REPORT on CHILDHOOD IMMUNISATION

Chairman: In July of this year, the Committee agreed to consider the issue of child vaccination, including an examination of the current vaccination policy and practices, poor take-up rates and public concerns about the risks or adverse affects involved. We invited written submissions from the general public, the medical profession, health boards and others. To date, we have received in excess of 80 submissions. The Committee also agreed that it would invite selected correspondents to address it in person. At today's meeting we will hear the views of the Department of Health and Children, the public health directors and the Irish Pharmaceutical Healthcare Association - which is the representative body for the pharmaceutical industry in Ireland. I will call on each of the groups to make an opening presentation of approximately ten but not more than 15 minutes. This will then be followed by a question and answer session.

I will now introduce the people who will be addressing the Committee today. From the Department of Health and Children we have Dr. Jim Kiely, chief medical officer, Dr. John Devlin, assistant chief medical officer, Ms Dora Hennessy and Fergal Goodman from the Department's community health area and Dr. Michael Mulcahy. Representing the public health directors from the health boards are Dr. Kevin Kelleher, director of public health in the Mid-Western Health Board, Dr. Patrick Doorley, director of public health in the Midland Health Board, and Ms Maureen Windle, representing the health board CEOs. From the Irish Pharmaceutical Healthcare Association we are joined by Ann Nolan, Brian Murphy and Dr. Mike Watson.

I wish to remind our guests that we, as Members of the Committee, have privilege but, unfortunately, that does not extend to them. I call on Dr. Kevin Kelleher, public health director at the Mid-Western Health Board to commence proceedings.

Dr Kelleher: Thanks very much, Chairman and Members. I wish to make two points before I start. This is actually a submission from both the directors of public health and from the chief executive officers of the health board. That is why the three of us are here. We are also presenting it as an aid to your discussions and we want to be party to those discussions.

First, it would be useful for you to understand Dr. Doorley's and my backgrounds. Both of us have been in public health for 15 or 20 years. We have both had long involvement in immunisation, Dr. Doorley here in Ireland and I have a history, prior to my arrival here, of ten years or more involvement in the area in the UK. I was also a paediatric registrar in the children's hospital in Birmingham prior to that. So both of us have had quite a long involvement in this process.

To begin with, you have my presentation. I will just take a number of the slides, I will not refer to all of them. However, you have all the slides and our more substantive document as well. It is important to say that immunisation is very safe and very effective. Immunisation is one of the greatest public health triumphs of the 20th century. It is a very major and important part of our health services and our impact on health in the world, particularly here in Ireland. Second, it is very cost-effective; it is a cheap intervention that saves children, particularly, from having to enter hospital. It is very important to realise that immunisation saves children from entering hospital and also that it saves their lives. Children used to die from the diseases that immunisation is there to prevent; they do not die now. That is very important.

There are very few contra-indications to immunisation. Very few children do not need to have immunisation medically. Actually, the literature is beginning to show that there are virtually none. However, there are some still but very few. The benefits of immunisation greatly outweigh the risks. There are risks, we are not denying that, but the benefits are vastly greater. There is no denying that in the medical literature which we provided for in our full report. A problem we face as well is that when we have low uptake rates, we are opening ourselves to outbreaks of the diseases we are trying to prevent. I will refer to those later.

What have been the successes of vaccines? We have eradicated a disease in this world which used to ravage its population, namely, smallpox. A disease which used to be feared in the earlier part of our history has been eradicated totally because of vaccination. We are close to doing so with another disease: polio. Polio has been eradicated in the western hemisphere and is close to being eradicated and it is anticipated that it will be eradicated by the middle of this decade in the rest of the world. These are major successes. I am sure people here know people who had polio and are aware of the damaging effects it has on people's lives. That has now stopped. We are controlling diseases.

One of the most recent examples of that is the disease haemophilus influenzae. We introduced a vaccine for that in the earlier part of the last decade and that disease has now virtually disappeared. When I was a paediatric registrar in hospitals, we lived in fear of that disease and also of a disease called epiglottitis which caused children to have severe breathing difficulties. if you talk to people who are in training now and they have never seen the disease. I used to be in trepidation on the weekends I was on call that we might get cases of the disease in because they were very difficult to cope with. We were always on tenterhooks, but you do not see the disease now simply because of the vaccine we have developed.

Similarly with measles, we can control the disease and if we get our immunisation rates right the disease virtually does not occur and we can actually identify explicitly why it happened. Diphtheria has disappeared, it is now folklore in this country. Unfortunately, there was an outbreak of diphtheria in Russia in the past decade because the immunisation rates there fell and the disease returned. We can prevent and control these diseases. The position is similar with whooping cough.

There has been a tenfold decrease in Ireland of haemophilus influenzae - Hib. We expect a further decline as more children are immunised against it. These are important issues for our children who should not have to go into hospital as a consequence of not being immunised.

If I could just talk now about the measles outbreak this year in Dublin. Because of our low uptake of immunisation against measles - less than 80 per cent, in parts of the country much less - we had an outbreak of measles in north Dublin this year. If you look at slide 13 which is on page 5 or 6, you can see the incidence of measles over the past 20 years or so. Measles occurs in epidemics and this year we have had such an epidemic in north Dublin. In 1999 there were 150 cases in the whole of Ireland. In the first six months of this year there were 1,100 cases, the majority of which occurred in Dublin.

Some 10 per cent of those children were admitted to hospital and six went into intensive care. We know two children had measles-related deaths as a result. That is solely because we did not have the correct level of uptake of measles vaccine in the country. Our uptake levels in Ireland are not as we would have wished them to be. We recognise that and that is an issue we are doing something about. The levels are not there and I will come back again to some of the reasons that is so.

On cost-effectiveness, there have been well in excess of 160 studies looking at the cost-effectiveness of vaccination. They consistently show that immunisation is cost-effective and, more remarkably, helps save admissions to hospital and actually saves money to the health care system as well, which is very important for us all.

I want to talk about the issue of the communication to parents of immunisation and its risks. We recognise that this is a very important part of the procedures that need to take place. Our system is set up so that there is quite a number of occasions on which that communication can occur with parents. There is literature available but, more importantly, we have organised within our system for our health care professionals to have specific time to have those discussions with the parents. It is a fundamental part of the public health nurse's job on her first visit to a mother and baby after birth to speak to them and explain to them the issues surrounding immunisation. They are then asked to go on to see their general practitioner to have further discussions about it. On each occasion they visit the general practitioner, they have an opportunity to discuss the issues surrounding immunisation on each time that comes. So, our system is actually designed to make sure that information is passed on and there is an opportunity for parents to discuss and be informed about immunisation. We provide that information.

Our difficulty is there is a lot of information within the system that is both misleading and inaccurate about immunisation and we have to counteract that. That has caused us difficulties as can be seen from our immunisation rates. We fully support and we strongly advocate that parents must make an informed choice about immunisation. That is the parents' responsibility and our job is to help them to make that decision and to deliver the service, if they so wish, as a consequence of that.

What can be done to improve the uptake within Ireland at the moment? We recognise that one of the major difficulties to be faced at the moment is the information system we have about immunisation. The system does not readily support accurate information being obtained. All the health boards over the last two years have been working very feverishly and actively about getting something done in this area. The directors of public health with the CEOs have done a number of studies looking at how best to do this and we have shown quite clearly that, if we can get the systems correct, we can improve immunisation rates by five to ten percentage points.

We need to improve the systems within the health boards and we need to help general practitioners to improve the systems within their practices. We need to get the information to flow rapidly. We need the information back into the system within days of the child being immunised. Sometimes now it is months if not years before some of that information comes back. We need to improve those systems. That is because much of this system is a paper-based system and we would wish to move over to a fully electronic system. So, there are issues there we need to do.

We are also actively targeting those areas where there are low uptakes. We do this in a variety of ways. We look at geographical areas or groups that may have low uptake. We also look at it by general practitioner or by public health nurse caseloads to see what we can do to help those individuals. Increasingly we want to focus on babies who are three to seven months old who have not yet started the programme. It is important because the evidence is quite clear that, if children are not immunised by the time they are a year, they are highly unlikely ever to be immunised. So, the issue is to come to them at the point of three to six months to make an effort to make sure they are making an informed choice about whether or not to be immunised at that point in time.

