1 The Chair The Hon. P. D. Cummins AM Victorian Law Reform Commission GPO Box 4637 Melbourne Vic 3001. Attention: Dr Ian Freckelton, Q.C. SUMBISSION: Medicinal Cannabis Issues Paper March 2015 AUTHOUR: Name Withheld DATE: 17 th April, 2015. RE: VLRC considerations on lawful access to cannabis under a regulated medicinal cannabis scheme in Victoria. _______________________________________________________________________ I refer to the above matter and thank the Victorian Law Reform Commission (‘’the Commission’’) for the opportunity to make a submission on a matter of great significance for the future health and well being of many chronically and terminally ill Victorians and their families. The Commissions work as detailed in this paper, was comprehensive and impressive. It is my intention however in this present submission, to address lawful access to medicinal cannabis and the Commissions remarks made in regard to the same.
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The Chair
The Hon. P. D. Cummins AM
Victorian Law Reform Commission
GPO Box 4637
Melbourne Vic 3001.
Attention: Dr Ian Freckelton, Q.C.
SUMBISSION: Medicinal Cannabis Issues Paper March 2015
AUTHOUR: Name Withheld
DATE: 17th April, 2015.
RE: VLRC considerations on lawful access to cannabis under a regulated
I refer to the above matter and thank the Victorian Law Reform Commission
(‘’the Commission’’) for the opportunity to make a submission on a matter of
great significance for the future health and well being of many chronically and
terminally ill Victorians and their families.
The Commissions work as detailed in this paper, was comprehensive and
impressive. It is my intention however in this present submission, to address
lawful access to medicinal cannabis and the Commissions remarks made in
regard to the same.
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It is my contention, that any lawful access scheme founded on the basis of
compassionate need, should provide access to as many Victorians in
legitimate need as possible, in order to alleviate suffering, improve their
quality of life and or save it.
PERSONAL BACKGROUND & INTEREST
I was admitted to practice as a lawyer in the state of Victoria. During this
period, I also studied system design methodology a the University of Ottawa
in Canada, for the purposes of assisting corporations, non for profit,
government and community groups in the creation of alternative dispute
resolution systems. I retired from practice due to an acute onset illness. Since
that time I have been largely bedridden and housebound. Although I have
been gravely ill, the underlying cause of my illness remained unknown for a
number of years. Through my own research and with the assistance of
physicians and specialist laboratories (both here and overseas), it was
discovered that I have a number of poorly understood and or acknowledged
medical conditions. Of these, one is rare and another is so extremely rare, that
I am the only patient thought to currently suffer with this illness in Australia.
My illnesses involve central nervous and immune system dysfunction. Nearly
every major system in my body is affected and dysfunctional, resulting in a
constellation of over 70 symptoms varying in number, duration and intensity.
It is not uncommon for me to have ‘’symptom storms’’ involving multiple
symptoms, systems and organs. This is primarily due to my body fighting off
a number of chronic and serious medical conditions. One rare condition I was
diagnosed with in 2013 (Sarcoidosis), has complicated matters further due to
the formulation of multiple benign tumors in my lungs and lymph glands. In
addition, and as a result of the illnesses I have, I am also fighting multiple
chronic and serious bacterial and viral infections and have developed multiple
chemical sensitivities. I cannot tolerate a quarter of the lowest doses of
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pharmaceuticals having the most benign safety profiles, without suffering
extreme and or rare side effects, which in some cases have been life
threatening. Although I experience a wide range of distressing and
debilitating symptoms, chronic unrelenting muscular skeletal, neuralgic and
inter cranial pain and pressure (the later which I have endured nearly every
day for the last 18 months) have in recent times, been the most difficult. The
pain interferes with sleep and normal functioning. It is relentless and severe. It
is not responsive to common pain relief medications and I have been
hospitalized on many occasions, most recently associated with repeated flares
of what is thought to be inter cranial pain and pressure associated with viral
meningitis. Intravenous steroids have helped with the pain cycle, but they are
contraindicated in the extremely rare disease I suffer from: Idiopathic CD4
Lymphocytopenia or non HIV+ AIDS: a condition where patients have AIDS
but it is not caused by the HIV virus. Intravenous steroids suppress my
immune system further and appears to result in the loss of the very few CD 4
cells I have left.
There are currently no cures for my illnesses or recognized treatments. I am
unable to access HIV medications and or services, because even though I
have AIDS, I do not have the HIV virus.
I am currently investigating an experimental therapy designed to improve my
immune system function, but is very risky and will involve an investment of
$25,000 and requires that I travel overseas. Due to complications associated
with my health, it has not been a viable option to date.
