The Therapeutic Goods Administration (TGA) currently has two access pathways in which Australian medical practitioners may prescribe unregistered cannabinoid medicines.
A recent disallowance motion by Senator Di Natale changes the regulations to enable terminally ill patients to access medicinal cannabis products.
Elaine Darby, managing director, commented: “AusCann believes that excluding cannabinoid medicines from this pathway was not necessary given the safety evidence in respect to cannabinoids that has come out of pre-clinical and clinical studies.
“We are pleased terminally ill patients will now be able to access cannabinoid medicines through the TGA’s Special Access Scheme Category A.”
The changes explained
The TGA’s two access pathways in which Australian medical practitioners may prescribe unregistered cannabinoid medicines are the Authorised Prescriber Scheme (APS) and the Special Access Scheme (SAS) Category B.
Both of these pathways require the medicinal practitioner to apply for and wait for approval from the TGA prior to being able to prescribe.
SAS Category A does not require prior approval but is a process where the medical practitioner notifies the TGA they have prescribed the medicines.
Prior to the changes, any unregistered therapeutic goods can potentially be supplied via the
SAS Category A process, except for:
- Prohibited substances in Schedule 9 of the Poisons Standard; and
- Medicinal cannabis products.
Senator Di Natale’s disallowance motion changes the regulation to enable terminally ill patients to access medicinal cannabis products through the TGA SAS Category A process.
AusCann is a medical cannabis company that commenced trading on the ASX in February after it raised the maximum $5 million under a prospectus offering.
The company aims to produce and provide high quality, affordable and clinically validated cannabis medicines to patients.
It is bringing together leading expertise and operations across all aspects of the medical cannabis value chain, from cultivation and production, through to manufacture and distribution of products and has built a strong team of experts and partners across the globe.
- Canopy Growth Corp (CVE:CGC): the largest producer of medicinal cannabis globally;
- DayaCann: the only licensed medicinal cannabis grower in Chile; and
- Tasmanian Alkaloids: producer of ~40% of the world’s alkaloid raw material.
During early May, AusCann was granted a licence to cultivate medicinal cannabis in Australia.
The global cannabis market is currently valued at US$50 billion and growing, with an estimated 600,000 patients currently receiving treatment.