15 Dec 2020
This document has just been posted on the TGA website. Click TGA logo on right to access.
Key change: Increase of maximum recommended daily dose to 150 mg or less of cannabidiol (daily dose previously 60mg)
In a groundbreaking vote, the U.S. House of Representatives on Friday passed a comprehensive bill that would remove marijuana from the Controlled Substances Act and end the federal government’s decades-old prohibition on the plant.
Lawmakers in effect voted to legalize marijuana by approving the social justice-focused Marijuana Opportunity, Reinvestment and Expungement (MORE) Act by a margin of 228-164 after an hour of debate. A handful of Republicans voted for the measure. (How each legislator voted is available here.)
The vote – while largely symbolic because the bill still must pass the Senate – comes only two days after the United Nations took the historic step of reclassifying cannabis as a less dangerous drug.
Click picture for full story
By Isabella Kwai, The New York Times, 2 Dec 2020
Photo credit: Loulou d'Aki for The New York Times
A United Nations commission voted on Wednesday to remove cannabis for medicinal purposes from a category of the world’s most dangerous drugs, a highly anticipated and long-delayed decision that could clear the way for an expansion of marijuana research and medical use.
The vote by the Commission for Narcotic Drugs, which is based in Vienna and includes 53 member states, considered a series of recommendations from the World Health Organization on reclassifying cannabis and its derivatives.
But attention centered on a key recommendation to remove cannabis from Schedule IV of the 1961 Single Convention on Narcotic Drugs — where it was listed alongside dangerous and highly addictive opioids like heroin.
Experts say that the vote will have no immediate impact on loosening international controls because governments will still have jurisdiction over how to classify cannabis.
But many countries look to global conventions for guidance, and United Nations recognition is a symbolic win for advocates of drug policy change who say that international law is out of date.
“This is a huge, historic victory for us, we couldn’t hope for more,” said Kenzi Riboulet-Zemouli, an independent researcher for drug policy who has closely monitored the vote and the position of member states. He said that cannabis had been used throughout history for medicinal purposes and that the decision on Wednesday reinstated that status.
BANGKOK, Nov 25 (TNA) – The Narcotics Control Board decided to remove cannabis plants from the list of narcotics, catagory 5 to allow wider use for medicinal purposes.
Permanent Secretary for Public Health, Kiarttiphum Wongjit and Secretary-General of the Food and Drug Administration, Paisan Dankhum told a press briefing that the Narcotics Control Board resolved to remove leaves, stems, stalks and roots of cannabis plants including both Kancha and Kanchong from the narcotics list.
The removal is to pave the way for more access to use cannabis for medical purposes as well as in textile, cosmetic and pharmaceutical industries.
The cannabis-derived compound CBD is not a narcotic drug because “it does not appear to have any psychotropic effect or any harmful effect on human health”, the EU’s highest court has ruled.
The decision by the court of justice of the European Union deals a severe blow to efforts by some EU countries to limit the sale of CBD, while simultaneously giving the CBD industry a boost. Many products are currently sold in the EU in a legal grey area.
The ruling was made in relation to the prosecution in France of KanaVape, a company that exports CBD oil made from whole hemp plants.
Under French law, only the fibre and seeds of hemp – a variety of the cannabis plant containing less than 0.2% of the psychoactive cannabinoid THC – may be put to commercial use, not the flower.
The court ruled that the French ban on the marketing of hemp-derived CBD products contradicted EU law on the free movement of goods.
“The national court must assess available scientific data in order to make sure that the real risk to public health alleged does not appear to be based on purely hypothetical considerations,” the court wrote.
“A decision to prohibit the marketing of CBD, which indeed constitutes the most restrictive obstacle to trade in products lawfully manufactured and marketed in other [EU] member states, can be adopted only if that risk appears sufficiently established.”
It noted that two key UN conventions classifying illegal drug do not specifically mention CBD, although they mention “cannabis extracts”.
The ruling also highlighted that France had not banned synthetic CBD, which has the same properties but is not produced using the entire cannabis plant.
Antonin Cohen, who faced the charges along with his fellow KanaVape co-founder Sébastien Béguerie, said the lack of clear regulations on CBD prevented safe market development.
“It is fundamental to develop strict quality standards in the interests of consumers in order to avoid the circulation of dangerous products,” he said. “My goal is to improve access to the benefits of plants, in a legal and secure environment.”
