International IP protection at risk for COVID-19 vaccines


The global biotech industry is united in its drive for equitable access to COVID-19 vaccines, but the proposal to waiver IP protection that is before the World Trade Organization (WTO) will not overcome the barriers preventing access.

Vaccine production is complicated and few organisations around the world can do it at scale, at low cost, and in compliance with the strict standards and public expectations of manufacturing safety. Supply chain and distribution challenges, regrettably, are preventing increased vaccine output and delivery.

The Biden Government backflipped last week on its support of the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver, followed by other countries, including Australia. The waiver would see, under certain circumstances, member countries set aside patent rights for a medicine or vaccine in response to a public health emergency.

While it typically takes many years to develop biotech IP, once approved it requires safe and approved manufacturing facilities, a stable and expeditious supply chain, and a sizable and trained workforce to deliver them. Waiving IP rights would jeopardise the existing quality control systems in place, and make it far more difficult to distinguish genuine vaccine products from ‘knock-offs’ that may target vulnerable communities. It would also not address the workforce challenges.

AusBiotech members represent a wide range of biotech firms that rely on IP to fund their research, turning ideas into products, and a platform to partner globally. Allowing international governments to waive IP rights would undermine the global collaboration that has led to more than one billion vaccine doses being administered in 188 countries so far.

AusBiotech CEO, Lorraine Chiroiu, said, “The impacts being felt in countries hard-hit by COVID-19 is tragic, but highlights the importance of the biotech sector and the IP it relies upon to deliver new vaccines.

“The best way to end the COVID-19 pandemic is to immunise individuals across the globe, and the answers don’t lie in removing our innovators’ IP rights through the TRIPS waiver. It will not address the current access barriers being faced in the developing world, and the changes could cause long-term detrimental effects to our global development of vaccines and therapies.

“Weakening IP protection and disincentivising investment into biotech companies must be considered with extreme caution. Fostering these technologies is essential, and we must retain the protection and sustainability of the critical research and innovation behind the industry’s life-saving technologies, and avoid setting precedents. Disincentivising investment could result in less technologies available and less willingness to engage in global collaborations when we face the next, inevitable, pandemic.”

AusBiotech’s IP Advisory Group Chair, Declan McKeveney, Senior Counsel, FB Rice, added, “The WTO TRIPs waiver may have well-intentioned support but it overlooks key aspects of the current innovation system and it is by no means clear that its implementation would solve the problems it purports to address.

“No clear evidence has been provided as to IP rights being a barrier to COVID-19 vaccine access. It would appear that a more significant challenge relates to manufacturing bottlenecks and it is not clear how the waiver proposal would address these in any way. Holding up IP rights as a barrier to faster vaccine production and distribution also ignores the significant time challenge presented to any country in scaling up vaccine production while maintaining essential regulatory approval standards to ensure safe and efficacious vaccine production.

“Importantly, the waiver proposal also ignores the already significant waiving of patent enforcement rights; provision of key manufacturing information and data; and wide-spread collaboration exhibited by a number of the key biotechnology players who have enabled the successful design and production of a number of efficacious vaccines. The dissemination of the necessary technology can, and is, being achieved by existing technology transfer means including licensing arrangements and large numbers of vaccine doses are already being produced with capacity increasing all of the time.

“It is key to acknowledge that the incredible speed with which this has been achieved has been based, for example in the case of the mRNA vaccines, on technology which was incentivised and developed over many years under existing IP regimes by biotechnology companies spending significant amounts of resources in addressing challenging technological problems and accepting all of the uncertainty, both scientific and financial, that goes with the development of new therapeutics.”

WTO negotiations typically take time to reach consensus-based decision making, and due to the complexity of the challenges being faced. Scaling up manufacturing also takes time – and it is the distribution of vaccines, rather than the IP behind them, that countries need to remain focused on to achieve greater access.