Updated: Sep 4, 2018
PharmaCann New Zealand made a written submission on the Bill and CEO Chris Fowlie presented at Parliament on 2 May 2018. The Health Select Committee’s report, released on 23 July 2018, has made several amendments have been made to the bill.
The National Party has now withdrawn support for the Government Bill and proposed their own Private Member’s Bill, which provides a different medicinal cannabis scheme. This bill has not been drawn from the ballot.
The Government Bill will proceed to the second reading in Parliament, likely to be in September, when MPs may propose amendments. It will likely be law by October or November, and licensing may begin soon after. Regulations covering production and manufacturing standards for MC products are expected to take 6-12 months, coming into effect mid- to late-2019.
PharmaCann has analysed both bills and identified opportunities for improvements. We support efforts to influence the development of legislation to enable urgent, affordable and safe access. This includes:
Raising awareness and supporting lobbying efforts
Helping found a peak industry group (the New Zealand Medicinal Cannabis Council)
Developing an industry master plan
Engaging with decision makers, regulators and stakeholders.
The Government’s Medicinal Cannabis Amendment Bill
Feature: De-schedule all non-psychoactive cannabinoids. Only psychoactive cannabinoids are counted in the 2% tolerance allowed for CBD products
PharmaCann's response: It will reduce costs and enable a wider range of products to be more easily accessible.
Override Medicines Act s20 to allow limited communications about unconsented medicinal cannabis products
Promoting awareness of medicinal cannabis products. Instore (pharmacy) promotions should be allowed.
Exemption for terminal patients largely unchanged – moved to exemptions section in MoDA
Advocate widening the compassionate exemption to severe and debilitating conditions; allowing self-provision; protecting caregivers; and allowing patients to obtain products from our portal or other LPs.
Allows new standards for cultivation and manufacture, and does not require clinical trials for efficacy
PharmaCann strongly advocated for this, to reduce costs and time to market.
Allows licences to be issued for commercial orresearch and study purposes
PharmaCann advocated allowing commercial production. However, the new bill also prohibits non-commercial production.
Who can work in the industry is unchanged
PharmaCann supports allowing workers of good character. The rules are expected to be based on the Industrial Hemp Regulations.
Details of the medicinal cannabis scheme left to regulations and MOH policy
We advocated for more detail in the Bill, however recognise regulations potentially allow greater flexibility. Resourcing and expertise for regulators need to be addressed. PharmaCann supports a unified industry voice with meaningful stakeholder engagement.
National Party (Shane Reti) Private Member’s Bill
Feature: Creates a Patient ID Card system: cards issued by GPs are used by patients for pharmacy dispensing
PharmaCann's response: This is compatible with our portal, which features a flexible workflow system that can be modified to cater to changing regulatory requirements, including dispensing pathways.
MC products produced to pharmaceutical (GMP) grade and continue to be regulated by MedSafe under existing pathways
While we support manufacturing products to the highest standards, the existing process has failed to make products available or affordable. Product standards should allow various grades, depending on formulation, dose and delivery method, with an accelerated approvals pathway.
Prohibits “loose leaf” medicinal cannabis and self-provision
Cannabis flowers can be produced to GMP standard. However, PharmaCann’s strong focus on R&D and research partnership with AUT means we can quickly enter the market with novel formulations and delivery methods.
Prohibits anyone with a conviction from working in the industry
We support good character tests but also want to provide legitimate employment pathways for experienced cannabis growers.
Exclusion zones for production and manufacturing facilities: 5km from residential areas and 1km from schools or wai tapu
There is currently no exclusion zone. However, there would be minimal impact on PharmaCann.
PharmaCann is able to implement our plan to provide medicinal cannabis products under either scenario. We believe there are good aspects to both bills.
We encourage Parliament to enact legislation with a sense of urgency. The quicker Parliament can pass legislation the sooner we can provide relief to New Zealand patients.