Malcolm Turnbull: Give Dying Patients Back Their Right to Access Cannabis under Category A, and Stop the States from Putting in Barriers that Delay Access

Please sign and take a Stand for Sick and Dying patients who need Urgent and Immediate Access to cannabis TODAY

UPDATE - SENATE MOTION VOTE 11 MAY 2017


Senator Di Natale's motion to block government amending legislation  to remove Category A access did not get through the Senate.


The vote was a tie 32-32 but needed 1 more vote to stop the Government from getting its discriminatory amending legislation through.


Senators from Labor, Derryn Hinch and David Leyonhjelm supported the Greens motion to keep Category A access.


One Nation and Xenophon voted against patients being able to access cannabis medicines through Category A.


One Nation and Nick Xenophon Senators put political and corporate interests before patients and sided with the Government and its discriminatory legislation. These amendments only applied to cannabis medicines.

All other Schedule 4 and 8 unapproved/unregistered medicines can still be accessed through Category A without a doctor needing TGA approval.


Instead of patients having quicker access, patients with life threatening conditions need to go through Category B which means their doctor needs TGA and in most cases state approval.


We are now preparing to get the issues with patient access through the Special Access Scheme to court as well as the long overdue issues with patients still being arrested and charged under unjust state criminal drug laws.
Although Queensland changed health regulations in December 2015 to allow access through Category B, the process can take months as QLD Health duplicates at a state level the TGA process, even though the doctor has TGA approval, refers cases to an expert panel for review, and can take up to 3 months to give the doctor a decision. Under new laws that came into effect in Queensland on 1 March 2017, state approval is now also needed for Schedule 4 CBD.


Under new legislation in South Australia a specialist can treat a patient for 2 months without state approval if the patient has a palliative care statement. State approval is not needed for Schedule 4 CBD.
Laws also vary in the other states. Please check with your state health department.


Thank you everyone for your support.


IMPORTANT UPDATE - SENATE VOTE DEFERRED TO 11 MAY 2017

IMPORTANT UPDATE - SENATE VOTE 23 MARCH 2017 

CATEGORY A RIGHTS WILL GO TO A VOTE IN THE AUSTRALIAN SENATE ON 23 MARCH 2017 

Senator Di Natale has put forward a motion to block the Government's changes to Category A.  If successful, patients will have immediate and fast tracked access under Category A of the SAS.  You can read more on our website.

http://medicalcannabisqld.wixsite.com/medicalcannabisqld

What has our Government done for terminal patients and patients with serious life threatening conditions who need urgent access to cannabis? Many, whose plights have been used by politicians in Parliament, and in the media for political point scoring and gain.

Last November the Government moved the goal posts on seriously ill and dying patients

The media coverage that the Federal Government legalised or decriminalised cannabis across Australia in February 2016 is false and misleading. Furthermore the claim that from 1st November 2016 patients could go to their doctor and be prescribed cannabis is simply political spin and propaganda.  

Behind closed doors, Sussan Ley and Malcolm Turnbull's Cabinet have just taken away from seriously ill and dying patients, their right to use Category A of the Special Access Scheme (SAS)

The down scheduling of cannabis from Schedule 9 to a Schedule 8 "controlled drug" on 1 November 2016, should have given seriously ill and terminal patients urgent and efficient access to cannabis under Category A of the SAS.

But on the same day that cannabis became Schedule 8, Sussan Ley made discretionary changes to the Therapeutic Goods Regulations with the approval of Malcolm Turnbull's Cabinet, that eliminated the legal rights of seriously ill, terminal and palliative care patients to URGENT access to any form of cannabis under Category A of the SAS. The changes also apply to the personal importation scheme. Now Cateogry A patients must use Category B which needs TGA and State approval. 

Sussan Ley has not honoured her commitment from October 2015 to make the SAS work for patients!  

The attached video (October 2015) is when the Federal Health Minister, Sussan Ley announced in the Australian Parliament that the Commonwealth intended to introduce legislation in December 2015 to amend the Narcotic Drugs Act 1967 to allow the states to cultivate cannabis for medical purposes. 

During the same speech, Sussan Ley also made a very firm commitment to make the Special Access Scheme (SAS) work as effectively and as well as possible for patients who needed urgent access. 

