In a comment piece published in the New Zealand Medical Journal, University of Otago toxicologists say that even if cannabis products benefit patients, they say it would not be able to meet the regulatory approval of other medicines, which requires exact compositions to be known and for batches to be consistently replicated.
New Zealand has a clear frame work which defines the standards required for something to be considered a medicine, yet appears on the cusp on creating a whole new class of “medicine” to accommodate medicinal cannabis, say the authors, Drs Michelle Glass and John Ashton. Dr Glass is chair of the Medicinal Cannabis Research Collaborative.
They argue that cannabis is not a single substance, but a mixture of substances whose exact composition varies between products.
Regulatory approval of medicines requires exact composition to be known and be able to be replicated for batch to batch conformity. It requires detailed stability data and to ensure that products are free from contaminants. Clinical efficacy must be proven, and adverse effects monitored. If we are going to ask doctors to prescribe cannabis as a medicine, why would cannabis products not be required to meet existing standards?”
Their article questions why we are inventing a whole new definition of a medicine just for cannabis. While it might not fit the legal definition of a medicine, the authors say cannabis products should be held to the same standards as other medicines and we shouldn’t be inventing a whole new definition of a medicine just for cannabis.