Q（Question）

May a company provide information on unapproved drugs, off-label drugs, or unapproved dosage regimens to a physician or pharmacist for the purpose of co-authoring an academic journal article with a company researcher?

A（MHLW answer）

In the described situation, providing such information is permissible. However, compliance with relevant laws and regulations including the Clinical Trials Act and applicable guidelines is required.

Items requiring particular attention: (1)

So what (meaning): Co-authorship for academic publication allows sharing of unapproved drug information with a physician or pharmacist, provided the company complies with the Clinical Trials Act and related guidelines.

So why (rationale): Academic co-authorship is categorized outside sales information activity (item 1), but legal compliance obligations remain independent of that categorization.

Commentary — background, application, practical notes

Sharing unapproved drug information with healthcare professionals for the purpose of co-authoring an academic journal article is recognized as a legitimate scientific activity distinct from promotional information provision. Crucially, however, this permission is expressly conditioned on compliance with the Clinical Trials Act and other applicable laws and guidelines.

A typical co-authorship scenario involves a company researcher—often from the Medical Affairs department—leading the analysis and drafting of a manuscript based on clinical study data, with a physician or pharmacist who has clinical expertise invited as a co-author. In this context, sharing unpublished trial data and both positive and negative analytical results with the co-author is a necessary part of the collaboration and is permitted.

Two boundary errors are common. First, using a co-authorship arrangement to disguise company-driven promotional messaging in academic form—sometimes referred to as ghostwriting—is strongly condemned under the Clinical Trials Act and industry self-regulatory codes, and does not fall within the scope of this permission. Second, using the same co-authored paper as the basis for providing off-label information to other physicians who are not part of the collaboration is a separate act subject to the request-based principle. The permission granted here applies within the specific boundaries of the co-authorship itself and does not generalize beyond it.