Draft legislation

[Chato]

No worries Bud I get your meaning the second time round

 

peace

c

[Mr Articulate]

greetnz

 

http://www.talkleft.com/story/2009/11/12/21351/765

UK Drug Reform Group Releases Blueprint for Legalization

 

a UK think tank and drug reform organization, released a new book today, After the War on Drugs: Blueprint for Regulation. The executive summary is here(pdf.) As to Transform:

 

Transform’s vision is a world in which the War on Drugs is over, and effective and humane systems of drug regulation have been established.

 

Its "medium term goals":

 

• To explore alternatives to drug prohibition, and build trust in models of regulation
• To bring together a coalition calling on governments and the UN to count the cost of current drug policy
• To reframe the drug policy debate within a wellbeing perspective that considers the impact of policy on human rights, human security and human development

Some highlights in this BBC article. [More...]

 

 

From the book's main page:

 

For the first time, ‘After the War on Drugs: Blueprint for Regulation' answers that question by proposing specific models of regulation for each main type and preparation of prohibited drug, coupled with the principles and rationale for doing so.

 

We demonstrate that moving to the legal regulation of drugs is not an unthinkable, politically impossible step in the dark, but a sensible, pragmatic approach to control drug production, supply and use.

 

The book does not support outright legalization, which it says would be as much of a failure as the other absolutist position, prohibition.

 

Rather, it wants to regulate the sale of drugs. How? By a five tier system:

 

Prescription: the most controlling model, this would be an exact equivalent to current prescription models for medical drugs, and some opiate maintenance programmes.

 

Pharmacy sales: drugs would be made available through pharmacies or pharmacy-like outlets, either on prescription or over the counter. Licensed sales: vendors would be granted a licence to sell specific drugs under certain, clearly defined conditions, on off-licence like premises.

 

Licensed premises: vendors would be licensed to manage premises where drugs would be sold and consumed, much like public houses and bars.

 

Unlicensed sales: certain low risk substances could be managed through food and beverage legislation, as— for example — coffee is currently managed.

 

What does it mean for adult users?

 

A variety of controls could be put in place to manage adult users. Most immediately, degree of intoxication could be measured; drugs should not be sold to those not in a state to use them responsibly. Vendors might also have to witness consumption for certain substances, as is currently the case with methadone prescriptions in some pharmacies.

 

Purchasers/users could be asked to produce a licence for a given drug before purchase. Licence acquisition could be dependent on passing a test, ensuring that the licensee fully understands the risks inherent in use of a particular drug. Related training programmes would provide an invaluable opportunity to augment drug and health education for a key target population. Data collection methods tied to licences could provide an invaluable means of tracking and managing individual drug usage.

 

As to specific drugs:

 

• Cannabis and opium sale and consumption: membership based coffee-shop style licensed premises

• Cocaine powder, ecstasy and amphetamine: licensed pharmacy models and licensed/named purchasers

• Psychedelics: drug clubs/groups for supervised use in licensed venues

• The riskiest drugs and preparations (including injectable drugs) most associated with problematic/chronic dependent use: prescription/supervised use models

• Lower potency/risk drugs and preparations: a range of licensed sales models

forward ever

stronger together

100% legalize and regulate all drugz

its happening

globally 6 nations have done so to date

Australia is watching Portugal very closely

and the stats are strictly positive to date

legalization soon come

irey guidance

 

 

 

Thanks, Radic. That's awesome - exactly the sort of thing I'm looking for. I shall enjoy reading this, methinks.

