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Archive for: Art. 52 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 GIF-P-R-450/147-3/ZW/09/10

April 28th, 2010, Tomasz Rychlicki

The Main Pharmaceutical Inspector (MPI) questioned the legality of a few ads that were aired on different TV channels. See for instance the decision of the the Main Pharmaceutical Inspector of 4 March 2010, no. GIF-P-R-450/147-3/ZW/09/10, with regard to indication of a sponsor in “The producer of Guajazyl – cough syrup, invites to a forecast” (in Polish “Na prognozę pogody zaprasza producent Guajazylu – wykrztuśnego syropu na kaszel”), the decision of the the Main Pharmaceutical Inspector of 10 March 2010, no. GIF-P-R-450/141-4/ZW/09/10, with regard to indication of a sponsor in “The producer of Pectosol – herbal preparation on cough, invites to a program” (in Polish: “Na program zaprasza producent Pectosolu – ziołowego preparatu na kaszel”), the decision of the the Main Pharmaceutical Inspector of 6 January 2010, no GIF-P-R-450/126-3/ZW/09/10, with regard to indication of a sponsor in “The producer of DEXAPINI invites to a forecast. DEXAPINI – goodnight without a cough” (in Polish: “Na prognozę pogody zaprasza producent syropu DEXAPINI. DEXAPINI – dobranoc bez kaszlu”).

According to the provisions of Article 17(1) of the Polish Act of 29 December 1992 on Broadcasting – LOB – (in Polish: Ustawa o radiofonii i telewizji), published in Journal of Law (Dziennik Ustaw) of 1993, No 7 item 34, consolidated text of 19 Novemver 2004, Journal of Laws (Dziennik Ustaw) No 253 item 2531, with subsequent amendments, sponsored programmes or other broadcasts shall be identified as such by sponsor credits at their beginning or end. Such credits may specify only the sponsor’s name, business name, trademark or contain some other identification of the business operator or its business activities, the image of a single product or service. According to article 4 pt. 7 of the LOB, the “sponsorship” shall mean a direct or indirect financing or co-financing of the production or transmission of a programme or other broadcasts by an entity other than the broadcaster or producer of the programme, with a view to establishing, enhancing or promoting the renown of the name, business name, product or service, trademark. The MPI held that publishing of information relating to the product, not the manufacturer’s is basically beyond the scope of sponsorship. The MPI ruled that these sponsorship spots were illegal advertising of the medicinal products.

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.

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 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.