Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
A Neurology Pharmaceutical Survey relating to the use of botulinum toxin injections for the treatment of primary headache or migraine disseminated by Allergan Ltd. was ruled in breach of the ABPI Code of Practice following a complaint to the Prescription Medicines Code of Practice Authority (CASE AUTH/2274/10/09 published in March 2010).
The survey was found to be promoting Botox in a manner which was inconsistent with its summary of product characteristics. An associated payment of a cheque for £35 to recipients of the survey was ruled on appeal from Allergan not to breach the ABPI Code.
On reading the report, the MHRA was concerned that the survey and associated payment promoted an unlicensed use of botulinum toxin products to doctors and offered them a prohibited benefit. Regulations 3A(1) and 21(1) of the Advertising Regulations provide that:
"3A(1) No person shall issue an advertisement relating to a relevant medicinal product unless that advertisement complies with the particulars listed in the summary of product characteristics."
"21(1) … where relevant medicinal products are being promoted to persons qualified to prescribe or supply relevant medicinal products, no person shall supply, offer or promise to such persons any gift, pecuniary advantage or benefit in kind, unless it is inexpensive and relevant to the practice of medicine or pharmacy."
Following advice from the Independent Review Panel on Advertising, the MHRA made a determination that the survey was an advertisement in breach of regulation 3A(1) of the Advertising Regulations and that the cheque was in breach of regulation 21(1).
Allergan confirmed that they did not intend to use the survey again. They agreed to issue a corrective statement to all recipients of the survey and cheque.
Regulation 21(5) of the Advertising Regulations provides that:
"21(5) No person qualified to prescribe or supply relevant medicinal products shall solicit or accept any gift, pecuniary advantage, benefit in kind, hospitality or sponsorship prohibited by this regulation."
No determination was made on this point as it was deemed not in the public interest in this case to pursue doctors who had accepted the payment in good faith as recompense for completing a survey. Recipients were asked to donate the money to charity.
Corrective statements and all papers relating to this case are published below.
Date case raised: 8 March 2010
Date action agreed: 4 June 2010
Date of publication: 16 July 2010
MHRA determination 
