Q（Question）

When an overseas affiliate of a Japanese company hosts a lecture at which information on drugs approved abroad—covering unapproved indications or dosage regimens domestically—is presented, and a Japanese physician or pharmacist attends that lecture without any encouragement or initiative from the Japanese company, does this constitute information provision by the Japanese company on unapproved drugs, off-label drugs, or unapproved dosage regimens?

A（MHLW answer）

No, it does not.

Items requiring particular attention: (1)

So what (meaning): When Japanese physicians attend an overseas affiliate's lecture entirely on their own initiative—without the Japanese company's involvement—the information presented there is not attributed to the Japanese company as its own act of information provision.

So why (rationale): Without any active involvement or solicitation by the Japanese company, the activity cannot be classified as that company's sales or information provision activity under item (1).

Commentary — background, application, practical notes

This question resolves a grey area that arises in international corporate group structures. Specifically, it asks whether information presented at a lecture organized by an overseas affiliate of a Japanese company constitutes information provision by the Japanese company when Japanese physicians or pharmacists attend independently. The answer is no, provided the Japanese company has not actively involved itself or solicited their participation.

A plausible scenario: an overseas subsidiary hosts a product lecture at an international academic conference, presenting information consistent with that country's approved labeling. A Japanese physician attending the conference independently stops by the lecture. If the Japanese parent company has not encouraged, guided, or financially supported that physician's attendance at the lecture, the information presented there is not attributed to the Japanese company.

The 'without encouragement or initiative by the Japanese company' requirement is interpreted strictly. If the Japanese company's representative shares the lecture schedule and venue with a physician, communicates in a way that suggests they attend, or covers travel and accommodation costs premised on attendance at that lecture, active involvement can be established and the exemption ceases to apply. Independent participation in form but guided participation in substance does not qualify for this carve-out.