The aim of the new bill is to clear the way for importers to stock more medicinal cannabis products.
The Guardian newspaper reports.
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”.
“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.
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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.
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