Pharmaceutical Advertising 2019 Comparisons

Last Updated June 11, 2019

Law and Practice

Authors



Martini Manna Avvocati is made up of three partners, three of counsels, one junior associate and one trainee. It is based in Milan and Brescia, with a desk office in Vicenza, and is active on all matters relating to pharmaceutical advertising. The team assists Italian and foreign pharmaceutical companies with advertising, intellectual property, data protection and commercial matters.

The advertising of pharmaceutical products is highly regulated in Italy by:

  • the Italian Medicines Code (Legislative Decree No 219 of 24 April 2006, which implemented Directive 2001/83/EC);
  • the Italian Consumer Code (Legislative Decree No 206 of 6 September 2005); and
  • the Decree on Misleading and Comparative Advertising (Legislative Decree No 145 of 2 August 2007).

Furthermore, there are Ministry of Health (MoH) guidelines relating to the advertising of over-the-counter (OTC) medicinal products and non-prescription medicines (NPMs), including online advertising, as well as guidelines issued by the Italian Medicines Agency (AIFA) relating to sector events and the Code of Marketing Communication issued by the Italian Advertising Standards Authority (IAP).

In addition, sector associations also publish their own self-regulatory codes and guidelines, including, in particular, the Farmindustria’s Code of Conduct (dated March 2018) and the similar Assogenerici code (the latter association representing generics and biosimilars in Italy).

Self-regulatory codes are binding for all the relevant association’s members and to those who voluntarily decide to abide by it. They are therefore not legally binding for non-members. The legal value is that of a contract between the parties.

For instance, the Code of Marketing Communication is binding for advertisers, agencies, advertising and marketing consultants, media of any kind and for any company that has accepted the code directly or through membership of an association or an agreement to execute marketing communication as to ensure compliance with the decisions of the IAP’s Review Board and the IAP’s Jury, or to accept the provisions of the Code, the IAP’s additional self-regulations and the rulings of the IAP’s Jury and Review Board.

Advertising is defined as any informative, customer acquisition or persuasive action whose purpose is to promote the prescription, supply, sale or consumption of pharmaceutical products (Article 113 of the Medicines Code). The legal definition of advertising is broad and includes advertising of medicinal products to the public and to anyone that is authorised to prescribe medicinal products (ie physicians) and to supply them (ie pharmacists), including:

  • visits by medical sale representatives to anyone authorised to prescribe or to supply pharmaceutical products;
  • the supply of sample medicinal products;
  • granting, offering or promising an economic benefit or a benefit in kind whose value is not negligible; and
  • sponsoring promotional and scientific events attended by healthcare professionals (HCP), including paying travel and accommodation costs for said attendees.

The broad definition of advertising of medicinal products would include the dissemination of information relating to pharmaceutical products. In general, the key difference between advertising and information is the ultimate aim of a message. To be considered advertising that ultimate aim has to be for promotional purposes. In assessing that, all circumstances come into play, including the actions of who promoted a product and how.

A recent Court of Milan precedent ruled against a generic company for having published on their website the list of their products and prices, specifying the relevant active ingredients, reimbursement class, originator drug and excipients. The Court found that this constituted a breach of the laws on the advertising of medicinal products because the communication was characterised by the elements that make it an advertising as opposed to a merely informative message: ie, it focused on the company’s products only and did not provide consumers with objective and general information on the differences between originators and generic medicines; it was not directed at qualified operators but at the general public of consumers, and with visualisation methods that did not require any active research by consumers, so that even those who were not interested in the medicines in question could see them; and they were chosen within different substitution lists and manipulated.

Disease awareness campaigns are not considered advertising if their aim is solely to raise awareness and promote correct information regarding a disease and possible treatment, provided that it is in the interest of the general public and it does not refer to any specific medicine.

The law does not specifically contemplate press releases. Regardless, it is market practice to issue a press release only to announce the launch of a product (with the product name and active ingredient) and the press release is issued in close proximity to the launch date in order to reinforce it is for information, not promotional, purposes. The same principle applies to the length of time the press release is circulated.

Comparative advertising for pharmaceutical products to the general public is prohibited in Italy. The Medicines Code prohibits the use of any suggestion regarding the non-efficacy of a medicinal product or that a product is better or the same as another therapy or product.

Comparative advertising is allowed to HCP but, although the law does not prohibit the use of another company’s brand, it is common practice to make reference to the relevant active ingredient rather than a product name.

In principle, AIFA does not prohibit the comparison of medicines in advertising to HCP provided that there is no margin for misleading the audience. The indications have to be exactly the same; the summary of product characteristics (SmPC) must be properly referenced without any partial references or distortions of the content and where applicable, the sale price and reimbursement condition for the National Health System (NHS) shall be specified.

