"Is the Copy Better than the Original? The Regulation of Orphan Drugs: a US-EU Comparative Perspective"

Abstract

The US Orphan Drug Act of 1983 pioneered the regulation of this type of medicines, and its success encouraged other countries to enact similar legislation. Among these new orphan drug laws is the one that was drafted in the European Union in 2000. This paper attempts to scrutinize some of the key points of the initial American regulatory framework as well as the main criticisms that it received and to subsequently take a look at the responses that European authorities have devised to address such attacks to the American text. The overwhelming satisfaction surrounding US law may explain the great similarity with its European younger brother, even though the “copy†has tried to make some modest contributions from its own, for instance while addressing what perhaps is the most serious caveat of the law: the abuses by the industry that lead to high prices and “blockbuster orphansâ€. However, both jurisdictions still have some more aspects to ameliorate in order to create a more perfect set of incentives that may assure the availability of remedies for rare diseases striking a better balance between competition and innovation. Besides, some newly raised issues, like the necessity of international cooperation to address the challenges posed by a global pharmaceutical market and the need for extending the benefits of orphan drug legislation to so-called “third-world diseasesâ€, are awaiting legal answers.