Erosion or evolution? Socially responsible adaptations to regulatory approval of healthcare interventions
Sara Attinger1, Macquarie University Macquarie Park 1Macquarie University, Macquarie Park, NSW, Australia
Abstract
In recent years, regulatory processes governing the approval of new health technologies have undergone several changes aimed at expediting access to interventions. Many of these changes include adapting evidence standards for safety and efficacy. While such evidence-adapted regulatory processes (EARPs) have provided more timely access to beneficial interventions, critics argue that reducing evidentiary thresholds erodes regulation, compromises safety, and undermines evidence-based medicine. On the other hand, proponents of EARPs view them as an evolution, representing a maturation of previously burdensome or paternalistic systems. While supporters and critics primarily focus on scientific, clinical, and economic impacts of EARPs, there is another, neglected consideration: how EARPs are portrayed and understood, and how these influence public, political, and professional discourses about ‘approved’ interventions.
In this presentation, we argue that through the promissory work of product and policy labels such as ‘advanced’, ‘breakthrough’ and ‘regenerative’, regulatory approval creates three ethically significant issues: (i) increased usage of products and accompanying collective risk and harm, (ii) challenges with withdrawing conditional approval when ongoing evidence suggests approval may not be warranted, and (iii) increased pressure on payers to fund products approved through EARPs.
We suggest principles to differentiate between regulatory changes as ‘evolution’ or ‘erosion’ on a case-by-case basis and guide socially responsible EARPs. With health technology assessment (HTA) in Australia currently under review, we suggest how these principles may also be applied to adjusted evidentiary standards in HTA as part of a more coordinated approach to expediting access.
Biography
Sara Attinger is a research assistant in the Department of Philosophy, Macquarie University and at Sydney Health Ethics, University of Sydney. Sara has worked in the private and public sector in legal, corporate and commercial roles and holds a BA and LLB (USyd).