A tough pill to swallow - Enforcing the prohibition on advertising prescription only medicines

As access to digital healthcare grows, consumers are benefiting from more choice, but they are also facing greater risks, particularly in respect of prescription only medicines (POMs). The UK regulator, the Advertising Standards Authority (ASA) is clamping down on rogue advertisers who are blurring the lines between consumer products and regulated medicines and promoting their products and services in breach of the ban on advertising POMs and POM treatments.

Here Fieldfisher Director, Sonal Patel Oliva, who works in our Advertising and Consumer law team, looks at how the UK regulator is tackling unauthorised advertising of POMs.

Access to healthcare has been rapidly evolving over the last few years and COVID-19 has further accelerated consumer use of digital healthcare services. Patients no longer solely rely on in-person GP appointments and pharmacy visits for example, with digital advances allowing consumers to use a variety of remote and digital healthcare services such as e-prescription services, NHS apps for appointments and other NHS services. Video and telephone triage and consultations, online pharmacies, online treatment services; and other online retailers are increasingly common.

These developments have led to greater accessibility to healthcare specialists and medicines via direct to consumer service and product offerings.

However, on the downside it has also increased the risk to consumers of being exposed to unlicensed retailers, below par or diluted products, access to POMs without the supervision of a healthcare professional and visibility of prohibited advertising of POMs.

Unauthorised advertising

As mentioned above, POMs are now readily available via a multitude of channels and some companies are increasingly marketing their products and services like consumer products, rather than regulated medicines. It is not uncommon to see products such as botox, hay fever injections and other POMs for weight loss, hair loss and skin conditions on social media timelines and websites, with some companies using promotional content, product claims, discount codes and user experiences to attract customers.

However, these activities are often in direct contravention of the prohibition on advertising POMs to the public in the UK. In fact, globally, only the US and New Zealand permit direct to consumer advertising of POMs.

Over the last year alone, the ASA has published a dozen rulings highlighting POMs that are being advertised contrary to the prohibition, including:

• Facebook ads for biotin jabs claiming positive effects on skin, hair and nails
• Tweets on Twitter promoting vitamin B12 injections
• Company website content promoting POM hair loss treatments
• Facebook and Instagram posts for Kenalog (hay fever steroid injections)
• Paid for Google ad for erectile dysfunction treatment from an online pharmacy. 

Enforcement action by the UK regulator

Following its investigations into each such breach of the advertising rules, the ASA published its findings in rulings on its website, highlighting that the advertisers either claimed to be unaware of the prohibition or were unconcerned by their failure to adhere to the advertising rules. They also sought undertakings from the advertisers not to publish such infringing ads again.

The ASA has also taken the more formal step of issuing enforcement notices for prescription only vitamin shots, botox, weight loss and hay fever steroid injections. Such notices have been published on the ASA's website and sent directly to a number of infringing advertisers within the relevant product category as a warning letter.

The notices reiterate the prohibition on advertising POMs, provide guidance and seek remedial steps from advertisers, with the threat that failure to do so would attract more formal enforcement action and referral to the Medicines & Healthcare Regulatory Agency and relevant professional regulatory bodies. This list of product categories is not exhaustive - it simply demonstrates the products that the ASA has focused on to date. It is very possible that the ASA could turn its attention to other product categories in the future.

The role of social media

Another point to note is that many of the adverts challenged by the ASA were social media ads. The increasing number of social media platforms, ad formats (videos, reels, stories, posts etc.) and the sheer volume of adverts has previously made it difficult for authorities to monitor advertising.

In addition to this, the ability to quickly take down and replace or revise social media ads means that brands might be more willing to take greater risks with the type of content that appears on social media. However, enforcement action by the ASA and its ability to focus on different product categories has been facilitated by the ASA's increased use of technology, resulting in a much more proactive approach to its monitoring activities.

The ASA has been using CCTV monitoring cameras on online sites, age based Avatars on websites and YouTube and data science and AI tools to scan digital content, including on social media platforms. In 2021, 89% of 20,456 ads were withdrawn or amended (AAWs) following proactive action from the ASA (with only 11% resulting from complaints from consumers, competitors and industry bodies). This is a significant increase from the 2016 figures, when only 47% of 4,824 ads were proactive AAWs.

What do you need to consider?

Although advances in technology are opening up wider access to the remote and digital healthcare market and medicines, they are also supporting the UK regulator to proactively monitor and pursue infringing advertisers and identify unauthorised advertising of POMs. Unauthorised advertising of POMs and POM treatments is clearly on the ASA's radar and it has already targeted advertisers in a number of product categories.
 
When planning your marketing strategies and materials for your products and services, you should consider the following:

1. Are your products and services medicines or medical treatments by function or presentation?
2. How are your products and services classified?
3. Do you hold the necessary licences, registrations and marketing authorisations (where relevant)?
4. Are your marketing strategies, activities and content compliant? 
5. Are your products and services caught by the ban on advertising POMs and POM treatments?

For more information on advertising and consumer law matters, please contact Sonal Patel Oliva.