Medical Cannabis in Europe: An Overview
Bailiwick Express reports that:
“Jersey's leading pain specialist has said he is "duty-bound" not to give patients medicinal cannabis as it contradicts his professional guidelines - despite feeling “pressure” to do so following a landmark vote allowing GPs to prescribe it. The comments came from Dr Chad Taylor, who specialises in treating chronic pain that persists for more than three months.”
“He told Express that the recent political decision on medicinal cannabis, as well as public expectation, had placed doctors in the difficult position of feeling pushed to prescribe cannabis-derived drugs, even though their professional guidance does not fully endorse their effectiveness or safety.”
This does seem a very negative approach, and perhaps what should be considered are developing proper protocols for prescribing medical cannabis. Obviously this is more or less a new drug on the market, but we may be able to learn from other countries, and even develop some protocols without reinventing the wheel.
In particular, Denmark seems to have adopted a cautious but positive approach which Dr Taylor should consider, and I will return to that later.
An Overview of Europe
A recent survey of the state of play was given online on 14th November 2018 by Peter Homberg, Partner and Head of the German Life Sciences Practice at Dentons, one of the top 10 global law firms, present in over 60 countries worldwide. This is worth bearing in mind, because one of the issues raised by Dr Taylor is that of medical liability.
He notes that:
“The prescription of cannabis for medical purposes – without the need for a special permission – was legalized in Germany in March 2017. Since then, a wave of approvals for medical cannabis has swept across Europe, with many countries following in Germany’s footsteps.”
“There has definitely been a development in medical cannabis products that we now see on the market. Traditionally, medical cannabis has been sold as dried cannabis flowers in the form of tea, as vaporizing material, or in the form of capsules containing the main psychoactive ingredient tetrahydrocannabinol (THC). Sometimes, also mouth sprays containing cannabis extract were used.”
“What we are seeing now is the appearance of non-medical food supplements containing very low concentrations of THC, under 0.2 percent. These products are characterized by their ingredient cannabidiol (CBD). CBD, unlike THC, does not have psychoactive effects and therefore does not need to be prescribed – provided the THC content remains below 0.2 percent. However, depending on the amount of CBD contained, these products are strictly regulated by other laws, such as the Novel Food Regulation or the Food Supplement Regulation. “
Medical Cannabis: the emerging pharmaceutical market
And on the matter of the lack of trials, it is true that there are not that many, but now that it can be prescribed, more will be coming in what is a rapidly increasing market. As Peter Homberg notes:
“In addition, some large Canadian cultivators are thinking about initiating clinical trials in Germany in order to get their cannabis products approved and authorized to be marketed as pharmaceuticals.”
“When Germany first legalized cannabis for medical use, other European countries, such as Portugal, Italy and the Netherlands followed suit.”
“Since the 1st November 2018, physicians in the United Kingdom are allowed to prescribe cannabis for medicinal purposes. This was triggered by a number of publications mentioning the alleged beneficial effect of medical cannabis on children with epilepsy. Specialist physicians in the UK can now prescribe medical cannabis for a limited range of conditions, such as severe epilepsy, vomiting or nausea caused by chemotherapy and multiple sclerosis.”
“Other countries to follow soon are Lithuania, considering the legalization of medicinal cannabis by May 2019, and Luxembourg, which has implemented a two-year pilot project already.”
“As of today, Germany, Denmark, Macedonia, Malta, Italy, Belgium, the Netherlands, Portugal, the Czech Republic, Luxembourg, Croatia, Estonia, Finland, Poland, Greece, Norway, Ireland, the UK and Lithuania are the countries in Europe that have legalized – or are considering the legalization of cannabis for medical purposes.”
A Changing Legal and Medical Landscape
So Jersey is not exactly leading the way, and it is important to get this right, but also to take stock of the developments in a rapidly changing landscape. As Mr Homberg notes:
“Before the law was liberalized, patients who suffered from certain diseases, like multiple sclerosis, cancer or chronic pain, could only use cannabis if they had applied for a specific exemption at the Federal Institute for Drugs and Medical Devices (BfArM). As regulations were extremely strict, only a few hundred patients were granted the permission to use the cannabis plant for medicinal purposes.”
And he sees much more effort coming from research into when prescription should be available, and what protocols should work best:
“We will also see a certain amount of effort put into research. With this new kind of liberalisation the indications that qualify for cannabinoid treatment have to be defined. Today we know that cannabis can help patients with for example chronic pain, cancer or multiple sclerosis, but in future we may discover more indications that will qualify for the treatment with cannabis.”
