NSW medicinal cannabis bill fails
The NSW Government has voted down legislation that would decriminalise cannabis possession.
- Human Immunodeficiency Virus (HIV);
- motor neurone disease;
- multiple sclerosis;
- the neurological disorder known as stiff person syndrome;
- severe and treatment-resistant nausea and vomiting due to chemotherapy;
- pain associated with cancer;
- neuropathic pain;
- an illness or condition declared by the regulations to be a terminal or serious medical condition.
Chemist Paul Mavor with the first medicinal cannabis imports from Canada last month. Pic: supplied.
Australian Medical Association (AMA) President Dr Michael Gannon has criticised Tuesday’s senate vote, which makes it easier for terminally ill patients to buy unregistered medicinal cannabis from overseas, saying he fears the drug could end up in the wrong hands but cannabis experts have called his reaction unfounded.
The vote was led by Greens leader Richard Di Natale after he lost the same vote in May, but this time it won the support of Labor, One Nation and various crossbenchers after a procedural loophole allowed a re-vote.
Medicinal cannabis will now be classed as a category A drug on the Therapeutic Goods Administration (TGA) list, making it easier for doctors to prescribe the medication to terminally ill people and drastically reducing the time it takes for patients to get hold of it.
The senate vote also means terminally ill people can legally import the drug more easily from regulated overseas markets, provided they have a prescription. The first medicinal cannabis imports came into Australia in May from Canadian company CanniMed.
The Australian medicinal cannabis market is currently in its infancy after it became legal to cultivate, produce and manufacture medicinal cannabis products on October 30 2016. Good domestic product is probably 12 to 24 months away so securing an overseas supply is a necessary option for sick Australians.
Supply is not the only problem, draconian rules around prescription are too.
When the federal government legislated to make medicinal cannabis legal for some terminally ill patients last year, it also tightened up the conditions that had to be met before it could be prescribed.
The drug was previously classified as a category B drug under the special access scheme, which meant doctors had to get prior approval from the TGA, their state or territory health department and their hospital ethics committee or relevant association, before treating terminally ill patients, rather than just informing the TGA they intended to prescribe it.
It has obviously had an impact. Fairfax reported this week that only 133 people have been able to access medicinal cannabis since new laws came in.
But some doctors aren’t in favour of relaxing the rules.
Dr Gannon told Sky News he was ‘disappointed’ with the senate’s decision and said that giving patients access to unregistered medicinal cannabis products from overseas would knock doctors’ confidence in prescribing it.
“You’ve already got a situation where doctors are querying exactly how effective medicinal cannabis is. If you in any way put any doubt in their minds about the safety, you're simply not going to see it prescribed by many doctors,” Dr Gannon said.
But he admitted the risks to patients were minimal.
“Certainly, in the palliative care setting, we're not worried about addiction and, to be honest, we're not too worried about major potential side effects. But we remain concerned about potential diversion into the general community.”
Dr Gannon said cannabis was still a major source of mental illness in the wider community and it was ‘absolutely essential’ any imports were safe.
“If cannabis was the panacea that the people who seem desperate to import it - if it really was that good, then it would be in liberal use across the entire medical system,” he said.
“We're excited about its potential in palliative care, we're excited about its potential when it comes to juvenile epilepsy, and forms of spasticity, but let's look for the evidence.”
His views echo those of federal Health Minister Greg Hunt, who called the senate’s decision ‘reckless and irresponsible’ and argued that cannabis could end up in the pockets of criminals and out on the streets.
AMA’s fears unfounded, says expert
But medicinal cannabis expert Rhys Cohen, who works for the Australian subsidiary of Israeli medicinal cannabis company Cann10, called Dr Gannon’s statements contradictory and ‘completely unfounded’.
He said medicinal cannabis was unlikely to be diverted illegally, partly because it was already ‘incredibly cheap and incredibly accessible’ in Australia and medicinal cannabis was considerably more expensive.
He said only a few countries, including Israel, Canada and the Netherlands, legally exported cannabis and they all tightly controlled their product.
Companies needed export licenses and permits and Australian companies needed import licenses and permits. Prescriptions could still come only from specialist medical practitioners.
“The changes allow people who are very soon going to die to access it faster than previously,” Mr Cohen said. “We’re not talking about Joe Bloggs with a bad leg here but people on their death beds dying of cancer wanting to get relief from pain.
“The idea that there’s a chance they will sell it on the street is just ridiculous.”
While Dr Gannon has argued that cannabis should be treated the same as every other drug, operation or therapy Mr Cohen said it had always been treated very differently from other drugs.
“Any unregistered drug in the medicine world was accessible through special access A, except cannabis,” he said.
Mr Cohen said he thought the AMA’s misgivings were that doctors would be put under more pressure to prescribe medicinal cannabis, especially given pent up demand.
However, while he agreed these concerns were legitimate he said doctors were responsible for educating themselves about medicinal cannabis, especially when it had been proven to work so well for chronic pain, epilepsy and multiple sclerosis.
[post_title] => Doctors on a downer over medicinal cannabis imports
[post_excerpt] => Concerns unfounded, says Australian cannabis expert.
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First medicinal cannabis import: CanniMed cannabis oil.
Seriously ill Australians can now access imported medicinal cannabis after the first licensed imports of the drug arrived in Perth last week.
The drug was imported by Australian wholesale company Health House International and ASX-listed cannabis company Creso Pharma, a Swiss company.
The cargo contained three different types of cannabis oil from Canadian company CanniMed, each designed to tackle different symptoms and retailing for about $350 a bottle, which should last patients about a month.
