CHAPTER 8 OPINION OF THE COMMITTEE

Medical Use Of Cannabis: Recommendations

8.1 We recognise that, in all the evidence we have received, there is not
enough rigorous scientific evidence to prove conclusively that cannabis
itself has, or indeed has not, medical value of any kind.

8.2 Nevertheless we have received enough anecdotal evidence (see above,
paragraphs 5.4, 20-22, 27-30) to convince us that cannabis almost certainly
does have genuine medical applications, especially in treating the painful
muscular spasms and other symptoms of MS and in the control of other forms
of pain.

8.3 We therefore recommend that clinical trials of cannabis for the
treatment of MS and chronic pain should be mounted as a matter of urgency.
We warmly welcome the fact that, in the course of our inquiry, both Dr
Geoffrey Guy of GW Pharmaceuticals, and the Royal Pharmaceutical Society's
working group under Sir William Asscher, have set off down this route
(paragraphs 5.44-48). We welcome the Asscher group's intention to compare
the effects of a standardised preparation of natural cannabis with those of
the one synthetic cannabinoid already available, dronabinol, on the basis
of the same dose level of THC.

8.4 Although neither Dr Guy nor the Asscher group contemplate trials of
smoked cannabis, we agree with the Chief Executive of the MRC that such a
trial should not be ruled out (paragraph 5.57). However we recognise the
dangers of smoking, and we do not envisage smoking being used to administer
any medicine eventually licensed. For this reason we recommend that
research be promoted into alternative modes of administration (e.g.
inhalation, sub-lingual, rectal) which would retain the benefit of rapid
absorption offered by smoking, without the adverse effects.

8.5 The Government have said repeatedly that, if sufficient evidence in
favour of cannabis as a medicine were produced for the MCA to be prepared
to license it, they would amend the Misuse of Drugs Regulations so as to
permit it to be prescribed. The problem with this policy is that it will
take several years at least for this to happen. The Asscher group's trials
are not expected to be complete before mid-2001, and will lead only to
"proof of principle", leaving others to proceed with any pharmaceutical
development. Dr Guy does not expect to receive a product licence in under
five years. In the mean time, 85,000 people in this country will continue
to suffer the very unpleasant symptoms of MS. Only a small proportion of
these are known to have tried cannabis illegally; but of these, significant
numbers report great relief of their symptoms. We do not believe that this
position is satisfactory.

8.6 We therefore recommend that the Government should take steps to
transfer cannabis and cannabis resin from Schedule 1 to the Misuse of Drugs
Regulations to Schedule 2 (see Box 3), so as to allow doctors to prescribe
an appropriate preparation of cannabis, albeit as an unlicensed medicine
and on the named-patient basis (see Box 6), and to allow doctors and
pharmacists to supply the drug prescribed. This would also, incidentally,
allow research without a special licence from the Home Office (see Box 8).

8.7 It is argued in some quarters that some of those who campaign for
medical use see it as a stalking-horse for the legalisation of recreational
use (paragraphs 7.28-30). We do not see this as a reason to resist medical
use if, as we believe, it is justified by the evidence. We prefer the
argument recently advanced by Austin Mitchell MP in the House of Commons
(14 January 1998, col. 317): at present, people who use cannabis for
medical reasons are caught in the front line of the war against drug abuse.
This makes criminals of people whose intentions are innocent, it adds to
the burden on enforcement agencies, and it brings the law into disrepute.
Legalising medical use on prescription, in the way that we recommend, would
create a clear separation between medical and recreational use, under
control of the health care professions. We believe it would in fact make
the line against recreational use easier to hold.

8.8 Before moving cannabis out of Schedule 1, the Government are required
by law to consult the Advisory Council on the Misuse of Drugs. We recommend
that they do so at once, and respond to this report only after receiving
and considering the advice of the Council. We recognise that this may take
longer than the time normally allowed for such responses.

Medical Use Of Cannabinoids: Recommendations

8.9 Unlike cannabis itself, the cannabinoid THC (dronabinol) and its
analogue nabilone are already accepted by the Government as having medical
value (paragraphs 5.11-17) -- producing the anomaly that, while cannabis
itself is banned as a psychoactive drug, THC, the principal substance which
makes it psychoactive, is in legitimate medical use. Some of our witnesses
are prepared (paragraph 5.50) to contemplate wider medical use of the
cannabinoids, but not of cannabis itself. We disagree, since some users of
both find cannabis itself more effective (paragraph 5.51). We do, however,
welcome the inclusion of THC in the trials proposed by the Asscher group,
in like-for-like comparison with cannabis itself.