Robert Jappie, a partner at the law firm Ince, said the ruling was “a big win” for the CBD industry.
“By confirming that there was no scientific evidence to suggest that CBD has a harmful effect on the human body, the court has made it very difficult for the European commission to pursue their proposed classification of CBD as a narcotic,” he said.
The World Health Organization says CBD is “generally well tolerated with a good safety profile” and that there is no evidence “of any public health-related problems associated with the use of pure CBD”.
In recent years there has been a marked growth in the use of CBD oils, tinctures, creams and other products by people seeking to relieve stress and anxiety and to reduce inflammation. A study in the European Journal of Pain suggests that skin-applied CBD can help lower arthritic pain, but there is a lack of clinical evidence for its overall efficacy, and concern over the unregulated nature of the CBD market.
Epidyolex, a CBD-based drug known as Epidiolex in the US, has been approved by US and European health authorities to treat two rare and severe types of childhood epilepsy – the only such drug to receive the status so far.
Thanks to Gary MacKenzie, Founder and Chairman, GDM Ventures and CEO Releaf Group Ltd who posted this article on LinkedIn.
Original story by Mattha Busby, The Guardian, Australian Edition (TheGuardian.com), 20 November 20
Northern New South Wales is quickly emerging as a nationwide leader in the production of - and research into - medicinal cannabis.
A New England grower has been given the state's first license to mass produce cannabis oil - a move which should substantially lower prices.
NBN News was given an exclusive tour by the company.
15 Sep 2020
As part of its commitment to environmental responsibility, Murray Meds has constructed a solar array to harness the abundant sunshine they receive at their site in Northern Victoria. This will offset an estimated 500 tonnes of CO2 emissions, which is the equivalent of taking almost 6 cars permanently off the road.
Click picture above for full story - commentary and extracts from the article below:
Last week, the TGA released an interim decision to amend the Poisons Standard to allow cannabidiol to be sold over the counter at a restricted dose to adults.
Although this, at first, may have seemed like good news, new research published in the International Journal of Drug Policy suggests the TGA's plan to allow chemists to sell a month's worth of cannabidiol at a maximum dose of 60mg per day is unlikely to benefit patients.
The paper's co-author, Professor Iain McGregor, academic director of Sydney University's Lambert Initiative for Cannabinoid Therapeutics, said much higher doses were needed to give relief to patients with chronic pain, insomnia, anxiety and epilepsy.
The public is invited to comment until October 13. A final decision is due in late November, with implementation in February. There are considerable issues with this proposed listing as it stands. The experts have commented. Now it's your turn to make your voice heard.
The Australian Medicinal Cannabis Association (ACMA) welcomes the reformation of the Parliamentary Friends of Medicinal Cannabis
AMCA today welcomed the reformation of the Federal Parliamentary Friends of Medicinal Cannabis.
The group represents an ongoing commitment to ensure progress continues to support both industry and patients to make the changes required to fully realise the goal of a healthy and strong industry combined with affordable patient access.
“We know that each of the members of the Parliamentary Friends of Medicinal Cannabis has the opportunity to positively impact the lives of many Australians, not just economically, but with their health and welfare,” ACMA Chair Lucy Haslam said today.
AMCA is a registered not-for-profit association formed to serve the interests of the broad variety of organisations and individuals across the Australian medicinal cannabis industry. It is focused on supporting a healthy and robust industry, which will ultimately benefit Australian patients.
“A lot has happened since members of our team helped to achieve legalisation of medicinal cannabis in 2016. The challenge is that a lot still needs to be done so that the goals for industry and patients alike can be realised,” Ms Haslam stated.
ACMA will be reaching out to each of the members of the Parliamentary Friends group over the coming days and weeks to share the organisation's goals, work and vision for the sector. Further information will be provided to the membership on this activity shortly.
The vision of AMCA is to see Australia leading the world in quality, affordable and accessible medicinal cannabis. To achieve this, AMCA believes firmly that it is essential to have a broad mix of members with a wide set of skills, in order to meet the needs of each facet of the complex medicinal cannabis industry, especially in these early days of industry development.
For further information, including a copy of the membership of the Parliamentary Friends of Medicinal Cannabis or to become an ACMA member, please email: firstname.lastname@example.org
"...new top dog Ecofibre, whose business focus may be hemp but its strength in CBD product sales and research make it a cannabis industry force to be reckoned with......"
... as one door closes another opens."
