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How NOT to advertise drugs in Poland
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 MPI) - 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 District 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 rules of the Polish Pharmaceutical Law (the PPL) - the Act of 6 September 2001 Pharmaceutical Law (Dziennik Ustaw of 2004 No. 53, pos 533 with later changes) in particular article 55 of the PPL:
[A]dvertisements of medicinal products should not be misleading, should objectively present a medicinal product and inform of its rational application.and article 56 of the PPL:
(...)
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;
It shall be prohibited to advertise medicinal products:The judgment of the District Administrative Court in Warsaw, (Act signature VII SA/Wa 556/08) is not final. The parties have a right to appeal to the Supreme Administrative Court. Posted by: Tomasz Rychlicki @ 11.34
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.
Tags: Advertising, drugs, Poland, Polish courts,
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