The advertising of medicines in Japan is regulated by both Japanese laws and regulations as well as self-regulatory codes created by trade associations in the pharmaceutical industry. The main law that regulates pharmaceutical advertising is the Pharmaceuticals and Medical Devices Act (Act No 145 of 10 August 1960, as amended) (the “PMD Act”). The major self-regulatory codes include the codes created by the Japan Pharmaceutical Manufacturers Association (JPMA) and those created by the Japan Self-Medication Industry (JSMI).

Laws and Regulations

In Japan, the Act against Unjustifiable Premiums and Misleading Representations (Act No 47 of 19 May 1997, as amended) (UPMRA) provides some general rules concerning advertising. However, in the case of pharmaceutical advertising, the PMD Act, which is the main law that regulates drugs, has several special articles that regulate pharmaceutical advertisements. 

PMD Act

Articles 66, 67 and 68 of the PMD Act provide for the following.

The prohibition of advertisements for unauthorised drugs

The PMD Act states that no person shall advertise the name, manufacturing process, indications or performance of a drug before obtaining the necessary marketing authorisation from the Japanese government.

The prohibition of false or exaggerated advertisements

The PMD Act states that no person shall, explicitly or implicitly, advertise, describe or disseminate the name, manufacturing process, indications or performance of a drug using false or exaggerated statements.

The prohibition of advertisements endorsed by a doctor

The PMD Act states that the advertisement, description or dissemination of statements giving the false impression of an endorsement by a medical doctor or other medical professional of the efficacy or performance of a drug shall be prohibited.

The prohibition of obscene statements or diagrams

The PMD Act states that no person shall use obscene statements or diagrams or those suggesting illegal abortions in connection with the advertisement of drugs.

The regulation of advertisements for drugs for designated diseases

The PMD Act states that no person shall advertise to the general public drugs intended for use in the cure of cancer, sarcoma or leukaemia, and that are likely to be highly dangerous if used without the direction of medical doctors or dentists.

Administrative fines

The PMD Act was amended on 17 November 2019 to introduce administrative fines for violations of the regulations on false or exaggerated advertising as well as cease and desist orders against pharmaceutical companies to correct improper advertising, among other revisions. These amendments came into effect on 1 August 2021. 

The MHLW Regulations

The Ministry of Health, Labour and Welfare (MHLW) is the competent governmental authority with regard to medicines in Japan and has promulgated the PMD Act Enforcement Ordinance, the PMD Act Enforcement Regulations and various other notices for the enforcement of the PMD Act. One example is the “Standards for Appropriate Advertising concerning Medical Goods” (Notification No 0929-4 of the Pharmaceutical Safety and Environmental Health Bureau of 29 September 2017) (the “MHLW Standards”), which were issued by the MHLW in the form of an official notice and which have as their central function the regulation of pharmaceutical advertising.

The MHLW Standards

The MHLW Standards prescribe the standards of conduct that must be adhered to by any person or entity when advertising drugs. The MHLW Standards consist of two parts: the first part relates to the interpretation of “False or Exaggerated Advertisements” under Article 66 (1) of the PMD Act, and the second part sets forth rules to prevent misuse, drug abuse and the deterioration of drug reliability.

Specifically, the first part of the MHLW Standards sets forth specific rules regarding:

• expressions related to product name;
• expressions related to manufacturing process; and
• expressions related to indication, dosage, administration and safety.

The second part of the MHLW Standards prescribes rules or restrictions regarding:

• the inducement of excessive use or abuse of drugs;
• advertising prescription-only medicines;
• expressions related to drug performance in advertising to the general public;
• drug addictiveness warnings;
• precautions;
• slander of other companies’ products;
• endorsements by healthcare professionals;
• premium advertising;
• offensive advertising;
• email advertising;
• statements on television or radio programmes; and
• the use of drugs as cosmetics or food.

The Detailing Guidelines

In order to prevent the dissemination of inappropriate information during the course of promotion activities, the MHLW issued its new “Guidelines Concerning Detailing Activities of Ethical Drugs” (the “Detailing Guidelines”) on 25 September 2018. The Detailing Guidelines took full effect on 1 October 2019 and include:

• basic principles for detailing activities;
• responsibilities of company management, including organisational measures (such as establishing independent supervisory divisions for monitoring activities), employee training and record-keeping;
• responsibilities of individuals who conduct detailing activities; and
• guidelines on offering information on unauthorised drugs and off-label uses.

Self-Regulatory Codes

With regard to prescription-only medicines, a trade association of leading Japanese pharmaceutical research companies issues the major self-regulatory codes. In particular, the JPMA Code is the main regulatory code that regulates pharmaceutical advertisements. The JPMA Code has two chapters. The first chapter is the Code of Practice (the “JPMA Code of Practice”) and the second chapter is the Promotion Code (the “JPMA Promotion Code”). The JPMA Code establishes the rules that all member companies must comply with when promoting prescription-only medicines.

The JPMA has also issued several additional guidelines relating to pharmaceutical promotion. Among these are the Guidelines for the Drafting of Prescription Pharmaceutical Products Informational Material (the “JPMA Drafting Guidelines”), see 5 Advertising to Healthcare Professionals.

With regard to advertising over-the-counter (OTC) medicines, the JSMI, a trade association of Japanese over-the-counter manufacturers, issued the Guidelines for Proper Advertising of Over-the-Counter Medicines (the “OTC Guidelines”). The OTC Guidelines apply to the advertising of non-prescription drugs to the general public. In particular, the OTC Guidelines regulate advertising through newspapers, magazines, television, radio, websites and other forms of mainstream media to ensure the appropriateness of publicity and advertising activities of non-prescription drugs.

Self-regulatory codes apply to the member companies of the particular trade association that created the code. For example, the codes created by the JPMA apply only to pharmaceutical companies that are JPMA member companies.

