Cannabis-based Medicines

Lord O'Shaughnessy Excerpts

Thursday 21st June 2018 Lords Chamber

[Baroness Meacher]

To ask Her Majesty’s Government what the terms of reference will be for the expert panel of clinicians to advise ministers on applications to prescribe cannabis-based medicines.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord O’Shaughnessy) (Con)]

My Lords, the commission from the Home Secretary is clear: he has asked Professor Dame Sally Davies to set up an expert clinical panel to provide advice to Ministers on licence applications made by a patient’s medical team for the use of cannabis-based products. Professor Dame Sally Davies is currently establishing a clinical panel that will agree the terms of reference.

[Baroness Meacher (CB)]

My Lords, I applaud the Home Secretary for his decisive action on medical cannabis. My Question relates to the second part of Professor Dame Sally Davies’s review. Bedrocan cannabis medicines have been used very safely and successfully in Holland for more than 20 years and are used increasingly across Europe. These medicines are currently subject to 23 random controlled trials and are also approved by European manufacturing standards. Can the Minister assure the House that the terms of reference for the wider review—I am not referring to the initial piece of work—will include the need for the MHRA, which regulates medicines, to consider defining a special category for whole-plant cannabis medicines? This idea came from within the MHRA, so I do not think it is unreasonable. If the review fails to make these medicines available in this country, is the Minister aware that 200,000 people in the UK with uncontrolled epileptic seizures will continue to be further brain-damaged every single day? This is a matter of urgency.

[Lord O’Shaughnessy]

I am grateful to the noble Baroness for her question. Like her, I applaud the speed with which the Home Secretary and the Health Secretary have acted in this matter. It is incredibly important to think about the various stages and actions that have been taken. First, there is an urgent need for the panel which Professor Dame Sally Davies is setting to consider specific licence applications. The second part is to review whether there are therapeutic benefits of cannabis and cannabis-derived products. Then there is the evidence-gathering process, and all the relevant evidence, including the major piece of work done by the US National Academy of Sciences and the paper to be published by the WHO, will be collected as part of that. As the Home Secretary set out on Tuesday, it will make recommendations to the Advisory Council on the Misuse of Drugs subsequent to proposals for rescheduling. That will happen this autumn, if those proposals come forward.

If I may just take the time to say this, the noble Baroness raises a third issue, which is long-term horizon scanning for Schedule 1 drugs for which a therapeutic benefit has not yet been demonstrated but which may be demonstrated in future. We clearly need to set up a device to do that, and the MHRA may be the right vehicle. That is something we are considering.

[Baroness Wheeler (Lab)]

My Lords, can the Minister update the House on the number of cases the expert panel is expected to consider? Assuming they are current cases, can we be reassured that they will be dealt with in a way that avoids the awful situation faced by Alfie Dingley and his parents and ensures they have the best possible medical treatment?

[Lord O’Shaughnessy]

I completely agree with the noble Baroness about the need for speediness. Frankly, at this point we do not know the number of cases. The Home Secretary said on Tuesday that the service will be up and running and receiving applications within a week of his Statement—so from next Tuesday onwards, with a panel constituted rapidly so that it can start considering them.

[Lord Forsyth of Drumlean (Con)]

My Lords, will my noble friend pass on the good wishes of this House to the Home Secretary and the Health Secretary for the speed with which they have acted in making cannabis-based medication available for the treatment of certain conditions? However, will the Health Secretary also take steps to make people aware of the real damage that cannabis taken for recreational use can do to our young people, in particular creating paranoia and mental illness? It would be irresponsible for any Government to condone the use of recreational cannabis given the damage that is caused to our young people in some cases.

--- Later in debate ---

[Lord O’Shaughnessy]

I will pass on my noble friend’s thanks to my right honourable colleagues. We agree with him that there is a very clear distinction: we know cannabis-based products can create harm but the question is whether they can also have therapeutic benefits. If they can, they need to be weighed in the balance and rescheduled appropriately. That does not diminish the negative impact that he has described that the recreational use of cannabis, particularly very strong strains, can have on young people.

[Baroness Walmsley (LD)]

My Lords, I thank the Minister for showing that he quite clearly understands the distinction between recreational and medicinal use. Is he also aware that Epidiolex, which is medicine produced by GW Pharmaceuticals for epilepsy sufferers and which will soon be approved, will not help children like Alfie Dingley who have uncontrolled epilepsy seizures? I understand that the cannabinoid CBDV is very important to such sufferers, and there is none of it in Epidiolex. Will the Minister ensure that the review takes account of the special needs of the 200,000 patients with uncontrollable seizures? Will the panel be able to hear from patients as well as studying research?

[Lord O’Shaughnessy]

The noble Baroness makes excellent points. I know she has been deeply involved in the Alfie Dingley case and I thank her for her work on that. What we are discovering is that it is not the case that just one drug is going to fix this for the 200,000 people who are suffering. There is a need for variety. So it cannot be the case that just because one thing is licensed it is used for everyone; it needs to be specific to the needs of the patient, which is the noble Baroness’s main point. The interim panel is there precisely to make decisions on an individual basis. It is a patch to the system, if you like, not a long-term change, which is why the review is in place so that we can ensure that many other products derived from cannabis, if they are proven to have therapeutic benefits, can be developed into drugs for the range of needs that are out there.

[Lord Blunkett (Lab)]

My Lords, 15 years ago trials were undertaken, one of which led to a separate authorisation of a derivative from cannabis for MS sufferers. I have not been clear on this from any of the reporting, so will the Minister say what trials are currently taking place in this country that could be brought to fruition? What evidence can we very quickly obtain from trials and evidence of legitimate use for medicinal purposes from the rest of the democratic world? How can it possibly be justifiable for us to provide 45% of usage for derivatives from cannabis grown in this country but not to be able to use it ourselves?

[Lord O’Shaughnessy]

The noble Lord speaks with great wisdom on this topic. The problem, as he knows, is that these drugs have been in Schedule 1 and, although in theory that allows for research, in reality it creates a very cautious environment that makes research difficult. That means that apart from Sativex, which has been licensed, and Epidiolex, which is in the process of being licensed, there are very few, if any, other drugs actually going through the clinical trials process in this country because of the very tight rules that have governed usage. Other countries have of course relaxed their rules and developed that evidence, and it is precisely that kind of evidence base that will be considered by Professor Davies in her review.