Pubdate: Tue, 21 Feb 2012
Source: MaltaToday (Malta)
Copyright: 2012sMediaToday Ltd, Vjal ir-Rihan, San Gwann SGN 02, Malta
Author: James Debono


Cannabis-Based Medicine 'Offers Relief to Patients Suffering From
Multiple Sclerosis and Neurophatic Pains'

Maltese patients suffering from intense muscle pain related to
ailments like multiple sclerosis (MS) or neurophatic diseases are
calling on the Maltese government to approve the importation of a new
cannabis based medicine in Malta.

Sativex, a cannabis based mouth spray, relieves painful spasticity of
the muscles which can make it hard to perform simple tasks like
unscrewing the lid from a bottle, has been approved by various EU
governments including the United Kingdom, Spain Germany, Denmark and

Outside the EU, the drug has also been approved in Canada and New

In the United Kingdom, the drug has been approved since 2010, while
Germany approved its use in May 2011.

Sativex, which is now marketed by pharmaceutical giant Bayer, contains
active ingredients called cannabinoids, which are extracted from
cannabis plants grown in a strictly controlled environment.

"We are being discriminated because while patients in other European
countries can have this drug prescribed legally to them this drug is
not available here," a patient suffering from neurophatic pain told

The patient referred to the fact that according to Schengen
regulations, foreigners can bring this medicine to Malta while Maltese
patients cannot buy it from Malta. The patient told MaltaToday that
while a close relative who suffers from the same condition is legally
entitled to this drug in the UK, in Malta doctors are not even aware
of this drug.

"In order to deal with the unbearable pain I have to take a number of
pills and live with the side effects while my relative has access to
Sativex which was highly effective in relieving his pain."

Another patient who talked to the newspaper and who suffers from MS
described the pain as constant and exhausting. "Sometimes you can't
sleep. It's impossible. It's like having a permanent cramp."

In the UK, 11,500 patients are eligible for treatment but at o11 a
day, the medicine is still considered too expensive and pressure is
mounting to include it on the NHS's list of free medicines.

Simon Gillespie, chief executive of the MS Society in the UK,
expressed his hope that Savitex will be made freely available on the
NHS to anyone who might benefit from it.

"At this stage we are not calling on the government to include Savitex
in its list of free medicines but at least it should be available in
Maltese pharmacies," the patient told MaltaToday.

A medicinal product can only be placed on the local market if it has a
'marketing authorisation' issued by the Medicines Authority, which
falls under the Ministry for Fair Competition, Small Business and Consumers.

A spokesperson for the Ministry told MaltaToday that this Authority
has not received an application for the marketing authorisation of

"Should the Medicines Authority receive a marketing authorisation
application for the product, the application will be evaluated."

An application for marketing authorisation has to be submitted by the
a representative of the company manufucturing the product. To date the
Medicines Authority has not received any application from the
marketing authorisation holder of Sativex for this product to be
registered on the market in Malta.

If the product is granted a marketing authorisation, the product can
be sold from pharmacies and patients would be able to purchase it
against a prescription and in accordance with any national legal
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MAP posted-by: Richard R Smith Jr.