The Medicines Code prohibits all advertising of unauthorised medicinal products, meaning in the absence of a marketing authorisation (MA) granted under the domestic or European procedure.

Likewise, it is prohibited to promote or advertise off-label use. A company may only respond reactively to unsolicited requests and send related documentation (but it must not be promotional).

In general, HCP belonging to the scientific community are allowed to discuss molecules of unlicensed medicines on the basis of the constitutional principles safeguarding and promoting scientific research and freedom of expression of thought and speech.

The AIFA 2010 Guidelines on Conferences allow pharmaceutical companies sponsoring congresses to provide information on molecules still undergoing testing, provided that the information is limited to the action mechanism and reference is not made to the therapeutic indications that have not yet been authorised.

In addition, Article 120 of the Medicines Code allows the dissemination, during international congresses, of information relating to an MA granted in another country, in the original language, on condition that physicians from that country participate in the congress. The AIFA 2010 Guidelines on congresses in addition require that it is specified that the medicine (or the new indication) has not been approved in Italy yet, and that the relevant information material is submitted with the same AIFA in advance.

Information on unauthorised medicines, including clinical trial results, may not be sent to HCP because by law, information must be consistent with the authorised SmPC (Article 114.2 of Medicines Code).

Such information can instead be provided by companies in order to answer specific and unsolicited requests for information about a particular medicine, in line with Article 113.2 of the Medicines Code which expressly considers it not being an advertising activity.

The law does not specifically regulate this point. In line with Article 113.2 of the Medicines Code, it is generally considered acceptable to reply to unsolicited requests from institutions such as hospitals and healthcare organisations in general; however, the information must not be promotional. To mitigate the risk of information constituting the promotion of a medicinal product, it is highly advisable to use only documented and verifiable data.

Under Article 115 of the Medicines Code, advertising to the general public for prescription-only medicines or medicines that contain psychotropic or psychoactive substances is prohibited in Italy. However:

  • the MoH may authorise vaccination campaigns promoted by pharmaceutical companies (Article 115.2 of the Medicines Code); and
  • the following shall not constitute advertising (Article 113.2 of the Medicines Code):
    1. labelling and the accompanying package leaflets;
    2. trade catalogues and price lists, provided they include no product claims; and
    3. information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products.

In this respect, the principles set forth by the European Court of Justice (ECJ) in case C – 316/09 also apply. Based on these, dissemination of information that is accessible only to someone who seeks to obtain it, has no advertising purposes and consists solely in the faithful reproduction of the packaging of the medicinal product and of the package leaflet or the SmPC, as approved by the authorities, does not amount to advertising and is therefore allowed also for prescription medicines (this was confirmed for example by the Milan IP Court decision no. 8240/2017).

Under Article 114 of the Medicines Code, NPMs, including OTC medicines, can be advertised to the general public on condition that:

  • the medicine has been granted with an MA which is valid in Italy;
  • all parts of the advertising comply with the particulars listed in the SmPC;
  • the advertising encourages the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties; and
  • the advertising is not misleading.

The advertisement shall comply with applicable laws (see 1.1 Laws and Self-regulatory Codes), including the Consumer Code, which requires that advertising be truthful, clear, correct and not misleading. Advertising is not compliant with the Consumer Code, amongst others, when:

  • it contains information that does not correspond to the truth;
  • it is likely to mislead the average consumer or make them take a commercial decision that they would not otherwise have taken;
  • it is likely to create confusion with products, brands, company names and other distinguishing marks of a competitor;
  • it amounts to illicit comparative advertising;
  • it omits relevant information and is likely to induce the average consumer to take a decision of a commercial nature that they would not otherwise have taken;
  • it is likely to endanger the health and safety of consumers and in any case to induce consumers to behave without the normal prudence and vigilance; and
  • it does not indicate its commercial intent.

The possibility to advertise NPMs in general, and not OTC medicines only, was affirmed by the Italian Council of State (Italy’s highest court for administrative law matters) in its decision no. 2217/2017. Before that, the MoH was of the opinion that only OTC medicines could be advertised.

Under Article 116 of the Medicines Code, the advertisement shall:

  • clearly show that the message is an advertisement and that the product is a medicinal product; and
  • include the following minimum information: the name of the medicinal product; the common name of the relevant active substance if the medicinal product contains only one active substance; the information necessary for correct use of the medicinal product; an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging, as the case may be (in written advertising, the invitation must be easily legible from the normal point of observation; in advertising in the daily and periodical press the font size shall not be smaller than 9).