"....in May 2020..THC announced it had acquired cannabis clinic network Tetra Health for $3million
....struck supply deal with MGC Pharma (ASX: MCX), another company on this list.
....linked up with (Cannatrek) to develop and manufacture Cannatrek-branded products"
"In February, (LGP) blazed onto the Australian Stock Exchange, smoking past the competition and landing in the Top 10 of Australia's top cannabis companies."
"Botanix's antibacterial platform.....became the first cannabinoid (CBD) program globally to receive Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA)."
After Grace* was diagnosed with cancer earlier this year, she turned to medicinal cannabis.
But accessing it through legal medical channels was a challenge: she faced long waiting times and substantial paperwork.
"I was offered through an illegal source where I could get it very quickly, and because my tumours were aggressive and time is of the essence, I decided to opt for the non-medical option," she tells ABC RN's Life Matters.
Grace started to get cannabidiol (CBD) oil sent to her in the post, in an olive oil bottle.
But concerns about the illegalities of the drug started to weigh on her conscience, and she worried about the chemical composition of the CBD oil she was taking.
"If you're obtaining it through a medical source and it's been approved, there's stringent procedures and processes in order to create that oil. Whereas if I'm getting it off an illegal source, it's hard to actually know exactly what I'm taking," she says.
She decided to "have another look at obtaining it through the medical channels" — but in the end, she opted to "stick with the illegal source".
"It just seemed like the most easiest, cost effective option for me," Grace says.
Nicholas Lintzeris, an addiction medicine specialist at the University of Sydney, says Grace's experience is not uncommon.
"The legal system we've had available now has been in place for about four years, and in the early days for the first couple of years we had a very clunky system," he says.
Professor Lintzeris was the lead researcher in a study on how Australians use medicinal cannabis — for everything from chronic pain to mental health conditions.
The online survey of more than 1,300 people found that while cannabis is used widely for medicinal reasons, the vast majority of respondents don't get it from their doctor.
"It was very difficult for patients to be able to find doctors who were knowledgeable and interested, the products were quite expensive, the legal hoops were quite pronounced. There were lots of hurdles, paperwork and so forth," Professor Lintzeris says.
"Most of our respondents were working. They were people who were holding down jobs, mums and dads with kids. So engaging with illicit activities such as that was a concern."
Life Matters listeners shared stories of similar hurdles:
"I have a well noted and long-term chronic pain condition, which has proven relief with CBD. Yet I have been constantly stymied in my attempts to get it prescribed. Thus I am forced to go through the black market with all its problems."
"My husband was prescribed medicinal cannabis for his cancer pain — incredibly expensive — around $350 for a very small bottle that may last a couple of months only. It was very helpful but we just couldn't afford to keep buying it."
"I'd rather be using medical cannabis than opium products any day. But it is so expensive to access legally and yet opium products are subsidised by the government. The addiction story for opioids is horrendous. Cognitive dissonance [is] the right word for our culture."
Access to legal medicinal cannabis is granted under the Special Access Scheme. It's managed by the Therapeutic Goods Administration, and you need a restricted prescription for it.
The application needs to be done by a doctor on your behalf, and it must show you have a medical reason for accessing cannabis.
Between the start of 2020 and May 31, more than 18,000 applications for medical cannabis were approved by the TGA.
Professor Lintzeris says the system has adapted and improved since medical cannabis was legalised at the federal level in 2016.
Initially people would face wait times of up to two months for approval, he says, but now that's more like two to four weeks — and that's not the only change.
"I think we're seeing some changes in the development of the marketplace, as more doctors take up this option and get better educated around what medical cannabis is, as the price of products is reducing and as more products come onto the market, and there's more and more consumers who are getting experienced with legal supplies," Professor Lintzeris says.
But he argues that some areas of the law are still lagging behind.
Driving with THC in your system is a criminal offence, even if you've been prescribed medical cannabis.
The standard advice for cannabis patients is to wait five days before driving, or risk a fine or a suspended licence, but there is ongoing debate about how much impairment THC actually causes.
"There's this inconsistency in Australia where we have a group of drug driving laws that really reflect what made sense for illicit cannabis or drug use," Professor Lintzeris says.
"Unfortunately, a THC-based medicine gets caught up in that drug driving. We have this anachronism in Australia where no other medication that's legally prescribed is subject to the same drug driving issues as medical cannabis."
It's something that proved a huge worry for Grace.
