24/03/21 | Senate Estimates | Community Affairs - Medicinal Marijuana
Senator VAN: Dr Skerritt, can you advise the committee of the countries that currently import medicinal cannabis into Australia?
Dr Skerritt : Australia, as time goes on, has significantly sourced manufacture—
Senator VAN: You don't need to be exhaustive.
Dr Skerritt : The countries from which we current import medicinal cannabis are: Canada, the UK, the USA, Austria, Columbia, China, the Czech Republic, Denmark, Germany, Israel, Jamaica, the Netherlands, New Zealand, Spain, Macedonia, Switzerland, Taiwan and Uruguay.
Senator VAN: How many registered producers of medicinal marijuana are there in Australia?
Dr Skerritt : We have issued 153 licences to 89 individual entities.
Senator VAN: What standard does the imported product have to meet? Is it an Australian standard, or is it an overseas regulatory standard?
Dr Skerritt : It's an Australian standard, which is set up in a therapeutic goods order, which is a legislative instrument made under ministerial delegation that sets the quality standards.
Senator VAN: For all products or just Australian products?
Dr Skerritt : It sets the quality standards for all products. The difference between Australian and imported cannabis is that domestically manufactured cannabis at the moment is required to be made to GMP standards. A public consultation, which has closed recently, was looking at whether that un-level playing field should be levelled between domestic and imported cannabis. A recommendation to the minister will be made in due course.
Senator VAN: So it is not currently—
Dr Skerritt : Currently, there isn't a requirement for imported medicinal cannabis to be made to this GMP standard, although it does have to meet this other standard known as Therapeutic Goods Order 93.
Senator VAN: Is the imported product held to a higher or lower standard than the Australian product?
Dr Skerritt : At the moment it could be argued that the standard is lower or less stringent, but that is currently under review by the government.
Senator VAN: Are there medicinal regulatory requirements around the Australian production and security of production for medicinal marijuana?
Dr Skerritt : We don't regulate security of production for offshore facilities. Different countries have different—
Senator VAN: No; for Australian producers.
Dr Skerritt : We do have specific requirements for security of production in Australia.
Senator VAN: You were saying that work is being done to level the standards.
Dr Skerritt : This is about the manufacturing quality, not the security issues.
Senator VAN: On those standards, what is the difference between, say, microbial counts or mould counts, et cetera in the Australian standard and the European ones?
Dr Skerritt : The same applies for both. It's for manufacturing quality. In a nutshell, domestically manufactured medicinal cannabis at the moment has to be manufactured under pharmaceutical-grade manufacturing conditions. With international, often it might be food or some intermediate between food and medicinal grade but again, that may change subject to government consideration. A public consultation is out. It has recently closed and soon will be providing—advice is the wrong word—what people said and providing government with options for a decision to be made.
Senator VAN: Currently, the European standard for, say—let's pick one—a microbial count would be less or equal to 500,000 CFUs per gram.
Dr Skerritt : The standard is exactly the same for domestic and imported medicinal cannabis because that's set up in TGO 93, Therapeutic Goods Order 93, which applies to both lots of cannabis.
Senator VAN: That's not what is understood in the industry—
Dr Skerritt : We meet with the industry regularly. I'll check with Mr Masri. You're meeting with the industry association at nine o'clock tomorrow morning?
Mr Masri : We're meeting with the industry on Friday.
Dr Skerritt : Friday, sorry; not tomorrow.
Full transcript here.
