Q（Question）

Although the Guidelines state that they apply 'regardless of the method or medium of provision,' does information provision through lectures given at events organized by a marketing authorization holder, upon its request, fall within the scope of the Guidelines?

A（MHLW answer）

Even if the lecture is given by an external expert such as a healthcare professional, if the intent and purpose of the event fulfill the requirements for 'sales information provision activities' as described in 2(2), the activity falls within the scope of the Guidelines.

So what (meaning): Lectures by external experts at company-sponsored events are subject to the Guidelines if the event itself is intended to promote sales. Using external speakers does not remove the activity from regulatory scope.

So why (rationale): Using external experts to create the appearance of neutral information provision is a recognized advertisement-like tactic; the Guidelines apply based on the intent and purpose of the event regardless of who delivers the content.

Commentary — background, application, practical notes

Arranging lectures by external experts such as physicians — with the pharmaceutical company covering the costs — has been a widely used form of promotional activity. The expectation has been that a physician speaking from personal clinical experience carries a different kind of persuasiveness from promotional materials presented directly by a pharmaceutical company. The Guidelines, however, explicitly state that they apply 'regardless of the method or medium of provision,' and this Q&A confirms that such indirect formats are assessed based on the intent and purpose of the event.

A typical scenario is a company-hosted physician forum at which a physician receiving a speaking fee delivers a lecture focused on trial results supporting the efficacy of the company's own product. When the pharmaceutical company is involved in selecting the topic, framing the theme, and reviewing the slides, the entire event constitutes sales information provision activity in substance, regardless of the fact that an external physician delivers the content.

The common mistake is attempting to claim an exemption on the grounds that 'the speaker is a physician, not a company materials presenter.' Because the relevant standard is the 'intent and purpose' of the event, what matters is not who delivers the information but what objective the event is organized to serve. The entire process — from setting the topic to reviewing the lecture content — therefore needs to be managed with the same scrutiny as formal materials review.