Europe shares in the celebration as the US fêtes 25 years of the Orphan Drug Act
It was on 4 January 1983 that then-US president Ronald Reagan signed into law the original US Orphan Drug Act. This gesture brought hope for millions of rare disease patients and their families in the US and around the world. Conceived to facilitate the development of new treatments for rare disorders, the Orphan Drug Act offers incentives to industry, notably seven years of market exclusivity as well as tax credits for various stages of research. Over 300 treatments have been brought to market since the Act came into effect; almost two thousand products have received orphan drug designations in the US. The European Union created its own version of this important legislation in 1999 and is quickly catching up in producing medicinal products for rare disorders. Other countries around the world have adopted similar legislation, including Japan, Australia, Korea and Taiwan. Today, the US and the EU enjoy a streamlined procedure for obtaining orphan drug designation that serves to simplify sponsor application in both territories and encourage orphan product development even further. There are several events underway this year to underscore the importance of the 25 year Orphan Drug Act milestone, including an international research conference, an anniversary gala, activities to encourage media coverage, and a campaign to get US President George W. Bush to designate May as "Orphan Drug Month". Europe meanwhile has its own publicity project in the works with the designation of 29 February as "European Rare Diseases Day". It seems that 2008 is already shaping up as a year of increased awareness for the needs of rare disease patients and their families. Happy New Year!