PERTH, Australia – As Australia closes its borders to all non-citizens and non-residents, it looks within the country for solutions to manage the worsening COVID-19 pandemic.
After a scorching summer and wildfires that swept through much of Australia, the pandemic couldn’t have come at a worse time for the country, and the government has stepped in to provide some immediate relief to struggling businesses and citizens.
Parliament has passed an AU$189 billion (US$111 billion) relief package that includes AU$17.6 billion for the government’s first economic stimulus package, AU$90 billion from the Reserve Bank of Australia, AU$15 billion from the government to deliver loans, and AU$66.1 billion in economic support for households and for businesses to keep people in jobs.
The government ordered all businesses except those providing essential services to shut down. States have also shut their borders.
Prime Minister Scott Morrison said the government was acting to cushion the blow from the coronavirus for businesses and households to help them get through to the other side of the crisis.
“We want to help businesses keep going as best they can and for as long as they can, or to pause instead of winding up their business. We want to ensure that when this crisis has passed Australian businesses can bounce back,” the prime minister said in a March 22 press conference.
“Our focus is on cushioning the blow and providing hope to every Australian that we will get through this and come out the other side together.”
Treasurer Josh Frydenberg said the $189 billion economic support package was the equivalent of 9.7% of the country’s GDP.
Health Minister Greg Hunt said 135,000 COVID-19 tests have been carried out, representing “one of the highest actual numbers in the world,” he said.
He also noted Australia has one of the lowest COVID-19 test positivity rates in the world at roughly 1% compared to 13% in the U.S., 5% in the U.K. and 3% in South Korea.
Even so, Chief Medical Officer Brendan Murphy said that some parts of the country had run out of test kits. The government has moved to bolster the dwindling stocks of test kits, ordering a further 1.5 million test kits.
In addition, Australia’s Therapeutic Goods Administration (TGA) has fast-tracked the approval of new ‘rapid tests’ that take just 15 minutes to work, with 500,000 tests due to arrive this week.
TGA has also extended an emergency exemption for accredited pathology labs to supply their own laboratory-developed tests without requiring those tests to be included on the Australian Register of Therapeutic Goods (ARTG). This has enabled Australian laboratories to immediately develop COVID-19 tests based on internationally available COVID-19 genomic information and to commence testing.
TGA said this emergency exemption allows COVID-19 diagnostic tests to be immediately supplied to accredited pathology laboratories while the TGA continues to expedite the regulatory assessment process for COVID-19 tests. The agency is working with IVD suppliers to ensure that tests used in managing the pandemic can accurately detect COVID-19 infections.
The agency clarified that the exemption does not allow for general supply of rapid tests, including serological rapid tests intended for use at the point of care (POC), other than to the accredited pathology labs specified in the exemption. It said that POC tests that have been included in the ARTG will be available for broader supply within Australia.
“The TGA is fielding a large number of enquiries from commercial suppliers of COVID-19 tests. Some of these suppliers are well known in Australia and have well-established supply networks and relationships with pathology providers and laboratories,” TGA said, noting that other suppliers are new to the Australian market and are “navigating our regulatory system for the first time.”
All applications in relation to COVID-19 tests are being expedited as a priority, and many of these tests are being moved to market quickly, and some supporting information such as real-time stability studies, will not yet be available. TGA said it would work with sponsors to ensure that validation efforts continue, and sponsors will be required to provide additional information over time.
Deputy Chief Medical Officer Paul Kelly said changes will soon be introduced on who can be tested, with the current prerequisite to have recently returned from overseas removed.
On March 22, the health minister enacted an exemption for COVID-19 medical devices, which allows the Department of Health to purchase face masks and other articles for a national stockpile. The exemption only applies to goods that are not already included in the ARTG; it does not permit the general supply of these items.
The TGA said it is supporting suppliers of products that are not covered by this exemption to include them in the ARTG as a priority.
The TGA also warned that the demand for surgical masks, surgical and isolation gowns, and surgical suits may overtake the supply available to healthcare organizations. In response, the agency is advising healthcare providers to use the products that are included on the ARTG so that they can be tracked accordingly.
Drug supplies not affected
Medicines Australia CEO Elizabeth de Somer has echoed calls by Prime Minister Scott Morrison, for Australians to stop stockpiling medicine during the ongoing pandemic.
“It is imperative, as an industry and as a nation, for us to employ every public health strategy and commit every effort to focus on COVID-19 and help to protect and treat the community,” de Somer said.
“Member companies of Medicines Australia and their global counterparts are working tirelessly to eradicate COVID-19 to increase diagnostic capability, develop a vaccine and find effective treatments. We hope this focus will generate success in the coming months. Each step forward will be shared.
“In the meantime, ensuring Australians requiring regular, essential medicine and care are able to continue to receive treatment – is our utmost priority,” said de Somer.
Medicines Australia is working with the Department of Health and TGA to ensure supply of essential medicines are maintained and measures are in place to minimize the potential for shortages.
Drug companies keep four to six months of stock, and sometimes more, in the country at all times, de Somer said, and they are now monitoring and updating stock levels on a daily basis.
Warnings on hydroxychloroquine
TGA is putting new restrictions on prescribers of hydroxychloroquine due to recent reports of off-label prescribing to treat COVID-19. Hydroxychloroquine is indicated to treat malaria and certain autoimmune diseases.
There are several clinical trials in Australia testing the malaria drug to treat COVID-19; however, the TGA warns that the drug could pose serious risks to patients including cardiac toxicity, irreversible eye damage and severe depletion of blood sugar.
To limit use of the drug, only certain types of specialists will be able to prescribe hydroxychloroquine to new patients, the TGA said. General practitioners and other medical practitioners can continue to prescribe repeats for hydroxychloroquine to patients in line with the registered indications for patients in whom the medication was prescribed prior to March 24, 2020.