Our strength is in our breadth
by MARTIN LANE 25 FEBRUARY 2021
The Narcotic Drugs Amendment (Medicinal Cannabis) Bill 2021 passed the House of Representatives last night and is likely to pass through the Senate without amendments.
Cannabiz co-founder Martin Lane and editor-at-large Rhys Cohen spoke with Australian Medicinal Cannabis Association (AMCA) secretary and lawyer Teresa Nicoletti and head of legal and regulatory affairs at Cann Group Steven Notaro about:
by JOEL HARDY, FEBRUARY 10, 2021
Most people wouldn’t know that we are the only country in the world allowing imported medical cannabis products into Australia that do not meet Good Manufacturing Practice (GMP) international standards.
Based on the huge increase in SAS-B products available, there is a real risk of inferior products adversely affecting patients. The current system also negatively impacts local manufacturers who have to comply with GMP rules, which adds costs and gives importers an unfair advantage. The Therapeutic Goods Administration (TGA) is currently considering submissions on the topic.
Writing in Cannabiz recently, editor-at-large Rhys Cohen outlined the options being considered by the Government:
“The Department of Health wants to ensure a level playing field for everyone by imposing similar quality standards on both imports and local products. They have proposed two possible solutions (other than ‘doing nothing’).
“The first is to insert new GMP requirements specific to medicinal cannabis in the Therapeutic Goods Regulations, and the second is to do essentially the same thing but by making changes to TGO93.
“The only meaningful difference between these options seems to be that amending the regulations would still allow for some non-GMP ingredients to reach Australian patients through compounding pharmacies, while amending TGO93 would be more comprehensive.”
Through my discussions with stakeholders, I am not sure patients and doctors are aware of TGO93, the lower threshold for imported ingredients for medical cannabis products. It’s a new standard that was created to increase supply for desperate patients and meet rapidly rising demand.
However, the form for importation is a self-declaration (think self-policing), with testing for stability, specifications and standards able to be conducted locally, presenting a potential risk to patients consuming imported products.
If changes are made to level the playing field, it is true that some patients may not be able to access their preferred brand. However, there would be a transition period to enable the affected brands to achieve GMP standards. In 95% of cases, ingredients can be replaced with an exact or very similar product or formulation that is GMP standard for the same price because competition remains high.
Lastly, it’s hard to estimate what effect such a move would have on prices immediately, but there are many domestic companies with existing supply that can scale, and there are still GMP-quality medicines that can be imported. I believe prices will continue to stay cost effective as companies vie for market share, even if some choose to exit.
Lucy Haslam, founder of patient advocacy group United in Compassion (UIC), says: “Australian patients have had to battle for the legal right to access medicinal cannabis. Currently, they are provided with potentially inferior and dangerous products via the legal pathway that was created to protect them from the harm associated with unregulated access.
“UIC believes that patients deserve high-quality GMP products from the domestic and international industry.”
by MARTIN LANE, FEBRUARY 9, 2021
Researchers in Israel have discovered medicinal cannabis may reduce blood pressure in older patients.
The team, from Ben-Gurion University of the Negev (BGU) and Soroka University Medical Center, studied the effect of cannabis on the blood pressure, heart rate, and metabolic parameters of adults with hypertension aged 60-plus.
BGU’s Dr Ran Abuhasira said: “Older adults are the fastest growing group of medical cannabis users, yet evidence on cardiovascular safety for this population is scarce.
“This study is part of our ongoing effort to provide clinical research on the actual physiological effects of cannabis over time.”
Patients were evaluated using 24-hour ambulatory blood pressure monitoring, ECG, blood tests, and body measurements before and three months after starting cannabis treatment.
In the study, published in the European Journal of Internal Medicine, the team found a significant reduction in 24-hour systolic and diastolic blood pressure values, with the lowest point occurring three hours after taking cannabis as an oil extract or by smoking.
Blood pressure reduced during the day and at night, with more significant changes at night.
The researchers theorised that pain relief, the most common indication for the prescription cannabis patient cohort, may also have contributed to a reduction in blood pressure.
by MARTIN LANE, FEBRUARY 8, 2021
United In Compassion’s 2021 Australian Medicinal Cannabis Symposium has been listed on Austrade’s Schedule of Approved Business Events, meaning eligible businesses can apply for a grant to cover up to 50% of the costs of attending as delegates or exhibitors.
The Symposium, which takes place on the Sunshine Coast from August 13-15, features a one-day nurses’ conference, two-day general symposium, and a training day for healthcare professionals hosted by the Society of Cannabis Clinicians Australian Chapter. There will also be a networking event, gala dinner and three-day trade exhibition.
Confirmed international speakers include associate professor Dedi Meiri (Israel); Dr Sue Sisley, Dr Peter Grinspoon, Dr Dustin Sulak and Dr Annabelle Manalo (all from the US); Sarah Flogan RN and Lynda Balneaves RN (both from Canada).
Special guests include Olivia Newton John, John Easterling and Professor Raphael Mechoulam.
The event will be MC’d by journalist and TV presenter Helen Kapalos, who made medicinal cannabis documentary A Life of Its Own in 2016.
Grants of up to $250,000 are available for eligible companies, with applications closing on March 30, or earlier if funding is exhausted.
by RHYS COHEN, FEBRUARY 5, 2021
The Narcotic Drugs Amendment (Medicinal Cannabis) Bill 2021 was introduced to the Commonwealth Parliament on Wednesday (February 3rd). If passed, it will make a number of changes to Australia’s commercial medicinal cannabis framework. Most notably:
• Replace the current three licence types (cultivation, manufacture and research) with a single licence.
