Pharmaceutical Advertising Laws and Regulations Report 2023-2024 Italy


1. General – Medicinal Products

1.1        What laws and codes of practice govern the advertising of medicinal products in your jurisdiction?

The advertising of medicinal products is governed by art. 113 et seq. of Legislative Decree 219, 24 April 2006 (“Code on Medicines”, which implements Directive 2001/83/EC and subsequent amendments), and by a series of secondary regulatory sources, including Guidelines issued by the Ministry of Health (“MOH”) on the use of new means of communication, such as digital and social tools in advertising over-the-counter medicinal products (“OTC”), the specifications for advertising of non-prescription medicines (“SOP”), these also issued by the MOH, and Guidelines issued by the Italian Medicine Agency (“AIFA”) on conferences, congresses, and the filing of advertising material.  Specific AIFA Guidelines on the advertising of medicinal products to healthcare professionals (“HCPs”) are currently being approved.  Furthermore, on 15 September 2022, the AIFA adopted the “Questions & Answers” document relating to the “Medical sales representatives” Online Service, which, although not binding, constitute a useful indication of the AIFA’s application practice with regard to promotional material for HCPs.

Advertising of medicinal products is also subject to the general provisions on advertising set out in Legislative Decree 206/2005 (“Consumer Code”) and Legislative Decree 145/2005 on misleading and comparative advertising (implementing Directive 2005/29, which amended Directive 84/450).

Italy also has self-regulatory codes such as the Farmindustria Code and the Code of the self-regulatory advertising institute (Istituto di Autodisciplina Pubblicitaria, “IAP”) (“IAP Code”), which set out specific regulations on the public advertising of medicinal products (art. 25).

1.2        How is “advertising” defined?

Art. 113 of the Code on Medicines defines the “advertising of medicinal products” as “any informative, customer acquisition or persuasive action whose purpose is to promote the prescription, supply, sale or consumption of medicinal products”.  This is a broad definition, which covers advertising to the public (allowed for OTC and SOP, prohibited for prescription products) and advertising to HCPs authorised to prescribe medicinal products (physicians) or to dispense them (pharmacists), which also includes visits by medical sales representatives, delivery of samples, sponsorship of scientific meetings and congresses organised for HCPs.  The laws apply to any party that performs the activity defined as “advertising of medicinal products” and not only to the holder of the Marketing Approval (“MA”), since their purpose is to safeguard public health.  The Court of Cassation issued ruling no. 10892 of 7 May 2018 with reference to an unauthorised public advertisement, with which it stated that the sanction should not only be imposed on the producer, but also on those who spread the advertisement.

1.3        What arrangements are companies required to have in place to ensure compliance with the various laws and codes of practice on advertising, such as “sign off” of promotional copy requirements?

According to art. 126 of the Code on Medicines, every MA Holder (“MAH”) must have a scientific office that oversees the information released to the market on its medicinal products, headed by a person who meets the legal requirements, which must ensure that the company’s advertising is legally compliant.  This scientific office must operate independently of the marketing division.  There is no sign-off requirement on promotional copy, but procedures providing documented evidence that the scientific service has verified the copy and activities are advisable, because breach of the verification obligation is subject to administrative penalties.  The Farmindustria Code envisages a system for annual certification of the correctness of scientific information activities.

1.4        Are there any legal or code requirements for companies to have specific standard operating procedures (SOPs) governing advertising activities or to employ personnel with a specific role? If so, what aspects should those SOPs cover and what are the requirements regarding specific personnel?

There are no legal requirements for companies to have SOPs.  It is advisable for companies to have SOPs governing the roles, duties and processes for assessing and approving the advertising of medicinal products, especially to HCPs, intended to (legitimately) promote the prescription of their products.  Relations with HCPs, and with the public bodies in which they work, constitute a delicate question as regards the prevention of certain offences (e.g., corruption, bribery), in view of companies’ administrative and also criminal liability under Legislative Decree 231/2001 (governing the responsibility of entities and companies) and the very heavy sanctions that may be imposed.  Procedures are also important for the certification envisaged by the Farmindustria Code.  Procedures should adopt the principle of separation of roles and powers so that each process provides for multiple parties to be involved in the various roles, thus facilitating control.  The Code on Medicines sets out subjective requirements (e.g., degrees in medicine, chemistry, pharmacy, etc.) for the crucial functions involved in advertising to HCPs (e.g., sales representatives and the head of the scientific office).

1.5        Must advertising be approved in advance by a regulatory or industry authority before use? If so, what is the procedure for approval? Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances?

Public advertising is allowed for OTC and SOP, subject to prior approval by the MOH, after consultation with the relevant Commission of Experts.  According to the Italian Competition Authority opinion dated 8 December 2019, those entitled to request approval should not only be the MAH but also any other subject entitled to sell the medicinal products.  The opinion of the Commission is not mandatory if the advertisement cannot be approved due to: a manifest breach of the Code on Medicines; an intended use for diffusion through the daily or periodical press, or through the radio, and has been approved by a recognised self-regulatory body; and being part of another advertisement that already has approval based on the opinion of the Commission.  Approval is requested through an application to the MOH and is deemed approved (by tacit consent) after 45 days from the date of presentation of the application.  Express approval may be given.  The advertisement must bear the approval date (in the case of express approval) or the date of the application (in the case of tacit consent).  If during the 45 days the MOH rejects the application or approves it in part, the applicant has 10 days to present a rebuttal.  If the advertisement has been definitively rejected (in whole or in part), the only possibility is to apply to the courts (administrative court).  If the advertisement has been approved in part, only the part that has been approved may be used.

For advertising to HCPs, all advertising targeting HCPs (with the exception of the reproduction of the Summary of Product Characteristics – “SmPC”) may be used 10 days after filing with the AIFA (filing takes place exclusively online (which has been the case since 1 June 2018)) in the absence of objections.  Gadgets must also be filed (e.g. pens, stickers, USB pen drives).

1.6        If the authorities consider that an advertisement which has been issued is in breach of the law and/or code of practice, do they have powers to stop the further publication of that advertisement? Can they insist on the issue of a corrective statement? Are there any rights of appeal?

The authorities have powers of supervision enabling them to intervene even after the approval of advertising (to the public and to HCPs).  In this case, they must provide adequate grounds for their intervention.  Review/withdrawal orders may also be issued by other advertising authorities (Italian Competition Authority) or by the courts in the event of disputes among companies.  The intervening authority may order the company to change the advertisement and/or to cease publication, and to also issue a corrective statement (in daily newspapers, on the company website, etc.).  Appeals against the orders of the healthcare authorities and the Competition Authority may be made to the administrative tribunal, while appeals against court rulings may be made to a higher court (e.g. court of appeal).

1.7        What are the penalties for failing to comply with the rules governing the advertising of medicines? Who has responsibility for enforcement and how strictly are the rules enforced? Are there any important examples where action has been taken against pharmaceutical companies? If there have not been such cases, please confirm. To what extent may competitors take direct action through the courts in relation to advertising infringements?

Failure to comply with the rules governing advertising to the public is liable to fines ranging from €2,600–€15,600 (art. 148.5 Code on Medicines) and from €10,000–€60,000 when in the press or in radio-television programmes (which do not have an advertising aim) images of a medicinal product are shown or the product is named in a context that could promote its consumption (i.e. product-placement).

Failure to comply with the rules governing advertising to HCPs is liable to fines ranging from €2,600–€15,600.  For medicinal products that are reimbursed by the National Health System (“NHS”), reimbursement may be suspended for a period ranging from 10 days to two years, depending on the gravity of the breach.  The suspension order is implemented after a complaint has been made to the MAH, who has 15 days to present a rebuttal to the AIFA (art. 148.18 and 19 Code on Medicines).

The healthcare authorities are: the AIFA for advertising to HCPs; the MOH for advertising to the public; and the Farmindustria Control Committee/Jury for self-regulation.  Furthermore, consumer associations may apply to the Competition Authority to intervene with regard to public advertising of medicinal products.  On 19 January 2017, the AIFA and the Competition Authority signed a memorandum of understanding to strengthen surveillance in the pharmaceuticals sector through mutual cooperation and coordination of their areas of intervention.

