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UK
Named Patient Prescribing for Sativex®
GW
announces that it has been informed by the Home Office
that the Drugs Minister, Paul Goggins, has confirmed
that Sativex® oromucosal spray, its cannabis-based
medicine, may be imported from Canada to satisfy its
prescription to individual patients in the UK as an
unlicensed medicine. This development is in response
to enquiries from a number of UK doctors and individual
patients who have been in contact with the Home Office
to request access to Sativex.
In accordance
with the Medicines Act, a medicine which has yet to
be licensed in the UK may be prescribed and supplied
in response to an unsolicited request to fulfil the
special needs of an individual patient under a physician’s
direct personal responsibility. The basis on which Sativex
may be imported, therefore, is the clinical judgement
of doctors in relation to specific nominated patients.
This development
follows the approval of Sativex by Health Canada in
April 2005. The medicine has been available on prescription
in Canada since late June.
More recently,
the Medicines and Healthcare products Regulatory Agency
(MHRA) has issued to GW a Wholesale Dealer’s (Importation
from non-EU countries) Licence, and has not objected
to the importation of Sativex under the regulations
for importation of medicines unlicensed in the UK.
Sativex will
remain a Schedule 1 controlled drug in the UK in line
with stated government policy. This means that the prescribing
of Sativex can only be permitted under Home Office licence.
The Home Office will therefore be developing a licensing
regime to fit these circumstances. GW expects to discuss
the implementation practicalities with the Home Office
over the coming weeks.
Clearance
for supply on an unlicensed basis does not affect GW’s
plans to seek full regulatory approval from the MHRA
for Sativex in the UK. The Company is currently conducting
a number of further Phase III trials and is still planning
to submit an application for Marketing Authorisation
to the MHRA during 2006. Only after such an approval
is granted can the product be promoted in the UK.
15/11/2005
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