This submission is made to the committee on behalf of in response to the proposed amendment to change the current Poisons Standard to create a new schedule 4 entry for cannabidiol (CBD) for therapeutic use with consideration of an Appendix D listing.

object to the proposal because it does not include the whole plant (cannabis) in its raw form. The most natural form of cbns and cbds occur in the fresh leaves of the cannabis plant, fresh non-dried leaves only release cbds you must dry and heat cannabis to receive the high from THC.

Although there have been many studies world wide supporting the use of raw cannabis make this submission on the grounds experience with this, after

THC - the ingredient that gets you 'stoned' - is not accessed at all in raw form.

The raw cannabis plant is a herb - not a drug

The cannabis plant has huge potential to heal in many ways. quality of life no longer a burden on the public health

system by taking responsibility decisions.

Endocannabinoids are natural in . CBNs react & work with endocanabinoids these can be accessed from the raw plant without the need of pharmaceutical imitations.

Why should expected to accept artificial cannabinoids when actually access all the cannabinoids from the raw plant? If the health department is serious about and determined to push preventative health - then to leave the benefits of the raw plant out of the equation would be seen by the public as bordering on insanity. It makes no sense.

There is absolutely no justifiable reason why we should have to settle for a synthetic version, that would be discrimination against a great many people in this country

Education is the key to success in this area, we as a country cannot afford to ignore cannabis & its healing potential especially with our aging population.

Scheduling CBD as a S4 (doctors prescription only) would only benefit a few and disadvantage too many. There would be thousands of people who would miss out on the benefits of cannabis due to prescription only and the cost. Why should this be the case, when people could raw form which can

?

Freedom of choice to discard pharmaceutical medicine should be standard.

do not harm others. How can this not be good?

Thank you for the chance to put to the committee

Kind Regards

references follow

references

explains this in very simple text:

" ...... cbns from the Cannabis plant not hemp have been recognised world wide for

its: healing potential since 1974, in America it has been recognised that unburned

cbns from the cannabis plant can cure a number of diseases is an antibiotic for

auto immune diseases these test were done on mice given oral cbns. The U.S

government holds a patent on this for a reason. In 1992 it was discovered that the

human body has endocannabiniod receptors that react to cbns

cb1s were proven to react with central nervous system, sleep pain memory mood

smell appetite & liver activity & gastrointestina l activity

cb2s were proven to react with periphera l nervous system,immune system &

gastrointestinal activity ... "

recommends eating

- or juicing and then drinking- raw cannabis leaf and bud as a way to achieve

mega dose therapeutic impact from marijuana without psychoactive effect. The

green plant contains tetrahydrocannabinol (THC} in its acid form, THCA, which is

not psychoactive. ----> http:/ /www.alternet.org/ .. ./juicing-raw-cannabis-miracle .. .

For some people, it still remains difficu lt to distinguish between the plant's

therapeutic and recreational uses.

http:/ /www.globalhea lingcenter.com/natural-hea lth/juicing-raw-cannabis-eating­

raw-cannabis/

Submission:

support the use of natural botanical medicinal cannabis flower and extracted cannabinoids for medical purposes in support the regulated commercial growing and processing of cannabis for medicinal and research purposes in The reasons support this are outlined below:

Reasons supportive of medicinal cannabis In the past year, have done extensive research – internet, watching TV reports, conversations with individuals who have used cannabis medicinally, newspaper reports, social media, reading medical books/reports, etc. (Please see for example, appendix A – copy from book regarding cannabis use for epilepsy, and appendix B - regarding Lyme disease). research has lead to conclude that it would be worthwhile trying medicinal cannabis – there is nothing to lose by trying it, and potential significant health and wellbeing outcomes to be gained.

believe that not only will the anti-convulsant properties of medicinal cannabis likely be of significant benefit also the anti-microbial properties of medicinal cannabis will further help in reducing seizures and lead to better quality of life outcomes research has established that every herb reported as having anti-seizure properties have one further factor in common - they all have anti-microbial properties).