The federal government gave the go ahead for companies to grow and manufacture medicinal cannabis late last year but it will still be a while before patients can access Australian product, said Health House Director Paul Mavor.
Mr Mavor said it would take some time for companies to get permission to set up their operations and then get them reinspected and licensed.
“Within 12 to 24 months we will be starting to see some really good [Australian] product and hopefully we will be exporting that,” Mr Mavor said.
Health House International was granted one of the first medicinal cannabis import licences in February, soon after Health Minister Greg Hunt gave the go ahead to fast-track medicinal cannabis imports while local cultivation catches up.
Australian product should be cheaper for patients as there will be much lower shipping costs and no freight duties but this will also depend on domestic (and possibly overseas) demand and whether companies can achieve economies of scale.
Around 100,000 Canadians currently use medicinal cannabis and Mr Mavor is predicting about 70,000 Australians will eventually follow suit.
Interestingly, Mr Mavor said that he had been speaking to some private insurance funds who had indicated they may be interested in subsidising the drug for some people, for example, those involved in car crashes or war veterans, because it could keep them out of hospital and keep costs down.
In a few years it is possible that medicinal cannabis will be listed under the Pharmaceutical Benefits Scheme, once it has been tested in the local market, says Mavor.
“It is likely. Some conditions that some patients are using medical cannabis for, they don’t have any other options.”
Cannabis is cost-effective because it has five different uses in one hit: it can relieve nausea, vomiting, anxiety, insomnia and chronic pain.
Health House International's Paul Mavor. Pic: Supplied.
But Mr Mavor said while demand in Australia is strong, the process for prescribing medicinal cannabis had been made torturously difficult by the federal government, which has left states and territories to set their own rules.
Many demand that patients get approval from both the federal and state or territory health departments because the drug is listed as a Special Access category B drug.
Federal legislation to make the drug category A, which would have allowed doctors to complete online form and obtain instant approval, was blocked in the senate this week by Pauline Hanson’s One Nation and the Nick Xenophon team.
Australian Greens Leader Dr Richard Di Natale said he was deeply disappointed that politicians had put the needs of terminally ill patients second to “their own political games”.
“Patients are currently waiting weeks and sometimes months for access to these treatments. This motion could have reduced that to a day or possibly hours,” Mr Di Natale said.
“For some of these patients, speedy access to medicinal cannabis is the difference between being able to eat or wasting away. These changes add time, stress, and difficulty for terminally ill patients accessing medicinal cannabis.”
Mr Mavor says the strictest prescription regime is in Western Australia, where a huge amount of information is demanded and approval must be sought from federal and state health departments and from the practitioner’s ethics board.
He said the easiest system was in South Australia, where doctors could prescribe the drug for two months for patients at any one time and Queensland, Victoria and NSW were passable.
Once prescription problems are ironed out the industry looks set to have a bright future ahead of it.
David Russell, Chief Operating Officer of Creso Pharma said the first successful import of medicinal cannabis products into Australia was “a ground-breaking moment for patients and the medical industry”.
“The Australian market has been catching up with community expectations while the regulatory framework around medicinal cannabis was being developed,” Mr Russell said.
“Now these products will allow patients to have the option of medicinal cannabis treatments if it is prescribed by their physician. This is particularly important given the unmet but often immediate need to access a timely medicinal cannabis supply across Australia.”
To be prescribed medicinal cannabis products, patients must see a physician who is an authorised prescriber, or apply for SAS Category B prescription under the Therapeutic Goods Administration regulations.
[post_title] => First medicinal cannabis imports arrive in Australia
[post_excerpt] => Prescription rules hold patients up.
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Hemp oil and seeds. Hemp seeds from low-THC Cannabis Sativa do not have an intoxicating effect when eaten as food.[/caption]
Queensland’s licensed industrial cannabis growers and researchers can now legally supply cannabis seeds to the budding Australian medicinal cannabis market, hopefully making the drug cheaper for patients.
The Palaszczuk government has changed the state’s Drugs Misuse Act 1986 so that Queensland’s industrial cannabis growers will be allowed to sell the seeds to companies further up the supply chain in what is set to be a growth industry since the federal government greenlighted medicinal cannabis to treat some conditions such as epilepsy, cancer and HIV.
Queensland Minister for Agriculture and Fisheries Bill Byrne said that the Queensland industrial cannabis industry had developed valuable cannabis seed lines for which it held plant breeder rights.
Industry players and patients had pushed for the amendment at public roundtable meetings held across the state last year.
“We listened to what industry had to say, and took the matter to Canberra, who are now allowing seed to be sourced from legal Australian breeders,” Mr Byrne said.
He said the changes meant Queensland’s industrial cannabis growers could compete with growers in other states to supply seed to licensed medicinal cannabis growers and scientific researchers.
“This creates new opportunities for Queenslanders. The changes will be mutually beneficial for licensed industrial cannabis growers and those Queensland businesses interested in being part of the emerging medicinal cannabis industry in Australia,” he said.
The Federal Government will maintain a strictly controlled licensing system and the new laws would not allow just anyone to grow their own cannabis for medicinal purposes, Mr Byrne emphasised.
But Queensland Health Minister Cameron Dick said the affordability of medicinal cannabis remained an issue for many sick Australians, despite recent changes approving the importation of medicinal cannabis and the first license to cultivate medicinal cannabis being issued in Australia.
Mr Dick said medicinal cannabis could be made more affordable by placing it on the Pharmaceutical Benefits Scheme.
“Unfortunately, (Federal Health) Minister Greg Hunt rejected the Palaszczuk government’s request to subsidise medicinal cannabis,” Mr Dick said.
