any means, electronic, photocopying,
recording, or (otherwise) used for advertising or promotional purposes,
general distribution, creative new collective works, or for resale, without
prior written permission of the copyright owner and publisher.
Translation
Hideaki Ogasawara
Chair, Planning & Public Relations Committee
The Japan Fair Trade Council of the Medical Devices Industry (JFTC)
CONTENTS
Notification No.8 of the Fair Trade Commission dated March
31, 2000
Regulations Concerning the Medical Devices Industry and Other
Similar Industries in Japan
The Fair Competition Code Concerning Restriction on Premium
Offers in the Medical Devices Industry in Japan
Enforcement of the Fair Competition Code on Premium Offers
in the Medical Devices Industry
Notification No.8 of the Fair Trade Commission dated
March 31, 2000
Restrictions on Premium Offers in the Ethical Drugs Industry, Medical Devices
Industry, and Hygienic Inspection Laboratory Industry shall be partially
amended as follows under the provisions within The Act Against Unjustifiable
Premiums and Misleading Representations (Act No. 134, Article 3 of 1962).
Restrictions on Premium Offers in the Ethical Drugs Industry, Medical
Devices Industry, and Hygienic Inspection Laboratory Industry.
The term "health services facilities for the aged defined in Article
6, Paragraph 4 of the Health and Medical Service Act for the Aged (Act No.
80, 1982) " in Paragraph 4 of the Notes shall be amended to "care
and health services facilities for the aged defined in Article 7, Paragraph
22 of the Long Term Care Insurance Act (Act No.123, 1997) ".
Supplementary Provision
This Notification shall take effect on April 1, 2000.
Regulations Concerning the Medical Devices Industry and
Other Similar Industries in Japan
[Notification No. 18 of the Fair Trade Commission dated November 16, 1998]
Restrictions on Premium Offers in the Ethical Drugs Industry and Hygienic
Inspection Laboratory Industry (Notification No.54 of the Fair Trade Commission,
1997) shall be partially amended as follows under the provisions within
The Act Against Unjustifiable Premiums and Misleading Representations (Act
No. 134, Article 3 of 1962).
Restrictions on Premium Offers in the Ethical Drugs Industry, Medical
Devices Industry, and Hygienic Inspection Laboratory Industry.
Those engaged in manufacturing or distributing ethical drugs, those
engaged in manufacturing or distributing medical devices, and those engaged
in hygienic inspection business shall not offer, as a means of unjustifiably
inducing transaction of ethical drugs, medical devices or hygienic inspection,
premiums to medical institutions and other similar institutions beyond the
extent of articles or services necessary for use of ethical drugs, medical
devices or hygienic inspection, or others found reasonable in light of normal
business practices.
(Notes)
| 1. |
The term "ethical drugs" as
used in this Notification shall mean pharmaceutical drugs defined
in Article 2, Paragraph 1 of the Pharmaceutical Affairs Act (Act No.145,
1960) and used for medical care at medical institutions and other
similar institutions. |
| 2. |
The term "medical devices"
as used in this Notification shall mean medical devices defined in
Article 2, Paragraph 4 of the Pharmaceutical Affairs Act and used
for medical care at medical institutions and other similar institutions. |
| 3. |
The term "hygienic inspection"
as used in this Notification shall mean inspections defined in Article
2, Paragraph 2 concerning The Clinical Laboratory Technicians, Hygienic
Inspection Technicians, and Other Similar Technicians Act (Act No.
76, 1968). |
| 4. |
The term "medical institutions and
other similar institutions" as used in this Notification shall
mean hospitals and clinics defined in Article 1- 5 of the Medical
Care Act (Act No. 205, 1948), health services facilities for the aged
defined in Article 6, Paragraph 4 of the Health and Medical Service
Act for the Aged (Act No. 80, 1982), pharmacies defined in Article
2, Paragraph 5 of the Pharmaceutical Affairs Act, and others engaging
in medical care, and contractors of hygienic inspection (including
board members, medical professionals, and other employees). |
Supplementary Provisions
| 1. |
This Notification shall take effect on
April 1, 1999. |
| 2. |
Premium offers which have taken place
in previous transactions prior to this Notification shall be governed
by pre-existing rules. |
The Fair Competition Code Concerning Restriction
on premium Offers in the Medical Devices Industry
[Authorized under the Fair Trade Commission on November 16, 1998
Notification No. 19 of the Fair Trade Commission dated November 16, 1998]
Article 1 (Purpose)
The Fair Competition Code (hereinafter referred to as "FCC") aims
to prevent unfair inducement of customers through restrictions on unjustifiable
premium offers in the medical devices manufacturing and distributing industry,
and to ensure fair competition and order within the industry.
