Medical Cannabis (Access) Bill

Mark Fletcher Excerpts

Friday 10th December 2021 Commons Chamber

[Katherine Fletcher]

Let me make a little progress. I am trying to defend science, but I am incredibly conscious that others want to speak and have other perspectives on the matter.

August bodies such as the British Paediatric Neurology Association, the General Medical Council, the National Institute for Health and Care Excellence and the Royal College of Physicians have all issued guidance around the original change in the law, which was initially cautious. NICE has recently updated its guidance to state:

“There is no recommendation against the use of cannabis based medical products.”

However, it still does not address the issue of a positive evidence base for the safety and effectiveness of these drugs. How do we do that?

[Mark Fletcher (Bolsover) (Con)]

In response to some of the passions expressed, I want to say that my hon. Friend is making an incredible speech. Not only is it emotional, but it outlines the difficulties of ethics, decision making, science and research. I have listened for the past 30 minutes, captivated by the way in which she is presenting the matter to the House. On behalf of all hon. Members here today, may I say thank you?

[Katherine Fletcher]

I thank my hon. Friend. I reassure the House that it is not only a surname that we have in common.

I think we are getting somewhere. We need a scientific evidence base that we can prescribe to doctors or the system more broadly that will give them more confidence—or, as the hon. Member for Manchester, Withington suggests, effectively a bypass mechanism that says, “I know we haven’t got any evidence, but on this we’ll have to look at the very compelling but relatively small numbers.” There is an implication that we should just throw out what is working very well.

This is where the hon. Member might welcome what I am trying to get at—well, he might. The gold standard randomised controlled trial requires a very strongly controlled placebo. There are two cohorts of people who absolutely do not know whether they are on the placebo or the real thing, because there are a series of cognitive biases that can kick in if they think they are receiving a medicine and are not. I agree 100% with, and understand why, anybody whose child is currently taking medicinal cannabis and is stable and happy, would never put themselves in a position where they would have a one in x chance of receiving a placebo as opposed to the medicine. I spoke with Joanne Griffiths directly about that and I understand that.

However, during the covid pandemic the scientific establishment has changed trial design and its ways of doing things, so it has to be possible to find a placebo cohort of children with similar conditions who are not taking additional cannabis medicine. There are a number of reasons why people might choose to not use it. The UK is not an island. The other problem is that the numbers are fantastically low, so there is a relatively low pool of people to play with. However, the UK has shown itself to be a leader in global science. I think it would be possible to find, in other countries where they have not taken the progressive steps we have taken in the UK to legalise medicinal cannabis, a group of children with similar medical conditions and use them as the placebo. There is an opportunity for the scientific community to maintain the gold standard of a double-blind trial, but not necessarily put people in the position where they need to come across.

My call to Government would be to speed up the current observation trials and to engage with scientific leadership—remember, it is this Government who are putting extra billions into research and development because we are a science superpower—on a more creative RCT trial, looking for the placebo that proves or disproves it over a series of numbers on a global scale.

I will draw my remarks to a close. It is in the pincer between medical ethics and standards of evidence where, tragically, young men like Ben sit, and we see the distress. There are potential solutions. I see the sense of measures in the Bill, but they come back too much to the idea that by voting for the Bill as an MP and as an unqualified individual, I will be telling a medical professional what to do. That is how I read the Bill.

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[Sally-Ann Hart (Hastings and Rye) (Con)]

I welcome this important debate brought by the hon. Member for Manchester, Withington (Jeff Smith). Since 1 November 2018, cannabis-based products for medicinal use have been listed in schedule 2 to the Misuse of Drugs Regulations 2001. The change in law was based on expert advice from the chief medical adviser to the UK Government and the Advisory Council on the Misuse of Drugs, both of whom said that the rescheduling of such products would facilitate the development of clinical evidence.

All of us in this House have enormous sympathy with individual cases. I pay tribute to the hon. Member for Middlesbrough (Andy McDonald) for telling his family story, which I heard with great sadness and compassion. We also have a wider duty to safeguard through clinical evidence. I feel strongly about safeguarding.

A change has also occurred in that specialist doctors included on the General Medical Council’s specialist register can now prescribe cannabis-based products for medicinal use where clinically appropriate and in the best interests of patients. GPs may prescribe licensed cannabis-based medicines subject to any restrictions under the product’s marketing authorisation, but the law prevents GPs from prescribing unlicensed cannabis-based products for medicinal use unless it is done under the direction of a specialist doctor. That, at the moment, until we have more licensed cannabis-based products, is there for safeguarding purposes.

There are licensed cannabis-based products—not very many, but I think there are two or three—already routinely available on the NHS, and access to those licensed products has been promoted. For example, the chief pharmaceutical officer recently issued a reminder to clinical commissioning groups and the NHS trusts in England, highlighting that Sativex, for example, is recommended by NICE and available on prescription. There is also cannabis-based epilepsy medication available.

