Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I thank the House for giving me the opportunity to provide an update on matters related to CervicalCheck. It is over a year since issues related to the CervicalCheck audit emerged. I welcome the opportunity to address a range of issues that have arisen in the past year and outline the work that is well under way in my Department, the HSE and the National Cancer Registry of Ireland to address them and, moreover, drive continued improvement in the screening service.

It is worth reflecting on what the CervicalCheck programme has achieved since it was set up in 2008. Since its inception, the programme has carried out more than 3 million screening tests. It has detected over 100,000 cases of abnormal cervical cells, many of which could have developed into cancer if not detected through screening and treated, where necessary. Cervical cancer rates have reduced, from around 14 cases per 100,000 women in the years 2009 to 2011, inclusive, to 10 cases per 100,000 women in the years 2013 to 2015, inclusive. The lifetime risk of a woman getting cervical cancer fell from one in 96 women in 2007 to one in 135 women in 2015 which, as Dr. Gabriel Scally noted in his report, represents a substantial improvement.

Dr. Scally also included in his report something to which I want to draw attention again - the substantial contribution CervicalCheck staff have made to women's health since the programme was established. I know how difficult a year it has been for them also.

Dr. Scally's report was produced following the in-depth scoping inquiry carried out by him and his team following a Government decision. This House's contribution in drafting the comprehensive terms of reference for the scoping inquiry helped to ensure his report identified the core issues and provided the framework to fix the flaws he identified in the screening service. He provided a progress report and a first report in June 2018 and his final report in September. All told, he made 56 recommendations which addressed a range of issues, including governance, audit, procurement and women's health.

An implementation plan for all recommendations has been developed and was published on the website of my Department on 12 December 2018, following a Government meeting. There are more than 120 actions in the implementation plan which, together, address all of Dr. Scally's recommendations. Some of the actions relate to work that had already been under way such as the establishment of a new board for the HSE and the proposed patient safety Bill. Others have been put in place in response to Dr. Scally’s report. Work has been ongoing since December across the range of actions. My Department, the HSE and the National Cancer Registry of Ireland all have important and ongoing work to do.

It is important to say Dr. Scally has, at my request, reviewed the implementation plan for his recommendations. He said publicly that never before had he drawn up a report and then been asked to oversee its implementation. That is how seriously we are taking this issue. He provided a very positive preliminary assessment last November and a more detailed report in February which was published on the website of my Department. He was clear in that report that significant effort and resources were being committed to addressing the problems that had been identified and that the appropriate resourcing and project management structures were in place.

As Deputies will be well aware, Dr. Scally has committed to providing a supplementary report on certain further aspects of the laboratories, including procurement, quality and accreditation arrangements and governance structures. I look forward to receiving and acting on this report in the coming weeks. The report will, of course, be published once it has been shared first with representatives of the 221+ patient support group. The full implementation of Dr. Scally's recommendations will ensure women can have absolute confidence in the cervical screening service. Screening saves lives. It is essential that women continue to use the programme and all of the indications are that they are continuing to use it.

It is important to acknowledge that there continue to be challenges, one of which is lab capacity. As Deputies are aware, following the issues which had emerged with the CervicalCheck screening programme, I made the decision to offer free out-of-cycle smears to any woman who was concerned about her health, where her general practitioner, GP, felt she should have a further test as part of providing reassurance. The reality at the time was that general practitioners, in difficult and pressurised circumstances, were dealing with large numbers of worried patients. GPs needed to be supported while they awaited supporting information to be developed and disseminated by CervicalCheck. Approximately 112,000 consultations were provided by GPs, highlighting the sense of worry in the country, while 57,810 early repeat smear tests were provided between 1 May and 31 December. In other words, about half of the consultations resulted in a smear test, which is very different from how it is portrayed. Some 112,000 women saw their doctor, about 50% of whom decided, in consultation with their GP, that a repeat smear would be beneficial as part of providing reassurance. I trust women and doctors in making those decisions.

Laboratory turnaround times have increased as a result. A backlog of over 80,000 smears had built up to the end of February 2019, a figure that has been well documented. This reflects the 57,000 or so additional smears but also the fact that, thankfully, more women were using the screening programme, including some who had never before engaged with it. The HSE has advised that it has sourced additional capacity internationally and that it is working to agree commercial arrangements and complete quality assurance processes in order to enable it to incorporate this capacity into the CervicalCheck programme. I know that this will be welcome news. It has been welcomed by the patient advocates, many cancer organisations and many Deputies in government and opposition.

The HSE is advising women that the natural history of cervical cancer indicates that the disease normally develops over a period of ten to 15 years. It has stated that, in this context, a delay in the return of cervical screening results is undesirable but not necessarily dangerous and that it poses a very low clinical risk. That is not an excuse for the backlog but an important message for the women of Ireland.