8.10 Dronabinol (THC), though not licensed in this country, has already
been moved to Schedule 2 to the Misuse of Drugs Regulations, and nabilone
is a licensed medicine and not a controlled drug; so no Government action
is required in either case to permit clinical trials or indeed
prescription. All cannabinoids other than THC remain in Schedule 1, and
transferring them would require agreement through the WHO under the 1971
Convention. We do not regard this as a priority, since we are not persuaded
that any other cannabinoid has a convincing medical use; but we recommend
that the Government should raise the matter of rescheduling the remaining
cannabinoids with the WHO in due course, in order to facilitate research.

Why Change The Law?

8.11 Our principal reason for recommending that the law be changed, to make
legal the use of cannabis for medical purposes, is compassionate. Illegal
medical use of cannabis is quite widespread (paragraphs 5.2-3); it is
sometimes connived at and even in some cases encouraged by health
professionals (paragraph 5.6); and yet at present it exposes patients and
in some cases their carers to all the distress of criminal proceedings,
with the possibility of serious penalties. We acknowledge that, if our
recommendation were implemented, the United Kingdom would be moving out of
step with many other countries; we consider that the Government should not
be afraid to give a lead in this matter in a responsible way.

8.12 As a secondary reason, we would observe that the law in this area
appears to be being enforced inconsistently, and in some cases with a very
light hand (paragraphs 7.2-5). Some cases are not brought to court; where
users of cannabis for medical purposes have been prosecuted, the sentence
has sometimes been light; and there have even been cases where juries have
refused to convict. The Minister told us that he was content to leave this
as a matter for the discretion of the prosecuting authorities and the
courts (QQ 668-673). That is a constitutionally proper position for a
Minister; but it is not the right position for Parliament. If statute law
is not enforced, Parliament is brought into disrepute; either enforcement
must be tightened up, or the law must be changed. In this case, we
recommend the latter.

8.13 A further subsidiary advantage of transfer from Schedule 1 to Schedule
2 would be the encouragement which this would give to research (paragraphs
7.18-26). There are exciting research opportunities in this field (see
Chapter 3), which (on the basis of the number of grants by the MRC and the
Wellcome Trust, and the number of Home Office research licences --
paragraph 5.39 and Box 8) are not being fully taken up in this country,
despite the excellence of British biomedical science. We are satisfied that
the Home Office are not being deliberately obstructive; and we are glad
that they have already taken up our proposal for a meeting between the
research community and those responsible for the research licensing regime
(paragraph 7.26). But, now that research in this field has taken off, and
the existence of important medical applications is (in our view) well
established, it is not appropriate for research to continue to be subject
to this extra layer of administration. Transfer to Schedule 2 would also go
some way to removing the stigma which many of our witnesses believe hangs
over research in this field, deterring researchers, funding bodies,
pharmaceutical companies and local ethics committees alike from involvement
in research which might turn out to be of great importance.

8.14 As the Minister pointed out to us, a doctor who prescribed cannabis on
these terms, in the absence of a product licensed by the MCA for the
relevant indication, would take on himself full responsibility for the
consequences (Q 679). This is true. However we have received evidence from
doctors who are currently prescribing nabilone on an unlicensed basis
(Notcutt Q 405). We believe that the overwhelming majority of members of
the medical profession can be trusted not to be reckless in this matter,
and that the professional regulatory bodies will deal effectively with any
who are.

8.15 The Minister also observed that, in some cases, someone charged with a
cannabis offence may claim medical use as a bogus defence or plea in
mitigation (Q 674). We do not doubt that this happens at present; and, in
the case of some people, it may be hard to tell where recreational use
stops and medical use begins (paragraph 5.5). Rescheduling so as to permit
prescription would in fact make this problem easier to deal with: rather
than having to investigate individual medical histories, as at present, the
authorities would simply ask to see the prescription.