“However we would urge Minister Hunt to reconsider his decision. As a government, we’ve put in place the most robust scheme in Australia to allow appropriate patients access to medicinal cannabis. We want it to be as affordable as possible, but that ball is now in the Commonwealth’s court.”
Meanwhile more and more medicinal cannabis companies - both Australian and international - are listing on the ASX in what has been described as the 'pot stock' boom. Read more here.
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[post_title] => QLD growers get the ok to sell cannabis seeds
[post_excerpt] => Cannabis on the PBS?
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Photo: Supplied.
The Hydroponics Company (THC) is the latest company to capitalise on the legalisation of medicinal cannabis in Australia, known as the ‘pot stock’ boom, and will begin trading on the ASX next month.
THC, headquartered in Sydney, aims to raise $5 to $8 million at 20 cents a share (the initial public offering being 25 to 40 million shares) to expand and diversify as a manufacturer and distributor of medicinal cannabis.
It joins AusCann, which started trading last month, Zelda Therapeutics, Perth company MGC Pharma, Creso Pharma and International Cannabis Corp, all of which have recently listed on the ASX.
The floodgates opened after it became legal to cultivate, produce and manufacture medicinal cannabis products in Australia on October 30 last year.
The ruling signalled the birth of a potentially highly profitable new industry in Australia, which thousands of chronically ill people and their families have been asking for for many years.
Medicinal cannabis can be used to treat severe pain, nausea and vomiting and to ease muscle spasticity. It can stimulate appetite as well as lift moods. It can provide relief for patients including those with cancer, epilepsy, HIV and MS.
A 2016 University of Sydney report, Medicinal Cannabis in Australia: Science, Regulation & Industry, found that the Australian medicinal cannabis market, once opened up, could spark initial demand for as much as 8,000kg of product, creating an industry worth more than $100 million a year.
The new industry will be regulated by the Office of Drug Control and the Therapeutic Goods Administration with individual states and territories having their own rules about who can prescribe it and which patients can access it.
The company says the cash from the Initial Public Offering will be used to increase its market share in hydroponic equipment and large-scale greenhouses and plant nutrients, alongside funding the development and delivery of medicinal cannabis in Australia.
THC’s medical cannabis division, Canndeo Limited, breeds and grows Cannabis sativa. According to THC, Canndeo has more Australian plant breeders’ rights than any other company and has 17 years of experience.
Canndeo has applied for a Medicinal Cannabis Research Application to grow cannabis in Australia and THC says a decision is expected in the coming weeks.
CEO of Canndeo, Dr Andrew Beehag, said the company was building its international alliances to take advantage of the new legislation and accelerate production in Australian.
“We are also very excited by the possibilities for patients here in Australia afflicted by dementia, neurological [problems], chronic pain, epilepsy and other debilitating conditions that may benefit from medicinal cannabis.”
It is not just the domestic market that Australian medicinal cannabis companies can tap. Cannabis is allowed for medical use in countries including 36 US states, France, Canada, Germany, the Netherlands, Uruguay, Chile, the Czech Republic and Israel.
The global market is burgeoning. THC’s prospectus says the North American medicinal cannabis industry is experiencing 30 to 40 per cent annual growth “driven by the trend to legalise cannabis for both medicinal and recreational use” with a projected impact of between $24.4 billion and $US44 billion for 2020.
THC’s CEO Hamish MacDonald said the company anticipated “aggressive growth” over the next one to two years, with revenue growing from more than $5 million in 2017 to more than $15 million by 2018.
But the industry in Australia is not without risk. Medicinal cannabis must be listed on the Australian Register of Therapeutic Goods, prior to approval by the Therapeutic Goods Administration.
Clinical trial data must be collected and companies must go through a lengthy, costly approval process where gaining approval for each new chemical entity can cost $250,000. Cannabis is a mixture of chemical compounds, which makes it more expensive and complex to get approved.
Last year, Government News spoke to Elaine Darby, Managing Director of Auscann, which hopes to grow and manufacture medicinal cannabis in Western Australia, about the hurdles companies in the industry face.
“The key limitation is to have expertise to grow and produce standardised medicine so that every batch is the same. There’s lots of expertise required to do that,” Ms Darby said.
“Manufacturers need to have clear runs of sight to the end user. They have to set up this supply chain … and identify patient groups.”
Growers need to be able to have a manufacturer to sell to, or to grow and manufacture the product – which is not smoked but usually liquid or capsules – themselves.
Ms Darby said: “Realistically it would limit the number of players at the start.”
But despite the convoluted process, the states and territories are getting on board.
NSW greenlit $9 million clinical cannabis trials in December 2014 partnering with Victoria, Queensland and Tasmania.
The first set of trials began last year with the focus on treating children with severe, drug-resistant epilepsy. The second and third sets of trials will target controlling chronic pain and chemotherapy-induced nausea and vomiting for patients with terminal illnesses.
NSW police have been asked to exercise discretion and not to charge registered adults with possession of marijuana.
In Queensland certain specialists, including oncologists, paediatric neurologists and palliative care specialists, have been able to can prescribe medicinal cannabis since March 1, 2017.
Other doctors will be able to apply to Queensland Health for permission to prescribe the drug on certain conditions.
Victoria has also legislated to allow medicinal cannabis to be legalised, with childhood epilepsy the first target for the trials. Tasmania, Western Australia, and other states are also passing legislation supporting the Federal government’s legislation to allow for limited medicinal cannabis use.
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[post_title] => More Australian companies join the medicinal cannabis 'pot stock' boom
[post_excerpt] => New industry for Australia.
