Update 6.50pm: The HSE has announced a new governance structure for the CervicalCheck programme, which will bring it under the management of the National Women and Infant Health Programme.
The Health Minister Simon Harris has tasked Hiqa with investigating the matter arising from the issues highlighted by Vicky Phelan, and says it will have all the necessary powers.
"Under the auspices of this statutory investigation an International Peer Review Group will examine the cervical screening programme in Ireland against international best practice and standards," he said.
"In addition I am appointing an International Clinical Expert Panel to provide the women concerned with an individual clinical review.
"This Clinical Expert Panel will also produce an overall report to inform HIQA’s investigation and the work of the International Peer Review Group.
"A liaison nurse specialist will co-ordinate the work of the Expert Panel and will identify and ensure the provision of any required supports for the women involved.
Minister for Health @SimonHarrisTD announcing a number of actions including requesting HIQA to perform an investigation into the cervical check screening programme, and the creation of a panel of international clinical experts to give those affected an individual clinical review pic.twitter.com/kevP450R2y— MerrionStreet.ie (@merrionstreet) April 30, 2018
"It is anticipated that the work of the Expert Group will be complete as soon as possible.
"I also intend to bring proposals to Government next week to legislate for mandatory open disclosure for serious reportable events.
"It is my hope and expectation that these steps will ensure the integrity of the cervical screening programme at the same time as providing learning for all cancer screening programmes."
The HSE also plans to announce a new Clinical Director for the CervicalCheck programme within the coming days.
Update 4.30pm: Vicky Phelan has vowed to take on the HSE following the news that 17 women who were affected by the smear test scandal have since died.
The cause of death of the 17 women is not yet known.
Vicky Phelan, who is terminally ill, settled a case with a US lab last week after she was wrongly told she had no abnormality in a 2011 smear.
Vicky said she was shocked to hear today's numbers.
"I'm very upset to be honest," she told the Ray D'Arcy Show on RTÉ Radio 1. "To think that there is 17 women, it was bad enough that I knew there was three. I'm quite upset today.
Vicky said she had hoped it was just her that was affected.
"You think it's a one-off, you know, that how could they do this to anybody else. I don't think anyone could ever have imagined the magnitude of this.
"It's very upsetting, really, for all those families. That could be my husband and my children and my family. I could have been one of those women, I could have been on that list."
She said she is glad the issue has been revealed and she hopes see changes in the system implemented.
"The bottom line to me is that people in office knew about this. Now they are quaking in their boots," she added.
Vicky urged women to continue getting smear tests.
"Cancer screening does save lives and I would be 100% behind telling women to go for their smears."
Despite the tolls of her treatment, Vicky would not consider stepping back from keeping up with the news and reporting about her case.
She said that she is "not that kind of person" and that the scope of the issue is motivating her to continue.
"I won’t have achieved anything with what I've done if I'm not still alive.
"I want to be alive to see the changes that this will effect going forward. So, you know, it's another impetus for me to keep fighting, to live, basically.
Listen to the interview here:
Meanwhile, The Irish Cancer Society (ICS) has said: "We are seeking reassurances on behalf of the women affected, and the many others who this week may be very concerned about their own negative smear results."
This afternoon the ICS has requested an urgent meeting with the Minister for Health Simon Harris to seek clarity on the following:
In a statement, the ICS said this "sad and tragic episode in the history of the Irish health service...has highlighted glaring errors of judgement and a level of transparency well below what patients should expect, and is at odds with the standards set out in the National Policy on Open Disclosure and the National Cancer Strategy’s commitment to patient-centred care.
"The Irish Cancer Society has supported the CervicalCheck programme since its establishment, and believes that cervical screening, combined with the HPV vaccine is the most effective method of all but eradicating cervical cancer in the coming decades. This is a life-saving programme, but significant errors of judgement have clearly been made in the handling of missed abnormalities.
"We would again like to thank Vicky Phelan, who through her unwavering strength and courage, has shone a spotlight on an issue that strikes at the core of cancer patient care in Ireland. Throughout this process, Vicky has repeatedly called on the women of Ireland to continue attending their cervical screening appointments.
"While the health system made serious missteps and its damaging mishandling of communication undeniably failed Vicky, cervical screening has saved women’s lives and will continue to do so while women use the programme. The Irish Cancer Society echoes Vicky’s calls to continue availing of cervical cancer screening."
In another development today, the head of the HSE says he first found out about Vicky Phelan's case from the news.
Now the Taoiseach says an inquiry into the Cervical Check programme will take place.
