Time between orphan drugs approval and patient access in Europe 2024, by country

Average time between marketing authorization and patient access for orphan drugs in Europe as of 2024, by country

CharacteristicAverage time in days
Serbia 95
Germany 96
Cyprus* 192
North Macedonia* 194
Denmark 202
Austria 206
Switzerland 329
Finland 365
Sweden 366
England*** 394
Scotland*** 401
Bosnia and Herzegovina* 417
Italy 431
Created with Highcharts 7.2.2Average time in days95959696192192194194202202206206329329365365366366394394401401417417431431476476491491492492530530533533558558578578597597597597601601613613615615622622671671700700704704716716744744750750798798958958SerbiaGermanyCyprus*North Macedonia*DenmarkAustriaSwitzerlandFinlandSwedenEngland***Scotland***Bosnia and Herzegovina*ItalySlovakiaLuxembourgIcelandGreeceNetherlandsHungarySloveniaFrance**IrelandNorwayBelgiumCzechiaEstoniaCroatia*LatviaSpainBulgariaRomaniaPolandPortugalLithuania
0501001502002503003504004505005506006507007508008509009501,0001,0501,100
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Sources

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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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