1. Which laws are applicable regarding advertising of medicines and medical devices?

  • Advertising of medicines is regulated in a specific section of Legislative Decree no. 219/2006 (“Code of Medicines”). In addition, the Ministry of Health issued specific guidelines on the advertising of non-prescription medicines (SOP) and OTC, as well as on the use of social media in the context of the medicines advertising. 
  • Advertising of medical devices is regulated in a specific section of Legislative Decree no. 46/1997. The Ministry of Health then adopted some acts to specify the discipline, issuing the Ministerial Decree no. 93/2006 and some Guidelines on the use of various advertising channels such as paper publications, call centres or social media. 
  • Furthermore, if the advertising is aimed to consumers, the advertisers will also be obliged to comply with the provisions set forth in the Legislative Decree no. 206/2005 (“Consumer Code”).

2. Are there any other legal regimes such as self-regulatory codes of conduct that govern the advertising of medicines and medical devices?

Yes, the most relevant codes of conduct are:

  • Code of Self-Discipline of Commercial Communication prepared by the Institute of Advertising Self-Regulation. This Code contains rules applicable to all types of advertising but dedicates a section to the advertising of “Medicinal products and healing treatments”.
  • Farmindustria Code of Conduct and Confindustria Dispositivi Medici Code of Conduct. Farmindustria is the Italian pharmaceutical companies' trade association. Confindustria Dispositivi Medici is the Italian trade association of medical devices' manufacturers and distributors. The Codes represent the commitment of the industry not only to abide by specific laws in force but also to operate on the basis of transparent standards of conduct that regulate the various circumstances in which corporate activities take place. The Codes also include some rules dedicated to advertising.

3. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?

3.1 The general public

Advertising of medicines and medical devices to the public always requires the authorisation of the Ministry of Health. A specific application for each single advert, even if the same advert is released through several different media, shall be submitted to the Ministry of Health for an authorisation to market drugs and medical devices to consumers. Should the Ministry of Health not provide this authorisation within 45 days of the date of the application, it is deemed to have been granted. The authorisation lasts for 24 months.

The fee to be paid to the Ministry of Health is equal to € 380,10 for each text, for each product and for each media both for medicines and for medical devices.

The authorisation is not required for:

  • Institutional advertising referring to the name or field of activity of the supplier or distributor, provided that it does not boast specific properties of the products;
  • Promotions consisting in the sale of multiple packs at the price of the unit pack or through similar methods.

3.2 Healthcare professionals

Advertising to Healthcare Professionals does not need to be authorised.

With regard to medicines only, the marketing material shall firstly be submitted to AIFA and, ten days after the submission, it can be delivered to the HCPs. No actual authorisation is required, there is only a duty to submit it to AIFA. The material cannot be used only if AIFA prohibits it.

4. Does the law in Italy regulate the advertising of prescription-only and over-the-counter medicines differently?

Yes, advertising to the public of medicines that can be purchased on prescription only is prohibited.

5. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?

5.1 Medicines

Promotion of medicines to the public is only permitted if the drugs are non-prescription or do not need the intervention of a doctor for diagnostic purposes.

The following kinds or drugs are not to be promoted to consumers at all:

  • Drugs which are available on medical prescription only;
  • Drugs which contain psychotropic or narcotic substances; and
  • Drugs which are totally or partially reimbursed by the National Health System.

Advertising to the public of a medicine product cannot contain any element that:

  • Suggest that it is not necessary to consult a doctor or surgery, in particular by offering a diagnosis or proposing a cure by correspondence;
  • Suggests that the efficacy of the medicinal product free from side effects or greater or equal to another treatment or another medicine;
  • Suggests that the medicine can improve the normal state of good health of the subject;
  • Suggests that the non-use of the medicine can have detrimental effects on the normal state of good health of the subject;
  • Is aimed exclusively or mainly at children;
  • Includes a recommendation from scientists, health professionals or persons widely known to the public;
  • Assimilates the medicinal product to a food product, a cosmetic product or another consumer product;
  • Suggests that the safety or efficacy of the medicine is due to the fact that it is a “natural” substance;
  • May lead to incorrect self-diagnosis;
  • Improperly, impressively or deceptively refers to claims of healing;
  • Improperly, impressively or deceptively uses visual representations of alterations of the human body due to illness or injury, or of the action of a medicine on the human body or on a part thereof.

