Andy McDonald
Main Page: Andy McDonald (Labour - Middlesbrough and Thornaby East)(2 years, 11 months ago)
Commons ChamberRead Full debate Read Hansard Text Watch Debate
Jeff Smith
The hon. Gentleman makes a really important point, and I agree. I do not agree with everything that the devolved Administration in Scotland do, but they do have an approach to these sorts of issues that is more focused on harm reduction and evidence than perhaps we have in England.
Cannabis-based medicines are already approved as a treatment for a small number of medical conditions. Currently, the National Institute for Health and Care Excellence guidelines recommend four licensed cannabis-based medical products that can be prescribed in the UK. I will talk about the terminology in a moment, but there are two THC-based medicines—dronabinol, which is licensed for appetite loss in AIDS patients and as an antiemetic in chemotherapy, and nabilone, which is a synthetic cannabinoid medicine licensed for nausea in individuals receiving chemotherapy. There is also Sativex, a combined THC and CBD medicine, which is licensed for muscle spasticity in multiple sclerosis patients, and Epidiolex, a CBD-based medicine—it is 99.8% CBD with less than 0.1% THC—for the two rare childhood epilepsies, Lennox-Gastaut syndrome and Dravet syndrome.
I am referring to THC and CBD; it might be helpful if I say a few words about terminology, and about the nature of cannabis, ahead of my next remarks about the proposals in the Bill. The cannabis plant is made up of something like 147 cannabinoids. They are the compounds that act on the cannabinoid system in the human body. There are also over 100 terpenes, which are aromatic compounds; flavonoids, which are pigments; and four other minor sets of compounds, so it is quite a complex botanical plant.
The complexity of the plant and its compounds is part of the issue that I will try to explain shortly, but the two main types of compounds that I am referring to are tetrahydrocannabinol, or THC, which is the psychoactive ingredient—very broadly and slightly simplistically, that is the ingredient that produces the high that recreational users experience, but it is also a painkiller—and cannabidiol, or CBD. Broadly, CBD has a more sedative effect—a kind of chill-out effect.
CBD on its own is legal in many countries, including this one; it is the THC content that makes cannabis illegal for recreational use in many countries. Different strains of cannabis plant have different balances of THC and CBD, and cannabis medicines do too. For example, Epidiolex, which is one of the most used medicines for severe epilepsy, is overwhelmingly CBD and has a very small amount of THC. Sativex has a higher proportion of THC. That is important because different treatments and balances work for different patients, and sometimes people have to adjust and tweak their treatment to find out what is right for them. If I refer to full-spectrum cannabis extract, that is a cannabis compound concentrate that preserves the full cannabinoid and terpene contents of the raw cannabis plant, including CBD, THC and other compounds. That is the plant, which is the basis of the medicine.
I want to provide three case studies of the real-life effect of cannabis-based medicines. Probably the most famous case is Alfie Dingley and his mum Hannah Deacon, whose campaign for access to medical cannabis helped to change the law in 2018. Alfie was perfectly healthy until he was four months old, when he became constantly sick and began having seizures. The seizures continued for months and he lost every skill he had developed. He was diagnosed with auto-immune epilepsy. The amount of time between Alfie’s clusters of seizures shortened as he got older. By the time he was five, they were happening every week. Each time, he needed up to five doses of intravenous steroids, which had a really negative effect on his personality and behaviour. Eventually, Alfie was diagnosed with a rare epilepsy syndrome which affects only nine known boys worldwide. There are slightly more girls with the syndrome, but only nine known boys in the world.
Hannah, Alfie’s mum, was desperate for a solution. She researched anything that might help and came across medical cannabis, so she learnt about the human cannabinoid system and cannabis medicines. At the time, Alfie’s doctors were telling her that regular steroids would eventually kill him, so to Hannah, cannabis medicines seemed like his only chance. She began the campaign for Alfie to have a prescription of cannabis medicines in the UK, where they were illegal at the time.
