Medicinal Cannabis

– in the House of Commons at 6:00 pm on 14th October 2004.

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Motion made, and Question proposed, That this House do now adjourn.—[Mr. Kemp.]

Photo of Mr Peter Bradley Mr Peter Bradley PPS (Rt Hon Alun Michael, Minister of State), Department for Environment, Food and Rural Affairs 6:02 pm, 14th October 2004

I cannot claim to be an expert on science, and much less so on pharmacology. I also accept the precautionary principle in the licensing of medicine, especially for new drugs about which insufficient is known or those on which there is room for significant doubt about their safety or efficacy. However, an exceptional case can be made for medicinal cannabis for reasons on which I shall elaborate. The art of good government is to know when to exercise compassion and discretion, and there is no more a pressing need for that than when its object is to relieve pain and suffering, which is the case that I shall make today.

I became involved in the campaign to legalise medicinal cannabis when my constituent, Kate Bradley, who is no relation, visited my surgery four or five years ago. Her story is compelling and poignant. In earlier years, she was a drug squad officer with West Midlands police until she took medical retirement. She was subsequently diagnosed as suffering with multiple sclerosis. Prescription medicines do not work for her, and she cannot legally obtain the one medicine that does work—cannabis. She is forced to procure what she regards as her medicine in her wheelchair on the streets from the kind of people whom she was locking up a few years ago.

The problem is not that Kate Bradley fears arrest, because I do not think that that is a significant risk, but that she cannot obtain a suitable supply of her medicine. In addition to the physical torment that MS visits on her, she suffers bitter humiliation. She and thousands of others do not wish to break the law, but what choice do they have when the only medicine that relieves the pain that they suffer is placed beyond their reach?

My concern is not about the Government's approach, because Ministers have been sympathetic. They are not unwilling to find a solution to the difficult problem, and I cannot believe that they are unable to do so. When I first raised the matter with the Department of Health in a parliamentary question in January 2001, it was confirmed that trials were under way on the GW Pharmaceuticals product Sativex, and that a report was expected in 2003.

There was a major step forward in October 2001 when, in reply to a further question of mine, a Home Office Minister confirmed:

"the Home Secretary has made it clear that if a product licence is recommended by the Medicines Control Agency he would approve the necessary changes to the Misuse of Drugs legislation. These changes can be made swiftly".—[Hansard, 29 October 2001; Vol. 373, c. 500W.]

That was encouraging, but since then progress has been painfully slow. We expected approvals by the end of 2003, perhaps with medicinal cannabis on the market by now, but on 3 November last year the Under-Secretary of State for the Home Department, my hon. Friend Caroline Flint, told me:

"The Medicines and Healthcare Products Regulatory Agency", which had succeeded the MCA,

"has yet to complete its evaluation of the safety, quality and effectiveness of the medical preparation of a cannabis-based drug developed and tested by GW Pharmaceuticals."—[Hansard, 3 November 2003; Vol. 412, c. 708.]

She went on to assure me that once marketing approval had been received, the Government would act quickly to ensure that the necessary changes were made to legislation.

The Minister then wrote to me on 12 May to tell me of a further setback in the process and that the MHRA had asked for further evidence from GW Pharmaceuticals. I stress that I am not criticising the Minister or, for that matter, the MHRA. They are doing things by the book. However, while delay follows delay, patients with MS are suffering and that suffering is unnecessary.

Photo of Martin Salter Martin Salter Labour, Reading West

I endorse every jot of my hon. Friend's case. Does he agree that there is a danger that with Parliament and the Home Office downgrading the recreational use of cannabis from a class B to a class C drug, unless action is forthcoming quickly MS patients and others who require the medicinal use of cannabis will resent the fact that the Government can take action on the drug in respect of its recreational use but drag their feet when it comes to its medicinal use?

Photo of Mr Peter Bradley Mr Peter Bradley PPS (Rt Hon Alun Michael, Minister of State), Department for Environment, Food and Rural Affairs

My hon. Friend anticipates my case and, indeed, makes it for me. He will forgive me if I do not respond immediately, because it will become clear that I agree with him.

Earlier this summer, Kate Bradley sent me an e-mail, which makes the case on its own. She said:

"The spasms I suffer are sheer hell. From the soles of my feet all through my body into my brain is a searing, crippling, unholy pain. It is so powerful it can force my body to crunch into a foetal position one moment and switch to plank-like rigidity the next. Only cannabis unlocks them. Following this my legs are then attacked by pain akin to that of a blow torch burning my skin off. Cannabis is the only relief from this too. There is nothing orthodox medicine can do. Only cannabis helps. The government has said that if its medical advisers give the go-ahead, it will legalise medicinal cannabis and that's been very encouraging. But the waiting is almost too much to bear."

