By Dr. Teresa Nicoletti, Partner and Helaena Short, Lawyer
NSW Health has removed the red tape that was delaying and blocking patient access to medicinal cannabis therapies in NSW. Access for one of our pro bono clients was authorised late last week, confirming that the new streamlined process is now operational. Now it is up to the remaining States and Territories to follow NSW Health’s lead.
On 2 March 2018, the NSW and Federal Ministers for Health jointly announced a change to the process for authorising the supply of medicinal cannabis in NSW, which it was said would, “in the coming weeks”, slash the red tape and to improve individual patient access. The announcement sparked hope for many patients in NSW, but like many announcements beforehand, there was some scepticism around whether real change would be effected.
Our team at Mills Oakley has for the past year been providing pro bono support to several patients to assist them and their treating doctors to navigate through the Australian regulatory framework for medicinal cannabis. We therefore have had first-hand experience of the frustrating duplication brought about by the separate approval requirements at the State and Territory level, and the introduction of “policies” which have been contrary to legislation.
In NSW, there is one particular patient whom we have been assisting for the past 6 months since she was granted approval by the TGA under the Special Access Scheme to access a medicinal cannabis product. The patient was subsequently refused access by NSW Health, on the basis of the same clinical evidence and specialist endorsement that the TGA approval was based on (see here for more information about this case). The patient suffers from debilitating, potentially life-threatening symptoms, which have failed to be effectively managed by any conventional medicines. In contrast, the patient’s previous use – albeit illicitly – of a CBD-rich whole-plant cannabis oil was transformative, and vastly improved the patient’s symptoms and her and her carers’ quality of life.
The duplication of the clinical assessment process by NSW Health following an identical assessment by the TGA not only caused an unreasonable, significant delay – in the end, a six month delay – for the patient’s access to life-changing therapy, but gave rise to starkly contradictory clinical conclusions by the Federal and State Health Departments, notwithstanding the fact that the same clinical evidence was submitted for assessment. It was particularly concerning to us that the decision of the TGA’s Chief Medical Officer to approve access, and the clinical judgement of the patient’s treating medical practitioners, were effectively overridden by a decision maker in NSW Health who was a non-practising pharmacist with no clinical experience in medicinal cannabis whatsoever.
It was therefore our view that the duplicative process in NSW was untenable, not just because of the unacceptable delays to patient access, but also because the clinical conclusions and recommendations which were made by NSW Health were regarded as clinically irresponsible by our expert clinical advisors (who also offered their time pro bono) and would actually have placed patients’ lives at risk. It is on this basis that we and a band of advocates, including the inimitable Lucy Haslam, repeatedly pressed NSW Health, and the Ministry itself, to implement changes that would eliminate the concerning issues we identified with the decision-making process in NSW. We are delighted that it appears that our concerns have been listened to, culminating with the announcement on 2 March 2018 to streamline the authorisation process in NSW.
The authorisation which was finally granted to our client’s treating medical practitioner last week, clearly demonstrates that the streamlined process is now operational.
What does the change mean for patients in NSW?
The NSW Health website confirms that the new authorisation process means that NSW Health will rely on the clinical assessment which is conducted by the TGA for patients involved in a clinical trial or otherwise seeking access under the Special Access Scheme or Authorised Prescriber Scheme. NSW Health will only go further to review such things as the credentials of the prescribing doctor and the patient’s history. Furthermore, for particular efficiency, NSW Health has promised to conduct its assessment concurrently with the TGA’s assessment to ensure that access is authorised as quickly as possible.
Notably, the new process for medicinal cannabis access aligns with the process which does and has always applied for other Schedule 8 substances in NSW, thus making the new, streamlined process consistent with the process for other unapproved therapies.
Although the announcement by NSW Health improves the prospects of access for patients in NSW, many other States and Territories also have requirements which unnecessarily duplicate aspects of the Federal schemes administered by the TGA (viz the Special Access Scheme and Authorised Prescriber Scheme), and maximise the hurdles that patients and their prescribers need to overcome in order to obtain access to medicinal cannabis in those jurisdictions.
Despite the benefit of this change for our NSW clients, we are supporting several other clients in other States or Territories who continue to face insurmountable challenges to access to medicinal cannabis. Each of these patients suffers from serious, debilitating conditions which not only result in substantially reduced quality of life, but also pose significant, ongoing risks to survival.
We implore the other State and Territory Health Departments to take NSW Health’s lead and eliminate the unnecessary duplication that is stifling patient access to medicinal cannabis. We applaud the leadership shown by NSW Health in recognising the futility of a separate, burdensome regulatory process and the potential risks arising from decisions which previously had the potential to seriously compromise patient health and safety.
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