Practical and Legal Issues for paediatric SPCs-John Lisman highlights inconsistencies in interpreting European Union legislation governing supplementary protection certificates and paediatric extensions.

摘要

When European Union legislators drafted the law governing supplementary protection certificates (SPCs) for extending protection for medicinal products - and especially when they created provisions for the paediatric extension - they failed to take into account practicalities. Regulation (EEC) No 1768/92 (the SPC regulation) - which came into force in January 1993 and was codified in Regulation (EC) No 469/2009 - has led to a number of questions of interpretation and has resulted in uncertainty.