Source: https://iclg.com/practice-areas/pharmaceutical-advertising-laws-and-regulations/italy
Timestamp: 2019-04-23 18:28:37+00:00

Document:
The advertising of medicinal products is governed by art. 113 et seq. of legislative decree no. 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), Guidelines issued by the Italian Medicine Agency (AIFA) on conferences, congresses, and filing of advertising material. Specific AIFA Guidelines on the advertising of medicinal products to HCPs are currently being approved.
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 (IAP Code), which set out specific regulations on the public advertising of medicinal products (art. 25).
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 non-prescription products, 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.
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.
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).
Public advertising is allowed for OTC and SOP, subject to prior approval by the MOH, after consultation with the relevant Commission of Experts. 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 in the absence of objections. Gadgets must also be filed (e.g., pens, stickers, USB pen drives).
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).
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 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 have 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. The Court of Milan recently 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.
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.
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; 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.
The Code on Medicines (art. 114.1) prohibits “any advertising” of medicinal products in the absence of a 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). 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 SPC 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 as yet 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 sub 2.4).
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.
The laws governing pharmaceuticals do not regulate press releases. The pharmaceutical company may not issue information to the public through 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.
Information on unauthorised medicines may not be sent to HCPs, since the law requires that information comply with the authorised SPC (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.
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 MOH Decree 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 recent MOH Decree 7 September 2017 regulates the use of medicines that have not yet been authorised (subject to testing) or that already have 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.
There are no regulations 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.
There are no guidelines on this topic. HCPs may be involved as expert consultants, both 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, inducement to prescribe, and checks should be carried out to ensure there are no incompatibilities and/or conflicts of interests 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, 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 Transfer Of Values (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, where the boundary between scientific and promotional value may be extremely blurred.
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, the sale price and 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).
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 referred 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.
The physician’s 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 only in the full-text version and with precise indication of the source (art. 120.4 Code on Medicines).
There are no specific guidelines on this point. The law and self-regulation require that all information 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 (Legislative Decree 145/2007, art. 4) provides, inter alia: that comparisons must be between products that satisfy the same needs; based on elements that are objective; complete; verifiable; non-misleading; and do not discredit other companies’ products.
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.
The distribution to HCPs of scientific papers and/or proceedings of congresses on medicines manufactured or marketed by the 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, the official proceedings only 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 has not been published and lacks a Digital Object Identifier (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.
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.
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.
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 euro (per year per physician), while the regional guidelines set the limit at 20 euro. 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, 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 euro, the item may be given free only to HCOs (not to individual physicians) and must be purchased from the company at central level.
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 compatibly with the administrative procedures of the entity, 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, tablets or similar, intended for personal use by physicians outside the HCO, or to be given to patients.
The allowed medical or educational materials are described in MOH Decree 14 April 2008 (cf. question 4.2). If the material satisfies the requirements of the decree, it could hypothetically also contain elements (documentable and verifiable) that lead HCPs autonomously to 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).
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 MEA – Managed Entry Agreements (cf. question 4.7).
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.
We refer back to question 4.5 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, 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.
“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 reimbursability 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 negotiate clearly 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).
during the event, the active ingredient of medicinal products may be indicated, but the commercial name may not be indicated, even if it is not related to the topic under discussion.
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 conflict of interests, 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.
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.
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).
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: 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: 4-star hotel; 60 euros 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.
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 who 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 4.8).
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 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.
Direct financial agreements between the company and trial investigators are not allowed: the written agreement must be signed with the HCPs 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 and set 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) 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.
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, that the contribution of the consultant adds value and is pertinent to his/her experience and expertise; that the consideration is compatible with fair market value; and that the service is real and verifiable.
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 the content prohibited under art. 117 of the Code on Medicines (cf. art. 90 EU Dir/2001/83).
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).
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.
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).
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 as 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).
The relationship with patient organisations is governed only by self-regulatory rules. Under art. 4.6 of the Farmindustria Code, direct and indirect support as well as collaboration (including consultancy) 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; 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 acting as experts/consultants on advisory boards) are permitted only on projects in the interests of public health or research. In this case too, a written agreement is required detailing the services and remuneration, which must be transparent and in line with fair market value. No company may ask to be the exclusive sponsor of a patient organisation.
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, Patient Support Programmes 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 free 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.
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.
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; it is not yet operational.
Also, in accordance with art. 5 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.
There is no such requirement in law, self-regulatory rules apply (cf. question 7.3).
data on OTC medicines, for promotional material of negligible value, meals, beverages and samples is not published.
aggregate TOVs as a percentage of total TOVs.
This topic is regulated by the MOH guidelines of 17 February 2010, supplemented on 6 February and 25 July 2017, 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, as 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 which 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.
The area 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.
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.
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.
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 and OTC medicinal products, 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 medicine 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 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.
The use of social media by pharmaceutical companies to advertise non-prescription and OTC medicines is governed by the recent MOH guidelines of 6 February – 25 July 2017, which adopt a more open approach than previously allowed even though there were no express prohibitions.
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 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 which 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 a copy-paste of 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.
The main development is the MOH guidelines on use of digital and social media in advertising non-prescription medicines and the corresponding guidelines of 20 December 2017 on advertising of medical devices.
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 medicines 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 prohibits advertising to the public only of prescription medicines.
The AIFA guidelines on advertising of medicinal products to HCPs are currently being finalised and will be approved by the end of summer 2018. These guidelines will provide additional important operating indications.
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 and HCPs and HCOs.

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