pursuing legal certainty in multilevel regulation - pursuing legal certainty in... · pursuing...

Download PURSUING LEGAL CERTAINTY IN MULTILEVEL REGULATION - Pursuing legal certainty in... · pursuing legal

If you can't read please download the document

Post on 23-Jul-2019

221 views

Category:

Documents

0 download

Embed Size (px)

TRANSCRIPT

  • 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

Recommended

View more >