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Wednesday, June 30 • 4:00pm - 5:00pm
#360 SL: Who Should Pay for Expanded Access?

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-634-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Alison Bateman-House, PhD, MA, MPH


Tom Watson

Andrew McFadyen

Christopher Robertson, JD, PhD, LLM

avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, Dept of Population Health, NYU Grossman School of Medicine, United States
Alison Bateman-House, PhD, MPH, MA, is an assistant professor in the Division of Medical Ethics at NYU Grossman School of Medicine and a Professor of Practice in Law at University of Arizona James E. Rogers College of Law. She is co-chair of the Working Group on Compassionate Use... Read More →
avatar for Andrew McFadyen

Andrew McFadyen

Executive Director, The Isaac Foundation, Canada
Andrew McFadyen is the executive director for The Isaac Foundation, an organization dedicated to helping patients and families affected by rare diseases. He is a member of the NYU working group on Compassionate Use and Pre Approval Access (CUPA), the NYU working group on Pediatric... Read More →
avatar for Tom Watson

Tom Watson

Executive Vice President, Early Access Programs, Bionical Emas, United Kingdom
For the last decade, Tom has partnered with Pharma and Biotech companies to design their strategy for Early/Expanded Access. Within this time, Tom has been involved in setting up and running over 250 EAPs in roles based in the U.S. and E.U. Tom heads up the Early/Expanded Access Programs... Read More →

Christopher Robertson

N.Neal Pike Scholar and Professor of Law, Boston University, United States
Professor Robertson is an expert in health law, institutional design, and decision making. His wide-ranging work includes torts, bioethics, professional responsibility, conflicts of interests, criminal justice, evidence, the First Amendment, racial disparities, and corruption.

Wednesday June 30, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  12: Value-Access, Forum