In Italy, the advertising on medicines is regulated by:
Additional rules on medicines advertising can be found in the self-regulatory codes, such as Farmindustria Code of Conduct and the Code of Conduct and Guidelines on Scientific Information about medicines adopted by Assogenerici (the association of manufacturers of generics and biosimilars).
Pharmaceutical companies must also comply with the general legislation on advertising, such as the Legislative Decree No 145/2007, implementing the Directive 2005/29/EC – "Unfair Commercial Practices Directive"; and the articles of the Legislative Decree No 206/2005 (the "Consumers Code") that implement the Directive 2005/29/EC – "Unfair Commercial Practices Directive". Moreover, they must refrain from any form of promotion of their medicines that can be considered as unfair competition pursuant to Article 2598 of Civil Code.
There is also a Code of Marketing Communication Self-Regulation Italy adopted by the Institute of Advertising Self-Regulation (IAP), which is a member the European Advertising Standards Alliance and of the International Council on Ad Self-Regulation.
Self-regulatory codes apply to pharmaceutical companies that are members of the industry associations that have adopted these codes and have the same legal value as a contract. However, those codes are not legally binding for non-members.
According to the Farmindustria Code of Conduct, pharmaceutical companies that carry out their activity in Italy and belong to multinational groups are responsible for the behaviour of any parent companies or affiliates that are not in compliance with the provisions on medicines advertising to Italian healthcare professionals (Article 1.7). Therefore, the Code should be complied with by the members’ parent companies or affiliates located outside Italy.
Medicines advertising is defined as any information, customer search or exhortation action intended to promote the prescription, supply, sale or consumption of medicines (Article 113 of Legislative Decree No 219/2006). The legal definition of medicines advertising is broadly interpreted by both the health authorities (AIFA and the Ministry of Health) and the Courts.
The law explicitly mentions the following types of medicines advertising:
The following activities, however, are explicitly excluded from the definition of medicines advertising:
In general, the difference between information and advertising is that the former aims at making people aware of something, while the latter encourages people to buy something. According to the prevailing case law, the information about medicines qualifies as advertising if, by virtue of its purpose, content and/or context, it encourages the targeted audience to prescribe, supply or buy a medicine.
Disease awareness campaigns or other patient-facing information (eg, patient leaflets) do not qualify as medicines advertising if they do not refer, even indirectly, to any medicine (Article 113 of Legislative Decree No 219/2006). This basically means that neither the commercial name nor the active principle of a medicine can be mentioned in a disease awareness campaign or other health information materials for patients. It is, however, possible to mention the sponsoring company’s name and logo, since this so-called "institutional advertising" falls outside the scope of medicines advertising.
The Ministry of Health may authorise vaccination campaigns promoted by pharmaceutical companies (Article 115 of Legislative Decree No 219/2006).
With specific regard to the patient support programs (PSPs), they are not considered as medicines advertising, provided that do not include any form of incentive to prescribe, dispense or use any medicine. A pharmaceutical company may not offer patient support as a way of inducing healthcare professionals to prescribe or recommend a medicine, or as a recognition for past prescribing or recommendation. Under Farmindustria Code of Conduct, the PSPs sponsored by pharmaceutical companies must not be decided or organised by their marketing function (Article 4.7). It is advisable to seek for AIFA’s advice on how to inform healthcare professionals and organisations of the existence of a PSP.
In Italy, there is no legal provision dealing with press releases regarding medicines. Press releases regarding investigational or prescription-only medicines are allowed provided that they do not fall within the definition of advertising (Article 114 and 115 of Legislative Decree No 219/2006).
Press releases regarding non-prescription medicines require the prior authorisation by the Ministry of Health if they appear to be promotional in nature (Article 118 of Legislative Decree No 219/2006). In this case, the promotional intent cannot be hidden by the redundancy of other information (Article 117 of Legislative Decree No 219/2006; Article 2.16 of Farmindustria Code of Conduct; Article 6 Assogenerici Code of Conduct).It is never possible to show a medicine and/or its name in images in printed publications, radio and television broadcasts and in any non-promotional messages disseminated to the public in a context that can encourage the use of the medicine (Article 115 of Legislative Decree).
In order to mitigate the risk that press releases regarding medicines might be qualified as advertising by the competent authorities, they should only provide minimal, high-level information about the medicine, mention the active principle (and not the brand name), and be published or otherwise disseminated through media that are accessible to the general public (eg, specialised trade press rather than mainstream media). In any case, press releases should never refer to the therapeutic indications or mechanism of action or any other scientific properties of prescription-only or unauthorised medicines, in order to avoid the risk of infringing the ban to promote such medicines to the general public, which also include journalists, shareholders, investors and employees.
Comparative advertising for medicines is allowed, provided that leads to believe that the efficacy of a medicine is higher to or equal to another medicine (Article 117 of Legislative Decree No 219/2006). Since there are no legal provisions specifically dealing with comparative advertising for medicines, the general rules on comparative advertising apply.
In particular, comparative advertising must:
Under Farmindustria Code of Conduct, indemonstrable comparisons without any objective basis are not allowed (Article 2.2).
In general, pharmaceutical companies do not use comparative advertising for medicines as they tend to consider it at risk of infringing the rules on medicines advertising. Indeed, advertising must present a medicine objectively and without exaggerating its properties, and, in all its parts (Article 114 of Legislative Decree No 219/2006), it must be consistent with the summary of product characteristics (Article 87 of Legislative Decree No 219/2006).
Advertising of unauthorised medicines or unauthorised indications is always prohibited (Article 114 of Legislative Decree No 219/2006). Pharmaceutical companies may provide non-promotional information that is needed to answer an unsolicited request concerning a medicine (Article 113 of Legislative Decree No 219/2006). Therefore, it is possible to respond to unsolicited medical requests for information concerning off-label use of a medicine.