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Victorian Premier Daniel Andrews with the government's crop
Pic: Facebook
A major new Australian industry could grow up around medicinal cannabis, with possibilities for global export opening up further down the track.
The Narcotics Drugs Amendment Act 2016 came into force last week giving the green light to cultivating and manufacturing cannabis for medicinal or scientific purposes in Australia and offering chronically ill patients some relief, where previously they were forced to source cannabis illegally, often of dubious quality.
A clutch of companies, both domestic and international, are poised to enter the Australian market and make the most of the new conditions and capitalise on the global demand for the product, which is effective against a broad range of medical conditions including chemotherapy-induced nausea, severe fitting and nerve pain.
Australian company MGC Pharmaceuticals, which already grows and manufactures medicinal cannabis overseas, has confirmed it is ready to go and Canadian company Tilray, which already cultivates and sells medicinal cannabis in Canada, has also flagged its interest in entering the new Australian market.
Government News spoke to Elaine Darby, Managing Director of Auscann, which hopes to grow and manufacture medicinal cannabis in Western Australia.
Ms Darby said there were a number of companies lined up to grow and or manufacture medicinal cannabis but they would need to be able to satisfy the requirements of the Office of Drug Control (ODC) first. The ODC is in charge of approving licenses, which are estimated to take 30 to 40 business days once requirements are satisfied.
But there are hurdles to overcome before companies can take advantage of the new law.
“The key limitation is to have expertise to grow and produce standardised medicine so that every batch is the same. There’s lots of expertise required to do that,” Ms Darby said.
“Manufacturers need to have clear runs of sight to the end user. They have to set up this supply chain … and identify patient groups.”
Supplying the drug to clinical studies is one possible niche area, another is to supply to doctors, who can prescribe it after gaining authority from the Therapeutic Goods Authority (TGA) and the state or territory health department.
Growers need to be able to have a manufacturer to sell to, or to grow and manufacture the product – which is not smoked but usually liquid or capsules – themselves.
Ms Darby said: “Realistically it would limit the number of players at the start.”
Access scheme
Establishing supply lines with doctors will be important for manufacturers (and growers) but the lack of a unified national access scheme could hamper this.
States and territories have different rules around which medical conditions qualify for access to the drug and some do not yet have an access scheme in place.
Doctors need approval from the TGA to prescribe medical cannabis and authorisation relevant state or territory government. In addition, they will need to comply with state rules about what conditions medicinal cannabis can be used to treat.
The states furthest down the track are probably NSW and Queensland.
NSW clinicians have been able to prescribe cannabis-based products From November 1 with no limitations on the medical conditions it can be used for. Applications are judged on individual merit and must be accompanied by clinical evidence on the potential benefits and harms. There is an expectation that the doctor has tried conventional treatments first.
The Queensland access system is similar and begins on March 1 2017.
Although Victoria was the first state to legalise medicinal cannabis and the state government grows its own crop for clinical trials, so far access has only been approved for children with severe epilepsy, although an independent medical committee will oversee the roll-out of medicinal cannabis to other patient groups.
Meanwhile, other states such as Western Australia and South Australia, are still working out their position although early indications suggest they are not restricting it to any specific medical conditions but on a case-by-case basis.
Access schemes for Tasmania and the ACT are expected to be in place by 2017 but the prescription guidelines are not yet known.
Ms Darby said a harmonised national system would have been better approach and not having one could cause some patients to cross borders to source medicinal cannabis.
“It’s a bit of a dog’s breakfast, I’m afraid,” she said. “I don’t think this will work long term. It would have been better if they had just left it to the TGA.”
A national access scheme could have seen approvals dealt with by the Authorised Prescriber Scheme, where clinicians become authorised prescribers and can prescribe a particular medicine for patients’ conditions without further TGA approval. Medical practitioners would need approval from the TGA before becoming an authorised prescriber.
The demand in Australia for medicinal cannabis is likely to be strong. There are an estimated 1.8 million patients have neuropathic pain, 130,000 have nausea from chemotherapy and 82,000 treatment resistant epilepsy and that does not take into account access to global markets.
Ms Darby said she had been “pleasantly surprised” at the interest from doctors who had approached the company to find out more.
“Doctors need to say “I’ve got this group of patients who I believe can benefit” and then put the case forward why.”
It will probably be late 2017 before chronically ill people can access Australian medicinal cannabis but it can be brought in from other countries, such as Canada before then.
Ms Darby said that the government had indicated that it was open to allowing the export of Australian-produced medicinal cannabis further down the track, once the regulatory system was well-established and working well.
“When they open up export as well it could be quite a significant industry for us. I think we could be leaders in this field because our medical techniques are quite advanced.
Indeed, Australia already exports opiates from Tasmania.
“Australia already has quite a strong reputation for the production of pharmaceutical narcotics and it doesn’t want to do anything to jeopardise that.
“Certainly I think there are a lot of markets out there that allow medical cannabis and would be very interested in Australia’s products because we have a good reputation. China could be really significant.”
Ms Darby says Auscann, which is going public in mid-December, is in a good position because it has established international partnerships with companies such as Canopy Growth Corp in Canada and a Spanish plant breeding company that has been producing medicinal cannabis for over a decade.
“They share expertise on types of strains they grow, how to manufacture products and patient data. Canopy has 16,000 patients they supply. All that knowledge is critical to get into this industry.”
Office of Drug Control
While there is not a national access scheme in place there is a national regulator, the Office of Drug Control (ODC), who will oversee it.
