Screening programmes should not be paused, the health minister has said, after several professional medical bodies warned their viability was under threat in the wake of a recent landmark High Court judgment.
Instead, there should be a “period of calm” while the attorney general studies the judgment to see if it has legal implications for the wider health service, including diagnostics, said Simon Harris.
The judgment, in the case of terminally ill Ruth Morrissey, requires screeners who read slides to have “absolute confidence” when deciding if a smear is negative, meaning no cell changes were found.
The Royal College of Surgeons in Ireland (RCSI), the Royal College of Physicians of Ireland (RCPI), and the Institute of Obstetricians and Gynaecologists have all expressed concern that this is setting such a high bar that it could jeopardise screening programmes if it meant a false negative amounted to a breach of care, opening the way to litigation.
It emerged last night that the director general of the HSE, Anne O’Connor, has written to Jim Breslin, secretary general of the Department of Health, recommending that the department appeal parts of the judgment.
In a letter obtained by RTÉ, Ms O’Connor said the “absolute confidence” threshold was “setting such a high bar in law” for population-based screening programmes that it would create “an environment that will result in unnecessary investigations and treatments among healthy people”.
She said it “threatens the viability of the screening programme”, and while “hugely conscious” of the impact litigation has had on Ms Morrissey and her family, she was reluctantly recommending an appeal of specific parts of the judgment following consultation with doctors and clinical bodies.
Mr Harris said he had heard lots of people comment on the judgment, as was their right, “but they are not the attorney general”.
He said the Government would wait for his advice and “if there is action needed, we will take action”.
One of two laboratories that read Ms Morrissey’s slides has already taken action. US laboratory Quest Diagnostics, found to have misread Ms Morrissey’s 2009 cervical smear slide, yesterday confirmed in the High Court it is to seek an expedited “leapfrog appeal” directly to the Supreme Court.
The issue of “absolute confidence” in relation to testing will be a part of the appeal.
Mr Justice Kevin Cross in his ruling last week held in the Morrissey case that “absolute confidence” is the screeners’ practical duty in relation to their analysis of what is on a slide.
Mr Justice Cross yesterday granted a stay on his final judgment against the HSE and Quest Diagnostics and MedLab, providing that €700,000 is paid straight away to the 37-year-old Limerick mother who is battling cervical cancer which has spread to the bone.
The judge said in his judgment he had decided “absolutely nothing new”.
He said the need for a screener to have absolute confidence was endorsed by the evidence in this case.
Referring to what he called “some of the hysterical comments” in the last week, Mr Justice Cross said “they should read what I said” in the judgment.
Outside court, Ms Morrissey’s solicitor Cian O’Carroll said a Supreme Court determination would be important to “at least quell such unhelpful threats” vis-a-vis the judgment jeopardising screening programmes.
“All that happened in this case is that law that has been established for some 20 years was restated and clarified in the way it applies to an element of one screening programme,” he said.
Mr Harris said the State had not made any decision in relation to an appeal, that they would meet with the AG next week, and a decision would be made during May.
A spokesperson for MedLab said they are continuing to study the ruling and are keeping their options open.