Dr. Gabriel Scally:

They are important questions which I will deal with in order.

Screening programmes are unusual in the healthcare world because, unlike most healthcare issues, it is not a question of someone who is unwell or feels unwell coming forward to seek help from the health service. Screening programmes are the health service asking people, on behalf of the State, to come forward. This places increased responsibility on the health service to ensure the programmes are well run and organised. That applies across the screening agenda, whether it be for colonic cancer, breast cancer or cervical cancer. Screening programmes are different in that way. They are also different in that there is a balance to be struck between benefit and disbenefit in screening. Breast screening is a good example because the active screening process exposes and has exposed some women to small levels of radiation which irradiate them. That was certainly the case pre-digital mammography. The benefit is that cancers will be detected early. The benefit outweighs the disbenefit in a well run and well organised screening programme. It it exactly the same with cervical screening. A well run cervical screening programme should prevent up to 75% of cervical cancers or detect them at an early enough stage to allow effective treatment.

Along the way there is the issue of what happens when the screening slides do not reveal the cancer or the pre-cancerous changes. That could occur for three reasons.

Even though the woman has an abnormality, no cells may be present in the slide, so the finding will be that the cells are normal and there is no problem. Alternatively, cells may be present but the persons who are reading the slide, which are generally dealt with by more than one cyto-screener, may not spot an abnormality. That may be for one or two reasons. It may not be very distinct or it may be a matter of judgment and their judgment is that there is nothing significant. Alternatively, it could be a very plain error where there are sufficient signs of abnormality but the person misses it.

I think a mechanism should be put in place to compensate a person due to an error which has potentially serious consequences. It should be done in such a way as to avoid adversarial proceedings and there should be a system in place to cover, I would argue, all the screening programmes, and immunisation should be dealt with in that way. In the UK, there is a system in place for immunisation where the Government has dispersed a very sizeable sum of money in compensation to a very small number of people who may be adversely affected by immunisation. That is in recognition of the fact that immunisation happens for the benefit of everyone but some people have, for whatever reason, an extreme reaction where that has resulted in disability to a certain level and there is an expert view that it cannot be ruled out that it was caused by immunisation, and so compensation may be awarded. A similar scheme would be appropriate in the case of screening. We ask people to come to us to have testing done. If they are failed by that through genuine error, there should be a mechanism to deal with that. I hope that Mr. Justice Charles Meenan will consider that but it is outside the remit of our report.

With regard to open disclosure, if one goes back to the review of slides and the way it was conducted, it was initially conceived of as an educational process for the laboratories. When CervicalCheck knew about cases of cervical cancer, remembering that it did not know about all cases, it sent a notification to the laboratories involved and those laboratories generally reviewed the slides. In some cases, particularly those we are interested in, they had an alternative reading of that slide which indicated that there were changes visible that would have indicated a change in treatment. The process was not designed to generate information to go back to CervicalCheck in particular. It was meant for use by the laboratories themselves, for their own educational purposes about the performance of the laboratory and its staff. Although a copy of the report came back, those were not aggregated or passed on to anyone. There was a decision to put those in a structured and ordered fashion and gather that information.

That decision came about at a time when the Health Service Executive implemented its open disclosure policy. A member of staff heard about it entirely fortuitously because that member of staff had been working in a hospital and still received some emails from that hospital, then received an email with an invitation to a meeting about open disclosure. This person came back to CervicalCheck and said there was a new thing called open disclosure and that it needed to take it into account in what it was doing. That is how open disclosure started to happen within CervicalCheck. We know it was not done at all well. As I made abundantly clear in the report, I find the open disclosure policy and guidelines that were in operation seriously deficient. They were not so much open disclosure guidelines as a policy where clinicians were encouraged to disclose if they wanted to. The guidelines gave them every chance of not disclosing and made it really easy for them not to disclose. It was not really open disclosure at all. That is why my recommendations are very plain and simple about open disclosure, particularly that there should be a statutory requirement for disclosure.

On the commission of inquiry, as the Chair correctly pointed out, it was not one of my recommendations, though it was my view. My view is that we were fortunate enough, partly because of the increased timespan that we had, to be able to deal with a substantial number of the issues in substantial depth. I was very cognisant of the view that had been expressed to me by quite a few of the women and relatives, that a major concern was to make sure that the screening service was fit and safe for their daughters and nieces in the future. Such was the range of deficiencies that I identified that I made recommendations across that wide range to put the system right. I feared that, if there was a move straightaway to a commission of inquiry, it would further delay the implementation of the recommendations and it would distract the system and the HSE in particular from getting on with doing what they should be doing. As I said in my foreword, that was my personal view rather than a recommendation. I would not have made it a recommendation because I would have been usurping the right of the Oireachtas to make that decision for itself and I have no business making a recommendation to the Oireachtas. It is perfectly capable of making that decision for itself.