In October 2020, South Africa and India called on World Trade Organisation (WTO) members to support a proposal to suspend the WTO’s agreement on Trade-Related Aspects of Intellectual Property Rights (Trips), for the duration of the coronavirus pandemic. 


The thinking behind the proposal is that, if patent rights are waived, vaccine production facilities can be established throughout the world, resulting in increased vaccine supply and expedited roll-out. 

On US President Biden’s 100th day in office, the US agreed that it, too, would support a temporary and targeted waiver of Covid-19 vaccine intellectual property (IP) protection, with Canada, New Zealand and the European Patent Office swiftly following suit. [1] 

On the other hand, countries still withholding support for the waiver include the UK, Australia, Japan, Switzerland, Norway, and Brazil, at the time of writing. 

In its Position Statement of 7 May 2021, the Max Planck Institute for Innovation and Competition presented a number of reasons why, although well-intentioned, such a waiver would not “be a necessary and suitable measure towards the pursued objectives”. 


One of the reasons put forward is that such a waiver of IP rights will not waive the regulatory requirements for vaccine authorisation, which are incredibly onerous and require significant resources to comply with. 

In this article, we explore what South Africa’s regulatory requirements are when it comes to vaccine authorisation and whether, in view of these requirements, a waiver of IP protection would actually speed up vaccine delivery and the time to global immunity for Covid-19. 


This article was first published in Bizcommunity.