I beg to move,
That this House has considered the compensation for people with narcolepsy and cataplexy linked to swine flu vaccination.
It is a pleasure to serve under your chairmanship, Mr Chope. I thank Mr Speaker for allowing this debate on an important issue, and I thank the Minister for being here to respond to the concerns that I will raise on behalf of my constituent, Lucas Carleton.
I begin by saying something about vaccinations in the broad sense. We are fortunate in this country to have a robust and comprehensive vaccination policy. The policy has saved countless lives since its incarnation almost 100 years ago. Through our vaccination programmes, and those of other nations, we have successfully eradicated diseases such as smallpox across the world, and have reduced the number of people affected by polio by something like 98% over the past three decades. To this day, the advice from mainstream medical professionals and the national health service is that everyone should be vaccinated, not only to protect themselves but for the wider benefit of the communities in which we all live.
Historically, we have seen the tragic consequences of terrible epidemics that vaccinations can protect us against. For example, during the ’20s and ’30s, Spanish flu killed more people than the first world war had. Vaccinations, which are often brushed off in our everyday lives as a painful exercise, save thousands of lives a year, reducing human suffering and misery on a huge scale.
There is no serious scientific debate among mainstream scientists about the benefits of vaccination to public health—medical advice is clear that vaccination is one of the most successful and cost-effective public health measures—but vaccination is not without controversy. There have been a small number of instances when vaccinations have been responsible for adverse reactions, causing sometimes long-term and sometimes irreversible problems. I stress that that is rare, but tragically it is the reason we are here today.
During 2008 and 2009 there was a global swine flu pandemic, also known as the H1N1 pandemic. The particular strain of flu originated in Mexico, but it quickly spread, leading to the World Health Organisation issuing its first ever “public health emergency of international concern” declaration. Cases were confirmed in 171 countries and more than half a million people are thought to have died as a consequence.
During the outbreak, the British Government decided to purchase enough swine flu vaccine to immunise the entire population with two doses, meaning that 120 million doses were ordered. Almost 99% of the vaccines that were given out were Pandemrix, manufactured by GlaxoSmithKline—GSK.
Vaccines, as with all pharmaceutical products, are subject to extensive clinical trials. However, it is recognised that during a pandemic the trials may not be as rigorous as they would otherwise be, because of the demand to safeguard lives. Completing mass trials can takes months or even years. For that reason, the European Union intervened and licensed Pandemrix for use within the EU, including the UK, without the completion of the normal rigorous trials. That was followed by advice from the UK’s Joint Council for Vaccination and Immunisation, which advised that the Government begin immunisation to protect against a swine flu pandemic in this country.
As a consequence of the speeding up of the licensing process by both the EU and national Governments, GSK was not prepared to supply the vaccine to Governments unless it was given indemnity from any liability. The UK Government gave GSK that indemnity. For a number of reasons, other countries were much more cautious about granting an early licence. For example, the Food and Drug Administration in the United States had a policy of not licensing adjuvant vaccines—that is where a substance is added to vaccines to increase the body’s immune response—without robust clinical trials demonstrating that they are safe. Adjuvant vaccines have additional chemicals that speed up the body’s immune reaction to the antigen, and it is considered that that sometimes increases the risk of adverse reactions. That possibility led other countries, such as Switzerland, to license Pandemrix only for adults and not for children.
Pandemic swine flu vaccinations were added to the Vaccine Damage Payment Act 1979 by the Vaccine Damage Payments (Specified Diseases) Order 2009 in September 2009. The vaccine was added to the Act for the duration of the pandemic campaign, which lasted from October 2009 to August 2010. The campaign ended when the Swedish and Finnish Governments expressed concerns about a vast increase in the number of paediatric narcolepsy cases in children under 10. The condition usually shows symptoms in those in the 15 to 30 age bracket. It was not until August 2010 that the Swedish and Finnish Governments discovered a link with Pandemrix. On 1 September 2010, Finland stopped vaccinating with Pandemrix. The UK Government discontinued the pandemic campaign from the same date, but encouraged GPs to continue vaccinating with Pandemrix where no seasonal flu vaccine was available.
