Foundations — Full Reading Version

Foundations — the foreword's spirit and the discipline of science

01The foreword is the constitution of the whole guide

The body of the creation guide does not begin with Part I and the product information summary. The opening foreword, "Introduction," is the higher-order norm that runs through every provision that follows. Skip it, and you lose sight of why each clause reads the way it does. Hold onto its spirit, and you keep a compass even where the guide says nothing explicit.

The foreword states several things plainly. Companies have a duty to convey accurate information to healthcare professionals. Conveying it without misleading the recipient matters as much as the accuracy itself. The basis for proper-use information is the electronic package insert; the product information summary and similar materials merely supplement it. Media have shifted from print to digital and the Web, yet the principles to uphold have not changed. The guide sets out basic matters rather than covering every territory, and anything outside its provisions still falls under the Pharmaceuticals and Medical Devices Act, the Standards for Fair Advertising, the sales information provision guidelines, and the JPMA Code. Materials for additional risk minimization under an RMP are handled separately, by a voluntary agreement.

02Five implications the foreword carries

The foreword does more than state; it carries operational implications between the lines. Putting them into words sharpens how you read the individual pages. Here they are, broken into five.

① "Supplement" builds the wall of the approved scope

The product information summary sits below the electronic package insert. The insert is the approved content itself; the summary is a document that complements it. For exactly that reason, the summary cannot exceed the approved scope by even one character. Indications and dosage may be written only within the approved frame. This single point is the source of the many "must nots" that follow.

② "Accurate and not misleading" is two separate duties

The duty not to lie and the duty not to mislead are not the same. Every word may be factually true, yet if the presentation leads the reader to form a false picture, that can be a violation. How an axis is drawn, where emphasis is placed, the order in which things are arranged. The demand is to manage not only the truth of the facts but the impression they raise.

③ "Not exhaustive; the unwritten still applies" forbids treating it as an answer key

Not written in the guide does not mean permitted. The guide sets out only basic matters, and unwritten territory is governed by the higher norms. This is also a device that keeps the guide from shrinking into a checklist of banned acts. It forecloses, from the start, the notion that dodging the letter of a clause gets you through.

④ The evolution of media is an assignment to re-translate print practice

Media have moved from print to digital and the Web. But because the principles are the same, the craft built up in print must be translated into the new media. How do print assumptions — character size, placement, ease of reference — get implemented in a world of screens and links? The guide devotes later chapters to each medium precisely to make this re-translation concrete.

⑤ RMP materials are tools for safe use before they are tools for selling

That materials for additional risk minimization under an RMP are handled in a separate frame reflects the true character of materials. A material is a tool for getting a product used safely before it is a tool for selling that product. This order of priority flows into the whole guide through the way safety information is handled.

03Understanding the hierarchy of scientific evidence

When the guide says "accurately," that accuracy rests on the quality of the evidence. The same result — "it worked" — carries entirely different weight depending on the study design behind it. Generally, meta-analyses and systematic reviews sit at the top, followed by randomized controlled trials, then observational studies (cohort and case-control), then case reports, and finally expert opinion and review articles.

The watershed of quality is peer review. Whether a claim has passed verification by independent experts changes its credibility greatly. And results from in vitro experiments or animal studies must not be tied directly to the human clinical setting, because of differences in species, dose, and experimental system. The guide repeatedly requires the notation "(animal species)" or "(in vitro)" to fix this hierarchy awareness into the writing itself.

04Trial design determines the weight of a conclusion

Before the numbers, ask what design produced them. This is the basis of reading a clinical trial.

Devices that even out bias

Randomization evens out both known and unknown bias across the two arms at once. Double blinding, by hiding the allocation from both patients and assessors, keeps expectation and subjectivity from seeping into the result. The choice of comparator carries meaning too: a placebo control shows the absolute effect of the drug, an active control shows its standing among existing drugs. What you can read off the trial changes with which one was placed.

