Galderma UK Ltd and Merck Serono named in advertisements for breaches of the ABPI Code of Practice

In addition Galderma was also publicly reprimanded and removed from the list of non-member companies that have agreed to comply with the Code.

Galderma – Case AUTH/2684/12/13

For sending promotional emails without the prior permission of the recipients, Galderma was ruled in breach of the following clauses of the Code:

Clause 9.1 - Failing to maintain high standards

Clause 9.9 - Failing to obtain prior permission from the recipients to send promotional emails.

The Code of Practice Panel ruled no breach of Clause 2 as the matters were not such as to bring discredit upon or reduce confidence in the pharmaceutical industry. The Panel was concerned about the difficulty in obtaining the relevant information from Galderma and considered that its responses demonstrated a general lack of understanding of the applicability of the Code. The Panel reported Galderma to the Code of Practice Appeal Board which publicly reprimanded the company; it also required an audit of Galderma's procedures. Galderma subsequently declined the audit and indicated that it no longer wished to accept the jurisdiction of the Authority. The Appeal Board removed Galderma from the list of non member companies that have agreed to comply with the Code and accept the jurisdiction of the Authority. The PMCPA thus can no longer accept responsibility for Galderma under the Code. The Medicines and Healthcare Products Regulatory Agency (MHRA) has been so informed.

 

Galderma – Case AUTH/2685/12/13

For offering a pecuniary advantage to health professionals in connection with attendance at a promotional meeting, Galderma was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the

pharmaceutical industry

Clause 9.1 - Failing to maintain high standards

Clause 18.1 - Offering a pecuniary advantage to health professionals in

connection with the promotion of medicines.

The Code of Practice Panel was concerned about Galderma's poor knowledge of the Code and/or a reckless attitude towards its application. The Panel reported Galderma to the Code of Practice Appeal Board which publicly reprimanded the company; it also required an audit of Galderma's procedures. Galderma subsequently declined the audit and indicated that it no longer wished to accept the jurisdiction of the Authority. The Appeal Board removed Galderma from the list of non member companies that have agreed to comply with the Code and accept the jurisdiction of the Authority. The PMCPA thus can no longer accept responsibility for Galderma under the Code. The Medicines and Healthcare Products Regulatory Agency (MHRA) has been so informed.

 

Merck Serono – Case AUTH/2705/3/14

For sending out a press release about Erbitux clinical trial data which, by the inclusion of misleading and exaggerated claims, provided the public with unbalanced information about survival rates in metastatic colorectal cancer, Merck Serono was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the

pharmaceutical industry

Clause 7.2 - Making a misleading claim

Clause 7.3 - Making a misleading comparison

Clause 7.10 - Making an exaggerated claim

Clause 9.1 - Failing to maintain high standards

Clause 10.2 - Providing a misleading quotation

Clause 22.2 - Making information available to the public which was not factual or presented in a balanced way.

 

The full case reports and the public reprimands for Galderma were published in the PMCPA November Code of Practice Review.

 

The advertisements will appear in the BMJ and The Pharmaceutical Journal on 6 December 2014 and The Nursing Standard on 10 December 2014.