Doctors are very hesitant to keep him on long-term antibiotics due to the risk factors, such as impairing the immune system, digestive problems that can arise, etc. From all reports

Submission

read, it seems individuals can be on medicinal cannabis long term without any side-effects. Additionally, understand it can be safely used alongside other herbal and alternate treatments. Medicinal cannabis is renowned for its anti-microbial properties – this will undoubtedly assist

achieve better, and sustainable health outcomes. Furthermore,

medicinal cannabis reportedly can relieve all these symptoms.

believe medicinal cannabis would offer the only remaining hope better health and wellbeing outcomes, throughout the past year, have considered purchasing medicinal cannabis (without a prescription). After hearing and reading about other people’s successes,

The legislation prohibiting medicinal cannabis is failing our family. If medical cannabis were permitted to be prescribed and used in , there are potential: a) quality of life outcomes for

From conversations with friends and acquaintances, it seems medicinal cannabis is a major current topic – in favour of it. Some s have made contact and asked whether

have considered medicinal cannabis . There appears to be strong community support and willingness to discuss.

believe the time to act is now – not only because of the community support, and individual needs, but also because of the commercial advantages. has an ideal climate to grow cannabis. also have the willingness and expertise of farmers and scientist. As has had a very successful medicinal opiates industry for decades as well as a range of herb-growing ventures, there is much expertise and community support for expanding into further medicinal botanicals, namely medical cannabis. economy could be significantly boosted by providing another agricultural product, by processing the botanicals locally, and by using the expertise of scientists (such as ) to research and develop techniques from growing through to processing of the cannabis products. These are jobs for . By having a properly regulated and scientifically/medically controlled industry, individuals will be much safer – people who are taking extreme risk by sourcing cannabis from non-regulated providers – the strength of the product is not controlled, the variety of cannabis used is not guaranteed ( understand that to achieve best outcomes, different strains are used for different ailments), the levels of THC/cannabinoids are unknown, and the hygiene of processing is unknown. Additionally, by accessing cannabis illegally, the continuity of product and access is tentative, as people will likely need to constantly find new suppliers are some are shut down due to

Submission:

police action as a result of current legislation. There is a need to have quality controlled medical cannabis prescribed (at a minimum, all registered GP’s should be able to prescribe, but ideally, we would like to see registered herbalists also permitted to prescribe). The only way to ensure the safety of individual users is to have a scientifically-based quality control and prescription system in place. If acts now, there is potential of establishing an industry prior to too many patents being taken out on cannabis products/processing systems, which will make it harder to establish a successful based industry in the future. Please see attached example (appendix F) of big pharmaceutical companies attempts to cash in on the industry through patenting products (much more can be gleaned through further internet research, so this is just one example). If wait too long, will run the risk that not only will multi-national pharmaceutical companies have the power to control where the raw material is grown and processed, but they will also have the control over the amount paid to farmers for growing their products – this could make it economically unviable for medical cannabis to be grown in , thus a product could be lost from agricultural sector – particularly farms. At the moment,

could have an edge in the market by producing not only quality cannabis products in a state that is highly trusted for growing and processing medicinal botanicals, but also by developing a niche market of organically-grown medicinal cannabis

. Additionally, if acts now, prior to too much of the market being controlled by multi-national pharmaceutical companies, there will be significant savings to the government in subsiding prescriptions through the PBS (see again appendix F), as the costs will likely be signicantly lower if the growing, processing and scientific/medical research is done in , producing uniquely

products. Furthermore, all the profits will stay in , rather than going off-shore to multi-national corporations. Additional benefits to could be realised with: less patients in hospital (eg less episodes of continual severe seizures); less costs for a range of pharmaceuticals to be subsidised; more people being able to return to work (eg those recovering from Lyme disease, or carers not having such a demanding workload).

believe medical cannabis industry will have significant social, economic and environmental outcomes for need it now.

This submission is made on behalf of the- under subsection 42ZCZK of the Therapeutic Goods Regulations 1990 (therreQUrations) in response to the proposed amendment to change the current Poisons Standard to create a new Schedule 4 entry for cannabidiol (CBD)for therapeutic use with consideration of an Appendix 0 listing.

The- is strongly opposed to the amendment being proposed. II Reasons for this are many. In summary they are:

0 it is not in the best interest of the majority of Australians ; 0 it is an unnecessary, costly, bureaucratic administrative step that will slow the forward progression of the legalisation of Cannabis medicine, for very little gain; 0 all sufferers who can benefit from whole-plant Cannabis' therapy will continue to suffer and will remain disadvantaged and in fear of prosecution ; and 0 in the opinion of reasonable minded Australians, if accepted, this proposal amounts to mal administration by the policy makers that will result in an unfair, unjust and unreasonable practice being established that is improperly d i scri minatory.

