On 14 November 2019, the Senate referred an inquiry into the current barriers to patient access to medicinal cannabis in Australia to the Senate Community Affairs References Committee for inquiry and report by 26 February 2020. Submissions are requested by 17 January 2020.
This submission outlines the response of NICM HRI to the Terms of Reference listed for this Senate Inquiry.
NICM HRl's position can be summarised as follows:
» If sufficient evidence exists that links compositional definition with safety, clinical effectiveness and cost effectiveness, then the Pharmaceutical Benefits Scheme (PBS) should be available and assist patient access to medicinal cannabis.
» Cannabis is a complex matrix of multiple phytochemical active constituents, and provision within the PBS would need to accommodate this complexity.
» Australia appears to have one of the more restrictive regulatory models in comparison to those established in other parts of the world. This includes both patient access and the licencing requirements for cultivators, manufacturers and researchers of legal medicinal cannabis.
» The high cost of legal medicinal cannabis products in Australia should be considered a significant barrier to access, causing legitimate patients to seek illicit cannabis for therapeutic use.
» Current drug driving laws as they relate to cannabis across Australia should be considered a significant barrier to legitimate patient access in their current format and are in need of review.
•ERA is a national evaluation of research quality in Australian universities conducted by the Australian Government It is administered by the Australian Research Council (ARC). ERAS is the highest rating, characterised by evidence of outst anding performance well above w orld st andard presented by the su ite of indicators used for evaluati on.
3 TERMS OF REFERENCE
12 a. the appropriateness of the current and associated symptoms. · Unpublished regulatory regime through the Therapeutic research from focus groups with women with Goods Administration (TGA) Special Access endometriosis has also identified that cost is a Scheme (SAS), Authorised Prescriber major limiting factor, potentially driving many Scheme and clinical trials to use ill icit products over legal ones. Access to unregulated illicit markets to obtain medicinal The appropriateness of any medicinal cannabis cannabis ra ises obvious public health concerns regulatory model should be evaluated based due to potential exposure to adulterated and on the ease of use by clinicians, and the speed non-quality assured product of unknown of access to a safe, quality-assured product provenance, removing patients from medical provided to t he end user at an affordable price. supervision and closing channels of effective Adequate resources and content expertise at the communication regarding possible risks and side federal and state/ territory government levels are effects. essential to ensure this is achievable. c. the interaction between state and territory b. the suitability of the Pharmaceut ical authorities and the Commonwealth, Benefits Scheme (PBS) for subsidising including overlap and variation between patient access to medicinal cannabis state and territory schemes products The Commonwealth has worked with state If sufficient evidence exists that links and territory governments to streamline and compositional definition with safety, clinical improve the speed of medicinal cannabis effectiveness ana cost-effectiveness then the access since first inception. The TGA has PBS should be available and assist patient consistently fast approval t imes, usually w ithin access to medicinal cannabis. Cannabis is a 48 hours, according to our researchers' ongoing complex matrix of multiple phytochemical active discussions with practising medical cannabis constituents and provision will also need to prescribers across NSW and Victoria. Where be·made within the PBS to accommodate this inconsistency seems to occur is: complexity. (1) the speed with which the various states To date the majority of medicinal cannabis and territories approve access after federal products being prescribed in Australi a are approval, accessed primarily through the SAS Category (2) if specialist medical support is required with B pathway, which is intended for exceptional medicinal cannabis applications, and clinical circumstances and contains products predominantly classified as unapproved (3) the amount of approvals that have been medicines. The majority of the medicinal granted across the states and territories. cannabis products currently accessible to Australian patients are imported and expensive, There exists a lack of regulatory harmonisation due chiefl y to the nascence of the current and consistency across the states and territories Australian medicinal cannabis industry to be currently in Australia. This may be contributing cost-competitive. To date only two Australian to the phenomenon witnessed in the early years companies have brought a product to market of medicinal cannabis implementation in the 3 since the amendments to the Narcotic Drugs USA A of "cannabis refugees", whereby patients Amendment Bill 2076, despite numerous and/ or their fami li es temporarily relocate to companies having been issued