Rate of orphan drugs availability Europe 2023, by country

This statistic displays the share of orphan medicines approved by the European Medicines Agency (EMA) between 2018 and 2021 which were available to patients in selected European countries as of January 5, 2023. According to the data, 90 percent of approved orphan medicines were available to patients in Germany, followed by 82 percent in Italy.

Percentage of orphan drugs approved by the EMA available to patients in Europe as of 2023, by country

Characteristic	Share of medicines available
Germany	90%
Italy	82%
France	79%
Austria	77%
Denmark	69%
Switzerland	61%
England	59%
Greece	56%
Scotland	54%
Spain**	51%
Czech Republic	48%
Luxemburg	48%
Netherlands	46%
Portugal	46%
Sweden	41%
Belgium	36%
Slovenia	36%
Finland	34%
Norway	34%
Romania	34%
Poland	33%
Ireland	26%
Cyprus*	23%
Hungary	21%
Iceland	20%
Bulgaria	18%
Croatia*	16%
Slovakia	11%
Estonia	10%
Malta*	7%
Serbia	7%
Turkey	7%
Latvia	5%
Albania*	3%
Bosnia and Herzegovina*	3%
North Macedonia*	3%
Lithuania	0%

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Release date

April 2023

More information

Region

Europe

Survey time period

as of January 5, 2023

Supplementary notes

61 orphan drug products were approved by the European Medicines Agency between 2018 and 2021.
In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE some hospital products are not covered by the general reimbursement scheme.
* Country did not complete a full dataset and therefore availability may be unrepresentative.
** In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009 relating to Medicines in Special Situations.

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