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PURSUING LEGAL CERTAINTY IN MULTILEVEL REGULATION

A SOCIOLEGAL STUDY OF MEDICAL DEVICE AND PHARMACEUTICAL

REGULATION IN EUROPE

Nupur Chowdhury

Thesis Committee Members:

Prof. Dr. Christa Altenstetter City University of New York

Prof. Dr. B. Dorbeck-Jung University of Twente

Dr. Robert Geertsma RIVM, Netherlands

Prof. Dr. Michiel Heldeweg University of Twente

Prof. Dr. Christopher Hodges University of Oxford

Prof. Dr. Maarten IJzerman University of Twente

Prof. Dr. Ramses Wessel University of Twente

The work described in this thesis was performed at the Law and Regulation Group,

Department of Public Administration, School of Management and Governance, University of

Twente, PO Box 217, 7500 AE, Enschede, The Netherlands.

Copyright 2013 Nupur Chowdhury. All rights reserved.

This thesis was printed at Gildeprint Drukkerrijen, Enschede

All rights reserved. No part of this book may be reproduced or transmitted, in any form or by

any means, electronic or mechanical, including photocopying, microfilming, and recording, or

by any information storage or retrieval system, without the prior written permission of the

author.

ISBN: 978-90-365-0023-4

DOI number: 10.3990/1.9789036500234

Official URL: http://dx.doi.org/10.3990/1.9789036500234

Cover design: Ray Rakesh Shankar Prasad

PURSUING LEGAL CERTAINTY IN MULTILEVEL REGULATION

A SOCIOLEGAL STUDY OF MEDICAL DEVICE AND PHARMACEUTICAL

REGULATION IN EUROPE

DISSERTATION

to obtain

the degree of doctor at the University of Twente,

on the authority of the rector magnificus,

prof.dr. H. Brinksma,

on account of the decision of the graduation committee,

to be publicly defended

on 6th

day of September 2013 at 12:45pm

by

Nupur Chowdhury

born on 6th

of February 1980,

in New Delhi, India.

The dissertation has been approved by:

Prof. Dr. B.R. Dorbeck-Jung (promoter)

Prof. Dr. R.A. Wessel (promoter)

7

Summary

One of the primary functions of law is to ensure that the legal structure governing all social relations is

predictable, coherent, consistent and applicable. All these characteristics of law taken together are

referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a

hierarchic system of rules characterised by stability, clarity, uniformity, calculable enforcement,

publicity and predictability. However, the current reality is that national legal systems no longer

operate in isolation, but within a multilevel legal order, wherein norms created both at the international

and regional level are directly applicable to national legal systems. Also norm creation is no longer the

exclusive prerogative of public officials of the state: private actors have an increasing influence on

norm creation as well. Social scientists have referred to this phenomenon of interacting and

overlapping competences as multilevel governance. Only recently have legal scholars focused

attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of

national legal orders) between the global, European and national regulatory spheres through the

concept of multilevel regulation.

In this project I use multilevel regulation as a term to characterise a regulatory space in which the

process of rule making, rule enforcement and rule adjudication (regulatory life cycle) is dispersed

across more than one administrative or territorial level amongst several different actors, both public

and private. I draw on the concept of a regulatory space, using it as a framing device to differentiate

between specific aspects of policy fields. The relationship between actors in such a space is non-

hierarchical. Lack of central ordering of the regulatory life cycle within this regulatory space is the

most important feature of such a space.

The implications of multilevel regulation for legal certainty have attracted limited attention from

scholars. The demand for legal certainty in regulatory practice is still a puzzle. I explore the idea of

legal certainty in terms of perception and expectations of regulatees in the context of medical products.

By medical products I mean pharmaceuticals and medical devices which can be differentiated as two

regulatory spaces and therefore form two case studies. As an exploratory project, this thesis is

necessarily stepping into new territory in terms of investigating legal certainty first in terms of

regulatee perceptions and expectations and second, because it studies this in the context of multilevel

regulation.

