The aims of this chapter are to look at the role of the EU in regulating pharmaceutical safety in the internal market, and to contrast that role with the EU’s peculiar capacity of co-regulator in the transnational space of pharmaceutical safety and efficacy governance. The intent of the analysis proposed in this piece is to highlight a dichotomy between the internal and external roles of the EU in the pharmaceutical rule-making arena. Whereas throughout the second half of the 20th century the EU has gained internally an ever more prominent and centralized role in the regulation of medicines, culminating with the adoption of Directive 2001/83/EC on the Community Code relating to medicinal products for human use (and subsequent amendments and addenda), externally the situation is one of significant complexity. The intricacies of the transnational institutional framework of pharmaceutical regulation need to be addressed and described in order to propose an understanding of the regulatory role for the traditional private law dimension. What is contended here is that while a form of ‘regulatory private law’ has been developing at a transnational level with intrinsic limits (what will be referred to as ‘non-measurable negotiations’), traditional forms of private law have the potential to vindicate a significant role in guiding the EU as a negotiator in the transnational ‘regulatory private law-making’.
|Title of host publication||Private Law in the External Relations of the EU|
|Editors||Marise Cremona, Hans-W Micklitz|
|Place of Publication||United Kingdom|
|Publisher||Oxford University Press|
|Publication status||Published - 2016|