Anyone may report advertising deemed incompatible to the authorities.  Competitors may also sue for unfair competition.  For example, the Court of Milan issued a ruling on the case of a generic drug manufacturer, which published a table listing its products (showing active ingredient, reimbursement class, name of the original product, price); the court considered that the publication of the table was a breach of advertising laws and an act of unfair competition due to the manner in which it was published, and because it referred to prescription drugs.

1.8        What is the relationship between any self-regulatory process and the supervisory and enforcement function of the competent authorities? Can and, in practice, do, the competent authorities investigate matters drawn to their attention that may constitute a breach of both the law and any relevant code and are already being assessed by any self-regulatory body? Do the authorities take up matters based on an adverse finding of any self-regulatory body?

The authorities’ approval and supervisory activities cannot be replaced by self-regulatory bodies.

Any decisions on advertisements or promotional activities (in favour of or against) already taken by a self-regulatory body (for example, by Farmindustria) are not binding on the authorities or courts, but they constitute elements to be considered when assessing the correctness of the advertisement and the company’s conduct.

1.9        In addition to any action based specifically upon the rules relating to advertising, what actions, if any, can be taken on the basis of unfair competition? Who may bring such an action?

Advertising of medicinal products that is in breach of the Code on Medicines may constitute unfair competition from a variety of viewpoints: absence of approval; advertising that creates confusion, discredits or denigrates competitor products; and/or advertising that takes undue advantage of the competitor’s brand reputation, trade name, or other distinguishing element.  The competitor may pursue a civil lawsuit to stop use of the unfair advertising and obtain compensation for damages.

2. Providing Information Prior to Authorisation of Medicinal Product

2.1        To what extent is it possible to make information available to healthcare professionals about a medicine before that product is authorised? For example, may information on such medicines be discussed, or made available, at scientific meetings? Does it make a difference if the meeting is sponsored by the company responsible for the product? Is the position the same with regard to the provision of off-label information (i.e. information relating to indications and/or other product variants not authorised)?

The Code on Medicines (art. 114.1) prohibits “any advertising” of medicinal products in the absence of an MA issued in accordance with national or EU procedures (the principle also applies to indications extensions).  Advertising to HCPs must always specify the classification for the purposes of supply, the price and the conditions for reimbursement by the NHS (art. 119.3).  The filing of promotional materials without such information is not accepted, with the exception of advertising limited to the name of the medicine.  For class C/nn medicines (for which NHS reimbursement conditions are yet to be negotiated), the SmPC may be divulged to HCPs, because it has been approved and consequently is not subject to additional filing.  The AIFA Guidelines of 11 February 2010 allow companies sponsoring congresses about their medicines to provide information on molecules still undergoing testing limited to the action mechanism, with no mention of the therapeutic indications that are currently unauthorised, and, for international congresses, to divulge information compliant with the MA of other countries, pointing out that the medicine (or the new indication) has not yet been approved in Italy.

At conferences not sponsored by the company, the independent scientific community may discuss molecules of unlicensed medicines by virtue of the constitutional principles safeguarding scientific research and the freedom of expression of thought.

Off-label use of medicines may not be promoted.  The company may only respond reactively to unsolicited requests and eventually send related documentation (not of a promotional nature, cf. answer to question 2.4).

The Question and Answer document linked to the Farmindustria Code (updated on 12 December 2022) clarifies that at non-continuing medical education (“CME”) lectures/symposia sponsored by pharmaceutical companies, it is not possible for the speaker to present or declare data that is not in line with the SmPCs approved in Italy, and that can be retained as off-label use of the drug.

2.2        May information on unauthorised medicines and/or off-label information be published? If so, in what circumstances?

There is no prohibition on the publication in scientific journals of information on unauthorised medicines and/or for off-label use, on the condition that there is no promotional content/intention.  Divulgation to the public of information on medicines indicating the commercial name or active ingredient is not allowed if the information comes, directly or indirectly, from the MAH; if it comes from a “lay” author, it is assessed on a case-by-case basis to identify clearly the purpose and context.  It is advisable to avoid divulgation to the public of information on off-label use of medicines.

2.3        Is it possible for companies to issue press releases about unauthorised medicines and/or off-label information? If so, what limitations apply? If differences apply depending on the target audience (e.g. specialised medical or scientific media vs. mainstream public media), please specify.

The laws governing pharmaceuticals do not regulate press releases.  The pharmaceutical company may not issue information to the public through a press release on unauthorised medicines or on off-label use, with the exception of limited cases of information on research and development plans and financial data.  The commercial name and active ingredient must not be named, and each situation should be assessed on a case-by-case basis with regard to context, recipients and the possibility that the information might acquire a promotional profile.

2.4        May such information be sent to healthcare professionals by the company? If so, must the healthcare professional request the information?

Information on unauthorised medicines may not be sent to HCPs, since the law requires that information comply with the authorised SmPC (art. 114.2 Code on Medicines).  The company may send HCPs answers to specific and unsolicited requests for information about a particular medicine, which art. 113.2 of the Code on Medicines considers extraneous to advertising.  It is essential that the company role be reactive and not proactive.

Art. 3.28 of the Farmindustria Code (updated on 5 April 2022) regulates the activity of “scientific exchange”, providing the possibility of carrying out activities for HCPs aimed at mutual sharing of non-promotional data and information on issues related to the healthcare context and its dynamics.

2.5        How has the ECJ judgment in the Ludwigs case, Case C-143/06, permitting manufacturers of non-approved medicinal products (i.e. products without a marketing authorisation) to make available to pharmacists price lists for such products (for named-patient/compassionate use purposes pursuant to Article 5 of the Directive), without this being treated as illegal advertising, been reflected in the legislation or practical guidance in your jurisdiction?

The above ECJ judgment has not had consequences in Italian law and practice, where access to unauthorised medicines is allowed in the cases envisaged by law, including importing from abroad, which is governed by the MOH Decree of 11 February 1997, under which a prescription is required for use by individual patients, subject to informed consent, but without the involvement of the pharmacy.  The MOH Decree of 7 September 2017 regulates the use of medicines that have not yet been authorised (subject to testing) or that already have an MA but are not available to patients (including for exceptional and unforeseen reasons, for a transitional period) if the company is willing to supply them free of charge.  These hypotheses relate to compassionate use purposes.

2.6        May information on unauthorised medicines or indications be sent to institutions to enable them to plan ahead in their budgets for products to be authorised in the future?

There are no legal requirements on this point.  In our opinion, the company may not provide such information proactively and in promotional contexts, but only reactively in response to unsolicited requests from hospitals or healthcare bodies, doing no more than answering the request using documented and verifiable data.  Art. 3.28 of the Farmindustria Code (updated on 5 April 2022) allows pharmaceutical companies to carry out institutional activities, access activities or further non-promotional interactions with institutions and healthcare professionals during the life cycle of the medicinal product, with the aim of guaranteeing the accessibility of medicines for treatment.

2.7        Is it possible for companies to involve healthcare professionals in market research exercises concerning possible launch materials for medicinal products or indications as yet unauthorised? If so, what limitations apply? Has any guideline been issued on market research of medicinal products?

There are no guidelines on this topic.  HCPs may be involved as expert consultants, individually or as members of advisory boards, to give the company scientific support in preparing the market launch of medicines.  Their involvement may not be for the purpose of promotion, or inducement to prescribe, and checks should be carried out to ensure there are no incompatibilities and/or conflicts of interest and to ascertain whether the prior authorisation of the entity should be sought if the professional is employed by a public entity (Legislative Decree 165/2001 and Law 240/2010).  The Farmindustria Code (art. 4.1) allows the engagement of physicians as company consultants, as conference speakers and moderators, in conducting observational studies, and in educational activities (the list is not exhaustive), on the condition that: there is a written contract; the nature of the service provided is specified; the remuneration is in line with fair market value; any travel and/or hospitality complies with the limits envisaged for conferences and congresses; the consultant discloses the relationship with the company on all occasions in which he/she writes or speaks in public about the topic to which the agreement refers; transparency obligations regarding Transfers Of Value (“TOVs”) are met; and documentation about the service provided is conserved for at least three years.  It is advisable for the company to implement specific SOPs to govern these types of relationship with HCPs, in particular market research (“MR”), where the boundary between scientific and promotional value may be extremely blurred.

