Q（Question）

Part 1-3 Principle (2)(iv) prohibits claiming the superiority of one's own product by disparaging or defaming competing products. Is it nonetheless permissible to provide information on competing products or comparative information between one's own and competing products when requested by a physician or pharmacist?

A（MHLW answer）

Providing information on competing products or comparative information in response to a request from a physician or pharmacist does not itself violate that provision. However, all of the following conditions must be met.

• Limit the content of the information provided to what was requested and limit recipients to the requesting party. Confirm with the requesting physician or pharmacist the specific information being sought.

• Do not pretend that a request was made when no request for information was received from healthcare professionals or patients.

• The information provided must not be false or exaggerated; it must be accurate and based on scientific and objective evidence. Do not selectively choose only information unfavorable to competing products.

• When direct comparison is scientifically inappropriate, provide that fact and its reasons, along with any other information necessary to promote accurate understanding.

Because this activity is part of marketing information activities, compliance with the Guidelines and the Standards for Appropriate Pharmaceutical Advertising is a prerequisite.

So what (meaning): Comparative product information is not prohibited when requested, but the scope must be limited to the requester and specific request, and all four conditions of scientific fairness must be satisfied.

So why (rationale): The anti-disparagement rule targets unsolicited attacks on competitors, not neutral responses to requests; the four conditions prevent abuse while enabling legitimate scientific exchange.

Commentary — background, application, practical notes

The prohibition in Part 1-3(2)(iv) — claiming one's own product is superior by disparaging or defaming competing products — is directed at unsolicited attacks on competitors initiated by the manufacturer. Providing comparative information in response to a request from a physician or pharmacist is a categorically different act that lies outside the prohibition's scope. Q&A Part 4 makes this explicit while imposing four conditions to prevent abuse. The framing is not 'an exception that lifts the ban' but rather 'a different activity that was never prohibited in the first place.'

Typical situations include a physician considering switching treatments who asks specifically 'what is the clinical difference between your product and the current drug?' or a pharmacist asking 'do you have any literature comparing the adverse event profiles of both agents?' In these cases, the MR or MSL may respond by satisfying all four conditions: (1) limiting content to what was requested; (2) limiting recipients to the requesting individual; (3) using scientifically and objectively grounded information; and (4) noting where direct comparison is scientifically inappropriate.

Two errors are particularly common in practice. The first is 'fabricating a request': steering a conversation so that an unsolicited comparison appears to have been requested by the healthcare professional is an explicit violation. The second is 'selective information choice': presenting only adverse event data unfavourable to a competing product while omitting unfavourable data about one's own product is prohibited. These two points are frequently overlooked and are among the issues most likely to draw regulatory scrutiny.