Current Edition

European Commission Review of SPC Legislation and Bolar Exemption

The SPC regulation was introduced 25 years ago and has
resulted in a complex landscape of national case law
and numerous decisions from the Court of Justice of
the European Union (CJEU) regarding its interpretation.
This article by Marie-Louise Jardle and Mike Nelson of
HGF highlights the complexity of exclusivity for medicinal
products in Europe and illustrates challenges faced by the
EC in seeking a fair balance which stimulates innovation
and the development of new medicines with the growing
costs of healthcare in Europe.