European regulation of medical devices and pharmaceuticals: regulatee expectations of legal certainty
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Cham
Springer International Publishing
[2014]
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis Klappentext |
| Beschreibung: | xiii, 185 Seiten Diagramme |
| ISBN: | 9783319045931 |
Internformat
MARC
| LEADER | 00000nam a2200000 c 4500 | ||
|---|---|---|---|
| 001 | BV044320326 | ||
| 003 | DE-604 | ||
| 005 | 20170607 | ||
| 007 | t | ||
| 008 | 170521s2014 |||| |||| 00||| eng d | ||
| 020 | |a 9783319045931 |9 978-3-319-04593-1 | ||
| 035 | |a (OCoLC)885404553 | ||
| 035 | |a (DE-599)BVBBV044320326 | ||
| 040 | |a DE-604 |b ger |e rda | ||
| 041 | 0 | |a eng | |
| 049 | |a DE-384 | ||
| 084 | |a PJ 2440 |0 (DE-625)136665: |2 rvk | ||
| 100 | 1 | |a Chowdhury, Nupur |e Verfasser |0 (DE-588)1050935896 |4 aut | |
| 245 | 1 | 0 | |a European regulation of medical devices and pharmaceuticals |b regulatee expectations of legal certainty |c Nupur Chowdhury |
| 264 | 1 | |a Cham |b Springer International Publishing |c [2014] | |
| 300 | |a xiii, 185 Seiten |b Diagramme | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 650 | 4 | |a Recht | |
| 650 | 4 | |a Wirtschaftspolitik | |
| 650 | 4 | |a Law | |
| 650 | 4 | |a Pharmacy | |
| 650 | 4 | |a Public health laws | |
| 650 | 4 | |a Europe |x Economic policy | |
| 650 | 0 | 7 | |a Medizinprodukt |0 (DE-588)4024018-6 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Öffentliches Gesundheitswesen |0 (DE-588)4139691-1 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Recht |0 (DE-588)4048737-4 |2 gnd |9 rswk-swf |
| 651 | 4 | |a Europa | |
| 651 | 7 | |a Europa |0 (DE-588)4015701-5 |2 gnd |9 rswk-swf | |
| 689 | 0 | 0 | |a Europa |0 (DE-588)4015701-5 |D g |
| 689 | 0 | 1 | |a Öffentliches Gesundheitswesen |0 (DE-588)4139691-1 |D s |
| 689 | 0 | 2 | |a Recht |0 (DE-588)4048737-4 |D s |
| 689 | 0 | |5 DE-604 | |
| 689 | 1 | 0 | |a Europa |0 (DE-588)4015701-5 |D g |
| 689 | 1 | 1 | |a Medizinprodukt |0 (DE-588)4024018-6 |D s |
| 689 | 1 | 2 | |a Recht |0 (DE-588)4048737-4 |D s |
| 689 | 1 | |5 DE-604 | |
| 776 | 0 | 8 | |i Erscheint auch als |n Online-Ausgabe |z 978-3-319-04594-8 |
| 856 | 4 | 2 | |m Digitalisierung UB Augsburg - ADAM Catalogue Enrichment |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029723810&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 856 | 4 | 2 | |m Digitalisierung UB Augsburg - ADAM Catalogue Enrichment |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029723810&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |3 Klappentext |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-029723810 | ||
