Malta: The Long And Painful Wait For Medical Cannabis

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Before the debate on the recreational use of cannabis, Maltese patients, like their fellow Europeans, had already started inquiring about the medical use of the plant. But despite new legislation, they have been left hanging for more than two years and they now fear that the proposed amendments will push prices through the roof, writes Sarah Carabott.

After two decades battling an ailment that “robbed” her of her life, a window of hope opened in Joanne’s life when she heard of medical cannabis treatment for Fibromyalgia.

She went for it by the book – or so she thought. She obtained a recommendation from her GP and two consultant certificates saying her severe fibromyalgia was characterized by constant pain, tiredness and loss of function, and that the condition had not improved despite multiple attempts at treatment.

But when Joanne*, documents in hand, went to pick up her non-psychoactive cannabidiol (CBD) oil, Port Health asked her to obtain a prescription from an oncologist.

However, when she duly turned up again with the prescription, she was told it was missing a stamp. By then she was so exhausted, with her condition bearing down on her, that she gave up and left it with the Customs Department.

“I then bought a little bottle of what I thought was CBD oil from someone in Malta, but they tricked me. I ended up with a little bottle of vegetable oil,” she said, waving the tiny bottle that she had bought for €100.

Although she did manage to get her hands on a bottle of the genuine stuff, she is still afraid of taking the full dose.

“I take a third of the recommended dosage as I’m scared that if I fall ill because of some other ailment and the doctors find out that I’m consuming CBD oil, they will ask questions about where I got it from,” she said.

It was because of the suffering of patients like Joanne that in 2014 MP Godfrey Farrugia called for the legalization of short-term personal use of non-smoked cannabis for purely medical purposes.

In April 2015, the Drug Dependence (Treatment not Imprisonment) Act came into force. It allows registered specialists to prescribe medicinal preparations of the plant cannabis licensed under the Medicines Act, if they believe there is no viable alternative.

Until 2017, patients were obtaining a prescription from a doctor and permission from the authorities to import CBD oil from a licensed international outlet. Up until some months ago, it could even be purchased from local health food stores.

But halfway through last year, the situation changed – patients were no longer allowed to import CBD oil for personal use. A doctor who had spoken to this newspaper at the time was informed that CBD oil – legal elsewhere in the EU – was now deemed illegal in Malta.

Several patients had to resort to importing it illicitly.

Towards the end of last year, new proposals were tabled to allow not just a specialist but any licensed medical practitioner to prescribe medicinal preparations of cannabis if there was no viable alternative, as well as synthetic cannabinoid products licensed under the Medicines Act or manufactured under Good Manufacturing Practice.

Patients will also have to be registered for a drug-control card, which could be withdrawn for a valid reason by the Superintendent of Public Health.

For Joanne, the wait has been too long. She has suffered the brunt of Fibromyalgia for 24 years, with the condition flaring up six years ago. She was finally diagnosed three years ago but the condition is so severe that at times she has spent weeks in bed.

“I go around feeling as though I’m carrying a man on my shoulders. So wearing a jacket is out of the question as the pain is unbearable.”

Over the years she has seen numerous specialists and tried out several treatments. She found that her pain is subdued when she consumes CBD oil and she suffers no side effects, unlike all the other medicines she has tried.

“Knowing that there is a natural treatment which is out of my reach here, but more readily available abroad, is so frustrating.

“Why is it taking so long to bring in easier procedures? I wish that politicians could live only one day in my shoes and spend a day locked up at home. It feels as if we cannot even speak out openly about it as it is not yet clear what is legal and what’s not,” Joanne said, while making it clear that she is against smoking the plant.

Strong evidence for use

There is strong evidence that natural or synthetic cannabis extracts can treat multiple sclerosis spasticity, chronic pain mainly associated with the nervous system, chemo-related nausea and glaucoma, among others.

Synthetic cannabis preparations fall under conventional medicine, such as tablets or aerosol spray. Plant extracts or derivative preparations are often considered as alternative medicine.

The plant contains hundreds of compounds, with the main psychoactive one known as THC. Another one is CBD, which does not appear to have the effect of making users ‘high’.

It is very hard to take a lethal dose but there is clinical evidence of cannabis dependency syndrome with chronic and high dose use.

What price pain relief?

The government’s recently tabled amendments on medical cannabis would regularize accessibility to the treatment and ensure the products are genuine, according to MP Godfrey Farrugia.

However, he fears the treatment will be unaffordable for patients. This could lead them to continue purchasing their medical cannabis derivatives online, not always of good quality.

Dr Farrugia, a Democratic Party MP, raised the issue in Parliament in 2014 after resigning as health minister under Labor. But despite getting the ball rolling through new laws in 2015, it took the government two years to implement the procedure that would allow people access to medical cannabis, Dr Farrugia told The Sunday Times of Malta.

As a registered family specialist, he has co-prescribed medical cannabis to 17 patients.

Although it only manages the symptoms and does not cure the ailment, the patient’s quality of life, and hence their dignity, improves, he says. Some of his patients were terminally ill with cancer and others had been diagnosed with Huntington Disease or Fibromyalgia.

Patients, he says, are now anxious to recover the time they lost due to the government’s delay. “If this was an exercise of political convenience, it is deplorable. Surely it shows lack of competence.”

His patients’ main concerns about the treatment are accessibility and affordability.

It appears the planned amendments will improve access, as patients will now be able to consult their family doctor over the treatment. However, one stumbling block could be the need to have a drug-control card, no matter the type of treatment.

Dr Farrugia insists that products containing the cannabis compound cannabidiol (CBD), which is not psychotropic, should never be prescribed through a control card system.

“Although logistically it is simpler to put all preparations – psychotropic and not – through a control card system, this should not be done. Even the World Health Organization has noted that CBD is not likely to be abused or create dependence.

“Moreover, the necessary prescription requires consultation, a one-on-one educational encounter where all treatment options are discussed, including cautions and contraindications of medicine, besides offering an opportunity for holistic and comprehensive healthcare.”

When it comes to affordability, all Good Manufacturing Practice (GMP) cannabis medication is expensive, with synthetic ones being exceptionally so. This is because GMP denotes high manufacturing standards and reliable clinical research.

However, Dr Farrugia is concerned that the government will go for one world-renowned brand and this would keep prices high. The market monopoly should be counteracted by allowing a competitive market, such as that in Denmark, he said, adding that this was the position adopted by the Democratic Party.

“I urge the government not to delay the second reading of this amendment any further, lessen the rigidity over CBD and ensure that we have a competitive market.

“Patients have been waiting far too long to have a regularized system that dispenses safe, high-quality medical cannabis products.

“I am in favour of wellbeing safeguards but against bureaucratic, inaccessible and unaffordable medication.”

He cautions that smoked cannabis should never be recommended for medical use as its effects very due to inhalation depth, puff frequency, retention of smoke, individual differences in absorption and metabolism by the liver.

Like tobacco smoke, cannabis smoke contains a good number of similar chemical constituents and these might lead to Chronic Obstructive Airway Disease and lung cancer, he added.

The WHO on CBD

Following an increased interest from Member States in the use of cannabis for medical indications, the WHO gathered “more robust scientific evidence on therapeutic use and side effects”.

Its Expert Committee on Drug Dependence did an initial review of CBD: “Current evidence shows that cannabidiol is not likely to be abused or create dependence as for other cannabinoids, such as Tetra Hydro Cannabinol (THC), for instance.”

The committee therefore concluded that current information does not justify scheduling of cannabidiol and postponed a fuller review of cannabidiol preparations to May 2018, when it will undertake a comprehensive review of cannabis and cannabis related substances.