On 26 January 2023, the UK’s Prescription Medicines Code of Practice Authority (“PMCPA”) published its “Social Media Guidance 2023” (the “Guidance”).
The Guidance is the first of its kind in the UK and is long-awaited.
The PMCPA is the self-regulatory body that administers and enforces the ABPI Code (the voluntary advertising code that many pharmaceutical companies adhere to in the UK). The ABPI Code sets out a number of overarching principles but does not address social media in detail. The PMCPA had some years ago published “digital guidelines” but these were archived for updating.
The first – and probably most important – thing to say about the Guidance is that it (finally) exists. Social media has become a major compliance headache for UK pharmaceutical companies. These days a significant number of PMCPA complaints, investigations and adjudications concern corporate or employee social media activity, particularly on LinkedIn. The absence of clear and codified guidance until now led to a lack of clarity. Key regulatory principles had evolved through a series of case rulings, which were often highly fact-dependent. While dissecting cases into the early hours may be interesting for us pharmaceutical advertising lawyers, compliance teams will likely appreciate having codified guidelines to refer to.
Secondly, the Guidance is likely to disappoint anyone hoping for seismic shifts in the PMCPA’s regulatory approach. Much of the Guidance aligns closely to rules and principles that had developed in the Authority’s case history. It also broadly aligns with EFPIA’s and IFPMA’s recently published “Guidelines Concerning the Use of Social Media and Digital Media Channels” (see our blog post).
Overall, the Guidance is probably a “mixed bag”:
- In many aspects, it pulls together and codifies principles that had developed and to some extent varied across a history of case rulings. For example, the Guidance now firmly advises companies to assume that any “work-related” activity by employees on their personal social media accounts is attributable to the company, absent “very clear” evidence otherwise. The Guidance also clarifies compliance points when using links within social media posts.
- There is also some relatively novel commentary around, for example, the possibility of clinical trial recruitment or routing patient support through social media.
- In other aspects, where industry commentators had hoped for a clear, pragmatic or even permissive approach, the Guidance does not clearly address some existing areas of ambiguity. The PMCPA historically takes a fact and case specific approach, so it is no surprise that in certain areas it is reluctant to fetter its discretion for future cases by publishing overly granular guidance. However, the risk is that it may well give rise to differing or unduly conservative interpretations. For example, given the volume of corporate news disseminated on Twitter and LinkedIn, commentators had hoped for a progressive and very clear position on corporate announcements from pharmaceutical companies. The Guidance goes into detail here in the Corporate News and Product and Pipeline Milestones sections; and the output is somewhat nuanced and leaves scope for differing interpretations.
- Similarly, there has been some controversy around whether naming a product on social media (without making a product claim or mentioning an indication, use, etc.) amounts to product promotion. The Guidance restates EFPIA’s view (which is that the name alone is still likely to be promotional) and gives “informal” additional advice.
Below we have highlighted some key points in the Guidance together with our headline observations. The PMCPA will introduce and discuss the Guidance through stakeholder events, which may bring out the need for further clarity.
If you would like to discuss the Guidance and what it means for your UK operations, please contact our specialist UK pharmaceutical advertising and communications lawyers: Grant Castle, Robin Blaney, Brian Kelly and Raj Gathani.
Longer Read: Some Key Points from the Guidance
I. General Principles
- Although social media has become a high-traffic forum for personal and professional communications, it does not benefit from relaxed or more lenient rules. Advertising prescription-only medicines and pre-approval medicines/uses is prohibited and pharmaceutical companies must “identify ways of utilising social media whilst complying with these restrictions.” In particular, “[t]he content, target audience and use of the [social media] platform are relevant factors to determine applicable rules, not the media as such.”
- The Guidance emphasises that the “open and transitory” nature of social media channels creates unique challenges for pharmaceutical companies. Companies should “consider carefully before engaging in and facilitating discussions about medicinal products or treatment options on these channels” and “how each activity is restricted and tailored to the needs of the intended audience.”
- Companies are encouraged to put in place internal social media guidelines which should “set the expectations and boundaries” and “clarify what behaviour is expected online.” It is implied (but not stated) that this should cover employee and corporate social media activities. A company’s internal guidance must be “clear and consistent with all applicable codes, laws and regulations.”
II. Transparency and Responsibility
- The Guidance stresses the importance of transparency: making clear when a pharmaceutical company or third party acting on its behalf is involved with a social media post (e.g., by publishing, producing or directing the content or funding/sponsoring the platform or post). The involvement of the company must be clear from the outset.
- The Guidance stresses the level of responsibility a pharmaceutical company carries for social media activities carried out by third-parties acting on the company’s behalf and where the company is deemed responsible for the activity of an employee/affiliate.
- Companies are strongly advised to preview (and where necessary certify) content created on their behalf by third parties, and require withdrawal rights for non-compliance.
- Companies may be held responsible for interactions with third-party content, such as “liking” a post from another company.
III. Employee Personal Social Media Activity
The Guidance reiterates that a company may be held responsible for employees’ personal social media activity:
“(a) if the employee can reasonably be perceived as representing the company, and/or
(b) if the employee is instructed, approved, or facilitated by the company to do so.”
Given the potential overlap between professional and personal social media activity, particularly on platforms like LinkedIn, the Guidance states:
“Pharmaceutical companies should assume that the ABPI Code would apply to all work-related, personal social media posts, for example, LinkedIn or Instagram posts/activity by their employees unless, for very clear reasons, it could be shown otherwise.”
