ICRDOD has published a review, exploring 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 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 in Bulgaria. The study further evaluates the average time period from market authorisation to positive reimbursement decision by Bulgarian health authorities. The analysis identifies several important challenges to orphan drugs’ access in Eastern Europe. The review is published in the Health Policy journal.
Rare Diseases Registries in Bulgaria