Senate Community Affairs Legislation Committee, , 2:30:00 to 2:34:28
Officials from the TGA and Office of Drug Control discuss the consultation process for regulating unapproved medicinal cannabis products and the growth of telehealth prescribing models.
Topics: Health, Law reform
Speakers: Prof Anthony Lawler, Avi Rebera, Senator Malcolm Roberts
Again with the cannabis industry and the feedback was that the TGA and the Office of Drug Control have no program in place to change current medical cannabis regulation. Is that accurate?
Thank you. Thank you for the question, Senator Arve, Assistant Secretary Office of Drug Control. Can you be a little bit more specific in terms of what regulations they're actually looking at in terms of wanting to change?
Can you just answer the question, please? Do you have any do you have any programme in place to change current current cannabis regulation? That's all.
Okay, thank you, Senator. So there has been a consultation that was undertaken late last year to look at the current regulation in terms of unapproved medicinal cannabis products and consideration around that current pathway that's being used by the industry to supply unapproved medicines. So the consultation was undertaken because we understand and there's been feedback from industry around concerns around the use of an unapproved product that hasn't been assessed by the TTA. And so part of that reform work that is being undertaken is looking at whether or not we need to make some changes to the regulation in relation to unapproved medicinal cannabis products and processing that. So there is consideration being undertaken at the moment from that aspect in relation to regulating code.
Fairly minor.
One of the reasons that we that I think we're probably keen for clarification, um, Senator, is that is that the TJ and the ODC have kind of regulatory touch points in a number of number of elements uh with respect to medicinal cannabis, including licensing of imports, um the way in which it's cultivated and grown, but also very specifically, I think to this question around the increasing use supply and access uh to medicinal cannabis. I think it's important to note that uh there are only a couple of uh approved medicinal cannabis products on the Australian Register of Therapeutic Goods, and as a consequence, kind of something like 98 or over 98% of the medicinal cannabis is accessed through our unapproved goods pathways, predominantly um authorised prescriber and special access. There's been clear indication from a number of uh very um uh engaged stakeholders, uh which includes the um health professionals uh but also states and territories uh who are seeing um the impact of increasing medicinal cannabis use, particularly in their health services and emergency departments around whether our uh regulatory settings for access to these unapproved goods remain uh fit for purpose. Uh there are a number of questions on notice that we've answered, including at the last estimates. I think it was um SQ 2602814, a few questions from Senator Wish Wilson around the process of consultation that we'd undertaken. Our focus is very much on safety. Uh our uh processes for providing access to unapproved goods have been established because it's obvious that there are instances in which goods that aren't on the register are appropriate for for patient care. They include through uh pathways such as the personal importation scheme, clinical trials uh and uh and also as I've mentioned the um special access and authorised prescriber schemes, but there is increasing concern me that the um rapid uh growth in uh in the prescribing of medicinal cannabis through these pathways, particularly given the interface with um novel um models of care, including online models, telehealth, uh the growth in social media advertising, but also through what we call vertically integrated models, where rather than seeing a health professional with a particular problem uh and uh and having treatment for that, you kind of get onto these services uh and you want a particular substance and you get a particular substance provides us with a level of concern. So we undertook a consultation, uh, the TGR undertook a consultation publicly last year from August to October on the use of medicinal cannabis unapproved products and the fitness of purpose for our um for our uh access pathways uh and the feedback that we've received from that uh will um inform regulatory reform options for government consideration in due course.