Weighing Access and Affordability - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Weighing Access and Affordability
Policymakers must balance fundamental issues involving access to medicines and pricing.

Pharmaceutical Technology
Volume 36, Issue 11, pp. 30

Of course, this conclusion begs the questions: Why were more new cancer drugs approved in the US than in Europe, and among the 29 drugs common to both regions, why were all of them approved and marketed first in the US? The answer is that approvals are, in part, a function of both regulatory policy (e.g., access to priority review and accelerated approval procedures) as well as institutional features, such as whether an environment is more conducive to the marketing of products. The US has fewer price controls and has less institutionalization of cost-effectiveness assessments as a possible barrier to market access. Consequently, pharmaceutical companies are more likely to seek approval and market their products first in the US.

If the following policy goal is presupposed—that is, to maximize aggregate health outcomes subject to a budget constraint—then the European scenario of granting less access to medicines deemed to offer less value (i.e., less cost-effective) may make sense. This scenario, however, is a societal or payer perspective and may not represent the best interests of individual patients, who are unlikely to care much about average, aggregated data. To them, having more immediate access offers hope, a chance at an extension of life, or an improvement in quality of life.

There may be a trade-off between access and pricing: greater access at the expense of higher, possibly unaffordable prices to patients. It's a "cruel irony."

Kenneth I. Kaitin, PhD, is professor and director, and Joshua P. Cohen, PhD, is assistant professor, both at the Tufts Center for the Study of Drug Development, Tufts School of Medicine,


1. K.I. Kaitin, Ed., "US Offers Patients Faster, Greater Access to Cancer Drugs than Europe," Tufts CSDD Impact Report 14 (4), 1–4 (2012).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Source: Pharmaceutical Technology,
Click here