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Authors: Will Holmes and Marie Manley.
In order to better reach consumers, the use by companies, including pharmaceutical manufacturers, of social media (from Facebook adverts to LinkedIn promotions, Instagram posts and employees’ tweets) has increased exponentially in recent years. Companies’ employees and affiliates are using social media more than ever, too, increasing the risk of exposing their companies to criticism if they are deemed to be promoting a product in contravention of the rules. Maria Isabel Manley and Will Holmes of Sidley Austin LLP discuss the UK advertising of prescription-only medicines using social media.
The regulatory framework applicable to medicinal product advertising is complex—and trying to get to grips with the regulatory regime for advertising pharmaceutical products on social media in the UK can be particularly confusing. There are multiple different regulators and sets of rules, governing what can and cannot be said. Determining which applies depends in part upon whether the product is a prescription-only medicine (POM), or can be sold over-the-counter (OTC). The legislative regime, set out in EU law under Title VIII of Directive 2001/83/EC and transposed into UK law by the UK Human Medicines Regulations 2012 (HMR 2012), is reflected in and supplemented by rules such as those set out for POMs in the Medicines and Healthcare products Regulatory Agency’s Blue Guide (the MHRA Blue Guide) and the Association of the British Pharmaceutical Industry’s Code of Practice (the ABPI Code) (administered by Prescription Medicines Code of Practice Authority (PMCPA)), and for all medicines in the UK Code of Non-broadcast Advertising and Direct & Promotional Marketing (the CAP Code) (governed by the Advertising Standards Authority (ASA)). To provide an example of the confusion presented by the multiple regimes: Section 12 of the CAP Code provides a set of rules for the promotion of pharmaceutical products to the public, including specific provision banning the advertising of POMs to the public. However, it is very rare to find ASA rulings on POM advertising—mainly because those are dealt with either by the bio/pharmaceutical industry’s self-regulated body, the PMCPA, or (in the most serious cases) by the MHRA.
To add further complexity, much of the time, cases about the advertisements of pharmaceuticals are not made public. This is often because the cases are settled before they require serious consideration by the regulator. That means that there is a dearth of case law by which pharmaceutical companies and their advisors can seek out guidance on what they can and cannot say in their advertisements. We have carried out an in-depth analysis of the published cases of the MHRA, PMCPA and ASA as they relate to the advertising of bio/pharmaceutical medicinal products on social media over the last two years. This article will explore some of the key trends as regards POMs that we have uncovered through this analysis, in order to provide some guidance as to the common pitfalls facing those trying to advertise their products on social media.
Under Article 88 of EU Directive 2001/83/EC, transposed into UK law via Regulation 284 of the HMR 2012, there is a strict prohibition on the publication of advertisements to the public likely to lead to the use of a POM, with an exception for approved vaccination campaigns. This ban is reflected in the other rules regulating the advertising of medicines to the public, like the MHRA’s Blue Guide and the ABPI Code.
In the MHRA’s 14th Annual Report on the regulation of medicines advertising, it states that in 2019 it worked with the ASA to put together an enforcement initiative on the advertising of botulinum toxin products, which are POMs, to address an increased case load in 2019—this work, it states ‘will have a particular focus on social media’. A high proportion of the complaints received by the MHRA in 2019 concerned the advertising of botulinum toxin products and other POMs to the public by cosmetic clinics and other service providers—the complaints were mainly about advertising for botulinum toxin products on websites and social media including Facebook, Instagram and Twitter.
Companies cannot, therefore, place advertisements for their POMs on social media. The ASA states on its website that no references to POMs should be made in media at all, because this is likely to be seen as promoting a POM. However, the ASA sets out an exception to this rule—references may be made to POMs on company websites, where balanced and factual information that is clearly non-promotional, and is not misleading, is included. The ABPI Code states that whilst POMs must not be advertised to the public, ‘information about POMs which is made available to the public either directly or indirectly must be factual and presented in a balanced way’ (rule 26.2). The Supplemental Information to clause 26.2 describes the very limited circumstances in which such information can be shared—for example in providing balanced, non-promotional information on diseases generally, or information in response to a request for information by a member of the public. Some information may also be made available to inform shareholders and the stock exchange by way of annual reports and announcements. This information must not be provided for the purpose of encouraging members of the public to ask their health professional to prescribe a specific POM.
