Sally-Ann Hart
Main Page: Sally-Ann Hart (Conservative - Hastings and Rye)(2 years, 4 months ago)
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Selaine Saxby (North Devon) (Con)
On sitting Fridays, I often find that we have much in common with Opposition Members and that, when we work together, such as through all-party parliamentary groups—the hon. Member for Gower (Tonia Antoniazzi) referenced such work—we are divided only by how, rather than whether, we will get there. I recognise what an emotive topic this is and send my deepest sympathies to the hon. Member for Middlesbrough (Andy McDonald), who shared his story. I am grateful not to have such a case in my inbox, because this is an incredibly emotional issue.
When we hear about individual cases of children and families with drug-resistant epilepsy who have found relief from whole-plant extract medical cannabis, all we want to do as human beings is help. Most of us came here to make people’s lives better, and we all want to expedite such things as far as is possible. I am a mathematician by training—I will not draw on medical GCSEs and A-levels—and, as I do not have such a case and therefore an emotional tie, I would like to use logic and talk through what the Government have done to make progress in the area before looking at the specifics of the Bill and how we have, hopefully, started to make some progress.
In November 2018, cannabis-based products for medicinal use, known as CBPMs, were rescheduled under the Misuse of Drugs Regulations 2001 from schedule 1 to schedule 2, as detailed in the excellent opening speech by the hon. Member for Manchester, Withington (Jeff Smith). I thank him for bringing the matter to the House to enable us to speak on it again. The change followed advice in July 2018 from the UK Government’s chief medical adviser and the Advisory Council on the Misuse of Drugs, both of whom said that the rescheduling of such products would facilitate the development of clinical evidence.
I have not been in this place that long but, for most of my two years here, we have been in a global pandemic. Again, my heart goes out to the families tied up in this, but the pandemic has slowed down medical trials and treatments for a huge number of people. My hon. Friend the Member for Crewe and Nantwich (Dr Mullan) referenced the need for research in the area. In the last 12 months, 18 trials of cannabis-based products for medicinal use have come forward, and six are now complete. Things are therefore moving, although perhaps not at the pace that we would like.
Since the change in the 2001 regulations, doctors on the General Medical Council’s specialist register have been able to prescribe an unlicensed CBPM if clinically appropriate for their patients. As we have heard, the law allows GPs to prescribe these products under the direction of a specialist as part of a shared care arrangement. Currently, all the CBPMs prescribed by specialist doctors are, as we have discussed, unlicensed medicines, which unlike licensed medicines have not undergone rigorous tests for quality, safety and efficacy. As has been said so passionately, such unlicensed medicines are treatments of last resort, and patients at that stage in their treatment pathway will be under the care of a doctor with specialist knowledge in their field and all the treatment options to take responsibility for such prescribing.
As we know, access to medical cannabis has been debated at length in both Houses. However, while it is understandable that these campaigns continue for greater access to unlicensed cannabis-based products for medicinal use funded by the NHS, as detailed so beautifully by my hon. Friend the Member for Dover (Mrs Elphicke), these products have not had their safety, quality or efficacy assessed or assured by the Medicines and Healthcare products Regulatory Agency or their clinical and cost-effectiveness assessed by the National Institute for Health and Care Excellence, otherwise known as NICE, which is the basis for NHS routine funding.
It is critical to progressing public funding decisions that manufacturers of those products invest in those clinical trials and prove that the products are safe and effective so that more of our constituents are able to access them. The National Institute for Health Research remains open to receiving good-quality proposals for research in this area. The latest clinical guidelines from NICE demonstrate a clear need for more evidence on the clinical and cost-effectiveness of the unlicensed medicines.
Sally-Ann Hart (Hastings and Rye) (Con)
On the NICE guidelines and the clinical evidence, does my hon. Friend agree that all medication, whether cannabis-based, heroin-based or cocaine-based medication, must have rigorous testing through clinical trials so that we understand the possible side-effects and everyone—GPs, all doctors and patients—has full knowledge in making the ultimate decision on whether a drug should be prescribed?
Selaine Saxby
I agree with my hon. Friend: it is vital that we fully understand the side-effects of these drugs that we know, when used in the wrong way, have clinical downsides.
