Pharmaceutical Advertising 2021 Comparisons

Last Updated March 04, 2021

Law and Practice

Authors



Avvocati Associati Franzosi Dal Negro Setti has a life sciences team that offers assistance and consulting services in all aspects concerning research, manufacturing, commercialisation and use of medical products and veterinary products, medical devices, special foods and cosmetics. The team provide advice in areas including: best practice and and compliance; contract drafting; joint ventures, company transfers and share transfers as well as extraordinary transactions in the relevant fields of industry; advertising, competition and parallel imports issues; relationships with regulatory authorities; and clinical trials. Representation in litigation is carried out before all competent authorities: ordinary civil courts, specialised IP divisions, administrative courts and European courts. Administrative litigation is of significant importance for the protection of interests of pharmaceutical companies. The team assists clients in out-of-court cases concerning regulatory aspects of pharmaceutical Marketing Authorization with reference to issuance, maintaining, review and protection. Furthermore, it offers assistance and consulting services on price negotiation systems and classification of drugs for reimbursement by the Italian National Health Service.

In Italy, advertising on medicines is regulated by:

  • the Legislative Decree No 219/2006 (implementing Directive 2001/83/EC (the “Medicines Code”);
  • the Guidelines of Regional Regulation of Scientific Information about medicines adopted by the Conference of Presidents of the Regions and Autonomous Provinces pursuant to Article 48, of Law No 326/2003;
  • the rules on the “scientific information” about medicines adopted by Regions, Provinces and hospitals;
  • the Ministry of Health’s Guidelines for the use of the new means of diffusion in the healthcare advertising of self-medication medicines (6 February 2017), Guidelines on advertising of OTC products via social networks (25 July 2017), and Guidelines on the advertising of self-medication medicines on Facebook (25 July 2018); and
  • the Italian Medicines Agency (AIFA)’s notice of 11 February 2010 “Information regarding conventions, conferences and meetings according to Article 124 of Legislative Decree No 219/2006”.

Additional rules on medicines advertising can be found in the self-regulatory codes, such as the Code of Conduct adopted by the industry association (Farmindustria) and the Code of Conduct and Guidelines on Scientific Information about medicines adopted by the association of manufacturers of generics and biosimilars (Egualia, formerly Assogenerici). 

Pharmaceutical companies must also comply with the general legislation on advertising, such as the Legislative Decree No 145/2007, implementing the Directive 2005/29/EC – “Unfair Commercial Practices Directive”; and the articles of the Legislative Decree No 206/2005 (the “Consumers Code”) that implement the Directive 2005/29/EC – “Unfair Commercial Practices Directive”. Moreover, they must refrain from any form of promotion of their medicines that can be considered as unfair competition pursuant to Article 2598 of Civil Code.

Self-regulatory codes apply to pharmaceutical companies that are members of the industry associations that have adopted these codes and have the same legal value as a contract.

According to the Farmindustria Code of Conduct, pharmaceutical companies that carry out their activity in Italy and belong to multinational groups are responsible for the behaviour of any parent companies or affiliates that are not in compliance with the provisions on medicines advertising to Italian healthcare professionals.

Medicines advertising is defined as any information, customer search or exhortation action intended to promote the prescription, supply, sale or consumption of medicines (Article 113 of Legislative Decree No 219/2006). The legal definition of medicines advertising is broadly interpreted by both the health authorities and the Courts.

The law mentions the following types of medicines advertising:

  • promotion of medicines to the public;
  • promotion of medicines to persons authorised to prescribe or dispense them, including the visit of sales representatives to persons authorised to prescribe medicines;
  • the supply of medicines samples;
  • inducement to prescribe or supply medicines by granting, offering or promising pecuniary or in-kind benefits, with the exception of things of  insignificant value;
  • sponsorship of promotional meetings attended by persons authorised to prescribe or supply medicines; and
  • patronage of scientific conferences medicines, in particular the payment of travel and hospitality expenses (Article 113 of Legislative Decree No 219/2006).

Conversely, the following activities are explicitly excluded from the definition of medicines advertising:

  • labelling and package leaflet;
  • the correspondence necessary to respond to a specific and unsolicited request for information on a specific medicine (the “scientific exchange”);
  • genuine information and informative documents concerning changes in packaging, warnings on undesirable effects in the context of pharmacovigilance, commercial catalogues and price lists, provided that there is no information about the medicine; and
  • information relating to human health or human diseases, provided that it does not refer, even indirectly, to a specific medicine (Article 113 of Legislative Decree No 219/2006).

The difference between information and advertising is that the former aims at making people aware of something, while the latter encourages people to buy something. According to the prevailing case law, the information about medicines qualifies as advertising if, by virtue of its purpose, content and/or context, it encourages the targeted audience to prescribe, supply or buy a medicine.

Disease awareness campaigns do not qualify as medicines advertising if they do not refer, even indirectly, to any medicine (Article 113 of Legislative Decree No 219/2006).

The Ministry of Health may authorise vaccination campaigns promoted by pharmaceutical companies (Article 115 of Legislative Decree No 219/2006).

With regard to the patient support programs (PSPs) – such as phone and in-home therapeutic support and therapy monitoring services, for instance through diagnostic activities – they are not considered as medicines advertising, provided that do not include any form of incentive to prescribe, dispense or use any medicine. In particular, a pharmaceutical company may not offer patient support as a way of inducing healthcare professionals to prescribe or recommend its medicine, or to reciprocate the benefit brought to it through the prescription or recommendation of its medicine. Under the Farmindustria Code of Conduct, the PSPs sponsored by pharmaceutical companies must not be decided or organised by their marketing function and they must be subject to the supervision of the compliance function.