• Remove licence expiry and renewal requirements, making them perpetual (unless revoked or surrendered).
• Shift some information requirements from the initial licence stage to the permit stage.
• Introduce a statement of purpose to the Narcotic Drugs Act clarifying that it is designed to “make medicinal cannabis products available for therapeutic purposes”.
The bill is the culmination of an extensive period of regulatory design and industry consultation.
The changes are informed by the recommendations of John McMillan AO in his review of the Narcotic Drugs Act, which was published in September 2019.
Since 2016, when the framework was first implemented, industry members have encountered a number of challenges with the licence and permit scheme.
Some organisations have had applications pending for more than two years, and industry members have reported delays, inconsistencies, and an overall lack of transparency in the process.
This has made it harder, more expensive, and riskier for Australian companies to cultivate and manufacture medicinal cannabis and delayed the widespread availability of affordable, Australian-made products.
This week’s media coverage of over-the-counter CBD has caused a surge in enquiries that health care professionals are struggling to cope with. Martin Lane investigates:
Hyped-up press coverage about the availability of over-the-counter CBD has left pharmacists and GPs dealing with an unprecedented wave of disappointed customers, according to an investigation by Cannabiz.
February 1 saw new regulations come into force making low-dose CBD available without a script, but products will require TGA approval and inclusion on the Australian Register of Therapeutic Goods (ARTG) along with a number of other restrictions.
Based on the requirement for ARTG registration, no CBD medicine is currently available which could be supplied over the counter and it may take another 12 months for that to happen.
However, stories in the mainstream media this week – some including commentary from cannabis companies themselves – inevitably focused on the availability of CBD rather than the nuances of the TGA’s decision.
In doing so, the coverage created a surge in demand that pharmacists have been unable to fulfill.
Nguyen said when staff refer customers to their GP for help, the response is often ‘my doctor doesn’t want to [prescribe CBD]’ or ‘my doctor doesn’t know how’. pharmacists have also contacted her asking what they should tell customers. “My patients are very confused. They’ve seen on the news that CBD is available over the counter and we have to explain the nuances of the TGA to them,” Nguyen said. “They say ‘what’s the TGA?’. It’s not what they want to hear.”
Nguyen said when staff refer customers to their GP for help, the response is often ‘my doctor doesn’t want to [prescribe CBD]’ or ‘my doctor doesn’t know how’. She said frustrated and confused customers are left feeling ‘that’s too hard, I can’t be bothered’, causing potentially far-reaching damage to the industry’s reputation. “We are trying to legitimise the industry and things like this don’t help. It makes it go backwards by raising patient expectations high and not delivering.” Nguyen said she has had several calls from other pharmacists asking for advice on how to manage customer enquiries. “Pharmacists have not received enough training, if any, on Schedule 4 medicines. They are hardly in a position where they are ready to understand Schedule 3 CBD, let alone convey to the patient what this means for them, and manage their expectations regarding timelines given there is no registered product available any time in the near future.”
GP and medicinal cannabis specialist Matty Moore said his patients in Dunsborough, WA have been contacting him to ask why they still need a script. “I’ve had four today [Tuesday], two on the phone and two face to face, saying ‘why do I have to see you, why do I need a script, it’s going to be in pharmacies now?’ They’re gobsmacked when I explain it to them because it’s all over the news.” Moore said because his patients are already using medicinal cannabis and seeing the benefits, they tend to “shrug their shoulders” when the registration process is explained to them.
However, he feared would-be patients without access to a knowledgeable GP who have been hoping to buy medicinal cannabis over the counter might now be tempted on to the black market.
“Black market [operators] are loving it because they’ve got another couple of years before they have to give up their business,” he added. Moore told Cannabiz he planned to spend time on social media explaining the situation to patients in order to help manage expectations and steer them away from the illicit market.
Richard Di Natale (head of the Healthcare Practitioner/Patient Advisory Council (HP/PAC) told Cannabiz patients’ expectations are not being met due to a lack of clarity around the approvals process. He said: “Until products become available as they are in other countries you are going to get pressure on pharmacists, doctors and healthcare professionals because expectation has been created.” He added the HP/PAC will be engaging with the TGA to look at streamlining the registration process to meet pent-up demand. “The TGA’s role is to ensure safety for patients, that’s important as a regulatory body. Unfortunately, the approval process can take months because companies need to ensure they have appropriate data. One hopes there’s some flexibility, [but] people are going to have to be patient. In the meantime, Di Natale warned: “It’s important that all stakeholders don’t raise patient expectations because reform in this area has been painfully slow.”
Cannabiz editor-at-large Rhys Cohen said: “No CBD products are currently available over the counter. At the earliest some may become available in one to two years. “This is a complex issue, and companies operating in the medicinal cannabis sector have an obligation to the public, not to mention their investors, to ensure the information they release is accurate, complete and reasonable. In the meantime, all this ‘CBD is available’ news coverage is going to send thousands of people to their pharmacy where they will be disappointed, jump online and buy unregulated CBD instead, exposing them to products with no quality or safety controls.”
The Australian Medicinal Cannabis Association (AMCA) secretary, Teresa Nicoletti said the industry has a duty of care to provide accurate information to patients via the media.
“The general public don’t understand the registration process and we can’t expect journalists to delve into the regulatory framework and understand what the finer details are. They rely on the industry to provide the right information.
”She said the problem was fuelled by some companies being new to the space, and not fully understanding the regulatory framework themselves, and others using media coverage to boost their profile in the market.
