We are switching over to our new website on Monday, 14 May 2018.

Take a look

Current Debates > Dáil Debates > 2008

Cancer Screening Programme: Dáil Éireann Debate

Statements. Vol. 656 No. 1

Page 7 of 147
Thursday, 29 May 2008

Minister for Health and Children (Deputy Mary Harney): I am very happy to have an
opportunity to talk about the Government’s cervical cancer screening programme. This debate
was requested last week by the Opposition. I was delighted to agree to the facilitation of the
debate.

This debate is about women and women who get cervical cancer in Ireland. On average, 75
women per year die in Ireland from cervical cancer. We know that from screening programmes,
we can save up to 80% of those lives. So we could save 60 of the 75 women who currently die
from cervical cancer. This debate must be about facts and data; it cannot be about innuendo,
rumour or about somebody who came out the wrong end of a procurement process or about
industrial relations issues. For many years there have been queries from Opposition Deputies and
pleas for the roll-out the cervical screening programme. That is something to which the
Government has been committed for quite some time.

Last year, we provided €5 million to the National Cancer Screening Service to prepare for the
roll-out of a screening population-based cervical screening programme. This year, we provided
€15 million towards the implementation of that programme. The intention is to begin the roll-out
of that screening programme on a national basis during the summer. It is expected that between
240,000 and 300,000 women aged between 25 and 60 will qualify for screening. In the case of
those aged 25 to 44, they will be called every three years and those aged 45 to 60 will be called
every five years. That is being done on the basis of best international evidence available to us.
The screening will be provided free of charge and this programme is the second one to be rolled
out by the National Cancer Screening Service, the first being the breast cancer screening
programme. Everybody in Ireland — particularly those who have used the service — and
outside it who have examined our breast screening programme consider it is highly successful
with a participation rate of almost 80%. By international standards, that is very high. The former
Minister, Deputy Nora Owen, said of the service in this House that it was a model of health
service delivery that she would recommend to anybody.

[15]Therefore, I very much regret what I regard as the utterly irresponsible comments made by
the Fine Gael spokesperson on health on the cervical screening programme. I do not say that
lightly. The fact is that last week Deputy Reilly said that 2,000 women’s lives would hang in the
balance. I regard that as an utterly irresponsible statement made for no reason other than to
scaremonger. Women have huge faith in the screening service and we want their faith in it to
continue. If we lose 75 women a year as a result of cervical cancer, one would need to multiply
that figure by 28 years to achieve the figure of approximately 2,000. All of us participating in
this debate have a responsibility to adhere to facts and not to innuendo. I appeal to everybody in
the House to make sure that in this and other debates on cancer screening we are not
irresponsible and do not try to make political points that have the effect of damaging a service
that has a significant reputation.

The National Cancer Screening Service is not part of the Health Service Executive, rather it is an
independent service accountable to the Department of Health and Children and the Minister for
Health and Children. It has its own independent board. The screening programme is now rolling
out an integrated service where a system of call, recall, laboratory, colposcopy and follow up
treatment will all be integrated and will all operate to best international practice.

The screening service had a two-stage tender process for the cytology service. It was open to all
laboratories in Ireland and internationally to put forward an application in the context of the
tender. The tender was clear. In order to meet the requirements, those who tendered had to fulfil
three conditions. First, they had to be accredited by an independent accreditation body, meeting
the international ISO standard. Second, they had to have a minimum throughput of 25,000
smears a year. Third, they had to be able to do a ten-day turnaround. Seven applications were
made and I understand the number considered was reduced to about four. The successful bidder
was Quest Diagnostics, which is the largest such facility in the world; last year, it dealt with 13
million smears. The tender was examined not by the Minister or any official from the
Department of Health and Children, but by a group established by National Cancer Screening
Service, which included doctors like Dr. O’Reilly, who has been running the service in the mid-
west, and a doctor from Northern Ireland, who was charged with the responsibility for quality
assurance there and who is also involved in the accreditation process in the UK. These are highly
reputable people who were asked to examine the tenders. A total of 80% of the marks given
related to quality and turnaround time and 20% of the marks given related to cost — that is the
factual position.

In regard to data, we have had a number of examples of where rumour and innuendo were
advanced here as fact. Two weeks ago on the Order of Business Deputy Reilly alleged that an
official from the HSE had worked for this company and he wondered what the official’s role was
in regard to this tender. Subsequently, when questioned by a media source, Deputy Reilly said he
was waiting to seek clarification, but he put forward in this House as a matter of fact that an
official had worked for this company. That is not the case. Journalists went on a wild goose
chase to find out who was this official. I appeal to people that when irresponsible statements,
innuendo and rumour are advanced in this House as fact around something as important as a
national screening programme that we would have the courage to withdraw those comments and
not have the good name of individuals bandied around by journalists and in other places. It is
grossly unfair, misleading and inaccurate. It is fiction and wrong.
Equally, Professor Miriam Wiley has had comments to make about data that was advanced in the
Private Members’ motion last week and I hope that will also be clarified. If we are not going to
base the debates in this House on data, evidence and information, we will not have informed
debates and we will not make the right decision.

[16]In regard to company, or preferred bidder, awarded the contract, which has not been signed
yet — obviously, there must be a cooling off period — the National Cancer Screening Service
did not have to go to tender but chose to do so for reasons of transparency, fairness and equity to
make sure it got the best quality assured service we would get. In line with the McGoogan
report, which stated that laboratories that participate in this screening programme should be
independently accredited, the screening service is living up to the advice domestically and to
best international practice on this issue. The fact is that the company that won it is accredited
independently. As I said, it is the largest such facility in the world and it does work for the
National Health Service in the United Kingdom. I have never met anyone in the company and do
not know anyone associated with it, but I understand it intends to put in place a laboratory
facility in this country.

I said that 75 women in Ireland a year die from cervical cancer. International evidence shows, as
has been demonstrably shown in the UK, that up to 80% of those deaths can be avoided.
However, the screening is not a test or a diagnosis of cancer. What it detects are abnormalities
that, if undetected and untreated, can lead to cancer. Some 800 women in Ireland in the last year
for which we have data were found to have abnormalities. The purpose of a screening
programme is early intervention to identify those abnormalities. In a lifetime, a woman can
expect to be called to the screening programme up to 11 times to identify those abnormalities
and, if detected, to intervene with treatment before cancer develops. We know such intervention
is highly successful with a success rate of up to 80%. The women affected by cervical cancer
tend to be young women with children and significant responsibilities. We also know that health
promotion has a major role to play in the prevention of cervical cancer. The cessation of
smoking has a huge contribution to make to its prevention. Sexual practices and the early onset
of sexual activity contribute to the development of cervical cancer. A vaccine has now come on
the market as a preventative measure. I asked the Health Information and Quality Authority to
do a technology assessment of that vaccine. The authority brought its recommendation to my
attention in recent weeks. This week, I received a recommendation from the National Cancer
Screening Service for the vaccine. I will work on the advice given to me and a decision will be
made this summer regarding the vaccine. Clearly, huge issues arise, not least that of parental
consent because we are dealing with minors. Since the vaccine will have to be administered
twice in a calendar year and since this will be done through a schools programme, we must begin
when the academic year begins. It will not be possible to begin the programme in September
2008, as has been suggested. We do not have the necessary lead-in time to allow us to do that.
What is important is that we make an early decision. The intention is that the decision be made
this summer.

The National Cancer Screening Service has an enormous reputation, as a result of the success of
BreastCheck. Our breast cancer screening service was the first in the world to go digital. That is
something of which we should be very proud. It has a huge participation rate and has gained the
enormous confidence of the women who use the service. Equally, I want to ensure that the
cervical cancer screening programme has enormous confidence. Screening will be done at
primary care level. It does not need to be done in acute hospitals. When women are contacted it
is important they go for a smear test and continue to do so on a regular basis. Tests will be done
every three years on women under 45 and every five years thereafter. As has happened in other
countries, this programme has the capacity, in time, greatly to reduce the incidence of cervical
cancer and, in particular, to reduce the death rate from that cancer by up to 80%. In everything
we have done we have followed best international practice. We have independent accreditation
and turn-around times of ten days.
[17]With the opportunistic screening which was occurring, women were waiting more than nine
months for test results. This is highly dangerous. This is why, in the past 18 months the HSE
outsourced more than 40,000 smear samples so that we could get earlier results for the women
who were awaiting them. It has been alleged in parliamentary questions that 12 errors were
detected. No one could say there were 12 false readings without seeing the data. I understand
that in one case out of 40,000 a high-grade lesion was discovered. This is not outside the scope
of these matters. The smears which were outsourced were not the urgent ones. Urgent cases were
examined domestically. A higher number of high-grade lesions would be picked up among
urgent case than among a different population group.

Two cytotechnologists will read the smears. They will be doubly examined, which is
appropriate.

It is important that this programme be rolled out quickly and I am satisfied that will happen over
this summer. It is important that it is quality assured. It is particularly important that women get
results within a four week period. Those standards meet best international practice in this area.
The women of Ireland want the best possible service. The contract will be awarded for two
years. This means that in the intervening period laboratories in Ireland can meet the independent
standard required to provide a cytology service which is quality assured. No one would want to
see us availing of services which are not quality assured. I have already explained that in
awarding the contract, 80% of points were allotted for quality and turnaround time and 20% for
price. As it happens, the price quoted by the successful applicant was one third of that quoted by
many of the domestic laboratories. Laboratories in other jurisdictions offered better value for
money that those which tendered in this jurisdiction.

