On 28 September 2022, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) published joint guidelines concerning the use of social media and digital media channels by pharmaceutical companies (Joint Digital Guidelines).  IFPMA  and EFPIA are umbrella trade bodies for the innovative pharmaceutical industry on the global and European stages, respectively.

The Joint Digital Guidelines are timely.  Digital communications and the use of social media have become hot compliance topics for the pharmaceutical industry, both in Europe and globally.  Actors in the healthcare world increasingly use digital communication channels; many clinicians, patients and patient organizations actually prefer to receive content digitally.  With more content comes higher compliance risk.  Digital communications, particularly over social media, can spread fast across borders and are often publicly accessible. 

It is no surprise that a very significant number of pharmaceutical advertising cases in European markets now concern digital channels or social media.  This certainly reflects our experience; and this is an area where our pharmaceutical advertising experts are continually advising clients.

The Joint Digital Guidelines are evolutionary rather than revolutionary.  They represent one of the first attempts to promulgate a set of principles for social media and digital channels that is granular, detailed and has an international outlook.  For the most part, they codify and consolidate existing compliance principles that have permeated the regulatory ether for some time.  Note, however, the focus on influencers and digital opinion leaders, which is to some extent novel.

Although the Joint Digital Guidelines have an international outlook, they clearly take their lead from European concepts and principles.  Much of the detail is based on EFPIA’s European digital guidelines.

The Joint Digital Guidelines are designed to be an “evolving resource” for the pharmaceutical industry when considering their digital and social media activities.  They apply to companies and industry bodies who are member of IFPMA or EFPIA.  By extension, they also apply to companies who are members of national industry bodies and those who submit to the jurisdiction of national self-regulatory bodies. 

The Joint Digital Guidelines are non-binding in nature and intended to be read within the context of existing laws, regulations and codes in this area.  No doubt they will influence the attitudes of national (self-)regulatory and enforcement bodies, which often require companies to operate to a higher compliance standard than required by applicable laws.  

Give the above, we can expect the Joint Digital Guidelines to be influential national level, but it remains unclear and how national approaches may need change.  Some national regulatory or self-regulatory codes have little to no existing guidance on digital activities — and in those cases the Joint Digital Guidelines would presumably become the new benchmark.  In other cases, particularly in the larger European markets such as France and the UK, there is already a significant body of rules and enforcement positions governing digital and social media interactions.  In some areas, thesego further than the IFPMA/EFPIA position.  In those cases, the influence of the Joint Digital Guidelines is harder to predict (at least at this stage).

Structure of the Joint Digital Guidelines

There are five main parts to the Joint Digital Guidelines:

  1. Key Principles
  • This part also sets out the key responsibilities and expectations for a pharmaceutical company engaging in digital communications.
  • Identifying “Allowed” Information: Risk Considerations
  • This part includes a list of questions and risk considerations that a company should ask itself before embarking on a digital communications program.
  • IFPMA Guidance for Various Digital Channels
  • This part comprises detailed guidance for particular media channels (i.e., websites, social media, blogs, podcasts, webinars, direct digital channels such as email, and discussion forums).
  • Specific Guidelines when Engaging with Online Influencers and Digital Opinion Leaders

Some of the content of the Joint Digital Guidelines will be familiar to readers of the EFPIA Code.  Section 2 (Identifying “Allowed” Information: Risk Considerations) and Section 3 (Guidance for Various Digital Channels) borrow heavily often verbatim from EFPIA’s European digital guidelines, in Annex 2 of the EFPIA Code.  This perhaps indicates that the European approach has broader international recognition and support; and is something that other industry bodies and national authorities wish to replicate more broadly.

Key takeaways from the Joint Digital Guidelines

The Joint Digital Guidelines are — in some parts — very granular, and a detailed analysis is beyond the scope of this blog (although Covington’s pharmaceutical advertising experts would no doubt delight in giving you chapter and verse do reach out).  However, below are some noteworthy points:

General Principles

  • IFPMA and EFPIA clearly acknowledge that “any information shared through… social media and digital channels [by or on behalf of pharmaceutical companies] may potentially be accessible from anywhere in the world, which generates risk and uncertainty…”  Also “social media is accessible to the public” and “one of the highest risks when using social media” is “unauthorized promotion [of a prescription-only and/or unapproved medicine] to the public.
  • Pharmaceutical companies should therefore take a “pragmatic and vigilant” approach to compliance.
  • Companies must not use digital channels to engage in improper promotion and promotional content.  Companies must comply with applicable rules to restrict access to promotional content only to the appropriate audience.
  • Companies who generate or sponsor content on social media or in digital channels (whether promotional or not) must ensure it is truthful, non-misleading, balanced, current and accurate.
  • Companies must be transparent about their involvement with, or influence on, digital or social media communications.  A company’s involvement should be clear from the communication itself.