“While companies need to answer to their shareholders and have a vested interest in any developments in the regulatory regime which help their share price and market capitalisation, they must be careful to ensure that any news coverage, in this case about over-the-counter CBD, is accurate and balanced, and does not mislead or misinform the public.”
South Australia has become the latest state to explore cannabis driving law reform with Greens upper house MP Tammy Franks taking up the crusade in collaboration with lobby group Drive Change.
Franks introduced a bill in parliament yesterday that will seek to lift the legal threat that hangs over patients holding medicinal cannabis prescriptions.
The bill is similar to the one drawn up by Reason Party leader Fiona Patten in Victoria. Franks said she has been in touch with Patten with the two politicians “actively collaborating to share insights from each jurisdiction as part of this important proposed law reform”.
Under current Australia-wide laws, drivers with any amount of THC in their system – however small – can be prosecuted even if there is no evidence to suggest their driving is impaired.
The industry has long called for an overhaul of the law which is widely felt to discriminate against medicinal cannabis users and often deters patients from taking the medicine they need.
Many face the distressing choice of either taking medicinal cannabis and risking prosecution – and possibly losing their job – or avoiding the drug altogether.
Ahead of tabling the bill, Franks held a roundtable discussion with parliamentary colleagues to raise awareness of the Drive Change campaign, which is fronted by former magistrate David Heilpern.
“In South Australia, and all jurisdictions in Australia, current drug-driving laws still discriminate against patients who are taking legally prescribed medicinal cannabis without impairment,” Franks said. “This is based on stigma, not science, and continues despite the legislative reforms that have allowed this medicine to be legally prescribed. Many patients are choosing to consume CBD-only medications for fear of random roadside drug testing and the risk of loss of licence because THC has been detected – and not because they are driving impaired. GPs who do prescribe are advising patients against driving because any risk of loss of licence would have far reaching impacts on them. Patients should not have to choose between medicine or mobility.”
The Greens’ push has been backed by the Australian Lawyers Alliance (ALA) which said the current laws discriminate against medicinal cannabis patients.
“People lose their licence, and sometimes their job, not because of impaired driving, but because of flawed laws,” ALA South Australia state president Sarah Vinall said. “Drivers who take opioids or other prescription medication do not find themselves in court or risk losing their licence, and neither should drivers who have taken a prescribed and legal dose of cannabis. We support the Bill introduced today because it will fix this unfair and outdated law that severely penalises medicinal cannabis patients.” Vinall said the laws are outdated, having been developed before cannabis became a legally recognised prescribed medication. “The law needs to change to stay relevant,” she said. “We urge all legislators in South Australia, and the South Australian Government, to support this Bill.”
Adelaide doctor Dr Joel Wren, a prescriber of medicinal cannabis, also backed the move.
“Patients are impacted by not being able to access their best medical option, invariably in circumstances where existing medications have failed or where side effects like addiction and accidental overdose are ever present,” he said. “In many cases, a patient forced to return to opioids or benzodiazepines is taking unnecessary health risks and many pain and anti-anxiety medications are of themselves a risk on roads, especially when combined with alcohol.”
Heilpern, who heads Drive Change, said the campaign wants to “engage with lawmakers in every state and territory. In South Australia we will continue to liaise with lawmakers as the bill proceeds through parliament and provide a valuable conduit between that process and the broader public by way of a digital nationwide campaign,” he said. “We’ll be amplifying the voice of medical professionals, lawmakers and industry who support the change and most importantly patients who need these horrifically unjust laws changed. “We encourage anyone who supports this cause to reach out to us at drivechangemc.org.au so they can be a part of helping to Drive Change.”
by MARTIN LANEJANUARY 28, 2021
Researchers in Germany have found more than half of Parkinson’s disease sufferers using cannabinoids to treat their condition report a beneficial clinical impact.
The team at the University Medical Center Hamburg-Eppendorf conducted a nationwide survey of German Parkinson Association members to test patient perceptions of medicinal cannabis and evaluate the experiences of those already using cannabis products.
More than 8% were already using cannabinoids, with 54% of users reporting a beneficial clinical effect. More than 40% said it helped with pain management and muscle cramps and more than 20% reported reduced stiffness, freezing, tremor, depression, anxiety and restless legs.
Patients reported inhaled cannabis products containing THC were more effective in treating stiffness than oral products containing CBD, but were slightly less well tolerated.
Patients using cannabis tended to be younger, more urban, and had greater awareness of the legal and clinical aspects of medicinal cannabis.
Around 65% of non-users were interested in using medicinal cannabis, but knowledge about different cannabinoids was limited, with only 9% aware of the differences between THC and CBD. This lack of knowledge,
combined with a fear of the side effects, were cited as the main reasons for not trying it.
The study is published in the Journal of Parkinson’s Disease.
by MARTIN LANEJANUARY 18, 2021
Bod Australia achieved record total attributable sales of A$3.33m in Q2 FY21, a 52% increase on the previous quarter and a 144% rise on Q2 FY20.
Sales for the period were supported by a number of purchase orders from exclusive global partner Health and Happiness Group for the launch of CBD and hemp products in key markets including the Netherlands, France, Italy and the UK as well as increased prescription volumes of medicinal cannabis product MediCabilis.
Bod expects sales growth to continue during 2021 as the company enters additional markets and achieves growth in medicinal cannabis sales in Australia and the UK.
Bod CEO Jo Patterson said: “The progress achieved over the last quarter is a great result for Bod. The company has considerably broadened its international footprint, with new market entries into the Netherlands, France and Italy, [and] extended its product ranges in the UK.
