Medicinal product advertisement to the public and promotion to healthcare professionals (HCPs) are regulated by Legislative Decree No 219/2006 (the “Italian Pharma Code”), Title VIII, Articles 113-128.

This regulatory framework is supplemented by the “Guidelines on advertising of over-the-counter (OTC) and medicinal products without prescription (medicinali senza obbligo di prescrizione – SOP)” issued by the Italian Ministry of Health on 21 July 2023. Such guidelines address, in particular, advertising on the web and specific media channels, as well as social networks (Facebook, Instagram, TikTok); and updated and replaced all previous ministerial guidelines applicable to advertising of OTC and SOP.

With reference to the promotion of medicinal products to HCPs, the Italian Drug Agency (Agenzia Italiana del Farmaco – AIFA) plays an essential role and it also published – on 3 May 2023 – Q&A containing clarifications on this topic (the “AIFA Q&A”).

Moreover, self-regulatory codes regulate the promotion of medicinal products: Farmindustria Deontological Code, the EFPIA Code of Practice, the Deontological Code adopted by Egualia (ie, main Italian association of generic and biosimilar medicines companies) and Article 25 of the Code of Commercial Communication Self-Regulation (Codice di Autodisciplina della Comunicazione Commerciale – the “IAP Code”).

The Farmindustria Deontological Code is binding only for companies that are members of Farmindustria (ie, Italian Association of Pharmaceutical Companies). However, its rules represent the best practice in the medicinal product field.

The EFPIA Code must be enforced by its member companies.

The IAP Code may only apply to the advertising of medicinal products to the public, when it is permitted under the Italian Pharma Code. It is binding exclusively on users, agencies, advertising and marketing consultants, operators of advertising media, and all those subjects who have accepted it directly or through their association, or by signing a contract.

Pursuant to Article 113 of the Italian Pharma Code, “advertising” of medicinal products means any action of information, customer research or exhortation intended to promote the prescription, supply, sale or consumption of medicines. It specifically includes the following: (i) advertising to the public; (ii) advertising of medicines to persons authorised to prescribe or dispense them (including visits carried out by sales representatives; the provision of medicinal products samples).

Advertising of medicinal products must conform to the information appearing in the summary of product characteristics and it (i) shall promote the rational use of the medicine by presenting it objectively and without exaggerating its properties, and (ii) cannot be misleading (Article 114, paragraph 2, 3 of the Italian Pharma Code).

The Italian Pharma Code does not consider advertising (i) the labelling and package insert; (ii) the correspondence necessary to respond to a precise, unsolicited request for information about a specific medicinal product; (iii) factual information and reference documents concerning, by way of example, packaging changes, warnings about adverse effects in the context of pharmacovigilance, sales catalogues and price lists, as long as no information about medicines is included; and (iv) information relating to human health or human disease, provided that it contains no reference, even indirectly, to a medicinal product.

Consequently, Disease Awareness Campaigns are not considered advertising if there are no references to medicines and their properties.

Under the Italian Pharma Code (Article 115, paragraph 5), in printed publications (as well as radio, television broadcasts) and in non-advertising messages disseminated to the public, it is prohibited to show pictures of medicinal products as well as their name in a context that may encourage consumption of such product.

Advertising to the public of SOP and OTC may be carried out through press releases (in daily or periodical press) only if it has been authorised by the Ministry of Health. Such ministerial authorisation is not required by the Italian Pharma Code in circumstances where advertisements in the daily or periodical press merely reproduce in full and without modification the indications, contraindications, appropriate precautions for use, interactions, special warnings, undesirable effects described in the package insert, with the possible addition of a photograph or a graphic representation of the outer packaging or primary packaging of the medicinal product.

In the context of medicinal product promotion aimed at HCPs, pharmaceutical companies shall file with the AIFA the reprint of articles specifically pertaining to the advertised medicine, as further specified in 5.5 Restrictions on Reprints of Journal Articles for Healthcare Professionals.

Pharmaceutical companies can also issue press releases concerning the company and the categories of its medicinal products as well as public health and human diseases, provided that they are structured without any form of promotional elements.

Medicinal product advertising to the public cannot induce people to believe that the efficacy of a medicine is higher or equal to another medical treatment or medicine (Article 117, paragraph 1, letter b of the Italian Pharma Code).

Moreover, advertising cannot compare medicinal products to food, cosmetics or other products (Article 117, paragraph 1, letter g of the Italian Pharma Code).

Comparative advertising is lawful if it is carried out between competing products, if it does not deceive consumers, including through confusion between products, if its statements concern essential, relevant and in any case verifiable characteristics, if it is not made for the sole purpose of discrediting the competitor. If conducted correctly, it represents a fundamental information tool available to consumers, as it supports market transparency. Manufacturers are allowed to highlight those qualities that make their product superior to those of others using scientific evidence, for example the so-called comparative head-to-head studies between medicinal products.

Article 114, paragraph 1, of the Italian Pharma Code prohibits any advertising of medicinal products without a marketing authorisation (MA) issued in accordance with the Legislative Decree 219/2006, EU Regulation 726/2004 or other binding European provisions.

