For decades the physical effects of chronic, life-threatening and terminal illnesses like cancer, MS and epilepsy have been treated with pharmaceutical drugs. However, anyone with first hand experience of caring for people with these conditions will know that the side effects of many pharmaceutical products used to manage pain, such as morphine or pethidine, have a significant negative impact for many users. Until now, non-toxic alternatives like medical cannabis have not been legally available in Australia. Australian patients are calling for greater access to medical grade cannabis products and cannabinoid medicines – some limited paths to access medical cannabis products have now been created for patients through Federal and State legislative changes.
The Federal Government in Australia has created pathways via amendments to the Narcotics Act to allow Medical Cannabis to be legally cultivated and manufactured for medical or research purposes across Australia, under strict conditions. Federal Health Minister Greg Hunt has also recently announced new pathways to allow Medical Cannabis to be imported and stockpiled to meet the immediate demand from Australian patients. More detail on this plan is required from government to provide certainty to both patients and industry. Additionally, each state is enacting laws to establish viable frameworks for Medical Cannabis to be cultivated and manufactured, for medical and research purposes. Victoria is leading the way; putting in place the Access to Medicinal Cannabis Bill 2015. The Victorian Government is also growing the first legal Cannabis crop in Australia and conducting research into the effects of medicinal Cannabis on otherwise untreatable epilepsy. Queensland has passed the Public Health (Medicinal Cannabis) Bill 2016, while NSW made amendments to their Poisons and Therapeutic Goods Regulations and have begun steps forward to undertake a state run clinical trial for chemotherapy patients – it has also developed the Medicinal Cannabis Compassionate Use Scheme to extend compassion to adults with a terminal illness. The states, in consultation with the Therapeutic Goods Administration (TGA), will need to determine which patients groups can access Medicinal Cannabis products, what types of products will be allowed for distribution, who will be allowed to prescribe the product and how they will be licensed to do so.
Some issues faced by industry and regulators that may cause further delays for patient access include: lack of clarity in relation to the TGA registration and/or listing processes for Medicinal Cannabis products, limitations around modelling of demand based on research trials for Medicinal Cannabis products, licensing commercial operations and patient access.
SO HOW CAN PATIENTS IN AUSTRALIA CURRENTLY ACCESS MEDICINAL CANNABIS PRODUCTS AND CANNABINOID MEDICINES?
In Australia there are currently three limited pathways that patients can use to access medicinal cannabis-based treatments. These include:
Special Access Scheme (SAS)
The SAS refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. Patients are grouped into two categories under the scheme:
Category A patients are defined as 'persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment'.
Category B patients are all other patients that do not fit the Category A definition.
Authorised Prescriber Scheme
There are circumstances where patients may require access to medicines or medical devices that have not been approved for supply by the TGA. In these circumstances a medical practitioner may be granted authority to become an authorised prescriber of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to specific patients (or classes of recipients) with a particular medical condition.
Medical Cannabis Clinical Trials
There is currently several different medical cannabis clinical trials occurring across Australia. The trials being conducted are looking into and documenting the medical efficacy of different medical cannabis preparations and compounds. Some of the conditions for which trials are currently planned or in progress include: Epilepsy (children & adults), and Cancer (chemo induced side effects), Botanical Medical Cannabis for Palliative care.
At LeafCann we are working with our local and international partners to fast track industry, product supply and create viable alternative pathways for Australian patients to access medicinal cannabis products.
lOBBY THE uN FOR REAL CHANGE ON mEDICAL CANNABIS
Australian authorities are hamstrung by the UN Single Convention on Narcotic Drugs and compassionate growers find themselves arrested and their supply seized. As a signatory Australia must enforce seizure and prosecution of illicit marijuana sources, despite the heartbreaking effects this has on seriously ill people with no alternative treatment to alleviate their symptoms, forcing many to break the law.
We must lobby the the United Nations Office on Drugs and Crime to look at options to allow Australia to announce an amnesty for illicit medicinal cannabis producers for a set period, upon registering their crop with the government, while local companies achieve licenses and produce their first commercial crops.
Email the Chief of this Secretariat - Jo Dedeyne-Amann - at firstname.lastname@example.org to voice your concern.