Deputy James Reilly: I would like to share time with Deputy Deirdre Clune.

I must comment on something the Minister said. No one’s good name or reputation was taken.
No name was mentioned. Journalists came to me with the name but I would not do anyone the
disservice of using his or her name in the House under privilege without absolute proof of a
problem.

The Minister mentioned Professor Miriam Wiley and the ESRI. I have mentioned the issue of
figures on a number of occasions. Accuracy is of the utmost importance when we are planning
our health services. I wish to clarify comments I made and which some people have found
confusing. My office was in touch with the ESRI by telephone and e-mail. I have expressed my
opinion regarding the implications of that information. There is a difference between the figures
given by Mayo General Hospital, which says 85 people were treated for breast cancer in 2007,
and the ESRI figure of 37, as quoted by the Minister. That is too big a gap to be ignored. It must
be examined. These data come from two sources: the National Cancer Registry and the hospitals.
Inaccurate information is heading into the ESRI, which cannot be asked to stand over figures
over which it has no control. The ESRI can stand over its analysis. I do not impugn its reputation
and I understand that its work is very important. I have sought a meeting with Professor Miriam
Wiley to clarify the information and to find out how the disparity arose.

I thank the Government for overruling the Minister for Health, who was not willing to concede
this debate when I called for it two weeks ago.

Cervical cancer kills more than 70 women a year in this country and afflicts thousands of others.
By initiating a cervical screening programme in conjunction with a cervical cancer vaccine we
could make this horrible disease, which affects so many of our women particularly during their
child bearing years, a thing of the past. I call on the Minister to introduce the vaccine without
delay. By her own admission, this has been recommended to her by three [18]different bodies. It
is time to move things on. A combined vaccination and screening programme would eradicate up
to 90% of cervical cancer cases.
Since my election to this House I have called on the Minister to introduce this programme and I
warned on each occasion that I could not see how it could be achieved in the timeframe she
promised, given that no preparation had been made between the HSE and the laboratories and
particularly as so few of them had been accredited. Notwithstanding this, I understand several
laboratories are now accredited, including Beaumont/Rotunda, RCSI, St. James’s Hospital
through its connection with Antrim and Altnagelvin Hospital, which has looked after the needs
of Donegal, Sligo and Leitrim. St. Luke’s is also mid-way through the process. While
accreditation is important as it ensures the right facilities are in place, it is not a guarantee of
outcome. That is, of itself it is not a guarantee of quality outcomes.

This call for action obviously fell on deaf ears as so many of the laboratories remained
unaccredited at the start of 2008. Instead of addressing this issue and ensuring that our
laboratories would be in a position to tender for and successfully provide cytology for our
National Cervical Screening Service, the Minister struck out on a new route to outsource the
entire smear reading service to another jurisdiction across the Atlantic. This rushed and ill-
considered decision has serious consequences for our health service and for the health of our
women and further begs the question as to why, when we seek out partners from the United
States of America, we cannot find a company that has not been guilty of over-billing. Though
technically not fraud in law, because they paid up before they were charged, nonetheless most
people would consider this fraudulent behaviour. This was not a once-off action. It was found to
be the case in 1998, again in 2001 and yet again in 2004. It was no small sum of money in total
either. It was $40 million dollars. This is not the sort of partner one would seek out for a business
venture, let alone a partner to provide an essential medical service where women’s lives are at
stake.

The Minister referred to the screening contract. I will read an extract from Council Directive
2004/18/EC:

Any economic operator may be excluded from participation in a contract where the economic
operator has been guilty of grave professional misconduct proven by any means which the
contracting authorities can demonstrate.

The sums of money paid for over-billing represent professional misconduct. These are not the
sort of people we should be dealing with where women’s lives are at stake.

There is, further, the issue of our loss of jobs. Over 100 highly skilled people will now be no
longer employed and will either become de-skilled through lack of activity or will emigrate to
continue to earn their livelihoods. This is a very odd situation when we have spent considerable
time encouraging people to take up science. Furthermore if in two years, as I anticipate, we find
we have made the wrong decision we will have to spend years rebuilding the service having
given a foreign multinational a virtual monopoly on cervical cytology. This loss of cytology will
further impact on the training of our pathologists for whom cytology is an integral part of
training. They will no longer be able to sit the UK examination in pathology as they currently do
unless they go there for training.

Most important, however, is the issue of reliability and the quality of testing. A study done by St.
Luke’s Hospital looking at the results of 14,500 smears read by Quest showed a 30% difference
in the pick-up rate for high grade pre-invasive cancer of the cervix. Critics of the study from the
NCSS have claimed it did not allow for urgent cases, but it did factor this in. Two other
laboratories, Cork and the Royal College of Surgeons in Ireland, examined the [19]figures for the
Quest smears that went from their laboratories. They discovered that it was a 50% difference but
they had not corrected for the urgent cases.

Accusations that the St. Luke’s results are being over-simplistically analysed is absolutely
outrageous and I refute it. An article published by St. Luke’s in the Irish Medical Journal
showed the expected rate of high grade pre-cancers is 1.9% and this is accepted internationally.
In a comparative study by St. Luke’s this figure comes up again while the Quest figures were
1.2%. Quest, therefore, could be missing up to 30% of high grade pre-cancers of the cervix,
placing Irish women at an unacceptable risk. These are statistics from medical professionals. I
see no reason to disbelieve my fellow professionals.

The other deeply disconcerting aspect of this decision is that there will no longer be the ability of
a multidisciplinary meeting to review the slides between the smear reader, the colposcopists and
the gistopathologists who would give further advice. The result of this is a less safe service with
some experts predicting 1,000 and another expert predicting up to 2,000 high grade pre-invasive
carcinomas being missed annually. This may be acceptable if there is a system of annual smear
tests, such as that in America. However, in Ireland it is intended to test every three to five years.
We cannot afford that margin of error.

I understand the tender contract specified adherence to NHS UK guidelines which specifically
state that no primary smear reader should spend more than four hours reading the smears. This in
effect limits each reader to about 50 smears per day. It is my understanding that each smear
reader in the Quest laboratories regularly reads 90 to 100 smears per day. How could they
possibly have satisfied the tender document in this case?

The McGoogan report, on which this screening programme was initially designed, looked to a
hub and spoke arrangement within the country. At no point did she mention outsourcing it, of
which I am sure she would not approve. The current capacity in our laboratories is
approximately 250,000 smears per annum. This would be well over 300,000 with the addition of
two imagers, equipment which allows for automated pre-screening. They only cost
approximately €125,000 per year to lease.

I ask the Minister not to ignore the McGoogan report or fragment our health service. Instead I
ask her to support and resource our laboratories to achieve accreditation which could be in place
by the autumn. She must invest in the imagers, thereby giving the women of Ireland the best
quality service which is surely, what they deserve. Yet again the talk is of putting the patient first
but the action says more about saving money. On this occasion, I beseech the Minister not to
take the cheap option but to put the patient first.

An Ceann Comhairle: Before I call Deputy Deirdre Clune, I remind people in the Visitors
Gallery that in the Parliament applause is simply not allowed. If it occurs again I will have to ask
people to leave.

Deputy Deirdre Clune: The development of a national cervical cancer screening programme
has been on the agenda for some time. It was promised in several programmes for Government
in 1997 and 2002. Only in 2008 are we debating the implementation of a valuable programme
that will save women’s lives. Up to 75 women die from cervical cancer every year. It affects not
just their families but their colleagues and friends. A screening programme such as this will save
up to 80% of those lives. It is vital it is implemented as soon as possible.

The programme, however, has been dogged by controversy. In 2006, there were six-month
waiting lists for smear tests. A large backlog developed and testing had to be outsourced, leading
to a lack of confidence in the system. It is important that when developing the programme,
women can have confidence in the system.

[20]Deputy James Reilly gave figures from various medical professionals. The Coombe Women’s
Hospital, St. James’s and University College Hospital Galway have also questioned the
outsourcing of the programme to Quest Diagnostics and its ability to instil confidence in the
screening programme. Dr. Conor O’Keane of the Royal College of Physicians of Ireland
questioned the future of pathology services in the country if this testing is outsourced. It is
important we maintain and develop expertise in this area. When the contract comes up for
renewal in three years we should hope that local laboratories can tender for the service. It is also
important if we want to attract young people into studying medical sciences.

The Minister referred to the breast screening programme being rolled out and I note the
excellence of the service in Cork. The number of cases uncovered in the few short weeks that the
service began in Cork highlighted the need for it. I compliment those involved in developing this
important service.

Have GPs agreed to take the smear tests as part of the cervical cancer screening programme?
They will be an important cog in the process and we must ensure there are no delays in the roll-
out of the programme. I was glad the Minister spoke positively about the introduction of a
cervical cancer vaccine programme. I accept it will be difficult and will involve parental consent.
It is a necessary programme to which I hope the Minister will give the thumbs-up. I hope it is
introduced as soon as possible.

Deputy Jan O’Sullivan: I wish to share time with Deputy Emmet Stagg.

