Financial and legislative aspects of drug development of orphan diseases on the European market – a systematic review

Abstract

ABSTRACTAccording to the European Commission, medical products for orphan diseases are those which affect fewer than five persons out of every 10 000. Producers are reluctant to develop these drugs under the common market conditions because the demand for these drugs does not guarantee return on investments into research and development of such products. Patients with orphan diseases, however, have the same rights for treatment as any other patient. To stimulate the research and development of drugs for orphan diseases, the governmental offices introduce various incentives for health and biotechnological industry. This started in the USA already in 1983 by passing a special law. Japan introduced this law in 1993 and Australia in 1997. Europe followed in 1999 by introducing common policy for all member states.The aim of this article is to specify current economic and legislative conditions in European countries and compare them with the legislation and approaches of the countries which started this initiative, i.e. USA, Japan, Australia or Singapore. In addition, the treatment costs of orphan diseases are specified and prospects of this field are evaluated.