5.1
Throughout the inquiry, the committee received evidence that cost was one of the biggest barriers for patients struggling to access medicinal cannabis.
5.2
For many patients who do manage to overcome the obstacles of seeking approval for an appropriate medicinal cannabis product, the cost of actually accessing that product can be significant. Medicinal Cannabis Industry Australia told the committee:
Every day we see patients crying out for cheaper or subsidised products.
5.3
The significant costs of accessing medicinal cannabis are contributing to some people choosing to access illicit cannabis products to self-medicate for a range of health conditions. Accessing cannabis through the illicit market has legal implications for individuals and raises concerns about quality and safety.
5.4
Another legal quandary, faced by patients accessing medicinal cannabis, is that people are not allowed to drive a car in Australia with any delta-9-tetrahydrocannabinol (THC) present in their body.
5.5
This chapter first examines the issues around the costs of accessing medicinal cannabis and the ways in which they can be mitigated.
5.6
The chapter then explores issues surrounding the use of illicit cannabis for self-medication, before considering the legality of driving while being treated with medicinal cannabis.
The costs of accessing medicinal cannabis
5.7
The costs of accessing medicinal cannabis can be grouped broadly into two categories: the cost of seeing a health professional to get a prescription; and the cost of acquiring the medicine once it is prescribed.
Medical appointments
5.8
Patients frequently described the significant costs they face in seeing health professionals in order to access a prescription for medicinal cannabis.
5.9
For example, one patient told the committee:
It cost me $200 for my initial appointment, $59 for any subsequent scripts, $80 follow up appt, $59 whenever I have to adjust dose or product, which I was able to afford by making a debt with centrelink [sic] …
5.10
Due to the unwillingness or refusal of their usual general practitioner (GP) to prescribe medicinal cannabis, many patients resort to visiting specialised 'cannabis clinics' to receive a prescription, which comes at a substantial cost.
5.11
The Medical Cannabis Users Association of Australia described that:
These clinics are charging fees to put in an application to the TGA that attracts no fee. They are charging "Specialist" consultation rates and monitoring fees for which patients can rarely get a Medicare or Health Fund rebate.
5.12
A patient submitted their experience with one of these clinics:
Firstly because I can't sit in a car for very long due to severe pain, I could not visit the closest clinic … So a Telehealth appointment was made only to discover there's no Medicare rebate for a Telehealth consultations (whereas a visit to actual clinic does attract a Medicare rebate). This first consult will cost $199 which is out of reach for anyone on any form of welfare payment.
5.13
The submission from Australian Pain Management Association also shared the experience of a number of patients using cannabis clinics, with patients describing costs of $300 to $500 for initial appointments with a health professional, often through telehealth set-ups.
5.14
Some submitters also referred to an additional 'prescribing charge' from one cannabis clinic for each repeat prescription.
5.15
The Society for Hospital Pharmacists described the costs charged by these clinics as 'unreasonable', noting that its members had reported that some clinics 'charge exorbitant amounts for what would typically be considered regular healthcare'.
Appointment subsidies through Medicare
5.16
Some submitters have proposed introducing a new Medicare Benefits Scheme (MBS) code for health professionals to use for the extended consultation time required for prescribing medicinal cannabis, noting that this would reduce costs for patients. Canopy Growth submitted:
The existing online TGA portal … takes a long time to complete, and cannot be completed in one-standard [sic] consultation. A new MBS code, recognising the longer consultation required for patient work-ups and application, would address this barrier to prescribing medicinal cannabis. In addition, patients will also benefit from a higher medicare reimbursement for their appointment and ultimately reduce their out-of pocket expense for seeking healthcare professional assistance.
5.17
Mills Oakley and CA Clinics also proposed that a 'medicinal cannabis service' code could be introduced, which would include 'consultation with a medical practitioner and the supply of a medicinal cannabis product'.
5.18
The committee notes that the General Practice and Primary Care Clinical Committee of the MBS Review Taskforce raised general concerns about the need for an MBS item code for extended GP consultations in 2018. That committee recommended the introduction of a new 'Level E' item code for GP consultations of 60 minutes or more. It is anticipated that the MBS Review Taskforce will make its recommendations to the Australian Government in relation to primary care item codes in mid-2020.
