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Access to orphan drugs - comparison across Balkan countries
Ana V Pejcic1, Georgi Iskrov2, Mihajlo Michael Jakovljevic3
1Faculty of Medical Sciences, University of Kragujevac, Svetozara Markovica 69, 34000 Kragujevac, Serbia.
Health Policy (Amsterdam, Netherlands)
|May 7, 2018
Summary
Orphan drug access varies significantly across Balkan countries, with EU Member States generally showing better availability than EU Candidates. Inequalities in access to these vital medicines for rare diseases persist, requiring collaborative solutions.
Area of Science:
- Health Policy
- Pharmaceutical Access
- Rare Diseases
Background:
- Orphan drug access presents a significant challenge in Balkan countries.
- Inequalities in access disproportionately affect rare disease patients in the region.
Purpose of the Study:
- To compare orphan drug accessibility across five EU Member States and two EU Candidate countries in the Balkans.
- To identify disparities in the registration, pricing, and availability of orphan medicinal products.
Main Methods:
- Cross-sectional study design.
- Analysis of medicinal products with orphan designation and market authorization as of January 1, 2017.
- Comparative analysis of orphan drug access across selected Balkan nations.
Main Results:
- Three tiers of orphan drug access were identified: Greece and Slovenia (top), Romania, Bulgaria, Croatia (middle), and Serbia, Montenegro (bottom).
- EU Candidate countries (Serbia, Montenegro) had a substantial number of EU-approved orphan drugs not even registered.
- A significant portion of EMA-authorized orphan drugs were not priced in Balkan countries, impacting patient access.
Conclusions:
- Public health resources and market size likely contribute to observed access inequalities.
- Urgent improvements in orphan drug accessibility are needed in the Balkan region.
- Cross-border collaboration on pricing, health technology assessment, and reimbursement is recommended to enhance access.
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