Medicinal Cannabis

Karin Smyth Excerpts

Thursday 30th January 2025 Westminster Hall

[The Minister for Secondary Care (Karin Smyth)]

It is a pleasure to serve under your chairship, Ms McVey. I congratulate the hon. Member for Strangford (Jim Shannon) on securing this debate. As he said, there are many hon. Members from both sides of the House representing constituents affected by the issue across the United Kingdom who would have liked to be here today. Obviously, health is a devolved matter. The hon. Gentleman spoke movingly about his constituents, and other colleagues talked about theirs. I agree with him. My words have been repeated back to me, so I do not need to say them again. This is an important issue for everyone in the Chamber and those who are listening in, as we all want to support people who are in very difficult circumstances.

The hon. Gentleman raised some key issues, which I will address. He said that landlords and the police are unaware of the legality surrounding prescribed medicinal cannabis. I encourage him to take that up with the Deputy Prime Minister and the Home Secretary. I understand that the Home Office has notified all police forces about the change to the law, and guidance has been issued to summarise what that means.

The hon. Gentleman mentioned electronic prescribing, which has been in operation for schedule 2 and 3 controlled drugs in NHS primary care settings since 2019. I am afraid there are no current plans to extend that to private clinics at this time.

The hon. Gentleman also spoke about an observational study with a small patient cohort. I am afraid that it would not produce results as robust as a randomised control trial, which is the gold standard for clinical trials, nor would it add to the current evidence base. It would not provide results suitable to inform routine clinical or NHS commissioning decisions, because there would be no way to compare the findings with what would have happened in the absence of the intervention. I will come on to clinical trials in more detail, but let us be clear about the problem we face, the challenge faced by all of us involved in this debate and the challenge faced by children, many of whom have been mentioned today.

Of course, we listen to Members of this House, and to patients, parents and families, who say that these medicines are safe and should be available. We must ensure the safety and effectiveness of all medicines. The benefits should outweigh any potential harm and, as the hon. Gentleman outlined, clinicians must have that assurance and clarity, too.

There are currently only two cannabis-based medicines in the world with marketing authorisations or licence. They are—I hope I do not stumble over them too—Sativex, for the treatment of muscle spasms in multiple sclerosis, and Epidyolex, for treatment related to two rare forms of epilepsy and tuberous sclerosis complex. Those medicines show that it is possible to develop cannabis-based treatments that have been assessed for safety, quality and efficacy. The evidence generated on their clinical effectiveness and cost-effectiveness can enable the National Institute for Care and Health Excellence to recommend them for use in the NHS.

The medicines we are talking about today are unlicensed, which means that they have not been assessed by the Medicines and Healthcare products Regulatory Agency. Indeed, they have not been assessed or granted market authorisations by any medicines regulator anywhere in the world. However, as has been noted, in 2018 the then Home Secretary, Sajid Javid, enabled the prescription of unlicensed cannabis-based products for medicinal use. That provided a lawful route to these medicines for prescriptions for individual patients who were not benefiting from standard treatments and were not part of clinical trials, while limiting the ability to prescribe to specialist doctors. That came on the heels of the review by Professor Dame Sally Davies, then the chief medical officer, which found enough evidence of benefit to recommend that cannabis-based medicine should be moved out of schedule 1 to the Misuse of Drugs Regulations 2001.

For epilepsy, that evidence was mainly in relation to cannabidiol, also known as CBD, rather than products containing the psychoactive compound tetrahydrocannabinol, or THC. The review did not provide evidence to support routine prescribing or funding of those medicines on the NHS, which the previous Government should have made clear at the time. Before we see routine prescribing of these unlicensed medicines, the NHS must have greater assurance on their clinical effectiveness and cost-effectiveness at a population level. I am not a clinician—we are all here as politicians—and it is right that prescribing any medicine or treatment is a clinical decision, whether it is done on the NHS or privately. It is not for us to influence those decisions, so I cannot comment on individual cases.

We want to see more medicines approved by the MHRA and available on the NHS. We inherited a broken system, and it will take time to fix that failure, but the Chancellor has made an in-year investment in the NHS to fill the black hole that we inherited and prevent our having to cut back on services. That means that, more than ever, the NHS must account for every penny that it spends and make difficult decisions on what treatments are made available.

The NHS must get the best possible value for its investment in medicines and consider the cost-effectiveness of treatments to ensure that resources are used efficiently. For that to be fair, medicines or treatments initiated privately would not routinely be prescribed by the NHS unless the requested treatment was already approved under existing policies, which unlicensed medicinal cannabis is not, or when there are individual, exceptional circumstances. That remains the case even if privately funded treatment has been shown to have clinical benefit for an individual patient. This is the current NHS policy for all treatment initiated and prescribed privately, and it is not specific to medicinal cannabis.

