Patient Safety Bill to be amended to make it mandatory for clinicians to inform patients of right to review

Minister says ‘we don’t normally legislate at that level’ but ‘there’s a particular unique context to this in Ireland’

Minister for Health Stephen Donnelly will amend patient safety legislation to ensure it is mandatory for clinicians to inform patients of a right to a review of their slides if cancer is diagnosed.

“That’s not normally what’s done. We don’t normally legislate at that level of operating procedure,” Mr Donnelly told the Dáil on Wednesday night, adding that “we’re all aware there’s a particularly unique context to this in Ireland”.

He said the mechanism “will ensure that every single patient will be given the choice” of a review although experience in the UK showed that half of patients did not want that review. The Minister said it would be mandatory to inform every patient, male or female, involved in any cancer screening service and diagnosed with the disease of this right.

The Minister was responding to Opposition demands over the Government’s legislative proposals to deal with the legacy of the CervicalCheck scandal.


The issue surfaced in 2018 after Vicky Phelan, who had cervical cancer, settled her High Court case for €2.5 million after she was given incorrect smear test results. It emerged that hundreds of women diagnosed with cervical cancer were not told about an audit of past smear tests. The HSE said at the time that in the cases of more than 200 women, the audit found on look-back that their screening tests “could have provided a different result or a warning of increased risk or evidence of developing cancer”.

Sinn Féin leader Mary Lou McDonald had earlier described the measures on mandatory disclosure of information to patients as “seriously flawed”.

Labour’s Alan Kelly said the legislation would “not pass the Vicky test”, a reference to Ms Phelan, who died last month after campaigning for years for the mandatory disclosure of “discordant” health slides to patients.

Ms McDonald said “there is provision for a right to review provided, and that’s a welcome thing, but there is a distinction between a right to review and a positive obligation on a clinician or a health service provider to reveal or pass on information”.

The Dáil was expected to pass the Patient Safety Bill on Wednesday evening after debate on some 50 amendments over two hours. But following talks, a four-hour debate was scheduled.

Mr Donnelly told TDs that it would take some time to “craft” the amendment to the Bill and the legislation was adjourned for further debate in January.

Sinn Féin health spokesman David Cullinane welcomed the Minister’s decision to amend the Bill and said it places a “legal obligation” on medical personnel to inform a woman of her right to review, rather than for her to request one.

The Minister insisted, however, that it was standard practice globally to conduct anonymous audits. Ms McDonald said that if that had been the case, Ms Phelan would not have discovered the discordance in her own cervical slide.

Mr Donnelly said “there is no perfect answer on this but the advice was to anonymise the audits” and that an expert group established by Dr Gabriel Scally following the CervicalCheck controversy had recommended anonymised audits.

Pointing to the UK experience of mandatory open disclosure, he said that when clinicians asked patients diagnosed with cancer if they wanted a review, 50 per cent to 60 per cent of people declined.

The department believed that the best option was to “put it entirely in the hands of the patient” to request a review if a discordance in their slide was found. But he will amend the Bill to make it mandatory for clinicians to inform patients that they can have a review.

Marie O'Halloran

Marie O'Halloran

Marie O'Halloran is Parliamentary Correspondent of The Irish Times