The weight gap between confirmatory and exploratory

A trial may be confirmatory — going to confirm one hypothesis fixed in advance — or exploratory — going to search for the hypothesis itself. The two bear entirely different weight as conclusions. A relationship seen in an exploratory trial is a "candidate to be verified next," not an established fact.

05Discipline of analysis — what it means to decide in advance

Even with the same data, a conclusion bends if the craft of analysis breaks down. The guide is strict on analysis because the room for arbitrariness here is large.

One primary endpoint, in principle

The primary endpoint to be confirmed is, in principle, narrowed to one in advance. Test many endpoints at once and the probability that one of them turns out "significant" by chance swells. To avoid this multiplicity, what counts as the primary endpoint is decided before the trial begins.

Pre-specified, or post hoc

An analysis written into the plan in advance (pre-specified) and one done after seeing the data (post hoc) are treated differently. A post hoc analysis should state, at its outset, that it is post hoc and why, and be presented modestly. A re-analysis that differs from the original plan is treated as post hoc even if it has been published.

Subgroups and ITT

Subgroup analyses are treated as exploratory, limited to those planned in advance, and presented alongside the whole-population result. To avoid the trick of dropping discontinued cases to improve appearances, the ITT principle (analyzing all randomized cases) is valued. A meta-analysis must follow the procedure of a systematic review.

06Do not mistake what the statistics mean

Each statistic answers a different question. Mistake the question, and a false conclusion is drawn from a correct number. The table below sorts the main measures by "what they say and what they do not."

The relationship between statistical significance and clinical significance is especially easy to misread. In a large trial, even a clinically tiny difference can reach statistical significance. Conversely, the absence of a significant difference does not mean "equivalent" — it may only mean the power to detect a difference fell short. A p-value is only a comparison against chance; it says nothing about effect size or clinical value itself. A hazard ratio, too, cannot be grasped without reading the confidence interval and the absolute difference together. A nominal p-value is any p-value from analyses other than the pre-specified confirmatory analysis, and cannot serve as the basis for a confirmatory conclusion.

07Three pillars running underneath — read them as design philosophy

Gather the foreword and the discipline of science together, and three design ideas run underneath the whole guide.

First pillar — closing off "factual yet misleading"

Beyond forbidding falsehood, close off misdirection through how facts are shown. This is implication ② carried straight into implementation. The fine restrictions on graph emphasis and selective extraction all derive from this pillar.

Second pillar — implementing balance as structure

The balance of efficacy and safety is secured by structure, not by good intentions. Make the safety text size equal to or larger than the efficacy text, show the page that serves as basis, hold reference information to a set share of the page. Such concrete specifications drop balance into "implementation." Safety in particular is imposed as an asymmetric duty: it must be disclosed even when unfavorable to the company. The very safety information that is inconvenient is what must not be hidden.

Third pillar — securing verifiability through structure

Sources, statistical methods, the date of creation or revision. By always requiring these to remain, the guide keeps a state in which a third party can later retrace a claim. Building verifiability in as structure is itself the guarantee of trust.

→ Source page: Foundations — the foreword's spirit and the discipline of science

(1) The duty to communicate accurately

Communicating accurate information about prescription drugs to healthcare professionals is not a discretionary act for pharmaceutical companies. The foreword to the Creation Guide opens by stating plainly that companies bear an obligation to transmit accurate information. That single sentence is the foundation on which every rule in the Guide rests. Why an obligation? Where does it come from? Grasping the answer is where reading the Guide must begin.

01Promoting appropriate use — "selling" is not the starting point

The foreword defines the purpose of a Product Information Summary as "communicating accurate information about individual prescription drugs and promoting their appropriate use." The phrase "appropriate use" sets this purpose on a different axis from sales promotion.

