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)
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
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
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
cannabisincluding smoked cannabis even though the Committee
acknowledged that smoking was dangerous and did not envisage smoking
being used to administer any eventually licensed medicinewithout
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
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
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.