Leo Varadkar (Dublin West, Fine Gael) | Oireachtas source

To clarify, in all 1,400 cases the original smears have been rechecked. The way the audit worked is that if a woman was diagnosed with cervical cancer between 2008 and 2014, they went back and checked all of the smear tests to see if there were false negatives or false positives. To reassure people, in all 1,400 cases those smear tests were rechecked already. That is the way this audit cycle works.

In relation to the laboratories, I hope I answered already - if I did not I am happy to repeat it or clarify - that we are moving towards a new more accurate test. No test is 100% accurate. There will still be false positives and false negatives, but we are moving to a new test which is a HPV-based test for cervical cancer screening. That new test will come in later in the year. That offers us an opportunity to reconfigure the laboratories and review which laboratories we use.

Whatever we do, it should be based on facts. We are letting women down and letting people's health down, in particular women's health, if we make decisions that are not based on facts. As I explained earlier, 50% of smears are checked in cytology laboratories here in Ireland and 50% are outsourced. Three different laboratories are used - two in the United States and one in Ireland - and so far there is no evidence that any of those laboratories is less accurate than the others in terms of false negatives in a statistically significant way. Whatever we do, it must be based on facts. We should not merely sack somebody or change the laboratories for some reason. In the interests of women and their health and doing what is right, we must base our decisions entirely on facts and evidence.

In terms of resignations, it is worth noting that the head of the programme, its clinical director, Professor Gráinne Flannelly, has already stepped down. We accept that she has made that decision, taking accountability for the appalling communication failures that occurred. However, it is also important to note that she is somebody who was involved in bringing in this programme over the years and as a consequence, helped not only to save many women's lives but also to ensure many women had much less invasive operations because their cancers were picked up earlier. We should be balanced in our response and recognition of that.

On the duty of candour issue, as I said, duty of candour is already in the medical council guidelines.

On the decision taken last November on mandatory open disclosure, this commitment was given to Deputy Clare Daly, who brought the amendment forward and made some good points in that debate in the Dáil, by the Minister both verbally and in writing that on foot of the legislation for voluntary open disclosure, which was passed by these Houses a few months ago, he would bring forward mandatory open disclosure in line with the programme for Government in cases where it is a serious reportable incident or error. The Minister is developing that legislation. It will be in the patient safety Bill. The Minister expects to bring a memorandum to Cabinet next week and we will get that legislation done as soon as possible.

If people think that merely changing the law or guidelines will resolve this problem once and for all, it will not. What is required is a change of culture in our healthcare. We need to move towards a culture of truth and that is something I would like to speak about later.

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