Once the family had raised enough money, they moved, in September 2017, to the Netherlands, where they could get medical cannabis legally. There they gave Alfie an oil prepared from Bedrolite, which is made by the Dutch company Bedrocan. That is a standardised strain of cannabis plant, with full extract CBD oil. Over the next three months, Alfie’s seizures became less frequent. They added THC oil called Bedica, also made by Bedrocan, under the guidance of their paediatric neurologist. Alfie went without seizures for 40 days. When he did have the clusters, they were less intense and were controlled much more easily. His cognitive development improved greatly.
Living abroad, however, was really hard for the family. After five months they ran out of money, so they had to come back home to the UK. In the UK, they had to fight for a prescription that contained both CBD and THC. Eventually, as a result of the campaign led by Hannah and other families, and under immense pressure from those desperate families, the Government agreed to change the law to make medical cannabis legal. Alfie finally received an NHS prescription for the products he had found so beneficial in the Netherlands in November 2018. It is still one of only three prescriptions in the UK, and his family had to go through an unusual process and special approvals to get that medicine.
Three years later, Hannah has recently reported that Alfie has not had a seizure in over 500 days. Before his medical cannabis treatment, he was having 150 fits a week. Although cannabis medicines are not a silver bullet for everyone, they have been absolutely life-transforming for Alfie, Hannah and the rest of the family. Alfie’s is a particularly unusual syndrome, but the majority of children in similar situations have not been able to get access to medicines despite their now being legal.
Andy McDonald (Middlesbrough) (Lab)
My hon. Friend is making a fabulous speech and I am sure people will study it after the event. He mentioned Mike Barnes. Does he agree with me and Mike Barnes that the children who are outside the syndromes he is so expertly describing have nothing to lose by trying to see if cannabis-based products work for them? Is it not a grave injustice that those children are denied that opportunity?
Jeff Smith
My hon. Friend makes a really important point. They have nothing to lose. The problem is that we have to balance benefit and risk and, for this cohort of children and lots of medical cannabis patients across the country, the benefit is far greater than the risk. That is the frustration, and the problem with access to medicine is that lots of patients with different conditions would benefit massively and, if we are being honest, I think we all know that the risk is pretty low.
I want to contrast Alfie’s case with the story of another mum and her son who does not have a prescription for his epilepsy. This young man is now 18; he started having seizures in 2016 when he was 12—does that add up? I thought I had got my dates wrong, but that is correct. In 2017, after trying treatment on seven different anti-epileptic drugs and 16 different combinations, he was diagnosed with drug-resistant epilepsy. A cocktail of pharmaceuticals left him with impaired cognition, memory loss and an inability to process new information. He was still having regular seizures and was often in and out of hospital, requiring emergency treatment for status epilepticus: a seizure or a series of seizures that last for more than five minutes and can be fatal.
In 2018, desperately looking for anything that might help, the boy’s mum took him to the Netherlands, where a hospital agreed to treat him with Bedrolite. The doctors there eventually concluded that conventional anti-epileptic drugs were making his seizures worse and weaned him off them gradually, resulting in his cognition and memory improving. When they tried to wean him off the cannabis-based medicine, Bedrolite, his symptoms rapidly deteriorated and he almost died. He was put back on an increased amount of Bedrolite in combination with two newer anti-epileptics, and he has now been completely seizure-free for more than a year.
That young man’s health depends on Bedrolite, which is a fraction of the cost of the emergency hospital treatment that he used to require. His Dutch neurologist said that adults with uncontrolled epilepsy as severe as his would likely have to live in an institution for their whole lives. However, the young man writes:
“I’m now able to think about my future for the first time in years and want to go to art school. We are desperate to come home but I’m really afraid of the seizures starting again if I’m not allowed a prescription for Bedrolite. My mum and I are so scared of more seizures again and that I won’t be allowed to carrying on living a healthy life like I can now.”
