Disclosure of Payments to Healthcare Professionals and Institutions

Checked and updated: October 11, 2026.
Scope: funding and disclosure under Clinical Trials Act Articles 32–35 and 42–43 and implementing Rules 88–91-2, and the April 2026 JPMA guideline revision and its application dates. Statutory obligations and industry standards are presented separately.

Disclosure required by law

1) The Clinical Trials Act and covered funding

The Clinical Trials Act took effect on April 1, 2018, against the background of the Diovan case and concerns about public trust and transparency in clinical research.

A marketing authorization holder or its statutorily defined related entity providing research funding for specified clinical research using products that the holder markets or intends to market must conclude a contract containing prescribed terms (Article 32). Article 33 requires publication of research funding and prescribed information on other financial or in-kind benefits. Rule 88, item (ii), limits specified clinical research for this funding-disclosure framework to research falling within Article 2(2)(i) of the Act.

On the provider side, related entities are those falling within the Companies Act definition of a subsidiary company, etc. (Article 2, item (iii-2); Rule 3). They are distinct from persons with a special relationship to the researcher (Rule 89). The latter include institutions to which the overall study manager or responsible physician belongs and specified organisations managing or supporting the research through which funding is provided. This framework does not apply indiscriminately to every payment by every pharmaceutical company for every clinical study.

2) Information and method of publication

Disclosure includes research funding, donations and remuneration for writing, lectures and related services. The required recipient, study identifier, research institution, contract count, amount and other details vary by category. Donations and remuneration are subject to prescribed recipient and timing conditions, including the study period and two years after its end (Rule 90).

Information-provision and hospitality expenses are treated differently depending on whether the prescribed totals for the provider’s entire preceding financial year—including event counts and costs, books and other information materials, and hospitality—are published. Otherwise, prescribed information-provision and hospitality payments to the overall study manager or responsible physician during the study and within two years after its end must also be disclosed. Consult current Rules 89–90 for recipients, exclusions and aggregation units.

3) Publication deadlines and duration

The Article 33 disclosure requirements first applied to financial years starting on or after October 1, 2018. Information must be published online or by another prescribed method within one year after each financial year ends and remain available for five years from publication (Rule 91 and the original supplementary provisions, Article 3).

Disclosure under industry standards

1) JPMA’s transparency guideline

JPMA first adopted its Transparency Guideline for the Relation between Corporate Activities and Medical Institutions in 2011. The current published version was revised on April 1, 2026. It is an industry standard separate from the statutory scheme. JPMA member companies are to adopt their own transparency policy as a code of practice, referring to the guideline, and publish prescribed funding and payment information on their websites.

Covered recipients include medical and research institutions, healthcare organisations, foundations, healthcare professionals and life-science researchers in Japan. Check each company’s policy and the guideline’s detailed scope and exceptions.

2) Disclosure categories A–E

This table summarises the main categories and disclosure units. It is not an exhaustive list of requirements; consult JPMA’s current guideline and commentary for details and exceptions.

Category A refers to the Ethical Guidelines for Medical and Biological Research Involving Human Subjects.

3) New items and when they apply

Disclosure of the two additions to category B—advertising expenses and supporting membership fees—applies to payments in each company’s financial years beginning in January 2027 or later. The revision date and the payment-period application date are different.

Advertising covers notices in journals, newsletters and websites issued by relevant societies, research groups and medical institutions. Add the payee organisation when the medium alone does not identify it. Advertising solicited for society meetings is classified as meeting support. Supporting membership concerns fees paid to support an organisation’s activities; ordinary or regular membership fees are excluded.

Sanctions

The Minister of Health, Labour and Welfare may recommend that a marketing authorization holder or its related entity violating Articles 32 or 33 conclude a contract or disclose information, and may publicise failure to follow the recommendation (Article 34).

For covered holders or related entities, unjustified non-compliance with Article 35(1) reporting or document-submission requirements, false reports or submissions, obstruction or evasion of inspection, or refusal to answer or false answers to questions may result in a fine of up to JPY 300,000 (Article 42). Article 43 provides for punishment of both the offender and the corporation or individual for whose business the offence was committed.

Primary sources checked

• MHLW: current Clinical Trials Act (Articles 2, 32–35 and 42–43)
• MHLW: current implementing Rules (3, 88–91-2 and supplementary provisions)
• JPMA: April 2026 revision notice
• JPMA: current guideline and commentary (Japanese)
• JPMA: current guideline (English)