Medical Cannabis under Prescription

Seema Kennedy Excerpts

Monday 20th May 2019 Commons Chamber

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

This has been a very moving and important debate. As I know from my own constituency, and as has been outlined with such passion by Members on both sides of the House, this matter leads to great distress for patients and their families. I recognise the deep frustration of families and patients, which has come across strongly this evening. All of us who are parents or who have cared for a loved one can empathise with them. I pay tribute to the hon. Member for Middlesbrough (Andy McDonald) and his wife Sally, who shared their experience with us. It is them and parents like them whom we are concentrating on this evening.

It would be remiss of me not to mention my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) and the hon. Member for Gower (Tonia Antoniazzi), all their work on the all-party group and their tenacity in keeping this issue on the agenda. Many points have been raised. Great frustration has been expressed and I have heard that. I will be speaking to the Secretary of State again and taking back all the messages to the officials, but I will try in my remarks to answer the points made.

In November last year, the law was changed to ensure that doctors on the specialist register of the General Medical Council can legally prescribe cannabis-based products for medicinal use in the UK. It is right that we put these decisions in the hands of clinicians because they are the ones with the best knowledge of all the treatments available for conditions in which they specialise. The Secretary of State and I have been clear that whether to prescribe must remain a clinical decision, to be made with patients and their families, taking into account the best available international clinical evidence—I want to reassure the House that we are in close contact with colleagues in other countries to ensure that we learn from their experiences—and the circumstances of each patient.

It is not for me as a politician to second-guess or pillory clinicians’ decisions. I was alarmed to hear my hon. Friend the Member for South Suffolk (James Cartlidge) say that doctors are being trolled for the decisions they are or are not making. They have the best interests of their patients at heart and their primary focus is to do no harm. But I recognise that we do not have the optimal system in place yet. It is undesirable that patients are travelling abroad. The Secretary of State and I are determined to do everything we can to ensure that patients can obtain medicines in this country if it is medically appropriate. There are already systems in place to do that and I want to do everything I can to understand why patients are not using those systems to access medicines here in the UK.

We want to continue to refine the system so that the demands of patients who want to try medicinal cannabis are balanced against other demands on NHS funding. Given the embryonic state of the evidence base on the effectiveness and cost-effectiveness of medicinal cannabis, that is not easy. However, we are working hard to ensure we get this right, because it is crucial. I have had many discussions about this with my hon. Friend the Member for Reigate (Crispin Blunt), who spoke with great passion. He mentioned the need for more evidence and the issue of growing a market. We will explore that with the Department for International Trade.

I want to pick up on a point that my hon. Friend the Member for Henley (John Howell) made about the number of prescriptions issued since November last year. Data show that, until the end of February, there had been six items issued in the community under NHS prescription. He thought there were none at all.

[Sir Mike Penning]

The evidence from the families and the APPG that I co-chair is that there have only been two. If the Minister knows of six, we would love to know not the individual cases but where the other four have come from. The families are confused because at the moment we only know of two.

[Seema Kennedy]

My information is that there are six and I will happily write to my right hon. Friend with more information.

As the House heard last month, the Secretary of State for Health and Social Care has met many of the families and patients who Members know through their work on the APPG or their constituencies. All of us could not help but be moved by these distressing cases and the continued efforts of those who support loved ones. The Secretary of State asked NHS England to conduct a process review to identify any inappropriate barriers to clinically appropriate prescribing. I am pleased to say that the review is under way, and NHS England is working with my right hon. Friend the Member for Hemel Hempstead, the all-party parliamentary group on medical cannabis under prescription and patient representative bodies to identify cases that might best illustrate the experience of a range of patients.

[Sir Mike Penning]

We have lots of time, but the Minister is being generous in giving way. Can she confirm when the interim report will be issued on the blockages and when the final report will be made to the Secretary of State? It was indicated to us at a meeting with NHS England only last week that there would be an interim report by the end of May and a report to the Secretary of State in June. Would the Minister like to confirm that?

[Seema Kennedy]

I will come on to timelines later in my remarks. NHS England is currently obtaining patient consent and scheduling the necessary interviews with clinicians, decision makers and their patients. The first interviews were held today.

