Is User Feedback Regulated Under Japanese Pharmaceutical and Medical Device Laws? A Guide to Related Legislation

Is it possible that a business owner is questioned for responsibility regarding posted reviews.

When considering purchasing a product, consumers can make better choices not only based on the information provided by the store, but also by referring to the raw impressions and opinions of consumers who have actually purchased the product. Reviews have such benefits for consumers, and there are various reviews available on the Internet.

In this article, we will explain how posting reviews can become problematic in relation to laws such as the Japanese Pharmaceuticals and Medical Devices Act, the Japanese Act against Unjustifiable Premiums and Misleading Representations, and the Japanese Health Promotion Act.

Are Reviews Subject to the Regulation of the Japanese Pharmaceuticals and Medical Devices Act?

Article 66 of the Japanese Pharmaceuticals and Medical Devices Act (PMD Act) prohibits all persons from advertising drugs, quasi-drugs, cosmetics, medical devices, or regenerative medicine products with false or exaggerated articles. Additionally, Article 68 prohibits all persons from advertising ① unapproved drugs, medical devices, or regenerative medicine products, and ② the names, manufacturing methods, efficacy, effects, or performance of unapproved medical devices or in vitro diagnostic drugs (the text of the PMD Act can be found here PMD Act.jn).

Therefore, the subjects of the PMD Act’s regulations are not limited to businesses. For example, if a general consumer posts a review on a health food sales page stating that they lost weight just by drinking it, implying that it has the efficacy and effects of a drug, and the business does not take action such as deletion, it could potentially become a legal issue.

Reference: Review Topics: Are Reviews Subject to Legal Measures? (JARO).jn

So, what exactly does “drug” refer to? The definition of “drug” is stipulated in Article 2 of the PMD Act, and whether or not an object falls under this definition is determined by:

• Whether the object has the purpose of being a drug
• Whether ordinary people recognize the object as having the purpose of being a drug

This is judged comprehensively, taking into account the raw materials, shape, and the purpose of use, efficacy, dosage, and sales method of the object, as well as the description at the time of sale.

For more specific criteria, the June 1, 1971 (Showa 46) Notice No. 476 of the Director of the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare “On the Guidance and Control of Unauthorized and Unapproved Drugs.jn” stipulates the following methods for determining “drugs”.

The scope of what is considered a drug is as follows:

(1) Regardless of the efficacy, shape, and dosage, if a component essence (raw material) that falls under Judgment Criterion 1 is blended or contained, it is generally considered a drug.

(2) In cases where a component essence (raw material) that does not fall under Judgment Criterion 1 is blended or contained, those that fall under any of the following ① to ③ are generally considered drugs.

① Those that claim medicinal effects

② Those that are exclusively in a medicinal shape, such as ampoules

③ Those whose dosage is medicinal

June 1, 1971 (Showa 46) Notice No. 476 of the Director of the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare “On the Guidance and Control of Unauthorized and Unapproved Drugs.jn”

Judgment Criterion 1 mentioned here refers to the standard for indicating components used as drugs. Therefore, products containing components listed in Judgment Criterion 1 are generally treated as drugs. On the other hand, even if a product does not actually contain the components listed in Judgment Criterion 1 (for example, health foods), if the content of the review claims “medicinal effects”, it may be considered a “drug” and may be subject to the PMD Act.

In this notice, the following are given as examples of “claims of medicinal efficacy and effects”, and if these expressions are included in the content of the review, it may become a problem.

(1) Efficacy and effects for the purpose of treating or preventing diseases

(Example) For people with diabetes, hypertension, arteriosclerosis, prevention of gastric and duodenal ulcers, improvement of liver and kidney disorders, improvement of cancer, for people with eye diseases, improvement of constipation, etc.

(2) Efficacy and effects mainly aimed at general enhancement and promotion of body tissue functions

However, expressions related to nutritional supplementation and health maintenance are not included in this category.

(Example) Fatigue recovery, strengthening (potency) toning, physical strength enhancement, appetite enhancement, anti-aging, enhancing learning ability, rejuvenation, rejuvenation, energizing, promoting metabolism, enhancing endocrine function, enhancing detoxification function, enhancing heart function, purifying blood, increasing natural healing ability against diseases, increasing digestion and absorption of the gastrointestinal tract, stomachic and intestinal regulation, during and after illness, promoting growth, etc.

June 1, 1971 (Showa 46) Notice No. 476 of the Director of the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare “On the Guidance and Control of Unauthorized and Unapproved Drugs” (partially extracted)).jn

For more details, please refer to the above notice and the September 22, 1987 (Showa 62) Pharmaceutical Administration No. 88 “On the Supervision and Guidance of Unauthorized and Unapproved Drugs”.jn. Also, please refer to the following article where we explain about the PMD Act.

Other Issues with Reviews

Posted reviews can sometimes cause problems not only with the Japanese Pharmaceuticals and Medical Devices Act, but also in relation to other laws and regulations. Let’s take a look at which laws and regulations are violated in what situations.