“Further, we have increased sales of our medicinal cannabis products in Australia and are now benefiting from this growth. Demand for our medicinal cannabis, CBD and hemp products continues to escalate and we expect binding purchase orders to increase during the current period and the remainder of FY21.”
by MARTIN LANEJANUARY 18, 2021
A team of Australian and New Zealand scientists have discovered a way of increasing the absorption of CBD in the blood of mice by almost half and in the brain by a quarter.
CBD is thought to have therapeutic benefits for some brain disorders because it reduces inflammation and acts as an antioxidant, but it is hard for the body to absorb when taken orally.
To address this problem, researchers from Curtin, Newcastle and Otago Universities produced CBD microcapsules, with the compound encapsulated in a gel.
They gave the capsules to mice along with capsules of deoxycholic acid, which increases absorption in the body, and measured levels of CBD in their blood and brains after 20 minutes, one hour, and three hours.
Compared with unencapsulated CBD oil, the new method increased the amount of CBD in the blood by an average of 47%, and in the brain by an average of 25%, according to the team.
With the new capsule combination, the peak concentration of CBD in the brain was 300% higher than with CBD oil, they added.
The peer-reviewed study was financially supported by Zelira Therapeutics.
by MARTIN LANEJANUARY 14, 2021
Cannatrek has announced it will supply medicinal cannabis products to LYPHE Group in support of Project Twenty21, Europe’s first and largest national medical cannabis registry.
By the end of 2021, Project Twenty21 aims to recruit up to 20,000 patients suffering from conditions including anxiety, chronic pain, epilepsy, multiple sclerosis, post-traumatic stress disorder, substance use disorder and Tourette’s Syndrome. It will help them access subsidized medical cannabis while simultaneously gathering evidence of efficacy.
Cannatrek will supply medicinal cannabis flowers for the project via LYPHE Group (Astral Health UK) which will be crushed and inhaled via a vaporizer.
Cannatrek CEO Tommy Huppert said: “For us it opens up international trade pathways in what is still a nascent industry. Project Twenty21, with 20,000 patients, represents a very big study and will produce lots of valuable data for Cannatrek and for the industry.”
He added: “Cannatrek is an important part of the supply chain for this study. Supply chains are being created very rapidly worldwide and we want to be front and centre of them.”
Chief commercial officer at LYPHE Group Chris Ashton said: “Project Twenty21 is an incredibly important study in the UK and presents a great opportunity for the industry to demonstrate with valuable data the effectiveness and safety of using medical cannabis.”
by MARTIN LANE JANUARY 13, 2021
Medicinal cannabis and industrial hemp firm ECS Botanics has signed a binding term sheet to acquire medical cannabis cultivator Murray Meds (MM).
Murray Meds has a fully licensed medicinal cannabis cultivation and manufacturing facility in Victoria with permits to cultivate and produce 3,500 grams of medical cannabis and a Cultivation, Research and Manufacturing Licence from the Australian Office of Drug Control.
It also holds a TGA GMP manufacture licence for dried flower, oils and tinctures.
Under the terms of the deal, ECS will own 100% of the issued capital in Murray Meds Pty Ltd and Flowerday Farms Pty Ltd.
ECS managing director Alex Keach said: “MM and ECS share a view on industry methods and a vision for the future. As a combined group we are positioning to become the largest and most geographically diversified cannabis producer in Australia.”
Murray Meds managing director Nan-Maree Schoerie added: “Both organisations are very grounded in their approach to delivering affordable medical cannabis as naturally and sustainably as we can, with shared values and an inherent drive to deliver for patients and shareholders.”
by SIMON PETTINGER JANUARY 12, 2021
Cymra Life Sciences chief operating officer Simon Pettinger argues cannabis companies need to think differently to jump the government’s regulatory hurdles and deliver cost-effective products to patients.
Car racing teams are always searching for incremental improvements to get a few milliseconds advantage, but once every few generations one team makes a dramatic change by thinking about solving a problem through a completely new lens. That’s how we at Cymra Life Sciences are thinking about cannabis.
Crops such as tomatoes, cucumbers and wheat have had hundreds of years of commercial development, while medicinal cannabis has had less than a decade and has been tightly controlled by government restrictions/legislation. It is essentially a new commercial crop.
Cymra’s head of breeding Matt Turner, who has more than 30 years of plant breeding experience, states: “Cannabis has been and continues to be restricted by governments around the world, hampering the speed of innovation around genetic improvement. The opportunity to make cannabis a more efficient and cost-effective crop to reduce costs for patients has huge worldwide potential.”
As one of the few worldwide companies focused on genetics, we set out to breed a plant that would make the agricultural efficiency of medicinal cannabis possible. Once this occurs at scale, patients will have affordable access to potentially beneficial medicines.
Of course, there will always be high-end segments of the cannabis industry who believe in premium indoor flower for smoking. However, we believe it is not sustainable for a patient who may have to pay more than $300 a month for their pain medication in Australia (we acknowledge that government regulation also plays a considerable part in the high patient costs).
Through innovative breeding we believe Australian cannabis cultivators can produce cheaper medicines and continue to operate in a high-cost country such as Australia. We set out to do this by focusing on plant agronomics, breeding new cannabis varieties with better input traits, that deliver agronomic efficiency gains, increased yields and resistance to pests and disease.
The industry has broadly welcomed the Therapeutic Goods Administration’s decision to down schedule low-dose CBD – with some important caveats.
On Wednesday, the TGA announced a significant change in its final decision, with the maximum dose increased to 150mg/day, up from the 60mg/day it signalled in its interim decision in September.
The implementation date of the down scheduling was also brought forward from June 1 to February 1, 2021.
