Cannabis-based products will be allowed to bypass usual processes required for medicines in New Zealand and go directly onto the market without any proof of safety or effectiveness. This unprecedented proposal is contained in the government’s consultation document on giving greater access to medicinal cannabis.
The government is introducing a scheme for regulating medicinal cannabis. The consultation covers proposed licensing, cultivation, manufacturing and product standards, and a prescription and enforcement regime.
The key driver for this seems to be that people currently access cannabis through the illegal recreational market. But even if there is no doubt that a regulated market would provide a safer environment for access, we argue that there could be a potential cost to patient safety.
From trial to market
The usual market pathway for a drug in New Zealand is the development and manufacture to good manufacturing practice (GMP) standards. This ensures each batch has the same amount of active ingredient and is free from contaminants.
Companies then run clinical trials, first on small groups of healthy subjects to establish the compound is safe and to understand how it behaves in the body. This information is essential to ascertain dosage.
Finally, the medicine moves into “efficacy” trials. This is the first time it is given to patients. These trials confirm safety and, importantly, establish effectiveness. The data are then presented to the medical regulatory body Medsafe, which decides if the drug can be prescribed.
Current medicinal cannabis regulations suggest bypassing all these processes and moving straight from manufacture to prescription. Whether or not manufacture needs to be to GMP standards is one of the consultation questions.medicinal-cannabis-scheme-consultation-document