Appropriate use means administering an approved drug for its approved indications, at the approved dosage, to the patients who need it, for no longer than necessary. The role of a Product Information Summary is to build the information environment that lets healthcare professionals make those judgments correctly. When materials tilt toward promotional exaggeration, prescribers make decisions on premises that do not reflect reality. The foreword places "promoting appropriate use" first in its statement of purpose precisely to make this structure explicit.

The idea that selling is sufficient is fundamentally incompatible with the aim of promoting appropriate use. Among the individual rules in the Guide, which are often read as advertising restrictions, the foreword's early statement of purpose carries structural weight that regulation alone cannot supply.

02Information asymmetry as the basis of the obligation

Physicians and pharmacists cannot read primary literature on every drug they handle. In practice, the information companies provide is the principal route through which healthcare professionals understand a product's efficacy and safety.

This is information asymmetry. Companies hold vast datasets accumulated from the earliest stages of development. Healthcare professionals have no independent means to verify the full picture. Inside this asymmetric structure, if companies select only favorable information to pass on, clinicians make judgments based on a distorted image. The consequences reach patients directly.

The foreword's use of the word "obligation" reflects the recognition that closing this asymmetry is the company's responsibility. Information provision is not a discretionary choice — it is a structural responsibility that the information-rich party owes to the information-poor party.

03An asymmetric obligation — disclosure includes unfavorable information

The duty to communicate accurate information does not apply only to information that is favorable to the company. Read in light of the foreword's spirit, safety information must be disclosed even when that information is unfavorable to the company.

This "asymmetric obligation" runs through the entire Guide as an undercurrent. Requirements that safety information be given equal or greater prominence than efficacy information, rules that important safety data appear in a form consistent with the package insert — all of these are structural safeguards against the temptation to show only what is convenient.

→ Source page: (1) The duty to communicate accurately

(2) The requirement not to mislead

The foreword states that communicating information "accurately, without causing misunderstanding" is increasingly important. The word order matters. "Without causing misunderstanding" comes before "accurately." That sequence is deliberate. Not deceiving is a necessary condition — but the foreword signals from the outset that it is not sufficient.

01Why "not deceiving" is not enough

Prohibiting falsehood is where all regulation begins. But it does not, by itself, achieve accurate communication. Using true facts as raw material while controlling how they are arranged, cropped, or weighted can produce in the reader an understanding that diverges sharply from the overall picture.

Consider a concrete case. A primary endpoint failed to reach statistical significance, but an exploratory subgroup analysis produced a significant result, and that result is placed prominently. Every number is accurate. But the reader concludes that solid efficacy evidence exists. No deception has occurred. Misunderstanding has.

The same applies to presenting only the relative risk reduction in large type while relegating the absolute risk reduction to a footnote. Both figures accurately reflect the trial. The presentation nonetheless engineers the impression that "this drug works." Accurate facts can be used to induce incorrect judgment — and that is why "not causing misunderstanding" is a demand one tier higher than "not deceiving."

02What it means to cause misunderstanding

Misunderstanding is hard to define because it depends on the reader's interpretation. In the context of the Creation Guide, however, it can be understood as follows: a state in which a reasonable healthcare professional, having reviewed the material, arrives at an understanding inconsistent with the actual weight and limitations of the underlying evidence.

Defined this way, the problem reaches beyond "what is written" to "what is absent." If unfavorable safety data are omitted, the reader may interpret their absence as "no particular concerns." If confidence intervals are not shown, the width of uncertainty around a point estimate goes unnoticed. Omission and asymmetric placement distort the reader's understanding just as surely as inaccurate text.

Three routes through which misunderstanding arises

Misunderstanding enters through three main channels. Selection — presenting only favorable results. Layout — giving favorable information large treatment and unfavorable information small treatment. Context stripping — excising a portion from the whole. None of these is fabrication. But each moves the reader's understanding away from reality in the same way that a lie would.

03Why this is a higher standard than accuracy alone

The obligation to "communicate accurately" imposes a higher standard than the obligation to "deliver correct information." Delivering correct information while the reader forms an incorrect understanding still falls short of compliance — that is the foreword's position.

