A website, www.dermaskin.com, promoting a health and beauty clinic included a home page which featured a variety of treatments and included the title "Anti-wrinkle Treatment" text underneath stated "Botox (Dysport, Vistabel, Azzalure, Xeomin, Bocouture) Botox is the trade name by which Botulinum Toxin A is widely known. It is a proven and safe treatment, which has been in use for over 16 years. To find out more click here". Clicking on the link connected to a separate page which explained how Botox was commonly used as a beauty treatment.
1. The Independent Healthcare Advisory Service (IHAS) challenged whether the reference to 'Botox' on the website home page breached the Code by advertising a prescription-only medicine to the public.
2. The ASA challenged whether the references to 'Botox' on the website more generally breached the Code by advertising a prescription-only medicine to the public.
1. & 2. Dermaskin Clinics agreed to remove the reference to Botox from their home page. They explained they had understood from industry guidance that the reference to Botox was only likely to be problematic when it appeared on the home page and that this was the basis on which they had agreed to remove the references to Botox from where it was first seen by the complainant. They also stated that the Botox page, which linked through from the "anti-wrinkle treatment" section on the home page, included a statement regarding the requirement to attend a consultation to determine the suitability of Botox on the areas of concern.
They said permissible references to treatment areas should take into account normal clinical practice in the UK and that the usage of Botox for facial lines and wrinkles were both common and widespread amongst the specialists and doctors within the speciality. It was known that Botox had high efficacy in the treatment of non-licensed facial lines and wrinkles. They believed the fact that this type of treatment had been analysed by clinicians across the UK did not automatically result in reference to the non-licensed treatment of lines and wrinkles as ‘promotional’ and that this only related to experimental or infrequent treatments.
They added that off-license use of medication was also allowed in the UK as long as the clinician took full responsibility and informed the patient of this. They said this position was supported by the fact that leading UK cosmetics insurers did not limit the usage of Botox to just the licensed areas of the face or body and that this position had been reached as a result of the safety of application and use and because of the widespread nature of the work that been carried out on Botox.
1. & 2. Upheld
The ASA understood the advertising of prescription-only medicines (POMs) to the general public was prohibited by the Human Medicines Regulations 2012 (HMRs) and that was reflected in the CAP Code (Edition 12) rule 12.12 12.12 Prescription-only medicines or prescription-only medical treatments may not be advertised to the public. However, we further understood that certain types of content that could be characterised as reference material or announcements of factual and informative nature were not covered under the scope of HMR’s definition of advertising and, as a result, could not be considered advertisements for the purposes of rule 12.12 12.12 Prescription-only medicines or prescription-only medical treatments may not be advertised to the public. We therefore assessed the claims on the website to establish whether they were of that nature and would be considered as advertising for the purposes of rule 12.12 12.12 Prescription-only medicines or prescription-only medical treatments may not be advertised to the public.
We understood the Dermaskin Clinics website was for a clinic that focused primarily on non-invasive beauty procedures. We also noted it offered Botox treatments and understood that Botox was a POM.
We noted the website made several references to Botox (including the registered names Dysport, Vistabel, Azzalure, Xeomin and Bocouture) originally on the home page (before DermaSkin Clinics amended the website) and also on the page that linked from that initial reference and which described how Botox worked.
We also noted Dermaskin Clinics had made changes to the website to remove the reference to the word “Botox”. However, we considered that the removal of the word itself (or its registered trade names) from the home page alone did not itself resolve the issue because visitors who clicked on the “anti-wrinkle treatment” hyperlink were then connected to a page titled “anti-wrinkle treatment” which included the sub-title “Botox (Dysport, Vistabel, Azzalure, Xeomin, Bocouture). The page went on to describe Botox and its potential application in detail.
We noted that page included the statement "Please note that this page informs you of how Botox works and that prior to administration a consultation would be required with the doctor to determine suitability. We will discuss treatment options that will encompass the problems and specific areas of concern you may have". We considered that although this additional text indicated that a consultation was required to confirm suitability of Botox for potential customers, the claim appeared within a promotion for Botox as a treatment and did not present Botox as a potential outcome of that consultation. We considered that in order to comply with the CAP Code, the consultation itself needed to be the subject of the ad and only referencing Botox as a potential outcome of that consultation. We further understood that any description of Botox as the potential outcome of a consultation needed to be presented in a balanced and factual way and for such factual references to reflect the content of the Summary of Product Characteristics (SPC) document.
