The Australian Government,

Department of Health.

Consultation: Invitation for public comment - Out-of-session ACMS meeting, November 2014

Email: medicines.scheduling@tga.gov.au(link sends e-mail) for items referred to the Advisory Committee on Medicines Scheduling.

Dear Sir/ Madam,

The large aging populations of Australia and other countries such as Switzerland rely heavily on taxes of a low population. Health cost is the largest expense with the aging sector of society. The largest benefactor of our health scheme for Australia’s Aging Population is decidedly Pharmaceutical Companies and not the taxpayers.

Therefore, one can say that routine medical care which must be spent on the active part of our nation is now being spent on the non-active part of our population.

suffer from . There is not much assistance available for ; however, there is expensive medicine available to treat anxiety.

imagine that most of population lives from day to day on Government Subsidised Medicine.

Have you considered the benefit that HOME GROWN CANNABIS will offer for the “older bones”? Many countries and states in the western world are recognizing the benefits of HOME GROWN CANNABIS and the large aging population. Below are some points I would like to make:

1. There is no cost to the taxpayer, or user. 2. Up to three year’s shelf life for home grown cannabis.

3. Relief is immediate. 4. It would be too late in the aging user’s life to be concerned with

“addiction”. 5. Reliable Sources have shown the health benefits of RAW cannabis. 6. Cannabis is relaxing, therapeutic, helps with sleep, energetic AND

recreational. (Many older folk are denied Alcohol recreation). 7. There are NO deaths related to RAW cannabis. 8. Older persons are generally known not to abuse substances. 9. There will be NO confusion with prescriptions. 10. Cannabis has been shown to invigorate the mind and most of all

(especially for elderly persons with muscular problems such as Post Polio/ Late Effects of Polio), it’s a muscle relaxant.

11. Medical institutions will be less “clogged” with the aged.

one concern:

Keeping Home Grown Cannabis safe from children together with other unauthorised persons.

Kindly consider my letter for your own research.

Kind Regards,

17 November 2014

Advisory Committee on Medicines Scheduling Therapeutic Goods Administration Department of Health Canberra ACT 2600

By email: medicines.scheduling@tga.gov.au

Submission Proposal to add Cannabidiol to Schedule 4, Poisons List

I offer some comments on the proposal to add cannabidiol (CBD) to edule 4 of the Poisons Stand ased on -

understanding of the experiences of the people who use their products .

• consider these submissions relevant to subsections s53E(l)(a), (b), (d) and (f) Therapeutic Goods Act 1989.

In- submission, cannabidiol should not be scheduled as a stand alone substance, because that is far from best practice in providing cannabis for medicinal purposes. The Schedule should be amended by adding "cannabis and its constituents" in its whole plant form.

- medicinal cannabis products are effective as whole products. ~ntain both cannabidiol and tetrahydrocannabinol (THC), in

varying proportions. They are able to adjust the mix, so that some of their oils and tinctures are mostly CBD, and some are higher in THC. But all contain both.

The- treating their~ith CBD oil will tell you that it takes quiteabitOf tinkering wi~o of CBD to THC in the oil to find what works best for need a higher dose ofTHC.

Preparations higher in THC tend to be good for pain relief, nausea relief and (famously) stimulating appetite, so these preparations would be favoured by people living with cancer or AIDS.

Medically, a legal regime which only allowed the use of CBD-only preparations would be not in the public interest. Cannabidiol is just one constituent of the 'benefits of cannabis graph' below, and by itself, does not work as well as it does with the rest of the plant.

The medicinal benefits of cannabis

Anabacc«tal lnhtbits (Jinur c.Ug10Wlh NtutOi)rotecbw Promoct-s bone 9'owth Atdutt~ MlzuN') and CO"WVUIWont. Reduces blood Sup,lf ltvth RfduCtS funct;On 11'1 tht 1mmunt Jnttm Rtducu enftlmmaton Rtducos uskolortt<y bloc~e Rtduct~ sm.d tncf'Stlnt cortrK'UO'k$ Rtducts vomrull9 and n•uw-a Rtllewspotn Rtliews an>Mty Stow. bKI.....,gtowth Supp.t.sst'l: muu:M ~p.Um\ Tr•nquoltztng TttltJ PIOflliiSU