 

 

 

Mr Articulate

(but you can call me Artie)

[dani]

Hey Mr Articulate

You will find that Radics posts are more than enjoyable..They are the most intelligent, informative and educational posts you will read, me thinks

Check any of the older crews posts and you will see how articulate and educated they are in all Canna knowledge regarding legalities, medical usage, legalisation and decriminalisation.. oh and grows of course

Enjoy the , I sure do

[Radic]

welcome Arte

that link is to the executive summary

the complete book, as a pdf, is available online.,.,. free

google search the title will reveal all

 

irey thanx for the big uppz sista dani

i love your posts too

you are crucial vibez sistren

if your plannin pon coming to mardiGrass check for i

im always up for good chin wag and cuppa

make i feel all warm and fuzzy you do

 

irey guidance

Edited January 2, 2011 by Radic

[Macciza]

High All

In NSW prospective Bills are drafted by a special dept. upon specific request I believe.

I am not sure if any exposure Bill was drafted as a result of the Medical Cannabis briefing paper but Carr was intending such legislation be drafted.

What is needed is to convince enough politicians to reinstate this issue and get a bill drafted

Cheers

Macciza

[Chronmasta]

I'll just clarify a bit, I'm not too good at explaining my ideas

 

sorry man, but im translating that as you want it legalized for recreation use but by way of using medical use as the argument?

 

 

That's not what I meant at all, I see medical and recreational use and two completely different things. What I meant was if the courts/porkers/whatever want to classify the recreational use of cannabis as anything, classify it as a medical 'issue' (refer to someone who can "help") instead of a criminal 'issue' (fine and/or jail time).

Of course what I ultimately would like is there to be no classification of cannabis as a scheduled drug.

 

 

So you want cannabis users to be treated as addicts with a medical problem not as a criminals??

 

I think your confusing cannabis and smack....

 

 

Not addicts as such, but along those lines if we can't get it un-scheduled.

 

Sorry if my explaining skills suck, I know what I want to say, but I have a hard time getting people to understand it

 

Aaron

thats ok mate, im pretty shiddi at understanding explanations

 

so now i take it as ... rather than call it recreation use of cannabis......more call it, "medication misuse"? or "substance abuse"?...(considering its not classed as a substance in the drug misuse and trafficking act 1985)

 

im probly wrong again

 

just....if thats right, then the answer to that would be to continue pushing for rescheduling from sch1 to sch2 in order to legalize Cannabis for Medical use

 

sorry if im just ranting bullshit with no idea of what ya saying ....im just trying to suss which angle ya coming from

 

 

[Radic]

greetnz

rescheduling from sch1 to sch2 in order to legalize Cannabis for Medical use ../../../public/style_emoticons/default/scratchchin.gif

in oz sch 9 is no medicinal use

sch 8 is reserved for the most dangerous drugs there is.,,.., and the most restricted for medicinal use

that has already been done

S8 sativex cleared the way for natural cannabinoil extracts

yummy full strength THC, CBD CBN .,.,.cannabis tincture.,.,

that also means

if we offer medicinal evidence in oz courts

the judge can now accept it and listen to your rave

 

gotta love dat

 

In NSW prospective Bills are drafted by a special dept. upon specific request I believe.

I am not sure if any exposure Bill was drafted as a result of the Medical Cannabis briefing paper but Carr was intending such legislation be drafted.

What is needed is to convince enough politicians to reinstate this issue and get a bill drafted

right on macciza

bobs wife had cancer and the rumour goes she was treating it with cannabis

 

irey guidance

[Chronmasta]

yeah radic, i know i`ve read that somewhere, i just cant think where, ....can ya give mi a link please?...just in the single convention on narcotic drugs 1961, and the drug misuse and trafficking act 1985, both have cannabis and cannabis "other" as a schedule 1 substance/drug

[Radic]

greetnz

the link wont show this info cause they changed it

but i did copy all this from that link

nowa hear dis

The National Drugs and Poisons Scheduling Committe (NDPSC) have now recognised the therapeutic benefits of cannabinoids and scheduled a botanical extract of Cannabis sativa which includes the cannabinoids listed below as a new Schedule 8 entry in a buccal spray. (Sativex)

 

www.tga.gov.au/ndpsc/index.htm

 

Schedule 8 – New entry

 

NABIXIMOLS (botanical extract of Cannabis sativa which includes the following cannabinoids: tetrahydrocannabinol, cannabidiol, cannabinol, cannabigerol, cannabichromene, cannabidiolic acid, tetrahydrocannabinolic acid, tetrahydrocannabivarol, and cannabidivarol, where tetrahydrocannabinol and cannabidiol (in approximately equal proportions) comprise not less than 90 per cent of the total cannabinoid content) in a buccal spray for human therapeutic use.

