REPORT
Appendix
1: Membership of the Select Committee
Appendix
2: Government response
SECOND
REPORT
4TH
MARCH 1999
By
the Select Committee appointed to consider Science and Technology
ORDERED TO REPORT
CANNABIS:
GOVERNMENT RESPONSE
In November 1998 we reported on Cannabis: the Scientific and Medical Evidence
(9th Report 1997-98, HL Paper 151). We recommended that, though cannabis should
remain a controlled drug, the law should be changed to allow doctors to prescribe
an appropriate preparation of cannabis if they saw fit.
The
Government rejected this recommendation on the day of publication. This was a
departure from the usual convention, as the Government concede. They put their
case when the House of Lords debated our report on 3 December (Hansard
col. 703). They have now made a formal written response to our report, which is
printed here as Appendix 2.
In
reporting the Government's response for the information of the House, we would
observe that its main arguments against our recommendations are ones which we
considered in the course of our inquiry. We continue to find them unpersuasive.
The Government argue
that prohibition protects patients from taking substances of unproven efficacy,
quality and safety. We found enough evidence, albeit largely anecdotal, to convince
us that cannabis is efficacious, especially against the symptoms of MS and in
the control of pain. The evidence is set out in Chapter 5 of our original report.
Significant numbers of sufferers are taking cannabis at present, in defiance of
the law and without medical supervision or quality control; our recommendation
would enable the health professions and the pharmaceutical industry to collaborate
to provide appropriate preparations.
As
for safety, cannabis is well known to be safe in terms of acute toxicity. Nonetheless
using it does involve risks, discussed in Chapter 4 of our report, from which
people currently using it for medical purposes are unprotected. We recommended
that the medical professional bodies should provide guidance on responsible prescribing,
to protect at-risk groups and to take account of the dangers of intoxication and
addiction.
Secondly,
the Government argue that permitting prescription now would reduce the momentum
of research. On the contrary, we found evidence, set out in Chapter 7, that research
has been held back by the stigma and bureaucracy associated with the status of
cannabis as an illegal drug.
Finally,
the Government question the capability of doctors to deal with patients demanding
cannabis for improper purposes. In our report, we expressed more confidence in
the medical profession and its regulatory bodies (paragraph 8.14) than the Government
appear to feel; and we recommended special safeguards against diversion (paragraph
8.17). We would observe in addition that cannabis is well known to be readily
available to the non-therapeutic user, by means far easier than deceiving a GP.
In
conclusion, we regret that the mind of the Government appears to be closed on
this issue, and hope that the results of new research now under way may cause
them to revisit our recommendations at an early date.
APPENDIX
1
Current
members of the Select Committee
Lord
Birdwood
Lord
Haskel
Baroness Hogg
Lord Howie of Troon
Lord Jenkin of Roding
Lord Kirkwood
Lord
Nathan
Lord Perry
of Walton
Baroness
Platt of Writtle
Lord
Ponsonby of Shulbrede
Lord
Porter of Luddenham
Lord
Quirk
Lord Rea
Lord
Soulsby of Swaffham Prior
Lord
Tombs
Lord Walton
of Detchant
Lord
Winston (Chairman)
Members
of the Sub-Committee which conducted the original enquiry
Lord
Butterfield
Lord
Butterworth
Lord
Carmichael of Kelvingrove
Lord
Dixon-Smith
Lord
Kirkwood
Lord Nathan
Lord Perry of Walton
(Chairman)
Lord Porter
of Luddenham
Lord
Rea
Lord Soulsby
of Swaffham Prior
Lord
Walton of Detchant
Lord
Winston
APPENDIX
2
GOVERNMENT
REPLY TO THE REPORT OF THE HOUSE OF LORDS SELECT COMMITTEE ON SCIENCE AND TECHNOLOGY,
"CANNABIS, THE SCIENTIFIC AND MEDICAL EVIDENCE" (9TH REPORT, HL PAPER
151, SESSION 1997-98)
Introduction
1.
The Government welcomes the report's contribution to the debates on the therapeutic
and non-therapeutic (referred to in the report as "recreational") uses
of cannabis. It draws together a large volume of material and presents it in a
highly readable form.
