CHAPTER 7 CHANGING THE LAW ON MEDICAL USE AND RESEARCH: REVIEW OF THE EVIDENCE
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.
Prosecution for use of cannabis for medical purposes
7.2 It is not known what proportion of prosecutions for possession of cannabis arise from medical use. The ACT drew our attention to 15 reported cases of people charged with cultivation, possession and/or supply in medical situations since 1996: of the 12 cases where the outcome was known, one resulted in a sentence of 50 hours' community service; in the other 11, either the prosecution was abandoned, the defendant was acquitted, or the sentence was no greater than a conditional discharge. IDMU offer further figures (p 258); they comment that, although outcomes in such cases are highly variable, juries seem more likely to acquit "where there is convincing medical evidence, given similar circumstances concerning paraphernalia".
7.3 People who use cannabis for medical purposes face prosecution if caught cultivating or possessing cannabis; but, according to Austin Mitchell MP, "It is bringing the law into a certain amount of difficulty and disrepute because either the police are cautioning or the courts are giving very lenient sentences" (Q 132). Dr Pertwee considers it unsatisfactory that such people are sometimes prosecuted, unsatisfactory that law-breaking is sometimes tolerated, and unsatisfactory that the position is inconsistent around the country (Q 313).
7.4 The BMA report recommends, "While research is under way, police, the courts and other prosecuting authorities should be aware of the medicinal reasons for the unlawful use of cannabis by those suffering from certain medical conditions for whom other drugs have proved ineffective" (cp Q 55). Similarly the Multiple Sclerosis Society want the law to treat people caught using cannabis for medical reasons in an "appropriately compassionate fashion" (p 90). They report that most people convicted in such circumstances receive a suspended sentence; but they are concerned about the way the system treats people as much as about the verdict (Q 341; cp IDMU p 261).
7.5 Mr Howarth, the Under-Secretary of State, declined to comment on how the Crown Prosecution Service and the courts treat such cases (QQ 668-673), beyond observing that in some cases the plea-in-mitigation of medical use might be trumped-up (Q 674). The Home Office added that official statistics do not distinguish between cases with a medical aspect and cases without; but that, on the anecdotal evidence, outcomes in medical cases were not obviously out of line with outcomes in purely recreational cases (Q 675). (The proportion of persons in the United Kingdom dealt with for possession of cannabis who are cautioned rather than prosecuted rose from 35 per cent in 1986 to 62 per cent in 1995—Home Office Statistical Bulletin 10/98.)
Possible transfer from Schedule 1 to Schedule 2
7.6 According to the Home Office (p 150), cannabis could be transferred from Schedule 1 to Schedule 2 by statutory instrument, subject to negative resolution in Parliament. The ACMD would have to be consulted first. According to the Minister (Q 676), under the 1961 UN Convention, rescheduling cannabis itself and cannabis resin would not require international agreement; but, under the 1971 Convention, rescheduling cannabinol and its derivatives other than dronabinol would require prior amendment of the Schedules to the Convention through the WHO and the UN Commission on Narcotic Drugs, as happened in the case of dronabinol in 1995.
7.7 Rescheduling would allow doctors to prescribe; but the Home Office say, "Our understanding is that the ability of doctors to prescribe cannabis would be hampered in practice if a cannabis-based medicine had not been granted a marketing authorisation by the MCA". The Minister said that there were "compelling policy reasons" for requiring an MCA licence first (Q 676). When asked to explain the practical difficulties, he referred to the extra burden of responsibility which a doctor takes on by prescribing an unlicensed medicine (Q 679); he queried the wisdom of permitting prescription without proof of safety and quality (Q 680); and he noted that the ACMD had not called for change (Q 688).
7.8 Rescheduling would also allow doctors and pharmacists to manufacture and supply (Q 680); anyone else, including a pharmaceutical company, would require a Home Office licence. It would not in itself disapply section 8 of the Misuse of Drugs Act, which makes it an offence to allow cannabis to be smoked on premises; but this could be done by secondary legislation (Q 684).
7.9 So the Government could reschedule cannabis; the next question is, whether they should. Dr Lambert says, "Many patients are already illegally using cannabis...Their needs must be addressed whilst formal studies are undertaken". 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.
7.18 As noted in Chapter 3, cannabinoid pharmacology is currently a lively field of research. However, until Dr Guy's initiative, no new cannabis-based medicines were in commercial clinical development (Wall Q 134). As to why this should be so, most of our witnesses point to the "stigma" of working with a "disreputable" substance and a Schedule 1 controlled drug (e.g. Austin Mitchell MP Q 132, Pertwee Q 317, Robson Q 482). Others point to the likelihood that a non-synthetic cannabis-based medicine would be cheap and therefore unprofitable, and the markets for it small (RPharmSoc p 289; Lader QQ 7, 17)—though Professor Ashton and the BMA believe that the global market is potentially large (Q 57). Dr Pertwee believes that drug companies are very interested in the possibility of cannabinoids which avoid psychotropic effects by acting only on the CB2 receptor (Q 281); they are "dying to get in there, but they do not know what to do" (Q 295).