Conduct that violates self-regulatory codes does not necessarily violate Japanese laws and regulations; such conduct is only illegal if it independently violates Japanese laws and regulations. However, a violator may face sanctions under the self-regulatory codes, potentially damaging its reputation.

Notice No 148 dated 29 September 1998, issued by the Pharmaceutical Safety Bureau of the MHLW, defines “advertising” for the purposes of the PMD Act. This notice states that “advertising” has all of the following three characteristics:

• it has a clear intention to induce customers to make purchases;
• the product names of particular medicines are clearly expressed; and
• it can be seen by the general public.

Advertising and other information are distinguished by the definition of “advertising” given in 2.1 Definition of Advertising. First, advertising must be clearly intended to induce customers to make purchases. For example, it is not likely that a book in a medical library describing certain drugs and targeted at researchers would have such an intention. The second requirement – the clear expression of product names – may be met even in cases where particular product names are not mentioned; this would be the case if the general public could recognise particular medicines from the pictures or descriptions of those medicines in the advertisement. Finally, the third requirement – the ability to be seen by the general public – would not be likely to be satisfied if the relevant information is, for instance, only provided to patients in a hospital, since the narrow scope of its distribution would limit the potential for the information to reach the general public.

Disease-awareness campaigns and other patient-facing information do not qualify as “advertising” under the PMD Act unless they satisfy all three parts of the definition of advertising set out above. For example, if a disease-awareness campaign informs the public in a general way about a certain disease and does not name specific medicines, it is not considered “advertising” under the PMD Act. However, a disease-awareness campaign that provides patient-facing information concerning prescription-only medicines to the general public would run a risk of being “advertising” under the PMD Act. In this regard, the JPMA Code of Practice suggests that the content of disease awareness activities targeting ordinary citizens and patients be closely examined from the planning stages to ensure that they will not be considered prohibited advertising.

Press releases regarding medicines are not prohibited. However, if a press release satisfies the three parts of the definition of advertising mentioned in 2.1 Definition of Advertising, both the regulations concerning advertising under the PMD Act and the MHLW Standards will apply.

Generally, the restrictions under the PMD Act are more stringent when the target audience is the general public than when the target audience is healthcare professionals. For example, advertisements for pharmaceutical products used for cancer, sarcoma or leukaemia aimed at the general public are prohibited under Article 67 of the PMD Act.

Comparative advertising of medicines is not prohibited but is restricted by Japanese law and self-regulatory codes. According to the Commentary to Article 9 of the MHLW Standards, a pharmaceutical company’s comparative advertising must only feature its own products and the advertising must specify the name of those products. Comparisons with competitors’ products are prohibited. In addition, when a pharmaceutical company compares two of its own products, the company must ensure that it provides a sufficient explanation of the products.

Further, the JPMA Promotion Code stipulates that comparative advertising “shall be based on scientific data and, in principle, shall be made using generic names”.

Finally, the Consumer Affairs Agency has issued general guidelines for comparative advertising. These guidelines suggest that a comparative advertisement shall be considered a “Misleading Representation” prohibited under the UPMRA if:

• it makes comparisons using unproven or unprovable facts;
• it emphasises unimportant matters as if they were important or makes comparisons based on an unfair selection of products; or
• it merely slanders or defames competitors’ products.

Article 68 of the PMD Act expressly prohibits advertising unauthorised medicines or unauthorised indications. However, providing information on unauthorised medicines or unauthorised indications that falls outside the definition of “advertising” under the PMD Act is allowed. 

Guidelines for Providing Information

The Detailing Guidelines allow providing information on unauthorised medicines and unauthorised indications only when (i) requested by healthcare professionals, patients, patient organisations, and/or the general public and (ii) the following conditions are met:

• separating information on unauthorised medicines and unauthorised indications from other promotion activities;
• providing such information only to individuals who have actually requested it;
• providing only accurate information that is based on scientific and objective evidence, without omissions, emphases, exaggerations or misleading summaries;
• providing information relating to a clinical trial involving a pharmaceutical company only if the research adheres to Good Clinical Practice, the Clinical Research Act or other equivalent rules;
• providing negative information such as information relating to adverse effects;
• clearly indicating that such indication, dosage or method of administration has not been approved; and
• preparing and maintaining records detailing information that has been provided on unauthorised medicines and unauthorised indications.

Cases Permitting Additional Information

The JPMA Promotion Code requires that member companies may only provide certain information, such as indication, dosage and administration, which may not deviate from the approved label for the relevant drug. However, the Commentary to the JPMA Promotion Code lists several cases in which the provision of other information is permitted if the information is provided for the purpose of promoting the right to know about scientific/medical advancements for both medical/pharmaceutical experts and the general public. These cases include:

• presenting research findings at scientific conferences or scientific journals;
• displaying exhibition materials at an international scientific conference (limited to unapproved drugs that have been approved in at least one country);
• supplying previously reviewed academic literature; and
• disclosing information to stockholders as required by law.

Moreover, the Commentary notes that, even if the activity consists of providing information as permitted above, the company must take special care not to be involved in any inappropriate promotional activities for its own commercial purposes.

The Commentary to the JPMA Promotion Code lists two cases in which providing information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals is allowed.

The first case is the presentation of clinical research results during a scientific conference. However, seminars sponsored by pharmaceutical companies are not covered by this exception.

The second case is the display, by a pharmaceutical company, of educational samples of an unapproved medicine at an exhibition during an international scientific conference held inside or outside Japan to the extent that Japanese medical professionals are in attendance. This only applies, however, when the unapproved medicine has been approved in at least one other country. If no countries have approved the product, the company may not display a sample of the product. In addition, the pharmaceutical company may not distribute samples of unapproved medicines and related scientific materials to anyone during the conference.

As mentioned in 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications, the Detailing Guidelines provide certain conditions for providing information on unauthorised medicines or unauthorised indications and such conditions will also apply to the provision of information during a scientific conference.