Under Article 118 of the Medicines Code, any advertisement authorised by the MoH shall also include the date in which it was authorised or, in case of tacit authorisation, the date in which the relevant authorisation was requested (see 6.1 Requirements for Prior Notification/Authorisation). This is not required for radio advertisements.

Based on the Guidelines for NPMs Advertising published by the MoH on 7 May 2018, advertisements of NPMs that are not OTC medicines shall also include the following wording (in Italian): “È un medicinale senza obbligo di prescrizione (SOP) che può essere consegnato solo dal farmacista. Ascolta il tuo Farmacista” (“This is a non-prescription medicine that can only be provided by the pharmacist. Listen to your pharmacist”). In audio messages the sentence must be read at the same speed as the remaining advertising and information text. As an alternative to the aforementioned sentence, the following reduced version can be read: “È un medicinale che può essere consegnato solo dal farmacista. Ascoltalo” (“This is a medicine that can only be given by pharmacists. Listen to them”).

Under Article 117 of the Medicines Code, the advertisement shall not contain any material that:

  • gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail;
  • suggests that the effects of taking the medicine are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicinal product;
  • suggests that the health of the subject can be enhanced by taking the medicine;
  • suggests that the health of the subject could be affected by not taking the medicine (this prohibition shall not apply to the vaccination campaigns referred to in Article 115.2 of the Medicines Code);
  • is directed exclusively or principally at children;
  • includes a recommendation by scientists, HCP or persons who are widely known amongst the public;
  • equates the medicinal product to a foodstuff, cosmetic or other consumer product;
  • suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural;
  • could lead to erroneous self-diagnosis;
  • refers, in improper, impressive or misleading terms, to claims of recovery; and
  • uses, in improper, impressive or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof.

The dissemination of messages whose advertising purpose is concealed by the redundancy of other information is not permitted.

No provision requires or prohibits the mentioning of the price in advertisements.

Under Article 4.6 of Farmindustria’s Code of Conduct, any form of economic support, whether direct or indirect, by a pharmaceutical company towards a patient association shall comply with the following criteria:

  • the parties shall firstly enter into an agreement regulating the amount of and reasons for the financing;
  • the public use by the company of the logo or material owned by a patient association shall be authorised in advance by the association, upon proper definition of the purposes for, and the manner of, using them;
  • any form of sponsorship by the pharmaceutical companies vis à vis the patient associations shall be transparent and have no promotional purposes;
  • no company can request to be the sole financier of a patient association; and
  • in all cases in which journeys or other forms of hospitality are provided, the provisions regarding conferences and congresses shall apply (see 9.3 Sponsorship of Scientific Meetings).

Companies shall publish on their own websites, at least during the entire first three months of each year, a list of the patient associations to which they provided financial support in the previous year, including the amount paid to each association.

Contracts between companies and patient associations under which the latter provide services to companies are allowed only if such services are provided for the purpose of supporting healthcare or research. Representatives of patient associations may also be engaged as experts and advisors to participate in advisory board meetings or as speakers. In all of these cases, a written agreement shall be firstly entered into by the parties, specifying the nature of the services to be provided and the criteria for the payment of those services and evidencing a legitimate need for the services. The compensation for the services shall be reasonable and not exceed the fair market value of the services provided.

Companies shall make publicly available each year a list of patient associations that they have engaged to provide services.

Under Article 117.1.f of the Medicines Code, the advertisement shall not include any recommendation by HCP. The latter are in addition prohibited from advertising medicines under their code of ethics.

Scientific papers by HCP can be included in advertisements on condition that they are faithfully reproduced and the relevant precise sources are indicated. Quotations that, isolated from the context from which they are drawn, may be partial or distortive, are not allowed (Article 120.4 of the Medicines Code). In addition, in case the advertisement is included in a medium that also includes informative contents (eg scientific papers), the advertisement shall be clearly distinct from the informative content (Article 2.16 of Farmindustria’s Code of Conduct).

Under Article 119 of the Medicines Code, any advertising of a medicinal product to HCP, ie, to persons qualified to prescribe the product (physicians) or supply it (pharmacists), shall include:

  • the SmPC;
  • the product’s supply classification;
  • its selling price; and
  • the conditions for reimbursement by the NHS.

Notwithstanding the above, advertising directed at HCP might include only the name of the medicinal product, with the indication of the common name of the relevant active substance(s). The name of the MA holder and that of the possible different company commercialising the product might also be included.

Specific supplementary provisions apply to advertising to physicians and to advertising to pharmacists.