ODC licensure regions that are m ore accommodating to since this time. medicina l cannabis access, w hether in Australia or abroad. A harmonised and consistent access If patients are not able to access affordable, pathway involv ing all key stakeholders should be quality-assured medicinal cannabis products 1 A rmour M, Si nclair J. Chalmers KJ. Smith CA Self-management strategies that can be prescribed and monitored by amongst Australian women with endometriosis: a national onl ine su rvey. BMC Complement Altern Med. 2019 Jan 15;19(1):1 7. their medical professional, then t hey w ill likely 2 Sinclair J, Smith CA. Abbott J. Chalmers KJ. Pate OW, Armour M. Can- resort to the illicit market. As an example, nabis Use. a Self-Management Strategy Among Australian Women W ith Endometriosis: Results From a National Online Survey. J Obstet Gynaecol Can. recent research published by NICM HRI has 2019 Nov 7. 3 Phillips D. Marijuana refugees: Families relocating to Colorado so kids can use demonstrated that women with endometriosis cannabis oil to fight seizu res, legal la ndscape changing in other states. Missou li an. are using illicit cannabis to manage their pain 2014. p. https//m1ssoulian.com/l1festyles/health-med-fit/mar11uana-refugees families-relocating-to-colorado-so-k1ds-can-use/article_Oe0670aa-dabb-lle3- 8c2d-019bb2963f4.html. 4 Marijuana Refugees: Looking for new homes 1n pot-legal states. NBC News; 2014. p . https://www.nbcnews.com/business/consumer/marijuana-refugees-look- 1ng -new -homes-pot-legal-states-n2278l. 4 priori t ised to increase the li kelihood of patients NICM HRI was part of a co ll aboration w hi ch seeking legitimate access. delivered t he first category 1 Roya l Australi an College of General Practitioners (RACGP) d. Australia's regulatory regime in comparison accredited medicinal cannabis education course to international best practice models for in Australi a. The curricu lum included an overview medicinal cannabis regulation and patient of the anatomy, physiology and dysfunction of access the ECS.
Australia appears to have one of the more The TGA has developed guidance documents on restrictive regulatory models in comparison to the use of medicinal cannabis in condit ions such those establi shed in other parts of the world as paediatric epil epsy, multiple sclerosis, nausea such as Canada, Israel, the Netherl ands and and vomit ing, pa lliative ca re and chroni c non _certain states within the USA. This includes cancer pain, but other conditions including post both patient access and the licencing required traumatic stress disorder (PTSD), fibromyalgia, for companies to cultivate, research and anxiety, ulcerative coli tis, autism and insomnia5 manufacture medicinal cannabis products. are also being prescribed and approved, which is Excessively onerous restrictions on patient encouraging. access may inadvertently encourage prospective patients to use illicit market products. g. sources of information for doctors about uses of medicinal cannabis and how these e. the availability of training for doctors in might be improved and widened the current TGA regulatory regime for prescribing medicinal cannabis to their There is a relative paucity of balanced, good patients quality and independent information available to medical practitioners currently on the c li nica l There is a large amount of text (online and uses and prescribing of medicinal cannabis printed) on how medical practitioners ca n utili se in Australi a. Medicinal cannabis companies the SAS Category B and Authorised Prescriber commonly provide such information to doctors, Schemes for medicinal cannabis applications however, this is not necessaril y independently on the TGA website, including various state assessed. Recommendations on improving and territory contact details . This takes an this area could include the TGA publishing extensive amount of time to read through and guidance documents of a clinicall y useful nature may not su it t he t ime poor nature of busy on some of t he emerging conditions being medical cl inicians, w ith many simply too busy to prescribed for by Australian doctors, such as engage in the process and/or referring patients fibromyalgia, anxiety and PTSD. Further, the to speciality cannabis c li nics. Short courses preparation of generali sed guidance documents on medicinal cannabis prescribing can train of an educational nature specific to medicinal c li nicians on the various approval processes, cannabis prescribing and the ECS, such as but these are inconsistently available and have is observed in the Green Book of t he Israeli limited places on offer. These training programs Ministry of Health, would be an excell ent could be further supported An online portal resource for Australian medical doctors util ising v ideos and infographics to outline the prescrib ing process may be a useful tool h. delays in access, and the practice of to increase t he education of doctors in this product substitution, due to importation emerging field . of medicinal cannabis and the shortage of Australian manufactured medicinal f. the education of doctors in the Endogenous cannabis products Cannabinoid System (ECS), and the appropriateness of medicinal cannabis As addressed above. treatments for various indications i. the current status of the domestic regulated In October 2019 a medicinal cannabis education medicinal cannabis industry event w ith over 130 medical practitioners and nurses in attendance was hosted at Prince As addressed above. Charles Hospital in Bri sbane. Notably, none of the attendees had studied the ECS in their undergraduate or postgraduate training 5 Request for documents relating to Special Access Scheme Category 8 pathway programs. for medicinal cannabis products for the period 1/11/2016 to 31/08/2019 - FOi 1311 . Therapeutic Goods Adminis tration; 2019. 5 TERMS OF REFERENCE CONTINUED
