The Home Office has issued a licence for a British pharmaceuticals company to investigate the uses of cannabis as a medicine.
GW Pharmaceuticals, founded by Dr Geoffrey Guy, has been licensed under the Misuse of Drugs Act 1971 to proceed with a complete pharmaceutical research and development programme into cannabis and its chemical compounds, and in particular into delivery methods other than smoking. The objectives of the research and development programme will be:
- initially to develop standardised extracts of cannabis sativa (the most common cannabis plant), specially grown under controlled conditions.
- to establish the best delivery method into patients - other than smoking - of cannabis and/or its constituents, and to establish if safe therapeutic uses exist in a range of illnesses.
- to provide materials for clinical trials and extended monitoring programmes.
- to prepare data for Product Licence Approval by the Medicine Controls Agency.
- to expand the programme internationally with academic researchers and pharmaceutical partners.
- eventually to identify purified fractions and/or subsets including single entities, which may have useful therapeutic applications or can serve as research tools.
All work will be carried out at secure research facilities in the UK.
Dr Guy said, "There is a considerable body of evidence to suggest that cannabis may have a number of medicinal uses: for the relief of pain and spasticity in multiple sclerosis; for pain relief in other neurological disorders, such as paraplegia and neuralgia; as an appetite stimulant in treating AIDS patients with wasting disease; for the prevention of nausea and vomiting associated with cancer chemotherapy; and in the eye disease, glaucoma. But there have been very few systematic research programmes or controlled clinical trials. Our aim will be to establish the medical facts."
The licences have been issued to enable a full pharmaceutical research programme to be undertaken. In the event of a Product Licence being granted for a cannabis-based medicine, the Home Office would be very willing to come forward with a change in the controls of the Misuse of Drugs Act 1971 to allow the prescribing of such a medicine.
Although the licences will also cover all researchers nominated by Dr Guy and approved by the Home Office to participate in the programme, Dr Guy and GW Pharmaceuticals Ltd will remain responsible for the appropriate use of the cannabis materials and the conduct of the work according to the prescribed schedules of the licences.
Dr Guy added, "I am grateful to the Home Office for the very positive way in which these discussions were conducted and the very sound legal and regulatory footing upon which the programme is now based. The Home Office has been most helpful in assisting GW Pharmaceuticals in generating policies regarding security, controlled drug records, staff health and safety and secure handling of materials. The scale of this operation will be sufficient to allow the acquisition of 500-600 patient years of safety and efficacy data."