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posted 2 years ago
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:
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:
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:
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.
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