The recent changes to the Farmindustria Code of Conduct provided the opportunity for Elisa Stefanini and Claudio Todisco of the "Portolano Cavallo" law firm to publish on 14 June 2023 within the column “Digital impact in Life Sciences: Legal Corner” on AboutPharma.com, the article entitled "Non-promotional communication: a new impetus for digital from the Farmindustria code?”
The article reads that "The recent changes to the Farmindustria Code on interactions other than drug promotion can help give a new impetus to the communication of pharmaceutical companies also through digital channels, as they provide important clarifications and reassurances to companies, on which they can build new communication strategies on the various available channels (websites, blogs, podcasts, webinars, etc.).
The only constraint specific to the digital context is to protect a communication designed for a certain category of recipients from possible access by other recipients, for which it will be necessary to use restricted access areas and implement user identity verification systems. For the rest, even the "digital" forms of interaction will have to follow the same rules and precautions as physical interactions.
The issue of interactions between companies and subjects other than doctors involved in the chain of acquisition, dispensing and drug administration has always aroused particular interest in sector operators. In fact, a whole series of particularly important activities, other than promotional ones, can be traced back to these interactions, such as the dissemination of information on the 
pathology or pharmaco-economic type, on the methods of administering a drug, as well as on treatments being tested and on the new frontiers of research.
But to what extent these activities remain non-promotional and therefore can they be addressed to subjects other than those authorized to prescribe or dispense the drug pursuant to article 119 of Legislative Decree 219/2006, better known as the Drug Code? The Code does not provide specific discipline for these forms of communication, essentially limiting itself to regulating the promotion of medicines to doctors and pharmacists carried out by scientific representatives, subject by the same Code to specific rules and procedures (article 119 et seq.).
An initial answer - the article says - to this question can be found in the very definition of advertising referred to in article 113 of the Code, understood as "any action of information, customer research or exhortation, intended to promote the prescription, supply, sale or consumption of medicines". What distinguishes advertising from other forms of communication/information is the "intent" of the person who implements it (eg to increase the prescription or sale of medicines). If, on the other hand, for example, training for the training of nurses in the administration of a particularly complex therapy is carried out, it is difficult to find a promotional intent in this.
Therefore, in the absence of ad hoc regulations, companies have been able to obtain general indications regarding the methods of interaction with healthcare professionals from the general regulation on the advertising of medicines pursuant to Title VIII of the Medicines Code, starting from the distinction between mere communication (non-advertising), institutional advertising and what should instead be considered product advertising.
The recent initiative by Farmindustria took place in this regulatory framework, adopting some amendments to its Code of Conduct (articles 3.25 and following), providing more information and reassurances to operators in this regard.
The new article 3.25 of the Farmindustria Code provides some indications regarding the interactions with non-prescribing subjects involved in the administration of therapies, allowing companies to carry out information and training activities also through territorial operating personnel, provided that:
- the activities have no promotional purpose (in particular, any form of advertising of medicines as defined by the Drug Code is expressly prohibited);
- all the information processed is connected to the role of these subjects in the patient management process, in clinical research and in the correct and safe administration of the therapy.
The article also states that even non-prescribers can participate in events, courses and congresses organized or sponsored by companies, provided they concern issues not related to medicines pursuant to article 124, paragraph 9, of the Drug Code.
More specific indications are also provided for by the Farmindustria Code (article 3.27) with reference to the following types of non-promotional interactions: "Access to the drug and institutional affairs”, “Account management" and "Scientific Exchange".
Then the issue of the Medical science liaison (msl). According to what is said in the article
“especially in the context of the Scientific Exchange, makes the figure of the Medical science liaison (MSL) which, unlike thescientific informant, who carries out commercial activities and reports to the related corporate function, is dedicated to building and maintaining exclusively medical-scientific relationships and refers to the medical area.
Although the figure of the MSL is not regulated, the fact of entrusting this type of interaction to a subject other than a scientific rep, who possesses purely medical skills (effectiveness and safety of drugs, pathologies, clinical studies, etc.), strengthens the idea that these are exchanges and interactions built on a non-promotional basis, which belong to company functions other than the commercial one.
Depending on the case, MSLs can also proactively share information related to clinical practice, the company pipeline or access to new products, partially freeing themselves from the rigorous constraints underlying medical and scientific information.
Clearly, in confirmation of the fact that this type of communication obeys information and training rather than promotional logics, it is also important that all the surrounding elements, such as the materials and language used, as well as the places and methods in which the meetings take place are thought of in the same logic.
Given the delicacy of this type of communication, it is always advisable for companies to set up a supervisory system, identifying one or more managers within the company in relation to communication and information activities aimed at non-prescriptive subjects. It is also useful to adopt internal procedures and rules, in order to guarantee compliance with the general rules on the advertising of medicinal products and with the indications provided by Farmindustria.
Note: Farmindustria Code of Conduct
Legislative Decree 24 April 2006, n. 219
Article 113 Legislative Decree 219/06
Art. 119 Legislative Decree 219/06
Art. 122 Legislative Decree 219/06
Art. 126 Legislative Decree 219/06
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Editor's note: Thearticle is well informed and documented but it creates some perplexities when it comes to thescientific informant, who carries out commercial activities and which reports to the related corporate function. If we are talking about drug sales representatives (ISF), the relevant company function by law is the "Scientific Service" (art. 122 And 126 of Legislative Decree 219/06) which must be independent from marketing. The art. 113 which appears to authorize commercial activity of the ISF actually speaks in general (even of the OTC) and as regards prescription medicines, Legislative Decree 219/06 is severely limiting (from art. 119 and following) if one refers precisely to articles 122 and 126 which places the ISF in fact employed by a scientific service, distinct and separate from marketing, obviously meaning marketing as a manipulative sales technique. The rationale is to avoid that the drug is treated as a normal consumer good (as essentially specified by the law itself).
"If the advertising of indeterminate medicines were excluded from the scope of application of European Directive 2001/83 (of which Legislative Decree 219/06 is the implementation), the prohibitions, conditions and restrictions that it provides for in the field of advertising due to the risks that can derive from an excessive and reckless use of medicines would largely be deprived of their useful effect and the essential objective of ensuring the protection of public health pursued by this directive would be largely compromised” Promoting the prescription, supply, sale or consumption of medicines is understood in a broad sense on all medicines and not specific. “Directive 2001/831 which harmonizes the provisions on the advertising of medicinal products, subjects it to conditions, restrictions and prohibitions in order to ensure the protection of public health”. (source: Judgment of the European Court of 22 December 2022)
Therefore, it is not enough to desire the commercial scientific rep or to refer to Deontological Codes or Work Contracts to affirm their legitimacy. Any Court will declare the nullity of what is contrary to the law as the Cassation has already done several times and as AIFA itself has reiterated.
The attempt is to create a dichotomy between commercial information from the ISF and scientific (or supposedly scientific) information from the MSL. MSLs unencumbered by laws, rules and regulations so they can tell whoever they want (that the company wants) even what an ISF can't tell. All cloaked in scientific prestige unlike the now discredited ISF (commercial) never defended or valued by pharmaceutical companies. They are "tools of the trade" a former president of Farmindustria once said!
Related news: Law 62/2022 on transparency in the pharmaceutical sector and relations with the Farmindustria Code of Conduct
