Dr. Tony Holohan:

I thank the committee for the opportunity to address it. I will start by acknowledging the important role that Vicky Phelan has played in highlighting a number of major weaknesses in how people have experienced our national cervical screening programme, CervicalCheck. The Minister has publicly commented on his swift action so far to address these issues. He has also expressed his gratitude in public to Vicky Phelan, which I will do here again, for her courage in bringing forward these issues. Without her, we would not have the opportunity to learn the lessons that I am confident we will learn from this circumstance. Without attempting to set out a comprehensive roll call, she adds her name to a range of other patients to whom we are grateful who had to come forward in similar circumstances to raise issues of public concern, leading to improvements in the system. Not least of these are Susie Long, Rebecca O'Malley, Róisín and Mark Molly and Shauna Keyes, but there are many others. Our challenge will be to derive what value and learning we can from Vicky Phelan's experience, which she courageously brought forward, and use them to improve the system.

Vicky Phelan was diagnosed with cervical cancer in July 2014 and, sadly, was informed in 2017 that her cancer was incurable. In 2014, CervicalCheck's clinical audit of Ms Phelan's 2011 smear test result, which was reported at the time as normal, identified a query squamous cell carcinoma. However, Ms Phelan was not made aware of this finding until September 2017. This delay has raised serious concerns about the processes for providing information to patients and clinicians.

Subsequent to the controversy that arose surrounding her case, the HSE initially advised that, between 2008 and early 2018, 1,482 cervical cancer cases were notified to CervicalCheck. The majority were women who had already been referred for further investigation or for treatment by CervicalCheck. As part of the clinical audit process, these notified cases were re-examined and a number were flagged for further cytology review. In 208 of these cases, the cytology review recommendations differed from the original results.

Last Friday, 27 April, the HSE established a serious incident management team, SIMT, to oversee and direct the management of this incident. The SIMT has reported that approximately 162 of the 208 women involved have now been informed of the outcome of the audit process. Communication with these women is ongoing. We have further details, which we would be happy to share with members. I regret to say that 17 of the 208 patients are deceased. Like the Minister, we express our sympathies to the families of those patients.

Arising from the work of the SIMT, and as outlined by the Minister last night on the floor of the Dáil, the number of cases of cervical cancer notified to CervicalCheck - 1,482 - does not represent all of the cases of cervical cancer occurring in Ireland since the establishment of the programme in September 2008. I regret to say that I do not at this point have the necessary information to confirm how many additional cases this might represent, but work has started on ascertaining what that number is. We will detail that work. The Minister has directed that immediate steps be taken so that information from the national cancer registry on any additional case of cervical cancer that occurred during that period is provided to the CervicalCheck programme. Any screening history that those additional cases may have - not all will necessarily have been screened - will be established. If any of these women was screened through the CervicalCheck programme, her case will be reviewed in further detail, with cytology review where necessary. A helpline has been in operation at the national cancer screening service since Friday and clinical staff are following up with women on their specific clinical questions.

Since 2008, some 3 million smears have been carried out by CervicalCheck. It is important to note that the cervical screening test is not a diagnostic test, only a screening test, that is, a test to indicate the possibility of pre-cancerous or cancerous lesions, thereby identifying women who need to be referred for further investigation or follow-up. Smear tests can produce false positive and false negative results.

Therefore, cervical cancer may well develop in the time interval between a negative screening test and the next scheduled screening in any cervical screening programme. The current primary screening test used by CervicalCheck is a cytology test which is known to have low sensitivity, that is, it produces a not insignificant number of false negative results. Naturally, many women are now concerned about their own health following the publicity surrounding CervicalCheck. It is certainly our intention, if we may, to use the committee and its indulgence to reassure people about the performance of the programme in relation to those people. In order to provide assurance, CervicalCheck will make the necessary arrangements to enable any woman who has had a CervicalCheck smear test to have a consultation with her GP, in order to help her determine whether she wishes to have a further test without charge. These arrangements are currently being worked through and will be confirmed this week. We will hear further detail of this over the course of the afternoon.

In addition, in February 2018, the Minister approved the introduction of primary HPV screening for cervical smear samples, and I can confirm that this will be introduced later this year. A Health Information and Quality Authority, HIQA, health technology assessment has found that HPV screening would benefit women by making the screening process much more clinically effective as well as reducing unnecessary tests, and greatly elongating the interval between tests for individuals.

I would now like to turn to the steps that are being taken to ensure the integrity of the CervicalCheck screening programme. Non-disclosure of information to affected patients has raised concerns for users within the health service. Patients have an absolute right to be provided with honest, open and prompt communication about any adverse event that may have caused them harm. This is underpinned in the medical practitioner's code of conduct and the HSE open disclosure policy. The Civil Liability (Amendment) Act 2017, which includes provisions that support open disclosure, became law last year. These provisions were drafted to create a safe space for professionals to be open and transparent with patients in order that they would be given as much information as possible, as early as possible, including an apology where appropriate. By doing this, we have taken away any fears that doctors may have in being open and apologising to patients, specifically, fears of creating legal liabilities for themselves. There is no longer room for excuses. The patient has a right to know and should be told.

The next step is to further strengthen and protect open and honest communications between patients and the health service by bringing forward proposals for mandatory open disclosure for serious reportable events. A stand-alone patient safety Bill goes to Government next week to expedite this. The Minister’s intention is to have an independent statutory investigation to examine the CervicalCheck screening programme. This investigation will have all the necessary powers to investigate the issues highlighted by Ms Phelan and will place particular focus on the quality assurance systems, clinical audit processes and communications with patients within the cervical screening programme.

As part of this, a comprehensive examination of the cervical screening programme in Ireland against international best practice and standards will be undertaken. The investigation will also identify, within its terms of reference, any implications that may apply to other cancer screening programmes. In addition to this statutory investigation, we are now working on putting in place, as a matter of urgency, an international clinical expert process to provide the women concerned with an individual clinical review. This panel will also produce an overall report to inform the statutory investigation and the work of the international peer review group. We are mindful of the need to provide support to these women and a liaison nurse specialist will co-ordinate the work of the expert group. We intend to include patient advocates as part of that process also.

Cervical cancer is the second most common cause of death due to cancer in women aged between 25 and 39 years. Every year in Ireland approximately 270 women are diagnosed with cervical cancer and just under 100 deaths occur from it. Cervical cells change slowly and take time to develop into cancer cells, making cervical cancer a preventable disease. Even with the inherent challenges in screening, having regular smear tests can pick up early cell changes or pre-cancerous growths and reduce the risk of cervical cancer. This is the scientific basis of screening. I must emphasise how important it is that women continue to have their smears and take this test, which can and will continue to save lives.

It is our intention to take these necessary steps in order to ensure the integrity of the cervical screening programme while at the same time disseminating any learning to all cancer screening programmes. These programmes are an important component of the progress that we have made over the past ten years in cancer survivorship for people in this country. The Department is fully committed to the further development of our cancer services and to delivering the ambitious roadmap set out for these services as outlined in the national cancer strategy which was launched last year. We will be happy to take any questions from the committee members.