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Archive for: Art. 57 PHL

Advertising of pharmaceuticals, case VI SA/ Wa 1136/10

July 29th, 2010, Tomasz Rychlicki

This is the continuation of a story described in “Advertising of pharmaceuticals, case II GSK 461/09“. The Voivodeship Administrative Court in Warsaw in its judgment case file VI SA/ Wa 1136/10 canceled the decision of the Main Pharmaceutical Inspector (MPI) that ordered the Polish Federation for Women and Family Planning (in Polish: Federacja na rzecz Kobiet i Planowania Rodziny) to remove information about different contraceptions. Such information was published on the website operated by the PFWFP. Being bound by a legal interpretation issued by the Supreme Administrative Court, the VAC ruled that the mere use of the name of a pharmaceutical product does not prejudge that such message is advertising. One cannot automatically equate information on medicinal products with an incentive to use them.

Advertising of pharmaceuticals, case II GSK 461/09

March 14th, 2010, Tomasz Rychlicki

The Main Pharmaceutical Inspector (MPI) found that Polish Federation for Women and Family Planning (in Polish: Federacja na rzecz Kobiet i Planowania Rodziny) is publishing the names of contraceptives on its Internet website, and therefore the Federation advertises these products. The MPI ordered the immediate cessation of such actions because it may encourages the use and prescription of such medical preparations and public advertisement of medicinal products as contraceptives, that are issued only on prescription, is prohibited by provisions of 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

The Federation filed a complaint to the Voivodeship Administrative Court (VAC) in Warsaw. The VAC in a judgment of 3 March 2009, case file VII SA/Wa 2108/08, has overturned the decision of the MPI, but only because the incomplete material was submitted. The VAC agreed that MPI’s decision was justified with regard to cessation of public advertisement of contraceptives. The Federation filed a cassation complaint.

The Supreme Administrative Cort (SAC) in a judgment of 10 March 2010, case file II GSK 461/09, ruled that the provisions of article 52 are legible and obvious, but they must relate to the circumstances of a particular case and to all reasons of actions taken in order to inform about the medicinal product. According to the SAC these circumstances were not considered and the VAC also omitted the statutory objectives of the Federation. The major role of the Polish Federation for Women and Family Planning is to inform of the various methods of family planning. Publishing the name of contraceptives, cannot be treated as an encouragement for its use. The information does not come from the responsible entity, and the publication of characteristics of medicinal products is not considered as advertising. If the order issued by the MPI was sustained, such information could not be published at all.

Therefore, the SAC annulled the questioned judgments of the Voivodeship Administrative Court and returned the case to the VAC for reconsideration.

Advertising of pharmaceuticals, case II CSK 289/07

January 24th, 2009, Tomasz Rychlicki

According to one of the older judgments of the of the Supreme Court – Civil Chamber of 2 October 2007, case file II CSK 289/07, published in the Jurisprudence of the Supreme Court, the Civil Chamber (in Polish: Orzecznictwo Sądu Najwyższego Izba Cywilna) of 2008, No 12, item 140, p. 54, a public advertisement of promotional prices (price cuts) of drugs that is made by comparing these reduced prices with the higher prices, suggesting periodic drug sales at a lower price, is a prohibited public advertising of medicines as referred to in article 57(1)(i) and (iii) 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 subsequent amendments.

1. Advertising of the following medicinal products, addressed to the general public, shall be prohibited:
i) dispensed exclusively on doctor’s prescription
(…)
iii) included, according to separate regulations, on the lists of the reimbursable medicines and authorized for issuing without prescription, with the proper name identical with the name mentioned on these lists.

It is also the act of unfair competition as provided in article 16(1)(i) of the Act of 16 April 1993 on Combating Unfair Competition – CUC – (in Polish: ustawa o zwalczaniu nieuczciwej konkurencji), Journal of Laws (Dziennik Ustaw) No 47, item 211, with subsequent amendments.

In the field of advertising the act of unfair competition shall be, in particular, the following:
1) advertising contrary to provisions of the law, good practices or offending human dignity,

The Court ruled that assessment whether advertising can be deemed as misleading should refer to the model of the average recipient of this kind of advertising – the consumer of advertised products or services.

In this case, it was the average consumer of pharmaceuticals, to which advertising newspapers and leaflets were directed. As the Supreme Court noted in its judgment of 3 December 2003, case file I CK 358/02, the model of the average consumer, who is reasonably well informed and reasonably observant and circumspect, is now used widely adopted in the Republic of Poland as it is in the European Union.

However, the model of an average consumer could not be defined and considered in isolation from the conditions of this specific case and the realities concerning recipients of specific products to which the advertising is directed. Therefore, one could not ignore the fact that such consumers are often very ill persons, often with reduced capacity of perception and limited ability of reasonable and critical evaluation, as well as they are often elderly, which is also a significant group of consumers of medicines. These are typically the person more susceptible to suggestion and less critical. These people are targeted by pharmaceutical advertising and, while assessing the possibility of confusion, the characteristics of this kind of audience should be taken into account as a model of the average consumer.

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.