As a result of the barriers to access in the UK, the mother and son are effectively living in medical cannabis exile in the Netherlands. That is not right.
The third example is not a child with epilepsy. Lucy Stafford has a condition called Ehlers-Danlos syndrome. She had been almost permanently in hospital, having suffered from joint dislocations after her first surgery when she was 10 and another 19 operations throughout her teenage years. Her condition deteriorated. She became bed-bound at 17. She said:
“I was kept alive by intravenous feeding tubes and taking fentanyl to ease the debilitating pain of dislocating multiple joints a day”.
As many people know, fentanyl is an opioid that has been responsible for a very large number of overdose deaths in the USA. We do not really want people to take it if there is an alternative. The alternative to lots of opioid treatments is, in my view, medical cannabis.
Lucy faced extreme pain from a permanently dislocated jaw, and when she was in hospital, she faced potential death from sepsis. Lucy’s pain specialist suggested medical cannabis as a last resort. The prescription was turned down for NHS funding, with a letter saying that cannabis was unlikely to work and that there was a one in four chance that she would end up with psychosis, so Lucy and her mother went to Amsterdam and sourced medical cannabis. Eventually, her jaw began to unlock. She was able to reduce her opiates and other pharmaceutical medications. She has since become able to walk unaided. She is now back in the UK and she started a degree in neuroscience at the University of Sussex this September.
Lucy’s private prescription for cannabis in the UK initially cost £1,450 a month. She is now enrolled in a medical cannabis trial called Project Twenty21 run by an organisation called Drug Science. I draw attention to my entry in the Register of Members’ Financial Interests: I am an unpaid trustee of Drug Science, which does fantastic work in its research into drugs. Project Twenty21 facilitates access to medical cannabis effectively at cost price, once patients have been seen and diagnosed by specialists, so Lucy’s medicine now costs her about £450 a month. As an example of the potential saving to the NHS, when Lucy was on a feeding tube her medication alone cost more than £250 a day, and the hospital room cost very much more. Overall, the estimated cost to the NHS is probably more than £100,000 a year. Despite the huge savings, her local hospital trust refuses to allow her physician to prescribe medical cannabis for her on the grounds of
“lack of evidence of efficacy”.
That is the key problem in the UK: the difficulty of getting through the barriers in the system. Lucy’s life has clearly been absolutely transformed by medical cannabis, but because of the systemic barriers, she has not been able to access it through the NHS. That is not logical in any way. It would make much more sense for the hospital trust to support her.
We know that cannabis-based medical products work for many patients. We know that they are legal. We know that they are effective. They are being privately prescribed by some specialists in the UK, but patients cannot get them on the NHS, so ordinary families are sometimes paying a fortune for their treatment. Some are having to go to Holland to get their medication.
One thing really demonstrates the absurdity of the situation. Because of import-export problems since Brexit, it has now become even more difficult to import Bedrocan products, which are the medicines produced in Holland, so the Government have done a deal that has facilitated the imports and licensed production facilities in the UK. Virtually nobody can get medical cannabis on prescription on the NHS, but the Government accept its efficacy enough to have done a deal with the Dutch Government to ensure a supply of Bedrocan for UK families and have even gone to lengths to start having it produced in the UK. It does not make any sense at all—it cannot be right.
Why are we in a situation where patients cannot get these NHS prescriptions? The general consensus is that it stems from a nervousness regarding the evidence and the guidance about these medicines, and a consequent reluctance of many clinicians to prescribe on the NHS. There are a very limited number who will prescribe privately: in the case of childhood epilepsy, there have been only three specialists willing to prescribe. One is now retired, and the others are not able to take on any more patients, so there is another blockage. There is also a reluctance among clinical commissioning groups and trusts to fund prescriptions; Lucy’s hospital trust is a good example.
