A pharmaceutical company was ordered to cease their advertising in its current form and fined DKK 50,000 plus VAT
On 31 January 2024, the Investigator’s Panel, appointed by the Danish Ethical Committee for the Pharmaceutical Industry (ENLI), found a company’s use of promotional material on an exhibition stand in violation of the Promotion Code (adopted by ENLI). The case arose after another company filed a complaint to ENLI.
The case involved 3 different complaints considered by the Panel.
The first complaint concerned the requirements of the Promotion Code (adopted by ENLI) for information in advertising for medicinal products, Information about dosage, the delivery group, and the date of the latest revision of the material was not provided. Further it was not informed, as required, that the summary of product characteristics can be obtained free of charge from the marketing holder. Also, sections that did not use the specific wording of the summary of product characteristics or were abbreviated, were not highlighted as required. Several noteworthy elements were inappropriately omitted. This includes the premise of optimal underlying pharmacological and non-pharmacological treatment, among others. Finally, there was no reference to the current prices on medicinpriser.dk. Overall, the mandatory information was not easy to read.
The second complaint concerns the documentation of claims about medicines. The Panel assessed that several statements were not properly documented in the material. This is, for example, the statement "Prolastina, the most preferred choice among healthcare professionals". In addition, two of the statements violate the requirement for objectivity in the Advertising Code. Finally, the statement "Prolastina with more than 35 years of clinical experience" is documented by reference to data-on-file and market research that can be purchased. The requirement for documentation of indirect claims for medicinal products is not fulfilled by this type of documentation.
The third complaint concerns reference to mandatory texts, which in this case were on a roll-up. Such information must appear clear for the natural target audience of the advertisement to be able to read it easily. The statement on the roll-up was: "Full product information is available at the exhibition stand". The Panel found based on earlier practice that there is an exception to the main rule, but that it is strictly interpreted. This means that it is not enough to make the mandatory information available at a stand next to a roll-up, but that the compulsory text must be freely available and clearly indicated on the roll-up.
The Panel ruled in favor of the complainant in all three matters. The company was ordered to cease using the advertisement in its current form and was also fined DKK 50,000 + VAT.
The decision can be read here (in Danish only).
