UK Guidance Tackles Social Media ‘Compliance Headache’ For Pharma
Announcing product milestones and liking LinkedIn posts are just some of the topics addressed in a long-awaited guidance that deals with the challenges prescription drug makers face in the UK when using social media.
Liking a LinkedIn post, recruiting participants for clinical trials, disseminating corporate news and announcing product or pipeline milestones. These are among the topics covered by a first-of-its-kind UK guidance that aims to help pharmaceutical companies that manufacture prescription drugs navigate the potential pitfalls of social media.
The Social Media Guidance 2023 was published by the Prescription Medicines Code of Practice Authority, the independent body that administers the Association of the British Pharmaceutical Industry’s Code of Practice.
“We recognise that social media can pose particular challenges for companies under the ABPI Code,” said PMCPA director Alex Fell. “With its wide reach and international audience, information on medicines can be seen by audiences it wasn’t intended for,” Fell explained.
The new guidance, according to law firm Covington & Burling, is “long-awaited.” Social media has become “a major compliance headache” for UK pharmaceutical companies, it said (see sidebar).
“These days a significant number of PMCPA complaints, investigations and adjudications concern corporate or employee social media activity, particularly on LinkedIn,” observed the firm. “The absence of clear and codified guidance until now led to a lack of clarity.”
The new guidance, published on 26 January, was produced in consultation with the Medicines and Healthcare products Regulatory Agency (MHRA), the ABPI and pharmaceutical companies.
It reflects the relevant UK legal requirements as well as the codes of practice and guidance and advice from the European Federation of Pharmaceutical Industries and Associations, the International Federation of Pharmaceutical Manufacturers & Associations, and the MHRA. It also outlines the PMCPA’s views based on available case precedent. (Also see "Industry Explains How To Avoid Risks When Using Social Media & Digital Channels" - Pink Sheet, 10 Oct, 2022.)
Promoting prescription-only medicines (POMs) to the public is prohibited by UK law (and by European law) as is the advertising of a medicine which has not received a marketing authorization.
The guidance says that since companies are prohibited from promoting POMs and pre-approved drugs, they must “identify ways of utilising social media whilst complying with these restrictions.”
It warns, for example, that if an “employee’s personal use of social media was found to be in scope of the ABPI Code, the company would be held responsible.” It says that 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.
“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,” Covington & Burling observed.
“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 [a] corporate announcement and becomes a communication to the general public.”
The PMCPA guidance urges companies to make sure they have appropriate policies in place and that relevant employees receive regular training appropriate to their role, for responsible conduct on social media.
Regarding clinical trial recruitment, the guidance says that companies must ensure that the advertising “is carefully targeted at appropriate individuals who it can reasonably be assumed fulfil the demographics/criteria for the trial and can then be screened. Any information shared must not raise unfounded hopes of entry into the trial or successful treatment outcomes.”
An example of what might be considered acceptable is “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 [National Health Service]/body organising/conducting the trial.”
Posting Corporate News
The guidance clarifies that any corporate news that companies post or share on social media must be appropriate for the public and should not be product related.
It can include, for example, new executive appointments, corporate partnerships and acquisitions, employee recognition, and company awards. “This category does not include signposting to information about products or pipeline assets, including clinical research… Such shared/disseminated content should not directly or indirectly mention products.”
Product and Pipeline Milestones
The PMCPA guidance notes that while companies increasingly want to use social media to inform investors or journalists of product and pipeline milestones, using these digital channels to do so is complex because they “are open to a broad audience, beyond the intended audience for the post itself.”
It discusses several safeguards that companies should consider when contemplating making such posts on social media. These include tailoring the material to the intended audience, clearly signposting the intended audience at which the post is being targeted, and ensuring that the information provided is factual, balanced and non-promotional.
In an example of what might be acceptable, the guidance says that this could be an informative statement shared via a corporate public LinkedIn account which is linked to a press release within the media section on the 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].”