It takes more than 21 months for a new orphan drug to reach Sweden, the average time to availability has risen by 153 days
Patients in Sweden now wait an average of 651 days for newly authorised orphan drugs to reach them, more than a year and a half after the medicines secure central EU marketing authorisation, according to the Patients W.A.I.T. Indicator 2025, the annual benchmark published by the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The wait has lengthened sharply over the past year. The average time to availability rose by 153 days – from 498 to 651 – an increase of 30 per cent on the previous report.
Oskar Ahlberg, vice-president of Rare Disease Sweden, attributed the delays to companies “not always being quick to apply” and to a national approval system he described as complicated and “focused on trying to secure the lowest possible price, rather than starting to treat Swedish patients as soon as possible”. He added that some companies “do not even consider it worth the effort to offer new, innovative medicines to Sweden”.
“Companies may choose not to market an orphan drug in Sweden if, for example, the patient population is very small. However, recent data from the industry suggests that many still apply for reimbursement,” Katarina Antonov, head of analysis at LIF, the Swedish Association of Research-Based Pharmaceutical Companies, explained.