3. Advertisements to Healthcare Professionals

3.1        What information must appear in advertisements directed to healthcare professionals?

Under the Code on Medicines (art. 119.3), advertising of a medicinal product to HCPs must always: include the authorised SmPC when the advertising is released; specify the classification of the medicine for the purposes of supply; specify the sale price; and specify the conditions for reimbursement by the NHS.  The AIFA deems that the practice of delivering the SmPC to the physician through the sale representatives does not replace the obligation for the SmPC to be included in every promotional instrument.  As an exception to this rule, advertising to HCPs may be limited to the name of the medicine, with the specification of the common name of its active ingredient(s).  The name of the MAH may be added to these indications, possibly followed by the name of the party who actually markets the product (e.g. the distributor).

3.2        Are there any restrictions on the information that may appear in an advertisement? May an advertisement refer to: (a) studies not mentioned in the SmPC; or (b) studies which have not been published either in peer-reviewed journals or at all (“data on file”)?

Advertising of medicines must be consistent with the information in the SmPC and with the documentation presented in the application for the MA or with its updates (arts 114.2 and 120.3 Code on Medicines).  The information must be exact, complete, up to date and verifiable (therefore referring to published data).  Exaggerated declarations, universal and hyperbolic assertions (such as “perfectly tolerated”, “fully safe”, “preferred medicine”) are not allowed (art. 2.2 Farmindustria Code).  Promotional mention of off-label data is not allowed.  The AIFA Guidelines of 2010 allow for information on molecules being studied to be presented on company stands at congresses, and many companies present material on clinical development plans and study drawings.

According to the AIFA Guidelines on the advertising of medicinal products to HCPs (that have not been approved yet) and the AIFA’s “Questions & Answers” document relating to the “Medical sales representatives” Online Service (cf. question 1.1), works that have not been published cannot be used in advertisements.  For this reason, there could be a risk that, in the event that data/information contained in data on file is used in the development of promotional material, said material will not pass the AIFA’s scrutiny.

3.3        Are there any restrictions to the inclusion of endorsements by healthcare professionals in promotional materials?

The physicians’ Code of Conduct (art. 57) does not allow product endorsements, especially in promotional materials.  Scientific papers published by physicians containing references to molecules or medicines may be reproduced in promotional materials, but only in the full-text version and with precise indication of the source (art. 120.4 Code on Medicines).

3.4        Is it a requirement that there be data from any, or a particular number of, “head to head” clinical trials before comparative claims may be made?

There are no specific guidelines on this point.  The law and self-regulation require that all information and content in promotional materials for HCPs be demonstrable and based on objective elements.  Among the conditions set out for comparisons to be legitimate, the law on comparative advertising (art. 4 Legislative Decree 145/2007) provides, inter alia, that comparisons: must be between products that satisfy the same needs; must be based on elements that are objective, complete, verifiable and non-misleading; and must not discredit other companies’ products.

3.5        What rules govern comparative advertisements? Is it possible to use another company’s brand name as part of that comparison? Would it be possible to refer to a competitor’s product or indication which had not yet been authorised in your jurisdiction?

Comparative advertising is governed by the above-mentioned Legislative Decree 145/2007.  Conditions for licit comparative advertising are contained in art. 4 (see also question 3.4).  Use of another company’s brand name in comparisons is not prohibited a priori, but it should be assessed on a case-by-case basis.  Reference to the other company’s active ingredient is preferable.

AIFA practice allows, in principle, for a comparison of medicines in advertising to HCPs with no misleading elements, which compares medicines with: indications that are exactly the same; properties extracted faithfully from the SmPCs without partial references or distortions; and those containing the classification for the purposes of supply, the sale price and the conditions for reimbursement by the NHS.  In our opinion, references to unauthorised indications in promotional contexts are not possible.

3.6        What rules govern the distribution of scientific papers and/or proceedings of congresses to healthcare professionals?

The distribution to HCPs of scientific papers and/or proceedings of congresses on medicines manufactured or marketed by a company is possible only after filing with the AIFA 10 days before use.  Journals referred to in Medline, books and monographs referred to in OPAC, SBN or in MAI, and only the official proceedings of national or international congresses may be used as sources of scientific information, provided that they have been published and may therefore be verified by the HCPs.

Abstracts, posters, and work that have not been published and lack a Digital Object Identifier (“DOI”) (e.g. “in press”), as well as case reports and expert opinions, may not be used either as sources or, even less, as promotional material.  In AIFA practice, issues of independent journals referred to in Medline that are published and distributed on a regular basis are considered to be advertising only when they contain a direct or indirect reference to a medicine or to its active ingredient and are distributed, in full or as reprints of individual articles, by the MAH.  Divulgation of works with final approval from the Editorial Board published on the web in a definitive version and identified by DOIs is allowed.

3.7        Are “teaser” advertisements (i.e. advertisements that alert a reader to the fact that information on something new will follow, without specifying the nature of what will follow) permitted?

The law does not provide indications regarding teaser advertisements.  The content of the teaser would have to be assessed on a case-by-case basis, also with regard to the condition that all advertising must be transparent.

3.8        Where Product A is authorised for a particular indication to be used in combination with another Product B, which is separately authorised to a different company, and whose SmPC does not refer expressly to use with Product A, so that in terms of the SmPC for Product B, use of Product B for Product A’s indication would be off-label, can the holder of the MA for Product A nevertheless rely upon the approved use of Product B with Product A in Product A’s SmPC, to promote the combination use? Can the holder of the MA for Product B also promote such combination use based on the approved SmPC for Product A or must the holder of the MA for Product B first vary the SmPC for Product B?

This is a special case to be evaluated on a case-by-case basis and in consideration of the entire context.  In general terms, it can be seen that the holder of the MA for Product A (which is authorised for a particular indication to be used in combination with Product B, and whose SmPC expressly refers to use with Product B) can promote the combination use; on the contrary, the holder of the MA for Product B (which is not authorised for a particular indication to be used in combination with Product A, and whose SmPC does not expressly refer to use with Product A) cannot promote the combination use.

4. Gifts and Financial Incentives

4.1        Is it possible to provide healthcare professionals with samples of medicinal products? If so, what restrictions apply?

Samples of medicinal products – except those containing psychotropic or narcotic substances – may only be provided to physicians (including those working in hospitals) authorised to prescribe, and upon their prior request in writing (dated and signed).  Samples are delivered only by sales representatives, with these limits:

  • eight samples per year (two per visit) in the first 18 months after the launch of the medicine; and
  • 10 samples per year (four per visit) after the first 18 months following the launch.

The Regions may also introduce limits on the number of samples, so the allowed quantities need to be checked at local level.  Samples of medicinal products subject to reimbursement by the NHS must be indelibly marked “free sample – not to be sold” or a similar expression.  Specific requirements apply for the box and label of the samples.

4.2        Are there any restrictions on the value of payments or benefits that may be provided to healthcare professionals or healthcare organisations for consultancy services? Is it necessary to obtain advance approval from the authorities for the arrangements?

Art. 4.1 of the Farmindustria Code provides that, for the consultancy services provided by HCPs, the remuneration recognised by the pharmaceutical companies shall be identified according to cost-effectiveness criteria and reflect the market value of the services themselves.  Furthermore, the service must be regulated by a written contract (cf. question 2.7) and the adequacy and traceability of the initiative must be guaranteed.  If travel or any form of hospitality is envisaged, the provisions of the Code regarding conventions and congresses will apply (cf. question 5.2).

As regards the need for advance approval, it is necessary to recall the provisions of art. 53 of Legislative Decree 165/2001, which, subject to the exceptions referred to in paragraph 6 of the same article, provides for the need for public administration employees to obtain the prior authorisation of the entity to which they belong, before carrying out paid assignments for other subjects, be they public or private.

In any case, even where authorisation is not required pursuant to art. 53 of Legislative Decree 165/2001, the regulations of the entities may provide for specific obligations for their employees prior to the assignment of tasks by third parties.

4.3        Is it possible to give gifts or donations of money to healthcare professionals? If so, what restrictions apply? If monetary limits apply, please specify.

The Code on Medicines prohibits the giving, offering or promising of pecuniary or in-kind rewards and benefits to physicians and pharmacists, unless these are of “negligible value” and related in some way to their work.  The same principle applies in self-regulation, which quantifies the “negligible value” as €25 (per year per physician), while the regional guidelines set the limit at €20.  The Farmindustria Code (art. 2.13) also prohibits the offer of economic incentives to HCPs to compensate for time taken away from their normal professional activities to attend congresses.  Gifts with the name of the medicine or the company must be filed with the AIFA 10 days before distribution.

