Call for cannabis-based mouth spray approval

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 Sweden. 

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

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 MaltaToday.

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 £11 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 Sativex. 

"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 requirements.