Medicinal Cannabis Industry Australia (MCIA) welcomed the change as providing the industry with the flexibility to develop products for the Schedule 3 registered pathway.
However, it said it would continue to work with the TGA with a view to lifting the dose to 300 mg/day as “this is the threshold at which higher quality evidence accumulates around CBD efficacy, in the absence of significant safety concerns”.
MCIA chair Peter Crock added: “Down-scheduling CBD will benefit patients by allowing them to move from the illicit market and providing easier and more affordable access to high-quality products.”
While noting products will require TGA approval and inclusion on the Australian Register of Therapeutic Goods (ARTG), along with a number of other restrictions, Crock said the decision will provide a pathway for the industry to develop products for this market.
“If fewer consumers seek out illicit CBD products, which have unknown content and quality, then this move ultimately promotes greater safety for patients, which has to be the priority,” he added.
The Australian Medicinal Cannabis Association (AMCA) also welcomed the decision, but noted no medicines currently meet the criteria for a Schedule 3 medicine.
It cited the example of Epidyolex, a CBD-containing product currently registered on the ARTG which contains cannabidiol in a concentration of 100mg/ml, but with a stated starting dose of 2.5mg per kilogram twice daily, which equates to 300-350mg per day for a 60-70 kilogram adult.
AMCA secretary Teresa Nicoletti added: “That being the case, Epidyolex remains a Schedule 4 medicine at its starting dose or higher, and patients will not be able to access it as a Schedule 3 medicine. Based on the requirement for ARTG registration, no CBD medicine is currently available which could be supplied [over the counter].
Ultimately, Schedule 3 CBD medicines will only be available if companies invest in generating the comprehensive data packages of quality, safety and efficacy that would be required to support registration on the ARTG.
“In the meantime, we anticipate patients will continue to access CBD as a Schedule 4 medicine, while the industry waits to see whether companies have any interest in working towards ARTG registration.”
Elixinol Global executive director and group CEO Oliver Horn described the TGA’s decision to increase the maximum daily dose as a “big surprise for the better”, but said it still left Australia lagging behind the rest of the world when it comes to consumer access.
He said: “The good news is that more people will have access to safe and effective CBD products now. However, the TGA’s approach is not reflective of the overall global trend and in particular the regulatory frameworks recently confirmed by the European Commission, which classifies CBD as food.
“Under the EU’s ruling, product suppliers have to demonstrate stringent safety standards but not efficacy. Even under the new TGA ruling, and with an increased dosage, proving efficacy for specific indications will prove challenging and will increase the barriers to entry into the Australian market.
“The vast illegal supply of CBD products from online suppliers into Australia will continue to exist simply because it’s more convenient, easily accessible and likely to be cheaper.
“The TGA ruling misses an opportunity to create a compliant, legal and buoyant domestic CBD market by demanding proof of efficacy and over-regulating the market. It’s a step forward, but global markets are moving forwards faster.”
Bod Australia revealed it has established a medical advisory board to explore the possibilities created by the down scheduling, with Lambert Initiative academic director Iain McGregor and head of neurology at Gold Coast University Hospital, Arman Sabet, among the board members.
Chief executive Jo Patterson told Cannabiz the company would initially pore through academic and medical literature to see if there is material supporting efficacy at 150mg.
She said Bod already has a CBD isolate targeting stress, anxiety and sleep disorder that it will look to register on the ARTG.
“Our ambition is to get a product to market as soon as possible,” Patterson said. “We will sit down with the TGA in the new year and discuss what sort of indication we are looking at for a registration.
“If there is enough literature in the public domain then the task of clinical trials may not be required. But if we do have to go down the clinical path trial, we will. We already have trials designed so if we need to go to phase 2 or phase 3 trials we are ready.”
Bod already has data from observational trials that provided “good insights into dosage and efficacy”, she added.
The listed company said it would also explore opportunities for its consumer-focused CBD and hemp products.
FreshLeaf Analytics regulatory specialist Tony Whittaker warned there were still hurdles for the industry to jump. He said: “The TGA has exacting standards, which will present a significant challenge to this young industry. We look forward to working with TGA to clarify the requirements for over-the-counter CBD products and navigating the path to approval and commercialisation.”
Tim Drury, the director of Southern Cannabis Holdings, which owns FreshLeaf, added: “Low-dose CBD has the potential to become a significant market in Australia for cannabis products.
Companies wanting to compete in this space need to overcome substantial challenges – demonstrating safety, efficacy and quality of manufacturing – but the first to do so will be best positioned to succeed in a market that will, by our estimation, exceed A$200 million per annum.”
by Emma Castle, 14 December
Australian biotechnology company CannaPacific is working in partnership with the CSIRO to trial novel encapsulation technologies for medicinal cannabinoids.
The objective of the trial is to find new encapsulation technology that reduces variability and increases bioavailability.
Dr Alison White, inventor of the technology and CSIRO-AIBN postdoctoral research fellow, said mineral-based thin shells were used to completely surround the cannabinoid with a protective barrier to form a microcapsule.
“This barrier is designed to prevent premature release of the drug, and allows a higher level of control over where and when the drug is released. By controlling the dissolution rate of the microcapsules, we anticipate a more consistent delivery of the cannabinoids into the bloodstream,” said White.
The greater control the technology will provide is anticipated to remedy the current inconsistency of oil-based cannabinoid products. When coupled with optimised formulations of specific cannabinoid medicines, this improved delivery should reduce variability and increase efficacy.
by Martin Lane, 14 December
OnTracka has struck deals for the launch of a white-labelled cannabis tracking app and connecting portal that will see a minimum of 12 prescribing doctors adopting OnTracka technology to power their clinics.