There is one pharmaceutical company situated in the USA, that has developed
a drug (at stage 2 clinical trials) for patients specifically with my extremely rare
condition: idiopathic CD4 lymphocytopenia or “ICL”. I am advised by my
physician however, that the drug is prohibitively expensive and as a result, is
not currently accessible or being made available by the pharmaceutical
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company on compassionate grounds. It is expected to be registered with the
Therapeutic Goods Administration in the next five years, however I will not be
able to access it as I am told that it will be made available for the exclusive
use of patients with the HIV virus. As I do not have the HIV virus, I will be
denied access to it, even though it was developed for, and trialed on, patients
with ICL. I suppose with an estimated 140 people in the world with ICL, its not
commercially viable to market it to such patients and so, the very people it
was designed to assist, will not be given access to it. Such are the limitations
of the current regulatory system and the wonderful commercial world in
which we live. I am hopeful however, that a compassionate medicinal cannabis
scheme might recognize circumstances such as these faced by patients with
rare illnesses, as a circumstance that might be considered ‘’exceptional’’
enough to warrant lawful access to therapeutic cannabis in a medicinal
cannabis scheme prescribing access on the basis of ‘’exceptional
circumstances’.
Set against this background, I began to research alternative therapies and in
doing so, came across the science associated with cannabis.
Having studied the benefits associated with the cannabis plant for close to
two years, I believe it to be a safe, affordable (with a self grown operation),
natural, convenient, easy to administer therapy, that will address my suffering
and work toward the restoration of my health. If lawfully regulated under a
model like those successfully operating in Canada and the USA, it would be a
therapy that I could easily participate in, either by: growing my own cannabis
(thus having control over the quality and having the same tested at reputable
laboratories of my choice), or by participating in a compassionate club and or
having access to the convenience of a medicinal cannabis dispensary when
needed.
At this point, medicinal cannabis is the only realistic and comparatively safe
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treatment option available to me.
I understand that cannabis is relatively easy to find for medicinal use.
However I have elected not to use it. I have been tormented by thoughts of
unlawful activity, experiencing feelings of great despair and loss that I have
found myself in a position of having to choose between everything that I
have believed in and stood for (the law) and trying to save my own life. The
unlawful status surrounding cannabis, does not only affect me, it also affects
those I live with. If prosecuted, my partner would stand to loose his current
professional license. Even if I could overcome these barriers, I would also be
faced with not knowing and or being able to determine, the composition of
the cannabis being supplied. I cannot take cannabis without knowing that it is
free of chemicals, pesticides, mold, fungi and bacteria. Any of these
substances has the potential, with my current state of health, to kill me.
I require lawful access to affordable medicinal cannabis that is regulated and
tested for its constituents and quality. I support the abolition of the laws of
prohibition, as well as the proposals for a medicinal cannabis scheme in
Victoria.
I now wish to address the following matters arising out of the Commissions
issues paper on a proposed medicinal cannabis scheme for Victoria:
1. Terms of Reference
2. Exceptional Circumstances
3. Attempts to define ‘’Exceptional Circumstances””
4. Concerns and comments
1. TERMS OF REFERENCE
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1. The terms of reference given to the Commission request the Commission,
amongst other things, to determine how the law can be used to enable
Victorians to be treated with cannabis in ‘’exceptional circumstances’’.
2. The question becomes: what would constitute circumstances that might be
said to be exceptional enough to grant Victorians lawful access cannabis,
for therapeutic purposes?
3. The term: ‘’exceptional circumstances’’ was an unfortunate choice on the
part of the Victorian government for the following reasons:
It is unclear from the terms of reference, whether the term was:
purely descriptive use as an extension of the term ‘’medicinal
cannabis’’ to emphasize and or distinguish lawful cannabis from
recreational use or
intended to constitute a key access criteria to be employed in a
medicinal cannabis scheme.
4. The Commission has proceeded on the understanding that the term was
intended as a key access criteria for any proposed medicinal cannabis
scheme.
5. On the basis of that understanding, the Victorian government by providing
a key access criteria to the Commission has resulted in:
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directed design options, which in turn has the potential to
influence outcomes and or any recommendations made by the
Commission.
the best possible outcomes, options and recommendations
having been potentially lost, due to a pre-established frame of
reference.
Pre-establishing a design/design framework.
It is submitted, that this is at odds with a collaborative design process
involving all key stakeholders, where needs are considered and contributions
made, leading to ownership and therefore use of the design by the parties. A
system that is imposed upon parties is unlikely to be successful.
2. EXCEPTIONAL CIRCUMSTANCES
1. It is not a neutral term, but is a reference to the current laws of
prohibition.
From a system design perspective, failing to use neutral terms can
adversely affect the degree of stakeholder participation, as well as
outcomes. This is unnecessarily inflammatory and can create obstacles.
