Healthy Skepticism Library item: 16590

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Publication type: news

Jack A
UK watchdog rules out action on Roche
The Finanical Times 2009 Sep 29
http://www.ft.com/cms/s/0/b8869a58-ac5a-11de-a754-00144feabdc0.html?nclick_check=1

Full text:

The European Commission will consider whether to bring legal action against Roche, the pharmaceutical group, after the UK drugs watchdog decided not to pursue the company over its marketing of a slimming drug.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said on Monday that it had decided not to pursue a case against Roche after sanctions were imposed last year by the industry’s trade association over aggressive sales practices related to the slimming drug Xenical in private clinics.

The regulator’s decision clears the way for the issue to be discussed in Brussels by the enterprise and industry directorate in a case that highlights uncertainties in the respective disciplinary roles of national, European Union and professional regulators.

The Prescription Medicines Code of Practice Authority, the self-regulatory arm of the Association of the British Pharmaceutical Industry, suspended Roche from membership for 12 months last year for “bringing the pharmaceutical industry into disrepute” over Xenical.

The reprimand involved no financial penalty and triggered a separate investigation by the MHRA, which has powers to prosecute and had launched a criminal case leading to the conviction of a man.

The agency told the Financial Times: “The MHRA has successfully taken action against those who posed the greatest risk to the public in 2004. Roche also took the appropriate action at the time and dismissed those involved in this case.”

The MHRA had since reviewed all the evidence and taken legal advice, which concluded that there was no realistic prospect of a successful prosecution against Roche, so no further action would be taken,

Its decision exhausts any possibility of a prosecution being brought in the UK, allowing the case to be considered by Brussels under so far untested European legislation that could impose a fine of up to 5 per cent of EU turnover for any breach of the licensing conditions for Xenical. The case has raised questions over the most appropriate watchdog for the industry.

It has been further complicated by Roche’s decision at the start of this year to withdraw from the UK trade body. The company, which could not be reached for comment, said it still abided by the disciplinary body of the pharmaceutical industry.