OBJECTIVES: Early notification of impending drug shortages is an essential measure for mitigating and preventing inadequate medicines supply. Since 2019 it has been an obligation of pharmaceutical companies in the EU area to notify about shortages a minimum of two months in advance. This study aims to investigate realization of this legal obligation across EU/EEA countries.

METHODS: Information about actual notification times in 2020-2022 was searched from 25 drug shortage registers in the EU/EEA area. Data from eight countries (Belgium, Croatia, Finland, Germany, Norway, Slovakia, Slovenia, and Sweden) was publicly available and was analyzed to review actual compliance.

RESULTS: The median notification time for most countries was 0 days, meaning that drug shortages were mostly notified on the day they started or after that. In Finland, median notification time was 6 days, and in Slovakia 1 day. Mostly there was no improvement in notification during this period. The exception was Finland, where national authorities temporarily introduced heightened fees for belated notifications.

When only production-related shortages were analyzed from four countries (Belgium, Croatia, Germany, and Norway), median notification times ranged between 0 to -8 days. From three countries (Belgium, Slovenia, Slovakia) notification times for market withdrawals of drug products were also available and analyzed. Median notification times for product withdrawals were between 3 and 20 days.

CONCLUSIONS: Lack of incentives and effective sanctions have created a situation where pharmaceutical manufacturers have largely ignored the obligation for early notification. A functional advance notification system would require reliable regulatory oversight and active enforcement.