Roche quits ABPI
pharmafile | June 30, 2009 | News story | Research and Development, Sales and Marketing | ABPI, Roche, UK
Roche is to give up its ABPI membership in a surprise move that could undermine the UK’s system of industry self-regulation.
The company said it had “decided not to re-join the ABPI for the time being” but said it would “continue to review this situation. It also reiterated its commitment to continue to operate within the Code of Practice.
Roche is also understood to be leaving the equivalent body in the US, PhRMA, suggesting the move is part of a global review of its compliance practices.
The company is integrating its biotech subsidiary Genentech into its wider business, and is said to be ready to become a member of the US biotechnology association the BIO instead.
Roche’s UK affiliate was suspended from the ABPI for six months in 2008 after it came to light the company made payments to private diet clinics which prescribed Roche’s obesity drug Xenical.
Other companies which have been suspended have resumed membership immediately, and Roche’s decision not to rejoin has come as a shock.
In a statement, Roche said: “In line with any commercial business we continually review our operations, and our time away from the ABPI has enabled us to reflect upon the nature of this relationship and consideration of mutual needs for the future. We have concluded that this is something we need to review further and for that reason, we have decided not to re-join the ABPI for the time being.”
The upshot is that the PMCPA, the body that polices the ABPI’s self-regulatory Code of Practice will be unable to penalise Roche for any future misdemeanours.
Roche says the decision does not alter its commitment to good working practices or its commitment to “ensure compliance with the high standards of our industry.”
The company reiterated that it has strengthened its compliance procedures after the investigation, including the creation of a dedicated compliance team.
Self-regulation in doubt
The move puts the ABPI in a very difficult position, throwing into question the viability of the current self-regulation system.
If a company of the size and stature of Roche exits the ABPI, others may follow, and the UK government may even feel it necessary to introduce a statutory regulatory system.
The ABPI derives a six-figure annual subscription from Roche, and is said to be disputing the company’s right to leave the association.
Chris Brinsmead, president of the ABPI and UK head of AstraZeneca, told the Financial Times: “Roche is thinking through the situation. There is an ongoing dialogue. Technically it is still a member. The ABPI doesn’t want to see any member company walk away. A unified front makes sense.”
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