Public reprimands for Galderma

Unsolicited emails

Galderma UK Limited has been publicly reprimanded by the Code of Practice Appeal Board for failing to provide the Authority with a full and frank disclosure of relevant information at the outset and for its fundamental lack of understanding of the Code (Cases AUTH/2684/12/13 and AUTH/2685/12/13).

In Case AUTH/2684/12/13, the Code of Practice Panel ruled breaches of the Code in relation to two unsolicited emails. In order to make its rulings, however, the Panel (and the case preparation manager) had to repeatedly ask Galderma for further information. The Panel considered that Galderma’s responses demonstrated a general lack of understanding of the applicability of the Code.

The Panel reported Galderma to the Appeal Board. On consideration of that report in May 2014, the Appeal Board considered that Galderma had demonstrated significant obfuscation in its responses to the Authority and it was appalled at the company’s general lack of knowledge of the requirements of the Code. The Appeal Board decided to require an audit of Galderma’s procedures in relation to the Code.

The Panel also ruled breaches of the Code in Case AUTH/2685/12/13 in relation to arrangements for a meeting. The Panel considered that a number of matters demonstrated that Galderma had a very poor knowledge of the requirements of the Code and/or a reckless attitude towards its application.

The Panel reported Galderma to the Appeal Board. On consideration of that report in May 2014, the Appeal Board was appalled and extremely concerned about the materials and arrangements for the meeting. In its view there were astonishing failures at all levels. Furthermore, the Appeal Board questioned Galderma’s care and attention taken in its responses to the Panel and its appeal in this case and considered that the circumstances of the meeting implied, inter alia, a lack of control by Galderma. The Appeal Board decided to require an audit of Galderma’s procedures in relation to the Code.

As Galderma subsequently declined the audit in relation to
both cases and indicated that it no longer wished to accept the jurisdiction of the PMCPA, the Authority once more reported the company to the Appeal Board which decided to remove it from the list of non member companies that had agreed to comply with the Code and accept the jurisdiction of the PMCPA. The Authority advised the Medicines and Healthcare Products Regulatory Agency (MHRA) that responsibility for Galderma under the Code could no longer be accepted.