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Who Should Pay for Expanded Access?
Session Chair(s)
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.
Speaker(s)
Panelist
Tom Watson
Bionical Emas, United Kingdom
Executive Vice President, Early Access Programs
Panelist
Andrew McFadyen
The Isaac Foundation, Canada
Executive Director
Panelist
Christopher Robertson, JD, PhD, LLM
Boston University, United States
N.Neal Pike Scholar and Professor of Law