UK: Ironing Out The Wrinkles In The Advertising Of Prescription-Only Medicines

This month the UK Advertising Standards Authority (ASA) highlighted the rules around the advertising of prescription-only medicines (POMs) as the ASA clamped down on two website-based advertising campaigns for the POM Botulinum Toxin A (more commonly referred to as "Botox").

The advertising of POMs is prohibited under UK regulations (for example, the Human Medicines Regulations 2012 (HMRs)) and Rule 12.12 of the UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (Code). However, material of a purely factual and/or informative nature does not fall under the scope of the HMRs as "advertising" and so could not be considered an advertisement for the purposes of Rule 12.12. Reference or factual/informative content is therefore permitted, as long as it is a true reflection of the drug licence.

Two health and beauty clinics, Dermaskin Clinics and HB Health of Knightsbridge, made references to Botox on the home pages of their websites, with links through to pages with further details about the treatment. The Independent Healthcare Advisory Service and the ASA challenged whether the references breached the Code by advertising a POM to the public.

The ASA was concerned that visitors to the websites could access information about Botox directly, rather than following a consultation with a doctor. Furthermore, although some of the information provided was fair and factual, there was also promotional wording such as "revolutionary treatment", "astonishing results" and "Botox dramatically softens facial lines and wrinkles leaving you looking younger". Furthermore, POMs are only licensed for use of the therapeutic indications detailed in their summary of product characteristics ("SPC") and Botox is only licensed for the treatment of glabella (frown) lines in the area of cosmetic therapy. However, the websites discussed the treatment of various other facial lines and wrinkles, such as "forehead wrinkles", "bunny lines on the nose" and "smokers lines around the lips".

Both advertisers agreed to remove references to Botox from their home pages, but the ASA felt that this did not resolve the issues. Dermaskin Clinics argued that references to treatment areas should take into account normal clinical practice, given that these uses of Botox are common amongst specialists and doctors.

The ASA ruled against the advertisers. Although the ASA understood that it was common in clinical practice for Botox to be used in areas not specified in the SPC, it considered that such references on the websites went beyond factual information that was representative of the SPC and constituted a promotion of a POM to the general public and a breach of the Code. The ASA warned both advertisers to take special care when referencing Botox in the future and were instructed to remove the adverts in their current form.

Although both of these rulings relate specifically to Botox, they provide useful guidance on the Code requirements around advertising of POMs more generally. There are three key takeaway points:

• A medical consultation must be the subject of any advertisement, with the POM only referenced as a potential outcome.
• Any information relating to a POM must be presented in a balanced and factual way and in all cases must reflect the content of the drug licence/SPC.
• References to POMs must only discuss licensed uses of the drug.

© Arnold & Porter Kaye Scholer LLP 2014 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.