Explained: What are mandatory open disclosure laws?

Explained: What Are Mandatory Open Disclosure Laws?
Under the proposed laws, hospitals and other health care providers would be required to inform patients of certain adverse incidents, or patient safety incidents, that occur during the course of care. Photo: PA Images
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Fiachra Gallagher

One day after the death of cervical cancer campaigner Vicky Phelan (48), Taoiseach Micheál Martin told the Dáil that the laws she tirelessly advocated for in the wake of the CervicalCheck scandal would be approved by the end of the year.

But what exactly is mandatory disclosure, and what would it entail?


What are mandatory open disclosure laws?

Under the proposed laws, hospitals and other health care providers would be required to inform patients of certain adverse incidents, or patient safety incidents, that occur during the course of care.

A patient safety incident can be interpreted as an instance of preventable harm or injury which occurs to a patient during their care.

Why is mandatory open disclosure important?

The new law is important for transparency.

To use the example of Ms Phelan: she underwent a smear test for cervical cancer in 2011. The test showed no abnormalities, but in 2014, she was diagnosed with cervical cancer.


An internal CervicalCheck review in 2014 found that Ms Phelan's smear test — along with several other women's tests — were "false negatives".

However, Ms Phelan was not informed of the review of her smear test until 2017.

Speaking in the High Court in 2019, Ms Phelan said: "I was in shock when I was told. I am angry, extremely angry. If I was diagnosed I probably would have had to have a procedure and at worse a hysterectomy."

"If I was told sooner, I would not be in a position of a terminal cancer diagnosis," she added at the time.


When will the legislation be enacted?

The Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 outlines the proposed legislation.

As of March 2022, the bill is at the fourth Dáil stage of five. Amendments to the bill are still being drafted, including the final list of what qualifies as a patient safety incident.

After passing the Dáil, it will go to the Seanad to be approved, before being signed into law by the President.

The Taoiseach pledged to have the new legislation "brought to conclusion before the end of the end year" on Tuesday.


“I want the legislation concluded by the end of the year, and we will work with might and main to make sure that happens,” he said.

Is there debate around the new laws?

The Irish Times reported on Wednesday that the HSE have warned of "negative consequences" to the State's cancer screening services in light of disclosure laws.

The concerns centre around interval cancers — a cancer detected after a screening test which was interpreted as normal.

Vicky Phelan’s passion ‘front and centre’ as new l...
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Interval cancers occur within every screening programme, the HSE says, and are unavoidable. For example, in breast cancer screening, approximately two cases of interval cancers will occur in every 1,000 women screened.


Minister for Health Stephen Donnelly has been reported as saying that incidents of interval cancers — including past occurrences — should be disclosed to patients under the new legislation. This is despite these cancers not fitting neatly under the definition of patient safety incidents.

HSE officials voiced concerns about interval cancers being presented as patient safety incidents — when in reality, they say, these cancers are "expected occurrence" in screening programmes.

In the Dáil on Tuesday, the Taoiseach said there “have been many different perspectives among health professionals for a long time, although many would support the duty of candour and the spirit and the idea in principle of candour in respect of full disclosure to patients”.

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