The Commentary to the JPMA Promotion Code allows the supply, by a pharmaceutical company, of peer-reviewed scientific journal articles, such as reprints of medical journals, upon the request of a medical doctor. However, companies shall not proactively induce a medical doctor to request such scientific journal articles.

As mentioned in 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications, the Detailing Guidelines provide certain conditions for providing information on unauthorised medicines or unauthorised indications.

There are no Japanese laws or self-regulatory codes that expressly regulate the sending of information on unauthorised medicines or indications to healthcare institutions to enable them to prepare budgets. Given that there are no laws or self-regulatory codes that permit such transmission of information, there remains a risk that such conduct would be considered a “promotional activity on unauthorised medicines or unauthorised indications”, which is prohibited under Article 68 of the PMD Act.

Japan’s compassionate use programme is intended to promote the expansion of clinical trials for patients who are interested in using unapproved products but are unable to join a clinical trial because they do not meet the inclusion criteria. This expanded trial system applies to investigational products that have gone through or are currently going through a clinical trial that is in the final stage of development; generally, clinical trials conducted to verify efficacy and safety after indications, dosage and administration have been established through a separate series of studies (“Main Trials”). 

In order to provide such patients with information on the ongoing Main Trials or expanded trials, the PMDA will publish on its website certain information, such as a description of the investigational product (investigational ingredient code), contact information for the trial sponsor, subject disease, and scheduled period of the trial. Provision of such information by pharmaceutical companies is allowed “reactively” (ie, only upon actual request from healthcare professionals, patients, etc) and under strict compliance with all requirements stipulated in the Detailing Guidelines as explained in 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications. Accordingly, publication of such information by pharmaceutical companies is not permitted.

Advertising Prescription-Only Medicines

Advertising prescription-only medicines to the general public is prohibited in Japan. Article 5 (1) of the MHLW Standards expressly prohibits such advertising. In addition, Article 67 (1) of the PMD Act prohibits advertising drugs for specified diseases and regenerative medicines to the general public.

Advertising Over-the-Counter Medicines

Advertising OTC medicines to the general public is not prohibited but is restricted by the PMD Act and the MHLW Standards, as well as by self-regulatory codes.

Advertising for OTC medicines is subject to the rules concerning advertising under the PMD Act and the MHLW Standards, which are described in 1 Pharmaceutical Advertising: Regulatory Framework. In this regard, it should be noted that Article 6 of the MHLW Standards stipulates a particular restriction on advertisements to the general public concerning the efficacy of drugs for diseases that cannot be expected to be cured without a doctor’s or dentist’s diagnosis or treatment. This Article provides that any such advertisements targeted to the general public must not suggest that the diseases can be cured without such a diagnosis or treatment.

In addition, the OTC Guidelines regulate advertising through newspapers, magazines, television, radio, websites and other forms of mainstream media to ensure the appropriateness of the publicity and advertising activities for non-prescription drugs.

There is no law or regulation that provides exactly what information must be included in pharmaceutical advertising aimed at the general public. However, under the PMD Act and the MHLW Standards, if advertising contains information as to the names of the products, their manufacturing process or their indication, dosage, administration or safety, the advertising must follow the following rules:

• companies shall use only authorised brand names, generic names or, for products that do not require marketing authorisation, names listed on the Japanese Pharmacopeia;
• companies shall describe the manufacturing process accurately and not in a way that could lead the general public to mistakenly believe in the superiority of the product;
• Article 3 (1) and (4) of the MHLW Standards prohibit companies from using expressions that are beyond the scope of or deviate from the authorised indication, dosage, administration or safety of the products (ie, “off-label promotion”);
• for products that do not require marketing authorisation, Article 3 (2) and (4) of the MHLW Standards provides that companies shall not use expressions beyond the scope of the product’s efficacy, dosage, administration or safety as generally recognised in the field of medicine or pharmacy; and
• the MHLW Standards include several other relevant rules, including prohibitions on certain claims relating to the efficacy or safety of products and prohibitions on slander and/or defamation of competitors’ products.

Beyond the question of what information to include, the OTC Guidelines identify specific statements that are required or prohibited in advertisements for each category of OTC medicines. For instance, advertisements for cold medicines must use the phrase “relief of cold symptoms” but cannot include the statement “this will not make a patient sleepy”. Also, advertisements for cold medicines on television or through streaming a video on the internet must display the statement “this product shall be used only after receiving an explanation from a pharmacist and after carefully reading the warning label” for one second or more with clear and distinct characters.

The price of the medicine can be mentioned in advertising aimed at the general public, although doing so is not required by laws or self-regulatory codes.

There are no laws or regulations that expressly impose restrictions on interactions between patients or patient organisations and industry.

The JPMA Code of Practice sets forth the rules concerning collaboration with patient groups. First, when a pharmaceutical company has any relationships or collaboration with patient institutions, the company must respect the independence of the institutions and the company’s activities must meet a high ethical standard. Further, the company must make an effort to promote sufficient mutual understanding with patient groups regarding the purpose and scope of the collaboration.

Secondly, a disclosure of the sponsorship is required. Further, the purpose and scope of the sponsorship shall be agreed upon between both parties and shall be made in writing and recorded in order to ensure transparency. Finally, the member companies that are collaborating with patient organisations shall establish internal company guidelines based on the “Guideline on Collaboration with Patient Organisations” issued by the JPMA.

There is no national law or regulation that explicitly provides which information must be included in pharmaceutical advertising directed at healthcare professionals.

However, if such advertising contains information relating to the names of the products, the manufacturing process, indication, dosage, administration or safety of or in relation to the drugs, as well as other relevant items, the advertising would be subject to the MHLW Standards, as described in 4.2 Information Contained in Pharmaceutical Advertising to the General Public.

