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Making Advanced Therapies Affordable and Accessible: Two Strategic Approaches.

Ubaka Ogbogu¹, Lauren Albrecht¹

¹Faculty of Law, University of Alberta, Edmonton, Alberta, Canada.

Developing World Bioethics

|September 10, 2025

Summary

This article presents two strategies to overcome the

Keywords:

COVID‐19 vaccine Glybera access and affordability advanced therapies global health equity medicines reimbursement schemes valley of death

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Area of Science:

Health Economics
Pharmaceutical Policy
Biotechnology Access

Background:

High development costs and market access issues create 'valleys of death' for advanced therapies.
Several promising therapies have been withdrawn due to economic and access barriers.
Ensuring patient access to innovative treatments is a critical global health challenge.

Purpose of the Study:

To explore complementary strategies for improving affordability and access to advanced therapies.
To analyze systemic reforms and early-stage R&D integration for therapy accessibility.
To provide actionable insights for pharmaceutical policy and innovation.

Main Methods:

Analysis of case studies, including Glybera, to identify barriers to therapy access.
Examination of a 'rehabilitative' approach focusing on system reforms (reimbursement, regulation, manufacturing).
Evaluation of a 'transformative' approach integrating affordability into early-stage R&D (local innovation, IP, adaptive regulation).

Main Results:

Rehabilitative strategies can reform existing systems for better therapy access.
Transformative strategies embed affordability and access from the outset of R&D.
The COVID-19 vaccine experience highlights the potential of these integrated strategies.

Conclusions:

A dual approach of system reform and early-stage integration is crucial for advanced therapy affordability and access.
Implementing equitable practices in R&D and adaptive regulatory frameworks can accelerate global delivery.
Sustainable access to innovative medicines requires proactive planning and policy intervention.