Non-Measurable Negotiations: The EU between Transnational Regulation of Pharmaceuticals and Private Law

in M. Cremona and H-W. Micklitz (eds)., Private Law in the External Relations of the EU (Oxford: Oxford University Press, 2016)

27 Pages Posted: 28 Jan 2018

See all articles by Marco Rizzi

Marco Rizzi

The University of Western Australia Law School

Date Written: January 2016

Abstract

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’.

Keywords: Risk regulation, Health Law, Product liability, Pharmaceutical Law, Transnational law

JEL Classification: K13, K23, K32, I28

Suggested Citation

Rizzi, Marco, Non-Measurable Negotiations: The EU between Transnational Regulation of Pharmaceuticals and Private Law (January 2016). in M. Cremona and H-W. Micklitz (eds)., Private Law in the External Relations of the EU (Oxford: Oxford University Press, 2016), Available at SSRN: https://ssrn.com/abstract=3102233

Marco Rizzi (Contact Author)

The University of Western Australia Law School ( email )

M253
35 Stirling Highway
Crawley, Western Australia 6009
Australia

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