I welcome this important debate which I have been requesting on the Order of Business over the
past two weeks. I thank the Labour Party Whip, Deputy Emmet Stagg, for pursuing the matter at
the Whips’ meetings.

I assure the Minister that we are fully supportive of a good, accredited and safe programme of
cancer screening, whether for cervical or breast screening or any other type of screening.
However, I do not know whether it was intentional on the part of the Minister but there was an
implication in her contribution that this screening was not available in this country and this is not
true. We have accredited laboratories of a very high standard. The awarding of the contract to a
company outside the country implies that the expertise is not available here and this needs to be
clarified. I urge the Minister to provide this clarification in her response.

I welcome the fact that the Minister has said that while Quest Diagnostics is the preferred bidder,
the contract has not yet been signed and there is some time. I urge the Minister to listen to what
we are saying in the House today and to what is being said by other people who are very
concerned about the decision to outsource the entire cytology screening programme. One source
of this concern is the editorial in this week’s Irish Medical News which expresses serious
concern that the outsourcing of the entire service is not desirable.

The awarding of the entire contract for the Irish cervical screening programme to one bidder,
Quest Diagnostics, a US-based private company, will result in the loss of jobs and skills which
the Government cannot ignore. This is not just a matter for the national cancer screening service
even though the Minister has said it is nothing to do with her or with her Department. However,
its consequences are of national concern. I would suggest we are being penny wise but pound
foolish and there are serious long-term consequences of this decision.

It is important to explain the context of the decision. The Irish cancer screening programme was
first established as a pilot programme in the mid-west region where I live. The intention was that
this programme would be evaluated after a period, that any necessary lessons would be learned
and a national programme would be subsequently rolled out. Along with thousands of other
women in the mid west, I benefited from this screening and I welcome the fact it will [21]be
available to women in the rest of the country. The Labour Party is fully supportive of the need
for the highest standard in the quality of the screening methodology and the expertise of those
who carry out the tests. There is absolute agreement on all sides of the House and throughout the
country on this. What deeply concerns us is the awarding of the entire contract to one private
non-Irish company, to the exclusion of all the Irish laboratories. This puts accountability at a
further remove and this is not a good idea. Cytology will be separated from other aspects of
patient care and this will not result in an integrated, patient-centred service which is vitally
important.

A number of measures were identified during the pilot programme which would require to be
implemented in order to roll out the programme to the rest of the country. These include the need
to improve laboratory facilities, introduce quality assurance and accreditation and train extra
staff to facilitate the full roll-out. There was close co-operation between the pilot phase screening
programme and the cytology laboratories in Ireland. General practitioners and other providers of
service took the smears and sent them to a number of laboratories around the country. The
laboratories did the testing and also set about improving their facilities and their turnaround
time. At least three, if not more, Irish laboratories are now fully accredited and others are in the
final stages of achieving accreditation.

The other significant action taken to prepare for the roll-out was the establishment of a specific
higher education course to train medical scientists to carry out the smears. This was one of the
recommendations of the report by Dr. Euphemia McGoogan who carried out the evaluation of
the pilot programme. This state-of-the-art course is in place and is training highly skilled
graduates at DIT Kevin Street.

Deputy James Reilly: Hear, hear.

Deputy Jan O’Sullivan: It was set up at significant cost to the taxpayer with expensive
equipment and expert academic staff. If all the testing is to be carried out by Quest Diagnostics,
then all that effort and money will be down the drain. There will be no jobs for the students,
there will be no cytology expertise in Ireland and there will be no backup if Quest does not seek
to renew its contract or if anything goes wrong in the meantime.

We urgently need joined-up thinking in Government on this issue before it is too late. The
Minister cannot close her mind to all that has gone before and hide behind the independence she
has given to the national cancer screening service. Privatising and exporting the entire testing
service has implications that are too serious to be decided purely within the narrow requirements
of the national cancer screening service.

I do not have time to discuss the argument as to whether Quest’s methodology is inferior to the
Irish model although it has been claimed by those more expert than I that Irish screeners have
double the specificity for picking up abnormalities compared to US screeners. I will not refer to
the fraud charges that have been highlighted in the media. These may or may not be relevant, but
the argument I am making stands up, irrespective of these factors.

If a rare species of animal, bird or insect was threatened with extinction from our country we
would do everything we could to protect it and rightly so. We must be equally vigilant in
protecting unique specialist skills which our people need for the future. I am not arguing that all
of the testing must be carried out by Irish laboratories, rather that a significant amount should be.
The tendering criteria stipulated that there must be a ten-day turnaround — to which the Minister
referred — and that the prospective bidder must handle at least 25,000 samples per year. I
understand there were Irish bidders that fulfilled these criteria. I have serious questions as to why
such strict criteria were set particularly as the McGoogan report suggested four working weeks
as an appropriate turnaround time. I ask the Minister to address [22]this point in her reply. I take
the point she said that 80% was for the turnaround and quality assurance but I question what part
of this is the turnaround and why it decreased from four weeks to ten days. Was this in order to
specifically exclude Irish laboratories? Is this decision the precursor of more privatisation of
Irish laboratory services? This is another concern. Are other pathology jobs at risk?

Following on from the Minister’s own co-location plans which willseparate public and private
patients on the campuses of many of ourlarger hospitals and which we in the Labour Party
vehemently oppose, there has been more farming out of services to the private sector by the HSE
and the national cancer screening programme. In my own constituency, kidney dialysis is to be
provided by a multinational company. A sum of €15 million to €20 million has been paid to
KPMG to administer the health repayment scheme. Even the letters to patients in the north east
whose X-rays are being reviewed were sent by a private firm. It is difficult to believe there was
any justification for contracting out that particular job. We are very concerned that this again
represents more outsourcing, more privatisation and a failure to trust and invest in the Irish
public health service.

I have no expectation that the Minister will share my concerns about the privatisation of cervical
screening or of any other service. She is ideologically committed to privatisation. However, I do
expect her partners in Government, Fianna Fáil and the Green Party, to be concerned about this
continuous privatisation within the health service. I expect her and her Government colleagues to
protect the jobs and essential skills needed for this country. I expect her to care about educating
young people. Their expectations about pursuing a career in this country are being raised only to
have the door shut in their faces.

I urge the Minister to intervene before this contract is signed. I welcome the fact she has said
today that Quest Diagnostics is the preferred bidder but that there is some time still available. I
urge her to consider all of the implications of this decision and also to consider the fact that we
have the highest of standards and accredited laboratories in this country. We have trained
workers who will lose their jobs and students are currently studying in DIT Kevin Street to work
in cytology labs. We are in danger of losing these skills and in two years' time the skills will be
gone. I urge the Minister to change her mind on this issue. I urge her to intervene to ensure that
Irish laboratories are included in this contract as there is a national interest at stake.

Deputy Emmet Stagg: I wish to declare an interest. I worked in this area for 25 years as a
medical scientist and I welcome colleagues, old and new, to the Visitors Gallery. They are being
silenced, of course, by the Ceann Comhairle so they are mute today.

For 40 years, medical scientists have screened literally millions of cervical smears. Thousands of
Irish women have had their lives saved because of this high quality service. The expertise was
built up slowly over the years until it reached a level that is literally second to none in the world.
We are now about to permanently wipe out that invaluable pool of expertise and sacrifice it on
the altar of the Minister, Deputy Harney’s privatisation agenda.

The comments of the Minister for Health and Children and the Tánaiste in the Dáil, and of Mr.
Tony O’Brien of the National Cancer Screening Service, to the effect that Irish women have not
had an accurate and quality cytology service in the past, is not only grossly insulting to the
professional integrity of the medical scientists involved but also highly inaccurate and damaging,
by any international standards.

Some 70 medical scientists in cytology laboratories now face an end to their careers. In addition,
the country faces an end to sufficiency in cervical cancer screening and an absolute
[23]dependence on foreign private sector operators for a vital part of patient health. No other
country in the world exports the health of its citizens in this way.

The quality of the outsourced work to the preferred bidder, Quest Diagnostics, has, on analysis,
shown major discrepancies even on corrected figures. No amount of statistical fudging by the
Minister or Tony O’Brien will improve Quest’s low detection rate. If the screening programme is
outsourced to Quest, the outcome for Irish women will be a decreased accuracy in the pick-up
rate for high-grade smears, leading to an increase in cervical cancer and dire consequences for
Irish women.

The Health Information and Quality Authority, HIQA, is the independent authority on all aspects
of quality in the health service. Has it been asked to analyse the discrepancies in Quest’s results
and, if not, why not? Is HIQA happy with the outsourcing to Quest? Dr. Tracey Cooper, the CEO
of HIQA, should be asked to report and comment on this matter. That is his job and it is what
HIQA is there for.

The decision to outsource can only be explained by the political ideology of the Minister and the
Government. This is another step in the privatisation of the health service towards a for-profit
service, if one can afford it.