It should also be noted that the legalization process in Germany has been strictly performed and controlled by the government
The reason is what has been known anecdotally for some time, that strong alternative painkillers can have detrimental side effects. Some oral steriods, for example, cannot be prescribed for pain relief over a long period due to diminishing effect and increased risk of very serious side effects.
“For medical purposes, cannabis can be used, for example, as an alternative for other pain therapies, which may not be working or have strong side effects. People with chronic pain, for example, often experience strong side effects from their pain medications. These can be alleviated with cannabis.”
“Amongst other indications, cannabis may also relieve symptoms of cancer patients and multiple sclerosis patients. It contains THC. That is the component it is most famous for. THC binds to specific receptors in the human central and peripheral nervous system called cannabis receptors (CB). For example, if THC binds to CB1 in the spinal cord, this reduces the perception of pain”
Denmark: A Pilot Program
Denmark this year has also initiated a four-year medical cannabis pilot program with guidelines, and perhaps Jersey can look to this in drawing up its own legislation. The guidelines are laid out in the act of medical cannabis pilot program, which allows companies to apply for admission of cannabis products at the Danish Medicines Agency.
Products that have been accepted by the Danish Medicines Agency are free to be legally prescribed by doctors and distributed by pharmacies within Denmark.
The Danish Medicines Agency has written guidelines for doctors to consult if they are considering to prescribe medicinal cannabis. The guidelines are based on extensive literature searches, evaluation of cannabis schemes in Holland, Canada and Israel, and evaluation of the background leading to previous licensing of cannabis-containing medicines in Europe and the USA as well as assessments of the thorough review of the scientific evidence from the National Academy of Sciences (USA, 2017).
It should be noted that the Danish Medicines Agency assesses that medicinal cannabis should be considered only for the following indications that are supported by some evidence that medicinal cannabis could have an effect.
The relevant indications are:
A Rapid Expansion of Research
Those indications appear quite narrow. But the situation is changing all the time, and as governments and medical agencies are trying to chart hitherto uncharted waters.
As Peter Homberg notes:
“To date, scientific research into the effects of medical cannabis has been restricted by the law. With the start of the medical cannabis pilot program, Denmark is encouraging research projects in order to gather more science-based information about the use and effect of cannabis for medical use.”
Positions have changed from even five years ago, and that it is important to create a framework which will allow adequate clinical trials, proper protocols for prescribing that are both safe and not too narrowly restrictive to rule out future discoveries. Jersey doctors should not just be expected to prescribe to patient demand, but they should also keep up to date with the latest information in a new and innovating industry.
In particular, Denmark seems to have adopted a cautious but positive approach which Dr Taylor should consider, and I will return to that later.
An Overview of Europe
A recent survey of the state of play was given online on 14th November 2018 by Peter Homberg, Partner and Head of the German Life Sciences Practice at Dentons, one of the top 10 global law firms, present in over 60 countries worldwide. This is worth bearing in mind, because one of the issues raised by Dr Taylor is that of medical liability.
He notes that:
“The prescription of cannabis for medical purposes – without the need for a special permission – was legalized in Germany in March 2017. Since then, a wave of approvals for medical cannabis has swept across Europe, with many countries following in Germany’s footsteps.”
“There has definitely been a development in medical cannabis products that we now see on the market. Traditionally, medical cannabis has been sold as dried cannabis flowers in the form of tea, as vaporizing material, or in the form of capsules containing the main psychoactive ingredient tetrahydrocannabinol (THC). Sometimes, also mouth sprays containing cannabis extract were used.”
“What we are seeing now is the appearance of non-medical food supplements containing very low concentrations of THC, under 0.2 percent. These products are characterized by their ingredient cannabidiol (CBD). CBD, unlike THC, does not have psychoactive effects and therefore does not need to be prescribed – provided the THC content remains below 0.2 percent. However, depending on the amount of CBD contained, these products are strictly regulated by other laws, such as the Novel Food Regulation or the Food Supplement Regulation. “
Medical Cannabis: the emerging pharmaceutical market
And on the matter of the lack of trials, it is true that there are not that many, but now that it can be prescribed, more will be coming in what is a rapidly increasing market. As Peter Homberg notes:
“In addition, some large Canadian cultivators are thinking about initiating clinical trials in Germany in order to get their cannabis products approved and authorized to be marketed as pharmaceuticals.”
“When Germany first legalized cannabis for medical use, other European countries, such as Portugal, Italy and the Netherlands followed suit.”
“Since the 1st November 2018, physicians in the United Kingdom are allowed to prescribe cannabis for medicinal purposes. This was triggered by a number of publications mentioning the alleged beneficial effect of medical cannabis on children with epilepsy. Specialist physicians in the UK can now prescribe medical cannabis for a limited range of conditions, such as severe epilepsy, vomiting or nausea caused by chemotherapy and multiple sclerosis.”