Sussan Ley: "While it's legal to import supplies and provide them always of course with your doctor at the centre of your treatment we know those supplies are very hard to get and are very expensive .... the SAS that operates within the Therapeutic Goods Administration is the one there now for patients that need help urgently and I am committed to make the Special Access Scheme work as effectively and as well as possible. ...... the steps we take in health must always be with the patients in mind and this is very much a measure for the patients.... their advice, their input, their passion and their advocacy has brought this to the attention of the Australian Parliament. Sussan Ley's Facebook page -19 October 2015.

There is still no lawful supply of cannabis available in Australia as the Federal Government has not granted any cultivation or manufacturing licences. 

*Every step from seed to patient needs Federal and state approval. 

Currently the only way for patients to access a lawful supply of cannabis is to import it themselves from overseas, with the support of their own doctors and pharmacist through the Special Access Scheme (SAS).  

The Government research trials have been beset with problems from when they were announced almost 2 years ago. The NSW Government has recently announced that the trial for the terminally ill is not likely to start until sometime next year.

* The trials are using imported cannabis that is coming from countries that allow their patients to access the exact same cannabis.

At a State and Territory level, cannabis is being controlled as a drug of addiction similar to methadone. After doctors obtain the mandatory TGA Category B approval, they must also obtain state approval under a bureaucratic process that duplicates the TGA process, delaying access for months.

Patients all across Australia, have been left as criminals under unjust State drug laws; parents at the added risk of the intervention of child services, while an untaxed and unregulated black market continues to flourish, costing the states billions in law enforcement, courts, prisons and legal aid costs that are mostly outsourced to private firms.

....  AND NOW SICK AND DYING PATIENTS HAVE BEEN DEALT ANOTHER INSULTING BLOW 

Down scheduling of cannabis to Schedule 8

On 1 November 2016 when cannabis was rescheduled from Schedule 9 to Schedule 8 "Controlled Drug" in the Poisons Standard (SUSMP), there was an expectation that seriously ill and dying patients would have URGENT and EFFICIENT access to cannabis under Category A of the SAS, as doctors only need to notify the TGA they are treating a patient with an unapproved medicine, instead of waiting months on end for TGA Category B approval and State approval.

But on the same day, in an unconscionable act that only applies to cannabis and not any other unapproved substance, Federal Health Minister Sussan Ley, with approval from Prime Minister Turnbull and his Cabinet made discretionary changes to the Therapeutic Goods Regulations that take away the legal rights of seriously ill and dying patients to be able to access any form of cannabis through Category A. 

Sussan Ley's change to the regulations has not only captured Schedule 8 cannabis, patients can no longer use Category A to access Schedule 4 Cannabidiol (CBD), even if it is CBD hemp oil from the low or no THC industrial cannabis plant which is sold overseas as a food supplement, or Schedule 8 nabiximols. 

PLEASE SIGN AND SHARE OUR PETITION TODAY

When you sign this petition, all Federal Members of Parliament will receive a copy of the attached letter.

1. We want the new Health Minister Greg Hunt and Malcolm Turnbull, to give seriously ill and dying patients back their rights to urgent access to cannabis under Category A of the Special Access Scheme.

2. We want the Government to honour Sussan Ley's commitment to make the SAS work effectively for patients who need urgent access!

3. We want all Federal, and State and Territory Governments to stop coming between the doctor patient relationship and get out of the way of patients who, with the support of their own doctors, are trying to access cannabis, as there is more than sufficient evidence to draw on from overseas that shows cannabis to be a very safe, non toxic and effective herbal medicine for a range of conditions!

4. We want State and Territory Governments to stop criminalising patients and carers under unjust state and territory drug laws if patients are using cannabis for medical purposes.

MORE IMPORTANT INFORMATION

This is very long read, but this is a very complex issue, when it shouldn't be. Patients should be able to access cannabis in a timely manner, and without fear of being arrested and charged under unjust state drug laws.

What the changes mean for patients - Australia wide

* Category A cannot be used to access any form of cannabis.  

* Category A patients can still access ANY other unapproved/unregistered  therapeutic good or device, even dangerous drugs such as thalidomide - JUST NOT CANNABIS! 

* Doctors must apply for TGA approval under Category B on a case by case basis, for all patients, even if the doctor has determined that his or her patient meets Category A criteria.

