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For independent pharmacy owners, the launch of Wegovy pills brings a familiar challenge – how to promote a weight management service without crossing the regulatory line into unlawful promotion of a POM. Richard Hough explains…

The recent arrival of Wegovy tablets on the UK market represents a significant development in weight management treatment.

Approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in June this year, oral semaglutide offers eligible patients a needle-free alternative to injectable GLP-1 medicines and has already generated substantial consumer interest.

For independent pharmacy owners, however, the launch raises a familiar challenge. How do you promote a weight management service without crossing the regulatory line into the unlawful promotion of a prescription only medicine (POM)?

The answer matters. In recent years, regulators have come under pressure to scrutinise online pharmacies, particularly those who are involved in the supply of weight loss medicines.

The commercial opportunities which are presented by GLP-1s must therefore be balanced against a complex legal and regulatory framework.

Legally, the starting point is straightforward. Regulation 284 of the Human Medicines Regulations 2012 (HMR) prohibits advertisements to the public that are likely to lead to the use of a POM.

This position is reinforced by MHRA's "Blue Guide" and the Advertising Standards Authority’s (ASA) CAP Code (rule 12.12), which state that POMs may not be promoted or advertised directly to members of the public. 

The challenge is that consumers increasingly search online for medicines by brand name. Operating under incredibly tough financial circumstances, it is understandable that many pharmacies may wish to capture this consumer demand, whilst regulators take the view that promotion of a named POM to the public undermines the safeguards which are associated with such supplies.

There is, however, an important distinction between promoting a clinical service and promoting a medicine. A pharmacy may generally advertise the availability of a weight management service, provided that the focus remains on the service rather than a particular POM.

Advertising which refers to independent prescribing, pharmacist-led assessments, dietary support and clinical suitability assessments is generally likely to be considered less problematic than advertising which is centred on a named medicine.

In practice, regulators will look at the overall impression created by the advertisement.

Using images of branded product packaging, repeated references to Wegovy tablets, pricing information linked to a particular medicine or comparative efficacy claims may all suggest that the real purpose of the advertisement is to promote the medicine rather than the service.

A recurring theme in recent ASA adjudications is that businesses often argue that they are promoting a service, while the ASA concludes that the overall presentation of the advertisement is that it promotes a POM.

The ASA assesses webpages in their entirety, including headings, imagery, embedded links, testimonials and consumer calls to action. The regulator has also shown concern where weight loss advertising could exploit insecurities around body image, trivialise the use of medicines or make efficacy claims that cannot be substantiated.

The MHRA is responsible for enforcing medicines advertising legislation. Where it identifies a potential breach, it will often begin with informal engagement, requesting amendments or removal of non-compliant content.

However, the MHRA also has at its disposal more extensive enforcement powers, including the publication of compliance rulings, formal enforcement action and, in serious cases, criminal prosecution under the HMR. For many, however, the biggest risk of MHRA enforcement action is reputational. 

The ASA cannot impose financial penalties directly, but it can require advertising to be withdrawn or amended and publish adverse adjudications on its website. As with the MHRA, the biggest risk is in most cases of infringement of ASA standards is likely to be reputational.

The General Pharmaceutical Council's (GPhC) focus is on patient safety and pharmacy governance rather than advertising law. However, advertising concerns can quickly become professional concerns where marketing practices indicate poor governance, commercial pressure overriding clinical judgment or inappropriate prescribing practices.

The GPhC has repeatedly highlighted concerns regarding online prescribing models and weight loss services (including in its recent GPhC joint statement with the MHRA and ASA).

Previous regulatory activity has included inspections, enforcement action against registered pharmacies and fitness to practise proceedings involving pharmacy professionals who are connected with unsafe online prescribing practices. 

The practical reality, however, is that regulators are most likely to investigate where there is a clear consumer complaint, competitor complaint, media scrutiny or wider patient safety concern. Weight loss medicines often present all four triggers.

The launch of Wegovy tablets has undoubtedly created commercial opportunities for independent pharmacies, which should be approached with caution.

The least risky course of action is to promote the clinical weight management service rather than the medicine, ensure all content undergoes regulatory review (don’t let your marketing team go rogue) before publication and maintain robust prescribing governance arrangements.

In an increasingly competitive market with the lure of a potentially significant commercial upside, it may be tempting to push the boundaries.

Recent regulatory activity suggests that the MHRA, ASA and GPhC are paying closer attention than ever before but it remains to be seen how effective such closer scrutiny will be.

Richard Hough is a partner and head of healthcare at Brabners and a former pharmacist.