Vascr.taxant

the - researcher who discovered THC, called it concept of many cannabinoids and other

constituents working in concert, synergistically. Information is available at http://www.internationalcbc.cornlblog/the-disaster-of-cbd-only-legislation/

It is important to avoid over reaction to the risk of intoxication as a "side effect". Considering the dire health circumstances of many who use cannabis medicinally, the possibility of some intoxication is of little or no consequence. People who use - products have not complained about any intoxicating effect. That includes - administering cannabis to --It is possible to isolate CBD from cannabis, but only at a very high cost. The cost of extracting it from the whole plant would have to be reflected in a very high consumer price for CBD-only products. And for an inferior product. Anecdotal reports from users o~the CBD-only spray, continue to be negative about its effectiveness compared to natural preparations.

The negative outcomes which flow from allowing a CBD-only regime are not in the interests of good public health.

•

To

The Therapeutic Goods Association,

P.O Box 100,

Woden, A.C.T

2606

12~ November, 2014

REF: Notice inviting public submissions under Subsection 4lZCZK of the Therapeutic Goods Regulations1990 Regulations.

The main objective: TO RE-SCHEDULE CANNABINOIDS ( e.g. Marijuana, Cannabis and Hemp) FROM SCHEDULE 8 TO A SCHEDULE 4 DRUG.

To whom it may concern

This letter is written in support of the re--scheduling of C•nnabinoids from a schedule 8 to schedule 4 drugs. The purpose of this letter Is to provide factual evidence ioto why cannabis is a safer drug alternative to tbqt of legal pharmaceutical drugs which are used as neurological drugs for the purpose of anti psychotics, anti depressants and anti inflammatory medication.

Referring to;

Section 52 E Secretary to take certain marten into account in exercising powers,

In exercising a power under subsection 52D (2) the Secretary must take the following matters Into account (where relevant).

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(a) The risks and benefits of tbt use of a substante;

The benefit of cannabis for medicinal purposes is the fact that cannabis does not cross the "Blood Brain Barrier" like opiates and alcohol do. This means tha~ when the body is heavily intoxicated by opiates and alcohol, The subject forgets to breathe or is unable to breathe.

The proof in opiates being capable of depriving the body of oxygen is demonstrated in post operative surgery. Patient's saturation levels and respirations are monitored regularly when they are receiving morphine for pain management. Patients are encouraged to breathe deeply and are given oxygen to ensure adequate oxygen intake.

Morphine acts on the central nervous system. Even in small amounts, morphine depresses the respiratory system. Morphine rarely provides pain relief, but in most cases reduces the level of suffering. Repeated use leads to physical dependence. (Harris, Nagy, Vardaxis, 2006, pg.1127).

Synthetic Opiates such as are legal and are prescribed for pain, are term relief. This is due to the fact that they lead to physical dependence. (Tiziani, A, 2006, pg.571).

Another benefit of medicinal cannabis is the fact that it is the only in~patentable substance that binds on synaptic nerve endings within the btain and central nervous system. When Cannabis binds on synaptic nerve endings, it does release several neurotransmitters, one of which has been discovered to be dopamine.

Dopamine is a neurotransmitter necessary for the brain and central nervous system as it assists with movement. Dendrites and Neuro - transmitters send messages to other dendrites an.d synaptic nerves within the central nervous system to enable body parts to move. ·

Alcohol and some anti psychotic drugs deplete dopamine within the brain and central nervous system and thus has potential to cause Parkinson's clisease. Parkinson's disease can also result from metallic poisoning from neurological drugs (Phenothiazine derivatives). (Harris, P, Nagy, S, Vardaxis, N. 2006, pg.1339).

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This substance is used in anti psychotic medication chlorpromazine and prochlorperazine. These phenothiazine derivatives are withheld from patients with severe CNS depression or epilepsy. (Harris~P,Nagy,S, Vardaxis,N,2006,pg.1339).

Pharmacologist- has discovered in his experiments with rats, that over a perio~oes restore damaged myelin sheath, (the cause of multiple sclerosis) which covers nerves within the central nervous system. Medical cannabis has been recommended for those suffering from Parkinson's disease and Multiple sclerosis.

has mentioned in. documentary on that there may ~ome minor risks

marijuana consumption in some young people 15 years and under. These risks may relate to a lack of co--ordination.

mentioned that this may be due to cognitive development and fine TTHlrTCOT" movement; it should also be taken into consideration that the brain is not fully developed until the age of 21 .

