Note: This advice is given by the CAP Executive about non-broadcast advertising. It does not constitute legal advice. It does not bind CAP, CAP advisory panels or the Advertising Standards Authority.
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Erectile dysfunction (ED), sometimes known as impotence, is the inability to get and maintain an erection that is sufficient for sexual activity. It is very common and mainly affects men over the age of 40.
- Is the ED treatment a licensed medicine?
- Is the ED treatment Viagra or another Prescription-only medicine?
- Is the ED treatment a device?
- Is the ED treatment a therapy?
Is the ED treatment a licensed medicine?
Only those medicines which are licensed to treat erectile dysfunction should include references to the treatment of ED in their advertising (12.1 and 12.11).
In 2012, the ASA upheld complaints about a direct mailing for a blue pill which stated “Defeat: Erectile Dysfunction, Premature Ejaculation & Low Testosterone Once And For All! Maximize Pleasure, Libido, Arousal & Release ... Enjoy All Night Sex!” It considered made medicinal claims for an unlicensed product (Wyldfire Ltd, 10 October 2012).
Marketers who unsure about whether their product is a medicine and needs a licence should contact the MHRA.
Is the ED treatment Viagra or another Prescription-only medicine?
Some forms of Viagra are prescription-only medicine (POM) used for the treatment of sexual dysfunction and as such may not be advertised to the public either directly or indirectly. (Rule 12.12). In 2015, the ASA considered a sponsored search ad for a pharmacy which included the claims “Rise up to erection problems” and “Erection help” and which referred to the relative cost savings for treatment against competitors. It was established that the recommended treatment did not always include a POM and that in such cases the treatment comprised of advice relating to lifestyle changes, information on the causes of Erectile Dysfunction (ED), alternative treatments and recommendations for further investigations. However, it was also established that the reference to the saving in the ad could only apply to the POM treatment for ED because at the time the ad appeared, the POM was the only treatment which carried a charge. As such, the ASA ruled that the ad indirectly advertised a POM to the public (Superdrug Stores plc, 11 February 2015).
In November 2017, the MHRA re-classified Viagra Connect from a prescription-only medicine (POM) to a pharmacy medicine (P), following consultation and advice from the Commission on Human Medicines. As such, marketers may refer to this particular product in their ads, provided no element of the ad is likely to indirectly promote a POM. As with all medicines, marketers must obtain a licence from the MHRA before selling or marketing the product in the UK and all claims about the product must conform to the licence and the product’s summary of product characteristics (SPC).
Marketers selling Viagra Connect and wanting to refer to the treatment of erectile dysfunction more generally should take care to ensure they aren’t indirectly promoting POMs. If they sell both POM and non-POM treatments, marketers are strongly advised to ensure they advertise these in line with the above guidance, to avoid breaching rule 12.12.
Is the ED treatment a device?
Advertising claims that a device can to treat or help with erectile dysfunction are likely to render that product a medical device. Marketers would therefore need to ensure the advertised device is appropriately CE Marked before making any medicinal claims. Marketers unsure about whether their product is a device should read this MHRA guidance.
The ASA and CAP consider that erectile dysfunction is a condition where treatment should be carried out under the supervision of a suitably qualified health professional. Advertising claims that a device can be used to treat erectile dysfunction (or claims that are likely to have the same meaning) could be considered to discourage essential medical treatment, if the treatment using that device is not being carried out under the supervision of a suitably qualified health professional (rule 12.2). Ads for CE-Marked devices where the referenced ED treatments are carried out under suitably qualified medical supervision should only make objective claims for which robust documentary evidence is held. The ASA is likely to expect that evidence to be in the form of clinical trials on humans.
Is the ED treatment a therapy?
The ASA and CAP consider that erectile dysfunction is a considered for which treatment should be carried out under the supervision of a suitably qualified health professional.
Advertising claims that a therapy can be used to treat erectile dysfunction (or claims that are likely to have the same meaning) could be considered to discourage essential medical treatment, if that treatment is not being carried out under the supervision of a suitably qualified health professional (rule 12.2).
If the treatment is carried out under appropriate medical supervision, the advertised treatment claims would need to be supported by robust documentary evidence in the form of clinical trials.