Time between non-oncology orphan drugs approval and patient access in Europe 2024

Average time between marketing approval and patient access for non-oncology orphan drugs in Europe as of 2024, by country

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Release date

June 2024

Region

Europe

Survey time period

as of January 5, 2024

Supplementary notes

Data collected is for drugs launched from 2019 to 2022. In most countries, availability equates to granting of access to the reimbursement list, except in DK, FI, NO, SE some hospital products are not covered by the general reimbursement scheme. The time to availability (formerly known as length of delay) is the days between EMA marketing authorization and the date of availability to patients. 

* These countries did not complete a full dataset and therefore availability may be unrepresentative.
** The source mentions that it does not consider France's system of temporary authorization for some products, which means this time will be higher than in reality.
*** MHRA’s Early Access to Medicines Scheme provides access before marketing authorization but is not included within this analysis, and would reduce the overall days for a small subset of medicines.

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