Furthermore, it is not permitted to give consumers free samples or to give them promotional offers on drugs.

Finally, it is worth to consider that some supplementary rules are provided by the Guidelines of 25 July 2017 and 7 May 2018 by the Ministry of Health on the use of: emails, call centres, websites, messages, social Media (Facebook, Instagram and YouTube) in non-prescription medicines (SOP) and OTC advertising.

5.2 Medical devices

Advertisements of medical devices to the public are limited as follows:

  • Advertisements of medical devices which can be used upon medical prescription only and/or require the assistance of HCPs to be used are forbidden;
  • Advertisements of medical devices which can be used lacking the requirements under 1 above is allowed provided that they are duly authorised by the Ministry of Health.

As an exception to the above, mere accessories of medical devices (e.g. frames for glasses) are not subject to the rules on medical devices' advertisements insofar as they are chosen by the patient only on the basis of aesthetic factors, thus not taking into account medical aspects.

6. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?

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, ten 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.

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.

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.

7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?

7.1 Medicines

Marketing statements must always be substantiated by documented and verifiable evidence. The minimum particulars to be included in all advertising are:

  • The information listed in the summary of the product characteristics,
  • The supply category of the drug, and
  • The selling price and the conditions under which it can be reimbursed by the national health system.

The promotional material may also include the name of the drug, the name of the active ingredient, together with the name of the license holder and of the co-promoter, if any.

7.2 Medical devices

The elements present in the advertisement must be consistent with the label and the instructions for use of the product.
The advertisement must: (i) encourage a rational use of the medical device; (ii) be truthful, fair and not misleading; (iii) have a clear advertising purpose which must not be concealed by the presence of too many information of different nature.

The advertisement shall contain the following elements: (i) the statement “E' un dispositivo medico CE” (it is a EC medical device); (ii) the denomination of the product and its class; (iii) a clear urging to read the warnings and/or the instructions for use. In advertisements on printed materials, the urging shall be in a font no smaller than 9, whereas in case of audio-video advertisements, the urging must be stated in a clear and normal-paced manner.

In case the advertisements are published online on websites, or in specific areas thereof, which are meant exclusively for healthcare professionals, undertakings shall set up a specific disclaimer warning user that the information therein contained is aimed to healthcare professionals only.

8. What information must appear in advertisements directed to the general public?

8.1 Medicines

Promotion to consumers of a medicine shall:

  1. Clearly allow to understand that the message is a promotion about a medicine:
  2. Include the following minimum information:
    • The name of the drug as well as the name of the active ingredient (the latter only if the drug contains only one active ingredient);
    • The information necessary for correct use of the drug;
    • An express and legible invitation to read carefully the instruction on the package leaflet or on the outer packaging. In case of promotional messages included in newspapers or periodical press, such an invitation must be in font size nine.

The advertisement shall then contain the number and the date of the authorisation thereof or, should the latter case occur, the date of the application.

8.2 Medical devices

The elements present in the advertisement of a medical device must be consistent with the label and the instructions for use of the product.

The advertisement must:

  • encourage a rational use of the medical device;
  • be truthful, fair and not misleading;
  • have a clear advertising purpose which must not be concealed by the presence of too many information of different nature.

The advertisement shall contain the following elements:

  1. the statement “E' un dispositivo medico CE” (it is a EC medical device);
  2. the denomination of the product and its class;
  3. a clear urging to read the warnings and/or the instructions for use. In advertisements on printed materials, the urging shall be in a font no smaller than 9, whereas in case of audio-video advertisements, the urging must be stated in a clear and normal-paced manner.

The following content is not allowed:

  1. content that induces a wrongful self-diagnosis;
  2. content that makes the consultation of a doctor appear unnecessary;
  3. content that may induce the patient to believe that the lack of use of the medical device will be detrimental to his health and/or to believe that the use of the medical devices bears no contraindications;
  4. content that makes misleading reference to the healing capacities of the product;
  5. messages exclusively or mainly addressed to children; (vi) messages by scientists, medical practitioners or notorious people. 

The advertisement must be in Italian. In case words in a foreign language are present (e.g. technical expressions), they must be translated and appropriately explained.