As regards the former, under Article 120 of the Medicines Code:

  • the information contained in the advertising material shall be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to be properly informed on the therapeutic effect and the characteristics of the medicinal product;
  • for homeopathic or anthroposophical medicines without therapeutic indications, the physician may be given the necessary documentation to remember the dosage and fields of application through publications drawn from one of the European pharmacopoeias or from the homeopathic or anthroposophical literature. In the latter case, it must be clearly indicated that there is currently no scientifically proven evidence of the effectiveness of the homeopathic or anthroposophical medicinal product;
  • articles, tables and other illustrative material taken from medical journals or scientific works shall be faithfully reproduced, and the relevant sources shall be indicated. Quotations that, isolated from the context from which they are drawn, which maybe partial or distortive, are not allowed;
  • any advertising material shall also include the date in which it was notified to AIFA (see 6.1); and
  • advertising can also be carried out through visits to the laboratories and research centres of pharmaceutical companies, provided they are oriented to the development of knowledge in the fields of chemistry, pharmaceutical technology, pharmacology, toxicology, biotechnology and/or biochemistry.

As regards advertising to pharmacists, under Article 121 of the Medicines Code:

  • advertising of prescription medicines shall be limited to the information contained in the SmPC, unless it is addressed to hospital pharmacists;
  • for NPMs, advertising may include other documentation useful to enable the pharmacist to provide the client with advice on the use of the product, if necessary; and
  • the material that does not consist in a simple reproduction of the SmPC is subject to the provisions of the above-mentioned Article 120.

Draft guidelines on advertising to HCP were provided by AIFA to the relevant stakeholders in early 2018, but they have not been finalised so far.

Advertising to HCP can refer to clinical studies that are not included in the SmPC on condition that they comply with the requirements posed by the provisions on advertising mentioned above and are consistent with the SmPC and the documents submitted in order to apply for the MA or for its updates. This was expressly confirmed by the Lazio Administrative Court in its decision no. 1416/2014 relating to medical devices.

Companies can provide reprints of journal articles to HCP on condition that articles, tables and other illustrative matter taken from medical journals or scientific works is faithfully reproduced and the relevant precise sources are indicated. Quotations that, when isolated from the context from which they are drawn, may be partial  or distortive, are not allowed. See also 9.1 Gifts to Healthcare Professionals.

Advertisements directed to the general public shall be previously authorised by the MoH under Article 118 of the Medicines Code. Failure to require amendments to the advertising or deny the authorisation within 45 days shall constitute tacit authorisation. The authorisation will generally expire after 24 months. In case the authorisation is denied, the pharmaceutical company can oppose the denial within ten days. In case of dismissal of the opposition, an appeal against the denial can be submitted before the competent Administrative Court.

Prior authorisation by the MoH is not required in case of:

  • advertisements in the daily or periodical press and on web pages, which are limited to reproducing the indications, contraindications, appropriate precautions for use and interactions, special warnings, undesirable effects described in the package leaflet, with the possible addition of a photograph or a graphic representation of the outer packaging or the primary packaging of the medicinal product; and
  • photographs or graphic representations of the external packaging or primary packaging of the medicines published on websites authorised to sell NPMs or placed on the price tags showing the price of sale to the public and any applied discounts exposed by pharmacists.

Advertising material directed to HCP shall be previously notified to AIFA under Article 120 of the Medicines Code. The advertisement can be disseminated if AIFA does not prohibit it within ten days from such notice. Gadgets (eg USB pen drives) must also be submitted in advance.

No standard operating procedures are legally required, although they are advisable, also in light of Legislative Decree No 231/2001 regulating corporate administrative liability for crimes committed or attempted in the company’s interest (eg bribery, which might arise in connection with advertising to HCP). These should regulate the process aimed at the assessment and approval of the advertising materials, as well as the roles of the persons involved in these activities.

Under Article 126 of the Medicines Code, the MA holder – or the company commercialising the product in Italy, where the former is domiciled abroad – shall establish a scientific service in charge of the information about the medicinal products that they place on the market. The director of this service shall have a degree in medicine, pharmacy, chemistry or pharmaceutical technology. The scientific service shall be independent of the company’s marketing department.

The scientific service shall:

  • ensure that advertising of medicinal products complies with the Medicines Code;
  • verify that medical sales representatives employed by the company have been adequately trained and fulfil the obligations imposed by the Medicines Code;
  • provide AIFA with the information and assistance they require to carry out their responsibilities; and
  • ensure that the decisions taken by the MoH and AIFA under the Medicines Code are immediately and fully complied with.

In addition, pursuant to Article 1.13 of Farmindustria’s Code of Conduct, by February 28st of each year member companies shall acquire and submit to Farmindustria’s chairman a certificate attesting the compliance with the procedures governing marketing and scientific information activities in the preceding year. The certificate shall be issued by certification bodies approved by Accredia (the Italian Accreditation Agency). Companies belonging to the National Committee of the Small Enterprises may use a simplified procedure based on the instructions of the relevant certification bodies.

