With the publication of Farmindustria’s new Code of Ethics (an association set up by pharma companies operating in Italy), there is a breakthrough concerning the disclosure of health information on prescription drugs.
After several years, Farmindustria incorporates some principles already expressed at EU and national level, aimed at resolving the ever-present risk of confusion between advertising and informational activities.
More precisely, Article 113 of the so-called Code of Pharmaceuticals (Legislative Decree No. 219/2006) defines advertising of medicinal products (indiscriminately those addressed to the public or under prescription) as ‘any action of information, customer research or exhortation, intended to promote the prescription, sale or consumption of medicinal products’. These activities are identified as having a mere commercial purpose and therefore meant to encourage sales, and do not include the dissemination of scientific information. The latter is in fact imposed by law in order to safeguard the constitutionally protected right to health. On the other hand, the law expressly prohibits the advertising to the public of prescription drugs.
However, it should be borne in mind that the Code of Pharmaceuticals (and, as we shall shortly see, the EU Court of Justice as well) excludes from the applicability of the cited rule (and thus does not consider information disseminated to be advertising) any information that has as its subject matter:
- labelling and package leaflets;
- the necessary correspondence for specific enquiries about a particular medicine;
- information on packaging, adverse-reaction warnings, sales catalogues and price lists, as long as they do not contain information on the medicinal product.
These aspects were later clarified and extended by the Court of Justice of the EU (judgment of 5 May 2011 in Case C-316/09). In particular, the Court identified the main features of a communication of an informative nature, which, to be such, must:
- contain information limited to the accurate reproduction of the packaging and package leaflet or even a summary of product characteristics as approved by the competent authorities (e.g. AIFA);
- be free of any selection or manipulation of information (e.g. the mere indication of the benefits of the drug), since this would otherwise suggest an intention to give the message an advertising character;
- contain information available by means of a ‘pull’ system, by which consultation of the aforementioned information would be made possible only through an active search action by the user, thus preventing the person not interested in the medicine from being forced to view – even if unwillingly – the relevant information. A different approach is adopted in the case of a ‘push’ system, by means of which the Internet user is ‘hit’ by unwanted communications that automatically appear on the screen (which is precisely a typical advertising marketing strategy).
However, it is only after more than a decade that Farmindustria, on 19 January 2022, transposed the EU interpretation ‘on paper’, thereby softening the general ban on disclosing information on prescription-only medicines to the public (in the sense provided for in Article 113 of the Code of Pharmaceuticals).
To this end, the new Farmindustria Code introduces three new provisions that would allow pharmaceutical companies, in a non-promotional context and without advertising purposes, to:
- interact, also through their territorial operational staff (e.g. pharmaceutical sales representatives), with non-prescribers who are involved in the administration of therapies, who may participate in events, courses or congresses not related to medicinal products (Art. 3.25);
- inform the general public about products and pathologies, including by publishing information on the pharma company’s brand on publicly accessible websites (which could already be considered a possible institutional advertising) and the full and literal reproduction of the package leaflet, as well as of the packaging. This is not without precise limits: on the one hand the information must not be modified or reworked or only partially disseminated; on the other hand, it must only be accessible following active action by the user. In essence, the use of typical marketing techniques is not permitted (Art. 3.26)
- providing non-promotional information on medicinal products to various stakeholders such as: healthcare and non-healthcare professionals, healthcare organisations.
Specifically, the rules on interactions are outlined with respect to activities regarding (i) access and institutional affairs (allowed the use of materials with pharmaco-economic content or related to the value of the product, in order to ensure better accessibility to medicines) (ii) account management (allowed the delivery of price lists as part of interaction with public or private entities, in order to facilitate the application of commercial policies on the supply of medicines), and (iii) scientific exchange (allowed the proactive sharing of data and insights related to clinical practice or new product access activities), (Art. 3.28)
The codification of these cases is to be welcomed, since if on the one hand it maintains the primary objective of protecting the constitutionally recognised rights of the user/patient (the prevailing right to health, but also the right to be informed), on the other hand it seeks to consolidate the right of pharmaceutical companies to interact – albeit cautiously and with limits – also with the public, which until now has been excluded from any activity.
However, only after some time will it be possible to concretely verify the effects and/or possible critical application issues that pharmaceutical companies might incur with their future informational activities, the lawfulness of which will have to be verified on a case-by-case basis.