There are concerns that government ‘haste’ to widen patient access to cannabis-based medicines by year’s end will expose
doctors to legal threat, leaving them caught in the crossfire between patient demand and their professional obligations.
In a Viewpoint article published in this Friday’s New Zealand Medical Journal, researchers from both the Medical
Research Institute of New Zealand (MRINZ) and Otago University argue that the current mis-alignment of legislation and
professional standards in prescribing regulations will put New Zealand doctors in an impossible situation, leaving many
reluctant to prescribe cannabis-based medicines due to their having insufficient trial, safety and efficacy data,
running the risk of patient harm. Co-author Dr Irene Braithwaite, a Deputy-Director at the MRINZ, says with time running
out to amend and clarify existing regulations, most doctors will shy away from prescribing cannabis medicines once they
are able to, resulting in a potential backlash from frustrated patients.
“There is a real concern that doctors are effectively being set up to fail” says Dr Braithwaite. “Patient expectations
are being raised, many will line up wanting these products and won’t be happy to be turned away. Meanwhile prescribers
will be in fear of potential medicolegal jeopardy if they concede to legislated pressure to prescribe them. Many of
these products currently fail to even meet the definition of a medicine under the current Medicines Act”.
Public consultation on proposals for the Ministry of Health’s Medicinal Cannabis Scheme closed last week, with
regulations due to be in place by December this year. The Scheme seeks to establish a Medicinal Cannabis Agency, a
licensing regime to enable domestic commercial cultivation and manufacture of medicinal cannabis and to widen patient
access by allowing New Zealand doctors to prescribe them. It follows the passing of the Misuse of Drugs (Medicinal
Cannabis) Bill last December, an amendment to the Misuse of Drugs Act 1975, which now allows a legal defence for
terminally ill and palliative patients to consume marijuana without fear of prosecution. Prior to that amendment, only
appropriate specialists could prescribe Medsafe-approved Sativex for spasticity in Multiple Sclerosis without
Ministerial approval. All other cannabis-based medicines and products were classed as B1 controlled drugs, requiring
Ministerial approval to prescribe.
The Viewpoint authors state that while much has been written regarding the pros, cons and ‘how to’s” of improving
patient access to medicinal cannabis products, little has been written so far specifically reflecting the requirements
of current prescribing laws, regulations and principles to which the Medicines Act, New Zealand Medical Council (NZMC)
and the New Zealand Medical Association (NZMA) require doctors to adhere.
“It has been very difficult for medical bodies to submit proposals for this upcoming Scheme when it has not even been
established what manufacturing quality standards will be put in place for these products, let alone the types of
products that might be available, or what tests might be required to demonstrate safety” says Dr Giles Newton-Howes,
Viewpoint co-author, addiction specialist and Associate Professor at the University of Otago. “The NZMC’s ‘Statement on
Good Prescribing Practice’ advises doctors that they must be familiar with the indications, adverse effects,
contraindications, major drug interactions, appropriate dosages and monitoring requirements for the drugs they
prescribe, reminding them too that medicines can’t be prescribed simply because patients demand them. However, most
cannabis-based products currently have insufficient information about how they are made or how safe and effective they
are to be licensed as a medicine in New Zealand”.
Dr Braithwaite points to current problems in the UK, which passed legislation nine months ago allowing specialist
doctors to prescribe cannabis-based medicines. Britain’s National Institute for Health and Care Excellence (NICE) last
week moved to block routine access to all cannabis-based products due to concerns over insufficient evidence they are
safe. NICE is now calling for fast-tracked clinical trials to provide the evidence needed to establish their safety.
The Royal New Zealand College of General Practitioners (NZCGP) says the Viewpoint article raises some interesting points
around the potential legal ramifications for medicinal cannabis products which are not Medsafe-approved.
“These products are likely to become more prevalent as a consequence of the recent legislative changes” says College
Chief Executive Lynne Hayman. “We anticipate that the Ministry of Health will provide guidance to health practitioners
involved in the prescribing process. Specialist organisations such as the Medical Protection Society and Medico-Legal
Society are also likely to consider the risks raised in this article and will be able to provide expert legal guidance
to their members”.
The authors recommend that in the absence of pre-emptive Medsafe review and guidance on the issue, data needs to be
collected once the Medicinal Cannabis Scheme comes into effect to capture beneficial (and adverse) clinical outcomes as
well as wider health, economic and social impacts. They say New Zealand is ideally placed to action such data collection
using existing National Health Index databases.