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"[25]. 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[26], 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.
Research
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"[27].
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[28].
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
|
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