Dear Mr Vosseler,

Thank you for your letter of 16 March in regard to the case of your client, Mr DT Clark and his application for use of cannabis for medical treatment of tetraplegia and associated muscle spasms.

You have asked whether I am able to review an application made in 1994 by Mr Clark for authorisation to use cannabis, or consider a new application.

I understand that your client, Mr Clark, has been informed that the provisions of the Misuse of Drugs Act 1973 (sic) require a medical practitioner to make the application, in authorising the prescribing of a controlled drug. Mr Clark has only submitted general letters of support from doctors. Therefore, there are no legislative grounds to review that application further.

The Ministry would be open to receiving a further application from any practitioner who is willing to prescribe a cannabis product for Mr Clark. However, the conditions relating to research are still appropriate and will still apply. The authorisation would not be simply a permission to obtain and smoke the Class C Part 1 Controlled Drug, cannabis plant material.

Information recently supplied on Mr Clark's behalf to the Ministry of Health concerning recent inquiries by the British House of Lords refers to therapeutic trials of cannabis products proposed or underway in that country. The trial of a sub-lingual cannabinol spray sponsored by GW Pharmaceuticals appears to be the sort of formal trial use of a new medicine on individual subjects which would be relatively easy to adapt to the New Zealand situation. A small-scale trial of this sort would not need prior assessment by the Health Research Council, under section 30 of the Medicines Act, but as it is an innovative treatment, the trial protocol would have to be assessed by the local ethics committee.

The Ministry of Health has been advised that an ethics committee would require the prescribing doctor to create a protocol for a study to show the effectiveness of cannabinoid against the best standard treatment. The protocol would require the clinician to identify the symptoms that were to be controlled (the primary end-points) and any other gains in health status that may occur (secondary end-points) and detail objective measurement techniques to assess effectiveness over a limited period of time.

Ideally, the study protocol would be double-blinded, where neither the patient nor the clinician knows when the patient is receiving 'best standard treatment' or cannabinoid, or include a crossover period where the patient is stabilised on 'best standard treatment' and then swapped over to cannabinoid. The study protocol would require the clinician to collect data on both the safety and effectiveness of the cannabinoid and standard treatments. The ethics committee would determine the minimum requirements for each study on a case-by-case basis.

The ethics committee would require the doctor to report on efficacy and also any side effects that occurred on a six monthly basis. The prescribing doctor would also b required to report any serious adverse effects directly to the Ministry of Health.

Provided ethics committee approval is obtained, the Ministry of Health officials would be available to advise on the procedure and the licenses necessary for obtaining the product. The new medicine under trial would not be subsidised and so the cost of the supply would have to be borne by your client.

Thank you for your correspondence on this matter.