Research & Development

While many producers and applicants are keen to have an R+D department, few understand what this actually entails.

Research and development with cannabis is a strong growth industry in this emerging market in Canada. While many producers and applicants are keen to have an R+D department, few understand what this actually means or how to achieve this. The cannabis industry needs to borrow best practices from the pharmaceutical and commercial cultivation industries, and CCI has expertise in both.

To clarify, experimenting with phenotypes and breeding techniques can be done by a licensed producer under the ACMPR; it does not require a separate licence. Also note that in vitro analytical testing of cannabis materials for biomarker and contaminant levels is also permitted under the LP licence.

However, when it comes to developing unique extracts/derivatives, dosage forms or finished products, an ACMPR licence does not allow this. If the ultimate purpose in conducting such activities is research for scientific purpose, this requires a Dealer’s Licence under the Narcotic Control Regulations (8,9) and Controlled Drugs and Substances Act. This type of licence allows a company to produce, make, assemble, import, export, sell, provide, transport, send or deliver a narcotic. Remember that cannabis is, and in the future will still be scheduled as, a narcotic.

Setting up an experimental laboratory for the purpose of research and development requires a considerable amount of forethought and planning, not to mention procedures and process. NHP Consulting has expertise from the pharmaceutical industry to provide all of this, including equipment sourcing/qualification/installation, software validation, standard operating procedures, security system design/implementation, and research support. Achieving a Dealer’s Licence is simply one component of this.

It must be emphasized that a Dealer’s Licence can only produce materials that are for research – they cannot eventually be sold for consumption. For example, a licensed producer cannot send crude cannabis buds to a licensed dealer for oil extraction and sell such oil to their clients. However, a licensed dealer could manufacture a cannabis derivative for a licensed producer if the products are to be used for a clinical trial. Having said this, there is a great deal of uncertainty still at the government and industry level as to where this line is drawn. For example, a licensed dealer can conduct activities for “biotechnological support services” such as seeds and clones, and at present there is an industry understanding that such could be used for propagation by an LP – eventually providing saleable product to consumers.