Medical Cannabis under Prescription: Children with Epilepsy

Maria Caulfield Excerpts

Wednesday 3rd November 2021 Westminster Hall

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

I would like to start by congratulating my hon. Friend the Member for South Leicestershire (Alberto Costa) on securing the debate. He lobbies on this issue almost daily, representing constituents such as Maya and Evelina so well. I fully appreciate the strength of feeling and the impact that this issue has on some of the most vulnerable children in their daily struggle with drug-resistant epilepsy. That is why, three years ago, my right hon. Friend the Secretary of State for Health and Social Care, who was then Home Secretary, changed the law to recognise the need to allow unlicensed cannabis-based products to be prescribed by specialist doctors. The Government are supportive and have used many levers, which has been quite challenging at times.

My right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) hit the nail on the head when he said that this is now more a clinical issue than a political one. In many cases, doctors are unwilling to prescribe medicinal cannabis; we heard from a number of Members that we may be down to just one clinician left who is willing to do that. The main reason is that these products are still unlicensed. The way that medicine works in this country is that the Medicines and Healthcare Products Regulatory Agency will license a product after significant research, not just into the efficacy—we have heard from many Members that there is a strong feeling that these medicines work—but into the adverse events and potential side effects. In prescribing these medications, the clinicians will take responsibility both for the drugs working and for any impact of those drugs.

[Sir Mike Penning]

This is the argument that always comes up in the briefings for Ministers. If it is not safe, how are prescriptions being given for free on the NHS? If it is safe, give it to the rest of them. It cannot be right that time and again Ministers use the argument about safety, when prescriptions are given free on the NHS.

[Maria Caulfield]

These are clinical decisions. No one is saying that these products are not safe, but there is not the evidence base to get the licence. The MHRA does this for every single medicine, not just medicinal cannabis.

I want to set out how we can get to a place where we can get these drugs licensed and clinicians will feel confident in prescribing them. We recognise that, for many children, these drugs improve their quality of life—individuals have reported improvements—but without that research evidence base, the MHRA will not give a licence. The MHRA is an independent body—it is not controlled by the Government—and the clinicians will take advice and guidance from it. We may agree or disagree with how the MHRA licenses a medicine, but that is the process for all drugs. It is not just the MHRA—no country in the world has licensed this product. The Food and Drug Administration has not; the European Medicines Agency has not; the MHRA has not. The solution is in pushing the clinical research needed for a licence to be granted, which would open up prescribing for clinicians around the country.

[Andy McDonald]

Do the Minister and the MHRA not recognise that there is an abundance of practical evidence from the families who have scrimped and saved and raised money through charitable activities to fund the administration of the drug, and that it works? Surely that is persuasive. These families have not got time to wait for the research that the Minister is talking about, and I am yet to hear anybody tell me what harm would be done if that drug were to be given to those who need it and want it.

[Maria Caulfield]

There are concerns, particularly around the THC element, that there could be some effect on the developing brain and on heart conditions. Research is needed not just on the effect of the drugs, but on their safety.

I want to point out that the Government have made funds available for good-quality research. That does not have to be done by the manufacturers; it can be done by charities, clinicians or researchers. A range of people can come forward to carry out clinical research. The MHRA—

[Ronnie Cowan]

Will the Minister give way?

[Maria Caulfield]

I will not; I have only a couple of minutes left.

The MHRA is well equipped to provide advice to any applicants wishing to conduct clinical trials.

[Christine Jardine]

Will the Minister give way?

[Maria Caulfield]

I have literally got two minutes left.

Currently, 13 trials are ongoing across the United Kingdom. In the previous 12 months, six of the other trials of cannabis-based products were completed, so some research is coming through the pipeline to help with that evidence base. I want to touch on one—the randomised clinical control trial mentioned by my hon. Friend the Member for South Leicestershire.

It is true that one study has three arms, one of which is a placebo. Having worked in clinical research myself, I reassure my hon. Friend that there are strict ethical guidelines for any clinical research. If someone is allocated to the placebo arm but it is clear when monitoring the research that one arm is doing significantly better than another, the trial has to be unblinded. Anyone on a placebo arm is automatically put on the arm that is doing best. I worked on clinical research for breast cancer, when we were trying to get Herceptin licensed, and for some patients that was the quickest way to get the drug. If there is clear evidence that one arm is working far better than others, patients can be moved on to that arm. It is a way of fast-tracking the drug for licensing.

I reassure Members that I absolutely understand the issue. The Government have changed the law to allow use of medical cannabis, but unless we give clinicians the confidence that the drugs, first, work—a feeling that they do seems to be the consensus in the Chamber—and, secondly, have a safety profile, they will not prescribe them. We can debate it forever in the House, but the clinicians have to be convinced. The way to do that is to get the product licensed, and the way to do that is to get good-quality research that the MHRA can look at to feel confident in licensing that drug.

The Government’s view is that there is funding for such research. My commitment to Members present today is that I will work with other colleagues to see whether we can speed up applications for research, encouraging them to come forward. For many Members, that is not the answer that they wanted to hear; they want me to stand up and say, “The drugs will be available tomorrow and we have people to prescribe them.”

[Ronnie Cowan]

We have to re-categorise cannabis from schedule 2 to schedule 4. That will open the gateway to medical research. Right now, it is hard for a lot of medical researchers to gain access to the product in the first place.

--- Later in debate ---

[Maria Caulfield]

The licensing process is independent of Government, but we have levers to speed that up to ensure that the research coming through the pipeline—I have outlined some studies already in progress—will help the evidence base. We have been here before with other drugs in other sectors and we have manged to get there. We have another debate on Thursday, at which I am sure Members will press me further, but my commitment is that we will use every lever possible to get the research and the licensing process through, so that doctors across the country feel confident to prescribe this medicine, which makes such a difference to young people’s lives.