One of the country's leading cancer research specialists has said new regulations on clinical trials will cause vital life-saving cancer research to be scrapped.
Calling for the new regulations to be abandoned, Dr John Crown described the current proposals as "an unmitigated disaster about to break over the heads of cancer research".
Dr Crown believes the new proposals, in the form of a new EU directive, jeopardises research which could ultimately save the lives of "thousands of patients".
The proposals place strict new administrative controls on clinical trials of new treatments. Under the new regulations, the sponsor of a trial is required to pay the entire cost of treatment for each patient taking part in the trial.
The regulations are aimed at regulating commercially-led trials of new drugs by major pharmaceutical firms.
According to Dr Crown, who is based at St Vincent's Hospital in Dublin, three-quarters of all clinical trials are not commercial, but research-led.
These are operated with limited funding, and will not survive under the proposed new regime. Such trials have led to major breakthroughs in cancer treatment, including the treatment of childhood leukaemia.
"It places a very high barrier over which it will be very difficult to cross," he said. "The financial, administrative and labour costs of trials will increase significantly. Commercially-led trials will be able to continue, however the other three-quarters of trials will not."
Under the current system, the research is financed mainly through the healthcare system.
In some cases a pharmaceutical firm will supply limited financial support in a case where its drug forms part of the treatment.
Dr Crown was speaking in advance of his inaugural address in Dublin City University, where he has been given the Thomas Baldwin Research Chair in Translational Cancer Research.
The Irish Clinical Oncology Group (ICOG), which represents the interests of cancer research specialists, has already met with officials from the Department of Health on the new directive.
Along with colleagues from other European countries, ICOG is launching a campaign to have the directive repealed because of their concerns about the potential impact on cancer research.
Dr Crown points out to major research currently underway in Ireland into the impact of simple over-the-counter painkillers, and whether they improve the effects of chemotherapy on some forms of cancer.
"This simply would not have taken place under the new proposals," he said.
There has been a major increase in cancer research in Ireland in recent years. Six major clinical trials involving 10,000 patients world-wide, including 1,000 in Ireland, have taken place here.