I served for 25 years as a medical technologist and, in addition, I served for ten years on the
executive of the union representing that group. I want to issue a word of warning to the Minister.
There are approximately 2,500 medical technologists and scientists in the country who are fully
unionised and their unions have a mandate from their members for industrial action. If 70 of
their members have their hard-won careers terminated by this crazy outsourcing and
privatisation, it is highly unlikely that their union will stand idly by. They will have my full
support in whatever action they take to protect the lives of women in Ireland, their careers and
the knowledge base that we have built up here. I ask the Minister to consider this matter very
seriously. It is seldom that such a debate is held in this House. The Government agreed to the
Opposition’s request for a debate because of the urgency and importance of the issue. Before a
final decision is made on this matter, the Minister should seriously take on board the points that
have been made in this debate by the Opposition, as well as the views of experts outside the
House.

Deputy Aengus Ó Snodaigh: Cervical cancer is the second most common cancer in women
under 45 and the third most common cancer in women in Ireland. On average, almost 200
women in this State develop the disease every year. In contrast to most other cancers, this one
affects mainly younger women, with 60% of cases occurring in women aged 50 or younger.

Faigheann 70 mná sna Fiche-Sé Chontae bás de thoradh ailse an mhuiníl gach bhliain. Léirigh
suirbhé anuraidh nach bhfuil a fhois ag ach 29% de mná na hÉireann go bhfuil vacsaín ann chun
déileáil leis an ailse seo. In ainneoin gurb é an dara ailse is coitianta i mná faoi 45 bliain d’aois,
ní fios de triúr as gach ceathrar mná cad is cúis leis, nó na fáthanna taobh thiar de.

It needs to be known as widely as possible that this cancer can be prevented by means of a
simple test, the cervical smear test. It is a scandal and a disgrace that successive Governments
have failed to roll out a national testing programme and that only this year progress is being
made in this regard.

On 24 February 2005, there was a unanimous call from the Irish Cancer Society and 24 other
organisations, including trade unions, professional bodies and women’s networks, for a State-
wide pre-cancer screening programme. Comprehensive screening leading to early detection and
treatment can and will dramatically reduce the incidence and development of cervical cancer and
the resulting terrible death toll.

[24]There is far too little information for women to highlight the fact that screening can be life-
saving. That information and the associated screening need to be as widely available as possible.
There must be quick progress in moving the screening programme beyond the current phase one
in the mid-western HSE area. The promise is that the national cervical screening programme will
be free to all women between 25 and 60 years of age. Screening will be provided every three
years for women aged between 25 and 44, and every five years for women aged between 45 and
60, in line with best international practice. That is the commitment given by the Government to
the women of this country and it must be kept.

It is very important that this long-promised national screening programme is not disrupted, as so
much other patient care is being disrupted, by current HSE cutbacks. That would be a betrayal of
the women of Ireland and their families, and it would condemn thousands of them to serious
illness, which is preventable.

If the Government is only interested in bookkeeping, cutting this programme would make no
economic sense as the cost of cancer treatment in the future, which could have been prevented or
treated through early screening, will far outweigh the cost of the screening programme.

On 9 May, the National Cancer Screening Service, NCSS, announced a preferred bidder for the
provision of laboratory testing services for the national cervical screening programme. This was
described as an important milestone which, in the coming months, will enable the NCSS to
launch the first quality-assured, population-based national cervical screening programme for
women aged 25 to 60. However, major concerns have been raised about the use of laboratories
outside this country for these tests. In particular, major concerns have been raised about the
company named as the preferred bidder, Quest Diagnostics.

Quest has won the tender to analyse 300,000 Irish smear tests a year, but consultant pathologists
from the Coombe Women’s Hospital, St. James’s Hospital and St. Luke’s Hospital in Dublin,
and University College Hospital in Galway stated that missed cases would arise because the
diagnostic rate of pre-cancerous cells at Quest Diagnostics in the US is 30% less than that of
Irish laboratories.

This concern has been echoed by the Irish Association for Clinical Cytology, IACC, which has
expressed its disquiet at the decision to award the contract for cervical screening services to
Quest, thereby excluding Irish laboratories. The IACC says this decision will have serious
implications for the long-term quality of the cervical screening programme.

12 o’clock

The association lists its main concerns as follows: quality in detection rates — from recently
adjusted figures, excluding urgent smear policy, at least 30% of cases with pre-cancerous cells
will go undetected based on the data from the previous outsourcing exercise by the NCSS to
Quest Diagnostics; Irish laboratories’ ability to tender for future work. the exclusion of the Irish
cytology laboratories at this stage will result in the loss of cervical cytology as a discipline and
laboratory service in this State — once lost, the re-establishment of this service will not be
feasible due to the extensive training requirements and the loss of expertise and skill-mix that
has taken years to develop here; and the creation of a monopoly. By contracting to one
organisation the NCSS has tied itself to Quest Diagnostics without an alternative provider of
services. If there is an issue with the provision of service down the line, there will be no
domestic laboratories available to deliver such a service.

It also highlighted a reduction in mortality rates by 80%. Although this figure has been quoted as
the potential reduction rate of mortality for cervical cancer, this can only be achieved in the
setting of a population that has not been screened before and not in a relatively heavily
[25]screened population as in Ireland. We would be concerned that an increase in mortality and
morbidity may result in Ireland by using a laboratory with low detection rates.

The Irish Association for Clinical Cytology states that Irish laboratories provide a quality
screening service as evidenced by comparison of incidence and mortality rates to other European
countries. Even without an organised national screening programme, this State compares
favourably to the UK which has had an organised screening programme for more than 20 years.

There is significant concern that testing for this screening programme has been placed in the
hands of a multinational giant that has been convicted of fraud in the US. Quest Diagnostics has
paid out almost $40 million in fraud settlements over the past decade. It made major settlements
in 1998, 2001 and 2004 after being investigated in connection with the billing of federal health
care programmes for unnecessary tests. In 2004, Quest Diagnostics paid more than $11 million
to settle a lawsuit that alleged the company billed Medicare, a federal health care programme,
for certain blood tests that doctors had not specifically ordered. Janette Byrne of the Patients
Together campaigning group, which is trying to improve the standard of patient care in Ireland,
said: “We would definitely question why public money is being given to a company that has
been investigated for acting fraudulently in another country.”

It seems the Minister for Health and Children would rather listen to corporate executives in the
private health business than to health experts and patients in Ireland. Not only are our health
services being privatised, but jobs and services are being exported. Trained and trainee
laboratory technicians in Ireland are being written off by this decision and many will have to
emigrate to find work in the future.

Incidentally, another corporation, Fresenius, has been contracted by the HSE to carry out dialysis
services. This corporation paid the biggest ever criminal and civil fraud fine to the US
Government in 2000 — $0.5 billion. The Fresenius scam involved fraudulent and fictitious
blood-testing claims, kickbacks to dialysis facilities in return for blood-testing contracts and
fraudulent claims against State health insurers. This company, which will be based in Limerick,
has been given a major role in the provision of dialysis in our health services in the mid-west and
south eastareas.

During questions on the issue of the cervical cancer screening programme last October, my
colleague, Deputy Ó Caolain, asked the Minister if it was preferable that the testing labs should
be here. The Minister replied: “Yes, ideally we must have our own laboratory facilities in
Ireland.” This does not seem to be the case now.

I have been contacted by a medical scientist, a constituent of mine, who has raised her concern at
the outsourcing to Quest Diagnostics. She set out, in her letter to me yesterday, those concerns in
the following terms: awarding this contract is handing a monopoly to a private company whose
bottom line is profit not patients; the method of screening done by Quest Diagnostics is not up to
the same standard as the public labs in Ireland — this means that more Irish women will die —
and cytology labs in public hospitals will not be able to apply for the tender in two years’ time as
they will not be able to keep up their screening skills. These skills will be lost forever so it will
not be possible to reintroduce the service in the future if anything goes wrong. The HSE has a
sorry history with its privatisation agenda and she does not want to see it happening with
laboratory services.

She concluded by stating: “As a woman and mother of two daughters I am horrified to think that
the standards of screening cervical smears are going to be reduced unnecessarily and put us at
risk.” The Minister must listen to such expert voices — those involved in the service, those
working in the service and the patients who have to use the service.

The warped mentality behind this decision is the same warped mentality that has forced the
Coombe Women and Infants University Hospital to take the unnecessary step of discontinuing
[26]the cervical smear testing at that hospital. This was highlighted recently by my colleague,
Councillor Ray McHugh, when his wife was told that the Coombe was suspending smear tests as
a result of HSE cuts due to lack of staff. That is how illogical the approach of the Government
and the HSE has been in terms of addressing the concerns of patients, cervical cancer and the
screening programme it promised.

Deputy Mary Alexandra White: I wish to share time with Deputy Mary O’Rourke.

I am pleased to speak here this morning. I believe the health system is slowly but surely
reforming and the great challenges facing it are being addressed over time. The Green Party
believes in equitable access to health services and recent achievements by the Government and
the careful and co-ordinated approach by Professor Keane and the national cancer control
programme, the encouraging signs of consultants accepting the contracts being offered by the
Department of Health and Children and this latest development concerning the National Cancer
Screening Service proposed contract for cervical cancer screening represent signs of reform and
improvements in health care for the people of Ireland, particularly women. Many challenges
remain, but everybody in this House must welcome the reform and improvements we are
witnessing.

In recent weeks there has much coverage and criticism of the NCSS’s announcement of a
preferred bidder for the provision of laboratory testing services for the national cervical
screening programme. Much of it has centred on concerns over jobs losses of laboratory workers
involved in cervical cancer screening. Others have voiced complaints about the tendering
process itself. I wish to make several points about the tendering process and the implications of
any contract with Quest Diagnostics lest any undue concerns gain further credence here.

