As long as the commitment to deliver accurate information lives only inside one person, it fades the day that person transfers and breaks on the night quarter-end pressure peaks. Most violations recorded over seven years were not acts of bad faith. Even where the will toward integrity existed, without the structures to support it, that will erodes under sustained pressure. The core of this principle is transplanting individual conscience into a culture that functions regardless of who holds the role.
So What / So Why — Why This Principle Is Necessary
The FY2025 Ministry of Health, Labour and Welfare monitoring report states: "For certain competitive pharmaceuticals, cases were found suggesting that some companies were systematically engaged in inappropriate promotional information activities." This is not a story about individual MRs going astray. It is a story about a sales organization moving in a coordinated direction.
Consider the allergy medication case documented in the same report. At a lecture meeting organized by a pharmaceutical company, the physician presenter repeatedly introduced dosing methods that differed from the approved label and distributed slides that dismissed a competitor's product without evidentiary basis. The report notes this was "distributed to attendees who wished to receive it, without prior review by the promotional information oversight division" — the stated reason being "lack of time for confirmation." After the issue came to light, no corrective action was taken for all attendees. A review mechanism existed. It simply did not function.
"A mechanism exists" and "a mechanism functions" are two different things. A checklist, an approval document — if either is skipped under deadline pressure, it is not a mechanism. Conversely, even without a checklist, if there is an atmosphere in which someone can say "something is wrong here," most violations stop. Turning individual conscience into structure means designing that atmosphere: not adding rules, but creating an environment where those rules are followed without anyone having to ask.
The Principle — What I Want to Be
I find it alarming when I am the only person who knows the right way to do something. If the knowledge exists only in my head, it disappears the day I leave. If the integrity exists only in my feelings, I will be the first to give up on a late night when a deadline closes in.
That is why I want to articulate the reasoning behind my judgments. "Why do I present this data from both sides?" "Why do I decline this off-label explanation?" — if I act on habit alone without being able to explain the reasons in my own words, those habits are fragile under pressure. If I understand the reasons, I can hold the line even when I am uncertain.
Honestly, I am often not in a position to build systems. I cannot redesign the review division's processes or rewrite the performance evaluation framework. Still, within the scope of the team I manage, within what I can pass on to my successor — have I explained why a given rule exists? When asked, did I have an answer beyond "because management said so"? That is where it has to start.
I want my integrity to carry forward to my successor, and to the successor after that. That is what this principle is aiming for.
Daily Practice — Concrete Actions and Checks
- Make a habit of adding "why" in a single sentence. When a checklist item says "include both efficacy and safety," add one sentence when handing it to a successor or colleague explaining why that item exists. If the reasoning behind a rule does not travel with it, the next person will skip it the moment pressure mounts.
- Once a month, check whether you can explain things in your own words. Can you explain why prescription-duration limits exist, or why COI disclosure is required, without looking at a training manual? If not, that item has not yet become a real structure inside you either.
- Distinguish between the form and the substance of prior review. Beyond confirming that review was completed, ask whether the reviewer had the time and the information to actually read the content. In the FY2025 case, review was skipped because "there was no time." Precisely when deadlines are tight, think concretely: if we skip this now, what gets through?
- Record moments when something felt wrong. Even when you could not speak up, note that "this bothered me." Prepare for the next time the same situation arises. The act of recording a feeling is also practice in articulating your own decision criteria.
- Hand over cases during transitions, not just procedures. Include in any handover not only the how-to document, but also "what I was uncertain about in this situation" and "why I reached this judgment." When a successor faces the same pressure, it is the reasoning — not the procedure — that helps.
- Do not treat "management approved it" as the end of judgment. Even for materials that passed through an approval process, confirm for yourself: is this content scientifically accurate? Are both efficacy and safety addressed? The more responsibility is distributed, the more easily a structure emerges in which no one performs a final check.
Moments of Test — Under Pressure
This principle is tested hardest when three conditions converge: "no time," "numbers are short," and "the relationship with this physician might suffer."
Two weeks before quarter-end, at a facility where a competitor's product is already adopted, you discover a problem with the presenter's slides. Sending them back through review means the lecture date will not be met. "Maybe it is not that serious." "The physician has already agreed." — at this point, the conscience has already begun negotiating with another voice. As the second series vol-10, "Redesigning Pressure," analyzes in detail, relying on a single person's integrity in this moment is structurally unsound from the start. Unless the organization lowers the cost of stopping, individuals will rationally choose to skip.
