Pharmaceutical companies urge government to take immediate action over innovative drug approval delays

Cyprus ranks 22nd out of 36 countries in the EU and European Economic Area when it comes to patient access to innovative medicines, according to findings of a recent study.

The European W.A.I.T. (Waiting to Access Innovative Therapies) Indicator study was conducted by the European Federation of Pharmaceutical Industries and Associations (EFPIA) for the period 2020–2023.

The Cyprus Association of Research and Development Pharmaceutical Companies (KEFEA) said the ranking highlights the long-standing challenges in the approval and market availability of new pharmaceutical treatments in the Cypriot healthcare system.

The average time from approval to availability of innovative medicines in Cyprus is 531 days

“Based on data from the report – published on 7 May 2025 – significant differences remain in the time it takes for patients to access new medicines (ranging from 128 days in Germany to 840 days in Portugal, with an average of 518 days),” KEFEA said. “In Cyprus, the average time from approval to availability of innovative medicines is 531 days, and for some therapies, it has reached up to 1,300 days.”

As for medicine availability, only 63 out of 173 approved innovative medicines (36%) were made available in Cyprus during this period. The average across the 36 countries is 46% (80 innovative medicines), while Germany remains the leader, providing access to 156 of the 173 approved medicines.

Too many restrictions

“It is noteworthy that of the 63 innovative medicines available in Cyprus, only 3% are provided without restrictions—compared to 99% in Germany—while 90% are subject to restricted access or require a specific case-by-case approval process through the Named Patient Requests Committee (EOA),” KEFEA said, adding that other specialised medicines, such as cancer or orphan drugs (usually for rare diseases), are available only through restricted access and mainly via the EOA. According to the study, none of these have been fully integrated into the reimbursement system.

KEFEA said it has “repeatedly pointed out the issues of access and availability of innovative medicines and therapies in Cyprus, while also proposing feasible and immediate solutions to improve patient access to all medicines”.

However, six years after the introduction of the General Health System (GeSY), these problems have not been resolved, it added. “Moreover, the Ministry of Health’s decision to transfer the EOA under the Health Insurance Organisation (HIO) has not only exacerbated delays in providing urgent medications to patients but also slowed the completion of pending assessments, further compounding an already serious issue.”

KEFEA urges immediate action

KEFEA expressed “deep concern over the very real risk of a gap in the availability of new and innovative—and even conventional—therapies in the country” if the situation does not improve immediately.

“For this reason, KEFEA urges the responsible authorities, both at the HIO and the Ministry of Health, to make decisive moves and take immediate action to clear the existing backlog of medicines pending evaluation. This will make room for the timely evaluation of new applications and help uphold the legally mandated timelines,” it concluded.