We need to ensure that the myths and the inaccuracies about immunisation are removed from the system. That is about both professional and public education. We want to make sure that there is specialist advice readily available in those few difficult cases that might exist.

We have to accept that this is a parental responsibility about whether or not their child should be immunised. We will be willing to do anything that may help them make that decision, but ultimately it is a parental responsibility and it is, therefore, something the parents must decide, not us the professionals. Our job is to support that decision.

This is one of the most important public health interventions that we have at the moment here in Ireland. This is about our children. This is about us preventing our children going into hospital. I have had my children in hospital for other reasons. It is a dreadful problem to have your child in hospital. They are incredibly distressed. We know we have an intervention here that stops children going into hospital. These diseases are not mild diseases. Measles is a very unpleasant disease. Some 10 per cent of children who get measles go into hospital. A child in hospital is not nice, for the child or for the family. It causes great problems. We know we can stop that and I think we have every responsibility to make sure we stop that.

On the issue of safety which others of my colleagues will talk about in more depth, the evidence in the scientific literature is clear. The benefits from immunisation are vast. The evidence about problems are minimal, and virtually every time we have been told there is a problem with a vaccine, it has turned out not to be true when challenged by the scientists who are there and who can do that for us. Repeatedly they have shown that, when people say there is a problem with this vaccine or that one, they are proved not to be so. We accept and we are responsible for making sure that parents are able to make an informed decision and it is our responsibility to make sure that happens. We do not wish to impose this on parents, but we wish to help parents make a responsible decision.

Epidemics of vaccine preventable diseases will continue to occur. We will continue to have measles outbreaks like we have had in Dublin and children dying as a consequence of those outbreaks if we do not do something about improving our uptake rates.

Chairman: We now have Dr. Jim Kiely from the Department of Health and Children.

Dr. Kiely: On behalf of the Department of Health and Children, I thank the Chairman and the Members of the Committee for giving us the opportunity to meet them to discuss the health and welfare of our children and the important role immunisation policy has played and we know will continue to play in future in improving child health. Some of the things I will say will be related to what Dr. Kelleher has already mentioned, but I think the things that he has raised are of such vital importance that they are important enough to bear repetition. So, if I do mention them again, I ask the committee to bear that in mind.

We agree with Dr. Kelleher that immunisation is one of the most important and cost-effective public health measures that exists and it is a vital element of the health services that we provide to children from infancy. The Department's policy is to promote immunisation based on Irish and international scientific advice where the benefits of the intervention far outweigh the possible risks. We have sound evidence both from our own data and internationally that the incidence of vaccine preventable diseases has been greatly reduced with lower illness and lower death rates among children and that this development is directly related to the introduction and the implementation of effective vaccination policies. These diseases, and Dr. Kelleher has mentioned some of them, are now at a level where people can easily forget how serious they can be and, perhaps inevitably, the focus of concern for some and many has shifted from the diseases to the vaccines and the safety of the vaccines in particular.

It might be helpful if I outline briefly the historical situation in relation to communicable diseases in Ireland as the situation has changed substantially in recent decades. As Dr. Kelleher again mentioned, 50 years ago communicable diseases accounted for the deaths of almost one in four Irish people. These diseases included not only tuberculosis but typhoid fever, scarlet fever, whooping cough, diphtheria, 'flu, polio and measles. In children aged between one and five, the vast majority of deaths were caused by infectious diseases, including pneumonia, tuberculosis and the other diseases I have just mentioned.

These diseases included not only tuberculosis but typhoid fever, scarlet fever, whooping cough, diphtheria, flu, polio and measles. In children aged between one and five years, the vast majority of deaths were caused by infectious diseases, including phenomena, TB and the other diseases I mentioned. In the intervening period, improved economic and social conditions, together with public health action, have virtually eliminated many of these diseases. The submission which the Department already made to the committee and which is available includes graphs which illustrate the reduction which has been achieved over the past number of decades. Much of this reduction in infectious diseases is attributable to medical advances, including the development of vaccines and new drugs.

In common with the rest of the developed world, Ireland has a programme of child immunisation. The Irish targets to reduce communicable diseases are in accordance with the recommendations of the WHO. The intention of child immunisation has always been to protect vulnerable individuals as early in life as possible from the risk of death, disease and long term complications attributable to specific infections. If a sufficiently high uptake of immunisation can be achieved and maintained, the community generally will be protected and ultimately we hope to see these diseases eventually eliminated. This has been achieved with smallpox and it is expected that within the next year or two, polio will also be declared to have been eliminated worldwide. After this, the objective is to achieve the elimination of measles, which in many countries has already almost disappeared owing to high immunisation rates. Another striking example of the benefits of immunisation is the ten-fold reduction in the incidence of haemophilus disease, which was mentioned by Dr. Kelleher, following the introduction of the routine vaccination against it in 1992.

The policy we adopt in the Department is guided by advice from a range of independent expert sources both in Ireland and internationally. In Ireland, these include the immunisation advisory committee of the College of Physicians of Ireland, the National Disease Surveillance Centre and the Irish Medicines Board, and at international level we are guided by the WHO.

Account has to be taken of issues such as the pattern of infectious diseases in Ireland and elsewhere, the development of new vaccines from time to time and ensuring the vaccines used in the immunisation programme are both safe and effective. By way of illustrating the developments which are occurring regularly in the field of immunisation, in a major EU initiative a new programme to protect children and young people against group C meningococcal disease was launched in October of this year. The public response to this programme has been good so far and the indications at this early stage are that uptake is good. None of us need to be reminded of how frightening and devastating meningitis can be and the introduction of this new vaccine will, we hope, lead to a major reduction in the incidence of the particular strain of the disease, group C, which accounts for about one third of meningitis cases in Ireland. It is worth noting that in Britain, where the vaccine was introduced in autumn 1999, just over one year ago, a reduction of approximately 75 per cent in cases of group C meningococcal disease has already been achieved. It is hoped that in the coming years vaccines to protect against group B meningitis, which accounts for about two thirds of meningitis cases in Ireland, will also become available.

The immunisation programme is kept under constant review and includes the incorporation of new and improved vaccines as they become available. For example, in 1996 when the acellular DTP vaccine was developed with an improved safety profile, the previous product was replaced and the new product immediately implemented. Under the primary immunisation programme, parents are offered free immunisation for their children against a range of potentially serious childhood diseases. This service is provided mainly through the family doctor. Visits for immunisation are scheduled for two, four, six and 15 months and the diseases against which the immunisation is offered as those we have already talked about and which Dr. Kelleher has so graphically described.

The delivery arrangements in place follow from a review carried out in 1994 by a review group established by the Minister of Health at the time. This recommended that the general practitioner was ideally placed to deliver primary immunisation and therefore should be the principal health professional involved in delivering this service. This recommendation was made in the context and on the basis that the GP will be able to consult with parents, explain the benefits and possible risks and allow them to make an informed decision on this most important aspect of their child's health. I wish to again underline what Dr. Kelleher said about our wish to facilitate parents to make informed choices, that they are given the information in a free and full way by the GP, know the up and down sides of vaccines and make an informed decision. That is the basis on which we implement the programme.

It is acknowledged that reported immunisation uptake in Ireland is below the target of 95 per cent and indeed it does not compare well with the rest of the EU. For DPT, polio, Hib immunisation, uptake is approximately 85 per cent. However, for MMR it is lower, averaging about 76 per cent nationally. As Dr. Kelleher mentioned, the Department, the health boards and other parties to the programme are working to achieve the 95 per cent uptake by addressing a number of issues which are believed to have contributed to the low uptake. We have, unfortunately, recently seen where immunisation is below the target level, the community is vulnerable to outbreaks of disease. There have been over 1,500 cases of measles this year, with many children - approximately 10 per cent - having been hospitalised, with two deaths associated with the disease. While the indications are that this outbreak has been brought under control, it underlines the need for a high uptake of MMR vaccine to be achieved and maintained if future outbreaks are to be avoided.

