Medical Device Advertising in Italy: new perspective
The Italian legislation on Medical Devices includes very restrictive rules about medical Device advertising (not included in ECC Directive).
To be more precise:
Art. 21 of D.Lgs. n. 46/97 on medical device advertising establishes there are two different categories:
1) Medical devices whose advertisement is totally prohibited :
This category includes products which require a medical prescription or professional assistance at the purchase/usage stage;
2) Medical devices whose advertisement is allowed with prior authorisation:
This category includes all the other medical devices, different than those above mentioned
This rule doesn’t include any provision about standards to evaluate medical device advertising.
A) The application field
Ministry Decree of 23/02/06 identified the application field of the above mentioned rules, mitigating this severe regulation.
This Decree introduces two relevant exceptions to the ban n. 1).
1) According to Art. 1, subsection 2, the advertising ban regarding medical device subjected to medical prescription/ medical assistance is not applicable when the advertising allows the consumer to choose between one or more options.
In this case, the advertising will be promoted with prior Health Minister authorisation.
2) According to Art. 3 of the Decree, institutional advertising[1] is now free.
B) Evaluation standards
The MOH has recently decided to evaluate medical device advertising requests by applying the standards in force for medical products advertisings.
These standards are listed by art. 90 of Dir 2011/83/EC concerning medical devices:
“The advertising of a medicinal product to the general public shall not contain any material which:
(a) gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail;
(b) suggests that the effects of taking the medicine are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicinal product;
(c) suggests that the health of the subject can be enhanced by taking the medicine;
(d) suggests that the health of the subject could be affected by not taking the medicine; this prohibition shall not apply to the vaccination campaigns referred to in Article 88(4);
(e) is directed exclusively or principally at children;
(f) refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products;
(g) suggests that the medicinal product is a foodstuff, cosmetic or other consumer product;
(h) suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural;
(i) could, by a description or detailed representation of a case history, lead to erroneous self-diagnosis;
(j) refers, in improper, alarming or misleading terms, to claims of recovery;
(k) uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof;
(l) mentions that the medicinal product has been granted a marketing authorization.”
Now it’s clearer how to arrange a medical device advertising campaign.
C) Recent caselaw
Although advertising authorisation is still mandatory, the MOH’s actual approach about medical advertising authorisation is more “flexible” than in the past due to a new case law.
During year 2012, the Italian government issued Law. N. 27/2012, which, in order to liberalize Italian marketplace, introduced a new perspective that can be summarized as follows:
· the market needs to be free;
· restrictions can be introduced only for relevant reasons (e.g. health security);
· in any case, these restrictions must respect the European principle of proportionality;
· the restriction interpretations and applications need to be limited.
In the last two years, the new liberalization “wind” influenced the court decisions: the most relevant decision on medical device advertising was issued by Tar Lazio with judgement n.8943/2014, in which the above mentioned new principles get application.
Here is the case that brought to the judgment.
An Italian company filed a request to obtain the authorization for a medical device advertising campaign.
The advertising was made up of a short movie about a mouthwash (which belongs to medical devices) and a toothpaste (which is a cosmetic product).
During the movie, a famous actor went on stage: he just showed off, without speaking.
The MOH rejected the request because of a ban listed by art. 90 lett f) of Dir 2011/83/EC [2].
The company decided to file a petition before an Italian Administrative Court (TAR LAZIO), which accepted the company’s legal claim.
Here’s why: the Court decided that the rejection was illegal because the MOH applied the ban stated by art. 90 lett f) in a too wide way.
In fact, art. 90 lett. f) only forbids that a “celebrity could encourage the consumption of products”, while, in the short movie, the famous actor just stands out without saying anything.
Therefore, he doesn’t “encourage” the consuption of the medical device at all.
For this reason, TAR Lazio evaluated the MHO rejection to be illegal.
In a few words:
· the judge declared the ban must be applied according to a strict interpretation;
· art. 90 lett f) only concerns the suggestion and/or encouragement to consumption of medical devices by influential persons or VIPs. If these persons don’t “encourage” or “suggest” anything , the ban cannot be applied.
This decision is the sign of a new orientation rising by the Courts.
By the way, this judgment is not the only one stating like that, since many other judgments have already come to the same orientation (e.g. Tar Lazio judgements no 9032/2014 can be taken into account).
The MHO can limit medical device advertising only when this limit is provided by the law and in the respect of a strict interpretation.
[1]the definition of “institutional advertising” is: “The promotional message aimed at creating an image, enhancing reputation, building goodwill, or advocating an idea or the philosophy of an organization, instead of sales promotion. When employed by an organization to market itself (instead of its products), it is called corporate advertising.
[2] The advertising of a medicinal product to the general public shall not contain any material which: f) refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products