Medical Cannabis: Alleviation of Health Conditions

Maria Caulfield Excerpts

Thursday 4th November 2021 Commons Chamber

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

I congratulate the hon. Member for Inverclyde (Ronnie Cowan) on bringing forward this debate. As has been said, this is the second day in a row that we are debating this important issue, and I appreciate the depth of feeling on it. I know there are many Members who wished to speak today but who have not been able to, including the hon. Member for Gower (Tonia Antoniazzi) and my hon. Friends the Members for Dover (Mrs Elphicke)—Teagan Appleby is her constituent—and for South Derbyshire (Mrs Wheeler).

As I said yesterday, I have huge sympathy for the issues, problems and struggles that patients and their families are facing. They are trying desperately to access these drugs. No one wants a resolution to this more than me and the Secretary of State, who, as has had been said a number of times, changed the law when he was Home Secretary to try to resolve this situation.

Yesterday, I confirmed the Government’s absolute commitment to take an evidence-based approach to unlicensed cannabis-based products for medicinal use in order to ensure that there is evidence that they are effective but also safe. A number of colleagues have asked why the Government cannot accept non-randomised controlled trials as evidence. The Government are not involved in the process of licensing the medicines; that is done by the independent regulator. The Government’s responsibility is in changing the law, which has already been done, but I very much take the point that we should be able to influence the speed at which the licensing process can take place. I will point out in my remarks how we are doing that.

I am willing to work with colleagues across the House, whether that is the hon. Member for Manchester, Withington (Jeff Smith), with his private Member’s Bill, or SNP Members. This is a non-political issue that we want to see resolved, but the Government are not the body responsible for licensing medication or assessing the worthiness of the research, whether that is randomised controlled trials or any other form of evidence.

Before I set out what is being done, I want to provide an update on the matter of Bedrocan, because the hon. Member for North Tyneside (Mary Glindon), my hon. Friend the Member for Reigate (Crispin Blunt) and the hon. Member for Inverclyde all mentioned it. The commercial agreement between Transvaal Apotheek and UK specialist medicines manufacturer Target Healthcare is progressing, and the MHRA and the Home Office are working with those companies to ensure that all regulatory standards for manufacturing these medicines are met.

On 16 September, the Home Office granted a six-month licence, which will allow Target to move on to testing its equipment and procedures using cannabis from the Netherlands and validating their production of Bedrocan oils. Departmental officials continue to work closely with the Dutch Government, Transvaal, the Home Office and the MHRA to ensure continuity of supply until domestic production can be established, and I will keep the House updated on progress. I hope that is a little glimmer of hope on that issue.

I am aware that there is huge patient demand for access to medical cannabis, and that many are convinced it is helping them with an array of medical conditions from chronic pain to cancer. To date, however, much of the evidence suggesting cannabis could be effective as a treatment is anecdotal. While that has some strength in observational studies, from the regulator’s point of view it often needs more robust clinical data.

There are two licensed cannabis-based products and one synthetic cannabinoid that mimics the effects of THC, which is the element I think most campaigners are looking for. We do have Sativex to treat severe spasticity in adults with multiple sclerosis, Epidyolex for the treatment of two rare forms of epilepsy and Nabilone for nausea and vomiting, so we are making some progress. I hear from campaigners that the THC element remains outstanding. Those products that are licensed are proof that when manufacturers invest in clinical trials, the potential of cannabis as a medicine can be realised. Clinical trials generate the data needed by our world-leading medicines regulator, the Medicines and Healthcare products Regulatory Agency, to assess for safety, and it is then for NICE to approve the NHS funding element of that.

Let me reiterate that this is a multiple-step process. Orkambi has been mentioned; the issue with that was not licensing—it had a licence—but NHS funding. If we get to the licensing stage, the Government can do a huge amount more to fast-track things and be involved in discussions. Licensing, however, is an independent process, and that is the point at which we are stuck.

[Crispin Blunt]

I used that parallel as an example. I totally respect my hon. Friend’s point about licensing progress—of course she is correct—but this is about thinking imaginatively to work our way through the problems to the right solution. That applies desperately in this situation, as it did with Orkambi.

[Maria Caulfield]

Absolutely. The Government are committed to trying to resolve the blockage to licensing, which is the main factor hindering the prescription of these drugs. The Health and Social Care Secretary changed the law when he was Home Secretary, but that was not the end of the issue, and that is why we are taking these next steps. It is important not to dismiss the importance of licensed medication. We know from history that when medication that may have a good clinical effect is not tested thoroughly, there can be grave consequences, just as with thalidomide. The safety of a medicine is as important as its efficacy. I am not casting aspersions on cannabis, but the regulator has responsibility for all medicines, and it takes that issue very seriously.

[Dr Julian Lewis]

That argument would surely carry more weight if the people doing the testing outlined some sort of timeline and plan for concluding a testing programme, rather than apparently letting things drift on aimlessly for years on end.

[Maria Caulfield]

I take my right hon. Friend’s point. I will come on to that, and to timelines for the research that is in progress. Many of the products that we are talking about have not been licensed by any licensing authority across the world, including the Food and Drug Administration, the European Medicines Agency and our domestic MHRA. This is not just a UK problem; it is not the UK Government who are holding this back.