The practical context makes this demand rational. Clinicians are busy. There is rarely time to read a material from cover to cover. Impressions formed at a glance, numbers that catch the eye, the summary block — these are the inputs from which judgments are quickly assembled. Material authors cannot assume careful reading. They must design for what a distracted, skimming reader takes away.

→ Source page: (2) The requirement not to mislead

(3) The philosophy of supplementation

The foreword establishes that the foundation of appropriate-use information is the (electronic) package insert, and that the Product Information Summary merely supplements it. The sentence is short, but this hierarchy is the root from which every constraint in the Creation Guide branches. The prohibition on going one word beyond approved content, the obligation to include safety information without omission — both derive from here.

01What it means for the package insert to be the "source of record"

The electronic package insert is the official record of what the national authority has approved: indications, dosage, contraindications, adverse reactions, interactions. The content of the package insert is determined by what the government approved, nothing more. No matter how well-designed a Product Information Summary may be, it cannot step outside the approved record.

Being the "source of record" carries three concrete implications. First, the approved content sets the ceiling on what may be stated — unapproved indications or dosages may not appear. Second, when the package insert is revised, the Product Information Summary must follow — if the original changes, the supplement must change with it. Third, where the Product Information Summary contradicts the package insert, the summary is wrong — the original always takes precedence.

What digitization changed, and what it did not

The transition from paper package inserts to electronic ones changed how the document is accessed. It did not change the package insert's position as the source of record. Digitization is an operational shift. The hierarchy between the package insert and the Product Information Summary remains unchanged.

02What supplementing means — and where deviation begins

To supplement means to make approved content easier to understand, or to organize information for a particular clinical audience or setting, taking the original as given. Presenting package insert content in a visual format, pulling out items relevant to a specific patient population, adding academic context to deepen understanding — these are legitimate acts of supplementing.

Deviation begins when the purpose of supplementing is exceeded. The following are typical cases.

• Adding content that touches on unapproved indications
• Suggesting dosages or routes outside the approved range
• Failing to present safety information boxed in the package insert with equivalent prominence
• Omitting contraindications, or positioning them so they are unlikely to be noticed

Each of these crosses out of legitimate supplementing. Inserting unapproved claims into a material is not supplementing the package insert — it is attempting to rewrite the limits the package insert defines.

03The chain of constraints the hierarchy generates

The hierarchy — package insert as original, Product Information Summary as supplement — generates constraints one by one. The most significant are as follows.

Indications and dosage are limited to approved content. Indications pending approval, or uses approved in other countries but not yet domestically approved, cannot appear in supplementary materials. What does not exist in the original cannot be created by the supplement.

Safety information from the package insert may not be omitted. Information corresponding to warnings and contraindications must be presented in the summary with equivalent treatment. What the original treats as high-priority cannot be downgraded by the supplement.

Tracking revisions is required. When the package insert is revised, the Product Information Summary must reflect the revision. A summary still based on a superseded package insert may contradict the current original.

→ Source page: (3) The philosophy of supplementation

(4) The implications of non-exhaustiveness

The Creation Guide defines itself as a document of fundamental matters, not a complete answer to every question that can arise in materials production. That framing is not modesty — it is a design choice. The Guide acknowledges openly that unspecified territory exists, and in the same breath instructs how to behave there. The reading "if it is not written, it is permitted" is foreclosed from the first sentence.

01The weight of declaring "this does not cover everything"

Practitioners repeatedly encounter questions like: "Does this material fall under the Creation Guide?" or "Does this expression violate the Guide?" When a rule text can supply an answer every time, the task is straightforward. But reality does not cooperate. Material formats, types of information, and contexts of provision are too varied for any document to enumerate in advance.