In the course of the pricing and reimbursement procedure, pharmaceutical companies may also provide information about unauthorised medicines or unauthorised indications to the AIFA’s Technical-scientific Committee in order to demonstrate that these medicines/indications meet the criteria set out in the Inter-ministerial Committee for Economic Planning’s Resolution No 3 of 1 February 2001 (eg, cost-effectiveness for medicines where no effective therapy exists; risk-benefit ratio compared to alternative medicines for the same indication; and therapy costs per day in comparison to products of the same efficacy).
The rules on medicines advertising apply to the information on medicines provided by pharmaceutical companies during scientific conferences directed at healthcare professionals. Therefore, also in that context, the supply of information about unauthorised medicines or unauthorised indications is, in general, forbidden.
However, in the course of international conferences directed at healthcare professionals, pharmaceutical companies may distribute informational materials related to medicines authorised in other Countries, provided that these materials have been previously submitted to AIFA in accordance with Article 120 of Legislative Decree No 219/2006, and they make it clear that the medicines (or the new therapeutic indications) have not been authorised in Italy (AIFA’s notice of 11 February 2010). Moreover, in conferences or congresses and other meetings regarding medicines directed at healthcare professionals, pharmaceutical companies may provide information related to mechanism of action of investigational medicines, without mentioning the therapeutic indications that have not been authorised in Italy (AIFA’s notice of 11 February 2010).
It is possible to send information on unauthorised medicines or unauthorised indications to healthcare professionals exclusively in response to the latter’s unsolicited requests (Article 113 of Legislative Decree No 219/2006). Such information must not go beyond the scope of the specific request, and must be factual, objective and purely scientific.
Pharmaceutical companies cannot proactively send information on unauthorised medicines or unauthorised indications to healthcare institutions so that they can prepare budgets or for any other purposes.
However, they can send information on unauthorised medicines or unauthorised indications to healthcare organisations in response to unsolicited requests from them (Article 113 of Legislative Decree No 219/2006).
It is not forbidden to publish the availability of compassionate use programmes or other forms of early access, provided that no information about prescription-only or investigational medicines or unauthorised indications of authorised medicines is made accessible to the general public. It is advisable to seek for AIFA’s advice on any form of communication aimed at informing healthcare professionals of the availability of compassionate use programmes or other forms of early access.
Advertising to the general public for prescription-only medicines or medicines containing substances defined as psychotropic or narcotic is forbidden (Article 115 of Legislative Decree No 219/2006). It is also forbidden to promote medicines which are wholly or partially reimbursed by the National Health System (NHS), that, in general, are prescription-only medicines.
It is never possible to distribute medicines to the public for promotional purposes (Article 115 of Legislative Decree No 219/2006).
Advertising to the general public for over-the-counter (OTC) medicines requires the prior authorisation by the Ministry of Health, unless it falls within one of the exemptions from the prior authorisation requirement (ie, advertisements in the daily or periodical press and on web pages which merely reproduce the indications, contraindications, the appropriate precautions for use, interactions, special warnings, undesirable effects described in the package leaflet, with the possible addition of a photograph or graphic representation of the outer packaging or primary packaging of the medicine; or photographs or graphic representations of the external packaging or primary packaging of the medicines affixed on the websites through which may be sold OTC medicines online, and on the sale price signs to the public and any discounts applied by pharmacies and para-pharmacies) (Article 118 of Legislative Decree No 219/2006).
The Supreme Administrative Court has made it clear that not only OTC medicines, but also the other non-prescription medicines may be promoted to the general public under the conditions laid down in the applicable rules (Consiglio di Stato’s ruling No 2217 of 12 May 2017).
Where permitted, advertising directed at the general public must never include any element that suggests that: it is unnecessary to consult a doctor; the medicine has no side effects or its efficacy is higher than or equal to another medicine; the medicine can improve the individual’s good health conditions; the failure to use the medicine may have detrimental effects on the individual’s good health conditions; the medicine is aimed exclusively or mainly at children; the medicine is recommended by scientists, healthcare professionals or popular people; the medicine can be assimilated to food, cosmetics or other consumer goods; and/or the safety or efficacy of the medicine is due to its natural component (Article 117 of Legislative Decree No 219/2006). Moreover, medicines advertising must not contain any element that can lead to incorrect self-diagnosis, refers, in improper, alarming or misleading terms, to claims of recovery; uses in an improper, impressive or deceptive way visual representations of the alterations of the human body due to diseases or injuries, or of the action of a medicine on the human body or on a part of it, and/or mentions that the medicinal product has been granted a marketing authorisation (Article 117 of Legislative Decree No 219/2006).
In this respect, Farmindustria Code of Conduct specifies that “universal and exaggerated claims” such as “the preferred drug”, “absolutely innocuous”, “fully tolerated” or a statement that a medicine has no side effects or toxicity risk are not allowed (Article 2.2 and 2.10). Since non-prescription medicines can only be delivered to customers by a pharmacist, in pharmacies and para-pharmacies it is not possible to use promotional means, such as exhibitors or shelves which display non-prescription medicines. Specific restrictions apply to the advertising in the online environment given to its specificities (see 7.1 Regulation of Advertising of Medicinal Products on the Internet and 7.2 Advertising of Medicines on Social Media). As to the information that must be included in medicines advertising directed at general public, see 4.2 Information Contained in Advertising to the General Public.
As a general rule, medicines advertising must be consistent in all its parts with the summary of product characteristics and encourage the rational use of the medicinal product, presenting it objectively and without exaggerating its properties. It must never be misleading (Article 114 of Legislative Decree No 219/2006).
Medicines advertising directed at the general public must always include certain minimum information: the qualification as medicine; the commercial name of the medicine and the common name of the active principle; essential information for a correct use of the medicine; a clear and explicit indication to carefully read the warnings mentioned in the package leaflet or on the outer packaging (Article 116 of Legislative Decree No 219/2006).