Responsibilities

  • Companies must establish systems to review and monitor their activities, content, and materials on social media and digital channels.  This includes compliance monitoring e.g., the timely removal of inappropriate comments.  However, there is no expectation to monitor independent third-party content that is beyond the company’s ownership, control or influence (unless local laws or codes expressly require this).
  • Companies’ pharmacovigilance responsibilities will also be relevant to their digital/social media activities, including with respect to their monitoring, record‑keeping and reporting obligations.
  • Companies must ensure that any information on digital channels is up-to-date and clearly displays for each page and/or item the date of posting or last updating.  This is a relatively novel requirement for some countries.

Online Influencers and Digital Opinion Leaders

Perhaps the most novel and interesting aspect of the Joint Digital Guidelines is its commentary on engaging with influencers and digital opinion leaders.  These might include celebrities and social media influencers; but also people who hold particular influence in healthcare fields such as well-known doctors, patients, patient advocates, etc.

According to the Joint Digital Guidelines:

Engaging with online influencers requires subtle and careful evaluation, including of the risks of undue influence towards HCPs or patients or vulnerable groups, or risks that such digital content could be perceived as improper promotion of pharmaceutical products.

The Joint Digital Guidelines go on to set out some key principles for these types of engagements.  In particular:

  • Promotional Risks engaging with influencers cannot be an indirect vehicle to promote products where this would otherwise be unlawful.
  • Undue Influence the rationale for a company to engage with an influencer or opinion leader should be “considered and documented.”  This is to avoid the perception of impropriety and undue influence (e.g., a reward for past decisions, an incentive to promote, or undue influence over future decisions).
  • Services and Remuneration the influencer/opinion leader must provide “bona fide services” or those that “serve a legitimate need” and any compensation must be “appropriate and reasonable.

Traditionally, compliance requirements of this kind apply to company engagements with healthcare professionals or patient groups.  The apparent extension to “influencers” and “digital opinion leaders” most likely reflects areas of current compliance risk and activity.  For pharma compliance geeks like us, this is rather interesting.

Responsibilities for Specific Channels

  • Websites
    • Companies may be held accountable for the content of third-party websites, where the company initiates, influences, selects or provides the content or concept, or where the company pays the authors directly.
  • Similarly, companies must be “confident” about the content of any third-party websites that they link to.
  • Search engine optimization “has become an important tool” to take audiences to the most appropriate content.  However, this must comply with applicable rules.
  • Liability for Employee Social Media Activity
    • This has been a controversial subject in Europe, and the European approach appears to have been extended in the Joint Digital Guidelines.  According to the guidance, pharmaceutical companies may be held responsible for their employees’ social media activities (on personal accounts) “…including a) if the employee can reasonably be perceived as representing the company; and b) if the employee is instructed, approved, or facilitated by the company to do so.”  Companies must therefore provide appropriate compliance training to employees.
  • Webinars
    • A company may be the direct organizer of a webinar; engage a third-party to run a webinar; or simply be a sponsor for third-party webinar.  The company may be liable for the content unless there is a strictly arm’s length arrangement where the company only provides financial support to an independent third-party.

If you have any questions about the Joint Digital Guidelines, their impact, and/or pharmaceutical advertising and communications generally, please do not hesitate to get in touch with one of our many international experts. 

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Photo of Grant Castle Grant Castle

Grant Castle practices in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management.

Grant Castle practices in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management. He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products. He has developed considerable expertise in coordinating regulatory projects covering jurisdictions outside of Europe, including Canada, South America, Eastern Europe, the former Soviet Union, Africa, the Near East, Japan, and Australia. His transactional work includes advice on regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.

Photo of Raj Gathani Raj Gathani

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals…

Supporting clients in the pharmaceutical, healthcare, medical device and consumer products sectors, Raj Gathani’s practice is built around EU and UK regulatory and strategic advice.

Increasingly, Raj concentrates on post market-launch projects, such as advising on advertising compliance, communications, interactions with healthcare professionals and patients, pricing controls and reimbursement strategies particularly in the UK and the Republic of Ireland.

Healthcare, its structure and delivery are specialist practice areas for Raj, particularly having operated healthcare and pharmacy businesses for eight years prior to joining the firm. This experience enables Raj to provide in-depth advice to healthcare clients –particularly those in the digital health space – as well as other life sciences companies whose work engages medical practice, dispensing and health-services rules.

Photo of Robin Blaney Robin Blaney

Robin Blaney has broad experience in the life sciences sector including involvement in corporate, commercial, litigation, data privacy, and regulatory matters. He has gained particular experience in licensing, collaborative, and commercial transactions for life sciences clients. His regulatory practice includes pharmaceutical, medical device…

Robin Blaney has broad experience in the life sciences sector including involvement in corporate, commercial, litigation, data privacy, and regulatory matters. He has gained particular experience in licensing, collaborative, and commercial transactions for life sciences clients. His regulatory practice includes pharmaceutical, medical device, food, and consumer product regulation.