The Government continue to support the establishment of clinical trials with NHS England and the National Institute for Health Research, but they have been clear that the law enables lawful access where deemed clinically appropriate. The most significant barrier to access on the NHS is the lack of evidence on the quality, safety, and clinical and cost-effectiveness of these products. That sounds uncaring, but I want to revisit the black-and-whiteness behind the terrible emotion tied up with these individual cases.
I understand that the Royal College of General Practitioners is supportive of the Government’s position that, until the evidence base has developed further, GPs should not be asked to initiate prescribing these products independently of a specialist. I suspect that trust in doctors in this particular area is well placed, which in my mind makes clauses 1 and 2 hard to support.
There is indeed clear merit in understanding, then overcoming any barriers to accessing unlicensed cannabis-based medicines on the NHS. That is why in March 2019 the then Health Secretary commissioned NHS England and NHS Improvement to review NHS systems and processes and identify and recommend any actions necessary to addressing barriers to clinically appropriate prescribing of unlicensed cannabis-based medicines on the NHS.
The findings of that review were reported in August 2019 and the majority of recommendations have now been implemented. Since this work has been undertaken recently and the recommendations acted on, I find it hard to support clause 3 of the Bill, as so much has already been achieved by non-legislative means. I very much hope that trials will progress to enable more families to access this treatment, and I take this opportunity to thank the hon. Member for Manchester, Withington for introducing his Bill.
Sally-Ann Hart (Hastings and Rye) (Con)
I welcome this important debate brought by the hon. Member for Manchester, Withington (Jeff Smith). Since 1 November 2018, cannabis-based products for medicinal use have been listed in schedule 2 to the Misuse of Drugs Regulations 2001. The change in law was based on expert advice from the chief medical adviser to the UK Government and the Advisory Council on the Misuse of Drugs, both of whom said that the rescheduling of such products would facilitate the development of clinical evidence.
All of us in this House have enormous sympathy with individual cases. I pay tribute to the hon. Member for Middlesbrough (Andy McDonald) for telling his family story, which I heard with great sadness and compassion. We also have a wider duty to safeguard through clinical evidence. I feel strongly about safeguarding.
A change has also occurred in that specialist doctors included on the General Medical Council’s specialist register can now prescribe cannabis-based products for medicinal use where clinically appropriate and in the best interests of patients. GPs may prescribe licensed cannabis-based medicines subject to any restrictions under the product’s marketing authorisation, but the law prevents GPs from prescribing unlicensed cannabis-based products for medicinal use unless it is done under the direction of a specialist doctor. That, at the moment, until we have more licensed cannabis-based products, is there for safeguarding purposes.
There are licensed cannabis-based products—not very many, but I think there are two or three—already routinely available on the NHS, and access to those licensed products has been promoted. For example, the chief pharmaceutical officer recently issued a reminder to clinical commissioning groups and the NHS trusts in England, highlighting that Sativex, for example, is recommended by NICE and available on prescription. There is also cannabis-based epilepsy medication available.
On Sativex, I wonder whether that sort of cannabis- based medication would have helped my aunt, who died aged 38 from multiple sclerosis. By the time she died at 38, she was practically blind and wheelchair-bound, so I feel very strongly that the right medication must be clinically looked at and evidenced in order for the right prescriptions to be made.
Mark Fletcher
We have heard a number of incredibly personal stories of family members or constituents today, but my hon. Friend’s point is that we should not only let the personal impacts influence us, but ensure that the evidence comes forward as well. Does she agree that it is vital we have both in this debate?
Sally-Ann Hart
I thank my hon. Friend for that comment. Very often in political debate we are driven by emotion, and that is right, because we have that emotion driving us forward to make change. However, that emotion must be tempered sometimes by evidence. When we are trying to get legislation through Parliament, we all know that there must be a good evidence base for us to work with to drive that legislation through.
In addition to the licensed cannabis-based products, since the change in regulations, doctors on the GMC’s specialist register have been able to prescribe unlicensed cannabis-based products for medicinal use if clinically appropriate for their patients. The law allows GPs to prescribe those products under the direction of a specialist, as part of a shared care arrangement.