Article 2 (Definition)
| 1. |
The term "medical devices"
as used in the FCC shall mean medical devices defined in Article 2,
Paragraph 4 of the Pharmaceutical Affairs Act (Act No. 145, 1960)
and used for medical care at medical institutions and other similar
institutions. |
| 2. |
The term "medical devices manufacturers"
as used in the FCC shall mean entities who are engaged in manufacture
or import of medical devices in their business operations and who
adhere to the FCC. |
| 3. |
The term "medical devices distributors"
as used in the FCC shall mean entities who are engaged in distribution
of medical devices in their business operations and who adhere to
the FCC. |
| 4. |
The term "business entities"
as used in the FCC shall mean medical devices manufacturers, and distributors
and those engaged in related activities. |
| 5. |
The term " medical institutions
and other similar institutions" as used in the FCC shall mean
hospitals and clinics defined in Article 1-5 of the Medical Care Act
(Act No.205, 1948), health services facilities for the aged defined
in Article 6, Paragraph 4 of the Health and Medical Service Act for
the Aged (Act No. 80, 1982), and others engaging in medical care and
shall include board members, medical professionals, and other employees. |
| 6. |
The term "premiums" as used
in the FCC shall mean any articles, money, or other kinds of economic
benefits which business entities (medical devices manufacturers and
distributors and those engaged in related activities) may offer, irrespective
of methods employed, to the other parties in connection with transactions
of their medical devices as a means of inducing customers, (with the
exception of premiums that do not include any economic benefits such
as discounts or after- sales services in light of normal business
practices, nor any economic benefits which are found as belonging
to the medical devices in light of normal business practices) as listed
below;
| (1) |
Goods, land, buildings and other
structures |
| (2) |
Money, money certificates, bank
deposit certificates, lottery certificates, bond or share certificates,
shopping certificates, and other securities |
| (3) |
Entertainment (including invitation
free of charge or with favorable fees to movies, shows, sports,
travel, and other amusements) |
| (4) |
Conveniences, labors, and other
services |
|
Article 3 (Principle of Restriction on Premium Offers)
The business entities shall not offer premiums to medical institutions and
other similar institutions as a means of unjustifiably inducing transactions
of medical devices.
Article 4 (Restricted Premium Offers)
Examples of premium offers that violate the provisions of Article
3 are as follows;
| (1) |
Money and articles, travel, entertainment,
conveniences and labors, and other services offered as a means of
inducing selection or purchase of the medical devices to medical doctors,
dentists or other medical professionals belonging to medical institutions
and other similar institutions. |
| (2) |
Gratuitous offer of medical devices,
conveniences and labors, and other services to medical institutions
and other similar institutions as a means of inducing selection or
purchase of the medical devices. |
Article 5 (Unrestricted Premium Offers)
Examples of offers of premiums or economic benefits that do not violate
the FCC are as follows;
| (1) |
Offer of articles or conveniences or
other services required for proper use of medical devices marketed
by a company or to cope with an emergency |
| (2) |
Offer of medical information or supply
of explanatory leaflets or materials for medical devices marketed
by a company |
| (3) |
Offer of sample medical devices in compliance with
the standards stipulated in the Enforcement Rule |
| (4) |
Payment of remuneration and expenses for research
or study regarding medicine or medical devices such as post-marketing
surveillance or clinical studies of the medical device consigned to
medical institutions and other similar institutions |
| (5) |
Offer of articles or services not considered extravagant
or excessive pertaining to seminars or the like, organized for the
medical institutions and other similar institutions, to deepen understanding
of the medical devices marketed by a company or payment of attending
expenses thereto |
Article 6 (Restriction on Premium Offers to Medical Devices Distributors)
Medical devices manufacturers shall not offer premiums to medical
devices distributors in violation of the provision of Article 19 (Prohibition
of Unfair Trade Practices) concerning The Prohibition of Private Monopoly
and Maintenance of Fair Trade Act (Act No. 54, 1947).
Article 7 (Fair Trade Council)
| 1. |
The Japan Fair Trade Council of the Medical
Devices Industry (hereinafter referred to as "JFTC") shall
be established in order to achieve the objectives of the FCC. |
| 2. |
The JFTC shall be composed of business
entities and associations of business entities participating in the
FCC. |
| 3. |
The JFTC shall perform the following
functions;
| (1) |
Matters pertaining to promotion
of greater awareness and understanding of the FCC. |
| (2) |
Matters pertaining to counseling,
guidance and disposition of complaints on the FCC. |
| (3) |
Matters pertaining to investigation
of suspected violations of the FCC. |
| (4) |
Matters pertaining to action against
business entities who violate the FCC. |
| (5) |
Matters pertaining to promote greater
awareness on The Act Against Unjustifiable Premiums and Misleading
Representations and laws and regulations on fair trade, and
toward prevention of violations thereof. |
| (6) |
Matters pertaining to liaison and
coordination with government agencies concerned. |
| (7) |
Other matters pertaining to the
enforcement of the FCC. |
|
Article 8 (Obligation to Cooperate)
Business entities shall cooperate with the JFTC in order to ensure
smooth enforcement of the FCC.