* Category B approval is now needed to access Schedule 4 Cannabidiol (CBD), even if it is CBD hemp oil extracted from the low THC industrial cannabis plant.

* Category B approval is now also needed for Schedule 8 nabiximols (e.g. Sativex).  

State approval

* After doctors obtain mandatory TGA Category B approval, they also need to apply for State approval.

* The states have classified cannabis as a drug of addiction, and put in extra controls and barriers that do not apply to any other substance including drugs of addiction. Furthermore, the states are also treating patients as if they are drug dependent, for example, in Queensland, doctors do not need State approval to treat patients with any other Schedule 8 controlled substance unless the doctor determines that the patient is drug dependent.

Please note: We are waiting on confirmation on whether State approval will now also be needed for CBD and nabiximols as these were previously excluded under Queensland law.

Sussan Ley's reasons for stopping access via Category A

Sussan Ley's explanation statement: "Medicinal cannabis products, which are not yet considered to be “established pharmaceuticals”, require adequate level of regulatory oversight and safeguards to the public to ensure that high quality, safe and effective products are used in appropriate circumstances. At the current time, Category A and other pathways to access unapproved medicines are not considered to provide this level of oversight and are therefore unavailable." You can read Sussan Ley's Explanatory Statement in full here.

No warning or public consultation - changes made behind closed doors

There was no public notice or consultation, or input from patient advocacy groups about the changes. They were not included in the changes to the Narcotic Drugs Act that were passed by the House of Representatives and the Senate in February, or more recently in October when Parliament made further amendments for security and licence charges.

These changes were made behind closed doors by Sussan Ley and Malcolm Turnbull's Cabinet. Obscure details were posted on the TGA website on 31 October 2016.

How Category A patients are defined in the Therapeutic Goods Regulations:

“persons who are seriously ill with a condition from which death is reasonably  likely to occur within a matter of months, OR from which premature death is reasonably likely to occur in the absence of early treatment.”  All other patients can access unapproved medicines under Category B which needs TGA and State approval.

Interpretation of Category A - Australian Parliament 1991

"The way the definition of Category A was intended to be interpreted can be gained by reference to the discussion in the Australian Parliament in 1991 at the time the definition was being framed for inclusion in the Act. The following statement was made by Senator Tate:

"when people are confronting the certainty of death and have a terminal or life-threatening illness, special provisions clearly ought to be made to help them psychologically face that prospect by giving them assurance that virtually whatever they wish, by way of administration of a drug of which they have learnt, can be undertaken" (Hansard, Senate 12 December 1991).

Patient's right to access unapproved medicines under the SAS 

The SAS is very much patient driven as generally the patient finds out about the treatment, organises and pays the supplier, and must give their full informed consent and assume full liability for any adverse outcomes of the treatment. The SAS provides that under certain circumstances a patient has a right to access ANY unapproved therapeutic good. 

* Any registered medical practitioner in Australia, who forms the view that his/her patient meets Category A criteria can import or supply ANY unapproved therapeutic good WITHOUT TGA approval, except for substances listed in Schedule 9.

* Cannabis is now the ONLY therapeutic good that cannot be accessed via Category A.

* The TGA state that the choice of the classification of each patient lies with the prescribing doctor, not with the TGA or the State. Even if a doctor determines their patient is Category A, ALL patients now come under Category B.

* GPs or specialists can apply for SAS approval, there are no age restrictions, or restrictions on the medical conditions that can be treated with unapproved medicines.

* Even though Queensland has the most progressive medical cannabis provisions, the state process can take months. There are no restrictions on age or medical conditions that can be treated.

* Some of the States have restricted access to specialists only, or patients with certain conditions. 

For further information about Category A and B see the TGA's publication: Access to Unapproved Therapeutic Goods via the Special Access Scheme (Nov 2009).

THERE WAS NO JUSTIFICATION TO TAKE AWAY SICK AND DYING PATIENTS RIGHTS TO ACCESS CANNABIS UNDER CATEGORY A 

* The intentions of Parliament when the Special Access Scheme was introduced in 1991 are very clear - seriously ill and dying patients should be able to access  "...virtually whatever they wish, by way of administration of a drug of which they have learnt.." 

*It is a patient's right, in consultation with their doctor, to choose their own treatment, NOT the Government. 

* Patients were able to access Schedule 4 and Schedule 8 nabiximols under Category A before the changes were made.

