Medical Cannabis (Access) Bill
Debate between Sally-Ann Hart and Mark Fletcher
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.
Sally-Ann Hart
I am sure the Minister has heard my hon. Friend’s comments and will take them on board.
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.
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.
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?