2.
The report was published on 11 November 1998 and, in a departure from the usual
conventions, the Government responded immediately to, and rejected, the recommendations
that cannabis should be prescribable by doctors. The Government felt that, in
the circumstances of its firmly grounded and logical position on the availability
of cannabis for therapeutic purposes, it should not remain silent and thereby
raise speculation that it regarded the question as open. We return to the question
of the policy later.
3.
The House of Lords debated the report on 3 December on a motion initiated by the
Chairman of the Committee, Lord Perry of Walton (columns 671-708). This reply
has the benefit of being informed by that debate, repeats and expands on some
of the points made by the Government spokesman in that debate (Lord Hoyle), and
responds to the recommendations which were not discussed in the debate.
Recommendation
(i). Clinical trials of cannabis for the treatment of MS and chronic pain should
be mounted as a matter of urgency
4.
The Government too would welcome clinical trials into the therapeutic uses of
cannabis. The report referred to work which is being undertaken by GW Pharmaceuticals,
the Royal Pharmaceutical Society and various others towards that end. The Government
is content to leave it to the research community to decide whether cannabis as
a whole or individual cannabinoids offer the best prospect.
5.
In either event, the Government is willing to license medical research and trials
involving cannabis or the cannabinoids, subject to the conditions set out in Box
8 of the Report.
6.
In addition to considering applications for licences, the Home Office Drugs Inspectorate
is willing to discuss general research-related licensing issues. The Drugs Inspectorate
attended the launch on 11 January of the Royal Pharmaceutical Society of Great
Britain's working party's protocols for use in trials of cannabinoids; the Medicines
Control Agency was also present. The occasion provided the opportunity for a question
and answer session on licensing matters. The Inspectorate is also planning to
take part in a colloquium to be organised in the spring by GW Pharmaceuticals.
If further exploration of issues relating to the issue of licences proves necessary,
the Inspectorate stands ready to take part in other meetings (in combination with
other bodies as necessary) to give advice and assistance.
Recommendation
(ii). Research should be promoted into alternative modes of administration (e.g.
inhalation, sub-lingual, rectal) which would retain the benefit of rapid absorption
by smoking, without the adverse effects
7.
Based on the scientific evidence presented to the Committee including the BMA
report, it seems likely that a route of administration other than by mouth would
improve the availability of a prescribed dose and the reliability of its effect.
The Government therefore accepts this recommendation and would wish to encourage
research in this area among those who are looking to develop cannabis as a medicine.
Recommendation
(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
8.
The Government expressed its concerns about this recommendation at the time of
publication of the Report and during the debate on 3 December.
9.
Schedule 1 to the Regulations lists those substances which are not generally acknowledged
to have therapeutic value. As well as cannabis, cannabis resin, and the cannabinoids
(save nabilone and dronabinol) it includes coca leaf, Ecstasy, LSD, and raw opium.
The fact that a drug is in Schedule 1 does not mean that it can never be moved
to a schedule which imposes lesser controls. The report describes the mechanics
of making a change in paragraph 7.6. Cannabis and cannabis resin, although not
the cannabinoids, could be rescheduled without international agreement. The question,
as the report says, is whether they should be.
10.
There is a well-established procedure which prospective medicines have to go through
in order to ensure their safety, quality and efficacy. The very purpose of having
these standards is to try and ensure, so far as is possible, that patients are
not given medicines which are of poor quality, unsafe or ineffective. The Government's
view is that it would not be proper to allow cannabis to be prescribed by doctors
before those characteristics have been scientifically established. The report
admits that such a position has not been reached. It nonetheless takes the view
that there are compassionate grounds for allowing doctors to prescribe cannabis—including
smoked cannabis even though the Committee acknowledged that smoking was dangerous
and did not envisage smoking being used to administer any eventually licensed
medicine—without the results of trials into the drug being known. The Government
believes that such a move would be premature.
11.
The Government has very great sympathy for those whose conditions are not helped
by existing medication. But it sees no case for setting aside the controls which
exist to protect the public and allowing doctors to prescribe, even on a named
patient basis, raw cannabis with unknown standards of safety, quality and efficacy.