 

Appendix D, Paragraph 3 – New entry

 

NABIXIMOLS.

 

Appendix K – New entry

 

 

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 57 - October 2009

 

11. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS

 

11.1 NABIXIMOLS – A SPECIFIC EXTRACT OF CANNABIS SATIVA

 

PURPOSE

 

The Committee considered the scheduling of nabiximols.

 

BACKGROUND

 

Cannabidiol (CBD) is a cannabinoid found in Cannabis sativa. CBD was reputed to have analgesic, anticonvulsant, muscle relaxant, anxiolytic, neuroprotective, anti-oxidant and anti-psychotic activity. CBD was not specifically scheduled.

 

Delta-9-tetrahydrocannabinol (THC) is the main psychoactive substance found in Cannabis sativa.

 

At the November 1994 meeting, the Committee agreed to a XXXXX recommendation to schedule THC for therapeutic use in Schedule 8, with additional controls through a listing in Appendix D, paragraph 3 i.e. requiring authorisation by the Secretary of the Department of Health and Ageing under section 19 of the Therapeutic Goods Act 1989.

 

At the February 1995 meeting, the Committee added an Appendix K

listing because of sedative effects. At the August 1995 meeting, the SUSDP references to delta-9-tetrahydrocannabinol were replaced with the International Non-proprietary Name ‘dronabinol’.

 

Nabiximols (a specific extract of Cannabis sativa)

 

In recent years, CBD has been under investigation, in combination with THC, for use as an adjunctive analgesic treatment in multiple sclerosis (MS). In 2005, Canadian authorities approved the marketing of XXXXX, a THC+CBD buccal spray for MS patients to alleviate neuropathic pain and spasticity.

 

At the February 2009 meeting, the Committee noted that there had been enquiries to jurisdictions regarding the availability of a THC+CBD preparation (XXXXX). The Committee noted that there had been approvals for THC+CBD through the TGA’s Special Access Scheme (SAS) but it had been difficult for jurisdictions to also approve access given the unclear scheduling status of CBD. The Committee decided to gazette consideration of CBD for therapeutic use for the June 2009 meeting (noting that the THC component was captured by the dronabinol Schedule 8 entry).

 

At the June 2009 meeting, the Committee noted that the THC+CBD formulation also had small amounts of other cannabinoids that were also likely to be captured by the Schedule 9 cannabis entry. Hence the problem that certain jurisdictions could not allow access to Schedule 9 substances for medical purposes, regardless of SAS approval, would remain.

 

Members agreed that it was appropriate to allow access to this specific THC+CBD preparation and suggested that a pragmatic approach would be to create a Schedule 8 entry that was specific to this formulation, noting that this would also remove any possibility of the entry allowing inappropriate access to cannabis-type substances.

 

Members therefore agreed to gazette for consideration at the October 2009 meeting a new Schedule 8 entry for this specific Cannabis sativa extract, together with a listing in Appendix D, paragraph 3.

 

Following the June 2009 meeting, it was established that the US Adopted Names Council had designated ‘nabiximols’ as the approved non-proprietary name for an extract of Cannabis sativa containing, as major components, THC+CBD, and as minorcomponents, related cannabinoids and non-cannabinoid components alpha- and trans- caryophyllenes i.e. the specific THC+CBD formulation considered appropriate for inclusion in Schedule 8 by the June 2009 meeting.

 

DISCUSSION - SUBMISSIONS

 

The Committee noted that no pre-meeting submissions were received.