The foreword acknowledges this honestly: the Guide captures fundamental matters and does not cover every type of material or situation. That declaration conveys two things simultaneously. First, the absence of an explicit rule does not mean freedom. Second, practitioners are expected to exercise judgment even in unspecified territory.

"Not listed" is not the same as "not regulated"

A material or expression not mentioned in the Creation Guide is not outside the regulatory perimeter. "Not written" and "not regulated" are different states. The Guide is a practical handbook; above it sit layers of law, administrative guidance, and industry self-regulation. There is no space within the Guide's world where a reader can form judgments without reference to those layers.

02Higher-order norms are always in operation

The foreword is explicit: matters outside the scope of the Creation Guide remain subject to the following norms.

• The Pharmaceutical and Medical Device Act (PMD Act) — prohibits exaggerated advertising and claims of unapproved indications. Its reach touches every dimension of materials production.
• Standards for Fair Advertising of Drugs and Other Products — Ministry of Health, Labour and Welfare administrative standards governing the propriety of expression across advertising in general.
• Guidelines for sales information provision activities (sales information guidelines) — comprehensive administrative guidance covering information provision through MRs and materials alike.
• JPMA Code of Practice (JPMA Code) — the industry's self-regulatory framework defining appropriate relationships with healthcare professionals.

These are not parallel rules sitting alongside the Creation Guide — they are the upper layer on which the Guide rests. The Guide's individual provisions translate those higher-order norms into operational terms for materials production. When a Creation Guide provision yields no answer, the next reference is the higher-order norm itself.

03The concept of a norm ceiling

The Creation Guide functions less like a floor (a minimum threshold to clear) and more like a ceiling frame (the full boundary within which judgment must be exercised). Satisfying the Guide's stated requirements is not sufficient; the question is whether the material clears the entire space defined by the upper-layer norms as well.

The practical implication is clear. A material may satisfy the Creation Guide and still raise issues under the PMD Act or the sales information guidelines. Conversely, the PMD Act's prohibition on exaggerated advertising applies to any material, whether or not the Guide addresses the specific form of expression involved. The Guide cannot substitute for law or administrative standards.

How the purpose of reading the Guide shifts

Understanding this structure changes how practitioners read the Guide's provisions. The text is not a list of what is and is not allowed; it is a translation of higher-order principles into operational guidance. Where no provision exists, the underlying principles — do not mislead, present facts without selective emphasis, preserve verifiability — become the direct reference for judgment.

04A design that closes off loophole-seeking

The weakness of exhaustive rule-making is that every gap in enumeration becomes a potential loophole. The logic "this act does not appear on the prohibited list" can be used to justify exactly what the rule was intended to prevent.

A principles-based design avoids this structurally. By stating upper-level norms first and treating specific provisions as illustrations, it renders the argument "this act is not listed" irrelevant. Even when a particular act is not mentioned in the Guide, the relevant question is whether it constitutes exaggerated advertising under the PMD Act, or falls within the scope of the sales information guidelines. Stepping outside the Guide's enumeration does not mean stepping outside the regulatory perimeter.

05How to frame the question in practice

With this structure in view, the question in day-to-day materials work changes form. Rather than "is this prohibition written somewhere in the Guide?", the question becomes: "does this expression raise concerns under the PMD Act, Standards for Fair Advertising, sales information guidelines, or JPMA Code?" The Guide offers the first foothold toward that question; the final frame of judgment is the full stack of upper-layer norms.

Searching for where the problem was written after the fact is reactive. Prevention requires designing materials with the full norm layer in view, not only the Creation Guide.

→ Source page: (4) The implications of non-exhaustiveness

(5) Media evolution and consistency

The media through which appropriate-use information reaches healthcare professionals have long since moved beyond print. Tablet-based digital content, new forms of Web delivery, presentations with embedded video — the shape of materials keeps changing. Yet the foreword states one thing plainly: the obligation not to mislead and to convey information accurately does not shift with the medium. The evolution of media is not an exemption from discipline; it is a standing assignment to implement the same discipline in new forms.

