Senate debates

Thursday, 19 October 2017

Bills

Medicinal Cannabis Legislation Amendment (Securing Patient Access) Bill 2017; Second Reading

9:44 am

Photo of Slade BrockmanSlade Brockman (WA, Liberal Party) Share this | Hansard source

With indulgence, I want to thank all the members of the Senate for their warm words of support and encouragement following my first speech a couple of days ago.

The government will not be supporting this bill. The issue of medical cannabis is a recurring one that the government has resolved in a way that provides access to those Australians who need it, makes the use of medical marijuana a medical decision and keeps adequate safeguards in place to ensure access is not misused. It has been made clear that medical cannabis is potentially valuable in some cases, particularly in a palliative care setting, but the media surrounding this bill has, unfortunately, been extremely misleading. Central to this false campaign is the allegation that the Office of Drug Control is breaching legislation by not permitting the import of medical cannabis products for use in Special Access Scheme category A. There is no truth to this. It is based on a misinterpretation of a letter sent to existing importers under the bulk import policy reinforcing the standards of their import permissions and how they are conditioned for supply under the Special Access Scheme category B and Authorised Prescriber Scheme. This letter was a necessary measure to ensure the regulations were being followed, due to the fact that at least one importer interpreted the disallowance motion as meaning that they could supply under the Special Access Scheme category A, which was not allowed. Doing so would breach the conditions of their licence and potentially be subject to regulatory action under the Customs Act 1901. The letter contained no language that stated or implied in any way that they could not import product for the purpose of supplying under category A. The Office of Drug Control has always been very clear about this and has always given Special Access Scheme category A swift application processing times—I understand it's a one-day priority processing time.

There have been five notifications to the TGA since the disallowance motion, but the Office of Drug Control has only received and processed one import permission application for category A. In accordance with the regulation, namely regulation 5 of the Customs (Prohibited Imports) Regulations 1956, the office must thoroughly and necessarily make an assessment of each Special Access Scheme category A importation.

I feel it's important to note at this point that this scheme was established by the government in October 2016, with bipartisan support, in order to ensure access to medicinal cannabis for terminally ill patients. This issue has been looked at extensively by the parliament—and often with a bipartisan approach. The Legal and Constitutional Affairs Committee report in 2015 was one such example. This report covered extensively the safety and efficacy of medicinal marijuana and the regulatory framework around its use. One thing that was very clear from this report was that, at best, medical benefits of marijuana are equivocal, untested and in need of further research. The report said:

For example, Professor Wayne Hall, Director of the Centre for Youth Substance Abuse Research at the University of Queensland, expressed the view that the current research indicated medicinal cannabis is 'at best, modestly effective for some purposes (for example vomiting and nausea) and probably for others (for example chronic pain, depression, muscle spasm)'. Professor Hall stated:

'An informed policy towards the medical use of cannabinoids requires much better evidence than we currently have...we need clinical trials of the safety and efficacy of CBD and other cannabinoids in treating intractable epilepsy and chronic pain. Evidence from these trials is essential for rational decisions to be made about the medical use of cannabinoids.'

The Royal Australasian College of Physicians considered that 'while medicinal marijuana shows some potential for certain patients, further research is required to determine its efficacy and it should be subject to the same scrutiny as any other medicine'.

Painaustralia expressed the view that, for individuals with chronic non-cancer pain, there is little proven evidence for the effectiveness of cannabinoids in helping patients, and that it did not endorse the use of cannabinoids for this group of patients 'until such time as a clear therapeutic role for [cannabinoids] is identified in the scientific literature'.

On a point of clarification, medicinal cannabis can be administered in a variety of ways that do not include smoking, which very obviously carries heavy known risks. These include oral administration by a pill, oromucosal spray, tinctures, ointments, the ingestion of oil derived from cannabis plants and vaporisation of a herbal product. As a side note, the Turnbull government also does not support changing the current legal status of vaping for a number of reasons, but, first and foremost, that there is limited scientific and medical understanding of the effects. Evidence, when making these kinds of regulatory decisions, is vital.

