Promotion of botulinum toxin type A - Summary Report - November 2022
Published 14 February 2023
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Promotion of unlicensed botulinum toxin type A by Oreon Life Science.
Merz Pharma UK Ltd complained about an advertisement for a botulinum toxin type A product by a Korean company called Oreon Life Science at the Facial Aesthetic Conference and Exhibition in London in June 2022. The complainant alleged that a display hosted by Oreon Life Science at the conference showed images of vials of a medicine (with a brand name visible and subsequently with a brand name removed) that does not hold a UK Marketing Authorisation (licence). Next to the images was the statement: “The New Botulinum Toxin Type A”.
Regulation 279 of the Human Medicines Regulation 2012 prohibits the advertisement of medicinal products that do not hold a valid Marketing Authorisation. While the prohibition does not prevent factual answers to unsolicited questions about an unlicensed medicine, any activity that appears to be designed to solicit such questions would be considered promotional and in breach of the prohibition (for further information, see chapter 4 of the MHRA Blue Guide).
MHRA upheld the complaint and considered that a medicine not licensed in a UK territory had been promoted at a UK conference; we noted that the event website described it as: “The UK’s premier medical aesthetic conference and exhibition”. While advertising material relating to products that are not licensed in the UK may be displayed at international conferences of high scientific standing provided that a significant proportion of attendees are outside the UK, material should (among other requirements) prominently indicate that the product is unlicensed in the UK. From the information provided, we could not see such a statement. MHRA also considered that removal of the brand name from the display in this instance was insufficient to prevent questions about the unlicensed product being solicited.
Oreon Life Science did not respond fully to all of MHRA’s requests for information about their presence at the conference, and MHRA was disappointed not to have received full cooperation in a complaints investigation as expected of all companies conducting activity on UK territory. However, Oreon Life Science did confirm that they had reviewed their procedures and had made amendments to ensure that an unlicensed medicine in the UK is not promoted in the territory. They stated that they have reviewed their marketing activity for overall compliance as required for the UK as set out in the MHRA Blue Guide.