If a GP decides to accept ongoing shared care responsibilities and prescribing, they must be competent to exercise their share of clinical responsibility and confident and happy to accept the associated legal and professional responsibilities of doing so. It is right that we put those decisions in the hands of specialist clinicians, those with the best knowledge of all the treatments available for the conditions they are specialist in.
However, the law did not relate to funding those products within the NHS, which is governed by a range of processes and procedures to ensure equitable distribution of funding, prioritising funding for those medicines that have proved their safety, quality, whether they work and their cost-effectiveness. This is where the evidence base is vital.
Currently, almost all cannabis-based products for medicinal use prescribed by specialist doctors are unlicensed medicines, which, unlike licensed medicines, have not undergone rigorous tests for quality, safety and efficacy. They are treatments of last resort, and patients will be at a stage in their treatment pathway where they will be under the care of a specialist doctor who has expert knowledge of their field and of all treatment options and will take responsibility for prescribing. Prescribing is limited to specialist doctors because it is important that that restriction forms part of the checks and balances that the Advisory Council on the Misuse of Drugs asked the Government to put in place when rescheduling cannabis-based products for medicinal use to minimise the risk of misuse and diversion. No matter how much we all want to see a change made, we are all aware that unfortunately there are people out there who would use medical cannabis as an excuse for recreational drug use. We have to avoid that at all costs.
Ben Everitt
On specialist prescribers, perhaps the barrier is not just the fact that prescription is limited, but the stigma around it. GPs are reluctant to engage with anything to do with cannabis because they almost feel that they might get professional blowback as a result of prescribing it.
Sally-Ann Hart
My hon. Friend raises a very good point. I would add that perhaps the reason why GPs are not forthcoming when it comes to working with specialist doctors is that they want to prescribe medicines that they know have been rigorously tested and to be aware of the possible side effects. We have to be aware that GPs take an oath, as my hon. Friend the Member for South Ribble (Katherine Fletcher) said, and part of that oath is that they will not do anything that will damage a patient. If a GP cannot be sure of the side effects or sure that drugs have not been rigorously tested with clinical evidence, they will be less inclined to offer those drugs.
Dr Hudson
There has been a lot of commonality today in the quest for increased knowledge about what is going on and for improving the evidence base, but also for the confidence of practitioners in being able to prescribe. Does my hon. Friend agree that it would unite us across the House if there were a renewed impetus from the Government to increase the information for medical practitioners about what can be done, so more of them can be confident in doing it, as well as a renewed impetus for the funding for research trials? That would give us a common momentum towards what we are all hoping to achieve.
Sally-Ann Hart
I thank my hon. Friend for his points. I have now forgotten his first point—I apologise for that—but I will come on later to clinical trials and the funding for them. Could he repeat his first point?
Dr Hudson
It was about renewed impetus from the Government to improve the outreach of information to medical practitioners so that more of them are aware of the licensed products, their capabilities and the clinical indications. As a veterinary surgeon, I feel very sympathetic to my colleagues in the medical profession, who want to be able to treat their patients with the best evidence base and the best information possible. Ministers could renew the impetus for more information for practitioners, as well as more funding for research. Those were my first and second points.
Sally-Ann Hart
I thank my hon. Friend so much. I just want to reiterate that the chief pharmaceutical officer recently issued a reminder to clinical commissioning groups and NHS trusts in England, highlighting the fact that cannabis-based drugs are available. What my hon. Friend is suggesting is that GPs need to be given even more regular information.
Jeff Smith
Immediately before the last few interventions, the hon. Lady said that we all know that people would try to use medical cannabis as recreational cannabis. I have to ask her where the evidence is for that. The fact is that these medicines are not the same as recreational cannabis. Look at Epidiolex or Bedrolite: people do not use them to get high. We are talking about completely different things. I really think that that is a red herring that the hon. Lady should not have thrown in.
Sally-Ann Hart
I thank the hon. Gentleman for his comments. I retract the statement that “we all know”, but there is a risk that some people may use medicinal cannabis as an excuse for growing cannabis for recreational use.