Companies must first be licensed by the ODC and then apply for a permit to produce medicinal cannabis, supplying the ODC with details on a number of factors, including how many and what plants and strains will be grown and what products will be made in what quantity. The permit will need to be reapplied for every year.
Federal Health Minister Sussan Ley said: “I am confident creating one single, nationally-consistent cultivation scheme, rather than eight individual arrangements, will not only help speed up the legislative and regulatory process, but ultimately access to medicinal cannabis products as well.
“A national regulator will also allow the government to closely track the development of cannabis products for medicinal use from cultivation to supply and curtail any attempts by criminals to get involved.”
Ms Darby said the regulations were fair and not too strict or oppressive.
“The key thing is security requirements to put in place. They are very concerned that the product could be pushed through into the illicit market so there are a lot of checks and balances.”
[post_title] => Medicinal cannabis, a major new industry for Australia
[post_excerpt] => Massive potential for exports.
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The ACT is well known for having the most relaxed cannabis laws in the country but the Territory has been slower than other states to establish a medicinal cannabis scheme for the very sick. That’s all about to change.
Although it is illegal to grow, possess or use cannabis anywhere in Australia, if you are caught with less than 25g of marijuana or two non-hydroponic plants in the ACT you will be slapped with a $100 fine but no criminal charges but the ACT has lagged behind Queensland, Victoria and NSW in introducing a medicinal cannabis scheme.
ACT Assistant Health Minister Meegan Fitzharris announced today (Thursday) that the ACT will give people safe, legal access to high quality medicinal cannabis, following the recent interim decision by the Therapeutic Goods Administration to downgrade cannabis from a prohibited substance to a controlled drug.
Ms Fitzharris said getting the scheme up and running was a priority but it needed to be built on evidence.
“At the moment, there are no clinical guidelines on what types of conditions medicinal cannabis can and should be prescribed for,” she said.
“The ACT Government will develop evidence-based guidelines to inform and support medical practitioners in how to best prescribe medicinal cannabis products. We will also develop education materials for clinicians and the general public to support these guidelines.”
Despite the move, the ACT will not agree to license the cultivation and manufacture of medicinal cannabis within its borders, even though federal legislation allows it.
Instead of growing the stuff the ACT would lead the R&D to develop a framework for the prescription, use and distribution of medicinal cannabis.
Ms Fitzharris said: “We already have some of the best medical researchers in the country based at our local institutions and advancing research on the efficacy of medicinal cannabis to treat a range of illnesses and conditions presents another opportunity to support cutting edge research in Canberra and showcase our city as the research capital of Australia.”
The University of Canberra is currently running a $1 million medical cannabis trial for treating melanoma in partnership with Cann Pharmaceutical.
The ACT government will set up two expert advisory committees to deal with the issues thrown up by the scheme.
The Medicinal Cannabis Medical Advisory Panel will advise on developing clinical guidelines and regulations while the Medicinal Cannabis Advisory Group will advise government on the broader economic, legal and social issues related to the introduction of a Medicinal Cannabis Scheme, including criminal activity and law enforcement.
The Medicinal Cannabis Scheme is expected to be in place by 2017.
ACT Greens MLA Shane Rattenbury, whose 2015 Bill to introduce medicinal cannabis was rejected by the major parties, welcomed the government’s positive policy shift but said it should act quickly.
“In the past there have unfortunately been policy commitments on medicinal cannabis by other state governments which have never come to fruition – for example over a decade ago NSW promised a medicinal cannabis scheme when under public pressure only to later abandon the promise and make no progress at all,” he said.
He urged the government not to be too restrictive about who could access the scheme and said it should include people with terminal illnesses as well as other serious illnesses, including children with severe epilepsy. with the backing of a doctor.
Rattenbury argued that the scheme should happen within one year and until then there should be an amnesty for very sick people found in possession of small amounts of cannabis for medical use.
He added that it would be best if it was not just limited to pharmaceutical cannabis products because there were not many of them and they would take many years to develop further.
[post_title] => Medicinal cannabis for ACT
[post_excerpt] => Canberra catches up.
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Victoria has beaten NSW to the punch and legalised locally-produced medicinal cannabis products from 2017.
State Premier Dan Andrews announced the decision yesterday (October 6) to make cannabis available to people in “exceptional circumstances”.
This includes treatment for: muscle spasm or severe pain from multiple sclerosis; severe pain, nausea, vomiting or wasting from cancer or HIV/AIDS; epileptic seizures where other treatments have failed; and for people suffering severe chronic pain, where two specialists have granted approval.
Mr Andrews said he was delivering on an election commitment to allow medicinal cannabis for terminally ill people.
“I’ve seen first-hand how medicinal cannabis can change people’s lives,” he said. “This landmark reform means Victorian families will no longer have to decide between breaking the law and watching their child suffer.”
The decision also heralds the birth of cannabis cultivation and manufacturing industries in Victoria, necessary in order to establish an ongoing, reliable supply for patients.
The government will begin a cultivation trial at a Victorian research facility, to be overseen by the Department of Economic Development, Jobs, Transport and Resources.
This department will gain new powers to regulate licensed growers who are cultivating cannabis for medicinal purposes.
The go-ahead follows a report by the Victorian Law Reform Commissioner, who was asked to explore how the law could be changed to help those in severe pain to safely access medicinal cannabis.
The Commissioner’s Report on Medicinal Cannabis, tabled in Parliament tabled yesterday, includes 42 recommendations and addresses key issues including:
• Cultivation, manufacture and supply of high quality medicinal cannabis products within Victoria
• Patient eligibility
• Appropriate clinical oversight involving specialists, general practitioners, nurses and pharmacists
• The need for ongoing research and clinical trials
A new Office of Medicinal Cannabis will be establish within the Department of Health and Human Services with the remit of overseeing the manufacture and dispensing of cannabis, as well as developing clinical guidance and encouraging new research.
