Advertising health-related products such as pharmaceuticals and medical devices in Japan is subject to a stringent and multifaceted regulatory framework, primarily governed by the "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" (PMD Act or Yakkiho). This framework is designed to protect public health by ensuring that consumers and healthcare professionals receive accurate, balanced information, and to prevent the improper use of these products based on misleading or exaggerated claims. The regulations extend to pharmaceuticals (both prescription and Over-The-Counter), medical devices, quasi-drugs, and cosmetics, with specific rules tailored to each category's potential impact on health.

Core Prohibitions Under the PMD Act (Yakkiho)

The PMD Act lays down fundamental prohibitions that form the bedrock of advertising control for these products. These restrictions apply broadly to "any person" (nannin mo), meaning that not only Marketing Authorization Holders (MAHs) and manufacturers but also advertising agencies, media outlets, and individuals can be held accountable for violations.

Article 66: Prohibition of False or Exaggerated Advertising (誇大広告等の禁止 - Kodai Kōkoku-tō no Kinshi)

This is perhaps the most critical provision governing the content of advertisements.

• Paragraph 1 broadly prohibits any person from advertising, describing, or circulating false or exaggerated statements regarding the name, manufacturing method, efficacy, effects, or performance of pharmaceuticals, quasi-drugs, cosmetics, medical devices, or regenerative medicine products. The key concern is preventing statements that could mislead individuals into believing something that is untrue or scientifically unproven. This extends to any claim, whether explicit or implicit, that gives a false impression about the product.
• Paragraph 2 specifically prohibits advertising that could be misunderstood as a physician or other healthcare professional guaranteeing the efficacy or effect of a product. It also bans the use of obscene or morally offensive documents or diagrams in such advertising.
• Paragraph 3, added later to address concerns particularly around cancer-related product promotion, imposes stricter obligations when advertising products for designated diseases like cancer. It mandates that such advertising must not cause misunderstanding about efficacy or safety and must be based on accurate medical and pharmaceutical knowledge.

The terms "advertising" (広告 - kōkoku), "description" (記述 - kijutsu), and "circulation" (流布 - rufu) are interpreted broadly. Generally, an activity is considered advertising if it has the clear intent to attract customers to a specific product, the product is identifiable, and the information is disseminated to the public or a segment thereof.

Article 67: Restrictions on Advertising for Designated Diseases (特定疾病用医薬品・医療機器の広告制限 - Tokutei Shippei-yō Iyakuhin・Iryōkiki no Kōkoku Seigen)

For pharmaceuticals or medical devices intended for use in treating specific, MHLW-designated diseases (such as cancer, sarcoma, and leukemia, as specified by cabinet order), advertising to the general public is severely restricted. The rationale is to prevent individuals from attempting self-treatment for serious conditions based on advertising, which could delay or interfere with appropriate medical care, or create false hope. Advertising for these products is primarily permissible when targeted at medical, pharmaceutical, and other relevant healthcare professionals.

Article 68: Prohibition of Advertising Unapproved Products (承認前の医薬品等の広告の禁止 - Shōnin-mae no Iyakuhin-tō no Kōkoku no Kinshi)

This article strictly prohibits advertising the name, manufacturing method, efficacy, effects, or performance of any pharmaceutical, medical device, or regenerative medicine product before it has received the necessary marketing approval (or certification, where applicable) from the MHLW. This ban is crucial to prevent the promotion and potential use of products whose safety, efficacy, and quality have not yet been officially validated by the regulatory authorities. This applies even to information disseminated for research or academic purposes if it effectively functions as pre-approval promotion to potential users or prescribers outside of controlled clinical trial settings.

The "Proper Advertising Standards for Pharmaceuticals, etc." (医薬品等適正広告基準 - Iyakuhin-tō Tekisei Kōkoku Kijun)

While the PMD Act provides the legal prohibitions, more detailed and practical guidance is provided by the "Proper Advertising Standards for Pharmaceuticals, etc." These standards are issued by the MHLW (typically as a notification from the Director-General of the Pharmaceutical Safety and Environmental Health Bureau). Although not law in themselves, non-adherence to these standards can trigger administrative guidance or warnings from regulatory authorities and can be used as evidence in determining whether a violation of the PMD Act has occurred.

