The Medicines and Healthcare products Regulatory Agency (MHRA), Advertising Standards Authority (ASA), and the General Pharmaceutical Council (GPhC) are issuing a warning to businesses seeking to promote newly licensed medicines, as well as those that do not yet have a licence.
We have seen recent examples of businesses promoting
- pipeline products, such as newer forms of oral and injectable products used for weight management, including waiting lists for these products, and
- newly licensed oral GLP-1s, which are prescription-only medicines (POMs).
The CAP Code is clear that medicines must have a licence from the MHRA before they are marketed (rule 12.11) and that prescription-only medicines or prescription-only medical treatments cannot be advertised to the public (rule 12.12).
Given that the products are either still subject to regulatory review or are classed as POMs, referencing them by name or using language such as ‘GLP-1 tablets’, ‘oral GLP-1s’ or ‘the new weight-loss tablets’ is likely to breach the Code. That includes where waiting lists for those medicines are being advertised. The ASA’s Enforcement Notice sets out the actions that the respective regulators may take against non-compliant advertisers.
We are jointly emphasising the importance of reviewing advertising as a matter of priority to ensure all advertisers in the sector work within the rules. The ASA will continue to work alongside its regulatory partners, such as the MHRA and the GPhC to ensure that patients remain protected and that professional standards are maintained.
Julian Beach, MHRA Executive Director of Healthcare Quality and Access, said
“Medicinal products are not ordinary consumer goods, and improper use or overconsumption may have serious health consequences. The Human Medicines Regulations, including those provisions that relate to advertising of medicines, exist to protect the public. These Regulations prohibit the advertisement of a medicinal product for which there is no Marketing Authorisation in force. Creating consumer demand for a medicinal product by promotion of such a product before any UK regulatory appraisal for safety, quality and efficacy and subsequent authorisation has been completed is not permitted. The Regulations also prohibit the publication of an advertisement to the public likely to lead to the use of a prescription-only medicine.
“A consultation with a healthcare professional is the most appropriate way to determine suitable treatment options for an individual patient. It is vital that those who are responsible for marketing of treatment services understand the rules in place to protect consumers and remember their professional duty to safeguard healthcare consultations and decision-making.”
Jess Tye, Regulatory Projects Manager at the ASA, said
“The weight-management sector is fast-moving, and we regularly see new approaches in advertising from businesses. We remain vigilant to these changes and will continue to act swiftly to take action where advertisers are not sticking to the rules. We expect advertisers to heed this warning to protect consumers and maintain a level playing field for businesses.”
Roz Gittins, Chief Pharmacy Officer at the GPhC, said
“We will not hesitate to act where those that we register fail to meet our standards. This can include taking enforcement action against the pharmacy, the owner, the Superintendent Pharmacist, or individual registrants. We will continue to work collaboratively with other regulators to keep the public safe.”