Moreover, any promotional material relating to non-prescription medicines must include the following statement: “È un medicinale senza obbligo di prescrizione (SOP) che può essere consegnato solo dal farmacista. Ascolta il tuo farmacista”, that is “It is a non-prescription medicine that can only be delivered by a pharmacist. Consult your pharmacist” (Ministry of Health’s Guidelines of 7 May 2018).
In oral advertising, it is possible to use a shorter sentence: “È un medicinale che può essere consegnato solo dal farmacista. Ascoltalo”, that is “This is a medicine that can only be delivered by a pharmacist. Consult the latter” (Ministry of Health’s Guidelines of 7 May 2018).
Medicines advertising on Facebook pages is allowed, provided that the following disclaimer is displayed: “Il Ministero della salute autorizza esclusivamente il contenuto del messaggio pubblicitario. Eventuali commenti sono di esclusiva responsabilità dell’utente, l’azienda si dissocia dai commenti degli utenti”, that is “The Ministry of Health has authorised only the advertising content. Any comments are the sole responsibility of the user; the company denies any responsibility for the comments of the users” (Ministry of Health’s Guidelines of 25 July 2018). This is a precautionary measure since all interactive functionalities (eg, comment, share, like, emoticons) on Facebook pages must be deactivated.
With specific regard to medicines advertising published online, it is possible to include links from sites, banners, and other frames to others containing advertising directed at the general public that has been authorised by the Ministry of Health, provided that the company which is responsible for the online publication of the promotional material provides the user with the following warning: “state abbandonando il sito Azienda XXXXXX… contente materiale promozionale autorizzato ai sensi della vigente normativa in materia di pubblicità sanitaria”, that is "you are leaving the Company XXXXXX site… containing promotional material authorised under the applicable legislation on healthcare advertising” (Ministry of Health’s Guidelines of 6 February 2017). This wording is not required in the case the link that can be activated refers exclusively to the Package Leaflet and, eventually, to an image of the medicine package.
Self-regulatory codes impose a series of restrictions on interactions between patients or patient organisations and industry (Article 4.6 of Farmindustria Code of Conduct and Article 6 of Assogenerici Code of Conduct).
In particular, any form of economic support, whether direct or indirect, provided by a pharmaceutical company to a patient association shall comply with certain requirements. First of all, the company must previously enter into a specific agreement with the patient association aimed at regulating the amount of financing and the reasons for its disbursement. To this end, a pharmaceutical company must adopt a standard internal procedure for the approval of this type of agreements. Furthermore, the sponsorship by the pharmaceutical companies of a patient association’s project or activity must be transparent and without promotional intent. A company cannot request to be the single sponsor of a patient association.
If a company wants to offer hospitality to the members of a patient association, it must comply with the provisions of the applicable Code of Conduct dealing with hospitality to healthcare professionals in conferences and congresses. The use by a pharmaceutical company of the logo or the materials of a patient association must be previously authorised by the association. To this end, the purposes for, and the manner of, using the logo shall be clearly defined from the outset.
For transparency purposes, pharmaceutical companies make publicly available on their websites a list of patient associations to which they have provided financial support in the previous year, specifying the amount given to each Association. For the sole purpose of safeguarding public health or for research purposes, pharmaceutical companies and associations of patients can enter into agreements whereby services are provided to the pharmaceutical companies.
Moreover, pharmaceutical companies may engage representatives of associations as experts and consultants (for instance, in advisory boards and congresses), provided that an agreement is entered into in advance setting forth the nature of the services to be supplied and the criteria for payment for the services. The agreement must clearly explain and support with adequate documentation why the services are needed. The consideration paid for the services must be reasonable and cannot exceed the fair market value of the services rendered.
Every year, pharmaceutical companies must make publicly available a list of Patient Associations that they have engaged to provide contracted Services.
Advertising directed at healthcare professionals must always include the summary of product characteristics that is authorised at the time of advertising, the classification of the medicine for the purposes of its supply regime, the price and the conditions for the dispensation of the medicine at the expense of the National Health Service (Article 119 of Legislative Decree No 219/2006). Alternatively, advertising directed at healthcare professionals may only mention the name of the medicine, with the specification of the common name of its active substance(s). In addition, the name of the marketing authorisation holder (MAH), eventually followed by the name of the company which under a contract with the MAH commercialises the medicine in the national territory, the so-called concessionario di vendita, may be indicated (Article 119 of Legislative Decree No 219/2006).
With specific regard to the advertising directed at doctors, any document or material related to a medicine, except for the authorised summary of product characteristics, must be filed with AIFA before the advertising campaign starts and can be provided to the doctor by the pharmaceutical company if, within ten days from the filing date, AIFA has not raised any objections. The filing date must be indicated in the promotional material (Article 120 of Legislative Decree No 219/2006). Anytime this material is updated it must be submitted again to AIFA.
All the information contained in the documentation provided to doctors must be accurate, updated, verifiable and sufficiently complete to allow the doctor to be adequately informed about the therapeutic effect and characteristics of the medicine. The information itself must comply with the documentation presented for the release of the marketing authorisation for the medicine or its updates (Article 120 of Legislative Decree No 219/2006).
Articles, tables and other illustrations taken from medical journals or scientific works must be reproduced in full and faithfully, with an exact indication of the source. Quotations are not allowed if they, apart from the context from which they are drawn, can be partial or distortive (Article 120 of Legislative Decree No 219/2006). Advertising to doctors can also be delivered in the context of visits to the laboratories and research centres of pharmaceutical companies, provided they are oriented towards the development of knowledge in the fields of chemistry, pharmaceutical technology, pharmacology, toxicology, biotechnology and biochemistry (Article 120 of Legislative Decree No 219/2006).
Advertising for prescription-only medicines directed at pharmacists must be limited to the information contained in the summary of product characteristics. That limitation does not apply to hospital pharmacists (Article 121 of Legislative Decree No 219/2006). Advertising for non-prescription medicines directed at pharmacists may include other useful documentation to allow the pharmacist to advice the customer on the use of the product (Article 121 of Legislative Decree No 219/2006).
