15 October 2015
The developing campaign around medicinal cannabis has eerie overtones of last year’s row about psychoactive substances, where reason and logic quickly gave way to lowest common denominator decision-making, equivalent to mob rule.
So, with eternal optimism that informed debate will always prevail, but tempered by an uneasy fear that once more common sense may be swept aside by public passion, let me set out the current situation as dispassionately as I can.
In New Zealand, medical practitioners can prescribe medicines approved and registered under the Medicines Act. Registration occurs after a rigorous clinical testing process, and PHARMAC separately decides whether to fund the product. One medicinal cannabis product, Sativex, is currently so registered, and PHARMAC is currently considering whether to subsidise it. No other medicinal cannabis products have been submitted for registration in New Zealand.
Where medicines are unregistered and therefore unapproved, there has been a procedure set out in the Medicines Act for many years now to allow the Minister to approve the prescription of such an unapproved product, upon the application of a medical practitioner or specialist. That application has to be lodged with the Ministry of Health, stating the product, the purposes for which it is being sought, the dosage, along with general clinical assessments of its likely clinical efficacy and safety. The Ministry then makes a clinical assessment of the case, and recommends a course of action to the Minister. To date, only one application ever has been made for a medicinal cannabis product, which was the case I approved earlier this year.
I am not a clinician, so therefore, in considering any such applications, I have made it very clear that I will be strongly guided by the clinical advice which I receive. The reason for the decision in such cases being made at a Ministerial level has nothing to do with cannabis, but is simply because the applications are being made as an exception to the existing law.
So, patients seeking access to medicinal cannabis products need to consult their medical advisers in the first instance. If Sativex is not deemed suitable, then they need to discuss what other alternatives might be best for them, and whether an application under the Medicines Act is the appropriate way to proceed. Again, there is nothing unusual or particular to medicinal cannabis in that – we do not make any prescription medicines available without the support of the specialist or medical practitioner, for obvious reasons, and medicinal cannabis should be treated exactly the same way.
However, I would be concerned if it became clear that personal antipathy to cannabis was causing some doctors not to seek approval for medicinal cannabis products for their patients, in cases where it was potentially beneficial. My strong plea to them is to always put the best interests of their patients ahead of any personal views they might hold, when considering such cases.
We are watching closely the clinical trials being conducted in the United States and Australia, but they are not likely to produce results before 2016-2017 at the earliest. It is possible that were the FDA or the Therapeutic Goods Agency to approve medicinal cannabis products as a result of these trials our regulator Medsafe would look to follow suit here, but that is still some time away. What is clear, however, is that any approval is likely to be for a very limited range of products in highly specific and regulated circumstances, and certainly not the open slather situation some seem to be expecting.
Meantime, the provisions of our Medicines Act will continue to apply, including the opportunities for doctors to seek access to these products in the general interests of their patients. For my part, I will consider any case that comes before me on its particular merits, and without any reference to whatever external noise there might be at the time.
Anxious patients and their families deserve no less.