Clinical negligence claims against doctors, nurses and other healthcare staff could end up costing the State up to €121 million, it has emerged.
The deputy director of the State Claims Agency, Ciarán Breen, told a Dublin conference yesterday that to date the agency has received over 1,360 claims in relation to alleged negligence under the State's clinical indemnity scheme.
Up to the beginning of September, a total of 157 of these had been fully resolved at about €3 million. However, 1,207 claims remain outstanding, with a further potential exposure to the State of €118 million.
Mr Breen told the conference that the State had a potential exposure of around €74 million in relation to outstanding general claims on the books of the State Claims Agency for employer liability, public liability and property damage.
He made his comments at a conference on medical research and clinical trials organised by the State Claims Agency, Hayes solicitors, the Department of Health and Aon Healthcare.
Hilary Muldowney, a partner at Hayes solicitors, told yesterday's conference that a recent court ruling in Belgium had major implications for Irish hospitals and their ethics committees in relation to the operation of clinical trials.
She said that the ruling, made by a court in Ghent last October, had altered the previously-held opinion in regard to liability for negligence.
She said the case related to a clinical trial of an appetite inhibitor. In the course of the trial, a participant developed a rare and lethal heart-lung condition. She said the court had found that the trial had been conducted irresponsibly.
However, it held that the sponsor should only bear 25 per cent of the liability, with the hospital and its ethics committee responsible for 75 per cent of the liability.
Ms Muldowney said prior to this verdict, it was believed that an ethics committee could not be held responsible for errors during a clinical trial.
"However it is now clear that the ethics committee has an obligation to ensure that the trial is conducted ethically and judiciously. It is no longer reasonable to assume that the sponsor, in developing the concept of the trial, carries the largest proportion of liability.
"The onus is also on the ethics committee and the organising authority to ensure a full due diligence is performed prior to the commencement of any such trial," she said.
Dr Teresa Maguire, of the Health Research Board, told the conference that the "prime barrier" to clinical research in Ireland was time and that structures and supports were needed to "buy out" time in order to undertake research.
She said the culture of hospitals meant that research was not seen as a major part of clinical care.
Dr Maguire said there was "a need to foster a hospital culture that recognises that clinical excellence is underpinned by clinical research and that clinical researchers need to have time out from patient care to devote to research".
She said healthcare administrators needed to be encouraged to become more research literate and that research needed a champion in the Department of Health.
