Introduction
- In 1961 the Single Convention on Narcotic Drugs came into effect.
- Cannabis is in Schedule IV of the Convention.
- Australia is a signatory to the Convention.
Australian authorities have often pointed to these facts and then gone on to further assert that our ratification of this instrument therefore requires Australia to criminalise all aspects of cannabis use. This is not so. It can be argued that the opposite is in fact the case.
Article 2 of the Single Convention directs that a signatory shall consider the prevailing conditions in their country. And, if in its opinion the prevailing conditions in its country render it the most appropriate means of protecting the public health and welfare, prohibit the production, manufacture, export and import of, trade in, possession or use of Schedule IV drugs.
Note that the Convention directs that a scheduled drug be treated in a criminal fashion (prohibited) if a signatory country deems that this is the most appropriate means of protecting the public health and welfare.
In Canada, Croatia, the Czech Republic, Israel, Mexico, the Netherlands, Peru, Portugal, Spain, Switzerland and in parts of the United States legislatures have recently undertaken assessments as to prevailing conditions and have determined that the criminalisation of cannabis use is unwarranted.
Now, in Australia, there is occurring a similar reassessment as to whether or not the criminalisation of the use of cannabis is the most appropriate means of protecting the public health and welfare.
Every jurisdiction which has ever provided this subject with any degree of lucid rational appraisal, considered the scientific and medical literature, and heard patient testimony, has been left in no doubt that for some people cannabis is a vital medicine that is absolutely required.
The most difficult problems that will be faced by the NSW inquiry will not relate to deciding whether or not cannabis might be a medicine. (These assessments are entirely outside of the committee’s jurisdiction and pay grade and have already been made elsewhere by scientists, doctors, & hundreds of thousands of your very own constituents.)
The most difficult problems faced by the committee will relate to the fashioning of regulations that will enable patients to gain access to a vital medicine even while its use for non-medical purposes will still attract criminal penalties.
The Recreational Elephant in the Medicinal Cannabis Room
In jurisdiction after jurisdiction, all around the world, the developing of regulations and practices enabling a medicinal trade in cannabis has focused on putting up Chinese Walls to insulate the legal trade from an illegal ‘black market’.
Where the use of cannabis for industrial, recreational, or other pursuits is illegal and is subject to criminal sanctions there is no way in which a rational regulatory regime can be developed.
Until such a time as the black market is done away with then the regulatory framework that must be erected to facilitate the provision of medicinal cannabis to patients is so ludicrously complex that it is almost unworkable.
Such a circumstance leads to a number of identifiable faults which are manifestly evident in the regulations pertaining to medicinal cannabis in the United States & Canada:
- The cost of the material input will be grossly inflated.
- Regulations and paperwork will be ludicrously abundant.
- Physicians will be put in the frontline to act as ‘gatekeepers’ for recreational users.
- Citizens will be encouraged to lie to gain access to recreational drugs.
- Citizens will be encouraged to regularize their consumption of cannabis by treating it as a required therapeutic agent.
- Pharmaceutical companies will be required to erect elaborate security systems to guard a herb.
- Many people who might find work in a legal industry will be precluded from the industry (as they have experience in the industry).
- Our court system will be asked to arbitrate on medical matters.
- The medical & therapeutic market will bleed into the black market.
- The black market will bleed into the medical & therapeutic market.
- The regulations that are crafted will be focused on protecting and policing at the expense of facilitating and enabling.
- The medical cannabis industry will be targeted by organized crime groups.
- The cost of policing cannabis use in our society will increase rather than decrease.
Rational Cannabis Regulations
The HEMP Party of Australia is confident that any rational assessment relating to the most appropriate means of protecting the public health and welfare of Australians will recommend that all criminal penalties associated with cannabis be removed.
It is a further observation that no rational suite of regulations governing the production, distribution, sale, prescription, and dispensary modality, regarding medicinal cannabis can be drafted while cannabis use within the community still attracts criminal penalties.
This of course begs the question: what are suitable and appropriate regulations governing the production and use of cannabis in our society?
The commercial production, distribution, and sale of cannabis should be regulated like all other commodities within our community.
- As a recreational agent the social use and commercial production and distribution of cannabis should be regulated and taxed in the same way as wine.
- As a therapeutic agent its social use and commercial production and distribution should be overseen and regulated by the Therapeutic Goods Administration (TGA) and its distribution and sale regulated and taxed in the same manner as are all other therapeutic goods.
- For all other uses (industrial, hempseed oil, hemp meal, fibre, stockfeed, etc etc) the commercial exploitation of cannabis as a crop should be governed by appropriate regulations formulated and overseen by an industry association (i.e., the HEMP Farmers Association of Australia).