[Jim Shannon]

I thank the Minister for her comprehensive response. A constituent of her colleague, the hon. Member for South Ribble (Mr Foster), is in the Gallery today. Her young boy, Ben, is receiving Bedrolite and Bedica, which are both proven to assist him in having a 98% reduction in fits. The same thing happens to my young constituent, wee Sophia, and to many others as well, including Charlie, the constituent of the hon. Member for Broadland and Fakenham (Jerome Mayhew). If there is a proven evidential base, which there quite clearly is, should it not be part of the evidential base for NICE to ensure that all these medications are taken on board?

[Karin Smyth]

I will come on to the research.

As we have heard, and as I recognise, fewer than five patients have accessed these medicines on the NHS, so access is truly exceptional. The testimony of the children and families accessing these treatments privately—often at great personal cost, as we have heard this afternoon—is truly heartbreaking. I am sure we can all agree that all Government spending on health must be evidence-based, and colleagues are seeking to ensure that that is the case.

If we are to see more cannabis-based medicines routinely available on the NHS, we need more research. The National Institute for Health and Care Research, also known as the NIHR, and the MHRA are there to support manufacturers and researchers to develop new medicines and design quality studies. I strongly encourage the manufacturers of those products to invest in research to prove that they are safe and effective and meet the rigorous standards that we rightly expect for all medicines. They should engage with the NIHR and the MHRA on clinical research and medicines licensing processes. That is key in providing doctors with the confidence to prescribe cannabis-based products in the same way that they use any other licensed medicines recommended for use on the NHS, but we are not waiting for industry to respond to patient voices.

The NIHR and NHS England have recently confirmed more than £8.5 million in funding for clinical trials to investigate whether cannabis-based medicines are effective in the treatment of drug-related epilepsies. As I said when we were in opposition, and as has been highlighted today, action in this space is vital. Epilepsy is a terrible disease, and it can be life-limiting in the most serious cases.

We also know that although epilepsy is a fairly common neurological condition, affecting 1% to 2% of the population, about 30% of cases will sadly have seizures that are resistant to current treatments, so it is absolutely right that the NIHR and NHS England are pioneering truly world-first trials that will investigate the safety and effectiveness of CBD and THC in adults and children with treatment-resistant epilepsy. The trials will be co-led by experts from University College London and Great Ormond Street hospital and will look to recruit around 480 patients from across the UK. The study details are published on the NIHR website, and I understand that it will publish further details soon.

Further funding has also been awarded to the University of Edinburgh to investigate the efficacy of CBD in patients with neuropathic pain due to chemotherapy. Those are two examples of the type of research that we desperately need in this area of medicine, and a further 28 studies looking at cannabis-based medicines have been approved by the MHRA since 2018. It is an emotive and complex debate, but the clinical trials give me encouragement that there is a way forward. If the evidence supports it, we will see more cannabis-based medicines approved by the regulators and recommended by NICE. That is the only way we will see the evidence base improved and give clinicians the confidence to prescribe.

To conclude, the hon. Member for Strangford has brought this debate forward with his customary good faith and compassion.

[Jim Shannon]

Will the hon. Lady give way?

[Karin Smyth]

I will take another intervention.

[Jim Shannon]

I am sorry. I am not intervening just for the heck of it; I just want a wee bit of clarification. I welcome the fact that the Minister is referring to the trials, and how long they are. I ask the Minister, very quickly: how long will it be before they are complete? Also, I asked the Minister beforehand if she would agree to a meeting with the hon. Member for South Ribble and his constituent just to clarify the matter and take forward the case for a wee bairn. Those are my two asks.

[Karin Smyth]

I cannot answer the question about trials and research directly because, obviously, trials are run by the specialists at NIHR, in the usual way, and I am sure that the request for meeting has been heard. It would probably not be with me, but I am sure the officials have heard it and that the hon. Gentleman will have a response.

I thank the Opposition spokesperson for reading out my contribution and highlighting how proactive we are being, only seven months since forming the new Government. I am proud that the trials that we are looking to do are world firsts. No other country in the world is taking the same action to prove that the medicines are safe and effective. I know it will not come as much consolation to those families who are at the end of their tether with talk of processes, debates and regulations. I also know it may not feel like it, based on some of the things I have said today, but I think there is a way forward. There may be some light at the end of the tunnel, and this Government will do what we can to support NHS England and the NIHR to get the trials done.