Decision

19 August 2016: Overseas Advisory Board Meeting for UK healthcare professionals in Zagreb & PMCPA CASE AUTH/2820/2/16

Published 4 October 2016

A three day meeting combining a site visit to Hospira’s Zagreb biologics manufacturing site and an advisory board associated with Hospira’s biosimilars held on 13-15 July 2015 in Zagreb, Croatia for UK healthcare professionals was ruled in breach of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice (the Code). The investigation followed publication of an article by the Daily Telegraph which was taken up as a complaint by the Prescription Medicines Code of Practice Authority (PMCPA) - CASE AUTH/2820/2/16.

The meeting was found to be promotional and an inducement to prescribe or recommend Hospira products because it was held outside the UK without a clear and cogent reason, and was therefore found in breach of the Code. The PMCPA found the arrangements were such that UK healthcare professionals had not attended a genuine advisory board meeting and the overall arrangements brought discredit upon and reduced confidence in the pharmaceutical industry. The PMCPA also ruled that high standards had not been maintained.

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]}.

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

0.1 Corrective statement

Dear [insert name of HCP]

Overseas Meeting for UK healthcare professionals in Zagreb – PMCPA CASE AUTH/2820/2/16

I am writing to you on behalf of Hospira UK Limited (“Hospira”) following your attendance at the manufacturing site and an advisory board held in Zagreb, Croatia on 13-15 July 2015 (the “Meeting”).

Following publication of an article entitled ‘The NHS officials with second jobs at drug firms’ on 17 February 2016 by the Daily Telegraph the Prescription Medicines Code of Practice Authority (the “PMCPA”) considered the criticism of the Meeting as a complaint under the Association of the British Pharmaceutical Industry Code of Practice for the Pharmaceutical Industry (the “Code”).

The complaint was investigated by the PMCPA and Hospira was held to have breached the PMCPA Code.

Whilst the PMCPA Panel did not hold that the level of subsistence alone to be excessive, it considered that the total hospitality provided was out of proportion to the occasion. The Panel concluded that the three day meeting in Zagreb was promotional and therefore constituted an inducement to prescribe or recommend Hospira products. It also ruled that there was no clear and cogent reason to hold the Meeting outside the United Kingdom and that the arrangements were such that UK HCPs had not attended a genuine advisory board meeting. The PMCPA found that the overall arrangements brought discredit upon and reduced confidence in the pharmaceutical industry. The PMCPA also ruled that high standards had not been maintained and found Hospira to be in breach of a number of provisions of the Code. Full details of the complaint, including Hospira’s explanation and the PMCPA ruling are attached as a PDF, and can also be accessed at the following URL: http://www.pmcpa.org.uk/cases/Pages/2820.aspx

Hospira has 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 breach regulations 300(1) and 300(4) of the Human Medicines Regulations 2012 .

Hospira respects the decision of the PMCPA and regrets that the-Meeting was not Code compliant, however, at no time did the Company intend for this to be the case. Please be assured that Hospira acted in good faith and takes its compliance with the Code (and other applicable laws, regulations and industry codes of practice) very seriously and is committed to continue to enhance its processes and procedures to meet the highest standards of conduct, as outlined by the Code.

We regret any inconvenience this may have caused.

Yours sincerely

[Name] Business Unit Head, Biosimilars Hospira UK Limited

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. ↩