Dáil Éireann díospóireacht -
Thursday, 19 May 1983

Vol. 342 No. 9

Adjournment Debate. - Vaccine-Damaged Children.

Mr. Shatter

I wish to thank the Chair for allowing me to raise this matter on the Adjournment, which arises directly from a number of Dáil questions I tabled today and which were dealt with by the Minister. It might be of assistance to the House if I outlined briefly the history of this matter.

It goes back to the early 1970s when a number of parents alleged their children had suffered permanent brain damage as a result of the three-in-one vaccination programme, which included vaccination for whooping cough. Following representations made by them to the Department of Health, in 1975 the records of some of the children were examined by medical officers attached to the Department who concluded that no children had been adversely affected by the vaccine. Although the Department concluded no children had been adversely affected at that stage, about that time the Department introduced new procedures. They introduced a form of questionnaire that doctors or nurses would ask parents to reply to before the children were administered the whooping cough vaccine.

The parents did not accept the medical officers' view in 1975 that the children had not been affected by the vaccine and they continued to put pressure on the Government to clarify the position. In February 1977 this matter was raised in the Dáil and the then Minister for Health, Mr. Brendan Corish, rejected allegations that 30 children had suffered brain damage as a result of the whooping vaccine.

The parents still did not accept the approach coming from the Department, and as a result of further representations in autumn 1977 the then Minister for Health, Deputy Haughey, established an expert medical group to examine and assess cases of alleged damage resulting from the administration of the whooping cough vaccine. This group took an extremely long period before they produced a report. Their report was finally made available to the former Minister for Health, Deputy Woods, at the beginning of July 1982. In a press release on 24 July 1982 it was stated the group had completed its examinations of some 54 persons whom it was alleged suffered permanent brain damage as a result of the administration of the whooping cough vaccine. In the press release it was stated that on the balance of probability 14 of these people had suffered a disability while 40 had not done so. It is worth stating that that report only became available in July 1982 as a result of considerable adverse publicity generated in the preceding three months. As a result of a meeting I had with the former Minister for Health in June 1982 the expert medical group were required to conclude their deliberations and report.

At that stage the Government did not clarify whether they were going to make any payments of an ex gratia nature in respect of the children whom it was alleged had suffered brain damage and whom the group had accepted had suffered brain damage. On 4 November 1982 Deputy Woods announced that the Government had decided to offer a payment of £10,000 on an ex gratia basis in respect of the 14 children on condition that “no further claims would be made against the State or any public authority in respect of the damage suffered by these children”.

All the parents who have alleged they have a child who suffered a disability as a result of whooping cough vaccine are extremely unhappy at the manner in which they have been treated by successive Governments in the past eight years. It is clear as a result of the representations they made in the early part of the 1970s that the Department of Health changed their procedures. The report produced during the lifetime of the previous Government only became available because of adverse publicity. The parents whose children had been adjudged unaffected by the whooping cough vaccine have been denied access to the reports prepared by the expert medical group and, despite their looking for them, no information has been made available to them stating the basis on which the expert medical group have reached their conclusions. A number of parents believe the matter has not been decided properly and that the serious disabilities of their children result from the administration of the whooping cough vaccine.

I do not accept what the Minister has said that these reports are confidential, that they might contain information that would distress the parents and that they should not be made available to them. At all times the parents co-operated with the Department, despite the unduly long time it took the expert medical group to reach their conclusions. They made themselves and their children available whenever requested to do so. It seems to me there is no valid reason for not allowing the reports to be produced and the information available to the expert medical groups to be made available to the parents. Because this information has been refused to them, this is giving rise to suspicion and is creating a worry on their part that the matter has not been dealt with properly. It is also creating a suspicion that there has been some kind of cover-up. I am not suggesting there has been a cover-up. Members of this House must accept that the doctors who formed the expert medical group are eminent and respected members of the medical profession. I am sure they have dealt with the matter in as best a way as they could and I am sure they believe they made the right decisions. The problem is that the parents do not believe they made the right decisions and the fact that the parents are denied access to basic information is fuelling that suspicion. This information must be made available to the parents. If matters have been dealt with properly the parents can be so reassured, but if they have not been dealt with properly the parents have the right to know about it. It is quite wrong the parents have been denied access to information to which they consider they are entitled.

We heard from the Minister in connection with the ex gratia payment that although 14 children have been adjudged to date as affected by the vaccine, only two sets of parents have accepted the payments. By requiring the parents to agree that no further claims will be made against the State arising out of the damage done to the children, the parents are being asked to sign away their rights to bring court proceedings which could result in their obtaining a far greater sum of money by way of compensation for the damage done to their children. However, they can only claim this if they are able to establish not only that their children were affected by the vaccine, which is something the group has established, but also if they can prove negligence on the part of the State or the health board. It is quite possible that, while it is accepted that the children have been affected by the vaccine, in the context of a court case it may not be possible for the parents to prove negligence. It is quite understandable that the Department have made the ex gratia payments on a “without prejudice” basis and without admitting liability; but the condition that prohibits parents from proceeding to the courts if they feel they should do so is wrong. There is no reason the Department should impose such a condition.

