Archive for: Art. 53 PHL

Advertising of pharmaceuticals, case II GSK 199/08

June 30th, 2008, Tomasz Rychlicki

Apteka przy Ratuszu – Centrum Farmaceutyczne (the pharmacy) in Białystok had published a brochure titled “Megaextracharges” (Megadopłaty) in which it has provided information about promotional prices of medicinal products that were available in “Apteka przy Ratuszu”. The Main Pharmaceutical Inspector (MPI) – the central organ of the Polish administration which has the authorithy to supervise compliance with the regulations of Pharmaceutical Law in the scope of advertisements – has ruled that such advertising is prohibited by the Polish Pharmaceutical Law and has ordered the owners of the pharmacy to cease distribiution of brochures and leaflets.

Article 52 of the Polish Act on Pharmaceutical Law – PHL – (in Polish: ustawa prawo farmaceutyczne) of 6 September 2001, published in Journal of Laws (Dziennik Ustaw) of 2008, No 45, item 271, with later amendments provides definition of advertising.

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

Article 53(1-2) of the PHL allows for limited advertising.

1. Advertising of a medicinal product must not be misleading, it shall show the medicinal product objectively and it shall inform about its rational application.

2. Advertising of a medicinal product can not consist of offering or promising of any benefits, in direct or indirect way, in exchange for product’s purchase or delivery of proofs that the product was purchased.

The owners filled a complaint before the Voivodeship Administrative Court (VAC) in Warsaw. The Court overruled the MPI’s decision and held that the disputed brochures provided information only about the possibility to buy cheap medicines which, in consequence, did not fulfil the definition of “advertising of a medicinal product” as provided in Article 52 of the PPL. The VAC did not find any circumstances of “encouragement to buy” in those promotional materials.

The MPI filled a cassation complaint before the Supreme Administrative Court. The SAC agreed with the Main Pharmaceutical Inspector and held that the lower court should assess not only the visual incentive to buy, but also the “actual intention”, while testing the differences between information and advertising.

The Supreme Administrative Court in a judgment of of 26 June 2008, case file II GSK 199/08 clearly noted that prices promotions encouraging to medicinal products purchases in a specific pharmacy are the advertising of a medicinal product and a company which applies it.

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