Roche’s ABPI exit – a deliberate snub?
pharmafile | July 3, 2009 | News story | Research and Development, Sales and Marketing |Â Â ABPI, RocheÂ
By Nicola O’Brien
Roche is yet to explain its controversial exit from the ABPI, but the company seems determined to make a point with its rebuff of the association.
A spokesperson told Pharmafocus the pharma company remains committed to the self-regulatory Code of Practice that governs the industry, and indicated its issue was instead with the trade association itself.
Roche UK’s Susie Hackett said: “It’s not to do with the Code, it’s to do with the membership of the ABPI. We will be completely compliant with the Code of Practice, and we are committed to working within the self-regulatory system.”
Roche’s UK affiliate was suspended from the ABPI for six months in 2008 after it came to light the company had made payments to private diet clinics which prescribed Roche’s obesity drug Xenical – a major breach of the Code of Practice.
Suspension or expulsion from the ABPI is the highest level of sanction that can be dealt to a company in breach, after five measures that include audit, issue of a corrective statement, and a public reprimand, all of which are overseen by the Code authority the PMCPA.
In February 2009 it was announced that Roche had been reinstated to the ABPI after completing its suspension period, but the company has now denied this was the case.
It chose not to return at that time and said the recent furore around its departure from the trade association, revealed first by the Financial Times on Sunday, has actually been late in coming.
Hackett said: “We let [the ABPI] know a good few months ago. This is not a new decision. This decision was taken a while back and we let them know we would not be rejoining.”
Only two other companies have been suspended from the ABPI in recent years and both resumed their membership immediately, making Roche’s move a particular shock.
Hackett acknowledged that the punishment of suspension was an embarrassment, saying: “I don’t think any company wants to be in that position.”
The company has not made an explicit link between the suspension and its choice to leave, but the timing suggests Roche may have been upset with the punishment and that relations subsequently soured.
When asked about this Hackett said only: “The decision has been based on what is needed for the future, not what has happened in the past.
“We are just looking at what is needed, and what Roche wants for the future. And the decision has been made on that.”
The company is also leaving the US pharmaceutical trade association PhRMA, but its exit from the ABPI looks unconnected with any new global approach to compliance, as some reports have suggested with reference Roche’s US move.
Hackett confirmed this, saying: “This is a UK-based decision, unrelated to anything happening outside the UK.”
The indications are then specific to the UK, the ABPI, and can be easily read as a snub, either over its suspension last year or the body’s overall representation of the industry.
Impact
The move means the ABPI loses Roche’s six-figure annual subscription and the PMCPA will be unable to penalise the company with its strongest sanction – suspension from the association – for any possible future misdemeanours.
This has sparked media speculation over the integrity of pharma self-regulation and, although both the company and trade association are saying as little as possible, it is clear the move has unsettled the ABPI.
If a company of the size and stature of Roche exits the ABPI, others could follow, undermining its authority and status. Some say it could also lead the UK government to introduce statutory regulation.
But the ABPI, like Roche, has said the move does not affect the integrity of the system, and does not compromise its authority.
A spokesman told Pharmafocus: “All sanctions from the PMCPA still apply, apart from suspension.”
“The line that’s gaining traction, that this is the end of self-regulation for the industry, for our money this is a bit overblown.”
This would go someway to indicating a more personal complaint between the two sides, particularly as the association is disputing the company’s right to leave, at least for now.
The ABPI says it still regards Roche as a member, even if only due to the complex membership rules and extended notice period required if a company decides to leave.
It says it is still in talks with the company, and while these continue it is unable to comment further.
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