Press releases regarding investigational or prescription medicines are allowed provided that they do not fall within the definition of advertising (Article 114 and 115 of Legislative Decree No 219/2006).

Press releases regarding non-prescription medicines require the prior authorisation by the Ministry of Health if they appear to be promotional in nature (Article 118 of Legislative Decree No 219/2006). In this case, the promotional intent cannot be hidden by the redundancy of other information (Article 117 of Legislative Decree No 219/2006).

It is never possible to show a medicine and/or its name in images in printed publications, radio and television broadcasts and in any non-promotional messages disseminated to the general public in a context that may encourage the use of the medicine (Article 115 of Legislative Decree).

In any case, press releases should never refer to the therapeutic indications or mechanism of action or any other scientific properties of prescription or unauthorised medicines, in order to avoid the risk of infringing the ban to promote such medicines to the general public, which also include journalists, shareholders, investors and employees.

Comparative advertising for medicines is not allowed when that leads to believe that the efficacy of a medicine is higher to or equal to another medicine (Article 117 of Legislative Decree No 219/2006).

Under the Farmindustria Code of Conduct, indemonstrable comparisons without an objective basis are not allowed.

Advertising must present a medicine objectively and without exaggerating its properties, and, in all its parts (Article 114 of Legislative Decree No 219/2006), it must be consistent with the summary of product characteristics (Article 87 of Legislative Decree No 219/2006).

Advertising of unauthorised medicines or unauthorised indications is always prohibited (Article 114 of Legislative Decree No 219/2006). Pharmaceutical companies may provide non-promotional information that is needed to answer an unsolicited request concerning a medicine (Article 113 of Legislative Decree No 219/2006). Therefore, it is possible to respond to unsolicited medical requests for information concerning off-label use of a medicine.

In the course of the pricing and reimbursement procedure, pharmaceutical companies may also provide information about unauthorised medicines or unauthorised indications to the AIFA’s Technical-scientific Committee in order to prove that these medicines/indications meet the requirements set out in the Ministerial Decree of 2 August 2019 on the “Criteria and methods under which the Italian Medicines Agency determines, through negotiation, the prices of medicines reimbursed by the National Health Service”.

The rules on medicines advertising apply to the information on medicines provided by pharmaceutical companies during scientific conferences directed at healthcare professionals. Also in that context, the supply of information about unauthorised medicines or unauthorised indications is, in general, forbidden.

However, in the course of international conferences directed at healthcare professionals, pharmaceutical companies may distribute informational materials related to medicines authorised in other Countries, provided that these materials have been previously submitted to AIFA in accordance with Article 120 of Legislative Decree No 219/2006, and they make it clear that the medicines (or the new therapeutic indications) have not been authorised in Italy (AIFA’s notice of 11 February 2010).

It is possible to send information on unauthorised medicines or unauthorised indications to healthcare professionals exclusively in response to the latter’s unsolicited requests (Article 113 of Legislative Decree No 219/2006).

Pharmaceutical companies cannot proactively send information on unauthorised medicines or unauthorised indications to healthcare institutions so that they can prepare budgets or for any other purposes.

However, they can send information on unauthorised medicines or unauthorised indications to healthcare organisations in response to unsolicited requests made by their healthcare professionals (Article 113 of Legislative Decree No 219/2006).

It is permitted to publish the availability of compassionate use programmes or other forms of early access, provided that no information about prescription or investigational medicines or unauthorised indications of authorised medicines is made accessible to the general public

Advertising to the general public for prescription-only medicines or medicines containing substances defined as psychotropic or narcotic is forbidden (Article 115 of Legislative Decree No 219/2006). It is also forbidden to promote medicines which are reimbursed by the National Health System (NHS), that, in general, are prescription-only medicines.

It is never possible to distribute medicines to the public for promotional purposes (Article 115 of Legislative Decree No 219/2006).

Advertising to the general public for over-the-counter (OTC) medicines requires the prior authorisation by the Ministry of Health, (Article 118 of Legislative Decree No 219/2006).

The Supreme Administrative Court has made it clear that not only OTC medicines, but also the other non-prescription medicines may be promoted to the general public under the conditions laid down in the applicable rules (Consiglio di Stato’s ruling No 2217/2017).

Elements to be Excluded from Advertising to the General Public

Where permitted, advertising directed at the general public must never include any element that may suggest that:

  • it is unnecessary to consult a doctor;
  • the medicine has no side effects or its efficacy is higher than or equal to another medicine;
  • the medicine can improve the individual’s good health conditions;
  • the failure to use the medicine may have detrimental effects on the individual’s good health conditions;
  • the medicine is aimed exclusively or mainly at children;
  • the medicine is recommended by scientists, healthcare professionals or popular people;
  • the medicine can be assimilated to food, cosmetics or other consumer goods; and/or
  • the safety or efficacy of the medicine is due to its natural component (Article 117 of Legislative Decree No 219/2006).

In this respect, Farmindustria Code of Conduct specifies that “universal and exaggerated claims” such as “the preferred drug”, “absolutely safe”, “fully tolerated” or a statement that a medicine has no side effects or toxicity risk are not allowed. Since non-prescription medicines can only be delivered to customers by a pharmacist, in pharmacies and parapharmacies it is not possible to use promotional means, such as exhibitors or shelves which display non-prescription medicines. Specific restrictions apply to the advertising in the online environment given to its specificities (see 7.1 Regulation of Advertising of Medicinal Products on the Internet and 7.2 Advertising of Medicines on Social Media). As to the information that must be included in medicines advertising directed at general public, see 4.2 Information Contained in Pharmaceutical Advertising to the General Public.