I want to touch briefly on devolved matters. Health is a devolved matter, but officials across the UK have been working closely on the development of this policy. The law is exactly the same in all four countries of the UK and only funding is devolved. Members have said that clinicians might be nervous about prescription and that we need to improve training. I will talk about this later, but the training package that has been commissioned from Health Education England will be made available across the UK.

[Jim Shannon]

The Minister has heard my comments on behalf of my young constituent, Sophia Gibson, who is getting medicinal cannabis through the trust area. May I suggest that, if that is how it is done for my constituent in Northern Ireland, it could be done for people across the rest of the United Kingdom through their trust area or non-governmental organisations—wherever the responsibility lies?

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[Seema Kennedy]

I thank the hon. Gentleman for his comments. Prescription is in the hands of the clinician. Whether the prescription is paid for is ruled on locally and I will talk about that later.

I would like to tell my right hon. Friend the Member for Hemel Hempstead that a report, including any recommendations, is expected shortly. We will carefully consider any further action we might take to improve access in the light of that report and the clinical guidelines that are due to be issued by NICE. Members are rightly frustrated with the slow pace, because of the distressing cases and because of examples they have seen from abroad. NICE guidelines have been expedited. They would normally take two years to produce, but these guidelines will come out in half that time, this autumn.

Members have said that patient expectations are not being met and that clinicians are taking an overly cautious approach. With new medicines, we need a strong evidence base. That base is still in development, partly because of the historical overhang.

[Crispin Blunt]

Will the Minister give way?

[Seema Kennedy]

I was about to refer to my hon. Friend, but I will let him speak for himself.

[Crispin Blunt]

The Minister was probably going to pick up the point I made about the assessment of the risk-reward ratio. Humanity has goodness knows how many thousands of years of use of this plant, and it may need a different risk-reward assessment base from the classic medical variety. Sitting in the background for all the people who regulate our medicines is thalidomide and their anxiety about what might happen. We might need a different framework for this.

[Seema Kennedy]

My hon. Friend raises an interesting point, as he always does. The normal NHS medicines governance systems apply, and they are being used to support good clinical practice and safe and effective prescribing, but we could of course do more to educate and support the health profession.

I want to pick up another point raised by my hon. Friend the Member for Henley, about who does the prescribing of these medicines. These are not frontline medicines, and it is right that specialists who have detailed knowledge of all the treatments available for these particularly difficult cases are the ones who should be responsible for prescribing. Cannabis-based products would not normally be considered until a patient was at the stage in their treatment pathway when they were under the treatment of a specialist.

On education, Health Education England has been commissioned to develop an online training package. The aim of the package is to familiarise those working in the health sector with the change in the law and provide straightforward information about the products and what is known about their mechanisms of action. It will support and underpin the knowledge and understanding gained by specialists as experience in prescribing these products grows.

[Charlie Elphicke]

My hon. Friend is being generous in taking interventions. She has set out the risks, but may I pay tribute to her and the Secretary of State, who have not simply looked at all the risks and roadblocks that medics put up, but have said how important it is to produce answers, find solutions and take things forward? I urge them to continue with this excellent work to make sure that progress is made, and to continue to push forward.

[Seema Kennedy]

I thank my hon. Friend. That is why, after the urgent question last month, the Secretary of State issued the process review. As I have said to my right hon. Friend the Member for Hemel Hempstead, that review will be reporting shortly.

We cannot be sure that cannabis-based products are safe or effective. There is a body of anecdotal evidence of therapeutic benefit, and the chief medical officer concluded that the evidence was sufficient to recommend that these products be considered for rescheduling from schedule 1 to schedule 2 under the Misuse of Drugs Regulations 2001, and that their medicinal benefits be further examined. All products in schedule 2 can be prescribed; cannabis-based products for medicinal use are no exception.

I want to talk quickly about the evidence base. Some people have talked about randomised controlled trials, which are what we normally use when there is anecdotal evidence. As hon. Members have said, parents are arbiters of this evidence. The normal procedure is that we do not base prescribing decisions on anecdotal evidence, which is why we have asked the NIHR to stimulate further research. We need to build up the existing evidence base, including through observational trials.