Personal use and cultivation for personal consumption
- As there is no level of personal use of cannabis at home that might occasion any significant level of harm then the HEMP Party believes that the regulation of personal cannabis use at home is inappropriate.
- The appropriate level of regulation for the personal use of cannabis at home is none.
- As there is no level of cannabis production at home that might occasion any appreciable personal or social harm the HEMP Party believes that it is inappropriate to regulate the production of cannabis at home for personal use.
- The appropriate level of regulation for the growing of cannabis at home, for personal consumption, is none.
Negative consequences?
The following observations from an essay by Professor Nutt entitled ‘Hypothesising an alternative: Applying the scientific process to drug policy’ should be borne in mind:
“There is good evidence that decriminalisation does not radically increase drug use and can reduce some measures of harm, as shown by a balanced review of the first ten years of the Portugal experience of decriminalisation.”
“An increase in the availability of some drugs may actually lead to a reduction in the use of other more harmful drugs, so reducing net harms to society. We saw a noteworthy example of this in the past few years with the advent of the stimulant mephedrone. As this became popular, cocaine users seem to have switched to mephedrone and cocaine deaths fell by almost a quarter.”
“Approaches which explicitly reject an evidence-based public health approach, but instead focus on incarceration and criminalisation of addicts, continue to utterly fail, at enormous financial and human cost.”
“It is now time to begin to introduce a more rational evidence-based approach to drug policy to minimise harms. We must consider all drugs, including alcohol, as part of the problem to be tackled.”
Developing pharmacopoeia & prescription guidelines for Australia
An agreed scale of variation and grading?
In the UK there is no state/federal divide, so there is no corresponding need to worry about overly ambitious state legislation being slapped down as being unconstitutional. There is also, effectively, only one level of government that needs to be convinced of a need for change. Perhaps this is why the debate in the UK seems to have at times moved a little further than it has in Australia?
At least there has been some discussion about possible prescription practices that attend the use of cannabis as a medical agent. There has also been some quantitative work undertaken in sampling seizures of cannabis and in trying to correlate the type and potency of the seized drugs with the stated intent of the user (ie – recreational / medical). This quantitative data is of immediate interest.
Executive Summary from the HOME OFFICE CANNABIS POTENCY STUDY 2008:
- This study was funded by the Home Office. It arose from a recommendation in the 2006 Cannabis report of the Advisory Council on the Misuse of Drugs (ACMD).
- The proportion of herbal cannabis has increased markedly in recent years.
- In 2002 it was estimated that it represented around 30% of police seizures of cannabis, but by 2004/5 had reached 55%.
- Twenty-three Police Forces in England and Wales participated in the study. Forces were requested to submit samples confiscated from street-level users. In early 2008, they submitted 2,921 samples for analysis to either the Forensic Science Service Ltd (FSS) or LGC Forensics at Culham (LGC F).
- Initial laboratory examination showed that 80.8% were herbal cannabis and 15.3% were cannabis resin. The remaining 3.9% were either indeterminate or not cannabis.
- Microscopic examination of around two-thirds of the samples showed that over 97% of the herbal cannabis had been grown by intensive methods (sinsemilla). The remainder was classed as traditional imported herbal cannabis.
- Regional variations were found in the market share of herbal cannabis. Thus North Wales, South Wales, Cleveland and Devon and Cornwall submitted proportionately fewer herbal cannabis samples, whereas Essex, Metropolitan and Avon and Somerset submitted proportionately more. These differences were statistically significant at the 0.1% confidence interval.
- The mean THC concentration (potency) of the sinsemilla samples was 16.2% (range = 4.1 to 46%). The median potency was 15.0%, close to values reported by others in the past few years.
- The mean THC concentration (potency) of the traditional imported herbal cannabis samples was 8.4% (range = 0.3 to 22%); median = 9.0%. Only a very small number of samples were received and analysed.
- The mean potency of cannabis resin was 5.9% (range = 1.3 to 27.8%). The median = 5.0% was typical of values reported by others over many years. Cannabis resin had a mean CBD content of 3.5% (range = 0.1 to 7.3%), but the CBD content of herbal cannabis was less than 0.1% in nearly all cases.