Any document or material, except for the authorised summary of product characteristics, related to a medicine must be previously filed with AIFA in accordance with Article 120 of Legislative Decree No 219/2006. This does not apply to purely commercial information (Article 121 of Legislative Decree No 219/2006). Information about medicines must be provided to both doctors and pharmacists by the companies’ commercial representatives in compliance with the requirements laid down in Article 122 of Legislative Decree No 219/2006, the Guidelines of Regional Regulation of Scientific Information about medicines adopted by the Conference of Presidents of the Regions and Autonomous Provinces pursuant to Article 48, paragraph 21, 22, 23, 24 of Law No 326/2003, and the rules on the "scientific information" about medicines adopted by Regions, Provinces and hospitals.
Specific requirements apply to the sponsorship by pharmaceutical companies of conferences or congresses and other meetings regarding medicines directed at healthcare professionals (Article 124 of Legislative Decree No 219/2006; AIFA’s notice of 11 February 2010; Chapter 3 of, respectively, Farmindustria and Assogenerici Codes of Conduct), as well as to the distribution of free samples (Article 125 of Legislative Decree No 219/2006; rules on the "scientific information" about medicines adopted at regional, local and hospital level).
Medicines advertising must be consistent with the information included in the summary of product characteristics or with its updates (Articles 114 and 120 of Legislative Decree No 219/2006). All the information about medicines provided to healthcare professionals must be “verifiable”, “documented and documentable” and scientific publications must be faithfully reproduced in full (Article 120 of Legislative Decree No 219/2006; Articles 2.2 and 2.12 of Farmindustria Code of Conduct).
In general, no information on unauthorised medicines or indications can be provided to healthcare professionals, except that under the conditions and circumstances described in AIFA’s notice of 11 February 2010. In the context of conferences, congresses or meetings on topics related to medicines, it is possible for pharmaceutical companies to exhibit inside their stands printed materials about molecules under investigation. This kind of information must be related only to their mechanism of action without mentioning any therapeutic indications which has not been authorised yet.
In general, if the combination use of two medicines commercialised by two different companies is mentioned in the summary of product characteristics of only one of the medicines, only the company which commercialises the medicine may promote its use in combination with the other medicine. By contrast, the company that commercialises the medicine whose summary of product characteristics does not mention the combination use should, in principle, refrain from promoting such use.
Articles, tables and other illustrations taken from medical journals or scientific works must be reproduced in full and faithfully, with an exact indication of the source. Quotations are not allowed if they, apart from the context from which they are drawn, can be partial or distortive (Article 120 of Legislative Decree No 219/2006).
The Farmindustria Code of Conduct specifies that the texts, tables and other illustrations taken from medical reviews or scientific works shall be reproduced faithfully and in full, and with an exact indication of the source. No citations are admissible that appear partial and/ or contradictory with respect to the author's intentions when separated from the context in which they originally appeared (Article 2.12).
There are no legal provisions specifically dealing with Medical Science Liaisons (MSLs). Companies’ MSLs must comply with general rules on medicines advertising.
Therefore, MSLs are not permitted to proactively discuss scientific information on unauthorised medicines or indications with healthcare professionals, but they can provide such information in response to unsolicited requests from healthcare professionals (Articles 113 and 114 of Legislative Decree No 219/2006).
Advertising of non-prescription medicines to the general public must be previously authorised by the Ministry of Health (Article 118 of Legislative Decree No 219/2006). The application for authorisation will be deemed approved, if upon expiry of a 45-day term as from the date the application for authorisation was filed, the Ministry of Health has not notified the applicant that the application is denied or requires amendments. In this case, the advertising must contain the following wording: “autorizzazione su domanda del ...”, that is “authorised as per the application filed on [date of filing with the Ministry of Health]”. Radio advertising messages are exempt from providing this information on the authorisation.
If, within the 45-day term as from the date the application for authorisation was filed, the Ministry of Health notifies the applicant that authorisation can only be granted if certain changes are made, as set out in the notice, the applicant is authorised to disseminate the advertising message amended according to the Ministry’s indications. In this case, the advertising must contain the following wording: “autorizzazione del ...”, that is “authorised on [date of the Ministry’s notice to the applicant]”. Radio advertising messages are exempt from providing this information on the authorisation.
If, within the 45-day term from the date of the application, the Ministry of Health informs the applicant that the authorisation is denied, the application will be deemed definitively rejected unless the applicant submits comments within the following ten days. If the applicant submits comments to obtain authorisation for an advertising message that is different to the object of the notice from the Ministry then such comments are deemed for all intents and purposes to be a new application for authorisation. Otherwise, if the applicant’s comments merely reiterate the initial application then the Ministry of Health will rule definitively on the application. Authorisations for medicines advertising are valid for a 24-month period, without prejudice to the possibility of the Ministry of Health to reasonably establish a shorter validity period, in relation to the characteristics of the message disclosed.
The Ministry of Health has specified that the authorisation can be requested by the marketing authorisation holder (or its local representative in Italy) or by the company that, under an agreement with the MAH, commercialises a medicine in the national territory (guidance on the Authorisation for health advertising for self-medication and non-prescription drugs published on the Ministry’s website). The application for authorisation must specify means of dissemination of the promotional message (eg, television and cinema short film; radio release; daily and periodical press; media intended for dissemination through pharmacies and para-pharmacies; road signs and similar; or internet).
The authorisation for an advertising message granted for one or more media can be extended to another medium, without requiring a new application for authorisation. To this end, the company, which intends to extend the authorisation to another medium, must submit a communication to the Ministry of Health, indicating the references of the original authorisation, the means of dissemination for which the extension of the original authorisation is requested (Guidelines of 6 February 2017). The extension of the authorisation to another means of dissemination, without submitting a new application for authorisation, is allowed only if the advertising message, is the same as the one previously authorised and is intended to be disclosed in the original form (script, video or audio) for which authorisation was granted. The expiry date of the extended authorisation remains the same as the date of the initial one (Guidelines of 6 February 2017).
