Dr. Tony Holohan:

I have been chief medical officer for ten years. I cannot recall a time in those years when patients were gripped by such widespread fear and concern as they are now. Of course, given the nature of the events that have unfolded in recent weeks, the fear and concern are entirely understandable, but it has been difficult to get real facts, which people can trust, into the public domain and hence into public understanding. I welcome the opportunity to contribute in this regard this morning.

We know things went wrong. It is true that lessons must be learned but it is important that we be clear about what actually came to light. Arising from the publicity following the Vicky Phelan court case, questions arose as to whether other patients might be in a similar situation. Had Vicky Phelan not highlighted her case, we might not have become aware that other women had not had the findings of the CervicalCheck clinical audit disclosed to them by their clinicians. We therefore owe a debt of gratitude to Vicky Phelan.

It has become clear since the case that the non-disclosure of clinical audit findings was widespread. It has also become clear that the issue of disclosure was the subject of dispute among some elements of the relevant clinical community. I can provide assurance that the Department was not aware of these issues until this controversy arose, towards the end of April. We have since had the opportunity to engage directly with a view to understanding, directing and investigating what happened.

Let me be clear on what we knew in 2016. First, no Minister was advised. Second, the decision not to escalate was a fair and reasonable decision based on the information available to the Department at the time.

It was reasonable because the information provided in the briefing notes provided by the HSE to the Department was evidence of ongoing improvement to how the service was being delivered, rather than the identification of problems that might require escalation to Ministers. The HSE has confirmed, and will confirm, that no systems of escalation within its organisation in relation to the implementation of the audit programme were activated.

In respect of CervicalCheck, it is important to point out how much has been achieved in recent years. Before 2008 in this country we had a disorganised arrangement of random screening were random women were getting too many smears and many others were not getting any smears at all. On an annual basis, we were doing more smears in the country at that time than we do currently. Smears were being examined in a wide range of laboratories, many of which were too small and not fit for purpose. There were no quality assurance arrangements in place and there were very long turnaround times for reporting of smear results. In 2008, the population-based programme which invites patients to come forward to their GPs for smears was established with those smears being sent to accredited laboratories and appropriate follow-up in colposcopy services. Prior to 2008, cervical cancer incidents were rising but we know that the impact since 2008 has been a 7% annualised reduction after 2010 in the incidence of cervical cancer, a clear impact of the programme.

Let me turn briefly to open disclosure. It is important, given some of the debate that has taken place, that we make the position of the Department clear. The Department does not and never has regarded open disclosure as optional. Open disclosure should happen in the right way, in every circumstance in which it is indicated. Patients simply must be informed. I know that this can be a challenge for the medical profession but professionals in this country are rising to that challenge. Our legislative approach is to encourage doctors to do the right thing in circumstances where disclosure is required. We know from international evidence that one of the reasons that disclosure does not always happen in the right way or at all is that doctors may fear the medico-legal consequences. We have directly addressed this fear through the voluntary disclosure legislation, the Civil Liability (Amendment) Act 2017. The regulations are to be signed within the coming weeks. That legislation provides that if doctors disclose appropriately, they will not contribute further to any legal risks they may have. That is intended to create a so-called safe space to encourage people to do the right thing.

That is not to say that we do not see a role for mandatory open disclosure, so a stepped approach is required. Therefore, following many months of work, we have secured Government approval for the patient safety Bill to introduce mandatory open disclosure for a specified list of serious reportable events. This is in line with the UK duty of candour. However, it goes further in that it is not just an obligation on organisations, as with the duty of candour in the UK, rather it is an obligation on doctors to disclose. Thus, the commitment to open disclosure in this country could be regarded as exceeding - when we have enacted that legislation - that which is placed on doctors in the UK.

It is really important that I am clear that we absolutely recognise that at the centre of this are tragic cases. We are fully sensitive to that. I want to engage, and the Department would wish to engage, directly with the individuals involved in these cases, as we have done in the past in other situations, to ensure we fully understand their perspectives and fully engage them in the process of further policy development and oversight so that we can ensure that any lessons that can be derived here can be properly applied to improvements in the future.