A layer of bureaucracy has been removed from accessing unregistered cannabis medicines in the Australian state of New South Wales.
Late last week, the NSW and Federal Health ministers announced instead of approvals being required by both the Commonwealth and NSW Health, this will be replaced by a single clinical assessment by the Therapeutic Goods Administration (TGA).
“This approach by NSW to cut red tape and remove barriers is a template for other States to follow,” said Federal Minister for Health Greg Hunt. “Strong safeguards remain in place to access medicinal cannabis but this move ends a duplication of regulatory requirements.”
According to Minister Hunt, the new process would mean doctors would typically receive approval within 36 hours, which he says will be one of the quickest approval times for medical access in Australia.
It’s expected the new arrangement will commence in the coming weeks.
The news came just a couple of weeks after the NSW Government was accused of purposely delaying medical cannabis applications made by doctors wanting to prescribe medicines for their patients.
Currently, there are no limits to the symptoms and conditions for which a cannabis medicine may be prescribed in New South Wales. In order to gain approval for an unregistered product, a doctor must provide the TGA with information including a drug’s composition, formulation, dosage, administration form and known adverse effects.
A justification for using the medicine for treating a particular illness is also required, along with information as to why a registered product cannot be used for the treatment of the patient.
Even if approval is gained, the issue of affordability remains a major issue precluding use of cannabis medicines.
“…the reality is that many of the unregistered products available for access are very expensive and are not subsidised by Australia’s Pharmaceutical Benefit Scheme,” states the Lambert Initiative for Cannabinoid Therapeutics. “Consequently, these are basically out of reach of patients with chronic illnesses, many of whom are unable to work and may be on disability pensions.”
Additionally, doctors may also not be insured against adverse outcomes occurring in patients who have been prescribed a medicinal cannabis product, adding a layer of risk to medical practitioners.