Founder Chad Walkaden (pictured) said the move will give their patients access to the best health care in Australia.
Under the arrangement, prescribing doctors subscribed to OnTracka Enterprise will be the first in the world to benefit from The Portal, the Sydney tech start-up’s second product. Prescribing doctors will encourage their patients to download and populate the app with data including dosage, side effects, exercise, mood and overall health.
The doctor will be able to access the data in real-time via the secure portal and use it to track the patient’s progress and inform their ongoing health care plan during consultations, improve compliance and safety around dosing as well as prescription management.
Patients will be able to invite other health professionals involved in their care to access their data to better inform their treatment recommendations.
by Martin Lane, 10 December
After last week’s decision by the US House of Representatives to end federal marijuana prohibition, on Wednesday it passed a bill to reduce barriers and expand scientific research into medical cannabis.
The move would enable researchers to study medical cannabis products sold in states where it is legal in order to better understand their impact and encourage more doctors to prescribe it.
Unlike the Marijuana Opportunity Reinvestment and Expungement (MORE) Act, the Medical Marijuana Research Act attracted strong bipartisan support, but it is still likely to come unstuck when it reaches the Republican-controlled Senate.
by Steve Jones, 10 December
EXCLUSIVE: Three medicinal cannabis products publicly named by the Therapeutic Goods Administration as having failed to comply with required standards have been exonerated by third party analysis in a development that will increase pressure to produce standardised lab testing across Australia.
The disparity in test results will also concern the TGA which in September stated that five products were found to be stronger or weaker than permitted under Therapeutic Goods Order 93 (TGO93) regulations.
by Martin Lane, 8 December
The Therapeutic Goods Administration approved more than 6,300 medicinal cannabis prescriptions in October, the highest total in 2020, according to the latest data.
Figures published by the TGA revealed 6,356 prescriptions were approved through the Special Access Scheme, beating the previous record of 6,206 in September.
It brings the total number of SAS-B approvals in 2020 to 52,151.
In total, the TGA has now approved more than 80,000 SAS-B applications for unapproved medicinal cannabis products.
The number of Authorised Prescribers rose from 146 to 149 as at November 30.
by Martin Lane, 7 December
Australian Natural Therapeutics Group (ANTG) has been granted a licence in New South Wales to produce large quantities of medicinal cannabis oil for commercial use – a move which it says will ultimately mean more affordable access for Australian patients.
ANTG CEO and founder Matt Cantelo hailed it as a victory for the buy-local movement.
“Allowing more Australian cultivation of oil for the commercial market will be a major turn for the local industry, which traditionally has high barriers to entry,” he said.
ANTG’s growing and manufacturing facility, at an undisclosed location on the outskirts of Armidale, is already producing three strains of cannabis flower as well as oil extract for research and clinical trials.
Speaking after the company was granted GACP and GMP-accreditation, Cantelo said: “The difficulty in acquiring commercial licensing has led to a saturation of the Australian medicinal cannabis market from countries such as Canada, where companies are not required to meet the same level of restrictions placed on Australian businesses.”
by Martin Lane, 4 December
Cannatrek has signed a multi-year supply agreement to export dried cannabis flowers to German-based Nimbus Health.
The Australian medicinal cannabis producer will supply an initial 200 kgs to Nimbus, with the potential to increase to larger commercial quantities as distribution channels are established across Germany and other European regions.
The first batch of Cannatrek’s dried flowers is planned for shipment in the first half of 2021 and will be used in a range of medicines to treat pain, anxiety, sleep disorders and depression.
Cannatrek CEO Tommy Huppert said the move represents a significant step in the company’s growth plans and a sign of the growing popularity of Australian product.
“We are thrilled to be supplying such an important German partner, which gives us a toehold in the large European market. Cannatrek’s brand will arrive in Europe early next year.”
“Australia is a great place to grow medicinal cannabis because of its ample, hot sun that produces excellent terpene profiles and quality products.”
by Rhys Cohen, 3 December
In the second of a two-part investigation into the TGA’s handling of medicinal cannabis advertising complaints, Cannabiz editor-at-large Rhys Cohen analyses the body’s own data to explore how effective its procedures are and suggests industry self-regulation may be the best way forward.
by Martin Lane, 3 December
The United Nations Commission on Narcotic Drugs has accepted a World Health Organisation recommendation overnight to remove cannabis and cannabis resin from Schedule IV of the 1961 Single Convention on Narcotic Drugs.
In a move which could have far-reaching implications for the global medicinal cannabis industry, the Vienna-based UN agency voted 27-25 in favour, with one abstention.
Under the UN’s system, Schedule IV substances are considered the most dangerous and addictive drugs. Cannabis will now be classified under Schedule I, which is the least restrictive drug classification.
The schedules balance a drug’s medical application against any harm it might cause.
While the vote does not leave the way clear for member nations to legalise cannabis under the international drug control system, taking cannabis off the strictest schedule – and the tacit acknowledgement of its medical benefits – could lead to the loosening of international controls and boost campaigns to legalise medicinal cannabis around the world.
by Emma Castle, 2 December
New research shows cannabidiol (CBD) is safe for driving and the effects of THC fade in just four hours in a huge boost for drug-driving reform campaigners.
The study, led by the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney and conducted at Maastricht University in the Netherlands, was published today in the Journal of the American Medical Association.
Lead author Dr Thomas Arkell said: “These findings indicate for the first time that CBD, when given without THC, does not affect a subject’s ability to drive. That’s great news for those using or considering treatment using CBD-based products.”