First,there is the issue of the procurement process and the speculation about the capacity
criterion announced by the NCSS at the time of tendering. The procurement process was open to
all laboratories in Ireland and internationally, public and private, in accordance with the usual
EU procurement guidelines.

Each applicant was required to meet certain criteria, namely, currently screening a minimum of
25,000 cervical smear samples per annum at each proposed laboratory and the capacity and
ability to process smears within a ten-day turnaround in order to facilitate the delivery of results
to women within four weeks of their smear test. This requirement is reflected in European
guidelines.

To ensure a quality assured service, the NCSS requires participating laboratories to currently
screen a minimum of 25,000 cervical smear samples per annum at each proposed laboratory. It
was an essential requirement to ensure the necessary level of expertise. Although the overall
requirement for the programme is a target of 300,000 smears per annum, the procurement
process was designed to allow for one or a number of tenderers if each met all tender criteria.

The second public concern worth addressing is that of a disparity in detection rates between
those of Quest Diagnostics and Irish laboratories at the same time. The NCSS has highlighted
that the analysis was not a comparative one of identical samples and that in the same analysis the
performance of Quest Diagnostics matched that of an Irish accredited lab. Moreover, a high
pick-up rate overlooks the fact that an individual laboratory could be overcalling abnormalities
and subjecting women to needless anxiety, worry and investigation. A positive smear does not
automatically mean a diagnosis of cancer. It means a requirement for further investigation.

Deputy James Reilly: It was published in the Irish Medical Journal.

[27]Deputy Mary Alexandra White: The last point is the legitimate one regarding the loss of
Irish jobs. On this, the Health Service Executive has accepted its responsibility to ensure medical
laboratory scientists employed in cytology are redeployed in the health system.

It must be remembered the new contract the NCSS is set to sign will be good news for 1.1
million women who will receive test results within four weeks rather than waiting for six months
in some cases. Each year, 180 women are diagnosed with cervical cancer and last year 73
women died from this form of cancer. We need to address delays of up to six months in smear
test results. The NCSS has indicated that implementation of the national programme could
reduce mortality rates from cervical cancer by up to 80%. The women of my constituency of
Carlow-Kilkenny want a quick, efficient service and an end to the agonising delays spent
waiting for test results.
Deputy Mary O’Rourke: I thank Deputy White for allowing me five minutes of her time,
particularly as I was late in arranging to speak in this debate. I am pleased the Minister is present
to speak about the cervical cancer screening service. One of the welcome features of her tenure
has been her willingness, when important health matters surface, to engage in public debate in
the Chamber by first laying out her stall, so to speak, before replying to questions raised by
Deputies.

I do not propose to address specific issues related to cervical cancer but instead I propose to
make a case on behalf of the women of Ireland who are coming late to a recognition of their
needs in cancer specialties. As a result, there is impatience in the system in terms of the need to
give women an opportunity to access a service, determine their needs and receive expert
guidance and follow-up services. We have had many tears in the midlands and I have listened to
and shared the many concerns expressed by women in the region. The best way to serve the
people is to establish the best possible system for cancer services. The discussion on the centres
of excellence should be considered definitively and concluded because there is nothing to
debate. If one wants the very best for people, one does not opt for half measures or centres which
may be good, one opts for the best.

The Minister, in speaking about the BreastCheck service, has given me licence to raise this issue.
The roll-out of BreastCheck, a humane system which women understand, has been marvellous.

Deputy Jan O’Sullivan: Not everybody has access to the service.

Deputy Emmet Stagg: It has not been rolled out.

Acting Chairman (Deputy Johnny Brady): Deputy Stagg was not interrupted and he should
allow Deputy O’Rourke to continue without interruption.

Deputy Emmet Stagg: The BreastCheck service had not been rolled out.

Deputy Mary O’Rourke: Having heard the Deputy wax lyrical, I ask him to allow me to
speak and observe the rules of democracy. I do not care how long it took to roll out the
BreastCheck service, it is working satisfactorily.

Deputy Emmet Stagg: It has not been rolled out yet.

Acting Chairman: I ask the Deputy to allow Deputy O’Rourke to continue without
interruption.

[28]Deputy Mary O’Rourke: While I have experienced this type of carry-on many times,
Deputy Stagg’s interruptions are disgraceful. No one dared interrupt him whereas he believes he
can interrupt me because I am a woman.

Deputy Emmet Stagg: I interrupted the Deputy because she is speaking rubbish.

Deputy Mary O’Rourke: In my time, I have heard a great deal of rubbish from that
gentleman — he is full of it.

I have observed BreastCheck and it is a professional, finely tuned, wonderful service. May I ask
the Minister, without interruption, the reason women aged 65 years and over are deemed to be
invisible and denied access to the service? I cannot understand the reason for this. Many women
have told me they are prevented from accessing the service because they are aged over 65 years.
Professor Keane, whom I met recently, seems to be a very good man and he informed me of an
aspiration to make the BreastCheck service available to women aged over 65 years. I want this
aspiration to become a reality.
If BreastCheck is to be a professional, universal programme, one cannot argue in favour of
excluding women of a certain age from using it because the incidence of breast cancer in this
group is lower than in other groups. The incidence of breast cancer in women aged over 65 years
is high and belies the statistics we often see. Everybody seems to be afraid to point this out. We
do not need to erect a cordon sanitaire around women of this age, although I wish women in this
group were immune from bullies and other obstructions life places before them. I plead with the
Minister to ensure BreastCheck is made available to women aged 65 years and over. Cervical
cancer screening services will be of great benefit to women.

Deputy Olwyn Enright: I wish to share time with Deputy Creighton.

I have listened to some interesting comments in this debate but it is wrong to suggest the women
of Ireland were late in voicing their needs. They have been doing so for a considerable period
but the Government has been late in meeting their needs. The issue of screening has been
characterised by a remarkable lack of urgency in all cancer specialties, whether breast or cervical
cancer or other cancers affecting men and women. While progress has been made in rolling out
the BreastCheck programme, I understand the service is not universally available.

I concur with Deputy O’Rourke on the need to address the issue of women aged over 65 years. I
note the Minister and her officials are nodding and hope progress will be made on this matter.

The purpose of today’s statements is to discuss cervical cancer services. The roll-out of services
in this area has been remarkably slow. We have heard accurate statistics on cervical cancer and
Deputies largely agree on what is the current position in this area. Figures show between 170
and 240 new cases of cervical cancer are diagnosed and upwards of 73 women die from the
condition annually. When Deputy Michael Noonan was Minister for Health one of the priorities
in the national cancer strategy launched in 1996 was to establish a national screening service for
cervical cancer. When one extrapolates from the figures I cited, one finds that the lives of
approximately 900 women could have been saved if the service had been introduced 12 years
ago. This is an important statistic, particularly given that the families of the women who died
from this disease are probably still grieving.

While I welcome the Minister’s commitment to roll out a national cervical cancer screening
service, we have heard such commitments previously. I hope in this case it will be met. Since
being elected to the House six years ago, I and other Deputies have repeatedly raised the need to
provide cervical cancer screening. A service is not available to the majority of women in the
constituency of Laois-Offaly, which I share with the Minister of State at the Department of
[29]Health and Children, Deputy John Moloney. I look forward to a nationwide service being
rolled out without delay.

I ask the Minister to elaborate on whether a vaccine will be made available. Judging by her
choice of language, it appears she will make a positive decision and provide the vaccine. I hope
that is the case. The Minister will probably agree that vaccinating young people against cervical
cancer will be difficult given the need for parental involvement. Notwithstanding this, it would
be a worthwhile initiative and I hope progress will be made in this matter. The Minister
mentioned that she has the HIQA report. When the vaccine was rolled out in the UK, the head of
cancer research there said that it was an exciting step towards preventing cancer. Taken in
conjunction with screening, it will be an exciting step here and I look forward to it happening.

I am not expert on pathology, but I have listened to the debate on the issue. The Minister for
Health and Children was previously the Minister for Enterprise, Trade and Employment. In my
own time as spokesperson on education, I became aware of the difficulty in building an ethos for
research and science in Ireland. The service needs support from that basis. There are excellent
accredited labs in Ireland. The Minister for Finance spoke about the decision in value for money
terms. Nobody in Fine Gael will say that value for money is not important, but we must also
look at long-term value, and not just value for money in one particular contract. Training people
to be qualified pathologists, developing that service around the country but then effectively
pulling the rug from under them has a long-term cost which weakens the value for money
argument.

From both positive and negative publicity, women are very aware of breast cancer and the need
for self-checking, screening and so on. People are a little bit less aware of the need for vigilance
about cervical cancer. The All Ireland Cancer Foundation currently has a road show travelling
around the country and a website, www.tellher.ie, which is a good idea. While I do not normally
call for advertising campaigns as we waste money on a lot of them, if we can have an advertising
campaign for Transport 21, then we can have a campaign to make people aware of the need for
vigilance in this area and the need for screening.