In addition to the above general provisions on pharmaceutical advertising, the MoH published specific Guidelines on Advertising OTC medicines on New Media, which were last updated on 6 February 2017. These Guidelines – which should now apply also to NPMs, based on the Council of State decision of 2017 mentioned under 4.1 – provide as follows:

  • on 'institutional websites', ie, company’s websites that promote the company’s image or logo without any intent to promote its products, the list of the company’s OTC medicines can be published without the MoH’s prior authorisation. The relevant medicines’ names can link to the sole package leaflet and, eventually, to an image of the packaging. No message relating to the health properties of the product can be included there;
  • on any company’s websites other than products’ websites, advertisements can be published, upon the MoH’s prior authorisation, on condition that:
    1. the advertising message is clearly identified; and
    2. it is specified that the MoH’s authorisation only refers to the advertising message;
  • in the case of products’ websites, the company must provide to the MoH the site map indicating the relevant advertising parts for which authorisation is sought. The company must clearly identify the advertising messages and specify that the authorisation only refers to the advertising messages;
  • links to other contents – either authorised or not requiring any authorisation – are permitted on condition that the company provides the following information (in Italian): “state abbandonando il sito Azienda XXXXXX… contente materiale promozionale autorizzato ai sensi della vigente normativa in materia di pubblicità sanitaria” (“You are leaving the Company XXXXXX website ... containing promotional material authorised pursuant to the current legislation on health advertising”) (this is not required when the sole package leaflet and image of the packaging are linked);
  • links to other contents that would require authorisation but have not been authorised are not permitted;
  • advertising can also be published on third parties’ websites upon the MoH’s prior authorisation; and
  • the dissemination of authorised advertising messages via email is permitted on condition that, when submitting the relevant application for authorisation with the MoH, the company declares that the messages will be disseminated only with the consumer’s consent, and that the latter can freely revoke his or her own consent and request cancellation of his or her data.

In addition to the above, Article 4.5 of Farmindustria’s Code of Conduct requires that the sponsor, the source of all information set forth in the website, the designated recipients of such information and the purposes of the website are clearly identified.

In addition to the above general provisions on pharmaceutical advertising, based on the MoH’s Guidelines on Advertising OTC medicines on New Media, as updated on 6 February 2017 and on 25 July 2017, and on the MoH’s Supplementary Guidelines on Advertising OTC medicines on Facebook of 25 July 2018 (both of which Guidelines should now apply also to NPMs, as mentioned in 7.1 Regulation of Advertising of Medicinal Products on the Internet), advertising on social media is permitted only under the conditions set forth below.

Facebook

  • authorised advertising messages can be published on the company’s Facebook wall – including its app/mobile version – only on condition that comments and reactions (eg like, emoticons) are disabled;
  • all messages must contain the following disclaimer (in Italian): “Il Ministero della Salute autorizza esclusivamente il contenuto pubblicitario. Eventuali commenti sono di esclusiva responsabilità dell’utente, l’azienda si dissocia dai commenti degli utenti” (“the Ministry of Health only authorises the content of the advertising message. Any comments are the sole responsibility of the users. The company dissociates itself from the users’ comments”);
  • the advertisement can include a link to the product’s website, if this has been authorised by the MoH;
  • ads including one or more image(s) and a short text can also be published on the right-hand column of the company’s Facebook wall. Since, by clicking on the advertisement, the user will be directed to an external website, the company must indicate the destination website(s) and if they contain authorised advertisements. This kind of advertisements shall only be accessible through a browser, and not via app;
  • sponsored messages can be published on the Messenger app provided that the interactivity functionalities (comment, share, like reactions, emoticons) are disabled;
  • specific rules are provided in relation to the way in which the single kinds of advertisement (ie text, video, canvas, etc) shall be produced and submitted to the MoH for authorisation; and
  • posts relating to the company’s products, even when having a purely scientific content, shall obtain the MoH’s prior authorisation, unless they relate to products, which can be advertised in the absence of the MoH’s authorisation.

YouTube

  • authorised advertisements can be disseminated on YouTube only on condition that the following functionalities are disabled: 'allow comments', 'users can see the votes of this video' and 'allow embedding';
  • the thumbnail must contain the graphic representation of the product and/or the representation of the official identification stamp for non-prescription medicines; and
  • pre-roll authorised videos transmitted before the video content searched by the user are permitted.

Instagram

  • images or short video advertisements can be published in the 'stories' section where users do not have the ability to comment, express reactions or share them; and
  • the 'discover more' link accompanying a video can lead directly to the product’s website authorised by the MoH.

