On 26 January 2023, the Prescription Medicines Code of Practice Authority (the PMCPA) published long-awaited Guidance on Social Media 2023 (the Guidance). While a Digital Guidance note, which covered certain issues arising from use of social media, was published by PMCPA in 2016, the large number of complaints since that time is evidence of continued uncertainty regarding permitted activity in this area.
However, while the Guidance acknowledges the challenges introduced by the “open and transitory” nature of social media, it broadly reflects recent PMCPA decisions and rejects the more permissive approach that some stakeholders had advocated was appropriate. Nevertheless, the additional clarity provided by the Guidance is welcome and, by defining general principles applicable to use of social media and issuing more detailed guidance in certain areas, PMCPA has provided a framework to assist companies in managing their social media activity going forward.
Application of the Guidance
Social media is defined as “a term used to describe websites and applications that enable users to create and share content and to interact with one another in social networks, for example, Twitter, LinkedIn, Facebook, Instagram, Tik Tok, YouTube.”
A key premise of the Guidance is that social media is “only a platform for communicating and consuming information” and that laws, regulations and codes applicable to other platforms are equally applicable to digital communications. The challenges associated with use of social media, in view of the prohibition on promotion of unlicensed medicinal products and indications and the fact that prescription only medicines (POMs) may not be promoted to members of the public, are expressly recognised. The remainder of the Guidance simply considers the general requirements in the particular context of social media.
Two key principles are highlighted:
- Transparency – The Guidance states that pharmaceutical companies should always be transparent about their communications and materials they publish. Any content posted on social media, including content posted by third parties on behalf of the company, should therefore include a clear statement about the company’s involvement.
- Responsibility – Pharmaceutical companies are accountable under the ABPI Code of Practice (the Code) for social media activity that has a “UK nexus” because it is posted of shared by a UK company and/or refers to the availability or use of products in the UK, including activity by affiliates, material disseminated by third parties acting on their behalf and potentially material or activities that they sponsor. Consistent with a raft of recent PMCPA decisions, content posted by employees in a personal capacity, which refers to their professional role, is likely to come within the scope of the Code and under the responsibility of the employing pharmaceutical company “unless, for very clear reasons, it could be shown otherwise.”
The Guidance sets out overarching considerations for all social media activity under two headings:
- Pharmacovigilance – The Guidance notes that companies should ensure social media platforms are monitored for pharmacovigilance purposes and that users are signposted to where they can report adverse events.
- Other legislation and codes – In addition to the Code, all social media activity is expected to comply with other relevant legislation, guidance and codes on advertising and promotion such as the EFPIA Principles for the use of digital channels.
The detailed guidance is broken down into various topics including:
- Links – Companies are responsible for the content of any links they provide on social media channels, and companies should confirm that the content they link to is appropriate before including it in a post. The post should indicate whether the link is to the pharmaceutical company material/website or other non-company material/website.
- Hashtags and tagging – Tagging other persons or entities has the effect of directing readers to the associated social media accounts. Companies should be cautious about inclusion of tags unless satisfied that the tagged account is compliant with the requirements of the Code. In relation to hashtags, companies should ensure that only hashtags that are relevant to the content of the material are chosen. Inclusion of hashtags that contain a claim for a POM or the name of a product are likely to constitute promotion of that product.
- Responding to misinformation/ correcting inaccuracies – The Guidance notes that this is a difficult area as, by correcting certain information, a company is essentially confirming that the remaining information is accurate. The approach to be followed is therefore a matter of company policy. The Guidance suggests that posting a link to the full SPC, package leaflet or the electronic medicines compendium (eMC) might not be viewed as an unreasonable response.
- Signposting vs posting/sharing/re-sharing – Signposting directs viewers to certain information whilst indicating the audience for whom the information is intended. Confirmation that the viewer forms part of the intended audience is required prior to access, and the information on the ‘signpost’ must not be promotional, but be sufficient to enable the viewer to determine whether the information is relevant to them. In contrast, posting (creation of content), sharing and re-sharing (engagement or interaction with existing content) on social media involves proactive dissemination of information. The holder of the account responsible for such activities is accountable for the content and is required to ensure that it is certified as compliant with the Code, where necessary.
- Corporate news and announcements – Companies must ensure that news or announcements issued to the general public on social media are appropriate for the audience. Companies may share information relating to new executive appointments, corporate partnerships, acquisitions, employee recognition, and company awards, but information should not relate to products, pipeline assets or clinical research.
- Professional profiles and job advertising – Employee job titles and company job advertisements should avoid mentioning POMs as this is likely to constitute promotion. However, the inclusion of limited information about a product or therapy area in “an appropriate and proportionate way” within the ‘Experience’ section of a professional profile may be acceptable.
- Disease awareness for the public – Companies are permitted to post or share non-promotional information via social media with the intention of increasing disease awareness and providing educational information on a disease and its management. Such material must be certified.
- Patient support – Pharmaceutical companies may use social media to host information for patients who have been prescribed a specific POM (such as videos about how to take a medicinal product) hosted in secured sections on social media platforms such as YouTube. The target audience must be clearly identified and the content should be appropriate for that audience.
- Product and pipeline milestones – While press releases and other materials relating to product or pipeline milestones may be directed towards persons with a legitimate need to have such information (including relevant journalists and investors), where this is disseminated on social media, it is likely to be open to the wider public and may be read by a broader audience than intended. The Guidance therefore recommends that companies should consider using dedicated closed groups for journalists and investors to share appropriate information. Companies should also take into account certain safeguards when considering publication of posts intended for investors, such as clear signposting of the intended audience, and ensuring that links to press releases on a company’s website are to sections tailored to the intended audience.
- Working with social media influencers – Companies are permitted to engage social media influencers as consultants because of their expertise in digital engagement. Transparency is “critical” and the relationship between the pharmaceutical company and the influencer must be made clear at the outset. The Guidance notes the risks associated with engagement of influencers including that their activity could be deemed to constitute undue influence on health professionals or the public or improper promotion of medicinal products. The company can be found liable for the influencer’s conduct even if he or she acts contrary to written instructions.
- Clinical trial recruitment – Advertising the need for participants for clinical trials should be “carefully targeted at appropriate individuals who it can reasonably be assumed fulfil the demographics/criteria for the trial and can then be screened”. The information shared must not refer to specific products or raise unfounded hopes of entry into the trial or successful treatment outcomes.
- Communications via social media are subject to all of the requirements of traditional forms of advertising and, where there is a UK nexus, this includes the Code
- Use of social media raises particular challenges in view of the difficulties limiting access to the intended audience (for example health professionals or investors)
- Companies should consider the purpose of any communication and whether the content is appropriate for the audience, taking into account the functionality of the relevant social media platform, the terms and conditions for use and removal of material
- Posting of new content and sharing/ resharing existing content is likely to result in proactive dissemination of such communications by the account holder and therefore, where necessary, all such material should be certified in accordance with the Code
- Employees should assume that all social media activity (including through personal accounts) will be subject to the Code, if it refers to professional matters or names products
- Platforms that permit the addition of user generated content are high risk; consideration must be given to compliance with GDPR, sites should be moderated and inappropriate content removed and pharmacovigilance data collected
- Companies should issue local guidelines and provide training to employees on use of social media