Association of British Pharmaceutical Industry
A UK pharmaceutical company’s “unacceptable” advisory board meeting – highlighted in a series of Daily Telegraph articles in July 2015 – breached the industry’s code of practice, the regulator has ruled.
An interim case report, published on 16 December 2015 by the Prescription Medicines Code of Practice Authority (PMCPA), found serious concerns with the two-day trip attended by “key NHS medicines management personnel”. The meeting was organised on behalf of Stirling Anglian Pharmaceuticals earlier this year.
An investigation was prompted by allegations contained in the Daily Telegraph articles relating to the practice of paying health officials to advise pharmaceutical companies.
The PMCPA’s code of practice panel, which assesses complaints under the code, says in its report: “The primary focus of the [meeting] was in providing information to and influencing participants rather than the provision of advice to the company.”
The report also expresses concern that a £500 payment was made for each of the two days when only one afternoon was described as having an advisory board element. “UK health professionals had been paid to attend a meeting where medicines were promoted including pipeline products. This was unacceptable,” it says.
The PMCPA is the self-regulatory body that independently administers the Association of the British Pharmaceutical Industry’s (ABPI) code of practice. Its final report on the case has been delayed while Stirling Anglian’s procedures in relation to the code are audited in January 2016 at the PMCPA’s request.
The case centres on the appropriateness of an advisory board meeting held in Germany in July 2015, organised through a third-party company, which included a presentation about the company, a tour of a manufacturing facility and discussions about Stirling Anglian’s products. Hospitality included accommodation and dinner at a hotel. All 12 UK health professionals were each paid £500 per day by Stirling Anglian for attending the two-day trip.
Payments to health professionals for relevant advice are allowed under the code, but companies must comply with certain clauses about how advisory boards should be organised. These boards must be for obtaining advice, not to promote products.
However, the PMCPA report says the “unacceptable” arrangements in this case meant Stirling Anglian had breached seven clauses in the ABPI code of practice. The panel saw no obvious issue for which Stirling Anglian needed to convene an advisory board to seek advice, and says that the role of the participants had not been made clear.
The hotel used “appeared to be a lavish and deluxe venue” more akin to leisure travel than business purposes and was therefore “not appropriate”, the report says. The amount spent on dinner – around €100 per head – exceeded the limit of €60 in the local German code. The overall level of hospitality was “out of proportion to the occasion”, according to the report.
Although the hospitality was provided and paid for by the manufacturer, and a third-party company organised the trip on the company’s behalf, the panel says Stirling Anglian had “ultimate responsibility” under the code for all arrangements, which “brought discredit upon and reduced confidence in the pharmaceutical industry”.
The case was referred to PMCPA’s Appeal Board, which was “extremely concerned that UK health professionals had attended the meeting on the false understanding that it was an advisory board and had been paid to do so”.
The board requested that the company issue a corrective statement to all UK attendees at the meeting. It will consider whether further sanctions are needed once the company has undergone January’s audit.
In a statement, Stirling Anglian Pharmaceuticals says it accepts the findings and that it has co-operated throughout the investigation with the PMCPA. “In the light of the findings we have ceased to commission advisory boards and have asked an independent expert to carry out an external audit of all our processes,” says its chair Stephen Scullion.
