Advertising of medicinal products must encourage people to use the products appropriately in accordance with the Medicines Act. The advertising of medicinal products must not be improper or induce people to use the products unnecessarily. Fimea monitors the advertising of all medicinal products.
Fimea intervenes in the illegal advertising of medicinal products on the basis of a defect or fault in such advertising. The process can be initiated by a complaint submitted to Fimea, also one submitted by a private individual. The complaint must always include the complainant’s contact information. No anonymous complaints are processed.
Fimea sends a reprimand to the pharmaceutical company concerning fraudulent marketing or a clarification request and a copy of the complaint submitted, but will not provide the complainant’s contact information. The company is given the opportunity to submit a rejoinder, on the basis of which Fimea will then decide on the need for further action. If further action is required, the company will be informed of the action in writing and can also submit a rejoinder. Both the company and the complainant will be informed of the action taken and the conclusion of the process.
Fimea guidelines applicable in Finland to the advertising of medicines under additional monitoring
Recommendation for quality criteria for sales promotions of medicines
The work of pharmaceutical sales representatives is marketing, which is aimed at promoting the use of medicines.
A sales promotion event at its best provides up-to-date and good quality information about medicines and their use to practising doctors and pharmacists. In line with the rest of the pharmaceutical marketing, Fimea in Finland also monitors compliance with all parts of the pharmaceutical legislation at sales promotions. Fimea (former NAM) established in 2007 quality criteria for these sales promotion events based on the points in the Medicines Act and Decree important with respect to the communication of appropriate information about medicines which promotes their correct and safe use.
The quality criteria comprise a recommendation which Fimea hopes that the pharmaceutical companies will follow in their marketing. To the professional attending a sales promotion event the recommadation will give a perception of what can be expected of the information content of the presentation. Later Fimea will monitor the extent to which the criteria are followed at these events.
The advertising of medicinal products is prescribed under:
Medicines Act (395/1987), 91–94 §
Medicines Decree, 25, 25a–i §
Consumer Protection Act (38/1978)