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The Chief Pharmaceutical Inspector’s prescription for pharmaceutical advertising compliance with the law — 6 decisions advertisers should be aware of!

Since 2006 the Chief Pharmaceutical Inspector (CPI) has issued more than 300 decisions ordering an immediate discontinuance of broadcasting of unlawful medicinal products’ advertising. Such interventions were predominantly caused by misleading the target audience  as to the effects and characteristics of advertised medicinal products. Though some of them are controversial, each decision constitutes invaluable guidance for working on medicinal products’ advertising.

CPI omniscient …

We wrote earlier about how one can advertise medicinal products without even knowing about it in relation to the Inspector’s decision concerning an article in Twój Styl magazine, the author of which described the side effects of contraceptive pills. The article included information that a certain contraceptive didn’t cause any side effects, which the Inspector considered unlawful marketing (more: http://lswipblog.pl/en/2015/09/are-you-advertising-medicinal-products-and-dont-even-know-about-it/).

CPI in the theatre…

The Kamienica Theatre may have been surprised by charges of medicinal product’s advertising, whereby the Inspector ordered the discontinuance of the advertising of a product named “Acard, being incompliant with binding regulations, by referring to the slogan “A na serce Acard, niech pamięta” (“Remember: Acard for your heart”) — used during a scene of the play “I tak Cię kocham” (“I love you anyway”). Even though the Theatre’s proxy explained the questioned phrase was only a colloquial term, the advert was banned.

CPI on “head colds”…

As it has been demonstrated in practice, errors in advertising can happen to the best ad makers. Johnson & Johnson learned its lesson when the Inspector ordered them to discontinue advertising a medicinal product named “Sudafed.” The Inspector considered the following advertising slogan misleading: “condition of head cold” or “quick relief for the head cold,” justifying that the medical literature does not acknowledge a disease unit known as a “head cold.” Johnson & Johnson argued the phrase “head cold” was introduced to illustrate to the patient the possibility of using the product when a cold involves the head or upper respiratory tract. However, according to the Inspector, the condition of head cold is not supported by the approved Summary of Product Characteristics, hence its advertising is unallowable (more about the decision: http://lswipblog.pl/en/2015/04/severe-headache-of-the-chief-pharmaceutical-inspector/).

CPI on the radio…

Can informational material be included in an advert? The Inspector ordered MSD Polska to immediately discontinue the advertising of an unlawful, according to current regulations, advert of a medicinal product named “Sligard” broadcast on radio stations. The provisions of the Pharmaceutical Law forbid promoting medicinal products that are by prescription only (as is “Sligard”). The Company argued that the following radio spot:

“One doesn’t want to know about certain matters.

Every day 5 Polish women die from cervical cancer. You may be one of them!

You should do whatever is necessary to prevent this!

Have you been vaccinated against cervical cancer?

Ask your doctor and learn more at www.hpv.pl.

The campaign is supported by MDS Polska.”

does not refer to any medicinal product, its content relates only to prevention and it contributes to public awareness, hence there can be no question of medicinal product’s advertising. The Inspector disagreed and emphasised that in order to decide whether certain information material is or isn’t an advert, what matters is its content and the purpose of the message — not the title of the material given by the author. Therefore, referring to certain material as “information” is not sufficient, if in reality the message contains certain hints that help identify a medicinal product to which the advert refers.

CPI, the linguist…

Ad makers should be particularly careful when using such phrases as “the strongest and the fastest,” “severe pain,” “piercing headache” — which was brought to the attention of USP Zdrowie. In its decisions, the Inspector emphasizes that an advert has to present a medicinal product in an objective way, according to the Summary of Product Characteristics. If, as per the Summary, a medicinal product relieves mild pain, using phrases such as “severe” or “piercing” will mislead the consumers.

CPI with a ruler…

“Before using, look through the leaflet, which includes indications, contraindications, unwanted actions, as well as dosage data and information connected with the usage of the medicinal product, or consult the doctor or a chemist, as every medicinal product used contrary to its purpose can be dangerous to your life and health” — this is the warning that an advert of a medicinal product must contain. What’s important, however, is how this message is presented. The Inspector ordered Ewopharma AG to immediately discontinue the advertising of a medicinal product named “Revalid” and considered it unlawful. In an advert in ELLE magazine the Company failed to provide the text in its proper form, i.e. so that the text could be distinguished from the background — the distance of the letters from the lower and upper edges of the background cannot be bigger than half the height of the letters and the distance between rows cannot be bigger than the height of the letters. In this case the distance was bigger, hence the Inspector issued a negative decision.

Although it may seem the number of provisions regulating pharmaceutical advertising may trigger severe headaches among ad makers, one should remember that reliable advertising, which complies with the law, plays a crucial role from the point of view of both consumers and specialists. A reliable cure for such headaches will therefore be getting to know the statutory requirements and the Inspector’s decisions, as well as… checking for the latest information in our blog.

#advertising #chief #chief pharmaceutical inspector #medicinal products #pharmaceutical law

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