Abstract
Numerous patients suffering from orphan diseases still lack a treatment. Pharmaceutical companies play a crucial role in the advancement of orphan drug development. This systematic literature review aims to identify and categorise current incentivising factors for pharmaceutical companies to develop orphan drugs.
Highlights
Numerous patients suffering from orphan diseases still lack a treatment
The Orphan Drug Act (ODA) passed in the USA in 1983 was the first of its kind to address the need for development of rare disease drugs
Papers were categorised into key themes which were identified as significant factors that incentivise the pharmaceutical industry to develop drugs for rare diseases (Figure 3)
Summary
Pharmaceutical companies play a crucial role in the advancement of orphan drug development. This systematic literature review aims to identify and categorise current incentivising factors for pharmaceutical companies to develop orphan drugs. The Orphan Drug Act (ODA) passed in the USA in 1983 was the first of its kind to address the need for development of rare disease drugs. The regulation introduced the procedure for orphan designation in Europe and the incentives orphan medicines would receive. It established the Committee for Orphan Medicinal Products (COMP), a committee under the European Medicines Agency (EMA) responsible for evaluations of orphan designation applications and general protocol assistance [1]
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