Chapter 10 of Part III ("Other Materials") covers literature reprints. You take an article from a scholarly journal or a diagnosis-and-treatment guideline, and you hand it to a healthcare professional. At first glance this looks like the dullest, safest material of all: you are simply copying an existing paper and passing it along. Yet the Guide places no small number of fences here. Why would constraints be needed on a paper that someone else wrote and that has already cleared peer review? Answering that question is the key to reading this chapter.
A reprint is a paper that appeared in a journal, extracted at an appropriate unit such as the whole article. As a rule it is a material provided in response to a healthcare professional's request — not something a company pushes out on its own initiative. That single phrase, "in response to a request," is the center of gravity for the entire chapter.
01Why the Guide reaches a third party's paper
The foreword serves as the constitution of the whole Guide. Read closely, it carries the implication that what a company owes is not only the duty not to lie, but the duty not to mislead. Even when a fact is correct in itself, if the way it is presented forms a false picture in the recipient's mind, that can be a violation.
Reprints are where this duty not to mislead reappears in a changed form. The content of a paper is the work of a third party and has been peer-reviewed. The company does not alter a single word of it. And yet three choices remain in the company's hands: which paper to select, at what unit to extract it, and to whom and how to deliver it. The bias of selection and distribution can create a false impression without any tampering with the text. So the Guide places its fences not on the paper's content, but on the margin of choice the company still holds.
The foreword contains one more passage that cannot be overlooked: the Guide sets out basic matters and does not cover everything, and areas it does not regulate still fall under the Pharmaceutical and Medical Device Act, the Fair Advertising Standards, the information-provision guidelines, and the JPMA Code. This is a device to shut down the reading that "not in the manual = permitted." Whether to make a reprint, likewise, is not settled by mechanically checking the chapter's text; the Guide's stance is that you must scrutinize the content from the standpoint of the JPMA Code and the Chapter 1 basic considerations before deciding.
02"In response to a request" — material that is not pushed
A reprint is not a material to distribute actively. You hand it over only after a healthcare professional asks. This passivity is one of the three threads running through Part III — materials provided "on request" must not be pushed — applied to reprints.
Why must it be passive? Active mass distribution would turn a specific paper, and thus a specific viewpoint, into an advertising device imprinted on clinical practice. Even when the paper's content is neutral, if the distributor's intent is "I want this result seen widely," the act of distribution itself builds a biased information environment. Passivity is a structural fence to cut that circuit. It places the origin of the information flow on the healthcare professional's side, not the company's.
Holding "on request" up as a pretext while, in substance, preparing in advance the paper the company wants to circulate — this is active distribution dressed as passive. What the Guide dislikes is precisely this disguised initiative.
03Which papers may, and may not, become reprints
Not every paper can be made into a reprint. For literature touching on the efficacy of the company's own drug in particular, a line is drawn around what may be included.
What is excluded from efficacy literature
For literature concerning the efficacy of the company's own drug, reviews, overviews, articles, and contributions are not included as reprints. The reason for excluding these four lies in the discipline of evidence the foreword sets out.
Scientific evidence has a hierarchy. Meta-analyses and systematic reviews sit at the top, followed by randomized controlled trials, observational studies, and case reports, with expert opinion and narrative reviews at the bottom. The presence or absence of peer review is the watershed of quality. Reviews and overviews re-assemble multiple studies through the author's lens, and the author's interpretation enters. Articles and contributions are likewise processed discourse rather than primary data.
In efficacy — the domain most prone to exaggeration — making these into reprints would let a company present "an author's favorable interpretation" as though it were primary evidence. So the reprinting of efficacy literature is narrowed to original papers that interpose no interpretive layer. This is the reprint-version expression of the "scientific basis, fairness, objectivity" that Chapter 1 repeats.
| Category | Standing | Reprint of efficacy literature |
|---|---|---|
| Original paper | Primary data, peer-reviewed | May be eligible |
| Review / overview | Author re-assembles studies | Not included |
| Article / contribution | Processed discourse | Not included |
The unit of extraction
Reprinting is done at an appropriate unit, such as the whole article. If you pull out only part of a paper and drop the statements of conclusion or limitation, the caveats the original carefully placed disappear. Extracting only a figure, or a single paragraph of the discussion, risks distorting the original's true intent. Taking the paper as the self-contained unit it is becomes the way, in the reprint setting, to uphold Chapter 1's principles of "do not distort the source data" and "do not present only favorable results."
04Web posting — the passivity that digitization easily breaks
The foreword notes that the media for materials have evolved from paper toward digital and the Web. And it carries the implication that how to translate paper-era practice into digital remains an assignment. Web posting of reprints is where that assignment surfaces most sharply.
For a paper reprint, "hand it over on request" holds naturally. But the moment you post it on the Web, it tends to become accessible to anyone, and the design principle of passivity collapses. So the Guide sets concrete conditions for preserving passivity even in digital form.
Conditions to preserve passivity
- Keep it independent from the product page. Built into a product's promotional flow, a reprint becomes advertising in effect. Separate the information's entrance from product promotion.
- Limit it to the individual requester. Make it viewable only by the person who asked. Open it to an unspecified crowd and the premise of "on request" collapses.
- Do not make it viewable by a mere Yes/No. A form where anyone enters by pressing one confirmation button is no different from outright publication. A mechanism to verify the authenticity of the request is needed.
- Do not actively solicit by email or the like. Sending "a reprint is available here" is active distribution dressed as passive. Such steering crosses the "do not push" line of Chapter 2.
These four conditions are not scattered prohibitions. They all point at one thing — maintaining passivity even on the Web. The passivity that physical handover carried naturally on paper must be rebuilt by design in the digital setting. That is this chapter's answer to the assignment.
05Three questions that govern a reprint
You do not need to memorize the chapter's text. When you make a reprint, asking yourself the following three will keep the spirit of the Guide largely intact.
- Is this something put out because it was requested, or because you wanted to put it out? If the latter, suspect a disguise of passivity.
- Do the selection and the extraction distort the original's true intent? For efficacy, is it narrowed to the original paper, and is it complete at the article unit?
- If posted on the Web, is it designed to reach only the person who asked? Is it independent from the product flow, and free of steering?
A literature reprint is a material the company does not write. That is exactly why the Guide places its fences not on the content written, but on the choices left to the company — to select, to extract, to deliver. Even with neutral content, a false impression can be built through selection and distribution; here, the foreword's duty not to mislead takes this particular shape.
Passivity, the narrowing to original papers, and the four conditions for Web posting all derive from a single design thread: "on request, the original paper, to the person who asked alone." Rather than being overwhelmed by the number of provisions, see that one thread, and the practice of reprints settles itself.