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.
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.
