Q（Question）

Does the fact that Q1 through Q9 address requests mean that comparative information between one's own and competing products cannot be provided at all unless physicians or pharmacists make a request?

A（MHLW answer）

Q1 through Q9 were written assuming situations in which marketing authorization holders are asked by physicians or pharmacists to provide comparative product information as part of marketing information activities; they were not intended to indicate that comparative information may only be provided when a request is made. When providing comparative information without a request from a physician or pharmacist, this must be done appropriately in light of 'On the Applicability of Advertising of Drugs, etc. under the Pharmaceutical Affairs Law' (Notification No. Yakukankan 148, September 29, 1998, Director of Supervisory Guidance Division, Pharmaceutical Safety Bureau, Ministry of Health and Welfare) and Section 2, Part 4-9 of 'Explanation and Considerations for Standards for Appropriate Pharmaceutical Advertising' (Notification No. Yakuseikaнmasa 0929 No. 5, September 29, 2017). Note that providing comparative information on one's own and competing products when the intent is not to attract customers — such as providing information related to promoting appropriate drug use or ensuring stable supply — does not constitute advertising and is permissible.

So what (meaning): Q1-Q9 address the request-driven scenario only; proactive comparative information provision without a request is not automatically prohibited but must be assessed for advertising applicability. Comparative information with no customer-solicitation intent (e.g., appropriate use promotion) is not advertising.

So why (rationale): Whether comparative information is permissible depends on advertising applicability and the absence of disparagement, not on whether a request was made; this clarification prevents unnecessary self-restraint.

Commentary — background, application, practical notes

Q10 makes explicit that Q1 through Q9 were written in the context of request-driven provision, and confirms that proactive comparative information provision without a prior request is not categorically prohibited. The Q&A restates the fundamental framework: whether comparative information may be provided depends on 'advertising applicability' and 'the presence or absence of disparagement,' not on whether a request was made.

When providing comparative information without a request, two branching questions must be assessed. The first is 'is there intent to attract customers?' Information provided without customer-solicitation intent — such as information related to promoting appropriate use or ensuring stable supply — does not qualify as advertising, and comparative information may be included in such communications without issue. The second question is 'does it amount to disparagement?' If comparative information is selective, one-sided, false, or exaggerated, it is prohibited regardless of whether a request was made.

The most common practical misreading is concluding, after reading Q1 to Q9, that proactive comparative information provision is entirely prohibited. This is unnecessary self-restraint, and Q10 was specifically added to correct it. The opposite misreading also exists: 'as long as a request is made, anything goes.' Even when responding to a request, the four conditions of Q1 — prohibiting selective information, requiring scientific objectivity, and so on — must all be satisfied; the existence of a 'request' is only one of the conditions. Avoiding both misreadings is the starting point for sound compliance practice.