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.

26 A member of the Independent Inquiry into the Misuse of Drugs Act-see
paragraph 6.19.

27 Hirst R A, Lambert D G and Notcutt W G, op. cit. Back 28 Holdcroft A et
al, op. cit.

Checked-by: Richard Lake