The House will be aware that I have asked the HSE to introduce as soon as possible human papilloma virus, HPV, testing as the primary screening method for the prevention of cervical cancer. This is in line with developments in cervical screening internationally. Ireland will be among the first countries in the world to make this transition. The HSE is engaging with other countries which have already made the switch in order to identify learnings for the project across a range of work streams, including reconfiguration of laboratories, procurement, information and communications technology, ICT, and colposcopy services.

The report on the scoping inquiry led by Dr. Scally outlines the difference between the current testing approach, using the traditional cytology test as the primary test, and the newer HPV test. It states that for every 1,000 women screened, around 20 will have pre-cancerous changes. The traditional test will identify 15 of the women, while the HPV test will correctly identify 18. In other words, it is a more sensitive and accurate test. Funding to implement the switch to HPV screening and, importantly, extend the HPV vaccination to boys, an issue on which I know Deputy Kelly has advocated, has been allocated in budget 2019. Vaccination for boys will be introduced in September.

The independent expert panel review, which is being conducted by the Royal College of Obstetricians and Gynaecologists, RCOG, will provide further clarity and assurance to the women who have consented to take part. I am the first to admit that this has taken longer than expected, particularly due to the necessity of seeking consent from women or their next of kin. However, I am pleased the review is now progressing well, with the transfer of all slides due to complete shortly. Of crucial importance is that the results of the review are disclosed to women in a sensitive and quality assured manner, and work is ongoing to ensure the right process is in place for this to happen.

On 16 April 2019, the Government approved my proposal for the drafting of a Bill to establish a tribunal to hear and determine claims arising from the retrospective CervicalCheck cytology clinical audit and from the expert panel review of cervical screening, in particular in respect of the reading of smears. This arises from recommendations made by Mr. Justice Charles Meenan in his report on an alternative system for dealing with claims arising from CervicalCheck. The proposed tribunal will be chaired by Ms Justice Mary Irvine, a serving judge of the Superior Courts, and will be open to individuals who are part of the 221 group, along with individuals who are identified during the RCOG review, where this review presents findings discordant with those of the original cytology examination.

I am pleased that we have this opportunity to put in place a new process to hear and determine claims for these cases. Mr. Justice Meenan’s report provides a roadmap through a complex legal environment and the tribunal that he proposes is substantially different to anything that has been done before. It has never been done before in our country. Getting this right involves striking a careful balance between several important priorities, including the well-being of women and their families, the continued viability of life-saving cancer screening programmes, and the need to properly hold the State and private operators to account. Following consultation with the office of the Attorney General, the general scheme of the legislation is now available on my Department's website. The Bill has gone for drafting to the Office of Parliamentary Counsel. I have issued a letter to the Chairman of the Oireachtas Joint Committee on Health, Deputy Harty, who is present, to offer a briefing by my officials to committee members. This is complex legislation but it is a priority for the Government. Let me be clear that it is my intention to pass the legislation through both Houses before they rise for the summer recess.

On 11 March 2019, the Government agreed to my proposal to establish an ex gratiascheme for women affected by the non-disclosure of the CervicalCheck audit. The scheme is designed to provide an alternative, non-adversarial and person-centred option for women affected by the CervicalCheck non-disclosure issue. The Government also approved the appointment of an independent assessment panel. I have appointed the other two members of the panel, namely, Ms Brigid Doherty and Dr. Kevin Connolly, along with the judge. The panel has begun its work and held its first meeting on 1 May 2019. The role of the panel is to make a determination as to the appropriate amount of the ex gratiapayment. Under the terms of scheme, the same amount will be paid to each woman, or her estate, who is assessed by the panel not to have had appropriate and timely disclosure. All women, or their next of kin, in the 221 cohort identified from the clinical audit as having discordance in their smear test results will be eligible to participate in the scheme and I am pleased that letters of invitations were issued yesterday. The terms of the scheme will shortly be available on my Department's website.

Members can see the considerable focus on the various issues raised over the past year, and the progress that has been made in responding to them. My overriding priority remains public health. The country has the opportunity to drive the virtual eradication of cervical cancer through a combination of screening and vaccination against HPV. Since the inception of the cervical screening programme, the incidence of cervical cancer in Ireland has been falling and we must build on this. This is very much the focus of the work of my Department, the HSE, and the many brilliant patient advocates in implementing the recommendations of Dr. Gabriel Scally, as well as in the important development of extending the HPV vaccine to boys this year. My priorities now are the ex gratiascheme, the Meenan tribunal legislation and ensuring the capacity is in place to reduce the backlog turnaround times.

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