These standards are extensive and cover a wide array of advertising practices. Key principles include:

• Objectivity and Factual Basis: All claims must be truthful, scientifically sound, and presented objectively.
• Scope of Efficacy: Claims regarding efficacy or effects must not deviate from the scope approved or recognized for that specific product.
• Balanced Information: Information on benefits must be balanced with clear disclosure of relevant risks, side effects, and contraindications.
• Comparisons: Comparative advertising is generally discouraged. If made, comparisons must be strictly objective, based on verifiable facts, and must not unfairly disparage competitors' products.
• Guarantees of Effect: Any expression that could be interpreted as guaranteeing the efficacy or safety of a product is prohibited.
• Use of Medical Terminology: Language should be appropriate for the target audience. For consumer-directed advertising, complex medical terms should be avoided or clearly explained.
• Endorsements: Endorsements by healthcare professionals, celebrities, or patients are heavily restricted, particularly for prescription drugs, to prevent undue influence.
• Inducement of Anxiety: Advertising should not create excessive fear or anxiety to promote product use.

Recent Revisions to the Standards (Effective April 1, 2024):
It is critical to note that these standards are periodically updated. A significant revision to the "Proper Advertising Standards for Pharmaceuticals, etc." came into effect on April 1, 2024. Key changes in this revision include, but are not limited to:

• Enhanced Rules for Internet and Social Media Advertising: Stricter guidelines for advertising on websites, social networking services (SNS), search engine advertising, and affiliate marketing, emphasizing transparency and the clear identification of advertising content (distinguishing from editorial or user-generated content).
• Strengthened Patient-Centric Information: A greater emphasis on providing information that is truly useful and understandable from a patient's perspective, ensuring that benefits are not overemphasized at the expense of risk information.
• Clarification on Comparative Advertising: More detailed rules on when and how comparative claims can be made, reinforcing the need for objectivity and direct relevance.
• Considerations for Vulnerable Populations: Increased attention to advertising directed at or featuring vulnerable groups, such as children or the elderly, to prevent exploitation or misunderstanding.
• Information on Manufacturing Methods: Clarification on how information related to manufacturing methods can be presented to avoid misleading consumers about product quality or superiority.

Businesses must refer to the latest version of these standards when developing any advertising materials.

Specific Advertising Rules by Product Category

The general prohibitions and standards are applied with specific nuances depending on the product category:

Prescription Pharmaceuticals (医療用医薬品 - Iryō-yō Iyakuhin)

• Target Audience: Advertising is almost exclusively aimed at healthcare professionals (HCPs) such as physicians, dentists, and pharmacists.
• Direct-To-Consumer Advertising (DTCA): Generally prohibited. While disease awareness campaigns by pharmaceutical companies are permissible, they must be educational in nature and carefully constructed to avoid indirectly promoting specific prescription products.
• Information at Medical Venues: Strict rules govern the distribution of promotional materials at medical congresses, exhibitions, and seminars. For instance, providing detailed product brochures to individuals not verified as HCPs is typically not allowed.

Over-The-Counter (OTC) Pharmaceuticals (一般用医薬品 - Ippan-yō Iyakuhin)

• Public Advertising Permitted: Advertising to the general public is allowed but must rigorously adhere to PMD Act Article 66 and the Proper Advertising Standards.
• Alignment with Approved Claims: Efficacy claims must precisely match the approved indications for the specific OTC drug and its risk classification (Guidance-Requiring, Class 1, Class 2, or Class 3).
• Testimonials and Online Reviews: The use of patient testimonials, online user reviews (kuchikomi), and product recommendations (rikomendo) in advertising is a sensitive area. While user-generated content itself is not directly regulated as advertising, if a company promotes or utilizes such content in a way that it effectively becomes part of their advertising message, it must not be misleading or unsubstantiated.

Medical Devices (医療機器 - Iryōkiki)

• General PMD Act Rules Apply: Medical device advertising is subject to Articles 66 (false/exaggerated claims) and 68 (no pre-approval advertising).
• Risk Classification Impact: The content and channels for advertising may be influenced by the device's risk classification. For highly invasive or high-risk devices (e.g., Class III or IV), advertising to the general public is often restricted, similar to prescription drugs for designated diseases.
• Software as a Medical Device (SaMD): Advertising for SaMD must accurately reflect its approved functions and limitations, avoiding claims that overstate its diagnostic or therapeutic capabilities.

