AUTH/3166/2/19 - Complainant v Sanofi

Alleged promotion of Epilim on Twitter

  • Received
    27 February 2019
  • Case number
  • Applicable Code year
  • Completed
    11 June 2019
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the May 2020 Review

Case Summary

A complainant who described him/herself as a concerned UK health professional, complained about a tweet sent by Sanofi UK.  The tweet referred to Epilim (sodium valproate) and read:

               ‘Today we spoke @IMMDSReview [the

Independent Medicines and Medical Devices Safety Review].  We have fully engaged in assisting the Review team to consider the complex issue arising from the use of Epilim to treat women and girls of child-bearing potential suffering from epilepsy.’

Epilim was indicated for the treatment of generalized, partial or other epilepsy.  The summary of product characteristics (SPC) stated that for female children and women of childbearing potential, valproate must be initiated and supervised by a specialist experienced in the management of epilepsy.  Valproate should not be used in female children and women of childbearing potential unless other treatments were ineffective or not tolerated.  Further information was provided in a number of sections of the SPC including that every effort should be made to switch female children to alternative treatment before they reached adulthood. 

The complainant noted that Epilim (sodium valproate) had a black triangle.  The tweet included the brand name and the indication which was likely to attract interest in the use of Epilim in patients.  The complainant alleged that as this was a promotional item sent out by the official Sanofi Twitter account, it was quite a serious matter and Clauses 2 and others needed to be addressed.  The complainant noted that Twitter reached massive audiences extremely quickly and had the ability to do vastly more damage than traditional advertisements in medical journals and yet it appeared that much less care was taken.

The detailed response from Sanofi is given below.

The Panel noted Sanofi’s submission that the tweet at issue contained material of general public interest; in the Panel’s view, it was highly likely that Sanofi’s Twitter followers would include members of the public.  The Panel further noted that the nature of Twitter was such that tweets could be broadly and quickly disseminated in the public domain.  When material was available to the public it needed to comply with the relevant requirements of the Code.  Members of the public would include health professionals.  There was no submission from Sanofi that the tweet was restricted in any way.

In the Panel’s view, the tweet was not intended as advertising for a health professional audience and therefore the allegations relating to the promotion to health professionals were not relevant.  The Panel ruled no breach in relation to these allegations. The Panel considered that as a general matter it was not necessarily a breach of the Code to tweet information to the public and some people would be interested in the ongoing safety review.  The complainant had not provided any information to show that the public would not be interested in the information.  Conversely, Sanofi submitted that the review had been established to examine concerns raised by patients and families, ie the public.  The Panel considered all the circumstances including that the complainant had not met the burden of proving his/her complaint on the balance of probabilities in this regard and ruled no breach.

The Panel did not consider that the tweet amounted to disguised promotion.  The company name, the name of the medicine and its indication were given.  In the Panel’s view, the general public would not be misled into thinking the nature of the tweet was disguised.  This requirement was generally relevant when material for health professionals was disguised promotional material. The Panel ruled no breach of the Code.

In relation to the allegations about certification, the Panel considered that the tweet should have been certified.  It related to a medicine and was intended for the public and a breach was ruled.  The Panel ruled no breach in relation to the requirement to certify promotional material for health professionals.

The Panel noted the submission from Sanofi regarding its arrangements for training.  In the Panel’s view, the ruling of a breach of the Code did not in itself mean that a company had not met the training requirements.  The Panel considered that the complainant had not proved, on the balance of probabilities, that a breach had occurred.

The Panel was concerned that the tweet did not explain that the review related to the adverse effects of sodium valproate – of which Epilim was one brand.  Nor did the tweet reflect the important safety information in the current Epilim SPC regarding the cautions for the use of valproate in female children and women of childbearing potential.  No explanation was given of the ‘complex issue arising’ from the use of Epilim in that patient group.  Some readers might be left with the impression that there were no restrictions on the use of Epilim; insufficient information was provided in order for readers to understand the significance of, and the reason for, the review.  In the Panel’s view, the tweet did not give a balanced view and, in that regard, was misleading about the ongoing safety review and the use of the medicine; it might raise unfounded hopes of successful treatment.  The Panel therefore ruled a breach of the Code.  The Panel noted that the complainant raised a general point about safety, referring to the use of the black triangle.  The Panel considered that its ruling of a breach covered the general allegation referring to the use of the black triangle.

The Panel noted that the tweet named a prescription only medicine (Epilim) and referred to its use (in epilepsy).  In that regard, the Panel considered that, on balance, a prescription only medicine had been advertised to the public and ruled a breach of the Code.

The Panel also ruled a breach as high standards had not been maintained.

The Panel noted that the tweet linked to  @IMMDSReview.  It considered that it would be clear to readers that this was the IMMDS Review Twitter handle and not a Sanofi site.  The Panel therefore ruled no breach of the requirement to  be clear when leaving a company site.

The Panel noted its rulings and comments above but did not consider that the particular circumstances of this case were such as to warrant a breach of Clause 2 which was a sign of particular censure.