As a general rule, medicines advertising must be consistent in all its parts with the summary of product characteristics and encourage the rational use of the medicinal product, presenting it objectively and without exaggerating its properties. It must never be misleading (Article 114 of Legislative Decree No 219/2006).

Medicines advertising directed at the general public must always include certain minimum information:

  • the qualification as medicine;
  • the commercial name of the medicine and the common name of the active principle;
  • essential information for a correct use of the medicine; and
  • a clear and explicit indication to carefully read the warnings mentioned in the package leaflet or on the outer packaging (Article 116 of Legislative Decree No 219/2006).

Moreover, any promotional material relating to non-prescription medicines must include the following statement: ““It is a non-prescription medicine that can only be delivered by a pharmacist. Consult your pharmacist” (Ministry of Health’s Guidelines of 7 May 2018).

Advertising on Facebook and other Social Media

Medicines advertising on Facebook pages is allowed, provided that the following disclaimer is displayed: “The Ministry of Health has authorised only the advertising content. Any comments are the sole responsibility of the user; the company is not responsible for the comments of the users” (Ministry of Health’s Guidelines of 25 July 2018). This is a precautionary measure since all interactive functionalities (eg, comment, share, like, etc) on Facebook pages must be deactivated.

Links from sites

With specific regard to medicines advertising published online, it is possible to include links from sites, banners, and other frames to others containing advertising directed at the general public that has been authorised by the Ministry of Health, provided that the company which is responsible for the online publication of the promotional material provides the user with the following warning: “you are leaving the Company XXXXXX site… containing promotional material authorised in accordance with the legislation on medicines advertising” (Ministry of Health’s Guidelines of 6 February 2017). This wording is not required in the case the link only leads to the package leaflet and, eventually, to an image of the medicine package.

Self-regulatory codes (the Farmindustria and Egualia Codes of Conduct) impose a series of restrictions on interactions between patients or patient organisations and industry.

In particular, any form of economic support provided by a pharmaceutical company to a patient association shall comply with specific requirements. The company must previously enter into a specific agreement with the patient association aimed at regulating the amount of financing and the reasons for its disbursement. The pharmaceutical company must adopt a standard internal procedure for the approval of this type of agreements. The sponsorship by the pharmaceutical companies of a patient association’s project or activity must be transparent and without promotional intent.

If a company wants to offer hospitality to the members of a patient association, it must comply with the provisions of the applicable Code of Conduct dealing with hospitality to healthcare professionals in conferences and congresses.

The use by a pharmaceutical company of the logo or the materials of a patient association must be previously authorised by the association.

Transparency

For transparency purposes, pharmaceutical companies must make publicly available on their websites a list of patient associations to which they have provided financial support in the previous year, specifying the amount given to each Association.

Pharmaceutical companies may engage representatives of associations as experts and consultants (for instance, in advisory boards and congresses), provided that they previously enter into an agreement specifying the needs to be met, the services to be provided and the criteria for their remuneration, which must be reasonable and cannot exceed the fair market value of the services rendered..

Every year, pharmaceutical companies must make publicly available a list of Patient Associations that they have engaged for the provision of services.

Advertising directed at healthcare professionals must always include the summary of product characteristics, the classification of the medicine for the purposes of its supply regime, the price and the conditions for the supply of the medicine at the expense of the National Health Service (Article 119 of Legislative Decree No 219/2006). Alternatively, advertising directed at healthcare professionals may only mention the name of the medicine, with the specification of the common name of its active substance(s). In addition, the name of the marketing authorisation holder (MAH), eventually followed by the name of the company which under a contract with the MAH commercialises the medicine in the national territory (concessionario di vendita), may be indicated (Article 119 of Legislative Decree No 219/2006).

With specific regard to the advertising addressed to doctors, any document or material related to a medicine, except for the authorised summary of product characteristics, must be previously submitted to AIFA (Article 120 of Legislative Decree No 219/2006), see 6.1 Requirements for Prior Notification/Authorisation.

Up-to-date Information and Visits to Labs

All the information contained in the documentation provided to doctors must be accurate, up to date, verifiable and sufficiently complete to allow the doctor to be adequately informed about the therapeutic effect and characteristics of the medicine. (Article 120 of Legislative Decree No 219/2006).

The visits by doctors to the laboratories and research centres of pharmaceutical companies, which fall within the definition of medicines advertising, must be intended to the development of knowledge in the fields of chemistry, pharmaceutical technology, pharmacology, toxicology, biotechnology and biochemistry (Article 120 of Legislative Decree No 219/2006).

Advertising for prescription medicines addressed to pharmacists must be limited to the information contained in SmPC. That limitation does not apply to hospital pharmacists (Article 121 of Legislative Decree No 219/2006).

Advertising of non-prescription medicines addressed to pharmacists may include information that helps the pharmacist advice the customer on the appropriate use of the medicine (Article 121 of Legislative Decree No 219/2006).

Provision of Information

Information about medicines must be provided to both doctors and pharmacists by the companies’ sales representatives in compliance with the requirements laid down in Article 122 of Legislative Decree No 219/2006, complemented by the Guidelines of Regional Regulation of Scientific Information about medicines adopted by the Conference of Presidents of the Regions and Autonomous Provinces, and the rules on the “scientific information” about medicines adopted by the Regions for their respective territories. The distribution by sales representatives of free samples to the prescribing doctors is regulated by Article 125 of Legislative Decree No 219/2006 and by the cited rules on “scientific information” about medicines.

Conferences and Congresses

There is a series of specific and detailed requirements for the organisation or the sponsorship by pharmaceutical companies of conferences or congresses and other meetings concerning medicines addressed to healthcare professionals (Article 124 of Legislative Decree No 219/2006; AIFA’s notice of 11 February 2010; and Farmindustria and Egualia Codes of Conduct).