Within the above limits, the MOH Decree issued on 14 April 2008 allows the offer of high-quality scientific books, CD-DVDs or passwords for access to medical-scientific websites, subscriptions to indexed scientific journals of established publishers, and registration to online medical-scientific newsletters.  The Farmindustria Code is more restrictive: it states that if the value of the item is more than €25, the item may only be given for free to healthcare organisations (“HCOs”) (not to individual physicians) and must be purchased from the company at central level.

4.4        Is it possible to give gifts or donations of money to healthcare organisations such as hospitals? Is it possible to donate equipment, or to fund the cost of medical or technical services (such as the cost of a nurse, or the cost of laboratory analyses)? If so, what restrictions would apply? If monetary limits apply, please specify.

This is a donation of money to HCOs.  The donation is normally made for scientific purposes without any consideration or compensation for the company.  It is essential to follow the compliance procedures of the public entity and to verify whether a notarial deed is required, which depends on the amount of the donation (a notarial deed is not required for donations of a modest amount and the limit is assessed in relation to the capacity of the donor).  The question of donations is a delicate one, since the donation must not represent, even indirectly, an incentive to prescribe or to encourage use of the company’s medicines.  It is advisable that the company implement SOPs to make the donation process transparent and secure, and to establish limits, for example, in cases where a tender for a medicine contract, an assessment of a medicinal product for inclusion in the hospital’s list of products, or a clinical trial is underway.  Gifts are not possible.  The law does not prohibit donations in kind, but the principles referred to above with regard to the absence of compensation apply.  Additionally, the Farmindustria Code (art. 2.15) allows the donation of instruments strictly related to the medical profession to universities, hospitals and clinics, and public health organisations operating in the territory and compatibly with the administrative procedures of the entity and of the regulatory framework, with the exclusion of donations or bailments of interchangeable instruments – used in a different or alternative fashion with respect to diagnostic or therapeutic purposes – such as smartphones, smartwatches, tablets or similar, intended for personal use by physicians outside the HCO, or to be given to patients.

4.5        Is it possible to provide medical or educational goods and services to healthcare professionals that could lead to changes in prescribing patterns? For example, would there be any objection to the provision of such goods or services if they could lead either to the expansion of the market for, or an increased market share for, the products of the provider of the goods or services?

The allowed medical or educational materials are described in the MOH Decree of 14 April 2008 (cf. question 4.3).  If the material satisfies the requirements of the decree, it could hypothetically also contain elements (documentable and verifiable) that lead HCPs to autonomously make changes in their prescribing patterns.  It is always advisable to assess the material on a case-by-case basis to ensure that it is not of a promotional nature.  Services may not be provided in favour of HCPs, as this would be in breach of art. 123 of the Code on Medicines, and might also constitute an unlawful act of bribery (art. 170 Royal Decree 27 July 1934, no. 1265).

4.6        Do the rules on advertising and inducements permit the offer of a volume-related discount to institutions purchasing medicinal products? If so, what types of arrangements are permitted?

In connection with advertising, no incentive may be given to favour the purchase or use of medicinal products.

“Price volume” agreements may be stipulated at a central level with the AIFA during negotiation of the reimbursement price of medicines when there is a multiplicity of Managed Entry Agreements (“MEAs”) (cf. question 4.8).

Purchases of medicinal products by public entities take place through public tenders and by law.  The criterion is the most economically advantageous offer, identified on the basis of the best quality/price ratio or based on price or cost.  The economic offer generally provides for only the percentage discount applied with respect to the reserve price, valid for the entire presumed quantity of the supply, to be indicated.  In cases where negotiation directly with the public entity is allowed, the company may make an offer with volume-related discounts.  The offer must be made in writing.

4.7        Is it possible to offer to provide, or to pay for, additional medical or technical services or equipment where this is contingent on the purchase of medicinal products? If so, what conditions would need to be observed? Are commercial arrangements whereby the purchase of a particular medicine is linked to provision of certain associated benefits (such as apparatus for administration or the provision of training on its use) as part of the purchase price (“package deals”) acceptable? If so, what rules apply?

We refer back to question 4.6 on tenders for public supplies.  Consistently with the criterion whereby the contract is awarded to the lowest price, the tender regulations generally provide that the final winning price be all-inclusive and also include the cost of any administration devices.  Consequently, offers in cash or in kind to favour the purchase of medicinal procedures are not allowed.  Consideration may be given to Patient Support Programmes (“PSPs”), but at the moment these programmes are not a “measurable” factor in connection with offers for the purchase of medicines or negotiation of the price of medicines (see question 6.7).

4.8        Is it possible to offer a refund scheme if the product does not work? If so, what conditions would need to be observed? Does it make a difference whether the product is a prescription-only medicine, or an over-the-counter medicine?

“Payment by result”, “risk sharing” or “cost sharing” agreements (MEAs) are very widespread and are drawn up by the company with the AIFA during negotiations on the reimbursement of the medicine.  During negotiations, all the contractual conditions and (objective) criteria are set to establish when the medicinal product has not had the expected therapeutic response, and if there can be a refund.  It is advisable that the company clearly negotiate refund timing and procedures and the overlaps with the pay-back system operating in Italy in relation to the fixed spending ceilings for sales to hospitals and the territory (e.g. pay-back or claw-back).  The Italian system currently uses the “payment upon result” scheme for the very new and expensive medicine, Car-T: in this scheme, payment is not made until the result is ascertained; this is in contrast with “payment by result”, where the NHS pays for the medicinal products and thereafter the company issues credit notes for non-responding patients.

4.9        Are more complex patient access schemes or managed access agreements, whereby pharmaceutical companies offer special financial terms for supply of medicinal products (e.g. rebates, dose or cost caps, risk share arrangements, outcomes-based schemes), permitted in your country? If so, what rules apply?

See question 4.8.

4.10      Is it acceptable for one or more pharmaceutical companies to work together with the National Health System in your country, pooling skills, experience and/or resources for the joint development and implementation of specific projects? If so, what rules apply?

In addition to financing sponsorship, donations and grants, in Italy, pharmaceutical companies may collaborate with the NHS with specific agreements (like technical sponsorship or public-private partnership agreements), aimed at providing a better quality of its services and promoting innovation of the administrative organisation, placing as conditions: i) pursuing public interest; ii) the absence of conflict of interest between the public and private activities; and iii) savings in expenditure compared to the available resources.  The award of works, services or supplies for amounts higher than €40,000 is subject to prior publication on the website of the contracting organisation, for at least 30 days, of a specific notice, with which the search for sponsors for specific interventions is made known, or the receipt of a sponsorship proposal is communicated, briefly indicating the content of the proposed contract.  After the publication period of the notice, the contract can be freely negotiated, provided that it is in compliance with the principles of impartiality and equal treatment between operators who have expressed interest.

The ALISEI Cluster (Advanced Life Science in Italy) operates in Italy, which promotes the interaction between the multidisciplinary research system, the pharmaceutical-biomedical industry, and public institutions in the health sector, to give a concrete boost to research and innovation in the country.  ALISEI elaborated on a Strategic Plan for the years 2017–2020, which identified four priority macro-trajectories:

  • e-Health, advanced diagnostics, medical devices and minimal invasiveness.
  • Biotechnology, bioinformatics and pharmaceutical development.
  • Regenerative, predictive and personalised medicine.
  • Nutraceutical, nutritional and functional foods.

After defining these trajectories, the new Strategic Plan identified priority action areas in relation to the growth of the national innovation ecosystem: (i) to support and encourage technology transfer and enhance life-science research; and (ii) to act on the growth and sustainability of research infrastructures.  The ALISEI Cluster represents an important source to create a strong network between the public and private environments.

