AusBiotech joins global biotechnology peak industry bodies in their concern of the leaked ‘compromise text’ by World Trade Organization (WTO) in negotiations on a proposed IP waiver for COVID-19 vaccines.
The leaked text indicates a compromise had been reached by four (quad) WTO members: USA, Europe, India, and South Africa.
The text of the proposed WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver would see, under certain circumstances, member countries set aside patent rights for a vaccine in response to COVID-19, and for COVID-19 therapeutics and diagnostics in the future.
Industry notes a misguided understanding of equitable access remains and the proposal to waive IP protection that is before the WTO will not overcome the real barriers, despite voluntary global agreements and unparalleled R&D efforts and levels of cooperation that have taken place, including 371 collaborations on vaccines manufacturing and 155 for therapeutics.
The ‘compromise text' proposes to waive several patents in one notification thereby removing the requirement to grant compulsory licenses for individual patents, which are considered on ‘individual merits’. Instead, a single compulsory license could be granted, if these are necessary for the production of a COVID-19 vaccine. There is concern that this could capture IP only used tangentially in a COVID vaccine, and force the transfer of significant technology with value in other applications.
The proposal also seeks to broaden its scope to therapeutics and diagnostics, which risks impacting antibody and antiviral investment, where first-generation products are starting to show promising clinical results.
Steve Bates, Chair of International Council of Biotechnology Associations (ICBA) said, “The leaked QUAD proposal of a waiver on intellectual property rights for COVID vaccines would, if agreed, have a chilling impact on investment into the small companies that have been at the heart of the solutions to COVID-19. It would do nothing to solve the challenges we face in 2022 and make it far harder for small companies pioneering in this space in future.”
“… This proposal directly threatens this innovative ecosystem’s ability to attract the capital needed to develop next generation of vaccines whilst doing nothing to solve the access challenges we have in 2022.
“Weakening IP rights does nothing to facilitate the distribution of these manufactured vaccines to people around the world who most need them – rather prioritising addressing healthcare infrastructure and vaccine hesitancy in the developing world would lead to more shots in arms.”
AusBiotech is a member of the ICBA, a coalition of non-profit, national biotechnology trade associations formed to promote public understanding of, and to advocate for, public policies that support the growth of the innovative biotechnology industries.
If agreed, the proposal would undermine the global, innovative ecosystem of SMEs, with countries no longer needing to obtain prior approval from the IP rights-holders – this means that companies may not be informed of compulsory licensing approaches that are being adopted in countries, which could lead to manufacturing inefficiency as manufacturers try to follow the recipe ‘blind’.
WTO negotiations are lengthy due to their requirement to reach consensus-based decision making and due to the complexity of the challenges being faced. To achieve greater vaccine access, focus is best applied to addressing hurdles such as the bottlenecks and shortages in global supply chains, vaccine hesitancy, and strained health-care systems in low-and middle-income countries.