HEC-Ecole de gestion de l'Université de Liège
HEC-Ecole de gestion de l'Université de Liège

SPC manufacturing waiver : consequences for a generic and innovative Bioteh company.

Gallez, Anne ULiège
Promotor(s) : Alexandre, Marc ULiège
Date of defense : 4-Nov-2020 • Permalink :
Title : SPC manufacturing waiver : consequences for a generic and innovative Bioteh company.
Translated title : [fr] Dérogation au certificat complémentaire de protection à la fabrication : conséquences pour une entreprise de biotechnologique générique et innovante
Author : Gallez, Anne ULiège
Date of defense  : 4-Nov-2020
Advisor(s) : Alexandre, Marc ULiège
Committee's member(s) : Vanbrabant, Bernard ULiège
Cappuyns, Patricia ULiège
Language : English
Number of pages : 102
Keywords : [en] SPC manufacturing waiver
[en] generic
[en] innovation
[en] patent
[en] medicinal products
Discipline(s) : Business & economic sciences > General management & organizational theory
Business & economic sciences > Production, distribution & supply chain management
Target public : Researchers
Professionals of domain
General public
Institution(s) : Université de Liège, Liège, Belgique
Degree: Master en sciences de gestion, à finalité spécialisée en management général (Horaire décalé)
Faculty: Master thesis of the HEC-Ecole de gestion de l'Université de Liège


[en] As compensation for the time invested during preclinical and clinical studies and to
continue to encourage European pharmaceutical companies to invest in the research and
innovation, the EU proposed a uniform and communal solution, called the « Supplementary
Protection Certificate» (SPC). Unfortunately, this extension of protection accorded to patented
medicines presents unintended side effects, by conferring « time » advantages to generic or
biosimilar companies, located in countries outside the EU, where a SPC does not exist or in
which the SPC duration is shorter. The SPC manufacturing waiver aims to restore a level
playing field between manufacturers of generic and biosimilar products located inside and
outside EU and to enhance the competitiveness of the UE. The SPC manufacturing waiver
allows manufacturers, located within the EU, to produce generic and biosimilar during the
protection period covered by the SPC of a patented medicine, and to export them to « third
countries ». In addition to the exportation, the EU-based manufacturers can produce and store
generic products, in order to serve the EU markets quickly and immediately, as soon as the SPC expires. Thus, generic and biosimilar companies, located in EU compete directly, based on the, so called, «EU Day-1 entry» concept. The SPC manufacturing waiver is perceived positively or negatively according to several actors of pharmaceutical industry sector.



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  • Gallez, Anne ULiège Université de Liège > Doct. sc. bioméd. & pharma. (paysage)


Committee's member(s)

  • Vanbrabant, Bernard ULiège Université de Liège - ULiège > Département de droit > Droit de la propriété intellectuelle
    ORBi View his publications on ORBi
  • Cappuyns, Patricia ULiège Université de Liège - ULiège > Département de droit > Propiété intellectuelle - Droits des brevets
    ORBi View his publications on ORBi
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