4.11      May pharmaceutical companies sponsor continuing medical education? If so, what rules apply?

Pharmaceutical companies may sponsor CME events.  A special set of rules apply (State Regions Agreement of 2 February 2017 and Operating Manuals approved by the National Commission for Continuous Training – “CNFC” on 6 December 2018 and on 4 February 2021, in application of the State Regions Agreement) to ensure that HCP education is not influenced by parties with commercial interests in the healthcare sector.  HCPs may acquire not more than ⅓ of their education requirement through recruitment (economic and other benefits such as hospitality, etc.) by the sponsor company.  The regulations are very detailed, but the main principles are as follows:

  • the pharmaceutical company may sponsor the CME event (exclusively or non-exclusively) with a specific written contract;
  • the sponsor may not select and/or indicate the tutors and the moderators, and all relations with tutors and moderators (including economic relations) are mediated by the provider, who must be an independent accredited third party;
  • the name and logo of the sponsor may appear only before the start and after the end of the event and on the last page of materials, leaflets and the event programme;
  • the sponsor may be involved in the distribution of promotional material for the event and may have no more than two of its representatives at the venue; and
  • during the event, the active ingredient of medicinal products may be indicated, but the commercial name may not be indicated, even if it is related to the topic under discussion.

In March 2021, “” – the National Agency for Regional Services – made models available on its website of sponsorship contracts for CME events between the provider and companies, which take the updates made by the 2017 Agreement and related Operating Manuals into account.  At the same time, has also published a vademecum that contains the principles that govern CME sponsorship contracts.

4.12      What general anti-bribery rules apply to the interactions between pharmaceutical companies and healthcare professionals or healthcare organisations? Please summarise. What is the relationship between the competent authorities for pharmaceutical advertising and the anti-bribery/anti-corruption supervisory and enforcement functions? Can and, in practice, do the anti-bribery competent authorities investigate matters that may constitute both a breach of the advertising rules and the anti-bribery legislation, in circumstances where these are already being assessed by the pharmaceutical competent authorities or the self-regulatory bodies?

In addition to the criminal code, which prosecutes corruption, the main rules designed to prevent the corruption of HCPs are contained in the Code on Medicines and the Farmindustria Code.  Many rules refer to relations between companies and HCPs in connection with promotional activities.  The main rules are: no utility (gifts, donations) may be made to physicians to induce prescribing, except for items of negligible value, hospitality at conferences and congresses (which is strictly regulated); and collaboration (which must be justified, specified in writing, be remunerated at fair market value, the efficacy of the service must be demonstrated, there must be no conflicts of interest, and for employees of public entities the authorisation of the entity must be obtained).

To strengthen the preventive system, the Farmindustria Code has introduced rules on the publication of TOVs.

In 2022, the so-called “Sunshine Act” (Law no. 62/2022) was published in the Official Journal, after a long elaboration which began in 2018.  The Law provides for the obligation to publish transfers of value made by pharmaceutical companies to HCPs (if they have a unit value of more than €100 or a total annual value of more than €1,000) and to HCOs (if they have a unit value of more than €1,000 or a total annual value of more than €2,500), and introduces administrative pecuniary sanctions in the cases of failure to communicate, communication of incomplete information and communication of false information against manufacturing companies as the parties responsible for the truthfulness of the data contained in the communications.

Law no. 62/2022 is not yet applicable, since the reporting obligations shall apply as from the second six-month period following the six-month period in progress on the date of publication in the Official Journal of the notice in which the MOH shall communicate the date of commencement of operation of the online public register in which the information related to transfers will be published.

Pharmaceutical companies in Italy implement organisation models in accordance with Legislative Decree 231/2001, which introduced corporate liability for offences (including corruption, fraud to the detriment of the State, and others) committed by employees, managers and co-workers.

Enforcement of the rules on the promotion of medicinal products is the responsibility of the AIFA and/or the MOH, which, in the event of breaches, apply the envisaged administrative penalties; in cases where they believe a crime has been committed (e.g., corruption), they are required to inform the public prosecutor.  Investigations of crimes of corruption may be initiated autonomously by the public prosecutor when it learns of criminal activity.  The two authorities may conduct their activities in parallel.

5. Hospitality and Related Payments

5.1        What rules govern the offering of hospitality to healthcare professionals? Does it make a difference if the hospitality offered to those healthcare professionals will take place in another country and, in those circumstances, should the arrangements be approved by the company affiliate in the country where the healthcare professionals reside or the affiliate where the hospitality takes place? Is there a threshold applicable to the costs of hospitality or meals provided to a healthcare professional?

Hospitality to HCPs for congresses and meetings sponsored by the pharmaceutical company is governed by art. 124.4 of the Code on Medicines.  Prior AIFA approval is required and must be applied for 60 days before the date of the congress, with details of the meeting and a breakdown of planned expenditure attached to the application.  The AIFA issues its opinion within 45 days of receipt of the application.  Congresses organised directly or indirectly by the Italian company attended mainly by Italian physicians may not take place abroad.  In any case, the laws and codes of conduct of the country hosting the event also apply.  If the event is organised by the parent/by the local affiliate, the Italian company will be responsible for their arrangements for Italian physicians invited abroad.  The law does not place thresholds on hospitality: the principle of sobriety applies.  Expenditure thresholds and other conditions are set by the Farmindustria Code (cf. question 5.2).

5.2        Is it possible to pay for a healthcare professional in connection with attending a scientific meeting? If so, what may be paid for? Is it possible to pay for his expenses (travel, accommodation, enrolment fees)? Is it possible to pay him for his time?

The company may offer hospitality for the congress (travel, accommodation and enrolment fees), but may not pay any form of compensation for his/her time.

Hospitality conditions are as follows: travel and hospitality expenses are limited to qualified HCPs and do not extend to persons accompanying them, hospitality may not extend beyond 12 hours before the start of the meeting or 12 hours after the end, and may not prevail on the technical-scientific purposes of the event.  Art. 3 of the Farmindustria Code also sets expenditure ceilings: four-star hotel; €60 per meal; travel in economy class; business class only for speakers and moderators and for international events if the flight is more than six consecutive hours; and gala dinners or cultural events/tourism are not included.  The same professional may not be invited more than twice a year.

5.3        To what extent will a pharmaceutical company be held responsible by the regulatory authorities for the contents of, and the hospitality arrangements for, scientific meetings, either meetings directly sponsored or organised by the company or independent meetings in respect of which a pharmaceutical company may provide sponsorship to individual healthcare professionals to attend?

The pharmaceutical company is responsible for the contents of the meeting and its organisation, according to the details declared in the approval application.  For events for which approval is not required, the company is nevertheless responsible for content and arrangements.  Any breach of the Code on Medicines (including breaches reported by third parties) will be examined by the AIFA, which has the right to prohibit the meeting from taking place.  Severe rules apply in particular to CME events where the provider is the main guarantor for compliance with the rules and for the scientific nature of the content (cf. question 4.11).

5.4        Is it possible to pay healthcare professionals to provide expert services (e.g. participating in advisory boards)? If so, what restrictions apply?

It is possible to pay HCPs to participate in advisory boards.  The rules are the same as those that apply to collaboration (cf. question 2.7), based on the conditions of art. 4.1 of the Farmindustria Code.  The advisory board must not be created to promote medicines or to induce the prescribing of medicines.  If the expert is a public-sector employee, the approval of the entity may be required for him/her to participate in the advisory board.  In any case, the expert must have no incompatibilities or conflicts of interest in undertaking the engagement.  It is advisable that the company implement appropriate SOPs with regard to advisory boards to ensure activities are transparent and documentable.

5.5        Is it possible to pay healthcare professionals to take part in post-marketing surveillance studies? What rules govern such studies?

Direct financial agreements between the company and trial Investigators are not allowed: the written agreement must be signed with the HCP’s employer.  Post-marketing surveillance studies are subject to the AIFA Guidelines of 20 March 2008.  The Farmindustria Code (art. 4.4) refers to the AIFA Guidelines, which set out the conditions for the execution of such studies: written contract between sponsors and participating bodies; protocol approved by the medical division of the company or by the scientific office; remuneration based on criteria of cost-effectiveness and fair market value; sales representatives may be involved only with logistic and non-negotiable questions; and any tools (tablets, smartphones should preferably be avoided) are to be supplied only to the institution and must be returned on completion of the study.  The company is responsible even if it assigns execution of studies to third parties.

With reference to clinical trials and, specifically, with regard to conflicts of interest, art. 6, par. 4 of the recent Legislative Decree 52/2019 provides for, as a requirement for the participation in clinical trials, the absence of ties of dependence, consultancy or collaboration in any capacity, between the Investigator and the sponsor, with respect to the planned trial.

