Advertising of pharmaceuticals, case VI SA/Wa 1758/09

January 6th, 2010, Tomasz Rychlicki

The Polish court issued a first judgment regarding TV/radio sponsored programmes and advertising of pharmaceutical products. US Pharmacia Company prepared a TV spot that was aired with a TV show. The following statement appeared in the spot.

The programme is sponsored by the manufacturer of Apap Noc medicine. Apap Noc – now also available in the big package. Combats pain and helps you fall asleep.

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 the regulations provided in Article 4 pt. 7 of the LOB, the “sponsorship” should 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 Polish Act of 6 September 2001 on Pharmaceutical Law – PHL – (in Polish: ustawa prawo farmaceutyczne), published in Journal of Laws (Dziennik Ustaw) of 2008, No 45, item 271, with subsequent amendments, does not include provisions relating to sponsorship of programs or other broadcasts in radio and television. The Main Pharmaceutical Inspector (MPI) is the central organ of public administration authorized to ensure compliance with pharmaceutical regulations in the context of advertising. According to MPI many pharmaceutical companies are trying to skip the strict sponsorship rules for advertising of pharmaceutical/medicinal products. MPI has already delivered several decisions requiring pharmaceutical companies to immediately cease advertising of medicines, and only US Pharmacia appealed this decision to the Voivodeship Administrative Court. The company argued that the spot was aimed at enhancing the reputation of the medicinal product. The MPI argued that it is unacceptable to add any other indications relating to both the sponsor and the subject of its activities, in particular the goods and services. Such behaviour turns sponsorship into advertising activity.

The Voivodeship Administrative Court in its judgment of 18 December 2009 case file VI SA/Wa 1758/09 ruled that the sponsorship cannot be used as unacceptable advertisement. It has to be a form of promotion separated from advertising. The content and meaning of communication and the message broadcasted decides whether we are dealing with advertising or with corporate sponsorships. The Court also emphasized that each advertising of medicinal product has to be made in accordance with the current Regulation of the Minister of Health of 21 November 2008 on the advertising of medicinal products, published in Journal of Laws (Dziennik Ustaw) No 210 item 1327. The advertising of a medicinal product targeted to the public must contain the following essential information:

  • the name of the medicinal product
  • the INN of the active substanc, in the case of medicinal products containing more than 3 active substances, the term “complex product”
  • the dose of the active substance or active substance concentrations, with the exception of a complex product
  • pharmaceutical form of the product
  • indication or indications for therapeutic use
  • contra-indications
  • identification of the responsible entity

The advertising of medicinal product targeted to the public that is made in the audio-visual form additionally has to contain a warning of the following content:

Before use read the leaflet included in the package or consult with your doctor or pharmacist, as each drug that was used improperly may threaten your life or health.

This warning shall be placed in the bottom of the ad, in terms of representing not less than 20% of its surface, so as to make the text stand out from the background plane visible, legible, motionless, placed horizontally, the distance of letters from the top and bottom edge of the background plane ad cannot be bigger than 1/2 in height and the distance between the lines of the string cannot be bigger than the height of the letters. This warning must be read clearly in the Polish language and it has to appear on the screen no less than 8 seconds. The same rules regarding the warning apply to the advertising of a medicinal product targeted to the public that was prepared as a sound message.
Advertising product targeted to the public in a static visual form, shall contain a warning stating:

Before use read the label, which includes indications, contra-indications, data on adverse effects and dosage and information about the medicinal product, or consult a doctor or pharmacist, as each drug used improperly threatening your life or health.

The Warning shall be placed in the bottom of the ad, in terms of representing not less than 10% of its surface in such a way as to make the text stand out from the background plane visible, legible, motionless, placed horizontally, the distance of letters from the top and bottom edges of the background plane of the ad cannot be bigger than 1/2 in height and the distance between lines of the inscription cannot be bigger than the height of the letters. In the case of advertising to the public in a visual form which includes more than one page, a warning has to be placed on the first page.

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