Mr. Jim Breslin:

Ithank members for the opportunity to meet with them this morning. I am joined by my colleague, Dr. Tony Holohan, chief medical officer.

I know the committee had the privilege of hearing at first hand from Ms Vicky Phelan and Mr. Stephen Teap last night. Their brave testimony over recent days, and that of other women and families, has raised profound questions for the way the national cervical screening programme, and the health service generally, engages with people. They have been willing to speak publicly about deeply personal matters. In doing so, they have drawn attention to their experience in the hope that this will lead to change. At the very heart of that change must be how the health service engages with individuals when things go wrong.

The CervicalCheck programme was established to help prevent cervical cancer. Before it was introduced we were not making any impact on cervical cancer but following its introduction we are seeing a steady reduction each year. However, every time a cervical cancer is not prevented it is a tragedy. That is compounded when women who have been diagnosed with cancer are not properly informed of the results of a subsequent audit. I would particularly like to acknowledge the powerful and deeply generous nature of the advice given when a woman who has such a painful experience encourages others to continue to participate in the programme in the interests of their health.

These powerful testimonies place on all of us a responsibility to act to address weaknesses while sustaining the national cervical cancer screening programme in the interests of current and future generations of Irish women. The Department is committed to discharging its particular responsibility to take the necessary steps, in association with the Health Service Executive, HSE, health professionals and others, to restore the trust of women in the CervicalCheck programme and, indeed, in our health service more generally.

Last week, the Government commissioned a leading UK expert, Dr. Gabriel Scally, to conduct an inquiry to establish the facts and to review all aspects of CervicalCheck. We are determined to do everything we can to assist Dr. Scally in his inquiries so that we can all find out what happened, and why it happened, to make sure that we have a robust cancer screening programme for women, and that lessons are learned for the future.

However, the focus needs to be on the women most affected as well as the CervicalCheck programme. On Friday last, the Government agreed a comprehensive package of health and social care measures to support the 209 women and their families who have been diagnosed with cervical cancer and whose audit result differed from their original smear test. The Government has committed to ensuring that these women and their families are supported to the fullest extent possible. The HSE nationally and locally is implementing these support arrangements and will be in a position to update the committee.

The health and social care measures include a discretionary medical card for each woman affected, or their next of kin in cases where the woman has sadly died, so that they can all avail of health services, including medicines provided under the medical card scheme, free of charge; out-of-pocket medical costs incurred, including the cost of any medicines which have been prescribed by their treating clinician; primary care supports, including counselling for the women affected and counselling for the immediate family members of these women, including bereavement counselling, where needed; and other health and social care supports, including travel costs and child-minding.

An international clinical expert review panel is also being established. The main purpose of the panel is to provide women with facts and independent expert assessment of those facts. The panel’s findings will also contribute to the overall independent assessment of the quality of the CervicalCheck programme.

The review will consider in depth all cases of invasive cervical cancer in Ireland since CervicalCheck was established. Women who developed cancer and who were screened by CervicalCheck will be identified and their screening histories will be examined. The expert panel will review the cases of those women who have had previous screening tests prior to their diagnosis and undertake a re-examination of cytology tests. Where the expert panel opinion of cytology results differs from the original results provided by CervicalCheck, the panel will endeavour to determine, wherever possible, any failures to prevent cancer or to intervene at an earlier stage. The panel will prepare individual reports for those affected, setting out the facts and their independent assessment.

The Government has also announced that the State Claims Agency is advancing a new initiative aimed at expediting resolution of the nine outstanding legal cases in a sensitive manner utilising mediation wherever possible.

In addition, last week, the Minister for Health received Government approval to provide in law for mandatory open disclosure, through the forthcoming patient safety Bill, in respect of serious patient safety incidents such as these. The Bill will also provide for mandatory reporting of these serious events to the appropriate regulatory authority, such as the Health Information and Quality Authority, HIQA. Policy on open disclosure has been informed by a number of elements, including the experiences of other comparable countries and the Report of the Commission on Patient Safety and Quality, the Madden report.