Based on the MoH’s Guidelines on Advertising OTC medicines on the New Media as updated on 6 February 2017, the information addressed to HCP must be accessible only to them, even when it is disseminated via internet. The same is stated by Article 4.5 of Farmindustria’s Code of Conduct.

Therefore, companies must provide for encrypted areas of their websites that can only be accessed with a password, to be provided to physicians, pharmacists and other HCP once they have provided the data required for their identification. It follows that, in case of websites with free access to the general public, links to information areas for HCP only must not permit the general public to reach that areas.

The Italian Criminal Code provisions dealing with the crime of bribery set up penalties of up to six years’ imprisonment for the official, or person in charge of a public duty, who receives money or other benefits to influence the exercise of his or her duties, and for the briber; the soliciting of a bribe by the official or person in charge of a public duty is punished even more harshly.  These  provisions may apply, and have been applied, to improper interactions between pharmaceutical companies and healthcare providers when the latter work within the public health service and take the bribe in order to alter their actions in connection with such role.

These rules formally apply to benefits provided to individuals. Nevertheless, if the benefit provided to an organisation ends up influencing the actions of an individual, they will apply. Conversely, a bribe taken in the ultimate interest of an organisation may entail the corporate administrative liability of the latter.

Articles 170 to 172 of Decree no. 1265/34, so-called Unified Act of Health Laws (herein “Unified Act”) deal with the crime of pharmaceutical bribery, which, unlike general bribery, on the one hand, does not require the bribed physician to be in charge of a public duty; on the other, it requires the specific intent to facilitate the circulation of certain pharmaceutical products. In particular, Article 172 of the Unified Act prohibits the offering or promise of money or other benefits to HCP with the purpose of facilitating, through prescription or any other means, the circulation of any medicine. Penalties of up to one year’s detention and pecuniary fines are provided for both the briber and the bribed person; the pharmaceutical company involved can be shut down for a three-month period or, in case of repeat offenders, indefinitely. This prohibition applies to benefits provided to individuals, but will also apply to benefits provided to individuals through organisations.

Article 123 of the Medicines Code prohibits the granting, offering or promising of any prizes, pecuniary advantages or rewards in kind to physicians or pharmacists, unless they are of 'negligible value' and are related to the HCP activity. These provisions are echoed by Farmindustria’s Code of Conduct, which adds the prohibition to compensate HCP for time taken in order to participate in congressional events (Article 2.13).

Information material not related to the specific product may be given for free. A 2008 MoH Decree specifies that such information material may consist of books of remarkable scientific value, subscriptions to reputed medical magazines, subscription to newsletters, CD, DVDs or password-protected access to websites. It may be given free of charge exclusively to public health service institutions and professionals. The Farmindustria’s Code of Conduct is stricter: under its Article 2.14, items with a value of EUR25 or more may be given free of charge only to public healthcare organisations.

Under Article 125 of the Medicines Code, free samples of a medicinal product for human use can be provided exclusively to physicians who are authorised to prescribe it and can only be supplied and delivered by a pharmaceutical sales representative.

Samples can only be supplied in response to a written request, stamped, signed and dated by the consignee.

Pharmaceutical representatives can provide each HCP with no more than two samples per visit for each dosage unit or dosage form, up to a maximum of eight samples per year. If the product has been marketed for over 18 months, the maximum number allowed is four per visit and ten per year.

Article 2.17 of Farmindustria’s Code of Conduct reflects the above provisions.

Each sample must be visually identical to the smallest package placed on the market, although its content may be smaller, in units or volume, than the product as sold, provided that it is therapeutically suitable and that any differences in content and packages from the product as licensed are clearly reported on the sample’s label. Samples shall be accompanied by an SmPC. The exterior and interior packaging shall bear, in indelible ink, the wording “free sample – sale is prohibited” or wording to the same effect.

Pharmaceutical companies shall provide their representatives with suitable stowage means and with a number of free samples proportionate to the number of visits to physicians planned during a maximum one-month period.

Pharmaceutical companies are required to collect from their pharmaceutical representatives all requests for samples and to keep for 18 months evidence that the samples were supplied in in compliance with the law.

The supply of samples containing psychotropic or narcotic substances is prohibited.

The MoH, upon the AIFA’s proposal, may at its discretion set further limitations to the provision of free samples by decree.

Under Article 124 of the Medicines Code, pharmaceutical companies may sponsor scientific meetings or congresses on topics relevant to their products, provided that they give a 60-day prior notice to AIFA disclosing their details and details of the event, including the audience to whom the initiative is addressed, the relation between the topics discussed and the products marketed by the organiser, the scientific credentials of the speakers and a provisional budget. A company will then be allowed to sponsor or organise the event if AIFA issues its favourable opinion within 45 days after it receives the notice of sponsorship described above.