As to advertising directed at healthcare professionals (HCPs), any document or material related to a medicine, except for the authorised summary of product characteristics, must be filed with AIFA, before starting the advertising campaign and can be provided to the HCP by the pharmaceutical company once ten days have passed since the filing date. The filing date must be indicated in the promotional material (Articles 120 and 121 of Legislative Decree No 219/2006).
Every company which commercialises medicines in Italy must have, within its organisation, a Scientific Service that is responsible for the supervision and approval of all information about the medicines that is provided by the company to healthcare professionals and/or the general public (Article 126 of Legislative Decree No 219/2006). The head of the Scientific Service must fulfil certain professional requirements.
The Scientific Service must be independent from the Marketing division. It must supervise the activity carried out by the company’s commercial representatives who are responsible for providing information about the medicines to healthcare professionals (Article 122 of Legislative Decree No 219/2006). Pharmaceutical companies must employ commercial representatives who fulfil the professional requirements laid down in Article 122 of Legislative Decree No 219/2006, and ensure the constant updating of the technical and scientific training of those employees.
In this respect, Farmindustria Code of Conduct specifies that pharmaceutical companies must ensure that their commercial representatives can provide healthcare professionals with information on the properties and characteristics of the medicines so that the latter are used for therapeutically correct purposes (Article 2.6). Companies are also responsible for training of medical sales representatives to collect feedback on their medicines, as this is a means to ensure the fullest information on the products being marketed (Article 2.7).
Commercial representatives must report to the Scientific Service and to the head of the Pharmacovigilance all information on the undesirable effects of the medicines, providing, where possible, a copy of the standard report forms used by the doctor (Article 122 of Legislative Decree No 219/2006). Pharmaceutical companies are not required to adopt SOPs for ensuring compliance with the rules on medicinal advertising. However, it is advisable to adopt these SOPs considering that pharmaceutical companies must ensure that their medicines advertising complies with Legislative Decree No 219/2006 and the health authorities’ prescriptions (Article 126 of Legislative Decree No 219/2006).
Advertising on the internet for medicines is subject to the same requirements, restrictions and pre-clearance regime that apply to the other forms of advertising. In addition, medicines advertising over the Internet must comply with the Guidelines adopted by the Ministry of Health of 6 February 2017, of 25 July 2017 and of 25 July 2018.
On the company’s institutional website, it is possible – without the prior authorisation from the Ministry of Health – to publish the list of its non-prescription medicines whose names refer (via activated link) exclusively to the package leaflet and, eventually, to an image of the package. In this context, no message concerning the health properties of the medicines can be displayed, since it would require the prior authorisation by the Ministry of Health (Guidelines of 6 February 2017).
If a company wants to publish on its website advertising for medicines, it must indicate the Internet address where advertising will be displayed in the application for authorisation to be filed with the Ministry of Health. The company must specify the advertising message and that the Ministry’s authorisation covers only such messages (Guidelines of 6 February 2017). With regards to product websites, the company must send the site map to the Ministry indicating the parts relating to advertising that require the authorisation. Also in this case, the company must specify the advertising messages and that the Ministry’s authorisation covers only such messages (Guidelines of 6 February 2017).
The information directed at healthcare professionals must be accessible only to them, even when it is spread via the internet. Therefore, pharmaceutical companies must create encrypted areas that can be accessed with a password, to be issued to doctors or pharmacists once they have sent the data necessary for their identification (Ministry of Health’s Guidelines of 6 February 2017 and Article 4.5 of Farmindustria Code). Links from sites, banners, and other frames to others containing promotional material addressed to the general public duly authorised by the Ministry of Health are allowed, provided that the company responsible for the online publication of promotional material inform the Internet users that they are leaving the website containing advertising duly authorised by the Ministry of Health (see 4.2 Information Contained in Advertising to the General Public).
Links from sites, banners, and other frames containing authorised promotional material to other sites, banners or frames not containing promotional material in Italian language that would require the Ministry of Health’s prior authorisation, such as health educational information or self-medication, are allowed, provided that the company responsible for the online publication of the promotional material inform the Internet users as specified in the previous paragraph.
Links from sites, banners, and other frames containing authorised promotional material to other sites, Italian or foreign banners or frames containing promotional material in Italian language that would require the Ministry of Health’s prior authorisation (which is missing) are not allowed. There are no legal restrictions to the promotion on the internet of the name, logo and image of a pharmaceutical company (the so-called "institutional" advertising).
However, under the industry self-regulatory codes, every website operated by an Italian company or a company operating in Italy that is addressed to the general public and to Italian healthcare professionals must ensure that the sponsor, the source of all information available on the website, the recipients of such information and the objectives of the website are all clearly identified and specified (Article 4.5 of Farmindustria Code of Conduct; Article 5 of Assogenerici Code of Conduct).
The Ministry of Health has made it clear that, since advertising of medicines authorised by the Ministry cannot be changed by the pharmaceutical company or any third parties, the use of social media – which generally allows users to express their own opinions – could infringe that rule (Guidelines of 25 July 2017). Therefore, the use of social media is not allowed, except for the specific cases described in the Ministry’s Guidelines of 6 February 2017, of 25 July 2017 and of 25 July 2018.
In short, pharmaceutical companies may publish authorised advertising on Facebook, YouTube and Instagram, provided that the interactive functionalities are deactivated. On the other hand, advertising for medicines cannot be disseminated via Twitter, since for now the minimum mandatory content of medicines advertising is not contained in a single Tweet.
Pharmaceutical companies must ensure that the sections of the website containing promotional information and materials that cannot be provided to the general public are accessible only to doctors and pharmacists (Ministry of Health’s Guidelines of 6 February 2017 and Article 4.5 of Farmindustria Code).
