Exports approved but what about Australian patients?

January, 2018

Federal Minister for Health, Greg Hunt, recently announced that medicinal cannabis products manufactured in Australia will be legalised for export so that Australia can compete in the global market. However, substantial hurdles continue to stifle domestic access to medicinal cannabis, such that an international export agenda has the potential to further disadvantage Australian patients. Partner, Dr Teresa Nicoletti and Lawyer, Helaena Short, discuss.

On 4 January 2018, Minister Hunt announced the Turnbull Government’s intention to legalise the export of medicinal cannabis products manufactured in Australia in accordance with the 2016 amendments to the Narcotic Drugs Act 1967 (see here).[1] With the global medicinal cannabis industry expected to be worth $US34 billion by 2021 (see here), the Minister suggested that the change would “give Australian farmers and manufacturers the best shot at being the world’s number one exporter of medicinal cannabis”.

The Office of Drug Control has clarified that the Minister’s announcement relates only to finished cannabis preparations for medicinal use (and not unprocessed raw cannabis), in order to comply with Australia’s obligations under the Single Convention on Narcotic Drugs 1961 (see here).

However, the Minister’s perspective on the position of Australian patients and their treating doctors within the existing domestic schemes for the prescription and supply of medicinal cannabis appears to be deceptively optimistic. The Minister stated:

We want a robust Australian medicinal cannabis industry so that doctors have safe, quality domestic products that they can confidently prescribe to their patients. Doctors can apply under the Therapeutic Goods Administration’s Special Access Scheme Category or via an Authorised Prescriber to legally prescribe medicinal cannabis products.

Statements like the one above are misleading; they suggest that doctors are the sole decision-makers for Australian patients when it comes to access to medicinal cannabis products. In reality, however, the support of doctors and even the Therapeutic Goods Administration (TGA) is not, in the main, enough to secure access for any Australian patients.

Decision-making at the Commonwealth level

As we have previously discussed, the Special Access Scheme (SAS) allows doctors to apply to the TGA for access to an unapproved medicine, including a medicinal cannabis product, for use in the treatment of a patient under their care. The application process involves the evaluation of substantial clinical, and in some cases anecdotal, evidence supporting the safety of the proposed medicine, in addition to details of the patient’s condition, treatment history, the treating doctor(s) and the proposed process for supply. The TGA is responsible for determining whether or not access in the circumstances is clinically appropriate.

Alternatively, applications for authorisation to prescribe medicinal cannabis under the Authorised Prescribed Scheme (APS) are evaluated by an Ethics Committee (EC) or Specialist College with which the applicant is affiliated. It is significant, therefore, that several major medical groups, including the Royal Australian College of General Practitioners, the Royal Australasian College of Physicians and the Australian Medical Association, have publicly expressed concerns about the safety of medical cannabis and, accordingly, are unlikely to endorse any applications by their affiliated members for access under the APS. It is notable, however, that even those organisations are now conceding that access to medicinal cannabis is too difficult and bureaucratic.

Decision-making at the State and Territory level

Furthermore, notwithstanding the comprehensive application and assessment processes at the Commonwealth level, there is evidence that the professional opinion of Australian doctors, ECs (or Colleges) and even the TGA are being entirely disregarded by State and Territory health authorities, which have the final say in any decision to supply medicinal cannabis within their respective jurisdiction. In this regard, the Minister’s assertion that there are “now no real government barriers at all to accessing medicinal cannabis” is plainly wrong.

An example of the hurdles that patients face is highlighted in an application by a registered GP in respect of which our team at Mills Oakley has been providing pro bono assistance to secure access to a medicinal cannabis product for the treatment of an elderly patient with Alzheimer-related symptoms. The GP, whose application was supported by one of Australia’s leading neurologists, was granted approval under Category B of the SAS by the TGA’s Senior Medical Advisor last year. Notwithstanding this, despite the submission of the same information and evidence provided to the TGA and, indeed, the submission of substantial additional evidence, a delegate who was not a medical doctor nor a clinician, but a non-practising pharmacist, subsequently refused to grant the GP an authority to prescribe and supply a medicinal cannabis product under Part 8 of the Poisons and Therapeutic Goods Regulations 2008 (NSW), thus overriding the decision of the TGA and the judgement of the patient’s treating doctors, neurologist, and external scientific and clinical advisors.

Having regard to these circumstances (as merely one example), although Minister Hunt has confidently declared that the Government is committed to making it easier for doctors and the TGA to facilitate access to medicinal cannabis for Australian patients, he has downplayed the hurdles which he surely knows exist at the State and Territory level, and which continue to override the decision of doctors and the TGA and stifle any reasonable domestic access to medicinal cannabis products. In our view, until crucial decisions affecting patient access are truly left in the hands of doctors and not the bureaucracy, adequate access to medicinal cannabis within Australia will be nothing more than a pipe dream.

Quantifying demand

Mills Oakley supports the Government’s decision to facilitate Australia’s entry into the global medicinal cannabis market. However, we remain concerned for Australian patients and their treating doctors, who are ready and willing to prescribe and supply medicinal cannabis products for use in the management of a range of diseases and medical conditions.

The Minister has proposed that export licences will be conditional on rules requiring stock to be made available to Australian patients first (see here).[2] However, whilst the process for obtaining authority to access and supply medicinal cannabis at the State and Territory level remains untenable, the domestic demand for medicinal cannabis cannot be accurately quantified.

In our view, while the State and Territory health authorities are able to unjustifiably intrude on the TGA’s jurisdiction and decision-making and improperly interfere with, and override, the decisions of doctors acting in their patients’ best interests, the domestic medicinal cannabis industry will have no choice but to direct its products to export in order to maintain commercial viability.

It is time for the State and Territory Governments to relax their strangle-hold on domestic access to medicinal cannabis and put patients first. Once the TGA has approved or authorised access, doctors should be the sole decision-makers when it comes to the interests of their patients. There is absolutely no reason why a domestic access scheme cannot operate and flourish alongside a burgeoning export market. Political agendas need to be set aside – it is time to listen to what the Australian public and commercial enterprise have been screaming loud and clear since the notion of an Australian medicinal cannabis industry was first introduced.

[1]‘Turnbull Government To Allow Medicinal Cannabis Exports’ (4 January 2018) Greg Hunt Home Page.

[2] Alice Uribe and Tom McIlroy, ‘Medicinal cannabis stocks surge on export tick’ (4 January 2018, 12:36 PM) Australian Financial Review.

Contact Mills Oakley

For further information, please do not hesitate to contact:

Teresa Nicoletti

Dr Teresa Nicoletti 
Partner | Intellectual Property, Health and Life Sciences
T: +61 2 8035 7860
E: tnicoletti@millsoakley.com.au

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