Section 3 of Part 1 of the Guidelines on Promotional Information Activities for Prescription Drugs (Yakuseihatsu 0925 No. 1) establishes the foundational principles governing all information-provision activities that pharmaceutical companies conduct toward healthcare professionals. The starting point is the obligation under Article 68-2 of the Pharmaceuticals and Medical Devices Act to provide information necessary for the proper use of medicines — including contraindications from the package insert and safety measures under the Risk Management Plan (RMP). On that foundation, the Guidelines set out three pillars: requirements to be met, prohibited acts, and proactive obligations.
Appropriately communicating contraindications and RMP-mandated safety measures is the bedrock of all three pillars. The three-tier structure — requirements, prohibitions, and proactive duties — converges on a single objective: delivering accurate, complete information without selective omission.
01Principle (1) — Requirements to Be Met
Four minimum conditions determine whether an information-provision activity is appropriate: information must stay within the approved scope, cover both efficacy and safety, be grounded in scientific evidence, and cite its sources. These four requirements form the baseline.
So what: Implying off-label uses, promoting efficacy while concealing adverse events, or presenting figures without citing their source — each makes the entire activity non-compliant.
So why: Healthcare professionals base prescribing decisions on the information they receive. Incomplete or inaccurate information translates directly into prescribing errors; minimum quality standards protect patient safety at the point of information exchange.
02Principle (2) — Prohibited Acts
Seven categories of conduct are explicitly prohibited: false or exaggerated claims, recommending unapproved uses, inducing prescriptions without scientific basis, disparaging competitors, stoking undue anxiety about diseases, misleading disease-awareness communications, and any other expression likely to cause improper use. Together they cover the situations where information provision is most at risk of becoming covert promotion.
So what: A single prohibited act renders the entire activity non-compliant, regardless of how it is framed. Labelling something "information provision" does not protect it if the substance constitutes inducement or exaggeration.
So why: Commercial interest and patient safety are structurally in tension in prescription drug promotion. An explicit prohibited-acts list removes interpretive ambiguity between companies and regulators about where the line sits.
03Principle (3) — Proactive Obligations
Three affirmative duties require companies to go beyond the minimum: disclosing study methods alongside results, reporting negative findings from comparative trials, and proactively providing information requested by the Ministry of Health, Labour and Welfare or PMDA.
So what: Silence on unfavourable data is not acceptable even when no one has asked. If a healthcare professional needs a piece of information to make a sound clinical decision, the company must volunteer it.
So why: Companies always have an incentive to present only favourable data. Codifying proactive obligations structurally corrects the information asymmetry that would otherwise disadvantage prescribers and patients.
04How the Three Principles Interlock
Principle (1) sets the floor, Principle (2) marks the boundary, and Principle (3) adds an affirmative ceiling. Meeting the requirements while avoiding prohibited acts is necessary but not sufficient; companies must also fulfil proactive duties to be considered fully compliant.
So what: Compliance review follows three sequential gates: Does it meet requirements? Does it avoid prohibited acts? Does it discharge proactive duties? In practice, the third gate is where most materials fail.
So why: "Not false but incomplete" is the most dangerous state for medical information. The three-tier structure deliberately separates legal permissibility from genuine appropriateness and demands the higher standard.
Section 3 of Part 1 defines the full landscape of prescription drug information-provision activities through three pillars: requirements, prohibitions, and proactive duties. Each sub-principle (msa1-3a / msa1-3b / msa1-3c) elaborates on one pillar in detail.