8.16 As with any medicine, there are some groups of patients for whom
cannabis-based medicines will not be appropriate. On the evidence before
us, cannabis-based medicines should not be prescribed for persons with, or
predisposed towards, schizophrenic illness (paragraph 4.12) or
cardiovascular conditions (paragraph 4.4); nor, pending further research,
should they be prescribed for pregnant women (paragraphs 4.15-16). As with
many medicines, users should be warned of possible effects on driving
ability (paragraphs 4.6-9) and cognitive function (paragraph 4.13). As with
any potentially addictive medicine, the risk of addiction (paragraphs
4.23-33) should be weighed up when deciding whether to prescribe, and the
user should be warned. Therefore, if doctors are permitted to prescribe
cannabis on an unlicensed basis, the medical professional bodies should
provide firm guidance on how to do so responsibly (paragraph 7.17).

8.17 As with any medicine which is open to abuse, safeguards must be put in
place by the professional regulatory bodies to prevent diversion to
improper purposes (paragraph 7.27). These might include a system of
declarations to be signed by the doctor and the patient.

Recreational Use

8.18 It is believed in some quarters that the current absolute prohibition
on the recreational use of cannabis and its derivatives is not justified by
the adverse consequences for the user and the public. On the evidence
before us, we disagree. On the contrary, we endorse the Government's
statement in Tackling Drugs: "The more evidence becomes available about the
risks of...cannabis,...the more discredited the notion that [it is]
harmless" (paragraph 6.16).

8.19 The harms must not be overstated: cannabis is neither poisonous
(paragraph 4.3), nor highly addictive, and we do not believe that it can
cause schizophrenia in a previously well user with no predisposition to
develop the disease. However, we are satisfied that:

- -- It is intoxicating, enough to impair the ability to carry out
safety-critical tasks (such as flying, driving or operating machinery) for
several hours after taking (paragraphs 4.6-9);

- -- It can have adverse psychic effects ranging from temporary distress,
through transient psychosis, to the exacerbation of pre-existing mental
illness (paragraphs 4.10-12);

- -- Regular use can lead to psychological dependence (paragraphs 4.23-33);
and, in some dependent individuals (perhaps 5-10 per cent of regular
users), regular heavy use can produce a state of near continuous
intoxication, making normal life impossible;

- -- Withdrawal may occasionally involve unpleasant symptoms (paragraphs
4.23-25);

- -- Cannabis impairs cognitive function during use (paragraph 4.6);

- -- It increases the heart rate and lowers the blood pressure, carrying
risks to people with cardiovascular conditions, especially first-time users
who have not developed tolerance to this effect (paragraph 4.4).

8.20 Moreover, it is possible, though not proved, that the effects of
cannabis on driving etc. may last longer than a few hours after taking
(paragraph 4.7); that the damage to cognitive function may endure after
withdrawal (paragraph 4.13); and that cannabis has adverse effects on the
immune system (paragraph 5.16) and on fertility and reproduction
(paragraphs 4.15-16).

8.21 In addition, smoking cannabis carries similar risks of respiratory
disorders to smoking tobacco. It is also possible, though not proved, that
exposure to cannabis smoke increases the risk of cancers of the mouth,
throat and lung (paragraphs 4.17-18).

8.22 Therefore, on the basis of the scientific evidence which we have
collected, we recommend that cannabis and its derivatives should continue
to be controlled drugs.

SUMMARY OF RECOMMENDATIONS

8.23

(i) Clinical trials of cannabis for the treatment of MS and chronic pain
should be mounted as a matter of urgency (paragraph 8.3).

(ii) Research should be promoted into alternative modes of administration
(e.g. inhalation, sub-lingual, rectal) which would retain the benefit of
rapid absorption offered by smoking, without the adverse effects (paragraph
8.4).

(iii) The Government should take steps to transfer cannabis and cannabis
resin from Schedule 1 to the Misuse of Drugs Regulations to Schedule 2, so
as to allow doctors to prescribe an appropriate preparation of cannabis,
albeit as an unlicensed medicine and on the named-patient basis, and to
allow doctors and pharmacists to supply the drug prescribed (paragraph 8.6).

(iv) The Government should consult the Advisory Council on the Misuse of
Drugs on this matter at once, and respond to this report only after
receiving and considering their advice (paragraph 8.8).

(v) The Government should raise the question of rescheduling the remaining
cannabinoids with the WHO in due course (paragraph 8.10).

(vi) If doctors are permitted to prescribe cannabis on an unlicensed basis,
the medical professional bodies should provide firm guidance on how to do
so responsibly (paragraph 8.16); and safeguards must be put in place by the
professional regulatory bodies to prevent diversion to improper purposes
(paragraph 8.17).

(vii) Cannabis and its derivatives should continue to be controlled drugs
(paragraph 8.22).

Checked-by: Richard Lake