Department of Law, European University Institute, I-50014 San Domenico di Fiesole (FI), ITALY.
The thesis argues for a 'pedagogical' role for courts in the US and EU in ameliorating the increasingly transnational regulation of pharmaceutical product safety through complementary monitoring of the outputs of regulatory processes. The study is divided into two parts.
First, the thesis explores the regulatory institutional design in the US and EU. The parallel development of the FDA and EMA suggests that both markets have achieved consolidated domestic/regional regulatory frameworks, which do however show multiple weak spots. These vulnerabilities are aggravated by a strong push towards transnationalisation of regulatory procedures: domestic systems are now permeated by potentially disruptive exogenous elements (e.g. the ratification of transnationally negotiated protocols and increasing reliance on foreign clinical trials data). The thesis explores issues of effectiveness of safety delivery and legitimacy of rule-making processes to suggest scope for improvement in both areas.
The second part considers the potential contribution of the judiciary, particularly national courts in the US and EU, to investigate whether the exercise of complementary judicial governance can enhance the effectiveness and legitimacy of an otherwise essentially closed and self-perpetuating system. A selection of cases grounds the claim that, through liability litigation, courts have the capacity to improve the safety levels delivered by regulation and thereby to contribute to output-based legitimacy of the institutional design. This claim is tested in light of acknowledged strengths and limitations of court processes and with regard to differentiating elements at the national level, particularly regarding access to justice.
The concluding argument reassembles the results of the study to recommend the existing tool of domestic litigation as a response to certain vulnerabilities in pharmaceutical regulation. The 'hard look' doctrine described by Sheila Jasanoff grounds the normative claim for a 'pedagogical' role for courts, enhancing regulation beyond the outcome of isolated cases – ad adiuvandum rather than contra.