Vaccine Damage Payments Act

Lord Beith Excerpts

Tuesday 24th March 2015 Westminster Hall

[Mr Brown]

I thank my hon. Friend for his intervention. He is exactly right. It was absolutely astounding to hear the heartbreaking stories at our last meeting and to think that a young woman who had been fit and healthy now suddenly finds herself asleep for most of the day and has to be awakened on an ongoing basis to be fed. That is no quality of life at all. Something is seriously wrong. The worlds of these young women have been turned upside down. For some of them, to spend a few hours at school in a week is a major challenge. That issue could probably merit an Adjournment debate on its own. I am aware that the hon. Member for Reigate (Crispin Blunt) held a short debate on the topic back in May 2009. It is worth pointing out that there are serious concerns about the manner in which an individual’s allergic reaction to a vaccine is recorded—it might be better put as “not recorded” in many cases. Where there is an allergic reaction, it is only right that it is properly recorded, so that we can not only determine what is happening to the individual but get a broader perspective.

In October 2011, a proposal paper was produced by the vaccine victim support group—an unincorporated association with more than 300 members—and the all-party group for vaccine damaged people. They came together and were looking for reform of the Vaccine Damage Payments Act, which established in the UK a statutory no-fault system of a single lump sum payment from public funds for cases of proven serious permanent disablement resulting from vaccination. Most developed countries have established such systems. The scheme in this country is administered by the Department for Work and Pensions, with appeals being resolved within Her Majesty’s Courts and Tribunals Service. We are now 36 years on, and the system has continued, with relatively minor changes only.

The vaccine victim support group and the all-party group contend that reform of the system is highly desirable to deal with anomalies that now exist in the system, to reflect the changing landscape of today, to reassure the public about the safety and efficacy of vaccination, to reduce litigation and to promote and extend the uptake of vaccination to promote health and the elimination of disease. Both groups support the UK national vaccination programme and recognise that the benefits of vaccination outweigh the risks. Vaccines have significantly contributed to the elimination of disease, the increase in life expectancy and the improvement in public health.

Reform of the UK system of statutory vaccine injury compensation has the prospect of achieving important tangible benefits for the UK that mean that it would be irresponsible not to explore and effect reform through consultation with all relevant stakeholders, which include the pharmaceutical industry, the Department of Health immunisation team, the DWP and, via support groups, affected individuals.

The Act was brought into being by Parliament to put on a statutory footing a system of ex gratia awards of compensation for vaccine injury that had developed during the 1970s, largely as a result of whole-cell whooping cough and smallpox vaccine injury. The Department of Health had made a number of ex gratia awards to individuals who had suffered serious permanent disability as a result of catastrophic brain injury that they had suffered as infants shortly after DPT—diphtheria, pertussis and tetanus—vaccination.

The Government had commissioned Professor David Miller to conduct the national childhood encephalopathy study—NCES—a large-scale epidemiological study of incidents of brain injury and onset of seizure disorders following DPT vaccination. The study, published in May 1981, found a significant association between DPT vaccination and severe neurological injury and death.

The statutory scheme initially required an 80% and permanent level of disability to have been suffered, but later that threshold was reduced to 60%. Awards were initially £10,000. That was increased, in various changes, to £20,000, then £30,000 and then £40,000. The level of payment was largely based on the understanding that that was interim compensation pending the outcome of the litigation against the Wellcome Foundation.

In 1986, the United States enacted the National Childhood Vaccine Injury Act. That established a system of compensation in the US court of federal claims. Until four years ago, that had awarded compensatory damages in 2,806 cases, of which 1,266 involved the DPT vaccine, use of which ceased in 1996. That involved an outlay at that time of $2.2 billion. The fund to administer the scheme is established from a small tax on each dose of vaccine. That has proved relatively successful in the United States, and our all-party group has wondered for a long time why we do not in the UK, for every vaccine that is given, put into a fund a couple of pence. That is all it would take to deal with this issue. However, that has been rejected not only by this Government, but by the Labour Government in the 13 years for which they were in office. I think that we need to reconsider where we are.