Datensatz im Suchindex
| _version_ | 1804177538180710400 |
|---|---|
| adam_text | Contents
1 Introduction......................................................... 1
1.1 Introduction to the Problem..................................... 1
1.2 Theoretical Landscape of Legal Responses........................ 4
1.2.1 International Constitutionalism and Global Administrative
Law...................................................... 5
1.2.2 Legal Pluralism and Systems Theory....................... 8
1.2.3 Spotlight on an Under-Researched Issue.................. 10
1.3 Multilevel Regulation and Legal Certainty...................... 13
1.4 Research Question and Chapter Outline.......................... 16
References.......................................................... 20
2 Conceptualizing Multilevel Regulation............................... 25
2.1 Introduction................................................... 25
2.2 Multilevel Governance as an Inspiration for
Multilevel Regulation.......................................... 31
2.3 Defining Multilevel Regulation................................. 35
2.3.1 How Is Multilevel Regulation Different from Multilevel
Governance?............................................. 35
2.3.2 Towards a Definition of Multilevel Regulation: An
Analysis of Key Features................................ 37
2.3.3 Multilevel Regulation: Response from Legal Scholars ... 39
2.4 Conclusion..................................................... 41
References.......................................................... 42
3 Reconceptualizing Legal Certainty: From a Principle of Positive
Law to Regulatee Expectations....................................... 47
3.1 Introduction................................................... 47
3.2 Legal Certainty: Legal Positivist Scholarship.................. 50
3.3 Review of Weber’s Ideas........................................ 54
3.4 Empirical Understanding of Legal Certainty..................... 60
3.5 Excavating Litigant Notions of Legal Certainty:
From the ECJ Case Law.......................................... 62
67
68
71
71
73
75
77
77
79
80
81
82
85
85
88
89
89
92
93
95
97
99
99
101
103
103
105
106
108
108
111
114
117
119
121
121
122
3.6 Conclusion..................................................
References.......................................................
Explanation of Methodological Choices............................
4.1 Introduction................................................
4.2 Conceptualization...........................................
4.3 Research Methods............................................
4.4 Operationalization of the Concepts..........................
4.5 Recruitment, Sampling and the Research Process..............
4.5.1 Medical Device Case Study............................
4.5.2 Pharmaceutical Case Study............................
4.6 Analytical Strategy.........................................
References.......................................................
Pilot Study of Regulatory Uncertainty in Marketing Authorization
of Medical Products in Europe....................................
5.1 Introduction................................................
5.2 Aspects of the Regulatory System ...........................
5.3 Study Results...............................................
5.3.1 How Has European Regulation Shaped
Product Sectors?.....................................
5.3.2 How Has the European Regulations Impacted Regulatory
Uncertainty in These Product Sectors?................
5.3.3 How Has This Shaped Compliance Strategies?...........
5.4 Discussion and Conclusion ..................................
References.......................................................
Case Study on Medical Devices Regulation in Europe...............
6.1 Introduction................................................
6.2 History of Regulation in the Medical Device Sector..........
6.3 Is the Medical Device Regulatory Space Multilevel
in Nature?..................................................
6.3.1 Rule Making..........................................
6.3.2 Rule Application.....................................
6.3.3 Rule Adjudication....................................
6.4 What Is the Regulatee Perception of Multilevelness?.........
6.4.1 Rule Making, Rule Application and
Rule Adjudication....................................
6.4.2 Regulatory Relationships.............................
6.5 What Are the Regulatee Perceptions and Expectations of Legal
Certainty?..................................................
6.6 Analysis and Conclusion.....................................
References.......................................................
Case Study on Pharmaceutical Regulation in Europe................
7.1 Introduction................................................
7.2 History of Regulation in the Pharmaceutical Sector..........
7.3 Is the Pharmaceutical Regulatory Space Multilevel
in Nature?.................................................... 127
7.3.1 Rule Making............................................ 127
7.3.2 Rule Application....................................... 129
7.3.3 Rule Adjudication...................................... 129
7.4 What Is the Regulatee Perception of Multilevelness?........... 131
7.5 What Are the Regulatee Perceptions and Expectations of Legal
Certainty?.................................................... 132
7.6 Analysis and Conclusion. ..................................... 138
References......................................................... 139
8 Case Study on Borderline Medical Products in Europe......... 141
8.1 Introduction.................................................. 141
8.2 Borderline Versus Border Area................................. 143
8.3 Judicial Decision-Making on Science Issues.................... 149
8.4 Regulatory Status of EU Guidance Documents ................... 152
8.5 From Recast to Review......................................... 155
8.6 Conclusion.................................................... 158
References......................................................... 159
9 Conclusion......................................................... 161
9.1 Introduction.................................................. 161
9.2 Response to the Primary Research Question..................... 162
9.3 Theoretical Contributions..................................... 165
9.4 Scalability, Limitations and Ideas for Future Research........ 167
References......................................................... 169
Annexure I: Questionnaire for Medical Devices Case Study................ 171
Annexure II: Questionnaire for Pharmaceuticals Case Study............. 179
One of the primary functions of law is to ensure that the legal structure governing all
social relations is predictable, coherent, consistent and applicable. Taken together, these
characteristics of law are referred to as legal certainty. In traditional approaches to legal
certainty, lawr is regarded as a hierarchical system of rules characterized 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, w herein norms created at both 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 the author uses multilevel regulation as a term to characterize a regulatory
space in which the process of rule making, rule enforcement and rule adjudication (the
regulatory lifecycle) is dispersed across more than one administrative or territorial level
and amongst several different actors, both public and private. The author draws 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 and they may be independent of each other. Tire lack of central ordering
of the regulatory lifecycle within this regulatory space is the most important feature
of such a space.
