I welcome Mr. Niall Behan, CEO of the Irish Family Planning Association; Mr. John McCormack, CEO of the Irish Cancer Society; and Mr. Tony O'Brien, CEO of the National Cancer Screening Service Board, and their colleagues. I propose to take submissions from our guests before inviting members to either make comments or pose questions. Mr. Behan will make the first presentation.
Cervical Cancer Control Strategies: Discussion.
Mr. Niall Behan
On behalf of the Irish Family Planning Association and its partner organisations, I thank the joint committee for giving me the opportunity to discuss cervical cancer control strategies. I am joined by Dr. Jacek Kisielewicz — or "Dr. K"— the senior physician at our Cathal Brugha Street clinic; Ms Meghan Doherty, the IFPA's policy officer, and Dr. Claire Barry, medical adviser with GlaxoSmithKline.
Ireland has an opportunity to beat cervical cancer. If we can get our policies and services right, there is a prospect of this being the first country to defeat a cancerous disease. We know how to prevent the underlying causes of cervical cancer, detect early signs before cancer develops and provide effective treatment when these signs are detected. Eradication of cervical cancer as a killer of women is within our reach.
Since 1969, the Irish Family Planning Association has helped people to make informed choices about their sexual and reproductive health through its clinical services, counselling and training programmes. It is our aim to use those services to eradicate cervical cancer. As part of its medical service, IFPA doctors and nurses provide approximately 7,000 smear tests annually. In addition, each year we provide training for over 200 doctors, midwives and nurses in the areas of sexual and reproductive health through our accredited family planning course. This puts us in a unique position to discuss cervical cancer from both a service provider's and an advocate's perspective.
I wish to focus on the value of an integrated approach to cervical cancer control that includes screening, education and vaccination. Young women in Ireland and throughout the world are enduring unimaginable pain and suffering and ultimately dying from cervical cancer, a disease that can be prevented. Each year over 70 women in Ireland, 15,000 women in the European Union and 250,000 women worldwide die from cervical cancer. It is now possible, with the use of available technologies such as screening and vaccination, to prevent the intense physical, emotional and psychological distress experienced by women diagnosed with cervical cancer.
Cervical cancer is caused by long-term infection with certain types of the human papilloma virus, HPV. This virus is easily transmitted through normal sexual activity. Every sexually active woman is at risk of HPV infection. It is estimated that approximately 80% of the population will acquire an HPV infection at some point. Most will clear the infection on their own and will not even know that they were infected. However, some women will not clear it and it is they who are at risk of developing cervical cancer. HPV infection has no symptoms and without regular screening, women may not know they are at risk until the cancer has developed. Once cervical cancer has reached an advanced stage, it is difficult to treat and causes severe gynaecological, bladder and bowel problems. Regular screening is important because it allows for earlier detection and treatment and, therefore, reduced morbidity.
In Ireland figures from 2005 indicate that over 1,500 women were diagnosed with pre-cancerous lesions of the cervix. The figures also show that 252 women are newly diagnosed with cervical cancer and that over 70 die each year.
An important aspect of the disease is that it primarily affects younger women. The average age of death from cervical cancer is 56, which compares with 66 for breast cancer. Trends in mortality from the disease are upwards, unfortunately, and there has been an increase of 1.5% per year since 1978. We are actually losing the battle against a disease we could be defeating. This is in contrast to other countries such as the UK, Canada and Australia in which mortality rates have fallen dramatically.
Falling mortality rates can be attributed to organised screening programmes which enable early detection and treatment. The IFPA, along with its partners, welcomes the roll-out of this programme and we want to support it in whatever way we can. It has been a long wait and the pilot programme has been running in the mid-western area for ten years. We support the implementation of a high-quality and organised service that will save women's lives. The IFPA aims to support the programme as a service provider, as well as training medics to take smears in the correct manner.
According to the European Centre for Disease Prevention and Control, for a screening programme to be considered successful there must be at least an 80% uptake among women invited for screens. In order to achieve this target, the National Cancer Screening Service must examine the reasons some women do not attend for their screen when invited. We must also look at the barriers experienced by many women in accessing appropriate services.
It is our experience that many women are reluctant to attend for screening because they are afraid and anxious about the test, do not have enough information or do not want to attend the local GP. They may not be sure about the service. This is backed up by the Women's Health Council and one of my colleagues here today can give the committee numerous examples of women who do not attend for a regular smear because of fear and apprehension.
In a 2006 report, the National Cancer Registry Board found that women from disadvantaged areas are 2.6 times more likely to be diagnosed with cervical cancer. This is connected to larger issues related to access to health services for women in disadvantaged areas. Screening has the potential to dramatically reduce mortality from cervical cancer but it also has the potential to reduce health disparities for those who experience barriers to accessing health services.
Some of the groups we could talk about are made up of women with disabilities, who are largely assumed by some health-care providers not to be sexually active and are therefore not routinely offered basic sexual health services. Women from rural areas have poor access to health services in general due to lack of facilities in their area. The ability to have a choice in smear taker is especially important for rural women as they may not wish to attend their local GP for reasons of gender and familiarity. Choice is very important with these types of services.
Lesbian women may not be aware they are at the same risk for transmitting and contracting the HPV virus as heterosexual women. Cultural differences may inhibit immigrant women from participating in screening programmes. Women on low incomes may not be able to afford to travel and set up child care arrangements for their family and arrangements for work responsibilities to access screening.
Innovative strategies must be in place to address take-up issues and communicate with women in a way that they understand and trust. Numerous examples of innovative strategies can be found in places such as the Netherlands and Australia. In the Netherlands, women who do not respond to their screening invitation are sent an at-home HPV test they can use themselves and in Australia, the national screening programme consulted with Aboriginal women to develop guidelines and principles of practice for cervical screening.
The other main plank in the strategies against cervical cancer must be education. Women need to know the causes of cervical cancer, how to minimise their risk and also the rationale behind regular screening. Most surveys done at the moment show there is still a lack of information and awareness out there. Many Irish women are not aware of the link between HPV and cervical cancer, the benefits of vaccination or the need for regular screening.
We still see on a regular basis in our clinics women who have been misinformed, with examples every day or every second day. A woman who recently attended an IFPA clinic did not think she needed to be screened because she recently had a baby.
Lack of quality information and education has created undue stress for many women and resulted in avoidance of smears. Many women report to us fear, anxiety, embarrassment and even dread about having cervical smears. Other women are not aware of the choices available to them regarding the gender of the smear taker or that they can have their smear taken by a practitioner other than their local GP or family doctor.
There is also a need to increase education for GPs, as well as the population, on cervical screening. I hope family planning clinics like our own will continue to play an important role in addressing some of these issues.
To get the information across, it cannot just be delivered through media and leaflets in GP surgeries. There must also be community-based initiatives. Much of the information is quite technical and difficult to communicate through the usual means. We should have community-based initiatives that will stimulate dialogue among women and have the potential to act as a trusted place for knowledge and advice.
