June 19, 2023

Non-promotional communication: Boost for digital from the Farmindustria Code?

The Italian version of this article has been published on June 14, 2023 on AboutPharma.com, within our bi-monthly column “Digital impact in Life Sciences: Legal Corner”.

The recent amendments to the Farmindustria Code on non-promotional drug interactions may boost pharmaceutical companies’ communication via digital and other channels. The amendments provide much-needed clarification and reassurance, and in response companies may build new communication strategies on the various channels available (websites, blogs, podcasts, webinars, and so forth).

The only constraint specific to the digital context is that of protecting communication designed for a certain category of recipients from possible access by other recipients; restricted areas must be created and systems employed to verify user identity. Additionally, digital forms of interaction will have to follow the same rules and precautions as physical interaction, to the extent applicable, and they must comply with the principles of transparency and accountability that guide all forms of communication and corporate presence in the digital sphere.

Non-promotional interactions

Players in the sector have long paid close attention to interactions between companies and parties other than doctors in the drug acquisition, dispensing, and administration pipeline. Indeed, a whole series of activities other than promotional activities, such as the dissemination of information on pathology, economic issues, administration, treatments undergoing trials, and new research frontiers, may be involved in such interactions.

But to what extent do these activities remain non-promotional and can therefore be addressed to persons other than those authorized to prescribe or dispense drugs pursuant to Article 119 of Legislative Decree 219/2006, known as the Drug Code? The code does not provide specific regulations for such communication, essentially limiting its scope to regulating medicine promotion by medical representatives to doctors and pharmacists. Dedicated rules and procedures in the Drug Code (Article 119 et seq.) govern that type of promotion.

One answer to the above question can be found in the definition of advertising in Article 113 of the Drug Code, meaning “any action of information, canvassing, or exhortation intended to promote the prescription, supply, sale, or consumption of medicinal products.” What distinguishes advertising from other forms of communication/information is the intent of those who carry it out (e.g., to increase the prescription or sale of medicines). Conversely, one would be hard-pressed to define nurses being trained to administer a particularly complex therapy as an activity with promotional intent.

In the absence of ad hoc rules, companies have drawn general indications for how to interact with healthcare professionals from the general rules on the advertising of medicines set out in Title VIII of the Code for Medicines, starting with the distinction between mere (non-advertising) communication, institutional advertising, and what should instead be considered product advertising.

Within this regulatory framework, Farmindustria recently made some changes to its Code of Conduct (Article 3.25 et seq.) to offer more guidance and reassurance to those in the field.

The Farmindustria Code: Relationships with non-prescribers

The new Article 3.25 of the Farmindustria Code provides indications for interactions with non-prescribers involved in the administration of therapies, allowing companies to carry out information sessions and training through local operations staff, provided that

  • the activities do not have a promotional purpose (in particular, any form of advertising of medicines as defined by the Code of Medicines is expressly prohibited);
  • all information covered is related to the role of these subjects in the patient management process, clinical research, and correct and safe administration of therapy.

As for the materials, Farmindustria specifies that package leaflet and materials produced for the purpose of minimizing the risk of the use of medicines may be used, provided that they are used in the format and, where applicable, in the manner authorized by the regulatory authorities.

Thus, the key for this type of communication to be admissible seems to be that it be limited to what is strictly necessary to achieve its objective. Material addressing nurses, for example, should offer no information other than how the drug is administered and patient management instructions may be provided as long as such management is a part of their positions. That is why it is important to limit access and verify the identities of the recipients of such communications, including in the digital sphere.

Participation in conferences and webinars

Pursuant to the Farmindustria Code (Article 3.25), non-prescribers may participate in events, courses, and conferences organized and sponsored by companies, as long as they are on “subjects not related to medicinal products,” as established in Article 124(9) of the Medicines Code.

It is unclear in this context exactly how “subjects not related to medicinal products,” wording taken from Article 124(9), should be interpreted. One interpretation of this provision that takes into account the concrete needs and ultimate interests of patients may lead to the conclusion that nurses may not be invited to participate in promotional conferences and meetings on drugs, but that they may be involved in non-promotional educational initiatives, such as those relating to therapy administration methods (both physical and virtual). Additionally, Article 113 of the Medicines Code defines advertising, inter alia, as “the sponsorship of promotional meetings attended by persons authorized to prescribe or supply medicines,” thus specifying that these are promotional meetings.

Market access, account management, and scientific exchange

More specific indications are provided by the Farmindustria Code (Article 3.27) with reference to the following types of non-promotional interactions:

  • Market access and institutional affairs: The use of materials with pharmaceutical-economic content or content related to the value of the product or on the subject of health policies, pathologies, and patient course of treatment is permitted, provided that they differ in form and content from the materials used for promotional activities.
  • Account management: Activities related to the application of the company’s commercial policies, such as the delivery of product lists, are permitted, provided they are free of promotional elements.
  • Scientific exchange: Proactive sharing of data and insights related to clinical practice, company pipeline, and new product access activities is permitted (while different information on products already on the market may only be provided on a reactive basis, in response to a specific unsolicited request, with the request fully traceable).

Medical science liaison

The development of non-promotional interactions with third parties, especially in the context of scientific exchange, makes the role of medical science liaison (MSL) increasingly important in pharmaceutical companies. Unlike sales representatives, who conduct sales activities and report to the relevant corporate office, an MSL builds and maintains relationships of an exclusively medical-scientific nature and reports to the medical division.

Although the role of an MSL is not regulated, a person in this role is not a sales representative and possesses purely medical knowledge (efficacy and safety of drugs, pathologies, clinical studies, and so on), which reinforces the idea that such exchanges and interactions are built on a non-promotional foundation and performed by someone who reports to a corporate office other than the sales office.

In some cases, an SLM may also proactively share information related to clinical practice, the company pipeline, or new product access, and in doing so they may partly free themself from the strict constraints to which scientific-medical information is subject. Clearly, since this type of communication follows informative and formative logic rather than promotional logic, all the surrounding elements, such as the materials and language used, as well as meeting locations and modalities, should be selected following the same logic.

Given the delicacy of this type of communication, it is always advisable for a company to arrange for oversight by choosing one or more people (internally) responsible for communication and information to non-prescribers. It is also useful to have internal procedures and rules to ensure compliance with the general rules on advertising of medicines and Farmindustria indications.

A look at the proposed reform of pharmaceutical legislation

The very recent proposal for the reform of the Framework Directive on Medicinal Products 2001/83/EC, adopted by the European Commission on April 26, introduces some changes that seem to strengthen the positions of healthcare professionals other than doctors as recipients of drug promotion and communication campaigns. Indeed, the text available broadens the definition of advertising of medicinal products (Article 175) to include communications to those authorized not only to prescribe and dispense medicinal products, but also to administer them (basically nurses), who will therefore also be eligible to be targeted by promotional initiatives for medicinal products.

If this proposal is approved, the impact will be very significant. On the one hand, expressly including nurses as targets of promotional activities will provide firmer ground for companies interested in addressing them. On the other hand, communication to these subjects would probably be subject to the same rules and controls that apply to scientific-medical information (e.g., filing materials with the AIFA), which would certainly make these interactions more rigid. Furthermore, the issue of including nurses among possible participants in conferences and meetings under Article 124 of the Code for Medicines does not seem to be settled, since Article 183 of the proposal merely mentions “persons qualified to prescribe or supply medicinal products.”

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