17 women who were part of an audit of the programme have died, but the HSE does not yet have a cause of death for them.
Director General Tony O’Brien says the HSE is not responsible for "dragging people through the courts".
"It is little understood, but needs to be understood, that the HSE does not represent itself in any action sought, brought, seeking damages.
"Under legislation, the cases are defended by another agency of the state called the State Claims Agency which has a statutory mandate to direct lawyers and to determine the nature of the defence."
Update 2.35pm: The HSE has said that there have been 17 deaths and that 208 patients have been affected by the CervicalCheck test controversy.
The cause of death of the 17 women is not yet known.
Of the 208 women affected, 162 were not informed that a review had been conducted of their outcome.
The Children's Minister Katherine Zappone says she understands the frustration at the drip feeding of information about the number of women affected.
"I feel very empathic, particularly in relation to the women and families who is will most impact," she said.
Fianna Fáil leader Micheál Martin says there are questions for the government to answer about how they handled this.
"I was somewhat surprised, the Minister said yesterday he was informed on the 16th, that we weren't told then," he said.
"Maybe he didn't realise the enormity of it but the fact that he wasn't alerted to the enormity of it or the systemic nature of it.
"My understanding of it is he is saying he was told about only one individual analysed case.
Earlier: Vicky Phelan's solicitor believes number of women affected by cervical cancer test scandal will rise
Vicky Phelan's lawyer has branded reports that half of women affected by cervical cancer tests scandal were not told that they may have had a delayed diagnosis as "shocking".
Cian O'Carroll said that the conduct throughout the Cervical Check has been appalling adding "it is particularly disgusting when you learn of the number of people that have died".
This morning, RTÉ Radio's Morning Ireland programme said that figures they had seen show at least 12 women who were wrongly given the cancer test all clear have died.
The HSE says it cannot confirm reports that 12 women whose cancer diagnosis was delayed have died.
Mr O'Carroll said that he has heard from a number of women who are telling similar stories to Ms Phelan.
He said that he does not trust the figure of 206 women that have been affected by the scandal and expects more people to take cases similar to Ms Phelan's.
"In July 2016, when as Gráinne Flannelly said, they had concluded one year of trying to figure out how to communicate this information through to clinicians around the country and they chose in July 2016 to write to those clinicians and tell them in cases where a woman has died simply ensure the result is recorded in the woman's notes.
"In other words, do not tell her family."
Mr O'Carroll was speaking on RTÉ Radio's Today with Sean O'Rourke this morning.
Mr O'Carroll was asked about claims by Dr David Gibbons, former chair of the Cytology/Histology Group within the Quality Assurance Committee of the National Cervical Screening Programme, that concerns had been raised with the HSE about the outsourcing of cervical smear tests to the US but were brushed aside.
"I think the answer to that may be well to do with pricing," the solicitor told Sean O'Rourke.
When speaking of the inquiry into the matter, Mr O'Carroll said: "We have to find out why a direction was given to the families of women who were dead and the women who are now gravely ill.
"That was clearly done, deliberately having consciously considered what the plan would be to inform clinicians as to what they would do next and that's clear from the correspondence we've seen and of course from the letter from July 2016".
"You cannot have a system where an organisation, no matter how conscious they may be, clearly there is a risk that their reporting would tend away from liability against themselves."
He said that the inquiry must look into the cover-up in Vicky Phelan's case and who was responsible.
"Why is it that her case was fought so vigorously even when the minister himself was informed about this case two or three days before it began?
"What was it about this case that they were so determined that she would be forced into a confidentiality clause that through her courage she ultimately defeated them on?
"Clearly, people in office knew that this case was going to cause serious trouble for people."
You can listen to the full interview below.
Earlier: HSE cannot confirm that 12 women have died in cervical cancer tests scandal; Varadkar confirms inquiry
The HSE says it cannot confirm reports that 12 women whose cancer diagnosis was delayed have died.
Earlier, RTÉ Radio's Morning Ireland programme said that figures they had seen show at least 12 women who were wrongly given the cancer test all clear have died.
Taoiseach Leo Varadkar has said there will be an inquiry into the matter and that there are some serious questions to be answered.
"There will be an inquiry and we are discussing across the day the details as to how that inquiry will operate but that inquiry will establish the facts and we need to do that,"
"It will also try to understand why these appalling communication failures happened and also look at the laboratory testing and whether a different form of testing might have reduced the number of false negatives."