Education on HPV and cervical cancer must be incorporated into a national sexual health strategy. It should also be strongly linked to the social, personal and health education curriculum young people get in schools.
Until recently, regular screening was the only tool available to fight cervical cancer. We now have two HPV vaccines that have been proven almost 100% effective in preventing the most common types of the virus that causes 70% of cervical cancer cases. These are effective vaccines when administered to girls before their sexual debut and before any exposure to the HPV virus and could help in the battle against cervical cancer.
The vaccines must be administered in three doses over a period of six months. The vaccines are safe, well-tolerated and have the potential to significantly reduce the economic, psychological and physical toll associated not just with a cancer diagnosis but also with follow up of abnormal smear tests.
The World Health Organisation, the European Centre for Disease Prevention and Control, 15 EU countries, Canada, USA, Australia and New Zealand have recommended routine vaccination of pre-adolescent girls in order to reduce the burden of cervical cancer. At the moment, the national immunisation advisory committee and the National Cancer Screening Service have both reviewed the benefits of introducing a national HPV vaccination programme and commissioned a health economic evaluation to determine the cost effectiveness in an Irish setting. We are waiting for a report from HIQA, which is due shortly. However, it remains unclear what the next steps will be after HIQA reports on the vaccination programme. No funding has been allocated for the roll out of the vaccination programme in 2008. If we are serious about getting the vaccination programme up and running, this must be addressed. Ireland is once again lagging behind the majority of other European countries and our nearest neighbour. Girls in Northern Ireland, for example, will be receiving the HPV vaccine in September of this year.
At what age?
Mr. Niall Behan
At age 12 to 13. We must establish the vaccination programme as quickly as possible. At the moment, the vaccine is available through GP surgeries and family planning clinics, at a cost of approximately €600 for three doses. The cost is prohibitive and in our experience there has not been a great take-up. Approximately ten girls have come to us in the past year to 18 months. If we continue at that rate, we will never make any significant impact.
The World Health Organisation and the European Centre for Disease Prevention and Control, ECDC, recommend state-funded, routine vaccination of pre-adolescent girls delivered through schools. If the vaccination remains available only to those who can afford it, cervical cancer will become a disease of the disadvantaged. In our view, this is a violation of the human right to health.
In order to be successful, parents and young people must be informed about cervical cancer, HPV screening and the vaccine. A report by the Danish Department of Health found that while Danish parents were mostly positive about the vaccine, they still wanted to find out more about it, how it worked and how safe it was for their children. Similarly in Canada, the Royal College of Obstetricians and Gynaecologists emphasised the need for a balanced view of the HPV vaccine, so that parents and children could make informed choices about their health care. To date, these concerns have been mirrored in the IFPA clinics. Parents have expressed some uncertainty about vaccinating their children because they feel they do not have enough information. A successful vaccine programme requires an information campaign for parents, similar to the one that has been integrated into the Danish programme. This ensures a high take up and, if done properly, does not delay the early implementation of a programme.
We know, from the organisations that work in this area, the benefits of the vaccine. However, some information has yet to be confirmed. Follow-up data are only available for five years and everyone must be aware of that. This means that protection after five years is unknown. We do not know if a booster will be necessary. However, new data are emerging all the time and I understand it is increasingly positive about the long-term effectiveness of the vaccine. I understand that Dr. Claire Barry has additional information on this, which has become available this week, if the committee requires it.
I must stress that the medical community, international policy makers and sexual and reproductive health advocates are unanimous in their support for routine vaccination for pre-adolescent girls, as a powerful tool that we cannot ignore. We cannot justify waiting to improve the health of women when we have the tools available to do so.
The committee should be aware that the vaccination will not replace screening, as women could still contract cancer-causing HPV types that the vaccine will not protect against. Similarly, screening alone will not prevent the cause of cervical cancer. The strategy we advocate is vaccination in combination with screening and education. Models have predicted that such a strategy will reduce cervical cancer much more than screening alone. With an integrated and successful implementation of these tools, we have the ability to eliminate cervical cancer from the island of Ireland.
Successful cervical cancer control strategies could have an immense impact on the health and economic well-being of women and are necessary for the realisation of women's human rights regarding health. We ask the committee to integrate four elements into its work plan. The first is to ensure there are community-based projects that encourage active engagement with the issues surrounding cervical cancer. Such projects can serve to normalise regular screening and routine vaccination. We need a conversation among women and men around cervical cancer. In order to do this, we need community-based peer education programmes that will complement the promotion of a national screening programme.
The second element is to ensure that a date is set for the implementation of the national cervical screening programme. We ask that the committee should monitor that programme to ensure there is high uptake, a choice of smear taker and that the service and processing of results are quality assured.
Third, we ask that the committee should ensure the integration of education on HPV, preventative sexual health and cervical cancer into the education system, specifically in the social, personal and health education, SPHE, curriculum, as a unique model. We also ask that this work should be integrated into a national sexual health strategy.
Fourth, we ask that the committee should ensure that budget allocations are made this year for a free, school-based vaccination programme for pre-adolescent girls.
I thank Mr. Behan and now invite Mr. John McCormack to make a presentation.
Mr. John McCormack
On behalf of the Irish Cancer Society, I would like to say how pleased we are to be here today to present to the committee on this very important subject. There is no doubt that women in Ireland are dying needlessly from cervical cancer because we do not yet have a national screening programme. This has exercised us a lot because we hear about the women who have died needlessly.
I will hand over to Ms Jane Curtin, our communications manager, who will present our paper today.
I wish to apologise in advance, but I will have to leave at 4.05 p.m. However, I will return to the meeting as soon as I can. I mean no disrespect and am very interested in what Ms Curtin has to say.
We will have to excuse Deputy James Reilly and Senator Phil Prendergast, both of whom have other duties to which they must attend. Senator Prendergast would like to ask a brief question before she leaves.
I thank the Chairman and apologise for having to leave the meeting because this subject is very close to my heart. I am very involved in the SPHE classes. As a midwife for more than 23 years, I deal with the sexually-transmitted infections and sexual health aspects of the programme in schools for girls in south Tipperary and south Kilkenny.
I wish to ask about the cost of the vaccine. I am fully supportive and believe everyone should be involved in any screening programme which could prevent cervical cancer. However, if there were to be a national screening programme — and I am sure the census data will give us an indicator of the size of the roll out — would there be a process for negotiating a reduction in the cost, which at €600 is quite severe? Similarly, the cost for those who have to undergo treatment for endometriosis, another gender-based treatment, is very prohibitive. Only those women who are well off and can afford the vaccine will avail of it unless it is part of the national screening programme. That is my concern and I thank the Chairman for allowing me to express it now.
