RESET! Briefing Document V14 April 2018
Current version RESET14
Download the full set of 5 .pdfs (5mb) in a .zip file
Here is our latest RESET! briefing document. If you are short on time just read the first 2 pages, which I have also reproduced below under "10 minute RESET!"
You can read the latest version in new window or review here:
RESET! Regulations Part 1 Guidance changes
This is the first of a set of 4 documents to make the regulation changes that we need to implement RESET! This first document makes changes to the guidance documents, which are written in plain english, so my changes are also plain english. You can read the latest version in new window or review here:
RESET! Regulations Part 2 - Poisons Schedule Amendment
For a full explanation of this document please see RESET! at Page 28
Here is a Legislative Instrument I have prepared to reschedule medical cannabis to match the RESET! proposal. My understanding of Parliamentary practice is this needs to be introduced into the House of Representatives, and then tabled in the Senate by the Government to sit for 30 days to allow for motions to disallow. You can read the latest version in new window or review here:
RESET! Regulations Part 3 - Narcotics Drugs Regulations
These changes relate to procedural fairness in the issuing of licenses, a reduction in some excessive fees and a clarification that "bonds" do not forfeit if not called on. You can read the latest version in new window or review here:
RESET! Regulations Part 4 - Other Matters
For more information please see RESET Page 30. These changes relate to clearing the way for medical cannabis to be approved and listed on the ARTG with the urgency the matter deserves. There are also a series of new regulations in Section 3 to add clarity to the ODC's rules in respect of cultivation, processing and transport which were far to vague to provide the clarity necessary to make an investment decision. You can read the latest version in new window or review here:
10 minute RESET!
Every day 275,000 Australians break the law to illegally access medical cannabis. As many as one million Australians do so every year (source AMA). Clearly if a legal medication worked they would use that and not risk breaking the law. With public support for medical cannabis standing at 91% (Roy Morgan), it is hard to understand why the Government is being so intransigent.
Medical cannabis was banned at the start of the pharmaceutical age because, as a natural substance, it cannot be patented. When our own Prime Minister has investments in big pharma and Lucy Turnbull chairs a pharmaceutical company with products directly competing with cannabis their intransigence suddenly makes sense.
The recent discovery of a human endocannabinoid system perfectly matched to the cannabis plant has re-ignited the debate on medical cannabis. The cannabis plant contains cannabinoids that are normally made by the human body – yes our bodies make cannabinoids! A normal body can make enough and does not need an external source. Someone who has suffered a trauma, major illness or has a weak endocannabinoid system can’t make enough of their own, and so will benefit from cannabinoids from an external source, such as cannabis. Cannabinoids are also found in other plants such as turmeric & black pepper.
So for the first time we have the scientific understanding of the way in which cannabis heals the body – it is not a drug, in that it does no work directly on the illness - rather it is a complementary medicine that helps the body’s own healing process.
The Government has had their hand forced by the weight of public opinion, the success of legal cannabis overseas and a recent ruling by the United Nations that CBD should not be regulated. The Government’s response was to pretend to legalise medical cannabis. They introduced amendments that did indeed provide the legislative framework for legalisation. However they then brought in regulations that are so complicated & labour intensive that only a few hundred people have been able to get approval. Many who have put in strong applications have been denied, so there is something else going on within the authorising agencies other than just bureaucracy.
RESET! works with the existing system, making changes to the regulations to make medical cannabis more accessible.
We support local growers using best practice to produce raw plant, which is then turned into medicine using the UN’s own best practice manufacturing (called GMP). From there we use the new Fast Track Approval System to get product into chemists quickly, while being registered on the ARTG (Australian Register of Pharmaceutical Goods) so it can be prescribed by doctors via the Pharmaceutical Benefits Scheme (PBS) to anyone with a medical need. The arbiter of that medical need is of course their doctor, not a bureaucrat in Canberra.
The Office of Drug Control and the TGA have already produced regulations to cover growing, processing, manufacture, packaging and licensing. Most of those are workable, a small number reflect a lack of understanding of the subject matter and have been re-worded for clarity more than anything else.
AT all times RESET! stays within the requirements of the United Nations Convention on Narcotic Drugs. As long as we are in the UN we do not have any other choice. Mind you we can fix that!
RESET! opens with a series of statements that in a meeting would be called “move the balance”, listing which regulations are not going to be changed, for clarity. Then:
- Reschedule cannabis from Schedule 8 to Schedule 4 (Prescription only medication) and add an additional listing under Schedule 3 to permit non-internal use for skin creams and pet medications. This is a simple explanation, see Scheduling for more information.
- Create an expert subcommittee in the existing TGA committee system to advise the Secretary on the merit of each medical cannabis application & help with workload;
- Add Israel to the list of Approved Countries to take existing data from, as they lead the world in medical cannabis research and are currently excluded;
- Introduce procedural fairness into the ODC rules, especially in respect of the personal information being requested for licensees (they want 50+ years of applicant personal history);
- Changing the wording of bond to actually mean bond and not a fee;
- Change the 10J requirement that every plant must be sold before it is grown, by adding an additional contingency for spoilage that can be traded between license holders to maintain continuity and quality of supply;
- Explicitly state a license is for 3 years unless surrendered or revoked;
- Toned down some aspects of the security requirements that were not workable;
- Specified the forms of medical cannabis allowed as:
- pill and capsule
- liquid for vaporization or nebulization
- topical forms for skin conditions
- blended green plant (aka smoothie) sold similarly to Nudie juices
- Dried or fresh unprocessed green leaf is not included. This will be controversial and I explain the reasons later in this document.
- Inclusion of medical cannabis products on the ARTG so Doctors can prescribe and also listing those medications on the PBS so they can be subsidised.
- Clearer rules on growing, insuring, transporting and destroying unsold or damaged cannabis. These do not change the ODC rules, they just take out the guessing game about what will and will not bring a large fine.