Figures indicate that one in 2,000 people have narcolepsy that is not related to vaccination. When it comes to compensation, how would the hon. Gentleman ensure that those who are vaccinated and are due compensation actually get it?
The hon. Gentleman’s intervention is timely, because he raises the issue to which I now turn. Lucas Carleton is a young boy who lives in my constituency in Liverpool. On 17 January 2011, he was vaccinated with Pandemrix. He was seven years old at the time and was in good health. His mother, Pauline, asked her GP to vaccinate Lucas because a family friend had recently been very ill with swine flu and, perfectly understandably, she believed it was a responsible step to get her son vaccinated. A week or two after Lucas received the vaccination, he began to experience excessive daytime sleepiness, which is a common characteristic of narcolepsy. He also started falling when he laughed or got excited, made strange facial expressions and experienced a loss of control of his tongue. That is known as cataplexy and is a common symptom of narcolepsy. After two to three weeks, Pauline sought medical help from a GP and Lucas was taken to hospital on a number of occasions. In August 2011, he was diagnosed with narcolepsy.
Narcolepsy is an incurable neurological disorder that until 1999 was classified as a psychiatric condition. Its main symptoms involve excessive daytime sleeping, hallucinations, sleep paralysis, temperature control problems and cataplexy. Cataplexy is a side symptom of narcolepsy that causes involuntary muscle relaxation brought on, for example, by laughing or anger. Narcolepsy begins in the hypothalamus, the part of our brain that controls our autonomic nervous system, which involves processes such as breathing and the regulation of the heart. Narcolepsy occurs when the brain cells that produce neurotoxins in the hypothalamus are destroyed, either through a trauma or through the body’s immune system mistaking those cells as foreign bodies.
The Department for Work and Pensions has accepted that the Pandemrix vaccine is capable of causing narcolepsy in children. It has also accepted that, in many cases, Pandemrix did in fact cause narcolepsy in children. However, it disputes that narcolepsy amounts to a severe disability. That is an issue on which the DWP has been defeated in court, but I understand that it is appealing against the decision. Herein lies the issue: the 1979 Act recognises that there can be adverse reactions to vaccines that can cause severe and irreversible damage to patients. Since the Act was passed, around 900 people have been awarded compensation, which is a very small number when compared with the 650,000 children vaccinated every year. Compensation can range from £120,000 into the millions.
The pandemic swine flu vaccine was part of the 1979 Act from September 2009 until it was removed by the Vaccine Damage Payments (Specified Disease) (Revocation and Savings) Order 2010. That is preventing Lucas from claiming compensation, as he had the vaccine administered outside that period, in January 2011. If the pandemic swine flu compensation period was simply extended to April 2011, Lucas and others who had adverse reactions could claim compensation for the reaction to the vaccine.
The hon. Gentleman is making a powerful argument, and I congratulate him on securing the debate. My constituent Ben Foy sadly suffers exactly the same symptoms as Lucas, and the DWP has acknowledged that there is a link between Ben’s swine flu vaccination and the development of narcolepsy and cataplexy. The Department appears to acknowledge that he is disabled as a result, as Ben is in receipt of disability living allowance, but it is saying that his case is not severe enough and there are no grounds for that disability compensation. As can be imagined, the family feel that that is a complete insult. Does the hon. Gentleman have any thoughts on that?
I am grateful to the hon. Gentleman for making that point. While the focus of my remarks has been on the compensation period, there is clearly a related issue with the attitude of the DWP on the severity of disability. I concur with the important point that he raised on behalf of his constituent. A number of other families in other constituencies around the country are also affected, and I welcome the colleagues from all parties who are in the Chamber for this debate.
It is worth reiterating the point that the hon. Gentleman just made: the Government have accepted that there is a causal link between the vaccine and narcolepsy. Since 2014, the Department of Health has had responsibility for the 1979 Act, which is a welcome change. Bringing the Department of Health into the process should ensure that responsibility for the legislation is controlled by health professionals, rather than benefits officials. That shift of responsibility can be a good thing for constituents like mine who have outstanding compensation claims. I am asking the Department for Health to extend the compensation scheme to make it possible for all citizens who have life-changing conditions as a result of vaccines to claim compensation. That is not only important for the individual families suffering as a consequence of adverse reactions; it is crucial to ensuring public confidence in the vaccination system.