Filling a prescription
5.19
Submitters described that the expense of medicinal cannabis products is the key barrier to access for many patients.
5.20
FreshLeaf Analytics have reported that patients are paying an average of $5 to $15 per day for medicinal cannabis in Australia, but that paediatric epilepsy patients pay on average more than $50 per day.
5.21
Mrs Ireland from Epilepsy Action Australia told the committee that their clients reported that:
… when they do go through their general practitioner, neurologist or epileptologist, there are predicted costs of up to $1,300 per month. That is what one person quoted. Another person quoted that one CBD bottle per week currently costs $370. They're the kinds of costs that we're facing for epilepsy.
5.22
Ms Lyn Cleaver told the committee that the annual cost quoted by her son's neurologist for a prescribed medicinal cannabis product was between $60 000 and $100 000.
5.23
The TGA acknowledged that prices for medicinal cannabis can 'vary tremendously' depending on the product and the dosage required:
Some of the low-dose THC products are as little as $5 to $6 a day. That's still a lot if you're on a pension, but if you're in a good job, like all of us here, that's affordable. The challenge is for the children, especially the larger children, who are on the cannabidiol medicines for epilepsy, because the amount of cannabidiol used for each child—the actual quantity, the size of pill—is quite large.
Delivery and storage costs
5.24
Part of the cost of filling a prescription for medicinal cannabis is the cost incurred by pharmacies in supplying the product, such as specialist delivery fees and storage costs.
5.25
Some submitters also noted that the cost of medicinal cannabis appears to be high due to the reliance on overseas products, as discussed in Chapter 4, which contributes to additional importation and delivery fees.
5.26
The Pharmaceutical Society of Australia explained that:
At the higher end, the delivery fee may represent over 30% of the total cost of the order while some wholesalers may not charge a delivery fee if a large quantity of products is requested through a single order. Other wholesalers charge a Dangerous Drug (DD) handling fee to offset some of the costs associated with the special storage, delivery and inventory recording requirements of these products.
5.27
Multiple Sclerosis Australia shared the experience of a patient where delivery costs accounted for nearly half the cost of their script:
… I first tried my local pharmacy … who charged me $220 for a 25 ml bottle of the medicinal cannabis product. He told me that about $100 of this was for a special security courier.
5.28
The Australasian College of Nutritional and Environmental Medicine (ACNEM) noted that changes to the scheduling of cannabidiol (CBD), as discussed in Chapter 4 of this report, could remove some of the more stringent security and delivery requirements and their resultant costs for pharmacists.
No products available on the PBS
5.29
One of the biggest frustrations expressed by patients is that the medicinal cannabis products they are being prescribed through the TGA's access pathways are not available for subsidy under the Pharmaceutical Benefits Scheme (PBS).
5.30
ACNEM submitted that:
Subsidisation of [medicinal cannabis] products under the Pharmaceutical Benefits Scheme (PBS) would have tremendous benefits for the Australian public, helping make [medicinal cannabis] more affordable.
5.31
The Department of Health (Department) explained that the Australian Government is unable to include a medicine in the PBS without a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent, expert advisory body:
When considering a medicine proposed for PBS listing, the PBAC is required by that legislation to give consideration to the effectiveness and cost of the medicine, including by comparing the effectiveness and cost with that of alternative treatments.
5.32
For a product to be considered for inclusion on the PBS, it must also first be listed in the Australian Register of Therapeutic Goods (ARTG). Submitters noted that the lack of medicinal cannabis in the ARTG is one of the biggest barriers to seeing medicinal cannabis included in the PBS.
5.33
As discussed in Chapter 4, nabiximols (brand name Sativex) is the only medicinal cannabis product currently listed in the ARTG. Some submitters noted that the sponsors of Sativex had made an application for it to be considered by the PBAC in March 2020, following a failed application for inclusion in 2013. This application has been supported by patients with multiple sclerosis and their support groups.
