CervicalCheck: Legal claims threaten programme, WHO warns

An “exponential” rise in legal claims against the Irish cervical cancer screening programme risks rendering it financially unsustainable, a World Health Organisation (WHO) agency has warned.

The CervicalCheck programme was potentially liable for €300 million in legal claims by last August, against an operating budget of just €34 million in 2019, according to the report by the WHO’s cancer arm.

The report by the International Agency for Research on Cancer (IARC) links the rise in litigation against CervicalCheck to the 2018 controversy that followed a botched audit of cervical cancers detected in 1.1 million women who had been screened in the years 2008-2014.

One of these women was Vicky Phelan, whose court case led to revelations that hundreds of women with cancer had not been informed of the results of their slide review.

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“Although the Irish cervical screening service has consistently met the highest international performance standards, since the audit incidents there has been an exponential increase in the number of legal cases in Ireland arising from participation in screening programmes,” the IARC report states.

The report on recommendations for best practice in screening programmes is described as a “collaborative initiative” between IARC, based in France, the Health Service Executive and the Department of Health. It says the recommendations were prompted by “events in Ireland” following the 2018 audit.

The purpose of audits is to drive improvements in screening programmes “rather than blaming an individual professional or an organisational entity for perceived lapses”, it states.

“It is not possible to achieve zero-error screening in standard practice, no matter how high the quality of cancer screening is.”

The public good and the responsibility to provide a high-quality screening programme outweigh the possible risks to an individual from participating in the audit, the report says.

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“Thus, not obtaining individual informed consent at the time of a programmatic audit is justified. However, this means that the women who undergo screening must be informed at the time of the screening of the possibility of an audit.”

While it should be possible to make a claim for negligence with respect to cervical screening, the standards applied by courts in assessing claims “should accommodate and reflect the reality of cervical screening, including hindsight bias in an audit of cancers”.

“The determination of whether the particular screening error was serious enough to be categorised as negligent and/or serious enough to entitle the participant to compensation needs to consider the inherent limitations of cervical screening.”

Missing abnormalities

Among the key learnings from “incidents” in Ireland are that screening tests for cervical cancer are “very different” from diagnostic tests: “they will both miss and overcall abnormalities routinely, even in a programme that is performing well”.

The report notes a wide divergence in practice across screening programmes internationally about disclosing audit results. “The inconsistent approach to disclosure of audit discrepancies proved very problematic in Ireland and generated a great deal of public criticism of the cervical screening programme, with some people characterising the non-disclosure as a ‘cover-up’.”

The report by Dr Gabriel Scally into the CervicalCheck controversy found CervicalCheck’s audit was poorly designed and recommended patients being involved in the process in future.

The IARC report says audits should use anonymised data, “whereby consent from each screening participant is not necessary and disclosure of findings is not possible”.

* This article was amended on Thursday, July 6th, 2023.