Drug watchdog the MHRA has been very active recently against marketers of botox treatments including two offering this as a competition prize, one of which was major woman’s monthly Bella. Jonathan Mayner reveals whether these activities turned out to be a suitable case for regulatory treatment.
Topic: Health & Beauty
Who: MHRA, Bella magazine, various health & beauty practitioners
When: 2010-2011
Where: UK
Law stated as at: 08 July 2011
What happened:
In spite of the fact that botox is a well-known cosmetic treatment with a clear market in the general public, it remains a prescription only medicine ("POM") subject to very stringent regulations which restrict, among other things, how it can be advertised. Marketinglaw recently reviewed the results of complaints made to the relevant regulatory bodies over the course of the last year or so and discovered that advertisers are regularly falling foul of these regulations in respect of botox. So who can botox advertising be legally aimed at and why and how are advertisers getting it wrong?
Who regulates the marketing of medicines in the UK
While the Advertising Standards Authority does have some scope to investigate the advertising of medicines, such matters are usually dealt with by industry-specific regulators. The Medicines and Healthcare products Regulatory Agency (the "MHRA") is empowered by statute to regulate the pharmaceuticals industry, including the marketing of medicines and healthcare products. The Medicines (Advertising) Regulations 1994 (the "Advertising Regulations") and the Medicines (Monitoring of Advertising) Regulations 1994 (the "Monitoring Regulations") are the key pieces of legislation dealing with advertisement of medicines in the UK.
Under section 7 of the Advertising Regulations, advertisements for POMs cannot be targeted directly at consumers. Where marketing of POMs is mistakenly or otherwise directed at the general public, the MHRA will generally hear any complaints raised and take appropriate action.
What is botox?
Botox (short for Botulinum toxin) is a naturally occurring neurotoxin which can cause botulism poisoning, a life threatening illness in humans. It is also used clinically, via injections, to treat various conditions including muscular spasms, certain symptoms of motor neuron syndrome, chronic migraine, excessive sweating and the cosmetic treatment of wrinkles.
Botox is manufactured by Allergan Inc although other companies manufacture the toxin under different trade names such as Merz Pharma's Xeomin, however "botox" is commonly used to refer to the clinically-used toxin generally rather than as a specific reference to Allergan's Botox product.
Given these products' toxicity levels and the dangers inherent in their use they are classified as POMs in the UK, with the consequence that advertising for botox cannot be targeted to the general public.
Clinics and beauty salons under scrutiny
The MHRA regularly reports the results of investigations into complaints that it receives in relation to advertisements for medicines. Over the past year or so a number of reports have related to investigations of advertisements for botox treatments made by private clinics and beauty salons. In some cases these reports name only one or two establishments, but as recently as March 2011 a single report named 28 businesses (ranging from recognisable names such as Harley Body Clinic to small hair and beauty salons) which had amended their advertising in response to MHRA investigations into complaints that botox was being advertised to the public.
The prevalence of these actions indicates a degree of confusion among health & beauty practitioners about the status of botox as a POM and / or the laws governing the promotion of such products.
Such confusion is perhaps understandable on the part of the proprietors of a small beauty salon, however it would be surprising indeed if private clinics run by healthcare professionals were not aware of botox's POM status. More likely these clinics are falling foul of the Advertising Regulations because they are producing materials which are being held out as being for general information purposes, but which the MHRA are finding to be advertisements directed to the public.
Competition Prizes
In April 2011 the MHRA announced that it had received a complaint from a healthcare professional about an advertisement leaflet issued by Pall Mall Medical, a private clinic. The leaflet advertised an open evening at the clinic at which Botox was being offered as a competition prize. The MHRA investigated and upheld the complaint and reported that the clinic promptly reviewed their procedures to ensure that future marketing materials complied with the relevant legislation.
