Advertising of pharmaceuticals, case VI SA/Wa 2110/09

March 17th, 2010, Tomasz Rychlicki

On June 2009, the Polish newspaper Gazeta Wyborcza published an article (sort of an advertorial) containing images that depicted packagings of Stoperan and Septolete medicines, together with a note instructing that the leaflet attached to these products should also be read.

The Main Pharmaceutical Inspector (MPI) ordered the immediate cessation of such actions in a decision of 4 September 2009, case no. GIF-P-R-450-81-4/JD/09, PDF file. The MPI has fund that the publication did not meet the requirements set in the Polish pharmaceutical law with regard to advertising of medicinal products. It was not commissioned by the responsible entity and it did not contain the detailed characteristics of the products or the required and established warnings.

Agora S.A., the owner of Gazeta Wyborcza, filed a complaint to the Voivodeship Administrative Court (VAC) in Warsaw. The VAC in a judgment of 11 MArch 2010, case file VI SA/Wa 2110/09, ruled that medicines are dangerous products and therefore the strict requirements and regulations for advertising of such preparations were introduced, and they do not allow for the so-called hidden advertising. The Court agreed with MPI’s findings that the article published by Gazeta Wyborcza contained information about two medicinal products and that could encourage the use of these preparations, which is contrary to article 52(1) of the The Polish Act on Pharmaceutical Law – PHL – (in Polish: ustawa prawo famraceutyczne) of 6 September 2001, published in Journal of Laws (Dziennik Ustaw) of 2008, No 45, item 271, with later amendments.

Advertising a medicinal product shall mean any activity consisting in informing about and encouraging to use the medicinal product

This judgment is not yet final. A cassation complaint may be filed to the Supreme Administrative Court.

See also “Polish regulations on pharmaceutical trade marks” and “Polish case law on advertising of pharmaceuticals“.