As for self-regulatory codes, the JPMA Drafting Guidelines provide that advertising directed at healthcare professionals must contain the following information in principle:

• name of the product (both brand name and generic name);
• therapeutic category;
• regulatory classification;
• indications;
• dosage/administration;
• warnings/contraindications/precautions;
• presence on the National Health Insurance (NHI) reimbursement price list;
• name of marketing authorisation holder (contact and address for more product information);
• limitation of administration period;
• conditions for approval; and
• creation date of the advertisement.

Even if an advertisement is intended to promote only the name of a product, statements made in the advertisement shall contain at least the name of the product (both brand name and generic name), therapeutic category, regulatory classification, presence on the NHI reimbursement price list, and the name of the marketing authorisation holder (contact and address for more product information).

Specific Prohibited Statements

Beyond the question of which information to include, the JPMA Promotion Code identifies specific statements that may or may not be used in advertisements to healthcare professionals. For example, it prohibits stating that “there are few adverse reactions” without also citing the conditions of use or without providing a summary of relevant data, including the relevant adverse reactions, to back up such a safety claim. The JPMA Promotion Code also attempts to promote the quality and clarity of the information being presented. For example, the advertising materials must not only emphasise the efficacy of the product but must also include product safety information, including adverse reactions, in order to create a fair and balanced statement of the advertising. Further, the contact and address for seeking more information on the product must be described clearly.

Price

The advertising must mention whether or not the medicine is registered on the NHI reimbursement price list, rather than the price itself.

Reference in pharmaceutical advertisement to data on file or generated from other clinical studies not included in the Summary of Product Characteristics is not prohibited. However, references to data on file or generated from clinical studies are limited in certain ways by law and by self-regulatory codes.

First, the general rules on advertising (such as the prohibition of false or exaggerated advertisements and advertising that recommends unapproved drugs or off-label uses) under the PMD Act will apply.

Secondly, references to data on file or generated from other clinical studies shall be subject to the specific regulations provided by the JPMA Drafting Guidelines. For example, statements shall only concern indications approved in Japan. In addition, the study must be published in a peer-reviewed journal.

In Japan, combination products are treated as one product (ie, pharmaceutical, medical device or regenerative medicine product) and will have one Summary of Product Characteristics.

No specific rules exist for the advertising of companion diagnostic medicines. As companion diagnostic medicines are included as medicines under the PMD Act, the advertising regulations that apply to medicines also apply to companion diagnostic medicines. The fact that a diagnostic is a companion diagnostic for a certain drug must be included in the Summary of Product Characteristics.

Reprints of journal articles for healthcare professionals are subject to the conditions set forth in both laws and regulations and self-regulatory codes. Major restrictions on reprints are as follows.

• The reprint must be authorised by the author(s) under copyright law.
• The contents of the journal article shall not violate the PMD Act. In particular, the contents of the journal article shall not be false or exaggerated advertising, advertising that recommends unapproved drugs or off-label uses or advertising that slanders and/or defames competitors’ products.
• In principle, the reprint must be related to the company’s own product and supplied in response to a request from a healthcare professional. In other words, a pharmaceutical company must refrain from actively inducing a healthcare professional to request such a reprint.

There is no national law or regulation that specifically refers to or governs the activities of Medical Science Liaisons (MSLs) or Medical Affairs (MA) activities in Japan. However, in keeping with global practice, the number of pharmaceutical companies establishing MA sections and MSLs in Japan has been on the rise recently. Against this background, the JPMA issued a “Consensus Statement on Medical Affairs Activities” and “Consensus Statement on Medical Science Liaison Activities” (“JPMA MSL Statement”) on 1 April 2019. In the JPMA MSL Statement, an MSL is defined as “a person who belongs to a division independent from the company’s commercial divisions and whose main role is to interact with external experts in the field of medicine or science”. 

The JPMA MSL Statement also provides that MSL activities should not be aimed at promoting sales of the company’s drugs. As the definition shows, an MSL’s main role is to interact with external experts. However, this does not mean that MSLs are prevented from responding reactively to requests from other healthcare professionals, including requests for information on unauthorised medicines or indications. When MSLs provide any such information on unauthorised medicines or indications at the request of healthcare professionals, they must comply with the requirements under the Detailing Guidelines as explained in 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications. 

In Japan, advertisements for medicines do not require prior authorisation from, nor notification to, any regulator. Management should establish a monitoring department within the company, independent of the department in charge of sales information provision activities, in order to ensure that these activities, including the MSL’s activities, are being properly carried out. 

The Detailing Guidelines require that companies establish internal systems to ensure appropriate conduct with respect to promotion activities. This includes establishing a “promotion supervisory department” responsible for monitoring promotional materials and promotion activities, which must be separate from the company’s sales and marketing division. Companies are also required to set up a “review and supervisory committee”, which must include members who are independent of the company, to provide independent advice to the promotion supervisory department. In addition, the Detailing Guidelines require, among others:

• the preparation of standard operating procedures for promotional activities;
• the preparation and maintenance of business records (including records of any verbal explanations made during detailing activities); 
• the prior review and approval of marketing materials by the promotion supervisory department based upon advice from the review and supervisory committee;
• periodic training for both employees and officers; and
• the establishment of a telephone tip-line to field complaints about promotional activities.

The JPMA Promotion Code also requires that JPMA member companies:

• establish internal systems to comply with relevant laws, regulations and industry self-regulations;
• appoint a promotional material officer; and
• establish an in-house oversight system so that only reviewed promotional materials and advertisements are used. 

Generally, the same laws, regulations and self-regulatory codes concerning pharmaceutical advertising will also apply to advertising on the internet for medical products. In addition, the Commentary to the JPMA Promotion Code provides specific rules concerning access restrictions on internet-accessible information related to prescription-only medicines.

As advertising prescription-only medicines to the general public is prohibited, when a pharmaceutical company provides healthcare professionals with product-related information concerning prescription-only medicines through the internet, the company must restrict access to the relevant websites so that only healthcare professionals have access to such information.