Issues under the Japanese Act against Unjustifiable Premiums and Misleading Representations

Article 5 of the Japanese Act against Unjustifiable Premiums and Misleading Representations prohibits unfair representations. The term “representation” here refers to advertisements and other displays made by a business operator about the content or trading conditions of the goods or services they provide, or other matters related to these transactions, as a means of attracting customers (Article 2, Paragraph 4). Therefore, reviews written by consumers who purchase or use products/services do not generally fall under the “representation” in the Act against Unjustifiable Premiums and Misleading Representations.

However, if a business operator providing goods or services posts review information on a review site themselves, or has a third party post it, as a means of attracting customers, and if the review information is mistaken by general consumers to be significantly superior or advantageous compared to the actual goods/services or those of other business operators, it constitutes a review that violates Article 5 of the Act against Unjustifiable Premiums and Misleading Representations.

The Issues and Points to Note Regarding Advertising Representations in Internet Consumer Transactions under the Act against Unjustifiable Premiums and Misleading Representations.jn (Consumer Affairs Agency) lists the following example as a case that poses a problem under the Act against Unjustifiable Premiums and Misleading Representations.

A business operator who runs a store providing goods or services requests a business operator who acts as a proxy for posting reviews to write a large number of reviews in the review information section of the site related to the goods or services they provide, thereby changing the evaluation on the review site itself. Despite the fact that there were not many favorable evaluations for the goods/services on the review site originally, they make it appear as if they are receiving favorable evaluations from a large number of general consumers regarding the quality and other content of the goods/services they provide.

Issues and Points to Note Regarding Advertising Representations in Internet Consumer Transactions under the Act against Unjustifiable Premiums and Misleading Representations.jn

Issues under the Japanese Health Promotion Act

The issue surrounding posted reviews under the Japanese Health Promotion Act is whether they fall under the false and exaggerated claims prohibited by Article 65, Paragraph 1 of the Act.

No person shall, when advertising or otherwise presenting information about a product for sale as food, make any representation that significantly deviates from the truth or that could significantly mislead people regarding the effects of health maintenance and promotion and other matters stipulated by a Cabinet Office Ordinance (referred to as “effects of health maintenance and promotion, etc.” in the following paragraph).

Article 65, Paragraph 1 of the Japanese Health Promotion Act

Here, we will explain the interpretation of the law, referring to the “Points to Note under the Act against Unjustifiable Premiums and Misleading Representations and the Health Promotion Act Regarding Health Foods.jn” (Consumer Affairs Agency) published by the Consumer Affairs Agency.

As for the scope of regulation, the phrase “no person” suggests that not only food manufacturers and sellers, but also newspaper companies, magazine companies, broadcasters, internet media companies, advertising agencies that mediate or broker advertisements for these media companies, service providers, etc., could potentially be subject to regulation. In particular, the business operator who made the representation is subject to regulation. This includes:

1. Business operators who have actively decided on the content of the representation themselves or in collaboration with others,
2. Business operators who have determined the content based on explanations about the content of the representation by others,
3. Business operators who have delegated the decision to other business operators.

This means, for example, that if an affiliate posts content that constitutes a false and exaggerated advertisement for a health food product sold by an advertiser, the advertiser may be held legally responsible, even if the advertiser was not specifically aware of the content of the representation.

Furthermore, whether something is “significantly” misleading is determined on a case-by-case basis for each advertisement. For example, the following could potentially be considered “exaggerated advertising representations”:

A business operator selling health foods commissions a business operator who posts reviews on behalf of others to post numerous reviews in the review information section of a site about the health foods they sell, thereby changing the overall rating on the review site. Despite the fact that there were not originally many favorable reviews for the health food product on the review site, they make it appear as if the product’s health maintenance and promotion effects, etc., have received favorable reviews from a majority of general consumers.

“Points to Note under the Act against Unjustifiable Premiums and Misleading Representations and the Health Promotion Act Regarding Health Foods” p.16

Normally, general consumers take into account a certain degree of exaggeration when judging the content of advertisements and selecting products. However, in the above example, general consumers cannot recognize it as an advertisement, and the impact of the representation on product selection is significant, which is why it is subject to regulation.

Issues under the Japanese Medical Care Act

The revision of the Japanese Medical Care Act in 2017 (Heisei 29) led to a review of advertising regulations related to medical services. This revision included websites of medical institutions as new subjects of regulation, considering the protection of patients. On the other hand, to address concerns about patients not being able to access information they want to know (such as about free medical examinations), the revision has lifted advertising restrictions under certain conditions.

In the following, we will look at the advertisements that are regulated, along with the contents of the revision, referring to the Japanese Medical Advertising Guidelines.jn.