01Medium neutrality as a principle

The foreword mentions the diversity of media not to establish different standards for different media, but for the opposite reason. Whatever medium is used, accuracy, balance, and verifiability are equally required. This is medium neutrality — the principle that sits above all specific-media provisions.

Medium neutrality means that a digital format does not relax the balance requirements for textual information, and a Web context does not eliminate the obligation to cite sources. Differences in how a medium expresses information are differences of means toward the same end, not changes to the end itself.

When "means differ" is mistaken for "principle is waived"

Problems arise when "it is technically difficult in this medium" or "screen constraints make the print format impossible" is used to justify stepping back from the discipline itself. For example, scaling down the text size of safety information on-screen, citing display constraints that exist on paper, is effectively a workaround using technical limitation as cover. Where a medium imposes genuine constraints, the obligation is to find a way to achieve equivalent information assurance within those constraints — not to declare the obligation inapplicable.

02From print to screen — what changes and what does not

A change of medium expands the options for implementation. Interactive figures, hyperlinks to supporting detail, video explanations of clinical trial design — digital can do things print cannot. But that expansion in expressive range carries new risks alongside it.

Risks specific to digital

Information that was visible at a glance on a printed page may be scattered across linked pages in a digital format. Unless the reader actively navigates to a safety information page, they may never encounter it. Placing critical information behind a scroll or a tap achieves in practice the same effect as relegating it to fine print in a footer.

Interactive emphasis — color changes, animation, enlarged display — can make efficacy information stand out. If safety information is correspondingly buried in comparison, the balance obligation is violated. The stronger the medium's expressive capacity, the sharper the question of how to secure balance as a structural feature rather than a design intention.

What does not change

Some requirements hold regardless of the medium. Sources must be cited. Safety information must be given visibility equal to or greater than efficacy information. Content beyond the approved indication may not appear. These apply equally across print, screen, static content, and dynamic content.

03Website characteristics and the discipline they require

A website has properties distinct from both print and tablet. Links allow navigation anywhere. Search engines surface individual pages without their surrounding context. Content can be updated with low friction. Each of these introduces specific questions about how to implement discipline.

The most consequential is the standalone-reading problem. A printed material is typically read as a single object; safety information on a separate page still sits within the same document. On the Web, a search result may bring a reader directly to an efficacy-focused page. If that page, read in isolation, provides no clear path to safety information, the adequacy of the information provision is in question.

04Who is responsible for responding to media evolution

The Creation Guide is not revised each time a new medium appears. That would be the consequence of an exhaustive enumeration approach. Under a principles-based design, responses to new media are developed by practitioners translating upper-layer principles — without waiting for a Guide revision.

That translation work falls to the individuals creating materials and the medical affairs and regulatory colleagues supporting those judgments. "How do we implement the obligation to inform without misleading, in this medium?" — that question, asked continuously, is the only decision axis available when the Guide does not supply an answer.

05RMP materials and the medium question

Materials created for additional risk minimisation activities under a Risk Management Plan (RMP) occupy a specific position in any discussion of media. These materials are subject to required displays set out in the voluntary agreement dated 5 June 2017 (JFPA Notification No. 367), and that obligation applies regardless of the format in which the material is produced.

When a digital version of an RMP material is produced, the question is whether the display required in the print version is secured on-screen in an equivalent or stronger form. This is medium neutrality applied to the specific requirements of RMP materials. The medium changes; the obligation to fulfill RMP display requirements does not.

→ Source page: (5) Media evolution and consistency

(6) The hierarchy of higher norms

When practitioners in materials production find themselves uncertain about the source of a particular requirement, that uncertainty usually traces back to an incomplete picture of the layered norm structure. There is a law — the Pharmaceutical and Medical Device Act. Above the Creation Guide sit administrative standards and guidelines. There is an industry self-regulatory code. The Creation Guide itself is the practical implementation at the operational level. And for certain materials, a separate voluntary agreement on RMP displays adds another layer of obligation. These do not coexist as equals; they are stacked in a hierarchy.