Furthermore, because Botox references needed to be presented within the context of a consultation, we considered that website ads should not provide separate information on Botox which could be navigated to directly, without consumers also viewing information about the consultation process.
We noted the website included claims such as "this revolutionary treatment … .is the most popular such treatment in the world" and "thousands of these treatments are performed every year with astonishing results". It was felt that these went beyond factual references to Botox and constituted a direct promotion of a POM.
We also noted the website included claims such as "Botox is the trade name by which Botulinum Toxin A is widely known. It has been used for a variety of medical conditions including blapharspasm and muscle spasticity for over 20 years”. We noted this piece of content was both factual and a fair representation of the SPC. We therefore considered that this type of factual claim was likely to be acceptable because it did not fall under the scope of 12.12 12.12 Prescription-only medicines or prescription-only medical treatments may not be advertised to the public.
Furthermore, we noted the ad stated “Botox works within a few days but can take as long as 14 - 21 days for the full paralysing effects to show through. Botox anti-wrinkle injections are not permanent so we recommend repeat treatments at 3 - 6 monthly intervals”. We considered that this was a fair reflection of the reference to repeat treatments of glabella lines in the SPC which stated “Improvement of severity of glabellar lines generally occurs within one week after treatment. The affect was demonstrated for up to 4 months after injection. Treatment intervals should not be more frequent than every three months”. We therefore considered that this particular statement was also likely to be acceptable because it was factual and fairly reflected the SPC and therefore it did not fall under the scope of 12.12 12.12 Prescription-only medicines or prescription-only medical treatments may not be advertised to the public. /p>
We noted the ad made statements which did not appear to be clear promotional claims, but equally did not constitute a fair representation of the factual information contained within the SPC and were therefore problematic. Such claims included “You may notice that the botox works more effectively and lasts longer with each subsequent treatments”. We considered these factual claims went beyond the SPC and therefore breached rule 12.12 12.12 Prescription-only medicines or prescription-only medical treatments may not be advertised to the public. of the Code.
We understood that POMs were only licensed for use for the “therapeutic indications” details in the SPC and noted the only aesthetic use for which Botox was licensed was the ‘glabellar’ lines, which are the vertical lines on the forehead between the eyes. Whilst we understood that in both normal clinical practice and off-license practice, Botox was commonly used to treat other lines and wrinkles, we understood that Botox was not licensed for use on any other lines or wrinkles or for any other aesthetic treatment. We noted the website made references to the glabella lines in the general description of the Botox product. However, we noted the page also included the text “Common botox Treatment areas: Forehead lines, glabella lines (frown), crows Feet (side of eyes), Infra-orbital lines (below the eyes - subject to skin condition), Peri-oral lines (lipstick bleed lines - sometimes combined with dermal fillers), chin puckering, nasal flaring” and that the ad included claims such as “…Vistabel, is the most popular treatment in the world, prescribed by doctors to eliminate wrinkles in the upper third of the face. This includes forehead lines … and crow’s feet around the eyes”. Although we accepted that it was common in clinical practice for Botox to be used in areas not specified in the SPC, we considered such references constituted an ad for a POM because they went beyond factual information that was representative of the SPC.
We noted the ad featured before and after images of vertical forehead lines with text underneath stating “After just one treatment the forehead lines have virtually disappeared”. We noted the ad included references to treatment areas for which Botox was not licensed and considered those references therefore breached the Code. Although photographic images were likely to be acceptable providing they were used to explain to consumers where the glabella lines were, we considered that any visual images which showed the potential outcome of treatment would be understood as an efficacy claim and therefore constituted a promotion for Botox, thus breaching 12.12 12.12 Prescription-only medicines or prescription-only medical treatments may not be advertised to the public. /p>
Because many of the direct and implied references to Botox within the website constituted a promotion of a POM to the general public, we therefore concluded that the Code had been breached.
The ad breached CAP Code (Edition 12) rule 12.12 12.12 Prescription-only medicines or prescription-only medical treatments may not be advertised to the public. (Medicines, medical devices, health-related products and beauty products).
The ad should not appear again in its current form. We told Dermaskin Clinics to take special care when referencing Botox in the future.