j. the impacts on the mental and physical such as paediatric epilepsy, with costs estimated wellbeing of those patients struggling to be approximately $992 per month on to access medicinal cannabis through average.6 Medical cannabis patients are at ri sk Australia's regulatory regime of taking less than the prescribed amount (i.e. underdosing) to make the medicin e last longer The challenges that patients may face due to the high cost and lack of government attempting to access legal medicinal cannabis subsidy and anecdotal reports confirm this. under Australia's current regulatory regime include: Medicinal cannabis products are dispensed by pharmacists in Australia, which is also (1) finding a medica l prescriber wi ll ing and contributing to high costs to patients. A 2018 experienced to assist, report by Cannabis Access Clinics purports that pharmacy mark-up of medicinal cannabis (2) the time it takes to actuall y receive approved products ranges between the average of 26% medicine, to up to 140%.6 According to advocates, the (3) ensuring a continuing ongoing and cost structures implemented by some medicinal unchanging supply of product, cannabis specific clinics may also contribute (4) being able to afford the ongoing costs of the to the cost burden to patients.8 Chronically ill medicine, along with patients, particularly if on pensions or disability (5) possible social , religious or cultural support, may find the financial burden of legal discrimination due to the stigma associated medicinal cannabis too great, risking a diversion with consuming cannabis. to illicit market products.
m. the number of Australian patients All of these factors can potentially negatively continuing to rely on unregulated supply of impact the physical and mental wellbeing of medicinal cannabis due to access barriers patients, and compound patient suffering. and the impacts associated with that
k. the particular barriers for those in rural Estimates of how many Australian patients that and remote areas in accessing medicinal are currently utilising unregulated il licit supply cannabis legally of cannabis for therapeutic purposes va ries, but ranges between 100,000 to 200,000 people.9 Problems described above are exacerbated Cannabis is the most w idely used ill icit drug in in remote and rural areas due to shortage of Australia,10 w ith data suggesting Australia and trained c li nicians. New Zealand are some of t he largest consumers of illicit cannabis in the world per capita with I. the significant financial barriers to significant proportions likely to be using accessing medicinal cannabis treatment cannabis for therapeutic benefit and not solely recreational use.11 Based on feedback from current legal patients of medicinal cannabis for chronic pain conditions, Drivers that may be contributing to the demand monthly expenditure can range from between of illicitly supplied products include: $250 to $400 per month, with an average cost 1. The high cost of legal medicinal cannabis 6 of $353 per month. For comparative purposes, products currently in Australi a; 53% of women using illicit cannabis to manage 2. Finding medical practitioners appropriately the pain and symptoms of endometriosis educated in the ECS and medicinal cannabis reported spending less than $100 per month2 however, other Australian surveys of people prescribing; using illicit ca nnabis for therapeutic purposes 3. Finding medical practitioners w illing to suggest mean monthly expenditures of between prescribe medicinal cannabis and go through 7 $274 - $378. The cost of using legal products is 8 Kerr J . Cannab is users say cl1n1c Is 'cash grab'. Courier Mail. 5/10/2018. 9 McGregor I. W hy so few Australians are using medicinal cannabis on prescrip considerably higher for some specific conditions tion. Sydney Morning Herald 2017. 10 Alcohol, tobacco and other drugs in Australia. Australian mst1tute of Health 6 Australian Medicinal Cannabis Pricing Analysis. Cannabis Access Clinics; and Welfare: Australian Government: 2019; Available from: https://www.aihw.gov. 2018; Available from: https://cannab1sa<;:cessclinics.com.au/wp-content/up au/ reports/phe/221/alcohol-tobacco-other-drugs-australia/contents/drug-types/ loads/2019/06/CAC_MedicinalCannab,sPncingAnalysis_Online.pdf. cannabis. 7 Lintzens N, Oriels J, Elias N. A rnold JC, McGregor IS, Allsop DJ. Medicinal can 11 Global Overview of Drug Demand and Supply. United Nations Office on Drugs nabis ,n Australia. 2016: the Cannabis as Medicine Survey (CAMS-16). Med J Aust. and Crime: 2019: Available from: https://wdr.unodc.org/wdr2019/prelaunch/ 2018 Aug 3:209(5):211-6. WDR19_Booklet_2_DRUG_DEMAND.pdf.
