Home Office has issued a licence for a British pharmaceuticals company
to investigate the uses of cannabis as a medicine.
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:
to develop standardised extracts of cannabis sativa (the most
common cannabis plant), specially grown under controlled conditions.
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.
provide materials for clinical trials and extended monitoring
prepare data for Product Licence Approval by the Medicine Controls
expand the programme internationally with academic researchers
and pharmaceutical partners.
to identify purified fractions and/or subsets including single
entities, which may have useful therapeutic applications or can
serve as research tools.
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."
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.
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.
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."