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
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| 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).
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| 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).
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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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