This statistic displays the average time between an orphan medicine gaining marketing authorization and patient access in European countries as of January 5, 2024. According to the data, Germany had an average time of 96 days between authorization and patient access for orphan medicines (for drugs launched from 2019 to 2022), compared to almost 960 days in Lithuania.
Average time between marketing authorization and patient access for orphan drugs in Europe as of 2024, by country
(in days)
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.Â
* 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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IQVIA, & EFPIA. (June 25, 2024). Average time between marketing authorization and patient access for orphan drugs in Europe as of 2024, by country (in days) [Graph]. In Statista. Retrieved December 21, 2024, from https://www.statista.com/statistics/1248711/europe-time-between-orphan-drugs-authorization-and-access/
IQVIA, und EFPIA. "Average time between marketing authorization and patient access for orphan drugs in Europe as of 2024, by country (in days)." Chart. June 25, 2024. Statista. Accessed December 21, 2024. https://www.statista.com/statistics/1248711/europe-time-between-orphan-drugs-authorization-and-access/
IQVIA, EFPIA. (2024). Average time between marketing authorization and patient access for orphan drugs in Europe as of 2024, by country (in days). Statista. Statista Inc.. Accessed: December 21, 2024. https://www.statista.com/statistics/1248711/europe-time-between-orphan-drugs-authorization-and-access/
IQVIA, and EFPIA. "Average Time between Marketing Authorization and Patient Access for Orphan Drugs in Europe as of 2024, by Country (in Days)." Statista, Statista Inc., 25 Jun 2024, https://www.statista.com/statistics/1248711/europe-time-between-orphan-drugs-authorization-and-access/
IQVIA & EFPIA, Average time between marketing authorization and patient access for orphan drugs in Europe as of 2024, by country (in days) Statista, https://www.statista.com/statistics/1248711/europe-time-between-orphan-drugs-authorization-and-access/ (last visited December 21, 2024)
Average time between marketing authorization and patient access for orphan drugs in Europe as of 2024, by country (in days) [Graph], IQVIA, & EFPIA, June 25, 2024. [Online]. Available: https://www.statista.com/statistics/1248711/europe-time-between-orphan-drugs-authorization-and-access/