The question, therefore, is: what is considered a sufficient access restriction? In this regard, the Commentary provides that if all the conditions set out below are satisfied, then an access restriction will be considered sufficient:

• the name of the pharmaceutical company is provided, the website states that the information is targeted at healthcare professionals and the person intending to access the information understands that the information is targeted at healthcare professionals;
• the information is appropriate for healthcare professionals; and
• if a company website targeting healthcare professionals links to an external website, the contents of the external website and the external website itself are appropriate for healthcare professionals and the owner or author of the external website can be clearly verified.

As long as a pharmaceutical company uses a sufficient access restriction, it is not required to use any particular method of establishing passwords.

As mentioned in 7.1 The Advertisement of Medical Products on the Internet, pharmaceutical companies must include access restrictions on websites containing advertising or other information intended for healthcare professionals, since advertising prescription-only medicines to the general public is prohibited.

Generally speaking, the provision of disease awareness information and/or materials to patients online is subject to the same laws, regulations and self-regulatory codes as apply to those activities offline. As mentioned in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information, the JPMA Code of Practice suggests that the content of disease awareness activities targeting ordinary citizens and patients be closely inspected from the planning stages so that they will not be considered prohibited advertising.

There are no specific laws, regulations or self-regulatory codes in Japan that address online scientific meetings. As a result, online scientific meetings would be subject to the same laws, regulations and self-regulatory codes that apply to in-person scientific meetings. 

Generally, the same laws, regulations and self-regulatory codes concerning pharmaceutical advertising will also apply to pharmaceutical advertising on social media. The JPMA Code of Practice, in particular, describes several issues to which pharmaceutical companies must pay close attention when advertising through social media.

The JPMA Code of Practice defines “social media” as media formed by interactive communication mainly through the internet, where the users, including individuals, send various information. The main feature of social media is that an individual can easily and promptly send information to the general public. Due to this characteristic of the medium, inappropriate information, including false information, may be broadly transmitted to the general public without any confirmation of the accuracy of the information. Therefore, the JPMA Code of Practice requires member companies to take all responsibility for such social media content and, before advertising on social media, the companies must confirm that all relevant subsidiaries, parent companies, affiliates, planning companies, agencies, employees, etc, comply with the JPMA Code.

Further, the JPMA Code of Practice requires that member companies pay special attention to the following:

• The PMD Act and the MHLW Standards are to be complied with.
• When a member company plans or supports social media activities, that company shall take responsibility for verifying the appropriateness of published content including content posted by third parties and shall take appropriate steps (including take-downs) in the event that inappropriate information is posted, such as information relating to unapproved use, slander and/or defamation of other companies’ products or information regarding adverse events.
• Only information that has passed careful scrutiny by the appropriate department within the company shall be released.
• When a company is acting as a sponsor, it shall clearly indicate its company name.

Anti-bribery rules generally applicable to pharmaceutical companies and healthcare professionals or organisations are provided in the Penal Code (Act No 45 of 24 April 1907, as amended). In addition, pharmaceutical companies are expected to comply with the National Public Service Ethics Code (the “Ethics Code”). Further, the Unfair Competition Prevention Act (Act No 47 of 19 May 1993, as amended) (UCPA) provides rules regarding bribery to foreign officials. These regulations apply only to benefits provided to recipients who are individuals (eg, public officers).

Penal Code

Article 198 of the Penal Code is the basic anti-bribery regulation that directly applies to officers or employees of pharmaceutical companies. Article 198 provides that any person who gives, offers or promises to give a bribe to a public official shall be punished by imprisonment with labour for not more than three years or a fine of not more than JPY2.5 million.

Bribery under the Penal Code is broadly defined. It covers not only money or goods but also any benefit (material or immaterial) sufficient to satisfy a person’s desires. “Public Official” is also broadly defined. The term includes not only national or local government officials but also individuals deemed government officials under special laws.

National Public Service Ethics Code

The Ethics Code is a code established by the Cabinet based on the National Public Service Act for the purpose of maintaining the integrity of, and citizens’ trust in, public service. The Ethics Code prohibits national public officials from receiving money or goods from interested parties. In some situations, pharmaceutical companies can be considered such “interested parties”. The Ethics Code provides for some exemptions, including, among others:

• accepting gifts that are distributed widely to the public as promotional goods or as souvenirs; and
• accepting souvenirs at a large dinner party. 

Pharmaceutical companies are expected not to participate in conduct that violates the Ethics Code in order to prevent illegal acts by national public officers.

Unfair Competition Prevention Act

Article 18 (1) of the UCPA prohibits any person from giving, offering or promising to give any benefit to a foreign public official to have that foreign public official act or refrain from acting in relation to the performance of their official duties, in order to make any illicit gains in business with regard to an international commercial transaction. Pursuant to the 2023 amendment of the UCPA that will take effect on 1 April 2024, the penalties for this violation will be raised substantially. From 1 April 2024, an employee of a pharmaceutical company who violates Article 18 would face imprisonment with labour for up to ten years and/or a fine of up to JPY30 million. Pursuant to the amendment, this will also apply to foreign employees of Japanese entities who conduct such an illicit act outside Japan. Further, the pharmaceutical company itself may also be subject to a fine of up to JPY1 billion.

The UPMRA and the Fair Competition Code concerning Restriction on Premium Offers in the Ethical Pharmaceutical Drugs Marketing Industry (the “Fair Competition Code”) regulate offering benefits or other inducements to prescribe to healthcare professionals or organisations. The JPMA Promotion Code contains similar rules. These regulations apply to benefits provided both to individuals and organisations.

