Healthy Skepticism Library item: 15912

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Publication type: news

Jack A.
Roche move throws industry into doubt
Financial Times 2009 Jun 28
http://www.ft.com/cms/s/0/07df879e-6427-11de-a818-00144feabdc0.html

Full text:

The future of self regulation in the pharmaceutical sector has been thrown into doubt after one of the largest companies operating in the UK withdrew from an industry trade body.

The British arm of Roche of Switzerland resolved this spring not to renew its membership of the Association of the British Pharmaceutical Industry, after it was suspended for six months for “bringing the industry into disrepute”.

Even though Roche says it will continue to comply with the ABPI’s code of practice, the action removes the option for its regulators to order similarly harsh sanctions in the future.

The government’s Medicines and Healthcare Regulatory Products Agency can prosecute drug companies, but until now has left most disciplinary action to the Prescription Medicines Code of Practice Authority, which is run by the ABPI.

The resignation has created tension within the ABPI, which derives a substantial six-figure subscription from Roche and is disputing its right to leave. More broadly, it raises questions over the organisation’s ability to regulate the industry at arm’s length.

Chris Brinsmead, president of the ABPI and UK head of AstraZeneca, said: “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.”

After its suspension last year for a serious breach of the code of practice, related to aggressive sales practices for its slimming drug Xenical in private clinics, Roche was criticised in a second case for failing to stop a programme that offered incentives to patients to take a treatment it makes for cystic fibrosis.

However, the PMCPA ruled that because Roche was already suspended over the first case, no further action would be taken beyond the public reprimand. The decision came in spite of concerns over Roche’s internal rules designed to ensure that the authority’s decisions were fully implemented, an issue the company had undertaken to resolve and demonstrate through audits imposed as part of its punishment over Xenical.

Heather Simmonds, head of the PMCPA, stressed that in considering the second case against Roche, its appeals board had acted independently of the ABPI and agreed no further action was necessary. She added that the company had complied with audits.

A Roche statement said it had “decided not to rejoin the ABPI for the time being” and that it would continue to work within the code of practice.