Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I am very pleased to be back in Seanad Éireann. As Senators are aware, on 12 September I published the report on the scoping inquiry into the CervicalCheck screening programme. I welcome the opportunity to speak to the House about the report. I publicly acknowledge the extraordinary contributions of Vicky Phelan, Stephen Teap, Lorraine Walsh and many other women and their families who have shared their stories with us.

Through his report, Dr. Scally has brought much needed clarity to the CervicalCheck crisis. Such clarity and understanding are crucial if we are to address what went wrong. We now understand that, at its heart, the crisis is about the failure to tell women about their own medical information - to disclose to them the results of a retrospective audit of their screening history carried out after they had been diagnosed with cervical cancer. The failure to disclose was utterly wrong and unacceptable. Furthermore, the way in which many of those affected were eventually told about the outcome of the audit added to the pain they were experiencing in dealing with the aftermath of a cancer diagnosis.

It is fair to say some of the complexities were not always well understood in recent months. It is clear that some people believed women had not been told that they had cancer. That view was expressed in each of the Houses. Others assumed that a diagnosis of cervical cancer in a woman whose screen had returned a negative result was automatically negligent. Thanks to Dr. Scally’s report, we now have a much greater understanding of the complexities involved in our screening programmes. The report is based on intensive work by him and his team of experts over a relatively short period. While it provides welcome reassurance about the quality and safety of the laboratories being used by the Irish screening service, it clearly sets out the enormous impact the lack of disclosure of retrospective audit results had on those affected. The Government has accepted all 50 recommendations made in the report and I am committed to moving ahead with their implementation. I ask and hope for and I am sure I will receive the support of Members on all sides of the Seanad and the Dáil in putting all of our energy into delivering the recommendations because they will lead to a world class screening programme. If implemented, they will help us to make cervical cancer an extraordinarily rare disease in this country, which must be our aim. When this debacle first broke and I met and spoke to Vicky Phelan, she told me, as have others since, that she wanted to know that some good could come out of this awful situation. That good can be to make cervical cancer an extraordinarily rare disease in this country and save women's lives. We must all put our efforts into pursuing these goals.

As an implementation priority, I will work on the establishment of a new independent patient safety council. As its first task, the council will carry out a detailed review of the existing policy on open disclosure. The resulting policy will have legislative underpinning and operate across the health service.

The establishment of a statutory duty of candour is a further key requirement. The Patient Safety Bill is scheduled to undergo pre-legislative scrutiny tomorrow at the Joint Committee on Health. I ask members of that committee to give this issue the priority, attention and time it requires in order to pass this landmark legislation which will make a duty of candour a legal requirement. The Bill provides the legislative framework for several important patient safety issues, including mandatory open disclosure of serious patient safety incidents. I wish to ensure the requirement to disclose or a duty of candour will apply to individuals and institutions, rather than institutions alone, as is the case in certain other jurisdictions.

The Government is committed to the continuation of CervicalCheck, BreastCheck and BowelScreen. We know that screening saves lives. Dr. Scally has been clear that the continuation of the screening programme is crucial. His report affirms that the laboratories contracted to CervicalCheck are providing a quality service. It is very important that this be recognised. Leaving aside whatever else went wrong, charges were made, possibly in this House and certainly in the Lower House, regarding the quality and safety of the laboratories. The number one query I received from women by email, in my constituency office and as I went about my business was whether the laboratories responsible for carrying out screening were safe and whether women could be assured of the quality of the results. Dr. Scally examined the issue and visited the laboratories with three other medical experts, a senior counsel and a barrister at law. They concluded that the laboratories being used by the screening service were safe. That is a very important point for all Members to reiterate.

Crucially, Dr. Scally has found no reason for the existing contracts for laboratory services not to continue until the new HPV testing regime is introduced next year. He is satisfied with the quality management processes in the laboratories and his report presents no evidence that the rates of discordant smear reporting or the performance of the programme fell below what was expected. It is essential that we clearly and emphatically send the message that this is a high quality and effective programme and that screening reduces the risk of developing the disease. I know that some of the women most impacted on by this issue have been very determined that that message is sent clearly.

As Members now know, screening alone is not enough to prevent all women from getting cervical cancer. Sadly, false negative results are inherent in screening programmes. Page 11 of Dr. Scally's report is very revealing in that regard. It states that, for every 1,000 women screened, 20 will have pre-cancerous cells. Screening will detect the pre-cancerous cells in 15 of the women but, sadly, miss them in five of the 20. The good news is that as we move to HPV testing that rate of detection of 15 of 20 will increase to 18 of 20. That is why it is imperative for us to invest in and deliver the HPV testing programme and we are determined to do so. I have given approval for the switch to HPV testing as the primary cervical screening test, which, as I have stated, will reduce the rate of false negatives. Work is under way to progress that change.