Ms Jane Curtin
We are also joined by Ms Norma Cronin, the health promotion manager from the Irish Cancer Society. I wish to reiterate some of the points already raised by the Irish Family Planning Association, bring the committee members up to speed on our understanding of developments in the cervical screening arena and address some of the society's questions and concerns.
In Ireland, over 70 women a year die from cervical cancer, twice as many women are diagnosed with cervical cancer every year and thousands of women undergo treatment for cervical pre-cancer. The Irish Cancer Society, as the national cancer care charity, unequivocally supports the establishment of a free nationwide cervical screening programme, which will aim to reduce both the incidence of and mortality from cervical cancer by the detection and timely and effective treatment of cervical pre-cancer. In countries where such programmes have been rolled out, such as in Scandinavia and British Columbia, a significant reduction in both mortality and the incidence of cervical cancer has resulted. The UK, our nearest neighbour, rolled out such a programme in 1998 and has witnessed a reduction in incidence and mortality.
The National Cancer Screening Service, NCSS, is due to announce the date for the roll-out of our programme in summer 2008 and €15 million was allocated for this purpose in budget 2008. The Irish Cancer Society asks that there be no further delays and that the roll-out actually takes place in 2008, rather than just its announcement.
On the organisation of a free nationwide cervical screening programme, two factors are of fundamental importance for the effective screening of a population. They are the organisation of the programme and the validity of the screening test. Screening programmes should be organised in such a way that the target population is adequately identified and that at-risk individuals in the population are identified and encouraged to avail of screening.
The National Cancer Screening Service has updated us on how the pieces of the jigsaw will be put in place. The Irish Cancer Society understands that the register of those who need to be screened will contain 1.1 million women aged between 25 and 60 years. Women aged between 25 and 45 will be invited for screening every three years and women aged between 45 and 60 will be screened every five years. The aim is for 300,000 women to be invited for screening during the first year of operation. Participation will be voluntary but the NCSS will conduct a systematic and proactive follow-up to encourage women to attend for their appointment. The programme will aim for a four-week turnaround from conducting the smear test to giving a woman her result. The programme will have to limit women presenting for opportunistic screening or screening outside the established programme.
The NCSS is aiming for an uptake of at least 80% in its first year of operation, which is quite an aggressive target. As the Irish Family Planning Association stated, there will need to be a high-profile education and awareness campaign to maximise uptake, particularly in groups which might not avail of screening, such as those in the younger cohort aged between 25 and 30 years, who might not necessarily understand the importance of presenting for regular smear tests, and those in the older cohort aged 55 years or over. The NCSS has also advised us of the barriers that might exist, impacting negatively on uptake. Those barriers include socio-economic status, education, income, non-national status, perception, inertia, ignorance and doubt and the barriers will need to be examined and tackled appropriately to encourage uptake in those groups.
There will be NCSS representatives on the ground across the country to further encourage attendance. As part of the ongoing educational and awareness programme highlighting the importance of having regular smear tests, we urge an educational programme on the link between cigarette smoking and the development of cervical cancer. People who smoke find it harder to dispel HPV and are subsequently at greater risk of developing cervical pre-cancer.
The National Cancer Screening Service is currently involved in a consultation process regarding a contract for smear takers. The screening programme will be quality assured and standardised to maximise the potential and minimise the risk of harm. Laboratories participating in the screening service will also be quality assured and will be able to cope with the volume of smears coming through the system. Smear takers, who will largely comprise GPs, will be given referral guidelines for women who present with abnormalities and who may need to be referred for colposcopy and treatment for cervical pre-cancer. Colposcopy services, a vital component of any screening service, will also be quality audited. The Irish Cancer Society requests an update that all of the above procedures and standards have been put in place in anticipation of the successful roll-out of the free nationwide cervical screening programme.
The second vital component of a successful screening programme is the validity of the screening test. The Irish Cancer Society understands that the traditional method for taking a cervical smear involves scraping the cervix and smearing the resultant sample on a glass slide. The interpretation of this test can be difficult due to factors such as air drying of the specimen and the presence of blood and inflammatory exudates obscuring the cells. A new technique known as liquid-based cytology differs from this conventional technique by placing the sample in a liquid that washes the cells that are then filtered and put onto a slide. This has been shown to reduce the percentage of unsatisfactory smears while increasing the detection of high-grade cervical pre-cancer abnormalities. This technology also has the potential for automated screening. A possible downside, however, is the increased detection of low-grade abnormalities, which may not be clinically relevant, with an increased referral rate for colposcopy.
This technology has implications for the cost of screening and its efficacy. The cost-effectiveness of this kind of test is currently the subject of a pilot scheme in the UK NHS cervical screening programme.
Cervical cytology, like any screening tool, is therefore imperfect. Technological advances may improve the process but these improvements will incur an increased cost. The Irish Cancer Society requests an update on the type of screening test that will be used as part of the free nationwide cervical screening programme and would like to see the rationale for the choice of that test.
As Mr. Behan said, it is now generally recognised that infection with the human papilloma virus, HPV, is a necessary pre-requisite for the development of most, if not all, cervical cancers. The HPV virus is passed through normal sexual contact and is incredibly common, with a lifetime risk of infection of approximately 80%. Most infections occur within 18 months of initiation of sexual activity and most women who have been infected will experience a transient infection with spontaneous resolution within 18 months. Less than 20% of women will show signs of persistent infection beyond this time. This leads to the existence of pre-cancerous abnormalities which have no symptoms and, if undetected by a smear test, many will produce an invasive cervical cancer within a ten to 15-year period. The difficulty arises from the fact that it is impossible to discriminate between those women who are at risk of persistent infection and those who are not.
Two HPV vaccines are currently in the market place. The rationale for the vaccination of women is that women who have not previously been exposed to the virus would be presented with a viral-like particular which is incapable of transforming the cell's DNA. By exposing young girls to this vaccination, antibodies are produced which then protect that girl from infection with those types of HPV when she becomes sexually active. Evidence therefore points to the fact that the target population for the vaccine should be young girls, through a mass vaccination programme. Any programme should aim to vaccinate young girls before their sexual debut and, with a group of girls aged between 12 and 14 being identified, should involve a catch-up programme where older girls are offered the vaccination.
Given the cost of these vaccines, cost-effectiveness is crucial and the findings from the recent health technology assessment will inform policy in this regard. An interesting question, however, arises as to whether women who have been previously exposed to the HPV virus would benefit from the vaccine. This issue has been the subject of much debate, particularly in Ireland, vis-à-vis the availability of this vaccine to medical card holders. Unfortunately, according to the guidance from the Irish Cancer Society’s medical committee, there has been no published evidence on the efficacy of this vaccine when used in a group of women who have been already exposed to the HPV virus.