 

June 2009 Minutes

 

The Committee recalled the following from Members’ discussion at the June 2009 meeting:

 

• Certain jurisdictions could not allow access to Schedule 9 substances for medical purposes. Therefore, in the absence of a Schedule 8 (or lower) listing, access could not be granted by these State and Territory health authorities.

 

• The Committee agreed that efficacy was a primary consideration, given that this treatment had yet to be assessed by the TGA. While overseas clinical trial data were reassuring, it was noted that no trials have taken place in Australia as yet. This may be partly due to the current Schedule 9 status of this therapy.

 

Members also recalled the following regarding findings by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA):

 

• Partly evaluated nabiximols in 2007 but the application was withdrawn before the evaluation was complete. The MHRA, in a December 2007 Public Information Report, noted that the evidence of efficacy was not considered to be sufficient at the time. Key issues that the MHRA stated need to be resolved included:

 

- The magnitude of the estimated treatment effect on the self-reported measure of spasticity in trials was small in the overall patient population.

 

- The applicant had presented post-hoc analyses supporting an argument that non responders could be identified in a four week therapeutic trial, and that the mean treatment effect in the remaining patients who would continue to receive treatment, would be clinically significant. This approach was welcomed.

 

However, it had not been prospectively investigated whether the effect calculated in thepost-hoc analysis could be translated into a pre-specified meaningful benefit for the patient. There was a lack of clinical data investigating such conditions of use, as no therapeutic trial followed by exclusion of non-responders was used in the pivotal trials.

 

- Further clinical data were necessary to investigate the effectiveness of the

proposed four week therapeutic trial in identifying responders and excluding non- responders, and to clarify the magnitude and clinical relevance of the efficacy achieved in the subgroup of patients who continue to be treated with nabiximols following a successful therapeutic trial.

 

The pivotal clinical trial data should clarify the potential efficacy benefits in a subgroup of patients against the potential risks to a larger number of patients of a four week therapeutic trial of nabiximols.

 

- MS was a chronic disorder and there was a lack of evidence of maintenance of efficacy with long-term treatment.

 

- The pattern of CNS side effects such as sedation was highly suggestive that some unbinding was possible. This issue still needed to be considered in the overall evidence of efficacy. The smaller the differences between active and placebo, the greater was the concern that a relevant contribution of that apparent difference may not be real if a source of bias existed. If a compelling treatment effect could be shown it might be concluded that the possibility of unbinding might not represent a major concern.

 

Members additionally recalled the following from the June 2009 meeting regarding new 2009 studies announced by XXXXX:

 

• In February 2009, XXXXX announced positive results from a placebo-controlled randomized withdrawal study of nabiximols in patients with spasticity due to MS.

 

This study:

 

- was intended to assess the maintenance of spasticity relief in patients who remain on nabiximols versus those who switch to placebo;

 

- was performed following guidance from the MHRA and, according to XXXXX, provided evidence of long term efficacy;

 

- evaluated 36 MS patients with spasticity who had previously been taking

nabiximols on prescription where mean duration of prior nabiximols prescription use was 3.6 years;

 

- patients were randomized to nabiximols or placebo for 4 weeks in a double-blinded manner and patients were not permitted to adjust their dose;

 

- the prospectively defined primary efficacy endpoint - the time to treatment failure - was statistically significantly in favour (p=0.013);

 

- the difference between nabiximols and placebo was also significant for the patient global impression of change (p=0.017) and the carer functional-ability global impression of change (p=0.001) meaning that the carer recognised that the patient’s spasticity became worse when they stopped taking nabiximols – providing independent verification of the primary endpoint;

 

- there was no evidence of a withdrawal syndrome, despite a very prolonged period on the medicine and, overall, there was a similar frequency and severity of adverse events in both the nabiximols and placebo groups, with more than 85 per cent of such events being deemed mild or moderate.