The whooping cough vaccination programme is a Government-sponsored programme and it is recognised that it should continue in the public interest. The Minister was correct in saying that it is desirable for the vast majority of children to receive the whooping cough vaccination. Indeed, the consequences of whooping cough can be as damaging for children who suffer from whooping cough as have been the consequences to this small group of children who have been administered the vaccine. If we have a public health programme that encourages vaccination, we have, in the interest of the community, a duty towards those who suffer damage. It must be accepted that prior to 1974 the State did not have the efficient types of controls now exercised to ascertain if children suffer any contra-indications that could indicate to medical personnel that brain damage might result from the administration of the vaccine. There is no doubt that if the controls now existing had operated some of the 14 children who have been adjudged to have been affected might not have been vaccinated. Even though we exercise these controls now it is unrealistic to presume that in future no child will suffer damage as the result of the vaccine. Since June last year 36 additional cases have been referred to the independent medical group and this indicates this is not a once-off type of problem. It will be with us for a period.

One of the reasons I asked the Minister if he is aware of the ages of these children in the 36 new cases that have arisen is to ascertain if any of those cases have arisen since the controls were introduced in 1974. I believe the State has a duty to deal with this matter in quite a different way from the manner in which it has been dealt with to date. I believe legislation should be introduced to establish a formal statutory procedure whereby parents can have adjudged if their children have suffered damage as a result of the administration of whooping cough vaccine and should provide for making an ex gratia payment if such is established. The point should be made — the Minister adverted to it — that nobody can compensate these children or their parents for the damage they have suffered. All of the parents I have met sincerely believe their children have been affected by the vaccine. I have no doubt, in the context of all the children that have been examined by the medical group, although their parents sincerely believe they have all been affected by the vaccine, that some have not been and that their disabilities arise from other reasons.

Those parents do not want essentially to get compensation. The majority are anxious to find out if it was the administration of the vaccine that caused the severe disabilities their children suffer from. I believe they have a right to ascertain that. I believe we should establish formal statutory procedures to allow such adjudications to be made. I also believe there should be a proper appeals tribunal. The Minister is wrong in stating, as he did earlier today, that we have applied the most sophisticated way for dealing with these problems. That is simply not the case. If one looks across the water, in England they have established a statutory procedure to tackle this area. Initially, decisions are made by personnel in the equivalent of our Department of Health but, if in England a decision is reached that a child has not been damaged as a result of the vaccination programme there is an expert medical appeals tribunal to which the parents can appeal. The Department of Health in England make available to the parents all the information on which the original decision was made by that Department. This procedure does not simply apply to England only. It applies to the entire United Kingdom including Northern Ireland, which means at present that children whom it is alleged have suffered brain damage as a result of this vaccine in Northern Ireland are afforded greater rights than children who live in the Republic. When there is an appeal in England they are given access to all relevant information for the purpose of the appeal.

In the context of other European countries as long ago as 1972 Denmark introduced statutory provisions to deal with this area. As I said earlier today, France, Germany, England and a number of other countries have statutory procedures. Some of the statutory procedures are not specific in that they do not only deal with whooping cough vaccine. Some of them deal with claims in relation to damage suffered by public health vaccination or medication programmes. The one in Denmark, which goes back to 1972, is specifically concerned with whooping cough vaccine.

It is important that the parents who believe wrong decisions have been made are given the opportunity to have an independent tribunal re-examine their cases on the basis of all the original information that was available to the expert medical group. I urge the Minister to establish such a tribunal. This is not to cast aspersions on the integrity of the expert medical group. It would be an acknowledgement that people with the best will in the world occasionally get things wrong. While it has been suggested to the parents that the expert medical group could act as an appellant body from their own decisions that is completely unrealistic. It is like asking the District Court to hear appeals against District Court decisions. It is not a way of ensuring satisfaction that this matter is being properly dealt with.

With regard to the question of ex gratia payments the Minister suggested that the existing English restrictions are the same as the restrictions in Ireland. That is not the case because the acceptance by a parent in England of an ex gratia payment does not prevent the parent bringing proceedings. The English legislation of 1979 expressly provides that the receipt of an ex gratia payment “does not prejudice the right of any person to institute or carry on proceedings in respect of disablement suffered as a result of vaccination”. It merely provides that in any civil proceedings the court shall treat a compensation payment, if it is ordered, as paid on account of any damages which the court awards in respect of such disablement. If parents in England go to court, prove negligence and are awarded £30,000 or £40,000 by way of a sum against the State, and those parents have already received, on behalf of their child, an ex gratia payment of £10,000, that is taken into account in relation to the total payment to be made.