The implications of multilevel regulation for the notion of legal certainty have attracted
limited attention from scholars and the demand for legal certainty in regulatory
practice is still a puzzle. The book explores the idea of legal certainty in terms of
the perceptions and expectations of regulatees in the context of medical products -
specifically, pharmaceuticals and medical devices, which can be differentiated as two
regulatory spaces and therefore form two case studies. As an exploratory project, the
book necessarily explores new territory in terms of investigating legal certainty first
in terms of regulatee perceptions and expectations and second, because it studies it in
the context of multilevel regulation.
|
| any_adam_object | 1 |
| author | Chowdhury, Nupur |
| author_GND | (DE-588)1050935896 |
| author_facet | Chowdhury, Nupur |
| author_role | aut |
| author_sort | Chowdhury, Nupur |
| author_variant | n c nc |
| building | Verbundindex |
| bvnumber | BV044320326 |
| classification_rvk | PJ 2440 |
| ctrlnum | (OCoLC)885404553 (DE-599)BVBBV044320326 |
| discipline | Rechtswissenschaft |
| format | Book |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>02296nam a2200529 c 4500</leader><controlfield tag="001">BV044320326</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">20170607 </controlfield><controlfield tag="007">t</controlfield><controlfield tag="008">170521s2014 |||| |||| 00||| eng d</controlfield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9783319045931</subfield><subfield code="9">978-3-319-04593-1</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)885404553</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV044320326</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-384</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">PJ 2440</subfield><subfield code="0">(DE-625)136665:</subfield><subfield code="2">rvk</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Chowdhury, Nupur</subfield><subfield code="e">Verfasser</subfield><subfield code="0">(DE-588)1050935896</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">European regulation of medical devices and pharmaceuticals</subfield><subfield code="b">regulatee expectations of legal certainty</subfield><subfield code="c">Nupur Chowdhury</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Cham</subfield><subfield code="b">Springer International Publishing</subfield><subfield code="c">[2014]</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">xiii, 185 Seiten</subfield><subfield code="b">Diagramme</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">n</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">nc</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Recht</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Wirtschaftspolitik</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Law</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Pharmacy</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Public health laws</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Europe</subfield><subfield code="x">Economic policy</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Medizinprodukt</subfield><subfield code="0">(DE-588)4024018-6</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Öffentliches Gesundheitswesen</subfield><subfield code="0">(DE-588)4139691-1</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Recht</subfield><subfield code="0">(DE-588)4048737-4</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="651" ind1=" " ind2="4"><subfield code="a">Europa</subfield></datafield><datafield tag="651" ind1=" " ind2="7"><subfield code="a">Europa</subfield><subfield code="0">(DE-588)4015701-5</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="689" ind1="0" ind2="0"><subfield code="a">Europa</subfield><subfield code="0">(DE-588)4015701-5</subfield><subfield code="D">g</subfield></datafield><datafield tag="689" ind1="0" ind2="1"><subfield code="a">Öffentliches Gesundheitswesen</subfield><subfield code="0">(DE-588)4139691-1</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2="2"><subfield code="a">Recht</subfield><subfield code="0">(DE-588)4048737-4</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="689" ind1="1" ind2="0"><subfield code="a">Europa</subfield><subfield code="0">(DE-588)4015701-5</subfield><subfield code="D">g</subfield></datafield><datafield tag="689" ind1="1" ind2="1"><subfield code="a">Medizinprodukt</subfield><subfield code="0">(DE-588)4024018-6</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2="2"><subfield code="a">Recht</subfield><subfield code="0">(DE-588)4048737-4</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="776" ind1="0" ind2="8"><subfield