* This is discrimination against patients who use cannabis, as this exclusion only applies to cannabis and no other therapeutic good.  

* Cannabis has been used since ancient times. There are decades of modern research evidence from overseas, and that has been used by the Federal Government itself, that show that cannabis is a very safe and effective treatment for a range of conditions.

* No other country makes patients wait for research trials, or controls unregistered/unapproved cannabis (a botanical product) under a prescription and scheduling model that requires both Federal and State government approval. 

* The cannabis used for the research trials is being exported from countries that allow patients direct access for actual use to treat a range of conditions on the recommendation of their doctor. 

Corporate interests and researchers more concerned about their research grants should not stand in the way of patient access

The Federal and State Governments have gone to great lengths to deny patients access but accommodate and fund research trials on behalf of corporations. 

Researchers more concerned about their funding grants have lobbied state Governments to put in place barriers that make access to cannabis almost impossible for patients to obtain. Referring to the NSW state government funded research, Professor Martin from Newcastle University said:

"We certainly don't want to stop what's going on at the moment, it's a great investment. It's worth waiting to get this right, because once it's .. cannabis... is out there in the community it will be harder to get access to research funding  ... more rigorous research is needed into medical marijuana before it is rolled out as a therapeutic good.”

Access to cannabis under the SAS and through authorised prescribers will not be sustainable for industry

When cannabis becomes available for supply from within Australia, access will still be under the SAS or through authorised prescribers. Anyone seeking a cultivation licence licence must show patient demand which will be very difficult for companies. 

Doctors will still need to obtain TGA and State approval, and for example, in Queensland all pharmacists also need to be approved. Doctors also need to report back to both the TGA and Queensland Health on the patients progress, and pharmacists need to notify Queensland Health each time they dispense the cannabis.

Medical Cannabis Advisory Group Queensland 

We want the Government to put patietns before profits. We did not support the Federal Government's commercial pharmaceutical prescription model or the use of the TGA's exemption pathways as the only avenue of supply. 

We have fought hard for the rights of all patients to access cannabis and for an affordable supply from state licenced not for profits, and exemptions from criminal charges under unjust state drug laws.

We thank everyone who has supported our advocacy, petitions and submissions that have resulted in changes to the Queensland Health (Drugs and Poisons) Regulations in November, December 2015, and further changes in June 2016. Queensland was the first state to allow patient access to cannabis but there is still a lot to be done at a state level as these changes do not go far enough. 

Lindsay Carter's case 

Our advocacy for Lindsay, also resulted in him being the first patient in Australia, and Queensland to be approved access to Schedule 9 cannabis. 

It has taken 18 long months for Lindsay to finally have his cannabis treatment dispensed from the pharmacy. No patient should have to wait this long or go through such lengthy convoluted processes to obtain both Federal and State Government approvals to access a safe botanical medicine like cannabis when dangerous drugs such as morphine, methadone and benzodiazepines can be prescribed and dispensed on the same day.

Just after Minister Ley's speech last year October 2015, we issued a legal  Notice for Review on Minister Ley in Lindsay's Special Access Scheme case and within days received a response that the TGA would approve his Category B application. We also issued a Notice on the Attorney General of Queensland, which also prompted the State to amend the Health (Drugs and Poisons) Regulations.

We are now looking at legal options against the Federal and State Governments again, and will keep everyone posted. 

The Government needs to stop coming between the doctor patient relationship, and get out of the way of patients who, with the support of their doctors are trying to access cannabis as there is sufficient evidence to draw on from overseas to show cannabis to be a very safe and effective therapy for a range of conditions.

PLEASE SIGN AND SHARE OUR PETITION TODAY

Thank you for taking the time to read our petition.

This is a very complex issue when it shouldn't be. Patients with the support of their own doctors should be able to access cannabis in a timely manner, and without fear of being arrested and charged under unjust state drug laws.  

This petition is supported by the following groups.

Medical Cannabis Advisory Group QueenslandFacebook

Queensland Medical Cannabis Collective

United in Compassion 

MCUA

Weeded Warrior

WACAN

Medical Cannabis Advisory Group Contact Details. 

Postal Address: PO Box 77 Fortitude Valley, QLD, 4006

Email address: medicalcannabisadvisorygroup@gmail.com

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