Deputy Lucinda Creighton: I thank Deputy Reilly for giving me the opportunity to speak on
this very important motion. I am again very disappointed to hear a Green Party Deputy speaking
from a script clearly prepared by a civil servant and performing a U-turn on his party’s position
just over 12 months ago. We used to hear criticisms from the Green Party of the move toward
promoting privatisation of the health service above patients, but the party now seems to have
bought into this lock, stock and barrel. I do not know the price the party paid, but it is very
disappointing to see that from its public representatives in the Dáil.

It is disappointing to think that we still do not have a national roll-out of cervical screening and
the vaccine service. They are vital elements in the prevention of cancer in Ireland. There are
more than 240 new cases of cervical cancer every year, with anywhere between 80 and 90
women dying from this illness annually. I am not sure that we have the right type of response
from the Government benches. Evidence suggests that mortality rates can be cut by 80% with a
national roll-out of proper screening. As a woman, I am very disappointed to see this has not
happened yet.

The Fianna Fáil manifesto promised a national roll-out of cervical screening in 1997. Five years
later, the two Government parties stated that they recognised the need to ensure that people in all
parts of the country have reasonable access to cancer services, and that they would ensure this
objective is achieved. That objective has clearly not been achieved. I sometimes feel sorry for
the Minister, as I know that during the last general election, Fianna Fáil candidates in my own
constituency blamed her for the problems in the health service. It is clearly an issue of collective
responsibility, but Fianna Fáil always passes the buck and it is more than con[30]venient to blame
the Progressive Democrats Party for the problems in the health service, as opposed to taking
collective Cabinet responsibility.

Significant concerns about Quest Diagnostics were clearly outlined by Deputies Reilly and
Enright. The detection rate of pre-cancer cells is 30% lower than that of Irish laboratories, a
statistic that has been supported by evidence and educated opinion in the Irish Medical Journal
and elsewhere. That is a major concern and the Minister cannot afford to turn a blind eye to it.
Of equal concern is the credibility and legitimacy of this private company. Serious question
marks hang over the Government’s decision to award the contract to Quest Diagnostics. An
article in the Irish Independent on May 15 stated that Quest Diagnostics paid out $40 million in
fraud cases in 1998, 2001 and 2004. Irish women can hardly have trust and confidence in such a
company. It is quite alarming that the Government parties have awarded such a vital contract to a
company of such a dubious background.

There are legal consequences to all this, to which Deputy Reilly alluded. Council Directive
2004/18 EC clearly states that any economic operator may be excluded from participation in a
public service contract where that economic operator has been guilty of grave professional
misconduct, proven by any means which the contracting authorities can demonstrate. This
particular contractor has admitted that it has been obliged to pay out $40 million in
compensation for fraud, yet the Government is satisfied to award a public contract of national
importance to this company. I find that bizarre and I would like the Minister to give an
explanation to the House for it.

Deputy Michael D. Higgins: I listened with great care to the debate that has taken place. A
number of fundamental issues arise. Some have been touched on in the last contribution. On the
degree of accountability that will be present from the allocation of a contract, moving from a
tender to a contract, in the case of State laboratories and the educational preparation of technical
and medical personnel, there are elaborate measures of accountability in the public system in
respect of professional practice, the duties of institutions and hospitals, and preparation and
validation. These are the skills and accountable mechanisms in a public system.

The alternative that the Minister described is to move outside the jurisdiction to describe a
tendering process where the accountability mechanisms are neither explicit nor under the control
of the State. They are under the gaze of the courts in their own jurisdiction. It is only fair to say
that the favoured tenderer is not alone in drawing one court decision after another, almost all of
which are in the same vein and relate to excessive testing where it was unnecessary and where
the federal and individual states are involved. They relate to overpricing and over-billing, and
figures of €40 million have been mentioned. That is the accountability that is offered as the
alternative to the public system.

The Minister mentions that after two years there will be a review and we will move on to a new
condition of contract. In a later flourish she suggests that those who get the contract may have a
laboratory in this country. One may ask if this is in anticipation of the two years or if it is on
condition that the contract will be renewed after two years. These questions can be dealt with
reasonably.

How will the capacity to have diversity in bidding at the end of two years be established if the
professionals have been prepared and the equipment purchased but it cannot be seen by RTE
cameras and the students who have been prepared have not been allowed to gather experience?
If one wants security in any model of health, one wants it to be integrated where one can deliver
accountability and give some certainty. It is like walking out of one’s house and staring at a
bungalow in the distance. What provision is there for continuity for these [31]people and the
capacity to prefer an alternative bid in two years’ time that would be integrated with the Irish
health system?

I refer to the procurement criteria. Everyone who spoke rightly emphasised what worries every
woman, the natural anxiety about speed and accuracy of diagnosis. How were the volume and
turnaround requirement established as criteria? The Minister suggests 80% relates to quality and
turnaround. I contradict a point of the Minister, the suggestion that several different units within
the Irish system could have combined to offer an alternative to the contract that is coming from
abroad. That does not fit with the facts as I know them and I am perfectly happy to illustrate
them.

There is a suggestion that 20% of the tender assessment was based on cost. The Minister differs
from me politically. If cost is based on very large volumes with a lower level of quality and
performance and a murky level of corporate ethics, does it not worry the Minister that just for
the sake of the turnaround and to meet the volumes, she is willing to put at risk the existing and
potential infrastructure that might provide a fine service over which she would have full
accountability? She is saying that the corporate ethic of a bidder from abroad, over which she
will not have the same level of accountability, is welcome in the short term. To contrast is to
sacrifice good and careful planning at the cost of an immediate knee-jerk response.

There are those who say none of this matters but it does matter. Medicine all over the world has
been damaged by people who suggest that what is important is a sickness industry rather than a
health policy.

Deputy James Reilly: Why did the Minister not instruct the HSE to invest in the labs? When
I met the NCSS yesterday, it made clear that its role was procurement and that laboratories were
none of its business. That points the finger firmly at the Minister. It is objectionable that the
NCSS would issue a statement impugning my consideration of women and delay this project, for
which I have called for nine years. Having waited that length of time and having lost many lives
as a consequence of the delays of the Government that has been in power all that time, the
Minister will now rush in at the end and will, as many Members pointed out, cause the
fragmentation of our public health service. I can only surmise this is a further part of the agenda
to undermine the public health service, in addition to privatisation drives, co-located hospitals
and other initiatives.

Why did the Minister not allow investment in the labs to proceed? Will the Minister confirm that
Altnagelvin Hospital, which operates under the Western Health and Social Care Trust of
Northern Ireland and covered the north west, is deeply unhappy with the way the tender was
carried out and is threatening legal action?

Minister for Health and Children (Deputy Mary Harney): The NCSS is independent of the
HSE. It is a stand-alone body and reports to the Department and the Minister for Health and
Children. I have confidence in the screening service and Deputies have attested to their
experiences of BreastCheck, which is acknowledged domestically and internationally to have
been rolled out in a most appropriate fashion. When I asked the NCSS to roll out a cervical
screening programme I did not tell it how to do it. I have confidence in its capacity to make
those decisions. As Minister for Health and Children, I make the policy and allow those with
expertise to implement it at clinical level or at other levels.

Deputy Higgins asked why we decided on 25,000 as a minimum throughput and a ten day
turnaround. We did so because these are the international standards. We will not have quality
assurance and the women of Ireland will not have the best possible cervical screening standard
unless we follow international best practice, as followed in the UK and several other countries
that have introduced effective screening programmes and reduced mortality from cervical
[32]cancer by 80%. In our case we could reduce it by up to 60 women per year out of 75. I refer
the Deputy to page 163 of the European Standard. I did not invent this, I provided the money and
asked the experts to put a cervical screening programme into effect for women affected, aged
between 25 and 60, as quickly as possible. Furthermore, there was a two-stage tender process
that was robust and transparent. They did not have to go to tender.

Deputy James Reilly: I hesitate to interrupt but could the Minister answer the question
rather than make a speech? We heard the Minister’s speech.

Deputy Mary Harney: I personally believe going to tender is the appropriate way forward in
accordance with EU guidelines.

Deputy Emmet Stagg: That is filibuster.

Deputy Mary Harney: It is not filibuster. The tenders were evaluated by Dr. Linda Caughley,
Quality Assurance Director for Northern Ireland and adviser in regard to accreditation in the
UK, Miriam O’Reilly and others.

On the public laboratories and the HSE, the HSE, as the Deputy will be aware, undertook a
review of laboratory services. The review is quite controversial because it makes radical
proposals on what we need to do in terms of laboratory facilities in the public health system to
ensure quality assured facilities are available to patients. No question arises in respect of
resources. It is a matter for the HSE, Professor Drumm, and his management team to advance
the recommendations in that review in the interests of the public health system.

One would think from this debate that what was at issue was a failed bid or industrial relations
issues. We are not closing down laboratories in Ireland.

Deputy Emmet Stagg: The Minister is taking away their work.

Deputy Mary Harney: We are saying, as is the case in respect of BreastCheck, this cervical
screening programme will be rolled out to best international standards.

Deputy Emmet Stagg: That is questionable.

Deputy Mary Harney: In the mid-west, Deputy O’Sullivan, women have to wait more than
six months for the result of their smear tests.

Deputy Jan O’Sullivan: Not always.

Deputy Mary Harney: That is not a quality assured service. We cannot roll out the service
on this basis. It would make absolutely no sense to do so.

