A year on from introduction of the Medicinal Cannabis Scheme on April 1, 2020, only one company has managed to meet the benchmarks to sell pharmaceutical grade cannabis in New Zealand.

Last month, Toronto-based cannabis giant Tilray was granted approval for its FS Oral Solution THC25 product. That's the fourth Tilray product to meet the minimum quality standard under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019.

Medicinal Cannabis Agency (MCA) approval means the Nasdaq-listed Canadian firm currently holds an effective monopoly on products based on cannabidiol, or CBD, which can be prescribed by a general practitioner or medical specialist.

There are 16 applications currently queued up from seven companies awaiting approval from the MCA to say that they meet the good manufacturing practice code (GMP) under the regulations.

The lack of market competition has prompted health minister Andrew Little to push back the transitional period for cannabis regulation by six months, from April 1 to Sept 30. 

Part of the reason was the covid-19 pandemic, which had limited companies’ ability to apply, affected global supply chains, and added “challenges to suppliers seeking to have products assessed," he said.

Provisional approval

In the meantime, patients will still be able to access products while prospective suppliers are given the additional time they need to apply to the agency for verification.

Beyond Tilray, these include provisionally approved products, including Sativex and products supplied by Auckland’s Medleaf and Tauranga-based Eqalis.

Mark Lucas, chief executive of NZX-listed Cannasouth, said the Hamilton-based company currently had three products awaiting agency sign off. 

What the delays translated to, he said, was that the industry still didn’t have a true appreciation of how high NZ’s regulatory bar had been set. 

The GMP requirements had largely been based on the German standards, which were “well above” the good production practices, or GPP standards followed in Canada, he said.

For Cannasouth, the NZ market would remain an important one, but Lucas said its focus would be on exports into the German and Australian markets, which were “crying out” for pharmaceutical grade products.

Access and affordability

NZ Medical Cannabis Council executive director Sally King said under the scheme it will still be possible for doctors to prescribe products that have not been assessed after the new deadline has passed but it will be more difficult, with doctors needing to coordinate the importation on a named-patient basis. 

King said while the intent of the law was to improve access and affordability, it isn’t clear to the industry how this policy is being delivered.

"Our quality standards are world class, but the ministry isn’t resourced to develop a new industry. Rather they are there to regulate a five million person domestic market.”