On January 1, a new version of the Farmaindustria Code, will enter into force, replacing the current version, issued in 2016. This post aims to highlight the most striking innovations in terms of promoting prescription medicines in a   digital environment, including advertising on social networks.

The Pharmaceutical Industry Code of Best Practices (the Farmaindustria Code) is probably the most important self-regulating instrument in the pharmaceutical industry. It regulates advertising of prescription medicines and relations between laboratories and health professionals, healthcare bodies and patients associations.

It is important to recall that, as a general rule, the promotion of prescription medicines in the digital sphere under no circumstances exempts laboratories from the requirement to comply with the Farmaindustria Code, irrespective of the communications medium, format or channels used to this end. Therefore, prohibitions that are valid offline, apply equally online. In this regard, laboratories are required to refrain from using any media that, given their nature, characteristics, technical limitations, conditions of use etc. fail to ensure compliance with the established regulations. The most important rule is the prohibition on advertising prescription medicines to the general public, namely, anyone who is not a health care professional qualified to prescribe and dispense medicines.

Notwithstanding these requirements, it is clear that the pharmaceutical industry’s growing use of new technologies to promote prescription medicines calls for closer control of applicable regulations in the digital environment. The regulations, set forth in article 8 of the Farmaindustria Code require laboratories to:

  • Include in their websites a clear and prominent warning indicating that the information published on the site is addressed exclusively to health care professionals who are qualified to prescribe or dispense medicines. The new version of the Code reinforces this rule, and it now specifies in addition, that there should be a verification system or a declaration of professional health care qualification should be obtained from the person accessing such information.
  • Implement guidelines and a code of conduct and indicate the consequences of a failure to comply with this requirement, along with a procedure for controlling content to which access is allowed, and how it is stored, temporarily copied or provided as a link. This procedure should include the obligation to correct any irregularities in a diligent and expedient manner. It also specifies the need for codes of conduct and guidelines for employees and third parties acting under the control of the laboratories, which define how to behave responsibly in the digital sphere when sharing information on the company, and when using a specific medium, format or channel that it has provided to this end. In this respect, the new version of the Code adds that guidelines should expressly specify the prohibition on advertising prescription medicines to the general public.
  • The new version includes the requirement to expressly train employees in order to prevent any conduct prohibited by the Farmaindustria Code, such as sharing inappropriate content – albeit in terms of style or tone – (commenting on competitive products, off-label promotion of medicines etc.) which employees could possibly share, provide links to, publish or make comments on in their personal social networks (albeit public or private). Therefore, the Code makes it clear that the obligation extends as far as the content that employees might post on their own personal social media.
  • The new version also clarifies the fact that pharmaceutical companies will also be responsible for compliance with the terms and conditions of the social networks that they use.
  • Given that companies are responsible for content that is reproduced during meetings that they have organized or sponsored in the main, the new Code requires that measures should be set up to avoid disclosure on social networks or other communications media, if that dissemination could directly or indirectly be considered advertising of prescription medicines to the general public. This will require some form of attestation that health professionals and employees attending the meeting have been duly informed of this fact. With this in mind, the Code recommends that safeguards be incorporated in the documentation and/or contracts entered into with speakers and attendees.

Finally, a further innovation relating to the digital sphere (but included in clause 11 of the Farmaindusria Code), which probably derives from the increase in scientific and professional virtual meetings held online because of the COVID-19 pandemic, is the prohibition in virtual meetings on offering any kind of hospitality (social events, travel, accommodation and/or other expenses).

Although the Code regulations only apply to companies associated with Farmaindustria or individual adherents to the Code, it nevertheless provides a valuable guide for the whole industry. Furthermore, it is important to note that the Code makes pharmaceutical companies responsible for compliance even in the case of the activities of companies within their group, irrespective of whether or not they belong to Farmaindustria or adhere to the Code.

Unquestionably, the new version includes requirements and obligations that will strengthen commitment within the industry to ensure the transparency, ethical conduct and responsibility of pharmaceutical companies, as they will be required to implement all these changes in their internal policies.

Cintia Bernhardt

Garrigues Intellectual Property Department