James Daly
My hon. Friend is making a very good speech. I fully accept the points that other hon. Members are making, but when the law was changed in 2018, it was not changed with a proviso that there had to be a certain amount of medical evidence to support the use of non-licensed cannabis treatments. It gave specialist practitioners the right to suggest that those products should be used. The problem a lot of the time, as my hon. Friend the Member for Carshalton and Wallington (Elliot Colburn) said, is that the clinical commissioning group—the people with the money—will not financially support such a recommendation. There are two sides to this, but a lot of practitioners do want to make sure that these medications come in and are used to support treatments at the earliest opportunity.
Sally-Ann Hart
I am sure the Minister has heard my hon. Friend’s comments and will take them on board.
Sally-Ann Hart
I will give way, but can I then make some progress? Is it on this point?
Mark Fletcher
It is slightly separate, as I am going back in my hon. Friend’s speech, but I thank her for giving way. She has taken many interventions, and I think she is doing a marvellous job. I want to go back to her point about specialists being able to prescribe versus GPs. I have a particular concern about the pressures on GPs at the moment, particularly coming out of the pandemic and the fact that there is such demand and such a backlog in the system. My concern is that this is a further complication that GPs would have to work through. Although I am not necessarily against the thrust of where we are going with today’s Bill, does she share the concern that GPs have a lot on already?
Sally-Ann Hart
I would agree with my hon. Friend on the basis that GPs have a lot on at the moment. I know that they are having to get involved in the roll-out of boosters and more vaccinations for covid. Therefore, when doctors in general practice are actually looking after patients, whether face to face or in a telephone conversation, they need to have the certainty, surety and confidence that whatever they are prescribing for their patients has been approved by NICE or whichever organisations are required to approve our medicine prescriptions.
Ben Everitt
I am very grateful for my hon. Friend’s generosity, and perhaps this intervention may allow her to pivot to the rest of her speech. We are almost in a chicken and egg situation now, with only three treatments available through the licensing system, but needing to get so many more through. With GPs or prescribers having only those three to choose from and really not trusting all the evidence before them, we need more evidence. This goes back to what my hon. Friend the Member for Crewe and Nantwich (Dr Mullan) said about needing more hard evidence to give the licensing authorities the confidence to push these things through and, crucially, GPs and prescribers the confidence to be able to make the call about whether these things are the right medicines for the right people. Again, as he pointed out, not every treatment is suitable for everybody, and we need to be absolutely clear that we have the evidence to show that the side-effects are minimal for all groups before prescribers make such calls.
Sally-Ann Hart
Yes, I absolutely agree with what my hon. Friend says, and I will be coming to the call for evidence a little bit later in my speech—
Sally-Ann Hart
Can I just finish one sentence?
I will be coming back to the need for more evidence and for manufacturing businesses to come forward, because there is huge potential. There is huge potential for manufacturing businesses and pharmaceutical companies to come forward with evidence to expand the amount of cannabis-based products that will and should be available on prescription from the NHS, so that the mothers who are trying their best for their young people and children are not having to pay a fortune to get this medicine privately.
Barbara Keeley
It is obvious to see what is going on here—Government Members are trying to talk out the Bill—but an argument was made in the previous intervention that we needed more evidence. This Bill would provide that, because it would bring forward a commission that would consolidate evidence and give a suitable framework for assessing cannabis products. That is what it is all about. Government Members worried about evidence should vote for the Bill.
Dr Mullan
Yes. I gently ask Opposition Members to consider whether they can think of any example where we have used primary legislation to further the advance of research for a particular series of treatments. It is not how we do it. There is a whole series of programmes and ways in which we do that in our NHS, and primary legislation is not it.
Sally-Ann Hart
I agree with my hon. Friend, because we have a regulatory pathway in place—I will come back to this a little later, when I can move on with my speech—under the Misuse of Drugs Act 1971 regulations and medicines regulation, through which cannabis-based medicines have already been approved for use in the NHS.
To go back to prescribing, the prescriptions are limited to specialist doctors and GPs working with those specialist doctors. They are not the first-line treatments, and patients will always be at a stage in their treatment pathway where they are in the care of a specialist doctor. While the evidence base remains limited—we have all spoken about how important it is to ramp up that evidence base—it is right that the decision to prescribe unlicensed products lies essentially with specialist doctors, because they have that expert knowledge in their field, and they take the responsibility for prescribing.