2. The use of this term and its reference to prohibition then lends itself to
defining the term (and therefore lawful access) through a much
narrower lens than may otherwise be the case or that a compassionate
scheme, might otherwise employ.
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3. The referencing referred to, frames the approach as a predominantly
legal one rather than what a compassionate frame would call for i.e.: a
focus dictating what would be in the best interests of chronically ill
Victorians.
4. ‘’Exceptional circumstances’’ suggests that the circumstances under
consideration are uncommon or unusual. A consideration of ‘’all the
circumstances’’ is not enough, as the term ‘’exceptional” mandates that
consideration must be had to circumstances which when evaluated
identify those that must stand out from the rest. The term elevates or
favors circumstances that are: uncommon, remarkable, outstanding or
unique. It follows, that many merit worthy circumstances that might
otherwise qualify for access may not qualify as ‘’exceptional.’’ The term
is an exclusionary term. Compassion or benevolence involve notions of
loving kindness, empathy, concern, fairness, consideration and
generosity. Such a term is inclusionary. An exclusionary term that will
determine lawful access to cannabis is at odds with the essence of a
model that is at its heart, inclusionary. A compassionate scheme, the
objective of which might broadly be stated as one to alleviate human
suffering and or improve quality of life, cannot by virtue of its nature
be exclusionary and accept only those circumstances deemed
outstanding or unique.
5. As a potential lawful access criteria, the term “exceptional
circumstances’’ is therefore undesirable and unnecessarily narrow. This
is especially so given:
a. the United Nations Single Convention on Narcotic Drugs 1961
b. that any scheme will be a tightly regulated one.
6. Australia is a signatory to the United Nations Single Convention on
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Narcotic Drugs 1961 (‘’the convention’’), which it ratified in 1967.
Although this convention declares cannabis a prohibited, controlled and
tightly regulated substance, it recognizes its utility and importance to
society as a medicinal therapeutic agent. The convention:
recognizes the medicinal use of cannabis1 states that it is ‘’indispensable’’ “for the relief of pain and suffering”2 states that ‘’adequate provision’’ of cannabis ‘’must’’ be made available
for such purposes.3
7. The convention does not place further qualifications or restrictions on
the term medical use, other than to refer to pain and suffering.
8. It is submitted that cannabis must be made available to provide relief
for pain and suffering without any further qualifications.
9. It is submitted that to limit access to cannabis by employing an access
criteria such as ‘’exceptional circumstances” in a medicinal cannabis
scheme that might exclude a person access to it for relief from their
pain and or suffering, may run counter to and be in direction
convention of, the nature and operation of the convention.
3. ATTEMPTS TO DEFINE EXCEPTIONAL CIRCUMSTANCES
1. It is submitted that on the basis of the matters referred to at
paragraphs 5-9 above, that employing this term may run counter to the
United Nations Single Convention on Narcotic Drugs 1961. And or
in the alternative, the approach taken by the Commission to define
‘’exceptional circumstances’’ and therefore determine lawful access is
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flawed for the following reasons.
2. At paragraph 3.1 of the issues paper, the Commission states that in
order to identify what might constitute those circumstances:
a. it is ‘’first necessary’’ to consider scientific research findings
about claims associated with the efficacy of cannabis and
b. evaluate that evidence, so as to identify those Victorians most
likely to benefit from its use, in order to
c. assist in making a determination as to how the government
could ‘’appropriately’’ and ‘’compassionately’’ delineate
circumstances that would grant lawful access to cannabis by
Victorian patients.
From a conceptual system design perspective, this approach and starting
position is flawed.
3. It is submitted that the evidentiary approach taken by the Commission
referred to at paragraph 3.1 & 3.2 above, to identify and define
‘’exceptional circumstances’’ focused upon:
the efficacy of medicinal cannabis in scientific literature
a determination as to whether and to what degree,
superior treatments may exist for certain conditions
whether they should be offered as an adjunct to other
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treatment options.
It is submitted that this approach is flawed because it operates on the
basis of the following assumptions:
a. that cannabis in all its forms would be a registered medicine
b. registered medicines are assessed for their efficacy and
therefore cannabis must be assessed in this manner
c. registered medicines are assessed for the superiority over pre
existing medicines and or treatments.
4. It is submitted that these assumptions are incorrect and fail to
recognize:
a. cannabis is not primarily a ‘’therapeutic good’’ and or a
‘’medicine’’ for the purposes of the national therapeutic goods
scheme
b. only registered “medicines” governed by the national
therapeutic goods scheme must be shown to be efficacious and
further
c. registered “medicines” governed by the national therapeutic
goods regulatory framework are not required to demonstrate
that they are superior to existing medicines and so evidence as
to:
- whether other forms of treatment exist and or
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- the extent to which they may present as better treatment
options and or
- whether cannabis should be offered as a main or adjunct
treatment .
are not appropriate or material.
