The Minister for Immigration (Robert Jenrick)
In the years that I have served as a Minister, I do not think I can recall a debate in which expectations were set so low about my response before I even stood up.
I thank my hon. Friend the Member for Reigate (Crispin Blunt), the hon. Member for Inverclyde (Ronnie Cowan) and the hon. Member for Warrington North (Charlotte Nichols) for securing the debate. I am grateful to them and to all the other Members who have contributed. This is the first debate that I have participated in on this subject, as colleagues have said. The House has raised the topic of psilocybin and other psychedelic drugs with the Minister for Crime, Policing and Fire, my right hon. Friend the Member for Croydon South (Chris Philp). I appreciate the disappointment felt by my hon. Friend the Member for Reigate that the Minister is unable to be with us today to respond directly to his concerns, but I am afraid he was drawn away on other departmental business. I recognise that this is a topic of substantial interest to Members of the House, who, again, have made the case with passion.
Crispin Blunt
Could the Minister give a bit of detail about the duties that have taken the drugs Minister away from the House?
Robert Jenrick
I am afraid I do not know the precise departmental visit that my right hon. Friend the Member for Croydon South is on. But knowing him, if he was here, he would certainly wish to be part of this debate and to continue the conversation that he has had with hon. Friend the Member for Reigate. It is only because of other departmental business that he was not able to join us today.
I want to begin by recognising, as others have done, the personal interest that the hon. Member for Warrington North has in this topic. I concur with your comments, Madam Deputy Speaker, that the hon. Member spoke with great conviction and very deeply. I have heard her speak on other subjects that we have a shared interest in, such as the fight against antisemitism, with the same eloquence and bravery that she showed today.
It may be helpful at the outset to remind the House that medicines policy, including the availability of medicines for prescribing, is led by the Department of Health and Social Care. Medicines are licensed and regulated by the Medicines and Healthcare products Regulatory Agency. However, the Home Office is responsible for controlled drugs legislation. Our controlled drugs licensing regime supports research and clinical trials in the UK. The two Departments work together on issues connected to controlled drugs in healthcare. I will endeavour to set out the Government’s position this afternoon.
Controlled drugs legislation seeks to prevent criminality while permitting access for legitimate use, including for medicines development. The Misuse of Drugs Regulations 2001 enable the use of controlled drugs in healthcare. The Home Office’s controlled drugs licensing regime enables the possession, supply, production, import and export of controlled drugs to support industry, pharmaceutical research and healthcare. These controls are subject to review in light of any emerging evidence and in consultation with the Advisory Council on the Misuse of Drugs, which has been referenced many times this afternoon.
There is an established process for medicines, including those that contain controlled drugs, to be developed, evaluated in clinical trials and licensed, based on an assessment of their quality, safety and efficacy by the MHRA. The MHRA supports the safe and scientifically sound conduct of clinical trials in this area, and provides regulatory and scientific advice to companies at all stages of developing medicines. Should a company submit an application for a marketing authorisation, otherwise known as product licence, it will ultimately be a decision for the MHRA whether to license a product based on a psychedelic drug as a therapy.
Charlotte Nichols
The Minister refers to marketing authorisation. In this case, psilocybin, as we have discussed, is something that grows in mushrooms across the UK. Is the Minister suggesting that people would be able to access psilocybin only if it were in another substance?
Robert Jenrick
I am by no means an expert in this field, but I think I am suggesting that were this to be a drug that is licensed, it would need to go through the MHRA process in the usual way.
I would like to come to a point made by the hon. Lady earlier around the costs involved in a first-time application for a controlled drug licence of the kind we have been discussing. She quoted a substantial figure, which would be concerning as it would be prohibitively costly for smaller manufacturers or researchers. The figures that I have been quoted are that first-time application for a licence costs £3,700 and a standard renewal costs £326. I will write to the hon. Lady with those figures and if she contests them in any way, then I or the Minister for Crime, Policing and Fire, my right hon. Friend the Member for Croydon South (Chris Philp) will be happy to respond.
Ronnie Cowan
The cost is not just about the licence. Because it is a schedule 1 drug, more dangerous than heroin, the way in which it is stored in a laboratory, so that people cannot get access to it, and the set-up needed around the laboratory has caused a lot of people to say that they simply cannot afford to make such modifications to their laboratories and start the investigation in the first place.
Robert Jenrick
I see that point. In a moment, I will come on to the work that the Government are doing in that regard, and more broadly, to facilitate research and make it more accessible to a broader range of organisations.
To finish the point about the process involved, once granted a medicine licence by the MHRA, medicines can be assessed by the National Institute for Health and Care Excellence, which makes recommendations about routine prescribing on the NHS.
I thank the hon. Members who described the promising research emerging on the potential benefit of psilocybin. Studies in the UK include publicly funded research. For example, the National Institute for Health and Care Excellence is funding King’s College London to carry out a trial evaluating the feasibility, safety and efficacy of psilocybin for adults who are unresponsive to or intolerant of treatment for depression.