This followed a similar investigation reported by the MHRA in June 2010 in which the regulator had investigated a complaint by another healthcare professional against the major monthly women's magazine Bella. The magazine had held a competition in March 2010 in which its readers were offered the chance to win botox treatment. This was deemed by the regulator to be a promotion of a POM to the public and Bella was forced to withdraw the prize (no doubt to the disappointment of those readers who had entered the competition) and had to conduct a review of their internal clearance processes in relation to their activities relating to medicinal products to ensure future compliance.
Given that commentary on botox regularly features in health and beauty and celebrity magazines it seems that a degree of caution is clearly advisable on the part of publishers to ensure that they are not deemed to be in breach of the Advertising Regulations.
What constitutes an advertisement?
The clear message here is that advertisers and publishers need to avoid explicit references to botox or any similar POM in any material that could be construed to be an advertisement to the public. In response to MHRA action (and perhaps increasing awareness of the POM status of botox) compliant health & beauty practitioners tend to make generic references to "anti-wrinkle injections" or suchlike.
Furthermore, clinics need to be very careful about what reference or other material they produce for the benefit of customers. The Blue Guide, a booklet published by the MHRA to provide guidance to advertisers states that:
"Advertising is understood to encompass written or spoken words intended to encourage . . . use of medicines by the public, generally by means of highlighting qualities of the medicine ("product claims"). The Regulations exclude from that definition reference material, factual informative statements or announcements, trade catalogues and price lists, provided that they do not make a product claim"
Anecdotally it seems that clinics are attempting to highlight their willingness to provide botox treatments to the public without being deemed to be advertising to the public by producing informative material (such as factual articles about the history and uses of botox, types of treatment, side effects etc.) either online or in pamphlet form. Producing such material without being deemed to be making product claims which might induce the general public to seek out the treatment is unsurprisingly proving to be a tightrope walk that few have mastered.
Other, safer ways in which clinics and other advertisers can seemingly attract customers without making product claims would appear to be through the use of words such as "botox" and other brand names for the toxin as meta-tags in their website code or as advertising keywords such as via Google's Adwords system, both of which methods seek to ensure that consumers searching for botox and similar treatments will find links to the websites of treatment providers without those providers actually promoting botox per se, provided of course that any information on the underlying website is compliant and that references to such treatments are suitably generic. It remains to be seen whether the MHRA would seek to restrict this type of advertising behaviour in the future, although there would seem to be nothing in the Advertising Regulations expressly prohibiting it.
Consequences of advertising prescription only medicines to the public
When treatments such as botox prove popular with the general public, there are clear commercial incentives for pushing the boundaries of the Advertising Regulations in seeking out new customers. However section 23 of the Advertising Regulations provides a clear disincentive in that certain breaches (including breach of the prohibition against the advertisement of POMs to the public) are criminal offences punishable by a fine and / or up to two years in prison.
In that context, the MHRA's preferred approach of naming and shaming offenders, seeking retraction of the offending promotions and demanding a review of any relevant compliance procedures seems tame indeed. This softly, softly approach is understandable given that many advertisers may be unaware that they are breaking the law and that criminal sanctions may be deemed too extreme in the circumstances, however given the regularity with which the MHRA is having to investigate botox promotions, the regulator's actions are certainly not having a deterrent effect (although clearly once the MHRA becomes involved advertisers are falling into line, the threat of criminal sanctions no doubt uppermost in their minds).
Why this matters:
The consistency and persistence of the MHRA in responding to complaints and taking action against clinics and other advertisers in relation to the promotion of botox to the public is a reminder of the fact that just because there is a market in the general public for a product does not mean that it can be promoted directly to the public if the product is in fact a POM.
Where a product such as botox has entered the public consciousness so effectively it is understandable that occasionally advertisers mistakenly believe that these treatments are not POMs and can be promoted to the public. That said, the raft of MHRA actions against private medical practices indicates that even advertisers who ought to know that these treatments are POMs are getting it wrong and that great care is required when drafting any materials on botox which are intended for public consumption.