That said, there is no need to wait for organizational redesign before doing anything. Saying out loud "I think this will become a problem later" is something you can practice today. Writing down a single sentence of reasoning and keeping a record is something you can do today. Even if you cannot move the formal review process, you can document the problem and pass it to the next person.
There are always moments when the decision about where to draw the line must be made alone. What helps in those moments is the "why" you articulated to yourself before the pressure arrived. Against the voice that says "it is fine to skip this because there is no time," what decides the fork is whether you can imagine concretely what happens on the other side of that skip.
An Anchor — Something to Return to When You Are Close to Breaking
The Guidelines on Promotional Information Activities for Prescription Drugs lay out four principles as their foundational thinking: "based on scientific and objective evidence," "accurately from both efficacy and safety perspectives," "conducted from the standpoint of fair competition," and "transparency regarding conflicts of interest." This is not a list of prohibitions. It is a declaration of what to uphold as an intermediary for information that enters medical care.
In the allergy medication case recorded in FY2025, slides that repeatedly introduced off-label dosing, dismissed a competitor's product without basis, and concluded with "safe, simple, and of great benefit to patients" while omitting any reference to safety information were distributed without prior review. After the issue came to light, no corrective action was taken for all attendees. The full account is in Analysis Series vol-09, "Other Inappropriate Promotional Practices." Reading it makes clear this was not the kind of failure that individual integrity alone could have prevented. If the review mechanism had functioned, this information would have been stopped.
On a night when you are close to breaking, the place to return to is not the fine print of regulations but the meaning of these principles. Basing decisions on scientific evidence means not showing only the data that is convenient. Addressing both efficacy and safety means conveying risks in the same measure as the evidence of benefit. Transparency on conflicts of interest means not concealing the source so that the audience can evaluate the information. These principles carry meaning precisely in the situations where they are hardest to uphold.
Holding the question — "would this principle still be functioning if I were no longer here?" — is what gradually turns conscience into structure.
As We Should Be ── Ten Convictions for Material Creators ── Map of 10 chapters
- Part 1: Scientific Evidence Steward — I Am Not a Salesperson
- Part 2: Taking Responsibility for the Reader's Mental Image
- Part 3: The Conscience That Doubts Conclusions — Led by Data
- Part 4: Sign the Whole — Not Just One Slide
- Part 5: Duty to Tell — Efficacy and Safety on Equal Footing
- Part 6: Own It — Don't Hide Behind "The Physician Decides"
- Part 7: The Right Distance from Numbers — Quotas as Constraints, Not Goals
- Part 8: Respect for Competitors — Fair Play Builds Trust
- Part 9: Staying Open — Disclosing Limitations, Uncertainty, and Conflicts of Interest on Your Own
- Part 10 (this chapter): Embedding Conscience into the Organization's Systems — From the Individual to the Organization, Made Visible
- Conscience held inside one person is vulnerable to change. Each time a person transfers, pressure builds, or a deadline closes in, a structure that depends on individual integrity alone breaks. The lecture case recorded in FY2025 shows that prior review was omitted "due to lack of time for confirmation" — this was a structural failure, not a personal judgment call.
- 'A rule exists' and 'a rule functions' are different things. A checklist or an approval document that gets skipped under pressure cannot be called a mechanism. The right questions are whether the system raises the cost of bypassing review, and whether there is an atmosphere in which someone can say 'something is wrong.'
- Whether a team member can explain the 'why' behind a rule in their own words is a measure of culture. The more people who can explain the rationale for prescription-duration limits, the purpose of COI disclosure, and the necessity of balanced presentation — without a procedure manual — the harder it becomes for local rationalization to take hold. It is conviction, not knowledge, that changes behavior under pressure.
- Ministry of Health, Labour and Welfare. "Report on the Monitoring Project for Promotional Information Activities on Prescription Drugs." FY2025 (2025).
- Ministry of Health, Labour and Welfare. "Guidelines on Promotional Information Activities for Prescription Drugs." September 25, 2019.
- Japan Pharmaceutical Manufacturers Association. "Code of Practice on Promotional Information Activities for Prescription Drugs." 2019.
- Ministry of Health, Labour and Welfare. "Standards for Appropriate Advertising of Drugs and Other Products." September 29, 2017. Yakusei-hatsu 0929 No. 4.
- Edmondson, A. C. The Fearless Organization: Creating Psychological Safety in the Workplace for Learning, Innovation, and Growth. Wiley, 2018.
- Reason, J. Managing the Risks of Organizational Accidents. Ashgate, 1997.