Global access to orphan drugs: disparities in policies
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PharmacoEconomics & Outcomes News 866, p16 - 14 Nov 2020 Global access to orphan drugs: disparities in policies The number of countries with orphan drug policies (ODPs) is growing but policies are more common in wealthier countries or areas, and incentives are required to improve the affordability of orphan drugs throughout the world, say authors of systematic review published in Value in Health. Investigators conducted a systematic literature search and obtained information from national pharmacovigilance centres up to July 2019 to identify policies on access to and regulation of orphan drugs for rare diseases in 194 WHO member countries and six non-member areas (Hong Kong, Taiwan, Macau, Kosovo, Palestine and Sahrawi Republic), in order to evaluate global ODPs on development, licensing, pricing and reimbursement of orphan drugs. Data from 172 drug regulatory documents and 77 publications were included in the analysis. Overall, ODPs were identified in 46% of the 200 countries/areas; they were most common in Europe (77.8%) and least common in Africa (12.8%). The establishment of OPs increased in non-high-income countries between 2013 and 2019; 54% of the 37 ODPs established during that period were in low- or middle-income countries/areas and 27% were in upper-middle income countries/areas. Only 19% of low-income countries/areas established ODPs. Countries/areas with ODPs had greater national incomes than those without ODPs (gross income per capita $10 875 vs $3950; p
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