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Challenges to orphan drugs access in Eastern Europe: The case of Bulgaria


  • Iskrov, Georgi
  • Miteva-Katrandzhieva, Tsonka
  • Stefanov, Rumen


This article explores how an Eastern European country could deal with orphan drugs access, combining EU policies with its own national settings. The cross-sectional observational study takes the total number of orphan drugs (61) available on EU level by March 2011, and then consecutively filters it through the requirements and criteria of relevant Bulgarian legislation on registration, pricing and reimbursement of medicinal products, obtaining the final number of accessible orphan drugs (16) in Bulgaria. The study further evaluates the average time period from market authorisation to positive reimbursement decision by Bulgarian health authorities (43±29.1months).

Suggested Citation

  • Iskrov, Georgi & Miteva-Katrandzhieva, Tsonka & Stefanov, Rumen, 2012. "Challenges to orphan drugs access in Eastern Europe: The case of Bulgaria," Health Policy, Elsevier, vol. 108(1), pages 10-18.
  • Handle: RePEc:eee:hepoli:v:108:y:2012:i:1:p:10-18
    DOI: 10.1016/j.healthpol.2012.08.013

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    References listed on IDEAS

    1. Kalo, Zoltan & Muszbek, Noemi & Bodrogi, Jozsef & Bidlo, Judit, 2007. "Does therapeutic reference pricing always result in cost-containment?: The Hungarian evidence," Health Policy, Elsevier, vol. 80(3), pages 402-412, March.
    2. Brekke, Kurt R. & Konigbauer, Ingrid & Straume, Odd Rune, 2007. "Reference pricing of pharmaceuticals," Journal of Health Economics, Elsevier, vol. 26(3), pages 613-642, May.
    3. Rosenberg-Yunger, Zahava R.S. & Daar, Abdallah S. & Thorsteinsdóttir, Halla & Martin, Douglas K., 2011. "Priority setting for orphan drugs: An international comparison," Health Policy, Elsevier, vol. 100(1), pages 25-34, April.
    4. Bombard, Yvonne & Abelson, Julia & Simeonov, Dorina & Gauvin, Francois-Pierre, 2011. "Eliciting ethical and social values in health technology assessment: A participatory approach," Social Science & Medicine, Elsevier, vol. 73(1), pages 135-144, July.
    5. Kolasa, Katarzyna & Schubert, Sebastian & Manca, Andrea & Hermanowski, Tadeusz, 2011. "A review of Health Technology Assessment (HTA) recommendations for drug therapies issued between 2007 and 2009 and their impact on policymaking processes in Poland," Health Policy, Elsevier, vol. 102(2), pages 145-151.
    6. Denis, Alain & Mergaert, Lut & Fostier, Christel & Cleemput, Irina & Simoens, Steven, 2010. "A comparative study of European rare disease and orphan drug markets," Health Policy, Elsevier, vol. 97(2-3), pages 173-179, October.
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    1. repec:eee:hepoli:v:121:y:2017:i:12:p:1240-1248 is not listed on IDEAS


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