The ECJ's Ruling in the Genetics Case: A Muddying of the Waters on the Interaction between the Basic Pharmaceutical Legislation and the SPC Regulation?

摘要

The strict application by the European Court of Justice of the law on generic approvals in the case of Generics (UK) Ltd v The Licensing Authority (acting via the Medicines and Healthcare products Regulatory Agency) is a victory for the innovative pharmaceutical industry. Following the ECJ's ruling, a product that was initially granted a marketing authorisation under national rules which was never updated to meet current Community legislative requirements cannot be used as a "reference medicinal product" for the''approval of a generic version containing the same active substance.The ECJ's decision, rendered on 18 June, is not surprising. It raises, however, an interesting question as to the interaction between the basic European pharmaceutical legislation, namely Directive 2001/83 (as amended), and Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products.