UPMRA

Article 4 of the UPMRA allows the Prime Minister to restrict the offering of premiums in various ways, including through a prohibition. Under Article 6 (2) of the UPMRA, the Cabinet issued a public notice entitled: “Restrictions on the Offering of Premiums in the Ethical Pharmaceutical Drugs, Medical Devices and Sanitation Inspection Industries”. The notice prohibits pharmaceutical companies from offering articles, services or other premiums to healthcare institutions as a means of inducing unjust transactions beyond what is commercially reasonable for the usage or sanitary inspection of ethical pharmaceutical drugs.

Fair Competition Code

“Fair competition codes” are self-regulatory codes set up by the business associations of specific industries based on the UPMRA restrictions on the provision of premiums. Generally, fair competition codes will include UPMRA rules as well as supplemental rules not provided under the UPMRA depending on the nature of the products and transactions in the relevant industry. The pharmaceutical industry established the Fair Competition Code, which pharmaceutical companies are currently complying with.

The Fair Competition Code provides that pharmaceutical companies shall not offer premiums to healthcare professionals or institutions as a means of unjustifiably inducing drug transactions. If, however, based on standard commercial practices the offers of economic benefits are considered to be discounts, after-sale services or benefits in connection with the drugs, they are no longer categorised as offers of premiums. In addition, even if money, goods or economic benefits are considered premiums, there are some cases in which offering premiums is permitted (several examples are listed). In addition, if premiums are “small sum offerings”, offering them will not violate the Fair Competition Code.

The JPMA Promotion Code

The JPMA Promotion Code has several provisions regarding offering benefits to healthcare professionals or institutions. It regulates, among other issues:

• the total amount of sample drugs that can be supplied;
• food, drinks, and gifts that can accompany lectures;
• gift-giving; and
• provisions of cash or its equivalent that may negatively affect the proper use of drugs.

The Fair Competition Code and the JPMA Promotion Code regulate the offering of gifts to healthcare professionals.

The Fair Competition Code lists several examples of permitted gift-giving activities, including:

• offers of articles or services that are necessary for the use of or for enhancing the benefits of ethical pharmaceutical drugs;
• offers of medical or pharmaceutical information on ethical pharmaceutical drugs; and
• offers of articles or services not considered extravagant or excessive in relation to seminars, or the payment of expenses for individuals to attend such seminars, which are organised for medical or other similar institutions in order to promote the understanding of certain ethical pharmaceutical drugs.

The JPMA Promotion Code prohibits member companies from offering healthcare professionals and medical institutions, among other entities, any goods that could potentially negatively affect the appropriate use of drugs or damage drug credibility.

The Fair Competition Code and the JPMA Promotion Code impose limitations on providing samples to healthcare professionals.

The Enforcement Rules and the Operating Standards of the Fair Competition Code provide the basic rules for offering samples of drugs. In the case of product samples for reference the following rules apply:

• The number of units of the drug contained in one package must not exceed the maximum number allowed.
• The number of packages provided shall be the minimum necessary for the purpose of providing samples.
• If the drug is provided through a wholesaler, the destination medical institutions must be designated by the pharmaceutical company.
• Pharmaceutical companies must supply the relevant drug information to the recipient healthcare professionals.

Similar rules apply to the provision of clinical drug samples.

The JPMA Promotion Code states that member companies must provide only the minimum amount of samples and must also provide the relevant drug information.

Pharmaceutical companies are allowed to sponsor scientific meetings or congresses and/or attendance by healthcare professionals at these events, but only in a limited capacity and in strict compliance with the Fair Competition Code and the JPMA Promotion Code.

With regard to a seminar for healthcare professionals concerning a pharmaceutical company’s own drugs, the company can provide non-extravagant articles or services and can bear some related expenses. For example, companies may provide tea and snacks or lunch boxes, hold small social gatherings, cover transportation and accommodation expenses and compensate the lecturer. The seminar should be held in an appropriate place in light of its purposes; for this reason, it would be sensible to avoid a resort, a place for sightseeing or a location overseas (the JPMA Promotion Code expressly provides that pharmaceutical companies shall, in principle, hold such seminars in Japan). Even if such seminars are permitted to take place abroad, the payment of travel expenses must be limited to the travel expenses of healthcare professionals who will provide information on the company’s drugs to all participants.

The rules under the Fair Competition Code set forth the types of entertainment/hospitality that pharmaceutical companies may or may not provide to healthcare professionals. By way of example, providing entertainment such as karaoke or golf is prohibited.

Pharmaceutical companies may provide grants or donations to healthcare professionals or healthcare institutions subject to the restrictions under the Fair Competition Code and the JPMA Promotion Code.

Under the Fair Competition Code, pharmaceutical companies may not provide donations to healthcare professionals or healthcare institutions as a means of unjustly inducing drug transactions. The question of whether the donations have such a purpose is decided based on detailed criteria provided in the Operating Standards of the Fair Competition Code. 

With regard to monetary donations, according to the Operating Standards criteria, pharmaceutical companies may make monetary donations to healthcare institutions within the bounds of standard commercial practice; such donations would not be considered a means of unjustly inducing drug transactions.

With regard to non-monetary donations, the Operating Standards criteria state that pharmaceutical companies may voluntarily provide their own drugs to healthcare institutions in the case of a disaster and to the medical faculty of universities as long as doing so meaningfully contributes to the students’ lessons.

Under the JPMA Promotion Code, pharmaceutical companies shall not provide donations to healthcare professionals or healthcare institutions that may influence the appropriate use of drugs.

In practice, pharmaceutical companies in Japan usually sell their drugs to wholesalers, who in turn sell the drugs to healthcare institutions. Thus, since pharmaceutical companies do not tend to sell directly to healthcare institutions, any rebates or discounts would mostly be provided to wholesalers rather than healthcare institutions. As to such rebates or discounts provided to wholesalers, the Anti-monopoly Act (Act No 54 of 14 April 1947, as amended) may prohibit certain conduct such as adjusting the discount or rebate amount in exchange for the wholesaler agreeing to follow a suggested price.

