Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I welcome the chance to be in the Seanad for what I hope will be an opportunity to pass the CervicalCheck Tribunal Bill 2019 so that we can provide an alternative pathway to the courts system for women who are seeking justice and answers in respect of a botched retrospective audit and all the pain, suffering and damage that caused. I am happy to take the opportunity in Seanad Éireann, at the request of Senators Nash and Bacik, to comment on the situation regarding the 800 women. I do so in the context that we have made a lot of progress in recent days and weeks on CervicalCheck and on some of the issues. We now have a situation where the backlog of smear tests is significantly reduced. I expect it to be gone effectively, as a result of the additional capacity, by the time these Houses resume. We have secured additional capacity in labs that have been accredited and have met what I call the Scally standard. I have met Dr. Scally to ensure he is satisfied with the standard of those labs as well. This means the programme can continue and women can continue to be called at regular intervals, something that was in doubt in recent months.We are preparing to move to the HPV test. We will be one of the first countries in the world to do so. It will reduce the number of false negatives and false positives, which is important. There are plans in place to roll out the HPV vaccine for boys and that will begin in September in schools. We are continuing to push back against the misinformation regarding the HPV vaccine for girls and we are seeing some encouraging signs in that regard. We can state with honesty that within a generation we will be able effectively to eradicate cervical cancer in our country. It is important that women know that according to the most recent report of Dr. Gabriel Scally the laboratories being used are safe and accredited. I sometimes hear comments above and beyond what is in the Scally report. Dr. Scally was clear in that regard.

Of course, the issue that has recently emerged is a source of great frustration, annoyance and worry for women and I hope I can provide them with some reassurance this morning. Most importantly, I hope and expect that the chief clinical officer of the HSE, Dr. Colm Henry, will soon provide commentary regarding the clinical risk. I do not want women to be worried about a clinical risk that may not exist, although the matter is still extremely upsetting and frustrating from an administrative point of view. We need to try to provide reassurance from a clinical perspective regarding this impact.

Last Tuesday, the HSE advised the Department that it became aware in June that due to an IT issue at a Quest Diagnostics laboratory, several results letters were not issued to women and-or their GPs. The HSE also advised that it is working to ensure that all women and GPs are informed and receive the results. Communications are ongoing with the group of women identified as not having received results. My understanding is that from today GPs will receive the results manually, which is very important. It should have happened previously and it is extremely frustrating that it did not. While the electronic issue is being dealt with, the manual results can be sent to GPs from today.

For the group of women who, regrettably, were not issued with a results letter due to this IT issue, it is important to state from a reassurance point of view that the tests in question were primarily repeat HPV tests carried out in the Chantilly laboratory between 1 October 2018 and 25 June 2019. It is important to state that this test was carried out as a precautionary measure. Senators will recall discussions previously in the House after Quest Diagnostics advised CervicalCheck that HPV testing was carried out initially outside the recommended timeframe on several cervical screening samples. Senators will remember that Dr. Peter McKenna, clinical director of the national women and infants health programme, stated that there was no or very low clinical risk in that regard. As the women affected and their GPs were advised at the time by CervicalCheck's clinical team, these tests were carried out to provide reassurance and women's original HPV results were unlikely to change. That is a very important message for the women of Ireland to know. The overwhelming majority of the tests were precautionary and carried out to reassure, as explained by the HSE and its clinicians at the time, and it was highly unlikely that results would change as a result of this additional test.

The HSE stated that it has identified a small number of tests affected by this issue that were carried out outside the period described above and it has contacted these women directly to communicate their results. That is important because there are women at home today who are wondering whether they have been impacted by this issue. There are two groups involved, one of which involves women who have been contacted directly by the HSE and another of women for whom it was a precautionary test with a result that is highly unlikely to change and in regard to which Dr. Peter McKenna stated there is very low clinical risk. I hope that provides reassurance while not taking away from the rightful annoyance that people should feel regarding this situation happening again.

The existence of an IT issue was identified following engagement in June by my Department with the national screening service based on representations from an individual. I welcome the fact that the HSE has rightly apologised sincerely for the IT issue and the confusion and worry it is likely to have caused for the individuals concerned. I understand that the HSE is now confident that the IT system in the Chantilly laboratory can generate electronic results for women and GPs. The HSE will continue to monitor closely and engage with the lab in this regard. It goes without saying that my Department will also continue to monitor very closely the situation and engage with the HSE in this regard.

It is important for women to know that letters are being issued to women today. It is important for them to know that the overwhelming majority of the tests relate to a test done for reassurance, a precautionary measure involving a result that is unlikely to change. I am not taking away from the rightful annoyance people have in this regard, but I hope that provides some degree of clarity and reassurance. Dr. Colm Henry, the chief clinical officer of the HSE, will engage and communicate on this matter today to provide further reassurance and clarity from a clinical point of view to the women of Ireland.

On the amendment, I wish to acknowledge a number of very helpful amendments tabled by the Labour Party in the Dáil, several of which I was able to accept or adapt to a version which I brought forward on Report Stage in the Dáil. The amendment regarding providing women with an additional six months beyond the Statute of Limitations if the tribunal was not in a position to help was particularly constructive. We had good engagement on the issue of free legal aid and the scope of the tribunal, to which this amendment very much directly relates.

We asked Mr. Justice Charles Meenan, an eminent judge with a long track record in the area of clinical negligence, to look at an alternative pathway for the 221 women who have been affected. We then decided it right and proper to include those who are going through the Royal College of Obstetricians and Gynaecologists, RCOG, process where discordance may be found and that it was also appropriate to include the small number of women whose slides were missing or not located in time for them to participate in the RCOG review. The group of 221 or more women where there is discordance, those who participate in the RCOG review and where there is discordance and the small number whose slides were missing such that they could not participate in the RCOG review to determine discordance are all included in the current scope of the tribunal.

During discussion of the Bill in the Dáil I was asked to consider widening that scope to include women who decided for a variety of reasons which we should not second guess that they did not wish to participate in an independent audit and, as such, were not audited by CervicalCheck's retrospective audit. They may have declined to participate in the RCOG process so far, but may reconsider with the establishment of the tribunal and should be given one more opportunity to decide. I am sure some women will decide to participate while others will decide that their cancer journey is in the past and they are happy to leave it there. Different women will make different choices. I could not progress that measure in advance of the summer recess due to legal issues and the requirement for Government approval, but I intend to return to the Oireachtas early in autumn to widen the scope in order to offer those women who have had cervical cancer and are known to the cancer registry but, to date, opted not to participate in the RCOG review one more opportunity to participate. That proposal met with cross-party agreement and satisfaction in the Lower House and I hope it will receive a similar response in this House. Obviously, I want the Bill to be passed such that during the summer months Ms Justice Mary Irvine and others can begin the process of establishing the tribunal.