These are not material considerations applicable to the cannabis
plant/cannabis plant material and require a higher evidentiary
threshold than is currently should be applied to cannabis.
It is submitted that quality and safety are the only relevant issues
associated with cannabis under the existing regulatory scheme.
Efficacy, together with considerations of existing and or more
suitable therapeutic agents are not.
5. It is submitted that the current approach taken by the Commission
would be to:
a. apply a criteria that is factually incorrect and inappropriate
b. is likely to produce access outcomes that are unnecessarily
narrow, manifestly unjust and materially at odds with the
compassionate nature of the proposed scheme and international
laws4
c. In short, it will exclude more people than necessary from
accessing medicinal cannabis to alleviate their pain and suffering,
which Australia is required to do under its international treaty
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obligations, which will only see Victorians abandoning such a
scheme, returning to the illicit market and or commencing
litigation.
To support these contentions, I turn to a discussion of the
regulatory frame work.
4. COMMENTS ON EXISTING REGULATORY SCHEME
1. The quality, safety and efficacy of ‘’therapeutic goods’’ and ‘’medicines’’
are governed under the Therapeutic Goods Act 1989 (Cth).
2. The supply, sale and distribution of such are regulated by the state of
Victoria under Drugs Poisons and Controlled Substances Act 1981
(VIC).
3. The operation of the Therapeutic Goods Act 1989 (Cth) was extended
to Victoria by the Therapeutic Goods Act 2010 (Vic), S 6. It applies to
all natural and other legal persons, as well as the Victorian executive
government.5
4. For current purposes and in reference to cannabis, ‘’Therapeutic
goods’’ are:
a. goods
b. goods that are in any way represented, presented or likely to be
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taken to be :
for ‘’therapeutic use’’
use as an ingredient or compound in the manufacture of a
therapeutic good
goods declared as therapeutic goods under S 7.
5. The term ‘’goods’’ is not defined.
6. For present purposes and in reference to cannabis, a ‘’good’’ has
‘’therapeutic use’’ when it is used in or in connection with:
preventing, diagnosing, curing or alleviating a disease, ailment,
defect or injury in a person
influencing, inhibiting or modifying a physiological process in
persons or
testing the susceptibility of persons to a disease or ailment.
7. “Medicines” for the purposes of the regulatory scheme are
‘therapeutic goods’’ as defined, that are represented or likely to
achieve their intended therapeutic action in or on the body.
8. The regulatory scheme only applies to ‘’goods’’ that are ‘’therapeutic
goods’’, as well as ‘’medicines’’.
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9. ‘’Medicines’’ that are governed by the regulatory frame work, are
evaluated and are either entered on to a register of approved (referred
to as registered medicines/ therapeutic goods) or a list (referred to as
listed medicines/therapeutic goods).
10. The degree of risk inherent in a good, determines if it is to be
registered or listed.
11. Listed goods are acknowledged as having lower risks and do not
require an efficacy evaluation. The evaluation process to authorise the
product for supply and sale, is lower than that required of a registered
medicine. Quality and safety are the main concern, and efficacy
considerations are only relevant in so far as they may relate to quality
or safety. The safety evaluation examines the toxicological profile of a
substance to determine if it meets the requirements of its intended
purpose and therefore safe to use.
12. Not all substances are ‘’goods’’, ‘’therapeutic goods’’ or ‘’medicines’’
for the purposes of the regulatory scheme.
13. Not all substances that have a therapeutic operation on the body are
‘’medicines’’ for the purposes of the regulatory scheme.
14. It is acknowledged by the Commonwealth, that some substances sit at
what is referred to as the regulatory ‘’medicine/food interface’’. This is
an area in which substances that are ‘’foods’’ are not regarded as
medicines (‘’therapeutic goods’’), even though they may have a
therapeutic operation in or on the body. These substances are not
governed by the Therapeutic Goods Administration (“TGA”) or the
regulatory scheme.
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15. In addition to stating what a ‘’therapeutic good’’ is for the purposes of
the regulatory scheme, the definition of ‘’therapeutic good’’ under the
legislation also states what it is not.
16. A ‘’therapeutic good’’ as defined, does not include substances for
which there is an identifiable standard under the Food Standards
Australia New Zealand Act 1991 (Cth) or goods which, in Australia or
New Zealand, (FSANZ) have a tradition of use as foods for humans in
the form in which they are presented.
17. This clearly acknowledges that foods that have identifiable standards
under the Food Standards Australia New Zealand Act 1991 (Cth) are
not ‘’therapeutic goods’’, or ‘’medicines’’ and are not administered
under the national therapeutic goods regulatory scheme.
