Last week the Health Minister Andrew little accused Medical Cannabis companies of not “getting off their asses” regarding product assessments, and then politicising the first partially NZ made products as an indicator of success.
Medleaf disputes this allegation, with multiple agreements in place that failed to materialize over quirks in the NZ Scheme. Of significance, we have a commercial agreement with the worlds most affordable EU GMP supplier of CBD, with product dossiers in the hundreds of pages that simply haven’t been submitted due to the resistance to be proactive at MEDSAFE.
In a follow-up interview, the Health Minister assured listeners that our standards were the same as Germany’s GMP Standards. Business Development Manager, Shane Le Brun then refuted Andrew Little’s understanding of where NZs Quality Standards for Medical Cannabis products sits.
Medleaf is concerned about the impact of this understanding which is flawed.
“At every turn, the Cannabis Agency makes ‘interpretations’ that go against the stated aims of affordable and timely access”
“It is difficult to challenge these interpretations as it’s not enshrined in legislation or regulation, but merely the opinions of the assessors,” says Medleaf CEO Courtney Letica.
Medleaf has entered into commercial agreements with 5 companies, either EU or Australian GMP, and due to various quirks of the NZ regulations and resourcing issues, have yet to have a product approved. Many of these interpretations only came to light long after the submissions were made.
“One of the interpretations currently, threatens to block access to over half the flower applications under assessment”
“This same interpretation will demand irradiation for dried flower products, which we know is undesirable to some in the patient community,” says Courtney.
Medleaf’s view is that in the context of ever reducing penalties in the illicit market which Medleaf unreservedly supports, that maintaining excessively strict interpretations that stymie product availability and ensure reduced competition will ultimately reduce the desire for patients to seek out legal prescriptions.
“Medleaf would like to see an overhaul of the quality settings and interpretations while preserving the GMP Standard” “Ultimately, the ministers view that our standards were the same is Germany, is a desirable endpoint,”
“To get to that endpoint though, a comprehensive regulatory review must be taken of not just the text in regulations, but how they have been implemented and interpreted in practice, compared to other, more successful countries,” Says Courtney
