Importers of already-approved Covid rapid tests say they are being frustrated by long regulatory delays blocking them from selling the devices for home use, further strangling supply at a time of peak demand.
The Morrison government has faced sustained criticism over its failure to shore up supplies of Covid rapid tests ahead of the current Omicron wave, including by companies critical of the slow regulatory approval process.
Currently, Australia’s health regulator, the Therapeutic Goods Administration, needs to separately approve the same rapid Covid test for use in two different settings: at home through self-testing, or at various points of care under the supervision of a health practitioner of staff member.
Approvals for home tests were slow to commence and are still lagging badly behind. Just 18 tests have been approved for home use, while 59 rapid antigen or lateral flow tests have been approved for use in care settings.
Suppliers who already have approval to supply rapid tests in point of care settings are facing months-long delays to obtain the regulator’s green light to sell the same devices for self-testing, despite the fact they have already been deemed safe and reliable, and generally only require a tweaking of packaging and instructions.
One importer said they had been waiting three months for the TGA to examine the instructions included in the box of their already-approved rapid test, to ensure they were suitable for home use.
“That is a source of frustration for many importers,” he said.
“You would think that maybe if the TGA was to say to us ‘this is what your insert has to say’, we would say exactly that and away we go.”
“But in the meantime we are communicating backwards and forwards and have been doing so for some time.”
An analysis of registers published by the TGA shows 26 suppliers of rapid antigen or lateral flow tests are currently approved to sell tests for use in point of care settings, but not for home use. Not all of those 26 suppliers have applied for approval to sell their tests for home use and some rapid tests require the use of special instruments, not available in a home setting, to properly obtain a result.
The TGA said it is prioritising the assessment of self-tests, but suggested delays were often caused by applicants.
“For most applications received by the TGA, there is missing information that requires additional submissions from suppliers which in turn, extends the finalisation of the regulatory review and approval process until the information is submitted and then assessed,” a spokesperson said.
The spokesperson said self-tests must comply with minimum standards, including performance criteria and information on labelling and instructions for use that can be easily understood by consumers.
In cases where approval for point of care tests already existed, suppliers wanting to sell the same test for home use must provide additional information and change instructions for use to enable self-testing, the spokesperson said. Instructions written for health professionals contained assumed levels of knowledge that were “not suitable for consumers or lay-persons”, the TGA said.
The supplier is also required to show how they would provide support for self-testing, including, for example, through instructional YouTube videos. Suppliers must also provide usability testing by untrained, unsupervised users.
“The TGA’s assessment process ensures that Australians can be confident that the tests they are using are safe, perform as intended, with the relevant steps and support provided to consumers who purchase them.”
One test distributor said the approval process for an at-home Covid test had taken several months, despite the TGA having previously approved another supplier to sell identical tests for home use.
“It’s just so difficult and it’s taken far too long,” the distributor said.
They said tests cost about AUD$3.50 out of China, plus freight, warehousing and distribution costs.
National cabinet agreed on a plan late Wednesday evening to give disadvantaged people small cash payments to cover the cost. The agreement will provide up to 10 rapid antigen tests free to more than six million concession card-holders, but everyone else who is not a close contact of a case and symptomatic will still have to pay.
The prime minister, Scott Morrison, dismissed growing calls for universal free access to rapid testing kits, at odds with Labor leader Anthony Albanese, who on Wednesday called for rapid tests to be made freely available.
“We have considered the options and it is clear that this is the simplest, most efficient, fairest and most responsible way to fix the mess that Scott Morrison has made of testing at this critical juncture of the pandemic,” Albanese said.