18. Cannabis has been recognized as a traditional food source for
centuries. The Commission is referred to Annexure A.
19. Cannabis in its raw state (flower, resin, leaf, stem and seed) is a
herbaceous plant not a ‘’good’’ by any ordinary understanding of the
word in the context of supply and sale (i.e. merchandise); is not
considered a ‘’therapeutic good’’ as defined by the legislation and or
a ‘’medicine’’, despite its therapeutic operation in or on the body.
20. Cannabis sits at the regulatory food/medicine interface.
21. There are foods standards applicable to cannabis, and are most notable
in their current application to high CBD low THC seeds and oil (called
hemp foods).
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22. Although the FSANZ currently precludes cannabis (hemp seed and
products) being used as or incorporated into food, statements issued
by
Ministers of the FSANZ forum, clearly recognise cannabis as a food and
more over, a safe food for regulatory purposes.
23. The FSANZ undertaking a review of an application to reschedule high
CBD, low THC hemp cannabis seeds and products stated:
‘’ The Forum noted that FSANZ found that foods derived from the
seeds of low THC hemp do not present any safety concerns as food,’’.
It appears that the concerns were not associated with cannabis as food,
but rather, the degree to which it might interfere with roadside drug
testing. FSANZ is currently investigating the matter further.
24. It is submitted that cannabis in its raw form (flower, resin, leaf, stem,
seed,) and its use in food are not governed and cannot be considered
with reference to state or federal therapeutic goods legislative schemes.
25. This is consistent with the following facts:
current cultivated herbal plants for commercial sale in Victoria
are not regarded as therapeutic goods for the purposes of the
regulatory scheme
herbalist and their herbs and tinctures made up and provided to
patients from herbaceous plants they supply, are not regarded as
or treated as therapeutic goods for the purposes of the
regulatory scheme
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products made by compounding pharmacists for a specific
individual are unapproved therapeutic goods and do not require
to be registered with the TGA.
The TGA itself has reportedly stated that it deals with therapeutic
agents and is not positioned to deal with cannabis
the current cross party federal bill (referred to by the
Commission at Chapter 4 of the issues paper) proposing a new
legislative scheme to regulate the use of cannabis was
formulated in recognition of the fact that cannabis cannot be
regulated under the existing therapeutic goods frame work.
26. It is not appropriate to transfer this very high evidentiary and
evaluation standard (i.e. efficacy, other superior treatments assessment)
to substance that is not governed by the TGA scheme, other than
where it might provide some relevance to issues of quality and or
safety. The only appropriate evidentiary question therefore is: in what
circumstances is cannabis safe to use to alleviate pain and suffering?
27. Given these circumstances, it is unjust to use such evidence from
scientific literature as a means of defining ‘’exceptional circumstances”
and therefore determining a general lawful access criteria for Victorians
in need of medicinal cannabis.
28. The Victorian government may wish to adopt the following to defining
‘’exceptional circumstances’’ when attempting to design a medicinal
cannabis system:
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what is commonly understood by the term ‘’exceptional
circumstances’’ ?
What are desired outcomes of the scheme?
what does ‘’compassion’’ mean and a compassionate
approach require ?
what are the circumstances which have led Victorians to
illicitly seek out cannabis for medicinal use?
what requirements and limitations might have a bearing
on an access criteria? (i.e. Single Convention on Narcotics
1961).
for whom and under what circumstances, might cannabis be
generally regarded as a safe therapeutic, to alleviate pain and
suffering?
Having identified those circumstances and mindful of desired
outcomes, what other circumstances might be considered
‘’exceptional’’ when viewed through our identified
understanding of ‘’compassion”?
5. ADDRESSING COMMENTS & ISSUES RAISED BY THE COMMISSION
1. I refer to paragraph 3.89 of the issues paper. Save and with the
exception of pharmaceutical grade products such as Sativex et al,
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orthodox medicinal trials establishing safety and efficacy required of
regulated medicines under the therapeutic goods scheme, are not
relevant to, and or required, in respect to the use of the raw plant
material and its products.
2. I concur with the statement made in the issues paper at paragraph
3.90 that:‘’a scheme that makes cannabis available in exceptional
circumstances for persons with particular health needs should be driven
by compassionate consideration which provide treatment options not
wholly established by orthodox, double blind, placebo-controlled trials.”
3. I refer to paragraph 3.91 of the issues paper. Evidence based medicine
is not without fault. On this point I refer the Commission to the work of
Peter C Gotzsche, founder of the Cochrane Center and in particular his
most recent publication ‘’Deadly Medicines and Organised Crime: How Big Pharma has Corrupted Healthcare’’. Radcliffe. 2013.
