OBJECTIVES: Examine trends in the time between regulatory approval and launch/pricing and reimbursement in the EU5 and US and review EC authorised drugs not approved by FDA.

METHODS: Assessment of time from regulatory approval to price listing, including shifts over time for new molecular entities, formulations and combinations with EC approval. Analysis of drugs approved by the EC but not the FDA. Data gathered from official national HTA agencies and P&R bodies.

RESULTS: Of all EC approved drugs between 2009 and 2018, majority (88%) are launched in Germany and fewest in France (59%). Across the EU5, average time to market is consistently shortest in Germany and longest in France and Spain. Access to orphan drugs continues to be an issue in Spain; only 39% of all EC authorised drugs have completed pricing and reimbursement negotiations with average time to market being 67 weeks.

Overall time to launch post FDA approval is fastest in the US (6 weeks) with no significant change over the years. Interestingly, however 23% of EC authorised drugs are not launched in the US. Reasons identified include stricter intellectual property protection in the US, infrastructure limitations for smaller ex-US companies, greater acceptance of off label use and different evidence requirements.

CONCLUSIONS: Time to market in Europe is substantially longer than in the US and seems to be rising in some EU countries. Several factors may limit approval of drugs in the US that may have launched in Europe.