A literal interpretation of the decree appears at variance with the existing legislation on conflicts of interest and could penalise the Italian clinical research system, introducing a priori a static form of “incompatibility” with respect to the assumption of the role of Investigator, which is disproportionate in relation to the goal of safeguarding the independence and impartiality of the clinical trial.

The actual scope of application of the decree could become clear upon publication of the AIFA ruling, which will set out the procedures intended to safeguard the independence of the trial, and to guarantee the absence of conflicts of interest in the assessment of applications, as envisaged by art. 6, par. 3, quoted above.

5.6        Is it possible to pay healthcare professionals to take part in market research involving promotional materials?

As specific legislation neither exists in Italy nor at a regulatory or ethical level for MR, reference is made to the EphMRA Code (European Pharmaceutical Market Research Association).  The fee is usually paid directly by the research agency appointed by the pharmaceutical company, and should be: dependent only on the correct completion of a questionnaire/interview and not on any additional conditions in the case of one-off surveys; kept to a minimum; appropriate to the time involved; no more than the fair market value for that individual’s professional consultancy or advice; appropriate to the MR subject type; appropriate to the task(s); for patients/members of the public, a token of appreciation – not a fee for time; and handled only by the agency – however, if the MR is conducted by a company’s in-house researchers, MR subjects’ personal data must not be accessible to company personnel outside the research team.

The purpose of the consultancy of the HCP should be identified with respect to the justified needs of the company requesting assistance and to the absence of incompatibilities or conflicts of interest of the HCP in providing the service, also considering any public positions he/she holds.  So, while there are no prior preclusions on the purpose of the consultancy, in practice, it must be considered in relation to parameters that ensure the activity is legitimate, and remembering that utilities may not be given to physicians for promotional purposes.  In other words, the company must check that: the consultancy requirement is objective, real and justified; the contribution of the consultant adds value and is pertinent to his/her experience and expertise; the consideration is compatible with fair market value; and the service is real and verifiable.

6. Advertising to the General Public

6.1        Is it possible to advertise non-prescription medicines to the general public? If so, what restrictions apply?

OTC and SOP may be advertised to the general public after authorisation from the MOH (art. 118 Code on Medicines).  Advertising must be transparent, favour rational use of the medicine, present it in an objective manner without exaggerating its properties and must not be misleading.  It must provide the name of the medicine, information for correct use and an invitation to read the warnings.  It must not have content prohibited under art. 117 of the Code on Medicines (cf. art. 90 Directive 2001/83/EC).

6.2        Is it possible to advertise prescription-only medicines to the general public? If so, what restrictions apply?

It is forbidden to advertise prescription-only medicines or medicines containing psychotropic or narcotic substances to the general public, although the MOH may authorise vaccination campaigns promoted by pharmaceutical companies (art. 115.2 Code on Medicines).

6.3        If it is not possible to advertise prescription-only medicines to the general public, are disease awareness campaigns permitted encouraging those with a particular medical condition to consult their doctor, but mentioning no medicines? What restrictions apply?

Disease awareness campaigns are permitted to convey information about people’s health or diseases, provided that there is no reference, direct or indirect, to a medicinal product (art. 113.2 Code on Medicines).  Since there is no definition of “indirect mention”, reference must be made to the (meagre) case law on the question, which states that the mention of the medicinal product through the active ingredient constitutes a reference to the medicinal product, particularly when the product is the only one to contain that active ingredient.  Disease awareness campaigns should be assessed on a case-by-case basis with regard to all the content they divulge and the other information present in the context in which they are presented (e.g. websites, Facebook pages).  In this context, it is possible to recommend that medical advice should be sought to prevent or treat a disease, but the names of physicians may not be given if the information comes from a pharmaceutical company.

6.4        Is it possible to issue press releases concerning prescription-only medicines to non-scientific journals? If so, what conditions apply? Is it possible for the press release to refer to developments in relation to as yet unauthorised medicines or unauthorised indications?

There are no laws regarding press releases.  Public release of information on a medicinal product is accepted practice – including mention of the active ingredient or its name – solely for the purpose of announcing the medicine’s authorisation and for a period strictly contiguous with the authorisation date, so that it is clear that the announcement via press release is only for informative and not promotional purposes.  Any other situation should be assessed case by case (cf. also question 2.3).

6.5        What restrictions apply to describing products and research initiatives as background information in corporate brochures/Annual Reports?

In corporate brochures and Annual Reports, the company normally makes express mention of medicinal products, their dissemination and market positioning.  In order for such information not to be considered advertising, brochures and Annual Reports must address the parties concerned, not the general public.  An activity is qualified as advertising not only by the medium used but also by the manner in which that medium is disseminated and the audiences reached.  Content is significant too, and it is essential that the medicinal products (or active ingredients) be mentioned without over-detailed descriptions or claims about their properties.

Divulgation of general information about research and study is allowed, provided that it has no promotional content or intention (if it publicises a study for the purpose of recruiting patients, the prior opinion of the Ethics Committee must be sought).

6.6        What, if any, rules apply to meetings with, and the funding of, patient organisations?

The relationship with patient organisations is governed only by self-regulatory rules.  Under art. 4.6 of the Farmindustria Code (lastly updated on 5 April 2022), direct and indirect support (including sponsorship) is permitted, provided that: there is a written agreement setting out the amount and purpose of funding; use of the association logo and the procedures have had prior approval; sponsorship is transparent and is not for promotional purposes; no company may ask to be the exclusive sponsor of a patient organisation; for travel and hospitality, the regulations governing congresses apply; and the list of the patient organisations supported the previous year, with the purpose and amount of funding, is published on the company website (for the first three months of the year).  Contracts for services to the company (also through representatives of the association and through “expert patients” acting as consultants, e.g. on advisory boards or speakers) are permitted only on projects in the interests of public health or research and must not have promotional purposes.  A written agreement is required detailing the services and the remuneration, which must be transparent and in line with fair market value.

6.7        May companies provide items to or for the benefit of patients? If so, are there any restrictions in relation to the type of items or the circumstances in which they may be supplied?

The law makes no restrictions, except for the prohibition on providing medicinal products (to the public).  The question is not regulated by the Farmindustria Code.  Nevertheless, the supply of items directly to or for the benefit of patients is not contemplated in order to avoid such action being regarded as an illegitimate form of advertising of medicines.  Any items that may be needed are delivered through the bodies that assist patients. 

In Italy, PSPs to enhance compliance with innovative treatments are spreading, which may justify support for the benefit of the patient; nonetheless, this is made available through the decision of the physician or the body assisting the patient.  Case-by-case assessment is advisable.  It should also be remembered that privacy law does not allow companies to know the names of patients.  Art 4.7 of the Farmindustria Code, which regulates PSPs, has recently been modified.

6.8        What are the rules governing company funding of patient support programmes?

PSPs are not defined by law but rather by the Farmindustria Code.  Art. 4.7 (updated on 19 January 2022) defines a PSP as an initiative whose purpose is the provision of additional services by a pharmaceutical company, not substituting those provided by a healthcare institution or by the NHS, for the direct benefit of a patient who is being treated with a specific drug already authorised for marketing.

The pharmaceutical company may fund a provider to organise a PSP.  In this case, the provider will be able to send its own specialised, qualified and previously trained personnel to the patient’s home or to public or private healthcare facilities, provided that the relationship between the company and the provider is in the form of a service contract, and therefore not in any form related to the administration of labour or secondment.  The company is still responsible for the services provided by the external provider in charge.

The program and the material used must not, in any case, be a promotional tool, but functional only to the communication of information necessary for the appropriate use of the drug.

The duration of services offered by the PSP must be pre-defined and congruent with the identified need and the relative desired benefit for the patient.

The business function with decision-making responsibility for the PSP must be non-commercial and operate under the supervision of the company’s compliance function.

The PSP is responsible for pharmacovigilance management, privacy management, materials management, and compliance.

The pharmaceutical company must remain uninvolved in the processing of personal data of patients involved in the PSP.  The company will only be able to view aggregate data for statistical purposes on the use of the service.

A Questions and Answers document (updated on 12 December 2022) is available, which provides additional useful information for companies.  It is advisable to keep current legislation applicable to the various issues that may arise on a case-by-case basis in mind (pharmaceutical, labour law, data processing, etc.).