Please note that the CervicalCheck Freephone Information line, 1800 45 45 55 is currently receiving a large volume of calls. We acknowledge that callers may experience some difficulties getting through and apologise for this. pic.twitter.com/RxrC2yWMU5— HSE Ireland (@HSELive) April 30, 2018
Earlier: At least 12 women have died in cervical cancer tests scandal
By Fiachra O Cionnaith, Political Correspondent
At least a dozen women affected by the botched cervical cancer screening tests scandal have died and more than 100 have seen their care negatively affected by what happened.
The scale of what happened has been revealed in leaked HSE figures from a 2014 clinical audit which are expected to be published by outgoing HSE director general Tony O Brien today.
RTE Radio's Morning Ireland programme said the figures show at least 12 women who were wrongly given the cancer test all clear have died.
In addition, more than half of the 206 women affected have also seen their care impacted by the incorrect negative results.
The situation was revealed after a €2.5m High Court ruling in favour of 43-year-old mother Vicky Phelan, who has been diagnosed with terminal cancer.
The HSE had sought a confidentiality clause with Ms Phelan, which she refused, as part of the settlement.
Cabinet is expected to consider setting up a statutory inquiry into the scandal on Tuesday.
Finance Minister Paschal Donohoe has said "all commitments" to women affected by the cervical cancer tests scandal "will be met" amid growing speculation a statutory inquiry and compensation fund could be launched.
Speaking to the Irish Examiner at a Grangegorman DIT site event this morning, Mr Donohoe said a range of options will be considered by cabinet tomorrow.
Asked if a statutory inquiry should be launched to find out what happened, Mr Donohoe said "Minister Harris is now reviewing a number of options to find out what went wrong" and that these will be discussed tomorrow.
The Finance Minister also did not rule out the creation of a compensation fund - which given last week's €2.5m settlement to Vicky Phelan could reach into the tens of millions - when asked, saying:
"Of course any commitments to women who are so worried where they are at the moment, of course they will be met."
Mr Donohoe would not be drawn on whether cabinet will also choose to end the need for women to have to go through divisive high court cases over what happened by deciding to offer a humanitarian alternative to the courts.
However, he again stressed the Government must "ensure the commitments we have to women who are scared they have been let down, that we meet those commitments, and we will".
Education Minister Richard Bruton also said the possibility of a statutory inquiry "has to be determined" and that "the cabinet will sit down and discuss that tomorrow".
He said a "roadmap" is now needed on what should happen next, and stressed the Government must do all it can to re-assure the public as to the competence and safety of the CervicalCheck smear test system.
Earlier: FG TD 'would not be surprised' if more died as a result of cervical cancer scandal
A pharmacist and Fine Gael TD says she would not be surprised if there are more deaths as a result of the cervical cancer scandal.
At least 206 women received a delayed diagnosis but the HSE says it will not be able to comment on the number of deaths before its serious incident management team completes its review.
The government is thought to be considering a statutory inquiry into the matter.
Deputy Kate O'Connell says survival rates dramatically decrease once the cancerous cells are untreated for more than three years.
"Five year undetected pre-cancerous cells, you're looking at 30-40% of the women not surviving," said Deputy O'Connell.
"So if cervical cancer is not detected the outcomes are very bad.
"I expect that number to grow, quite frankly, I do expect it to be definitely double digits."
CervicalCheck understands that some of our clients may be anxious about their cervical screening. Anyone with concerns can call us on Freephone 1800 45 45 55, this line is open Monday to Sunday 9am to 6pm, to request a call back to discuss your concerns. pic.twitter.com/2s9vUNHAzI— HSE Ireland (@HSELive) April 27, 2018
Earlier: Government considers statutory inquiry into Cervical Check scandal
The Government is considering a statutory inquiry into the cervical screening scandal.
More than 2,000 women have called the Cervical Check helpline that was set up over the weekend for women with concerns about their smear test results, after the case of Vicky Phelan who was incorrectly given the all-clear.
The line will stay open until 6 o'clock this evening and the HSE says call-backs are underway.
It also claims its audit of 206 individual results is nearing completion will engage today with all women still awaiting contact.
The Chairman of the National Association of General Practitioners, Dr Andrew Jordan, is urging women to continue to believe in the cervical check system.
"We're carrying out roughly 250,000 smears per annum, we're after reducing the incidents of cervical cancer by 7%," said Dr Jordan.
"The other thing is, it is important not to forget the HPV vaccination programme here because the HPV vaccine, it has the potential to wipe out cervical cancer."
Those wishing to contact the helpline can do so on Freephone 1800 45 45 55.