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Archive for: Art. 55 PHL

Advertising of pharmaceuticals, case VII SA/Wa 556/08

June 19th, 2008, Tomasz Rychlicki

US Pharmacia has commissioned a TV spot for Stoperan – a diarrhoea drug. The ad’s message promised an immediate effect and cure. The Main Pharmaceutical Inspector – the central organ of the Polish administration which has an authorithy to supervise compliance with the regulations of Pharmaceutical Law in the scope of advertisement, has ruled that this advertising spot was contrary to the charactersitics of the drug, because Stoperan works in 1-3 hours and achieves a therapeutic effect after 48-72 hours. In short, it does not cure, though it overcomes the cause.

US Pharmacia has appealed against the MPI’s decision, claiming that it has ceased the broadcasting and screening of the contested ads. The new version had the questioned parts removed and replaced by other to which the MPI did not submit any objections.

However, the Voivodeship Administrative Court has ruled that the MPI had the right to order the cessation of a medicinal product’s advertisement where it was contrary to the current legal regulations and US Pharmacia has violated the provisions of article 55 and 56 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 2004 No. 53, item 533, with later amendments.

Article 55
Advertisements of medicinal products should not be misleading, should objectively present a medicinal product and inform of its rational application.
(…)
Advertisements of a medicinal product addressed to the general public also cannot include any contents that would:
(…) assure that taking a given medicine guarantees an appropriate effect, it is not accompanied by any undesirable effects or that effect is better or the same as in the case of another method of treatment or treatment with the use of another medicinal product;
(…)
Article 56
It shall be prohibited to advertise medicinal products:
1) not authorized to turnover on the territory of the Republic of Poland;
2) containing information inconsistent with the approved Characteristics of the Medicinal Product.

The judgment of the Voivodeship Administrative Court in Warsaw of 17 June 2008, case file VII SA/Wa 556/08 is not final. The parties have a right to file a cassation complaint to the Supreme Administrative Court.

Advertising of pharmaceuticals, case VII SA/Wa 1157/07

December 7th, 2007, Tomasz Rychlicki

The Voivodeship Administrative Court in Warsaw in its judgment of 3 October 2007 case file VII SA/Wa 1157/07 held that a given activity is deemed as the advertising of pharmaceutical product, if it involves the transfer of information on the product while encouraging its use – i.e., it must be information describing the medicinal product in a way to encourage its use, information that is passed to increase the number of prescriptions, the supply of pharmaceutical product or its sale or consumption.

Advertising of pharmaceuticals, case I SA/Wa 584/05

February 7th, 2006, Tomasz Rychlicki

The Voivodeship Administrative Court in Warsaw in its judgment of 29 December 2005 case file I SA/Wa 584/05 held that the important element of pharmaceutical product advertising is the intention of the advertiser to cause a specific reaction of potential customers. Therefore any activity, regardless of its specific, individual way and method of its performance and measures used for its implementation should be considered as the advertising of a medicinal product if the goal of this activity is to increase sales of the advertised product.

Categories: Art. 55 PHL | Main Pharmaceutical Inspector | pharmaceutical products advertising | Voivodeship Administrative Court.