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.
It recently applied for an extra period of exclusivity which would have extended the length of time other firms were prevented from manufacturing the drug without its permission. It withdrew its application after a public outcry.
There are three things Australia should do to manage these sorts of situations.
1. Prepare to over-ride patents
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.
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 Organisation’s Agreement on Trade-Related Intellectual Property Rights allows for legislation that bypasses the need for negotiations in an emergency.
Australia should consider doing the same.
The Patent Act’s crown use provisions (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
If Australia doesn’t have the manufacturing capacity to produce a particular drug, or to produce enough of it to meet its population’s needs, it should be able to import a low-cost version from another country.
To reverse the waiver, the Australian Government needs to notify the 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 Rica’s proposal for a global COVID-19 pool
Finally, the Australian Government should follow The Netherlands in supporting Costa Rica’s proposal 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 the European Union as 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.
- ^ N95 face masks (www.msn.com)
- ^ release them (www.courier-journal.com)
- ^ remdesivir (www.drugs.com)
- ^ Drug companies should drop their patents and collaborate to fight coronavirus (theconversation.com)
- ^ extra period of exclusivity (www.npr.org)
- ^ withdrew (www.gilead.com)
- ^ Médecins Sans Frontières (msfaccess.org)
- ^ Patents Act (www5.austlii.edu.au)
- ^ Section 133, Para 3 (www5.austlii.edu.au)
- ^ Agreement on Trade-Related Intellectual Property Rights (www.wto.org)
- ^ Canada (theconversation.com)
- ^ Canada's coronavirus aid package guards against drug shortages with compulsory licensing (theconversation.com)
- ^ crown use (www5.austlii.edu.au)
- ^ voluntarily waive (www.keionline.org)
- ^ notify (www.keionline.org)
- ^ The Netherlands (www.healthpolicy-watch.org)
- ^ Costa Rica’s (www.presidencia.go.cr)
- ^ European Union (www.statnews.com)
- ^ Supplies needed for coronavirus healthcare workers: 89 million masks, 30 million gowns, 2.9 million litres of hand sanitiser. A month. (theconversation.com)
Authors: Deborah Gleeson, Senior Lecturer in Public Health, La Trobe University