Q（Question）

During a meeting with a physician or pharmacist, the company determined that the healthcare professional has a strong interest in a certain therapeutic area. May the company provide information on unapproved drugs, off-label drugs, or domestically unapproved dosages related to that area even without a specific request from the physician or pharmacist?

A（MHLW answer）

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

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

So what (meaning): Even when a physician's or pharmacist's area of interest is known, providing unapproved or off-label information without an explicit request at that time is prohibited. This covers follow-up emails and material deliveries as well — all unsolicited provision is impermissible.

So why (rationale): A request from a healthcare professional is a prerequisite for off-label information provision; allowing companies to broaden the recipient pool at their own discretion would blur the line with promotional activities.

Commentary — background, application, practical notes

Limiting provision of unapproved and off-label information to cases where the healthcare professional has made an explicit request is the foundational requirement of Section 4-3. When a company learns a physician's area of clinical interest and proactively brings unapproved information on that topic to the next visit, the activity becomes indistinguishable from promotional outreach. Acting on the assumption that 'interest implies intent to use' and voluntarily delivering information amounts to company-initiated information dissemination — precisely what the Guidelines are designed to prevent.

A typical violation involves a physician mentioning during a meeting that patient volume for a certain condition is increasing, prompting the company representative to prepare and bring a collection of off-label use literature on that condition to the next visit 'in case it is useful.' Because the physician made no request for that material on the day it is delivered, and the company inferred the need from the earlier conversation and prepared accordingly, the delivery constitutes unsolicited provision. The same prohibition applies to follow-up emails, postal mailings, and digital content sharing.

A frequently misunderstood scenario is whether a representative may produce and provide materials during the same meeting in which a physician expressed interest. The answer turns on whether the physician made an explicit request during that meeting. Expressing interest and requesting information are distinct acts, and inferring a request from expressed interest — then voluntarily providing materials based on that inference — is not permissible. Sending follow-up 'supplementary information related to materials previously provided' without a specific new request is equally prohibited as unsolicited provision.