Explanatory Notes At present no hemp product is "legal" to consume in Australia- the only country in the world to hold this view. The stubborn determination to keep it this way since 2008 by successive governments, despite the Food Safety Standard Committee's recommendations, is shameful in light of such overwhelming evidence world wide that confirms hemp as a super food. This decision needs to be addressed before any CBD product could be even be considered for internal use.

Cannabis extract (Nabiximols) has ALREADY been approved as safe and effective "medicine" by the TGA process- despite it being a plant extract. The people who need access to it via the "right channels" are being blocked at every turn by red tape and circular mazes which seem designed to forestall and frustrate. Ask anyone who has tried .

1

Cannabis is not a 'one-cannabinoid-fits-all' treatment. The healing power lies in full-spectrum whole plant extracts. Cannabis might be 'new' to the pharmaceutically trained, but been used for centuries. Consumers are now turning back to it in increasing numbers, as they know it as being a safer alternative to many pharmaceutical preparations. Australians are fed up with the risky side effects of 10 pills for one illness and the outrageous prices being charged. This cannot be justified when cannabis has the potential to be one medicine that could address10 problems; and can be grown for the price of a tomato plant. Surely you MUST recognise the implications of this, in reducing dependence on the health budget! Most health professionals are not acquainted with the endo-cannabinoid system and its connection with homoeostasis; or the system's ability to syphon off exactly what it needs and store or eliminate the rest from full-spectrum of cannabinoids in whole plant therapy and rely on anti drug agencies for information. Mental illness is no longer a valid reason to keep cannabis medicine from the people. Along with the Gateway theory, road carnage and an increase in violent crime - all dis-proven by statistics and news reports coming from legal US states. The therapeutic benefits of cannabis considerably outnumber any perceived threat to public safety. Alcohol poses more risk of harm to society than raw cannabis – but its use is condoned and encouraged by governments who continue to refuse to ban advertising or sponsorship deals with – including promoting it on apparel. Such hypocrisy makes a mockery of harm minimisation claims. For struggle daily with afflicted with intractable epilepsy or terminal cancer and other illnesses - this proposal offers crumbs. They are so desperate for legal access to cannabis' healing properties, they are willing to settle for this now. Every day they live in fear of having their taken from them - by death or the authorities. They have been running the gauntlet of the law for too long! Those affected by Iatrogenic disorders or rare and/or orphaned diseases for which there are 'no treatments', have turned to whole-plant botanical cannabis as a last resort and are experiencing undeniable results. In fact current research points to a group of baffling diseases that appear to be caused by cannabinoid deficiency. These people will be disadvantaged by this proposal as will glaucoma sufferers and cardiovascular patients. Individuals, victims of crime, ex service personnel, and emergency service personnel who can benefit most from whole plant therapy for treatment of PTSD are being left out in the cold. CBD does not work on the correct ECS receptors to bring symptom relief. Evidence suggests that this may be why cannabis became popular as a 'social' drug of choice in the 1970s by . A study is currently being conducted into this area in the US. CBD alone, is totally incapable of the exceptional results we are seeing in the media. The results being experienced by real patients, and come from whole-plant therapy, with a balance of THC and CBD working in synergy with the full-spectrum of cannabinoids (the “entourage effect’’); and Terpenes which clear and reset the receptors in the body to make

2

them more readily available for cannabinoids to attach. Without the terpenes the effectiveness of any cannabinoid is reduced. To put cannabis therapy (and any proposed trial) into the hands of doctors, would be a backward step. It will take too long to get results the community are getting now. The compassion networks have been operating for a long time and are trusted by those who have been totally let down by the conventional treatment. Thousands of Australians are already using or making their own cannabis preparations. They have no 'fear' of the medicine – only of the law. They trust it because it helps put an end to their suffering. A blueprint for compassionate clinics offering alternatives to sufferers is being developed. Doctors could learn from compassion networks which have learned from the international community and offer individualised care-plans that treat the mind, body and spirit as one, in a gentle stress-free environment that is much more conducive to the healing process. These support clinics can offer the full gamut of treatment including cannabis medical products; dietary advice and supplements; lifestyle changes, encompassing techniques like relaxation, meditation, massage, acupuncture, counselling, record keeping and making their own oil. Individual protocols are formulated. Healthcare is a personal choice. These healing centres could work in tandem with licensed growers - ready to grow the most appropriate variety for each individual - assuring a sustainable, consistent and safe supply of the cleanest raw product. These type of centres would be an invaluable asset to the health system lacking in public confidence and choice. Healing centres of this kind could only be possible on a larger scale, if cannabis were more appropriately classified as a botanical complimentary and this knowledge base utilised. Terminally ill do not have time to wait for doctors/ researchers to reinvent this wheel.

