REGULATIONS UNDER PHARMACEUTICAL AFFAIRS AND MEDICAL DEVICES ACT
REGULATIONS UNDER PHARMACEUTICAL AFFAIRS AND MEDICAL DEVICES ACT
The relevant provisions of the Pharmaceuticals and Medical Devices Act pertaining to advertisement of pharmaceuticals are as follows:
Relevant Provisions
Description
Article 66
Prohibition of false and exaggerated advertisement
Prohibition of advertisement, descriptions, and dissemination of false and exaggerated articles on the names, manufacturing methods, indications, effects, and performance of pharmaceuticals, etc.
Prohibition of advertisement, descriptions, and dissemination of articles that may cause misunderstanding that physicians, etc. guarantee the efficacy, efficacy, and performance of pharmaceuticals, etc.
Prohibition of use of implication of abortion and use of obscene documents and drawings.
Article 67
Restriction on advertisement of designated pharmaceuticals, etc.
Restriction of advertisement of pharmaceuticals, etc. to the general public other than healthcare professionals used for the treatment of cancer and other special diseases specified by Cabinet Order
Article 68
Prohibition of advertisement of pharmaceuticals prior to approval
Prohibition of advertisements on the names, manufacturing methods, indications, effects, and performance of pharmaceuticals prior to approval or certification.
Definition of Advertisement
Advertisement for pharmaceuticals in the Pharmaceuticals and Medical Devices Act is defined as follows by the notice issued by the Ministry of Health, Labour and Welfare (“MHLW”).
clearly intended to induce consumers to purchase products (or intended to enhance motivation of customers to purchase products);
present the commercial name and class clearly such as specified pharmaceuticals; and
is accessible to general public.
"Applicability of Advertisement of Pharmaceuticals, etc. in the Pharmaceutical Affairs Act (Notice No. 148 of the Inspection and Guidance Division, Pharmaceutical and Medical Safety Bureau, MHLW, dated September 29, 1998)"
Generally, the requirement (1) (2) (3) are referred as “induction”, “speficificity”, and “accessibility”.
According to the ruling of Diovan case (Tokyo High Court decision on November 19, 2018, which declared the definition of "advertisement"), the respective requirements are interpreted as follows.
Induction
(a) [Objective Induction] The fact that the notification act has the nature of a means of indusing customers to purchase in view of the contents and format thereof; and
(b) [Subjective Induction] The intention of the actor to utilize the notification itself as a means of indusing customers to purchase.
Specificity
The specific pharmaceuticals etc., are specified in the notification. In determining whether this specification has been made, consideration should be given to whether or not the product name, common name, abbreviation, etc. is displayed, as well as the media used for notification and the attributes of the notifyee.
Accesibility
To be notified (or planned to be notified) to an unspecified or large number of persons
Standards for proper advertisement of Pharmaceuticals
As mentioned above, there are only three provisions that directly
regulate advertisement of pharmaceuticals under the Pharmaceuticals and Medical Devices Act. In light of the essence of pharmaceuticals etc., Standards for Proper Advertisement of
Pharmaceuticals, etc. (the “Standards for Proper Advertisement”) provide the explanation of Article 66, Paragraph 1 of the Pharmaceuticals and Medical Devices Act, as well as the items to be
observed with respect to pharmaceuticals, etc. so as not customers to misuse, promote abuse, or not to reduce the credibility of pharmaceuticals etc.
Applicable Advertisement
Advertisement in all media, including newspapers, magazines, televisions, radios, websites, and social networking services
Responsibility of the Advertiser
To endeavor to communicate accurate information so that users can use pharmaceuticals properly
Prohibition of advertisements that may impair the dignity of pharmaceuticals or jeopardize the credibility of pharmaceuticals
Manufacturing Method
Prohibition of expressions that differ from actual manufacturing methods or that may give contradictory recognition to the facts about their superiority.
Efficacy, Performance, and Safety
Prohibition of expressions exceeding the range of approved indications, etc.
Prohibition of advertisements using false or inaccurate expressions of ingredients and quantities that may contradict the facts about their indications or safety
Prohibition of advertisements using wordings that goes beyond the approved range or inaccurate wordings that may contradict the facts about efficacy or safety
Prohibition of expressions guaranteeing efficacy or safety
Prohibition of maximum expressions regarding efficacy or safety
Prohibition of expression of quick-acting, long-acting, etc. that exceeds medically-or-pharmaceutically-recognized range
Prohibition of expressions not deemed to be original indications, etc.
Other
Prohibition of advertisement that may encourage overconsumption or abuse
Prohibition of advertisement of ethical pharmaceuticals to the general public
Prohibition of advertisement to defame other companies' products
Prohibition of expressions recommendations by healthcare professionals, etc.