Companies must therefore put “appropriate policies in place” and provide employees with “regular training […] for responsible conduct on social media.”
As is clear from PMCPA case history, the Guidance emphasises that a UK employee “liking” a third-party post (originating outside the UK) is likely to come within the scope of the ABPI Code. In our experience, this has been a real issue for some international companies, where employees often “like” content posted by overseas colleagues that is either non-compliant in the UK or where the “like” changes the context of the original communication, so that it is no longer corporate announcement and becomes a communication to the general public.
IV. Product References
The Guidance reflects the general principle that the dissemination of content over social media likely has a “proactive” quality.
The Guidance summarises EFPIA’s position that:
“any mention of a POM [(prescription only medicine)] [on social media] is likely to be considered promotion of that medicine to the public and is prohibited.”
The PMCPA Guidance provides “informal advice” that including a product name (brand or generic) in a social media post on its own, and “particularly if alongside its indication”, is presumptively promotional. It is then up to companies to prove otherwise, which is often difficult.
A product may also be promoted on social media without being named, but by indirect references to its use/indication.
The Guidance concludes that “[t]he proactive dissemination of material, including the name and/or indication of a medicine on social media, is likely to be considered promotion of that medicine.”
V. Guidance on Specific Aspects of Social Media
A. Corporate News and Announcements (General)
The Guidance states that any news or announcements a company posts/shares on social media “must be appropriate for the public.” The content “should not directly or indirectly mention products” and “not include signposting to information about products or pipeline assets, including clinical research.”
B. Product and Pipeline Milestones
Companies are increasingly looking to use social media channels to inform the corporate community (e.g., investors and financial journalists) about product and pipeline milestones. The Guidance acknowledges the difficulties of this because social media content is likely to be visible to the general public rather than the narrower corporate community.
It notes: “there is a difference between making a press release/information available only to investors or to the relevant press, to be published or not, and linking to it on a social media platform open to the wider public where it may be read by a broader than intended audience.”
The Guidance contemplates companies posting a limited news announcement on social media, which contains a link to a more detailed press release, which is clearly signposted and that readers may access should they choose to. Safeguards to consider in relation to such posts include:
- Tailoring each element to the relevant audience.
- Clear signposting of the intended audience the post is targeted at.
- Ensuring all information is factual, balanced and non-promotional.
- The risks that mentioning the name of the product and/or indication may be promotional.
- Requiring the audience to self-validate before accessing substantive product-related content (e.g., on the pharmaceutical company’s website).
According to the Guidance the following example may be acceptable:
“An informative statement shared via a corporate public LinkedIn account which is linked to a press release within the media section on [a company’s] corporate website about recently published results for an unlicensed medicine. The statement on LinkedIn should not mention product name or study name, but should clearly signpost the intended audience, for example, ‘For Investors’ or ‘For Medical Media’ and might state ‘new press release regarding recently published data in Oncology is available on our website [link to media section of corporate website].”
C. Use of Links Within Social Media Posts
The Guidance reminds companies that they carry responsibilities for any links they include in social media posts. This includes carrying out due diligence to ensure the linked-to content is appropriate and has a clear intended audience.
D. Tagging and Using Hashtags
In both cases, the Guidance advises companies to take caution. Tagging another social media account may lead the public to inappropriate accounts, views or content.
Hashtags (e.g., “#obesity”) can help users find and navigate topics of interest. However, the Guidance reminds companies that hashtags may constitute direct or indirect product claims, particularly when taken together with the other content of the post.
E. Public Disease Awareness
The Guidance confirms that companies may carry out and highlight genuine, non-promotional disease awareness activities on social media, provided (amongst other things) this adheres to wider disease awareness guidance in the UK (such as Appendix 7 of the MHRA’s Blue Guide).
F. Working with Social Media Influencers
According to the Guidance:
- “Transparency is critical and the relationship between the pharmaceutical company and the influencer must be made clear at the outset.”
- Companies must be mindful of the risks of undue influence and of indirect promotion, particularly as in certain cases the company may be liable for the content the influencer posts.
The Guidance gives the following example of what may be acceptable:
“Using a social media influencer who is living with the condition as a consultant to support a disease awareness campaign and share disease information to counteract misinformation.”
G. Patient Support
Companies might use certain channels, such as YouTube, to host patient-support content. That might include “how to” videos about the proper use of a medicine. The Guidance suggests this must be in secure, non-public sections, where the target audience is clear and the content appropriate for them.
H. Clinical Trial Recruitment
The Guidance notes that recruitment for clinical trials is complex, challenging and subject to broader clinical trials rules and requirements. In principle, the Guidance envisages some scope for companies to publicise the need for trial participants over social media in a targeted and non-promotional way.
Such content must:
- be “carefully targeted at appropriate individuals who it can reasonably be assumed fulfil the demographics/criteria for the trial and can then be screened.”
- “not raise unfounded hopes of entry into the trial or successful treatment outcomes.”
- “avoid referring to specific products”; instead companies “are encouraged to include a description that supports appropriate people/patients in the disease area to find out more information.”
The Guidance gives the following example of what may be acceptable:
“Paid Facebook advertisements targeting a specific demographic to invite patients with a condition to apply to participate in a clinical trial. A link should be provided to relevant information from the NHS/body organising/conducting the trial.”