 

• In March 2009, XXXXX announced preliminary results from a pivotal Phase III

double-blind randomised placebo-controlled study in patients with spasticity due to MS, who have achieved inadequate spasticity relief with existing therapies. This study:

 

- was requested by the MHRA in order to gain approval in this indication XXXXX;

 

- used an enriched design whereby 573 patients initially received nabiximols for 4 weeks in a single blind manner (Phase A), following which nabiximols responders (n=241) were randomized to continue on nabiximols or switch to placebo for a further 12 weeks in a double-blinded manner (Phase cool.gif and during the randomized period, patients were not permitted to adjust their dose;

 

- the prospectively defined primary efficacy endpoint of the study – the difference between the mean change in spasticity severity of nabiximols vs. placebo in Phase B - was highly statistically significantly in favour of nabiximols (p=0.0002);

 

- the difference between nabiximols and placebo was also significant for a number of secondary endpoints in that 74 per cent of nabiximols patients achieved an improvement of greater than 30 per cent in their spasticity score over the entire study versus 51 per cent on placebo (p=0.0003);

 

- in addition, statistically significant improvements were also seen in spasm frequency (p=0.005), sleep disturbance (p<0.0001), patient global impression of change (p=0.023), and physician global impression of change (p=0.005).

 

Members also recalled the following from pre-meeting submissions considered at the June 2009 meeting:

 

• XXXXX.

 

• XXXXX indicated that it had no objection to rescheduling CBD to Schedule 8.

 

Noted that such products were available in Canada, New Zealand and the United Kingdom as an adjunctive treatment for the symptomatic relief of neuropathic pain in adult patients suffering from MS as well as an adjunctive analgesic treatment in adult patients with advanced cancer. The submission reiterated that this combination increased clinical efficacy while reducing adverse effects (adverse effects were judged to be mild to moderate) and showed no evidence of tolerance. It was also noted that current scheduling was a barrier for jurisdictions to allow access through the SAS.

 

• XXXXX suggested that before rescheduling, the Committee needed to be certain there was convincing data available that supported the therapeutic efficacy of CBD.

 

It was noted that, presently, there was evidence for its role in neuropathic pain and other neurological disorders but most data appeared to be based on animal experiments. It was further suggested that, should down-scheduling occur, the use should be limited to classes of physicians who are authorised to prescribe it under State and Territory poisons legislation.

 

DISCUSSION – RELEVANT MATTERS UNDER 52E

 

The Committee agreed that the relevant matters under section 52E(1) included (cool.gif risks and benefits, (f) the need for access and (g) the potential for abuse.

 

Members acknowledged that there was a substantial degree of controversy regarding a therapeutic role for cannabis extracts. However, Members agreed that it was important to clarify that the matter before the Committee at this time was a proposal to consider appropriate scheduling for nabiximols. It was the regulator’s role, not the Committee’s, to approve particular products for use in Australia.

 

With regard to the current confusion as to whether jurisdictions could allow access to a nabiximols product that had been given a SAS approval, some Members reiterated that it was appropriate that this uncertainty be resolved so that jurisdictions could allow restricted access. The Committee generally agreed that this uncertainty could be clarified by creating a new parent entry in Schedule 8 for nabiximols.

 

Members also agreed, however, that this entry would need to be supplemented with additional controls.

 

A Member therefore proposed that, in addition to a Schedule 8 listing, and in line with current controls on dronabinol, nabiximols could be listed under Appendix D, paragraph 3 i.e. requiring authorisation by the Secretary of the Department of Health and Ageing under section 19 of the Therapeutic Goods Act 1989.

 

A Member opposed this suggestion, noting that a section 19 authorisation would require, amongst other conditions, approval by an ethics committee.

 

The Member contended that this would inappropriately add to the workload of such committees. Several Members were also concerned that an Appendix D, paragraph 3 listing would impact on possible clinical trials of nabiximols. The Committee generally agreed, however, that including

nabiximols in Appendix D, paragraph 3 was appropriate, particularly noting that:

 

• Without an Appendix D, paragraph 3 entry (i.e. just a Schedule 8 listing) the SAS access would include the broader access through SAS Category A (which does not require prior approval, just notification after the fact to supply to seriously ill patients). Members agreed that access without a prior approval process was inappropriate for nabiximols at this time.

