Promotion of unlicensed botulinum toxin type A by DFKBIOLAB inc.
Published 14 February 2023
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[COMPLAINANT redacted until publication] complained about an advertisement for a botulinum toxin type A product by a Korean company called DFKBIOLAB inc at the CCR Conference and Exhibition in London, UK on 13–14 October 2022, and on social media. The complainant alleged that a social media post of a counter display at the conference showed images of vials of a medicine (with a brand name visible) that does not hold a UK Marketing Authorisation (licence). Next to the image was a sign stating: “[Brand] is a botulinum toxin type A 100U” and a brochure for the product on display at the conference.
Regulation 279 of the Human Medicines Regulation 2012 prohibits the advertisement of medicinal products that do not hold a valid UK 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 likely 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 flagship event in medical aesthetics uniting surgical, dermatological and aesthetics specialties”. 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.
DFKBIOLAB inc confirmed that they will review their marketing activity to ensure that an unlicensed medicine in the UK is not promoted in the territory. The company also agreed to ensure overall compliance as required for the UK as set out in the MHRA Blue Guide going forward.