The Irish Cancer Society supports mass vaccination for all 12 year old girls with catch-up shots for older girls and looks forward to the timely recommendations of the HPV vaccination health technology assessment advisory committee, as well as the roll-out of a Government-funded mass vaccination programme. In the lead-up to the roll-out of this mass vaccination programme, the Irish Cancer Society encourages parents to see to it that their daughters are immunised if they can afford it. However, we understand the cost implications and acknowledge the inequality involved. We would like the advisory committee to complete its deliberations and to see the introduction of a mass vaccination programme as soon as possible. We are concerned, as we said, about the lack of evidence to support HPV vaccination in women outside this age group who have been exposed to the virus through normal sexual contact. As more information becomes available we will study it and update our position.
Mass vaccination programmes against HPV will not be sufficient on their own. A strategy for cancer control aimed at cervical cancer must include the immediate provision of an organised population-based screening programme as identified above. The vast majority of women in Ireland have already been exposed to HVP, the human papilloma virus, and there is a duty of care to provide for these women. In addition, there is no good test of those women who have and have not already been exposed to HPV infection. Until such evidence is available, it is important to stick to the message that regular cervical screening remains the best option for reducing cervical cancer in this group of women.
As that completes the presentation of the Irish Cancer Society, I invite Mr. Tony O'Brien to make his presentation.
Mr. Tony O’Brien
Let me introduce my colleagues: Dr. Gráinne Flannelly, a consultant gynaecologist and chairperson of our colposcopy and primary treatment quality assurance group; Dr. Marian O'Reilly who heads our cervical division and was director of the Irish cervical screening programme in the mid-west from its inception; and Dr. Alan Smith, who is a consultant in public health medicine with the National Cancer Screening Service.
The National Cancer Screening Service was established by the Minister on 1 January 2007 and it took over the role and functions of the former national breast screening board. Its remit therefore relates to BreastCheck, the national breast screening programme, which we had the opportunity to discuss here before, the roll out of a programme for the early diagnosis of cervical cancer and arrangements for primary treatment in such classes of women as may be determined by the Minister from time to time. The board also has a function in advising the Minister on health technologies, including vaccines relating to the prevention of cervical cancer, the provision of advice to the Minister on the carrying out of programmes concerning any cancer — programmes in this case taken to mean population early detection programmes — and the board shall also implement special measures to promote participation in its programmes by disadvantaged persons. That is the remit of the board, an agency of the Department of Health and Children.
The Irish cervical screening programme has been operating for a number of years in the three counties of the former mid-western health board area and came under the board's governance on 1 January, having been previously part of the Mid-western Health Board and then the Health Service Executive. It is no longer part of the HSE but is part of the NCSS. The first step that we took on the programme was to change its screening intervals from five yearly to three yearly for women aged 25 years to 44 years and five yearly thereafter. Let me respond to one of the points made by Ms Jane Curtin by stating that the programme is an entirely liquid based cytology based programme and has been so for two years. That is the basis on which the national programme will operate.
In order to bring the national programme to fruition later this year, a number of important current steps are under way and these relate to the individual elements which when joined together can provide a quality assured cervical screening programme. In no particular order, they relate to smear taking and the provision of services on a national basis with a choice of provider to each woman so that she can have access to the smear taker at an appropriate time. In order to bring that about, we have just completed a fairly wide-ranging consultation with prospective smear takers, based on a draft contract which we have published and widely disseminated. We are in the process of assimilating the responses to that, with a view to improving that contract prior to its being offered. This contract will be the basis upon which women will have access to free smear taking. It will set the parameters within which the service will be provided and it will establish the financial relationship between the NCSS on behalf of the State and the individual smear takers who will be medical practitioners in primary care settings, be they general practitioners or those in clinics, such as the Limerick family planning clinic which currently participates, as indeed do other clinics in many setting around the country.
Are they all GPs?
Mr. Tony O’Brien
No, they are all medical practitioners in primary care settings. The preponderance of them are likely to be GPs because of the distribution of GPs around the country, but there are also family planning clinics, well woman clinics and potentially other streams of activity, particularly where it may become apparent to us that there are gaps in the coverage or particular uptake challenges that call for additional measures in certain areas. That is the first part. As I stated, we closed out the consultation last week, although we are still receiving input and are happy to do so.
We plan in the next number of weeks to complete our assessment to revise the contract and move to the formal offer of contracts to smear takers. Cytology is what takes place in the laboratory once the sample is take. We place very considerable emphasis on this aspect of the service because it has been one of the great challenges that has existed hitherto. Three major issues arise. First is quality, the second is capacity and the third is turnaround time. Our board's position is very clear that every slide taken as a result of an invitation from us must be processed within ten days of receipt in an accredited laboratory, operating to verifiable standards. In net terms we require sufficient capacity to enable the total screening population at any given time to receive both primary and, where necessary, secondary smear tests.
We have pursued that through a public procurement process in accordance with European standards and have completed the first phase of assessment of the returned tenders. We are currently engaged in that process. We expect before the end of April to have made our selection and be in a position to appoint laboratory service providers under contract. Specific standards will apply in order to do that and we will be in a position to quality audit and verify them.
Let me reiterate that what is required is international quality accreditation, turnaround time of no more than ten days from receipt in the laboratory and sufficient capacity that we can deal with any bubbles of demand that might emerge. This is to change the current position or the position that has been prevalent until very recently where women could wait up to and in excess of 30 weeks for a result, which is no basis on which to provide a national screening programme. The NCSS will have no part of any programme on that basis.
The next issue, assuming we have reason to refer for further assessment, is to provide an appropriate network of colposcopy services. Again we will require BSCCP accreditation, which is a recognised international accreditation standard. We are currently in the process through our quality assurance group of almost completing a round of visits to identify current capacity and any particular challenges that exist there and will take steps to ensure there is appropriate capacity in line with the standards we require. Following on from that, a small number of women will go on to require primary surgical treatment and the designation of appropriate centres will be conducted in association with the national cancer control programme, which has governance over that aspect of the process.
Accordingly I am able to tell you that all the necessary pieces of the jigsaw are in place. Our board's position is that quality assurance will be the governor on timing, although we have been provided with substantial funds to enable us to launch the programme mid-year. Other funds must be released from current activities being undertaken by the Health Service Executive and we are in the process of identifying and releasing them, in particular those which relate to opportunistic screening. I think the joint committee heard that a figure of about 300,000 invitations per annum will follow from a national programme. Approximately that number of smears are currently being processed in several laboratories in Ireland, but they are not part of a programme and many of them are of women who are having smear tests on a much more frequent basis than is appropriate. Of course, many other women are not having smear tests at all. In order to corral this activity into an appropriately quality assured process, it will be necessary to end access to opportunistic smear taking, which has arisen in the absence of an organised programme. For the first period, any woman who wishes to have a smear test will be able to do so through the programme — there will not be a difficulty there. The launch date will be determined essentially when these key issues have come together. We expect to conclude the cytology procurement at the end of April which will give us the opportunity to set a date for the summer. Quality assurance will determine it. That is the principle we have applied to BreastCheck and it is sacrosanct for the board of the NCSS.