Kate Bradley is not alone. According to the MS Society:

"in a recent survey of 100 patients, 43 per cent. said they used cannabis. Of the people who said they have never used it, 76 per cent. said they would do so if the drug were not illegal".

I do not want to make statistical claims that are too strong, but based on that survey, my calculations suggest that of 85,000 MS sufferers more than 36,000 will have used medicinal cannabis—albeit illegally—and a further 36,000 would have used it if were it legal. That adds up to 86 per cent. of all those people who suffer from MS. So 86 per cent. of them believe that cannabis could relieve their symptoms.

This prompts the question of why patients should have to choose between controlling their pain and breaking the law. That is why I asked the Minister in the summer whether, pending the approval from the MHRA, the Government would allow the limited and controlled cultivation, and dependable quality monitoring, of cannabis for those for whom their GPs prescribe it, which is the arrangement in Canada.

In repeating that call tonight, I believe that I have a simpler and much more acceptable proposition, which I shall come on to.

I said earlier that an exceptional case can be made for the legalisation of medicinal cannabis. A huge amount, for example, is already known about the drug's medicinal qualities and properties as well as its side effects. It has been in use as a therapy for 5,000 years. Queen Victoria used it as a tincture, and it has properties as an analgesic, anti-emetic and appetite stimulant. MS is the principal condition that it can alleviate, but it has also been argued that it can help patients suffering from AIDS, arthritis, cancer, chronic pain, epilepsy, glaucoma, menstrual and labour pain and migraine. Recent research by Dr. John Zajicek of the Peninsular Medical School in Devon suggests that it may not simply relieve the symptoms of MS but arrest them.

There is a dispute about the side effects of medicinal cannabis, and some people believe that it contributes to memory loss. Those side effects, however, are unlikely to be significant and I doubt that much will be discovered now that has not been known for many hundreds of years. Alternative pain treatments are far more harmful and, in some cases, dangerous than cannabis. Some, for example, can damage the liver severely. A single overdose of morphine can kill. There is no recorded death from cannabis—at least, I am not aware of one—in the past 100 years, and I have been advised that someone has to take many thousand times the normal dose of cannabis to die from its toxicity.

Cannabis is legal in Canada and eight US states. A growing body of opinion in the UK supports its legalisation here. The MS Society said:

"On the evidence now available . . . those who might benefit should have treatment prescribed on the NHS".

The British Medical Association says that

"the law should be changed to allow the therapeutic use of cannabis", although it wants further research to isolate its therapeutic properties. The Lancet said that

"it would be reasonable to judge cannabis less of a threat than alcohol or tobacco".

Indeed, before it stopped taking the drugs, the Daily Express said in an editorial on 10 January 2001:

"The Government must legalise the use of cannabis for medical purposes immediately. Otherwise we are going to get many more instances where normally law-abiding citizens are forced to go to the criminal underworld to get the one drug that can help relieve a devastating medical condition."

A growing number of medical practitioners share that view. I recently received a letter from Paul Davies, a consultant neurologist at Northampton general hospital, who has been involved in the trialling of GW Pharmaceuticals' new product Sativex, a spray that is applied under the tongue. He said:

"I have seen some very beneficial effects of this drug in some of my patients. Of course there have been others who have not been helped, and we have had a few side effects but none has been serious. My own judgement based on experience and available data to date, is that Sativex is a safe drug and can be very helpful to treat symptoms in patients with multiple sclerosis, who have not obtained benefit from currently licensed products."

Dr. William Notcutt of the James Paget hospital in Great Yarmouth has campaigned to have medicinal cannabis recognised for 10 years or so, and I pay tribute to him for helping me to develop my knowledge and views. He told me that

"when patients ask why they cannot be prescribed what they know will relieve their pain and will most likely be more effective and less harmful than what they are currently taking, I simply have no answer for them. It is a matter of common sense as well as humanity that medicinal cannabis should be made available to patients whose doctors wish to prescribe it and without further delay".

Patients who participated in the recent trials were lucky, as medicinal cannabis worked for 80 per cent. of them. In September, the Home Office agreed to license the continuing prescription of the drug to more than 500 of those patients. That enlightened decision prompts the question—why, if they are allowed access to a pain-relieving drug, cannot the other 85,000 people with MS, whose problems and pain are just as bad, receive it?