code="i">Erscheint auch als</subfield><subfield code="n">Online-Ausgabe</subfield><subfield code="z">978-3-319-04594-8</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="m">Digitalisierung UB Augsburg - ADAM Catalogue Enrichment</subfield><subfield code="q">application/pdf</subfield><subfield code="u">http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029723810&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA</subfield><subfield code="3">Inhaltsverzeichnis</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="m">Digitalisierung UB Augsburg - ADAM Catalogue Enrichment</subfield><subfield code="q">application/pdf</subfield><subfield code="u">http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029723810&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA</subfield><subfield code="3">Klappentext</subfield></datafield><datafield tag="999" ind1=" " ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-029723810</subfield></datafield></record></collection> |
| geographic | Europa Europa (DE-588)4015701-5 gnd |
| geographic_facet | Europa |
| id | DE-604.BV044320326 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:49:40Z |
| institution | BVB |
| isbn | 9783319045931 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-029723810 |
| oclc_num | 885404553 |
| open_access_boolean | |
| owner | DE-384 |
| owner_facet | DE-384 |
| physical | xiii, 185 Seiten Diagramme |
| publishDate | 2014 |
| publishDateSearch | 2014 |
| publishDateSort | 2014 |
| publisher | Springer International Publishing |
| record_format | marc |
| spelling | Chowdhury, Nupur Verfasser (DE-588)1050935896 aut European regulation of medical devices and pharmaceuticals regulatee expectations of legal certainty Nupur Chowdhury Cham Springer International Publishing [2014] xiii, 185 Seiten Diagramme txt rdacontent n rdamedia nc rdacarrier Recht Wirtschaftspolitik Law Pharmacy Public health laws Europe Economic policy Medizinprodukt (DE-588)4024018-6 gnd rswk-swf Öffentliches Gesundheitswesen (DE-588)4139691-1 gnd rswk-swf Recht (DE-588)4048737-4 gnd rswk-swf Europa Europa (DE-588)4015701-5 gnd rswk-swf Europa (DE-588)4015701-5 g Öffentliches Gesundheitswesen (DE-588)4139691-1 s Recht (DE-588)4048737-4 s DE-604 Medizinprodukt (DE-588)4024018-6 s Erscheint auch als Online-Ausgabe 978-3-319-04594-8 Digitalisierung UB Augsburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029723810&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Digitalisierung UB Augsburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029723810&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Klappentext |
| spellingShingle | Chowdhury, Nupur European regulation of medical devices and pharmaceuticals regulatee expectations of legal certainty Recht Wirtschaftspolitik Law Pharmacy Public health laws Europe Economic policy Medizinprodukt (DE-588)4024018-6 gnd Öffentliches Gesundheitswesen (DE-588)4139691-1 gnd Recht (DE-588)4048737-4 gnd |
| subject_GND | (DE-588)4024018-6 (DE-588)4139691-1 (DE-588)4048737-4 (DE-588)4015701-5 |
| title | European regulation of medical devices and pharmaceuticals regulatee expectations of legal certainty |
| title_auth | European regulation of medical devices and pharmaceuticals regulatee expectations of legal certainty |
| title_exact_search | European regulation of medical devices and pharmaceuticals regulatee expectations of legal certainty |
| title_full | European regulation of medical devices and pharmaceuticals regulatee expectations of legal certainty Nupur Chowdhury |
| title_fullStr | European regulation of medical devices and pharmaceuticals regulatee expectations of legal certainty Nupur Chowdhury |
| title_full_unstemmed | European regulation of medical devices and pharmaceuticals regulatee expectations of legal certainty Nupur Chowdhury |
| title_short | European regulation of medical devices and pharmaceuticals |
| title_sort | european regulation of medical devices and pharmaceuticals regulatee expectations of legal certainty |
| title_sub | regulatee expectations of legal certainty |
| topic | Recht Wirtschaftspolitik Law Pharmacy Public health laws Europe Economic policy Medizinprodukt (DE-588)4024018-6 gnd Öffentliches Gesundheitswesen (DE-588)4139691-1 gnd Recht (DE-588)4048737-4 gnd |
| topic_facet | Recht Wirtschaftspolitik Law Pharmacy Public health laws Europe Economic policy Medizinprodukt Öffentliches Gesundheitswesen Europa |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029723810&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029723810&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT chowdhurynupur europeanregulationofmedicaldevicesandpharmaceuticalsregulateeexpectationsoflegalcertainty |