At the moment, only a small number of cannabis-based medicines are licensed by the Medicines and Healthcare Products Regulatory Agency for the small number of specific conditions that I outlined earlier, so the cannabis medicines that are generally prescribed in the UK are unlicensed and prescribed as “specials”. Clinicians, even specialists, are sometimes reluctant to prescribe those unlicensed products. In the narrow pool of those who can prescribe, there is often a reluctance to prescribe unlicensed cannabis-based medicines, owing to a lack of knowledge and training; confusion over conflicting guidance from Government bodies such as the National Institute for Health and Care Excellence, and from the NHS and professional bodies such as the British Paediatric Neurology Association; a lack of confidence in the evidence base because of a lack of randomised controlled data; and ultimately a fear of repercussions because of the personal liability when prescribing an unlicensed medicine.
Currently, only specialist doctors on the General Medical Council specialist register are allowed to initiate a prescription, although GPs can carry it on under the guidance of a specialist. The specialists who do want to prescribe usually face barriers from their NHS trust or CCG, which normally declines to fund the prescriptions. If an NHS prescription is to be made, it has to go for approval to what is called a higher authority, usually a CCG or trust, which is usually reluctant to fund because of the problem relating to evidence and contradictory guidance. I should add that that process applies to no medicines other than medical cannabis.
For some time, campaigners have pressed the NHS and the Department of Health and Social Care to explain the process and the pathway that can deliver an NHS prescription in cases in which an NHS specialist wants to prescribe cannabis-based medical products. Perhaps the Minister could enlighten us, because although the Government committed themselves to doing that in 2019, it has not happened. The only solution suggested so far is an individual funding request, but we know that families who have tried to take that route have been rejected and told that the patient has not demonstrated clinical exceptionality. It is very difficult to obtain funds in that way. If the impact that medical cannabis has on that cohort of epileptic children with extremely rare and severe diseases is not deemed clinically exceptional, I would ask what is.
There are two ways in which we need to make progress. First, we need clinicians to be confident in the specials that they are able to prescribe, and we need NHS bodies to be confident enough to fund them. Secondly, we need more safe, effective cannabis-based medicines to be licensed. That is a key issue, because although there is a wide body of evidence for the efficacy and safety of cannabis medicines, it is largely patient-reported or observational and evaluative. The UK’s medical regulatory bodies generally only license medicines on the basis of randomised control trial data. I do not think anyone would deny that double-blind placebo randomised control trial data are the gold standard for medical trials aiming to demonstrate the safety and efficacy of medicines, but they are not the only way of demonstrating those qualities, and they are very difficult to carry out on whole-extract plant cannabis products.
Cannabis-based medicines are not made up of a single compound, and patients often use bespoke mixtures to treat their conditions most effectively. Let me quote Professor Mike Barnes, as my hon. Friend the Member for Middlesbrough (Andy McDonald) did earlier. He has said:
“While there are some RCTs”
—randomised control trials—
“for CBMPs”
—cannabis-based medical products—they are generally for isolates of those products, and
“the cannabis plant doesn’t lend itself to being studied this way as it’s a botanical product with several different components.”
Many experts, including Professor Barnes, would argue that we need to look at a different evidence base to demonstrate the safety and efficacy of whole-plant extract cannabis-based medicines.
Even Sir Michael Rawlins, the previous head of the MHRA and NICE, pointed out in 2008 that RCTs were not the only way of obtaining getting evidence. He said:
“Randomised controlled trials… regarded at the ‘gold standard’ of evidence, have been put on an undeserved pedestal. Their appearance at the top of ‘hierarchies’ of evidence is inappropriate; and hierarchies, themselves, are illusory tools for assessing evidence. They should be replaced by a diversity of approaches that involve analysing the totality of the evidence-base.”
There are many other sources of evidence that could equally inform medical practice. They could include patient reported outcome measures—PROM—trials, real-world evidence effectiveness trials, pharmacoepidemiology —I can never get that word right—which means looking at real-world evidence among a large group of patients, observational research, and n=l trials.
