Q（Question）

Regarding principle ④, which requires that specific conflict of interest information be 'clearly stated,' is it sufficient to record only the information that can be ascertained if the paper being cited does not include a conflict of interest disclosure?

A（MHLW answer）

This provision concerns conflicts of interest with the company itself, and confirming the provision of goods, money, labor, and other benefits by the company is a matter that should naturally be conducted. Therefore, papers for which such confirmation cannot be made should not be used.

Furthermore, for sales information provision materials that have already been prepared and are in use, the conflict of interest disclosures should be reviewed and revised sequentially.

So what (meaning): If a paper lacks a conflict of interest section, the company must still independently verify whether it provided financial or other support to the study authors. Papers where this cannot be confirmed must not be used in materials — a partial disclosure stating only 'what is known' is insufficient.

So why (rationale): A company is always in a position to know what benefits it has provided to researchers; the conflict of interest requirement is designed to ensure the integrity of third-party literature cited in promotional materials, so ignorance of one's own provision of support is not accepted.

Commentary — background, application, practical notes

The conflict of interest (COI) management requirement concerns the financial and material relationship between the pharmaceutical company and the researchers or authors, and the company itself bears the responsibility for confirming this. The absence of a COI disclosure section in a paper, or the statement that there is 'no conflict of interest,' does not eliminate the company's obligation to verify on its own. Whether the company has provided money, goods, or services to the researchers should be confirmable from the company's own accounting records and documentation, and failure to conduct this verification is not accepted.

A typical scenario is one where a physician investigator who conducted a trial using the company's own product received lecture fees, consulting fees, or research funding from the company, yet the paper's COI section is blank or states 'the authors declare no conflict of interest.' In such a case, the company's own conflict of interest with the physician can be verified through the company's payment records; relying solely on the paper's declaration to conclude there is no problem is not permissible.

The defining feature of this provision is its clear 'no' in response to the question 'is it sufficient to record only the information that can be ascertained?', going further to state that 'papers for which such confirmation cannot be made should not be used.' A strict position is adopted: if confirmation is difficult, use is prohibited. At the same time, a practical transitional measure is also required for materials already in use — that conflict of interest disclosures should be reviewed and updated sequentially.