I would like to turn to the issue of vaccine safety, which has been discussed this morning and at previous meetings of the Committee. In order for confidence in the immunisation programme to be maintained, parents and health professionals involved in delivering the immunisation programme must be reassured that vaccines are safe. They must have accurate information about the benefits and possible side affects. The international consensus which we draw upon in this regard is that the vaccines we have in our programme are safe and effective. Nonetheless, we are aware that from time to time concerns have been expressed about the safety of some vaccines, most notably and most recently MMR. We deal in some detail with that issue in our submission. This issue is of paramount importance to us and the concerns which have been raised have been carefully evaluated by the Department and appropriate independent experts in the international peer review scientific committee in order to ensure the vaccines are safe and effective. I take this opportunity to emphasise that all the expert advice available to us in the Department is that the vaccines in use are safe and are highly effective both in individuals and in the community in general. The Department will continue to monitor any further research in this area.

It is also important to note that vaccines are subject to rigorous testing before being licensed and are also subject to ongoing monitoring when in use. The Irish Medicines Board, the licensing authority, is an independent body the objective of which is to ensure in so far as possible, consistent with current medical and scientific knowledge, the quality, safety and efficacy of all medicines available in Ireland, including vaccines. Following the licensing of a medicinal product such as a vaccine, the IMB monitors the type and frequency of reported side effects. While over the years many hypotheses have been advanced which have sought to link various vaccines with the development of various conditions in children, I must stress that such links have not yet been proven. It is important to bear in mind that children receive a series of vaccinations in the first 18 months or so of their lives, the same period during which certain disabilities may become apparent. The emergence of a disability, therefore, may be a coincidental event and cannot be assumed to be vaccine related simply on the basis of a temporary relationship. It is acknowledged that in common with other therapeutic substances, adverse reactions to vaccines can occasionally occur and there are mechanisms in place to record and investigate such events. Nevertheless, it is considered in this country as in others that the benefits to children far outweigh the potential risks and they help protect children from serious consequences of previously prevalent diseases. In other words, the chances of a child suffering a serious reaction to a vaccine are much smaller than the chances of contracting the disease with all the appalling sequelae which can occur. The identification and use of contrary indications to the vaccines also helps further reduce any potential risk through the vaccine.

In conclusion, I again stress that immunisation has been proven to be a very safe and effective measure in combating infectious diseases in children and in the community generally. The reduction in the incidence of infectious disease, the elimination of some conditions and the consequent improvement in children's health which have been achieved to date are very largely due to the development and use of effective vaccines. The primary immunisation programme, for which we have a policy responsibility, will continue to be an essential element of our health services for our children and will be adapted as necessary to respond to developments in the field of vaccination in future in terms of new vaccine development, the availability of such vaccines and, in particular, the safety profile of all vaccines in use.

Ms Nolan: The Irish Pharmaceutical Healthcare Association represents the pharmaceutical industry in Ireland and our members include those companies which supply the various childhood vaccines given to Irish children. We are very pleased to have the opportunity to be before the Committee to set out the facts about childhood vaccines.

My colleague, Brian Murphy, will then outline some of the suggestions we make in our submission as to how uptake levels could be raised to the levels necessary to ensure that Irish children benefit as fully as possible from vaccines. I have attached a CV for each member of the delegation to the back of the submission in order that committee members will be aware of our individual competencies. The presentation is very much a précis of what is included in our paper, the bulk of whose text is substantiated and referenced throughout.

Unfortunately, some of the content of the presentation may involve some repetition of what our departmental colleagues said but I would like to go through the main points. Vaccination is one of the safest medical interventions and probably the most cost effective of all health care initiatives. More lives have been saved through vaccination against infectious diseases than through any other public health intervention, apart perhaps from the provision of clean water. Vaccination has eliminated many serious and potentially fatal diseases, particularly the introduction of the Hib-meningitis vaccine in 1993. The WHO is of the view that the benefits from vaccines for individuals and communities far outweigh the disadvantages and it is working to ensure that all people at risk are protected against vaccine-preventable diseases. In Ireland, vaccination is strongly recommended by the Department of Health and Children, a view endorsed by the Royal College of Physicians in Ireland, the Faculty of Paediatrics, the Irish College of General Practitioners and the National Disease Surveillance Centre.

The pharmaceutical industry researches, develops and manufactures medicines and vaccines. The industry is committed to developing and manufacturing safe and effective vaccines. Vaccines are notoriously difficult to produce, taking perhaps 20 months from start to finish. The manufacturing process is a lengthy and complex one which is subject to independent scrutiny by regulatory authorities throughout Europe. The Irish Medicines Board is the Irish licensing authority charged with that responsibility. All vaccines must undergo clinical trials before they are licensed for use. Several batches of the one vaccine are tested during a trial to ensure batch to batch consistency in terms of clinical safety and efficacy. It has been suggested in some quarters that clinical trials should be carried out on existing vaccines involving panels of vaccinated and non-vaccinated children. I would submit to any regulatory authority or vaccine manufacturer that such a proposition would not be acceptable from an ethical point of view on the basis that it would expose a panel of non-vaccinated children to the dangers inherent in catching a vaccine-preventable illness. Sadly, as has already been mentioned, we have seen all too clearly in Dublin this year the very real dangers posed to non-vaccinated children in the face of a measles outbreak.

Vaccines can only be approved for use and placed on the market following a rigorous benefit-risk assessment by independent scientific experts in national regulatory authorities. Even after a vaccine is licensed by the Irish Medicines Board, every batch undergoes internal batch release testing by the company and must also be submitted for testing to an independent, WHO-approved, external body prior to use. The safety of all vaccines is closely monitored after they are released on the market. In the EU, data on side effects or adverse reactions for all medicines, including vaccines, must be collected by the manufacturer and by regulatory authorities. Such data is gathered from reports of adverse reactions submitted by health care professionals and also from literature reports of adverse reactions. Doctors, nurses, dentists and pharmacists are encouraged to report adverse reactions through the use of the yellow card system here, even if they are not sure whether the vaccine caused the reaction. The information collected is scientifically evaluated and appropriate action is taken by the regulatory authority, where necessary. Systems have been established to ensure that reports of adverse drug reactions are exchanged between regulatory authorities worldwide. Therefore, the surveillance of vaccines in Ireland is not only based on experiences here and in other EU member states but also on additional data from outside the EU. The safety of vaccines is a key concern. As infectious diseases continue to decline, some people have become less aware of the consequences of illnesses such as diphtheria and tetanus and more concerned about the risks associated with vaccines. As vaccination is a common and memorable event, any illness following immunisation may be attributed to the vaccine even though scientific evidence to support a link between the two may be weak or non-existent. Although vaccines are, in general, extremely safe, no vaccine is completely without adverse effects. Minor reactions to vaccinations are common and expected but serious and major reactions are extremely rare.

To put the safety of vaccines in context, the risk of complications from vaccine preventable diseases far outweighs the risk of adverse events following the use of vaccines. Prior to the introduction of the national immunisation programmes, more than 2,000 Irish children per annum died of diseases which are now vaccine preventable. That figure equates to a mortality rate of 3 per cent. The incidence of severe adverse events following vaccination is closer to one in a million than three in a hundred. From a public health point of view, the benefit:risk ratio supports vaccination. That is a fact. That is not, of course, to deny that proper provision must be made for the small number of adverse events which may occur.

As measles have been the subject of much recent media interest, it is worth taking a closer look at the risks facing a child with measles compared with the risk of side effects associated with the MMR vaccine. The table provided shows some of the symptoms of the measles disease and the side effects of the MMR vaccine. For example, children with measles all get rashes and fevers whereas there is a 5 per cent chance of their getting a rash following a vaccine or a 5 to 15 per cent chance of fever. Some 18 out of every 100 children with measles will be hospitalised and two in 1,000 will die from the disease. Only one out of every 1,000 children will be hospitalised as a result of the MMR vaccine. I will not go down through the entire table. Our submission sets out equally stark comparisons for other infectious diseases such as whooping cough, mumps and rubella.

Health professionals have a responsibility to address parents' fears regarding the safety of vaccines by listening to them and providing them with accurate, understandable information about vaccination in order that they can make an informed decision to vaccinate their children. Vaccine manufacturers provide detailed information about their products in a patient information leaflet which accompanies the vaccine. Included in this information are lists of the contraindications and side-effects of all vaccines. I have provided examples of patient information leaflets in order that committee members can see for themselves the level of detail contained therein. The content of leaflets must be consistent with a summary of product characteristics which is approved by the Irish Medicines Board as part of the authorisation process for the vaccine. The industry wholeheartedly supports the provision of detailed information to parents prior to the vaccination of their children. However, health professionals can only inform patients once the parents present their children at surgeries. The current problem of low uptake results from parents deciding not to consult their doctors at all about vaccination. Such decisions are made on the basis of incomplete information which is often obtained from sources which are not medically qualified.

