23 January 2020
NICM Health Research Institute (NICM HRI) is one of the first research institutes in Australia to be granted a medicinal cannabis manufacturing licence by the Federal Government’s Office of Drug Control.
The licence will allow researchers from NICM HRI’s Australian Medicinal Cannabis Research and Education Collaboration (AMCREC) to undertake important research, from the genetics of medicinal cannabis, all the way through to the analysis of a quality-assured finished product.
For clarity, NICM HRI will not be manufacturing finished medicinal cannabis products for industry, but the licence supports the Institute’s research and development purposes. This broader scope of research includes cannabis genetics, plant biology, phytochemical analysis, preclinical pharmacology in vitro and in vivo work, and human clinical trials.
Coordinating Lead of AMCREC and NICM HRI Research Fellow, Justin Sinclair said as the global appetite for medical cannabis reaches “green fever”, the new licence showcases NICM HRI’s leadership and capabilities in this rapidly emerging field.
“The idea behind NICM HRI’s AMCREC initiative is to create an innovative and collaborative environment to service the research requirements of industry, all the while keeping the end patient in mind. With this licence, that goal is in sight,” said Mr Sinclair.
“There is no other research institute in the country that specialises in plant medicines, from preclinical pharmacology through to human clinical trials.
“Our plant and herbal expertise, along with our TGA accredited laboratories, sees our team well placed to deliver important emerging research across fields such as plant chemistry, cultivation, pharmacology, clinical trials, product development and workplace health and safety.”
Medicinal cannabis use was legalised in Australia in 2016 for patients with certain serious medical conditions for which sufficient evidence exists. This includes palliative care, chemotherapy-induced nausea and vomiting, chronic pain, multiple sclerosis and epilepsy in paediatric and adult patients.
The researchers at NICM HRI are currently working on projects that hope to expand the evidence base across numerous other diseases and conditions.
“Currently we have clinical trials in various stages of development and implementation, including investigating medicinal cannabis for endometriosis, a painful condition that effects around 740,000 Australian women,” said Mr Sinclair.
Other potential areas for future medical cannabis research, according to Mr Sinclair, include novel dosage forms for cannabis delivery and the importance of quality assurance.
“The use of novel dosage forms for cannabis delivery is an evolving part of the medicinal cannabis industry both here and internationally. Quality assurance is also going to become important as the industry continues to grow, and with Australia’s reputation in this field, this will set us apart,” said Mr Sinclair.
Senior AMCREC member Professor Jerome Sarris sees the awarding of the licence to NICM HRI by the Office of Drug Control (ODC) as a critical next step in developing medicinal cannabis research in Australia.
“After years of working through the ODC’s rigorous application process, we are delighted to now be awarded a manufacturing licence,” said Professor Sarris.
“This will allow AMCREC to ramp up all manner of vital research on the cannabis plant for an array of therapeutic purposes - our vision is to provide a one-stop research stop to conduct truly ‘bush-to-bench-to-bedside’ research. We are now open for business and excited by the research opportunities.”