I believe the failure to tackle this problem in an open, non-secretive way and the failure to make information available is now having a dramatic effect on the three-in-one vaccination programme. The Minister may have a comment to make on this. Many parents, who do not fully understand the nature of this problem and who do not realise the risk of brain damage is confined to a very small group of children, are now refusing to allow children, who are not at risk of being affected by the vaccine, to be vaccinated. I am informed, as a result of this, that there has been a considerable increase in the number of children suffering from whooping cough in recent years. The Minister might be able to clarify the position in relation to that. Consequently, the failure to tackle this problem is not only causing a grave injustice to the children who have been damaged by the vaccine but it is also placing many children at risk of suffering from whooping cough who would not be at risk if they were vaccinated.

I urge the Minister to reconsider the advice he is being given by his Department officials on the basis of the very real concerns and worries I have expressed, which have been articulated to me by many of the parents who have found themselves in this position. Unfortunately, the only conclusion one can reach in relation to this issue is that it is being dealt with on an ad hoc basis by successive Ministers in successive Governments without any clear policy or without fully appreciating or understanding the position in which many of these parents find themselves.

I hope the Minister will seriously take the comments I am making. I know he is genuinely concerned about social issues. I hope on this issue he will not adhere to the civil service brief given to his colleague, in the seventies, Brendan Corish when he was a Minister, Deputy Haughey when he was a Minister, Deputy Eileen Desmond when she was a Minister, and Deputy Michael Woods when he was a Minister. I hope he will show some flair and innovation and deal with this in a humane and understanding way to ensure that the problems are properly dealt with.

Minister for Health (Mr. B. Desmond)

I assure the House that an entirely independent expert medical group on whooping cough vaccination was established in 1977 to examine persons who, it was claimed, had been permanently damaged by whooping cough vaccination, to review the medical information available to them and to indicate whether, in their opinion, the damage was attributable to the vaccination.

The group consisted of Professor Brendan O'Donnell, the Dublin Medical Officer of Health, who is a professor of preventive medicine in the Royal College of Surgeons, Ireland, Professor Edward Tempany, Paediatrician, Our Lady's Hospital, Crumlin, and Dr. Sean Murphy, neurologist, Jervis Street and St. Laurence's Hospital.

A total of 54 persons were examined by the group between 1977 and 1982. Of the 54 persons examined, the group concluded that 40 of these were not damaged by the vaccination and that there was a reasonable probability that the disability of the other 14 could be attributed to whooping cough vaccination.

Since the findings of the expert group were made known in July, 1982, the debate has related to four main issues. First, the special financial arrangements to be entered into for the 14 persons considered by the group to be damaged by the vaccine; second, the provision of the individual reports of the group to the parents of the 40 persons considered not to be vaccine-damaged; third, the establishment of an appeals system for the 40 persons, and fourth, permanent arrangements for dealing with vaccine-damage.

Before dealing in detail with these issues and the various matters which have been raised relating to them, it is necessary that the House should be aware of the procedures which the three members of the medical group adopted and the difficulties which they encountered in attempting to reach conclusions in individual cases. This background information is necessary to ensure that the question of vaccine-damage is put into a proper context and that consideration by the members is unemotive and objective.

The work of the group was of a retrospective nature and in some cases it was inquiring into incidents alleged to have taken place up to 30 years prior to the examination of the person by the group. Despite the lengthy periods of time involved, the group set out to develop as comprehensive a picture as possible of each person who applied for examination, so as to enable it to draw conclusions. The procedure it adopted consisted of discussion with parents to establish a detailed history followed by an examination of the person. In addition to a clinical examination, each person had relevant X-rays and tests. In certain cases, the group made inquiries from family doctors, paediatricians and others who had a knowledge of the case and examined medical records relating to the case.

At the outset, the group recognised that it would not be possible to prove conclusively in any case whether the person had been damaged by the vaccine. The reason for this is the fact that reactions which parents described to the group and which were recorded in such records as were available were reactions which, on the one hand, are generally recognised as occurring occasionally following whooping cough vaccination, while on the other hand, they are not uncommon occurrences in children who have never been vaccinated. Examples of such reactions are persistent screaming, collapse, infantile spasms and convulsions. In view of this, the group came to its conclusions on the balance of probabilities in each individual case. Where there was a reasonable doubt in any case, the group gave the benefit of that doubt to the applicant.

The members of the group have come in for severe criticism since the findings were made known and having regard to the facts of the matter this criticism is unjustified. It is fair to say that the expert medical group has looked objectively and sympathetically at each case and came to its conclusions having taken account of all the facts available to it.