Traditionally, an advertisement, as referred to here, was subject to regulation if it met all three of the following requirements:

1. Inducement (intention to induce patients to visit, etc.)
2. Specificity (the name of the doctor or hospital, etc. can be specified)
3. Cognizance (it is in a state that can be recognized by the general public)

Therefore, traditionally, due to the requirement of cognizance, TV commercials, billboards, and leaflet advertisements that the general public would see were subject to regulation. Websites, on the other hand, were not subject to regulation because they did not meet the requirement of cognizance, as patients actively search for and view the information themselves.

However, after the revision, websites also became subject to regulation as the requirement of cognizance was deemed unnecessary.

To prevent hindering patients’ appropriate choices, false, comparative superiority, exaggerated, and public order and morality violating advertisements are prohibited (Article 6-5, Paragraphs 1 and 2 of the Japanese Medical Practitioners Act). The matters that can be advertised are, unless otherwise specified, only those listed in Article 6-5, Paragraph 3 of the Japanese Medical Practitioners Act, such as the name of the hospital’s department, location, information about medical practitioners, and days and hours of medical treatment.

Items that are not usually considered medical advertisements include academic papers and presentations, articles in newspapers and magazines, testimonials and memoirs posted by patients themselves, notices and pamphlets distributed within the hospital, and advertisements for staff recruitment at medical institutions. These are generally not considered advertisements because they do not meet the requirement of ‘inducement’.

However, not all items that fall under these categories are exempt from being considered advertisements. For example, if it is recognized that the purpose is to increase patient visits to a specific medical institution by sending direct mail to an unspecified number of people under the guise of an academic paper, it is judged to have an inducement, and may be treated as an ‘advertisement’.

Responsibility and Countermeasures of Review Site Administrators

So, what responsibility does the administrator of a review site bear when illegal reviews are posted?

Normally, the administrator of a review site does not bear civil or criminal responsibility if they are aware of the existence of illegal information but take no action and simply leave it as is. However, if the site administrator not only ignores the existence of illegal information but also has an “active involvement” in the circulation of illegal information, they may be held responsible.

However, it is desirable for the administrator to take voluntary action after judging the illegality when they receive information from general users and others that illegal information is posted on the site, or when they discover information that they think is illegal. The “Guidelines for Responding to Illegal Information on the Internet.jn” (Japanese Telecommunications Business Association, etc.) lists specific measures (hereinafter referred to as “transmission prevention measures”) that site administrators can take against illegal information, such as:

1. Requesting the person who transmitted the illegal information to stop doing so
2. If the transmitter does not take the requested action even after repeated requests, the provider should make the illegal information un-receivable by the public (however, if there are reasonable grounds to judge that it is clearly illegal or harmful and urgent, the provider should make the illegal information un-receivable by the public without making the request in 1.)
3. If the transmitter repeatedly transmits illegal information, stop the transmitter’s use or terminate the usage contract with the transmitter

These are some of the measures listed.

Furthermore, the administrator of a review site may also receive a request for transmission prevention measures from the Japanese Ministry of Health, Labour and Welfare’s Pharmaceutical and Food Safety Bureau’s Surveillance and Guidance/Narcotics Control Department and prefectural pharmaceutical affairs departments. This is a request to the administrator by the above-mentioned agencies, and normally, no legal obligation arises for the administrator to take transmission prevention measures as a result of this. However, it is desirable for the provider who received the request to comply with it and take transmission prevention measures.

For more details, please see the “Guidelines for Responding to Illegal Information on the Internet.jn” and Pharmaceutical and Food Safety Bureau Narcotics Control Department Notice 0301 No. 1, March 1, 2010 (Heisei 22).jn.

Conclusion: Consult a Lawyer for Checking Compliance with the Japanese Pharmaceuticals and Medical Devices Act

In this article, we have discussed potential issues related to the Japanese Pharmaceuticals and Medical Devices Act and other related laws in posted reviews.

Deciding whether the content of a posted review is illegal involves not only the Japanese Pharmaceuticals and Medical Devices Act, but also the Japanese Act against Unjustifiable Premiums and Misleading Representations, the Japanese Health Promotion Act, and the Japanese Medical Practitioners Act. Therefore, due to the complexity of assessing the legality of review content in relation to multiple laws, we recommend consulting a lawyer.

Legal checks and suggestions for rewording in accordance with the Japanese Pharmaceuticals and Medical Devices Act and other laws are highly specialized areas. Monolith Law Firm has formed a team specializing in the Japanese Pharmaceuticals and Medical Devices Act, and we handle article checks for a wide range of products, from supplements to pharmaceuticals.

Measures Provided by Our Firm

Monolith Law Office is a legal office with extensive experience in both IT, particularly the internet, and law. We provide services such as legal checks of articles and landing pages, creation of guidelines, and sampling checks for various entities including media operators, review site operators, advertising agencies, direct-to-consumer (D2C) businesses such as supplement manufacturers, cosmetic manufacturers, clinics, and Application Service Provider (ASP) businesses.