01The four-layer structure

The norms relevant to materials production can be organized into four layers. The table below maps the full structure.

02The role of each layer and how they relate

Layer 1: PMD Act — the statutory foundation

The PMD Act provisions most directly relevant to materials production are the prohibition of exaggerated advertising (Article 66) and the prohibition of advertising unapproved efficacy, effectiveness, or performance (Article 68). These apply regardless of what the Creation Guide says. The principle that materials may only describe indications and dosage within the approved scope derives not from the Guide but from the PMD Act itself.

The PMD Act, as a national statute, establishes the uppermost regulatory boundary. No industry norm or voluntary code can authorize conduct that falls outside this boundary.

Layer 2: Administrative standards and guidelines — bridging law and practice

The PMD Act establishes principles, but the law's text alone makes it difficult to determine what "exaggerated" means in specific cases or what "appropriate information provision" requires in practice. Standards for Fair Advertising and the sales information guidelines serve that bridging function.

Standards for Fair Advertising provides administrative interpretive criteria for the expression used in advertising. The sales information guidelines reach further, covering information provision through MRs in addition to written materials, and specifying what appropriate conduct looks like across the full range of provision activities. Neither is a statute, but both are issued under MHLW notification and carry practical binding force.

Layer 3: JPMA Code — industry self-discipline

The JPMA Code is a code of conduct that member companies have voluntarily established. It addresses areas that law and administrative guidance do not fully cover: gifts and entertainment to healthcare professionals, the conduct of information provision, relationships with patient organizations, and related ethical standards. There are no statutory penalties for violations, but member companies are expected to comply, and failures are handled through industry-level mechanisms.

Layer 4: Creation Guide — the operational handbook

The Creation Guide translates the principles of the three layers above it into guidance for the specific situations of materials production: product information summaries, supplementary materials, and materials carried by MRs. The foreword's phrase "defines fundamental matters" captures this position accurately. The Guide is not a substitute for the upper layers; it provides operational-level direction based on those layers.

03The RMP display voluntary agreement — a separate obligation

Beyond the four-layer structure, certain materials carry an additional obligation. Materials created for additional risk minimisation activities under a Risk Management Plan (RMP) must include the displays specified in the voluntary agreement dated 5 June 2017 (JFPA Notification No. 367).

This display obligation sits outside the Creation Guide. Complying with the Guide is not sufficient for materials that fall within the RMP scope — those materials also require verification against the voluntary agreement. The foreword makes this explicit to prevent the misreading that consulting the Creation Guide alone is enough.

04Using the hierarchy to form judgments

This layered structure provides a sequence of inquiry. When a question arises about a particular material or expression, the following order applies.

Start at Layer 4: does the Creation Guide provide a specific provision? If so, that is the first reference point. If not, move up.

Check Layer 3: does the JPMA Code address the matter? Questions related to the propriety of information provision or relationships with healthcare professionals are examined here.

Check Layer 2: does the matter raise concerns under Standards for Fair Advertising or the sales information guidelines? This is where questions about exaggeration, balance, and the context of information provision are examined.

Check Layer 1: does the conduct risk violating the PMD Act's prohibitions? Indications outside the approved scope and exaggerated advertising connect directly to statutory violations.

This sequence does not end when one layer yields an answer. Completing the check across all layers is what constitutes a complete judgment.

→ Source page: (6) The hierarchy of higher norms

(7) The three-pillar ethical framework

The three requirements the foreword sets out — closing off the "true but misleading," implementing balance on the page, and guaranteeing verifiability through structure — are not stylistic rules. They are the concrete expression of an ethical stance. The three pillars directly reject the idea that legal compliance is sufficient. Even when a statement is factually accurate, if the reader forms a false conviction, that is an ethical failure.