Therefore, one is not permitted to file with AIFA promotional materials aimed at HCPs that are related to medicinal products or therapeutic indications not yet authorised in Italy.

Moreover, AIFA Q&A No 121 clarifies that where a medicinal product’s feature is not still authorised – such as new therapeutic indication or new way of administration – it cannot be advertised. Indeed, advertising must be in accordance with the information in the summary of product characteristics.

However, the Farmindustria Deontological Code clarifies that, in the context of scientific exchange with HCPs, a company’s medical affairs staff can carry out activities aimed at mutual sharing of data and non-promotional information on issues related to the healthcare context and its dynamics towards HCPs. For instance, the proactive sharing of data and insights connected to clinical practice as well as factual and non-promotional information relating to the company pipeline or connected to the access activities of new products, within certain limitations, further analysed in 3.3 Provision of Information to Healthcare Professionals.

During conferences, congresses and meetings concerning medicinal products and aimed at HCPs – held in accordance with Article 124 of the Italian Pharma Code – pharmaceutical companies may provide information on investigational molecules as long as such information refers exclusively to the molecule’s mechanism of action, with no mention of therapeutic indications not yet authorised. This is clarified by the document called “Notice regarding conferences, congresses and meetings referred to in Article 124 of Legislative Decree 219/2006” (Informativa in ordine ai convegni, congressi e riunioni di cui all’art.124, del D.L 219/06) published by AIFA on its website on 11 February 2010.

HCPs may make specific and unsolicited requests for information on a particular medicinal product. This is not considered advertising by the Italian Pharma Code and, consequently, it is permitted.

Moreover, the Farmindustria Deontological Code provides that a company’s medical affairs staff can carry out activities aimed at mutual sharing of data and non-promotional information on issues related to the healthcare context and its dynamics towards HCPs; specifically, the proactive sharing of data and insights connected to clinical practice as well as factual and non-promotional information relating to the company pipeline or connected to the access activities of new products (eg, the information contained in institutional sites, indexed independent publications).

With regard to information on the company pipeline, medical affairs staff can explain only the mechanism of action of pipeline medicinal products and the lines of development of these products using data from already-published studies (as clarified by Farmindustria Q&A dated 9 October 2023).

On the contrary, other information related to company medicinal products may be provided to HCPs exclusively on a reactive basis and upon specific unsolicited requests. Moreover, companies shall implement appropriate means to track such requests.

Pharmaceutical companies cannot send information on unauthorised medicines or unauthorised indications to healthcare institutions in order to support them in preparing budgets and other administrative activities.

Prior to the activation of compassionate-use programmes in Italy, pharmaceutical companies must notify AIFA and communicate the following data: (i) date of activation and date of closure of the compassionate-use programme, (ii) medicine that will be provided free of charge under the Ministerial Decree of 7 September 2017 on the use of the medicinal product undergoing clinical trial, and (iii) the period of free supply of the medicine. In addition, notification of the closing date of the compassionate use programme must be submitted to AIFA at least 30 days before the date.

Compassionate use programmes cannot, however, be advertised.

Pursuant to Article 115 of the Italian Pharma Code, the following medicinal products cannot be advertised to the public:

• prescription medicines;
• medicinal products that can be used only with the assistance of a healthcare professional;
• medicines containing psychotropic or narcotic substances;
• medicinal products reimbursed by the National Health Service (NHS);
• medicines prepared in a pharmacy on the basis of a prescription intended for a specific patient or according to the indications of the European Pharmacopoeia or national pharmacopoeias valid in the EU member states;
• medicinal products intended for research and development trials; and
• medicines prepared industrially at the written, unsolicited request of a physician.

However, the Ministry of Health may authorise vaccination campaigns promoted by pharmaceutical companies.

On the other hand, advertising to the public of SOP and OTC medicines is allowed. Advertising to the public must be authorised by the Ministry of Health. Should the Ministry of Health not provide authorisation within 45 days from application submitted by pharmaceutical companies, authorisation is deemed granted. Normally, authorisation is valid for two years, but the Ministry of Health may provide for a shorter period of validity based on the characteristics of the message disseminated.

Finally, pharmaceutical companies cannot distribute medicinal products for promotional purposes.

Under the Italian Pharma Code (Article 116), advertising of a medicine directed to the public must be carried out in a way that enables the advertising nature of the message to be evident to the public. Moreover, the product advertised shall be clearly identified as a medicine.

Advertising to the public must include:

• name of medicinal products and the common name of the active substance (the latter is not required if the medicinal product consists of several active substances);
• necessary information for the proper use of medicinal products; and
• a clear and legible invitation to read the warnings on the package insert or outer packaging of the medicinal product.

Such minimum content of medicines’ advertising to the public shall be written in a font size no smaller than body nine on the daily and periodical press.

In the light of this, advertising messages which contain a promotional purpose that is hidden by other information are prohibited (Article 117, c. 2, of the Italian Pharma Code).