NSW Premier Mike Baird approved clinical trials of medicinal cannabis for terminally ill adults in July this year, but they will not start until early 2016.
Meanwhile, Shadow Assistant Minister for Health, Stephen Johns, congratulated Mr Andrews but also pushed for a national medicinal cannabis scheme.
“State by state regulation means a person's access to pain relief is determined by where they live,” Mr Joseph said.
“The registration and scheduling of medicines is the exclusive responsibility of the federal government. There are also a range of other implications related to possession, trafficking and supply of cannabis in federal laws.
“Labor believes in a national approach based on medical science, not prejudice.”
[post_title] => Medicinal cannabis legalised in Victoria
[post_excerpt] => New cannabis industry to emerge.
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NSW will be the first Australian state or territory to conduct medicinal cannabis clinical trials for terminally ill adults with cancer after Premier Mike Baird gave the go-ahead to researchers at UNSW.
The NSW Government has committed $9 million to support medical cannabis clinical trials but there is no mention yet when trials treating children with severe epilepsy will begin, something Mr Baird pledged to explore last year.
The drug can be used to treat a wide range of conditions, including muscle spasms caused by epilepsy and multiple sclerosis, chemotherapy-induced nausea, Crohns disease and poor appetite caused by HIV.
University of New South Wales’ Chief Investigator Associate Professor Meera Agar – who has led several research studies into the management of terminally ill patients - will lead the research team and focus on how medicinal cannabis can improve poor appetite and appetite-related symptoms, such as nausea, in terminally ill adult cancer patients in their final stages of life.
The first part of the trial will be held at the Calvary Mater Newcastle Hospital in early 2016 and involve about 30 patients with the goal of discovering whether cannabis can be successfully inhaled as a vapour, what its side effects are and the frequency and size of the ideal dose, with initial results expected by the end of 2016.
Part two of the study could see it rolled out to major NSW regional and metropolitan hospitals with a larger number of patients. The next step will be for the research team to seek review and approval of the trial by a Human Research Ethics Committee.
Associate Professor Agar said the trial would evaluate two types of cannabis products - vaporised leaf cannabis and a pharmaceutical.
“It will be undertaken in two parts, and will assess the potential ability of cannabis to alleviate distressing symptoms including fatigue, low appetite, altered taste and smell for food, low mood, weight loss, nausea, insomnia and pain relief,” Professor Agar said.
“This will add to the existing body of evidence based research to help better understand and evaluate the potential benefits that medical cannabis products may have for terminally ill patients.”
Mr Baird said the first trial would be critical to better understanding how role medical cannabis could alleviate symptoms and pain in terminally ill patients.
“We do not want patients or carers having to play pharmacist - that is why it is so important to explore the safest and most effective ways we can deliver compassionate care and improve the quality of life,” Mr Baird said.
“Our trials will help to position NSW at the forefront of world-class research in this area and explore how we can complement the existing palliative care treatments and therapies patients receive.”
There is growing cross-party support for medicinal cannabis in many Australian states and territories after many sick people have publicly told their stories of how it has helped them control pain, nausea and seizures.
Queensland Premier Annastacia Palaszczuk and Victoria Premier Dan Andrews have both publicly backed the NSW trials Victoria and Mr Andrews has indicated he would work in partnership with NSW next year to run them, including those targeting children with serious epilepsy.
The ACT Legislative Assembly is currently considering the Greens’ draft bill to legalise medicinal cannabis, with a report expected to be ready before July 2016, while Tasmania is holding its own parliamentary inquiry into legalising medical cannabis, reporting at the beginning of 2016.
But although medicinal cannabis researchers and campaigners support clinical trials they have warned that the reality of it becoming available to seriously ill people could be many years away.
Troy Langmann is the founder of Tasman Health Cannabinoids, a company that has been trying to secure a research and development (R&D) license to grow medicinal cannabis in Tasmania and Norfolk Island. He told Government News earlier this year:
“Any positive steps are encouraging but it worries me that they may wait five years to allow this very safe medication to be distributed more widely. We know it’s safe, side effects are minimal and people prefer it over many currently prescribed medications, which in many cases are nowhere near as effective as cannabis,” Mr Langmann said.
“[Cannabis] is a complex medication - it contains over 500 different compounds and can be used for a huge variety of conditions, from depression to cancer.
“It’s just not feasible to do individual clinical studies to determine what it should be used for, for the sake of satisfying a peer reviewed study, when there is a desperate need for this medicine now.”
While NSW might be Australia’s pioneering medicinal cannabis state Australia is years behind other countries in researching and legalising the drug.
Cannabis is allowed for medical use in countries including 36 US states, France, the Netherlands, Uruguay, Chile, the Czech Republic and in Israeli hospitals and nursing homes.
[post_title] => First Australian medical cannabis clinical trial greenlighted
[post_excerpt] => Terminally ill adult cancer patients to take part
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Troy Langman receives a constant stream of requests from people broken by pain or deeply affected by watching someone they love suffer: people at their wits end in search of medicinal cannabis, a product which he has the expertise to make but he is not yet licensed to do so under Australian law.
Mr Langman is the founder of Tasman Health Cannabinoids (TasCann), a company that has been trying to secure a research and development (R&D) license to grow medicinal cannabis in Tasmania and Norfolk Island.