Does my hon. Friend agree that the quality of life of people who have been affected or damaged by the vaccine is dreadful and quite deplorable? We should be doing something as soon as we can to sort that out.
I thank my hon. Friend for making that point. He is absolutely right. In preparing for today, I was struck that some of the aspects of this subject are technical in character. It has been a little like going back to school and doing biology again in learning some of the terminology. What lies at the heart of the debate, however, is the lives of children and their families. I raised this issue on behalf of my constituent because I want to ensure that he and his family have the quality of life that any family should have the right to expect.
I was about to say that extending the compensation scheme is important not only as a matter of compassion and decency for the families concerned, but to ensure public confidence in the system of vaccination. There is barely a one in a million chance that people will react badly to a vaccine, so if it was certain that, were that to happen, there would be compensation, that would not only be right for the affected families but increase confidence in vaccination.
In conclusion, I am aware that the Department of Health has for some time been in discussions with the lawyer representing Lucas. I thank the Department for listening to my constituents’ concerns, but, on behalf of Lucas and his family, I urge the Minister to do everything she can to ensure that those discussions are brought to a successful conclusion.
It is a pleasure to serve under your chairmanship, Mr Chope. I congratulate the hon. Member for Liverpool, West Derby (Stephen Twigg) on securing this debate. I am aware that he has sought to support his young constituent and his family on this difficult matter for a number of years, and we have written to each other about this case previously. I was very pleased that, despite this sad case, the hon. Gentleman emphasised his general support for vaccination programmes. We are lucky to have a world-class national immunisation programme. Such programmes are a vital way of protecting individuals and the community as a whole from serious diseases, so I am grateful for his sentiments in that regard.
The hon. Gentleman referred to the global swine flu pandemic and the arrangements for licensing drugs during a pandemic. Flu pandemics are natural phenomena. They occur when a new flu virus emerges and spreads around the world and most people do not have immunity. Each pandemic is different. The nature of the virus, the population groups most likely to be affected and the impact cannot be known in advance. It is impossible to predict the severity of a new virus strain. Large swathes of the population can become infected over a relatively short period if transmission spreads rapidly. The potential impact of pandemic flu makes effective measures to limit the spread and morbidity of virus infection a public health priority. Countermeasures are employed in combination. Vaccination, when possible and appropriate, is one such countermeasure.
Thankfully, the H1N1 strain of swine flu turned out to be relatively mild, but we should not forget that it still caused more than 450 deaths in the UK. Pandemrix, the vaccine that the hon. Gentleman’s constituent received, was developed specifically for use in a flu pandemic when the number of lives lost and people with serious illness could not be known. Once a new pandemic strain emerges, it takes several months to produce batches of a specific vaccine to protect against it. As a pandemic strain of flu generally spreads rapidly, there is of course little time to undertake large-scale clinical trials. To address such constraints, the European Medicines Agency has a mechanism for the fast-track licensing of pandemic vaccines to address the immediate public health threat. The mechanism includes accelerated clinical trials while permitting the use of the vaccine in advance of receipt of all the required clinical trial data.
It would be unfeasible to conduct very large clinical trials in the midst of a pandemic, when time is of the essence, to identify risks that are very rare. Indeed, regardless of the pandemic situation, very rare potential risks can generally be identified only after a medicine or vaccine has been licensed and used in the wider population. All Governments have a responsibility to protect public health. The decision to commence the swine flu vaccination programme, which was made by previous Ministers in 2009, would have been based on the expert advice of the Joint Committee on Vaccination and Immunisation, an independent expert committee that advises Ministers in the Department.