This proposal was submitted by the . It makes references to : • With the current public interest in cannabis as a medicine and with at least two therapeutic products containing cannabidiol in the pipeline

there are strong reasons to reconsider how cannabidiol is scheduled in the SUSMP.

is a man-made synthetic. It is not in the

public interest to use Plastic CBD.The public interest lies in trialling the real thing. • Definitive and specific scheduling of cannabidiol will ensure regulatory certainty for those conducting clinical trials with this substance.

The is the only one we know who considering conducting trials....

It seems the ship is being steered in the direction of synthetically produced “cannabis” medicine. This amounts to misleading the Australian people. The speculation floating around has been born of mistrust. There has been no

3

transparency or indication of what is being considered by the working committee, until this press release dated 15th October appeared on the internet:

“..An Australian Company has recently been given the go-ahead to grow high CBD hemp for medicine in for medicinal purposes, it was announced today. The has seen the potential for industrial hemp medicine production in Australia. The type of medicine being seen throughout the media recently being successfully used for Epilepsy, Cancer, Parkinson’s and other significant modern diseases are now able to be grown and processed in Australia...."

“...High CBD hemp’ Crops are expected to be planted within the next few weeks in . The special breeds selected from are based on decades of research into special cannabinoid varieties bred specifically for medicinal use.....

….Hemp seed oil, low in THC and high in CBD is now available legally in Australia for external use. No claims are able to be made until legislation and TGA approval has been approved – expected early next year....”

This proposal to schedule CBD as S4; the timing of this 'out-of-session' meeting; this press release; and the Premier needing a decision by December on a Cannabis medicine trial, all point to one thing – the safe and easy way out - a CBD only trial. Our next concern is about where this product is to come from. Australian farmers are so bound up in gov. red tape that it is not a friendly industry to be involved in and unless the noose is loosened on the licensing procedures, it will remain the case. These prospects have been extremely distressing to the people of Australia who expect a FAIR TRIAL with REAL cannabis like they have seen in the media. That is what most Australians are counting on because they want to make informed, balanced choices about their health care needs – this path stands in the way of that right.

Re: Appendix D listing: When looking at the additional controls being considered on possession or supply, believe they are not applicable and totally unnecessary.

are talking about non psychoactive CBD oil extracted from industrial hemp plants. Cannabidiol is a single substance that in no way, shape or form can get users “high” and holds no appeal in the illicit market. Therefore: it has no “ specific health risk” that may be mitigated by restricting availability through specialist medical practitioners” it has NO “specific high potential for abuse”, (warranting) “restrictions on availability” it has NO “significant potential for illicit diversion and/or abuse” as it has no

4

marketability or value because it cant get you “high”. there are no “specific health risks” - mood stabilisers, mood enhancers and changed perceptions are wanted effects of psychiatric medications; and psychosis can be caused by alcohol, prescription medications, genetics and childbirth... it needs NO “further restrictions on access” - it needs the noose loosened. there are NO “ implications for professional practice by affected healthcare practitioners and regulatory control by the states and territories. “ ADDITIONAL REASONS for Objection: CBD is not a poison and is non psychoactive therefore it need not be on the SUSMP at all and it should not require a script. One reasons for opposing cannabidiol (CBD) only, is that it is not a 'medicine' – it is aggressively marketed online as a 'dietary supplement'. It is not dangerous nor toxic. Responsibility for self medicating presents little or no risk to the user or to the safety of the public – in much the same way as Vit C or panadol poses a negligible risk. There was no scientific validity in the reasons for Cannabis being included in the schedule in the first place. It was based on manufactured hysteria. Cannabis was a respected therapeutic agent from 1840 until 1937. to relieve menstrual pain. There is no legitimate reason to use synthetic man-made CBD primarily based on cost; when Hemp extract is a botanical, recreated with uniform precision by nature herself and could be readily available to all now, at little cost through using the raw product as an extracted juice. Any and all attempts to bring about the medical use of cannabis have been stonewalled by the AMA and stalled by successive governments for decades. To make CBD available on prescription only, is putting it in the judgemental and ill-informed hands of medicos - who have long ignored its potential and medicinal properties, to the detriment of public health - some of whom may not to inform, recommend or offer it to patients. the only restrictions placed on it should be that it is a product of Australia - using ONLY the Australian grown product and manufacturing companies. As a soil rejuvenater, imported hemp goods may come from tainted or contaminated source. Any product imported should be thoroughly tested here before use of imported product is approved. CONCLUSION If considering any re scheduling, it would certainly make more sense in the long run, to consider de scheduling hemp and cannabis completely at this time. This would in turn give agricultural industry a boost and allow trials to go ahead unimpeded by