The Academic Director of the Lambert Initiative Professor Iain McGregor said the results prove the current laws in Australia are not fit for purpose: “With rapidly changing attitudes towards medical and non-medical use of cannabis, driving under the influence of cannabis is emerging as an important and somewhat controversial public health issue."
by Martin Lane, 24 November
Former Federal Green Party leader Dr Richard Di Natale has been named as the inaugural chair of the newly established Healthcare Practitioner/Patient Advisory Council. The group will provide independent advice to and engage with the Australian medicinal cannabis industry, medical experts, and patient advocates to raise awareness of the applications of medicinal cannabis.
Di Natale said: “This council will ensure there continues to be a strong focus on facilitating patient access to medicinal cannabis. I look forward to engaging with colleagues from the health, research and patient advocacy sectors to increase awareness of medicinal cannabis to Australians and to shape policy to support education and awareness of medicinal cannabis.”
Australian Medicinal Cannabis Association (AMCA) chair Lucy Haslam said: “We are delighted to see the establishment of the Healthcare Practitioner/Patient Advisory Council with Dr Richard Di Natale as the inaugural chair, along with other respected individuals in this field representing patients, their healthcare practitioners, advocates and researchers.
Dr Di Natale has been a strong supporter of patient access to medicinal cannabis for many years since advocating for legislative change for people like Dan Haslam in 2014, and to see him continue his advocacy beyond his parliamentary career demonstrates just how committed he continues to be.
We see this council as another step in making real progress towards improving awareness and facilitating patient access to safe and affordable medicinal cannabis for Australian patients.”
by Steve Jones, 19 November
The industry has been urged to drive out ‘cowboys’ by informing authorities of illegal advertising and exposing baseless medical claims, particularly those made by celebrities.
The Therapeutic Goods Administration said it was striving to tackle the problem, but admitted it was struggling to win the battle.
TGA boss John Skerritt said the health regulator has received 400 complaints relating to the advertising and supply of medicinal cannabis by “websites and clinics”. “This partly reflects that it’s a new industry and partly because there are some cowboys,” he said.
While advertising of medicinal cannabis products by Australian firms is banned, the TGA does not have jurisdiction over offshore firms marketing locally.
Among the major frustrations are endorsements and claims made by celebrities surrounding CBD.
TGA first assistant secretary of regulatory health, Gillian Mitchell, called on the industry to “drown out” celebrity messaging.
Speaking during this week’s PharmOut Medicinal Cannabis Conference, Mitchell said a newly drawn up list of priorities for advertising compliance again included medicinal cannabis.
by Steve Jones, 17 November
The top official overseeing medicinal cannabis in Australia has vowed to continue to ease the administrative burden on industry after conceding the current demands surrounding permit applications are “excessive”.
John Skerritt, who heads the Therapeutic Goods Administration and Office of Drug Control (ODC), said consultation is underway on a simplified process that will demand far less from applicants.
He also confirmed that a consultation period would start before the end of the year over proposals to require imported products to be GMP compliant.
Skerritt told the PharmOut Medicinal Cannabis Conference that feedback from the industry had suggested the permit process was “overly complex”, a sentiment also shared with Professor John McMillan during his review last year of the Narcotic Drugs Act.
Skerritt appeared to acknowledge that the current process – which requires an inordinate amount of time-consuming, complex and repetitive paperwork – needed reform.
“The excessive caution and high level of prescription of what was required was really a function of the fact that it was a new scheme and lawmakers were very cautious and worried about diversion of medicinal cannabis,” he said.
by Emma Castle, 16 November
FreshLeaf Analytics MD Cassandra Hunt:
Speaking at the PharmOut Medicinal Cannabis Conference, she unpacked Freshleaf’s latest market report and encouraged the audience to pursue ‘differentiation by innovation’.
Hunt said: “The majority of companies focus on offer and product performance, but the ones who get the greatest returns knit together five types of innovation.”
She advised delegates to: 1. Gather some inspirational insights around unmet needs from patients and healthcare professionals; 2. Select your innovation platform; 3. Consider types of innovation that tend to get overlooked; 4. Knit together four types of innovation; and 5. Revisit reasonably often, adding innovation is “not a set and forget exercise”. “Innovation doesn’t have to be a heavy drain on resources,” added Hunt.
Quoting research by innovation consultants Doblin, she said innovation could be broken down into ‘configuration’, including innovation around the profit model, network, structure and business processes; ‘offer’ including distinctive aspects of the product performance and product system; and ‘experience’, including service, channel, brand and engagement.
by Martin Lane,16 November
Federal health minister Greg Hunt has said government reforms have helped the Australian medicinal cannabis sector grow to be worth $1.8 billion, but called on the industry to work with him to deliver further growth domestically and overseas.
Opening the Medicinal Cannabis Conference 2020 this morning, Hunt said legalisation in 2016, an emergency national inventory to support patients and faster regulatory pathways had allowed new products, providers and developers into the Australian market..........
Hunt said ".......the Government’s task now is to help the industry register more products and develop the domestic market.
He told delegates: “I’m open to your ideas. What are the next steps that you need to see from the Australian Government? I may not accept all of them, but I want to hear the ideas.”
by Steve Jones, 12 November
The Australian cannabis sector must put clinical research and product innovation at its core as it enters a new phase of growth and maturity, according to senior business leaders.
But it must also tackle familiar issues that continue to hamper progress and frustrate local producers.
In a wide-ranging discussion at the GCI cannabis summit, industry executives identified different quality standards for local and imported products, and the promotion of cannabis as a “cure-all” medicine, as on-going issues that need addressing.
