The COVID-19 pandemic demonstrated that the current purely market-driven approaches to drug discovery and development alone are insufficient to drive equitable access to new therapies either in preparation for, or in response to, pandemics. A new global framework driven by equity is under negotiation at the World Health Organization to support pandemic preparedness and response. Some believe that the global intellectual property (IP) system itself is part of the problem and propose a purely Open Science approach. In this article, we discuss how existing IP frameworks and contractual agreements may be used to create rights and obligations to generate a more effective global response in future, drawing on experience gained in the COVID Moonshot program, a purely Open Science collaboration, and the ASAP AViDD drug discovery consortium, which uses a hybrid, phased model of Open Science, patent filing and contractual agreements. We conclude that 'straight to generic' drug discovery is appropriate in some domains, and that targeted patent protection, coupled with open licensing, can offer a route to generating affordable and equitable access for therapy areas where market forces have failed. The Extended Data contains a copy of our model IP policy, which can be used as a template by other discovery efforts seeking to ensure their drug candidates can be developed for globally equitable and affordable access.
Keywords: Pandemic Preparedness; equitable access; intellectual property; licensing; novel therapeutics; patents.
Drug discovery and development organizations usually recoup their investment in this risky and expensive process by filing patents on drug candidates which, if granted, give them a time-limited monopoly on the manufacture, sale or licensing of the drug. This means they can negotiate its price and terms of distribution, which creates distortions in access globally. In an alternative ‘Open Science’ approach, R&D organizations publish all the information about a prospective drug without applying for patents, meaning that anyone can use this knowledge to make and sell the drug, while the R&D organizations have no control over how it is priced or distributed. In a pandemic, fast-spreading viruses must be rapidly contained by delivering drugs to where they are most needed. This requires innovation and global access, but this is stifled in both models – in the first because of patent abuses, in the second because the lack of control may jeopardize the most efficient development. The authors share a model that prioritizes globally fair and affordable pricing by creating ‘maximally permissive licenses’ based on ‘minimally defensive patents’. They explain the practical and bioethical background to their proposals and share an example of collective management of intellectual property and licensing agreement that is being used in the AI-driven Structure-enabled Antiviral Platform (ASAP) Center’s Pandemic Preparedness work.
Copyright: © 2024 Griffen EJ et al.