Our terms of reference specify disadvantage, which has featured largely. When the programme is launched there will be a substantial education and public awareness campaign, with one for providers too, designed to change people's understanding of cervical testing, the appropriate intervals and so on. It will be substantial and have many angles, which will replicate many of the features of BreastCheck and the cervical screening programme in the mid-west. I have mentioned the disadvantages with which the latter programme had to deal, not least its lack of access to timely turnaround in laboratories, which has a significant impact on women's willingness to take part in such a programme. Notwithstanding this, in 2006 the programme achieved a 62.2% overall uptake which was creditable, given the disadvantages under which it operated.
BreastCheck faces the same challenges in respect of predisposition which might limit an individual's willingness to take up the programme, but it has steadily achieved the necessary level of uptake. According to the OECD it ranks fifth in the world for organised breast screening programme participation rates. Many of those lessons will inform our approach to mobilising uptake using many of the techniques already mentioned, at ground and macro levels and so on.
Choice of provider is a key determinant and will be a feature of how we intend to promote participation so that women know they can go to providers of their own choice. With regard to HPV vaccination, the Minister provided the report of the national immunisation advisory committee to the NCSS with the request that we advise her on the priority, the cohort to be addressed and several other specific factors. In response, we commissioned a formal health technology assessment by the Health Information and Quality Authority, HIQA, which is part of its statutory remit as provided by the Oireachtas last year. HIQA has completed that work and we and the Minister have just received the report. Our board will consider the report in furtherance of its function of providing that advice to the Minister and members will not therefore expect me to discuss the report in detail. I can only say that I expect that the NCSS board will discharge its function rapidly and make its recommendation to the Minister soon.
I thank everybody concerned for their presentations and apologise on behalf of some members who had to leave the meeting. They will try to return.
This committee does not have a funding basis but has the power to make recommendations. Mr. O'Brien has made it clear that some problems revolve around funding and more around the will of the Department to promote vaccination and screening. In a nutshell he is saying that if we implemented an immediate policy of nationwide screening and vaccination at the age of 12 we would have a 90% success rate. I recently heard a Scottish MEP talk about the level of success possible if we had vaccination and screening.
Mr. Tony O’Brien
It is important to emphasise that if public policy goes the way the IFPA and the ICS have articulated it, there will inevitably be a lag time. If all girls aged 12 or 13 were offered this vaccination and a proportion of them accepted, it would be another 12 years before they would enter the screening population. This is a long-term project. It would not be possible to comment on overall effectiveness without getting into the territory of the health technology assessment and I feel constrained from doing so.
If 70% of 12 to 14 year olds took up the vaccination, would it not be necessary in 12 years' time to shift the resources from screening to vaccination?
Mr. Tony O’Brien
There is a degree of consensus that for the foreseeable future the two things would go hand in hand. It would be necessary to provide a screening programme long into the future and consequently there would be no shift of resources from one to the other on a 12-year horizon.
I welcome the groups and thank them for their presentations. I appreciate the importance of this issue. How confident are they that the resources will be made available to ensure that this is rolled out before the end of the summer? Many projects that we had expected over recent months to be rolled out are not funded to the promised level. Did Mr. O'Brien say that in April the NCSS would decide on the date for the summer roll-out? If Mr. O'Brien is not in a position to name the date, can we presume that it will be before the end of August? If it does not happen by then serious questions will arise.
Has the IFPA negotiated arrangements for the delivery and competent authority of the screening and does the approach to the screening and other issues meet its standards? It gave us figures for cervical cancer up to 2005. Does it have figures for 2006 and 2007? It spoke about problems identified in the mid-west, especially in respect of the turnaround time. What other problems did it experience there and what solutions have been identified to overcome those problems? What is the take-up in the mid-west compared with Holland and other international examples? What arrangements has it made for reporting back to general practitioners? Is there a system in place for reporting the results of tests to the colposcopy clinics?
I too welcome the three groups and the opportunity to discuss this issue. The groups have provided a great deal of information. We have had the opportunity before to raise some of these questions. It is a no-brainer to screen and vaccinate because the benefits are so significant. There do not seem to be any contra-indications or difficulties, but if there are would somebody point them out? That over 70 women die per annum from this disease when we know how to get rid of it shows that we should get on with the programme. I am glad to hear that we seem to be doing so. We should be getting on with it and I am glad to hear that it looks as if we are. I share Deputy Neville's concerns that Mr. O'Brien will be unable to keep his arms around the money, given the HSE's cutbacks. Is he confident he has the funding in the bag to roll out the screening programme? Unlike BreastCheck, this programme will be rolled out everywhere at the same time. Are all general practitioners eligible to participate? Is a training programme available? For example, GPs must do courses to give family planning advice. Can any woman attend her GP and have the test done? I welcome the involvement of family planning clinics. I have had a long relationship with the Limerick family planning clinic and I am aware of the good work it does.
Like Deputy Neville, I am interested in learning from the screening programme in the mid-west. I have had more than one screening because I live in the area and it was a positive development for women in the mid-west. Deputy Neville asked about the uptake generally but I would like to know whether an assessment has been carried out of the uptake in disadvantaged communities. Women in such communities have a 2.6% higher chance of contracting cervical cancer. Does Mr. O'Brien anticipate specific targeting? Reference was made to peer activities and so on. Many community health projects are in place and I wonder whether the organisations can link up with them. That would be the most sensible way forward. Women from disadvantaged areas are in various community groups and it will be vital to access sectors of the community in which screening uptake is low traditionally.
Will family planning be mandatory in the SPHE course in schools? How will the information be rolled out in schools? Once the vaccine is available, presumably it will be provided in the schools anyway and, therefore, all schools will have to participate. I do not know whether anyone has thought that far ahead.
The vaccine will be expensive but it is available in Northern Ireland and it must be introduced here, irrespective of the cost. I do not know if there is evidence that the cost will reduce. Many medical products are expensive when they are launched but they become less expensive following advances in research and so on.
Mr. O'Brien stated that opportunistic screening will end. I presume he means that once the programme is up and running, screening will be undertaken routinely and, therefore, opportunistic screening will not be needed. Will there be a delay in calling women once the programme is launched? Can women apply immediately or must they wait for a letter? Women who are concerned about their family history or who have other concerns could be at the end of the list. Will it be introduced for all women immediately?
Mr. O'Brien is the only person I ever dealt with regarding BreastCheck and his approach, which concentrates on capacity and excellence, is the way forward. I have great confidence in his team to introduce this programme. I campaigned for BreastCheck for a long number of years and now that we have it in the south, we are confident it will prove very beneficial, as it has in the rest of the State and the rest of the world.