"My biggest concern was that if I was to get pulled over while driving, if I registered for THC in a random drug test, I could lose my licence," she says.
Like Grace, Professor Lintzeris also points out that that if you're self-medicating rather than going through a doctor, there are risks.
"There's no capacity of standardisation of product or quality control, both in terms of what's in this batch, how much THC or CBD in this batch compared to the batch from last month," he says.
Despite the legalisation of medicinal cannabis in Australia, group bodies such as the Royal Australian College of General Practitioners (RACGP) continue to take a cautious stance on prescribing medicinal cannabis patients, calling for more high-quality research into the safety and effectiveness of it.
The RACGP pointed Life Matters to a statement, which said it doesn't "recommend the use of cannabis products", but does "recognise that a specialist GP may offer to prescribe it to a limited number of patients".
After four months using CBD oil through an illicit producer, Grace is willing to accept the risks.
"I do find that there is little to no side-effects of using the cannabis oil — which was a concern initially — and it's a cost-effective option," she says.
"When I went down that [medical] channel, what I found was that there were a lot of hoops I had to jump through, a lot of paperwork, and a lot of people who had to be involved.
"And even then if I was deemed worthy of the CBD oil, I was going to be sent this particular oil every six weeks.
"But the illegal CBD oil I got straight away, it was very easy to access and cost effective. So I opted to stay using the illegal source."
*Name changed to protect the person's identity.
"I missed kids' birthdays, I missed grandkids' birthdays, fishing, going out in the garden," he said.
"I was virtually numb, it got to the stage where nothing really mattered."
"It was pretty much limiting me on anything. It was a major event even to go shopping."
The great grandfather had injured his back while building a friend's house.
Mr Leamer had to give up work and in the mid-90s began taking pain relievers with codeine in them.
Within 18 months, he had moved onto oxycodone and finally, morphine.
"It got to the stage that I couldn't function properly. I couldn't make a coherent sentence," he said.
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Australians report using medicinal cannabis for chronic pain, mental health and sleep with the majority sourcing cannabis illicitly, despite medicinal cannabis being legal, a new survey from the University of Sydney has revealed.
The results from the Cannabis As Medicine Survey (CAMS:18), conducted by staff at the Discipline of Addiction Medicine in conjunction with the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney, provide insight into how Australians are using cannabis as medicine.
The results of the previous Cannabis As Medicine Survey (CAMS:16), the biggest national survey of medicinal cannabis users in Australia in more than a decade, provided a snapshot of people self-medicating before any medicinal cannabis use was legalised.
The aim of the two-year follow-up survey was to monitor changes in how Australians were accessing and using medical cannabis following its legalisation in 2016. The survey of 1388 Australians was conducted between September 2018 and March 2019.
Lead author and addiction medicine specialist Professor Nicholas Lintzeris said:
“There continues to be considerable demand for medical cannabis in Australia that has not been completely met by available models of prescription by medical practitioners. The uncertainties experienced by people in the community around the cannabis products they are accessing illegally is a concern.
“However, the few people who report accessing legally prescribed medical cannabis products did have favourable reports, suggesting there is a path forward. I think it is still early days for the Australian medicinal cannabis system.”
Co-author and academic director of the Lambert Initiative Professor Iain McGregor said: “This is an important snapshot into the reality of medicinal cannabis access in the Australian community. There are clearly many Australians with serious medical conditions who are yet to gain official access to medicinal cannabis products, even though they would like such access. These users continue to risk hazards associated with non-standardised cannabis products of unknown origin as well as a possible criminal conviction as a result of their current patterns of self-medication.
“We need to accelerate the pace of change through innovations such as over-the-counter access to CBD (cannabidiol, the chemical found in cannabis plants) products and improved education and guidance for doctors and specialists in this area. Better quality evidence around medicinal cannabis effectiveness, particularly for conditions such as insomnia and depression, is also critical.”
Legal cannabis growers will be able to export medicinal cannabis and hemp into more overseas markets.
Federal parliament passed a bill on Wednesday to give farmers access to export opportunities in South East Asia, China, Canada and the lucrative US market.
Australia will now be able to certify legitimate exports of narcotic products, helping producers export to countries that need government approval.
Agriculture Minister David Littleproud said certification would provide assurances to trading partners and help farmers.
"This bill will enable agricultural industries to come out firing after the threat of COVID-19 has passed," he said on Wednesday.
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