I completely understand why some groups have campaigned for greater access to unlicensed cannabis-based products for medicinal use funded by the NHS. However, I feel very strongly that these products—we are looking at a drug that has multiple chemicals in it, and I will come back to that later—have not had their safety and quality, and whether they work and are efficacious, assessed or assured by the Medicines and Healthcare Products Regulatory Agency or their clinical or cost-effectiveness assessed by NICE, and that has to be the basis for all NHS routine funding. The NHS has a duty of care. People trust it. We trust the NHS. We trust our doctors to ensure they are giving us the best possible advice and prescribing the best possible medicine that has been rigorously tested and has a clinical evidence base.
When GPs are looking at medicines and whether something is approved, they are looking at a cost-benefit analysis. Throughout covid, we have been looking at what age to give people vaccines. At the beginning, a cost-benefit analysis was made about whether the benefit of giving an over-18 a vaccine outweighed the cost or risks involved. We have to be very careful about that when taking any medication forward.
It is critical to progressing public funding decisions that manufacturers of these products invest in clinical trials and prove that their products are safe, effective and work. The National Institute for Health Research remains open to receiving good-quality proposals for research in this area as a priority, and it is clear, as I said earlier, that there is huge potential in cannabis-based medicines. Manufacturers need to ramp up putting quality proposals forward for research, so that more cannabis-based medicines can be approved for NHS use. That is not for us in this House to dictate, but for those businesses to put forward their proposals to get clinical trials going, so we have a much wider selection of drugs available for NHS prescriptions.
Lia Nici
Does my hon. Friend agree that it is not just about drug companies missing out on a huge business opportunity, as well as the health benefits? It is for the NHS and clinical commissioning groups to ask for, and to promote the fact that they are looking for good-quality research and good-quality products to put in their systems.
Sally-Ann Hart
I agree with my hon. Friend. That reminds me of a request I made to our local CCG. It is up to MPs to lobby local CCGs and for constituents to lobby their MPs. I lobbied our local CCG recently with regard to—[Interruption.]
Katherine Fletcher
I apologise for the heckling of nerdery. Neurofibromatosis.
Sally-Ann Hart
I thank my hon. Friend for prompting me to remember it. Neurofibromatosis is a terribly rare disease. It would be great if we could have the café au lait marks put in children’s red books, but of course we need the evidence base to do that. I lobbied our local CCG to see if it could do that and I know it has been taken higher up the chain to see what evidence base we need. I quite agree with my hon. Friend the Member for Great Grimsby (Lia Nici), because we can lobby and the CCG can do the same.
Mark Fletcher
On both sides of the House, there is a clear demand to see that evidence base come forward. We are sending a very powerful message to companies and manufacturers by saying, “Please provide us with this evidence, because we want to go in the same of direction”. My hon. Friend is doing a very good job on that front.
Sally-Ann Hart
I thank my hon. Friend for his comments. I agree that there is huge scope for the pharmaceutical industry in this area.
The latest clinical guidelines from NICE demonstrate a clear need for more evidence on the clinical and cost-effectiveness of unlicensed medicines to support routine prescribing and funding decisions on the NHS. That is why access on the NHS remains limited and prescribing is almost entirely within the private sector. We have to ask why there are so few licensed products. As we have all highlighted today, that is up to manufacturers and we cannot force manufacturers to apply for marketing authorisation. It has to come from them. While we can encourage, as my hon. Friend the Member for Great Grimsby pointed out, we are dependent on manufacturers being prepared to subject their products to rigorous clinical trials to demonstrate their benefits; and to demonstrate that those benefits outweigh any significant risk, as well as the cost-benefit analysis and the fact that they provide a material benefit over and above more established treatment options.
The MHRA is well equipped to provide independent advice to researchers and companies wishing to conduct clinical trials in the UK. We need to get the message out that they are there waiting for manufacturing businesses to come forward with their clinical trials. The MHRA, which is rightly recognised internationally for requiring the highest standards of quality, safety and efficacy, will assess any information submitted in support of applications for marketing authorisations.
I shall move on briefly to clause 3, which proposes that a commission be established to
“propose a framework for the assessment of cannabis-based medicines and their suitability for prescription in England”.
