Key Points for Developing
Non-Medical Testing Services

Consumer-facing, non-medical testing services are on the rise. Using genetic testing services as an example, the following sections introduce key points to consider, relevant authorities for consultation, and other important information. Ultimately, it is crucial to seek paid consultation from a lawyer specializing in this field.

Please note: Machine translated. Please refer to the original Japanese for accuracy. Doing business in Japan typically requires Japanese-speaking staff or local support.

@K.Kamitani

1. Handling of Personal Information

In genetic testing services especially, test results fall under "Personally Identifiable Information" and "Special Care-Required Personal Information" under the Act on the Protection of Personal Information, requiring the strictest level of protection. Providing this information to third parties without the individual's consent is, in principle, prohibited.

• Obtaining Clear Consent: You must specifically explain the purpose for which information is acquired, used, and potentially provided to third parties, and obtain clear consent from the individual.
• Security Measures: You are obligated to implement the highest level of physical and technical security measures to prevent leakage, loss, or damage of acquired personal information (especially genetic information).
• Ensuring Transparency: You must establish and publish a privacy policy, making your information handling policies readily available for users to review at any time.

It is essential to comply fully by referring to guidelines such as the METI's Guidelines for the Protection of Personal Information in Business Fields Using Personal Genetic Information and the voluntary standards of the Association of Genetic Information Handling (AGIH).

Guidelines for the Proper Handling of Personal Genetic Information in Business Fields

Personal Information Protection Commission, Ministry of Economy, Trade and Industry (METI)

https://www.ppc.go.jp/personalinfo/legal/gentec_data_guideline/

Voluntary Standards for DTC Genetic Testing Services (Notice of Revision)

Association of Genetic Information Handling (AGIH)

https://aogi.jp/news-20/

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2. Act against Unjustifiable Premiums and Misleading Representations

Overview of the Act

This act prohibits misleading representations that could cause consumers to misjudge the quality, content, price, or other aspects of goods and services (misrepresentation of superiority, misrepresentation of advantage).

Compliance Matters for Operators of Genetic Testing Businesses

Ministry of Economy, Trade and Industry (METI)

https://www.meti.go.jp/policy/mono_info_service/mono/bio/zyunshu.pdf

Key Points

• Disclosure of Scientific Evidence: Making definitive statements like "accurately determines the risk of XX" without sufficient evidence may be considered a "misrepresentation of superiority," so it is important to be cautious.
• Display of Test Limitations: Failing to communicate the limitations of the service, such as by stating "this test tells you everything," may create excessive expectations and could be judged as a "misrepresentation of superiority," so caution is needed.
• Comparison with Other Companies: Making claims like "industry-No.1 accuracy" without objective evidence may be deemed a "misrepresentation of superiority" that misleads consumers into believing your service is significantly better than others, so it is important to be careful.

Reference

Title: Consultation, Reporting, and Information Provision regarding the Act against Unjustifiable Premiums and Misleading Representations

Organization: Consumer Affairs Agency

https://www.caa.go.jp/policies/policy/representation/contact/

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3. Medical Practitioners' Act

Overview of the Act

This act prohibits non-physicians from engaging in "medical practice" (diagnosis, treatment, etc.). It is essential to clearly distinguish between providing information and the medical act of "diagnosis."

Interpretation of Article 17 of the Medical Practitioners' Act, Article 17 of the Dentists Act, and Article 31 of the Act on Public Health Nurses, Midwives and Nurses

Ministry of Health, Labour and Welfare (MHLW)

https://www.mhlw.go.jp/shingi/2003/02/s0203-2g.html

Regarding the "Interpretation of Article 17 of the Medical Practitioners' Act..." (Part 2)

Ministry of Health, Labour and Welfare (MHLW)

https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/hukushi_kaigo/seikatsuhogo/gensoku_ikoui.html

Key Points

• Clarification of Non-Diagnostic Purpose: If disclaimers like "this test is not a diagnosis" are unclear, the entire service could be mistaken for a medical act, so caution is needed.
• Avoidance of Definitive Language: Using definitive statements like "you have X disease" could be considered a "diagnosis," which is reserved for physicians, and may violate the Medical Practitioners' Act, so it is important to be cautious.
• Prohibition of Specific Treatment Recommendations: Recommending specific drugs or treatments based on test results could be considered the "medical acts" of diagnosis and treatment, so caution is required.

