The European Agency for the Evaluation of Medicines and European Regulation of Pharmaceuticals

Abstract: The new European Agency for the Evaluation of Medicinal Products is the focus of the EC's new regulatory framework for approval of pharmaceuticals for human and veterinary use. This article considers past efforts at European pharmaceutical regulation, discusses the new 'centralised' and 'decentralised' procedures, and offers a functional analysis of the new system. It addresses European regulation of biotechnology, including Parliament's 1995 rejection of the proposed biotechnology directive using its codecision powers. It also reviews European case law and suggests that the Court of Justice's decision in Keck provides a useful way to analyse pharmaceuticals' place in the free movement of goods. While the new framework will likely improve approval of pharmaceuticals and over time lead to greater centralisation of the process, Member States will still retain some autonomy over the actual use of approved drugs, particularly through their continued control of conditions of reimbursement in national health systems.