Q（Question）

Regarding principle ②, which states 'provide not only information on the efficacy of prescription drugs but also safety information including adverse reactions, and do not arbitrarily select the information provided,' is it correct to interpret this as requiring the provision of balanced and appropriate information that includes both favorable and unfavorable information?

A（MHLW answer）

That understanding is correct.

So what (meaning): Both efficacy and safety information — including adverse reactions — must be provided without arbitrarily omitting data unfavorable to the company. Selective extraction of favorable data is not permissible.

So why (rationale): Balanced information provision is essential for healthcare professionals to make accurate treatment decisions; one-sided information undermines patient safety and appropriate drug use.

Commentary — background, application, practical notes

The requirement to 'not arbitrarily select the information provided' directly targets the problem of one-sided information provision. Selecting and shaping the content of information to favor the company's own interests interferes with healthcare professionals' ability to make appropriate prescribing decisions and poses a risk of harm to patients; the principle of balanced information provision was therefore established.

Typical practical scenarios include citing multiple trial results but omitting studies where the primary endpoint showed no statistically significant difference, presenting only studies where a favorable secondary endpoint outcome was observed; or excerpting only the subgroup analysis from a meta-analysis where the overall effect size was small but a specific subgroup showed a high effect.

The misunderstanding most commonly encountered is 'there is no problem because no false information is included.' Even when each individual citation is scientifically accurate, if the overall impression created by the selection, combination, and emphasis of citations diverges from what the original papers and trial results actually show, this constitutes 'arbitrary selection of information.' In particular, the materials review process should incorporate a step that specifically checks whether the overall balance of a set of materials is faithful to the underlying evidence.