As I have discussed, there is already a regulatory pathway in place under the Misuse of Drug Regulations 2001 and other medicines legislation through which cannabis-based medicines have been approved for use on the NHS.
Jane Hunt
Is this more about trust? If the regulations are in place, that would give GPs and other medical professionals the chance to be bold. This is a bit like what I said to the Secretary of State for Education about the dreadful case of poor Arthur, which was about social workers having the opportunity to be bold. We should recognise that these people have years of professionalism behind them, so why not give them the opportunity to be bold? The Bill proposed by the hon. Member for Manchester, Withington (Jeff Smith) has given us an opportunity to say, “We support you to make those decisions. Please make them and let us have that evidence as well.”
Sally-Ann Hart
I agree with my hon. Friend. We all have huge sympathy with the Bill. I hope that, with the debate and the discussions going on today, we all—the manufacturers, the Ministers and us—are emboldened to look at how we can promote the matter and engage with manufacturing industries so that we have a better choice of cannabis-based medicines for prescription purposes on the NHS. It is important to note that.
Obviously, as has been discussed today, we are all aiming for the same thing. We sit as Members of different parties in this House, but we very often want the same thing. We want to create a better healthcare system. We want to create a better medicine prescribing system. We want to reduce poverty and disadvantage. We want to create better education systems and so on. Sometimes, though, we have a different way of doing it. That is what the debate entails; it is about the way that we do things.
Tom Randall
I have been listening intently to my hon. Friend. During the course of the debate, we have heard from many self-professed science geeks, talking about the nature of cannabis and other issues. Given that we are talking about primary legislation here, and given my hon. Friend’s background as a solicitor, I wondered whether she had given any thought to the usefulness or the appropriateness of using primary legislation to achieve the goals that the hon. Member for Manchester, Withington (Jeff Smith) seeks to achieve by bringing this Bill before the House this afternoon.
Sally-Ann Hart
I am not a science geek. I would not even say that I was a legal eagle geek, but I do understand that primary legislation is very important in certain circumstances, but perhaps in this sort of situation it is not the right route to go down, because there are so many other methods that are perhaps better—methods where you involve the manufacturers, the doctors and clinical staff—
Tonia Antoniazzi
What has been put to the House today is a solution and a way forward following almost four and a half years’ work. Every single option has been explored, and it really disappoints me to see hon. Members from the 2019 intake talking out the Bill because they have been told to do so. All the Government want to do is kick the can down the road. That is not acceptable, and it is not a way forward. We all have empathy and sympathy for these families, so let us get something done and let us use this Bill to move forward.
Sally-Ann Hart
I thank the hon. Lady for her passion. The whole point of debates in this Chamber is to properly scrutinise proposed legislation so that we make the right decisions.
Sally-Ann Hart
I will give way in a minute.
We already have legislation and pathways in place. The Government have made big inroads on facilitating cannabis-based products for NHS prescription. We are on the path. Do you think primary legislation will force the hand of pharmaceutical companies or manufacturing businesses to bring forward products for clinical trials?
Tonia Antoniazzi
That is quite incredible. I invite every Conservative Member to join the APPG on access to medical cannabis under prescription, to understand better where we are. We are not in a good place. We have explored all the options, and this is not a request for big pharma to come in. I used to play rugby, and I have a friend who followed me in playing for Wales. She is a wonderful woman, and her child is now going on to Epidiolex because the family cannot afford to go on to Bedrocan. She knows she has to give Epidiolex a chance, but she knows it will not work and she is not being given the option because of the two-tier system this Government created.
Madam Deputy Speaker (Dame Eleanor Laing)
Before the hon. Lady answers the intervention, I must ask her not to use the word “you.” When one says “you,” one means the Chair. I have not interrupted the flow of her speech, but she has said “you” a few times, and I would be grateful if she would say “the hon. Lady” rather than “you” because “you” means the Chair.
Sally-Ann Hart
Thank you for your advice, Madam Deputy Speaker. I take it on board, and I apologise for using that term in the House. I know I should not be saying it. When you are—[Laughter.] When one is going with the flow, it just comes out.