In January last year, King’s College London published the results of a small-scale study suggesting that psilocybin can be administered safely, under certain circumstances and to healthy individuals. That is clearly encouraging. However, the researchers acknowledge that larger and longer trials, including comparison with existing treatments, would be required to determine the efficacy and safety of psilocybin for this disorder.
Crispin Blunt
I hope by now, as he has read his text, my right hon. Friend is beginning to work out that the administration of drugs policy is suboptimal, shall we say. Can he explain why esketamine is approved in Scotland, but not in England?
Robert Jenrick
I do not know the answer to that question, but I will happily ask officials who are listening to respond. It sounds like a matter for the Department of Health and Social Care rather than the Home Office, but I shall be pleased to give my hon. Friend a full reply as soon as possible.
Robert Jenrick
If my hon. Friend already knew the answer to his question, I wonder why he asked it in the first place.
Crispin Blunt
As my right hon. Friend well knows, one does not ask questions to which one does not know the answer. That is not a very wise thing to do in politics.
A point was raised with me by the public affairs director of a subsidiary of a major pharmaceutical company about the differential between physical and mental health treatments. This illustrates the difficulty of getting mental health treatments to the necessary standard for assessment by NICE, and is a further illustration of the different priorities given to the treatment of mental and physical health conditions.
Robert Jenrick
My hon. Friend has made his point very powerfully. Of course the Government’s ambition is to ensure that NICE, the MHRA and all our regulators work in the most research-friendly manner, and that applies to mental health treatments as much as to anything else.
If a manufacturer is successful in being granted a marketing authorisation by the MHRA for a medicine containing psilocybin, the Home Office is committed to swift action to remove psilocybin from schedule 1 and make it available for prescribing, subject to advice from the Advisory Council on the Misuse of Drugs on the appropriate scheduling and safeguards for the medicine. The same scrutiny should be applied to all potential medicines to ensure patient safety. While it is legally possible to enable prescribing in advance of marketing authorisation, the Government currently have no plans to move to that position.
Charlotte Nichols
The Minister keeps referring to medicines containing psilocybin. He does not seem to understand that psilocybin is the medicine, in and of itself. It does not need to be added to something else to make it work. This is why we are running into the issue. The Government keep telling us about a licensing regime in which there is a requirement to add something to the compound in order to make it some sort of novel substance, rather than looking at the substance that already exists and, as we have said, has been used for thousands of years with demonstrated safety and efficacy. Will the Minister talk about psilocybin, rather than medicines containing psilocybin?
Robert Jenrick
I understand the hon. Lady’s point. As I have said, the Government are funding research into psilocybin and its effect on patients with certain conditions. What we are discussing today is the Home Office’s role in ensuring that that research, as it emerges, can be considered as part of our drugs legalisation framework.
The Government have commissioned the ACMD to consider how better to enable research with respect to all schedule 1 drugs, and that includes the potential to extend schedule 2 status for research purposes to all schedule 1 drugs including psilocybin. This, I believe, is the point that my right hon. Friend the Minister for Crime, Policing and Fire made in the Adjournment debate, and he has written to the ACMD asking it to consider, in particular, the potential options available to extend schedule 2 status for research purposes to all schedule 1 drugs. He highlighted psilocybin specifically in his letter. If the hon. Member for Warrington North, my hon. Friend the Member for Reigate or, indeed, other interested Members have not seen it, I shall be happy to ensure that they receive a copy and can see the instructions that my right hon. Friend has given to the ACMD. My hon. Friend the Member for Reigate asked earlier about the likely timetable for any advice from the ACMD. I have been told that, while the ACMD is independent of Government, it is understood that its consideration is well advanced, and we should expect its advice in the near future.
The approach that we have taken in this regard should deliver much of what my hon. Friend and others are requesting. I should make a distinction: prescribing will remain unavailable outside a clinical trial. It is not for the Home Office to determine medicines policy, and I am sure that my hon. Friend and others will accept the general principle that medicines should be assessed on the basis of their safety, quality and efficacy before being made available to patients.
The two Departments continue to support the ACMD’s review. The chief scientific adviser to the Home Office recently convened a discussion with her counterpart in the Department of Health and Social Care and the Government’s chief medical officer on this precise subject. I understand that they had a very positive discussion and I know that they will be advocating for the best outcome for researchers and, of course, patients. When the ACMD provides its advice, the Government will consider it carefully before deciding how to proceed.
I thank Members for their contributions to the debate. I can assure my hon. Friend the Member for Reigate and others that the Government have heard what they have to say. I will ensure that my right hon. Friend the Minister for Crime, Policing and Fire is fully apprised of what was said in the debate, so that he and others can continue their conversation on this issue.
I reassure the whole House that the Government agree with the intent of much of what has been debated today, but rather than developing a bespoke approach for psilocybin alone, we consider our approach to be more ambitious. We want to tackle this issue across all categories of section 1 drugs to reduce barriers to legitimate research, rather than focusing on individual drugs. Equally, we must keep a firm focus on the need to tackle drug misuse, which causes such harm across our society. Both are vitally important aims, and we will continue working to strike the right balance in the interests of the public.