“Other countries to follow soon are Lithuania, considering the legalization of medicinal cannabis by May 2019, and Luxembourg, which has implemented a two-year pilot project already.”
“As of today, Germany, Denmark, Macedonia, Malta, Italy, Belgium, the Netherlands, Portugal, the Czech Republic, Luxembourg, Croatia, Estonia, Finland, Poland, Greece, Norway, Ireland, the UK and Lithuania are the countries in Europe that have legalized – or are considering the legalization of cannabis for medical purposes.”
A Changing Legal and Medical Landscape
So Jersey is not exactly leading the way, and it is important to get this right, but also to take stock of the developments in a rapidly changing landscape. As Mr Homberg notes:
“Before the law was liberalized, patients who suffered from certain diseases, like multiple sclerosis, cancer or chronic pain, could only use cannabis if they had applied for a specific exemption at the Federal Institute for Drugs and Medical Devices (BfArM). As regulations were extremely strict, only a few hundred patients were granted the permission to use the cannabis plant for medicinal purposes.”
And he sees much more effort coming from research into when prescription should be available, and what protocols should work best:
“We will also see a certain amount of effort put into research. With this new kind of liberalisation the indications that qualify for cannabinoid treatment have to be defined. Today we know that cannabis can help patients with for example chronic pain, cancer or multiple sclerosis, but in future we may discover more indications that will qualify for the treatment with cannabis.”
It should also be noted that the legalization process in Germany has been strictly performed and controlled by the government
The reason is what has been known anecdotally for some time, that strong alternative painkillers can have detrimental side effects. Some oral steriods, for example, cannot be prescribed for pain relief over a long period due to diminishing effect and increased risk of very serious side effects.
“For medical purposes, cannabis can be used, for example, as an alternative for other pain therapies, which may not be working or have strong side effects. People with chronic pain, for example, often experience strong side effects from their pain medications. These can be alleviated with cannabis.”
“Amongst other indications, cannabis may also relieve symptoms of cancer patients and multiple sclerosis patients. It contains THC. That is the component it is most famous for. THC binds to specific receptors in the human central and peripheral nervous system called cannabis receptors (CB). For example, if THC binds to CB1 in the spinal cord, this reduces the perception of pain”
Denmark: A Pilot Program
Denmark this year has also initiated a four-year medical cannabis pilot program with guidelines, and perhaps Jersey can look to this in drawing up its own legislation. The guidelines are laid out in the act of medical cannabis pilot program, which allows companies to apply for admission of cannabis products at the Danish Medicines Agency.
Products that have been accepted by the Danish Medicines Agency are free to be legally prescribed by doctors and distributed by pharmacies within Denmark.
The Danish Medicines Agency has written guidelines for doctors to consult if they are considering to prescribe medicinal cannabis. The guidelines are based on extensive literature searches, evaluation of cannabis schemes in Holland, Canada and Israel, and evaluation of the background leading to previous licensing of cannabis-containing medicines in Europe and the USA as well as assessments of the thorough review of the scientific evidence from the National Academy of Sciences (USA, 2017).
It should be noted that the Danish Medicines Agency assesses that medicinal cannabis should be considered only for the following indications that are supported by some evidence that medicinal cannabis could have an effect.
The relevant indications are:
- Painful spasms caused by multiple sclerosis
- Painful spasms caused by spinal cord damage
- Nausea after chemotherapy
- Neuropathic pain, i.e. pain due to a disease of the brain, spinal cord or nerves.
A Rapid Expansion of Research
Those indications appear quite narrow. But the situation is changing all the time, and as governments and medical agencies are trying to chart hitherto uncharted waters.
As Peter Homberg notes:
“To date, scientific research into the effects of medical cannabis has been restricted by the law. With the start of the medical cannabis pilot program, Denmark is encouraging research projects in order to gather more science-based information about the use and effect of cannabis for medical use.”
Positions have changed from even five years ago, and that it is important to create a framework which will allow adequate clinical trials, proper protocols for prescribing that are both safe and not too narrowly restrictive to rule out future discoveries. Jersey doctors should not just be expected to prescribe to patient demand, but they should also keep up to date with the latest information in a new and innovating industry.
References
https://labiotech.eu/sponsored/medical-cannabis-europe-germany-canada-dentons/
https://labiotech.eu/sponsored/legalization-medical-cannabis/
https://labiotech.eu/sponsored/medical-cannabis-approval-europe-dentons/
https://laegemiddelstyrelsen.dk/en/special/medicinal-cannabis/healthcare-professionals/guidelines-for-doctors/
Posts
1 comment:
Loved your blog! Keep posting.
Post a Comment