On Sativex, I wonder whether that sort of cannabis- based medication would have helped my aunt, who died aged 38 from multiple sclerosis. By the time she died at 38, she was practically blind and wheelchair-bound, so I feel very strongly that the right medication must be clinically looked at and evidenced in order for the right prescriptions to be made.

[Mark Fletcher]

We have heard a number of incredibly personal stories of family members or constituents today, but my hon. Friend’s point is that we should not only let the personal impacts influence us, but ensure that the evidence comes forward as well. Does she agree that it is vital we have both in this debate?

[Sally-Ann Hart]

I thank my hon. Friend for that comment. Very often in political debate we are driven by emotion, and that is right, because we have that emotion driving us forward to make change. However, that emotion must be tempered sometimes by evidence. When we are trying to get legislation through Parliament, we all know that there must be a good evidence base for us to work with to drive that legislation through.

In addition to the licensed cannabis-based products, since the change in regulations, doctors on the GMC’s specialist register have been able to prescribe unlicensed cannabis-based products for medicinal use if clinically appropriate for their patients. The law allows GPs to prescribe those products under the direction of a specialist, as part of a shared care arrangement.

If a GP decides to accept ongoing shared care responsibilities and prescribing, they must be competent to exercise their share of clinical responsibility and confident and happy to accept the associated legal and professional responsibilities of doing so. It is right that we put those decisions in the hands of specialist clinicians, those with the best knowledge of all the treatments available for the conditions they are specialist in.

However, the law did not relate to funding those products within the NHS, which is governed by a range of processes and procedures to ensure equitable distribution of funding, prioritising funding for those medicines that have proved their safety, quality, whether they work and their cost-effectiveness. This is where the evidence base is vital.

Currently, almost all cannabis-based products for medicinal use prescribed by specialist doctors are unlicensed medicines, which, unlike licensed medicines, have not undergone rigorous tests for quality, safety and efficacy. They are treatments of last resort, and patients will be at a stage in their treatment pathway where they will be under the care of a specialist doctor who has expert knowledge of their field and of all treatment options and will take responsibility for prescribing. Prescribing is limited to specialist doctors because it is important that that restriction forms part of the checks and balances that the Advisory Council on the Misuse of Drugs asked the Government to put in place when rescheduling cannabis-based products for medicinal use to minimise the risk of misuse and diversion. No matter how much we all want to see a change made, we are all aware that unfortunately there are people out there who would use medical cannabis as an excuse for recreational drug use. We have to avoid that at all costs.

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[Sally-Ann Hart]

I am sure the Minister has heard my hon. Friend’s comments and will take them on board.

[Mark Fletcher]

Will my hon. Friend give way?

[Sally-Ann Hart]

I will give way, but can I then make some progress? Is it on this point?

[Mark Fletcher]

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?

[Sally-Ann Hart]

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.

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[Sally-Ann Hart]

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.

[Mark Fletcher]

On both sides of the House, there is a clear demand to see that evidence base come forward. We are sending a very powerful message to companies and manufacturers by saying, “Please provide us with this evidence, because we want to go in the same of direction”. My hon. Friend is doing a very good job on that front.

[Sally-Ann Hart]

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.

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[Sally-Ann Hart]

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.

[Mark Fletcher]

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?

[Sally-Ann Hart]

I wholeheartedly agree with my hon. Friend.

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[Dr Mullan]

Perhaps the hon. Lady is inadvertently giving an incorrect impression of what I said. I made it very clear that this is the context for how clinicians behave in our NHS.

[Mark Fletcher]

Far from doing what has just been accused of you, I felt as though you are giving a—[Interruption.] The hon. Gentleman is giving a cautionary tale and providing context for this debate, and that is very important for this discussion.

[Dr Mullan]

I thank my hon. Friend.

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[Dr Mullan]

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.

[Mark Fletcher]

I think there has been an accusation from the Opposition Benches that my hon. Friend does not seem to be educated in this particular area. Can he outline for the benefit of the House how much he understands medicine?

[Dr Mullan]

I thank my hon. Friend. When it comes to the issues I want to come on to talk about, it is not so much my practice as a doctor, but the fact that several years before becoming an MP I worked for the national clinical audit commission. The whole task of that organisation and very many other organisations in the NHS is to attempt to get clinical practice to change. There can be evidence and acceptance of what is best, and it does not happen, for very many reasons. That is the point I am trying to get across today.

I understand the focus on this particular treatment and I do not in any way underestimate the impact on patients but, as a constituency MP, I have several other examples of other treatments and other things people want to have on the NHS that they are not able to access. We have to think about how we tackle that in the broader sense, and I do not believe that picking out a particular treatment and putting it into primary legislation is the way to do that.