The Complex Case for Another Hard Look

260 Pages·2015·2.91 MB·English

by  Marco Rizzi

The Complex Case for Another Hard Look
Transnational Pharmaceutical Regulation and the
Pedagogical Role of Courts
Marco Rizzi

Thesis submitted for assessment with a view to obtaining
the degree of Doctor of Laws of the European University Institute
Florence, 29 September 2015

European University Institute
Department of Law
The Complex Case for Another Hard Look
Transnational Pharmaceutical Regulation and the Pedagogical Role of
Courts
Marco Rizzi

Thesis submitted for assessment with a view to obtaining
the degree of Doctor of Laws of the European University Institute
Examining Board
Prof. Alberto Alemanno, HEC Paris
Prof. Claire Kilpatrick, EUI
Prof. Joana Mendes. Universiteit van Amsterdam
Prof. Hans-Wolfgang Micklitz, EUI (Supervisor)

© Marco Rizzi, 2015
No part of this thesis may be copied, reproduced or transmitted without prior
permission of the author

ABSTRACT

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.

ACKNOWLEDGMENTS

“That’s the thing about sailing…you gotta deal with it!”
[A worldly seaman, somewhere in the Indian Ocean]

The journey approaches its end, and looking back at the long incredible years that led to
this moment is a truly emotional exercise. I have taken this thesis with me across four
continents, countless countries, capitals, provinces, ports and country villages. As I sit to
reassemble those memories and acknowledge those who traveled with me I can only
picture a long and difficult sailing race, a regatta. One requiring the strongest equipment,
loving maintenance, friendly ports, a trusted crew and the guidance of shining stars. The
sailing can be (as it has been) hard, discouraging, scary, but also thrilling, fun and
exhilarating. And nothing, really nothing, matches the feeling of gazing at the horizon and
yelling from the top of your lungs “LAND HO!” - We made it! Yes, ‘we’, because one
does not get to port on his own.

First, I need to thank, wholeheartedly so, my supervisor Professor Hans-Wolfgang
Micklitz. If I have sailed so far I owe it to his patience, his support and his steady but
never invasive guidance. My gratitude to him is both of an academic and personal nature,
because no matter how badly the boat gets lost in a storm, or how much it drifts off when
the wind dies, a compass will always show the right course. I will miss having him as my
compass in the years to come. I can only hope I have learned enough to navigate on my
own. You surely taught me well.

I also wish to thank the members of my defense panel, Professors Claire Kilpatrick, Joana
Mendes and Alberto Alemanno, for taking the time to read and comment this thesis. Your
input is like a new wind when the boat has had a good rest after a long run. I hope this
breeze will take me and my work off to new routes in the future.

Long sailing journeys need ports along the way to make repairs, get new materials,
supplies, adjust the balance, recover strength and motivation. I am very grateful to the
BIICL of London and the UC Berkeley School of Law for having me when I was still very
much brainstorming about where to go exactly with this thesis. I wish to thank in
particular Dr Peter Feldschreiber for his essential insights of regulatory processes, and
Professor Talha Syed for our very inspiring chats in the San Francisco Bay Area.
The University of Seychelles is the port where I have come to a stop, and settled down for
the time being. Here I found the energies, the time and the will to conclude the work on
my thesis. I owe Professor Dennis Hardy and Dr Justin Valentin a debt that will be hard to
repay. Their encouragement and the freedom they gave me over the last academic year
have been simply invaluable.

Finally, I need to mention my port of origin, the Sant’Anna School in Pisa. My gratitude
goes to Professor Giovanni Comandé for pushing me and helping me muster the courage
to set sail and venture into unknown open waters.

Over the years invaluable help has come from Marlies Becker, Beate Hintzen and Rossella
Corridori. Thank you for being my winches and tell-tales, without which steadying the
boat and adjusting the sails is nearly impossible. And thank you Guia and Antonella for
working the larder, feeding me and comforting me with casual chats for so many years!

To go out at sea, obviously, you need canvas (quite a lot of it). It is hard to express in few
words my gratitude for the brilliant and wonderful friends who have been the essential
pieces of the variegated fabric of my mainsail: Ben, Christophe, Matteo, Carlo, Niccolo’,
Antoine, Daniela. I treasure each and every moment I spent with you and our endless
conversations (friendly or animated) ranging from literature, anthropology, legal theory,
politics, history, the EU, football, basketball, music, beer, whisky, bar management, bar
crawling, comic books and whatever else. Some of you I have seen more and some less
throughout these years. But, each in your own way, you all made me catch the best winds I
could hope for. And I cannot wait for whatever new adventures life will place on our
paths.

A spinnaker is a complicated sail, hard to maneuver, and it only really works on one board.
Yet, when you manage to catch that good downwind gust, there is nothing like the ‘spi’ to
make you fly. Caterina, Carlotta, Angelo, Pino, Pippo, Federico: unfortunately we haven’t
seen each other very often in these last years, really not enough. But with the spontaneity
of our occasional encounters, the richness, personal and intellectual, of our exchanges, the
sheer happiness of being together when we could, you gave me incredible boosts. Often at
times when I needed them the most. Often without you even knowing it.

Whether or not he wants one, if he is to complete his journey, a sailor needs a crew. And
here is the thing about crews: they choose you, not the other way around. There is simply
no way I can possibly give justice to the spectacularly diverse bunch of wonders who
chose to be my companions during this long sailing venture. Angelos, brother of the early
days and my all-time favorite basketball commentator. Brogiin, the only real-life diva I
have ever met. My very special quartet of acquired sisters: Jana, Hanna, Chiara and Giulia.
Salvatore and Mette, my Berkeley billiard-pool mates and inspiration for life decisions.
Elie, who knows like few others the pain and suffering of being a true football supporter.
Diego, who knows like no others the burden of driving me around at night. And also
Karolina, Lena, Igor, Laura, Daria, Pietro, Caterina, Punky (and the burgers). But how
could I not mention the great teams I had the absolute privilege to play and compete with?
The ‘Amici del Nuoto’, motley bunch of chlorine addicts. The inimitable ‘IUE Calcio –
Squadra Fantastica’ - our run to the B2 AICS title will always be one of my all-times
highlights. The brotherhood of the ‘Montecarla Spettacolo’… Thank you! For all the
magic, for everything!

The most trusted friends of a sailor are the stars. When everything else works, they
confirm all is well. When everything else fails, they guide you back to course. No matter
what, they will always be there, and unfortunately I do not possess adequate words to
express how grateful I am to my stars.
I want to thank from the bottom of my heart Mom and Dad for their unshakeable
support, and for showing me by example that happiness and fulfillment require as much
passion as they need dedication, be it in work, friendship or love. You are my Polaris, I can
always turn to you.
I want to thank Leonardo for bringing me great music, groovy rhythms, loud laughter and
precious lightness. I miss sharing a home with you. You are my Sirius, the brightest of all in
the sky.
Finally, my beautiful Jess. You surprised me with a gentle smile and took me by the hand
towards mysterious and wondrous dreamlands. You helped me (so much!) finish the long
and difficult journey of this thesis with love and patience. You are my Southern Cross,
pointing at new horizons in the world and in life.

Now that, after such a long regatta, the boat is finally coming to port, I wish to dedicate
this thesis to my guiding stars.

Genève, 14th September 2015