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Third-party generated content in the Pharmaceutical Industry. The challenge of influencers

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José Ignacio Olleros, member of the Pharmaceutical Working Group of the Spanish Association of Compliance (ASCOM), explains in this article that it is important to bear in mind that these medicines or products are not just another consumer item, but should be considered as a public good

The promotion of medicinal products is regulated in Spain by Royal Decree 1416/94 on the Advertising of Medicinal Products for Human Use, which implements the provisions of Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community code relating to medicinal products for human use (last amended on 26th July 2019) and the "Code of Good Practice of the Pharmaceutical Industry". In addition, there is a self-monitoring guide on the advertising of medicinal products for human use to the public, drafted by the Spanish Government. This regulatory framework explicitly prohibits the promotion of prescription medicines directly or indirectly to the general public. On the other hand, the current regulations on the advertising of non-prescription medicines to the public and medical devices expressly warn against "recommendations made by scientists, health professionals or other persons who may, due to their notoriety, incite the consumption of medicines or the use of medical devices", with the exception, in the latter case, of advertising promoted by the Public Administrations.

Likewise, each Marketing Authorisation Holder (MAH), through its company's Compliance Officer, must ensure that the laws and codes are complied with in all promotional activities in which it participates, including those commissioned from suppliers. Information on the safety of medicines is vital in the pharmaceutical sector, so we must ensure that the existence of possible adverse effects reported in the context of a promotional action is promptly communicated to the Pharmacovigilance departments through the normal channels. It is essential that each pharmaceutical company also ensures respect for privacy, truthfulness, cybersecurity, intellectual property and business secrecy in fair competition. Each of these key points must be considered when designing breach prevention programmes in the Compliance Healthcare environment.

It is therefore necessary to establish procedures, within each company's Compliance programmes, through which the activities and interventions of these partners can be controlled, ensuring that these actions - which depend on a contractual relationship with our companies - comply with the established standards of quality and regulations. All of this deserves stricter vigilance when these actions take place in the complex reality of the digital environment: social networks, websites, chats, blogs, etc. In this regard, although we lack explicit legislation in this regard, there are guides such as that of the IAB (World Association of Communication, Advertising and Digital Marketing) that regulate advertising in the digital environment.

But what about content generated by third parties, and what do we consider to be a "third party"?

Contracts with suppliers are binding only on the parties who participate in their formation with their will. Third parties do not have to bear the legal consequences arising from the business of others. This is the so-called relative effect of contracts in which the third party, being a stranger to the legal relationship between creditor and debtor, is legally protected from the consequences of a contract between the parties due to the principle of protection of third parties through unenforceability, i.e. the ineffectiveness of enforcing an act or contract against third parties (a contract is "unenforceable" against a third party).

As to who is a "third party", we could say that "third party" is opposed to "part", i.e., "third party" is one who is not a "part": "party" to the specific and well-determined legal, business or contractual relationship. However, their actions take place within the social contract, in the Rousseaunian sense, by virtue of which everyone owes respect to the rules of the game established by society.

Thus, when we speak of third parties, we refer to those who do not act as authorised and officially accredited socio-economic agents, subject to deontology, as well as to duty and control established by legal norms and corporate agreements within the health care activity itself.

On the other hand, content generated by third parties becomes particularly relevant when we refer to "other persons" other than healthcare professionals, who may, due to their notoriety (we are referring to those known as influencers), incite the consumption of a medicinal product or the use of a healthcare product. Indeed, due to their position of visibility in society, they can become creators or transformers of opinions with a direct or indirect impact on consumption or behaviour.

In particular, the ability of influencers to become "prescribers" of interest to brands has given rise to "influencer marketing" as a form of advertising, distinguishing with objective data those people who have real influence from the false influencers who organise, around them, marketing activities, including communication and advertising.

The effect of this phenomenon could be important in the health sector, insofar as the influencer's indications can bring patients closer to or move them away from the ordinary authorised ways to maintain their health, superimposing their promotional message on those of authorised agents, i.e., those issued by public health, marketing laboratories, health product manufacturers, etc.

The full article can be read in PMFarma.

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