8

Samenvatting

Een van de primaire functies van het recht is om ervoor te zorgen dat de juridische structuur voor

sociale relaties voorspelbaar, coherent, consistent en passend is. Deze kenmerken van het recht worden

gezamenlijk aangeduid met de term rechtszekerheid. In traditionele benaderingen van

rechtszekerheid, wordt het recht beschouwd als een hirarchisch systeem van regels, gekenmerkt door

stabiliteit, helderheid, uniformiteit, berekenbare handhaving, openheid en voorspelbaarheid. Echter, in

de huidige realiteit functioneren nationale rechtsstelsels niet meer in afzondering, maar binnen een

meerlagige (multilevel) rechtsorde, waarin normen gecreerd op internationaal en regionaal niveau

direct van toepassing zijn op de nationale rechtsstelsels. Normschepping is daarnaast niet langer het

exclusieve voorrecht van de staat: private actoren hebben een steeds grotere invloed op de

totstandkoming van nieuwe normen. Sociale wetenschappers hebben naar dit fenomeen van op elkaar

inwerkende en elkaar overlappende bevoegdheden verwezen als multilevel governance. Pas onlangs

hebben ook juristen de aandacht gevestigd op de toenemende onderlinge verbondenheid (en het

daarmee gepaard gaande verlies van de voorrang van de nationale rechtsorde) tussen de mondiale,

Europese en nationale regelgevingsferen via de notie van multilevel regulation.

In dit project gebruik ik multilevel regulation als een term voor de aanduiding van een regelruimte

waarin het proces van het maken en handhaving van regels en de functie ervan in gerechtelijke

procedures (de regelgevende levenscyclus) is verspreid over meer dan n administratief of territoriaal

niveau tussen de verschillende actoren, zowel publiek als privaat. Het concept van een regelgevende

ruimte wordt gebruikt als een framing-instrument om onderscheid te maken tussen specifieke aspecten

van beleidsterreinen. De relatie tussen de actoren in een dergelijke ruimte is niet-hirarchisch. Het

ontbreken van een centrale ordening in de regelgevingscyclus is het belangrijkste kenmerk van een

dergelijke ruimte.

De implicaties van multilevel regulation voor de notie van rechtszekerheid hebben weinig aandacht

getrokken van wetenschappers. Het belang van rechtszekerheid in de regelgevende praktijk is nog

steeds onduidelijk. In deze studie verken ik het concept rechtszekerheid met betrekking tot de

perceptie en verwachtingen van degenen die met de regels te maken krijgen. Ik doe dat met betrekking

tot de regulering van medische producten. Daarmee doel ik op zowel geneesmiddelen als medische

hulpmiddelen, waarvoor twee onderscheiden regulerende ruimtes bestaan en dus twee case studies

vormen. Dit proefschrift is daarmee verkennend langs twee lijnen. Ten eerste is dit het eerste

onderzoek naar rechtszekerheid in relatie tot de percepties en verwachtingen van degenen op wie de

regels betrekking hebben; ten tweede benadert het de regelgeving vanuit het perspectief van multilevel

regulation.

9

Acknowledgements

At the end of the number of little administrative details that lead up to ultimately the day on which the

thesis is defended, one does tend to get a bit greedy in cornering all the praise (as well as the brick

bats!). However although there is a principal and this is primarily a solitary journey but it is definitely

not a lonely road. In fact now when I do have an opportunity to catch my breath to think back it does

come across as a series of coincidences that brought me in proximity with some amazing persons that

have inadvertently become my collaborators in this journey.

First I wish to thank both my promoters Barbel Dorbeck-Jung and Ramses Wessel. I am honoured and

grateful to have had you both to guide me in this journey. Barbel you have been extremely patient,

caring and always helpful in providing me with complete access to you for discussions on any matter.

I appreciate both Bernards and your hospitality in welcoming me to your home and in generally

making me feel welcome in the faculty. I am also happy that I got to develop my skills in empirical

methodology primarily due to your encouragement. Ramses thank you for your support and your

critical comments on the thesis they have contributed significantly in shaping my ideas. I also

thoroughly enjoyed the opportunity to work with you on a critical theoretical aspect of the thesis.

I would also here thank all my teachers, Mrs. Samuels (who unfortunately has left us but continues to

inspire us), Miss K Avari and Miss Ahmed from Pratt Memorial School; and Prof. Rina Kashyap and

Prof. Nivedita Meno