A pilot programme of cervical smear testing is not available in the south. Deputy O'Sullivan referred to communities that experience a higher than average incidence of cervical cancer and where the women do not want to undergo smear tests. Is it intended to go to these areas to do these tests as opposed to expecting the women to attend a health centre for the test? Women gather at three different health centres in my area every morning and they are encouraged by the staff to do the test. I acknowledge Mr. O'Brien could not provide a definite date for the roll-out of the programme but I assume it will happen in the autumn. Will the test be free for all women? Contracts and negotiations must be undertaken regarding coverage and so on and health care professionals will be involved along with family planning clinics, which probably have a different ethos, but the programme does not necessarily have to be run be midwives, GPs or fully-qualified nurses. Could people be trained solely to do this work? A better response might be generated in encouraging women to do the test if this was done.
I welcome the presentations and I am delighted about the proposal. The sooner the programme is rolled out, the better, given that 70 women die from cervical cancer per annum, which is serious. The four-week turnaround in the smear test and quality assurance are important issues. The take up in the pilot scheme in the mid-west was 66%. Why did the other 34% of women miss out? I accept 100% will not be achieved but why were 34% of women missed by the pilot scheme? Will this happen when the programme is rolled out nationally?
I refer to the cost of vaccinating girls when they are aged 12 or 13. If the NHS provided the service, what was the cost? Education is important in this regard. Could it be compulsory for all 12 or 13 year old girls to have the vaccination? Are women immune for 14 years following the vaccination, thereby meaning they would not have to worry about screening until they are in their mid-20s? Are there side effects to the vaccination? I am worried that if the vaccination is not provided under the GMS scheme, it will be considered elitist because only the well-off will be able to afford it and many women will be left behind, resulting in a two-tier system, which I would not like. The sooner the programme is rolled out, the better. It will have the full support of the committee to make sure it is up and running by the middle of the year.
I have a number of questions about the programme. I have some concerns about the timeframe for the roll-out, which has already been heavily delayed. I heard the Minister state at the end of last year that it would be introduced in January this year but it has not. With the kind of cutbacks we have seen in frontline services, there is a question mark over the priority this will get. It should get priority and it is incredibly important that we move ahead and do what so many other countries have done. I am concerned it will not be prioritised and I wonder what assurances have been received on that matter.
I also ask about GPs and if there is an arrangement or agreement on fees for this process. I do not know if that was covered in the presentation and I apologise for not being able to be here for it. I take it fees for GPs will form an essential part of the process.
Many screening tests have been sent to America for analysis rather than to laboratories here and various questions have been raised about this in the past year. These concern the quality control and other criteria involved. Have we sufficient resources in laboratories here for nationwide screening? Will the results be analysed in Ireland or will they be sent abroad?
I have attended a number of presentations on the vaccination and I can see its benefits and the countries going ahead with it. Parents will have many questions about it and we will need a very good information campaign for everyone involved to get across the information currently available.
With regard to research, how long have the follow-up studies been and how many years do they cover at the moment? Are we confident about possible side effects? I ask this question because other lay people will do so also. I support the programme but at what stage is the research? There are many questions about vaccination. Women were told hormone replacement therapy, HRT, was the be all and end all, but there are now serious questions about aspects of it and the time period people should be on it.
I know people involved in this process in the North are very confident about it, but for the benefit of the committee, perhaps the witnesses could tell us about the research and the length of time the current studies cover. How many years has the vaccination been in effect and what are the results?
I offer my apologies to the representatives of the Irish Family Planning Association as I missed their presentation. I thank them for providing the text.
Some of my questions have already been addressed but I have some specific queries. I understand there was to be approval for an additional 30 posts for the implementation of the cervical cancer screening programme, which would facilitate integration and the roll-out of the programme. Will the representatives of the National Cancer Screening Service indicate if these 30 additional posts have been established or progressed? Have people been appointed or has the process been affected in any way by the employment squeeze and recruitment embargo within the HSE which was signalled to end at the end of last year but has found its way right into 2008 and up to the current month?
The issue of laboratories has been mentioned. I understand a procurement process was under way with regard to quality-assured and internationally accredited laboratory capacity necessary to carry out various tests. This process was to be completed by the end of March. Perhaps we could be updated on where the issue stands at this point.
Senator Fitzgerald mentioned laboratories abroad, which will certainly be internationally accredited, but what proportion of tests will be carried out at home?
I understand the service is also carrying out a baseline quality audit of existing clinical colposcopy services in this State to establish fitness for purpose with regard to the national cancer screening service programme. Will the witnesses provide an indication of progress on this? The stakeholder consultation process, which dealt with smear taker capacity, was to conclude by 28 February and did not take up on the leap year by grabbing 29 February. I assume this was done and dusted on 28 February but perhaps Mr. Tony O'Brien and other representatives of the NCSS could tell us if it was concluded within the signalled timeframe.
I am not being facetious but am concerned, as is every other member here, and I am very anxious to see this progress as soon and as safely as possible. Mr. O'Brien spoke in his contribution about naming a date for the commencement of the full roll-out of the national cancer screening service. He stated a date would be named later this year that will be "in the summer". The Taoiseach gives answers like this on the Lisbon treaty referendum and we cannot squeeze a date out of him either. I would like assurance that it is this summer we are talking about. We would all like that confirmation this afternoon.
Mr. Tony O’Brien
I will deal with the issue of resources first and work through the questions in groups.
The national cancer screening service is not part of the Health Service Executive and is therefore not part of the financial and full-time employment equivalent ceilings that apply to the executive. It has a separate allocation which comes from the Department of Health and Children's own Vote rather than that of the HSE.
The service is doubly blessed.
Mr. Tony O’Brien
It is separate funding. We were allocated a specific additional amount of funding in the Estimates for this year which relate to the roll-out of this programme. A relatively small piece of the funding is currently being discharged by the HSE, meeting the needs of opportunistic screening, and we are currently in the process of working through the extraction of that funding with the full co-operation of the national hospitals office.
On the whole-time equivalent issue, a number of posts related both to cervical screening and BreastCheck national expansion and integration into the NCSS were approved last year and many have been filled. The money, to quote the Chairman, is "in the bag". It is not in the bank but in the bag. All the resource concerns can be allayed, although that relates to the screening programme and not to any vaccination programme.
If there is to be a vaccination programme, it will not be under the governance of the National Cancer Screening Service. It will form part of a separate programme of activity related to vaccination and we would not be in the business of delivering the vaccine. That is not what we were established for and our purpose relates to policy issues. If there is to be a vaccination programme, there is no question of its being compulsory, as this would not be possible. It would instead function on the basis of informed and parental consent, particularly for the age group being discussed today.