5.34
The Pharmacy Guild of Australia and other submitters support the PBS as the most appropriate way to subsidise access to pharmaceuticals, including medicinal cannabis, in Australia.
Alternative subsidies to the PBS
5.35
Submitters noted that as most medicinal cannabis is currently unsuitable for inclusion in the PBS, alternative models of subsidy should be considered to assist patients in affording their prescriptions.
5.36
Despite these calls for medicine subsidies, the committee received only a small number of specific suggestions of what such a subsidy model could look like. For example, Epilepsy Action Australia suggested that:
A temporary subsidy [be] made available to people with epilepsy who are prescribed pharmaceutical grade cannabinoid-based medicines, until these medicines are listed on the ARTG and the PBS.
5.37
Medical Cannabis Research Australia also proposed the introduction of a broader federal or state government compassionate subsidy scheme where a patient is qualified for subsidy through an (unspecified) eligible condition and means testing.
5.38
However, Professors Wayne Hall and Michael Farrell submitted that introducing blanket government subsidies for medicinal cannabis for all patients would be problematic for several reasons, including that providing a public subsidy 'in the absence of evidence of cost-effectiveness would create a publicly-funded special access scheme for unevaluated drugs'. They argued that this approach:
… would create a precedent that may be used by advocates for the use of other unevaluated drugs to demand a similar subsidy from state and Federal governments solely because some patients claimed to benefit from using them. Producers could … demand a public subsidy for the medical use of the drug in the absence of evidence of safety, effectiveness and cost-effectiveness.
5.39
The Pharmacy Guild of Australia also submitted that it would be 'unnecessary and wasteful' to develop a parallel subsidy scheme to the PBS for medicinal cannabis, which would require:
… all the attendant bureaucracy and additional costs of evaluation, listing and claiming processes etc for medicinal cannabis products.
Private health insurance
5.40
A small number of submitters also recommended that the cost of medicinal cannabis products could be subsidised through private health insurance, as with other non-PBS medicines.
5.41
Little Green Pharma noted that private health fund subsidy is currently used to assist access to medicinal cannabis in Germany.
5.42
The committee understands that refunds for prescription medicines through most private health insurance in Australia can only be for non-PBS medicines which have been approved and registered in the ARTG.
Current subsidies for medicinal cannabis
5.43
The committee also received evidence about a number of existing subsidies available for certain patients receiving medicinal cannabis in Australia.
Compassionate access schemes
5.44
Under a compassionate access scheme, a sponsor – such as a drug company or a government body – pays for the full or partial cost of the prescribed medicinal cannabis product for the patient.
5.45
There are currently several state government-sponsored compassionate schemes currently available in Australia, summarised in Table 5.1 below.
Table 5.1: Compassionate access schemes for medicinal cannabis in Australian states
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New South Wales
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Compassionate Access Scheme for cannabidiol medicines (i.e. Epidiolex) for children with severe epilepsy, available through all paediatric neurologists in the state.
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Other compassionate access through Specialty Health Networks and Local Health Districts, where a clinician makes an application to access and fund a medicine through a Drugs and Therapeutics Committee.
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Queensland
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Compassionate Access Scheme for cannabidiol (Epidiolex) for children with severe epilepsy through clinical trials ceased in August 2019, but the Queensland government has indicated it will continue to subsidise the drug for scheme participants.
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Tasmania
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Controlled Access Scheme fully funds small number of patients approved by Tasmanian Department of Health, following application by a specialist. No other access to medicinal cannabis permitted in the state.
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Victoria
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Compassionate Access Scheme provides access to medicinal cannabis products for children suffering from severe intractable epilepsy, facilitated through hospitals participating in the scheme.
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Western Australia
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Compassionate Access Scheme for children with intractable, resistant epilepsy through the paediatric neurology service at Perth Children’s Hospital.
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5.46
Tilray, a medicinal cannabis provider, submitted that it has a compassionate access scheme in place for patients, and is the provider of products for some state government schemes.
