This year due to COVID, the Australian Medicinal Cannabis Conference 2020 is being hosted virtually, and we have had many generous presenters come on board to share valuable information and experience.
For those who are mainly concerned about the ODC regulatory updates (doctors and patient access topics excluded) I’ve summarised the main points from Adj Professor John Skerritt’s presentation and the ODC Q&A session below:
Regulatory update from the Australian Department of Health
As of 30th September the ODC have received 317 applications:
- 128 of those granted (52 cultivation, the rest research or manufacturing)
- 113 rejected/not accepted/withdrawn
- 47 permits granted (13 cultivation, 34 for research or manufacture).
The TGA have also granted 9 GMP Licences.
Single Licence Model and Administration
- Single Licence Model is being tabled for discussion in Parliament this December (or early next year at the latest) and will come into effect next year.
- As of the 1st Nov, changes to fees for manufacturing licences and permits have been implemented.
- The ODC also intend to increase their staff from 20 to 32 by the start of 2022.
There will also be changes to the information required in permits so you will no longer need to provide:
- detailed production schemes
- strain details
- cropping schedules
- limits on activities, etc.
The ODC has indicated that the details required in the future are likely to include only:
- nature of the products
- specified categories of supply to be undertaken
- overall maximum quantities you expect to handle.
They have also proposed that variations to permits will only be required if there is a significant volume change, or if you want to go from high to low THC and vice versa. These changes to the permitting process will include targeted consultation with stakeholders scheduled in December this year.
Update to ODC Security Guidance for high vs low-THC crops
Major changes have been made to the ODC Security Guidance which I’ve gone into more detail here. The changes have a huge impact on both the industrial hemp and medicinal cannabis industries.
Q & A session with the ODC
Note the content below is to be taken as discussion only. As mentioned by Prof Skerrit in his presentation, there are multiple medicinal cannabis industry consultations scheduled for the future and the ODC encourages all stakeholders to participate in a more formal forum. Also, until there is an official announcement or update of the parent regulator sites, it is best to defer to the current regulations.
Q: Could you provide an overview of amendments to the Narcotic Drugs Act?
A: A year or so ago the review conducted by John Mc Millan made several recommendations to streamline the regulatory burden on the ODC. The first tranche of reform occurred at the beginning of this year through updates to the Narcotics Drug Regulations, and the amendment to the Narcotic Drugs Act tabled for December will form the second tranche of reform, and includes the key issues in the report such as the single licence scheme. We will also be looking at section 11K – as it has been brought to our attention that it puts further burdens on the industry especially in regards to TGO 93. We would like to highlight that the ODC is going to hold another forum/webinar during the week of the 7th December, which will give more details and understanding of the Bill to be introduced. Details are on the ODC website and we have also put out a consultation paper about the permits.
Q: Can Australian companies import bulk packaged biomass?
A: There are a lot of details to consider, biomass is not necessarily covered as an API or finished good which makes it difficult to give an answer. The biggest question is whether the biomass contains an active ingredient of interest.
Q: Can the panel please confirm Prof Skerrit’s comments around the cultivation of Low THC cannabis and being able to use the flower for extraction of CBD?
A: You will be able to do this but you need to get a licence from the ODC to cover you. You also have to comply with state and territory security as well as appropriate to the level of THC in the crop.
Q: How should the industry handle celebrities advertising medicinal cannabis products?
A: 3 main things: first report to the TGA via the online advertising portal, second drown out the advertisements with factual information, third counter them directly online. It’s hard to take action against someone who is using an offshore website so there is a lot of grey area. The best way is public education, so clearly state on your own website what the legal status of medicinal cannabis is. The ODC have also produced videos and content on medicinal cannabis access, on the TGA website.
Q: Could the ODC and TGA licence cultivators and manufacturers have an electronic portal akin to the TGA business platform?
A: The ODC has developed a case management system, and depending on funds available we have earmarked a portal for development as a part of our agenda.
Q: Prof Skerritt mentioned the recent funding for ODC means we can now (from 2021) resource the ODC to the levels required. Does that mean the ODC has been limited in its capacity to fulfill its regulatory obligations due to a lack of funding since 2016?
A: Previous funding was based on initial estimates for the industry and didn’t capture how complex the application process would become and how many applications there would be. As part of the funding review, we have been allocated a sufficient budget to match the bulk of the work (assuming compliance and monitoring will now take up the majority of the time). We may make further changes to the fees and charges depending on the outcome of the permitting consultation and single licence model activation.
Q: In Senate estimates last month, ODC representatives were questioned about the back-log of ODC licence applications. The ODC representatives said the backlog has ‘nearly gone’. Can you clarify how many applicants remain in the queue and how long they have been waiting?
A: Yes there was a backlog, but we now have a separate team to deal with it. The majority of the backlog has now either been processed to a final decision or is waiting on a decision from third party external agencies (e.g. for fit and proper person checks).
Q: With the rescheduling of the low-dose CBD to S3, given the low dose will make it hard to prove efficacy, will low-dose CBD be able to be dropped down further into complementary medicines?
A: A scheduled substance cannot be a complementary medicine, and there is no intent right now to take it below S3. We acknowledge the advice for low-dose was provided based on safety, not efficacy, and have had a number of consultations come through highlighting this. This will be something that the delegate will take into consideration later in the year.
Q: What kind of licence will a hemp grower need to supply flowers to the medicinal cannabis market?
A: The single licence will deal with that (so no need to choose between cultivation or manufacturing licences) – there are obviously other state and territory requirements. It also depends on the form the cannabis material is supplied – you may require a GMP licence as well if you want to make finished products.
Q: A clarification please; Cannabis for commercial research purposes, e.g. used in the development of new extraction processes or formulation methods, etc. but not for direct human use, even if very low in THC, is Schedule 9. Is this correct?
A: Research is generally S9 but materials in S8 and S4 can also be used for research.
Q: GMP implications for GMP raw material export for processing?
A: There are some exemptions for herbal products but some jurisdictions have strict requirements for API and would require GMP.
Q: Within 2-3 years, Thailand will begin exporting medical cannabis to Oz at a wholesale cost that is below Oz growers’ cost of production. These imports will be protected by three separate Free Trade Agreements, which prohibit import quotas or customs duties. Will Thailand’s imported products be on a level regulatory playing field with Oz’ domestic producers?
A: Importation of medicinal cannabis also comes under another area of ODC, we make no discrimination to the country of source, as long as the broad conditions for quality are met.
Q: Are there any plans for the ODC to consider allocating account managers to individual licence holders?
A: The ODC is moving from focussing on licence applications to the compliance and monitoring phase. There are dangers of having account managers as it does not let us allocate staff flexibly, also it can cause regulatory capture and we want to avoid regulatory decisions being made on the basis of individuals.
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