7.19 Dr Notcutt believes that what puts companies off research involving a Schedule 1 drug is not the stigma, but the "sheer difficulty" (Q 414). The principal additional difficulty is the requirement to obtain a licence from the Home Office (see Box 8). If cannabis were moved to Schedule 2 to the Regulations, research licences would no longer be required (Q 677).
BOX 8: CANNABIS RESEARCH LICENCES
|Licences to possess any Schedule 1 drug for research may be granted by the Home Office under section 7 of the Misuse of Drugs Act and Regulation 5 of the Misuse of Drugs Regulations. The Under-Secretary of State at the Home Office, George Howarth MP, explained to us the conditions under which licences are granted (Q 662). There must be a legitimate reason for the research; details of method and timetable; ethical approval; and safeguards including safe custody and record-keeping. The research would normally be expected to be conducted at a university hospital or pharmaceutical company; and the method of administration must allow for control of dosage. According to the Home Office, there have been a total of 27 applications for cannabis research licences, of which 25 have been approved and two agreed in principle; no application for a licence has been refused (HC WA 255, 18 Dec. 1997).
|The Home Office supplied us with a list of 22 current licences. All are granted to named researchers, 20 at universities and two in hospitals. Most are for teaching or testing purposes; only three appear to be for research. Four of the licences were issued this year, compared with 22 over the previous 24 years; the Home Office attribute the increase to a Royal Pharmaceutical Society symposium on medical uses of cannabis in July 1997 (Q 666). There are 80 current research licences for Schedule 1 substances other than cannabis (Q 665). Among our witnesses, cannabis research licences are or have been held by Dr Pertwee, Dr Schon (see p 303 and Q 664), Dr Holdcroft (see paragraph 5.29), and Dr Guy (see paragraph 5.44); and Jo Barnes has a licence "in principle" for the Exeter pilot study (see paragraph 5.47).
7.20 In addition to the lack of commercial development work, there is little clinical research in this area. Professor Wall comments, "It is a paradox that a subject of such intense scientific interest should receive so little clinical attention. One reason...[is] the daunting and excessive bureaucratic control which artificially separates studies of cannabis from drugs such as narcotics. The other reason is the general social atmosphere which labels cannabis with every possible negative attitude" (p 31, cp Q 143). He compares the attitude to medical use of narcotics before the work of Dame Cicely Saunders (Q 127). Similarly Dr Lambert says, "The Schedule 1 status of cannabis has made modern clinical research almost impossible, primarily because of the legal, ethical and bureaucratic difficulties in conducting trials with patients. In addition, the general attitude towards cannabis...has not helped". 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).
Medical use and recreational use
7.27 "Without pressing the panic button", Professor Edwards points out that cannabis or preparations of cannabis supplied for medical use might be diverted to recreational use (Q 20). Professor Hall warns that, if doctors were allowed to prescribe cannabis, some might be tempted to profit from bogus prescriptions (Q 761). New Department of Health guidelines on clinical management of drug abuse are to cover "leakage" of prescribable controlled drugs (such as methadone) onto the black market; the Department comment that leakage of nabilone is "highly unlikely", since it is dispensed only by hospital pharmacies in small amounts (p 217). The BMA report says, "It would be prudent to develop a labelling system that does not identify prescribed drugs as cannabinoids, and to warn patients that such drugs should be kept in a place inaccessible to others". Professor Nathanson added that, ideally, cannabis-based medicines would be developed which had minimal psychoactive effects (Q 76).
7.28 On 23 January 1997, the then Under-Secretary of State, Home Office, told the House of Commons, "Many of those calling for the medical use of cannabis are using it as a stalking horse to promote the campaign for its legalisation" (HC col. 1060). David Copestake, a Methodist Minister who has researched and written in this field, takes this view; he observes that medical uses were once touted for tobacco (p 213). The NDPA say the same, claiming that the BMA has been "hi-jacked" and that the ACT are "very familiar" with lobbyists for legalisation (p 278). The Christian Institute agree (p 208).
7.29 The ACT insist that they are not calling for general legalisation (p 28). They point out that heroin (diamorphine) may be prescribed (it is a Class A drug under the Misuse of Drugs Act, yet in Schedule 2 to the 1985 Regulations). Dr Notcutt observes that there is no evidence that heroin abuse is thereby encouraged, and lists several other drugs of potential abuse which are used unlicensed in chronic pain (p 105). The MRC make the same point, and say (as do several other witnesses), "The question of potential medical uses for cannabis and its derivatives must be considered quite separately from the question of prohibition of recreational use" (p 144). According to Professor Hall, there is a stalking-horse element to the debate on medical use; but this should not be allowed to influence the argument either way (p 222).
7.30 The Department of Health still detect an element of the stalking-horse. However they acknowledge and support "the genuine concern of some people to find medicinal products for intractable conditions" (Q 176).
25 Hirst R A, Lambert D G and Notcutt W G, op. cit. Back
26 A member of the Independent Inquiry into the Misuse of Drugs Act-see paragraph 6.19. Back
27 Hirst R A, Lambert D G and Notcutt W G, op. cit. Back
28 Holdcroft A et al, op. cit. Back