In addition, Article 117 of the Italian Pharma Code limits the content of the advertising message by establishing that it cannot:

• make consultation with physicians or surgery appear unnecessary, particularly by offering a diagnosis or proposing treatment by correspondence;
• induce people to think that the medicine advertised does not have any side effects or that it has the same or higher efficacy than other medicinal products;
• lead to the belief that the medicinal product can improve the normal good health of the subject;
• lead to the assumption that the non-use of the medicine may have harmful effects on the subject’s normal good health (with the exception of vaccination campaigns authorised by the Ministry of Health);
• be aimed exclusively or predominantly at children;
• include recommendations from scientists, HCPs, or persons widely known to the public;
• compare medicines to cosmetics, food or other products;
• lead to the assumption that the medicine’s safety or efficacy is due to the fact that it is a “natural” substance;
• induce incorrect self-diagnosis;
• make improper, impressive, or misleading references to statements of recovery; or
• improperly, impressively or deceptively use visual representations of the alterations of the human body due to disease or injury, or of the action of a medicinal product on the human body or any part thereof.

Such limitations on the advertising’s content are set forth also in Article 25 of the IAP Code (for its scope and application, please see 1.2 Application and Influence of Self-Regulatory Codes on the Advertisement and Promotion of Medicines).

Pharmaceutical companies can:

• provide direct or indirect financial support for a patient association, in compliance with the requirements established by the Farmindustria Deontological Code (paragraph 4). In particular:
1. sponsorship must be transparent and free from any promotional purposes;
2. a specific agreement must be signed in advance in order to regulate the amount of the loan and the purpose of the financial support;
3. the public use by a pharmaceutical company of the logo or material owned by a patient organisation must be authorised in advance by the organisation itself; and
4. companies cannot request a patient organisation to be the sole lender; and
• make consulting assignments for representatives of patient organisations or “expert patients” under certain conditions stipulated in the Farmindustria Deontological Code; by way of example, the reasons for the activation of consultancy assignments must be well defined, documentable and non-promotional. “Expert patients” is defined by the Farmindustria Deontological Code as patients “who, in addition to having direct knowledge of the disease, have specific skills and experience in aspects related to medicine research and development, regulatory activities or advocacy activities understood as the ability to promote and support the causes and needs of a plurality of patients; these skills must be effective and documentable and may be accompanied by certifications or certificates issued following participation in courses and training programmes carried out by qualified and independent third parties” (paragraph 4.6).

Law No 62/2022 (Italian Sunshine Act) as well as the Farmindustria Deontological Code provide for disclosure obligations concerning transfer of values addressed to individuals operating in the healthcare sector (eg, subjects belonging to the health or administrative area and other subjects who operate, for any reason, within a health organisation (public or private), and who, for instance, exercise responsibility for the management and allocation of resources), or to health organisations (eg, patient associations), as further specified in 10. Pharmaceutical Companies: Transparency.

Advertising of medicinal products is allowed only to HCPs authorised to prescribe or dispense medicinal products (Article 119 of Italian Pharma Code). Medicines’ promotional materials aimed at HCPs must be filed with AIFA before the start of the advertising campaign, and they can only be provided to physicians ten days after the filing date (Article 120 of Italian Pharma Code). Moreover, the filing date must be indicated in the promotional material itself.

This type of advertising must include a summary of product characteristics, the specification of class, price, and the condition of reimbursement by the NHS. Promotional materials consisting exclusively of this information must not be filed with AIFA. The presence of the product and/or pharmaceutical company brand name is allowed (AIFA Q&A No 59).

All information in promotional materials must be accurate, updated, verifiable and sufficiently complete so that HCPs are adequately informed about the therapeutic effect and characteristics of the medicinal product.

Conversely, promotional materials cannot contain, by way of example, non-promotional content or promotional elements related to products other than the advertised medicine.

Information in promotional materials must be in accordance with the documentation submitted by pharmaceutical companies for the purpose of issuing the medicine’s marketing authorisation or its updates (Article 120, paragraph 3, of the Italian Pharma Code).

Abstracts, posters and unpublished papers without DOIs (Digital Object Identifiers) are not acceptable (under AIFA Q&A No 56).

Moreover, articles, tables and other illustrations taken from medical journals or scientific works must be reproduced entirely and faithfully, and the source must be indicated. The Italian Pharma Code (Article 120, paragraph 4) prohibits quotations that, taken out of the context from which they are extracted, may be biased or distorting.

In addition, the use of unpublished data is permitted if referred to as “data on file”, that must be made available to HCP in order to answer their requests.

Promotional  material concerning authorised medicines (or authorised therapeutic indications thereof) provided exclusively to physicians may contain information regarding the efficacy and safety of such medicinal products (or indications) even if taken from data on files, as long as that information is consistent with the SmPC and already present in the documentation submitted to AIFA for the purpose of the issue of the MA (or to obtain the extension of the therapeutic indications).