The industry is concerned by some of the reports which appear in the daily newspapers about vaccinations and I have outlined two examples of that in the submission. An article published in the Evening Herald last week was refuted out of hand by the Irish Medicines Board and the National Disease Surveillance Centre. A successful public health policy demands imaginative approaches to get parents to enter into dialogue in the first instance with health professionals. The balance of risk and benefit is very favourable for all of the common childhood vaccines used in Ireland and it is the IPHA's view that, having heard all of the facts, parents will conclude that vaccination provides clear benefits for their children.

I would like to address the alleged link between MMR and diseases such as Crohn’s disease and autism, a link which has also received a great deal of coverage in the media. The weight of evidence goes strongly against such a link. The Wakefield study, carried out on a group of 12 patients, suggests a possible link between MMR, bowel disease and autism. Many other studies carried out in this area have not received the same level of publicity as the Wakefield one. Professor Brent Taylor, professor of paediatrics at the same hospital as Wakefield studied 498 cases of autism disorders diagnosed since 1979 and did not find any association with MMR. Neither did he identify any increase following the introduction of MMR in 1988. Similarly, a Swedish study in this area did not identify any association between MMR and autism and found no change in the prevalence of autism in children born in Sweden following the introduction of MMR. Two other studies published in The Lancet in 1997 and a study in the British Medical Journal in 1998 did not demonstrate any link with the measles vaccine. Neither did the UK Committee on the Safety of Medicines which examined the records of 92 children with autism and 15 with Crohn's disease find any such link.

The National Disease Surveillance Centre expressed the view in a statement in April as follows: "It would be a disaster if children were to die of vaccine-preventable disease over this unsubstantiated vaccine scare. We join in one voice with the Department of Health, the Irish Medicines Board and the Royal College of Physicians to refute the allegations made about the link between the MMR vaccine and the development of autism."

For parents who find themselves in the tragic position of having a child with autism, there are many real issues to be tackled such as the nature of the disorder, the support services available for their children and so on. Every effort must be made to address these issues in a meaningful way in the appropriate forum. However, we believe it is important that they do not become embroiled in the discussions on the safety of vaccines.

It is necessary to have approximately 95 per cent of children immunised if a society is to be able to protect them against the spread of disease. It is a matter of considerable concern that vaccination rates in some parts of Ireland fall significantly below this level. The recent measles outbreak has shown the dangers inherent in allowing uptake rates to fall. In the first six months of 2000, 1,221 cases of measles were notified as against just 73 in the same period in 1999. Several children became seriously ill, requiring hospitalisation and, tragically, two died. Vaccination awareness campaigns have been run earlier this year by the IPHA in co-operation with the Health Promotion Unit in the Department of Health and Children and by the Office for Health Gain. The IPHA is happy to be involved in education campaigns about vaccines and medicines generally. Indeed, it is part of our overall strategy for the association. Unfortunately, despite these campaigns, uptake levels remain worryingly low.

Mr. Murphy: I would like to go through some of our recommendations. Coming from a perspective where we view vaccines as a very safe and effective medical intevention, we have great concerns that the level of uptake is so low. In accordance with the terms of reference of this inquiry, we thought we would make some recommendations as to how these uptake figures could be increased and, therefore, a greater number of children protected from preventable diseases.

The first recommendation is in the whole area of the provision of training and information to health professionals, to help them to address parental concerns about vaccination. This year's IPHA information campaign and the recent meningitis vaccination campaign offer useful experience from which to draw in developing such training and information. It is not sufficient just to say that parents must be provided with information. GPs and others in the area must be facilitated and provided with that information and given the sort of detailed information parents would like to receive. Second, it is important that the time is taken by healthcare professionals to listen to and reassure parents, to ensure their queries are answered. Third, we would like to see a more co-ordinated and in-depth approach to health promotion initiatives in the area of vaccination. There are very many good health promotion initiatives in this area but, by their nature, they tend to be one initiative and something a number of months or a year later. There needs to be more of a rolling programme. The evidence suggests that, particularly in the area of vaccination, if you do not have pretty much a continuous programme, the effect is lost because people's attention span is quite limited. We would need to do this in a co-ordinated way throughout the course of each year.

It is also important to be realistic about the times in which we now live. Given the stresses people are under and the limited amount of time they have available, we recommend that parents should be facilitated in arranging to have their children vaccinated, perhaps by arranging to have evening or weekend clinics or paid time off work to take a child for vaccination. This type of model already exists for parents in relation to care before and after the birth of a child when employees can take time off work. This is equally important in relation to vaccination. This might seem very small but it is a very practical concern that has come up during some of our discussions over the last year or so.

If we want to listen to what parents are saying, we need to research their views in this area. We advocate the commissioning of regular qualitative and quantitative market research. The type of issues that could be addressed in that research are as follows: why parents do not get their children vaccinated; what are their levels of awareness and knowledge of the various promotional initiatives that take place; what are their principal sources of information, both generally and specifically on medical matters. If this type of data were available, then targeted vaccination initiatives could be prepared which would help to raise uptake levels and thus provide better protection for children against these vaccine-preventable diseases.

We also believe it would be beneficial to establish a central vaccines planning and control unit within the Department of Health and Children with overall responsibility for vaccines promotion, policy, procurement and delivery. We are not suggesting a huge staff but basically a small co-ordinating unit that would ensure measures were being implemented by all those involved. It would be good to have improved dialogue between the pharmaceutical industry and vaccine policymakers. It is clear that there is a willingness on both sides to develop this dialogue further and we look forward to that. We would also echo the comments of the directors of public health in relation to the information flows regarding vaccination, in particular we believe that a major overhaul of the computerised childhood immunisation databases is required. Work on this has already commenced and there are improvements taking place. This issue relates to the type of society in which we now live. People move around much more than they used to. If we do not have computerised databases, it will mean that we will lose children through the cracks. Children may also be registered in two or three places so the figures may not be as bad as they appear in relation to uptake levels.

There should be an investigation of the possible revision of GP payment schedules for immunisation. It needs to be recognised that to achieve a 95 per cent immunisation level is a very difficult task in some areas, requiring a large amount of administration. Perhaps this should be more reflected in the payment schedules in particular areas throughout the country.

There could be improvements to the tendering system for vaccines with a view to facilitating the better operation of the supply chain. We have addressed this aspect in more detail in our submission.

In conclusion, I echo some of the comments made already. The development of childhood vaccines is one of the great success stories of modern medicine. As a result the opportunity exists to rid our children of the threat of many debilitating, and in some cases, potentially life-threatening diseases. Resulting from the deliberations of this committee, IPHA hopes that improvements such as those outlined above can be implemented, that parents can be reassured and children protected.

Chairman: Some Deputies wish to attend the Order of Business, therefore, I will call Deputy Mitchell.

Deputy G. Mitchell: In relation to Dr. Kelleher's presentation, what is the Department's view on a smart card for child immunisation? A record could be kept on this smart card which would in time feed into a national database information on immunisation. In most cases, a child's immunisation record depends on either having the same doctor from childhood or the memory of a parent.

My understanding in relation to many of the drugs used - I do not know whether this applies to immunisation and the categories we have been discussing - much of the testing takes place on adults. In other words, the drugs are not specifically tested on children throughout the European Union. Is that the case in relation to these particular drugs or what is the testing procedure? Is the testing done on adults, with a smaller dosage for children, or is there specific research done on the effects on children before the immunisation programmes take place?

What children are not able to take immunisation? I understand that some children fall into this category. Can you give an explanation for the outbreak of measles in north Dublin? Maybe I missed it, but I do think this was addressed in the presentation. Did Japan and Sweden resume vaccinations subsequently?

I would like to ask the IPHA about immunisation in the Third World. The reason I ask this is that we should be concerned about this issue from a humanitarian point of view. It seems that drugs which are relatively cheap here are very expensive in developing countries and people are not immunised for that reason. What is the approach of the IPHA and its international associated bodies to this issue? The spread of HIV and AIDS in Africa will have knock-on consequences for Europe. What are the implications of the absence of immunisation in the developing world for the developed world, including Ireland?