[Julie Cooper]

Does the Minister accept that these are not normal circumstances? These families and parents are absolutely desperate to access the medication that they have seen work for themselves. Can she find some way to circumvent the usual processes?

[Seema Kennedy]

I recognise the deep pain that families are going through, and I do take the point about the great frustration and desperation of the families. What I would say is that we have asked for more evidence, and we are working with everybody necessary to try to get this done as quickly as possible. NICE is internationally recognised for its robust and evidence-based evaluations and guidelines.

[Ronnie Cowan]

I have two families in my constituency whose children are both suffering from epilepsy. They are taking Bedrolite today, and the families know it is beneficial for their kids. That is anecdotal evidence, but it is in their houses and they can see it working. The prescriptions for the sources they have will run out in June and in July. Can the Minister tell me what I should say to those parents when their kids’ prescriptions run out?

[Seema Kennedy]

I do not feel able to comment on a specific issue when I am not a doctor, a clinician or a scientist—

[Ronnie Cowan]

As a parent?

[Seema Kennedy]

Of course I could as a parent, but again, I am not a doctor, and I am not here to make that call. What I would say is that I am very happy to meet the hon. Gentleman to get more of the facts he is presenting to me.

What is needed to support such prescription is evidence of efficacy, and for public funding evidence of cost-efficacy. That is the system we apply to all medicines and medical devices in the UK, and cannabis should not be treated any differently. The current evidence base has been summarised by the professional bodies in their interim clinical guidance, and it will be further examined and reported on by NICE shortly.

[Tonia Antoniazzi]

I have one question for the Minister: has the cost analysis been done on a particular case? When I spoke earlier, I spoke about Alfie Dingley. It would be very interesting to see the impact of his case financially–the benefit that has been gained to the NHS and the money that it has saved the NHS since he has been taking the drug.

[Seema Kennedy]

I apologise to the hon. Lady, because she did ask me that, and I am afraid I forgot to send a note to the Box. I am happy to write to her about whether that analysis has been done.

Many hon. Members, including my hon. Friend the Member for South Suffolk, talked about funding. Funding decisions are local decisions with clear local procedures. The process review is looking at this, and as I have said, it will report shortly. I call on the industry to invest in more trials, and to publish the results and the full underpinning data, because we all want to see licensed products that doctors can use with confidence.

Where there is supporting evidence, the Government and the NHS will work with companies to make the products available. Indeed, more than 110 patients are now being treated with a pure CBD extract product—Epidiolex, which numerous hon. Members have referred to—on an early access programme, ahead of a licensing decision by the European Medicines Agency. In developing a licensed product, the evidence has been generated on the safety profile and effectiveness of the product. It is this that provides clinicians with the confidence to prescribe and the system with the evidence it needs to make decisions on routine funding. The NHS does not routinely fund any new medicine until it has been through a process of evaluation to ensure that it is safe, effective and represents value for money.

On another point that the hon. Member for Gower brought up, about one of her constituents going on the Epidiolex trial, the specialist centres around the country are referring patients to GW Pharmaceuticals. There are certain criteria and a certain number of places, but if she wrote to me, I would be happy to meet her and we could discuss that further.

We need to develop further our knowledge base on these products. That is why good-quality clinical trials are imperative. We need to know more about the scale of the benefit of cannabis-based products across a wide range of indications. We also need to understand how this compares with existing treatments and, indeed, other promising new drugs that may be as effective.

[James Cartlidge]

The Minister is obviously aware that Epidiolex is a CBD-based medicine. Many parents believe, based on their anecdotal experience, that those compounds do not have as much impact on reducing seizures as THC, so can she assure me that the trials will also look at THC-based products?

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[Seema Kennedy]

I cannot say what will be in the trials, because I am not a scientist running them. What I can say is that we have made the call and want everybody who can to take part in the trials so that we have a much fuller picture and can get to a situation where we have licensed products that doctors feel safe prescribing.

I will conclude by thanking all hon. Members who have taken part in this useful debate. This is an extremely difficult area, and hon. Members have spoken movingly about heart-rending cases. I hope that I have shown that the Government take this very seriously. We are committed to ensuring that policy is implemented in a safe and sustainable way, making cannabis-based products available to patients where clinically appropriate.