In the case of two medicinal products used in combination for a specific therapeutic treatment, it is necessary to consider that promotional materials must contain information in accordance with the documentation submitted by the pharmaceutical company for the purpose of issuing the medicine’s MA or its updates. Therefore, promotional materials cannot cover the combined use of two medicinal products if their combined use for a given therapeutic treatment is not indicated in the summary of medicinal product characteristics. Conversely, if the summaries of product characteristics specify that such medicines are intended to be used together for a specific therapeutic treatment, then the promotional materials may provide the reference to both the medicines and their combined use.

If combined products are composed of a medical device (MD) and a medicinal product, it is necessary to understand the nature of the product in order to identify the applicable advertising regulations. By way of example, a MD containing a substance that, if used separately, would be considered a medicine, is considered a medical device under the Regulation EU 2017/745 if the substance has an ancillary action to the one performed by the MD. Conversely, if the action of the substance is principal and not ancillary, the entire product will be governed by the pharma regulation (with the exception of the safety and performance requirements peculiar to medical devices) and, consequently, the rules on advertising of medicines shall be applicable.

The same type of analysis shall be carried out to understand the nature of the so-called borderline products, by using the guidelines issued by the Medical Device Co-ordination Group “Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices”.

Pursuant to Article 2(7) of Regulation EU 2017/746, companion diagnostics are devices which are “essential for the safe and effective use of a corresponding medicinal product to: (a)  identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or (b)  identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product”.

As in vitro medical devices, advertising of companion diagnostics shall be carried out in accordance with the rules established by Article 22 of the Legislative Decree 138/2022 (which adapted Italian legislation to the provisions of the Regulation EU 2017/746 on in vitro diagnostic medical devices) and applicable Guidelines issued by the Italian Ministry of Health.

Moreover, promotional materials regarding medicines to be used together with companion diagnostics may refer to these in vitro medical devices in compliance with the regulations on the advertising of medicines, provided that it is consistent with the content of the summary of product characteristics.

Pharmaceutical companies shall file with the AIFA the reprint of articles specifically pertaining to the advertised medicine, as part of the promotional material addressed to HCPs.

In particular, pursuant to AIFA Q&A, reprints of specific articles from independent journals, indexed, regularly published and distributed as well as classifiable on the basis of current bibliometric indicators among those of the highest scientific level are considered promotional material if they contain a reference, even if indirect, to a medicine or its active ingredient and the owner of that medicinal product intends to use it in its advertising campaigns. For this reason, as with promotional materials, it must be filed with AIFA (as further explained in 5. Advertising to Healthcare Professionals).

Also sponsored publications are considered promotional materials. Consequently, they must meet all the requirements of medicines advertising: they are articles specifically relating to one or more medicinal products that appear in non-independent journals or that, for example, receive sponsorship from companies owning the medicines.

As clarified in 3.3 Provision of Information to Healthcare Professionals, under the Farmindustria Deontological Code, Medical Science Liaisons (MSL) can share proactively with the HCPs non-promotional data and information on issues related to the healthcare environment and its dynamics; specifically, data and insights connected to clinical practice as well as factual and non-promotional information relating to the company pipeline or connected to the access activities of new products.

Conversely, other information related to company medicinal products may be provided to HCPs exclusively on a reactive basis and upon specific unsolicited requests.

Promotional materials addressed to HCPs must be filed with AIFA before being used. They can be delivered to HCPs only after ten days from their submission to AIFA, in case of no objections by the latter. The date of submission must be indicated on the promotional materials filed.

Advertising of SOPs and OTCs to the public must be authorised by the Ministry of Health. If the Ministry of Health does not provide the authorisation within 45 days from application submitted by pharmaceutical companies, authorisation is deemed granted.

Promotional messages in newspapers as well as the periodical press that reproduce in full the information of the leaflet, with a possible picture or graphic representation of the primary or secondary package, are allowed without the Ministry of Health’s authorisation.

Pursuant to the Italian Pharma Code (Article 126), each marketing authorisation holder (MAH) must establish a Scientific Service (SS) in charge of scientific information and promotion (if any) of medicinal products put in place in the market. If the MAH is based abroad, such obligation must be fulfilled by the company that represents in Italy the MAH or which, in any case, provides for the import and distribution of the medicinal products (eg, sales dealer).

Moreover, pharmaceutical companies must appoint a scientific service responsible (SSR), who must meet the requirements established by Article 126 of the Italian Pharma Code (eg, degree in medicine and surgery or pharmacy, pharmaceutical chemistry and technology). The scientific service and the SSR must be based in Italy.

The SS must be independent from the pharmaceutical company’s marketing service.

Advertising of medicinal products on the internet is regulated by the Guidelines of the Ministry of Health on the on advertising of OTCs and SOPs, dated 21 July 2023. This type of advertising is allowed under certain conditions (please see 7.2 Restrictions on Access to Websites Containing Material Intended for Healthcare Professionals for rules related to medicinal products’ advertising addressed to HCPs).

Advertising of medicines on the internet is allowed under certain conditions (for promotional materials on the internet addressed to HCPs please see 7.2 Restrictions on Access to Websites Containing Material Intended for Healthcare Professionals). In particular, the internet is considered a medium for disseminating the promotional message. Therefore, any form of promotion of medicinal products through the internet must be specifically authorised. Institutional websites of pharmaceutical companies (or websites under their direct control) that promote the image or logo of a medicinal product for promotional purposes must also be authorised by the Italian Ministry of Health.

