Q（Question）

May Medical Affairs (MA) employees of a company present clinical trial data on unapproved drugs, off-label drugs, or unapproved dosage regimens at an academic conference?

A（MHLW answer）

It is permissible for company employees to present clinical trial data at a conference that the company does not organize or co-organize, in response to a request from the conference, and in accordance with the conditions of this guideline.

Items requiring particular attention: (2), (3), (7)

So what (meaning): MA employees may present unapproved-drug trial data at a third-party academic conference, but only when the presentation is given in response to a request from the organizing academic society—not self-initiated by the company.

So why (rationale): A presentation invited by the academic society is treated as a scientific activity separate from promotion; self-initiated presentations at company-sponsored events would fall under a different assessment against items (2), (3), and (7).

Commentary — background, application, practical notes

This question clarifies the regulatory status of a Medical Affairs (MA) employee presenting clinical trial data on unapproved or off-label drugs at an academic conference. The conclusion is that such a presentation is permissible when it takes place at a conference the company does not organize or co-organize, and when the presentation is given in response to a request from the conference.

Typical scenarios include MA employees giving poster or oral presentations at domestically or internationally organized third-party academic societies. In practice, the 'request from the conference' requirement is satisfied when the academic society has invited the employee as a speaker or when an abstract has been accepted through a scientific peer review process. The presentation of clinical trial data is classified as a scientific activity aimed at disseminating knowledge, which is inherently distinct from promotional activity.

The condition 'not organized or co-organized by the company' is a frequent source of ambiguity. If a company provides financial sponsorship or co-organizes a symposium or satellite session at which its MA employee presents, the activity may be assessed as equivalent to company-organized, removing the permissibility. The fact of having received a request from the conference should be verifiable from records; an MA employee independently selecting a presentation topic because 'it is an academic venue' does not satisfy the request requirement. Additionally, the content of the presentation must reflect balanced information (item 2), and the materials used must have undergone the company's internal review process (item 7) before the presentation proceeds.