Last year, TasCann was granted a license to grow cannabis for medicinal purposes on Norfolk Island but this was later revoked by the island’s Administrator, while an in-principle agreement with Tasmania’s former Labor government to conduct R&D in the state was overturned by the Liberals when they came to power in March 2014.
Mr Langman says that he and others involved publicly with medicinal cannabis receive “constant pleas” of help from desperate people searching for relief from their symptoms.
He is concerned that sick people are turning to the black market in cannabis because they have no other choice.
“It [the black market] leaves people open to other issues: people that probably aren’t doing a good job and also people who are getting ripped off or having to make the products themselves. That’s hard if you’re really sick,” Mr Langman says.
Cannabis can be used to treat a wide range of conditions, including muscle spasms caused by epilepsy and multiple sclerosis, chemotherapy-induced nausea, Crohns disease and poor appetite caused by HIV.
Mr Langman believes the solution is to legalise the production of medical cannabis under controlled conditions so that it is produced by professionals working to strict manufacturing standards, rather than to leave sick people on their own to risk sourcing an inferior, illegal product and facing prosecution.
“Quality and a regular supply cannot be guaranteed. Right now people are relying on kitchen chemists and dubious overseas supply,” he says.
Medicinal cannabis has been a hot topic recently as politicians of all stripes back clinical trials of medicinal cannabis, with many saying they have changed their stance after meeting very sick people who have been helped by the drug.
NSW Premier Mike Baird announced last year that he would sanction clinical trials exploring cannabis’ efficacy for treating children with severe epilepsy, the terminally ill and chemotherapy-induced nausea after he meeting Dan Haslam, who died of bowel cancer in February, and his mother Lucy - a passionate campaigner for medicinal cannabis.
Queensland Premier Annastacia Palaszczuk and Victoria Premier Dan Andrews have both publicly backed the NSW trials, which are slated to start taking patients from mid-2016.
But while the clinical trials are encouraging, the reality of sick people being able to legally use medicinal cannabis is at least two years away and possibly up to five years or more.
Mr Langman is cautiously positive about the trials but it is evident that he is heartbroken - as well as frustrated – by the delays, especially because he often speaks to people dealing with cripplingly pain who don’t have that long to wait.
“Any positive steps are encouraging but it worries me that they may wait five years to allow this very safe medication to be distributed more widely. We know it’s safe, side effects are minimal and people prefer it over many currently prescribed medications, which in many cases are nowhere near as effective as cannabis,” he says.
“People prefer access to a more natural medicinal product, rather than having to deal with the side effects that a lot of pharmaceutical products can bring.”
It is an expensive and lengthy process to get drugs approved under the Therapeutic Goods Administration (TGA), although the senate recently passed a federal bill establishing a separate regulator of medicinal cannabis, which would by-pass the TGA.
“Otherwise it costs $250,000 for the application to start the process to get drug approval. This is followed by lengthy clinical trials over five to ten years where the focus is on one medical compound treating one condition,” Mr Langman says.
“[Cannabis] is a complex medication - it contains over 500 different compounds and can be used for a huge variety of conditions, from depression to cancer.
“It’s just not feasible to do individual clinical studies to determine what it should be used for, for the sake of satisfying a peer reviewed study, when there is a desperate need for this medicine now.”
Mr Langman says Australia is’ way behind’ the rest of the world and most politicians and Australians want reform.
Cannabis is allowed for medical use in countries including 36 US states, France, the Netherlands, Uruguay, Chile, the Czech Republic and in Israeli hospitals and nursing homes.
“The public is behind this issue more and more. The fact is people are not going to stand for waiting five years and are using medicinal cannabis already, facing prosecution and visits from DOCS.”
He believes that age old prejudices combined with the self-interest and might of the powerful pharmaceutical companies may be holding back the chance for sick Australians to get relief through properly produced and controlled medicinal cannabis.
“It would be a great pity if the current trial process is effectively dead on arrival because of bureaucratic and financial interests,” Mr Langman says.
“People should not be forced to take risks on the black market when we know from overseas experience there are good treatments available.
“Still, I am optimistic. Public pressure got Australian governments to act and I am sure public pressure will ensure governments, in the end, do the right thing.”
[post_title] => Sick of stalling: patients forced onto cannabis black market by regulatory delays
[post_excerpt] => Medicinal cannabis at least two to five years away amid clinical trials.
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Momentum is gathering in NSW to legalise cannabis for medical purposes, hot on the heels of Victorian Opposition Labor Leader Daniel Andrews’ pledge to legalise medical cannabis oil for terminally ill people if he wins the state election in November.
Labor MP Adam Searle, who was part of a NSW parliamentary inquiry into legalising cannabis for medical purposes in May last year, says NSW could actually beat Victoria to the punch on getting the legislation through.
Mr Searle told Government News that the Victorian Opposition Leader’s commitment to asking the Victorian Law Reform Commission for advice on prescribing and regulating the drug with the aim of presenting a bill to Parliament by the end of 2015 if he won the election, was “not quite as radical as it seems”.
He argued that the NSW might be closer to legalising medical for people suffering from life-threatening, painful illnesses like cancer and HIV/AIDS because the idea received unanimous crossbench support from the committee conducting the 2013 NSW inquiry, members of which included the Nationals, the Shooters and Fishers Party and the Liberals, as well as Greens and Labor.
“Everybody could agree that people with terminal illnesses and their carers were the people who most urgently needed relief,” Mr Searle said.
“I’m very hopeful that the substance of what the committee reported can become law in the near future (in NSW)”.
The NSW parliamentary committee’s report examined the medical safety and success of cannabis, if and how it should be supplied for medical use and the legal implications of both.
