AUTH/3024/3/18 - Anonymous, non-contactable Hospital Consultant v GW Pharmaceuticals

Alleged promotion of Epidiolex

  • Received
    12 March 2018
  • Case number
    AUTH/3024/3/18
  • Applicable Code year
    2016
  • Completed
    18 October 2018
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the May 2019 Review

Case Summary

An anonymous, non-contactable complainant, who described themselves as a consultant neurologist, complained about the pre-licence promotion of Epidiolex (cannabidiol) by GW Pharmaceuticals at a hospital meeting in February 2018.  An application for a marketing authorization had been submitted to the European Medicines Agency (EMA) for its use as an adjunctive treatment for seizures associated with Lennox-Gastaut Syndrome and Dravet Syndrome.

The complainant had attended the multi-disciplinary team meeting at which GW Pharmaceuticals hosted a presentation on Epidiolex treatment.  The complainant stated that after the presentation, he/ she was informed that Epidiolex was unavailable to prescribe as it was not currently licensed in the UK or Europe.

The detailed response from GW Pharmaceuticals is given below.

The Panel noted that GW Pharmaceuticals referred to a third party organisation that employed managers to represent GW Pharmaceuticals.  The Panel noted that it was an established principle under the Code that companies were responsible for the acts/omissions of third parties acting on their behalf.

The Panel noted that an application for a marketing authorization for Epidiolex was submitted to the EMA on 29 December 2017; its proposed indications were as adjunctive treatment for seizures associated with Lennox-Gastaut Syndrome and Dravet Syndrome, each forms of child onset epilepsy.

The Panel noted that the slides provided by the parties in relation to the meeting in February differed.  The complainant provided photographs of nine slides, some of which were such that the full slide could not be seen, whilst GW Pharmaceuticals provided thirty-two slides.  The Panel noted GW Pharmaceuticals’ detailed submission about the slides including that those provided by the complainant were not those used at the meeting.  It was difficult in such circumstances to establish which set of slides was used.  The complainant could not be contacted for more information.  The Panel however noted that a photograph taken by GW Pharmaceuticals at the meeting of a particular slide appeared to be consistent with that slide as provided by the company as part of its response; both appeared to contain the header ‘Cannabidiol is an investigational product and is not licensed in the EU’.

The Panel examined the slides provided by both parties and noted that while most of the 32 slides provided by GW Pharmaceuticals stated that cannabidiol was not EMA approved, the nine slides provided by the complainant did not.  The Panel noted that the slides provided by GW Pharmaceuticals discussed cannabidiol, Phase III trial data including Dravet Syndrome and LennoxGastaut Syndrome and GW Pharmaceuticals’ cannabidiol pharmaceutical production.

The Panel noted GW Pharmaceuticals’ submission that the meeting in question was the legitimate exchange of medical and scientific information in response to an unsolicited enquiry about the development of cannabidiol.  The Panel noted that the Code prohibited the promotion of a medicine prior to the grant of its marketing authorization; supplementary information stated that the legitimate exchange of medical and scientific information during the development of a medicine was not prohibited provided that this did not constitute promotion which was prohibited by the Code.  The Panel queried whether a product subject to Phase III trials, and for which licence applications had been submitted, would be considered an investigational molecule or otherwise in development.  The Panel noted that the GW Pharmaceuticals’ slides included the proposed indications, usage and dosage.  In the Panel’s view and given the content of the presentations provided by each party, health professionals were likely to view Epidiolex as a pre-licence product.  The Panel considered that its view was supported by the list of questions asked by those present which included questions about cost, shelf life, storage and others relevant to the product’s use.  There did not, on the information before the Panel, appear to be an exchange of medical and scientific information about the development of the product.  In the Panel’s view, the presentation could not take the benefit of the supplementary information in the Code.

With regard to GW Pharmaceuticals’ submission that the presentation was provided in response to an unsolicited enquiry, the Panel noted that the Code provided an exemption to the definition of promotion stating that replies made in response to individual enquiries from members of the health professions or other relevant decision makers or in response to specific communications from them whether of enquiry or comment, were excluded from the definition of promotion, but only if they related solely to the subject matter of the letter or enquiry, were accurate and did not mislead and were not promotional in nature.  The Panel noted that the exemption only applied to unsolicited enquiries, an enquiry made without any prompting from the company.  If an enquirer subsequently requested further information this could be provided and would be exempt from the Code provided the additional information met the requirements of this exemption.  The Panel noted that when relying on this limited exemption in relation to a meeting about an unlicensed product, documentation was very important.

The Panel noted GW Pharmaceuticals’ submission that the presentation was provided in response to an unsolicited verbal request from health professionals for a medical presentation on updated clinical data and properties of cannabidiol in December 2017 during a meeting between two managers representing GW Pharmaceuticals and two doctors from the hospital in question.  The Panel noted that GW Pharmaceuticals provided some evidence in support of its position.  The general points covered in the presentation provided by GW Pharmaceuticals appeared to be consistent with the points raised by the health professionals.  When asked if the presentation was scientific or promotional in nature, one of the doctors stated that it was scientific in nature, as new scientific data which he/she had not seen before was shared.  The doctor stated that he/she was particularly interested to hear more about study results, safety information, side-effects, efficacy and also to get an update on recent trial data, when market approval might be expected and whether prescriptions on a named patient basis might be a possibility. The Panel noted the list of 12 attendees.  From the evidence before the Panel, it appeared that in requesting the meeting the two health professionals, rather than GW Pharmaceuticals, had decided that the content was appropriate for the small specialized departmental group.

Whilst the Panel had some concerns about the meeting, including the lack of formal documentation, it noted that based on the company’s account there was no evidence that the meeting went beyond the original information requested by the two doctors.  The Panel noted that the complainant bore the burden of proof and had not established that the meeting was promotional and not in response to an unsolicited request.  On the evidence before it, the Panel considered that, on balance, GW Pharmaceuticals could take the benefit of the exemption of the definition of promotion in the Code in relation to unsolicited requests and therefore did not consider on the particular facts of this case, that the meeting promoted Epidiolex prior to the grant of its license as alleged.  The Panel therefore ruled no breaches of the Code.