- There was a weak, but statistically-significant, correlation (r = 0.48; N = 112; P < 0.001) between the THC and the CBD content of resin.[1]
A similar wide variation in THC/CBD intensities and proportions has been detected in seizures in the US: Upon analysis by GCMS, the potency of the 42 sinsemilla samples was determined to range from 10.2% to 31.6% THC, with a mean of 19.4%. These results were surprisingly high, given that the average potency of marijuana in the U.S. has been typically estimated at around 3% to 4% by NIDA, with higher grade sinsemilla ranging towards 10% - 15%. The highest potency recorded came from a sample of hashish, which registered 68.6%. Yet even a sample of Mexican commercial grade registered a surprisingly high 11%, twice what we had expected. All of this cast a troubling shadow of doubt on our test results, although it appeared likely that we were dealing with highly potent varieties. …
In contrast, the CBD levels observed were surprisingly low. Only four of the sinsemilla samples had more than 0.3% CBD, and 35 of them had only trace amounts (<0.1%). However, one sample had an astoundingly high CBD content of 28.0% (plus 11.6% THC). Another registered 5.6% CBD and 13.4% THC. …
As for CBN, the majority of samples showed only trace amounts. The highest level detected was 1.4%, and only one other sample tested above 1%. CBN is a breakdown product of THC, so high CBN levels are expected in old, degraded samples.[2]
Implications for Australia
A review of the models currently in use in other locales does not provide for an uncomplicated list of statutes, codes, and charts amenable to any sort of easy translation to suit Australian conditions. Scientific work in overseas jurisdictions points to a need to not only encompass considerations relating to THC potency, but also levels of CBD and the relative age of the plants used as source materials (via CBN), also several more amorphous factors such as ‘harshness’ and ‘aroma’.
Requisite technical processes and methodological abilities are available, here, within NSW. What is not available is an agreed upon scale of variation and grading, formulated in a manner sufficient to meet the requirements of the Australian therapeutic goods environment.
The Therapeutic Goods Administration has detailed requirements regarding the sourcing, grading, processing, purity, weight, packaging, and documentation relating to all medicinal substances that might be distributed in our country. Most of these requirements can easily be met regarding medicinal cannabis. What is lacking are descriptive and definitive classifications enabling the sorting of various grades of cannabis relative to precise prescriptive directions.
A wide variability in the source stock available for medicinal cannabis production is probable (going by overseas experience) but this is something that can be suitably controlled for if careful attention is paid to all the potential variations that might be of import in the generation of an applicable Australian Standard for medical cannabis (and thence associated regulations governing the dispensing of the drug).
In an Australian Standard:
- the THC and CBD levels need to be located within a preferred potential therapeutic range.
- Testing for CBN is indicated as a control for old or overly mature stock.
- a subjective assessment of the quality of the source stock (aroma/harshness) should be incorporated.
Pharmacopeia practice.
It is essential that any Dispensary (trial or otherwise) only provide cannabis to those particular patients meeting the precise requirements dictated as sufficient to obtain a prescription. Prescription verification procedures must be mandatory and defined in regulation. Any leakage or illegal provision of cannabis to non-patients will act to discredit the dispensary model and will undoubtedly be counterproductive in a number of ways.
All cannabis stocked within a Dispensary Pharmacopoeia must be of a defined strength (potency), type (strain), and weight. Every gram must be traceable directly, via a paper trail, back to the grow-up process. This paper trail must be plainly reviewable and amenable to audit.
Procedures, regulations, and rules, overseeing Dispensary operations should be formulated in association with medical advice and this process largely guided by the best-practice of institutions currently operating dispensaries in California and Canada.
In some instances the Californian experience might prove to be the best guide (relating to the institutional practices of dispensary and grow-up) whereas other aspects of the project might be better off looking to the Canadian experience (regarding the integration of the project within the established medical environment in Australia).
Best practice?
No entirely successful models for meeting the needs of providing source stock for cannabis pharmacopeia seem to exist, however some simple observations might be made:
- Dispensaries must be able to licence individuals or corporations to grow cannabis source stock for their pharmacopeia.
- TGA regulations should be formulated regarding the process of dispensing medicinal cannabis.
- TGA guidelines should be formulated regarding the testing and grading of medicinal cannabis.
- The TGA should formulate Australian Standards regulating and defining grades of medicinal cannabis. Medical authorities should formulate prescription / recommendation methodologies utilising Australian Standards that define grades of medicinal cannabis (and their associated therapeutic attributes).
- Any medical cannabis regime in Australia must encompass a legal facility for patients to grow their own cannabis at home.
- Provision must be made to assist patients in assessing and quantifying the potency and characteristics of cannabis produced at home.
References:
[1] Sheila Hardwick Leslie King Home Office Cannabis Potency Study 2008.
[2] Dale Gieringer, Ph.D. ‘Medical Cannabis Potency Testing Project’.
December 2012 - James Moylan