6 appropriate access pathways; tetrahydrocannabinol (THC), but do not 4. Patients not having a medical condition calculate or assess the level of physical or deemed suitable for consideration by federal cognitive impairment that the recipient of the or state/territory regulatory agencies, or test is currently experiencing. Automatic loss - being rejected by the regulator or medicinal of licence, fines or potential gaol time (if having practitioner based on their presenting previous convictions) could be the consequence condition and symptomatology; of testing positive, even though the person involved may be a legitimate medical cannabis 5. Patients who have been using illicit supply patient under the care of a doctor. (via illicit purchase or home cultivation) and getting good therapeutic results, Unpublished qualitative data from focus groups but when switching to legal supply on women with endometriosis conducted at experienced suboptimal results, perhaps NICM HRI demonstrated that driving is a key due to differences in cannabinoid ratios or factor to not using legal medicinal cannabis as cannabinoid/terpene profiles; they do not wish to break drug driving laws 6. Patients who feel judged or embarrassed to and risk a criminal conviction. Due to current discuss the use of medicinal cannabis with drug driving laws, recruitment of patients for their medical practitioner due to associated medicinal cannabis trials can be difficult as stigma, and therefore use illicit cannabis inclusion criteria stipulates that participants to self-manage and do not inform medical cannot drive during the trial to comply with professionals; current laws. Due to the fact that cannabinoids 7. Patients who are concerned, through can stay in the body for an extended time due to potential privacy breaches, that it could their lipophilic nature, it is clearly demonstrable become known that they utilise medicinal that a person could test positive for THC · cannabis and the risk this could pose to presence, despite not being intoxicated or employment opportunities or their standing physically or cognitively impaired, under the in their individual communities; current laws. 8. Patients who were using cannabis illicitly for therapeutic purposes before legislation As part of this review specific to barriers to was enacted and continue to source their patient access, the Federal Government should own supply illicitly specifically of cannabis prioritise reviewing these laws for what is now flower (i.e. flos, bud) for smoking or a legitimate prescribed medicine in Australia. vapourising. Smoking and vapourising are Opioids and benzodiazepines are commonly the most common dosage forms utilised by prescribed by Australian medical doctors (with those using illicit cannabis for therapeutic less regulatory burden), and produce significant purposes, which has been demonstrated side effects such as physical and cognitive in recent surveys. 2·7 Many patients find impairment, yet are not tested for in current this dosage form has faster onset of drug driving tests, with patients essentially being action than orally manufactured medicinal told by their medical practitioner to not drive if cannabis products, and is easier to titrate they feel intoxicated. their required dose. Based on prescription numbers and dosage forms used through the SAS Category B pathway, cannabis flower appears to be prescribed very rarely in Australia, due largely to the perceived risk of harm of smoking or vapourising held by prescribing medical practitioners. n. any related matters.
The current drug driving laws in Australia should be considered as a significant barrier to patient access in their current form. Saliva swab tests utilised by police forces across Australia's states and territories are designed to detect the presence of the cannabinoid
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