I-2: Regulations on Bribery
This article summarizes the contents of 2️⃣ Regulations on bribery, "Chapter 1: Basic Structures of Regulations on Transfer of Value and Bribery to Healthcare Professionals".
For the Japanese version, please refer to the following.
See below for related articles.
（1）Regulation by law
1） Penal Code
A person who gives, offers, or promises to give a bribe to a public official in connection with the public officialʼs duties shall be punished by the crime of giving bribery （Article 198 of the Penal Code）. The term “public official” as used in the Penal Code is defined as “a national or local government official, a member of an assembly or committee, or other employees engaged in the performance of public duties in accordance with laws and regulations” （Article 7, para.1）. In addition, in relation to the application of the crime of bribery, there is a provision in laws other than the Penal Code that certain persons shall be regarded as public officials （so-called “deemed public officials”）. For example, the employees of the National Hospital Organizations （Article 14 of the Act on the National Hospital Organization） and the employees of the National University Corporation （Article 19 of the National University Corporation Act） are regarded as “deemed civil officials”.
“Duties” under the Penal Code mean any and all duties to be dealt with by a public official and any duties closely related thereto, and if his or her actions are made within his or her scope of the general authority as the public official, those actions are regarded within the “duties” regardless of the internal allocation of the duties within the organization.
A “bribe” refers to an unfair benefit as a consideration for the conduct of public officials in the course of their duties. Such benefits include not only monetary benefits but also non-monetary benefits that may satisfy the desires or needs of the public official including but not limited to receptions or entertainments.
2）Unfair Competition Prevention Act
A person who provides, offers, or promises to provide any money or any other gain to a foreign public official in relation to the public officialʼs duties to illicit unfair gain in international commercial transactions shall be punished by the crime of giving bribery to foreign public officials （Article 18 of the Unfair Competition Prevention Act）.
“Foreign public official” under the Act includes a person who engaged in public service of foreign national or local governments and their agents.
The term “duties” basically coincides with the definition in the Penal Code and refers to all duties to be dealt by foreign public officials and duties closely related thereto.
“Money or any other gain” is almost the same as the definition of “bribe” in the Penal Code and means not only the monetary interest but also non-monetary interests sufficient to satisfy the desires and needs of the public official.
As to bribery to foreign public officials, the Ministry of Economy, Trade and Industry （“METI”） has issued the “Guidelines for the Prevention of Bribery of Foreign Public Officials” （last revised September 2017）.
（2）Ethics-related regulations
1）Ethics Code for Public Officials
The National Public Service Ethics Act and the National Public Service Ethics Code （“Ethics Code”） were enacted in 2000 for the purpose of ensuring public trust in the duties of national public officials. The Codes are rules for national public officials on such as a prohibition of receiving gifts from interested parties.
HCPs who are national public officials are subject to the national-level Ethics Code for Public Officials, while local public officials are subject to the local ethic rules such as the Local Public Service Act or individual ethics rules）. In addition, Article 42-43 of the National Public Service Ethics Act obligates incorporated administrative agencies and local governments to take measures necessary to maintain ethics equivalent to the measures taken by the national government. Accordingly, even if an HCP is not a national public official, as ethics rules are established in accordance with the Ethics Codes for Public Officials, pharmaceutical companies need to confirm the ethical rules of the facility to which the HCP belongs. The National Hospital Organization and the Japan Community Health Care Organization （“JCHO”） have the separate ethics rules such as the Ethics Code of National Hospital Organization Personnel and the Ethics Code on of Officers and Employees of the Japan Community Health Care Organization.
2） Interested parties
Interested parties mean the parties those who are contacted by national public officials and are required to be dealt with carefully, and the officials are actually engaged in the affairs of such parties （Article 2, paragraph （1） of the Ethics Code）. Interested parties of government positions in the past 3 years and other personnelʼs interested parties who are clearly in contact for their own interests by exercising their influence over the per
personnel are also considered “interested parties” （Article 2, paragraph （2） of the Ethics Code）.
Employees of pharmaceutical companies are generally not interested parties as they are not the counterparty of the affairs of staff of national hospitals, but they will fall within interested parties when they conduct sales promotion activities of the companyʼs products because those activities are made on behalf of pharmaceutical wholesalers who has contracts with the hospitals and the activities lead to their profits.
Physicians, pharmacists, nurses, clinical laboratory technicians, and contract clerks who are not directly responsible for contracts but who are able to influence the purchase or selection of drugs fall under the category of the counterparty.
3）Prohibited acts and its exceptions
The following acts are prohibited for national public officials （Article 3 of the Ethics Code）.
（ⅰ）Receiving gifts of money, article, or real properties （including farewell gifts, congratulatory gifts, condolence money, offering of flowers and any other items equivalent thereto） from interested parties;
（ⅱ）Receiving money loans （in cases of banking business, limited to those without interest or with significantly low interest） from interested parties;
（ⅲ）Leasing goods or real properties from or at the expense of interested parties without providing compensation;
（ⅳ）Receiving the provision of services from or at the expense of interested parties without providing compensation;
（ⅴ）Receiving unlisted shares from interested parties;
（ⅵ）Receiving an entertainment or a treat from interested parties;
（ⅶ）Playing games or golf with interested parties;
（ⅷ）Taking a trip （excluding business trip for the purpose of public service） with interested parties; and
（ⅸ） Having interested parties conduct acts listed in the preceding items to third parties.
