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Dáil
‹ Leaders' Questions

CervicalCheck audit revelations

Summary

Micheál Martin challenges the Government over newly disclosed unscreened cervical cases and criticises the Health Minister's handling. The Taoiseach says the facts are still emerging, seeks time to establish them, and says the Minister's approval of the HSE director general's outside board role was valid and without conflict.

Last night, the Minister for Health revealed that there were more than 1,500 additional cervical cases which had not been audited. This shocking and out-of-the-blue revelation confirms that the response to this crisis to date from the Minister and the Department of Health has been neither competent nor comprehensive. It is now two weeks since the Minister was told about the issue and nearly a week since it became public, yet we are still discovering shocking and unsettling new information. The Taoiseach and the Government have had enough time to get on top of this issue and they need to do so urgently.

As Vicky Phelan said last night on "Prime Time", there is no one leading this and the news is changing daily. Ministers have run to the hills and TV programmes have been absent of senior Ministers to explain things to the public. Calm, competent authority is required in response to this crisis. Confidence in the cervical cancer screening programme is being undermined and women throughout the country are fearful and worried. They have been let down. Despite everything, it is worth reminding people that this cervical cancer screening programme has identified up to 50,000 precancerous changes in women without symptoms and has made a very positive contribution to women's health. The most effective route to restoring confidence is to have a competent, comprehensive inquiry that will get to the truth. The precise model is not actually the key. The key is the chair, the personnel and the terms of reference. Yesterday there was more uncertainty. The Government had spoken about a HIQA inquiry while, last night in the middle of a debate, we apparently moved to a commission of inquiry. We urgently need clarity.

This morning we learn from a story in The Irish Times that the Minister for Health, Deputy Harris, approved in writing that the director general of the HSE be allowed to take up a lucrative role at a US contraceptive manufacturer. I have no personal axe to grind with Mr. O'Brien, though I did have issues with the manner of his appointment by the then Minister, now Senator James Reilly, in the absence of a public competition. I believe the Minister made a serious error in consenting to this because if there is not a conflict of interest, there is a potential conflict of interest. I do not believe one can be director of the HSE and a member of the board of a health product manufacturer. In addition, the chairman of Evofem, the company in question, is Thomas Lynch who is chair of the board of Ireland East hospital group and the Mater Hospital. It is reasonable to say that a HSE director should devote the whole of his working time to his job as director, as per HSE policy and earlier statements.

Does the Taoiseach believe both positions are reconcilable? Does he agree that the Minister erred in making the decision to give consent to Mr. O'Brien taking this up, two months before he announced that he was going to retire as director general of the HSE in August? What steps is the Taoiseach now going to take to authoritatively deal with this crisis? Could we have some clarity, which is badly needed, on the form of the inquiry being proposed by the Government?

Comment on this
Leo Varadkar The Taoiseach Fine Gael

Once again, I want to say how deeply concerned and upset I and the whole Government are at the situation with which we are now grappling. We still do not know all the facts, and last night, as Members will be aware, new information was given to the Minister only a short time before he came into this House to make a statement and answer questions. He was put in the unenviable position of disclosing information to the House without having all the information himself, and we certainly do not have all the information.

I ask for some time and space to allow us to establish the facts and space for calm and for facts, which the Leader of the Opposition mentioned. There is an old piece of wisdom, which is, "Act in haste, repent at leisure." Whatever we do, I want to make sure we do the right thing. I do not want us to act in haste, make the wrong decision collectively, and then be sorry for it into the future. I know that many women in Ireland are very worried about this and many are feeling very vulnerable today.

As a Taoiseach, as a doctor, and as a brother of two sisters, I want to say a few things. First, this controversy relates to women who were already diagnosed with cervical cancer and are receiving treatment. There are many women in the country at the moment who are worried that they might have cancer and worried that the HSE and CervicalCheck know that and have not told them. That is not the case. Nobody is going to get a phone call or letter in the next few days to tell them that they have cancer and that it had been concealed from them in some way.

There are also many women who are worried about their smear tests, many of whom I have met in recent days. They are women who have a had a smear test recently, been given the all-clear, and are now wondering if that is true. I can reassure them that if they have been given the all-clear, it is true. There is a margin of error in these tests but it is under 1%, as is the case with all screening programmes internationally. We have no reason to believe that the information people have been given, to the effect that their tests are clear, is untrue. If anybody is concerned, we invite them to visit their GP to discuss the situation and we will meet the cost of the consultation and the repeat smear test. I thank the National Association of General Practitioners, NAGP, and the Irish Medical Organisation, IMO for their co-operation in this regard.