A well organised screening programme, combined with HPV vaccination for boys and girls, can bring us very close to eliminating the disease. I reiterate the absolute importance of the vaccination programme. I noted in horror that some of the Oireachtas Members who were most vociferous on the CervicalCheck screening programme opposed use of the HPV vaccine. The vaccine has saved lives. Some of those Members have written to me questioning the safety of a vaccine which can prevent the death of women from cervical cancer. The HPV vaccine is safe and saves lives. Members need not listen to me. However, they should listen to Laura Brennan, an incredible patient advocate who has cervical cancer and spoken about how she does not want any other girl to find herself in a similar position. If this is about reducing the rate of cervical cancer and saving women's lives, there is a duty on all Members to promote not only the most robust screening programme we can have in this country but also use of the HPV vaccine.It is appalling that the vaccine's uptake rate had fallen because of the misinformation that was allowed to get out there. People need to get their medical information from medical professionals, and www.hpv.iehas factual information for parents to make an informed decision. I want to see the HPV vaccine extended to boys. We are committed to introducing that next year subject to HIQA's report, which is due shortly. I have asked my Department to develop a HPV plan for the reduction of cervical cancers and other HPV-related cancers to the maximum extent possible, building on these changes and optimising uptake of screening and vaccination. It is through screening and vaccination hand in hand that we will eradicate this disgusting and despicable disease from our country.

I do not downplay in any way, shape or form the extraordinarily serious gaps that have been identified in the governance structures of our screening service. They need to be addressed in full through Dr. Scally's 50 recommendations. They must also be considered in terms of how they apply to governance structures in the health service more broadly. I emphasise that Dr. Scally has stated in unequivocal terms that he found no evidence of conspiracy, corruption or cover-up. This speaks to the integrity of our civil and public servants, some excellent people who get up every day and go to work to try to build a better health service. Some of the things that were said in the heat of the controversy questioned the integrity of public servants in leadership positions, so it is only right that we now acknowledge the actual position as outlined by the independent expert, who was assigned to establish the facts by those of us in the Oireachtas.

The report examines the provision of briefing notes on screening audit and disclosure to the Department of Health in 2016. These came into the public domain in May. I welcome the clarity provided. The inquiry considers that it would have been unreasonable to expect senior management in the HSE or, even more so, my departmental officials to have intervened on foot of these notes. According to the report, the subsequent problems were significantly associated with the failure to disclose, and it would have been difficult to predict this, given the reassurance that the briefing notes provided.

Dr. Scally has based his findings on careful examination of the contemporaneous records. He has reviewed more than 12,800 files, which is more than anyone in this House has, in order to get all of the facts and information. I fully accept his conclusions in this regard. I am clear that the decision of my officials not to escalate to me was correct in the context of his findings.

Accountability was an issue raised by many women and family members during their engagement with Dr. Scally’s review. He has been clear that the problems he has uncovered represent a system failure. In many ways, it is often more straightforward to receive a report asserting that X or Y individual did something. Sadly, when one reads the Scally report, the situation is far more complex. A whole-of-system response is required. I have already taken some steps, and I look forward to working with Senators on delivering them. For example, I have re-established a board for the HSE. I announced its chair designate only last week. It will provide the foundation for proper governance and accountability. I hope that we can get the Health Service Executive (Governance) Bill passed through the Houses this year so that the board can take office in January.

The key focus must be on implementation. My Department has already commenced the task of fully implementing the report. The CervicalCheck steering committee, which I established in June, will oversee and direct the implementation of all 50 recommendations. Importantly, the committee will publish its minutes and agenda, so everyone can, via my Department's website, find and track everything that is being done. The Department has established a working group to drive the work of implementation. I have already written to all of the organisations mentioned in the report, including the Medical Council, to ask them to commence preparations for implementation of the relevant recommendations. Questions remain to be answered about how clinicians interacted with patients, in this case women. Some of what women were told is extraordinarily worrying. It is not the first time we have seen women treated like this by the health service. For example, we saw it in respect of transvaginal mesh, sodium valproate and, dare I say it, issues relating to abortion and reproductive health. Sadly, we now see it in terms of CervicalCheck. I welcome Dr. Scally's recommendations in this regard. There are lessons for the Government, the HSE, clinicians and clinical leadership.

Dr. Scally's 50 recommendations are important and their breadth reveals the complexity involved. We must now begin the hard work of implementing each and every one of them. This is what will improve the quality of our screening programme. I propose to meet the patient representatives, including Vicky, Stephen and Lorraine, in the coming days to speak with them about the next steps and how to ensure their involvement. I propose to take Dr. Scally up on his offer to stay involved for the next 12 months and externally oversee the recommendations. This is not a report that he has written just to head back to the UK. He wants to oversee its implementation externally. I want him to appear before the Joint Committee on Health to update the Houses and the public on how he is getting on with delivering the recommendations. There will be a need for further inquiries - he has already pointed to a number of areas that require further examination - but we must also reflect on his views as to how best to go about that. Crucially, we must take on board the views of Members in both Houses and those who have been impacted.

We have a great deal of work to do, but Dr. Scally's report brings us to a place where we can approach it in an evidence-based fashion, focusing on implementation and delivery so that we can ensure that lessons are learned and lives are saved in future.