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Demands from patients, health-care professionals, and industry to streamline the market approval process for promising new therapies has prompted the introduction of programs that can provide more rapid access to stem cell-based products before evidence of safety and efficacy has been demonstrated in clinical trials. These products may be approved for marketing under "conditional authorizations," while uncertainty around safety and efficacy is reduced through the collection of clinical data in observational trials or registries. The rationale for conditional approval programs assumes that patients with unmet medical needs will benefit with rapid access to novel stem cell therapies. It also assumes that data gathered in actual clinical contexts is inherently better at reducing uncertainty than conventional clinical trial methods of demonstrating safety and efficacy. These assumptions may be overly optimistic and do not account for the broader societal burdens of prematurely releasing high-cost therapies with uncertain safety risks and benefits on to health-care markets. This essay focuses on the introduction of conditional approval programs for autologous somatic stem cell therapies and argues that these programs may conflict with, and potentially undermine, the normative commitments of regulatory agencies charged with promoting population health and protecting vulnerable groups from harm and exploitation. It concludes with suggestions of how programs designed to accelerate access to potentially helpful but experimental interventions could be reconfigured to be more equitable.

Driven by the need to address the immediate public health threats of the COVID-19 pandemic, this has seen a rise of the technocratic mode of governance around the world. A technocratic approach is evidence-based and relies upon the guidance of experts to respond to the public health crisis. The rise of technocracy reflects a utilitarian calculus that seeks to preserve the greater good. Taiwan’s pandemic response exemplifies the strengths and weaknesses of this type of governance. Based on an analysis of the relevant case law of the Taiwan Constitutional Court, legislation, and political developments this Article takes a legal-historical look and traces the current technocratic approach—defined for this Article as an experts-driven and procedural-driven process—which is a hallmark of Taiwan’s pandemic response. Examining Taiwan’s pandemic response through a human rights lens sheds light on a more complex relationship between the collective right to health and life, and the individual rights to health, work, privacy, and liberty during the pandemic.