Cannabis firms in New Zealand have praised the regulatory framework under the country’s new Medicinal Cannabis Scheme but acknowledged it will take some time for the industry to get on its feet.
Senior executives across the Tasman also accepted they face the same challenge as Australia in overcoming the reluctance of doctors to prescribe medicinal cannabis.
NZ’s Medicinal Cannabis Scheme came into effect on April 1 with GPs given the green light to prescribe medicinal cannabis. Companies are also able to apply for licences to cultivate, manufacture and distribute products.
As with Australia, the NZ industry will be held to demanding Good Manufacturing Practice standards.
But Paul Manning, founder and chief executive of Helius Therapeutics, said other “unique” requirements will further elevate the quality.
“The regulations have struck a good balance of being pragmatic and delivering improved access to high quality products for patients,” he said. “There are very specific requirements that will make it a little harder to import products to New Zealand and we require certain things that most other countries don’t.
“But in the long run, once operations are up and running and firing on all cylinders, we’ll be holding ourselves to what many people believe will be the highest quality standards in the world. That will put New Zealand in a great position to become an innovation hub in this part of the world.”
Manning said the industry “breathed a sigh of relief” when the regulator dropped its original plan instructing doctors to get specialist sign-off for prescriptions.
In Australia, sign off is still required by the Therapeutic Goods Administration (TGA) for medicinal cannabis prescriptions.
“It was proposed that specialist sign off would be required on top of a GP script in NZ but they did away with that,” he explained. “That was an added layer that we really didn’t need.”
Yet other challenges familiar to their Australian counterparts remain for the fledgling New Zealand industry, Manning admitted.
“The big challenge we are all facing is how do we upskill doctors and make sure we have the right education program to give them confidence to prescribe medicinal cannabis?” he said. “And of course there is the ongoing work around products and clinical studies to prove they work.”
Mark Lucas, chief executive and co-founder of Cannasouth, also described the Kiwi framework as a “good scheme”.
“Once operations are up and running and we’re firing on all cylinders, we’ll be holding ourselves to what many people believe will be the highest quality standards in the world.”
Helius therapeutics Founder and ceo paul manning
“Three or four years ago when we started working in this area, if we thought of a scheme we would like to have, this is not far away,” he said.
But he warned a problem could emerge for patients from October 1.
Under the scheme, all existing products have been given a six-month window when they will still be eligible. After that, patients could be bereft of medicine.
“I guess we’re all in a bit of rush to get products to market,” he said. “It’s potentially a problem for patients if we get to the end of the six months and there’s no products to replace the existing ones.
“But fundamentally we have a good set of regulations. The regulators have listened to feedback and tried to build a scheme that has the potential to be very successful.”
Lucas echoed Manning’s remarks concerning doctors’ knowledge, conceding that Covid-19 has set back the education process. He added doctors don’t want to be educated by the health ministry – which itself has no desire to perform such a role – while GPs are “cautious” about listening to pharmaceutical companies “as they can sense some bias”.
“What you’ll see here is what happened in Australia where more specialist doctors who understand medicinal cannabis will be writing more prescriptions,” he predicted. “Over time though, doctors will become less apprehensive.
“It’s a risk for them as they don’t necessarily know enough about it, so it’s going to take time. It all comes back to the scientific, clinical data and approaching them in the same way they are approached by other pharmaceutical products.
“They are intelligent people and if you present it in the right way there will be enough who will start writing prescriptions.”
Lucas predicted medicines will initially need to be imported before local production kicks into gear in 2021.
“The regulators have not over-regulated and are taking a risk-based approach. But it is still going to take a little while for all the licences to be processed and businesses can get operating to these GMP standards,” he said.
“There are a lot of people who want to get into the sector but I don’t think they fully understand what is required. It is a song and dance but ultimately that is what protects patients.”
Along with doctor education, medicine affordability will also be an issue, with Lucas suggesting firms need to be operating “at a certain level of scale” to combat the costs.
“If there are any unnecessary boundaries in terms of regulation, that adds to the cost. But New Zealand has a good framework. It’s just going to take a little while for companies to maximise the opportunity.”
Turning to the September referendum on recreational cannabis, Manning said it presented an opportunity to enter the wellness market.
“A popular school of thought in New Zealand is that a yes vote will open the way for recreational products but it would also allow non-prescription wellness products to come to market,” he said. “That would open the door to a whole wave of innovation for our industry.”
First and foremost though, Manning flagged the “huge opportunities” presented by the Medicinal Cannabis Scheme, with NZ having barely scratched the surface of the product potential.
Currently, medicines are largely sublingual oral products and capsules which he described as “commonplace therapeutics”.
“The big question for us is where do we go from here?” Manning said. “What are the opportunities around bioavailability, what are the opportunities with medical devices?
“There is a huge scientific treasure trove that is sitting in front of us that we want to unlock.”
Lucas said he was unconvinced by CBD products, arguing infused coffee and soft drinks could create a “fad mentality” where sub-standard products eventually “wear out”.
Far better to obtain prescription products from a pharmacy where the quality is controlled and where the medicine provides genuine benefits for a patient, he said.
Cannasouth, he revealed, was more focused on gathering clinical data and exploring “next generation formulations” containing alternative cannabinoids that target specific conditions.
“A lot of prescribers and the public think medicinal cannabis is smoking or is a simple oil with THC or CBD. That is just the tip of the iceberg,” he said.