5

suffocating restrictions.

The Secretary of the Commonwealth Department of Health, has the power to initiate a change in the Poisons Standard under the SCHEDULING POLICY FRAMEWORK FOR MEDICINES AND CHEMICALS:

4.5 Amendments to the Poisons Standard initiated by the Secretary Under section 520(3) of the Act the Secretary has power to amend the Poisons Standard on- own initiative. In the Secretary's opinion, there may be a need to initiare": scheduling review on the basis of information that becomes available. This information may be provided to the Secretary by a member of an advisory committee or the Department. When the Secretary decides to amend the Poisons Standard on • own initiative this is a final decision. The Poisons Standard is amende'd'in accordance with the procedures required to amend a legislative instrument.

It is by- definition a "botanical" and fits snugly int- complimentary medicine criteria.

This simple act would also make the access to cannabis' medicinal properties FAR less complicated and costly - in terms of time and human suffering - by cutting unnecessary red tape. America is on the brink of de schedul ing. The court rulings here, reflect the judicial opinion and the commonal ity of occurrence, of people fronting them for legitimate and demonstrable medicinal use, resulting in their being 'let off' in increasing numbers. There is NO need for this aggravation for sick people either.

More and more countries with simi lar or greater populations than Australia are ignoring the "treaties" that are way past their use-by date when it comes to modern science . The Secretary of the TGA has the power, under the act, to make scheduling decisions without political interference. Recommendations need to reflect what is really happening and should include a directive to advise all states and territories to remove the word 'cannabis' from all criminal legislative instruments and ensure that all non violent life- ruining convictions be squashed.

There is no justification or scientific evidence anywhere that confirms cannabis is harmful to humans. SMOKING cannabis is what is harmful. - medical users are acutely aware of th is and avoid this method of administration .

Cannabis medicine has gained acceptance and respect by the general populous, not only for its curative benefits, but in the variety of ways it can be administered . Ingesting it - raw as juice or vegetable matter; made into edibles; as an oil or tincture; vaporising; topically as ointment -even via suppository - all options.

It's most appropriate place is in the Complimentary Medicine market. This allows for patient choice and doctors to supervise a patient's progress and record resu lts (trial) of their patients care choice without fear of de registration .

are adamant they will continue to grow or seek out and buy the medicine as this is a safer alternative than to RISK

buying dodgy online though they fear the law - they need and trust cannabis more. NONE are criminals and should not be treated as such.

6

It is hoped that this collective of scientific minds will not remain overly cautious this time on this long drawn out issue. There are over 20,000 articles and fresh evidence coming out of recognised institutions almost daily, saying cannabis is good medicine – can only hope this will not be ignored. To continue to deny its therapeutic value to the masses, based on the perceived 'risks' of social degradation being the end result, boarders on negligence. It also brings the credibility and reasoning of the decision makers into question by the public who are well informed on the topic and expecting a FAIR TRIAL of cannabis medicine. It is time the doctors who tell patients from behind their hands to “keep doing what they are doing” came out of hiding. To bad they will not get the opportunity to speak up without fear of repercussions Finally, please keep in mind that the people are the end users of these products – their knowledge and input must be considered and respected. Thank you for the opportunity to contribute to this important issue Yours Sincerely

REFERENCES From CBD Hemp Oil is a dietary supplement made from Industrial Hemp. It is not Marijuana. It is available in all US states. No permit or prescription required

FOOD AND DRUG ADMINISTRATION (FDA) DISCLOSURE:

The content of this website has not been evaluated by the FDA and is **not intended to diagnose, treat, or cure any disease **

Press release

7

CBD Alone does NOT Treat Epilepsy Effectively

October 22, 2014/

This is not surprising to anyone who is knowledgeable about cannabis. Cannabidiol is a powerful anti-inflammatory with some anticonvulsant properties, however, tetrahydrocannabinol (THC) is a powerful anticonvulsant and anti-spasmodic compound. Also, these compounds work in synergy with one another and the other phytocannabinoids which naturally occur in the cannabis plant.