Pharmaceutical companies may provide disease awareness information to patients online provided that they do not refer, even indirectly, to their medicines. Indeed, information relating to human health or human diseases does not fall within the definition of medicines advertising, provided that it does not contain any reference, even indirect, to a medicine (Article 113 of Legislative Decree No 219/2006).
General anti-bribery rules may apply to interactions between pharmaceutical companies and healthcare professionals who work for public hospitals or healthcare organisations that are public in nature.
Pharmaceutical companies – like other legal persons – can be held liable for certain crimes committed, in their interest or to their benefit, by a natural person who, formally or practically, represent or manage the company or exercise a control over it ("corporate liability"). In order to mitigate such a risk, companies may adopt and effectively implement an organisation, management and control model that is adequate to prevent the commission of crimes (Legislative Decree No 231/2001).
The industry association Confindustria has adopted Guidelines for the realisation of the organisation, management and control model. Corruption risks may be present throughout the medicine lifecycle (ie, in the research and development, price definition or negotiation, prescription and distribution and supply phases). The Italian Anticorruption Authority has entered into an agreement with the Ministry of Health to determine how they should co-operate for preventing and combat corruption in the health sector.
In the context of the promotion of medicines to healthcare professionals, it is prohibited to grant, offer or promise prizes, pecuniary or in-kind benefits, unless they are of negligible value and are in any case related to the activity carried out by the doctor and pharmacist (Article 123 of Legislative Decree No 219/2006). Those gadgets can reproduce the name of medicinal product and/or the denomination of the active principle, and/or the corporate name of the marketing authorisation holder.
The negligible value must not exceed EUR20 per year for each individual doctor or pharmacist (Guidelines of Regional Regulation of Scientific Information about medicines adopted by the Conference of Presidents of the Regions and Autonomous Provinces pursuant to Article 48, paragraphs 21, 22, 23, 24 of Law No 326/2003).
Medical or educational materials not specifically related to a medicine can be given free of charge only to healthcare organisations (not to individual doctors) (Article 123 of Legislative Decree No 219/2006). In this respect, Farmindustria Code of Conduct specifies that such material must have a value not exceeding EUR25, and that companies must provide this material through their centralised functions (not through their field force) (Article 2.14).
Medical or educational materials may consist of:
Donations and free loans of instruments directly related to the medical profession are allowed only if they are granted to universities, hospitals and clinics, and in compliance with the administrative procedures of the concerned entity (Article 2.15 of Farmindustria Code of Conduct).
Donations and free loans of instruments that can be used by doctors not only for diagnostic or therapeutic purposes (such as smartphones, tablets or similar) are allowed only in the context of clinical trials (Article 2.15 of Farmindustria Code of Conduct). Pharmaceutical companies must not give or promise money or other benefits to doctors or pharmacists, for the purpose of facilitating in whatever form the use of medicines (Article 172 of Royal Decree No 1265/1934). This is a crime that can be punished with the order to close the factory where the medicine is manufactured or the revocation of the marketing authorisation.
Pharmaceutical companies are allowed to give gifts to healthcare professionals, provided that they are of negligible value and related to the professional activity of the recipients (see 8.2 Legislative or Self-Regulatory Provisions).
Companies may also offer hospitality to healthcare professionals who participate in scientific meetings and congresses by paying their travel, accommodation and/or registration fees (Article 124 of Legislative Decree No 219/2006. However, hospitality must not be offered for more than 12 hours prior to the event and 12 hours following its conclusion, and cannot “overshadow” the scientific purposes of the event (ibidem).
Under the Farmindustria Code, hospitality offered by pharmaceutical companies to healthcare professionals participating in scientific meetings and congresses must be limited to travel, accommodation and payment of the registration fees to the meeting or congress.
During the days of the congress the hospitality offered may also include meals and drinks up to a threshold of EUR60 per each healthcare professional per meal for all events in Italy. As for events held abroad, referral shall be made to the amounts and thresholds indicated in the Country’s Code of Conduct, where applicable. In any other case, the limit remains fixed at EUR60 also for events held abroad. The respect of the principle of sobriety shall, however, be guaranteed and the meal shall be offered preferably in the same hotel where the guests are staying or in contiguous structures (Article 3.16).
The hospitality cannot exceed a 12-hour time period prior to and immediately after the scientific meeting or congress and such hospitality may not “overshadow” the scientific characteristics of meeting or congress (Article 3.12).
In the context of scientific conferences either in or outside Italy it is forbidden to organise or sponsor activities with social, cultural or tourist purposes, including gala dinners. Social dinners organised by the conference for the participants as a whole are allowed and shall be included in the inscription fees for the conference. No hospitality of any kind can be offered to the persons accompanying the participants (Article 3.14).
Pharmaceutical companies may only offer economy class air travel to Italian healthcare professionals invited to Italian conferences in Italy or abroad while the category of hotel accommodation shall not exceed four stars. In the case of rail transport, it is allowed all travel classes except for Executive class (Article 3.3).
In the context of international conferences involving intercontinental flights longer than six consecutive hours of flight it is possible to offer the travel business class only for speakers and moderators included in the official program of the conference (Article 3.3).
Congresses organised directly or indirectly by pharmaceutical companies must be held in places and venues chosen for logistic, scientific and organisational reasons, and must have a scientific programme. In general, congresses cannot take place in seaside resorts during the period from June 1st to September 30th, or in mountain resorts from December 1st to March 31st (Article 3.8).
It is prohibited to offer or give any kind of benefit aimed at compensating healthcare professionals for the time spent to participate in congresses (Article 2.13).
Similar provisions can be found in the Assogenerici Code of Conduct.
Pharmaceutical companies, through their commercial representatives, may give free samples of a medicine only to doctors who are authorised to prescribe it. The samples may be delivered only upon a written request, bearing the date, stamp and signature of the recipient (Article 125 of Legislative Decree No 219/2006).
