1. In this short Inquiry we wanted to follow up issues relating to our earlier Inquiry, Cannabis: The Scientific and Medical Evidence (November 1998). In that Report, we recommended that doctors should be permitted to prescribe an appropriate preparation of cannabis if they saw fit, albeit as an unlicensed medicine and on a named-patient basis. In a departure from the usual convention, the Government rejected this recommendation on the morning the Report was published. The Government's written reply was no more encouraging. In March 1999, therefore, the Committee wrote: "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."

11. We are pleased to note that the Government now display a more encouraging attitude towards the licensing of therapeutic preparations of cannabis than we have previously detected. The Minister was quick to deny suggestions that the Government were hiding behind scientific opinion.

18. ...we consider it undesirable to prosecute genuine therapeutic users of cannabis who possess or grow cannabis for their own use.

24. We consider that the decision of the MCA is flawed for three reasons which are discussed in turn below:
(a) the MCA persist in treating CBD and cannabis oil as "new medicines", though cannabis oil, which contains both CBD and THC, has a long history of human use and appeared in the British Pharmacopoeia Codex until 1948;
(b) the studies which the MCA took to indicate an inhibition of spermatogenesis involved doses of CBD at least 100 times higher than the doses contemplated by either Dr Zajicek or G. W. Pharmaceuticals; and
(c) the potential side-effects of CBD about which the MCA are concerned might be regarded as trivial by those patients, such as those suffering from multiple sclerosis, who stand to benefit from medicines incorporating CBD. These concerns could be dealt with by issuing a warning to physicians who prescribe cannabis-based medicines. The attitude of the MCA in not allowing patients to make their own decisions could be regarded as overprotective.

25. Both the MCA and the Home Office persist in treating cannabis-based medicines as new medicines. Cannabis, however, has a history of medical use in man stretching back hundreds of years. For much of the nineteenth century and the first half of the twentieth century, moreover, it was administered in Britain as a tincture (cannabis oil in alcohol): thus the oral administration of cannabis extracts which contain significant quantities of CBD has a long history of medicinal use. In choosing to ignore the long history of safe therapeutic cannabis use, and in classifying cannabis extract (and CBD) as a "new medicine", the Government and the MCA are treating a long-established herbal extract as if it were just another new synthetic chemical, and are thus not making an informed scientific judgement.

27. There is always some risk in taking any medication; patients and their doctors should certainly be informed about the toxicological concerns that the MCA have raised, but these concerns should not prevent them from having access to what promises to be the only effective medication available to them.

28. Overall, we consider that the MCA's attitude means that cannabis-based medicines are not being dealt with in the same impartial manner as other medicines.

29. We believe that a thorough and impartial reappraisal of the published scientific literature on the safety of CBD and cannabis extracts should lead the MCA to reconsider their present overly cautious stance.

Recommendation 4. We consider that the Medicines Control Agency are not approaching the question of licensing cannabis-based medicines in a properly balanced way, especially given the long-established history of cannabis use, and the needs of patients for whom there is no medicinal alternative.

Government reply:

4. Recommendation: The MCA should reconsider their position on the licensing of medicines containing cannabidiol (CBD).

The Committee has expressed concerns that the MCA has taken an overcautious approach, leading to delays in any eventual approval of applications for a product licence. The Government has great sympathy for those whose conditions are not helped by existing medication. But it sees no case for setting aside the standards and regulations which exist to protect patients who volunteer for clinical trials and allowing them to be exposed to experimental medicines that have not been properly evaluated. There are well-established procedures derived from national and European legislation and EU guidelines which prospective medicines have to go through to minimise any risk in clinical trials. The Government believes that the MCA has handled its regulatory responsibilities properly on this issue in the interest of patient safety. Underlying the Committee’s concerns about delay is the issue of whether CBD and cannabis oil should be evaluated as new medicines. The Government considers that the new cannabis-based products under development are not long established herbal extracts and that these products should be classified as new medicinal products for the following reasons. Their compositions present new issues for which there is no current evidence. The older evidence was considered, but it was not possible to extrapolate from the anecdotal human experience with those older products, with unknown levels of cannabinoids, to the toxicity of Cannador. The pharmaceutical standard for tincture of cannabis in the British Pharmaceutical Codex of 1949, to which the Committee refers, does not state the levels of CBD present. The tincture therefore could not be considered equivalent to Cannador that contains up to 30% CBD or the GW Pharmaceutical product which contains over 50% CBD. The 1949 Pharmaceutical Codex Revision Committee referred to the uses of cannabis as follows, “Cannabis is too unreliable in action to be of value in therapeutics as a cerebral sedative or narcotic and its former use in mania and nervous disorders has been abandoned”.