Q（Question）

When a physician or pharmacist requests comparative drug pricing information between one's own and competing products, is it permissible to provide such information?

A（MHLW answer）

Drug pricing information is not subject to the regulations of the Guidelines as a content matter; however, because such provision is part of marketing information activities, compliance with the Guidelines and the Standards for Appropriate Pharmaceutical Advertising is a prerequisite. When providing such information, it must constitute a fair comparison that does not cause misunderstanding in physicians or pharmacists.

So what (meaning): Drug pricing comparisons fall outside the Guidelines' regulatory scope as content, but as part of promotional activity they must comply with advertising standards and be fair comparisons that do not mislead.

So why (rationale): Drug pricing differs from the scientific information the Guidelines primarily govern, but it influences prescribing and dispensing decisions, so fairness requirements still apply.

Commentary — background, application, practical notes

Drug pricing information does not fall within the 'scientific information about pharmaceuticals' that the Guidelines primarily regulate, so the scientific evidence requirements set out in Part 1-3(1) do not apply. However, because drug pricing information is still provided as part of marketing information activity, it remains subject to the general requirements of the Guidelines and the Standards for Appropriate Pharmaceutical Advertising, including the obligation to ensure fairness.

A typical scenario is a physician or pharmacist asking 'is there a difference in reimbursement points between your product and the competing product?' or 'how does the branded drug price compare to available generics?' Drug prices are publicly set by the Ministry of Health, Labour and Welfare, and presenting accurate figures is unproblematic. However, the impression created by a price comparison can differ significantly depending on whether the comparison uses daily cost, per-course cost, or per-unit cost, so explicitly identifying which calculation basis was used is important for preventing misunderstanding.

A practical caution: layering an assessment of 'pharmacoeconomic superiority' onto a drug price comparison introduces a separate compliance question — comparative advertising under the Standards for Appropriate Pharmaceutical Advertising — distinct from the scientific fairness requirements of the Guidelines. There is a meaningful regulatory distinction between simply stating 'the drug price is X yen' and asserting 'our product is superior in cost-effectiveness.' When providing drug price comparisons, the safest practice is for the medical affairs representative to present only the pricing figures without independently adding economic evaluations.