In 1988, the court in Loveday v. Renton and the Wellcome Foundation dismissed the claimants’ claims. The judge found that the claimants had failed to establish causation to the required standard of proof. That was based on his findings of flaws in the data analysis of the NCES. Professor Miller and his NCES team subsequently published a follow-up study, in November 1993, which addressed the judge’s criticisms of the original study. The conclusions of the follow-up study were essentially the same as those originally: on rare occasions, the vaccine can cause severe neurological injury. Then in 2000 the Government decided that the initial awards should be “topped up” to the real-terms equivalent of £100,000.

It had been suggested that anyone deemed to be vaccine damaged was carrying the SCN1A gene. That has been disproved by testing victims: they have all proved negative.

In 2010, the Legal Services Commission agreed in principle to fund a further review of the prospects of success of the surviving DPT claimants. Further litigation is therefore pending in that respect against the manufacturers and/or the Department of Health. The award now made for a successful application for vaccine damage payment is a single lump sum of £120,000. However, the majority of applicants—approximately 750 —have received only £78,000, because they received an initial payment of some £10,000. The payment is invariably made into a personal injury special needs trust, so that it is excluded, by statutory provision, from any assessment for means-tested benefits. That is done to ensure that it is received in addition to means-tested benefits such as incapacity benefit and disability living allowance, including components for care and mobility.

According to information supplied by the vaccine damage payments unit in 2011, a total of 931 awards had been made under the 1979 Act, of which 570 were related to the DPT vaccine. There were 89 applications to the unit in 2010 and 71 in 2011. One award was made in 2010, and no awards were made in 2011. So far, 3,983 applications have been rejected on medical grounds and 814 have been rejected for non-medical reasons—because the application was made either out of time or out of the scope of the scheme. The operation of the system has settled down, and after a flurry of historic awards in the early years, very few awards are now being made. The unit at one point consisted of two part-time members of staff. An appeal against the decision to refuse an award is made to the social security lower-tier tribunal, which is part of Her Majesty’s Courts and Tribunals Service.

The fact that surprisingly few awards are being made probably reflects the withdrawal of the DPT wholesale vaccine, the improvement in vaccine technology and the increased levels of safety and efficacy of vaccination. During the past few years, more vaccines, such as HPV and meningitis C, have been added to the national programme. It is likely that further vaccines—for example, varicella, H1N1, swine flu and hepatitis A and B—will be added in coming years. Many new types of vaccines are likely to become available in future years, because they are being developed to combat many sources of disease, such as malaria, candida, chlamydia, E. coli, genital herpes, hepatitis E, strep, rheumatoid arthritis, various cancers and numerous others.

There have been episodes of public concern about adverse reaction to vaccinations such as DPT in the 1970s, MMR in the late 1990s and early 2000s and, more recently, the HPV vaccine. Those episodes of concern have led to litigation, media sensationalism and public anxiety, and they have significantly reduced uptake of the vaccination, which has reduced the level of herd immunity on occasions and increased the incidence of outbreak of pandemic disease among unvaccinated populations. Those episodes of public concern caused anxiety and confusion to the public and resulted in considerable legal defence costs for pharmaceutical corporations and considerable cost to the UK legal aid purse. Litigation resolved few of the disputes, because hardly any cases reached trial. The public health programme was damaged by falling levels of vaccine uptake, and diseases in some cases were resurgent.

In 2003, uptake of the MMR vaccine fell to only 82%, largely as a result of Wakefield’s discredited autism theory. Even by the end of the MMR litigation, uptake had not fully recovered. In contrast, the United States achieves 98% vaccination uptake, possibly because all claims have to be brought in the federal courts under the vaccine programme rather than against a manufacturer. That shows that a proper safety net can boost the numbers of people who take part in a herd immunisation programme. Other countries have avoided the problem by enabling disputes over vaccine injury to be efficiently and proportionately resolved within a statutory compensation scheme, where individual cases can be thoroughly investigated and adjudicated. The lack of a fully comprehensive system for determining vaccine injury applications in the UK has contributed to the problems we face, so all stakeholders have an interest in reform.