5.47
It is not clear how many other drug companies currently offer compassionate access to their products in Australia. Evidence from one patient suggests that GD Pharma may be offering compassionate access, while another patient described that their requests for compassionate access from MedReleaf had gone unanswered.
5.48
The Medical Cannabis Users Association of Australia submitted that, in their experience, 90 per cent of patients were unaware of the availability of compassionate access from a drug company sponsor.
Department of Veterans Affairs
5.49
The Department of Veterans Affairs (DVA) also currently subsidises medicinal cannabis for patients in certain circumstances.
5.50
DVA is able to fund access to medicines, including unapproved medicines like medicinal cannabis, through the Repatriation Pharmaceutical Benefits Scheme (RPBS), which does not have the same rules as the PBS for listing medicines. Any medicine supplied through the RPBS is done so at the concessional co-payment rate, $6.60 per script in 2020.
5.51
For a veteran eligible for DVA medical treatment to receive medicinal cannabis under the RPBS, the following is considered:
the clinical need for the quantity of medicinal cannabis prescribed;
whether first-line treatments have been tried and failed;
whether the medicinal cannabis product is on the ARTG, or has been approved through TGA access pathways for unapproved medicines; and
a written assessment from a treating specialist that medicinal cannabis would benefit the patient.
5.52
While one submitter noted success in accessing medicinal cannabis through DVA as a treatment for post-traumatic stress disorder, others told the committee that they had not yet been successful in gaining subsidies.
5.53
United in Compassion submitted that, for many veterans:
The struggle to obtain Department of Veteran’s Affairs (DVA) funding of cannabinoid medications and device costs has also been arduous and inconsistent. This inconsistency puts further pressure on vulnerable people and exacerbates mental health trauma.
The 'green market' – illicit cannabis for medicinal purposes
5.54
The committee heard that many patients are choosing not to access medicinal cannabis legally due to the significant costs and the complexity of the legal access system, instead opting to self-medicate with illicit cannabis.
5.55
The National Institute of Complementary Medicine Health Research Institute submitted that:
If patients are not able to access affordable, quality-assured medicinal cannabis products that can be prescribed and monitored by their medical professional, then they will likely resort to the illicit market.
5.56
It is estimated that the number of people in Australia self-medicating with cannabis is around 100 000, although some submitters believe this number could be much higher.
5.57
A survey conducted by the Lambert Initiative for Cannabinoid Therapeutics (Lambert Initiative) at the University of Sydney found that only 25 out of the 931 respondents, less than 3 per cent, were accessing legal medicinal cannabis through the TGA schemes.
5.58
The illicit market of cannabis for self-medication was variously referred to as the 'black', 'grey' or 'green' market by submitters, and appears to encompass illicit products ranging from home-grown cannabis plants and home-made cannabis extracts and products to commercially-produced medicinal cannabis products that had been either imported illegally or diverted from the legal market in Australia.
5.59
Some patients told the committee that they felt the risks of accessing cannabis illegally had been outweighed by the benefits they had found in self-medication.
5.60
A patient who had been unable to find a doctor willing to prescribe medicinal cannabis for his pain submitted that he has been accessing cannabis through the black market:
… because it's way easier, and as I'm unable to choose from a selection of quality products like Cannabis patients are allowed in other jurisdictions, just buying whatever is available from the guy down the road is really the same as our "legal approved unapproved approved system". And as a sick person I really don't get out much anyway, so the blackmarket [sic] delivering is very handy.
Cost of illicit cannabis
5.61
Submitters also described that illicit cannabis products accessed through these markets were much more affordable than legally prescribed medicinal cannabis, but in some cases these prices are still higher than for subsidised pharmaceutical medicines on the PBS.
5.62
One patient described their experience of the cost of illicit cannabis:
It is highly expensive on the black market and from what I have seen, even more expensive on the SAS. … on the black market cannabis is about $20 per gram. Under the SAS the gram price I have heard is about $40 per gram. It is absurd and not affordable for poorer people.
5.63
Some submitters told the committee that they were not comfortable with accessing illicit products and were concerned about the risks of prosecution, but felt that they had no other choice.
