Orphan Drug

There are about 5,000-8,000 diseases affecting more than 5 million people worldwide, which have been defined as rare conditions. Patients affected by these diseases deserve the same rights of access to safe and effective treatments as those patients affected by a more prevalent condition.

The level of Research and Development costs for developing safe and efficacious treatments for rare diseases are equal to products for more prevalent diseases, with a much lower potential for return on investment. The Orphan Drugs are medicinal products without sponsors to develop them into commercially available treatments.

Therefore some large governmental bodies worldwide have introduced Orphan Drug programs in order to encourage innovative companies to enter into the research and development field of rare diseases and Orphan Drugs.

In the promotion of the development of Orphan Drugs different incentives such as Research and Development funds, tax credits, fee reduction, protocol assistance and market exclusivity for 5-10 years are included.

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