01What "Just Passing It Through" Means
Start with a definition. "Just passing it through" is the act of sending a vendor's deliverable to the next stage — the internal review board, or release to healthcare professionals and patients — without the content owner verifying the content. No proofreading marks, only a glance at the file name and version, a judgment that the layout looks clean so it must be fine. Each of these is handoff, not verification.
The motives behind it are understandable. Trust that the professionals got the content right. Time pressure, with a deadline near and no time to reread the full text. A division-of-labor mindset that says internal review is the final gate, so it will catch anything. All three look reasonable, and all three misread where responsibility sits.
02Production Can Transfer; Responsibility Cannot
An outsourcing contract transfers "the work of producing," not "the responsibility for the decision to publish." The regulatory addressee, as advertiser and claimant, remains the content owner (the pharmaceutical company) to the end. Both exaggerated advertising under Act §66 and pre-approval advertising under §68 target "the party that advertised," regardless of whether the work was outsourced. Even if the vendor wrote the copy, the moment you decide to release that material under your own name, the normative subject is the owner.
| Item | Transfers to vendor | Stays with owner |
|---|---|---|
| Production work | Yes — layout, copy, artwork | — |
| First-line quality control | Yes — vendor proofing/QC (see sister series) | — |
| Final check of content accuracy | No | Yes — post-receipt verification |
| Judgment of regulatory compliance | No | Yes — Act, ad standards, MSA-G |
| Decision to release or not | No | Yes — owner's sole authority |
| Regulatory addressee | No | Yes — as advertiser/claimant |
Whether the vendor's quality control works is a separate question. Building in production quality is the vendor's duty (see the sister series "Production Quality Management"), but that is no reason to skip verification by trusting it. The vendor's quality assurance and the owner's receipt verification only carry meaning as two independent gates.
03The Three Layers of Risk from Inaction
"Just passing it through" is not the active fabrication of a falsehood. It is the inaction of not verifying. But inaction makes risk real across three layers.
- Legal layer: Exaggeration (§66), advertising of unapproved drugs (§68), breach of the duty-of-effort to provide information (§68-2), and departures from the ad standards and MSA-G reach the world unverified. Administrative guidance, surcharges, and improvement orders fall on the commissioning company.
- Reputational layer: Once distributed, improper material is hard to recall and erodes trust from professionals and society. The MSA-G calls for internal disclosure and recurrence prevention, and the damage to brand and corporate posture is long-lived.
- Patient layer: Wrong efficacy or safety information distorts prescribing and ultimately harms patients. This is the root purpose of the rules and takes priority over the other two layers.
"The vendor's professionals made it, so the content should be fine. The layout is clean. The deadline is close, so let's send it straight to review." — Zero verification. The three-layer risk is forwarded to review and to the market.
"Cross-check efficacy wording against the approved package insert, confirm cited data against primary sources, audit the basis for comparative claims. Record that no departures were found, then send to review." — The owner's gate works.
04Why "I Didn't Know" Is No Defense
An owner who passed something through often pleads, "The vendor wrote it; I didn't know." This plea holds up neither normatively nor morally. There are three reasons.
First, not knowing is itself a breach of duty. The owner has an affirmative obligation to verify what is received. A departure you would have caught had you verified, but missed because you didn't — this is not a ground for exemption; it is the very inaction at issue. Responsibility for the "not knowing" you created yourself does not disappear.
Second, the regulatory addressee does not change. Neither the Act nor the ad standards require "knowledge" as an element. If you released it as advertiser, you are the subject, knowledge or not. The §68-2 duty-of-effort to provide information is also not discharged unless the owner can show evidence of the effort.
Third, moral responsibility is measured by knowability. Information you could have known by verifying, you did not see, while structurally positioned to know it. That is not "did not know" but "did not try to know," and the latter carries no exemption.
05Where Responsibility Lies — What Outsourcing Cannot Erase
Lay out where responsibility sits. Outsourcing distributes the work and first-line quality control; it does not distribute final accountability. The vendor bears contractual quality responsibility toward the owner, but that does not stand in for the owner's social and regulatory responsibility. The two responsibilities have different addressees.
| Type of responsibility | Who owes it to whom | Transfers on outsourcing? |
|---|---|---|
| Contractual quality of the work | Vendor → owner | Transfers (vendor bears it) |
| Accountability for compliance | Owner → regulators / society | Does not transfer |
| Moral responsibility for content | Owner → professionals / patients | Does not transfer |
| Final decision to release | Owner (sole authority) | Does not transfer |
If the vendor is at fault, you can pursue contractual liability. But that sits on a different layer from the responsibility the owner bears toward authorities and society. Being able to seek recourse is not the same as being exempt. Even if the owner "made the vendor pay damages," it cannot escape the fact that it was the party that put improper material into the world.