Medicines advertising must be consistent with the information included in the SmPC or with its updates (Articles 114 and 120 of Legislative Decree No 219/2006). All the information about medicines provided to healthcare professionals must be “verifiable”, “documented and documentable” and scientific publications must be faithfully reproduced in full (Article 120 of Legislative Decree No 219/2006).

No information on unauthorised medicines or indications can be provided to healthcare professionals. However, according to AIFA’s notice of 11 February 2010, in the context of conferences, congresses or meetings on topics related to medicines, pharmaceutical companies may exhibit inside their stands materials concerning molecules under investigation, provided that they only mention the mechanism of action of such molecules.

Advertising that refers to combination products or companion diagnostics that are not included in the SmPC is considered unlawful (Article 114 of Legislative Decree No 219/2006).

Therefore, if the combination use of two medicines commercialised by two different companies is mentioned in the summary of product characteristics of only one of the medicines, only the company which commercialises the medicine may promote its use in combination with the other medicine.

Articles, tables and other pictures taken from medical journals or scientific works must be reproduced in full and faithfully, quoting the source exactly. Quotes which, out of the context from which they were drawn, may be incomplete or misleading are not allowed (Article 120 of Legislative Decree No 219/2006; and the Farmindustria and Egualia Codes of Conduct).

There are no legal provisions specifically dealing with Medical Science Liaisons (MSLs). Companies’ MSLs – like any other employees – must comply with general rules on medicines advertising.

MSLs may not proactively provide healthcare professionals with information on unauthorised medicines or indications. They can provide such information only in response to unsolicited requests from healthcare professionals (Articles 113 and 114 of Legislative Decree No 219/2006).

Advertising of non-prescription medicines addressed to the general public must be previously authorised by the Ministry of Health (Article 118 of Legislative Decree No 219/2006). The advertising is allowed if within 45 days of receipt of the application, the Ministry of Health does not inform the applicant of the refusal of the authorisation.

Conversely, if, within the said 45-day term, the Ministry of Health informs the applicant that the authorisation may be granted only if certain changes are made, the applicant may use the advertising materials amended according to the Ministry’s indications. In this case, the advertising must specify that it has been authorised on the date of the Ministry’s notice to the applicant.

If, within the said 45-day term, the Ministry of Health notifies the refusal of the authorisation, the applicant may submit comments within the following ten days in order to sustain that the advertising complies with the law.

Authorisations for medicines advertising are valid for a 24-month period. The Ministry of Health may grant the authorisation with a shorter validity period, considering the characteristics of the advertising material.

Requesting Authorisation

The Ministry of Health specified that the authorisation can be requested by the marketing authorisation holder (or its local representative in Italy) or by the company that, under an agreement with the MAH, commercialises a medicine throughout the national territory.

The application for authorisation must specify the medium by which the advertising is disseminated (eg, TV, radio, daily and periodical press, internet, road signs, stands in pharmacies, etc).

The authorisation for an advertising material granted for one or more media can be extended to another medium, without requiring a new application for authorisation.. The extension of the authorisation to another means of dissemination, without submitting a new application for authorisation, is allowed only if the advertising material is the same as the one previously authorised and is intended to be disclosed in the original form (script, video or audio) for which authorisation was granted (Guidelines of 6 February 2017).

Advertising to HCPs

As to advertising addressed to healthcare professionals (HCPs), any document or material containing information about a medicine, except for the summary of product characteristics, must be previously submitted to AIFA and it can be provided to the HCPs if within ten days of the submission date AIFA does not raise any objections. (Articles 120 and 121 of Legislative Decree No 219/2006).

Every company which commercialises medicines in Italy must have, within its organisation, a scientific service that is responsible for the supervision and approval of all information about the medicines that is provided by the company to HCPs and/or the general public (Article 126 of Legislative Decree No 219/2006). The head of the Scientific Service must meet specific professional requirements.

The scientific service must be independent from the marketing division. It must supervise the activity carried out by the company’s sales representatives who are responsible for providing information about the medicines to HCPs (Article 122 of Legislative Decree No 219/2006). Pharmaceutical companies must employ sales representatives who fulfil the professional requirements laid down in Article 122 of Legislative Decree No 219/2006, and provide up-to-date technical and scientific training to those employees.

Sales representatives must report to the Scientific Service and to the head of the Pharmacovigilance all information on the undesirable effects of the medicines, providing, where possible, a copy of the standard report forms used by the prescribing doctors (Article 122 of Legislative Decree No 219/2006). Those legal requirements are further specified by the self-regulatory codes (the Farmindustria Code of Conduct and Egualia’s Guidelines on medical and scientific Information).

Pharmaceutical companies are not required to adopt standard operating procedures (SOPs) for ensuring compliance with the rules on medicinal advertising. However, it is advisable to adopt SOPs which ensure that any promotional activity is carried out in accordance with the law  (Article 126 of Legislative Decree No 219/2006).

Advertising on the internet for medicines is subject to the same requirements, restrictions and pre-clearance regime that apply to the other types of advertising. In addition, medicines advertising over the internet must comply with the Guidelines adopted by the Ministry of Health of 6 February 2017, of 25 July 2017 and of 25 July 2018.

On the company’s institutional website, it is possible – without the prior authorisation from the Ministry of Health – to publish the list of its non-prescription medicines whose names refer (via a link) exclusively to the package leaflet and, eventually, to an image of the package. No reference to therapeutic properties of the medicine may be displayed, since this would require the prior authorisation by the Ministry of Health (Guidelines of 6 February 2017).

If a company wants to publish on its website advertising for medicines, it must indicate on the application for authorisation to be filed with the Ministry of Health at which internet address the advertising will be displayed. The company must specify that the Ministry’s authorisation covers only the promotional material described in the application (Guidelines of 6 February 2017).

