Decision

14 June 2016: Two day Promotional Meeting about Remsima (infliximab) for UK healthcare professionals in Norway

Published 1 August 2016

A two day meeting entitled ‘Norway inflammatory bowel disease exchange’ for the promotion of Remsima held on 11-13 October 2015 by Napp in Norway for UK healthcare professionals was ruled in breach of the ABPI Code of Practice (the Code) following a complaint to the Prescription Medicines Code of Practice Authority (CASE AUTH/2795/9/15 published in May 2016). The meeting was found to be an inducement to prescribe or recommend Remsima because it was held outside the UK without a clear and cogent reason and was therefore found in breach of the Code by the Panel and the ABPI Appeal Board. The PMCPA and the ABPI Appeal Board also ruled that high standards had not been maintained.

On reading the report, MHRA was concerned that healthcare professionals have been put in a position where their actions were potentially in breach of medicines advertising legislation1.

Napp voluntarily agreed to issue a corrective statement to all UK healthcare professionals who attended the meeting in Norway, informing them to the findings of PMCPA case.

Corrective statement

June 2016

Dear HCP

Re: Remsima (infliximab): Two day Promotional Meeting for UK healthcare professionals held in Norway – PMCPA CASE AUTH/2795/9/15 & Potential breach of medicines advertising legislation

I am writing to you on behalf of Napp Pharmaceuticals Limited (Napp) as you were a delegate to the meeting held on 11-13th October 2015 in Oslo.

An anonymous complaint from a UK healthcare professional about the meeting was made to the Association of the British Pharmaceutical Industry (ABPI) Prescription Medicines Code of Practice Authority (PMCPA).

The complaint was investigated by the PMCPA and Napp was held to have breached the PMCPA Code of Practice (Code). In particular the PMCPA and the subsequent Appeal Board ruled that there was no clear and cogent reason for UK delegates to travel to Norway for the meeting, and that an alternative way could have been found to incorporate the Norwegian learning in to a meeting held in the UK. The Appeal Board considered that whilst the location of the meeting was unacceptable, the aim of the meeting was not unreasonable.

Whilst the PMCPA did not hold that the level of subsistence was excessive, it nevertheless found that holding a two day promotional meeting in Norway without a clear and cogent reason constituted an inducement to prescribe or recommend Remsima, in breach of the Code. The Appeal Board further upheld the ruling by the PMCPA Panel that high standards had not been maintained by Napp.

Napp have been asked to bring this case to your attention by the Medicines & Healthcare products Regulatory Agency. Acceptance of any prohibited benefit or hospitality would be a breach of Regulation 300(4) of the Human Medicines Regulations 2012.

Napp takes its responsibilities under the Code and Regulations very seriously. We recognise the finding of the PMCPA Panel and the Appeal Board that the location of the meeting was not acceptable. Nevertheless we believe Napp acted entirely in good faith and as a respected healthcare professional we sincerely regret having involved you in this matter.

Full details of the complaint, including Napp’s explanation and the PMCPA Panel and Appeal Board ruling are attached as a PDF, and can also be accessed at the following URL:

Anonymous, non-contactable v Napp

Yours sincerely

[Name], Medical Director