December 5, 2022

Medical and scientific communication on the web: New IFPMA-EFPIA guidelines

The Italian version of this article has been published on November 29, 2022 on AgendaDigitale.eu, within our “Legal Health” monthly column.

On September 28, two international associations representing the pharmaceutical industries, the IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) and the EFPIA (European Federation of Pharmaceutical Industries and Associations), published a joint Note for Guidance on social media and digital channels (“Guidance Note”) that offers guidance for pharmaceutical companies using the web to provide doctors and patients with information about their products and the diseases they are intended to treat.

This document builds on Annex 2 to the EFPIA Code of practice for the use of digital channels, providing more detail on specific aspects and types of online activities.

In our view, the Guidance Note is important not so much because the principles it contains are new, as they could already be gleaned from existing legislation and codes of conduct, but because having them written out clearly and systematically offers clarity and generates trust among practitioners.

Key principles

Transparency and accountability are key principles for digital communication from pharmaceutical companies, as cited in both the Guidance Note and Annex 2 to the EFPIA Code.

According to the principle of transparency, companies must clearly indicate when a form of communication is created or sponsored by them. This is a fundamental rule that we find in the EFPIA Code and also at the national level in the Farmindustria Code. By now we are all familiar with the phrase “With the unconditional contribution of,” whereby a company notes that it has merely provided economic support for a certain activity (including in online form) without determining its content or conditioning it in any way. This phrase is an outgrowth of the principle of transparency.

Under the principle of accountability, companies are accountable for content disseminated online (including on social media) that originates with and/or is branded and/or sponsored by the companies or by third parties acting on their behalf. Companies are responsible for (i) cybersecurity, which includes protecting users’ personal data; (ii) adequate monitoring; (iii) online activities carried out by their employees; and (iv) pharmacovigilance.

With regard to adequate monitoring, companies are not required to perform general oversight of activities carried out by independent third parties or on digital channels that cannot be traced back to the company. While this is true, it is also true that when a communication originates in a completely independent context and is then associated with the company, e.g., through a hashtag, the company becomes aware of such content and can be held liable if the content is inappropriate and the company does not take any steps to correct the situation.

With regard to accountability for the online activities of employees, a company will be held liable for any communications by its employees that appear to be made on behalf of the company or are disseminated at the company’s instruction, with its approval, or with its help.

Finally, under certain conditions a company is responsible for pharmacovigilance over information disseminated online about its products. The guidelines for Good Pharmacovigilance Practices (GPP) stipulates that marketing authorization holders should regularly check the Internet and digital media under their management or responsibility for potential reports of suspected adverse reactions.

Guidance for specific activities: Websites

Both documents provide guidance for various types of digital media. The fundamental rule for websites is that when such sites contain promotional information about products, access must be restricted to medical personnel and password-protected (or protected by disclaimers in the case of medical devices).

For further information, refer to the document issued by the Italian Medicines Agency (“AIFA”) in September 2022 that contains a scientific information Q&A section. It explains that companies that conduct online scientific promotional activities are required to adopt the strictest possible measures to prevent the information from reaching—through any channel, including the Internet—the public or, in any case, parties other than those to whom it lawfully may be addressed.

On the web, though, doctors’ and pharmacists’ personal and professional identifying data are freely accessible to anyone, so the procedure for registering to view specific reserved pages must provide an appropriate means of ascertaining a user’s real identity. The relevant documentation must always be available for inspection by the AIFA, if requested.

Having said that, pharmaceutical companies may publish on their websites—in pull and not push mode[1] and without any rewording—the trade names of medicines, including medicines available by prescription, possibly with package leaflets and RCPs (summaries of product characteristics), since these are a form of informational rather than promotional communication.

Blogs/forums/social media

For the sake of simplicity, we will treat the various digital channels in this group as a single category, based on the fact that users can interact with each other on these channels. Such channels may be open or closed, and, in the latter case, what was said above about the need to reserve access for the appropriate recipients applies.

In all cases, and particularly with regard to a platform created and managed by a third party on behalf of the company, special care must be taken to establish the role of the company itself; the principle of accountability mentioned above must be kept in mind.

If a company establishes content, provides materials, and selects, contracts, and remunerates authors directly, it is fully responsible for what takes place on the platform, and the company itself should therefore directly provide procedures for monitoring and timely intervention in the event of inappropriate content. On the other hand, if the company does not carry out any of the above activities directly and instead entrusts them entirely to a third party managing the platform and merely makes a financial contribution, its liability may be mitigated. This must be assessed on a case-by-case basis, as the boundaries of mutual liability may be blurred.

Podcasts/webinars

Product information offered in podcasts and webinars must be treated as promotional material for all intents and purposes and therefore filed with the AIFA under the standard procedures. The company is responsible for differentiating documentation of a promotional nature from documentation that is not subject to the provisions governing the advertising of medicines to be filed with the AIFA.

Some recommendations for online pharmaceutical companies

In view of the above, for better management of online presence in compliance with regulations, pharmaceutical companies are advised to adopt special guidelines for governing and handling certain internal processes, specifically the following:

  • social media policies, i.e., internal procedures for monitoring online activities, with the aim of providing criteria for monitoring and moderating online channels, indicating whether and under what circumstances content is to be considered inappropriate and therefore removed;
  • guidelines and training for employees on the criteria to be followed when using their profiles to disseminate content that concerns their professional experience and the company’s activities;
  • procedures and training for employees for pharmacovigilance activities to be performed in relation to social media and digital channels to ensure the necessary monitoring and reporting.

Lastly, we would like to emphasize the importance of contractual agreements with third parties to which activities relating to the company’s digital presence are outsourced. The roles and responsibilities of both should be established in a timely manner.

[1] Pull mode is when information is sought by the user and accessed in response to an affirmative action on their part; push mode is when information is conveyed/proposed to the user by a computer system.

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