The European Regulation on Orphan Medicinal Products

Valverde, J.L.
Pub. date
January 2001
3 of Pharmaceuticals Policy and Law
ISBN print
Medicine & Health, Medicine: Law & Policy
€75 / US$83 Excl. VAT
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Society cannot accept that certain individuals be denied the benefits of medical progress simply because the affliction from which they suffer affects only a small number of people. It is therefore up to the public authorities to provide the necessary incentives and to adapt their administrative procedures so as to make it as easy as possible to provide these patients with medicinal products which are just as safe and effective as any other medicinal product and meet the same quality standards.

In the United States, an incentive system for the development of orphan medicinal products (the “Orphan Drug Act”) was introduced in 1983. At the end of 1997, 152 orphan products had gone on to obtain marketing approval and are now being used by over 7 million patients.

The success of the U.S. orphan drug program has stimulated many foreign countries to seed to emulate it. The Singapore Government decided on an Orphan drug Act 1991, the Japanese in 1993, the Australian Government in 1997 and in July 1998, The European Commission approved the proposal for a European Parliament and Council Regulation on Orphan Medicinal products.

In the European Union, in the course of the last decade, a number of Member States have adopted specific measures to increase our knowledge of rare diseases.

The Commission has proposed a Decision of the European Parliament and Council adopting a programme of Community action 1999-2003 on rare diseases, including actions to provide information, to deal with clusters of rare diseases in a population and to support relevant patient organisations.