//= "[ssba-buttons]" ?>
The advertising of medicinal products is strictly regulated. During a pandemic, responsible entities should take extra care when producing advertising content. It may turn out that previously acceptable messages will instead raise the supervisory authorities’ concerns. So, what should we pay attention to?
We are all hoping for a better tomorrow, we are all doing more to protect ourselves and our loved ones. Every step we take we read, watch and listen about how we can stay safe and how to maintain our immune system. In times of an epidemic, and the associated uncertainty, certain messages are likely to reach us more clearly than before and to evoke some obvious associations.
Pursuant to Art. 53 para. 1 of the Act of 6 September 2001 – Pharmaceutical Law (further, the “Pharmaceutical Law”), “the advertising of a medicinal product cannot be misleading, should present the medicinal product objectively and should provide information on its rational use.” Misleading advertising is one of the most common forms of unfair advertising. It is worth quoting a fragment of the Judgment of the Voivodship Administrative Court (Wojewódzki Sąd Administracyjny; WSA) in Warsaw of 14 August 2007 (VII SA/Wa 982/07) here, where the court held that “an advertisement for a medicine should only make the consumer aware that the medicine in question exists on the market and that it is used in specific conditions. Due to the characteristics of advertising, the communications medium is a particular abbreviation, sometimes a simplification or a reference to an association. The law allows such means of expression, insofar as they do not contain false or misleading information”. An advertisement which evokes a false conviction or image of the product in its recipients could be found to be misleading. Of course, the use of superlatives is an integral part of advertising. On the other hand, certain expressions should be examined carefully, e.g. “the only”, “effective against viruses”. The ability to verify such statements is undoubtedly an important issue, which may determine whether they can be used.
Another provision which should be recalled when discussing the advertising of medicinal products in the context of any “antiviral” effects is Art. 56 pt. 2 of the Pharmaceutical Law, which prohibits advertisements which contain information which does not conform to the Summary of Product Characteristics. Messages suggesting that a medicinal product is effective against COVID-19 and thus may be used to prevent and treat infections, if not confirmed in the approved contents of both the Summary of Product Characteristics and the package leaflet, is therefore not permitted.
As demonstrated by the Chief Pharmaceutical Inspector’s (further, the “GIF”) recent practice, not only can the use of certain terms suggesting that a medicinal product has a specific effect raise concerns, so can the visual elements of a message. For example, the juxtaposition of a medicinal product and the image of a pathogen which the average recipient could reasonably associate with COVID-19 due to its graphic form could be questionable. In the GIF’s opinion, the presentation of a medicinal product in such a manner could be misleading with respect to its properties. It should be noted that the state of epidemic currently in effect on the territory of Poland, and the feelings of fear and danger in society caused by this situation, could exacerbate such and result in a less rational approach to the use of certain medicinal products, in the hopes of staying healthy or recovering from the illness.
The GIF referred to the above issues in its decision of 31 March 2020, issued in connection with administrative proceedings initiated against Aflofarm Farmacja Polska sp. z o.o. concerning the assessment of the conformity of an audio-visual advertisement for the medicinal product Neosine Forte tablets, which was directed to the general public by advertising spots broadcast by a number of TV stations. The GIF ordered Aflofarm to immediately cease advertising the product.
Although the GIF is the primary regulatory authority on the pharmaceutical market, the Office of Competition and Consumer Protection (Urząd Ochrony Konkurencji i Konsumentów; UOKiK), in a communication on its website, also points out that a pandemic is an extraordinary situation, which poses new challenges to both consumers and enterprises. Adapting advertising content is undoubtedly one such challenge.
Doubts may arise not only as to the content of advertisements for medicinal products, but also for foodstuffs, in particular dietary supplements. The Polish Society of Dietetics issued a statement warning that a large amount of unconfirmed information regarding the effectiveness of certain diets or dietary supplements in preventing coronavirus infection has recently been published. The Polish Society of Dietetics also noted that the European Food Safety Authority has not approved any statements regarding foods, or ingredients thereof, which could prevent infection. Such advertising content is also being reviewed by the Chief Sanitary Inspectorate. An example of this is the announcement of the inspection of a Polish company offering dietary supplements which, if used, would – according to the information presented – protect against COVID-19. Bearing in mind the fact that at the present time we know of no medicinal products, let alone vitamins, dietary supplements, or medical devices, the use of which could be recommended as protection against the coronavirus, enterprises should take a closer look at their advertising materials. In these] times it is especially important that their message is clear and understandable, and that it does not cause its recipients to [falsely believe that a given product has some beneficial or supportive effects taking into account both the words and graphics used in advertising materials.
Check what we’re referring to:
- Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2019, item 499)