Regarding the uptake rates of the first phase of the Irish cervical screening programme, the figures I quoted were for 2006 and showed a 62.2% uptake rate in that period. The figures for 2007 are not yet available. There is a validation process on how to invite people and when an invitation is judged to be satisfied, etc. In citing that figure I indicated this to be a very creditable performance and the problems or challenges I alluded to were not for the programme or the mid-west, but were national challenges affecting the context in which the programme operated. There would have been greater access to smear taking and testing in the mid-west than that alluded to in the figures. I will give a very specific example. A member of staff in the programme's own office went to a general practitioner in the mid-western region in the first part of last year and was told correctly that the GP could not give an indication as to when the result would be back from the laboratory, but if she was prepared to pay a set fee, the slide could go to a private laboratory in Dublin and consequently she would get her result in three or four weeks. In the face of such an exchange, it is no wonder the programme has struggled to enrol more women in the free public service. That is the reason we have placed very strong emphasis on turnaround times as the programme will never succeed in those circumstances. To reiterate, the problems are not problems of the programme but challenges of the context in which the programme operated and consequently we have been focused on changing that context. In that context, the programme has done very well in my view, but it could not be rolled out nationally on that basis because without having a reasonable prospect of achieving 80% take-up, the programme would be a failure. We are not about to roll out a programme on that basis.
With regard to opportunistic screening, I am referring to a seamless almost simultaneous phase in-phase out process, so there is no question of opportunistic screening being phased out before a programmatic approach is phased in. It is necessary, if we are putting in place through the procurement process a quality-assured laboratory service, that there would be no basis upon which the public sector could justify expending resources to facilitate women in having their slides assessed at laboratories that were not quality-assured and where there was no guarantee of turnaround time. Although we are separate from the HSE, we are very much part of the public health service and it is essential that the services are joined up and that a quality service is provided. We recognise, however, that there will be a number of women who have been part of an opportunistic or self-generated screening exercise over a number of years who will need to be accommodated and we will be operating a call-recall system. However, where women turn up spontaneously for the first of what otherwise would be an opportunistic screening, we will seek to enrol them in the programme and give them appropriate information about the right cycle and get them engaged in the programme cycle at that point. That would be a programme smear rather than an opportunistic smear provided to programme standards.
On a point of clarification, will women get a letter inviting them to a screening? How will it work?
Mr. Tony O’Brien
As the Deputy stated earlier this programme will roll out nationally rather than area by area. The phrase we have used is the "big bang" approach, but the call-recall process will be designed so that women within the three yearly and five yearly cycles are coming at regular intervals for screening. Obviously women will enter and leave that age group, and will enter and leave geographical areas, so the call-recall programme will be phased over five years. However, as women elect or seek to have smear tests, we will seek to enrol them at that point. There will be two types of women who enter the programme, those whom we go out and seek and those who self refer. Obviously we want both sets of women to become part of the programme and to have regular screening in accordance with the screening cycle that is appropriate to their age cohort.
Will women with a history or who have a family history be given priority?
Mr. Tony O’Brien
Not in relation to call and recall, but if as a result of participation in the programme there is an indication that more frequent screening is required, then that will be provided under the auspices of the programme. We would not have access to a woman's history.
May I clarify this point before we go on? When the programme rolls out, will the National Cancer Screening Service write to 300,000 women each year?
Mr. Tony O’Brien
Approximately.
Will these women be invited to undergo screening at their local facility?
Mr. Tony O’Brien
Yes.
By the end of a three-year cycle, will all the women within the age group have been invited to participate in the programme?
Mr. Tony O’Brien
All women within the ages of 25 to 44 years who fall within the three-year cycle will have been invited and women above that age range will be called in a five-yearly cycle. It evens out. Obviously what we hope to do over time is achieve a level curve of uptake on a continuous basis. Does that clarify the issues for Deputies?
Mr. Tony O’Brien
Let me respond to some of the other issues. The service will be free. The deadline for the consultation process was 28 February 2008. We had a very large response to that process, which we are glad of, because we wanted to improve the quality of the contract and take account of many issues that would be of concern to prospective smear takers, GPs and others. That information is being assimilated at present. We are working through all the issues and are coming up with answers to the concerns and so on. We intend to have a revised form of contract within a matter of weeks, which will be available for offer. On the question of fees, an established fee is currently in place which was negotiated a number of years ago and has been subject to an operating process and on that basis we intend to take this forward. There is an existing basis for that.
Let me respond to the questions on the laboratories. Our primary concern is quality assurance and capacity and not geography. We are carrying out this procurement in accordance with European procurement guidelines. It is a competitive process with a strong emphasis on quality standards. We have had the first round of examinations of those tenders and we are moving to the second stage of examination but I expect the whole process will be completed by about mid April. That means by the end of April, one of the key pieces of the jigsaw will be in place, opening the way for us to set a date.
When all the ingredients are ready, one can say one has a programme to roll out and that is the point at which one sets the date. The date is then set at a short but reasonable interval afterwards to enable all of the people who will be involved to get themselves ready to participate in the programme. We have funding that enables us to launch this programme this summer and that is our clear intention. The exact date has not yet been set because of certain critical factors that need to be in place.
With regard to areas of difficulty in terms of uptake, this is a common feature of all screening programmes and other programmes such as vaccination interventions and so on. There is clearly the need for a multiplicity of approaches and in the case of the cervical screening programme, as has been undertaken in the mid-western areas, there is the potential within certain constraints to take the screening to the community in certain areas and to take the information in many different ways.
In our approach to the contracting of smear takers we have provided for the potential for enhanced payments for those who participate in such programmes and we hold open the option of having parallel tracks of activity to go out to communities to do that. There are basically no holds barred and we will be looking very closely at the lessons learned here and elsewhere. The UK programme has achieved in excess of 80% and is achieving close to 80% at present, so this can be done. We are very confident that with a multiplicity of measures it can be achieved.
Were any Irish laboratories in a position to tender? Mr. O'Brien may not be able to answer that question, but I am interested because there were questions on the capacity and quality of the Irish laboratories.
Mr. Tony O’Brien
I can confirm there were submissions from laboratories in both parts of the island as well as from outside the island.
I assume the database is up to date and reliable. If it is, it will be the first database I have ever seen to work correctly. They could not get the correct information on medical card holders. How sure is Mr. O'Brien that the database is correct?
Mr. Tony O’Brien
It is not 100% of the eligible population. The programme will source data from a number of existing sources such as the Department of Social and Family Affairs, the general medical scheme, and private insurers, and in the mid-west they have used local hospitals as sources of data.
BreastCheck, using it as an example, is within 98% of census data for any given area. Our challenge is that in some areas we have 2% more than the census and in other areas up to 2% less. The basic problem is that we do not have a national population register for any given purpose and we therefore assemble our register from a number of sources. It is for this reason that we supplement the data gathering exercise with significant publicity around the issue of self-registration. In the case of this process we will seek to use the primary care settings, be they general practitioners or family planning clinics, as an important channel for self-registration. Our screening registers for both cervical and breast cancer use a number of identifiers to ensure the data is associated with the right individual. Therefore, the database function at that level is correct. The challenge is getting the total population data.
Given that Mr. O'Brien has the database in such good condition, could the committee recommend that he be put in charge of the voting register for the next election?
I am not sure we have those powers of recommendation.
There might be only women voting then and that would be the problem.