In its presentation the IPHA stated: "It is a matter of particular concern that vaccination rates in some parts of Ireland fall significantly below the level of 95 per cent which is recommended". How far below are they and in which regions? Maybe this information was given but I did not pick it up. Why are these areas below the recommended figure? In relation to the IPHA recommendation on the establishment of a central vaccines planning and control unit, has the Department of Health and Children considered this recommendation and what is its view on it?

I read the article in the Evening Herald which was submitted and the piece which shows, according to the Irish Medicines Board, that it was not accurate. The article states that parents are voting with their feet and are not bothering to have their children immunised because of the concerns they have. I already asked about the regions, but is there any national quantification of this? Are parents voting with their feet? Do the Department, IPHA or health boards see a role for community pharmacists in this area? The people most qualified in the community and who know most about drugs do not seem to be relied upon in assisting people to come to an understanding of the issue. There should a set-aside area in community pharmacies where the pharmacist can be consulted by people on the effects of drugs. This cannot be done when the pharmacist is standing behind a cash register. The community pharmacist is a greatly under-utilised resource which could give parents the opportunity to ask questions and to be informed.

Chairman: If I was a parent with real and genuine fears about vaccination, my response to Deputy Mitchell would be "they would say that, wouldn't they". I did not hear in any of the presentations that there could never be repercussions from vaccinations. Do you see in any circumstances where, because of the physical make-up of a child, there could be a connection between vaccination and autism?

Deputy Keaveney: The presentations were excellent and are a first step. Reference was repeatedly made to the risks outweighing the disadvantages. I accept that this is the case, but the problem arises in the case of those people who have not had a good experience. Reference was also made to the down-sides of vaccinations. The first two presentations referred to the controversy surrounding MMR and autism. It may be assumed erroneously that immunisation caused the problem. The Department of Health and Children stated that the emergence of a disability may, therefore, be a coincidental event and cannot be assumed to be vaccine related. If I was a parent I would be worried about the risks. How could Dr. Wakefield find these 12 children when Mr. Taylor looked at 400 or 500 people? Would it have been possible to vaccine these 12 children at a later stage and, if so, would the outcome have been different? I want to raise another question.

Chairman: Is it related?

Deputy Keaveney: Yes. Are all our vaccinations and the timing of them on a par with the rest of the EU and the US?

Dr. Kelleher: Deputy Mitchell referred to the smart card. We have two initiatives in the health boards which relate to this process. My health board has been asked by the Department of Health and Children to pilot a parent health-child health record for all children. This has been successfully introduced elsewhere in the world. The child's immunisation is recorded on paper and parents cherish these books for their children. People from abroad living here are proud to have a book with their child's full record. We are looking at the introduction of smart cards elsewhere in the system in terms of the GMS, etc. and the two may eventually be able to be merged. People value these records and this is why we are taking this route. This will help significantly.

On the question of what children should not be immunised, the absolute contradictions are minimal. Even at that point they should be discussed with a consultant paediatrician. In most the cases where there are potential contra-indications, the children have pre-existing severe diseases, often neurological. In those circumstances the discussion on whether the child should be immunised should be held with the consultant paediatrician. Often the inevitable decision is that the child should be immunised because the child will suffer more from the disease than immunisation. Again, this is a matter for discussion between the paediatrician and the family of the child concerned.

Japan and Sweden resumed vaccination and they now have high rates of immunisation for measles, mumps and rubella. The north Dublin outbreak was almost certainly as a result of measles being brought into the country from the UK, mainland Europe or elsewhere. This is how cases are caused - people carry in the disease. It is also probably because we have such a large---

Deputy G. Mitchell: I am sorry to interrupt you, but would those children not have been immunised? Was there a problem with the rate of immunisation which did not prevent the outbreak?

Dr. Kelleher: I was referring to how the disease came into the country. It may have been within the community and may have been brought in from outside the jurisdiction. The problem in north Dublin as well as in the rest of the country is that a large pool of children - approximately 25 per cent - are not immunised against measles. This means there is an opportunity for measles to occur within the community. Babies who are not normally immunised are protected by the system in that if there is a high level of immunisation in one year olds, toddlers, that protects babies who are most at risk. The reason for the outbreak is that only 75 per cent of the population were covered and there was a large enough group - 25 per cent of the population - not covered. Hopefully that has answered the Deputy's point.

On the issue of "They would say that anyway", our objective is to present the evidence that we know of and which has been put to the test of rigorous scientific debate. Increasingly, health care interventions should be scientifically proven and rigorously debated by experts. That is the evidence we are presenting. The relationship between autism and the MMR is being debated and the debate is coming down very strongly against the relationship. I am sure the debate will continue, but the evidence is quite strong.

On the issue of "never", we are clearly saying that vaccination and immunisation have an impact; there are known risks associated with them, but, clearly, those risks are significantly outweighed by the benefits to both individuals and the population as a whole. We are not denying that there are risks, but they are very small. This is detailed in table 7 in our submission. We recognise and talk about them.

Dr. Doorley: The answer to Deputy Mitchell's question about the low uptake is yes; the areas which are hit are those in which the uptake is low. It is important to bring to your attention that, almost invariably, these are the poorer areas. There is a social class gradient in the uptake of vaccination.

Deputy G. Mitchell: Is north County Dublin a poorer area?

Ms Hennessy: The uptake is slightly higher than in other areas of Dublin. There are pockets in certain areas north and south west of the Liffey where the uptake is low.

Deputy G. Mitchell: When you speak of north County Dublin are you including every area of the city north of the Liffey?

Ms Hennessy: North of the Liffey.

Dr. Doorley: That is the pattern. One need only look at what happened in 1994. I can name the areas, if the Deputy wishes, but it is the poorer areas which have been hit the most.

Dr. Kiely: We need to come in on this aspect of the discussion. "They would say that, wouldn't they?" is something that is always said when we talk in terms of promoting vaccinations. I started my presentation by thanking the Committee for giving us the opportunity to discuss the health and welfare of our children. There is no situation in which we would preside over a policy decision and the implementation of a policy where we were aware that there was a risk to children. There would be absolutely no reason we would continue to promote the MMR in the face of any reputable scientific information that it was a dangerous and counterproductive intervention. As Dr. Kelleher said, the entire debate has revolved around a number of papers from a particular centre. The international peer review scientific mechanism that is being brought into play in evaluating the evidence produced in relation to this is predominantly, if not entirely, of the opinion that there is no evidence within these papers of a definite link between the MMR and autism. Dr. Devlin may develop that theme a little further.

Deputy Keaveney mentioned the degree to which parents are aware of and build into their psyche the issue of adverse reactions and the downside of vaccinations. The reason the 1994 review of the vaccination programme insisted on the general practitioner being the central professional in delivering this service was the nature of the personal relationship between general practitioners and their patients; the way in which general practitioners can sit down and discuss in a very mature and informed way with parents the upside and downside of vaccines to enable parents to make an informed decision.

Parents do not have to make this decision on the first day they come. They can go away and think about it and come back the following week. They can raise whatever concerns they have about the vaccine again. It is on that basis that the general practitioner is deemed to be the most appropriate person because he or she is aware of the family history, may have vaccinated previous children and simply knows what there is to know about the family. It is in that context that the information is given, assimilated by the parents and an informed decision made.

There was a suggestion in the article in The Herald last week that the health authorities do not want parents to know the full facts. It is because we want them to know the full facts that we have assigned this central role to general practitioners. We know that if they know the full facts and make an informed decision, they will make the right decision for their child at that time.

Dr. Devlin: I will talk about some of the safety aspects. There are, obviously, many vaccines available, some of which are candidates for selection for our national immunisation programme. At the end of the day, few are selected. The reason for this is that there are many hurdles or barriers that these vaccines must clear before they are selected for introduction to our programme.

First, do we need the vaccines at all? This is based on the epidemiology of the disease in question. A good example is the national meningitis C vaccination programme. Ireland has one of the highest rates of this disease in Europe. On that basis, it was considered appropriate to introduce a vaccine against the disease. Another issue is whether the vaccines are effective, but, most importantly, whether the vaccines are safe. Safety is a priority for all of us, particularly on this side of the table.

To answer Deputy Mitchell's question in relation to how we go through the safety process, first, the regulatory authorities are responsible for dealing with this matter. They link in with the responsible agency in the European Union and the World Health Organisation. There is, therefore, a global effort to ensure safety is a priority.