.Since all facts, scientists, medical researchers, patients, and informed doctors know that CBD-oil alone is not an effective medical treatment, then why are so many legislators pushing "CBD only" legislation? Because it's easy and safe.

Cannabidiol lacks the psychoactive properties of THC, but it also lacks comprehensive medicinal efficacy

There is no CBD/THC debate amongst the experts; only the morons. Here's a question for the people who think that CBD only is effective: "Why don't one~ products that are legally available work like whole plant extracts?" - and others offer CBD tinctures that aren't worth the bottle in which they're packaged.

EXAMPLES OF LAB TESTING OF CBD OILS

" .. ... Over the course of the past year, cannabid iol , or CBD oil, has quickly become the rock star of the medical marijuana industry because of its ability to treat a variety of conditions -- including epilepsy -- without exposing patients to intoxicating effects.

However, the cannabinoid is still illegal in most of the United States, which has provided an opportunity for some hemp businesses to market a variation of knockoff CBD treatments that they claim have the same healing power as popular strains such as

complaints about some of these products, claiming they were making them sick, a

ucation - called Project CBD - launched a full-

8

practices.

Interestingly, Project CBD found that all three companies featured in the operated by the sam~ and shows that both subsidiaries of- .

These companies are infamous for making claims about their legal hemp oils being significant sources for CBD because they are derived from imported hemp paste -implying that legal hemp oils are a suitable alternative to CBD medicine.

are

Yet, as the report indicates, these products are only technically similar and do not provide the same health benefits as high-CBD cannabis strains .

• bel ieve that industrial hemp is not an optimal source of CBD, but it can be a viable source of CBD if certain hemp cultivators are grown organically in good soil and safe extraction and refinement methods are employed," wrote the authors of the report .... "

Project CBD assigned a writer to investigate and report on -a penny stock umbrella company that markets "hemp oil" pr'OcJUCtsinfused

canna (CBD), a medicinal component of the cannabis had hoped to shed light on the complex financial machinations subject that had been addressed by a few stock market general interest publications.

Project CBD was poised to publish complaints from several sources t

research when II heard

when they

I decided to delay re was any truth to these

in some cases "violently ill," product. whether

Ill investigation proceeded in an unanticipated direction, involving analytical lab tests, hemp oil production tours, and a crash course in scientific data regarding toxic solvents, heavy metals, and other contaminants. llhave presented II findings in this report.

One thing brough--u in this artic le that concerns me is on page 23, it points out that the products sold by have been found to contain heavy metals and decomposition-res1s an my co oxms derived from fungi ..... .

Document revised on November 4th 2014

I

Studies and trials

Several pharmaceutical drugs have been developed which either contain or have similar chemicals as those found in the cannabis plant. Some researchers have used their understanding of how the brain processes cannabinoids to develop drugs which follow the same pathways but work differently than marijuana.

A sample of those pharmaceutical drugs based on marijuana are listed below with their names, trade names, manufacturers, cannabis-related properties, suggested medical uses, and approval statuses.

PROHIBITON had no BASE in SCIENCE or MEDICINE

a over smoking marijuana was simply a smokescreen for to revent the cultivation or i of

patents on chemicals used in manufacturing plastics, paper, a pa valueless if hemp products and hemp oil derivatives became widely avai lable. But how could they prevent this harmless weed from making their billion dollar patents worthless?

Easy. Outlaw hemp cultivation and im rtation. But first the ublic needed to be convinced that he was an "evil".

10

In 1930, the Federal Bureau of Narcotics was created to enforce then existing laws regulating and prohibiting the use of opiates, heroin, and cocaine. In 1933 the Volstead Act was a led the of the 21st Amendment.

transitioned to Co ner . Between 1930 and 1937,­

nced several m~ on, more and more states, inundated with

outlawed the harmless herb.