Departure from evidence based medicine where benefits out weigh
known risks, has been a common approach in medical science where a
societal need has been identified. Examples are commonly seen in
relation to the regulatory supply of vaccines needed to address
pressing public health issues. Where demand is high, and regulatory
schemes would otherwise require further investigation, vaccines have
been made available outside of higher evidentiary standards associated
with medical literature and regulatory processes. It is therefore
acceptable when medical science and regulatory processes are failing
to meet the needs of society that society demands a departure from
these standards to assist people who are suffering and dying or under
threat of such. It is important that a reasonable expectation of
therapeutic benefit should not be assessed as one requiring further and
or lengthy clinical trials. It is noteworthy, that many pharmacological
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products are available on the basis of few and in some instances, a sole
clinical trial6 and many approved notwithstanding contradictory clinical
trial findings7. A balance must be attained between the channeling of
resources (the financial expense to the community associated with
clinical trials), the need for certainty, safety and efficacy (for registered
medicines) and the moral duty to assist in providing relief for human
suffering. It is questionable whether a reasonable therapeutic benefit
needs to be evident before a patient should be given access to a
therapy (given the current regulatory application to cannabis as a food)
and or alternatively, simply because it might, as the Commission
contends, ‘’raise false hopes’’. If patients are permitted to enter into
clinical trials of a novel therapeutic under such circumstances, then
patients with rare diseases or terminal illnesses, who have little or no
options available to them – should be given the same opportunity to
access medicinal cannabis without stipulations that a certain level of
therapeutic benefit must be evident. Sometimes, hope is the only thing
that keeps these patients alive. As previously stated, it is unfair to apply
efficacy regulatory criteria’s reserved for registered medicines (and
pharmaceutical grade cannabis products) as a determinant as to who
may have lawful access to cannabis.
4. I strongly reject the contention advanced by the Commission at
paragraph 3.91 that any potential benefit associated with medicinal
cannabis must be one that cannot already be reasonably obtained from
another available form of treatment. Many patients like myself, with
rare or poorly understood and or funded diseases, have little or no
treatments available to them. There are also patients, again like myself,
who are unable to take many medications and or treatments, due to
pre existing conditions and general contra indications, multiple
chemical sensitivities, an inability to metabolize certain drugs, and or
due to adverse drug reactions. There may also be compelling personal
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reasons as to why a person chooses to forego an existing treatment.
These may include religious, moral and or ethical considerations. Other
patients may not feel uncomfortable with the side effect profile and or
unable to tolerate them for the same reason. The stated stipulation will
therefore, not work for a large number of patients. These patients will
be driven into the illicit market. For those of us who cannot use the
illicit market -where are we to go? Where is the compassion in that
stipulation presented within those circumstances? Victorian patients
should not be denied lawful access to medicinal cannabis simply
because they have chosen, for whatever reasons, to forego an existing
treatment. Patients should be free to make informed health care
choices and decisions that they feel comfortable with and retain the
autonomy of that decision making process, so that they may make
health care choices appropriate for them in all the circumstances. I
consider it to be highly questionable to force a patient
into any treatment option, that they, for reasons of their choosing,
might otherwise reject, simply to gain access to an alternative
treatment such
as medicinal cannabis that may reduce or stop their suffering. I find
that
this has echo’s of and is similar to, a third line forcing commercial
trading activity, which is not sanctioned by the law. I believe the
approach denies and or nullifies a patients right to health care and the
consent that they might otherwise be free to provide. As such it raises
a question as to whether and the extent to which, this approach might
encroach upon individual human rights under relevant state, federal
and international
human rights laws.
5. I strongly reject the contention advanced by the Commission at
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paragraph 3.92. If a patient, including terminal patients, can consent to
and enter into clinical trials (especially those for a novel therapeutic
agent), ‘’where clinical knowledge is not sufficient to hold out a
reasonable prospect of an advantageous outcome, without an un
acceptable downside” then it is hard to see why and how the
justification can be maintained outside of that context. Once again, I
maintain that a patient (as demonstrated as a subject in a clinical trial
setting) retains the
right to make an informed choice and decision with regard to what
they perceive as an ‘’unacceptable down side’’. The patient should be
given this choice. Terminal patients, and patients with rare diseases and
or limited treatment options, should not be denied this right.
6. I reject the contentions advanced by the Commission at paragraph
3.93, 3.94 and 3.95.It is uncertain, (as it is with most medications), who
will sustain side effects from any new medications, what they might be
and how severe and prolonged they might be. These factors are all
unknown until the patient trials the medication. It is unknown whether
and to what extent a patient may suffer from the conditions described
and attributed to cannabis by the Commission at the paragraph
referred to in the issue paper. Once again, these are matters for the
informed consent and choice of a patient and or his or her guardian in
the case of a child.