Deputy Jan O’Sullivan: I am not suggesting the Minister should do so.

Deputy Mary Harney: Eighty per cent of the marks were for quality and turnaround and
20%, one fifth, were for price.

Deputy James Reilly: The Minister did not answer my question.

Deputy Mary Harney: I am not familiar with the details of the individual bidders. It would
be improper of me to interfere in a tender process. Legal issues aside, it would be highly
irregular.

Deputy James Reilly: I am advising the Minister——

[33]Deputy
Mary Harney: Deputy Reilly would be the first person to stand up in this House
and complain if I were ever to interfere with the tender process.

Deputy James Reilly: Nobody is asking the Minister to do that.

Deputy Mary Harney: I do not do that. The screening service will equally confirm that when
they are rolling out BreastCheck I do not tell them which county is next. That is purely a matter
for them. I tell them only to move on as quickly as possible.

Deputy James Reilly: With respect, the Minister must take some responsibility for what
could be the legal case. This will cost the taxpayer a considerable amount of money.

Deputy Mary Harney: I do not interfere in operational issues which are the responsibility of
other people.

An Ceann Comhairle: I call Deputy Jan O’Sullivan to put her question to the Minister.

Deputy James Reilly: The Minister cannot wash her hands of this.

Deputy Mary Harney: I am not washing my hands of it: I am defending what they have
done because I have total confidence in them, unlike Deputy Reilly. Deputy Reilly is scaring
2,000 women whose lives hang in the balance, which is highly irresponsible.
An Ceann Comhairle: I have called Deputy Jan O’Sullivan.

Deputy James Reilly: That is the opinion of professional people working in the area.

Deputy Mary Harney: That has not been verified by anybody.

An Ceann Comhairle: Deputy O’Sullivan should proceed with her question. Deputy Reilly
should not interrupt Deputy Jan O’Sullivan.

Deputy James Reilly: The figures are taken from the Irish Medical Journal and I am happy
to stand over them.

Deputy Jan O’Sullivan: Does the Minister accept that she has a role in regard to this issue?

Deputy Mary Harney: Yes, I do.

Deputy Emmet Stagg: Pontius Pilate.

Deputy Jan O’Sullivan: The Minister has accepted she has a role to play. Perhaps then she
will clarify for me what is that role. Does it include protecting the skills of cytology laboratory
staff in this country into the future? Does the Minister have a role in this regard? Also, is there
any joined-up thinking between the Minister and the Minister for Education and Science in terms
of the students in DIT who are currently pursuing this course or have pursued it in the past? Is
there any role for Government in this or is it completely a matter for a company from which the
Minister has distanced herself? I have no problem with the company which is doing a good job.

Will the Minister accept that she as Minister for Health and Children has a role in this in terms of
the long-term interests of the country? Does she accept that there were laboratories in Ireland
that met the standard qualification criteria in this regard and who made a bid for the contract?
The Minister appears to be implying Irish laboratories do not have the required qualifications.
My understanding is that there are laboratories in Ireland that can meet the ten [34]day turnaround
requirement and are accredited. Does the Minister accept that this is the case? My understanding
is that it is the case.

Does the Minister accept that Dr. McGoogan’s report specifically states that the turnaround time
should be four working weeks? Why was this timeframe reduced to ten days? Was consideration
given to the fact that laboratories in Ireland were not given the resources to bring themselves up
to the required standard? While some are up to standard those that had almost obtained
accreditation had a terribly hard time obtaining the resources required to enable them reach the
accreditation standard. It is understandable the laboratories assumed that if they could meet the
four-week turnaround time they would qualify for the contract.

It is unacceptable for the Minister for Health and Children to say she has no role in the matter or
that she cannot interfere in the process. The fact that the contract will be awarded to a company
outside the country and that cytology services will be located a couple of thousand miles away
from all other services provided for patients is her responsibility.

Deputy Mary Harney: I have a lot to do with it, Deputy. My obligation is to ensure there is
in place a screening programme and to get Government backing for it. This means I must obtain
resources to allow the screening service to recruit staff, roll out the programme and to pay for
cytology services and smear testing. It is also my responsibility to ensure the service being rolled
out is quality assured and is not inferior. The cost of the service is not at issue as alleged earlier
by Deputy Reilly. What is important is the quality of service provided.

I am not distancing myself from any company. I am simply saying that I have no connections
with it contrary to stories planted by various individuals in the tabloid media. I have never met
anyone from the company and I know nothing about it. In fact, I had never heard of the company
until last year when the HSE outsourced work to it.

It would be improper for me, as Minister for Health and Children, or any other Minister, to
interfere in a tendering process.

Deputy Jan O’Sullivan: I believe it would be proper and in the national interest.

Deputy Mary Harney: I could not interfere when the preferred bidder won the contract on
the basis of quality and turnaround time.

As regards turnaround times, the laboratory must turnaround a result within ten days of receipt
of a smear. This is necessary to facilitate the woman receiving a result within four weeks. This is
as recommended in the standards and is not inconsistent with Dr. McGoogan’s report which
referred to the necessity for women to receive a result within four weeks. The smear must be
taken, forwarded to the laboratory and returned by it before the woman can be contacted in
regard to the result and any necessary follow-up treatment such as colposcopy and so on can be
arranged. For a woman to obtain a result within four weeks a laboratory must turnaround a test
within ten days.

I should point out that the Royal College of Physicians in Ireland has stated: “In line with our
mission to promote the health of the nation the College supports [this was issued last night] the
implementation of the national cervical screening programme and the goal of reducing waiting
times for smear test results....”. The national screening service has met with and agreed to work
with the college in this regard. There has never been forced redundancy in the public sector. I do
not know why people are suggesting 70 or 100 people will lose their jobs.

Deputy Emmet Stagg: What are they going to do?

[35]DeputyMary Harney: There is plenty of work in the laboratories at Our Lady’s Hospital
for Sick Children in Crumlin and everywhere else.

Deputy Emmet Stagg: The Minister is giving their work away.

Deputy Mary Harney: There is plenty of work in the laboratories.

Deputy Emmet Stagg: We are talking about specialists. They cannot simply sweep floors.

Deputy Jan O’Sullivan: It is a very specific course.

Deputy Mary Harney: That is what the Royal College of Physicians in Ireland had to say.
They are the experts in pathology. I have listened to them and to the independent experts made
available to the cancer screening service. It has no vested interest except to put in place the best
service for the women of Ireland.

Deputy Aengus Ó Snodaigh: The Minister stated last October in a reply to Deputy Ó
Caoláin: “Yes, ideally we must have our own laboratory facilities in Ireland.” Does the Minister
not agree these facilities already exist? We have the trained technicians which the public health
service needs if it is to develop.

Will the Minister agree that sending the entire screening programme outside the country is
moving in the opposite direction and that we will not in the future have the capacity or
laboratory facilities required if this proposal proceeds? In doing this, the Minister is endangering
women’s lives especially given the diagnostic rate of pre-cancer cells at Quest is 30% less than
that which pertains in Irish laboratories. How does this square with the Minister’s quality
assured service? This decision is putting women’s lives at risk. It is not good enough for the
Minister to lay the blame on the NCSS and to wash her hands of its decision. She is the Minister
and is responsible and will be responsible if the death rate increases. We have an opportunity to
increase the capacity of the laboratories in Ireland, to ensure that the screening programme is
rolled out properly and to ensure that we have quality assurance in Ireland in laboratories which
are responsible and accountable to the Irish health service, not to a company which has been
found guilty of fraud continuously.

Deputy Mary Harney: Of course we want to have quality-assured laboratory facilities in

Ireland. Among the recommendations in the McGoogan report, which has been quoted here this
morning, is the need to rationalise our laboratory services. When I was in British Columbia two
years ago as part of the advanced preparation of the cancer control programme, I noted that a
laboratory there dealt with 600,000 smear tests per year. That is the volume it deals with to get
the quality assurance that is required. I am not suggesting that we move to 600,000 here but I am
simply saying that is what is happening in other places.

Regarding the data, it is like comparing apples and oranges. The data the Deputy quoted is not
peer-reviewed and has not appeared in any scientific journal. To quote a medical publication as a
scientific journal is wrong. The characteristics of the data in Ireland and the US are different
——

Deputy James Reilly: Is the Minister saying that the Irish Medical Journal is not a scientific
publication?

Deputy Mary Harney: The Irish Medical Journal has not published articles about
comparing this data and Deputy Reilly knows that. In relation to St. Luke’s——

Deputy James Reilly: St. Luke’s published a study in 2002 in the journal.

[36]Deputy
Mary Harney: Comparing us with the US? The same study? The Deputy is not
comparing like with like. He is talking about apples and oranges.

Deputy Aengus Ó Snodaigh: This is about women’s lives, not apples and oranges.

Deputy Mary Harney: Deputy Reilly is talking about different things. It is like last week
when Deputy Reilly——

Deputy James Reilly: It deals with the pick-up rates——

An Ceann Comhairle: Contributions should be addressed through the Chair to avoid much
of this argy-bargy.

Deputy Mary Harney: It is like the data last week, which Deputy Reilly got wrong.

Deputy James Reilly: No, it is not.

An Ceann Comhairle: The Minister, without interruption.