The need for clinical trials and new product was also imperative, with companies needing to demonstrate their potential to attract funds from increasingly savvy investors.
by Steve Jones, 12 November
The medicinal cannabis industry is still suffering from erroneous claims that CBD and THC hold the key to a multitude of conditions for which there is no evidence, a senior executive has warned.
Cann Group chief operating officer Shane Duncan said the “cure-all” message pushed by some had alienated GPs and was still causing health organisations to dismiss the medicine.
Speaking at the GCI cannabis summit, Duncan also reiterated the need for imported product to be held to the same standards as local medicine, a view shared by Little Green Pharma chief executive Fleta Solomon.
If the disparity in quality requirements continues, Australian manufacturers could be the victims of a price war that risks “bastardising” the local industry, she said.
by Emma Castle, 11 November
United In Compassion is calling for pledges of support for its planned Medicinal Cannabis Symposium to be held on the Sunshine Coast in August 2021.
Symposium organiser and United in Compassion founder Lucy Haslam said: “We are asking our industry partners to pledge support so that planning can begin in earnest. We are aware that if Covid 19 prevails and we experience another wave, a face-to-face symposium could be in jeopardy and would need to be postponed again or evolve into a virtual event.
“This means that pledges are important. There is a necessary long lead-up time to prepare an event of this size. If the symposium eventuates, those pledges will need to be fulfilled. If the symposium is cancelled, those pledges will not result in loss for you or your organisation.”
Haslam added that, as United in Compassion is a registered charity, all pledges are fully tax-deductible.
The symposium will include a full-day conference for nurses, three-day trade exhibition, networking welcome event, two-day general symposium, gala dinner event and an exclusive event for medical practitioners and health professionals hosted by the Society of Cannabis Clinicians Australian Chapter.
To pledge support for the symposium, or for more information, please click the button below.
by Saxon Wyatt, 9 November
" even with the ODC and TGA helping to move the industry in the right direction, the every-state-for-itself attitude is making national reform a little hazy. A case in point was the Greens’ efforts to make medicinal cannabis use a defence against drug-driving convictions being voted down in the NSW parliament.
".....we need to shift the perception of cannabis in this country from dangerous to desirable. Undoing all the fake news from the last century and breaking misconceptions that the ‘evil weed’ is a gateway to harder drugs, pedalled by low-life bikie gangs."
by Emma Castle, 4 November
The Australian Medicinal Cannabis Association (AMCA) and The Society of Cannabis Clinicians of the USA have announced the Australian chapter of The Society of Cannabis Clinicians.
At SCCAC’s inaugural meeting on 3rd November Dr James Connell (pictured) was elected president with Dr Joel Wren named vice president of the association.
The formation of the Society of Cannabis Clinicians Australian Chapter (SCCAC) follows the significant growth in prescribers and prescriptions since medical cannabis was legalised in 2016.
by Steve Jones, 5 November 2020
The Therapeutic Goods Administration approved almost 6,000 medicinal cannabis prescriptions in October, a slight decline from September but still up sharply year-on-year, latest data has shown.
Figures published by the TGA revealed 5,972 prescriptions were approved through the Special Access Scheme, down 4% from the previous month’s record of 6,206.
by Tegan Scates HIgh on Hemp Founder), 4 November 2020
In today’s market, Australians have access to a range of options for acquiring medical cannabis, whether legally or illegally. CBD remains one of the most sought-after medical cannabis products, thanks to its lack of hallucinatory effects and much-touted health benefits.
Since the legal route still contains several roadblocks to access, many Australians are turning to black market online sellers for the procurement of CBD products. Other avenues include personal connections, select health and wellbeing stores, and even multi-level marketing schemes.
by Steve Jones, 5 November 2020
Cannabidiol should remain under the guidance of doctors but exempt from the Special Access Scheme, a leading GP has said, as calls grow for a re-think on the down scheduling of low-dose CBD.
An interim decision to allow low doses to be sold without a prescription as a schedule 3 medicine was made in September, with a final ruling by the Therapeutics Goods Administration expected later this month.
Among the key industry concerns is that the current maximum dose set by the TGA – 60mg per day – is simply too low and will restrict the ability to bring products to market.
by Steve Jones, 15 October 2020
by Emma Castle, 7 October 2020
by Emma Castle, 7 October 2020
by Rhys Cohen, 6 October 2020
by Steve Jones, 6 October 2020
by Emma Castle, 29 September 2020
by Martin Lane, 9 September 2020
by Emma Castle, 8 September 2020
by Emma Castle, 7 September 2020
by Helen Kapalos, 2 September 2020
by Rhys Cohen, 1 September 2020
by Cannabiz Team, 1 September 2020
by Martin Lane, 18 August 2020
by Martin Lane, 17 August 2020
by Josie Tutty, 13 August 2020
by Steve Jones, 12 August 2020
by Josie Tutty, 12 August 2020
Speaking to Cannabiz about the launch, Teresa Nicoletti said AMCA represents the broad interests of the industry: “It’s not just about industry players, companies that have a vested interest in setting up medicinal cannabis businesses and have profitability as the goal,” she said. “We look at it more broadly because to have a viable industry, it involves a number of stakeholders including doctors, patients, nurses and caregivers.”
AMCA chair Lucy Haslam: “We’re all very patient centric, our end goal is to get to a place where Australian patients have the best system, where it’s easy to go to a doctor and get a prescription for medicinal cannabis. You can readily afford it. You don’t have to wait ages for it. We want all of that for Australian patients. And I think that’s what’s united us all in AMCA.