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The Parliamentary Under-Secretary of State for the Home Department (Caroline Flint): I congratulate my hon. Friend the Member for The Wrekin (Peter Bradley) on securing this debate. I welcome my hon. Friend the Member for Reading, West (Mr. Salter), who is a patron of the Berkshire multiple sclerosis therapy centre, and my hon. Friend the Member for Bassetlaw (John Mann), who takes a keen interest in all issues to do with drugs.
I welcome my hon. Friend's acknowledgement that the Government are committed, both through the Department of Health and the Home Office, to take the
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necessary procedures to ensure that if a suitable product derived from cannabis can be licensed, it can be provided as a product for people suffering from illnesses that mean that they would benefit from such a drug.
The medicinal use of cannabis is a cross-party issue, as has been clearly shown by the support that my hon. Friend has received for his early-day motions. The Government, too, would like to contribute to easing the plight of those with debilitating illnesses such as multiple sclerosis and other intractable, painful conditions by bringing to their assistance whatever relief is to be had as a result of an appropriate medicinal use of the drug.
My hon. Friend mentioned the reclassification of cannabis, as did my hon. Friend the Member for Reading, West. We should be clear that we reclassified cannabis to class C not because it is not a harmful drug, but because it is not as harmful as drugs in classes A and B.
Mr. Deputy Speaker (Sir Alan Haselhurst): Order. I am sorry to interrupt the hon. Lady, but she should not turn her back permanently on the Chair. That also has the practical defect of taking her voice away from the microphone.
Caroline Flint: I apologise, Mr. Deputy Speaker.
Cannabis was reclassified to class C because it is relatively less harmful than drugs in classes A and B. Since reclassification, we have been very conscious of lobbying from organisations linked to mental health and to young people as regards the problems associated with cannabis in several different forms. Cannabis is not a harmless drug, and we must be aware of that when we discuss its relationship with products derived from cannabis that could be used for medicinal purposes.
The Government have been clear and consistent in our position on the medicinal use of cannabis. I confirm again that we are prepared to license a medicine should it get the go-ahead from the Medicines and Healthcare products Regulatory Agency—the MHRA. As we have heard, it has been assessing an application made by GW Pharmaceuticals for its cannabis-based product, Sativex. Like my hon. Friend, I hope that there can be a safe and speedy resolution of that application so that we know exactly where we stand on this issue. I understand his and others' disappointment about the time that it has taken to reach a decision. Discussions between the MHRA and GW Pharmaceuticals are ongoing. Obviously, the details of this particular application are commercially sensitive, but we hope that a conclusion will arrive sooner rather than later.
The MHRA has a responsibility to ensure that all medicines meet the required standards of safety, quality and efficacy before they are granted a market authorisation. Those standards are laid down in European pharmaceutical legislation, so this is not an area that allows for unfettered flexibility. Applicants have to demonstrate that they can produce the product repeatedly to a consistent standard and that it is stable. The MHRA is an Executive agency of the Department of Health, not part of the Home Office, and it would be inappropriate for me to comment on how it reaches its
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decisions in any particular case. However, a cannabis-based medicine, like any other prospective medicinal product, can be granted a marketing authorisation for medical purposes only when sufficient data have been submitted to demonstrate that the product is satisfactory for the intended use.
This evening, my hon. Friend has called on the Government to place cannabis-based medicine in schedule 2 to the Misuse of Drugs Regulations 2001. In an early-day motion in July, he also argued for authorising the controlled production and prescription of cannabis itself for medicinal use. Although I understand the motivations behind those two demands and am sympathetic to them, it is difficult for the Government to support those proposals.
It would not be appropriate to circumvent or undermine the well-established process attached to the evaluation of the safety, quality and effectiveness of all products that are prospectively prescribable by the MHRA. That process is designed to protect public health.
Comment has been made on why cannabis cannot be moved to schedule 2, like heroin and cocaine, so that GPs may prescribe it on a named-patient basis. Heroin and cocaine may be prescribed under the Misuse of Drugs (Supply to Addicts) Regulations 1997, but in very restricted circumstances in the treatment of addiction where a person has become so dependent on the drug that he has an overwhelming desire for its administration to be continued. I should add that, because of this issue, we are looking into other areas involving the prescription of heroin. We have a number of pilots under way.
I do not think that there is a real parallel with the prescription of raw cannabis for therapeutic purposes. The transfer of cannabis from schedule 1 to schedule 2 of the regulations on a named-patient basis would enable the substance's lawful prescription. However, allowing the prescription of raw cannabis of uncertain quality and strength as a medicine would seriously blur the distinction between misuse and therapeutic use. It might create its own health problems. For example, it would usually be smoked and there is no guarantee that those who suffer from severe illnesses such as multiple sclerosis would get access to the quality of product that would bring them relief, so we do not intend to depart from our consistent, long-standing stance of reliance on the role of the MHRA.
My hon. Friend mentioned the idea of Sativex being included in schedule 2 as well, but, as I have said, it is undergoing an assessment as a product for use by the agency. We do not think, therefore, that at this stage it would be right or suitable to undermine that process.
My hon. Friend also mentioned that patients who were on the GW Pharmaceuticals trials and have benefited from Sativex are being continued on that medication on a compassionate basis and for free by the company, pending the MHRA's decision. However, I should make it clear that they are being provided not with raw cannabis, but with a product that is inhaled—a derivative of cannabis.
We supported that position because we thought it was the right thing to do, given the nature of the trial. Therefore, I am afraid to say that I must disappoint my
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hon. Friend this evening because we think it would be wholly premature to move a cannabis-based medicine to schedule 2 now.
Peter Bradley: Will my hon. Friend explain why, if it is acceptable for the 500 patients who participated in the trials to have Sativex on an exemption from schedule 1, it is not possible to extend that to those whose symptoms are just as distressing and painful, pending the conclusion of the MHRA process?
Caroline Flint: There are a number of reasons for that. First, to trial a drug we have to pilot it with a group of people in the first instance. Therefore, there are clear boundaries within which that trial can take place, which are overseen by the company and those who have been part of that pilot.
To place the medicine in schedule 2 at this stage would raise issues about the role of general practitioners, the schedules that needed to be changed, funding, the number of people who may come forward for treatment, and how that would operate in practice—there would be all sorts of issues in terms of practicality. However, first
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and foremost, even though people have had the product as part of a trial, we should not give the green light to something that has yet to receive its full licence. I understand where my hon. Friend is coming from but, under the circumstances, the reasons I have outlined do stand. We hope that there is a speedy conclusion to the agency's investigation into Sativex as a possible solution to many people's pain.
I understand the sentiments of hon. Members on this matter. Anyone who has had a relative suffering from an illness such as multiple sclerosis naturally wishes them to have relief as soon as possible but, in terms of my hon. Friend's suggestion, in this situation, we do not think that it is right to set a precedent with regard to schedule 2.
Having said that, I recognise how important the issue is to many people. We want it to be resolved as quickly as possible, so I offer my hon. Friend a meeting with me and Lord Warner, the Under-Secretary of State for Health, to see what can be done to bring the issue to a conclusion more quickly.
Question put and agreed to.
- Adjourned accordingly at half-past Six o'clock.
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