Links from Sites

Links from sites, banners, and other frames to others containing promotional material addressed to the general public duly authorised by the Ministry of Health are allowed, provided that the company responsible for the online publication of promotional material inform internet users that they are leaving the website containing advertising duly authorised by the Ministry of Health (see 4.2 Information Contained in Pharmaceutical Advertising to the General Public).

Links from sites, banners, and other frames containing authorised promotional material to other sites, banners or frames not containing promotional material in Italian language that would require the Ministry of Health’s prior authorisation, such as health educational information or self-medication, are allowed, provided that the company responsible for the online publication of the promotional material inform the internet users as specified in the previous paragraph.

Conversely, there are no legal restrictions to the promotion on the internet of the name, logo and image of a pharmaceutical company (“institutional advertising”).

Indicating Sources

Under the industry self-regulatory codes, every website operated by an Italian company or a company operating in Italy that is addressed to Italian HCPs and general public must clearly indicate the sponsor, the source of all information available on the website, the recipients of such information and the purposes of the website (Farmindustria and Egualia Codes of Conduct).

The Ministry of Health has made it clear that, since medicines advertising that is authorised by the Ministry cannot be changed by the pharmaceutical company or any third parties, the use of social media – which generally allows users to express their own opinions – might infringe that rule (Guidelines of 25 July 2017). Therefore, the use of social media is not allowed, except in those specific cases defined by Ministry’s Guidelines. Pharmaceutical companies may publish authorised advertising on Facebook, YouTube and Instagram, provided that the interactive functionalities are deactivated. Conversely, advertising for medicines cannot be disseminated via Twitter, since for now the minimum mandatory content of medicines advertising is not contained in a single Tweet. 

The information addressed to HCPs must be accessible only to them, even when it is disseminated via the internet (Ministry of Health’s Guidelines of 6 February 2017 and the Farmindustria and Egualia Codes of Conduct). Companies must previously submit to AIFA the promotional materials that will be disseminate via the internet, unless such materials have already been authorised and have not been modified.

Pharmaceutical companies may provide disease awareness information to patients online provided that they do not refer, even indirectly, to their medicines, since such information does not fall within the definition of medicines advertising (Article 113 of Legislative Decree No 219/2006).

Online scientific meetings are subject to the same rules that apply to in-presence scientific meetings.

The self-regulatory codes specify that scientific and medical training provided via the internet to HCPs, such as web meetings, e-meetings and online continuing medical education (FAD) that are sponsored by pharmaceutical companies cannot entail any form of hospitality and are not subject to any restrictions as to the duration.

Specific requirements for the FAD events are laid down in the continuing medical education (CME) regulations (Agreement between the State, the Regions and the Autonomous Provinces on the CME and the Handbook for the qualification of CME providers). For instance, it is possible to indicate the logo of the pharmaceutical company which sponsors the FAD event only before starting and and at the end of the event and on the last page of the FAD materials.

International Events

Online conferences are not necessarily considered as “international” events.

The events which take place abroad are subject to the same rules that apply to national events, and to some additional requirements (Article 124 of the Legislative Decree No 219/2006).

In particular, companies which sponsor such events need to obtain an explicit authorisation by AIFA (which is granted within 45 days from the submission of the request). Moreover, it is possible to provide information and materials in foreign languages that is in line with the marketing authorisations for the medicines granted by the health authorities in other Countries, provided that doctors coming from these Countries attend the scientific event.

The commercial name and/or the name of the active ingredient of authorised medicines in other Countries may be shown on the gadgets of minimal value that are given to HCPs in the course of international events (AIFA’s notice of 11 February 2010).

Interactions between pharmaceutical companies and HCPs must comply with anti-bribery rules.

Pharmaceutical companies – like other legal persons – can be held liable for certain crimes committed, in their interest or to their benefit, by a natural person who, formally or factually, represent or manage the company or exercise a control over it (“corporate liability”). In order to mitigate such a risk, companies may adopt and effectively implement an organisation, management and control model that is adequate to prevent the commission of crimes (Legislative Decree No 231/2001).

The industry association Confindustria has adopted Guidelines for the realisation of the organisation, management and control model. Corruption risks may be present throughout the medicine lifecycle (ie, in the research and development, price definition or negotiation, prescription and distribution and supply phases).

The Italian Anticorruption Authority has entered into an agreement with the Ministry of Health to determine how they should co-operate for preventing and combat corruption in the health sector. The anti-bribery rules apply to the public sector.

Pharmaceutical companies must not give or promise money or other benefits to doctors or pharmacists, for the purpose of facilitating in whatever form the use of medicines (Article 172 of Royal Decree No 1265/1934). This is a crime that can be punished with the order to close the manufacturing plant or the revocation of the marketing authorisation.

In the context of the promotion of medicines to HCPs, it is prohibited to grant, offer or promise prizes, pecuniary or in-kind benefits, unless they are of negligible value and related to the activity carried out by the doctor and pharmacist (Article 123 of Legislative Decree No 219/2006).

Those gadgets may include the name of medicinal product and/or of the active principle, and/or the corporate name of the marketing authorisation holder. The negligible value must not exceed EUR20 per year for each individual doctor or pharmacist. Such promotional materials must be submitted to AIFA except for those materials bearing only the corporate logo.

Additional restrictions apply to HCPs who are employed with public hospitals and health facilities (Article 4 of the Presidential Decree No 62/2013 “Code of Conduct of public employees”).