The sponsored events must have a strictly technical nature and be oriented towards the development of knowledge in chemistry, pharmaceutical science, biochemistry, physiology, pathology and clinical studies. Pharmaceutical companies may not take part in workers unions’ conventions or meetings.

Travel or hospitality costs must be limited to HCP and not be extended to any persons who may accompany them; hospitality may not exclusively exceed the window starting 12 hours before the event and ending 12 hours after the event.

The Farmindustria’s Code of Conduct is much more detailed on restrictions. Hospitality offered by pharmaceutical companies must be limited to travel, accommodation and registration expenses and daily meals. The value of meals should not exceed EUR60 EUR per meal when the event takes place in Italy or the applicable limit established by the local Code of Conduct, if any, in case of events taking place abroad. Economy-class flights (save in case of long-distance flights and limited to speakers and moderators), no executive-class train tickets and no more than four-star hotels shall be offered to Italian HCP invited to events in Italy or abroad.

Events taking place abroad or for which the pharmaceutical company involved expends more than EUR25,822.85 must be expressly authorised by AIFA, which will issue its decision within 45 days from the pharmaceutical company’s notice. However, under Article 3.4 of Farmindustria’s Code of Conduct, Italian pharmaceutical companies shall not organise events abroad where most of the attendees are Italian physicians.

No samples or information can be distributed or displayed within the meeting or congress, other than the SmPC, the event papers and the scientific works, provided they have been filed with AIFA. At international congresses it is allowed to divulge promotional material consistent with the relevant MA in their original language, provided that physicians from the countries where the product is authorised are in attendance.

The limitations provided for under Article 124 do not apply to pharmaceutical companies financing, also indirectly, congresses or meetings on topics irrelevant to the products they manufacture or market, provided that they refrain from promoting their products with HCP in the context of such events.

The sponsoring of non-scientific side events appears to run contrary to the rationale of Article 124 of the Decree (see 9.3 Sponsorship of Scientific Meetings). This is reinforced by Article 3.14 of the Farmindustria’s Code of Conduct, which expressly prohibits the organising or sponsoring of any social, cultural or touristic events or gala dinners within the context of congresses.

Article 4.2 of Farmindustria’s Code of Conduct allows the setting up of grants provided for specific projects having measurable goals and within the framework of a detailed general agreement with the relevant institution. All grants provided within the previous calendar year shall be made public on the pharmaceutical companies’ websites by June 30th of every year. An identical grant may not be provided to the same unit or department of the concerned institution before three years have passed.

Article 2.15 of allows the donation of strictly technical equipment only if made out to universities, hospitals and nursing homes, provided that said institutions’ internal policies and regulations on such donations are complied with.

Monetary donations to HCP would fall within the prohibition to provide gifts of any kind (see 9.1 Gifts to Healthcare Professionals). Monetary donations to organisations are not expressly prohibited but are a sensitive topic and should be managed with care in order to avoid any suspicion of bribery, particularly by complying with the relevant policies and regulations of the receiving organisation.

A rebate or discount offered in the context of information or presentation activities to HCP would be equivalent to a 'pecuniary advantage' prohibited under the Decree (see 9.1 Gifts to Healthcare Professionals). As regards supplies of pharmaceutical products to public entities, this ordinarily takes place in accordance with strictly regulated public tender procedures, which encourage rebates on the ordinary price to public (often imposing minimum rebates).

Under Article 4.1 of Farmindustria’s Code of Conduct, pharmaceutical companies may retain HCP as speakers or moderators at scientific meetings or as consultants for observation studies or for training and education, subject to the execution of a written agreement providing for the professional’s obligation to disclose his or her relationship with the company in all instances where he or she debates the subject-matter of the agreement and provided that the services are paid according to their market value.

AIFA must be notified in advance and approve the sponsoring of scientific meetings and congresses (see 9.3 Sponsorship of Scientific Meetings).

Transparency duties in Italy are only of a self-regulatory nature and bind only Farmindustria’s associates. Particularly, under Article 5 of Farmindustria’s Code of Conduct, every year pharmaceutical companies must disclose on their company’s website information about the previous year’s direct or indirect transfers of value to HCPs or institutions, using a standard template attached to the same Code. Each company shall endeavour to obtain prior consent to disclosure from each identifiable HCP concerned.

The information contained in the template includes donations and grants to healthcare organisations, sponsoring of events, fees for service and consultancy and transfers of value relating to R&D. Except for the last factor, data shall be disclosed whenever possible in individual, rather than aggregate, form. The data must remain publicly available for at least three years from the date of publication.