Notwithstanding the above, officials may conduct the prohibited acts of （i） and （viii） with those whom officials have a private relationship with and who fall under interested parties, only when these acts are considered not to bring about any suspicion or distrust from the citizens with regards to the fairness of execution of duty in light of the situation of interests in the course of their duties, the circumstance and the current situation of the private relationship and the manner of acts that officials intend to conduct （Article 3, paragraph （2） of the Ethics Code）.
Also, the following acts are allowed as exceptions of the prohibited acts.
（ⅰ）Receiving gifts of advertising materials or souvenirs to be widely and generally distributed from interested parties;
（ⅱ）Receiving gifts of souvenirs from interested parties at a buffet-style party that many persons attend （meaning a gathering serving food and drink in a stand-up style; the same applies hereinafter）; （ⅲ）When visiting an interested party as duties of that official, using goods provided by the interested party;
（ⅳ）When visiting an interested party as duties of that official, using a car （limited to that the interested party uses daily in its business, etc.） provided by the interested party （limited to those cases where using the car is considered appropriate in light of circumstances of transportation around the office, etc. of the interested party and other reasons）;
（ⅴ）Receiving refreshments from an interested party at a meeting or at any other gathering that an official attends as duties of that official;
（ⅵ）Receiving food and drink served from an interested party at a buffet-style party that many persons attend; and
（ⅶ）Receiving simple food and drink served from an interested party at a meeting that an official attends as duties of that official.
4）Notification of eating and drinking with interested parties
When an official eats and drinks with interested parties without the expenses required for the officialʼs own eating and drinking being born by the interested parties, and the expenses required for the officialʼs own eating and drinking exceeds ¥10,000, the official must notify the officialʼs ethics supervisory officer in advance, except for the following cases; provided, however, that if the official was unable to notify in advance due to unavoidable reasons, the official must notify the matters subsequently and promptly（Article 8 of the Ethics Code）.
（ⅰ）When eating and drinking with interested parties at a buffet-style party that many persons attend; or
（ⅱ）When eating and drinking with interested parties with whom the official has a private relationship with the expenses required for the officialʼs own eating and drinking being born by the parties or with a person with whom the official has a private relationship and who is not an interested party.
5）Prohibition of receiving remuneration for supervising of specific books
Officials must not receive a remuneration for supervising or compiling books for books prepared at the cost of subsidies or expense the national government or books more than half of those prepared are purchased by the national organ or the agency （Article 6, paragraph （1） of the Ethics Code）.
6）Restriction when conducting lectures
When an official intends, in response to requests with a remuneration from an interested party, to give lectures, etc., the official must obtain approval of ethics supervisory officer of that official in advance （Article 9, paragraph （1） of the Ethics Code）.
（3）Sanctions against violation
Bribery is a crime that is investigated and prosecuted by the police and public prosecutors. Penal provisions include imprisonment with work for not more than 5 years for general bribery （Article 197 of the Penal Code）, and imprisonment with work for not more than 3 years or a fine of not more than ¥2.5 million for giving bribery （Article 198 of the Penal Code）.
In addition, violations of the Unfair Competition Prevention Act are also crimes and are investigated and prosecuted by the police and public prosecutors. Penalties are defined as imprisonment with work for not more than 5 years or a fine of not more than ¥5 million （or both） for individuals and a fine of not more than ¥300 million for corporations （Article 21, Paragraph （2）, Item （vii） of the Unfair Competition Prevention Act）.
（4）Actual example of violation： Hirakata City Hospital
Case: Hirakata City Hospital
In 2000, the chairperson of the Pharmaceutical Affairs Committee of Hirakata City Hospital （as well as being its former president） received approximately ¥200,000 in cash from an employee of the Pharmaceutical Company A in connection with the selection of drugs at the meeting of the Pharmaceutical Affairs Committee in the month following the day when the payment was made, in which Committee the former president showed the intention to adopt Company Aʼs product. It also became clear that many MRs from approximately 30 pharmaceutical companies provided him entertainment, money and goods, as well as meals and invitation to golf tours. In this case, the former president and 8 MRs from 8 pharmaceutical companies and were prosecuted for bribery.
In response to this case, JFTC took measures against 9 member companies that committed such acts, including the “severe warning” to 1 company, the “warning” to 7 companies, and “guidance” to 1 company since such acts fell under “money, goods, invitation to tours, and entertainment provided to HCPs as means of inducing the selection or purchase of prescription drugs” as set forth in Article 4, paragraph （1） of the FCC and therefore violated Article 3 of the FCC. In addition, although violation of the FCC was not officially acknowledged, the 2 companies were also given “caution” from JFTC.
For the Japanese version, please refer to the following.
See below for related articles.
The full text and attachments are available at the following links (Japanese only).
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