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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