Andy McDonald (Middlesbrough) (Lab)
I confess to having been depressed many a time in this Chamber, but after that last contribution I cannot remember feeling as low as I do at this moment. [Interruption.] I ask Members please to take this Bill seriously. It is not in any way about telling medical practitioners what to do. I ask them please to read the Bill. The proposition opposite the argument around placebos that we would somehow look to a cohort in some other jurisdiction for available children to participate fills me with absolute and utter horror.
I rise to speak in support of the Bill, and in doing so I congratulate my hon. Friend the Member for Manchester, Withington (Jeff Smith) on his masterclass. If anybody needs to understand what Members have tried to persuade this place to do over many years, they should read that speech in Hansard. It was a comprehensive account. But we are here yet again. With respect to the hon. Member for South Ribble (Katherine Fletcher), she has taken us back years in going back to the basics—to the very beginnings of this debate—and I regret that bitterly. My hon. Friend has brought forward a modest, focused and eminently reasonable Bill, which I trust and hope will gain the support of the entire House.
The application of medical cannabis extends to and is of benefit to those with conditions such as intractable nausea, vomiting and chronic pain, but I want to focus my remarks on cases of epilepsy. We have had many a debate in this place about medical cannabis and heard incredibly moving stories from families about its wonderful efficacy in response to severe treatment-resistant epilepsy. Only last month, we had an excellent debate in Westminster Hall, secured by the hon. Member for South Leicestershire (Alberto Costa), who spoke with such eloquence and forensic accuracy about the efficacy of these treatments. We also heard from the right hon. Member for Hemel Hempstead (Sir Mike Penning), who has been a determined advocate in this campaign.
Notwithstanding the welcome change to the law to facilitate NHS prescriptions of medical cannabis, only three such prescriptions have been issued in the three years since 2018. As such, the parents of children with intractable epilepsy, knowing that the medical cannabis treatment they have procured works, with seizures much reduced or eliminated, have been left at breaking point emotionally and financially, having to find up to £2,000 a month to pay privately for this medicine. There can be no question but that those who issued those prescriptions did anything other than obey the Hippocratic oath.
None of us can imagine how on earth those loving parents cope with such massive costs. Up to £2,000 a month—that is the equivalent of an additional and very substantial mortgage; in fact, it would dwarf many people’s mortgage payments. Not even we MPs, on over £80,000 a year, could cope with that. How on earth can we expect those families to withstand those huge costs simply trying to keep their children alive and free from the ravages of seizures by accessing a known and proven prescriptive solution? That these families cannot secure NHS prescriptions for their children, when it has been proved beyond doubt that cannabis is efficacious, is a monumental shame. The campaign group End Our Pain rightly said that this saga has dragged on for far too long. Those families have petitioned, marched and campaigned with such dignity. They should not and must not be ignored.
The new Secretary of State for Health and Social Care was pivotal in the change in the law when he was Home Secretary. I urge him, the Minister and the Department to give effect to that change and remove all barriers to getting medical cannabis to those patients. The Bill will make an invaluable contribution to increasing prescription capacity by pointedly freeing up one of the blockages in getting these vital prescriptions to the people who desperately need them and who so evidently benefit from them.
It is a simple Bill with a mere three substantive, but very precise, clauses. The overall effect will be, first, to require the General Medical Council to operate a register of general practitioners who may prescribe cannabis-based products in England, changing the position from prescription only by consultants. It will also require the GMC to set the criteria to include training and professional development requirements to enable GPs to be on the register. It is up to each GP to decide whether they participate.
The second limb of the Bill will establish a commission to bring forward a framework for the assessment of cannabis-based medicines and their suitability for NHS prescription, and it will task such a commission with recommending measures to overcome barriers to gaining access to cannabis medicines on the NHS. I am sorry that the hon. Member for South Ribble is not in her place.
