Opening Statements to the Joint Oireachtas Committee on Health

Statement to the Joint Oireachtas Committee on Health by Jim Breslin, Secretary General, Department of Health

16 May 2017

I would like to thank the Committee for the opportunity for myself and Dr Tony Holohan, Chief Medical Officer of the Department of Health to meet with you this morning and to share some opening remarks.

I would at the outset like to recall the bravery of Ms Vicky Phelan, Ms Emma Mhic Mhathúna and the loved ones of other women that have come forward in recent days. Their testimony, and their willingness to speak publically about deeply personal matters has raised very serious questions. These questions relate to how the health service engages with individuals when things go wrong and the fact that the audit results for these women were not conveyed as they should have been.

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 steady reduction each year.  But 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 which is given when women who have had such painful experiences encourage 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 HSE, health professionals and others, to restore the trust of women in the CervicalCheck programme, and indeed in relation to 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 enquiries, so that we can all find out what happened and why it happened.  And to make sure that we have a robust cancer screening programme for women, and that lessons are learned for the future.

But 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 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 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. Also counselling services for the immediate family members of these women, including bereavement counselling where needed;
  • other health and social care supports, including travel costs and childminding.

An International Clinical Expert Review Panel is also being established as part of the Government’s investigation into CervicalCheck. 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 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 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 to 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 and will prepare individual reports for those affected, setting out the facts and their expert and 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. The Bill will also provide for mandatory reporting of these serious events to the appropriate regulatory authority, such as HIQA.

Yesterday the Department published records relating to the CervicalCheck clinical audit. The information submitted by the HSE in relation 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 health care.

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.

However, 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  The Department has at this stage publicly committed to engaging with the HSE on a full review of the implementation of its Open Disclosure Policy.

As I have mentioned the Government has approved the drafting of a Patient Safety Bill by the Department. This Bill will provide a mechanism to develop and introduce standards relating to clinical audit so as to ensure that open disclosure, including roles and responsibilities for such disclosure, are fully addressed in advance of 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 June. The Department will be subject to this Inquiry but the Committee can be assured we will provide full support and cooperation and address any learning and recommendations as a matter of priority.

Chairman, with your agreement, I will ask Tony Holohan to offer some additional remarks.


Statement to the Joint Oireachtas Committee on Health by Dr. Tony Holohan, Chief Medical Officer, Department of Health

16 May 2017


I have been Chief Medical Officer for 10 years.  In all those years, I cannot recall a time when patients were gripped by such widespread fear and concern.  Yes of course, given the nature of the events that have unfolded in recent weeks, this fear and concern is entirely understandable; but it has been hugely difficult to get real facts, which people can trust, into the public domain and hence into public understanding.

Therefore, I would now like to take the opportunity to get those facts across and in some way allay public concerns.  Yes, things went wrong that is true; lessons must be learnt that is also true; but it is important that we are clear about what actually came to light.  Arising from the publicity following the Vicky Phelan court case, questions arose as to whether other patients might be in a similar situation.  Had Vicky Phelan not highlighted her case, we might not have become aware that other women had not had the findings of the CervicalCheck clinical audit disclosed to them by their clinicians.  We owe a debt of gratitude to Vicky.  We have already expressed, and express again, our gratitude and thanks to her for creating the opportunity for us to learn and to improve our services.  This will ultimately benefit all women in the country.

It has become clear that the non-disclosure of clinical audit findings was widespread.  It has also become clear that the issue of disclosure was the subject of dispute among the relevant clinical community.  I can provide assurance that the Department was not aware of these issues until this controversy arose.  We have since had the opportunity to engage directly with a view to understanding, directing and investigating what happened.

So let me spell it out clearly; firstly, no Minister was advised.  Secondly, the decision not to escalate was a fair and reasonable decision.  It was reasonable because the information provided in the briefing notes provided by the HSE to the Department was evidence of ongoing improvement to how the service was being delivered, rather than the identification of a problem which, of its nature, required escalation to Ministerial level.  The HSE has and will confirm that within their systems no escalation of concern in relation to the implementation of this audit programme took place.

