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Are you advertising medicinal products — and don’t even know about it?

Advertising certain categories of goods in accordance with the law is not easy. There are many specific legal requirements that such advertising has to comply with. Worse, the prohibitive provisions of the Polish advertising law contains many general and ambiguous terms. Their meaning is left to state authorities — authorized to apply such provisions — to determine. This leads to paradoxical situations whereby the law, as interpreted by the authorities, differs from the intentions of the legislature. And such interpretation may of course vary, depending on any given situation. What is more, the law is always interpreted when issuing decisions, i.e. through “hands-on” experience.

Our example here concerns the advertising of medicinal products . Article 52 of the Pharmaceutical Law, which includes the definition of an advertisement of a medicinal product, in its main part states as follows:

Medicinal product advertising is an activity of informing on or encouraging the use of the medicinal product with an aim to increase the number of prescriptions, delivery, sale or consumption of medicinal products.

The definition stipulated in this way emphasises the aim of the author of an advertising message (the effect which the advertisement is expected to cause) — for example, an increase in the number of prescriptions. Issues of this nature are, of course, very subjective and may be interpreted in many ways. In practice, structuring the provision in this way means that what is and isn’t legal is determined — with hindsight — by the Chief Pharmaceutical Inspector (the CPI), i.e. the state authority issuing decisions requiring a given advertisement be stopped.

The CPI tends to consider a wide range of situations constituting advertising, which then leads to the blocking of a particular advertisement. An example is the recent decision  according to which an article in the Twój Styl magazine  was determined to be an advertisement of prescription-only-medicines. The situation involved an article describing the side effects of contraceptive pills, such as decreased libido. The article included information that a contraceptive which recently has become available on the Polish market does not cause such side effect.

The editors of the magazine indicated the aim of the article was by no means advertising of medicinal products or intended to lead to“an increase in the number of prescriptions.” The idea was to “provide the readers with information regarding the reasons for a decreased libido in connection with taking most contraceptives and presenting scientific data regarding one contraceptive which, according to research, does not cause a decreased libido”. The editors considered this all purely informative material. The aim of the article was not to encourage readers to purchase the product. Moreover, the article was not sponsored, nor did the publisher receive any benefits in connection with the sale of the medicinal product.

It would appear that such arguments are difficult to disprove. However, they didn’t convince the CPI. The Inspector emphasised in the decision that an advertisement of a medicinal product is not only a message encouraging to, for example, buy the product, but merely informing about it. The only important thing is whether an advertising activity aims at an increase in the product sale, consumption, etc. The Inspector interprets such an “aim” not as an intention of the author of a given message, but rather as a “possible effect,” which the authority interprets on its own. In practice, this confirms that the possibilities of interpretation of the provisions concerning advertising of medicinal products are, in fact, virtually unlimited.

As indicated by the party to the proceedings, such a restrictive attitude of the authority (i.e. considering the article to be an advertisement) would be harmful to the freedom of the press — which would not be able to inform about medical advances — and also for the constitutional freedom of speech. However, this argument was also refuted by the CPI. Freedom of speech cannot be unlimited and the law includes provisions to the effect that, according to the Inspector, ensure its appropriate level. Namely, according to the Pharmaceutical Law, the following shall not be considered advertising: “information relating to human or animal health or diseases, provided that there is no reference, even indirect, to medicinal products.” This is, however, another very ambiguous provision of the Law — what does it mean that information cannot have “even indirect” reference to medicinal products? Where is the border of such “indirectness”? In practice, the Inspector allows only for using the names of active substances (e.g. “acetylsalicylic acid”) or the so called common names (i.e. specialist marking by the World Health Organisation of a given type of medicinal product). According to the CPI, such possibilities of informing about medicinal products are sufficient in order to exercise the constitutional freedom of speech. Whether this is the case seems disputable.In the proceedings against the CPI, Twój Styl used another interesting argument. Namely, the CPI’s decision is an order to stop advertising, which in this case would mean the necessity to withdraw the magazine from sales. However, the case relates to an issue of the magazine which was already not available on the market when the proceedings were being conducted. The unsold issues of the magazine are withdrawn from the sales points and rendered for utilisation or paper recycling. Therefore, Twój Styl indicated that the CPI cannot issue an order to withdraw the magazine from distribution because this had already been done. The proceedings in such a case would, thus, be irrelevant.

Surprisingly, the Inspector did not agree with this seemingly incontestable argument either. The Inspector indicated “the absence of the magazine on the market is not equal to its withdrawal from circulation, since the issue is available as an archived material in reading rooms and libraries as well as in private archives.” It’s interesting that the Inspector referred to “private archives” — does that mean that in order to execute the CPI’s decision one would have to track down every sold magazine and retreive it from every reader?  Each issue of Twój Styl sells 150,000 to 200,000 copies, by the way. It’s questionable if whether such an order is enforceable at all.

This is not the first decision by the CPI which interprets the concept of medicinal products’ advertising in a broad sense. There have been situations where certain messages which did not include the name of a medicinal product (but only a call for vaccination against a particular illness) were determined as an advertisement (PDF ). Even a parody reference to a well-known advertisement slogan — “A na serce Acard, niech pamięta” (“Remember: Acard for your heart ”) — used in a scenario of a play was determined as such (PDF ) (although in that case it has to be mentioned that the situation was, in fact, ambiguous, as the medicinal product manufacturer was indeed a patron of the play).

A general tendency which can be seen in subsequent decisions of the Inspector is to treat certain contents as advertising even though the authors originally did not intend for them to be of such nature and without the cooperation of the medicinal product’s manufacturer. The recent decision by the CPI shows that the power of the Inspector reaches beyond the traditional advertising environment on radio or billboards. It is, therefore, worth remembering that, for example, an entry in a blog about health or even a reference to a medicinal product in an internet comment could be considered advertisement, if it informs about the named medicinal product’s effect.

#advertising #chief pharmaceutical inspector #Main Pharmaceutical Inspectorate #medicinal products #pharmaceutical law #press

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