Serono reprimanded on ABPI Code breach

25 June 2006

Following a complaint by rival multiple sclerosis drugmaker Germany's Schering AG, Swiss biotechnology major Serono has been publicly reprimanded by the Association of the British Pharmaceutical Industry's board of management following serious breaches of the Prescription Medicines Code of Practice.

Schering's UK subsidiary complained about an MS project sponsored by Serono described as "an observation of the clinical outcome of patients treated with high doses (44mcg) of the Swiss group's Rebif (interferon beta-1a), following cessation of treatment with lower dose interferon, defined at either 22mcg beta-1a or 250mcg beta-1b (Schering's Betaferon).

The company alleged that the "project," described as a "clinical practice audit," was in fact a research study requiring assessment by a research ethics committee. It also noted that doctors were offered L700 ($1,287) to participate in the project, saying that paying neurologists to collect data on patients switching to Rebif 44mcg was not justified by the amount of work involved and amounted to an "inducement to prescribe" Rebif.

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