OBJECTIVES: Examine the time between regulatory approval and launch/pricing and reimbursement (P&R) approval in the EU5 and analyse potential changes in market access timelines in the EU5 countries between 2009 and 2016.

METHODS: Examined new molecular entities, formulations and combinations with launches in the EU5 countries from 2009 to 2016. Time comparison for general medicines vs. orphan/oncology indications was made including shifts over time. Data gathered from official national HTA agencies and P&R bodies.

RESULTS: CONCLUSIONS: Wide disparity exists in the number of EMA approved medications commercially available in each of the EU5 countries and the time to market. It is important to recognize variation in ability to launch and timing disparities when analysing market access timelines and their implications on the availability of new drugs to patients.