Q（Question）

When a physician or pharmacist requests comparative efficacy information between one's own and competing products, is it permissible to provide information from conference presentations that have not yet been published as papers?

A（MHLW answer）

The handling of information provision is the same as A1.

Regarding cited materials, Guideline Part 1-3(1)(iii) establishes as a principle that 'information provided must be based on scientific and objective evidence and must be accurate enough to demonstrate that evidence. The scientific evidence must be verifiable and objectively evaluable by third parties, including the original data, or must have undergone propriety review by a third party (such as peer review of papers), including evaluation materials and review reports used in approval assessments.' The fact that a conference presentation has not been published as a paper does not alone render it impermissible; however, because conference presentations are not substantively peer-reviewed and evidence cannot be considered fully established, the information must be provided with a clear explanation that it derives from a conference presentation not yet published as a paper and that the evidence is not yet fully established. Additionally, because this activity is part of marketing information activities, compliance with the Guidelines and the Standards for Appropriate Pharmaceutical Advertising is a prerequisite.

So what (meaning): Conference-only data may be shared, but the presenter must explicitly state that the data is unpublished and not peer-reviewed and that the evidence base is not yet established.

So why (rationale): The Guidelines require evidence verifiable by third parties; conference abstracts lack peer review, so mandatory disclosure of this limitation prevents overinterpretation by healthcare professionals.

Commentary — background, application, practical notes

Guideline Part 1-3(1)(iii) requires that the scientific basis for information provided must be 'objectively evaluable and verifiable by third parties, including original data, or must have undergone propriety review by a third party such as peer review of papers.' Although conference presentations go through an abstract selection process, this differs substantially from peer review in both rigour and depth. Q4 does not prohibit the use of conference data, but it imposes an obligation to explicitly disclose the limitations of the evidence in order to prevent healthcare professionals from overvaluing it.

A typical scenario is a physician requesting comparative data — such as efficacy rates shown in an abstract or slides — that exists only as a conference presentation and has not been published as a paper. The provider must clearly communicate two points, both verbally and in writing: that the presentation has not been peer-reviewed, and that the evidence cannot be considered fully established at this time. Documentation of the provision — who received what information, when, and with what explanatory caveats — is also important for audit readiness.

A common practical error is assuming that labelling conference slides as 'reference information' is sufficient. The phrase 'reference information' does not adequately convey the limitations of the evidence. A specific statement that the material has 'not undergone third-party peer review' and that 'the evidence base is not yet established' is required; omitting this constitutes a Guideline violation. Additionally, using conference presentation data to emphasise comparative figures in a promotional context goes beyond the scope of request-driven provision and creates separate compliance problems.