Dr. Tony Holohan:

My apologies for that. I thank the committee for the opportunity to address it this morning. I am pleased to update it on the outcome of the independent expert panel review of CervicalCheck, and we have just heard some of the details, which we established last year following the Government's decision of May, and the current position on the national screening programme as it pertains. I am joined by Ms Tracey Conroy, assistant secretary, Dr. Ronan Glynn, the deputy chief medical officer and Ms Celeste O'Callaghan, principal officer.

As we know, the failure to disclose the results of the CervicalCheck retrospective audit to women and families, which emerged in April last year, resulted in widespread concern about the programme. Since then, the Department's overriding priority has been to ensure the viability and sustainability of our national cervical screening programme so it can continue to save lives and improve outcomes for cervical cancer.

Neither screening nor HPV vaccination alone are enough and we need both to work together in tandem if we are to make cervical cancer a rare disease in Ireland, which is our policy objective. In pursuit of this goal, the Department has engaged very closely with the HSE and, in particular, the national screening service on the implementation of the various Government decisions and the range of very difficult strategic and operational issues faced by the programme.

It is important to recognise, however, that this work has involved multiple other stakeholders coming together and working collectively through the many challenges that arise, as well as those who continue to deliver the service in a hugely pressurised environment. This includes patient advocates, patient representatives and clinicians. I take this opportunity to acknowledge the commitment, input and expertise of each of them. Most particularly, I thank the Royal College of Obstetricians and Gynaecologists, which, at our request, agreed to undertake what has been an enormously complex and challenging task to give individual women in the first instance, or their next of kin, the opportunity to have the benefit of expert independent assurance with regard to their individual cases.

Over the past 18 months, we have moved from a period of crisis to an emerging more stable environment. The necessary laboratory capacity has been secured to ensure continuation of the programme following complex negotiations led by the HSE. Recruitment for key posts that will strengthen the governance of the screening service has been undertaken and investment is ongoing in the development of national laboratory capacity, colposcopy services and the introduction of HPV primary immunisation, to add to the introduction of HPV immunisation for boys during the course of 2019.

From the perspective of women and families involved in this issue, an ex gratiascheme to address the issue of non-disclosure was put in place as well as a package of health and social care supports.

In the past 18 months, we have had two independent reviews of the programme: the scoping inquiry initially led by Dr. Scally, which concluded earlier this year, and now the independent expert panel review led by RCOG, which concluded two weeks ago. Dr. Scally provided the final report in September of last year and a supplementary report in May of this year. He found no evidence of deficiencies in screening quality but he did identify a significant number of management and governance issues and made a total of 58 recommendations to address these. A comprehensive implementation plan was developed in late 2018 for these actions with approximately 170 actions across the Department of Health, the HSE and the National Cancer Registry of Ireland. Significant progress has been made overall with in excess of two thirds of these actions now completed. That is in the oversight of the CervicalCheck steering group. Quarterly progress reports on this are published on the website of the Department of Health.

Patient representatives make a significant contribution on an ongoing basis to the work of the Department, the HSE and health agencies, and the patient voice has been central to our work, not just in respect of CervicalCheck but all of our work in the past 18 months. Patient representatives have been active participants in the CervicalCheck steering committee chaired by the Department and contributed significant time also to working with the HSE in regard to the many operational issues arising over the past year and a half that the executive is grappling with.

Ms Lorraine Walsh resigned from her work on the steering committee and with individuals and committees in the HSE and CervicalCheck at the end of October. The Minister has thanked her for all of her work. Her significant input to the work of the steering committee since its inception was acknowledged at its November meeting. We have the opportunity now to acknowledge that and thank her for the work she has done with us during the course of that committee. The Department is examining how best to provide necessary structures that will allow for appropriate selection and compensation policies to be put in place to ensure that patient representatives are appropriately recognised and remunerated for their work and contribution to health service design and reform. International models of patient representation are being examined as part of this work, which is at an advanced stage.

On 3 December, the aggregate report of the international clinical panel review was published following the Government decision taken that day. The first key objective of the review was to provide women, or their next of kin, with independent clinical assurance about the timing of their diagnosis and treatment. In total, 1,038 women chose to participate in the review and this was a very welcome number, which allowed robust and comprehensive analysis of the programme. The process of communicating individual reports to women or their next of kin commenced in late September. All of those who wished to do so have now received a report at an individual level setting out the reports findings. We were keen to ensure that individuals in the first instance have the opportunity to hear from their individual clinician before any aggregate report could be published.

There is no doubt that this has been a difficult process for many women or their next of kin particularly where, sadly, a woman may have died. The Department has engaged closely through this process with the HSE in its planning for a communication process that is as sensitive and supportively delivered as possible. We recognise the significant work that has been undertaken by the HSE, including the clinical need for the national women and infants programme and the engagement of colposcopists in particular on whom we are enormously dependent to support this process around the country.

The second key objective of the review was to publish the aggregate report, which includes recommendations, where appropriate, that have the aim of improving care for women. In that context, the concern that first arose in April of last year was an important dimension of the work of the independent panel and adds to the work undertaken by the separate scoping inquiry reported on by Dr. Scally. Based on its overall findings the expert panel has stated, and it is important to reiterate, that it is not an understatement to say for many women who participated in this review screening undoubtedly has saved their lives; that there is no doubt that the programme has been successful and has worked effectively; that women can have confidence in the CervicalCheck programme; and that their findings at a population level are in line with those seen in the English cervical screening programme and should not be viewed as a cause for concern with respect to the population overall. We regard these conclusions as very welcome given the importance of cervical screening from a public health point of view. We know it saves lives and it is vital, therefore, that women have confidence in the programme. The public can be reassured that the programme is operating effectively now. As we know, the panel has made ten recommendations, which generally align with the work being undertaken in both organisations, the HSE, and the Department, including in regard to the recommendations of Dr. Scally. The Minister has written to the HSE and the National Cancer Registry in respect of the implementation of those recommendations. The independent panel's report also concluded that many of the women who participated in the review are alive today because of CervicalCheck. That conclusion underlines once again the crucial importance of ensuring a strong, viable and sustainable cervical screening programme while working to ensure that cervical cancer becomes a rare disease in Ireland, an objective we all share.

The expert panel and Dr. Scally said that through a combination of screening and vaccination together with good uptake of both we can achieve this goal. The extension of the HPV vaccine to boys in September of this year and the introduction of HPV primary screening in quarter 1 next year are key steps towards that goal. Funding for both was provided in 2019. We will continue to engage closely with the HSE on its continued roll-out and implementation.

In addition, the focus remains on the continued implementation of the recommendations of the scoping inquiry and the implementation of the ten recommendations contained in the RCOG report. Through the combined effects of all these elements, we will have the opportunity to ensure that Ireland has a world class cervical cancer screening programme that will enable us to make cervical cancer a rare disease within a generation.