DEBORAH GLEESON & DAVID LEGG. Three simple things Australia should do to secure access to treatments, vaccines, tests and devices during the coronavirus crisis (The Conversation 21.4.20)
May 21, 2020
Patents and related intellectual property rights can present formidable barriers to procuring medicines, vaccines, diagnostic tests and medical devices.
They can cost lives, particularly during a public health emergency.
Two examples from the United States illustrate the point.
The US conglomerate 3M holds hundreds of patents onN95 face masks. The Governor of Kentucky has asked it torelease themso other manufacturers can make the masks.
Gilead Sciences holds a range of patents forremdesivir, one of the leading candidates for treating COVID-19.
It recently applied for anextra period of exclusivitywhich would have extended the length of time other firms were prevented from manufacturing the drug without its permission. Itwithdrewits application after a public outcry.
In the past few weeks 150 civil society organisations, includingMdecins Sans Frontires, have called on Gilead to forgo its patents.
There are three things Australia should do to manage these sorts of situations.
1. Prepare to over-ride patents
First, Australia should prepare to take advantage of some rarely-used but vitally important safeguards in the CommonwealthPatents Act.
They enable patents to be over-ridden when necessary to prevent shortages of vital medical supplies.
Under Sections 132-133, the Federal Court can order that a compulsory license be granted for a patented invention, meaning that a third party (such as a company that produces generic medicines or face masks) can manufacture copies of the invention without the permission of the patent owner.
This can be done under conditions outlined inSection 133, Para 3, which include that
- demand in Australia for the original invention is not being met on reasonable terms
- authorisation to exploit the original invention is essential to meet that demand
- the applicant has tried for a reasonable period, but without success, to obtain authority from the patentee to exploit the original invention on reasonable terms and conditions
- the patentee has given no satisfactory reason for failing to exploit the patent to the extent necessary to meet the demand for the original invention in Australia
Although the requirement that the applicant has tried for a reasonable period without success to obtain authority can slow down the process, the World Trade OrganisationsAgreement on Trade-Related Intellectual Property Rightsallows for legislation that bypasses the need for negotiations in an emergency.
Last monthCanadapassed such legislation, specifying that it was for the period of the coronavirus emergency.Australia should consider doing the same.
The Patent Actscrown useprovisions (Sections 163-170) provide another (potentially easier) mechanism allowing Australian governments to over-ride a patent in an emergency in order to provide a service primarily provided or funded by a government.
These provisions could also be redrafted to reduce ambiguity and make them easier to use in an emergency.
Using these provisions, particularly if they are made more workable, could mean that medical technologies could be manufactured locally if there are shortages or if they are not available from the patent holder at a reasonable price.
2. Reinstate the right to import low-cost medicines
Australia should also reverse its earlier decision tovoluntarily waiveits right to import medicines manufactured in another country under a compulsory license.
If Australia doesnt have the manufacturing capacity to produce a particular drug, or to produce enough of it to meet its populations needs, it should be able to import a low-cost version from another country.
To reverse the waiver, the Australian Government needs tonotifythe World Trade Organization that it has changed its policy and now considers itself an eligible importing country, at least in the context of an emergency.
3. Support Costa Ricas proposal for a global COVID-19 pool
Finally, the Australian Government should followThe Netherlandsin supportingCosta Ricasproposal for a World Health Organization global pool for rights on data and knowledge that can be of use for the prevention, detection and treatment of COVID-19.
Now put forward by theEuropean Unionas a draft resolution for the World Health Assembly, the initiative aims to provide free access to existing knowledge about diagnostic tests, devices, drugs and vaccines, enabling all countries to quickly access or produce affordable products.Each of three simple practical actions could prevent intellectual property rights from becoming an insurmountable barrier to accessing essential products during the emergency.

David Legge
David Legge is a scholar emeritus in the School of Public Health and Human Biosciences at La Trobe University in Melbourne and a founding member of the People’s Health Movement.