Commercial representatives may deliver to each healthcare professional up to two samples per visit for each dosage or pharmaceutical form of a medicine only in the 18 months following the product launch and within the maximum limit of eight annual samples for each dosage or form (Article 125 of Legislative Decree No 219/2006).
Commercial representatives may deliver to the doctor no more than four samples per visit, within the maximum limit of ten samples per year, chosen within the company’s medicines that have been commercialised for more than 18 months (ibidem).
Pharmaceutical companies must also comply with the internal rules and procedures of hospitals that deal with the supply of free samples. Similar provisions may be found in the industry self-regulatory codes (Articles 2.17 of Farmindustria Code and 5 of Assogenerici Code of Conduct).
Pharmaceutical companies may sponsor scientific meetings or congresses and attendance by healthcare professionals at these events under the conditions laid down in Article 124 of Legislative Decree No 219/2006 and in the applicable self-regulatory code (Chapter 3 of, respectively, Farmindustria and Assogenerici Codes of Conduct).
Every pharmaceutical company (ie, the marketing authorisation holder or a company which under an agreement with the latter commercialises a medicine on the national territory) which wants to sponsor a meeting or a congress on topics in anyway related to the use of a medicine must obtain the AIFA’s prior authorisation (Article 124 of Legislative Decree No 219/2006).
In order to obtain such authorisation, an application containing the details of the expenses and other relevant information (name, postal address and corporate data of the pharmaceutical company, the program of the meeting, the venue and starting day of the event, professional and scientific qualifications of the speakers, scientific rationale, categories of participants addressed by the event, products promoted during the congress) must be submitted 60 days before the day of the meeting or congress by the pharmaceutical company AIFA, which will issue its approval within 45 days from the date on which the application is received (Article 124 of Legislative Decree No 219/2006).
Where several pharmaceutical companies contribute to the organisation of a congress, convention or meeting, the communications to AIFA must be provided jointly, through the event planner, with a list of the companies taking part. The event planner must collect and send jointly to AIFA by ordinary mail each copy of all the application forms of the participating companies, along with the relevant information.
During a conference or a meeting relating to the use of medicines, pharmaceutical companies participating as sponsors, can distribute or show to healthcare professionals display panels, visuals, summary of Product Characteristics (SmPC), exhibition Banners and gadgets. Those materials are subjected to the rules on medicines advertising, including the ten days negative clearance system.
Pharmaceutical companies may also sponsor the Continuing Medical Educations (CME) events and courses. Specific rules apply to those events, such as the “Continuous training in health sector”, together with the annex “Criteria for the assignment of credits to CME activities”, adopted by the Agreement of 2 February 2017 between the Government, the Regions and the Autonomous Provinces of Trento and Bolzano, and effective from 2 February 2017. The Institution that in Italy has the power to provide the "accreditation" to the meetings is AGENAS.
During a CME event, pharmaceutical companies that sponsor the event may show or distribute to healthcare professionals the promotional materials relating to their medicines only outside the areas where the training is delivered (Article 77 of the cited Agreement). During the event, it is possible to indicate the active ingredient of medicines (not their commercial names). Medicines advertising cannot be included in the educational materials delivered in the event or in the event program, leaflets and advertising (ibidem).
Pharmaceutical companies are not allowed to organise or sponsor cultural, sports or other non-scientific events in relation to scientific conferences because hospitality must be limited to travel, accommodation and registration fees (Article 124 of Legislative Decree No 219/2006).
The Farmindustria Code of Conduct explicitly states that, in the context of conference meetings either in or outside Italy, it is forbidden to organise or sponsor activities with social, cultural or tourist purposes, including gala dinners (Article 3.14).
With regard to grants or donations to Healthcare Professionals see 8.2 Legislative or Self-Regulatory Provisions and 9.1 Gifts to Healthcare Professionals. As to grants or donations to healthcare institutions, they must comply with the internal rules and procedures adopted by those institutions, and may not be intended to, or have the effect of, circumventing the rules on public tenders.
The company should enter into a written agreement with the hospital, that should be signed or authorised by the top management of the latter (and not by a doctor). If the donation does not have a modest value, a notarial deed and other formalities are required (Articles 782 and 783 of Civil Code). The modest value must also be assessed in relation to the economic conditions of the donor.
According to the Italian Anticorruption Authority, public entities should ensure the transparency of any grants or donations (including the supply of products for free testing) received by private parties (National Anticorruption Plan of 2016). Thus, the internal rules of many hospitals require a disclosure of any grants received by private companies.
Although the hospitals’ internal rules may differ between them, they frequently provide that the free of charge (FOC) supply of products to the hospitals is acceptable provided that:
Pharmaceutical companies may negotiate with AIFA rebates and discounts that will apply to healthcare institutions which are part of the National Health System. In particular, the Menaged-Entry Agreements (MEAs) entered by AIFA with pharmaceutical companies allow conditional access to the market for some new medicines with unclear efficacy and safety profiles with a consequent modulation of the price and reimbursement schemes. The access and permanence of the medicine on the market and its price and reimbursement conditions often depend on the collection of evidence of therapeutic benefits or actual costs once the medicine has been made available or by price-volume agreements, discounts or capping. The most common MEAs include risk sharing agreements based on the outcome or clinical benefit expected from the new medicine (schemes based on health outcomes) and financial agreements (financial-based schemes). The first category includes the payment by result, risk sharing and success fee agreements, while the second includes the cost sharing and capping agreements.
In addition, pharmaceutical companies may offer their medicines at lower prices to compete in public tender procedures organised by public healthcare institutions at regional or local level. Pharmaceutical companies may also give rebates or discounts to healthcare institutions, provided that they do not infringe antitrust and/or anti-bribery rules.
Under the Farmindustria Code of Conduct, free information material for scientific or professional consultation not specifically connected to medicines may be distributed to public healthcare organisations provided that such material has a negligible value, namely a value of less than EUR25 (Article 2.14).
