The brand-name advertisement is the most reticent format among the ads aimed at healthcare professionals in print journals. Showing the product's name is, in itself, the whole purpose. No efficacy, no dosage, no data, no catchphrase belongs here. At first glance this looks like a cramped set of rules, but that very silence is the purest embodiment of the spirit the creation guide set out in its foreword. Why is only the name allowed? Trace the reason and you arrive at the foundation: that the original document for proper-use information is the electronic package insert.
A brand-name ad may carry only a narrow set of facts: the brand name and generic name, the therapeutic classification name, the regulatory category, whether the product is listed in the NHI price standard, and the name of the marketing-authorization holder. Call it the smallest possible unit of information an ad can contain.
01What a brand-name ad is — an ad that only announces a name
If a standard advertisement is one that "carries advertising DI and may present features, data, and catchphrases," the brand-name ad sits at the opposite pole. It centers on the product name and is accompanied by no information whatsoever about efficacy or safety. All the reader learns is the external fact that a product by this name exists, which company markets it, and whether it appears in the price standard.
The items that may be listed are confined to these five.
- Name (brand name and generic name)
- Therapeutic classification name
- Regulatory category
- Whether listed in the NHI price standard
- Marketing-authorization holder's name
A standard ad is required to carry efficacy and indications, dosage and administration, and even the precautions information including warnings and contraindications. The brand-name ad exists by not carrying those. An advertisement defined by subtraction, you might say.
The related format is the standard advertisement, which may handle efficacy and data. Keeping the boundary between the two in mind sharpens the outline of the brand-name ad. See the standard advertisement page for detail.
02Why no efficacy or safety information at all
This is the heart of the format. Write even a single line of efficacy and the guide immediately triggers a separate set of duties: if you state efficacy you must give safety equal or larger type, you must show the supporting data within the material, you must attach the source, you must not exceed the approved scope by one character. A whole array of heavy constraints rises at once. The brand-name ad severs this chain at the start, by never speaking of efficacy in the first place.
The foreword stated plainly that product information summaries and the like sit in a position that "complements" the electronic package insert. The original is the approved content itself, and a complement cannot exceed the original's scope. The brand-name ad, showing only a name, observes this subordinate relationship in the most straightforward way. Present efficacy in fragments and the reader cannot verify, from the ad alone, which part of the original it corresponds to. Information whose verifiability cannot be secured is simply not carried. That is the logic of the brand-name ad.
The notion that "a catchphrase unrelated to efficacy or safety should be fine" is mistaken. The guide requires that even wording or visuals not directly tied to efficacy or safety must not be carried if they relate to the product. Bring in nothing beyond the name and external form, however harmless it may appear.
Sealing off "true but misleading" at the most upstream point
One implication of the foreword is that the duty "not to lie" and the duty "not to mislead" are distinct. Even without writing a falsehood, if presentation alone forms a wrong impression, that is a violation. The brand-name ad satisfies this duty structurally, by blocking at the entrance the very information that creates room for misunderstanding. Say nothing, and there is no way to mislead. It is a preventive design, erring to the safe side.
03Handling of visuals and catchphrases
The same brake applies not only to text but to pictures and photographs. Efficacy may not be turned into an illustration. A product photo bearing efficacy or dosage may not be used. In other words, you cannot detour around what text forbids by using images. Change the medium of expression, and if the conveyed substance reaches efficacy or safety, it is the same violation.
| Aspect | May carry | Must not carry |
|---|---|---|
| Name / notation | English notation of the product name, product logo | A coined catchphrase that hints at the therapeutic action |
| Images | Product photo, dosage-form photo, product logo | An illustration of efficacy; a product photo bearing efficacy or dosage |
| Announcement | A "new release" notice | Efficacy, dosage, data |
| Corporate info | A company policy unrelated to the product | An efficacy appeal tied to the product |
Logos and photos can become a violation through "the art of combination"
The product logo, product photo, and dosage-form photo may each be carried on their own. The problem is their combination. Arrange several elements so as to hint at efficacy or dosage, or to emphasize a particular use, and the whole becomes a violation even though each element is lawful in isolation. Placing, beside a dosage-form photo, an image that evokes a certain scene so as to suggest the use, is one such composition. Note that judgment turns not on the legality of the elements but on the impression they synthesize.
Some corporate-side expression is permitted: the English notation of the product name, the product logo, a "new release" announcement, and the presentation of a company policy unrelated to the product. Because these do not speak of the product's efficacy or safety, they fit within the brand-name ad's frame.
04The required note — a path to the electronic package insert
A brand-name ad carries no efficacy and no precautions. Yet that differs from "hiding information." A clear path to the original — the electronic package insert — must be left in place. Concretely, a note to the effect of "for efficacy, dosage, warnings, contraindications and the like, refer to the electronic package insert" must be set in type of 8 points or larger.
This note is also the brand-name ad's own self-definition. It tells the reader, "only a name is written here; the information needed for a decision is in the original," and at the foot of the ad it reaffirms the foreword's structure in which product information summaries complement the electronic package insert. The lower bound on type size is set because a path that cannot be seen does not function as a path. The guide's habit of specifying even how things appear runs through here as well.
Adding the note does not mean a little efficacy may then be written. The note is a path, not an indulgence. As long as it is a brand-name ad, efficacy and safety information cannot be carried, with or without the note.
The brand-name ad is an advertisement narrowed to the single point of announcing a name. It speaks of neither efficacy nor safety, not to ration information, but to cut off at the entrance the misunderstanding that fragmentary information invites, and to defer judgment to the electronic package insert, the original for proper-use information. What is allowed is confined to the name, therapeutic classification, regulatory category, NHI listing status, and marketing-authorization holder's name, plus external expressions such as logos and product photos, and the note that serves as a path to the electronic package insert.
The constraint of saying nothing mirrors the foreword's spirit most faithfully. It fulfills the duty not to mislead by not bringing in the seeds of misunderstanding. The criterion that elements lawful in isolation become a violation when combined to hint at efficacy lies on the extension of the design philosophy that seals off "true but misleading."