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DIA 2021 Global Annual Meeting
Who Should Pay for Expanded Access?
Alison Bateman-House, PhD, MA, MPH
- Assistant Professor, Division of Medical Ethics, Dept of Population Health
- NYU Grossman School of Medicine, United States
Non-trial preapproval access involves costs: in producing product, in tracking safety and efficacy outcomes, and in developing a fair allocation strategy. Who is currently paying these costs? Who should be paying for these costs, and why?
Learning Objective : Describe legal, regulatory, and ethical issues concerning who should pay for preapproval access-related costs; Identify costs and paying parties within current legal and regulatory frameworks, US and abroad; Evaluate different payment strategies from the perspective of multiple stakeholders.
- Executive Vice President, Early Access Programs
- Bionical Emas, United Kingdom
- Executive Director
- The Isaac Foundation, Canada
Christopher Robertson, JD, PhD, LLM
- N.Neal Pike Scholar and Professor of Law
- Boston University, United States