My Lords, we are on the case. I completely recognise the problems faced by Alfie Dingley and all the individuals reliant on the previous arrangements with the Dutch Government for the supply of Bedrocan oils. The department is working urgently with Dutch Minister Tamara van Ark to find a solution that will enable these patients adequately to access the medications they need, and we are committed to setting up clinical trials to inform future NHS commissioning of cannabis-related medicines.
My Lords, I thank the Minister for that very encouraging response. He will know that time is of the essence because these medicines prevent children having severe fits, some of which are life-threatening. Can he go back to his department and educate some of his officials? Unfortunately, a lot of the families are very upset at being told that they can safely be switched to an alternative formulation. That is both ignorant and dangerous. All the expert clinicians who know about these issues say that that cannot be done safely. Even if it could, eventually putting these children back on to the original formulation sometimes does not work. Will he make sure that his officials listen to the clinicians who are expert in prescribing and in following the progress of people on these formulations?
My Lords, I am grateful for the noble Baroness’s kind words, and I will indeed take that patient feedback back to the department. I reassure her that this is an area where patients have undoubtedly led the way, and clinicians have to catch up. In doing so, there will need to be a meeting of minds and regulation in areas that are open to patient interpretation. In that period, there will undoubtedly need to be compromises on all sides.
My Lords, the law changed over two years ago. The then Home Secretary said:
“We have now delivered on our promises … we will work with the NHS to help support specialists in making the right prescribing decisions.”
But they have not; it has been a hollow promise for terminal brain cancer sufferers such as my nephew. NHS doctors will not prescribe medical cannabis, and the BMA advises medics not to prescribe it, yet I understand that the UK is the largest producer of medical cannabis in the world. Just how many prescriptions have been issued for unlicensed cannabis medicines, other than those subject to randomised control trials, in the last 12 months?
My Lords, the noble Baroness is being a little unfair; Health Education England published a medicinal cannabis education package on 8 August 2019. But we cannot force clinicians to make prescriptions. That is not how the health service works. We need to work on clinical trials to put in place the correct authorisations and to give marketing authorisations for these important and promising drugs. That will require collaboration between government, the regulator and industry, and I call on industry to step up to that challenge.
My Lords, some people in England and Wales are reliant on hormone therapies produced in the EU 27. Who precisely in the NHS is responsible for ensuring continuity of supply of those therapies to patients?
My Lords, procurement decisions in the NHS are done by the NHS. I do not think that a specific or unique group is focused precisely on hormone therapies, but I would be glad to go back to the department and write to the noble Baroness to confirm that.
My Lords, I draw your Lordships’ attention to my interests as set out in the register. If we can vaccinate 1.5 million people in a few weeks with a drug that did not even exist a couple of months ago, how come we cannot prescribe properly a drug that has been legal to prescribe for over two years? Cannabis contains over 120 different cannabinoids and eight terpenes, and the way in which these are configured makes a world of difference to their effectiveness. What training is being given to ensure that the right combination of cannabis oil required to treat different medical conditions is correctly prescribed? I think it is time that the Government stepped up to the plate on the training.
My Lords, I would turn around my noble friend’s proposition and ask this question. If many vaccine manufacturers can turn around clinical trials in eight months for an extremely complicated vaccine, how come the cannabis-producing companies cannot turn around clinical trials over years?
I thank the Minister for his reply. I declare that I am a cannabis user to counter pain, and no doubt later today we will be able to come back to that issue. I hope that his officials are watching to witness the support there is in this place for the role that he is trying to secure so that young sufferers who shake their brains to pieces might get relief today rather than tomorrow, when it is too late.
I thank the noble Lord for sharing that personal testimony, which is extremely touching and relevant. I share with him that there is a large amount of ministerial support for the principle of this exciting and interesting area. If there is any frustration on my behalf, it is only that somehow the industry has not matured to the point that it can sponsor the kinds of clinical trials that can take these important medicines through the necessary authorisation process that can put them on the NICE list so that they are available for more patients.
It is not surprising that people are astonished that important cannabis products, which can transform the lives of those suffering from debilitating, painful conditions, are approved yet still not available—and in some cases supply has been disrupted as a by-product of Brexit. Would the Minister care to speculate as to why this has not happened? It is not just that the companies have not stepped up—why have they not done so? Would the political will that has been brought to bear on various other issues faced by this Government, such as Brexit, not be usefully brought to bear on this one?
The noble Baroness puts a very reasonable challenge to the life sciences arrangements in the UK. We are blessed with major pharmaceutical companies, and a lively and exciting biotech industry, all of which are well plugged into the regulatory authorisation process. This is a novel, exciting, patient-led and innovative area. For those reasons, it has not had the financial backing of either business or the financial institutions to put in place the very simple, straightforward requirements of clinical trials, which are there for patient safety in the first place, not for government box-ticking. We are working extremely hard to try to resolve this Catch-22 situation and I hope very much indeed that we will be able to announce news on that shortly.
My Lords, it is nice to hear that the Government are taking this problem seriously. If these drugs are effective, would it not be a good idea to encourage the demand side of this equation, where doctors prescribe them, by pointing out what the drugs allow a child with epilepsy, for example, to do—that is, lead a normal life, get educated, get qualified and be able to have a job—and the cost to the state if they do not?
The noble Lord alludes to an important, although frustrating, point. If I may gently push back, the truth is that there is a large amount of very persuasive anecdotal evidence, some of which we have heard today. It is completely compelling—it is just not scientific. Patient safety relies on extremely rigorous clinical trial regimes; that is why we have safe medicines in the UK. It is simply not possible to persuade front-line clinicians to make prescriptions on the basis of anecdote rather than clinical study.
My Lords, I am delighted that the Minister is on the case and that we can make sure that this issue is resolved for this set of parents. On a wider note, however, would the Minister consider revisiting the NICE guidelines, last published in November 2019, which had a list of recommended research, to ensure that we potentially widen the base of research and bring more speed into the process?
The noble Baroness is right that research is the key. I reassure her that we are looking at ways to try to bring research forward. The issue is not with the NICE guidelines themselves; it is with getting the scientifically backed data to be able to justify the authorisations from the MHRA. We are working extremely closely with the NIHR. We are looking at the NHS, which, as the noble Baroness likely knows, does have manufacturing capability within itself for these kinds of drugs. As some noble Lords here will know, we are engaged in thoughts about how the NHS manufacturing capability can be used to mobilise clinical trials in this important area.
My Lords, the time allowed for this Question has now elapsed.