Masterarbeit

An Assessment of Regulatory Measures to Combat Drug Shortages. A Comparison of the Existing FDA System With the New EU System to be Introduced as Part of the ”Pharma Package”

André Pukowski (2025)

Summary

Language: English 

In recent years, shortages of antibiotics, antihypertensives, and pediatric antipyretics have increased significantly, presenting considerable challenges for both patients and healthcare providers. Regulatory agencies have been actively addressing the complex causes of these shortages, making this issue a central theme in the most comprehensive revision of European pharmaceutical legislation in over 20 years.

This thesis examines the regulatory measures that have been developed and implemented to combat drug shortages. While these measures facilitate the monitoring, prevention, and resolution of shortages, they also impose additional burdens on the stakeholders involved. This is particularly relevant in a context where patient welfare is paramount, yet financial pressures persist.

A key objective was to analyze and characterize the existing systems of the FDA and EMA in addressing drug shortages. In October 2024, an online survey was conducted among regulatory experts across Europe to assess the effectiveness of these measures.

The survey results indicate a broad acceptance of the measures among experts; however, many of these measures were perceived as relatively costly. A developed cost-benefit score revealed varying evaluations of the measures, with those included in the so-called “Pharma Package” being assessed as less cost-effective.

This investigation suggests that, in the future, either transparent information about the successful practical implementation of measures to combat shortages should be provided or these measures should be regularly reviewed.

Pages: 97

Annexes: 8, Pages: 103