06Turning Receipt into the Starting Point of Verification
The smallest structure that ends "just passing it through" is to redefine receipt itself. Position receipt not as taking delivery of a file (logistics) but as the starting point of verification (a quality gate). Concretely, the owner performs four things at receipt.
- Receipt: Confirm the version, files, and correspondence to the production brief, and bring the material into a verifiable state.
- Verification: Cross-check efficacy and safety wording against the package insert, confirm cited data against primary sources, audit the basis for comparative and superiority claims, and confirm compliance with the rules (Act §66/§68/§68-2, ad standards, MSA-G).
- Judgment: Explicitly decide pass / conditional pass / return, and judge as the owner whether it may go to internal review.
- Documentation: Record the verification items, judgment, judge, and date so you can later show "what was checked."
The concrete flow design for these four stages is detailed in Vol. 3, "Designing the Receipt Flow" (in preparation). What this installment fixes is the single point that receipt without verification is not receipt but a pass-through.
07Leaving a Judgment Behind — A Minimal Record Format
Translate moral responsibility into practice and it lands on "leaving the judgment in a record." "I made the effort" and "I checked" cannot be proven without a record. The §68-2 duty-of-effort, and adherence to the internal Code of Practice/SOP, can be shown to a third party only when a judgment record exists. Below is a minimal format for a receipt judgment.
| Record field | Content |
|---|---|
| Material ID / version | Identification of the deliverable and the specific version |
| Verification checklist | Efficacy cross-check / source confirmation / basis for comparison / rule compliance (§66, §68, §68-2, ad standards, MSA-G) |
| Judgment | Pass / conditional pass (conditions stated) / return (reasons stated) |
| Judge / date | The owner-side responsible judge and the date of judgment |
| Next stage | Sent to internal review / returned to vendor |
A record is a tool that protects you, and at the same time a mechanism that protects patients. Naming the judge means placing someone inside the organization who takes on the responsibility. Material that flows nameless is material no one is responsible for.
08The Owner's Stance — Trust and Verification Coexist
Avoid a misreading: verification is not distrust of the vendor. The better the vendor, the more it builds the deliverable assuming the owner will verify. Production that builds in being verified and production that leans on not being verified diverge in quality over time. The owner's verification gate is also external pressure that lifts the vendor's quality.
"Trust but verify" is an accurate motto for a two-gate design. Trusting the vendor and independently verifying as the owner do not contradict each other. It is "unconditional trust" that abandons verification that is the irresponsible posture — toward the vendor and toward the patient alike.
Vol. 1 set out the philosophy of the series; this installment laid out the structure of moral responsibility. From here we will build, in sequence, the concrete practice for discharging that responsibility — the receipt flow, verification checklist, judgment criteria, and record format. The aim is to put the tools for "not passing it through" in the owner's hands as procedure.
Key Points
- The work of production transfers on outsourcing, but the responsibility for what reaches the world — regulatory responsibility as the addressee under the Act, and moral responsibility toward professionals and patients — stays with the owner. Being able to seek recourse is not the same as being exempt.
- The inaction of "just passing it through" makes risk real across three layers — legal (§66 exaggeration, §68 pre-approval, §68-2 information provision), reputational, and patient. Positioned to know had you verified, "I didn't know" is not a defense but a confession.
- Position receipt as the starting point of verification, not logistics, and run receipt → verification → judgment → documentation by the owner's own hand. A record that names the judge protects both the patient and yourself.
Sources
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (the Act / "Yakkihō"), §66 (prohibition of exaggerated advertising), §68 (prohibition of advertising pre-approval products), §68-2 (duty-of-effort to provide information).
- Ministry of Health, Labour and Welfare, "Standards for Fair Advertising of Drugs, etc." (Yakuseihatsu No. 0929-4, 29 Sept 2017).
- Ministry of Health, Labour and Welfare, "Guidelines on Sales Information Provision Activities for Prescription Drugs" (Yakuseihatsu No. 0925-1, 25 Sept 2018; applied April 2019).