Several issues should be taken into consideration with regard to this statement, such as; what is the medical condition for the consumption of medical marijuana in the ft.rst place? Is the drug reducing the symptoms of neurological disturbances caused by epilepsy or Dravet syndrome or any others? What are the side effects from taking medical marijuana? Do these side effects outweigh the benefits to that of consumption of phannaceutical drugs? There is also the biological make up of the individual to take into consideration as well.

There is also the fact that some strains of marijuana are stronger than others., depending on what part of the plant is used for consumption and the route in which it is administered. Medical marijuana is going to act a lot faster through inhalation as it is binding on several sites such as the smooth muscle and other receptor sites within the brain and lungs.

A similar example ofthis can be seen through the use of bronchia dilators used by asthmatics and antibiotic ventilators used for swine flu.

Fertilizers and other chemicals used to cultivate the plant would have some bearing into the plant producing a stronger THC content than others. In the 1930s,

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hemp, marijuana and cannabis were not hydroponically grown under synthetic lighting. Chemicals and fertilizers have since changed in potency.

There is also the fact that due to cannabis being illegal in Australia since the 1930s-50s; there have been no past or recent placebo test trials conducted here in. Australia. There has not been any legal opportunity for consumers to try any other types of cannabis in order to see what works best and what doesn' t work in order to treat a multitude of illnesses.

(b) Tbe purposes for whicb a substance is to be used and the extent of use of a substance.

The purpose of the use of medical marijuana would be suitable for many neurological disorders, medical con.diti.ons such as post operative pain relief, chronic physical pain, manic depression and possibly other mental health illnesses. The extent of the use of the substance would be the same as any other pharmaceutical medication depending on the individual and their need for the drug.

(c) The toxicity of the substance. The toxicity of medical marijuana is nothing compared to that oflegal prescription drugs such as Lithium and Olanzapine. Lithium has potential to cause more brain damage to someone who may already have an acquired brain injury. Lithium can also cause more psychotic outbursts from those with acquired head injury suffering from bipolar disorder ( Tiziani,A,2006.pg.342). Olanzapine has serious side effects such as worsening of Parkinson's as it may antagonize direct and indirect dopamine agonists. (Tiziani, A, 2006, pg. 344).

(d) The dosage, formulation, labeling, packaging and presentation of a substance.

Pharmaceutical companies should be allowed to make medical marijuana oil for children suffering from neurological disorders. Doctors should be allowed to give prescriptions for such medication. The cost should be affordable the same as any other pharmaceutical drug .Adults who have chronic physical/psychological illnesses should be able to obtain a doctors certificate and should be given the opportunity to purchase a permit at a reasonable cost

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in order to grow 2 or 3 plants for medicinal purposes. Or purchase medical marijuana or cannabis in raw material, at an affordable cost. There should be dispensaries like chemists designed to sell medical marijuana and marijuana products such as eatables.

(e) The potential for abuse of a substaoce

There would be the same potential for the abuse of medical marijuana as there is for any other legal substance. The big difference is the opiates~ alcohol and any other prescription drugs are lethal. Alcohol causes alcoholic's dementia, liver disease, type 2 diabetes, pancreatitis, and blindness just to name a few. Marijuana is not toxic. It doesn't cross the ''Blood Brain Barrier." It doesn't destroy liver and kidneys through elimination like anti inflammatory prescription drugs and alcohol does. Marijuana does not cause violent outbursts like alcohol and some anti depressants and anti psychotics do. Medical marijuana has been proven not to be a dangerous drug. Substance abuse depends on the individual and the severity of pain or psychological needs the individual is suffering from at that particular moment of the individual's life.

(f) Any other matters that the Secretary considers necessary to protect public health.

The current state of affairs with these pharmaceutical legal drugs is in desperate need an overhaul. For close on 90 years of prohibition, too many people have lost their lives due to anti psychotics, anti depressants, anti inflammatory, alcohol, tobacco and opiates either through overdose, abuse over time, and accident.

(2) In exercising a power under subsection 5lD The Secretary must comply with any guidelines of;

(a) The Australian Health Ministers' Advisory Countil; and

(b) The subcommittee oftbe Council known as the National Co· ordioating Committee on Therapeutic Goods (or any replacement subcommittee);

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Notified to the Secretary for the purposes of tbls sedlon.