The initial trials are conducted on healthy volunteers. They involve a small number of people. The phase two trials involve using the vaccines in high risk individuals - people susceptible to the disease in question. These trials may involve hundreds of people. The third phase-----

Deputy G. Mitchell: Are they all adults?

Dr. Devlin: No, it can be a combination. For example, in the case of meningitis, that is the way the new vaccine was tested. Most importantly, phase three trials involve many thousands of people and using the vaccines in question in regions of countries. All the information is carefully evaluated and scrutinised not only by the national regulatory monitoring mechanisms, but also in Europe. Another important dimension is that there is a global post-licensing surveillance programme.

The issue of immunisation in Third World countries was raised. This is a very important issue, one which we have highlighted in our submission. In terms of the global burden of disease of developing countries, vaccine preventable illnesses constitute a huge burden. Ireland participates in the global effort to try to improve the situation. There is an Irish aid programme. Last Friday, World AIDS Day, the WHO acknowledged the support given by the Irish aid programme in contributing to the world AIDS programme, vaccines and so on.

It is very important that we discuss the autism issue, which, like many other countries, we are following very closely. This is often a highly technical area and it is very important that any research in this area is subject to peer review and careful scientific scrutiny. That has been our approach in this country, as it has in many others. The initial hypothesis was that children experience some kind of developmental regression shortly after receiving the MMR, but it is important to state that it was not concluded that the MMR causes autism. The original authors did not say that.

The papers have been subject to very careful scientific scrutiny, not just in this country, but also internationally, for example, by the Medical Research Council expert committee in the United Kingdom, British committee on the safety of medicines, the CDC in the United States, the agency responsible for dealing with this matter, and the WHO. Their initial reading was that they were concerned about the methodoly and said that the evidence did not support a causal link between the MMR and autism.

There have been, as we have heard, a number of other studies since.

Professor Taylor from the same hospital, in fact, as the original study was produced which said that there was no evidence of a link between MMR and the autistic spectrum disorder. There have been other studies from Sweden and Finland but I will not go through them.

Moving to the present date, this evidence was presented in the US before a congressional oversight committee and Dr. Wakefield published an article in September. Again, the whole process of peer review and scientific scrutiny has been applied to those papers. Very briefly, the conclusion from the CDC in America, the American Academy of Pediatrics, the Medical Research Council and another major US study of the vaccine, the Datalink project, which involved the CDC in America and is a large population based study into the possible link between MMR and autism, was that there is no association between MMR, inflammatory bowel disease and autism and they continue to recommend the use of MMR.

Obviously, as I said previously, vaccine safety is a priority. We continue to keep all this evidence under careful scientific scrutiny and review.

Deputy Cooper-Flynn: Last week, when the parents groups came before the Committee, each of them mentioned the Japanese experience and the fact that Japan withdrew the MMR vaccine in 1993. Not one group here this morning has mentioned that. Why is that? It is most unusual.

Dr. Devlin: Thank you for asking that. I am aware of the experience in Japan. Obviously, I cannot comment for the Japanese authorities but the MMR that was withdrawn in Japan was a vaccine manufactured in that country. It is different from the MMR that is available in the rest of Europe. It did appear to have a particular safety profile that was different from the MMRs that are used in other countries and they did withdraw the vaccine. The uptake of vaccines against these diseases obviously suffered and they have experienced outbreakes of the diseases. I am aware that the Japanese authorities at the moment are looking to introduce a different type of MMR vaccine against these diseases.

That experience is unique to that country. The pattern of communicable disease in Japan is quite different from that in the western hemisphere. They have other vaccines against different communicable diseases. The protocol or schedule we use in this country is very similar to those in other western European countries, the UK and America.

Chairman: Dr. Watson wishes to contribute.

Deputy G. Mitchell: Before he does, my question has not been answered.

Dr. Watson: I can address that as well. In Japan there are five vaccine manufacturers who were asked in the late 1980s to produce candidate components for an MMR vaccine. They put forward their candidates and in the end there was a mumps, measles and rubella from three different companies. It was combined into a universal vaccine and it was recommended from April 1989. Very quickly there were 311 reports of what is called aseptic meningitis - a rather alarming term that basically means a severe headache that is self limiting and with no long term consequences. They discovered that was due to the urabe, the mumps component of the vaccine and in 1991 the recommendation for that combination vaccine was withdrawn.

They continue to use the measles and rubella and, as has been said, they are looking into reintroducing a combination MMR vaccine as soon as they can. It has no relation to the autism question at all.

Deputy Cooper-Flynn: I am surprised that nobody mentioned that. It was extraordinary. That was a major feature in the presentations last week and nobody here offered a defence to that. If what you are saying is true, that seems reasonable. It seems really curious.

Dr. Watson: It is one of those myths. There are a lot of myths, such as all the single vaccines are available in France. That is a myth. Another is that French parents are given the choice on whether they want single or combined vaccines. That is a myth. It has just become folklore, I am afraid.

Deputy Cooper-Flynn: I know but people will wonder, if it is not tackled, whether you are only using the arguments that suit your side of the argument. That would be the question one might ask. Do you wish to answer Deputy Mitchell?

Dr. Watson: I will come back to the Wakefield paper. I will quote from the Wakefield paper and from a recent interview he gave on nationwide television in the US in November. The conclusions in the paper say: "We did not prove an association between measles, mumps and rubella vaccine and the syndrome described. We have identified a chronic enterocolitis in children that may be related to neuropsychiatric dysfunction. In most cases, onset of symptoms was after measles, mumps and rubella immunisation. Further investigations are needed to examine the syndrome". So, contrary to what we may be led to believe, this was not that they thought they had identified something but that they raised the hypothesis. That is how medical research moves forward. People ask a question and the scientific community addresses that question.

As we have heard, and this is an important point, all the research has been independent, international research. This has nothing to do with the vaccine manufacturers. This is independent research in the UK, the US, Japan and Finland and they have all come to the same conclusion. It is a good question because autism usually appears between the age of 18 and 24 months and the MMR vaccine is given at 15 to 18 months. It is good to ask if there is a relationship. The answer is no and that was the specific question the Brent Taylor paper addressed - is there any temporal relationship between the MMR and the onset of autism? The answer is no and we must accept that not as some kind of international conspiracy to dismiss Wakefield's conclusions but more an international consensus that it is actually time to move on.

It is time to forget that and time for autistic researchers to think about what actually causes autism, how to treat autism and how to prevent it. I will quote Dr. Wakefield on the American television programme "60 Minutes" on 12 November when he was asked specifically: "Have you proven that there is a link between MMR vaccine and autism?" He replied: "No, we haven't".

In response to the "We would say that, wouldn't we" comment, from an industry point of view we are obviously quite sensitive about that and it is precisely because we generate income from the sales of vaccine that we would not say it. I think we are all aware that the best way to destroy a business is to try and cover things up. You will be found out and when you are found out the business will be, quite rightly, damaged. I can give the Committee a good example. Last year in the United States a new vaccine was introduced for rotavirus. It is a common childhood diarrhea illness that affects a lot of nursery children. An oral vaccine was introduced in the United States and after hundreds of thousands of doses it was discovered that there were more blockages of the bowel in some of these children. As it turned out, the number of blockages was less with the vaccine than with the disease itself but that was looked at by the FDA and the manufacturer concerned and, despite the fact that the vaccine had the potential for billion dollar sales, it has been withdrawn.

There are many other examples. The lyme disease vaccine was recently withdrawn. There is an MMR example with the urabe strain that caused aseptic meningitis in the early 1990s that was withdrawn. The last thing the regulators or the companies want to do is cover things up.

From a personal, professional and parental point of view, the suggestion that I or anyone else in the industry would knowingly damage children for profit is, to put it politely, difficult to bear. I am sure if somebody accused you of that, you would find it difficult to bear as well.

I will now refer to testing in children. Unlike many other pharmaceuticals which are initially tested in adults, vaccines are tested in a target group and that is almost exclusively among children. For all the childhood vaccines the vast majority of the testing would be in children.

Deputy G. Mitchell: With parental consent?