My hon. Friend the Member for Manchester, Withington has made provision in such a commission for the careful consideration of evidence other than from conventional controlled trials, including from observational studies and other countries where cannabis-based medicines are more readily prescribed. This is not a case of licking a finger and sticking it in the air. It is about proper research on which we can rely. We have heard it explained to us how randomised trials are not the appropriate way to go about business. In any event, that being held up as the gold standard is certainly open to debate.
I am afraid that the mantra of conventional random trials is simply inhumane. We have a situation where patients and their families know that this works, but the current system is trapped in inflexible and flawed processes that badly fail epilepsy sufferers, who have to mortgage all that they have to pay for these prescriptions or continue to suffer the ravages of seizures and often some dreadful side effects of powerful drugs. This Bill is a careful step along the way in addressing one small part of the blockage to sufferers getting the right treatments.
Somewhat belatedly, I must declare an interest, Madam Deputy Speaker, as I have a 26-year-old son with epilepsy and severe developmental delay and special needs as a consequence. I would like to explore further whether medical cannabis might be of assistance to him, but hitherto, the system is as resistant as the condition itself. He had two older brothers, one of whom we lost when he was just 16 years old, 15 years ago—colleagues will have heard me mention him before. I do not know whether medical cannabis would have helped him, had we even known about it then, but I will do everything I can to assist families right now in their determination to get the medication that their children need.
We were confronted with our beloved Rory locked in status. I recall so vividly calling the ambulance and having him whisked off to hospital, where the consultant told us we better call a priest, and then all of us, my wife Sally, my son Paddy and my daughter Rosie, holding Rory as he died. I never want to have any of those families suffer such an outcome. I bitterly regret that I have not shown the courage and determination of people such as Hannah Deacon in securing that medication for her child. How I wish I had been as wise as she. I beg right hon. and hon. Members not to talk this Bill out today, as they have been instructed to do, but to do the right thing and help to take this small step today, to remove one of the barriers placed in the way of people so desperately in need of these treatments and to give them access to this life-changing and indeed life-saving treatment.
Dr Rosena Allin-Khan (Tooting) (Lab)
I must begin by paying tribute to my hon. Friend the Member for Manchester, Withington (Jeff Smith), a fantastic campaigner who is working across party lines and with affected families up and down the country to make a real difference, both for those who are unable to obtain the treatment they need and for those who are left paying huge sums of money for private prescriptions. I also pay tribute to my dear and hon. Friend the Member for Middlesbrough (Andy McDonald), whose bravery in speaking today adds powerful testimony to this debate. I know 100% that his story echoes those of the people we are fighting for in this debate.
The objectives of this Bill, for me, are clear and simple, but I fear, listening to some of the contributions today, it has been misunderstood. It would be a huge step forward for patients who need access to medical cannabis, and it creates a register of general practitioners trained in medical cannabis who are allowed to prescribe it, in addition to the specialist doctors who are already able to do so. Inclusion on the register is on an opt-in basis for GPs. The Bill importantly creates a commission to propose a framework for the assessment of cannabis-based medicines and their suitability for prescription in England, to sit alongside existing Medicines and Healthcare Products Regulatory Agency processes for conventional pharmaceutical drugs.
I think it is very clear that what the Bill is asking for is a step forward with an end in sight for the pain, anguish and heartache, not to mention bankruptcy, experienced by many families. No one is saying that there should not be a robust examination of all evidence, but we are saying that there are current mechanisms in place to protect people on the medication and that, while we wait for some extremely timely processes, there are families who cannot wait and who are very clearly benefiting from the medication. It is very important that we recognise that.
The commission is also tasked with recommending any other measures to overcome barriers to access on the NHS, which has been mentioned. Those changes would be welcome, as they would certainly help to reduce many of the barriers patients currently face when attempting to access medicinal cannabis. Progress in making cannabis-based medical products available to those who need them has been extremely slow. As we have heard today, there are people who have transitioned from childhood to adulthood while waiting for further progress on something that is important. The impact of continued seizures means that there is developmental delay for young people—the children we are talking about—and their ability to achieve their full potential in life. We cannot ignore that.