Madam Deputy Speaker
For the sake of clarity, it is okay if the hon. Lady says “when you are” when she means “when one is” because it is vernacular. I would not be so pernickety as to pick her up on that, and it is absolutely fine.
It is not often that I have the chance in a quiet House to clarify the rules that a lot of people do not understand, and that the hon. Lady clearly understands very well indeed. There are good reasons for the rules. It is not some old-fashioned tradition that we are sticking to because it is a tradition; it is because it changes the tenor of the debate. She is proceeding perfectly properly.
Sally-Ann Hart
Thank you, Madam Deputy Speaker. I understand that we have to use the right terminology because it depersonalises the debate, which is most important.
I am not sure whether I answered the intervention by the hon. Member for Gower (Tonia Antoniazzi), but I had better move on.
Barbara Keeley
The hon. Lady is talking about needing a debate on the Bill, but that debate could happen in Committee. All the points that Conservative Members are making—excruciatingly slowly to spin out the time and talk out the Bill—could happen there. The way that the legislative process works is that we get to Second Reading and vote for the Bill, then the details that Conservative Members are so keen to bring up now can be thrashed out in Committee. Let us make some progress.
Sally-Ann Hart
I thank the hon. Lady for her intervention, but if we only had debate in Committee, many hon. Members would not get to put forward their view, because they might not be on that Committee.
Sally-Ann Hart
Hon. Members have made great strides today.
To go back to clause (3)(1)(a), which proposes that a commission should be established to,
“propose a framework for the assessment of cannabis-based medicines and their suitability for prescription in England”,
I have already said that there is a regulatory pathway in place under the Misuse of Drugs Regulations 2001 and medicines legislation. It would be inappropriate to establish a commission or any other body that aimed to circumvent existing regulatory controls or to subject medicinal cannabis to any less stringent assessment than is the case for other medicines used for serious or chronic conditions.
Mark Fletcher
One of my difficulties with the Bill is with clause 3 and the precedent it would set that the House effectively gets to decide which medicines we should prioritise and for which conditions. Does my hon. Friend share my concern that, if we go down that route, we undermine our independent regulatory system that is based on science and evidence?
Ben Everitt
On that point, broadly, not many of the tricky problems that we deal with in this place are solved by the addition of more Government. Certainly, the danger of undermining NICE and the role of CCGs should not be underestimated. We need to take action to speed up the licensing of drugs as they come through, but I do not think that more Government is the way to do it.
Sally-Ann Hart
I agree on that point, and I wholeheartedly agree that we need to take more action to speed up the registering of prescription drugs, particularly if they are cannabis-based and there is an evidential base that they help many people who are in desperate need of that sort of medication.
The legislative changes presented in the Bill will not improve or expedite the development of the evidence required to support routine prescribing and funding on the NHS. I have raised the issue that manufacturing businesses and pharmaceutical companies need to come forward with their products for clinical trial. That is the most important thing.
I welcome the fact that the Government continue to support the establishment of clinical trials with NHS England and the National Institute for Health Research. From 1 April, a national patient registry was introduced to record patient outcomes. We talk about the amount of funding to do this or to do that, but we need closely to examine outcomes, because we need to know whether whatever goes in has a beneficial effect at the other end; that is vital, and we all have to take responsibility to ensure that it happens.
In recent years, there has been a lot of research into how medicinal cannabis can help epilepsy, mainly involving children with rare and serious epilepsy syndrome. Most studies have focused on CBD. The studies suggest that CBD may be an effective treatment for some rare types and hard-to-treat forms of epilepsy. There have been reports of side effects in about one in three people taking CBD, including drowsiness, reduced appetite and fatigue.
Most studies look at cannabis as an additional treatment for those who already take a number of prescribed epilepsy medicines, so it is difficult to tell whether cannabis works when taken on its own, and we have to be honest with ourselves about that. In addition, there do not appear to be any studies comparing medical cannabis with other medicines already licensed for treating epilepsy, so there seems to be no evidence—or not enough evidence—on whether medical cannabis is more or less safe, or more or less effective, than other epilepsy treatments.