5.64
One patient, a 60-year-old receiving a disability support pension, submitted:
The only options left for me are to grow cannabis plants and make the cannabis oil myself, or acquire a black market supply, and whilst both are far and away cheaper options, I am loathe to do so because of the criminal implications.
5.65
Another patient who had been prescribed legal medicinal cannabis, but could not afford to pay for his prescription, submitted:
Because I use black market supplies of cannabis I feel under constant threat of persecution from authorities and I worry that my supplier will be arrested and not be able to supply my needs which causes me great stress. I would like to not have to worry about these issues but the cost of legal medicinal Cannabis and the current pathways to access are huge barriers to me.
5.66
To combat cost as a barrier to access, some suppliers in the 'green market' offer compassionate access schemes for their products, offering illicit cannabis products at low or no costs to patients.
5.67
One submitter told the committee about the online illicit dispensary collective they had established to provide cannabis to around 350 people at low or no cost 'depending on how severe the medical condition was':
We did this because people were unable to get access to legal products due to the rigid regulations that have been put in place by the govt. The very few that were able to gain access to a legal product rated it both sub par compared to our "black market goods" and they said that the legal market was 2.5 - 5 times more expensive than our setup. Many were unable to continue treatment because of cost for products.
Quality of illicit cannabis
5.68
There are serious concerns about the quality of black market cannabis products which people are accessing for self-medication.
5.69
The Australasian College of Nutritional and Environmental Medicine told the committee that:
The danger associated with unregulated products is that they could contain contaminants such as heavy metals and pesticides, and that they may not contain the amount of active constituents they purport to.
5.70
United in Compassion cited a study by the Lambert Initiative which considered the black market products being accessed by parents of children with epilepsy:
It looked at cannabis that was being supplied to children with epilepsy through the black market. Parents thought they were giving their children high CBD. A lot of those products had high THC in them. It's important that people know what they're giving their loved ones.
5.71
Some submitters described the dangers of variability in the quality of illicit cannabis products, with Mills Oakley sharing the experience of one patient experiencing a 'horrific tonic clonic seizure' due to a 'suspect batch' of an illicit cannabis product.
5.72
One patient described that they believed it was safest to grow their own supply in light of concerns about the quality of black market products:
My best solution is to grow my own medicinal cannabis so that I can grow it organically and know exactly what I’m getting. I don’t want to go looking for black market products since I have no idea on the ratios of cannabinoids in them or whether they are contaminated with chemicals or come from generally poor growing conditions.
Criminal implications
5.73
People choosing to access illicit cannabis for self-medication, or who provide cannabis to patients, may be subject to criminal charges for possession or cultivation of a controlled substance, which carries varying penalties between states and territories.
5.74
In recent high profile cases, individuals have been prosecuted for the 'green market' supply of cannabis on a compassionate basis to others, or for their own use of illicit cannabis. Many of these cases have resulted in good behaviour bonds and no convictions being recorded.
5.75
Associate Professor Kate Seear and Springvale Monash Legal Service found:
Criminal justice responses to these developments have been inconsistent across Australia. These inconsistencies do not merely reflect differences between individual defendants and their circumstances (e.g. whether they have prior convictions) but fundamental differences in criminal law across the states and territories.
5.76
The Lambert Initiative and other submitters recommended to the committee that there should be an amnesty in all states and territories for individuals who are 'genuinely using illicit cannabis for medical reasons'.
5.77
The committee notes that New South Wales has introduced such an amnesty for people with terminal illness in that state. The Medicinal Cannabis Compassionate Use Scheme provides guidelines for police about using discretion to not charge adults certified by their doctor as having a terminal illness, or their carers, with possession of cannabis not lawfully prescribed.
5.78
Some submitters have also proposed that broader decriminalised personal cannabis cultivation and use, such as recently introduced in the Australian Capital Territory, could alleviate some of the legal barriers to self-medication.
Driving laws and medicinal cannabis
5.79
Currently, in all states and territories in Australia, it is an offence to drive while having detectable levels of THC in the body.
