Patent linkage, data exclusivity and public health: approaches for reform

Abstract

The COVID-19 Pandemic exposed the fragility of the global public health regime (N Jensen et al, ‘The COVID-19 pandemic underscores the need for an equity-focused global health agenda’ (2021) 8 Humanit Soc Sci Commun 15.). Never before in history, we had a vaccine for an ongoing pandemic which the majority had no access to. Even prior to the pandemic, the global public health regime was showing signs of vulnerability manifested by the rising costs of medicines and public health expenditure levels, increased levels of legal monopolies exasperated by originator drug manufacturers activities and the widening gap between those who can afford medicines and therapeutic treatments, and those who can’t, even for those residing in developed countries (M El Said, ‘The Global IP Response to COVID-19 Pandemic: A Tale of Several Ironies?’ (2022) 19 MJIEL 79–91.). In fact, global spending on pharmaceuticals is forecast to exceed pre-pandemic outlook to $1.2 trillion by 2028 (IQVIA, The Global Use of Medicines 2024: Outlook to 2028 (2024). Available at https://www.iqvia.com/-/media/iqvia/pdfs/china/viewpoints/iqvia-institute-general-use-of-medicines-2024-for-print.pdf (accessed 22 July 2024).). At a time when the world started to recover from the negative impact of the COVID-19 Pandemic, fears about the potential arrival of a new pandemic arising from the outbreak of Mpox in Africa started to emerge thus putting more strain on public health providers everywhere.

Many reasons may be attributed to the failure of addressing the public health needs of the majority at the global level; however, one of the main factors related to this is the role patent protection and regulatory approvals play in imposing market barriers and monopoly exclusivities on drugs and medicines. In more recent years, the role of data exclusivity restrictions and patent linkage mechanisms became apparent and a vital component of this debate.

The significance of this paper is demonstrated by the policy reform options it is advancing. This paper provides a review of the challenges posed by data exclusivity restrictions and patent linkage mechanisms and will propose policy recommendations and approaches in order to mitigate the negative impact on public health and access to medicines arising from patent linkage and data exclusivity protection. The paper will rely on specifically selected country case studies to demonstrate the feasibility of achieving such objectives.