In September, 1982, the Government decided that an ex gratia payment of £10,000 should be made in respect of each of the 14 persons on the clear condition that the sum would be used, as considered appropriate by the parents, for the benefit of their child, and that no claim would be made on the child's behalf in respect of the whooping cough vaccination. The offer by the Government did not involve the acceptance of any liability on the part of the State or any public authority in respect of the child's disability.

Two questions have arisen. One is whether the offer should be increased, and the second is whether the conditions attaching to it should be dropped. With regard to an increase in the offer, one must first of all consider whether it is appropriate that a special financial arrangement should be entered into in the case of whooping cough vaccination which is basically a protection given to a person against disease. Whooping cough is a distressing disease which can have severe complications such as convulsions, pneumonia, neurological illness and even death. In addition, there is no conclusive evidence that the vaccine caused the disability in any case.

There is a wide range of medical and social services available to cater for the special needs of disabled persons which would be available to the 14 persons, as appropriate. When the findings of the group were made known in July 1982, my Department asked each health board to ensure that the persons resident in their areas who were involved in the work of the group would be treated sympathetically and would benefit fully from all services available. In adopting this approach, my Department was conscious that the special needs of persons considered by the group not to be vaccine-damaged were no less than the persons considered to be vaccine-damaged and was careful not to distinguish between disabled persons on the basis of the possible cause of their disabilities. At this stage I see no reason for the provision of additional financial benefits of an excessive nature to the 14 persons considered to be vaccine-damaged.

Similarly when considering whether the conditions attaching to the offer are justifiable or not, one must refer back to the retrospective nature of the group's work, the inconclusive findings and the fact that whooping cough vaccination is voluntarily received by the individual for his protection. While I accept that there is a broad benefit to the community if a majority of persons are vaccinated, the protection received by the individual against the disease is the primary motivation for vaccination. In the light of these considerations, it is reasonable for the State to protect itself and the appropriate public authorities by not accepting liability for a person's disabilities and by seeking a waiver of claims in respect of a person's whooping cough vaccination. There has been a falling off in vaccination in recent times.

Many of the documents contained in the reports are of a sensitive and confidential nature and were furnished to the group purely for the purposes of its investigation. My Department have been advised that confidentiality would be breached if the documents were to be released.

In order to facilitate parents who wished to know how the group had arrived at their conclusions in respect of their child, my predecessor arranged for the chairman of the group to discuss the reports with such parents. A number of parents met the chairman who went through the reports with them and outlined in detail the considerations which the group had made in forming their opinions in respect of their children. Naturally, the parents were not satisfied with the chairman's explanations and requested that their children's cases be reviewed.

Once again to facilitate the parents, my predecessor agreed to a review of the cases, provided new and relevant evidence was produced which had not been considered previously. The stipulation that new and relevant evidence should be produced was not unreasonable as, in a situation where opinions are formed on the balance of probabilities, a review of the information originally submitted would be futile.

Some of the parents responded to this request and the evidence submitted was examined by the group. In no case did the group feel that the evidence was sufficient either to warrant a review of the case or to modify its original opinion that the vaccine was not the cause of the person's disability.

I cannot accept the proposed appeals system suggested by Deputy Shatter because the suggestion derives from the fact that an appeals system exists in the United Kingdom as part of the vaccine-damage payments scheme. In the UK, the appeals system is designed to appeal against the original decision taken by the Departmental Medical Officers on the basis of data submitted. There is no examination of the person on whose behalf the claim is submitted at the departmental stage. The Irish expert medical group actually examined each person as well as the data to support the claim that he was vaccine-damaged. It is fair to say, therefore, that the expert medical group's consideration of a person's claim, being based on an examination of the person and his records, would be comprehensive enough to determine whether or not the person was vaccine-damaged.

A great effort was made to resolve the situation. I do not accept that there should be permanent arrangements made in relation to this matter. The scheme in the UK is not a compensation one. It was made clear during the debates on the Vaccine-Damage Payments Bill going through the House of Commons in 1978 that it was a scheme of lump sums payments. It is the only scheme in the EEC which provides for the payment of a specified lump sum.

We are not unsympathetic to the persons involved but the issue must be considered having regard to the fact that vaccination is a proven preventive measure and that it is accepted that the benefits outweigh the risks that may be involved. As a result of the vaccination of infants, which I hope will continue, a wide range of infectious diseases have been brought under control and infant morbidity and mortality have been greatly reduced. It is of continuing importance that parents have their children vaccinated to afford them protection against infectious diseases. I regret I cannot continue the matter further.

The Dáil adjourned at 5.30 p.m. until 2.30 p.m. on Tuesday, 24 May 1983.