Decision

3 August 2016: Remsima (infliximab) Advisory Boards & PMCPA Case AUTH/2808/12/15

Published 4 October 2016

An advisory board meeting for Remsima held in London in November 2015 by Napp Pharmaceuticals Limited (Napp) 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/2808/12/15). The advisory board was found to be a promotional meeting and an inducement to prescribe or recommend Remsima and was therefore found in breach of the Code by the Panel and the Appeal Board. The PMCPA and the Appeal Board also ruled that high standards had not been maintained and the arrangements relating to the meeting brought discredit upon and reduced confidence in the pharmaceutical industry.

On reading the report, MHRA was concerned that healthcare professionals had been put in a position where their actions were potentially in breach of medicines advertising legislation^{[footnote 1]}.

Napp voluntarily agreed to issue a corrective statement to all UK healthcare professionals who had attended the meeting, informing them of the findings of the PMCPA case. MHRA is also taking action with the company to ensure future meeting arrangements for Remsima comply with the legal requirements.

0.1 Corrective statement

Dear HCP

Remsima (infliximab): Advisory Board meeting with UK healthcare professionals held in London – PMCPA CASE AUTH/2808/12/15 & Potential breach of medicines advertising legislation

I am writing to you on behalf of Napp Pharmaceuticals Limited (Napp) as you were an advisor at the meeting which was held on 18 November 2015 in London.

An anonymous complaint about the Advisory Board 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). The PMCPA Panel commented on the arrangements and feedback for the meeting and in particular what they held to be the unbalanced nature of the presentation, the number of similar recent advisory boards and the absence of a bona fide question to be addressed. The Panel did not consider that the arrangements were such that UK health professionals had attended a genuine advisory board meeting. It therefore ruled a breach of the Code which was upheld on appeal.

The Panel considered that, as it had ruled the arrangements did not meet the criteria for advisory boards, the meeting had become promotional in nature and therefore constituted an inducement to prescribe or recommend Remsima in breach of the Code. The PMCPA and ABPI Appeal Board also ruled that high standards had not been maintained and considered that the arrangements relating to the Advisory board meeting brought discredit upon and reduced confidence in the pharmaceutical industry.

Napp have been asked to bring this case to your attention by the Medicines & Healthcare products Regulatory Agency. Offer and acceptance of any prohibited benefit or hospitality would be a breach of regulations 300(1) and 300(4) of the Human Medicines Regulations 2012 .

Napp takes its responsibilities under the Code and Regulations very seriously. We respect the finding of the PMCPA Panel and the Appeal Board that the arrangements for the meeting did not meet the criteria for advisory boards. 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 here

Yours sincerely

[Name] Medical Director

1. Regulation 300 of the Human Medicines Regulations 2012 states that: (1) A person may not, in connection with the promotion of medicinal products to persons qualified to prescribe or supply them, supply, offer, or promise any gift, pecuniary advantage or benefit unless it is— (a) inexpensive; and (b) relevant to the practice of medicine or pharmacy. (4) A person qualified to prescribe or supply medicinal products may not solicit or accept any gift, pecuniary advantage, benefit or hospitality that is prohibited by this regulation. ↩