SANCTIONS FOR NON-COMPLIANCE
(1) Criminal measures
If an unapproved pharmaceutical is manufactured and marketed, it shall be imprisoned with work for not more than 3 years, a fine of not more than 3 million yen, or both (Article 84). For a false and exaggerated advertisement, it shall be imprisoned with work for not more than 2 years, a fine of not more than 2 million yen, or both (Article 85).
(2) Administrative measures
The Minister of MHLW may order the marketing authorization holder of pharmaceuticals to take the measures necessary to improve its operations if the marketing authorization holder of pharmaceuticals has violated the provisions of the Pharmaceutical and Medical Devices Act or orders based thereon when necessary to prevent the occurrence or spread of health and hygiene hazards (orders for improvement of operations, Article 72-4, Paragraph 1).
The Minister of MHLW may order a person who has given a false or exaggerated advertisement to discontinue the act or to take other measures sufficient to prevent the occurrence of public health hazards (discontinuation order: Article 72-5).
ACTUAL EXAMPLES OF ILLEGAL ADVERTISEMENT
MHLW judged that Takeda Pharmaceutical Company's promotional materials for Blopress, a treatment for hypertension, constituted an exaggerated advertisement under Article 66, Paragraph 1 of the Pharmaceuticals and Medical Devices Act, and in June 2015 MHLW issued the order for improvement of operations in accordance with Article 72-4, Paragraph 1 of the Act. This was the first case in which MHLW issued an administrative disposition in violation of Article 66 of the Pharmaceuticals and Medical Devices Act due to the exaggerated advertisement.
Among the promotional materials for Blopress, in addition to the catch copy "it is preferable to have more cards", there were five cards labeled "CKD," "diabetes," "nocturnal hypertension," "elderly” and “OVER 140/90." These were judged as an exaggerated advertisement of Blopress because it implies an indication other than "hypertension," which was the approved indication of Blopress. In addition, Takeda’s advertisement material was judged to be an exaggerated advertisement since the material emphasized the superiority of Blopress by adding arrows that gave an impression of significant difference and expressing the crossing-over as "golden cross while the results of clinical trials (CASE-J trial) comparing the effects of Blopress with other companies' antihypertensive pharmaceuticals showed no significant difference each other.
STRENGTHENED SANCTIONS BY INTRODUCTION OF SURCHARGE SYSTEM
1) Background of introduction of surcharge system
There have been cases of violations of the Pharmaceutical and Medical Devices Act, including false and exaggerated advertisement of pharmaceuticals and advertisement and sales of unapproved pharmaceuticals, and the number of cases in violation has not decreased. Some of these violations of the Pharmaceuticals and Medical Devices Act seem to be carried out for gaining economic profit as the primary purpose of the violation and it is pointed out that economic profit obtained from illegal activities should be collected by the government especially for the cases of false and exaggerated advertisement.
In Europe and the United States there are provisions of penalties and administrative depositions that enable the collection of the economic benefits of illegal activities and these provisions are also applied to violations of pharmaceutical-related regulations. In Japan, however, only a fine of ¥100 million is imposed on corporations based on the double punishment provision, and it is pointed out that deterrent has not worked to the high economic gains obtained by illegal activities.
Considering such circumstances, the Cabinet adopted the bill to introduce the surcharge system as a part of the revision of the Pharmaceutical and Medical Devices Act and submitted the bill to the Diet on March 19, 2019.
2) Surcharge system under other regulations
Currently, there are only four surcharge systems under other laws.
Antimonopoly Act (introduced in 1971)
Financial Instruments and Exchange Act (introduced in 2005)
Public Accountants Act (introduced in 2008)
Act against Unjustifiable Premiums and Misleading Representations (introduced in 2016)
Historically, surcharge systems have targeted economic crimes which directly aim at unjust monetary gains, which are regulated under the Antimonopoly Act and the Financial Instruments and Exchange Act. However, the scope of the surcharge systems is said to have expanded since the regulations of advertisement under the Act against Unjustifiable Premiums and Misleading Representations encompass a surcharge system.
3) Outline of surcharge system
The effective date of the surcharge system will be the day specified by Cabinet Order within a period not exceeding two years from the date of promulgation of the revised Pharmaceutical and Medical Devices Act. In the event of a false or exaggerated advertisement on pharmaceuticals, etc., the Minister of MHLW shall order the person subject to the surcharge to pay 4.5% of the total amount of sales of pharmaceuticals, etc. related to the surcharged act to the national treasury (provided, however, the Minister of MHLW may choose not to order surcharges when order for improvement of operations order for suspension of operations have been made, etc.).
The maximum period for surcharge calculation is three years. In addition, when there is an order to pay surcharges under the Act against Unjustifiable Premiums and Misleading Representations, 3% of total amount of compensation shall be reduced from surcharged amount.
Except in cases surcharge orders are anticipated, when the surcharged person reports to the MHLW of the acts that falls under the surcharge, 50% of surcharge shall be reduced from the surcharged amount.