Moreover, donations and loans free of charge of instruments directly related to the medical profession are allowed, provided that they are to the benefit of universities, hospitals and clinics and in compliance with the administrative procedures of the concerned entity (Article 2.15). Outside the context of clinical trials, it is not possible to grant donations or loans free of charge of instruments which may be used by doctors for purposes that are not merely diagnostic or therapeutic or which can be given to patients (ibidem).
Pharmaceutical companies may pay for services provided by healthcare professionals provided that they really need such services, the services have been provided and the compensation is in line with the fair market value of the services at issue. Companies should be able to demonstrate their actual need, the effective provision of the services, and the fair market value of the compensation.
Private parties may not engage public employees for the provision of remunerated services without the prior authorisation of the public entity to which the employees belong (Article 53 of Legislative Decree No 165/2001). Moreover, the compensation paid for the services rendered by a public employee must be disclosed to the public entity with which he/she is employed within fifteen days from the payment. Those rules also apply to healthcare professionals who work for the public administration.
The industry self-regulatory codes provide for specific requirements (Articles 4.1 of Farmindustria Code of Conduct and Article 1 of Chapter 4 of Assogenerici Code of Conduct). In particular, pharmaceutical companies must enter into written contracts with healthcare professionals specifying the nature of the service rendered and the objective need for the service. The compensation must reflect the market value of the specific service and is subjected to transparency requirements.
Grants or donations to healthcare organisations must be authorised and approved by the highest management of healthcare organisations, in compliance with their internal rules and procedures.
Pharmaceutical companies may engage healthcare professionals who work for a public entity for the provision of remunerated services only if they obtain the prior authorisation from the public entity (Article 53 of Legislative Decree No 165/2001). The latter must decide on the authorisation request within 30 days of receiving the request.
Pharmaceutical companies that have engaged healthcare professionals who work in public sector for the provision of remunerated services are required to disclose the amount of the compensation paid for the services rendered to the concerned public entity within fifteen days from the payment (Article 53 of Legislative Decree No 165/2001).
In the context of clinical trials, in order to protect the independence and the impartiality of the clinical trial, the principal investigator is required to declare to the clinical centre the absence of any consultancy or other contractual relationships with the pharmaceutical company that sponsors the clinical trial (Article 6 of Legislative Decree No 52/2019).
Public healthcare organisations must disclose any transfer of value received from a private party, including pharmaceutical companies, where a specific request for access to such data is made (Law No 241/1990, Legislative Decree No 150/2009 and Legislative Decree No 33/2013).
The industry self-regulatory codes impose on pharmaceutical companies the obligation to disclose details of transfers of value to healthcare professionals or healthcare institutions (chapter 5 of Farmindustria and Assogenerici Codes of Conduct, respectively).
On an annual basis, each pharmaceutical company must document and make publicly available on its website all transfers of value carried out directly or indirectly to healthcare professionals and organisations. The disclosure of such data must be on an individual basis or, in specific circumstances, in aggregate form.
The transparency requirements that are laid down in Italian legislation (see 10.1 Requirement to Disclose Details of Transfers of Value) apply to foreign companies and/or companies that do not yet have products on the market.
The transparency requirements laid down in the industry self-regulatory codes apply to foreign companies if the recipient of the transfer of value is domiciled in Italy (Article 5.4 of Farmindustria Code of Conduct). Otherwise, if the recipient is domiciled in another Country, the transfer of value must be disclosed (even by pharmaceutical companies established in Italy) in accordance with the industry code of conduct applicable in that Country.
The public bodies that are responsible for enforcing the rules on advertising and the rules on inducement are the following: AIFA, the Ministry of Health, the Italian Antitrust Authority, the Anticorruption Authority, (civil, administrative and criminal) Courts and the competent units of the police.
The rules on advertising contained in self-regulatory codes may be enforced by the bodies set up by the industry associations.
Companies can initiate proceedings against competitors for advertising infringements before any of the enforcement bodies mentioned in 11.1 Enforcement Bodies, depending on the specific rule that has been infringed by their competitors.
If medicines advertising addressed at healthcare professionals is not in compliance with the requirements laid down in Legislative Decree No 219/2006, AIFA may order the immediate cessation or suspension of the dissemination of the promotional message and, eventually, order the dissemination, at the expense of the liable company, of a press release to rectify the unlawful promotional message. The press release may be published by AIFA on the drug information bulletin and on its institutional website and, at the company’s expense, on the company’s website or in national newspapers (Article 119 of Legislative Decree No 219/2006).
Similarly, AIFA may prohibit a congress, conference or other meeting from taking place if the latter does not fulfil any requirements laid down in Legislative Decree No 219/2006 (Article 124 of Legislative Decree No 219/2006).
Moreover, the violation of the rules on advertising addressed at healthcare professionals may be punished with an administrative sanction ranging from EUR2,600 to EUR15,600 (Article 148 of Legislative Decree No 219/2006).
If medicines advertising addressed at general public is not in compliance with the requirements laid down in Legislative Decree No 219/2006, the Ministry of Health may order the immediate cessation of advertising, order the dissemination, at the expense of the liable company, of a press release to rectify the unlawful promotional message (Article 118 of Legislative Decree No 219/2006) or impose administrative fines. In particular, the Ministry of Health may apply to the liable company an administrative sanction ranging from EUR2,600 to EUR15,600 (Article 148 of Legislative Decree No 219/2006).
The violation of the rules laid down in self-regulatory codes may be punished with:
Formally speaking, procedures before or measures taken by regulatory authorities do not influence the procedures before or measures taken by courts because the latter must be fully independent in their judgment.
There is a growing attention by AIFA and the Ministry of Health to the promotion of medicines by new information and communication technologies.
Another issue that Italian authorities are trying to address is how to prevent conflicts of interests resulting from the various forms of interaction by pharmaceutical companies with healthcare professionals and organisations.