Article 9 (Investigation of Violations)
| 1. |
When the JFTC suspects a violation of
the provisions of Article 3 of the FCC, it may convene parties concerned
to hold hearings, refer necessary matters to parties concerned, seek
opinion from witnesses and conduct other necessary investigation. |
| 2. |
Business entities shall cooperate with
any investigation the JFTC conducts pursuant to the preceding provision. |
| 3. |
In the event that business entities refuse
to cooperate with an investigation under the provision of Paragraph
1, the JFTC may warn the business entities involved, in writing, that
they should cooperate with the investigation. In the event that business
entities do not comply with the warning, the JFTC may impose a penalty
of up to ΄100,000 or expel them from the FCC. |
Article 10 (Penalties for Violations)
| 1. |
In the event that a violation of the
provisions of Article 3 is found, the JFTC may warn the violator in
writing, that necessary action shall be taken to eliminate the violation,
that the same or similar type of violation shall not be repeated,
and other related remedial actions shall be taken. |
| 2. |
In the event that it is found that the
business entity warned under the provision of the preceding paragraph
has not complied with the warning, the JFTC may impose it a penalty
of up to ΄ 1,000,000, or expel from the FCC, or request the Fair Trade
Commission to take appropriate regulatory action. |
| 3. |
The JFTC, when issuing a warning, or
imposing a penalty on a violator, or expelling from the FCC in accordance
with the provision of Paragraph 3 of the preceding article or Paragraph
1 or 2 of this article, shall notify the Fair Trade Commission of
said action in writing without delay. |
Article 11 (Procedures for Violations)
| 1. |
In case action (excluding warning) is
to be taken in accordance with provisions of Paragraph 3 of Article
9, or Paragraph 2 of the preceding article, the JFTC shall draw up
a draft (hereinafter referred to as "Draft Decision")and
send it to the said business entity. |
| 2. |
The said business entity may file a written
appeal with the JFTC within 10 days after receipt of the Draft Decision. |
| 3. |
When such an appeal has been made, the
JFTC shall give the said business entity an opportunity to make and
prove its assertions, conduct additional review of the case based
on the new materials provided and thereupon make a formal decision
accordingly. |
| 4. |
When no opposition has been filed pursuant to the
provision of Paragraph 2 of this article, the JFTC shall make the
same decision as set forth in the Draft Decision. |
Article 12 (Establishment of Enforcement Rule)
| 1. |
The JFTC may establish an enforcement
rule on matters relating to the enforcement of the FCC. |
| 2. |
The JFTC shall obtain approval of the
Fair Trade Commission in advance before establishing or revising an
enforcement rule. |
Supplementary Provisions
| 1. |
The FCC shall take effect on April 1,
1999 except Article 7 (other than Paragraph 3, Items 3 and 4) and
Article 12 which shall take effect on the date of notification by
the Fair Trade Commission. |
| 2. |
When the system on benefits of medical
devices in medical care covered by health insurance is revised, the
FCC shall be reviewed accordingly to ensure fair competition in the
medical devices industry. |
Enforcement of the Fair Competition
Code on Premium Offers in the Medical Devices Industry
[Approved by the Fair Trade Commission on
December 2, 1998]
Article 1. (Meaning of Terns)
| 1. |
The meaning of terms used in the Fair
Competition Code (hereinafter referred to as "FCC") concerning
Restriction on Premium Offers in the Medical Devices Industry and
this enforcement rule shall be as follows;
| (1) |
All the medical devices used for
medical care at the medical institutions and other similar institutions
shall be included as medical devices in the FCC, no matter whether
they are covered or not covered by health insurance. |
| (2) |
The term "those engaged in
related activities" used in Article 2, Paragraph 4 of the
FCC refers to persons who market medical devices with their
own trade mark or name on by contracting out manufacturing of
medical devices to other manufacturers or sole agents or persons
under special contract with medical devices manufacturers who
are recognized to be engaged in practically the same business
as the manufacturers (e.g. seller), and who adhere to the FCC. |
| (3) |
The term "medical institutions
and other similar institutions" defined in Article 2, Paragraph
5 of the FCC shall include medical doctors, dentists, pharmacists,
and other medical professionals belonging to a medical institution
or the like, and board members, employees and others who participate
in selection or purchase of medical devices at the said institutions
(including "person engaged in medical administrative operations"). |
| (4) |
The term "any economic benefits
which are considered after-sales services used in normal business
practices" stipulated in the proviso in Article 2, Paragraph
6 of the FCC shall mean articles, conveniences, and other services
necessary for trading or use of medical devices (e.g. handling
and operating explanation, maintenance and inspection, repair
and the like within the guaranteed period) |
| (5) |
The term "any economic benefits
which are considered to be collateral to medical devices used
in normal business practices" specified in the proviso
in Article 2, Paragraph 6 of the FCC shall mean articles or
conveniences or other services which need to be provided with
medical devices because of their structure or function (e.g.
