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Hydroxychloroquine: Australian government waives regulatory requirements for drug

The Morrison government has waived therapeutic goods registration requirements for anti-malarial drugs touted by Donald Trump as a potential cure for Covid-19 to prepare for their urgent importation to Australia.

On Thursday, hydroxychloroquine and chloroquine was exempted from a requirement to be listed on the Australian register of therapeutic goods, which is generally the only way medicine can be lawfully supplied in Australia.

Similar exemptions were also granted to Remdesivir, Lopinavir and Ritonavir, which are all anti-viral drugs currently being investigated for the potential to combat Covid-19.

According to the Therapeutic Goods Act, exemptions can only be granted so that medicines may be stockpiled for a current or future health risk or “can be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred”.

Caroline Edwards, the health department’s acting secretary, made the exemption on the condition the drugs can only be imported, manufactured or supplied by a person with a contract or arrangement with the health department.

“The specified therapeutic goods must only be supplied in Australia for the prevention, treatment or alleviation of coronavirus disease (Covid-19) following advice from the Australian government department of health,” the exemption said.

The Australian government supports two trials involving hydroxychloroquine, which is an anti-malarial drug also used to treat autoimmune conditions such as rheumatoid arthritis and lupus.

The first, by the University of Queensland, is looking at whether a hydroxychloroquine and an HIV drug used either in combination or on their own can reduce severity and length of Covid-19 if given to patients with the virus early after diagnosis.

The second trial, being conducted by Melbourne’s Walter and Eliza Hall Institute and which Hunt said had “the potential for possible prevention” of the virus, will focus on giving 2,250 health workers around Australia given hydroxychloroquine preemptively before and while they are exposed to patients with the virus.

Hunt has said hydroxychloroquine may have potential in minimising the impact of and hasten the recovery from Covid-19.

On 25 March Hunt said there had been “some promising research so far” and on 23 March he said the drug is “associated with the potential to reduce the impact of coronavirus and speed the body’s capacity to recover from it”. However, he also said he was “cautiously” hopeful.

Trump has claimed the use of hydroxychloroquine in combination with azithromycin, an antibiotic, could be “one of the biggest game changers in the history of medicine” – only to be immediately contradicted by public health experts including his own top infectious diseases adviser, Dr Anthony Fauci, who warned that there was only “anecdotal evidence” that the drugs could be helpful.

Dr Gaetan Burgio, from the John Curtin School of Medical research at the Australian National University, had said “recent results from clinical trials indicated a possible improvement in shortening the duration of the infection”.

“However the results are disputed and the clinical trials are inconclusive,” he said. “To date there are no clear indications that chloroquine or hydroxychloroquine are a treatment option.”

The Therapeutic Goods Administration [TGA], which regulates drugs in Australia, has placed tight new restrictions on doctors who are authorised to write new prescriptions for the drug, limiting it to a small group of clinical specialties.

The TGA warned of increased off-label prescription of medicines containing hydroxychloroquine, citing a “a potential shortage of this product in Australia” and the medicine’s “well-known serious risks to patients including cardiac toxicity (potentially leading to sudden heart attacks), irreversible eye damage and severe depletion of blood sugar (potentially leading to coma)“.

The Pharmaceutical Society of Australia wrote to members urging them to “refuse the dispensing of hydroxychloroquine if there is not a genuine need”.

A health department spokesperson said the legislative changes “allow the importation and supply of a medicine including hydroxychloroquine or chloroquine to deal with the threat to public health by the Covid-19 emergency without a requirement to be included in the Australian register of therapeutic goods”.

The spokesperson noted safeguards including that a patient information leaflet must be supplied with the medicine.

Peter Collignon, a professor of infectious diseases, described the move as sensible as long as the drug was only given to approved providers and, in the first instance, used in clinical trials being undertaken by those providers. He gave the example of the antibiotic penicillin, which Australia almost ran out of several years ago due to issues with the supplier. Even though there were equivalent drugs in other countries, Australia was unable to import these to fill the gap because those specific brands had not been approved by the TGA, a process that can take a year or more.

Collignon said the changes to the Therapeutic Goods Act meant bureaucratic red-tape had been removed, which he said was reasonable given shortages of hydroxychloroquine in Australia which meant patients who needed it for severe and painful conditions like rheumatoid arthritis are struggling to get scripts filled.

“This does not mean, however, that any hydroxychloroquine in the stockpile should be given to Australians more widely before clinical trials are done,” he said. “I would hope it is used for the trials being done in Australia first and foremost.