Q（Question）

If a company's internal rules clearly stipulate that the activities of the Medical Affairs division or Medical Science Liaisons are separated from 'sales information provision activities,' may those activities be considered outside the scope of the Guidelines?

A（MHLW answer）

Whether an activity constitutes a 'sales information provision activity' is assessed and determined individually based on the actual activities conducted; therefore, the fact that internal rules stipulate a clear separation from 'sales information provision activities' does not automatically exclude those activities from the scope of the Guidelines.

So what (meaning): Internal rules separating Medical Affairs or MSL roles from sales promotion are not sufficient to achieve exemption. The actual content of each activity remains subject to individual assessment.

So why (rationale): Consistent with Q3, the regulatory principle focuses on actual activity rather than formal documentation, preventing companies from using internal rules as a shield against the Guidelines.

Commentary — background, application, practical notes

Medical Affairs (MA) and Medical Science Liaisons (MSLs) are established functions — particularly in global pharmaceutical companies — that are positioned as responsible for scientific exchange and treated as independent from the sales organization. Many companies explicitly articulate this independence in internal policies. The Guidelines, however, make clear that such institutional or documentary separation does not exempt activities from assessment on their substantive merits.

A typical scenario is an MSL hosting a webinar for physicians that introduces recent academic papers or real-world data analyses related to the company's own product. Even when the content is presented in a scientific framing, if the bulk of the information centers on data demonstrating the efficacy or usefulness of the company's own product, the actual character of the activity may be judged as sales information provision.

The practical mistake most commonly made is over-relying on a department's identity as 'scientific exchange specialists' and treating that identity as a shield against the Guidelines. When there is a gap between what the policies define and what the activity actually involves, the policy affords no protection. The existence of internal rules is not a substitute for accurately designing, reviewing, and documenting individual activities; MSL and MA activities should also be subject to materials review.