attachment / installment / wiring / operation adjustment of
the equipment, the storage container or the like). |
|
Article 2 (Sample Medical Devices)
The offering standards on sample medical devices stipulated in
Article 5, Item 3 of the FCC shall be as follows;
| (1) |
Definition of "sample medical devices"
The term "sample medical devices" shall mean the medical
devices offered free of charge to medical institutions and other similar
institutions so that the medical professionals can confirm outward
characteristics of the medical devices concerned such as shape or
can confirm and evaluate efficacy and safety of the medical devices
under clinical testing use prior to routine use of the medical devices. |
| (2) |
Offering Standard
| a. |
Sample medical devices shall be
labeled in a way that differentiates them from the marketed
products. |
| b. |
Sample medical devices shall be
supplied as per minimum quantity necessary for confirmation
or evaluation of the product as stipulated in the preceding
item. |
| c. |
Offer shall be made only when request
in writing is submitted by medical doctor or like person, to
use for clinical testing. |
|
Article 3 (Remuneration for Case Reports)
Remuneration for case reports in post marketing surveillance stipulated
in Article 5, Item 4 of the FCC shall be in accordance with the following
standards;
| (1) |
The term "case reports" shall
mean that medical doctors or like persons, in accordance with the
request of a medical device manufacturer, prepares a report concerning
the efficacy, safety, and quality of a certain type of post marketing
medical device in a particular format regarding the cases where a
medical doctor or like person, has in fact used or prescribed the
said medical device. |
| (2) |
Under the pretext of remuneration for
case reports, money shall not be offered as a means of inducing selection
or purchase of offererΥs medical devices: therefore, the following
matters shall be complied with;
| a. |
No request for a case report shall
be made to a medical institution and other similar institution
which has not adopted nor purchased the medical device surveyed,
nor on the condition that the said medical device will be adopted,
continue to be purchased or increase in purchased amount. |
| b. |
The number of cases surveyed shall
be reasonable in light of the purpose or content of the survey. |
| c. |
The requests shall be made to medical
institutions and other similar institutions which can perform
the purpose of the survey. |
| d. |
The requested institutions or the like shall
not be biased toward particular areas or particular type of
medical institutions and other similar institutions in light
of the purpose of the survey. |
| e. |
Excessive number of case reports shall not
be requested for clinical cases handled by the medical institutions,
or doctors, etc. |
| f. |
Requests for case reports shall be made in
writing. |
| g. |
Remuneration for case reports shall not be
more than an objective and fair amount calculated reasonably. |
|
Article 4. (Lectures and Meetings)
With respect to premium or the like, offers
at lecture meetings or the like, and other purposes for medical devices
marketed by a company stipulated in Article 5, Item 5 of the FCC, the following
shall pertain;
| (1) |
The term "lecture meetings and other
purposes for medical devices marketed by a company" shall mean
any meeting, irrespective of the title of the meeting such as an explanatory
meeting or seminar, to explain medical devices marketed by a company
to a number of medical institutions and other similar institutions. |
| (2) |
Attention shall be paid to the venue,
facility, and other means of holding such meetings, so to avoid being
misconstrued as invitations for travel or entertainment. |
| (3) |
The following is acceptable payment of expenses for
participation;
| a. |
Payment of remuneration, expenses
and honoraria to a lecturer or like person, requested by a company,
within the amount that is considered acceptable in light of
common practices shall be permissible. |
| b. |
Payment of necessary minimum amount
of travel expenses to the participants, other than lecturers,
shall be permissible. |
| c. |
Receptions, not considered extravagant
or excessive, held in connection with the meeting shall be permissible. |
|
Article 5 (Premium Offers, etc.)
Economic benefits as specified below shall not contravene the Provisions
of Article 3 of the FCC, even if they are considered as premium offers.
| (1) |
Offer of premiums within the quantity
which is considered reasonable in light of normal business practices. |
| (2) |
Gifts which are offered, or receptions
which are held, in line with customary social gatherings and which
are not considered extravagant or excessive in light of common practices. |
| (3) |
Gifts which are offered, or receptions which are
the customary memorial ceremonies of a company or medical institution
or other institution and which are not considered extravagant or excessive
in light of common practices. |
Article 6 (Detailed Enforcement Provisions)
The JFTC may establish detailed rules on
enforcement standards or procedures to enforce the FCC and the Enforcement
Rule by filing with the Fair Trade Commission.
Supplementary Provision
The Enforcement Rule shall take effect on the day the FCC takes effect
(April 1, 1999).
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