The pharmaceutical company that carries out the promotion of the medicinal product is responsible for submitting the application for authorisation to the Ministry of Health, regardless of the website where the message is placed.

Access to the website area containing advertising on medicines addressed to HCPs shall be available only to them. To this end, Guidelines issued by Ministry of Health on 21 July 2023 (“Guidelines on advertising of OTCs and SOPs”) require that the website sections for HCPs shall be accessible only with passwords that will be issued to HCPs after the transmission of their identification data.

AIFA also clarified that specific internet sections reserved for HCPs shall use appropriate means of verifying the user’s real identity.

The Italian Pharma Code (Article 113, paragraph 2, letter D) specifies that information related to human health or human disease is not considered advertising, provided it does not contain any reference – not even indirectly – to a medicinal product. Consequently, disease awareness information is not subject to the specific regulations concerning medicines’ advertising.

Moreover, Ministerial Guidelines of 21 July 2023 “on the advertising of OTCs and SOPs” clarifies that websites owned by pharmaceutical companies, or under their control, that disseminate information regarding human health or disease and that do not contain any reference, even indirectly, to a medicine do not require authorisation from the Ministry of Health.

Article 124 of Italian Pharma Code relating to “Conferences or congresses and other meetings concerning medicines” may apply to the events that take place online, although limited to prescriptions applicable to web events: for instance, prescriptions concerning travel and accommodation expenses will not apply since a webinar does not involve in-person participation. Moreover, pursuant to the Farmindustria Deontological Code, web meetings are not subject to any restrictions in terms of the duration of the session.

Pharmaceutical companies that hold the MA of medicinal products or that, under a specific agreement with the MAH, provide for the marketing of medicines, may organise or contribute to the realisation – through funding or provision of other benefits, even indirectly – in Italy, or abroad (or even remotely), a conference or meeting on issues relating to the use of medicinal products manufactured or marketed by the pharmaceutical company itself. To this end, pharmaceutical companies must send to the competent office of AIFA, at least 60 days before the starting date of the meeting, a communication – with certified signature – containing specific information requested by Article 124 of the Italian Pharma Code (eg, its name or company name, tax code and registered office).

Moreover, several pharmaceutical companies may contribute together to the realisation of these meetings: in this case, communications must be received by AIFA jointly – through the meeting’s organisers – with a summary overview of the participating companies, under penalty of ineffectiveness of the communication.

No form of distribution or display of samples of medicinal products or illustrative materials of medicines, except for the summary of medicinal product characteristics, congressional papers and scientific works, provided they are integral and duly filed with AIFA in accordance with Article 120 of the Italian Pharma Code, may be made. Therefore, promotional material related to the meeting can be sent to HCPs who attended the web event, only if (i) the promotional materials had been filed at AIFA, and (ii) pharmaceutical companies obtained the HCP’s consent to receive this type of material.

Pharmaceutical companies may also organise or contribute to conferences on topics not related to medicines that they produce or market. In this case, the rules established by Article 124 of the Italian Pharma Code do not apply. However, they may not carry out any form of medicines’ promotion toward HCPs during those meetings.

Prescription medicinal products cannot be advertised to the public. Therefore, they cannot be advertised on social media. On the contrary, SOP and OTC medicines may be promoted on the social channels expressly indicated by the Guidelines of Ministry of Health issued on 21 July 2023 regarding advertising of OTCs and SOPs (“Ministerial Guidelines”) – ie, Facebook, Instagram, YouTube, TikTok. Advertising on social media other than those listed by the Ministerial Guidelines is not allowed.

Advertising in such social media is permitted as long as the rules in the Ministerial Guidelines are followed. As general rule, the Ministerial Guidelines establish that advertising on social channels must comply with the so-called “static principle”. This means that certain settings shall be applied by pharmaceutical companies so that nobody can change the advertising message or add reactions to it – eg, on Facebook, the “comment” functionality and reactions (ie, emoticons) must be disabled.

Under Article 123 of the Italian Pharma Code, pharmaceutical companies cannot grant, offer or promise rewards, pecuniary benefit or benefits in kind (unless they are of negligible value – about EUR25 – and connectable to health professional activity) to physicians or pharmacists.

Moreover, Italian Criminal Code and Royal Decree No 1265/1934 provides for anti-bribery provisions.

In particular, Article 170 of R.D. 1265/1934 bans the conduct of a physician (or veterinarian) who receives money or other benefits or accepts a promise to facilitate the spread of medicinal products (eg, increasing prescriptions for specific medicines) or any other product for pharmaceutical use (crime called comparaggio); and Article 172 of R.D. 1265/1934 fines any subject who gives or promises to give money or other benefits to an HCP or pharmacist for the same purposes. This type of crime can occur any time a physician receives an inadmissible advantage from pharmaceutical companies. Italian law does not specify a specific benchmark in order to recognise an inadmissible advantage within the scope of this offence.

