EXCLUSIVE: New, streamlined processes are set to simplify Australia’s cumbersome Authorised Prescriber scheme in a move which could encourage more GPs to offer medicinal cannabis to patients, Cannabiz has learned.
Under changes quietly drawn up by the Therapeutic Goods Administration (TGA), Human Research Ethics Committees (HREC) will be able to provide prescribers with an endorsement for a broad category of products. Prescribers will still need to then seek product-specific approval from the TGA.
Obtaining HREC approval is the first step in becoming an AP.
Approval will only be required based on the schedule of the product – either schedule 4 or 8 – although the dosage form, route of administration, indication and class of patient must still be specified.
In a further change, HREC approvals can be issued for up to five years, a duration which is at the discretion of the endorsing body.
Previously, approvals only stretched to 12 or 24 months before the Authorised Prescriber had to reapply.
The changes to the documentation rules are likely to improve the HREC bottleneck where prescribers can wait many weeks for approval.
Yet while significant in reducing the amount of onerous paperwork needed for HREC approval, adjustments to the scheme fall short of providing the full flexibility APs have long desired. Nor do they address the onerous half yearly reporting requirements which often frustrates Authorised Prescribers.