Deputy Mary Harney: Some 39 women underwent breast surgery in Mayo. There were over
80 patients dealt with, some of whom had fine-needle aspirations. They did not have surgery.

An Ceann Comhairle: Deputy Reilly will have another chance.

Deputy Mary Harney: Let us compare like with like.

Deputy James Reilly: They had breast cancer.

Deputy Mary Harney: The Deputy can deal with Professor Wylie himself. I am simply
saying that if we are to talk about data and facts, let us talk about appropriate comparisons.

Deputy Aengus Ó Snodaigh: Has the Minister made those comparisons? Are there
comparisons available that can disprove the point? There are not. The Minister is wrong.

Deputy Mary Harney: Regarding St. Luke’s own data, the predictive value of high-grade
lesions varies from 72% to 75%. That means that one in four women get a false positive result.
That is a fact.

Deputy Michael D. Higgins: My question arises from one of the Minister’s earlier replies.
No one is suggesting that she should behave improperly in relation to the negotiation of a
contract, which is beyond her ministerial competence or responsibility. I am concerned that
regarding the review of the State or public systems, the Minister said that the report is now a
matter for Professor Drumm. I am sticking strictly here to what I have competence in, which
relates to political responsibility and policy. The Minister said that one matter is outside the area
of policy altogether, namely, impropriety. Let us agree on that point. However, she then referred
to Professor Drumm and said that he has responsibility for the preparation of the existing
services that we have, the provision of resources, the creation of their capacity, the utilisation of
the existing staff, the training and placement of student staff and so forth, but these are matters of
policy.

My point is very simple. The Minister for Health and Children is responsible for the situation in
which she finds herself. There is much we all agree on in wanting to assure women in the
speediest, shortest and most certain way. While the Minister has that situation to deal with, she
also has the issue of future planning to address and future planning is crucially a matter of
policy. On the basis of what we have heard, the Minister will have just the guarantee of a
[37]contract. We are contracting an international provider. That provider has assured the tendering
process in terms of turn-around and volume. However, the Minister does not have the capacity to
give guarantees, beyond the present even and into the future, with a contract relationship. The
contract relationship itself is under a considerable shadow because of the performance of those
with corporate responsibility in a number of areas which I will not go into now. That is a matter
of concern.

It is an inescapable issue of policy and what we should hear today is how the Minister will take
responsibility for the situation. Let us say two years from now, having assured us that those who
have given work in laboratories, have invested in equipment and have come through specific
training will be able to meet the volume and turn-around requirements, how will she be able to
say they can enter the field? The Minister for Education and Science is responsible for education
matters. The Minister for Health and Children used to be responsible for health matters. The
Minister cannot say that one aspect is to do with contracts over the waves in America, that
Professor Drumm is waiting to take responsibility for everything that is left over and she is just
in the Chamber to tell us about volumes and turn-around. The Minister cannot do that. She has a
responsibility to show the capacity of that which is not being chosen and how it makes its way
into the future, for the sake of national security and the integration of the health services.

Deputy James Reilly: On the issue of the published paper by St. Luke’s, having spoken to
the author this morning, I understand the study showed a 1.9% pick-up rate for high-grade, pre-
invasive cancers. When the author compared St. Luke’s work to that of Quest, he found that the
figure for St. Luke’s remained at 1.9%, while the figure for Quest was only 1.2%. They are the
facts that have been given to me. I suggest, as we have been having trouble over a lot of facts
recently, that HIQA might be involved, as suggested by Deputy Stagg, to adjudicate on the
matter and provide clarity. I do not want to mislead anybody and nor, I hope, does the Minister.
I wish to raise again an issue raised by Deputy Creighton and myself earlier in the debate and
ask the Minister to give a definitive answer. The Minister must accept responsibility for a
situation where a company, which has been reported as being guilty of fraud on three separate
occasions, is the preferred bidder in the tendering process. Council Directive 2004/18/EC states
that a company can be excluded from participation in a contract where it “has been guilty of
grave professional misconduct proven by any means which the contracting authorities can
demonstrate”. I put it to the Minister that it has been pretty well demonstrated by the authorities
in the United States that this is serious. I consider that $40 million in fraud claims represents
serious professional misconduct. What is the Minister’s attitude to this and can she assure the
people that they are not putting themselves in the hands of individuals and a company that we
will regret employing in the future? In fact, there could even be litigation involved here.

Deputy Mary Harney: The data that Deputy Reilly referred to from St. Luke’s was
published prior to 2002. That is why I said, in response to Deputy Ó Snodaigh, that one cannot
compare the smear tests outsourced by the HSE, of which there were 40,000 last year, with the
urgent cases dealt with in Ireland because the urgent cases clearly will have a higher rate of
abnormality than the group that was outsourced.

One in four women are given a false positive result.

Deputy James Reilly: They corrected for that in the study, with respect.

[38]DeputyMary Harney: The data in the medical journal to which Deputy Reilly refers was
published prior to 2002.

The company in question acquired a lot of laboratory facilities. It has been growing by
acquisition, which is why it is the biggest in the field. The payments issues with the authorities
in the United States centre on the laboratories that have been acquired. The company is
accredited by the authorities in the United States. It does work in the US and for the NHS in the
United Kingdom. Even if the preferred bidder did not proceed, I am not certain that the next on
the list is an Irish laboratory. I am not certain of that. There seems to be an assumption that if we
can get these people off the pitch, through some interference in the tendering process, then one
of our own laboratories will suddenly succeed.

Deputy Emmet Stagg: The terms of reference excluded our own laboratories.

Deputy Mary Harney: I am not certain that is correct.

1 o’clock

In response to Deputy Michael D. Higgins, for whom I have a lot of respect, my responsibility is
to ensure that the HSE has appropriate laboratory facilities. The report commissioned by the
HSE and the McGoogan report both refer to rationalisation. I do not know enough about hot labs
and cold labs and all that detail because I have no expertise in the area. However, rationalisation
of our laboratory facilities will be required to make sure we have quality-assured facilities for
the public health system in Ireland. This is the task of the HSE. It is not a resource issue. It is
about redeploying the resources we already invested in these facilities. If we do not have
rationalisation, we will not have appropriate quality.

Deputy Emmet Stagg: It will take away their work.

Deputy Mary Harney: There are also volumes involved and we are only 4.3 million people.

We must provide health services in a way which delivers quality assured pathology and
laboratory facilities for the health system.
Deputy Emmet Stagg: We will not need any laboratories.

Deputy Aengus Ó Snodaigh: It is a company that is guilty of fraud. What the Minister stated
about Quest is incorrect.

An Ceann Comhairle: Deputy Ó Snodaigh is out of order.

Deputy Aengus Ó Snodaigh: I might be out of order but the Minister misled the House.
Quest has been found guilty——

Deputy Mary Harney: The Deputy knows a great deal more about this type of subject than I
do.

Deputy Aengus Ó Snodaigh: ——and paid $11 million for certain blood tests that were not
ordered.

An Ceann Comhairle: I ask the Minister to carry on.

Deputy Aengus Ó Snodaigh: The Minister stated it was to do with purchasing various health
care——

An Ceann Comhairle: The Minister must be allowed to finish.

[39]Deputy
Mary Harney: I will not take a lecture from Deputy Ó Snodaigh. He started this
morning by wanting to stop us referring co-operation on criminal matters to a committee.

Deputy Aengus Ó Snodaigh: It paid out $11 million in one law suit alone.

An Ceann Comhairle: I ask the Minister to proceed without interruption.

Deputy Aengus Ó Snodaigh: The Minister is misleading the House.

An Ceann Comhairle: Deputy Ó Snodaigh is out of order.

Deputy Mary Harney: I am not misleading the House.

Of course there is disappointment with the procurement process that certain applicants who
tendered were not successful. I understand this point. People have raised issues with regard to
staffing. As I already stated, these staff are public servants. There is no question of forced
redundancy in the public sector, contrary to the rumours often put out that everybody will lose
their jobs.

Deputy Aengus Ó Snodaigh: The company was convicted of fraud.

Deputy Jan O’Sullivan: They will lose the expertise and skill.

Deputy Mary Harney: Already this year we recruited 6,000 more people to the public health
service.

The Royal College of Physicians of Ireland would not have issued the statement it issued last
night if it was not satisfied about the advancement and development of skills in laboratory
facilities in Ireland.

Deputy Emmet Stagg: That is a very small part of it.

Deputy Mary Harney: I will repeat what I stated earlier. It is hard to believe this debate is
about women and cervical screening. I hope all of us, particularly the women, will work together
to encourage women in every part of Ireland——

Deputy Michael D. Higgins: We all do.

Deputy Mary Harney: ——when they receive their correspondence to come forward for the
smear and participate in the programme, as Deputies on all sides of the House do with regard to
BreastCheck.

Deputy Michael D. Higgins: And women over 60.

Deputy Mary O’Rourke: Over 65.

Deputy Mary Harney: Deputy O’Rourke made a valid point——

Deputy Michael D. Higgins: One I make myself to my constituents.

Deputy Mary Harney: ——and this will happen. In every area of health we must have
priorities and we cannot do everything together. The jury is out with regard to screening for
prostate cancer and colorectal is next.

Last Updated: 16/04/2015 12:37:41 Page 7 of 147