Medical or Educational Materials

Medical or educational materials not specifically related to a medicine can be given free of charge only to healthcare organisations, not to individual doctors (Article 123 of Legislative Decree No 219/2006). In this respect, Farmindustria Code of Conduct specifies that such materials must have a value not exceeding EUR25, and that companies must provide these materials through their centralised functions (not through their field force).

Medical or educational materials may consist of:

  • high scientific quality professional books and monographs and taken from well-known editorial catalogues;
  • subscriptions to medical-scientific journals indexed in bibliographic databases or in any case published by professional editors; 
  • subscriptions to online newsletters with a medical/scientific content; and
  • CDs, DVDs or passwords for access to relevant websites with a medical/scientific content (Ministry of Health’s Decree of 14 April 2008).

Donations

Donations and free loans of instruments directly related to the medical profession are allowed only if they are granted to universities, hospitals and health facilities, and in compliance with the administrative procedures of the concerned entity.

Donations and free loans of instruments that can be used by doctors not only for diagnostic or therapeutic purposes (such as smartphones, tablets or similar) are allowed only in the context of clinical trials.

Pharmaceutical companies are allowed to give gifts to HCPs, provided that they are of negligible value and related to the professional activity of the recipients (see 8.2 Legislative or Self-Regulatory Provisions).

Companies may also offer hospitality to HCPs who participate in scientific meetings and congresses by paying their travel, accommodation and/or registration fees (Article 124 of Legislative Decree No 219/2006). However, hospitality must not be offered for more than 12 hours prior to the event and 12 hours following its conclusion, and cannot “overshadow” the scientific purposes of the event (ibidem).

Under the Farmindustria Code of Conduct, hospitality offered by pharmaceutical companies to HCPs participating in scientific meetings and congresses must be limited to travel, accommodation and payment of the registration fees to the meeting or congress. The hospitality cannot exceed a 12-hour time period prior to and immediately after the scientific meeting or congress and such hospitality may not “overshadow” the scientific characteristics of meeting or congress.

During the days of the congress the hospitality offered may also include meals and drinks up to a threshold of EUR60 per HCP per meal for all events in Italy. As for events held abroad, the limits and thresholds indicated in the foreign country’s Code of Conduct apply. In lack of these local limits and thresholds, the threshold of EUR60 applies also to the events held abroad. In any case, the principle of soberness must be complied with.

Sponsorship

In the context of scientific conferences either in or outside Italy it is forbidden to organise or sponsor activities with social, cultural or tourist purposes, including gala dinners. Social dinners organised by the conference for the participants as a whole are allowed and shall be included in the inscription fees for the conference. No hospitality of any kind can be offered to the persons accompanying the participants.

Air Travel

Pharmaceutical companies may only offer economy class air travel to Italian healthcare professionals invited to Italian conferences in Italy or abroad while the category of hotel accommodation shall not exceed four stars. In the case of rail transport, it is allowed all travel classes except for Executive class.

In the context of international conferences involving intercontinental flights longer than six consecutive hours of flight it is possible to offer the travel business class only for speakers and moderators included in the official program of the conference.

Other Items of Note

Congresses organised directly or indirectly by pharmaceutical companies must be held in locations chosen for logistical, scientific and organisational reasons, and must have a scientific programme.

It is prohibited to offer or give any kind of benefit aimed at compensating healthcare professionals for the time spent to participate in scientific congresses.

Similar provisions can be found in the Egualia Code of Conduct.

Pharmaceutical companies, through their sales representatives, may give free samples of a medicine only to doctors who are authorised to prescribe it. The samples may be delivered only upon a written request, bearing the date, stamp and signature of the recipient (Article 125 of Legislative Decree No 219/2006).

Sales representatives may deliver to each HCP up to two samples per visit for each dosage or pharmaceutical form of a medicine only in the 18 months following the product launch and within the maximum limit of eight annual samples for each dosage or form (Article 125 of Legislative Decree No 219/2006).

Sales representatives may deliver to the doctor no more than four samples per visit, within the maximum limit of ten samples per year, chosen within the company’s medicines that have been commercialised for more than 18 months (ibidem).

Pharmaceutical companies must also comply with the internal rules and procedures of hospitals that deal with the supply of free samples. Similar provisions may be found in the industry self-regulatory codes (the Farmindustria and Egualia Codes of Conduct).

Pharmaceutical companies may sponsor scientific meetings or congresses and attendance by HCPs at these events under the conditions laid down in Article 124 of Legislative Decree No 219/2006 and in the applicable self-regulatory code (the Farmindustria and Egualia Codes of Conduct). Every pharmaceutical company wanting to sponsor a meeting or a congress on topics in anyway related to the use of a medicine must obtain the AIFA’s prior authorisation (Article 124 of Legislative Decree No 219/2006).

In order to obtain such authorisation, an application containing the details of the costs and other relevant information (name, address and corporate data of the pharmaceutical company, the agenda of the meeting, the location and date of the event, professional and scientific qualifications of the speakers, scientific rationale, categories of participants, medicines that will be promoted during the scientific event) must be submitted 60 days prior to the date of the meeting or congress by the pharmaceutical company to AIFA, which will issue its approval within 45 days of receipt of the request (Article 124 of Legislative Decree No 219/2006).

Where several pharmaceutical companies contribute to the organisation of a congress, convention or meeting, the communications to AIFA must be provided jointly, through the event planner, with a list of the companies taking part. The event organiser must collect and send jointly to AIFA by ordinary mail each copy of all the application forms of the participating companies, along with the relevant information.

Inviting HCPs to Conferences

Under the self-regulatory codes, companies may not invite the same HCP to scientific congresses or conferences more than twice a year, except for speakers and moderators, in order to ensure a rotation between the participants. These limits do not apply only to those events that:

  • qualify as Continuing Medical Edications (CMEs);
  • are organised by public entities;
  • are held at the same public entities; or
  • do not entail any form of hospitality.

