AUTH/3264/10/19 - Anonymous v Merz

Cross-boarder activity between UK and Ireland

  • Received
    24 October 2019
  • Case number
    AUTH/3264/10/19
  • Applicable Code year
    2019
  • Completed
    13 February 2020
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published in the Review

Case Summary

An anonymous individual complained about unethical behaviour by Merz across the UK and Ireland with regard to Bocouture (botulinum toxin type A).

The complainant alleged cross border trading of Bocouture from Northern Ireland where it was licensed into the Republic of Ireland where it was not licensed. The complainant alleged that Bocouture was ordered and picked up by a Merz employee from a distributor in Northern Ireland and delivered to a customer at a named medical group based in Dublin. The complainant alleged that this was unethical, underhanded and concerning.

The complainant further alleged that Merz employees demonstrated controlling and threatening communication with the intention of directing sales of Merz medicines or medical devices through the Merz preferred distributing partners only. The complainant stated that a number of aesthetic clinics had told him/her that Merz employees were stating that product concerns or adverse event queries would not be supported if the Merz product in question had not been bought through the Merz UK affiliate business preferred partners. The complainant stated that such behaviour went against all ethical reporting requirements of drug and product safety concerns and was against ABPI and PMCPA principles. The bullying behaviour was to support the financial endeavours of the Merz UK business and did not account for patient safety.

The detailed response from Merz is given below.

The Panel noted that it appeared that the UK registered health professional worked in both Northern Ireland and the Republic of Ireland. The Panel noted that the health professional had ordered Bocouture to be delivered to his/her clinic in Northern Ireland where the medicine was licensed. According to Merz’s Deviation Report Form the ordered product, however, was to be used by the health professional to treat patients at his/her clinic in the Republic of Ireland where Bocouture was not licensed.

The Panel noted Merz’s submission that at no point was Bocouture promoted to health professionals in the Republic of Ireland. The Panel noted that the complainant bore the burden of proof and had not provided evidence to show that Bocouture had been promoted to the UK health professional contrary to the requirements of the Code and no breach was ruled.

The Panel noted that in an attempt to rectify a shipping error a Merz UK employee collected Bocouture from a warehouse in Northern Ireland and delivered it to the health professional at his/her clinic based in the Republic of Ireland. The Panel noted Merz’s submission that the employee only promoted devices and was therefore unaware of the potential Good Distribution Practice (GDP) and Code of Practice implications of his/her actions.

The Panel considered that in personally delivering Bocouture to the Republic of Ireland where it was not licensed meant that the employee had not maintained high standards and a breach was ruled.

The Panel noted that as part of the CAPA process relevant staff attended training with regards to the licensing status of Bocouture in Northern Ireland and the Republic of Ireland and the potential GDP/ABPI considerations. The Panel considered that in failing to provide this important training earlier, particularly considering the potential of employees and health professionals working across Northern Ireland and the Republic of Ireland, meant that Merz had failed to maintain high standards and a breach was ruled.

The Panel noted Merz’s submission that it could find no evidence of ‘controlling and threating communication or evidence that communication by representatives that ‘adverse event queries would not be supported by Merz UK and Ireland if the product is not bought from a preferred partner’ had occurred.

The Panel noted the difficulty in dealing with complaints based on one party’s word against the other; it was often impossible in such circumstances to determine precisely what had happened. The complainant had the burden of proving his/her complaint on the balance of probabilities. All complaints were judged on the evidence provided by the parties.

The Panel noted Merz’s submission that representatives were briefed in detail regarding the changing relationship with the company’s pharmacy wholesalers. According to Merz, the parameters within which Merz UK was able to operate under the new arrangements with its preferred partners were clearly briefed to both sales and medical teams.

The Panel considered that the complainant had not shown, on the balance of probabilities, that the Merz employees had not maintained a high standard of ethical conduct by demonstrating controlling and threatening communication with the intention of directing sales of Merz medicines or medical devices through the Merz preferred distributing partners. No breach of the Code was ruled in that regard.

Whilst the Panel queried whether stating in its Q&A document that Merz might be unable to provide ‘… product support to clinics’ could have been misinterpreted as potentially meaning support with product concerns or adverse event queries which would be of concern. The Panel noted Merz’s submission that pharmacovigilance was of the highest priority as illustrated by the annual training recently completed by all Merz Pharma UK employees, pharmacy wholesalers and third party consultants. Merz insisted on a pharmacovigilance agreement between Merz UK and any third party to ensure the safe and effective use of its medicines and devices. The Panel also noted Merz’s submission that any change in the support offered to customers was purely commercial. The Panel considered that whilst the Q&A could have been worded more clearly, on balance, there was no evidence to show that Merz product concerns or adverse event queries would not be supported by the Merz UK and Irish business if the Merz product in question had not been bought through the Merz UK affiliate business preferred partners as alleged. No breach of the Code was ruled in this regard.

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. No breach of Clause 2 was ruled.