7. I refer to paragraph 3.96 of the issues paper. I have addressed this
matter above in relation to the Commissions adoption of an efficacy
criteria in clinical literature as a means of establishing a lawful access
criteria. I pose the question: why? Why shouldn’t a compassionate
scheme allow all ‘’suffers’’ of the ‘’numerous medicinal conditions’’
access to medicinal cannabis? The United Nations Single Convention on
Narcotic Drugs 1961, recognizes that cannabis must be made available
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to alleviate pain and suffering. There is no further limitation or attempt
to define appropriate medicinal use. As submitted, ‘’exceptional
circumstances’’ as a criteria for lawful access, may be contrary to the
convention and to further refine that by stating that not all suffers of
all medical conditions for whom cannabis might be found efficacious (a
much higher standard that should be applied to cannabis), cannot
expect to have access under such a model, is creating an even
narrower access funnel. Clearly, if the Commission views efficacy of
medical literature the best evidence to try and determine a legal access
criteria under the notion of ‘’exceptional circumstances’’, why would it
then attempt to deny some patients access where the evidence of
efficacy of cannabis supports use for that patients medical condition? I
note such a statement is plainly at odds with the Commissions previous
statement at paragraph 3.88 of the issues paper and the
underpinnings of the scheme: which is compassion. In terms of how the
Commission and or state government might approach determining
lawful access, I refer the Commission to paragraph 4, sub paragraph
28 of this submission.
8. A number of jurisdictions noted by the Commission, have formulated a
lawful access criteria associated with cannabis for medicinal use, on the
basis of one or more of the following:
a list of symptoms
a list of medicinal conditions
a hybrid model including a list of symptoms and conditions
a hybrid model together with a general catch all provision to
cover additional circumstances
leaving the decision to a general medical practitioners discretion
leaving the decision to a general medical practitioners discretion
25
with one or more of the above criteria to be used as a guideline.
9. Lists, whether of symptoms or conditions, are generally exclusionary
rather than inclusionary. They are contrary to the notions of a
compassionate scheme. They are limited in their ability to alleviate
suffering and exclude many people in need. They are aptly referred to
as ‘’Schindler’s Lists’’
10. A list whether of symptoms or conditions, may or may not provide
certainty and confidence to time poor or ignorant medical practitioners
who may be unable or reluctant to consult scientific literature on the
therapeutic benefits of cannabis. Of course these barriers may be
overcome by compelling such practitioners to undergo cannabis
education as a part of mandatory continuing medical education
associated with the annual renewal of their professional licensing
requirements and paid for out of the revenues raised by any regulatory
medicinal cannabis scheme. I believe that this will be necessary, if such
a scheme involves the participation of medical practitioners and
patients are to be given access to cannabis. A scheme is of little use,
unless a patient can be given access and those involved in
recommending and or dispensing it, must therefore, be educated to
preclude their otherwise reluctant participation.
11. A list of symptoms will not provide certainty to even the most
educated medical practitioner on whether to prescribe or recommend
cannabis to a
patient who’s symptoms do not quite fit the description provided or
who’s symptoms, which may be the result of a chronic condition, are
not active at the time of request.
12. Some jurisdictions have made a list of symptoms as a category
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separate from, but in addition to, a list of medical conditions. This
design would overcome the problem referred to above. However, it
may, depending on how it is drafted, be read in a manner that is
unnecessarily restrictive. I.e.: symptoms relating to and stemming out of
the listed conditions. In such a case, a patient that has a rare or other
medical condition not listed, will be denied access under the scheme.
For example, cannabis has been recognized to have therapeutic
benefits for certain ailments associated with HIV/AIDS. Where a list of
symptoms
is associated to and or read in reference with a list of medical
conditions (whether the intention of the legislature or not), I would be
denied access to medicinal cannabis, because although I have AIDS and
the symptoms that medical cannabis may assist in that condition, I do
not have AIDS
caused by the HIV virus. Bill 3268 recently put before the legislature of
the state of Alabama, interestingly listed the condition “AIDS’’ rather
than HIV or HIV/AIDS as one of 25 medical conditions suitable for
access to medicinal cannabis. Therefore under that model, I would
certainly qualify for access. However, this demonstrates the different
outcomes and difficulties associated with a list approach.