(3) In exercising a power under subsection SlD(l) tbe Secretary must have regard to any recommendations or advh:e of the Advisory Committee on Medicines Scheduling or the Advisory Committee on Chemicals Scheduling.

(4) In exercising a power under subsection 52D(2) the Secretary may seek advice from either or both of the following;

(a)Any committee that the Secretary considers appropriate (whether or not the committee is established under this Act or the regulations);

(b) Any person.

In conclusion to this applicati~ I would like to mention that the war on drugs is not working. The Government and Health Ministers should be looking towards the "Drug Law Reform and the Ten Point Plan for Effective Drug Laws••.

Government Leaders, Health Ministers should focus on these laws. The first one being the most prominent and that is;

1) Treat drug use as a health and social issue. not a law enforcement problem. (Cuny,S, Cameron,D,2000,pg.572).

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Bibliography

Currie, S, Cameron, P, 2000, "Your Law", tbird edition~ Moreton Bay Publishing, South bank. Victoria, Australia.

Harris, P,Nagy,S,Vardaxis, N, 2006, "Mosby's Dlctionary,"Elsevler, Marrlckville, N.S.W, Australia.

Tiziaui.A, 2006, "Harvard's Nursing Guide To Dru&s, "seventh edition,Elsevier, Marrickville, N.S.W, Australia.

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Submission to the TGA regarding the proposed amendment to the Poisons Act from the WA Health Dept. requesting the de-listing of CBD and its prescription under an S4 scheduling level.

the request document and its been posted to for others to read. would like to submit to the Scheduling Committee that support the application for an amendment to the Poisons Act regarding medical cannabis consumption and feel this is long overdue.

To have CBD based cannabis strains available as end product will begin the process of legal consumption in this country and to have Dr's prescribing it will begin the process of integrating MC into the current legal medicine system. Which will help patients. Cannbidiol has a high functioning, useful medical value and we totally commend any move which makes this more available to patients here. As the low THC strains are currently legal to grow as industrial Hemp, we hope this will be the beginning of a viable industry that meets production needs in a legal and quality assured manner.

There has however, been a number of comments and views from showing concern over this for a variety of reasons. These concerns are mainly centred around the perceived 'splitting' of the plant into poisonous and non-poisonous cannabis. (bearing in mind that THC is not poisonous in any way, replicates the endogenous cannabinoid Anandamide and is widely used in the community without harm.) In fact very happy if the TGA could solve this issue once and for all by setting up a proffessional toxicity test for various strains of hybrids of cannabis to determine exactlty what level of 'poison' exists in the plant, what 'harms' it may have for humans and schedule accordingly based on the results.

The general feeling is that 'we' as a country can do a lot better for patients and the whole plant should be de-listed as soon as possible to allow development of products with maximum therapeutic value for patients. Of particular concern is the fact that many patients currently using Medical cannabis to successfully treat their conditions rely on multiple cannabinoid levels. As anyone who uses MC learns, its the combination of cannabinoids that makes using MC successful and it will simply make treatment more difficult for some patients to have somepreparations or mixes of cannabinoid medicines available and some not.

Simply put, CBD only cannabis medicine may not meet a lot of patients needs. Other cannabinoid profiles such as 1:1, high THC 20-1, THCA/THVC/CBDA etc. are widely used for many medical conditions.

The Scheduling committee may be getting submissions from people opposing the rescheduling on various grounds, most likely either because they don’t want 'any' kind of cannabis legal and others because they want it 'all' legal tomorrow. cant condone the first group the

best way to help get all the cannabinoids legally used is to pass the amendment appl ication for CBD as soon as possible and begin the long overdue process of integration.

I know that th is application is 'only' for CBD based medicines to be de-listed and made ava ilable for prescription so there's no point in wanting anyth ing more than it is possible for the committee to deliver. I n that context . hope for a positive outcome and encourage the approval of the appl ication for an amendment to the Poisons Act in full and as soon as possible.

To have any cannabis plant material approved for human consumption medically will be a solid move forward but we also hope this is just a f irst step in one of many that will see a science based appraisa l, not a politica l one, of the medical benefits of the cannabis plants 3 species of Sativa, I ndica and Ruderalis become a widely used, beneficial and popular medicine that will improve the lives of many patients, legally, rather than illegally as is currently the case.