 

• It was necessary to have safe guards in place to make it clear that the Committee was allowing tightly restricted access to nabiximols only, this was to in no way be extended to other cannabis extracts.

 

• An Appendix D, paragraph 3 listing did not prohibit use for clinical trials, but would permit use only by an authorised prescriber.

 

The Committee also noted that Appendix D, paragraph 3 was subject to an editorial consideration under item 21.1.4

 

A Member suggested that, in addition to an Appendix D, paragraph 3 entry, the Schedule 8 nabiximols entry needed to be more restrictive in order to remove any possibility of allowing inappropriate access to cannabis-type substances.

 

The Member argued that the entry should clearly state that nabiximols was a very specific combination of cannabinoids.

 

The Committee agreed that this was appropriate. The Committee also agreed that the Schedule 8 entry should limit the allowed presentation to buccal sprays as this would further reinforce the very restricted scope of this entry and would require any new presentation to be brought to the attention of the Committee.

 

The Committee also considered whether to limit the Schedule 8 entry to a single indication – MS. Several Members noted, however, that there were ongoing trials for using nabiximols for other indications, including the treatment of unresponsive cancer pain.

 

A Member noted that any issue of indications etc., would be addressed by the regulator through the conditions imposed by the Appendix D, paragraph 3 entry.

 

The Committee agreed to not restrict the Schedule 8 nabiximols entry by indication.

 

Members additionally agreed that it would be appropriate to include nabiximols in Appendix K due to sedating effects as noted in the Health Canada PI (www.doctordeluca.com/Library/AddictionMe...oductMonograph05.pdf).

 

Members also agreed that the SUSDP index would need to clarify to stakeholders that the scheduling of tetrahydrocannabinols and dronabinol may fall under the nabiximols entry.

 

RESOLUTION 2009/57 - 17

 

The Committee decided to create a new entry for nabiximols, including a list of cannabinoids present, in the form of a buccal spray for human therapeutic use, in Schedule 8. The Committee further decided:

 

• To create a new entry in Appendix D, paragraph 3 for nabiximols.

 

• To create a new entry in Appendix K for nabiximols.

 

• To create cross references in the index from tetrahydrocannabinols and dronabinol to nabiximols.

 

Schedule 8 – New entry

 

NABIXIMOLS (botanical extract of Cannabis sativa which includes the following cannabinoids: tetrahydrocannabinol, cannabidiol, cannabinol, cannabigerol, cannabichromene, cannabidiolic acid, tetrahydrocannabinolic acid, tetrahydrocannabivarol, and cannabidivarol, where tetrahydrocannabinol and cannabidiol (in approximately equal proportions) comprise not less than 90 per cent of the total cannabinoid content) in a buccal spray for human therapeutic use.

 

Appendix D, Paragraph 3 – New entry

 

NABIXIMOLS.

 

Appendix K – New entry

Nabiximols

yes i gotta love dat

legal cannabis tincture or natural cannabis extract

same ting

 

letz get positive

at least its a start

and there is no restriction pon adding other ailments

i hope chronic pain is next to get on that list

this is really exciting

i gotta make a phone call

id love to get a doc to prescribe hash oil for i

id really love to try someone elces cannabis tincture for a start

nabiximols is natural cannabis extract or cannabis tincture

well

this news tells i

that day asoon come

whata day

irey guidance

[Chronmasta]

yep i remember now, but if im right, without re reading it, does that say THC(the chem) is a schedule 8 compound?, which imo, for those circumstances is/would be great, but for the average grower who cant extract thc or even grow cannabis, wouldnt it be a good(not a better) idea to try amend the legislations? .....rather than try work on one aspect of it?,

why not try just get cannabis as a whole?

if that makes sense?

that way, people who need the plants can have it......as apposed to only being allowed to have an extract of it...

 

just my way of thinkn anyway