The UK’s vaccine injury compensation scheme, as established in the 1979 Act, contains a number of serious anomalies. Not all vaccines are covered. Vaccines for swine flu, smallpox, hepatitis A and B, and yellow fever are not covered. A separate scheme for smallpox vaccine compensation had to be set up by the Department of Health for workers to encourage front-line health workers to participate in vaccination. The vaccine programme is no longer just for children, as it was initially. Many people in their professional careers need to be vaccinated, otherwise they cannot work.

The influenza vaccine is not covered. The safety net has holes in it, and the vaccine victim support group and the all-party group submit that the gaps should be addressed. We believe that everyone who is resident in the UK and is vaccinated should be able to have recourse to the compensation scheme in the event of a serious adverse effect. The current scheme is aimed mainly at compensating children, although adults are also, on rare occasions, covered. The coverage is therefore patchy and not comprehensive. Given the very small numbers involved, the scheme could easily cover children and all adults.

Children who die before the age of two are not covered. That exception is difficult to justify, because losing a child at 18 months is as tragic and devastating as losing a child six months later, at the age of two. That exception should be abolished. The 60% injury threshold is a real issue. An arbitrary distinction is made in the scheme for injuries that are still significant, but that amount to 59% or lower. The refusal of any compensation for someone with a 59% permanent disability cannot objectively be justified, bearing in mind the very small number of awards that are made. To qualify for criminal injury compensation, the minimum threshold value of injury is £1,000, and a similar level should apply in vaccine injury cases.

The current compensation award of £120,000, rather than compensatory damages, creates anomalies. A child with catastrophic injury resulting from clinical negligence in the administration of a vaccine—in other words, in breach of contra-indication—may receive £3 million. A child with a similar injury resulting from an adverse reaction to a vaccine would receive only one twenty-fifth of that compensation. That means that the burden of caring for the disabled person falls largely on their families. The current vaccine injury award amounts to the cost of care for a seriously disabled person for less than one year. That cannot properly be described as compensation; it is only a token.

[Sir Alan Beith (Berwick-upon-Tweed) (LD)]

I welcome the attention that the hon. Gentleman has brought to this matter, as he has on previous occasions. The root of the problem is the distinction between compensation for negligence, which rightly exists to ensure that a negligent organisation pays a penalty, and the provision of the help that people who have suffered vaccine damage ought to get, even if there is no possibility of proving negligence. The hon. Gentleman has identified that that is a no-fault system. We really need to have such a system, which meets the genuine need of those who have faced such consequences without their having to prove negligence.

[Mr Brown]

I thank the right hon. Gentleman for that intervention. The point is the balance of probability, as I indicated earlier in relation to the United States. I know that we do not always like to compare our health service with that in the United States, but theirs is definitely based on the balance of probability. We need to be much more realistic and consider what that could mean for us in relation to vaccination and a vaccination programme. The level of award cannot be justified. Instead, the system should provide common-law damages. The numbers of awards made are such that that would place little burden on the public purse. Similarly, the scheme should also meet reasonable legal costs, so that clients do not have to enter damages-based contingency agreements to fund appeals.

There should be provision in the scheme for some flexibility on the date by which an application has to be made. The current scheme allows no extension of the time limit, even when the applicant does not have knowledge of the scheme or that they have a claim. Earlier today, the families made it abundantly clear to me that if a child suddenly becomes vaccine-damaged, the trauma that runs through the household and the family is such that they probably cannot think straight about what the future holds. It is about recognising the extremely difficult and traumatic time that families are going through. There should not be time bars that mean people get the response, “I’m very sorry, but you’re out of time for any kind of claim.” That just is not the way we should be operating in the 21st century.