I

Submission under subsection 42ZCZK of the Therapeutic Goods Regulations 1990 (the Regulations): To create a new Schedule 4 entry for cannabidiol for therapeutic use with consideration of an Appendix D listing

experience researching the nature and treatment of cannabis use disorder including the use of nabiximols and cannabidiol (CBD) in the management of cannabis withdrawal.

It is not clear from the invitation for public comment for the out-of-session meeting of the ACMS this month in which section of Appendix D of Schedule 4 it is proposed to place CBD. Inclusion with (synthetic THC) in section 3 would be less concerning than Section 1 with Nabiximols (botanical THC and CBD) as prescription by any authorised medical practitioner would markedly affect availability.

CBD is not currently being used as a standard therapy for any condition but has been investigated extensively in the laboratory over the past 20 years. In animal studies it has been receiving growing attention for its antiemetic, anticonvulsant, anti-inflammatory and antipsychotic properties. The action of CBD is stereospecific and it elicits its effect via antioxidant action and the inhibition of uptake of the endogenous cannabinoid anandamide. CBD possesses affinity for CB1 and CB2 receptors in the micromolar range. However, despite this very low affinity, CBD seems to antagonise CB1/CB2 agonists with KB values in the nanomolar range. Some have suggested that the reason for these conflicting findings may be that CBD acts as a non-competitive inverse agonist, thereby blocking the ability of agonists to activate CB1/CB2 receptors. Moreover, CBD has been found to antagonise the putative novel cannabinoid receptor GPR55, and the abnormal-CBD receptor. There is also evidence that CBD activates 5-HT1A serotonergic and TRPV1–2 vanilloid receptors, antagonises alpha-1 adrenergic and μ-opioid receptors, and inhibits synaptosomal uptake of noradrenaline, dopamine, serotonin and gaminobutyric acid and cellular uptake of anandamide at micromolar concentrations. Finally, CBD has been shown to both stimulate and inhibit the activity of fatty amide hydrolase (FAAH) which is responsible for the degradation of anandamide.

Following intravenous administration, CBD is rapidly distributed, followed by a prolonged elimination phase. It undergoes a significant first-pass effect leading to the formation of a number of metabolites, most notably 7-hydroxy-CBD and CBD-7-oic acid. Bioavailability of oral and smoked CBD in humans was found to be around 13-19% and 31%, respectively, providing further support for a substantial first-pass effect. Following a single oral administration in human volunteers, maximum plasma concentrations of CBD typically

Page 1 of 3

occurs 30-60 minutes after dosing. The half-life of oral CBD has been found to be 2-5 days. CBD has been studied at doses of up to 1280mg in controlled clinical trials of up to 4 weeks duration. The pharmacologic effects of CBD are dose-related and subject to considerable inter-patient variability but considered safe overall. No significant adverse events have been reported, however there is a potential for sedation at doses in excess of 1400 mg per day.

The internet is replete with false claims for the effectiveness of cannabis/THC/CBD in curing a variety of conditions including cancer, with its use in rare and tragic cases of intractable childhood epilepsy receiving wide media acclaim. These claims are largely based on in vitro animal models and parental anecdotes. Despite widespread availability of “medical marijuana” in the United States, it is not by medical prescription or specialist supervision and no clinical evidence of its efficacy has arisen over that time. As a result, the findings of the one or two high quality clinical trials into the use of CBD with Dravet’s Syndrome and similar conditions soon to be available are widely anticipated, despite the rarity of these conditions.

are currently undertaking a study using 600mg BD of oral synthetic CBD in an open-label pilot study with participants undertaking an inpatient admission for cannabis withdrawal. The committee may be aware that CBD is widely advertised on the internet, however, pharmaceutically pure CBD is more difficult to obtain and extremely expensive. Clearly price depends on the volume purchased, however, paid £83.20 per 300mg capsule for 100 capsules. In such an unregulated market the costs of developing a pure and stable product will be large and commercially unattractive (just as nabiximols is not commercially available in Australia as is not importing it). It is reasonable to predict that once the general public perceive CBD is approved by the TGA for its medicinal effects, the marketing of non-legitimate and unregulated oils and related preparations, which claim to be pure CBD, will greatly increase.

