The Senate sees Sense: Terminally ill patients may receive expedited access to medicinal cannabis

June, 2017

New votes by the One Nation Party in a surprise re-hearing of Senator Richard Di Natale’s medicinal cannabis motion mean that terminally ill patients may be able to access medicinal cannabis via Category A of the SAS once again. Partner, Dr Teresa Nicoletti and Paralegal, Helaena Short, discuss.

Earlier this year Senator Richard Di Natale of the Greens brought a motion to disallow the exclusion of medicinal cannabis from Category A of the Special Access Scheme (SAS) for unapproved medicines.

When it was initially heard on 11 May 2017, the Senate vote was split 32/32 and therefore the motion was unsuccessful. Following the decision, social media was swamped with accusations of lies and slander directed at One Nation and the Nick Xenophon Team members, who appeared to have prioritised their political interests over the interests of terminally patients (for more information, see our recent article here).

In a re-vote of Senator Di Natale’s motion, enabled by an administrative loophole (because Senator Jacqui Lambie had inadvertently missed the previous vote), Pauline Hanson’s One Nation Party voted in favour of the motion (after voting against the motion in May), thus teaming up with the Greens and Labor to deliver success for the motion and for terminally ill patients.

A Big Surprise for Politicians

The One Nation party’s new votes came as a shock to many.  Senator Hanson has accused the Government of misleading her before the previous vote, which caused a widespread backlash among One Nation supporters, given that the One Nation Party had publicly expressed its support for the medicinal cannabis movement throughout the election process.

It would appear that Senator Hanson is now comfortable that her misunderstandings (which we discussed in our previous article) have been adequately addressed, and she remains committed to facilitating access to medicinal cannabis, not stifling it. Senator Hanson told the Senate, “I will not stand in the way of dying patients’ dignity”.

Health Minister Greg Hunt described the outcome of the motion as “reckless and irresponsible” and suggested that lives would be put at risk and unregulated products would become more easily available. However, having regard to the safeguards that are already in place to control access to unapproved medicines via Category A of the SAS, these claims are unwarranted.

Terminally ill patients have been able to access all kinds of unapproved medicines under Category A of the SAS for many years, including, inter alia, substances with significant risk profiles and potential for abuse. In this regard, based on the seriousness of the patients’ conditions and their immediate need for relief from pain and suffering, the TGA regards the Category A pathway as sufficiently justified for any unapproved drug – except medicinal cannabis.

It is not clear therefore how use of Category A of the SAS, which has operated satisfactorily for many years and for many medicinal products, may be regarded as “reckless and irresponsible” for medicinal cannabis, even where it is acceptable for medicines with more significant risk profiles.

In our view, Minister Hunt’s claims plainly disregard the safeguards that are in place to control access to unapproved medicines in Australia. It is always the decision of a medical professional to prescribe a medicine under Category A of the SAS , and it is the responsibility of every doctor to ensure the eligibility criteria are met. In this regard, access to all unapproved medicines is appropriately fettered by the clinical criteria set by the TGA and the professional opinion of a registered medical practitioner.

A Big Win for Patients

As we have previously discussed, the Turnbull government introduced changes which arbitrarily excluded all medicinal cannabis products from Category A of the SAS.[1]

The SAS allows medical practitioners to import unapproved medicines for the treatment of individual patients classified into Category A or Category B. Supply to patients under Category A, that is, patients suffering from terminal or life-threatening conditions, does not require pre-approval from the Therapeutic Goods Administration (TGA) – therefore it is expeditious and efficient.

The motion which has now successfully passed through the Senate will disallow the exclusion of medicinal cannabis and thus re-instate the ability of terminally ill patients to utilise the Category A pathway for all medicines, including medicinal cannabis.

Fortunately, patients suffering from terminal or life-threatening illnesses may again be able to access imported medicinal cannabis therapies without enduring extensive approval waiting times or resorting to self-medication using illegally-obtained cannabis.’

A Big Outstanding Question

Despite the successful Senate vote and widespread public support for facilitating access to medicinal cannabis for, in particular, Australia’s most vulnerable patients, Minister Hunt has stated: “We cannot accept this, and I have asked the TGA for advice.”

As discussed above, Minister Hunt has suggested (albeit without justification) that removing the exclusion of medicinal cannabis from Category A of the SAS will detrimentally affect patient and community safety.  However, in our view, the real reason why Category A access to medicinal cannabis was stymied remains unknown.

The Department of Health directly informed us that access to imported medicinal cannabis was blocked to create a “level playing field” with the domestic medicinal cannabis scheme under which access is regulated differently from state to state. The obvious solution to this disparity would be to enable Category A access to medicinal cannabis under the domestic scheme. Indeed, it is unclear why this was not possible from the outset.

In our view, the Department of Health has not put forward any coherent argument which prioritises the immediate and ongoing need of patients or even accurately engages with Australia’s established and effective mechanisms to regulate the supply of medicines.

We are deeply concerned that Minister Hunt’s negative reaction to the outcome of the Senate vote may foreshadow a further intention by the Government to block and/or stifle Category A access to medicinal cannabis. Perhaps more transparency will assist patients, and the public, to understand the basis for the Department’s apparently ad hoc decision making.

The Health and Life Sciences team at Mills Oakley look forward to working with our existing clients, patients and health practitioners to ensure further progress is made in facilitating access to medicinal cannabis in Australia.

[1] Schedule 1 (Part 1) of the Therapeutic Goods and Other Legislation Amendment (Narcotic Drugs) Regulation 2016 (Cth).

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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