Q（Question）

When a company is providing information on unapproved drugs, off-label drugs, or unapproved dosage regimens to a physician or pharmacist who requested it, and another physician or pharmacist joins and asks to receive the same information, may the company provide information to that additional person?

A（MHLW answer）

Providing information to the additionally attending physician or pharmacist who has expressed a wish to receive it is permissible, provided the conditions of this guideline are met.

Items requiring particular attention: (3)

So what (meaning): If a second healthcare professional proactively joins and requests the information, the request-based principle is satisfied and providing them with the same information is allowed.

So why (rationale): The additional attendee's expressed wish constitutes a request under item (3), so the core requirement is met regardless of the number of recipients.

Commentary — background, application, practical notes

This question addresses what happens when a third party joins an ongoing session at which unapproved drug information is being provided in response to one healthcare professional's request. The answer—that information may also be provided to the newcomer if they request it—demonstrates that the request principle is about each individual's expressed desire, not about the number of people present.

A typical scenario: a representative is explaining off-label information to Physician A, who requested it, when Physician B from the same department enters and says they would like to hear the information as well. At that moment, Physician B has made a request, so providing the same information to Physician B is permissible.

A common error involves situations where the additional person has merely been present and overheard the exchange without explicitly expressing a wish to receive the information. Passive presence—simply being in the room when the information was discussed—does not constitute a request. Care is also needed to ensure that the provision to multiple attendees does not functionally resemble an unsolicited group presentation, a concern that connects directly to Q21 (the departmental briefing scenario). The joiner's expression of interest must be active and personal—'I would like to receive this information too'—not merely incidental.