Australia is in the grip of a drug crisis. There are currently 316 medicine shortage alerts listed by the Therapeutic Drugs Administration (TGA), with 39 listed as critical. Australia is in dire need of equine antithymocyte immunoglobulin, a drug used to prevent and treat kidney transplant rejection, antibiotic procaine benzylpenicillin and diabetes drug semaglutide.
While supply chains were disrupted during the pandemic, experts argue warning signs have been clear for more than a decade, with Australia relying too heavily on international markets, and a lack of price stability for drugs listed on the Pharmaceutical Benefits Scheme limiting manufacturing.
It means there are delays of months, if not years, for life-altering medication.
TikTok promotion causes spate of shortages
For Ross*, a Melbourne-based physician with type 2 diabetes, the semaglutide shortage has meant he’s had to increase the insulin he injects every day by 50%. Semaglutide is the active ingredient in the drug Ozempic, which is manufactured by pharmaceutical giant Novo Nordisk.
“It’s really frustrating,” he said. “You would have thought we’re a civilised society and you should have access to these things.”
Semaglutide has been approved for weight loss under other brand names, although Ozempic has only been approved for use in people with diabetes. The shortage has been exacerbated by it being promoted on social media sites such as TikTok as a “miracle” weight-loss drug, with the shortage expected to last until early next year.
“The doctors who prescribe it for weight loss should be penalised,” he said.
Chair of the Diabetes Specific Interest Network at the Royal Australian College of General Practitioners Dr Gary Deed told Crikey there isn’t a lot of evidence pointing to the drug’s efficacy in weight management.
“There are obviously people and doctors utilising it in a way that is inappropriate,” he said — but added these people’s needs were not “lesser”, given that obesity is a chronic disease that requires management.
The semaglutide shortage is indicative of a wider issue, Deed said, with doctors put on the back foot and simply told to stop prescribing important drugs.
“We prescribe things based on clinical decisions on an individual basis. And it’s like saying, well, your decision now has to be overwritten by the fact you can’t prescribe the most appropriate therapy. It leads to roadblocks in quality clinical care,” he said.
“Planning is difficult because you don’t know what’s available and what isn’t almost from week to week. It’s making management of patients difficult, and sometimes putting people at risk.”
Australia exposed by reliance on international markets
Around 90% of medicines in Australia are imported, leaving us particularly vulnerable to supply chain disruptions. While Australia relies on the US and Europe for many final-product medications, India and China produce many active ingredients.
Australia produces the active ingredient used to make more than half of the world’s opium, through poppies farmed mostly in Tasmania. But we’re still susceptible to morphine shortages thanks to our lack of onshore manufacturing facilities. The active ingredients are flown to Germany and then sold back to us as morphine products.
Dr Simon Quilty, a public health physician from the National Centre for Epidemiology and Population Health at Australian National University, told Crikey Australia’s lack of onshore facilities ran deep.
“Morphine is a simple product to manufacture, but we have no hope of manufacturing it here because we don’t even have the capacity to manufacture the glass vials it goes in,” he said.
It’s frustrating, he said, particularly because the impacts of shortages are felt deeply in remote and regional Australia, where it’s not uncommong for pharmacy shelves to be bare.
It’s not just an issue for individuals, he said, but a concern for Australia’s national security. In 2019, rising tensions between the US and China under the Trump administration caused the Pentagon to take a look at medications manufactured by China. In January, a Chinese-made heart drug was contaminated with a possible cancer-causing chemical, causing a year-long recall. The vast majority of pharmaceuticals taken by US servicepeople, including military personnel, are manufactured in China.
Writing on the wall for a decade
Quilty said warnings about shortages have circulated for more than a decade. He published a paper in 2011 warning that Australia’s national medical stockpile was lacklustre and shortages would become more frequent due to international disasters, calling for policies that encouraged local manufacturing industries to fill the gaps in essential pharmaceuticals and medical equipment. He believes Australia needs to focus on generic, everyday medicines like penicillin and antibiotics. His warnings, he said, fell on deaf ears.
“While the Americans and Europeans saw the vulnerability and started bolstering local manufacturing capacity, the Australian government did absolutely nothing with the warnings that have been given over the last 10 years,” he said.
Across 2019 and 2020, medicines supplied by manufacturers for $4 or less per pack were the most susceptible to shortages.
Quilty believes Australia’s powerful medical lobbying industry is partly to blame for the lack of onshore manufacturing of generic medicines. In 2017, the Grattan Institute reported Australia overpays by $500 million per year for prescription drugs, with prices three times higher than in New Zealand. Of seven commonly prescribed drugs, Australians paid on average five times the best international price.
Medicines Australia represents more than 50 companies that supply the majority of the medicines through the PBS. CEO Elizabeth de Somer told Crikey that while the industry supports local manufacturing projects, it’s not the single solution to adequately deal with shortages issues.
“Sovereign manufacturing is an enormous health opportunity for our country and the medicines industry is committed to working with the federal government and states and territories to make sure the underpinning policies are set up for success,” she said.
“Australia will always have a reliance on global supply chains, and we must therefore continue to forge strong international trade relationships and build on the medicines and industry ecosystem in Australia, to attract greater investment, research, development, commercialisation and patient access.”
Australian Medical Association president Professor Steve Robson told Crikey the government had been attempting to minimise the impact of pharmaceutical shortages, especially across the pandemic. As of July next year, drug manufacturers will be required to hold either four to six months’ supply of drugs in Australia for designated PBS medicines under the Medicines Supply Security Guarantee.
“These are welcome changes,” Robson said. “However, we need to do more, including developing a comprehensive strategy for medicines supply that supports domestic medicines manufacturing.”
A spokesperson for the Health Department told Crikey having a more resilient medicine supply chain was a priority for the Australian government but stressed that locally manufacturing the “thousands” of medicines approved for use in Australia wasn’t practical or economic.
“Contrary to media reports, the number of medicine shortages reported each month has been largely stable since the government implemented mandatory reporting of medicine shortages in January 2019,” the spokesperson said.
“The TGA has no legal power to obligate companies to manage their stock to avoid shortfalls in supply … while the [Medicines Supply Security Guarantee] will not prevent shortages it will help to ensure that Australian sponsors of medicines are better placed to continue supply when supply disruptions occur.”
*Name changed for privacy
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