01Closing off the "true but misleading" — ethics one level above accuracy

Stating facts and not misleading the reader are two different questions. Present the relative risk reduction prominently while pushing the absolute risk reduction to an inconspicuous location, and every number remains accurate while the reader's judgment is distorted. Describe a trial in which the primary endpoint failed to reach significance while foregrounding a post-hoc subgroup finding in the headline, and the reader will mistakenly believe evidence of efficacy exists. This is the "factually accurate yet misleading" pattern.

The Creation Guide is most alert to this pattern precisely because it is hard to detect. A falsehood can be verified. But "guidance through arrangement, selection, and truncation" is invisible as a problem, because the underlying material is correct. That is why the ethical obligation extends beyond "is this accurate?" to "does this mislead?"

How this is put into practice

The practical means are data disclosure and context preservation. Show absolute and relative risk reductions side by side. Do not omit confidence intervals. Start a graph's y-axis from zero. Each of these is an operation on "how facts are placed" to prevent misunderstanding. The core of this pillar is refusing to omit information that, while not technically a lie, would distort the reader's picture if absent.

02Implementing balance on the page

Promotional materials for prescription drugs are created to communicate efficacy. For this very reason, safety information is prone to being treated as secondary — small type, a corner location, a footnote. Technically "included" does not mean "communicated."

The Creation Guide requires warnings and contraindications to be displayed in Gothic type at 10 points or larger, with attention to framing, background color, and type color. The reasoning is that physical quantities — type size, placement — determine the quality of information transmission. If efficacy figures occupy the prominent position, the path to safety information must be equally prominent. "The balance pillar" means this, at the level of page layout.

The asymmetric duty — disclose even what harms your own interests

Balance demands something further. When pharmacological properties or toxicological findings suggest the possibility of adverse reactions in clinical use, they must be recorded — even when doing so works against the manufacturer's commercial interest. This applies to the safety pharmacology and toxicity sections of the material.

Presenting favorable information and omitting unfavorable information is the asymmetry that distorts the reader's judgment. The Creation Guide reverses that asymmetry. For safety-side information, it imposes a duty to disclose that overrides commercial motivation. This is the core of the asymmetric duty.

03Guaranteeing verifiability through structure

Claims made in a material must be checkable after the fact. "Which trial and which analysis did this efficacy figure come from?" "Which version of the package insert is being referenced, and when was it current?" A material that cannot answer these questions leaves its evidentiary basis floating in mid-air.

Verifiability is achieved by attaching source references, version numbers, and dates to all claims. The key references section retains bibliographic details. When clinical data come from regulatory submission materials, that fact is stated. The date of preparation or revision appears at the close. These are unobtrusive entries, but together they keep the path back to primary sources perpetually open.

Applied to meta-analyses

Verifiability is stated most concretely in the requirements for meta-analyses. The databases searched, the search keywords, the number of records identified, the number of articles assessed for eligibility, the number excluded and the reasons for exclusion — all of this is required so that "where was searched, what was selected, and what was dropped" can be traced later. A meta-analysis that does not disclose its search process offers no means to verify whether exclusions were made by design.

04The three pillars — a structural overview

05What the three pillars ask

What the three pillars share is a positive purpose — not merely a lower bound of "what must not be done" but an active commitment to supporting the judgment of healthcare professionals. The physicians and pharmacists who receive these materials are making prescribing decisions. The quality of their decisions has direct consequences for patients. A material designed on the principle of "no legal problem, no problem" degrades the quality of those decisions.

The ethics the three pillars demand provide a decision-making framework that prioritizes scientific integrity when it conflicts with commercial motivation. Not misleading, maintaining balance, ensuring verifiability — these are the minimum conditions for prescription drug information to merit trust, and at the same time they are the words that most concisely capture the spirit of the foreword as a whole.

→ Source page: (7) The three-pillar ethical framework