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We give guidance in this infographic on the do’s and don’ts from a regulatory standpoint of advertising medicines in Italy, which is becoming increasingly regulated.
We have analyzed the problem of advertising medicines in Italy in the infographic below in legal design style and in the rest of the article.
The notion of “advertising” – when referring to medicines – is quite broad and embraces any action of information, customer research or exhortation, intended to promote the prescription, supply, sale or consumption of such products. Pursuant to Legislative Decree 219/2006, which implements Directive 2001/83/EU in Italy, the definition of “advertising” includes not only forms of promotion in the strict sense, but also the following activities, among others:
- the supply of samples of medicines
- the sponsorship of promotional meetings attended by persons authorized to prescribe or supply medicinal products; and
- the sponsorship of scientific congresses attended by persons authorized to prescribe or supply medicinal products, in particular the payment of travel and subsistence expenses of the latter on that occasion.
On the other hand, they do not fall within the notion of advertising, and therefore are not subject to the relevant rules:
- the labelling and the package insert;
- the correspondence necessary to respond to a precise and unsolicited request for information on a particular medicinal product;
- factual information and reference documents relating, for example, to packaging changes, adverse-reaction warnings as part of pharmacovigilance, sales catalogues and price lists, provided that no information about the medicinal product is included therein;
- information relating to human health or diseases, provided that there is no reference, even indirect, to a medicinal product.
A fundamental requirement for the advertising of a medicinal product is that it has obtained a marketing authorisation, whereas the advertising of unauthorised medicinal products is always prohibited. Moreover, while the Legislative Decree 219/2006 does not set any limitation with respect to the type of medicinal products that can be advertised to healthcare professionals, according to the current legislation it is not possible to promote to the public
- medicines subject to medical prescription;
- medicines reimbursed by the healthcare system;
- medicines containing psychotropic or narcotic substances;
- medicines which, due to their composition and therapeutic objective, are designed and manufactured to be used with a doctor’s intervention.
Legislative Decree 219/2006 – in line with Directive 2001/83/EC – also regulates in detail the contents allowed in the advertising of medicinal products. In this sense, stricter rules apply when the promotion is aimed at the public. The intention of the EU and Italian legislators is in fact to protect those who – not being health professionals and therefore not having a specific scientific background – do not have the tools to fully understand the information received with reference to a specific product.
Without going into detail about the numerous provisions regulating the promotion of such products, it is sufficient to mention that the Legislative Decree 219/2006 provides that the advertising of a medicinal product to the public
- must be carried out in such a way that the advertising nature of the message is evident and the product is clearly identified as a medicinal product;
- must include at least:
- the name of the medicinal product and the common name of the active substance;
- information essential for the correct use of the medicinal product; and
- an explicit and clear invitation to read carefully the warnings given in the package leaflet.
You can follow the other infographics on advertising laws in different fields that we have prepared at the link HERE