This supplementary question is prompted by Mr. O'Brien's reply on the 30 additional posts. His response was that many of those posts have now been filled. Can he give the factual position? When does he expect all 30 posts to be filled? How many are currently filled? It would give us a more in-depth sense of the position.
Mr. Tony O’Brien
I would be happy to provide the full information on that but I do not carry that information in my head. In my own mind, the 30 had been merged with the total figure. There is obviously interplay, posts becoming vacant, etc., but there is no external barrier to the filling of those posts. A post is unfilled either because we have not moved to fill it yet or we have not been satisfied with the pool of applicants, but there is no external pressure.
The Deputy asked me a question about colposcopy to which I did not revert. The work being undertaken is revisiting a piece of work done by the cervical screening programme in 2003. The report is not yet complete. Frankly, we have found some issues where there are significant opportunities for improvement and given that those services are currently within the governance of the National Hospitals Office, we have shared the reports with that office.
The programme will be rolled out on an annual basis. Will it be rolled out on an equal regional basis across the country so that the greater Dublin area will not get priority and my area of the south east will be given equal status with the rest of the country?
Mr. Tony O’Brien
The programme will be rolled out equally nationally all on the same day.
I asked about research on the vaccination. Would anyone like to answer that or is it a matter for another day?
Mr. Tony O’Brien
Dr. Flannelly can give some information on that.
Dr. Gráinne Flannelly
As Senator Fitzgerald stated, it is quite interesting that public health policies in many countries have moved to recommending vaccination. It is such a new phenomenon that one has a vaccination that can prevent infection by viruses which cause 70% of cervical cancers.
I suppose the entire implementation has been fast-forwarded, as the vaccine representatives would agree. As a result, we do not have long-term data. We are not able to say that the kids who were vaccinated 20 years ago are more or less likely to have cervical cancer than the kids who were not vaccinated.
It would not be regarded as a panacea and that is why it is important not to throw the baby out with the bath water and stop screening those women, or to dilute the message that if one has had one's moment with the HPV virus — most of us will have had that moment within a six-month period of being sexually active — one's die is cast at that particular point in time. There is little evidence to show that it is of any potential benefit to those women and, in fact, the evidence suggests that on the chances of getting cervical cancer, there may be a comparative advantage of as low as 12% for those women. We would not say that all of those women should be vaccinated.
In answer to the question, the research is quite new. While we are always hearing about updates that are available, the amount of published research is quite small. However, it is so compelling that it has persuaded committees such as this and departments of health around the world to proceed.
Obviously, it is not free. Although the companies have altruistic moments, the provision of a vaccine to disadvantaged countries, such as Ireland, is not one of them. They will want to get as much money as possible. The more vaccines one buys, the more one can do a deal. The more companies in the market making vaccines, the better the deal one can get. At present, there are only two companies and two vaccines. As time progresses, I suspect there will be more companies, more vaccines, more sub-types, etc.
In terms of how acceptable Irish parents will find this vaccine, I agree that Irish women, and I suppose men, have a different cultural attitude to cervical screening and vaccination than, for example, Scandinavian women. If one speaks of Scandinavian or Dutch figures, they would have quite a different attitude to Irish women. It is a matter of a cultural shift so that Irish women perceive this as something that is important for them.
In the UK, which would be much closer to our scenario, there has been some interesting information from focus groups where they got parents together and told them about the vaccine. The parents initially said that it was fantastic that there was a vaccine that could prevent cervical cancer. Then they told them it was to prevent a sexually transmitted virus and the parents' view changed as they questioned whether it would give the wrong message. After an education programme, the vast majority of parents stated that on balance they might be prepared to give their daughter the vaccination. As a mother of a 12 year old, it is clear in my mind that she is constantly asking me when she is getting that vaccination. It is all about perception. The other matter the researchers spoke of is that this provides an opportunity to hold that open discussion. Not all parents will go for it, just as not all women will go for cervical screening. There will always be a hard core.
In terms of side effects, the FDA website publishes an up-to-date account of all the adverse incidents and severe incidents relating to vaccination. It is able to give the up-to-the-minute numbers of vaccinations given and it changes from day to day and from week to week. In terms of severe adverse incidents, they look at direct side effects and also severe adverse incidents that happened to the kids who have been vaccinated. Kids who have been vaccinated have had terrible things happen to them. In a country as big as America one finds that some of them have been involved in road traffic accidents and other incidents not directly the result of vaccinations. The FDA website does not seem to show a significant amount of adverse incidents. Like anything, it gives the local results that one gets from any injection and a viral influenza-like illness. I do not know if that sums it up. That is an amateur's version. The industry spokesperson may have more information.
Ms Claire Barry
With regard to the length of the follow up, this week we received the initial reports of 6.4 years of follow up for vaccinated women. We are committed to following them up to 9.5 years. We will have efficacy data up to 9.5 years. That is the position with any new vaccine, as the profile of how long the protection lasts is built up. For example, the same scenario applied to hepatitis B. We had to wait and see, but the data so far are very encouraging. We are looking at a long lasting, highly sustained efficacy of the vaccine. It is still 100% effective with a good safety profile.
I am commenting on our vaccine and I cannot comment on the other available vaccines. Ours is well tolerated. More than 40,000 women were involved in our clinical trials, which showed a safety profile comparable with the control group, that is, the women who did not receive the vaccine. All that information is in the public domain in the clinical trials registry.
The vaccine is cost effective when one considers the cost of treating the pre-cancerous lesions it prevents and the reduction in call back necessary in the screening programme. Vaccination and screening must work together because vaccination cannot prevent all cervical cancer cases. They must, therefore, work hand in hand. Vaccination could benefit the screening programme by reducing the burden on it. Vaccines are still subject to 21% VAT. If they are not part of a universal mass vaccination programme, consumers face a mark up in the pharmacies and the doctor's fee. They are significant costs faced by the individual. If we get to tender stage, there is room for negotiation and prices may well reduce.
Dr. Gráinne Flannelly
With regard to the research, there is a difference in perception with the efficacy being to prevent the virus infection but, from a screening service point of view, our end point is preventing cervical cancer. With the current level of follow up, it is practically impossible to know what the reduction in high grade cervical intraepithelial neoplasia, CIN, would be if all my daughter's generation were vaccinated tomorrow. There are many hypotheses and models, which might all slightly change, but time will tell and the question is how to do that.
Ms Claire Barry
The efficacy data come from an age range of 15 to 25. I appreciate the point about looking at the hard and fast efficacy of vaccinating 12 year olds, but if the 15 year old component of those large trials involving 20,000 women is examined, we are showing efficacy.
I thank everybody for the presentation. The Minister for Health and Children and the chief executive of the HSE appear before the committee on a quarterly basis and we will speak to the Minister in advance of her next appearance about definite dates and financial commitments for this programme.
The joint committee adjourned at 5.05 p.m. sine die.