The current scheme does not contain any table of injury where causation may, in certain circumstances, be presumed. The absence of such a table leaves open to doubt—and litigation—the question of causation, which makes the system more difficult to administer. The table under the US scheme recognises, for example, that if someone has a severe allergic reaction within four hours of receiving the tetanus vaccine, it is presumed that the tetanus vaccine caused the injury if no other cause is found. That goes back to the point raised by the right hon. Member for Berwick-upon-Tweed (Sir Alan Beith) and my response—that the absolute probability is that the tetanus vaccine was the cause. The table in the US is periodically revised after independent expert review, such as the reports published by the Institute of Medicine on the causality of injury by vaccines in 1991, 1994 and 2011.

The UK system of vaccine injury compensation has now existed for 36 years. It was created as an interim solution, but it has become a permanent one. There are many anomalies in coverage, and it does not fulfil the safety net function that would promote confidence in the uptake of vaccines. Fortunately, cases of serious permanent disablement and death caused by vaccines are extremely rare. The cost of extending the scheme to give comprehensive coverage and provide compensatory damages would be extremely low. If one award of medium severity is made in an average year, for example, the cost might be in the order of, say, £500,000. There would be some initial additional expenditure in paying a further top-up, in line with the level of compensatory damages, for the 931 cases that received a £100,000 top-up payment in 2000. However, that would mean no further ongoing litigation in respect of historical cases. The current award of £100,000 is difficult to justify in cases involving catastrophic injury and a lifetime of care and loss of earnings.

Vaccines have become safer, but the number of vaccines has grown and is likely to continue growing. The vast majority of adverse effects are mild and/or temporary, and only on extremely rare occasions are they serious and permanent. However, it is likely that there will always be a small number of casualties, and a no-fault safety net of compensatory damages will relieve the unfair burden of care and support from victims’ families and redistribute the cost across society. Crucially, it would avoid the need for litigation, promote confidence in the national vaccination programme and increase vaccine uptake, thereby reducing the incidence and cost of disease.

I hope the Minister will consider the points that she hears today. The timing of this debate might be wrong, but I have attempted to raise the profile of this issue over the past 12 months. In the dying days of this Parliament, perhaps the timing could not be better because, with both the Minister and my hon. Friend the shadow Minister in attendance, the next Government might want to consider this issue more closely. The electorate deserve a better deal than they have had previously.

There should have been significant publicity for this debate, and the families tried to encourage such publicity. They came close to getting support from the BBC, but the plug was apparently pulled at the last minute. The families are becoming increasingly suspicious that people do not want to discuss this issue, but it is an issue from which we cannot run away. The families lead their lives as best they can under extremely difficult circumstances. There is no escape for them. On a daily basis, life can be troublesome to say the least, and I suspect that life can often be very trying indeed. They have fought for decades, and they deserve some kind of light at the end of the tunnel, if that is possible. I gave an indication of this earlier, but is it reform of the legislation that we need or is it now time, 36 years after the original legislation was introduced, that we as parliamentarians sat down with the families and the pharmaceutical companies and asked, “Is there a better way of doing this?”? I honestly believe that we require not reform but a whole new concept of where we are going.

My right hon. Friend the Member for Coatbridge, Chryston and Bellshill (Mr Clarke) and I attended a meeting a few years ago when our good former colleague Ian Stewart was chair of the all-party group. We asked for a meeting with the pharmaceutical companies, which brought their legal teams with them. Those who know my right hon. Friend will recognise him as a placid and tolerant individual, but he walked out of that meeting, which he had not previously done in his entire political career. He was so disgusted with what the legal representatives of the pharmaceutical companies were saying that they tried his patience and he immediately left the room. He and, I hope, everyone in this room recognises the challenge that the families are going through. There is a better way of doing it, and I hope that today’s debate can be a starting point for us all.