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.