During a conference or a meeting relating to the use of medicines, pharmaceutical companies participating as sponsors, can distribute or show HCPs display panels, visuals, summary of product characteristics, exhibition banners and gadgets. Those materials are subjected to the rules on medicines advertising, including the ten days negative clearance system.

Continuing Medical Educations

Pharmaceutical companies may also sponsor the CME events and courses. The providers of CME of events are qualified by the public institution AGENAS.

During a CME event, pharmaceutical companies that sponsor the event may show or distribute to HCPs the promotional materials relating to their medicines only outside the areas where the training is delivered (Article 77 of the cited Agreement). During the event, it is possible to indicate the active ingredient of medicines (not their commercial names). Medicines advertising cannot be included in the educational materials delivered in the event or in the event program, leaflets and advertising (ibidem).

The self-regulatory codes reiterate that pharmaceutical companies which sponsor CME events may not identify and appoint, directly or indirectly, the speakers and moderators, or interfere with the choice of the scientific contents of the event, in compliance with the rules on CME. Moreover, the invitation to CME events of medical experts employed by public hospitals or health facilities cooperating with the National Health System, the sponsor company cannot indicate the name of the medical experts on the invitation and must send the latter to the hospitals or health facilities at least 60 days prior to the date of the CME event. The invitation may be nominative only if the public hospitals and health facilities so require.

The invitation must always specify the hospitality costs borne by the Pharmaceutical company (eg, registration fee, travel, accommodation) and the agenda of the event.

Pharmaceutical companies are not allowed to organise or sponsor cultural, sports or other non-scientific events in relation to scientific conferences because hospitality must be limited to travel, accommodation and registration fees (Article 124 of Legislative Decree No 219/2006).

With regard to grants or donations to HCPs, see 8.2 Legislative or Self-Regulatory Provisions and 9.1 Gifts to Healthcare Professionals. As to grants or donations to healthcare institutions, they must comply with the internal rules and procedures adopted by those institutions, and may not be intended to, or have the effect of, circumventing the rules on public tenders.

The company should enter into a written agreement with the hospital, that should be signed or authorised by the top management of the latter (and not by a doctor). If the donation does not have a modest value, a notarial deed and other formalities are required (Articles 782 and 783 of Civil Code). The modest value must also be assessed in relation to the economic conditions of the donor.

According to the Italian Anticorruption Authority, public entities should ensure the transparency of any grants or donations (including the supply of products for free testing) received by private parties (National Anticorruption Plan of 2016).

Although the hospitals’ internal rules may differ between them, they frequently provide that the free of charge (FOC) supply of medicines to the hospitals is acceptable provided that:

  • there are no conflicts of interest between the supplier and the hospital (ie, the supplier must not be subject to a hospital’s administrative proceeding, such as public tenders);
  • the FOC supply must not be, or appear to be, intended to obtain any benefit or advantage from the hospital;
  • the hospital must not be obliged to perform any service in exchange for that supply;
  • the FOC supply must not cause any costs to the hospital;
  • the medicine supplied FOC must be of modest economic value; and
  • the FOC supply must be occasional.

Pharmaceutical companies may negotiate with AIFA rebates and discounts that will apply to healthcare institutions which are part of the National Health System. In particular, the Managed-Entry Agreements (MEAs) entered by AIFA with pharmaceutical companies allow conditional access to the market for some new medicines with unclear efficacy and safety profiles with a consequent modulation of the price and reimbursement schemes. The most common MEAs include risk sharing agreements based on the outcome or clinical benefit expected from the new medicine (schemes based on health outcomes) and financial agreements (financial-based schemes). The first category includes the payment by result, risk sharing and success fee agreements, while the second includes the cost sharing and capping agreements.

In addition, pharmaceutical companies may offer their medicines at lower prices to compete in public tender procedures organised by public healthcare institutions at regional or local level. Pharmaceutical companies may also give rebates or discounts to healthcare institutions, provided that they do not infringe antitrust and/or anti-bribery rules.

Under the Farmindustria Code of Conduct, free information material for scientific or professional consultation not specifically related to medicines may be distributed to public healthcare organisations provided that such material has a negligible value, namely a value of less than EUR25. Similar requirements are laid down in the Egualia Code of Conduct.

Moreover, donations and loans free of charge of instruments directly related to the medical profession are allowed, provided that they are to the benefit of universities, hospitals and clinics and in compliance with the administrative procedures of the concerned entity (Farmindustria Code).

Pharmaceutical companies may pay for services provided by HCPs provided that they really need such services, the services have been provided and the compensation is in line with the fair market value of the services at issue. Companies should be able to demonstrate their actual need, the effective provision of the services, and the fair market value of the compensation.

Private parties may not engage public employees for the provision of remunerated services without the prior authorisation of the public entity to which the employees belong (Article 53 of Legislative Decree No 165/2001). Moreover, the compensation paid for the services rendered by a public employee must be disclosed to the public entity with which they are employed within 15 days from the payment. Those rules also apply to HCPs who work for the public administration.

The industry self-regulatory codes provide for specific requirements. In particular, pharmaceutical companies must enter into written contracts with HCPs specifying the nature of the service rendered and the objective need for the service. The compensation must reflect the market value of the specific service and is subjected to transparency requirements.

Private parties may not engage public employees for the provision of remunerated services without the prior authorisation of the public entity to which the employees belong (Article 53 of Legislative Decree No 165/2001). Moreover, the compensation paid for the services rendered by a public employee must be disclosed to the public entity with which they are employed within 15 days from the payment. Those rules also apply to healthcare professionals who work for the public administration.