Dr. Watson: Absolutely, it is with careful parental consent. That comes back to another issue that is often raised, that some of these studies only follow them up for three weeks and whether that is long enough. The careful parental consent means that everybody concerned - the parents, the doctor and any other health care professional involved - is clear about what is going on. They know they are in a study and that they are receiving an investigational product. Even at the end of three weeks when they suddenly stop being in the study one can be sure that if in a year's time something strange happens, they or the doctor concerned will think immediately, "Is this the vaccine?" The patient notes of anybody who was in a vaccine trial will have a big sticker on the front stating that the child was in the particular vaccine trial. People do not stop being in a study and if they feel anything unusual, they report it. Again, there are many examples of how things have been picked up through passive reporting.

With regard to developing countries, over the last 20 years there has been a dramatic improvement in uptake of vaccines in developing countries, largely through UNICEF, WHO, vaccine manufacturers and groups such as the Rotary Club. You might have heard of GAVI, the Global Alliance of Vaccine and Immunisation, a collaboration of all those groups and the Gates foundation. They have already raised a billion dollars and will be raising a billion and a half more. The group is providing funding for the 78 poorest countries in the world, that is, countries with a per capita income of less than $1,000 per head. Incidentally, the major cost is not the vaccine but the storage of the vaccine and the health care personnel who deliver it.

On safety, although there are very few people who should not receive a vaccine there is quite long list of people who should not. It is just they have very unusual conditions. They are very clearly outlined in the summary of product characteristics and the patient information leaflet under a section entitled Is MMRII right for you? They are very clearly identified.

That ties in with another question that often comes up: Is there some form of genetic testing or laboratory testing we should be doing to identify these children? The answer is no but it is already done very clearly here. There is a tick list - Does your child have leukaemia, or TB? Is there a neurological abnormality? Are they on steroids? There is a very clear list that can be gone through which will very clearly identify those children who should not receive the vaccine. Once those children have been excluded the chance of vaccine damage is very low. There is no genetic test, maybe there will be in the future but even then I suspect that clinical criteria are quicker and more practical than taking a blood sample, sending it off and waiting a week to get the result.

Chairman: Deputy Cooper-Flynn has a question.

Deputy G. Mitchell: A few questions I asked have not been addressed. I asked the officials of the Department of Health and Children if they had taken up the suggestion for a central vaccine planning and control unit within the Department and I also asked a question about the uptake rates. However, those are included in the brief that was submitted. I asked about a role for community pharmacists. I did not get a reply to those questions.

Ms Hennessy: The procurement of vaccines is currently centralised through the ERHA but we appreciate that there is room for improvement in the procedure both at national and regional levels and we are currently working with the health boards on that.

Deputy G. Mitchell: The unit would not just deal with procurement but also with vaccine policy promotion and delivery. There should be a central vaccine planning and control unit. Is that suggestion under consideration by the Department?

Ms. Windle: At chief executive officer level in the health boards, they have set up a national group to monitor the uptake across the country on a very close month by month basis. That information is fed into the Department regularly. We have taken a number of other steps as well to target specific groups in particular areas that we already mentioned in relation to low uptakes.

Deputy G. Mitchell: I take it the answer to my question is no.

Ms. Windle: The answer is yes.

Deputy G. Mitchell: Will a central vaccine planning and control unit cover all these matters?

Ms. Windle: There is the office of health gain which also plays a national role in terms of the co-ordination and the promotion of vaccines.

Dr. Kiely: There were three or four elements to the suggestion made by IPHA. We have absolutely no difficulty and it is our job to develop policy in relation to immunisation. In promoting that policy and promoting vaccinations our health promotion unit in the Department takes a very active role but the procurement, delivery, monitoring and tendering for vaccines. It is very much an operational thing to be undertaken by the authorities which deliver the vaccination programme i.e. the health boards. Maureen Windle's description of who that is currently being undertaken deals with that particular aspect of it. The answer to the Deputy's question is no, I do not think we will get involved in the procurement and operational end of the delivery of the vaccine programme. Policy and promotion will be the areas that we will be most involved in.

Deputy G. Mitchell: Has the Department considered a role for community pharmacists? They are a greatly under-utilised resource in terms of giving parents information and having access to information and professional advice.

Ms. Windle: Community pharmacists generally give advice but I agree with the Deputy it is an area in which perhaps we could do more work and we could have a more inclusive policy in relation to the involvement of pharmacies.

Deputy G. Mitchell: No parent would ask a pharmacist for advice on a personal matter such as this relating to his or her child as he or she stands beside a cash register. There should be a policy to provide a facility in pharmacies for parents to obtain a modicum of independent advice from a qualified person.

Ms. Windle: There are two issues here. First, we have to look at the willingness of the pharmacists in terms of what advice they would be expected to given and how close it would be to that given by general practitioners. The second point if it was done by agreement then one would have to look at the facilities that would be available.

Dr. Kelleher: As the Committee is aware, we are running the cervical screening programme in the mid-west. We have involved pharmacists in that programme. They are taking our literature. They have had training from us about it. It is something we are beginning to develop, to use community pharmacists because, as the Deputy quite rightly intimated, they have a large number of contacts with the public and they can do that. It is about creating the scenario that we can do that with. It is possible to do it but it takes time and training and things of that nature to go along that way.

Dr. Kiely: We need to reiterate, emphasise and underline the central role of the GP as the provider of the information in the context of providing health care to the entire family and to children as they grow up. There is always the possibility that if the advisory function in relation to this was dispersed conflicting advice and information may be given. We consider that the GP is the central, best qualified to deliver the very sensitive information------

Deputy G. Mitchell: I am sorry to interrupt Dr. Kiely but under protocol 9 of SI 150 of his Department pharmacists are charged with this responsibility.

Dr. Kiely: We consider that the GP in this particular situation in the context of the very sensitive, detailed and comprehensive information that has to be given to families on a continuous basis that this is the primary source we recommend in this area.

Deputy G. Mitchell: Pharmacists know more about medicines than doctors. Doctors may know more about health care than pharmacists but it is not a question of excluding one or the other. SI 150, protocol 9, provides for pharmacists to play a role in the community in advising people on the proper use of medication and this is the reason for limiting the number of pharmacists. It is a grossly under-utilised facility and the Department should consider using it, not at the exclusion of doctors but to complement their role.

Ms Nolan: As an ex-pharmacist I have a good understanding of the role and the potential of the pharmacist and the industry would agree with Deputy Mitchell that pharmacists are an under-utilised asset or resource in the system. I am not here to speak from the pharmacists' point of view but my guess is they would welcome an enhanced role. We have worked with them in our vaccination awareness campaign and found them most helpful and willing to be involved in the dissemination of information.

Deputy Cooper-Flynn: I wish to go back to Dr. Watson. Is it a good idea for a child to have a blood test to check on its natural immunities? Why administer a triple vaccine to a child if he or she has a natural immunity or has had measles?

I turn to IPHA in regard to what is ethical. Dr. Watson said he does not think it is ethical to expose a panel of unvaccinated children and he does not agree with the notion of control groups. How can a trial on children be carried out properly if a control group of unvaccinated children is not used? Given that Dr. Kelleher stated it is the parents' responsibility to vaccinate a child, if parents have taken the decision not to vaccinate their children there is a control group available. Those people will not receive the vaccine which, therefore, does not present an ethical problem because the parents have made the decision. Surely it would be better to have that control group in place to carry out a proper trial. Is that any worse, or less ethical, than carrying out trials for a drug that is not fully proofed using children?

I would like to ask you about ethics, and it is actually included in your recommendations. I refer to the investigation of the possible revision of GP payment schedules for immunisation. Is it ethical, if the vaccine stands up on its own merits and a GP explains this to a parent, that a company would want to pay a bonus payment to a GP if they increase the level of immunisation in an area? These are the points about which there is a little bit of contradiction. I fully understand Dr. Watson's point from a personal point of view about someone questioning whether or not a pharmaceutical company is being ethical. I genuinely understand from where he is coming on that but look at what the tobacco companies have been doing for years, and I am not saying there is a direct comparison between tobacco and the pharmaceutical company. When companies invest millions and billions of pounds in the development of a drug, and you would be very anxious to see that proper independent trials are carried out, I wonder, from an industry point of view, at what stage those independent trials are carried out? Is it after you have spent those millions and billions of pounds after which it is presented to the world? You might explain that from an industry point of view.

Deputy Keaveney: A significant number, 25 per cent or so, of people are not being vaccinated. I note the North Western Health Board is quite good.

