Legal red tape delays live-saving drug trials

A NUMBER of potentially life-saving clinical trials are under threat because of red tape.

Department of Health pharmacist Tom McGuinn confirmed yesterday that only trials currently underway would continue after May 1, because the necessary Irish legislation has not been introduced to implement the new EU Clinical Trials Directive.

Mr McGuinn said any new trials could not go ahead unless these legal requirements were met.

“Our whole objective is to minimise any hold-ups, but they can’t be ruled out,” Mr McGuinn said.

His admission has infuriated the Irish Clinical Oncology Research Group (ICORG). The group’s chief executive, Dr Brian Moulton, said the threat to future trials because of delays in legislation was “a mess constructed by him [Mr McGuinn]”.

Dr Moulton said the department had reneged on an agreement reached with ethics committees in January for a period of grace from May 1 to adapt to the new regulations, allowing new trials to commence.

Failure to honour this meant Irish researchers could lose important clinical trials with the knock-on effect of depriving patients of cutting-edge treatments.

Agencies sponsoring trials would go elsewhere, with plenty of opportunities in the new EU countries from May 1. Up to 200 applications a year are received by the Irish Medicines Board (IMB) to conduct clinical trials. Two upcoming cancer treatment trials would be under immediate threat, Dr Moulton claimed.

“A number of very important studies are due to start up this summer. There is a very exciting drug in colon cancer, of which there are 2,000 new cases each year, which will only be available here through research for the next three or four years.

“An international agency will come to us and ask if we are ready to go with the trial. But we will be unable to go ahead without ethics approval. The agency will then take their funding elsewhere.

“We also have a situation where a lung cancer study, run by a Canadian group, is at the stage of agreeing that Ireland can participate in the study and use the drug. We are in danger of losing that also,” Dr Moulton said.

Mr McGuinn admitted the department had not honoured its agreement with the ethics committees. But he said existing trials would be allowed to continue.

Under the new Irish legislation, a supervisory body must be set up to which ethics committees must apply for accreditation.

Mr McGuinn said yesterday Health Minister Micheál Martin and his department would make up the supervisory body and that the minister would decide whether or not to accredit committees.

Dr Moulton said it was news to him that the minister would act as the supervisory body, that up to now, this detail had not been communicated to the ethics committees.

The IMB, which licences trials, admitted it had not seen the final draft of the Irish legislation which will not be ready before mid-April.