Standardisation of health products in search of legitimacy: Rethinking judicial review?

Health products are among the most strictly regulated products on the EU internal market. This chapter analyses and compares standardisation in the areas of pharmaceuticals and medicinal products. While for pharmaceuticals standards are an important regulatory tool for the scientific and technical assessment of the quality, safety and efficacy of medicinal products, this area – in contrast to the regulation of medical devices – does not follow the ‘New Approach’. Pharmaceutical standards are thus not developed by private standardisation bodies, but by the European Medicines Agency in the form of nonbinding administrative guidelines. However, the chapter argues that these different types of standards are functionally comparable. Based on this finding, the possibilities of judicial review of these standards are examined, as the Court of Justice treats New Approach standards very differently from standards in administrative guidelines such as those for pharmaceuticals. This raises severe concerns in terms of legitimacy.