Serono calls for harmonisation of ethics commissions
Serono wants the criteria for the authorisation and monitoring of studies using medicines to be harmonised at an international level, a spokesman for the Swiss company has told APM.
Serono wants the criteria for the authorisation and monitoring of studies using medicines to be harmonised at an international level, a spokesman for the Swiss company has told APM.
"We obviously regret what happened in the UK. Our British team misinterpreted the national code of practice. More harmonisation in this area would be beneficial for everyone," the spokesman said.
Last week the Association of the British Pharmaceutical Industry (ABPI) reprimanded Serono for making large payments to British doctors who participated in an observational study of Rebif.
The reprimand was a victory for Schering, which had lodged a complaint in the first quarter of 2005. The German company told APM that this seemed to have been the first incident of this kind and was limited to the UK.
The study was subsequently halted in the UK but continued in Belgium, Denmark, Finland, the Netherlands and Sweden.
"Only in Finland was there an ethics commission which controlled the conditions of the study. Everywhere else, notably in the UK, a study is the responsibility of its lead investigator," the Serono spokesman said.
"Each country has defined its own conditions for carrying out scientific studies with medicines, whether they are clinical or observational. For an international company, it quickly becomes difficult to have an overview and to draw up a general line of conduct."