Section 3(2) of Part 1 of the Guidelines on Promotional Information Activities for Prescription Drugs enumerates seven categories of prohibited conduct. A single prohibited act renders the entire information-provision activity non-compliant. Together with the requirements in Principle (1) and the proactive duties in Principle (3), these prohibitions mark the boundary that separates appropriate information provision from promotion that crosses the line.

The common thread running through all seven categories is this: even a technically accurate statement can be prohibited if the manner of presentation distorts the recipient's judgment. Selection, emphasis, and context can mislead just as surely as falsehood.

01Prohibition ① — False, exaggerated, or misleading claims

Acts prohibited under the advertising regulations of Article 66 (prohibition of exaggerated advertising) of the Pharmaceuticals and Medical Devices Act and the Standards for Appropriate Advertising are equally prohibited in information-provision activities. This covers stating falsehoods, exaggerating facts, and — critically — using technically accurate language in a way that is nonetheless likely to mislead. Unsupported modifiers such as "highly effective," "no side effects," or "dramatic improvement" are classic examples.

So what: Advertising regulations apply regardless of the format. Slides at a scientific symposium, verbal explanations by a medical representative, or digital content all carry the same standard. Labelling something "information provision" does not create an exemption.

So why: This prohibition closes the loophole by which companies might otherwise avoid advertising rules by relabelling promotional communications as "educational." Activities covered by these Guidelines are subject to the same standard as formal advertising under the PMD Act.

02Prohibition ② — Recommending unapproved uses

Recommending uses — indications, dosing regimens, or patient populations — not covered by the domestic approval is prohibited. This applies equally to uses approved in other countries. Framing foreign approval as "how the drug is used abroad" does not protect the communication if it implies or encourages unapproved use in Japan.

So what: "Recommendation" is not limited to explicit instructions. A statement that "efficacy has been shown in this patient population" or "research into off-label applications is advancing" can constitute a recommendation depending on context.

So why: Unapproved use means use that has not been evaluated for safety and efficacy under Japan's regulatory process. Allowing companies to actively circulate unapproved-use information would expand such use without the benefit of that evaluation, exposing patients to unquantified risk.

03Prohibition ③ — Inducing prescriptions without scientific or objective basis

Inducing a healthcare professional to prescribe or use a specific medicine without scientific or objective grounds is prohibited. This includes social-proof tactics: "This drug is increasingly being used for cases like yours," or "Many physicians in your specialty choose this option." Prescription volume, peer behaviour, and authority endorsement are not substitutes for evidence of efficacy and safety.

So what: A factually accurate statement about prescription volume — "this medicine is the most frequently prescribed in its class" — does not become permissible inducement simply because it is true. The evidence required is clinical: efficacy and safety data, not utilisation statistics.

So why: Prescribing decisions must be grounded in scientific evidence. Social proof and appeal to authority exploit cognitive shortcuts that bypass evidence-based reasoning, undermining the foundation of clinical decision-making that regulators rely on to protect patients.

04Prohibition ④ — Disparaging competitors to claim superiority

Using statements that disparage or denigrate competing products — or that use comparable techniques — to position a company's own medicine as superior is prohibited. Objective comparative data from head-to-head trials are not automatically prohibited, but the manner of comparison must not belittle competitors or present a selectively unfavourable picture of their products.

So what: A statement that "Drug X has fewer adverse events than Drug Y" may be permissible if supported by a direct comparison trial — but disproportionately emphasising "Drug Y causes serious adverse events" crosses into disparagement even when the underlying fact is accurate.

So why: Competitive attacks exploit emotional reactions and divert attention from scientific comparison. The forum for prescription drug information should be one of clinical reasoning, not adversarial marketing.

05Prohibition ⑤ — Stoking undue fear about disease

Excessively emphasising the risk of contracting a disease or the severity of its symptoms in a way that induces unwarranted anxiety is prohibited. A presentation may be based on accurate facts but still violate this prohibition if the purpose or effect is to generate fear rather than to inform clinical judgment.

So what: The threshold is contextual: how far does the presentation deviate from standard medical risk communication for the condition? Translating statistical risk into emotionally charged language, or presenting only worst-case scenarios, are typical examples of "excessive" emphasis.

So why: Fear-based information shifts the prescribing motive from rational clinical judgment to emotional reaction. Accurate risk communication has a legitimate place; engineering anxiety to drive prescriptions does not.

06Prohibition ⑥ — Misleading disease-awareness communications that present drug treatment as the only option

In disease-awareness activities directed at patients or the general public, it is prohibited to create the impression that treatment with a prescription drug is the only available course of action. Where lifestyle modification, alternative treatments, or watchful waiting are legitimate options, omitting them while foregrounding pharmacotherapy misleads recipients about what is available to them.

So what: "Please consult your doctor about this condition" is generally acceptable. "Drug treatment is necessary" or "early pharmacotherapy is recommended" in awareness communications that implicitly single out a specific medicine veers into prohibited territory.

So why: Disease awareness is legitimately aimed at encouraging appropriate medical consultation and informed health decisions. When it serves instead as a vehicle for expanding drug prescriptions, patients lose access to balanced information about all their options. Maintaining the boundary between awareness and promotion protects patient autonomy.

07Prohibition ⑦ — Any other expression likely to induce improper or mistaken use

Even if conduct does not fall squarely within categories ①–⑥, any expression that is likely to induce improper use or misuse of a medicine is prohibited. This omnibus clause ensures that novel media, communication formats, and techniques that were not foreseen when the Guidelines were drafted remain within the regulatory framework.

So what: "It is not explicitly listed" is not a defence. If a new communication method could reasonably lead to improper use, it falls under this clause regardless of whether a specific rule addresses it.

So why: Any enumerated list leaves gaps; the catch-all clause prevents companies from exploiting those gaps through technical innovation or novel framing. It also signals that the purpose of the Guidelines — protecting appropriate use — takes precedence over literal compliance with a fixed list.

ProhibitionTypical patternHow to identify it
① False/exaggerated"Virtually no side effects" / "Guaranteed to work"Unsupported superlatives or absolutes
② Unapproved use"Used for X in other countries"Reference to non-domestic approved indications
③ Baseless inducement"Chosen by many physicians"Prescription promotion without clinical data
④ Competitor disparagement"Drug A has more adverse events than ours"Asymmetrically negative framing of competitor
⑤ Undue fearPresenting only worst-case disease progressionRisk language calibrated to generate anxiety
⑥ Only-option disease awareness"Drug treatment is necessary for this condition"Language that excludes non-drug options
⑦ Other misuse-inducingNovel formats or channels that lead to improper usePotential for improper use, regardless of precedent
Summary

The seven prohibitions share a common target: any expression that distorts the recipient's judgment, even if it is not technically false. Categories ①–⑥ cover the most common risk patterns; the omnibus category ⑦ keeps the list future-proof.