The industry self-regulatory codes provide for specific requirements. In particular, pharmaceutical companies must enter into written contracts with HCPs specifying the nature of the service rendered and the objective need for the service. The compensation must reflect the market value of the specific service and is subjected to transparency requirements.

Pharmaceutical companies that have engaged HCPs who work in public sector for the provision of remunerated services are required to disclose the amount of the compensation paid for the services rendered to the concerned public entity within fifteen days from the payment (Article 53 of Legislative Decree No 165/2001).

Public healthcare organisations must disclose any transfer of value received from a private party, including pharmaceutical companies, where a specific request for access to such data is made (Law No 241/1990, Legislative Decree No 150/2009 and Legislative Decree No 33/2013).

The industry self-regulatory codes impose on pharmaceutical companies the obligation to disclose details of transfers of value to HCPs or healthcare institutions (the Farmindustria and Egualia Codes of Conduct). On an annual basis, each pharmaceutical company must document and make publicly available on its website all transfers of value carried out directly or indirectly to HCPs and organisations. The disclosure of such data must be on an individual basis or, in specific circumstances, in aggregate form.

With the outbreak of the COVID-19 pandemic, the government has temporarily suspended the scientific congresses in order to avoid any disruption of HCPs’ activities. Online webinars sponsored by pharmaceutical companies have been held in lieu of in-presence events. Therefore, no hospitality could be offered to the participants by the companies which have financed the webinars. No exceptions to the disclosure obligation apply due to COVID-19 incidences.

The transparency requirements that are laid down in Italian legislation (see 10.1 Requirement for Pharmaceutical Companies to Disclose Details of Transfers of Value) apply to foreign companies and/or companies that do not yet have products on the market.

The transparency requirements laid down in the industry self-regulatory codes apply to foreign companies if the recipient of the transfer of value is domiciled in Italy (Farmindustria Code of Conduct). Otherwise, if the recipient is domiciled in another Country, the transfer of value must be disclosed (even by pharmaceutical companies established in Italy) in accordance with the industry code of conduct applicable in that Country.

Similar requirements are laid down in the Egualia Code of Conduct.

The public bodies that are responsible for enforcing the rules on advertising and the rules on inducement are the following: AIFA, the Ministry of Health, the Italian Antitrust Authority, the Anticorruption Authority, civil, administrative and criminal Courts and the police.

The rules on advertising contained in self-regulatory codes may be enforced by the bodies set up by the industry associations.

Companies can initiate proceedings against competitors for advertising infringements before any of the enforcement bodies mentioned in 11.1 Pharmaceutical Advertising: Enforcement Bodies, depending on the specific rule that has been infringed by their competitors.

Actions Available to AIFA

If medicines advertising addressed at HCPs is not in compliance with the requirements laid down in Legislative Decree No 219/2006, AIFA may order the immediate cessation or suspension of the dissemination of the promotional message and, eventually, order the dissemination, at the expense of the liable company, of a press release to rectify the unlawful promotional message. The press release may be published by AIFA on the drug information bulletin and on its institutional website and, at the company’s expense, on the company’s website or in national newspapers (Article 119 of Legislative Decree No 219/2006).

Similarly, AIFA may prohibit a congress, conference or other meeting from taking place if the latter does not fulfil any requirements laid down in Legislative Decree No 219/2006 (Article 124 of Legislative Decree No 219/2006).

Moreover, the violation of the rules on advertising addressed at HCPs may be punished with an administrative sanction ranging from EUR2,600 to 15,600 (Article 148 of Legislative Decree No 219/2006).

Actions Available to the Ministry of Health

If medicines advertising addressed at general public is not in compliance with the requirements laid down in Legislative Decree No 219/2006, the Ministry of Health may order the immediate cessation of advertising, order the dissemination, at the expense of the liable company, of a press release to rectify the unlawful promotional message (Article 118 of Legislative Decree No 219/2006) or impose administrative fines.

The violation of the rules laid down in self-regulatory codes may be punished with:

  • a warning with the request for the immediate interruption of the behaviour;
  • a written reprimand;
  • a temporary suspension;
  • the expulsion from industry association; and/or
  • a pecuniary sanction (the Farmindustria and Egualia Codes of Conduct).

Formally speaking, procedures before or measures taken by regulatory authorities do not influence the procedures before or measures taken by courts because the latter must be fully independent in their judgment.

There is a growing attention by AIFA and the Ministry of Health to the promotion of medicines by new information and communication technologies.

Another issue that Italian authorities are trying to address is how to prevent conflicts of interests resulting from the various forms of interaction by pharmaceutical companies with HCPs and organisations.

Avvocati Associati Franzosi Dal Negro Setti

Via Brera 5
20121
Milano
Italy

+39 02 859091

info@franzosi.com www.franzosi.com
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Law and Practice in Italy

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Avvocati Associati Franzosi Dal Negro Setti has a life sciences team that offers assistance and consulting services in all aspects concerning research, manufacturing, commercialisation and use of medical products and veterinary products, medical devices, special foods and cosmetics. The team provide advice in areas including: best practice and and compliance; contract drafting; joint ventures, company transfers and share transfers as well as extraordinary transactions in the relevant fields of industry; advertising, competition and parallel imports issues; relationships with regulatory authorities; and clinical trials. Representation in litigation is carried out before all competent authorities: ordinary civil courts, specialised IP divisions, administrative courts and European courts. Administrative litigation is of significant importance for the protection of interests of pharmaceutical companies. The team assists clients in out-of-court cases concerning regulatory aspects of pharmaceutical Marketing Authorization with reference to issuance, maintaining, review and protection. Furthermore, it offers assistance and consulting services on price negotiation systems and classification of drugs for reimbursement by the Italian National Health Service.