Labour welcomed the fact that the Government accepted the therapeutic use of cannabis in 2018, but it still remains too difficult for suffering patients to obtain the treatment that they need. Despite that change in the law over three years ago, the vast majority of people who would benefit from cannabis-based medical products are still unable to access them through the health service. The campaign group End our Pain believes that only three prescriptions have been granted through the NHS. That is surely nowhere near the levels that this House, patients and the wider medical community would have anticipated.
Andy McDonald
My hon. Friend is making a wonderful summary and presentation. Is she as frustrated as I am by some of the contributions that have been made today, which seem to suggest that we need to start again when having this debate? We have been through this process. The law has been changed to allow the prescription of these products, yet all we have are three. Is it not really frightening that we are now challenging the original decision to change the law? That is what has happened today.
Dr Allin-Khan
Absolutely. I thank my hon. Friend for his contribution. To take any further step backwards from the progress we have made in a cross-party collegiate manner would be a travesty. We would be letting down families across the country.
Dr Mullan
With the greatest possible respect, I do feel that I understand the challenges that the hon. Lady is talking about. I will go on to answer her question about the fact that we have talked about it for a long time, so how do we move it forward? As I will explain, unfortunately, that applies to a very wide range of treatments and clinical practices in the NHS and across the world. This is about the appropriateness of picking out one specific area of clinical practice and using primary legislation as a way to overcome one particular problem. That is my concern.
Andy McDonald
The hon. Gentleman is failing to grasp that we have done it. The change has been made. What I am hearing time and again from Government Members is them rewinding and revisiting the process. The medications we are talking about are authorised and have been prescribed. We do not need to go through this exercise again—we have done that, and we want to move on.
Dr Mullan
I have explained that there are two challenges here. There are licensed, accepted treatments that are not being used, and there are very many examples across the NHS and healthcare globally of accepted, best practice, effective treatments that are not necessarily used as widely as they should be. We should not be picking out a particular treatment and using primary legislation as a mechanism to overcome that in one example; we should be working across the system and doing the hard work that has to be done to change clinical practices, as I will go on to explain.
In terms of reopening the debate, as I have explained, there is still a debate to be had about unlicensed treatments where there is not an evidence base for their use. We are talking about two things today, and I wish hon. Members would be more careful in understanding the distinction between the two and not—[Interruption.] That is the argument I have made. I will carry on and make progress on the other issues I wish to discuss.
Dr Mullan
I respect the experience that the hon. Member brings to her role. At no point have I said that the only way in which we can proceed is through RCTs. Earlier in the debate, when Opposition Members started talking in broad terms about observational studies and, to my mind, they were unfortunately disparaging RCTs, my comments were about being cautious. RCTs are incredibly important—they are fundamental to the vast majority of clinical medicine. I agree that other types of studies will be needed in some circumstances, but people need to make those arguments to the National Institute of Health Research. It is not for us as parliamentarians to override well-established processes designed to ensure that things are done in an appropriate, fair, thought-through and well-funded way.
Andy McDonald
The hon. Member is eloquent, but he is making a case for the commission. As the explanatory note says, the commission would be
“required to consider the role of evidence other than from conventional controlled trials, including from observational studies and other countries in which cannabis-based medicines are more widely available.”
So the net is wide. We are not pre-determining the evidence that would be considered. Opposition Members are saying that randomised control trials are not appropriate—we agreed on that; he has said that that is problematic—and there are other ways to look at this. We are not pre-determining it. We are saying that a commission of experts should do exactly that. Can he not see that he is speaking in favour of the Bill?
Dr Mullan
As my hon. Friend says, this is creating complexities and competing relationships that need to be given considerably more thought, rather than our aiming to promote a particular treatment.
