Promotional materials: contents, dissemination and regulations
The advertising of medicinal products for human use is a complex subject, regulated by several norms (both at national and regional level), as well as by deontological codes intended to allow companies to carry out promotional activities on their drugs, ensuring at the same time a correct information.
The main provisions regulating contents and methods of the dissemination of the advertising of medicinal products are included in legislative decree 24 April 2006, no. 219, that is the Italian regulation to be referred to for all aspects of medicinal products for human use.
This legislative decree also details the characteristics and purposes of promotional materials, i.e. every material companies draft to advertise their medicines. This is the so called “information material” or “promotional material”, i.e. any material drafted or prepared for the purposes of the scientific information, that is the one addressed to health professionals. Promotional materials can be available in many forms: advertising leaflets, gadgets (these should be objects of low value, such as post-its, prescription pads, rulers, etc.), (indexed or not) reprints, slide kits, exhibition materials for congresses & meetings, materials to be published in websites, monographs, audiovisual material, material published on scientific journals, etc.
With the progress in technology and communication devices, pharmaceutical scientific information also learned how to use modern channels instead of the traditional dissemination of printed material. Now more than ever, in this time of health emergency, the dissemination of promotional material to doctors and pharmacists occurs through digital channels; brochures and leaflets have been replaced by online dissemination media, videos, e-learning, newsletters and smartphone applications. As for many other spheres, dematerialisation has become popular: printed scientific information is making more and more space to electronic materials, although there are many companies that still prefer the traditional paper material, accompanied by a direct contact between doctors and/or pharmacist and the pharmaceutical sales representatives.
The basic principle of promotional material, as established in the legislative decree 219/2006, is that ‘all the elements of the advertising of a medicine should comply with the information reported in the summary of product characteristics’. The latter should be a constant reference for the drafting of the promotional material. Moreover, the contents of the scientific information should always be updated, documented and documentable.
Once the information material has been drafted, it shall be submitted to the Italian Medicine Agency before the relevant advertising campaign starts. After 10 days – to be calculated as of the submission date – without any request or change by the Agency, according to a silent assent procedure, the advertising campaign can start, but not without having reported the date of the submission of the promotional material intended for the dissemination in the material itself.
As of 2018, all promotional materials concerning medicinal products authorised in Italy for the advertising of medicinal products can be submitted to the Agency only via the AIFA Front End application: an online procedure for which the Agency has published indications to be followed, as well as further step toward the modernisation of the authorising procedures for the advertising of medicinal products to health professionals.
Written by: Martina Tramontana