7. Transparency and Disclosure

7.1        Is there an obligation for companies to disclose details of ongoing and/or completed clinical trials? If so, is this obligation set out in the legislation or in a self-regulatory code of practice? What information should be disclosed, and when and how?

Parties funding a clinical trial in Europe are required to publish the results in EudraCT, the European database of clinical trials managed by the EMA, and provide the public with a summary of the results of the trial.  Since 2014, all trials must be published, independently of the result.  The EudraCT Register will be replaced by the database envisaged by Regulation (EU) 536/2014, after the end of the three-year transition period, following the date of application of the EU Regulation (31 January 2022).

In Italy, the AIFA clinical research on drugs portal (“PRC”), which is currently being reorganised with the migration of the data of the national observatory on clinical trials (“OsSC”), is the source of public information on clinical trials conducted on medicines in the country.  Finally, a register of observational studies (“RSO”) has been created to collect data on non-interventionist clinical research in a single national archive – though it is not yet operational.

Also, in accordance with art. 5.8 of the Farmindustria Code, pharmaceutical companies will be required to publish aggregate annual spending on R&D work (clinical trials and prospective observational studies involving collection of patient data), as well as spending for Investigators’ Meetings, advisory boards or hospitality, when related to research activities.

7.2        Is there a requirement in the legislation for companies to make publicly available information about transfers of value provided by them to healthcare professionals, healthcare organisations or patient organisations? If so, what companies are affected (i.e. do these requirements apply to companies that have not yet been granted a marketing authorisation and/or to foreign companies), what information should be disclosed, from what date and how?

Law no. 62/2022 mentioned above, adopted on 31 May 2022, provides for the obligation to publish transfers of value made by pharmaceutical companies to HCPs and HCOs (cf. question 4.12).

The obligations provided for in this Law apply to the so-called “manufacturing companies”, i.e. the subjects, including those belonging to the Third Sector, that carry out an activity directed to the production or marketing of medicinal products, instruments, equipment, goods and services, including non-health products and nutritional products, marketable in the field of human and veterinary health, or to the organisation of conferences and congresses concerning such matters.

These subjects shall publish in the public electronic register called “Sanità trasparente” (which means “Transparent Healthcare”):

  • conventions and payments in cash, goods, services or other benefits made by a manufacturing company in favour of a subject operating in the health sector (if they have a unit value of more than €100 or a total annual value of more than €1,000) or a HCO (if they have a unit value of more than €1,000 or a total annual value of more than €2,500); and
  • agreements between manufacturing companies and organisations that produce direct or indirect benefits, consisting in participation in conferences, training events, committees, advisory bodies or scientific committees or in the establishment of consultancy, teaching or research relationships.

The communication must be made within the six-month period following that in which the disbursements were made and/or the agreements and conventions were entered into and, if the manufacturing company is based abroad, the fulfilment may be carried out by its representative in Italy.

There is also an obligation for manufacturing companies to report, by 31 January of each year, the data of subjects operating in the health sector and HCOs that:

  • are holders of shares in the company’s capital or bonds issued by the company, registered for the previous year in the register of shareholders or in the bond register, or who
  • have received royalties from the company in the previous year for the granting of licences for the economic use of industrial or intellectual property rights.

Also, the disclosure of these data shall be made through the “Sanità trasparente” public electronic register.

The application of the disclosure obligations set out in Law no. 62/2022 is subject to the operation of the public electronic register, which is still to be set up on the MOH website.

7.3        Is there a requirement in your self-regulatory code for companies to make publicly available information about transfers of value provided by them to healthcare professionals, healthcare organisations or patient organisations? If so, what companies are affected (i.e. do these requirements apply to companies that have not yet been granted a marketing authorisation and/or to foreign companies), what information should be disclosed, from what date and how? Are companies obliged to disclose via a central platform?

Disclosure of TOVs made directly or indirectly for the benefit of HCPs, HCOs and patient organisations is set out in the Farmindustria Code (in accordance with the EFPIA Code).  It is binding only for associates; for other companies, it represents a principle of best practice for the purpose of compliance.  TOV data for each year is published within the first six months of the following year in the country where the beneficiary is domiciled, in accordance with the local self-regulatory code.  If the company does not have an affiliate in the country where the beneficiary is domiciled, the transferor company must publish the TOV data in accordance with the self-regulatory code of the country where the beneficiary is domiciled.  The data to be published is as follows:

  • for HCPs: expenditure for participation at conferences and congresses (enrolment, travel, hospitality, excluding meals and beverages) and remuneration for professional consultancy and services;
  • for HCOs: donations and contributions (including bailments), in cash and in kind; direct or indirect funding at congresses, including enrolment fees or travel costs and hospitality for physicians; and professional consultancy and services as shown in a written contract;
  • for patient associations, cf. question 6.6; and
  • data on OTC, for promotional material of negligible value, meals, beverages and samples is not published.

7.4        What should a company do if an individual healthcare professional who has received transfers of value from that company, refuses to agree to the disclosure of one or more of such transfers?

While companies must make every possible effort to obtain the consent of HCPs (art. 5.5 Farmindustria Code), if consent is not forthcoming, data is published in aggregate form according to the following criteria:

  • number of recipients (absolute value and as a percentage of the total);
  • aggregate figure for HCPs; and
  • aggregate TOVs as a percentage of total TOVs.

Law no. 62/2022 (the so-called “Sunshine Act”, cf. questions 4.12 and 7.2) does not provide for the possibility for the HCP to refuse to agree to the disclosure of one or more transfers, since, according to the Law, consent to the publication and processing of data is considered to be given when the relationship from which the obligation of transparency derives is established.

8. Digital Advertising and Social Media

8.1        How is Internet advertising regulated? What rules apply? How successfully has this been controlled?

This topic is regulated by the MOH Guidelines of 17 February 2010, supplemented on 6 February 2017, 25 July 2017 and 25 July 2018, which distinguish between advertising to the general public and to HCPs.

For advertising to the general public, the publication of web pages or banners, pop-up or overlay frames, and all other forms of presentation on the Internet is to be considered, to all intents and purposes, advertising requiring given prior approval by the MOH.  Approval is not required for institutional advertising, i.e. advertising that promotes the company image and/or logo, possibly accompanied by the list of marketed products, together with images of their packaging and leaflets, in the absence of any healthcare claim.

For advertising to HCPs, access to an Internet site must be restricted through encrypted areas, access to which is enabled with a password issued after transmission of the data needed to identify the HCP user.

The Farmindustria Code provides that every Internet site created by an Italian company or a company that operates in Italy that addresses the public and HCPs must clearly indicate the sponsor, the source of the information on the site, the recipients and the site objectives.

Advertising on Internet sites is controlled not only by the pre-clearance regime described above, but also by the competent authorities.  In Italy, special arms of the Carabinieri, the NAS anti-sophistication units and the Postal Police verify activities on the Internet and have in the past blocked unlawful activities, including advertising, by reporting them to the authorities.

8.2        What, if any, level of security is required to ensure that members of the general public do not have access to websites or digital platforms intended for healthcare professionals?

The area of websites dedicated to HCPs must be encrypted to ensure that access is reserved for them; on sites to which the public has access, the links to areas providing information for HCPs must act as barriers blocking access for all other parties.

These rules specifically apply to websites, but, in principle, they should also be applicable to digital platforms, since there is no significant difference between them and websites.

8.3        What rules apply to the content of independent websites or digital platforms that may be accessed by a link from a company-sponsored site? What rules apply to the reverse linking of independent sites to a company’s website or platform? Will the company be held responsible for the content of the independent site in either case?

Advertising on independent sites is allowed, subject to the receipt of MOH approval by the party promoting the product, irrespective of the site on which the advertisement appears.

In the case of links from sites (and also banners or other frames) which in turn contain advertising material, the above-mentioned guidelines distinguish between authorised advertising or advertising not subject to approval or non-authorised advertising, and provide that:

  • links are acceptable between sites that both contain authorised promotional material on the condition that the company responsible for the material on the Internet employs a disclaimer for the user: “You are leaving the XXX company website containing authorised promotional material pursuant to the current laws governing healthcare advertising”;
  • links are acceptable from a site containing authorised promotional materials to another site not containing promotional material subject to authorisation (e.g., containing information on healthcare education), provided that the user is alerted with a message as above; and
  • links are not acceptable from a site containing authorised promotional material to another site containing promotional material subject to authorisation that has not been authorised.