Deputy Cooper-Flynn: The Deputy is not parochial.

Deputy Keaveney: I am never parochial. Autism is an issue which has been raised with us and which is scaring people. If autism presents at 18 to 24 months, is it too late for parents to immunise their children after that? If people are concerned - you have to accept people will be concerned - is it worthwhile giving them that time to be concerned and then say to them that they have passed a critical time? Is there such a thing as a critical time?

Senator Jackman: I apologise for my absence - I had to attend the Order of Business in the Seanad. This question may have been answered but the presentations of last week are fresh in our minds. One case which arrested me was that of a parent whose first child has side effects. As a result, and with apparently little back up, she decided that her second and third child would not be vaccinated because of the extraordinary reaction of the first. You have stated that it may not necessarily have been because of immunisation but some other defect in the child. I felt there was a gap in communication in that she did not appear to have support in making that decision. Are parents who make these decisions in regard to their other children left high and dry or are they dependent on the GP who is supposed to be the advising agent? Dr. Kelleher said in his presentation that parents should be provided with objective information. I wondered about the word "should". Are they provided with such information or is it only a recommendation? I am a little at sea as to what advice would have been available for that women because she did not appear to have had advice. Nobody seemed to be able to tell her what had happened. I know you cannot speak about that particular person but she was extremely concerned about the side effects and the horrific description of what happened her first child. She had opted out and did not appear to have any support. You said appropriate compensation should be provided for the small number of people who experience vaccine related adverse affects. Compensation for what if, as you stated, you cannot prove the adverse affects are related to the vaccine? I am a little at sea as regards the recommendations.

Dr. Devlin: The first question raised was, is there value in deferring the vaccine until the so-called risk of these associated conditions, developmental disorders, has passed? The first thing to say in relation to that is the consensus is there is no link between MMR and autism and, indeed, between some of the other vaccines and some of the developmental diseases. The danger is that if you defer the vaccines until the age of two, three or whatever, you are exposing these children to the diseases in question. We have heard already about the seriousness of diseases like measles and the risk of severe complications, hospitalisation and so on. One or two countries have tried this - Japan was mentioned earlier - and they experienced epidemics with this thousands of cases and many deaths. That is something of which we need to be careful.

The other issue is, should we split the vaccine into its individual components. That has been raised before. Some people have said there may be a danger of overloading the immune system or whatever. Children are exposed to a variety of antigens and diseases all the time, so you do not overload the immune system. On whether we should split the vaccines, there is no scientific data to suggest that splitting MMR, in particular, into its individual components would have any benefit. That is not only the consensus of the Irish experts, it is also the consensus of the CDC in America, the World Health Organisation, the MRC and so on.

Deputy Cooper-Flynn: When I went abroad on holiday years ago, I got vaccinations against all the different things and I collapsed due to the overloading of my system. You talk about the overload factor in regard to children. They get 27 vaccines in a period of 18 months. Can a young immune system cope with that?

Dr. Devlin: At very early stages, children are not able to respond to the vaccine, that is, children younger than 12 months, but when they go beyond that stage, their immune systems are well able to cope with and adapt to the vaccines given to them. As I said, all of these vaccine protect against very different diseases. It is not as if one single immune system is dealing with everything. In fact, different parts of the immune system deal with the different diseases. The evidence and the serological information is clear that children are able to mount a so-called immune response and they then have protection against these diseases. The danger is that if you split these vaccines into their individual components, you are subjecting children to a lot of extra injections - a lot of parents are already concerned about the number of needles children get - and it would also delay the vaccination process and children would be liable to being susceptible to these diseases for a much longer period of time.

Chairman: Dr. Watson, would you like to respond to the question on ethics?

Dr. Watson: I would like to come back to the immune overload issue because it is often stated across national boundaries and history. In the 1850s when there was a campaign against the small pox vaccine, the concern was that the small pox vaccine would overload the immune system. A very good study from Germany has just been published in which children were vaccinated either at two months or three months. The group which had been vaccinated and a group that had not been were very carefully monitored for any kind of sniffling illness, tummy aches, diarrhoea and any kind of illness. If there was an immune overload, you would expect to find that they would be weak and that these infections would get in. The reality was that those who had been vaccinated had significantly less infections than those who had not been vaccinated. The result is quite the opposite. Not only does it not impair or overload the immune system, but it may actually boost the immune system. Members will have read in their papers various theories about us not been exposed to enough antigens these days. When a child falls in the playground and grazes their knee, a parent will notice they get this red mark around the outside of the graze - it is just like being vaccinated. When a child falls over in the playground hundreds of antigens go into that wound. The immune systems has millions of different cells each capable of recognising different antigens. Ten or hundred antigens going in at the same time is not a problem for the human immune system.

In terms of ethics and comparing vaccinated with unvaccinated children, we need to differentiate between pre-licence and post licence. Pre-licence, if efficacy needs to be proven, it will be. Large efficacy studies are conducted with many thousands of children. We saw that with a recent new conjugate vaccine where 35,000 children were investigated and compared to unvaccinated children. We have seen that in the past with acellular pertussis vaccines. It is ethical. It probably would not be licensed if it had not been proven.

Deputy Cooper-Flynn: Are those studies carried out?

Dr. Watson: Yes.

Deputy Cooper-Flynn: There are licensed studies and a control group is involved.

Dr. Watson: Absolutely.

Deputy Cooper-Flynn: Where the parents decide they do not want their child vaccinated and where there is a control group do you still find that is an ethical problem?

Dr. Watson: That is what you have seen in Dublin this year. You have seen a study conducted between vaccinated and non-vaccinated children. The unvaccinated children got measles and children have died. That is a study on-----

Deputy Cooper-Flynn: Is there such a study?

Dr. Watson: It is a population, a natural study.

Deputy Cooper-Flynn: Have we been presented with that?

Dr. Kiely: The operation in north Dublin was almost a natural experiment where one was comparing children who were vaccinated with children who were not vaccinated.

Deputy Cooper-Flynn: It was a real life, it was not-----

Dr. Kiely: The ones who were vaccinated got sick and some of them died. That was the natural experiment that happened, unfortunately.

Dr. Watson: You may not have heard that the Netherlands has been going through the same experience this year. There has been 3,000 cases and three deaths. Those are the two experiments, two trials to show what happens if people are not vaccinated.

Deputy Cooper-Flynn: What is the position on the payment of doctors and on the issue of information?

Dr. Kelleher: In terms of information we said one should where one does not have them, and one should continue to have them. A very important part of this issue concerns what has been said about informed choice.

We have raised compensation as an issue. We believe it should be debated at policy level. We know there are many problems with it, but we believe it should be debated. It is one of those issues included in things we did not want to avoid, so we raised it in our submission to be debated.

In terms of payment, general practitioners are paid in a different way from other people. I am salaried; they are not. That is how their payments are put together. They go through very convoluted negotiations. I have been party to them on occasion and they are extremely convoluted and long winded. That is how things come out. It is just the way they are paid. There is evidence in other parts of the world that it is very successful where there are those bonus payments. Higher levels are achieved. It needs to be discussed.

I think the ethics in this is an issue. What is the right ethic here? Is it that we do not immunise children and children die or we immunise children and there may be other problems? I think there is a possibility in the future that people could contemplate children who were no immunised as the cause of their children getting measles. That is a big issue we must look at now. We know it can be prevented. Why was it not prevented? Finally, Chairman, on behalf of the Department of Health and Children and the health boards I can say we will be more than happy to return to the Committee at a later stage if there are further questions or if there is further evidence that may be an issue.

Dr. Kiely: The Department of Health and Children will continue to promote and protect the health and welfare of our children through vaccination programmes that are based on the soundest of sound evidence. We will have particular regard to the effectiveness of these vaccines and especially to their safety. Those will be our pre-eminent considerations.

Deputy Cooper-Flynn: It would be appreciated if you could provide us with any documentation you have on licences and post licences.

Chairman: Ladies and gentlemen, I thank you for attending the Committee and presenting us with a thorough presentation. We will take up your offer on returning to the Committee. You may not be aware that Dr. Wakefield has indicated he wants to appear before the Committee. We have two further public meetings, I hope, before Christmas. Perhaps we will get back to you in the new year. In the meantime Nollaig bhí shona dul gach aon.

The Joint Committee adjourned at 11.35 a.m.

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