The science and evidence behind medical cannabis is complex and incomplete. The Australian government is taking advice on the matter from the Therapeutic Goods Administration and medical professionals, including the Australian and New Zealand Society of Palliative Medicine and the Royal Australian College of General Practitioners. These professionals agree with the current arrangements and do not support the changes as set out. It is potentially dangerous to patient safety to allow access to medicinal cannabis products through the Special Access Scheme category A, due to the fact that unlike other unregistered medicines under this scheme, with the single exception of Sativex, which is a formulated extract of the Cannabis sativa plant, no medicinal cannabis products have been subject to a full safety, quality and efficacy assessment by a competent medicines regulator anywhere in the world.

If government allowed medical products onto the market that have not been properly tested, we would be rightly criticised and all those opposite would be the first ones to stand up and criticise us. There is no easily accessible evidence of safety available that can be used to guide prescribing decisions that work in conjunction with the various medico-legal obligations that doctors have to their patients. Despite all this, I want to make it quite clear that terminally ill patients already have access to medicinal cannabis products and are gaining access to them. In consultation with their clinicians, patients are able to gain timely approvals from the Therapeutic Goods Administration to prescribe the medicine under Special Access Scheme category B, and that can happen in as little as one day. Any rhetoric about excessive delays or wait periods is false. The delays are occurring where the prescribing doctor has insufficient knowledge of the product, along with the risks and benefits associated with the medicine, and, therefore, cannot justify their decision in prescribing it, or cannot describe the product which they wish to prescribe.

For any condition, it is never in the best interests of the patient to have an ill-informed medical practitioner prescribing their care. However, this is a delicate matter and an area where having an informed doctor at the heart of these decisions is crucial. The government's policy on medicinal cannabis is central to a medical decision. It puts the medical professional at the centre of the decision to prescribe. In this way, the government adheres to the advice of the medical profession. If the medical professional does not support the use of a particular pathway, then the government will listen to that advice. Naturally, there are those who are strong supporters of medicinal cannabis being extremely accessible and seek to increase the availability of the drug. However, this is not necessarily a choice that the medical profession endorses. For example, on 13 June this year, AMA president Michael Gannon said:

… doctors are reluctant to prescribe medicinal cannabis. This is no different to any other new drug, new technology, new operation; we want to be assured of the safety, assured of the effectiveness.

Again, if governments weren't able to be very sure of the safety and effectiveness, and if doctors are not sure of the safety and effectiveness, then I think criticising the current regulatory regime is a mistake.

The Australian government has a responsibility to the Australian people to ensure the changes we make in this space are not done recklessly or without adequate forethought and research. Michael Gannon later said in the same interview:

… let's not forget, we're talking about cannabis, we're talking about a substance that, used in the form it's used by most people, is a major source of mental illness in our community. It's absolutely essential that we're assured that whatever's being brought into the country, whatever's being brought in for prescription is safe …

Beyond our own legislation, Australia is subject to a number of different international obligations that exist under various treaties, including the Single Convention on Narcotic Drugs 1961, which specifies the obligations of signatory states for narcotic drugs listed in various schedules to the UN convention. The Department of Health in its submission to an earlier inquiry into this issue noted that the Commonwealth is responsible for the implementation of Australia's treaty obligations, stating:

The Commonwealth is responsible for the implementation of international agreements that it enters into and generally has the power to make legislation to implement Australia's treaty obligations. Accordingly, the Commonwealth is responsible for ensuring that any Commonwealth, State or Territory medicinal cannabis scheme is consistent with Australia's treaty obligations under the three drug control conventions …

Further to this, obviously, we do have an additional layer of complexity in our federation, which is that states and territories have their own initiatives in this space.

While the government will use many different sources to make decisions about the use of medicinal cannabis, we listen to the medical profession, and I think we need to continue to do that into the future. There is a demand for medicinal cannabis, and the path we currently have in place allows a safe, legal and effective way for terminally ill patients to gain access to medicinal cannabis. As of 17 October, there have been 287 individual patients who've been given access to medicinal cannabis either via the Special Access Scheme or an authorised prescriber. Additionally, there have been 21 licences granted for domestic cultivation: nine for medicinal cannabis cultivation, six for further research and six for manufacturing. So, we can see that the scheme is working. It is allowing patients who feel that they need this drug, with the support of their medical practitioner, to gain access. On that basis, the government will not support this bill and will not be looking at making changes to this regulatory environment.

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