Moreover, the Italian Criminal Code (Articles 318, 319) regulates corruption in the exercise of a function, as well as acts contrary to the official duties carried out by a public official or person in charge of public service. This could be the case when a physician working in the NHS improperly advantages pharmaceutical companies in order to receive – for themself or a third party – money or other benefits. Such crime occurs both in the case where a physician actually received benefits as well as in the case where they simply accept the promise of it.

The same type of crime is provided for at Article 2635 of the Italian Civil Code in respect of private individuals (eg, private HCPs, officers, directors).

The Farmindustria Deontological Code provides specific rules concerning the provision by pharmaceutical companies to HCPs of free information material for scientific or professional consultation not specifically connected to medicinal products, as well as donations, loans for use and acts of liberality relating to instruments strictly related to the medical profession as well as donations or loans for use relating to fungible instruments with different or alternative methods of use with respect to diagnostic or therapeutic purpose. For further details, please see 9.5 Grants or Donations to Healthcare Professionals or Healthcare Institutions.

In order to avoid unlawful conduct and sanctions, pharmaceutical companies must draft their internal procedures in compliance with the rules established by the Italian Pharma Code, anti-bribery legislation and the Farmindustria Deontological Code (if applicable as mandatory, or as mere best practice).

Article 123 of the Italian Pharma Code specifies that pharmaceutical companies can offer gifts to physicians or pharmacists only if such gifts are of minimal value (ie, a value of less than EUR25 pursuant to the Farmindustria Deontological Code) and related to the activity carried out by HCPs.

Regarding the hospitality provided to HCPs at scientific meetings, pharmaceutical companies must meet strict rules established by the Italian Pharma Code and Farmindustria Deontological Code. In particular, pharmaceutical companies may offer hospitality during congress events with reference to travel, accommodation and payment of registration fees, provided that it is carried out in compliance with respect for the principle of sobriety from an economic perspective. By way of example, the Farmindustria Deontological Code allows only economy air travel offered to HCPs and accommodation in hotels of no more than four stars, as well as a threshold of EUR70 per HCP per meal for all events in Italy (and also abroad if the Code of Professional Conduct of the country in which the event is carried out does not establish a maximum reimbursement).

Moreover, pharmaceutical companies cannot offer hospitality to companions of the HCPs invited.

Pharmaceutical companies can provide samples of medicines for human use only to physicians authorised to prescribe them and exclusively through their sales representatives.

Moreover, samples of medicines can be delivered only on written request, in which the date, stamp and signature of the recipient appear. Sales representatives must also give physicians a summary of product characteristics along with a medicine sample.

The Italian Pharma Code also provides restrictions on the number of samples of medicines that can be delivered to each HCP: for instance, sales representatives may deliver to each physician only two samples per visit for each dosage or pharmaceutical form in the 18 months following the date on which the medicine is first marketed, and a maximum of eight samples per year for each dosage or form.

In addition, medicines samples cannot be delivered during nor collaterally with a congresses, conferences or other meetings.

Pharmaceutical companies that hold the marketing authorisation for medicinal products or that, under a specific agreement with the MAH, provide for the marketing of medicines, may organise or contribute to the realisation – in Italy – of a meeting on issues relating to the use of medicinal products manufactured or marketed by the pharmaceutical company itself, in compliance with Article 124 of the Italian Pharma Code.

Pharmaceutical companies may also organise or support meetings on themes not related to medicines that they market: in this case, regulation established by the above-mentioned Article 124 does not apply. However, they cannot carry out promotional activities relating to their medicinal products and addressed to HCPs.

As specified by Article 113 of the Italian Pharma Code, pharmaceutical companies can provide the patronage for scientific congresses where persons authorised to prescribe or supply medicines participate.

In case of Continuing Education in Medicine (Educazione Continua in Medicina – “ECM”) congress events, pharmaceutical companies cannot identify and appoint (directly or indirectly) the speakers and moderators nor interfere with the scientific contents.

Moreover, invitations for medical specialists employed by public entities or private affiliated facilities cannot be nominative and must be sent by pharmaceutical companies not to the HCP but to the public body/private facility at least 60 days before the starting date of the ECM congress event. Pharmaceutical companies may send nominative invitations only in case of non-response from the public body/private facility within the 30 days prior to the holding of the ECM congress event, provided that the healthcare structure does not have more restrictive provisions (eg, need for an express authorisation from the public entity/private facility).

Moreover, meetings organised directly/indirectly by pharmaceutical companies and attended mainly by Italian physicians are not allowed to be held abroad.

As specified by the Farmindustria Deontological Code, pharmaceutical companies cannot organise nor sponsor social, cultural or tourist events and gala dinners in the context of congressional events – both in Italy and abroad.

However, pharmaceutical companies can sponsor projects and events organised by healthcare and patient organisations – eg, sporting events to raise awareness of a particular disease, prevention and public health.

