Europe: time between orphan drugs authorization and access 2023, by country

This statistic displays the average time between an orphan medicine gaining marketing authorization and patient access in European countries as of January 5, 2023. According to the data, Germany had an average time of 89 days between authorization and patient access for orphan medicines (for drugs launchend from 2018 to 2021), compared to almost 1,800 days in Malta.

Average time between marketing authorization and patient access for orphan drugs in Europe as of 2023, by country (in days)

Characteristic	Average time in days
Germany	89
Albania*	149
Serbia	159
Austria	211
Turkey	229
Denmark	243
North Macedonia*	316
Finland	334
England***	362
Switzerland	384
Netherlands	415
Bosnia and Herzegovina*	417
Scotland***	457
Italy	477
Cyprus*	511
Greece	551
Luxemburg	565
Sweden	580
Hungary	595
Czech Republic	622
Norway	627
Belgium	638
France**	653
Croatia*	663
Iceland	679
Slovenia	704
Spain	786
Estonia	805
Slovakia	850
Bulgaria	859
Ireland	877
Latvia	886
Portugal	888
Romania	909
Poland	916
Malta	1,777

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Release date

April 2023

More information

Region

Europe

Survey time period

as of January 5, 2023

Supplementary notes

Data collected is for drugs launched from 2018 to 2021. 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 (previously known as length of delay) is the days between EMA marketing authorisation 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 take into account 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 prior to 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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