Authored By: Jeremy McGeown (New Zealand lawyer)
Associate Health Minister Peter Dunne announced earlier in February that approval for prescription of these products has now been delegated to the Ministry of Health, subject to compliance with ministerial guidelines. Previously, applications to prescribe non-pharmaceutical grade cannabis products had to receive sign-off directly from either the Minister or Associate Minister of Health.
The policy change signifies some increase in willingness on behalf of the government to relax decision-making and approval channels for the prescription of cannabis-based products and appears intended to simplify the process of obtaining cannabis treatments for both specialists and patients.
There are currently three categories of cannabis-products available for prescription in New Zealand:
- Pharmaceutical grade cannabis-based products that have consent for distribution in New Zealand;
- Pharmaceutical grade cannabis-based products that do not have consent for distribution in New Zealand; and
- Non-pharmaceutical grade cannabis-based products.
Following the recent policy change, pharmaceutical grade cannabis-products without consent for distribution and non-pharmaceutical grade cannabis-products are now subject to the same ministry approval regime, although the guidelines for assessing applications under each category differ in stringency.
While applications for non-pharmaceutical grade cannabis products can now be approved by the ministry, the guidelines for assessing such applications are significantly more rigorous than for pharmaceutical grade cannabis-products without consent for distribution.
The Ministry of Health makes their guidelines for approval for cannabis-based products publicly available on the Ministry website.
The guidelines were last updated on 8 February 2017, the same day that the policy change concerning approvals was announced. As it stands, the guidelines for assessing applications for non-pharmaceutical cannabis-based products are strict, reflecting the lack of available and robust data concerning the quality, safety and efficacy of non-pharmaceutical grade products. The Ministry of Health, when assessing an application for non-pharmaceutical grade products, is required to take in to account several factors:
- Whether the patient is suffering a severe or life-threatening condition, and whether there is evidence that conventional treatments have failed to control the symptoms of that condition.
- Whether qualified clinical specialists have assessed the risks and benefits of treatment with an unproven product, and, in particular, whether the risk of treatment with an unproven product has been assessed as less than the risk of no treatment at all. The Ministry will also assess whether potential benefits have been weighed against known adverse effects.
- Whether the application has come from a specialist appropriate to the condition being treated and whether the applicant and/or prescriber has sought adequate peer review.
- Whether the product to be subscribed has been analysed, preferably by a laboratory, to determine the concentration of the active ingredient.
- Whether a parent or guardian has provided consent.
The Ministry of Health had previously published the above list of factors as ‘criteria’, before loosening the terminology to ‘guidelines’. Despite this, it is not clear whether all the specified guidelines must be met in order for an application to be approved, or how much scope there is for Ministry to adopt a flexible approach in their assessment of an application.
According to Mr Dunne, approval has typically been granted quickly for the majority of applications submitted to the Minister. As such, the delegation of approval authority to the Ministry (instead of the Minister) may not have an immediately positive effect on the efficiency of the approvals process. There is also a risk that the guidelines may be interpreted more strictly by officials within the Ministry than they were by the Minister, and that the rigorous nature of the guidelines reflects the need for the Ministry to protect itself as it seeks to expand the availability of cannabis-based products. Until a comprehensive list of pharmaceutical-based products is made available to specialists for prescription, applicants may face a lengthier and more difficult application process under the new regime.
Despite this, the move does signify a desire from the government to make the prescription of medicinal cannabis a simpler procedural matter, and reflects increased Ministerial confidence in the public categorisation of medicinal cannabis as a legitimate, non-contentious treatment option for patients.