Under the Fair Competition Code, pharmaceutical companies may offer remuneration or expenses for research or certain studies. Also permitted are expenses for post-marketing surveillance for prescription-only medicines, as well as advertising fees for advertising drugs in journals. Such payments must meet the criteria provided in the Enforcement Rules and the Operating Standards of the Fair Competition Code. For instance, remuneration must be appropriate in light of the content of the relevant research.

The JPMA Promotion Code requires that any remuneration must be appropriate in relation to the services provided. Pharmaceutical companies must not pay healthcare professionals to provide consulting services only as a way of covertly providing them with prohibited monetary benefits.

No prior regulatory authorisations or notifications are required for the activities described in this section.

With regard to employer consent, pharmaceutical companies have internal company rules that regulate providing gifts, hospitality, donations or other payments/services to healthcare professionals and institutions. Such internal rules may require obtaining prior consent from or notification to the companies’ compliance divisions.

The Clinical Research Act

The Clinical Research Act (Act No 16 of 14 April 2017), which took effect on 1 April 2018, requires that pharmaceutical companies and their subsidiaries disclose certain transfers of value to healthcare professionals and institutions in connection with specified clinical research. Clinical research includes human trials examining the efficacy or safety of pharmaceuticals but would not include a clinical trial for a new drug conducted under the PMD Act.

Specified clinical research is defined as clinical research funded by pharmaceutical companies, clinical research on unapproved drugs or clinical research concerning off-label use of a drug.

Transfers of value that must be disclosed under the Clinical Research Act include research funds for specified clinical research, donations provided during the term of or within two years after specified clinical research, and fees for writing, lectures or other services provided during the term of and within two years after specified clinical research. The recipients of payments covered by the regulation include healthcare providers involved in specified clinical research, healthcare institutions or other organisations to which a principal investigator belongs, and organisations managing the specified clinical research. The transfers of value for specified clinical research made in each fiscal year shall be disclosed the following fiscal year on the company’s website.

The JPMA Transparency Guideline

The JPMA “Transparency Guideline for the Relation between Corporate Activities and Medical Institutions“ (the “Transparency Guideline”) requires that JPMA member companies disclose certain information regarding transfers of value made to healthcare professionals or healthcare institutions.

The Transparency Guideline further requires that each member company create its own internal “transparency policy” based on the Transparency Guideline. Therefore, each JPMA member company has established its own internal transparency policy and has been disclosing information on transfers of value it has made to healthcare institutions based on this internal policy.

Transfer categories

The Transparency Guideline creates five different categories of transfers of value (fees or expenses). For each category the relevant fees or expenses must be disclosed in detail. The five categories are:

• research and development expenses (such as those for clinical trials for new drugs);
• academic support expenses (such as donations to academic societies);
• manuscript/writing fees (such as fees for writing manuscripts containing scientific information regarding the pharmaceutical companies’ own drugs);
• expenses related to the provision of information (such as expenses for lectures and seminars); and
• other expenses (such as for hospitality as a social courtesy).

The types of transfers of value to be disclosed include not only cash but also medicines, medical devices and other goods. Value transferred through a third party, such as a subcontractor or foundation, must also be disclosed.

Recipients and disclosure

The recipients of payments covered by the Transparency Guideline include:

• healthcare institutions (such as hospitals and pharmacies);
• research institutes (such as medical and pharmaceutical departments of universities);
• healthcare associations (such as medical associations and pharmacists’ associations); and
• persons engaged in medical care and nursing care (such as doctors and nurses) and life-science researchers.

The transfers of value made in each fiscal year shall be disclosed the following fiscal year through the company’s website.

As the transparency requirements under the Clinical Trial Act would apply only to the marketing authorisation holder and its subsidiaries, the requirements would not apply to foreign companies or companies that do not sell products on the market in Japan.

The transparency requirements under trade association rules such as the Transparency Guideline (see 10.1 Requirement to Pharmaceutical Companies to Disclose Details of Transfers of Value) only bind members of such trade associations. Accordingly, the transparency requirements under the self-regulatory rules will not apply to foreign companies and/or companies that do not yet have products on the market, unless such companies are members of trade associations with transparency requirements.

Each Japanese law has one or more government agencies that are responsible for enforcement (ie, the regulatory authority). With regard to the PMD Act, as well as the MHLW Standards, the MHLW and the competent prefectural governor are the regulatory authorities. In the case of the UPMRA, the Prime Minister, the Consumer Affairs Agency, the Japan Fair Trade Commission and the competent prefectural governor are the regulatory authorities.

The main role of courts in administrative law enforcement (including for the PMD Act) is to impose criminal penalties on companies and their employees that violate the law. In the case of a serious violation, the regulatory authority will ask the Public Prosecutor’s Office to prosecute the company or its employee, and the Public Prosecutor’s Office will file charges against the company. The court will then render a final judgment.

With regard to the enforcement of self-regulatory codes, the codes usually establish an organ that is in charge of enforcing the code. In the case of the JPMA Promotion Code, the JPMA Code Compliance Committee is responsible for enforcement. As for the Fair Competition Code, the Fair Trade Council of the Ethical Pharmaceutical Drug Marketing Industry (the “Fair Trade Council”), which consists of the pharmaceutical companies designated by the code, is responsible for the Code’s enforcement.

In Japan, pharmaceutical companies may initiate civil litigation proceedings against their competitors before courts for certain types of advertising infringements of the UCPA.

Under the UCPA, a company whose business interests have been infringed or are likely to be infringed by a competitor’s dissemination of information or advertising likely to mislead the public as to the quality, content or manufacturing method of its goods or services (UCPA Article 2 (1) (xx)), or announcement or dissemination of a falsehood injurious to its business reputation (UCPA Article 2 (1) (xxi)), may seek an injunction against the competitor suspending or preventing the infringement (UCPA Article 3 (1)).