Pandemrix was used against H1N1 swine flu in the UK from October 2009 to March 2010. It was used again on a limited basis in the following flu season until March 2011. The hon. Gentleman has noted that his constituent received Pandemrix in January 2011, during the seasonal flu vaccination programme for winter 2010-11, rather than the specific response to the swine flu pandemic in 2009-10. As he noted, that is highly relevant. He summarised his constituent’s experience and described the impact that narcolepsy and cataplexy can have on an individual. I very much assure him that I do not underestimate how distressing narcolepsy can be, for both those with the condition and their carers. Indeed, I was talking to a constituent about that very issue only this past weekend. I fully recognise the impact that narcolepsy can have on quality of life. It is important that anyone with narcolepsy, with or without cataplexy, receives the appropriate care and attention so that they can manage their illness.
At the time Pandemrix was used in the UK, no potential association with narcolepsy was known. Following suggestions of a possible association with narcolepsy, its use was stopped in the UK in March 2011, on the advice of the EMA. The hon. Gentleman referred to the Vaccine Damage Payment Act 1979, which was designed to help to ease the burdens on those individuals to whom, on very rare occasions, vaccination has caused severe disablement. The degree of disablement is assessed on the same basis as for the industrial injuries disablement benefit scheme. It would not be appropriate to comment on the case raised by the hon. Gentleman.
Despite the title of this debate, I would like to clarify for the House that the vaccine damage payment scheme is not a compensation scheme. The hon. Gentleman referred to compensation ranging from £120,000 to millions of pounds; in fact, the VDPS provides a one-off, tax-free lump-sum payment of £120,000. The scheme does not prejudice the right of the injured person to pursue a claim against the manufacturer of the vaccine. As the hon. Gentleman alluded to, his constituent is pursuing that course of action and, again, it would not be appropriate for me to comment further on that case.
I appreciate that the Minister cannot comment on an individual case in this forum and that the discussions are ongoing, but is she able to comment on the affected time period? It is the definition of the time period that is denying my constituent access to the scheme.
I am aware of that and will address it shortly, although I suspect the hon. Gentleman might be disappointed by what I have to say.
A VDPS payment is for those who are severely disabled as a result of a vaccination against those diseases listed in the 1979 Act and those that have been specified by statutory instrument since then. As I have already mentioned, the hon. Gentleman noted that his constituent received Pandemrix in January 2011; however, the Act relates to diseases, not vaccines. The list of specified diseases covered by the Act includes pandemic influenza A (H1N1) swine flu, where vaccination was administered from 10 October 2009 to 31 August 2010—the period of the swine flu pandemic. That was a temporary addition considered appropriate by Ministers at the time. The hon. Gentleman’s constituent’s vaccination was administered in January 2011, so it was not given for pandemic swine flu, which is covered by the Act.
GlaxoSmithKline was indemnified because there was an issue of risk—that is the whole point. Why are the Government not as quick to effectively indemnify the victims of this vaccine?
Perhaps it would be easier if I wrote to the hon. Gentleman after the debate to clarify that point.
As I have said, it appears from the timing that the constituent of the hon. Member for Liverpool, West Derby received the vaccine during the 2010-11 flu season. The 1979 Act did not cover seasonal flu vaccination at that time as it was not part of the routine childhood immunisation programme. Influenza was added to the Act as a specified disease in February 2015, but the order stipulated that the vaccination against influenza must have been administered after 1 September 2013, when flu vaccination became part of the routine childhood immunisation programme. Unfortunately, that will not assist the hon. Gentleman’s constituent. I am afraid that it is not possible to accept a claim outside the conditions laid down in the Act. I recognise that that aspect of the scheme has produced an unfortunate result in this case, but we must work within the confines of the law. The Act has been in place for many years on the basis of disease rather than vaccine, and the Government currently have no plans to change how the scheme is run.
Of course, I have sympathy for the case that the hon. Gentleman has made on behalf of his constituent, and I recognise the frustration and disappointment that his constituent and his family will feel at my response. This is a complex topic, with no quick or easy answers, as successive Governments have found. I stress, though, that the VDPS is only one part of the wide range of support and help available to severely disabled people in the UK. Other examples include the disability living allowance, which provides an important non-contributory, non-means-tested and tax-free cash contribution towards the disability-related extra costs for severely disabled children. I encourage the hon. Gentleman’s constituents to consider what other entitlements might be available. I know that the hon. Gentleman will continue to offer Lucas and his family every support in that regard.
Question put and agreed to.