Tonia Antoniazzi
I thank the hon. Lady for her generosity, but it is very frustrating to be sitting on these Benches and listening to what she is saying, because it is not true. The problem is that children have been dying, and these families have tried absolutely everything. The unlicensed drugs that children have had to take before they even had access to medicinal cannabis put them practically into a coma just to be alive; that is not acceptable. Please—I beg her to come and join the all-party parliamentary group, and to educate herself and her colleagues better.
Sally-Ann Hart
I thank the hon. Member for her intervention, but more clinical evidence is required on cannabis-based drugs. It is really important that that clinical evidence is there for everybody to see.
Ben Everitt
My point relates to the evidence available for the CBD-related products and therapies to which my hon. Friend has been referring. There is a lack of evidence on the THC end of things. THC is the chemical in cannabis that gets people high, and there has therefore been a reluctance for researchers and so on to look into the evidence base. We need more structured and reliable evidence on medicinal cannabis across the board. As my hon. Friend the Member for Crewe and Nantwich has said in interventions, the evidence needs to be something on which we can rely, so that we can make better policy and push these treatments through the licensing paths quicker.
Sally-Ann Hart
I completely agree.
It is a really positive step that the NHS refractory epilepsy specialist clinical advisory service has been established to support clinicians working with patients to optimise the treatment of refractory epilepsy, and that an e-learning model has been developed by Health Education England. This shows what can be done as we move forward.
I have to highlight my concern with some of the arguments surrounding the legalisation of cannabis for medicinal use in the UK, especially those that call for sick people to be permitted to grow their own cannabis under licence. I recognise that the hon. Member for Manchester, Withington mentioned my concern that, if we give permission, we have to be careful that people do not abuse it for recreational purposes. We have to be aware of that. The argument that the continued ban on cannabis is irrational because cannabis works as a medicine for a number of medical conditions indicates that there may well be a push for cannabis to be legalised without any real proof required of safety and effectiveness.
Katherine Fletcher
My hon. Friend is making a really interesting point. It is very important that we are careful not to conflate the legalisation of cannabis for recreational use and what is already legal. I know she is not, but does she accept that clarification?
Sally-Ann Hart
I do not want to conflate them, but we have to be aware of that. We must also be aware that using cannabis, medicinally or otherwise, carries risk. There is really not enough data on the effects of cannabis on a child’s brain development, for example. Cannabis carries significant mental health risks for some individuals, and using it increases the risk of developing psychosis, depression and anxiety, as highlighted by Professor Colin Drummond, chair of the addictions faculty at the Royal College of Psychiatrists.
Dr Allin-Khan
What effect does the hon. Member think it has on a child’s brain to have upwards of 30 seizures a day?
Sally-Ann Hart
I absolutely welcome that intervention from the hon. Lady. Thirty brain seizures a day would have a devastating impact on a child, but we also have to look at the cost-benefit analysis of the drugs that are being administered.
Tonia Antoniazzi
On that point, the cost of having a child at home on medicinal cannabis is a lot less than the cost of having that child in hospital. We have 20 children who are living proof of that. We have been asking for over four years for an observational trial of those children. That was agreed to by the NHS and then it was reneged on. There is RESCAS—the Refractory Epilepsy Specialist Clinical Advisory Service—but RESCAS does not work. I am afraid that the hon. Lady is not speaking with a clear and informed view. Unfortunately, that is stopping these children getting what they need today with this Bill.
Sally-Ann Hart
The hon. Lady is clearly very passionate about this, but I feel very strongly that we have to make sure that all the right safeguards are in place. Many of these patients are children, and we have to make sure that they are not damaged when it comes to drug prescriptions.
In summary, it is vital that access to unlicensed medical cannabis must have safeguards and that cannabis-based medicinal products are rigorously tested in clinical trials to ensure safety, quality and efficacy. The social let alone economic costs are otherwise too high. The Government have been clear that the law enables lawful access where it is deemed clinically appropriate. The most significant barrier to access on the NHS is the lack of evidence of the quality, safety and clinical and cost-effectiveness of these products. In the absence of that evidence, clinicians are reticent to prescribe, as has been highlighted, and there are no legislative levers that the Government could support that would change that. Producers of unlicensed cannabis-based medicinal products, like those of any other medicine, need to invest in clinical trials to support the use of their products and be prepared to submit their products for scrutiny by the medicines regulator and NICE.