While the notion of making CBD more widely available is superficially attractive as a cannabinoid researcher, the unwanted effects are extremely concerning. The principal issue is that it will then be extremely difficult to undertake any scientific research using the double blind randomised controlled trial design that is required to indicate clinical efficacy for various conditions; as those seeking CBD can just access it via prescription without the need to engage in clinical trials.

Given there is NO evidence arising from human clinical trials of the conditions for which CBD may be efficacious this proposed wide availability of CBD ensures such research will not be feasible in this country in the future without disproportionate financial compensation to study participants to attract them into such studies. As there is no evidence of efficacy, failing to provide CBD via prescription is not depriving anyone of access to best practice treatment at this time. In the absence of an evidence-base the following questions are moot:

Page 2 of 3

• For which conditions might CBD be appropriately prescribed? • For which conditions is it contra-indicated? • Can it be used during pregnancy/lactation? • What other medications are contra-indicated with CBD? • Is it safe for infants and children? • At what dose? And by what protocol for titration? • At what frequency? • By which method administration, oral or vaporised oil? • In what form, synthetic, botanical or either? • For what duration? • What are the possible adverse effects in very high self-administered dosage

(>2G/day) • How much should be available in each prescription? • How frequently can prescriptions be filled? • If botanical – what level of THC or other cannabinoids/terpenes will be allowed? • If botanical can it only be sourced by GW Pharmaceuticals or similar licensed

companies or can cannabis growers provide uncertified CBD oils? • Can medical practitioners provide their own CBD oil preparation to patients via

prescription? • What training should medical prescribers of CBD undertake?

submit that until these questions can be answered in the same manner for CBD as other medications available under Schedule 4D it should not be included.

References available upon request.

16th November 2014

Page 3 of 3

Date: 16th November 2014

To: The Advisory Committee on Medicines Scheduling

Re: Proposed amendments to the poisons standard: To create a new Schedule 4 entry for Cannabidiol for therapeutic use

Thank you for the opportunity to make comment on the proposed amendments in relation to Cannabidiol (CBD) due to its therapeutic benefits.

undertook significant research and investigation into the benefits of Cannabis as a Medicine, including the benefits of Hemp as a nutrition source, and most especially the benefits of products high in CBD.

under the impression that the CBD contained within the Hemp/Cannabis plant was the most beneficial of all the Cannabinoids of the plants makeup; however purely CBD based treatments were not available to me at the time of commencement of our trial.

. Hemp seed oil is a nutritionally valuable product in its own right, rich in Omega 3 and 6, protein and more.

involved in the debate relating to the legalisation of Cannabis as a Medicine since

share information and offer families support, hope and a place to discuss their thoughts. Within the first month, this site had over 40,000 visits, highlighting the community interest in the use of Cannabis as a medicine.

Cannabis if used as a medicine, especially in the treatment of seriously ill patients, should be subject to medical regulation, recommendations and dispensing; in order that individual patients receive the most appropriate care relevant to their particular health requirements. Speaking out publically in relation to the use of Cannabis as a medicine has brought with it significant family and financial hardship. As an example, the respite service that assists

in the health industry and see the value of patients being treated with CBD based medications, and Hemp seed oil for the nutritional and health benefits they provide. There is evidence that CBD may be useful in the treatment of some forms of epilepsy some cancers, neurologically degenerative diseases, Schizophrenia, Diabetes, and a range of other medical conditions, and including drug dependency and with-drawl. The nutritional benefit of Hemp seed oil alone would assist in the management of malnutrition, one of the greatest co-morbidities with any significant illness. Malnutrition leads to: reduced ability to fight infection, poor wound healing, increased falls risk, reduced mental acuity and more.

hope that the Food Ministers will sign off on a change in legislation relating to Hemp as a food product early in 2015. CBD medications and Hemp seed oil as a nutritional product complement each other in relation to overall patient health and wellbeing.

but also from the research undertaken in relation to , and that of its

benefits to the general population, that rescheduling Cannabidiol from a schedule 9 substance to a schedule 4, would lead to significant benefit to patients, and their families, who are suffering from a range of significant and debilitating illnesses and conditions. CBD being a Schedule 4 medication would also mean that doctors could prescribe these medications

would be able to administer the medication according to the doctor’s drug chart orders. Rescheduling would also be a significant step forward in our medical history, in relation to ongoing research potential, and patient care. Thank you again for the opportunity to express opinion on this matter and happy to discuss this further, at your convenience.