Pharmaceutical companies can make donations and loans for use concerning instruments strictly related to the medical profession only in favour of university institutes, hospitals, nursing homes and public health organisations operating in the area, provided that this is carried out in compliance with the administrative procedures of the healthcare facility and the regulatory framework.

However, pharmaceutical companies cannot donate nor loan for use fungible instruments with different or alternative methods of use with respect to the diagnostic or therapeutic purpose – eg, smartphone, tablet, in favour of the above-mentioned structures or physicians for personal use outside healthcare facilities or patients. This prohibition does not apply in the scope of clinical trials.

On the contrary, pharmaceutical companies can carry out transfers of value (eg, donations, grants as well as free-of-charge leases) both in cash and benefits in kind in favour of healthcare organisations (ie, defined by the Farmindustria Deontological Code as any structure whether it is an association or medical, scientific, healthcare or research organisation, such as hospitals and foundations, that have their legal headquarters or main office or activity in Europe, or through which a physician may practice), provided that they are in compliance with transparency obligations.

Pharmaceutical companies cannot offer rebates or discounts on their medicinal products to HCPs.

Conversely, they can offer discounts to healthcare institutions, for instance during a tender. In this context it is necessary to highlight that the medicine’s price reimbursed by the NHS for certain medicines (medicinal products in Class A/H) is set through a negotiation procedure and an agreement between the marketing authorisation holder and AIFA. According to the Decree issued by the Italian Ministry of Health on 2 August 2019, the price contracted between the MAH and AIFA (ex-fabrica price) is the maximum purchase price for NHS entities.

HCPs can carry out collaborations with pharmaceutical companies as consultants for services, such as speakers and moderators at conferences, involvement in observational studies, training and educational services. These types of collaborations must meet certain requirements. For instance, as specified by the Farmindustria Deontological Code, physicians and pharmaceutical companies shall sign a written agreement in order to specify the nature of the service and the company’s need for the service, to clarify that the consultant shall undertake to disclose their relationship with the company whenever they write or speak in public on the subject matter to which the co-operative relationship refers.

The fee for services established by pharmaceutical companies shall be consistent with cost-performance criteria and reflect the market value of such services. Moreover, the activity shall be appropriate and duly documented.

In order to organise or sponsor congresses and other meetings, pharmaceutical companies must send to AIFA, at least 60 days before the starting date of the meeting, a communication containing specific information requested by Article 124 of the Italian Pharma Code (eg, its name or company name, tax code and registered office, professional and scientific qualification of the speakers). Pharmaceutical companies may proceed with the implementation or support for the meeting only if AIFA communicates its favourable opinion within 45 days of the communication duly sent by companies.

Secondly, as clarified by the Farmindustria Deontological Code, the authorisation of the sponsorship of congress events shall be issued by the company’s scientific director. Moreover, pharmaceutical companies shall implement internal procedures in order to verify the economic adequacy of the sponsorship costs incurred by the company in support of congress events.

Transfers of value addressed to HCPs and healthcare organisations (as well as patient organisations) shall be disclosed in accordance with applicable regulation.

Finally, specific rules are set out by the Farmindustria Deontological Code and possibly by healthcare structure’s statute related to invitations for ECM meetings for HCPs belonging to public bodies or private affiliated facilities, as further specified in 9.3 Sponsorship of Scientific Meetings.

Law 62/2022 (ie, the Italian Sunshine Act) provides disclosure obligations with regard to the following cases (under Articles 3, 4):

• agreements and disbursements in money, goods, services or other utilities in favour of (i) individuals operating in the healthcare sector if unitary value is more than EUR100, or total annual value of more than EUR1,000, or (ii) healthcare organisations if the unitary value is more than EUR1,000 or total annual value exceeding EUR2,500;
• agreements with individuals operating in the healthcare sectors or health organisations providing a direct or indirect benefit to them, namely, participation in conferences, training events, committees, commissions, advisory boards or scientific committees; or consultancy, teaching or research relationships; and
• transfer of values deriving from dividends in cases where HCP holds shares or an interest in a company and/or any other transfer of values deriving from industrial or intellectual property rights, such as royalties.

Manufacturers of medicinal products, instruments, equipment, goods and services, including non-health goods must communicate data related to the above-mentioned transfer of value in favour of individuals operating in the healthcare sector (eg, subjects belonging to the health or administrative area and other subjects who operate, for any reason, within a health organisation (public or private), and who, for instance, exercise responsibility for the management and allocation of resources) and health organisations (eg, patient associations and Continuing Education in Medicines Providers (ECM Providers) – both public and private).

Data to be published is listed by the Italian Sunshine Act (eg, name and surname, professional domicile and qualification, if the beneficiary is an individual – HCP); it will appear for five years from the date of publication in a Public Registry held by the Ministry of Health. All data must be nominative data.

However, the Italian Sunshine Act is not applicable yet (as of 19 February 2024); indeed, its application depends on the publication in the Italian Official Journal of the notice that the Public Registry held by the Ministry of Health is ready and functioning. By law the notice should have been published within six months from effective date of the law (ie, 26 December 2022). However, news on the subject is expected soon; indeed, the draft of the Ministerial Decree on the Public Registry is available, as is the final report of the consultation with stakeholders on the Decree.