Given these exceptions, it is perhaps not surprising that the regulators (and particularly the PMCPA) have had occasion to consider whether posts on social media (which purport to fall under the exception allowed for purely factual information) actually breach the prohibition on promoting POMs to the public. It has proved difficult for manufacturers to publish social media posts that provide purely factual information, without being found to promote a specific POM by the backdoor. For example, in the recent case Complainant v Sanofi, a manufacturer referenced its POM in a tweet, stating that the company had ‘fully engaged in assisting the Review team to consider the complex issue arising from the use of [the product] to treat women and girls of child-bearing potential suffering from epilepsy’. The PMCPA considered this to constitute an advertisement of a POM to the public, because the tweet named a POM and referred to its use. Another case, Complainant v GlaxoSmithKline, saw the PMCPA take issue with one of a series of tweets, in which a manufacturer gave details of the performance of a POM in some recent trials. Again, the PMCPA found that although the provision of certain financial information to the public is in principle acceptable, posts on Twitter are immediately visible to all of the account’s followers, regardless of whether or not they are healthcare professionals (HCPs). By identifying the achievement of positive headline results from trials relating to a POM, the manufacturer had promoted a POM to the public, in breach of the prohibition.
Ultimately, it is advisable to avoid referencing POMs in social media posts altogether: it may be difficult for companies to post about pharmaceutical products using social media platforms—to which the general public have access and to which it is not always possible to obscure posts from the public’s view.
The regulators have also focused on the spreading of social media posts for those other than the intended audience to see. The most prevalent examples have appeared on LinkedIn. The PMCPA has considered the platform to be somewhat distinct from other platforms, in that it is ‘a business and employment-orientated network and… primarily, although not exclusively associated with an individual’s professional heritage and current employment and interests’. With marketers wanting to provide information to professionals alone, LinkedIn appears to be a network that could let companies avoid the public, promoting POMs to HCPs without contravening the prohibition on promoting POMs to the public. Where this has been possible, the PMCPA has applied strictly the rules on what information needs to be shared when promoting to HCPs. In the case Anonymous v Grunenthal in October 2019, for example, the PMCPA criticised the company for failing to include prescribing information and other obligatory information when promoting to HCPs.
However, a number of cases have shown how difficult it is for marketers to limit the audience of their social media posts, including those on LinkedIn. In those cases, whilst marketers have attempted to create posts aimed at HCPs, they have reached members of the public. However, in many cases, posts theoretically only aimed at HCPs and employees have been ‘liked’ by employees of the marketer’s company, who have shared that post with their followers. The PMCPA has in those cases considered the employee’s action to be an endorsement of the post, and vicariously a promotion by the company of the POM in question to members of the public. In the October 2019 case, even the ‘liking’ by a UK employee of a post published by the company’s German sister company was enough for the PMCPA to find a nexus to the UK and a subsequent finding of a breach of the prohibition under the ABPI Code. Even strong social media training and guidance for employees, which may help companies avoid being put in a position where employees are spreading posts to the public, may not be enough to protect the company from being found to breach the prohibition, in situations where employees act against their training.
To the extent that it is possible, then, posts purely targeting HCPs must be ensured to contain all of the information required in any other HCP advertisement. On top of this, however, it may prove difficult to avoid posts being endorsed and spread by employees, which could lead to a subsequent finding of a breach of the prohibition on promotion of POMs to the public. Ultimately, marketers must be very careful about what they post and where they post it, particularly if they are providing information about POMs on social media.
The Coronavirus (COVID-19) crisis has highlighted our reliance on social media to stay connected. Whilst the current circumstances will not last forever, online communications are not going away. With the regulators having to react to new instances of companies using social media to connect with and market to potential customers, manufacturer clients and their advisors alike need to be aware that manufacturers’ activity on social media can have knock-on effects that could land companies in hot water. In particular, manufacturers should avoid posting anything on social media that might be interpreted as promoting POMs, and employees must be educated as to the effect of their online likes, shares, comments and retweets. Going forwards, posts and activity online (particularly concerning POMs, and whether by manufacturers themselves or by their employees) needs to be closely monitored and scrutinised for potential breaches of the regulatory regime.
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Maria Isabel (‘Marie’) Manley leads Sidley Austin’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law. She represents development-stage and established global life sciences companies in a broad spectrum of matters, both contentious and non-contentious. Marie advises clients in the pharmaceutical, biotechnology, medical devices, chemicals, cosmetics and food sectors in proceedings before both national and European courts and the regulatory agencies in the UK and across Europe. She has particular experience on issues arising during the life cycle of medicinal products, including IP, advertising, product liability and competition.
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