The Greens leader, Richard di Natale, has accused the federal government of “ignoring the will of parliament” on the importation of medicinal cannabis as doctors complain that the current system has “multiple obstacles” that prevent terminally ill patients from obtaining the drug.
Di Natale will introduce a bill on Tuesday to clear the way for importers to stock more medicinal cannabis products.
While the government made medicinal cannabis legal in 2016, it did not allow medical practitioners to prescribe terminally ill patients some previously approved products without seeking prior authorisation, under Category A of the Therapeutic Goods Administration’s special access scheme.
Access is only allowed through Category B, which requires a prescription, an approval letter from the Therapeutic Goods Administration and, in the case of medicinal cannabis, approval from the state or territory government where the patient lives. This process can take several months, making it impractical for terminally and severely ill patients.
In June, the Greens successfully moved a motion in the Senate to disallow the removal of medicinal cannabis from Category A so that terminally ill patients could access treatments faster. It passed 40 to 30 with support from Labor, One Nation and Independent senators Jacqui Lambie, Derryn Hinch, David Leyonhjelm and Lucy Gichuhi.
But the federal government’s Office of Drug Control responded by writing to importers warning they would be in “breach of your permit and licence conditions if you supply any imported medicinal cannabis product to a patient under Special Access Scheme A”.
Di Natale, who is a medical doctor, said the government had defied the will of the Senate and it had no authority to do so.
“It’s just another example of the government with their ideological blinkers on, not only ignoring science but ignoring legislation,” he told Guardian Australia.
“Even though the Senate has ruled that terminally ill patients should be able to access medicinal cannabis through Category A, the government is blackmailing the importers and threatening to remove their licence if they supply it.
The Medicinal Cannabis Legislation Amendment (Securing Patient Access) bill 2017, to be introduced by Di Natale on Tuesday afternoon, will prevent the government from using the contractual conditions of importers to block medicinal cannabis being imported for Category A use; and will clarify the ability to access the drugs under Category A. Di Natale is confident the bill will pass, given the disallowance motion also received majority Senate support.
Dr Teresa Nicoletti, a scientist and lawyer with more than 20 years’ experience in pharmaceutical law, said it was “disgusting” that importers had received the letter. She said the relevant customs regulations made it clear that if an importer applied to import a Category A drug, permission must be granted if it had provided the required information and if it held a licence authorising supply of the drug in the state or territory where its business was located.
“The government has basically said that ‘it doesn’t matter what the legislation says, we will do our own thing’,” Nicoletti, a partner with the law firm Mills Oakley, said.
“It makes a mockery of the legislation. I’m a strong believer in complying with legislation, and blocking access to medicinal cannabis after doing so was disallowed is in direct violation of the law.”
The need for doctors and patients to apply for medicinal cannabis products through the TGA as well as through their state or territory medical regulator under Category B meant patients had to duplicate their applications, which she said was an unnecessary layer of bureaucracy and a waste of time.
She said while she was not aware of any companies who had attempted to import medicinal cannabis for supply under Category A, she believed an importer would win if it was to challenge the government in court.
While part of her interest in the matter is legal, Nicoletti admits it is also personal. Her mother has Alzheimer’s, and medicinal cannabis has shown some promise in treating its symptoms. She also watched her father die a painful death from cancer.
“He died in excruciating pain,” she said. “I would have loved to have given him medicinal cannabis as he was on as much conventional pain treatment they could supply without killing him, and yet I couldn’t breach the law and try to get it for him illicitly as that would have put my livelihood at risk.
“I had to watch him die in extreme pain.”
The president of the Law Reform Foundation, Dr Alex Wodak, described cases such as that of Nicoletti’s father as heartbreaking.
“The long and short of it is the government are presenting a mirage,” he said. “It looks as though the laws are OK and they’re saying the right things, and yet the system is really a problem.
“There are clearly multiple obstacles to obtaining medicinal cannabis, and yet it’s very difficult for ordinary people to identify them. There’s clearly a smoke and mirrors operation going on. It’s a very complicated system which patients and their families find unwieldy and unhelpful and government officials get affronted when they’re told patients and families find the system difficult.”
“I don’t think every application for medicinal cannabis should be approved, but we need to be more flexible and have a compassionate access scheme, not just a rule-based system.”
The health minister, Greg Hunt, has been contacted for comment.
Lanai Carter has been fighting to get access to medicinal cannabis for her 18 year-old son Lindsay, who has a brain tumour and intractable epilepsy which cannot be controlled by anti-seizure medications. She has travelled to the US with Lindsay multiple times to access the drugs and despite Australia’s legalisation of medicinal cannabis, faces another trip to the US. She is fundraising for his treatment.
“The original intention for Category A was to provide urgent fast tracked access to medicine for chronically ill patients, but this relief for patients can only be effective if the state health departments respect the Category A process and don’t require a state application over and above the Therapeutic Goods Administration,” Carter, who lives in Queensland, said.
“This means that the whole intention of this scheme is undermined by a state application process which causes further delay.”
Carter said despite technically being able to apply for products under Category A for Lindsay, the process remains so laborious that she is still obtaining it under Category B. But the months taken between script approvals means that even if her son’s doctor puts in a new application for the products as soon as his prescription arrives, there is still a few months gap in between, where Lindsay is left without medication. Complicating matters is that the most effective cannabis treatments can not be easily exported to Australia from their country of origin due to export options being limited.
“Lindsay can suffer up to 20 seizures per day without the medical cannabis oil,” Carter said. “Seizures put him at risk of death from sudden unexpected death, brain injury, suffocation, aspiration, and complications of aspiration [breathing in Saliva during a seizure] can cause pneumonia which can cause premature death.
“The vaporised cannabis helps him also with his pain, nausea and stimulates his appetite. He lost 40 kilos since being diagnosed with the brain tumour but has now been able to regain seven kilos and stabilise his weight.
“Carers and patients already suffering with the burdens of chronic illness should not have to be worrying about enduring bureaucratic processes and any delays in access to any medicines.”
Clinical senior lecturer at the Australian National University Dr David Caldicott said “to say making medicinal cannabis legal has in any way made it easily accessible for the patients who need it or their clinicians would be a vast overstretch”.
He has written the first course for Australian doctors educating them on the history of medicinal marijuana in Australia, the regulatory system, the evidence for its use, potential side-effects and harms, and how to go about prescribing it to patients who need it.
He said “hundreds” of doctors had taken his course, because medical training rarely included information about medicinal cannabis and because the process for accessing it was so difficult for patients.
“You must understand there are definitely people who shouldn’t have it,” Caldicott said.
“What we’re trying to do is establish a middle ground far removed from extremism. This is a debate that can be had entirely on medical, scientific and intellectual merit. But people are deliberately or mistakenly confounding recreational and medicinal cannabis use.
“And the medical debate has been largely done and dusted overseas, where they have accepted that for some people medicinal cannabis works very well indeed. But the introduction of medicinal cannabis in Australia has become a dog’s breakfast. It’s become far more of a complicated black art than it needs to be.”
credit:420intel.com