Orphan Medicines in Cyprus: A Gap in Access

by: HealthcarePro SOLUTIONS

21 August, 2025 3 min to read

Orphan medicines—specialized drugs developed for rare diseases, which affect only a small fraction of the population—are essential yet often economically unviable products without government incentives (European Commission). Thanks to EU policies like market exclusivity, fee waivers, and centralized authorizations, the EU has made significant progress in stimulating the development of such treatments.

Yet in Cyprus, patients with rare conditions continue to face major barriers when trying to access these life-changing medicines.

Limited Availability and No Full Reimbursement

Currently, only around 36% of orphan medicines approved by the EU are available in Cyprus, and none of them are fully reimbursed through the national healthcare system.

Instead, access hinges on:

Named Patient Programs — on an individual basis, often slow and HR-intensive
Case-by-case Approvals — evaluated individually and inconsistently
Private Purchase — often prohibitively expensive for most patients

This fragmented access system leads to substantial delays, financial burdens, and inequity in care—even when treatments exist.

A Broader European Context

Across the EU, reimbursement policies vary greatly. In Western Europe, countries like France and Germany reimburse the majority of orphan medicines, while in smaller member states such as Cyprus, coverage is far more limited (European Commission).

With no specific national provisions for orphan drug coverage, Cyprus lags behind most EU peers in providing universal access.

Structural Gaps in Cyprus' System

Similar structural shortcomings extend beyond access to the drugs themselves:

Rare Disease Registries: Cyprus lacks national registries, though some disease-specific and patient-led registries exist (RD-Action Report).
Genetic Testing & Neonatal Screening: While financial coverage for some tests is provided, there is no legislation ensuring comprehensive or standardized access (RD-Action Report).
Clinical Guidelines & Education: There are no national clinical guidelines for rare diseases, though educational initiatives and awareness campaigns are ongoing (RD-Action Report).

Recent Developments & Hope on the Horizon

There are encouraging signs of progress:

Cyprus has added innovative medicines, including some orphan drugs, to the national Health Service list in recent years (Cyprus Ministry of Health).
The HIO (Health Insurance Organization) uses Managed Entry Agreements (MEAs)—outcome-based pricing deals—for innovative, high-cost medications, which may provide a pathway for orphan drugs (Health Insurance Organization Cyprus).
A Committee for Special Requests and a Vetting Council have been established to address rare drug requests and appeals for non-listed medications (Cyprus Ministry of Health).

While no structural fix has fully addressed the orphan drug gap, these changes signal a growing political and organizational readiness to improve access.

Summary Timeline

Key Issue	Cyprus' Status
Availability	Only ~36% of EU-approved orphan drugs accessible
Reimbursement	None are fully reimbursed
Access Mechanisms	Case-by-case, Named Programs, private payers
Structural Supports	Limited registries, no national rare disease programs or guidelines
Ongoing Measures	MEAs, special request committees, added innovation to lists

Why It Matters

Patients living with rare diseases often face urgency—every delay or barrier can mean deterioration, suffering, or losing critical treatment windows. Cyprus' current framework places unacceptable burdens on individuals and families, who must navigate red tape and scarcity just to survive.

What Needs to Happen Next

Integrate orphan medicines into the national reimbursement list with special criteria considered.
Support and strengthen national rare disease infrastructure—from registries to clinical guidelines.
Expand and formalize MEAs and innovative pricing strategies to accommodate high-cost treatments.
Ensure ongoing patient and clinician involvement in policy design and decision-making.
Promote cross-border or joint procurement agreements with other small EU member states to bolster negotiating leverage (European Commission).

By highlighting systemic gaps—and spotlighting modest yet meaningful reforms—this post not only informs but also advocates for urgent change. Cyprus has begun paving the way forward, but much more remains to be done to ensure equitable access to orphan medicines for all.