5.80
Many submitters raised concerns about the interactions between medicinal cannabis and driving laws, including:
drug tests which check for the presence of THC do not necessarily reflect the level of impairment that a driver may be experiencing, particularly as some tests can show positive results a month after exposure to cannabis;
patients who have a legal prescription for medicinal cannabis may still be subject to automatic loss of licence, large fines and/or jail time if they drive while taking that treatment and test positive to THC;
other prescription medicines, such as opioids and benzodiazepines, can cause significant impairment for drivers, but that these are not tested in current drug driving tests; and
patients in rural and remote locations are particularly disadvantaged by driving laws, as they are more likely to rely on their car for transport.
5.81
Submitters noted that these concerns are deterring patients from using medicinal cannabis products containing THC, as they do not want to face prosecution or be prevented from driving. For example, Dr Nicoletti told the committee:
Patients who have a prescription may not want to fill it, because they have a job in which they have to drive every day and they would be at risk of prosecution for doing something which they took steps to do lawfully.
5.82
The National Institute of Complementary Medicine Health Research Institute submitted that patients who are prescribed opiates or benzodiazepines are not subject to the same restrictions and are instead 'essentially being told by their medical practitioner to not drive if they feel intoxicated'.
5.83
Submitters noted the findings of the Lambert Initiative on the accuracy and validity of current mobile drug testing technologies, which established two commonly used tests to be inaccurate, giving either false positives or false negatives, in around 20 per cent of cases.
5.84
The Lambert Initiative has also completed a study into the effects of THC and CBD on driving impairment and is currently conducting research into the impact of CBD alone.
5.85
Professor Iain McGregor, Academic Director of the Lambert Initiative, told the committee that:
Cannabis and driving is actually a very complicated area. The tendency is to look at it through the prism of alcohol, but there are actually almost diametrically opposite effects for cannabis relative to alcohol. With alcohol, people overestimate their ability and tend to take risks as a result. With cannabis, people actually feel impaired. … When they do drive, there are quite reliable effects like a lower speed and a bigger distance between them and the car in front. Then, when you look at the crash risk associated with cannabis, it's moderately increased but it's a very, very small statistical effect compared to alcohol and even compared to some prescription medications that are commonly prescribed like benzodiazepines and sedating antidepressants like mirtazapine.
5.86
Professor McGregor further explained that the level of impairment faced by a patient taking medicinal cannabis does not directly correlate with the level of THC in their system:
If you give someone cannabis for the first time, they'll be very impaired for a couple of hours after consumption, but, if someone is a patient and they have used cannabis for two years, chronically every day, you will really struggle to find any sort of impairment whatsoever. So we need more research and we need more enlightened information for patients rather than just saying: 'Don't drive.'
5.87
Some submitters noted that other jurisdictions have more relaxed laws around THC and driving than in Australia:
in Canada it is only an offence to drive while impaired or intoxicated – there is no guidance about how much cannabis can be consumed before it is unsafe to drive or how long a driver should wait to drive after consuming cannabis; and
the United Kingdom still takes a 'zero-tolerance' approach to THC, but currently allows a reading of 2µg/L of THC in blood testing, 'a level where any claims of accidental exposure can be ruled out'.
5.88
The Lambert Initiative and other submitters proposed that patients in Australia who are legally prescribed medicinal cannabis should be exempted from prosecution for driving with THC in their system, unless there is clear evidence of impairment.
Committee view
5.89
The committee recognises that, for many patients, the struggle to access medicinal cannabis to date has been frustrating, costly and difficult.
5.90
For many patients, the costs of seeing a health practitioner to receive a prescription are significant. The committee is aware that the time taken by doctors to conduct an appointment for medicinal cannabis, particularly to complete the paperwork for the legal access pathways, is contributing to these costs.
5.91
The committee notes that broader concerns about the need for a Medicare Benefits Scheme item for long consultations for general practitioners has been raised by the General Practice and Primary Care Clinical Committee of the Medicare Benefits Scheme Review Taskforce in its recommendations.