The committee unanimously recommended that pharmaceutical cannabis be available to terminally ill people under the Pharmaceutical Benefits System.
Another recommendation included decriminalising seriously ill people who used cannabis for pain relief – including crude cannabis like plants or resin – by registering them as “incurable” after they had been diagnosed by a doctor.
“Cannabis products are emerging as a promising area of medicine, most notably in respect of a number of painful conditions that do not respond to existing treatments,” the final report said.
“The Committee agrees with the argument put forward by the majority of inquiry participants that provision be made for a very small and specific group of patients to use crude cannabis products for medical purposes legally.
“We recognise that particular attitudes have perhaps prevented us from recognising and harnessing the therapeutic potential of cannabinoids in Australia to date.”
But committee members could not agree on whether chronically ill people, such as Multiple Sclerosis sufferers, could use cannabis. Some were concerned about the long-term effects of using the drug but others felt the definition of “chronically ill” could be exploited by recreational cannabis users.
Mr Searle said: “There is movement. Things appear to be different. This represents a move in medical understanding but also an attitudinal change that comes with generational change but we’re not there yet.
“I think the real question for parliament now is, can we take this step when there isn’t any real reason not to? I think there’s an opportunity for action, hopefully non-partisan, but we will see.”
However, he cautioned that other Coalition members would have to be persuaded “in significant proportion” that is was the right thing to do.
It’s not just the NSW Coalition members who need to be persuaded, NSW Labor Opposition Leader John Robertson might need some convincing too.
Mr Robertson said he wanted to “build on the in-principle support expressed by the parliamentary committee” last year but he was not unequivocal in his enthusiasm.
“I am sympathetic to the plight of those who are suffering from a terminal illness and advocating for medical use of cannabis for pain relief – but it needs to be acknowledged there remains practical and regulatory issues that need to be worked through in this area,” Mr Robertson said.
“I think this is an issue that is above politics. Ultimately this is a medical issue and at every step along the way we need to be working with medical experts to ensure that we get this right.”
Meanwhile, medical cannabis has support from some other, perhaps unlikely, conservative quarters in NSW.
Nationals Tamworth MP Kevin Anderson – who has a young constituent with bowel cancer who uses cannabis to relieve chemotherapy side-effects - is currently drafting legislation for a private members’ bill. Liberal State Premier Mike Baird has given provisional support to the bill but he is known to have concerns over the supply and regulation of the drug.
The ACT appears to be jumping on board too. ACT Greens Member Shane Rattenbury, recently tabled an exposure draft bill into the ACT Legislative Assembly to legalise medical cannabis in the ACT. The bill has been sent to committee and will report back to the assembly before July next year. Consultation is open until September 15. The leaders of both other parties within the assembly have said they are open to looking at it but haven’t committed to a position at this stage.
Currently there is only one legal pharmaceutical cannabinoid in the Australian market: Sativex, used by people with MS to counter muscle spasms but it costs $500 per month, according to a 2014 Australian National Council on Drugs report.
Tasmania, whose Liberal government recently barred Tasman Health Cannabinoids from conducting medical cannabis growth and processing trials with the University of Tasmania, is currently holding its own parliamentary inquiry into legalising medical cannabis and is expected to report at the beginning of next year.
Tasmania already has a highly regulated, lucrative opiate poppy industry.
[post_title] => NSW may beat Victoria to legalise medical cannabis
[post_excerpt] => Push to harness cross-bench support from Parliamentary committee
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The NSW Government has voted down Labor legislation that would decriminalise cannabis possession.
The proposed legislation was to ensure that sufferers of terminal and serious medical conditions who rely on medicinal cannabis to ease their pain, would no longer be treated as criminals. The legislation would also create the mechanism to create a safe and lawful supply chain of product, to make access a practical reality for sufferers.
The legislation sought to decriminalise the possession of small amounts of cannabis (up to 15 grams) for treatment of chronic and serious medical conditions for medically certified sufferers and their carers, requiring them to receive photo identification and medical certification from NSW Health in order to possess medicinal cannabis. These amounts could be adjusted by regulation, according to medical treatment need.
Currently, people who purchase cannabis to alleviate the pain and distress associated with chronic and terminal illnesses face criminal penalties under the Crimes Act (1900).
The proposed legislation adopted the key recommendations from a NSW Parliamentary Inquiry into the use of cannabis for medicinal purposes, which received unanimous support from five political parties including NSW Labor, Liberal Party, National Party, the Greens and the Shooters, Fishers and Farmers Party.
"The unanimous recommendations of the Parliamentary inquiry were delivered in 2013,” said Opposition Leader in the Legislative Council Adam Searle. “Labor has always been ready, willing and able to work with the NSW Government to make access to medicinal cannabis a reality.”
“Those who are suffering from terminal and serious medical conditions deserve sympathy and support- and they should not be treated like a criminal for seeking respite from relentless and unwavering illness,” said Opposition Leader Luke Foley.
“It is deeply disappointing that the Government has denied legislation that will restore dignity to those people seeking temporary relief from the pain and suffering of their affliction.”
A number of other states have already legalised medicinal cannabis use (including Victoria and the ACT), and at one point NSW was expected to overtake Victoria with the legislation.
Illnesses that would be taken to be terminal or serious medical conditions:
- Human Immunodeficiency Virus (HIV);
- motor neurone disease;
- multiple sclerosis;
- the neurological disorder known as stiff person syndrome;
- severe and treatment-resistant nausea and vomiting due to chemotherapy;
- pain associated with cancer;
- neuropathic pain;
- an illness or condition declared by the regulations to be a terminal or serious medical condition.
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