As I said yesterday, I encourage manufacturers of these products to invest in clinical trials. Part of the Department’s work is providing funding for the National Institute for Health Research, which is actively opening its arms to charities, academics, researchers, manufacturers and third-sector organisations. Funding is available for clinical trials, if anyone wants to come forward with one, be it a randomised control trial, an observational study, a randomised control trial without a placebo arm, or a phase 1, 2 or 3 clinical study. The MHRA is willing to provide advice and support to any potential applicants who want to conduct a clinical trial or seek a licence for their medicines. There is funding and support; we need researchers to come forward with clinical trials.

[Ronnie Cowan]

A lot of research institutes are restricted in what they can do because they are trying to access a category 2 product. If it was category 4, life would be a lot simpler for them.

[Maria Caulfield]

The hon. Gentleman makes an excellent point, and going forward we perhaps need to unblock some of the blockages in that area. I take that point on board.

Clinical trials and the licensing process provide evidence and information that doctors rely on to support their treatment decisions. Many clinicians have fed back that they are reticent to prescribe these products until there is more evidence, because ultimately they are responsible for their patients when it comes to a treatment’s safety and effectiveness. Doctors are particularly unwilling, given the THC element of cannabis products; there is some emerging data and evidence of harm, particularly to children, including effects on the developing brain and heart. That is why the evidence base is so crucial, but I am happy—I say this especially to the hon. Member for Manchester, Withington, who sponsors the Medical Cannabis (Access) Bill—to consider what blockages could be unblocked to speed that process up.

Doctors are right to be cautious when prescribing any product if they are not confident in the evidence base. As I said yesterday, I am clear that prescription remains a clinical decision, as does prescription of any medication. It would be inappropriate for the Government to force clinicians to prescribe a medicine, but we will try to unblock some of the licensing blockages.

Let me highlight some of the studies that are starting to take off. This might have been mentioned, but from 1 April we have the establishment of clinical trials for NHS England and the NIHR. We have introduced a national patient registry, which will record patient outcomes, with a view to its being rolled out across the devolved Administrations. It is England-only at the moment. We are aiming to record the data of those who receive the medicines, and to consider side-effects, efficacy and a whole range of issues, in order to support clinicians working with patients, and to start to build an evidence base.

In addition, a randomised control trial is being set up. It has three arms, which will include one arm with CBD or THC, and one arm with a placebo. We expect it to open fairly soon. Those looking to access these drugs—children in particular—will be able to do so in a blinded way and can take part in the study. If the data come through relatively quickly, that will open up opportunities to submit evidence to the MHRA.

[Ronnie Cowan]

Who would offer a child who is on medication that stops them having 100 seizures a day a random test that potentially contains a placebo?

[Maria Caulfield]

I take the hon. Gentleman’s point, but many children are not accessing this medication, and this is a route to that. As I explained in yesterday’s debate, clinical randomised control trials with a placebo arm have extremely strict rules, and if one arm of the study is showing incredible progress and doing better than the other arms, the study must be stopped, patients unblinded, and everyone switched to the arm that is doing the best. In some circumstances, that has enabled people to access drugs under clinical research in a much quicker way. It does have some advantages.

[Christine Jardine]

That is all very well, but it brings us back to the fact that there are children who are already benefiting from the drugs. Even the NHS has asked whether it would not be beneficial to have an alternative trial, such as an observational one, and to use that evidence, rather than having a clinical trial with all these pitfalls.

[Maria Caulfield]

I take the hon. Lady’s point, but the MHRA, which is the regulator, and other regulators around the world have a tier of research that they will accept. The randomised controlled trial method is the gold standard, and the more randomised controlled data someone has, the more likely they are to get a trial approved quickly. Of course observational studies will be used. That is why, if researchers have a large group, want to do observational studies—we heard about the Sapphire clinic from the hon. Member for Inverclyde—and come forward with observational data, I encourage them to speak to the MHRA to see whether that is the sort of research that would be acceptable. It is important that they have those discussions with the regulating body, because it may well accept some of that evidence.

Until manufacturers, researchers, academics and those using these drugs in practice come forward with whatever research they feel would be acceptable and have those discussions, we will go round in a circle. I am keen that if observational studies are acceptable, we support them to happen. Whatever it takes, in research terms, to get a licence through, the Government are there, providing funding, advice and support. However, ultimately, they are not the body that can make that decision; but I think there is a willingness around the House to try to find a resolution.

It will take time to generate further evidence and see the results of clinical trials. The Health Secretary and I are committed to doing everything in our power to accelerate this work. There have been some helpful suggestions this afternoon that we may need to go away and look at.

I thank everyone again. Although this is the second debate on this subject in two days, I know that it will not be the last; the private Member’s Bill will come forward next month. I want to put on the record my commitment to this issue. It is extremely difficult. In yesterday’s debate, we heard constituents’ stories relayed by their MPs, including the hon. Member for Middlesbrough (Andy McDonald). They really are very moving testaments, and we want to find a way forward. We have changed the law, but that has clearly not been enough. We need to find a resolution, so that we can get these medications licensed if the clinical evidence is there, and we need to work with the regulator.

[Dr Cameron]

I know that the Minister is committed to this issue. Could the Government perhaps appoint a lead clinician for this issue, to give clinicians across the United Kingdom confidence, and to drive the issue forward at pace, so that we see movement in the short term?

[Maria Caulfield]

The hon. Lady makes a good point. If there are clinicians who want to take a lead on this, there is obviously scope to look at that, but we must be clear that we have to license and support research for this medicine in the way we would any other. I have given a commitment today to working with hon. Members on both sides of the House to demonstrate how seriously the Government take this issue.