5.92
The committee recommends that the Medicare Benefits Scheme Review Taskforce accept the General Practice and Primary Care Clinical Committee's recommendation to introduce a 'Level E' consultation item for general practice consultations of 60 minutes or longer, and includes this item in recommendations to the Australian Government relating to changes to Medicare Benefits Scheme items for primary care.
5.93
The committee also recognises the significant cost barrier faced by patients in paying for the medicinal cannabis products they have been prescribed.
5.94
While the introduction of more Australian-made products into the market may decrease some of the costs of importation and delivery, the committee shares the view of many submitters that the best way to ensure that medicinal cannabis products are affordable and accessible for patients is to include them in the Pharmaceutical Benefits Scheme. Before any medicine can be included in the Pharmaceutical Benefits Scheme, it must first be registered in the Australian Register of Therapeutic Goods and then be considered by Pharmaceutical Benefits Advisory Committee for its efficacy and cost in comparison with other treatments.
5.95
With Sativex (nabiximols) under consideration by the Pharmaceutical Benefits Advisory Committee this month, and Epidiolex (cannabidiol) expected to apply for Australian Register of Therapeutic Goods registration soon, the committee can see that the medicinal cannabis industry is slowly bringing products to market with the level of clinical evidence required for registration and future inclusion in the Pharmaceutical Benefits Scheme.
5.96
However, inclusion in the Pharmaceutical Benefits Scheme for these cannabis products may still take many years, so the committee recognises there will continue to be a need for compassionate access schemes for patients whose needs are not being addressed by registered and subsidised products.
5.97
The possible down-scheduling of low-dose cannabidiol to an over-the-counter medicine, as proposed in Chapter 4, may also alleviate some of the financial pressures faced by patients.
5.98
The committee hopes that the growth of the domestic medicinal cannabis industry, along with upcoming changes to the regulation of that industry, will ensure that more products are available quickly and at an affordable price for patients, and that the industry will be able to conduct the vital clinical research needed to seek regulatory approval for their products.
5.99
The committee notes that there is a key role for the medicinal cannabis industry to assist in compassionate supply of their products, but that evidence received suggests that patients' experiences in seeking this kind of compassionate access can vary between companies.
5.100
The committee recommends that medicinal cannabis industry peak bodies, such as Medicinal Cannabis Industry Australia and the Medical Cannabis Council, work with their members to implement compassionate pricing models for patients facing significant financial hardship in accessing medicinal cannabis products to treat their health conditions.
5.101
Several states also have compassionate access schemes in place to address the high costs of medicinal cannabis faced by patients, particularly paediatric patients with severe refractory epilepsies.
5.102
Unfortunately, such schemes are not available nationally and this is contributing to the 'postcode lottery' faced by patients in being able to access medicinal cannabis treatment and, in most states, these schemes are also limited to only certain patient groups with certain conditions.
5.103
The committee recommends that, until medicinal cannabis products are subsidised though the Pharmaceutical Benefits Scheme, the Australian Government:
investigate the establishment of a Commonwealth Compassionate Access Subsidy Scheme for medicinal cannabis, in consultation with industry and based on the best available evidence of efficacy for certain conditions; and
encourage all states and territories, through the COAG Health Council, to expand the provision of their own Compassionate Access Schemes to patients requiring treatment with medicinal cannabis.
5.104
It is clear that the significant costs associated with accessing medicinal cannabis legally are causing a large number of Australians to purchase or grow illicit cannabis for self-medication.
5.105
The committee is concerned that people accessing the 'black', 'grey' or 'green' market are exposed to risks of self-medicating with unsafe products that may not contain what they say they do, and are opening themselves to significant legal risks in cultivating and possessing illicit cannabis.
5.106
The committee is also concerned about the legal implications faced by people who use medicinal cannabis products and drive. These people may be subject to serious legal penalties for the presence of THC in their system, even if there is no evidence of impairment at the time of driving.
5.107
The committee recommends that the Australian Government, through COAG, encourage a review of state and territory criminal legislation in relation to:
amnesties for the possession and/or cultivation of cannabis for genuine self-medication purposes; and
current drug driving laws and their implications for patients with legal medicinal cannabis prescriptions.
Senator Rachel Siewert
Chair