Transfers of value relating to OTC products, to information material, to beverages and meals and to samples shall not be reported.

Even if a company does not have a subsidiary or an affiliate in the country where the recipient of the transfer of value is domiciled, it shall still disclose transfers of values in a manner consistent with the national code of such country. Therefore, transparency requirements apply to Italian companies with foreign recipients and of course to foreign companies with an Italian recipient (as long as they are Farmindustria’s members). There are no provisions exempting companies that do not yet have products on the market.

The authorities responsible for enforcing advertising and inducement rules are:

  • the MoH for breaches of the Medicines Code and their own Guidelines relating to advertising to the public;
  • the AIFA for breaches of the Medicines Code and their own Guidelines relating to advertising to HCP;
  • sector associations (eg, Farmindustria, Assogenerici) and IAP for breach of their self-regulations;
  • the Italian Competition Authority for breach of the advertising rules included in the Consumer Code and in the decree on Misleading and Comparative Advertising; and
  • the national civil and criminal courts for breaches of the advertising or inducement provisions amounting to civil or criminal illicit acts.

Pharmaceutical companies may start legal proceedings before the civil courts in those cases where disseminating the advertising message breaching the rules on advertising also amounts to unfair competition, in order to stop the unlawful conduct and also to claim damages.

Companies may also inform the authorities mentioned in 11.1 Enforcement Bodies for them to take the appropriate measures and can also file a criminal complaint in case the competitors’ behaviour constitutes a criminal offence.

Anyone found to be in breach of the rules governing advertising to the public can be fined from EUR2,600–15,600 (Article 148.15 Medicines Code). Anyone that in the press, radio-television programmes  or messages that do not have advertising aim but are disseminated to the public, shows images of a medicinal product or mentions the name of the same product in a context that could encourage its consumption,  can be fined from EUR10,000–60,000 (Article 148.14 Medicines Code).

In case of breach of the provision according to which the exterior and interior packaging shall bear, in indelible ink, the wording “free sample – sale is prohibited”, fine range from EUR5,000-30,000(Article 148.16 Medicines Code).

Anyone breaching the provision posed by Article 126 of the Medicines Code in respect of the company’s scientific service can be fined from EUR50.000-300.000 (Article 148.17 Medicines Code).

In the event of a breach of rules governing advertising to HCP, fines range from EUR2,600–15,600. In addition, medicinal products that are reimbursed by the NHS could have reimbursement suspended from ten days to two years depending on the seriousness of the breach. Prior to a suspension, an MA holder has 15 days to respond to a complaint to AIFA (Articles 148.18 and 148.19 Medicines Code).

In terms of breaching advertising rules, the MoH can order for unlawful advertising directed to the general public to be immediately stopped and for the breaching company to publish at its own cost a notice correcting and amending the advertising message, on the terms and conditions set out by the MoH (Article 118.13 Medicines Code).

Likewise, at any time, the AIFA can step in and prohibit or suspend the dissemination of an advertising message or other information or documents directed to HCP and prohibit a scientific or promotional event from going ahead.

Finally, in the event of a breach of the Farmindustria Code of Conduct, the same Farmindustria may issue a warning requesting that the breaching action be stopped immediately or temporarily suspend the company from Farmindustria.

For penalties and measures regarding rules on inducements see 8.2 Legislative or Self-Regulatory Provisions.

Court measures and self-regulatory measures are independent of each other. Decisions taken by a self-regulatory body (such as Farmindustria, Assogenerici and IAP) are not binding for the authorities or Courts although they would come into play in their assessment of whether a company has acted correctly.

Decisions taken by the authorities (ie ICA, MoH and AIFA) are appealed before the Regional Administrative Court (TAR) – decisions of TAR can be further appealed to the Supreme Administrative Court (Council of State).

There has been a strong trend in the past two years for companies to implement compliance policies aimed at identifying potential offences and achieving their prevention; in particular, in relation to how companies interact with HCP and healthcare organisations in general and vice versa.

One major change was the MoH guidelines concerning the use of digital and social media in advertising NPMs and medical devices. It was seen as an important step in closing up gaps in the law, especially in terms of new media and the fresh regulations required as a result.

Martini Manna Avvocati

Via Meravigli 16
20123 Milan

+39 02 45074727

+39 02 45070327

info@martinimanna.com www.martinimanna.com
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Law and Practice

Authors



Martini Manna Avvocati is made up of three partners, three of counsels, one junior associate and one trainee. It is based in Milan and Brescia, with a desk office in Vicenza, and is active on all matters relating to pharmaceutical advertising. The team assists Italian and foreign pharmaceutical companies with advertising, intellectual property, data protection and commercial matters.

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