Monday 7 November 2016

Orphan drugs
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.
Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect no more than 5 in 10,000 people in the European Union.
To date, the European Commission has already authorized 123 orphan medicines for the benefit of patients suffering from rare diseases. The sponsors responsible for these medicines benefit from incentives such as fee waivers for the regulatory procedures or a 10 year market exclusivity.
Equally important, the European Commission has designated 1395 products as orphan medicinal products. The sponsors developing these products benefit from incentives such as protocol assistance. This assistance should facilitate the development and authorization of innovative medicines for the benefit of the patients.
Orphan medicines legislation
Orphan medicines legislation aims at providing incentives for pharmaceutical companies to develop and market medicinal products to treat rare diseases.



A ground-breaking precedent was set by the United States in 1983 when the Orphan Drug Act came into effect. In the 1990s, first Japan, then Australia adopted orphan medicines legislations.

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