Q（Question）

When a physician or pharmacist requests information on unapproved/off-label drugs or domestically unapproved dosages and a peer-reviewed original article is provided in accordance with the Guidelines, may the same information be provided to other physicians or pharmacists who have not made a request to the company?

A（MHLW answer）

Without a request from a physician or pharmacist, provision of information on unapproved/off-label drugs or domestically unapproved dosages is not permitted.

Items requiring particular attention: (2), (3)

So what (meaning): Even if the same material was already provided to one healthcare professional who requested it, proactively distributing it to other non-requesting healthcare professionals is prohibited. The identity of the information does not justify wider distribution — each provision requires an individual request.

So why (rationale): Only responses to individual requests are permitted; the sameness of the information does not justify lateral distribution. Unsolicited distribution becomes indistinguishable from promotional activity and is therefore prohibited.

Commentary — background, application, practical notes

The 'individual request' requirement functions as a response to a specific healthcare professional making a specific request at a specific time. Having previously provided information to one physician does not license the company to distribute the same information to others who have not requested it. If that were permitted, companies could systematically disseminate unapproved information across an entire medical department or specialty — effectively achieving broad promotional distribution under the guise of request-response information provision.

Typical scenarios include being asked after a ward visit to 'pass the same information along to the other physicians on the team,' or attempting to distribute the same journal article to multiple physicians at a departmental meeting. In the first case, even if the original requesting physician wants the information shared, the absence of individual requests from the other physicians means it cannot be provided to them. In the second case, blanket distribution to all attendees is not permissible unless each physician present individually makes an explicit request during that meeting.

Common rationalizations — 'it is the same information, so there is no problem' and 'the physicians will share it with each other anyway' — both fail to satisfy the requirement. The identity of the information is not a qualifying condition for broader distribution. Nor is the reasoning 'physician A requested it, so I judged that providing it to physician B was also acceptable.' Each individual request is an independent event; a response to one physician does not create authority to respond on the same basis to another who has not asked.