Moreover, the Farmindustria Deontological Code provides disclosure obligations regarding transfers of value from pharmaceutical companies in favour of HCPs, health organisations, patients’ associations and expert patients. These obligations are mandatory for Farmindustria’s members. In this case, publication of data requested can be carried out on an aggregated basis if certain circumstances are met. Data shall be published on the companies’ website annually.

Companies that must comply with the disclosure obligations established by the Italian Sunshine Act are the so-called manufacturing companies, defined by Article 2(1)(a) of the Law 62/2022 as follows: any person, including those belonging to the third sector who, directly or in the role of intermediary or associated company, carries out as direct activity: (i) the production or placing on the market of medicinal products, instruments, equipment, goods or services, including non-health medicines, including nutritional products, marketable in the field of human and veterinary health; or (ii) the organisation of conferences and congresses concerning the same objects.

Therefore, any company falling under this definition must observe the duties established by the Italian Sunshine Act (when it is applicable).

Moreover, members of the Farmindustria Association must meet the disclosure obligations provided by its Deontological Code. In this context, the Farmindustria Deontological Code also clarifies that companies belonging to multinational groups that operate in Italy are responsible for the behaviour of their parent companies and associate companies for invitations issued to Italian physicians to attend events held either inside or outside Italy if their conduct is contrary to the rules established by the Farmindustria Code.

The authorities responsible for enforcement of pharmaceutical advertising rules (including monitoring on the risk of inducement) are the Ministry of Health (for medicinal products that can be advertised to the public) and AIFA (for medicinal products that can be promoted only to HCPs). Another enforcement agency is the Italian Competition Authority which is in charge of enforcing the Italian Consumer Code (Legislative Decree 206/2005) with regard to unfair commercial practices to consumers. The National Pharma Trade Association (Farmindustria) also enforces its Deontological Code in respect of its members. The same applies for the Istituto di Autodisciplina Pubblicitaria (IAP – Institute for Self-Regulation on Advertising).

Companies can flag and report advertising practices of competitors if they believe they are not compliant with applicable laws and regulations. Companies can file a claim before AIFA, the Ministry of Health as well as before the bodies of trade associations or self-regulation organisations if the target company is a member.

Companies can also file a claim in court if they believe a competitor’s advertising or advertising campaign is in violation of Article 2598 of Italian Civil Code (unfair competition practices). 

The Italian Pharma Code provides for different sanctions that range from an order of cease and desist, the publication of a rectification statement to administrative pecuniary sanctions for different types of violations related to advertising. Courts can also impose compensation for damages suffered as a consequence of the acts of unfair competition. Farmindustria also can impose different sanctions such as (i) warning with request to stop the behaviour, if still ongoing, and to ban it if necessary; (ii) written censorship; (iii) temporary suspension; and (iv) expulsion. Lastly, pecuniary sanctions can be applied. IAP can also sanction its members by means of cease-and-desist orders and publication of the decision.

The difference between self-regulatory authorities and courts is that measures taken by the self-regulatory authorities are applicable and binding only vis-à-vis the members of those authorities. Companies that are not members cannot be scrutinised nor sanctioned by those authorities. Measures taken by the courts and by the regulatory agencies (ie, AIFA, Ministry of Health) are binding and enforceable against all companies that violate the applicable laws. 

Courts are quite active with regard to the enforcement of pharmaceutical advertising rules. Indeed, in recent years there have been several decisions by civil and administrative courts on pharmaceutical advertising, considering also that boundaries are not always totally clear. AIFA is also quite active in investigating companies, enforcing applicable laws and sanctioning companies. This activity is often triggered by complaints filed before AIFA by competitors of the alleged wrongdoer.

Advertising of veterinary medicines is regulated by Article 38 and Annex V of the Legislative Decree No 218/2023, which adapted Italian legislation to the provisions set forth in Regulation (EU) 2019/6.

Only authorised or registered non-prescription veterinary medicinal products may be advertised to the public. Conversely, promotion of veterinary prescription medicines can be carried out by companies exclusively to veterinarians and persons authorised to supply veterinary medicinal products (Article 120 of the Regulation EU 2019/6).

Advertising of veterinary medicines to the public must be authorised by the Italian Ministry of Health. The MAH must submit to the Ministry of Health the request for the advertising message authorisation. Then, the Ministry of Health shall respond to the MAH – through a reasoned communication – within 45 days from the submission of their application. Authorisations of advertisement are valid for 24 months.

As with advertising for human medicines, advertising to the public of veterinary medicinal products must present the product objectively, without exaggerating its properties or misleading its users. In addition, the nature of the advertising message must be clear to the public and the product must be clearly identified as a medicinal product.

Moreover, Title V of Legislative Decree 218/2023 specifies the minimum content (eg, the target species, indications for use, and contraindications, including the prohibition of use in other animal species) and prohibited content (eg, content that makes consultation with a veterinary practitioner or surgery appear unnecessary) of messages advertising to the public relating to veterinary medicines.