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.
This chapter examines whether the subsidiarity principle influences the legislative choice between delegated and implementing acts, using the regulation of pharmaceuticals in the internal market as a case study. Whereas delegated acts have to be examined in the context of legislative subsidiarity due to their quasi-legislative nature, implementing acts affect the competences of the Member States to implement EU legislation under the principle of executive federalism. It is argued that as the constitutional differences of control for these types of acts have to a certain degree been blurred, subsidiarity seems to be less relevant in the choice between delegated and implementing acts, even in a regulatory area with complex competence divisions between the Union and the Member States.
Merijn Chamon and Sabrina Wirtz
The legislative framework of pharmaceuticals regulation in the internal market is foremost defined at EU level, while enforcement powers are predominantly shared in the sense that the EU enforcement authority relies on the national authorities. However, a parallel enforcement power has been created with the Penalties Regulation allowing for EU level sanctions. Moreover, the Urgent Union Procedure shows characteristics of subordinate enforcement. This enforcement structure leads to challenges to accountability, mainly resulting from the complexity of the composite procedures which have been put in place. This chapter examines the enforcement role of the European Medicines Agency and examines the accountability mechanisms applicable at the European level. In addition, it offers insights into the national enforcement means in Belgium as well as Germany and the corresponding accountability mechanisms.