Call for cannabis-based mouth spray approval

Cannabis-based medicine ‘offers relief to patients suffering from multiple sclerosis and neurophatic pains’

The mouth spray has been approved by various EU governments, including the UK and Germany
The mouth spray has been approved by various EU governments, including the UK and Germany

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.

This product should definitely be given to those that need it and cant afford it, i also believe and it has been said that the pure form of cannabis cannot be beat. Our new maltese government God willing they will legalise cannabis for adults over 18 and first and foremost pass a medical marijuana bill so we can start providing patients here in malta with properly grown medicine. I am a maltese citizen and am seeking medicinal cannabis advice for my lifelong pains and suffering. From what i understand about the Schengen Convention Article 75 protects patients and assists them attaining their medicine from another country within the EU after filling in the necessary paperwork and necessary signatures. The world is looking at cannabis very differently, we need to spread the good word about cannabis and all of its benefits.
@ David Caruana The BBC report refers to cannabis and its effect on driver's judgement. Perhaps you can enlighten us what is wrong about the conclusions of this report. @dscerri your interpretation is wrong. See first sentences of the report.
@Joe Mallia - 21/02/2012 20:24:06 Wrong again. You posted it, so RTFA: "The observed association between alcohol and crash risk is more significant than that for cannabis, the study says."
@ Joe Mallia: "Such drivers are a danger on the roads as much or more than drunken drivers" This only shows your total ignorance about the subject. While I would never suggest that anyone drives under the influence of neither alcohol, nor cannabis, I can never accept that a stoned driver is equally or more dangerous than a drunk driver, because that is simply not the case. It's quite useless thrwoing studies at each other because I have one that contradicts what you are saying, so maybe it's you who needs to wake up. "Why Medical Marijuana Laws Reduce Traffic Deaths States that legalize medical marijuana see fewer fatal car accidents, according to a new study, in part because people may be substituting marijuana smoking for drinking alcohol." TIME magazine Read more:
@dscerri what you missed is that cannabis "impairs brain and motor functions needed for safe driving". Such drivers are a danger on the roads as much or more than drunken drivers. Wake up sir!
@Joe Mallia - 21/02/2012 13:49:11 The article you linked to states: "Drivers who use cannabis up to three hours before driving are twice as likely to cause a collision as those not under the influence of drugs or alcohol, says a Canadian study." This is no different to driving under the influence of beer, wine, caffeine, cold and flu remedies...etc. Heck, people are even *more* likely to cause a collision under the influence of those substances. Tiredness causes plenty of accidents, but more still are caused by plain ol' stupidity. What do we ban next, low IQ? When was the last time you were in an accident caused by someone who was stoned? What's that you say, "never"? Go back to sleep.
"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." Why not just let people grow their own at home? Sometimes the simplest solutions are the most obvious.
The link below is ample proof of the danger that cannabis users cause while driving:
I agree that Sativex should be available on the local market. Nevertheless we would then have a rather absurd situation where you can legally buy pills made from a plant that will get you 10+ years behind bars if it's growing in a pot in your balcony.