Vaccine Damage Payments Act

Tony Cunningham Excerpts

Tuesday 24th March 2015 Westminster Hall

[Mr Brown]

My hon. Friend is exactly right. Today, we are looking at—it is in the debate’s long title—reform of this legislation. As will become clear as I progress through my contribution, we really need to reach a decision on whether this is about reform or about ripping it up, throwing it in the bin and starting again, because we have moved on significantly since 1979.

As I was saying, reform could be a win-win, in that we could promote social justice and ensure an increase in the rate of vaccination that would benefit society. I believe that vaccine manufacturers are strongly in favour of such a change and are willing to contribute to a fund—and, I hope, to discussions.

It is unconscionable to relegate so many people who are disabled to a battle over causation, and for justice, and it undermines rates of uptake of vaccines not to have an effective system. The numbers of those seriously injured are low, so the total cost of full compensation would be affordable and would be self-financed through the increase in vaccination and the reduction in the burden of disease in society.

Towards the end of last year, I met two parents down here in London. They related to me the stories of their daughters, who had both had a reaction to the human papilloma virus vaccine. We dedicated the last meeting of the all-party group, on 14 January, to hearing from some young women who were able to attend, but mainly from the parents of several young women who had had a severe reaction to the HPV vaccine. I think that it is safe to say that the majority of those cases centred on those young women now finding themselves profoundly affected by what can only be described as symptoms similar to those of ME—myalgic encephalomyelitis—or chronic fatigue syndrome. All those girls had been fit and healthy, were doing well academically and had the social life that we would expect any teenager to have.

[Sir Tony Cunningham (Workington) (Lab)]

To emphasise just how serious the consequences are, I point out that Steve Hinks’s daughter, to whom my hon. Friend may be referring, is often asleep for 23 hours a day. That is how serious the consequences are.

[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.