7.1     In law, it would be possible to make cannabis and/or additional cannabinoids prescribable by moving them from Schedule 1 to Schedule 2 to the Misuse of Drugs Regulations, in advance of any cannabis-based medicine being licensed and reaching the market. However, the Government are not willing to reschedule cannabis in advance of licensing. Licensing depends on research and clinical trials: the Government are satisfied with the arrangements for allowing research and trials, but some of our witnesses are not. In the mean time, medical use remains illegal.

]. IDMU finds the present position "inhumane", and "unjustifiable both on moral and on public health grounds" (p 229). Dr Pertwee says (p 68), "A strong case can be made on the grounds of common sense and compassion for allowing doctors to prescribe...(oral) cannabis now for serious symptoms including muscle spasms"; but he admits that it will take better evidence to persuade the Department of Health (Q 263; see also paragraph 7.15 below).

7.10     Dr Robson described the present position as an "affront to humanity" (Q 460). He called for "compassionate reefers" for AIDS and cancer patients (p 118), and possibly for patients with non-terminal conditions who might feel that the increased risk of cancer was worth taking (Q 469). He suggested that patients might be made to confirm in writing that the doctor had explained the risks; and that, if it were felt necessary, the number of doctors entitled to prescribe cannabis could be limited, as in the case of diamorphine (heroin) or cocaine prescribed for addicts under the Misuse of Drugs (Supply to Addicts) Regulations 1997 (Q 471). He added that research into synthetic cannabinoids might soon make herbal cannabis obsolete; but, in the mean time, "it just is not a dangerous enough drug for me to want to ban it" (Q 472).

7.11     The ACT want "medical preparations of natural cannabis...to be made available on a doctor's prescription while research is going ahead" (p 28), by moving cannabis from Schedule 1 to Schedule 2 (Q 133). They argue that "we know now that cannabis can be effective and is safe enough to be prescribed by a doctor...and there are people who need treatment now". Similarly, six of our witnesses, all users of cannabis for medical purposes themselves, want cannabis to be prescribable or otherwise legalised for medical use. 195 out of 200 respondents to the Disability Now survey, of whom 192 were disabled and 134 had taken cannabis for medical purposes, wanted such use to be legalised.

7.12     The London Medical Marijuana Support Group (p 271) consider the issue to be one of patients' rights: "Please do not continue to make sick people criminals". They call for either rescheduling, or a new system involving registration of patients. They would solve the problem of supply by allowing patients to grow their own, or by setting up co-operatives, or by permitting commercial cultivation. They argue that different users get benefit from different preparations; so they do not want a standardised preparation—though this would be better than nothing.

7.13     If the law cannot be changed, it could in theory be applied with flexibility. IDMU suggest "directives to the CPS on criteria to use when deciding whether a prosecution of a medical cannabis user is in the public interest" (p 225). According to the Home Office, however, systematic non-enforcement would be "quite unacceptable" (Q 671).

7.14     Though some witnesses to this Committee favour immediate transfer from Schedule 1 to Schedule 2, others are against it. Professor Radda insisted that anecdotal evidence, however large in volume, was not sufficient reason for rescheduling (Q 657). Sir William Asscher considers that immediate rescheduling would actually threaten proper trials, such as those proposed by his working party (see Chapter 5), by encouraging patients to use cannabis in an uncontrolled way rather than enrolling for the trial and risking receiving a placebo (Q 808).

7.15     The Multiple Sclerosis Society want sufferers to be able to make "informed choice about therapeutic agents"; therefore they would not support prescription of cannabis for MS in advance of proper trials (p 90, Q 368). The Royal Society say that, pending proper trials, "There is no persuasive case for the non-experimental medical use of cannabis"; and they are against smoking (p 295). The Royal Pharmaceutical Society take the same line (p 289); so does Professor Strang, who would be worried if cannabis were given "some easy track" (Q 249); so does Edward Jurith, on sabbatical in Manchester from the post of General Counsel to the White House Office of National Drug Control Policy (p 265). The Christian Institute agree: "The rules must remain the same for all substances...Rescheduling cannabis would declare that cannabis is suitable for medical use. The studies have not been done to demonstrate this" (p 207). They add that permitting cannabis to be smoked "would profoundly damage current health promotion attempts to dissuade smoking". They suggest that other steps might be taken to help MS sufferers who are resorting to cannabis. Dr Pertwee considers that permitting prescription of cannabis could not be justified until both nabilone and dronabinol had been tried and failed (Q 314).