To the women of Ireland, I want to say that I am determined to get to the bottom of this, to establish the facts and to restore confidence in our cancer screening system. A number of actions have been agreed this morning. First, we are going to ask a team of expert international cytopathologists to carry out a clinical review and to look again at the smears of all the women who were diagnosed with cancer in the past ten years. We do not have the exact figure but it is between 2,000 and 3,000. We will most likely find out that the majority of the additional 1,500, of whom we spoke yesterday, never had a smear test. The review will be led by the Royal College of Obstetricians and Gynaecologists and will try to identify the genuine false negatives and those cases which should have been reported differently. We believe this can be completed by the end of May.

Later this year, we are also going to bring in a new, more accurate smear test and we will be among the first countries in the world to do this. There will still be false negatives but not as many as in the past.

This test will be available to all women who want it. They will not have to wait three years for their routine appointment. This will be expensive and logistically difficult but it is something we need to do. There will be a statutory inquiry. There are limitations to a HIQA inquiry. We know what they are. There are problems also with a commission of inquiry and we know what they are as well.

There is a committee hearing today. We would like that committee hearing to take place as it provides an opportunity for many of the senior officials and senior doctors to answer some questions. Following the hearing, the Minister for Health will invite the spokespeople to meet him to discuss the best form of inquiry that should take place.

Comment on this
Pat the Cope Gallagher An Leas-Cheann Comhairle Fianna Fáil

I call Deputy Micheál Martin. The Taoiseach will have another opportunity to come in.

Comment on this
Leo Varadkar The Taoiseach Fine Gael

We will need a scheme of redress for women whose cancer was missed and should have been detected beyond normal error and for women where there was a breach of duty to inform them of the audit results. We will need to have a scheme of redress but we will need to establish the facts before we do that.

The House will be aware that Dr. Gráinne Flannelly, the clinical director of CervicalCheck, stepped down some days ago. I would like to inform the House that the senior official in charge in CervicalCheck, the director of CervicalCheck, is no longer in charge. Damien McCallion has been assigned to take over operations at CervicalCheck.

Comment on this
Pat the Cope Gallagher An Leas-Cheann Comhairle Fianna Fáil

I allowed the Taoiseach to continue beyond the time allocated because of the importance of the topic. I ask for Members' co-operation on time.

Comment on this

I asked the Taoiseach the serious question of whether or not he agreed that the Minister for Health had made a serious error in facilitating and consenting in writing to the director general of the HSE serving on a board of a company and he studiously avoided dealing with it. I would like an answer from the Taoiseach, first, on whether he believes the Minister made the correct decision in consenting to this and, second, if he thinks Mr. O'Brien's position on that board is reconcilable with his being a director general of the HSE, with all the inevitable potential conflict of interests that arise from such membership of that board, the personnel involved and so forth?

I put it to the Taoiseach that confidence in the cervical cancer screening programme has been undermined by the drip, drip feed of information and shocking new revelations. I do not think anyone on this side of the House could accuse the Taoiseach of acting in haste; the opposite is the case. I agree with Vicky Phelan that no one seems to be leading on this issue. There is no calm authority getting to grips with this crisis, and there has not been for the last two weeks, unfortunately. The only way we can get confidence in the cervical cancer screening programme is to exercise such authority and make clear decisions. I welcome the peer review of the cytology tests and so on but the Government needs to make clear decisions and to operate on the basis of being totally in charge of this issue, such that it is not going in all directions, as it was over the last two weeks. We need to get to grips with this issue.

Comment on this
Leo Varadkar The Taoiseach Fine Gael

On the director general's contract of employment, his contract allows him to serve on boards if there is no conflict of interest, and with ministerial consent. There is no conflict of interest with this appointment as the company does not have a relationship with the HSE and it does not trade in Ireland. Also, the Minister in approving it was aware that Mr. O'Brien was coming to the end of his term of office, which ends in 12 weeks' time. It is on that basis that the Minister approved it. I have no reason to question the validity of that decision. The work he is doing for that company, I am told, is five hours per month and this will be done in his own time and any board meetings he will be on annual leave.

On the drip, drip of information, I appreciate what the Deputy says. I do not want to be in a situation whereby my Ministers and I do not have all of the information to hand. We are working as hard as we can on this matter. The Government has been focused in the last number of days on getting all of the information together so that we can make the right decisions.

When I referred to "haste", I was referring to something different. I was referring to something which I think we should not do as a House, or as a Government, which is to make decisions without having all the information. I would ask the House for some calm and the time and space to establish all of the facts in order that we can take charge of this situation. I have listed a number of actions that we are taking.

Comment on this