COVID-19 medicines receive Australian Therapeutic Goods Administration exemption
Note: Nothing in our article is to be taken as providing medical advice or recommending or endorsing the use of the drugs mentioned below for any purpose.
Special measures have been passed in Australia which exempt specified treatments for COVID-19 from requirements to be registered on the Australian Register of Therapeutic Goods (ARTG) prior to their supply.
Generally speaking (and subject to a number of special arrangements), registration of pharmaceuticals, medical devices and other therapeutic goods on the ARTG is a pre-requisite to the lawful supply of those registered goods in Australia for the indications specified in the ARTG listing. ARTG registration follows a rigorous assessment of the goods by the Therapeutic Goods Administration. For a drug to be approved and registered, data demonstrating the safety and efficacy of that drug for a particular condition or disease is required, and that data is typically obtained by carrying out phase 3 (large-scale) clinical trials. It can take many years to run large-scale clinical trials and obtain sufficient safety and efficacy data to support an ARTG registration.
Exemptions for (potential) COVID-19 treatments
Clinical trials testing the safety and efficacy of (potential) COVID-19 treatments are underway around the world. However, as yet, no COVID-19 treatments have met what would be the “usual” regulatory approval criteria for new drugs, or new uses of existing drugs, as set by any of the world’s leading regulators. Despite this, given the urgency of the COVID-19 situation, the following exemptions from ARTG registration have been issued for (potential) treatments of COVID-19 in Australia.
- For hydroxychloroquine and chloroquine, pursuant to the Therapeutic Goods (Medicines—Hydroxychloroquine and Chloroquine) (COVID-19 Emergency) Exemption 2020, dated 2 April 2020. We note that there are pre-existing ARTG registrations for these medicines for treatment of other conditions and diseases such as malaria, rheumatoid arthritis and lupus.
- For lopinavir and ritonavir, pursuant to the Therapeutic Goods (Medicines—Lopinavir and Ritonavir) (COVID-19 Emergency) Exemption 2020 dated 2 April 2020. We note that there are pre-existing ARTG registrations for these medicines; ritonavir is registered for HIV treatment, and co-formulations of lopinavir and ritonavir are registered for HIV treatment.
- For remdesivir, pursuant to the Therapeutic Goods (Medicines—Remdesivir) (COVID-19 Emergency) Exemption 2020 dated 2 April 2020. Remdesivir is an anti-viral medication initially developed as a treatment for Ebola and is now an investigational medicine for COVID-19. Further information about remdesivir is available here.
These exemptions have been granted on certain conditions, including that the specified medicines:
(a) must only be imported, exported, manufactured or supplied by a person under a contract between the person and the Australian Government Department of Health for that purpose; and
(b) must only be supplied in Australia for the prevention, treatment or alleviation of coronavirus (COVID-19) following advice from the Australian Government Department of Health.
Exemptions have also been issued in relation to medical devices, including face masks, and in relation to COVID-19 testing.
Limits on prescribing hydroxychloroquine
Additionally, separate changes have been introduced which limit the types of Australian doctors who can issue new prescriptions of hydroxychloroquine, following the significant amounts of press coverage hydroxychloroquine has received as a potential COVID-19 treatment (in particular, due to comments by US President Donald Trump) and given that its safety and efficacy as a COVID-19 treatment is unproven and it carries risks of side effects, including causing potentially fatal irregular heartbeats (arrhythmias).
The Australian doctors granted authority to prescribe hydroxychloroquine to new patients are dermatologists, emergency medicine specialists, intensive care specialists, paediatrics and child health specialists, and physicians (noting many non-surgical medical specialists, such as rheumatologists, infectious disease specialists, cardiologists and oncologists, are physicians).
Change in regulation of COVID-19 treatments – general comments
As pharmaceutical and medical device companies around the world devote significant resources to searching for, and subsequently providing, COVID-19 treatments and vaccines (including by donating goods and offering to re-purpose their facilities), the special exemption measures available in Australia are worth keeping in mind.
Watching new ARTG registrations to obtain information regarding activities of other companies is part of many of our clients’ intellectual property management strategy, and extending those watching activities to the Australian government’s COVID-19 special exemptions may be helpful.