The open disclosure provisions brought forward last year were based on the principles set out in the Madden report. These proposals were also subject to pre-legislative scrutiny by the Joint Committee on Health. This legislation has since been enacted, following the passage of the Civil Liability (Amendment) Act 2017, and regulations flowing from it are due to be brought forward shortly. This approach is intended to help create a positive climate for open disclosure and to support the HSE’s national policy on open disclosure.

At no time has the Department of Health viewed open disclosure as something which clinicians or health service staff should regard as optional. It is quite clear that there is an expectation that patients should be told about any incidents regarding their care that may have occurred. This is clearly the standard expected in the HSE’s national policy on open disclosureand the requirements of the Medical Council for doctors, as we have just heard.

Like many health services internationally, we are seeking to achieve a health service where the relationship with patients is open, honest, listening and supportive. While progress in introducing such an approach has been made, this should be the everyday ethos of the health service. In this context, it is recognised that there are a number of very serious incidents where it is appropriate to introduce a requirement in law for mandatory open disclosure. That is why provisions for mandatory open disclosure will be incorporated into the forthcoming patient safety Bill, which will also provide for mandatory reporting of serious patient safety incidents to HIQA and others. The drafting of the patient safety Bill is being undertaken as a matter of priority within the Department.

The Department recognises the overriding importance of patient safety and quality in the delivery of health services and the need to ensure that all that can be done to prevent harm and error is done. The Department established the National Patient Safety Office 18 months ago and a range of important initiatives are under way on which we will be happy to provide further details. For example, the general scheme of the patient safety (licensing) Bill, which was approved by Government in December 2017 and referred to the Oireachtas, will ensure the need for all hospitals to have strong clinical governance and patient safety operating frameworks in place in order to be granted and maintain a licence to provide health services.

On Tuesday, the Department published records relating to the CervicalCheck clinical audit. The information submitted by the HSE in regard to this audit in 2016 provided the Department with an understanding that this was a retrospective clinical audit undertaken for quality assurance and learning purposes and that CervicalCheck had a clear objective to provide results to consultants in order to allow for direct communication with the women concerned. Both clinical audit and communication of the results of clinical audit to women were seen by the Department to be very worthy and valuable undertakings by the CervicalCheck programme. Clinical audit is an important means by which standards are maintained and advances made in healthcare.

I believe that a reasonable approach was taken by the Department at the time based upon the information available to it. There are two ways of looking at issues - based upon the information available at the time or with hindsight. Of course, had the subsequent widespread non-disclosure been escalated by CervicalCheck within the HSE and raised with the Department, this would have triggered a major concern and a much different attitude but based upon the information we had, we viewed the initiative taken to communicate audit findings to women in a positive light.

Let me be clear. The Department did not know about widespread non-disclosure of audit results. This has been confirmed by the HSE. Had we done so, that would have been escalated immediately. When we did become aware in April 2018, we immediately escalated the issue and worked with the HSE to put in place a serious incident management team to manage the response.

The widespread and still unfolding distress caused by the non-disclosure of the clinical audit results to the women concerned demands serious reflection. The Scally inquiry provides us with a mechanism to get an objective basis for introducing improvements where these can be identified. Those improvements will be introduced. However, some areas for improvement can already be recognised. As I set out last week, we will work with the HSE to review its open disclosure policy and the implementation of same in light of the experience to date. We will incorporate within the drafting of the patient safety Bill a mechanism to develop and introduce national standards for clinical audit. These standards will ensure that open disclosure, including roles and responsibilities for such disclosure, are fully addressed in advance of the commencement of an audit. As the CervicalCheck experience shows, it is important to anticipate the issues that will arise for the disclosure of clinical audit findings before commencing the process. The clinical audit standards to be introduced under the patient safety Bill should also entail a responsibility to record the fact that open disclosure has taken place.

I look forward to the recommendations produced by the Scally inquiry. The inquiry will produce an interim report at the start of June and a final report by the end of that month. The Department's role will be subject to detailed scrutiny by the inquiry. The committee can be assured that we will provide full support and co-operation and address any learning and recommendation as a matter of priority.