The advertisement shall then contain the number and the date of the authorisation thereof or, should the latter case occur, the date of the application.

9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?

Please refer to answer no. 7.

Moreover, please note that:

  • All elements of advertising of a medicinal product must be in accordance with the SmPC;
  • The information disclosed must be compliant with the documentation submitted for the purpose of obtaining the MA or its updates;
  • Articles, tables and other illustrations taken from medical journals or scientific works must be reproduced in full and faithfully, with the exact indication of the source;
  • For homeopathic or anthroposophical medicinal products without therapeutic indications, the doctor can be provided with the documentation useful for remembering posology and fields of application through publications taken from one of the European pharmacopoeias or from the homeopathic or anthroposophical literature. In the latter case, it must be stamped in a visible manner that are indications for which there is currently no scientifically proven evidence of the efficacy of the homeopathic or anthroposophical medicinal product.

10. Are there specific rules for comparative advertisement of medicines and medical devices?

No, there are not specific rules provided for medicines and medical devices other than the general provisions set by the Consumer Code. 

11. Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?

Yes, the Ministry of Health expressly regulated the matter of online advertising by issuing several Guidelines.

11.1 Medicines

  • Guidelines of 25th July 2017 and 7th May 2018 are relevant. The scope of application only regards advertising of non-prescription (SOP) and OTC advertising.

On this regard, please note the following:

  • Institutional Websites: Are the websites owned by the company that promotes its image or logo without any promotional intent of the products. On such institutional websites it is possible (without the prior authorisation of the Ministry of Health) to publish the list of its own non-prescription and self-medication medicines, reporting only the Information Leaflet and the image of the package.
  • Company Facebook pages of product or brand: They are admitted on condition that for all the contents therein published the “comments” and “reactions” (like, emoticon) are deactivated and that it is reported the disclaimer “The Ministry of Health authorizes only the advertising content. Any comments are the sole responsibility of the user, the company dissociates itself from the comments of the users.”. The Guidelines then provide for specific rules on the publication of contents (posts, images, videos).
  • Messenger platform: The use of the Messenger platform is allowed for sponsored messages, previously authorised, provided that some functions are disabled (comment, share, like reactions, emoticons).
  • YouTube Channel: The use of the YouTube platform is allowed for the dissemination of advertising messages (image, script, video, audio) provided that they have obtained prior authorisation from the Ministry of Health and on condition that the company guarantees some limitations to the use of the social network (e.g. the deactivation of “comments”).
  • Instagram: It is possible to include images or short authorised video advertisements in the “Stories” section where users, in viewing such images / videos, do not have the possibility to comment on them, express reactions or share them. When viewing the video, by clicking on “find out more”, it is possible to be brought back directly to the external product site, previously authorised by the Ministry.
  • Information for healthcare professionals: Must be accessible exclusively to the aforementioned operators, even when it is broadcast via the internet. Therefore, companies must guarantee that the website has an encrypted area can be accessed with a password, to be released to doctors, pharmacists and other health professionals, after they have sent the data necessary for their identification. Furthermore, even in the context of websites freely accessible to the general public, links to areas intended for the information of HCPs must have a barrier of access for those who are not HCPs.

11.2 Medical devices

As to medical devices, Guidelines of 20th December 2017 are relevant and provides for the same rules listed in let. a) to e) above.

On the contrary, the applicable rule on the advertisings addressed exclusively to HCPs is slightly different and provides that when such advertisings are disseminated via internet, the websites intended exclusively for HCPs, must include a special “disclaimer” stating that the information contained therein is exclusively for professional operators.

12. Please describe the enforcement mechanism. Which bodies monitor compliance with the advertisement provisions and what are the legal consequences (e.g. penalties) for non-compliance?

Control and supervision of the advertising regulation is the responsibility of the Ministry of Health. The Ministry is in charge of authorising the adverts as well as carrying out inspections and controls.

Failing to comply with it will cause the Ministry of Health to issue the following orders:

  • Immediate cessation of the advertisements;
  • Diffusion of a rectification message at the company's expenses;
  • Payment of a pecuniary sanctions from EUR 2.600 to EUR 15.600.

13. Any future developments in Italy?

With regard to the advertisement of medicinal products, there are no future developments envisaged. As to the medical devices, the new EU medical device regulation 2017/745 contains advertising related provisions.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.