OBJECTIVES: Analysis of time between regulatory approval and market access for medicinal products in the EU5 countries and US.

METHODS: Examined new molecular entities, formulations and combinations approved by the European Commission (EC) between January 2009 and December 2019, and their EU5 and US launches. Time comparisons were made for all products in scope, including analysis of orphan and oncology drug subgroups. Data was gathered from official national HTA agencies and P&R bodies.

RESULTS: Of all EC approved drugs between 2009 and 2019, majority (89%) are launched in Germany and fewest in France (58%). Across the EU5, average time to market for all drugs is consistently shortest in Germany (19 weeks) and longest in France (79 weeks) and Italy (80 weeks- excluding Class C-nn drugs). While time to market tends to be faster for oncology therapies in all countries (except France), it is longer for orphan drugs (except US and Germany).

In the last 3 years, average time to market has declined in Spain (69 weeks in 2019 vs. 75 weeks in 2017), and significantly increased in France (110 weeks in 2019 vs. 85 weeks in 2017). Overall time to launch post approval is fastest in the US (6 weeks) with no significant change over the years.

CONCLUSIONS: Analysis of market access trends across the EU5 shows that Germany continue to have the broadest and fastest access among the European countries. Time to market has been gradually increasing in Italy and France. In Spain, although overall time to market has shortened, access to orphan drugs is an issue, with <50% of EC approved orphan drugs marketed. US time to market is considerably shorter than in Europe; while the impact of Brexit on UK market access is yet to be seen.