Section 3(3) of Part 1 of the Guidelines on Promotional Information Activities for Prescription Drugs defines three affirmative obligations that go beyond the minimum requirements in Principle (1) and the prohibited acts in Principle (2). They are proactive duties: the company must fulfil them even when not prompted, and passive compliance is not sufficient.
All three obligations address information asymmetry. The pharmaceutical company knows its own product better than anyone. These duties convert that informational advantage into an obligation to equip healthcare professionals with what they need to make sound prescribing decisions.
01Proactive Duty ① — Disclose study methods alongside results to support accurate understanding
Providing trial results without describing how those results were obtained is insufficient. The study design (= how the trial was built and run) must be communicated alongside the findings. What counts as design here includes whether the trial was randomised (= patients assigned to each drug by chance, like a lottery, so the groups are not skewed), the extent of blinding (= keeping doctors and patients from knowing which drug is in use, to prevent bias), the trial duration, how endpoints (= the yardsticks used to judge whether a drug "worked") were defined, and the distinction between the primary endpoint (= the single main result the trial is built to confirm) and secondary endpoints (= the second-tier results checked alongside it). Only when methods are visible can the recipient assess the meaning and limits of the numbers.
So what: Presenting a "response rate (= the share of treated patients who showed a visible effect, such as tumour shrinkage) of 72%" requires also disclosing that the primary endpoint was imaging assessment at week X, the trial lasted Y weeks, and it was an open-label design (= a trial where both doctor and patient know which drug is given; not blinded). A physician needs that context to judge whether 72% is applicable to the patients in their practice.
So why: A result cannot be interpreted without its method. A 72% response rate from a randomised, double-blind trial (= a lottery-assigned trial in which neither doctor nor patient knows which drug is used — regarded as the most reliable design) carries a different evidential weight from the same figure in a single-arm (= only one group, with no comparison group) observational study. Without methodology, numbers circulate without context, and physicians are left to overgeneralise.
02Proactive Duty ② — State the design of comparative trials precisely, and provide negative findings
When communicating results from comparative trials, the trial design must be explicitly stated, and results must be interpreted in terms of that design. The design is one of three types: superiority (= a trial that tries to show the new drug is clearly better than an existing one), non-inferiority (= a trial that confirms the new drug is not much worse than an existing one), or equivalence (= a trial that shows the two work about the same). If the primary endpoint did not demonstrate superiority, that fact must be stated as such, even when secondary endpoints reached significance (= a difference clear enough that chance is an unlikely explanation). Negative information — results that did not reach statistical significance, safety signals (= early hints of a possible safety problem) — must be provided, not withheld.
So what: Presenting only a significant secondary endpoint while omitting the non-significant primary endpoint in a trial designed to test superiority violates this duty. Reporting a non-inferiority result as though it demonstrated superiority — "comparable or better efficacy" — is equally problematic.
So why: Trial design and interpretation are inseparable. A non-inferiority finding means only that the drug is not worse than the comparator by more than a pre-specified margin (= an allowed gap fixed in advance) — it does not establish superior efficacy. Without design disclosure and honest reporting of negative results, physicians form inflated impressions of what the evidence actually shows.
03Proactive Duty ③ — Proactively communicate items requested by the Ministry of Health, Labour and Welfare or PMDA
Information that the Ministry of Health, Labour and Welfare or PMDA (= Pharmaceuticals and Medical Devices Agency, the national body that reviews drugs and oversees post-market safety) has required the company to collect or communicate — post-marketing surveillance (= gathering real-world use data after launch to confirm safety) of adverse event incidence, safety signals identified in post-approval monitoring, risk information under specific conditions of use — must be proactively disseminated to healthcare professionals. Regulatory requirements to communicate safety information are obligations, not options.
So what: Typical examples are information on important identified risks (= adverse effects already confirmed) and important potential risks (= risks not yet confirmed but worth watching for) defined in the Risk Management Plan (RMP = a per-drug document listing the risks known at approval and those to be monitored going forward), and results from post-marketing studies (= studies that collect real use cases after launch to confirm safety) conducted as an approval condition. These are not discretionary; failure to communicate them is itself a compliance failure.
So why: Post-approval safety data captures risks that could not be fully characterised before approval. Regulators mandate its collection and communication precisely because pre-approval evaluation has inherent limits. If companies do not fulfil this obligation, the safety feedback loop that underpins the post-market monitoring system breaks down.
04What the three duties have in common
Each of the three obligations targets information that companies are structurally tempted to withhold: methodology that contextualises a favourable result (①), negative findings that qualify it (②), and post-approval safety data that may complicate the product's profile (③). The common element is that the obligation to disclose does not depend on whether a healthcare professional has asked.
So what: A material can satisfy requirements ① and avoid prohibitions ② while still failing to meet the proactive duties in ③. Compliance review must ask not only "what was provided?" but also "what was withheld?"
So why: Companies have a structural incentive to suppress unfavourable information. Codifying proactive duties creates institutional pressure that counteracts that incentive. The duties institutionalise the transfer of information that companies hold but healthcare professionals need.
Proactive duties ①–③ create obligations to disclose study methods, report negative findings, and communicate regulatory-required safety information. They fill the information completeness gaps that requirements (1) and prohibitions (2) alone cannot close.