argyrotsipi/train-dataset huggingface dataset:
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Mark Peter Fletcher (Conservative, Centre-right): 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?
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Ben Everitt (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Kieran John Mullan (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Lia Nici-Townend (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Jane Marion Hunt (Conservative, Centre-right): 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."
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Thomas William Randall (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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—
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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?
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Mark Peter Fletcher (Conservative, Centre-right): 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?
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Ben Everitt (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Ben Everitt (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Katherine Fletcher (Conservative, Centre-right): 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?
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Sally-Ann Hart (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Kieran John Mullan (Conservative, Centre-right): I encourage the hon. Lady to listen carefully to what I am saying. I said at the start of the debate that, absolutely, there are very good reasons for individual patients to receive this treatment. I have acknowledged that there are licensed treatments based on evidence, so I think she is kind of misrepresenting what I said. I said clearly that I am giving context to the—
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Kieran John Mullan (Conservative, Centre-right): 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.
Medical Cannabis (Access) Bill — House of Commons, 2021-12-10
Topic: Health
Kieran John Mullan (Conservative, Centre-right): 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.