13. As acknowledged in the issue paper, the Canadian government initially
adopted this model, requiring symptoms to be read in reference to a
medical condition. However, this design feature then required the
interpretation of a specialist physician. This resulted in further expense
to the patient and lengthy delays. I currently must wait anywhere
between 2-3 months to access my treating specialists. If an established
relationship with such a physician is required (as is required in some
overseas jurisdictions) before access is granted to a patient, it could
27
realistically take patients like myself, 12 months or more, before they
were able to have access to medicinal cannabis. This is a poor
outcome, employed as a result of the adoption of a poor design
feature. It is unrealistic and inhumane to ask the chronically ill
(especially those experiencing great pain and or suffering), or patients
with terminal conditions, to accept this outcome. This is a poor design
feature that fails to address the needs of the patient and is in
consistent with the underpinnings of a compassionate objective and or
system. Unsurprisingly, this aspect of the Canadian medicinal cannabis
system was not embraced by major stakeholders (patients). The system
failed. Patients remained in the illicit market and the Canadian
government was forced to abandon this requirement, replacing it with
the discretion of medical practitioners, with reference materials to
guide them in their decision making process.
14. Lists do not keep abreast with medical scientific developments and will
therefore exclude access for many patients in need. A PubMed search,
undertaken by NORML9 in the USA, found that there are over 20,000
pieces of scientific literature on cannabis and its medicinal applications.
Over half of these publications however, were made in the last 5 years
alone. This provides some indication of how rapidly science is
progressing in this field. It should be kept in mind, that the current
proposal for a medicinal cannabis scheme in ‘’exceptional
circumstances’’ has arisen precisely because of and as a direct response
to, the inability of the current medical, scientific and regulatory systems
to keep up with developments in this area and or meet societal needs.
It would therefore be a self defeating waste of tax payers money, in
designing a model intended to address these matters, to subsequently
turn around and adopt design features that would only produce the
same outcomes that has initiated the push towards the operation of a
system such as the one under discussion.
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15. Whilst some jurisdictions have addressed these problems by providing
an avenue for patients to lobby for additions to the list via an
administrative appeals type process, this is, it is submitted, a lazy
solution and one that involves expense for the government and the
patients, as well as delay. It is, in the context of dealing with the
chronically and terminally ill, devoid of compassion. It fails to recognize
that patients looking for access to medical cannabis, are already
stretched: physically, financially and emotionally. Chronically and
terminally ill patients will not have, nor can afford, the luxury of time to
invest in such a process. This approach fails to acknowledge that
patients will require resources that they do not customarily have access
to when ill (physical, emotional and or financial) to engage in this
process. Forcing chronically ill and terminally ill patients to waste their
precious little resources in this manner is devoid of compassion. It is
submitted that such an option would make a poor design feature, as it
is neither practical or realistic. As such, and failing to address patients
needs, adoption of such a feature would simply see patients failing to
embrace the system and returning to the illicit market. This option
defeats and undermines the operations of any medicinal cannabis
scheme. The objective is to design a scheme in such a way that as
many patients in legitimate need are funneled into a lawful access
channel, not to encourage them to turn to the illicit market because of
poor design elements.
16. I note that there are overseas jurisdictions which have embraced a
three tier system:
a list of symptoms as an exclusive criteria and or
29
a list of medical conditions as an exclusive and or additional criteria
and or
a general ‘’catch all’’ provision.
This approach whilst subject to some of the same criticisms as fore
mentioned, compensates for limitations with the inclusion of a ‘’catch
all’’ category.
17. A number of overseas jurisdictions currently employ this option, with
the most comprehensive currently being proposed in the state of
Alabama, USA, under bill 326.10 The Alabama model, in addition to
listing 25 medical conditions, provides access to medicinal cannabis for
any other chronic or persistent medical condition which either ‘’ (i)
substantially limits the ability of the person to conduct one or more
major life activities as defined in the Americans with Disabilities Act (ii)
have symptoms that could cause serious harm to the patients safety or
physical or mental health if not alleviated.”
If however, this clause has the practical effect of requiring an individual
to consult a specialist on one or more occasions, for a determination of
whether their condition ‘’substantially limits’’ their ability to conduct
one or more activities defined under the disability legislation, then this
aspect of the catch all clause suffers from the same limitations as those
addressed at paragraph 5, sub paragraph 13 above.
18. It is submitted, a premium system design approach takes note of
similar systems and in particular, any failures that were evident when
they were implemented. It is important that Victoria does the same. In
that regard, Victoria should pay heed to what took place in Canada, in
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relation to a list and or symptoms access criteria. For these reasons, I
support a general medical practitioner (‘GP” not specialist) discretionary
model that includes the following features:
certification of a patients medical condition
certification of the nature of a patients medical condition and
that access is necessary to alleviate pain and or suffering
certification that medicinal cannabis has been shown to be safe
to use for the patient in question
guidelines to be provided to the medical practitioner and or any
other therapeutic medicinal cannabis practitioners (‘’medicinal
cannabis practitioners”) in a summary similar to that provided by
Health Canada11
mandatory continuing medical education for medicinal cannabis
practitioners as a pre requisite for and condition attached to,
their annual professional licensing renewal
dosage and distribution to be determined by medicinal cannabis
