Medical & Pharmaceutical Regulation
Members of Brick Court Chambers have appeared in almost every case concerning pharmaceutical regulation that has been referred from our domestic courts to the ECJ. Collectively, we have an unparalleled expertise in this area of law. From early cases such as Ex parte Scotia and Ex parte Generics to more recent landmark ECJ rulings in the field including the SPC case Novartis and the data exclusivity case Synthon, our EU specialists have acted for innovators, generic companies and regulators.
Judicial review challenges in the medical and pharmaceutical field have also made important law at the domestic level. For example, we were instructed in Pfizer (the successful challenge to the initial refusal to reimburse prescriptions for Viagra), Source Informatics in the Court of Appeal concerning anonymised prescription data and in both the cases concerning the PPRS which have reached the High Court and above (BAEPD and GlaxoSmithKline). We acted for two parties in Smeaton, the challenge to the legality of the morning-after pill.
Members of Chambers remain very active in this field, appearing in cases pending both here (for example, challenges to decisions by NICE before the NICE Appeal Panel and on judicial review) and in Luxembourg (for example cases concerning the definition of medicinal product and the advertising of pharmaceuticals).
Recent cases of note have included:
- R (Generics UK) v Licensing Authority (ECJ)
- GlaxoSmithKline v Department of Health [2007] EWHC (Commercial Court)
- R (Synthon BV) v Licensing Authority & Smithkline Beecham plc (ECJ)
- R v Dept of Health, ex parte Source Informatics (Court of Appeal)
- R v MCA, ex parte Novartis (Court of Appeal and ECJ)