ABSTRACT
Background: Rare diseases-related services, care, and drugs (Orphan Drugs) in a lower-middle-income country such as Iran with international limitations due to the sanctions is a challenging issue in terms of their financing and providing. This study aims to address financing issues related to rare diseases in a lower-middle-income country that is under international sanctions. Methods: This is a qualitative study that has been conducted through 14 interviews with experts from different stakeholders in the country to find the challenges of financing rare diseases and orphan drugs in Iran through a content analysis according to Mayring's approach. We accomplished this study based on the World Health Organization's universal health coverage model. Results: We achieved four themes and 12 sub-themes. The themes are the unstable and sanctioned economy including 4 sub-themes; extending the covered population by the social security net in the country including 2 sub-themes; reducing the cost-sharing for the covered population including 4 sub-themes; including more orphan drugs and services including 2 sub-themes. Conclusion: The financing of rare diseases and orphan drugs in Iran is challenged by several contextual and internal factors. The political issues seem to have the main contribution of the challenge to develop an efficient and effective financing mechanism for rare diseases and orphan drugs. This is especially can be related to the politicians' commitments and pursuing an effective plan to allocate the financial resources to rare diseases. However, the country's economic situation, especially at the macro level because of international limitations, has intensified the problem.
