“Advertising of medicinal products” means any action informing, searching for customers or any exhortation, intending to promote the prescription, supply, sale or consumption of medicines. It goes without saying that this is an extremely delicate activity that can only occur through a competent corporate body addressing the subjects authorised to prescribe and dispense medicines.
The corporate service of pharmaceutical scientific information allows the transmission of information on drugs for human use to doctors and pharmacists: composition, therapeutic activity, indications, posology, method of use, precautions, and any reimbursement by the National Health Service, are all information transmitted to health operators by the pharmaceutical sales representatives. This activity is also aimed at informing the professionals of this sector about other aspects regarding any research and use of drugs – results of controlled clinical trials on efficacy and tolerability, immediate and long-term toxicity – in order to ensure a use of the drug that is as much correct as possible.
Scientific information is therefore essential in the health sector, because – through the Medical Directions of pharmaceutical companies and Pharmaceutical Sales Representatives – it represents a relevant reference point for doctors’ updating. The purpose of scientific information is in fact a continuous updating of health professionals, on one side promoting a correct use of the drugs in terms of efficacy and tolerability, on the other informing them on new products, new indications, new dosages, new pharmaceutical forms that became available.
The advertising of drugs to doctors and pharmacists is however regulated by specific legal provisions that pharmaceutical companies must comply with. The norms establish the requirements and restrictions for the advertising addressed to the figures authorised to drug prescription and dispensation. The main regulation on this topic is Chapter VIII of legislative decree 24 April 2006, no. 219; however, the Italian Medicine Agency, that is also competent for this aspect, recently drafted some guidelines that are very useful for all operators of this sector.
Guidelines on the advertising of medicinal products to health professionals
The guidelines on the advertising of medicinal products to health professionals are in fact intended to support companies in the preparation of an appropriate promotion of their medicines and to provide a clear key of interpretation to the subjects addressed by advertising and to monitoring authorities. However, as in many other fields, the application of the regulation in the daily practice involves a series of critical issues, partly due to the margin of interpretation provided for by the norm itself. There are some points, though, that are steady and unquestionable, where the norms are clear and do not leave any room for interpretations.
First of all, the basic principle that any advertising of a medicine with no marketing authorisation is forbidden. The second, as we have already seen, is that such advertising can only be addressed to doctors and pharmacists: regulations do not provide for other different subjects (such as nurses) to be the addressee of medical scientific information, in spite of the fact that they are often responsible for the drug administration.
But the essential principle at the base of medicines advertising is that this cannot be addressed to patients, except for advertising of OTCs and no-prescription drugs (however, such advertising should be preliminarily approved by the Ministry of Health): a ban that is particularly important in this 2020, when fears generated by the spreading of the coronavirus have further stressed in citizens the desire to collect information autonomously in search of presumed effective therapies available. The goal of such ban is precisely to protect patients’ health ensuring that information on drug reaches them only through health professionals.
By fulfilling the legal obligations on the advertising of medicinal products to health professionals, scientific information is then strictly involved in the protection of patients’ health, and it is therefore a key function in the organisation of any pharmaceutical company intending to operate in compliance with the regulations in force.