The company may also claim damages to its business interests resulting from intentional or negligent infringement related to the above conduct. 

For example, a pharmaceutical company may file a lawsuit in a Japanese court seeking an injunction and/or compensation of damages against a competitor if the competitor creates an advertisement containing falsehoods or slander regarding the pharmaceutical company’s products.

Penalties or Measures Imposed by Regulators

In practice, Japanese regulatory authorities, such as the MHLW or the Prime Minister, will most likely issue an administrative “guidance” in the first instance against a pharmaceutical company found to be in violation, which is basically an official request to remedy the illegal conduct.  If the company does not follow such guidance, the authority will then issue an administrative “disposition”.

Under the PMD Act, the MHLW or the competent prefectural governor may take the following administrative dispositions, among others:

• order a pharmaceutical company that violated the PMD Act to comply with a “business improvement order” (eg, an order to improve internal review systems for advertisements) (Articles 72-4);
• order a pharmaceutical company that advertised a pharmaceutical product before obtaining the necessary marketing authorisation (prohibited under Article 68) to take certain measures to prevent any such violation in the future (Article 72-5); or
• withdraw a pharmaceutical company’s manufacturing and/or marketing licence or suspend all or part of its business for a certain period, as determined by the MHLW, for a company that violated the PMD Act (Article 75).

In addition, as mentioned in 1.1 Laws and Self-Regulatory Codes Concerning the Advertisement and Promotion of Medicines, the amendments of the PMD Act, which became effective on 1 August 2021, include administrative fines for violations of the regulations on false or exaggerated advertising as well as cease and desist orders against pharmaceutical companies engaged in such improper advertising.

A company that has had its manufacturing and/or marketing licence withdrawn has the right to appeal such a disposition above under the Administrative Appeal Act (Act No 160 of 15 September 1962, as amended).

The JPMA Code Compliance Committee

The JPMA Code Compliance Committee may take actions against pharmaceutical companies that violate the JPMA Promotion Code to address the companies’ violations in accordance with the “Rules of Actions against the Breach of the Promotion Code”. Actions the aforementioned committee may take include, among others, serious warning, suspension of membership or expulsion from the JPMA.

The Fair Trade Council

The Fair Trade Council may order companies violating the Fair Competition Code to take certain measures. If the violator does not comply with such an order, the council may impose a penalty, including a fine of up to JPY1 million or expulsion from the council. The council may also request the Consumer Affairs Agency to take necessary actions.

Penalties Imposed by Courts

Courts may impose criminal penalties on pharmaceutical companies and/or on their officers and employees who violate the relevant laws. The major criminal sanctions for the violation of pharmaceutical advertising rules and rules on inducements to prescribe are as follows:

• false or exaggerated advertising and advertising for an unauthorised drug: imprisonment with labour for not more than two years and/or a fine of up to JPY2 million (PMD Act Article 85);
• advertising to the general public pharmaceutical products intended for use in the cure of cancer, sarcoma or leukaemia: imprisonment with labour for not more than one year and/or a fine of up to JPY1 million (PMD Act Article 86);
• violation of a cease-and-desist order from the Secretary General of the Consumer Affairs Agency: imprisonment with labour for not more than two years or a fine of up to JPY3 million (UPMRA Article 36);
• bribery of a public official: imprisonment with labour for not more than three years or a fine of up to JPY2.5 million (Penal Code Article 198); and
• bribery of a foreign public official: imprisonment with labour for not more than ten years and/or a fine of up to JPY30 million (UCPA Article 21 (4) (iv)).

While only individuals are subject to criminal sanctions under the Penal Code, both individuals and companies may be subject to criminal sanctions under the PMD Act, the UPMRA and the UCPA (PMD Act Article 90 (ii), UPMRA Article 38 (1) and UCPA Article 22 (1) (i)).

The procedures before and measures taken by the self-regulatory authority and the courts are conducted separately and independently.

The MHLW is strengthening its enforcement activities in relation to pharmaceutical advertising. In 2016, the MHLW began monitoring the advertising of ethical drugs in order to identify violations early, and encourage voluntary measures on behalf of the pharmaceutical companies and trade associations. This endeavour included the appointment of an anonymous healthcare institution to identify problematic items in advertisements and promotional information provided by pharmaceutical companies, including on their websites or in specialist journals. 

On 1 October 2019, the MHLW expanded the monitoring activity above to include information from any healthcare institution on a voluntary basis. As a result of these monitoring activities, the MHLW identified 17 possible violations, including 23 problematic items, in 2022. 

In addition, as mentioned in 1.1 Laws and Self-Regulatory Codes Concerning the Advertisement and Promotion of Medicines, the MHLW issued the Detailing Guidelines in 2018 and amended the PMD Act in 2019 to include administrative fines for violations of the regulations on false or exaggerated advertising as well as cease and desist orders against pharmaceutical companies engaged in improper advertising. As of 31 January 2024, there are no cases where such administrative fines were imposed. 

As veterinary medicines are included in the definition of “medicines” under the PMD Act, the same advertising regulations under the PMD Act apply to veterinary medicines. The difference is that for veterinary medicines, the regulatory authority is not the MHLW, but the Ministry of Agriculture, Forestry and Fisheries (MAFF) and the competent prefectural governors. MAFF has issued “Standards for Appropriate Advertising concerning Veterinary Medicine” (Notification 12 Chiku A No 728 of the Livestock Industry Bureau of 31 March 2000). Similar to the MHLW Standards, the MAFF standards list prohibited expressions in advertisements, including language that is misleading as to the effectiveness of the medicine or that denigrates other companies.

While the regulatory body is different, enforcement measures that may be taken under the PMD Act by the MAFF in respect of veterinary medicines are the same as those taken by the MHLW for human medicines.

The views and opinions set forth herein are the personal views or opinions of the authors; they do not necessarily reflect views or opinions of the law firm with which they are associated.