12. The
Government is also concerned that if the prescription of raw cannabis was permitted,
as recommended in the report, the current momentum behind research into a suitable
medicinal product based on cannabis and the cannabinoids would be checked to the
detriment of proper scientific evaluation.
13.
The Government is supported by the British Medical Association and the Royal Society
in its view that raw cannabis should not be available for medicinal purposes and
that further research is required.
14.
In addition the Government has to be mindful of the implications for the totality
of controls on cannabis of allowing the prescription of raw cannabis before a
medicinal form has been developed. We return to this point in paragraphs 19-23
below.
Recommendation
(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
15.
The Advisory Council had a meeting arranged for 19 November, shortly after publication
of the report on 11 November. The Government did not seek the Council's view on
the recommendations at that meeting since it would have been disingenuous to seek
a view having already decided that the recommendations would not be accepted.
The Council noted that the Government had already firmly indicated that it would
not be willing to amend the law as recommended and took the view that there was
accordingly nothing to be gained by giving detailed consideration to the question.
16. Before
any change in the law on cannabis, or any other controlled drug, is made, the
Council has, under the terms of the Misuse of Drugs Act 1971, to be consulted.
However, because the Government was not willing, and therefore was not proposing,
to change the law in response to the recommendation there was no legal obligation
for the Council to be consulted.
Recommendation
(v). The Government should raise the question of rescheduling the remaining cannabinoids
with the WHO in due course
17.
Dronabinol, one of the cannabinoids, is, as the report mentions, already subject
to less stringent controls under the 1971 UN Convention on Psychotropic Substances
than the other cannabinoids because of its now recognised therapeutic value. Accordingly
it is in Schedule 2 rather than Schedule 1 of the Misuse of Drugs Regulations
1985.
18.
If it becomes clear that any of the remaining cannabinoids have therapeutic potential
the Government will seek amendment of the 1971 Convention which would make it
possible to place these substances in Schedule 2 of the 1985 Regulations without
breach of the Convention.
Recommendation
(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;
and safeguards must be put in place by the professional regulatory bodies to prevent
diversion to improper purposes
19.
The recommendation falls because the Government is unwilling to allow cannabis
to be prescribed on an unlicensed basis. But it may be worth describing some of
the implications of the recommendation were it to be implemented.
20.
If cannabis could be prescribed on a named patient basis the doctor would, as
the report acknowledges, take on him or herself full responsibility not only for
the welfare of their patient but also for a person being allowed to possess cannabis.
In the case of cannabis we do not believe that it would be reasonable to burden
doctors with that responsibility.
21.
If doctors were permitted to prescribe cannabis it could, in the absence of a
marketing authorisation (product licence), be prescribed for any ailment which
the doctor chose. Doctors would come under enormous pressure from some patients
to prescribe cannabis for a variety of conditions. In the face of that pressure,
whatever guidance might be given by their professional bodies, without statutory
control some doctors would undoubtedly give in and prescribe; other doctors believing
in the benefits of cannabis would prescribe it anyway. It would not be long before
the situation deteriorated to the extent now seen in California where "cannabis
clubs" provide supplies on a doctor's certificate purchased by the patient.
This situation is now being challenged by the federal authorities.
22.
Allowing raw cannabis (which would usually be smoked) as a medicine would seriously
blur the distinction between misuse and therapeutic use. It would send confusing
messages to the public about the risks of misusing the drug. People caught in
possession of unprescribed cannabis by the police would frequently argue that
it was for therapeutic purposes and claim that the prescription had been lost.
23. On
the other hand, if a medicinal form of the drug were available it would be possible
to retain a clear difference between the two forms. The risk of diversion of the
medicinal form to the illicit market would be no greater than it is for current
medicines which contain controlled drugs, on which there are controls on production,
supply and possession.
Recommendation
(vii). Cannabis and its derivatives should continue to be controlled drugs
24.
The Government agrees and is glad of the Committee's concurrence that raw cannabis
should not be permitted for non-therapeutic purposes.