I think the characterisation of the Department, my colleagues and me in the media in recent days has been unfair.  The Department is far from an organisation that is unwilling to seek proper disclosure to patients, that is unwilling to directly performance manage the HSE, and to escalate appropriately to Ministers.  Any fair assessment of our work record will show that this is simply untrue.

Firstly, in relation to cancer, both I and the Assistant Secretary in Acute Hospitals have a long and very proud record of a hands-on involvement and achievement in major cancer developments. A key component of our work has been to drive extensions to cancer screening, starting with breast to cervical and to bowel screen.  We were hands on in the establishment of these programmes.

In the case of cervical cancer particularly, it is important to point out just how much has been achieved.  Before 2008 we had a disorganised arrangement of random screening were many women were getting too many smears and many others were not getting any smears at all.  On an annual basis, we were doing more smears in the country at that time, than we are now.  Smears were examined in a wide range of laboratories, many of which were too small and not fit for purpose.  There were no quality assurance arrangements in place and there were very long turnaround times for reporting of smear results.  In 2008 we introduced a population based programme which invites patients to come forward to their GPs for smears, those smears are sent to accredited laboratories and appropriate follow up colposcopy services were put in place.

Before 2008, cervical cancer incidents were rising and doctors working at the coal face in gynaecology spoke passionately about young women presenting symptomatically with very late advanced cancers that required radical surgical treatments and often had poor prognosis.  Since 2010 we can categorically demonstrate that the national programme is delivering on average a 7% reduction in incidents.

Much has been spoken of the fact that this issue was not escalated to the Minister.  I, as Chief Medical Officer, and the Assistant Secretary, Acute Hospitals, have a long established practise of appropriate escalation of issues to Ministers, often in circumstances where the issues being escalated are difficult and challenging and may pose political challenges for the Ministers in question.

From our responses to individual incidents in the time of Minister Martin, to the establishment of the Patient Safety Commission by Minister Harney, through to the work on major challenging issues such as Portlaoise and other maternity services up to and including the Maternity Strategy, and the establishment of the National Patient Safety Office by Minister Varadkar, we have a long track record of not just escalating, but working hands on with a succession of Ministers and the senior leadership of the health system, and most importantly with patients and patient groups, to spearhead what has been an enormous programme of reform.

Let me now move on to open disclosure.   Various theories have been reported around the advice I gave to the then Minister Varadkar and the Government in relation to open disclosure, so let me make some facts clear:

I do not regard open disclosure as optional.  Open disclosure should happen in the right way, in every circumstance in which it is indicated.  Patients simply must be informed.  I know that this can be a challenge for the medical profession internationally, but professionals in this country are rising to that challenge.  Our legislative approach is to encourage doctors to do the right thing in circumstances where disclosure is required.  We know from the evidence internationally that one of the reasons that disclosure does not happen is that doctors fear the medico legal consequences.  We have directly addressed this fear through the voluntary disclosure legislation which we have introduced.  That legislation provides that if doctors disclose appropriately, they will not contribute further to any legal risks they may have.  That is intended to create a safe space and encourage people to do the right thing.

That is not to say that we do not see a role for mandatory open disclosure, so a stepped approach is required.  Following many months of work, we have secured Government approval to introduce mandatory open disclosure for a specified list of serious reportable events.  This is in line with the UK Duty of Candour.  However, it goes further in that it places the duty directly on doctors, and not simply on organisations, to make those disclosures.  Thus the commitment to open disclosure in this country exceeds that in the UK and is based on our assessment of what will work best to encourage and support disclosure in the right way and required disclosure where events are sufficiently serious.  This has been the result of a huge amount of work by the Department over a long period of time.

It is really important that I am clear that we absolutely recognise that there are very tragic cases at the centre of the current controversy.  We are fully sensitive to that.  I want to engage directly with those people to better understand their perspectives and to ensure that their perspectives are directly fed into policy making and to policy oversight such that  lessons for the health system are applied.