Quasi-Drugs (医薬部外品 - Iyaku Bugaihin)

• Permitted Efficacy Claims: A key feature of quasi-drugs is the ability to advertise their MHLW-approved or recognized "effects/efficacy" (kōnō kōka), such as "prevents acne" or "whitens skin by suppressing melanin production." This allows for more specific functional claims than cosmetics.
• No Pharmaceutical-like Claims: Advertising must not suggest that quasi-drugs can treat, cure, or prevent diseases in a manner similar to pharmaceuticals. The claims must be consistent with their milder action.
• "Medicated Cosmetics" (Yakuyō Keshōhin): This large sub-category of quasi-drugs is heavily advertised, with a focus on their specific approved effects.

Cosmetics (化粧品 - Keshōhin)

• Limited Scope of Claims: Cosmetic advertising claims are strictly limited to the PMD Act's definition of cosmetic functions: cleansing, beautifying, increasing attractiveness, altering appearance, or keeping the skin or hair in good condition.
• No Physiological or Therapeutic Claims: Cosmetics cannot claim to affect the body's structure or physiological functions (e.g., "regenerates cells," "boosts collagen production" in a way that implies a drug-like mechanism) or to have therapeutic or preventive effects on diseases or specific skin/hair conditions beyond general grooming.

Special Considerations in Japanese Advertising Landscape

• Internet and Digital Advertising: All PMD Act rules and the Proper Advertising Standards fully apply to online platforms, including company websites, social media campaigns, search engine marketing, video advertisements, and influencer marketing. Regulatory bodies like the MHLW and PMDA actively monitor online advertising for non-compliance. The 2024 revised standards place particular emphasis on digital advertising practices.
• Comparative Advertising: While not entirely banned, comparative advertising is viewed with caution. Any comparisons must be objective, scientifically substantiated, fair, and must not disparage competitors or their products. The revised standards provide more granular guidance on this.
• Use of Scientific Data and Publications: Referencing clinical trial data or scientific papers in advertising requires careful handling. Information must be presented accurately, without selective reporting or taking findings out of context, and must not imply efficacy beyond what has been approved.
• Health Foods (健康食品 - Kenkō Shokuhin): While health foods are primarily regulated under the Health Promotion Act (健康増進法 - Kenkō Zōshin Hō) and the Food Labeling Act (食品表示法 - Shokuhin Hyōji Hō), if they are advertised with claims that suggest drug-like efficacy (i.e., treating, preventing, or diagnosing disease, or affecting body structure/function in a drug-like manner), they can fall under the PMD Act as unapproved pharmaceuticals, making their advertising illegal.

Enforcement and Penalties for Non-Compliance

Violations of the PMD Act's advertising regulations can lead to a range of enforcement actions by the MHLW or prefectural governments:

• Administrative Guidance (行政指導 - Gyōsei Shidō) and Warnings: Initial actions often involve guidance to cease or rectify the problematic advertising.
• Corrective Action Orders: Formal orders can be issued to take specific corrective measures.
• Public Announcement of Violations: Authorities may publicly name companies that have committed serious or repeated violations.
• Penalties: For violations of Articles 66, 67, or 68, the PMD Act prescribes penalties that can include fines and, for severe or malicious cases, imprisonment.
• Orders for Discontinuance and Surcharges under the Act against Unjustifiable Premiums and Misleading Representations (景品表示法 - Keihyōhō): This separate law, administered by the Consumer Affairs Agency, also targets misleading representations about goods and services generally, and can be applied to health product advertising, potentially leading to significant administrative surcharges based on sales.

Conclusion

The regulatory environment for advertising pharmaceuticals, medical devices, quasi-drugs, and cosmetics in Japan is notably strict and detailed, reflecting a strong commitment to consumer protection and the promotion of public health. The PMD Act's core prohibitions against false, exaggerated, and pre-approval advertising, complemented by the comprehensive "Proper Advertising Standards for Pharmaceuticals, etc." (especially its latest 2024 revision), create a framework that demands meticulous attention to accuracy, balance, and scientific substantiation. For all businesses involved in marketing these products in Japan, a proactive and thorough review of all advertising and promotional materials by legal and regulatory experts familiar with the nuances of the Japanese system is not just advisable but essential for ensuring compliance and maintaining a trustworthy market presence.