7.16     The BMA report recommends, "The WHO should advise the UN Commission on Narcotic Drugs to reschedule certain cannabinoids under the UN Convention on Psychotropic Substances, as in the case of dronabinol [which was rescheduled in 1995]. In response the Home Office should alter the Misuse of Drugs Act accordingly." Alternatively, "The Government should consider changing the Misuse of Drugs Act to allow the prescription of cannabinoids to patients with particular medical conditions that are not adequately controlled by existing treatments". On the other hand, David Nutt, Professor of Psychopharmacology at the University of Bristol[], considers that the availability of nabilone, which may be prescribed on an unlicensed basis for any of the conditions identified by the BMA, makes it unnecessary to change the law (p 280).

7.17     The Royal Pharmaceutical Society caution that, if unlicensed use of cannabinoids becomes more common (as the BMA think it might, following their report—Q 83), there should be "full consultation between the medical and pharmacy professions" (p 290). They urge the Government to consider moving all cannabinoids from Schedule 1 to Schedule 2.

]. This is regrettable, since there is "a wide range of possibilities and a massive opportunity for research". The Royal Pharmaceutical Society blame the "disappointing" lack of evidence on the "stigma" attached to cannabis, and the burden of licensing (p 288).

7.21     Professor Hall also believes that research has been chilled by the link with recreational use. He regards this link as "spurious". He observes, "The recent discovery of the cannabinoid receptor may help to overcome some of the resistance...by holding out the prospect that the psychoactive effects...can be disengaged from [the] other therapeutically desirable effects" (p 222). The Multiple Sclerosis Society believe that the stigma attached to cannabis as a medicine can be countered by "raising awareness" and taking the issue seriously, which to some extent has already happened (Q 372); and they know of numerous volunteers for trials (Q 389).

7.22     Dr Holdcroft notes two further difficulties: the lack of standardised preparations (she produced her own capsules), and the medicolegal problems of working with cannabis-naive subjects[]. Dr Notcutt blames the licensing system, and the problem of supply (Q 413); he is optimistic that Dr Guy's initiative may surmount both obstacles. Austin Mitchell MP believes that ethical committees "run a mile" from sanctioning clinical research using a Schedule 1 drug (Q 132). Professor Edwards likewise points to ethical problems (Q 19); he recommends, before blind trials, "a small series of open clinical investigations with repeat and careful observations on the individual patient". The National Drug Prevention Alliance, noting that the prospective markets may be too small to warrant the commercial cost of trials, suggest that trials might be grant-aided from public funds (p 279—they regard this as preferable to licensing without trials).

7.23     The Department of Health say, "Both the Home Office and MCA have always indicated that they are prepared to look sympathetically at well-founded research proposals in this area" (p 48, cp Q 167). However Dr Kendall calls for "relaxation of the level of control" over trials (p 268). Dr Robson, in his review for the Department, says, "Research will only be possible if the regulations imposed under the Misuse of Drugs Act are made more flexible". IDMU say (p 229), "The present licensing system and policy has severely limited research opportunities and should be reviewed"; given the rise in research activity noted above, the United Kingdom academic community and pharmaceutical industry may miss opportunities if the research licensing regime is not relaxed.

7.24     Yet the Multiple Sclerosis Society believe that the present system obstructs research more by its effect on attitudes than by practicalities (Q 388); and it is the impression of Austin Mitchell MP (Q 132) and Clare Hodges (Q 136) that the Home Office are already more flexible than they used to be. Professor Radda believes that a good research proposal will receive a licence without difficulty, and that scientists today are well used to regulation of this kind (Q 630). Dr Guy says that, although consultation was lengthy (from application to grant took 4 months—Q 663), the Home Office have been "most helpful" (p 162).

7.25     The BMA report said, "The regulation of cannabis and cannabinoids should be sufficiently flexible to allow such compounds to be researched without a Misuse of Drugs Act licence issued by the Home Office". In evidence, the BMA reported "very positive feedback" from the Department of Health and the Home Office on the pace of the licensing process (Q 82); but they said that at present there was serious delay (Q 92). The Home Office responded, saying, "Applications for research licences are dealt with as expeditiously as the circumstances allow" (p 149); the Minister gave the time from application to grant in the last six cases, which averaged seven weeks (Q 663). The BMA hope that guidelines for trials would help to accelerate the process (Q 92).

7.26     The Committee put to the BMA the idea of a meeting between the Home Office and researchers, and they welcomed it (Q 93). The Home Office say that they would be happy to hold such a meeting, jointly with the Department of Health: "It would provide a useful opportunity to highlight some of the complex issues involved such as the supply of standardised cannabis, and the adoption of sound methodologies". Work is now in hand to set up such a meeting (Q 686).

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