Although, as my hon. Friend Mr. Salter said, recreational cannabis was recently reclassified from class B to class C, medicinal cannabis remains on schedule 1 under the misuse of drugs regulations. It is grouped with LSD and ecstasy in schedule 1 as a drug with no medicinal value, which is patently absurd given cannabis's 500-year history as a therapy, and schedule 2 includes drugs that are far more dangerous than cannabis such as morphine, heroin and cocaine.

If cannabis were in schedule 2, or for that matter any other schedule, GPs and other doctors could legally prescribe it even if it were not approved by the MHRA, which happens with many other well known, often used and perfectly safe drugs under MCA guidance note 14. Despite cannabis's known therapeutic value, it cannot be prescribed, which is nonsensical. It was removed from the British formulary comparatively recently—1971—and I simply ask for its restoration to the position that it occupied for many hundreds of years.

It is only in the past few decades that cannabis, a drug which has been used as a medicine for 5,000 years, has become associated with recreational abuse, but most therapeutic drugs can be abused. Tranquillisers such as Valium and diazepam, hypnotics such as Temazepam and painkillers are frequently abused, but there is no question of banning them. If all drugs that could be and are abused were banned, few medicines would be left in the cabinet. The argument is that cannabis, which has become known as a recreational drug, also has medicinal properties and arguably greater benefits and less dangerous side effects than drugs that are in common use. It should not be proscribed; it should be prescribed.

MS patients are suffering because we have a hang-up about the 1960s. The generation that grew up with recreational cannabis should not deny patients access to cannabis's medicinal properties. The solution is simple: we should apply to cannabis the same exemption as already applies to many other treatments under the MCA guidance note of February 2000, which is entitled, "The Supply of Unlicensed Relevant Medicinal Products for Individual Patients." If cannabis were exempt, doctors could prescribe to individual named patients who, in their professional opinion, would benefit from it, which is, as I said, already common practice—cannabis could not be marketed until it received its approval.

In making that plea, I simply echo the recommendations made some time ago by the House of Lords Science and Technology Committee. In 1998, in a report on the scientific and medical evidence about cannabis, it said:

"the Government should take steps to transfer cannabis and cannabis resin from Schedule 1 to the Misuse of Drugs Regulations to Schedule 2, so as to allow doctors to prescribe an appropriate preparation of cannabis, albeit as an unlicensed medicine and on the named-patient basis, and to allow doctors and pharmacists to supply the drug prescribed."

Three years later, the follow-up report criticised the "excessive and disproportionate caution" on the part of the MCA:

"Patients with severe conditions such as multiple sclerosis are being denied the right to make informed choices about their medication. There is always some risk in taking any medication; patients and their doctors should certainly be informed about toxicological concerns that the MCA have raised, but these concerns should not prevent them from having access to what promises to be the only medication available to them."

Often, I do not agree with the views of the House of Lords—certainly not over the past few days—but I certainly agree with it on that matter, as do some 50 MPs from all parties who have signed my early-day motion calling for the legalisation of controlled cannabis for medicinal use.

Let patients make their own informed decisions whether the risk from the only relief from their excruciating pain represents a greater threat to their health and well-being than the disease from which they suffer. Who are we, as politicians, to stand between people suffering torments that we cannot imagine and the medicines that they need to make their lives tolerable?

My original plea to the Minister was to allow the production and prescription of herbal cannabis for therapeutic uses, but since then GW Pharmaceuticals has conducted successful trials, and the Home Office has granted a licence to prescribe to participants. It would be a small step to act out of common sense and compassion and move medicinal cannabis to schedule 2 of the regulations so that doctors can prescribe more widely on a named-patient basis as MCA guidance note 14 allows. As I said at the outset, the hallmark of a good Government is that they know the difference between the done thing and the right thing, and I hope that my faith will be supported by my hon. Friend the Minister's remarks.

Photo of Caroline Flint Caroline Flint Parliamentary Under-Secretary (Home Office) 6:19 pm, 14th October 2004

I congratulate my hon. Friend Peter Bradley on securing this debate. I welcome my hon. Friend Mr. Salter, who is a patron of the Berkshire multiple sclerosis therapy centre, and my hon. Friend 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 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.

Photo of Alan Haselhurst Alan Haselhurst Deputy Speaker and Chairman of Ways and Means

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.

Photo of Caroline Flint Caroline Flint Parliamentary Under-Secretary (Home Office)

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 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 hon. Friend this evening because we think it would be wholly premature to move a cannabis-based medicine to schedule 2 now.

Photo of Mr Peter Bradley Mr Peter Bradley PPS (Rt Hon Alun Michael, Minister of State), Department for Environment, Food and Rural Affairs

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?

Photo of Caroline Flint Caroline Flint Parliamentary Under-Secretary (Home Office)

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 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.