We have talked about the risks. I now want to describe some of the many ways in which healthcare practitioners are held to account for their decisions. This is particularly important in relation to the unlicensed use of a medicine. First there is the sense of personal, moral or social responsibility that we would hope anyone involved in healthcare feels. Even if we do not necessarily take the Hippocratic oath any more, we are signed up on the basis of the fundamental principle, “First, do no harm”. Understanding that can be complicated, as I have tried to explain in relation to side-effects, for example.
Secondly, we are accountable to our employer. For example, a person working in a hospital is not free to practise as they wish. Their employer will have reasonable expectations that they ensure that their practice is safe, evidence based and works in the best interests of their patients. Increasingly, employers will place a big emphasis on following best practice guidelines from royal colleges, the National Institute for Health and Care Excellence and others that restrict their practice in some regard.
Andy McDonald
There is nothing in this Bill that will substitute our view and our professional assessment for that home medical practitioner. I want to congratulate the Members on the Conservative Benches: the clock is running down to 2.30 and they have successfully talked out this Bill. May I just ask anybody on those Benches to volunteer some explanation that I can take back to my constituents who wanted to see us make progress today, and we have not. By the way, can they also think of something that I may be able to say to my wife?
Dr Mullan
I think the hon. Member will understand that legislative progress is not an exercise purely in discussion. We should not be putting forward legislation if Members on one side of the House do not feel that that legislation should be passing into law. I am very happy to say that, for the reasons that I have outlined and will continue to outline, I do not feel that this legislation is appropriate, and I do that and will still sleep soundly tonight. It does not mean that I do not understand the deep concern, the hurt, and the anguish that individual parents are feeling. As I have said, I have worked in this field for a long time. There are very many people who suffer hurt and anguish in relation to treatments. I can talk about my own personal experience. My mother was diagnosed and treated for cancer. There was a period of a couple of years where I had seen a treatment that I wanted her to be on because I felt that it would be effective. There was some evidence to suggest that it was effective. We had to wait a couple of years for the further studies to come out, recommending that particular treatment. I have a young boy in my constituency, or a neighbouring constituency, whose family has raised an enormous amount of money to go to another part of the world to try a treatment that we do not consider to be sufficiently evidence-based—
Dr Mullan
I am not familiar with the discussions the hon. Member may or may not have had—I am sure the hon. Member did have them—with the Government in relation to pots of money. Again, I will gently say that there are enormous pressures on NHS budgets. That is why we have NICE, for example, to take out some of the emotion and personal feelings people have in relation to clinical care, and to try to look objectively at what secures value for money. I am not aware of what work the Department may have done on whether this represented an equitable use of resources for this particular area of clinical care. I will be happy to write to the Minister and make inquiries, as I am sure Opposition Members and the all-party group have done.
Andy McDonald
On cost-efficiency, does the hon. Member not agree that, considering the cost of emergency admissions to hospital and the use of intensive care and expensive medicines that do not work as effectively, this system would be a much better use of national health resources and would actually be a financial economic benefit to our nation, not a detriment?
Dr Mullan
I agree. I am sure that that is part of the reason why some treatments secured a licence and NICE approval. Again, we must not give the impression to people listening to the debate that the NHS’s systems are not engaging with this issue. I am sure that some treatments were approved. I am sure—or would hope, if the evidence is there—that future treatments might also secure approval as we go forward, particularly if the evidence is there to demonstrate that they are of use. I just reiterate that the things that Members on the Opposition Benches have been asking for have been happening. It may be at a rate that frustrates them, but I share that frustration, as do many others, and it goes across lots of different clinical treatments. I have direct experience of it, and it is not just an issue for the NHS; it is a global issue for modern healthcare systems when a vast amount of money is going into medical research with new treatments all the time. Governments need systems to decide which treatments they approve and so that they can look at the evidence properly. That is why we have the MHRA, NICE, the royal college guidelines and NHS best practice guidelines. All those things are in place.