6.1 Medicines
Marketing activities can only be directed to HCPs who are authorised to prescribe or supply the relevant drugs. Marketing material shall firstly be submitted to AIFA and, 10 days after the submission, it can be delivered to the HCPs.
In general terms the following marketing activities are permitted with regard to HCPs:
- Verbal information;
- Delivery of promotional material;
- Free samples (although it very strictly regulated in terms of quantity);
- Scientific congresses and conventions;
- Refresher courses;
- Visits to companies’ laboratories;
- Investigators’ meetings;
- Scholarships and scientific consultancy.
Exaggerated statements, universal and exaggerated claims and comparisons without any objective basis are inadmissible. Use of email, automated calling systems and other electronic communication aiming at divulging promotional material regularly approved by AIFA is prohibited, unless the company holds a prior written and informed consent from the HCPs to whom the material is addressed.
Recently, the Ministry of Health clarified that information intended for HCPs must only be accessible to these latter, even when disseminated via the Internet, and therefore the Companies must provide for the establishment of encrypted areas that can be accessed by HCPs only upon duly identification process.
It follows that, even within sites with public and free access, links to areas intended for the information of HCPs must in any case constitute a barrier to access, for those who do not qualify as such.
The presence of advertising aimed at HCPs authorised by the Ministry of Health is instead admissible.
6.2 Medical devices
As a preliminary remark, it is worth recalling that no authorisation is necessary for advertisements directed towards healthcare professionals only. Indeed, rules generally address advertisements towards patients.
Advertisings towards healthcare professionals, although being not subject to authorisation, are considered advertisement nonetheless: therefore, they shall be truthful, fair and have a clear promotional purpose.
In addition, advertisings of medical devices shall not:
- attribute to the device functions and properties it lacks;
- create false impressions regarding treatment or diagnosis, functions or properties that the device lacks;
- fail to inform the user or patient of a potential risk associated with the use of the device in accordance with its intended purpose;
- propose uses of the device other than those stated to be part of the intended purpose for which the conformity assessment was carried out.
Finally, it is worth to consider that some supplementary rules are provided by the Guidelines of 20 December 2017 by the Ministry of Health on the use of: emails, call centres, websites, messages, social media (Facebook, Instagram and YouTube) in medical devices’ advertising.
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