Pharma company behind Baden-Baden junket reprimanded by watchdog

A pharma company which paid for NHS budget holders to go on a luxury trip to the German spa resort of Baden-Baden has been heavily reprimanded by the UK industry watchdog.

First brought to light by an undercover investigation by the Daily Telegraph newspaper in July, Stirling Anglian Pharmaceuticals paid for 12 health service managers to attend an 'advisory board' meeting in Baden-Baden, but the real aim was to induce them to use their products - those attending were even paid £500 a day for the two-day trip.

Now the UK pharma industry's self-regulatory body the Prescription Medicines Code of Practice Authority (PMCPA) has confirmed the newspaper report as accurate, and has handed out one of its strictest reprimands to the firm.

Overall, the company was found to have breached seven clauses of the Code: Clauses 2, 9.1, 18.1, 21, 22.1, 22.2 and 23.1. The most serious of these is Clause 2, which means the company has "brought discredit and reduced confidence" in the pharma industry.

The Appeal Board has ordered an audit of the company's procedures in relation to the ABPI Code of Conduct to take place in January 2016. It says 'further sanctions' will be considered when it sees this audit report.

Under normal circumstances, industry association the ABPI could hand down the heaviest penalty, suspension of ABPI membership - but as Stirling Anglian is not a member, this is not an option in this case.

Shortly after the Daily Telegraph allegations came to light, health secretary Jeremy Hunt declared a new 'Sunshine rule' making it mandatory for NHS employees to declare any gifts and payments – underlining the idea that responsibility for being 'above board' rests with NHS staff as well as pharma companies.

The full report by the PMCPA makes for lurid reading, and is hugely embarrassing for the UK industry, which has been trying to distance itself from allegations of sleaze and inappropriate influence on NHS decision-makers.

Stirling Anglian defended the advisory board as a 'necessary' and 'entirely appropriate' way of engaging with customers – and it emerged four previous such trips had taken place. But the PMCPA dismissed this entirely, judging the 'advisory board' to be a fig leaf, concealing a clear intent to influence the NHS managers to switch to one of their products, iCal-D3, a branded generic vitamin and calcium supplement.

The PMCPA found that the trip was not a valid advisory board, as the £500-a-day payment was for the whole trip, not just for the brief advisory board meeting.  It judged that the advsiory meeting raised no clear issue requiring advice, and instead concluded with leading questions about whether the NHS managers would authorise use of the products on their return to the UK.

The event also included the participation of software company SAP, as well as a visit to the pharma firm's manufacturing partners in Germany, arrangements which the PMPCA also found to be irregular and in breach of the Code.

Once it started to probe the company's expenses, the watchdog was shocked further by lavish spending on the wining and dining of its NHS guests, as well as Stirling's evasive answers to its questions.

It found the pre-dinner drinks at the hotel cost a hefty €447 – Stirling claimed this bill was not for the attendees, but for its staff, its manufacturing colleagues and SAP – a tale which the PMCPA found hard to believe.

As the event was held in Germany, the local pharma code limit on hospitality applied - €60 per person for dinner, but this was far exceeded, with the firm spending around €100 (£71.43) per head.

In an unusually frank condemnation of a company, the PMPCA Appeal Board said Stirling Anglian showed a "profound lack of Code expertise and oversight" and said arrangements for the meeting had been 'shambolic'.

On top of the reprimands, Stirling Anglian has also been ordered to issue a corrective statement to all the UK attendees, referring to the PMCPA report.

After initially denying any wrongdoing - including a letter to The Pharmaceutical Journal from CEO Andrew Perrie - the company has now admitted its errors, and accepts the ruling.

It has now stopped organising advisory boards, has appointed a new general manager and has hired an external company to audit its processes.

Also involved in the case were two NHS-employed medicines management advisors, Paul Jerram and Omar Ali, and both were covertly filmed by the Daily Telegraph team explaining how the meetings worked. Omar Ali resigned from his role at Surrey and Sussex Hospital Trust, while Paul Jerram was suspended from his role by employers Isle of Wight Clinical Commissioning Group.

Transparency rules

Stirling Anglian's flagrant rule breaking, and the fact that it only came to light via a newspaper 'sting' raises questions about whether the ABPI Code is strong enough to prevent or identify future lapses by pharma companies. The ABPI Code is voluntary, cannot impose fines on companies found in breach, and the self-regulatory body the PMCPA can only act once a media report is published or complaint made.

While no further updates on plans for an NHS 'Sunshine rule' have been disclosed since the summer, the pharma industry across Europe is gearing up to disclose payments to all healthcare professionals and health organisations from the end of June 2016.

Many in the industry are nervous about how publishing payments to doctors could generate even more negative media coverage, but pharma leaders hope that full transparency will, in the long term, convince everyone that its relations with healthcare professionals are above board and appropriate.

Read the full PMCPA ruling here

Clarification: please note that the original version of this article incorrectly stated that Stirling Anglia is a member of the ABPI.