These rules specifically apply to websites, but, in principle, they should also be applicable to digital platforms, since there is no significant difference between them and websites.

8.4        What information may a pharmaceutical company place on its website that may be accessed by members of the public?

In addition to advertising for SOP with prior MOH authorisation, the company may divulge the following information, which does not require prior authorisation since it is not subject to the provisions governing advertising:

  • the information shown on the label and/or leaflet of the medicinal product (which have already received specific authorisation);
  • sales catalogues and product price lists (provided that information about the medicine does not appear); and
  • information relating to people’s health or to diseases, provided there is no direct or indirect reference to a medicinal product (disease awareness).

The MOH Guidelines of 6 February 2017 permit advertising, without prior MOH authorisation, of the list of non-prescription medicinal products and OTC, whose names provide an activatable link exclusively to the leaflet and possibly to an image of the package.  In this context, no message relating to the healthcare properties of the SOP may be visible, otherwise authorisation is necessary.

Italy applies the principle established by the ECJ (C-316/09) whereby information on prescription medicines may be published on an Internet site accessible to the public on the condition that such information is accessible exclusively to people who wish to obtain it (so-called “pull” system), with the exclusion of any so-called “push” activity, and that it consists solely of the faithful reproduction of the package of the authorised medicinal product and the literal and full reproduction of the leaflet or summary of SOP product characteristics approved by the authorities.

8.5        Are there specific rules, laws or guidance, controlling the use of social media by companies?

The use of social media by pharmaceutical companies to advertise SOP and OTC is governed by the MOH Guidelines of 6 February 2017, 25 July 2017 and 25 July 2018, which adopt a more open approach than previously allowed, even though there were no express prohibitions.

The guidelines allow the use of the main and most widespread social media (Facebook, Instagram and YouTube), but envisage restrictions to limit the use of interactive functions (e.g. like, counter, comments, content sharing, etc.).  The reason for this is the need to ensure that advertisements approved by the MOH are static by avoiding changes or alterations arising from typical “social” activities.  The MOH believes that any “change”, such as the addition of comments, advice, user recommendations, would undermine control of the advertisement for protection of consumer health.  To summarise:

  • Facebook: an advertising post (with authorisation) may be published on the right-hand column of the so-called “wall”; an advertisement may be published directly on the wall on the condition that the “comments” and “like” functions are deactivated.  Since the “share” function cannot be deactivated, the MOH requires all advertisements to contain a disclaimer that attributes responsibility for sharing to the user.
  • YouTube: authorised advertisements may be published, provided that interactive functions are deactivated.  Likes or dislikes may be expressed, but the number cannot be viewed.  The video may be shared, but only in the YouTube watch page, even if sharing takes place with the “share” button or through copying and pasting the URL (this guarantees the staticity of the advertisement).  Authorised videos may be reproduced in pre-roll mode, i.e. before the videos are searched for by the user.
  • Instagram: authorised advertising images or short videos may be published in the “Story” section, where users viewing these images/videos are not able to post comments, express reactions or share them.
  • Twitter: use of Twitter is currently not permitted, because it does not allow the minimum content of public advertising of medicinal products to be transmitted to the recipient in a single tweet.

8.6        Are there any restrictions on social media activity by company employees using their personal accounts, including interactions with third parties through “likes”, “applauds”, etc.?

The principles and regulatory provisions governing the advertising of medicinal products also apply to subjects acting independently from the company, as decided by the Court of Justice, ruling of 2 April 2009, in case C-421/07 (Damgaard case).  According to this ruling, art. 86.1 of Directive 2001/83/EC (taken up by art. 113 Legislative Decree 219/2006) does not limit its applicability to the company that owns the medicinal product: the scope of the regulation is extended to anyone who makes advertising messages regarding medicinal products, which potentially includes journalists who are subject to regulatory restrictions and cannot invoke the right to freedom of the press as a criterion for maximum freedom in their work, because the regulations on medicinal products protect the health of the general public.

In light of this principle, an activity carried out by the employee independently from his/her own company can still be considered advertising of medicinal specialities and assume an unlawful nature if not conducted in compliance with current legislation.

With specific regard to the advertising of medicinal products through social media, the provisions of the MOH Guidelines of 17 February 2010, supplemented on 6 February 2017, 25 July 2017 and 25 July 2018, also apply.  These guidelines distinguish between advertising to the general public and to HCPs (reference is made to the provisions of par. 8.5 of this publication).

Employees/collaborators must comply with any social media policies adopted by the company in order to regulate the management of these means, where their use is related to the company’s activity.  This is even more valid if the activity on social networks is also relevant for regulatory purposes.  As illustrated above, it is certainly appropriate for the company to regulate and/or limit such activity by means of company policies.

8.7        Are there specific rules governing advertising and promotional activity conducted virtually, including online interactions with healthcare professionals, virtual meetings and participation in virtual congresses and symposia?

The general principles and rules applicable to advertising and promotional activities also apply to remote activities.

With reference to advertising online and via social media, the provisions of the MOH Guidelines of 17 February 2010 (supplemented on 6 February 2017, 25 July 2017 and 25 July 2018), which distinguish between advertising to the general public and HCPs, as well as that expressed in the Farmindustria Code, in relation to company websites (to which reference is made to that expressed in questions 8.1–8.4) apply.

Virtual congresses are equivalent to in-person congresses, and the same rules apply to the latter.  The legislation referred to in art. 124 of Legislative Decree 219/2006 on conferences, congresses, and other meetings regarding medicinal products, which governs the relative authorisation regulations by the AIFA, applies indifferently to events in person and remote events, and for the purpose of payment of the relative tariffs, unless explicit derogations are made.

Farmindustria has also recently reiterated that the rules applicable to conferences and congresses as governed by the Code must also be considered applicable to remote events.

9. Developments in Pharmaceutical Advertising

9.1        What have been the significant developments in relation to the rules relating to pharmaceutical advertising in the last year?

The main development is represented by the “Questions & Answers” document relating to the “Medical sales representatives” Online Service adopted by the AIFA (cf. question 1.1).

There have not been other significant developments in relation to the rules relating to pharmaceutical advertising in the last year.

The most recent developments have been introduced as a consequence of the epidemiological emergency due to COVID-19, for carrying out medical-scientific information through remote methods, and for the implementation of specific safety measures for information to be provided in person.

The Questions and Answers document linked to the Farmindustria Code (updated on 12 December 2022) states that the rules provided for residential events also apply to remote events, as far as they are compatible.

With specific reference to advertising to the general public, the last main developments are the MOH Guidelines on use of digital and social media in advertising non-prescription medicines of 6 February 2017, 25 July 2017 and 25 July 2018, the corresponding Guidelines of 20 December 2017 on advertising of medical devices, and the specifications for advertising of SOP of 7 May 2018 – these also issued by the MOH.

Although only partially evaluable as a reference for pharmaceutical advertising, we recommend viewing the Digital Chart issued by the IAP for new forms of commercial communication created with digital technology (attached to the Code of Marketing Communication Self-Regulation Italy of the IAP, available on the website: [Hyperlink] ) as an expression of best practices for compliance during the proper production of advertising.

In the area of case law, attention is drawn to Council of State decision no. 2217 of 12 May 2017, which overrode a distinction operating in Italy between OTC and SOP, thus making it possible to advertise SOP too (previously this was not allowed by the MOH) and bringing Italy into line with European law, which does not make this distinction and only prohibits advertising to the public of prescription medicines.

9.2        Are any significant developments in the field of pharmaceutical advertising expected in the next year?

The AIFA Guidelines on advertising of medicinal products to HCPs are still being finalised.  These guidelines will provide additional important operating indications.

9.3        Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

The last year has certainly seen a consolidation and indeed a strengthening of the trend in the pharmaceutical sector to adopt organisation and control models designed to prevent offences, especially offences committed in relations between companies, HCPs and HCOs.

Numerous measures have recently been adopted by the Competition and Market Authority (“AGCM”) to combat the numerous commercial practices of promotion and sale of “anti-COVID-19” products, which were deemed misleading and aggressive, because they aimed to exploit the impaired ability of consumers to evaluate them due to the ongoing health emergency.


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