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4. PMD Act

Overview of the Act

This is an act to ensure the quality, efficacy, and safety of products such as pharmaceuticals and medical devices. If a test kit is deemed a "medical device" intended for "diagnosis," it requires national approval.

What is a Medical Device?

Pharmaceuticals and Medical Devices Agency (PMDA)

https://www.pmda.go.jp/safety/consultation-for-patients/on-devices/qa/0016.html

Key Points

• Denial of Diagnostic Purpose: Stating the product's purpose as the "diagnosis" of a specific disease may cause the product to be considered a "medical device," potentially violating the PMD Act, so caution is needed.
• Prohibition of Claims of Prevention/Treatment Effects: Claiming medicinal effects like "can prevent cancer" may be considered advertising an unapproved pharmaceutical, potentially violating the PMD Act, so caution is needed.
• Expressions Regarding Kit Performance: Using language that suggests the kit itself has disease-detecting capabilities, such as "high-precision cancer detection kit," could be misleading and cause it to be mistaken for a medical device, so caution is required.

Consultation

Confirmation of Medical Device Applicability: Pharmaceutical Affairs Division of each prefectural government (e.g., Tokyo)

https://www.tmiph.metro.tokyo.lg.jp/k_iryou/

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5. Health Promotion Act

Overview of the Act

This act prohibits false or exaggerated advertising regarding the effects on health maintenance and promotion for items sold as food.

Health Promotion Act (Prohibition of Exaggerated Advertising)

Consumer Affairs Agency

https://www.caa.go.jp/policies/policy/representation/extravagant_advertisement/

Key Points

• Prohibition of Health Effect Guarantees: Making guarantees based on test results, such as "if you take this supplement, you will definitely lose weight," constitutes false and exaggerated advertising, so caution is needed.
• Necessity of Objective Evidence: Using expressions that promise an effect, such as "the effects of XX are guaranteed," without scientific basis for recommended diets or nutrients could also be deemed false and exaggerated advertising, so caution is required.

Food Labeling

Food Labeling | Consumer Affairs Agency

https://www.caa.go.jp/policies/policy/food_labeling/

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6. Food Sanitation Act & Food Labeling Act

Overview of the Acts

The Food Sanitation Act relates to preventing health hazards from food and drink, while the Food Labeling Act covers the display of information like allergens and nutritional content. When selling food products alongside testing services, attention to both laws is necessary.

Revision of the Food Sanitation Act

Ministry of Health, Labour and Welfare (MHLW)

https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000197196.html

Key Points

• Ensuring Safety: Selling food that does not meet legal standards for ingredients or labeling constitutes illegal food sales, so caution is required.
• Thorough Allergen Labeling: Inaccurate allergen labeling can cause serious health problems for consumers and also violates the Food Labeling Act, so caution is needed.
• Hygiene Management: Inadequate hygiene management from production to transport could lead to food poisoning and result in liability for the business operator, so caution is required.

Reference

Food Sanitation Information "Mado" | Tokyo Metropolitan Health and Medical Bureau

https://www.hokeniryo1.metro.tokyo.lg.jp/shokuhin/j_toiawase.html

@K.Kamitani

7. Gray Zone Elimination System & System of Special Arrangements for New Business Activities

These are systems established by the government to allow businesses to operate with confidence when the interpretation of existing laws and regulations is unclear for a new business. By inquiring with a specific business plan, operators can receive an official response from the relevant ministry in advance regarding the applicability of regulations.

Utilizing these systems in parallel with legal consultation can be expected to reduce regulatory uncertainty.

Reference

Name: Gray Zone Elimination System & System of Special Arrangements for New Business Activities

Jurisdiction: Ministry of Health, Labour and Welfare (MHLW)

https://www.mhlw.go.jp/shinsei_boshu/gray_zone/gray_zone.html

@K.Kamitani

Consultation with a Lawyer

In medical-related businesses, it is necessary to comply with various laws, primarily the PMD Act. Even in non-medical businesses, it is crucial to be careful not to conflict with medical-related regulations, depending on the nature of the business, in addition to other relevant laws. Since it is nearly impossible for a company to navigate all these aspects, including labeling, on its own, it is recommended to seek paid assistance from a lawyer specializing in this field.

@K.Kamitani