Mutual transformation and the development of European policy spaces. The case of medicines licensing

Hauray, Boris; Urfalino, Philippe

doi:10.1080/13501760802662714

Cited by 19 publications

(11 citation statements)

References 28 publications

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“…The EMRN is understood as a least-likely case for centralized decision behaviour: the Commission has been granted some decision power in this field, but with its many mechanisms for member-state control the network could be expected to be characterized by decentralized decision behaviour (Gerring 2007: 116-9). A comprehensive regulatory system for medicines has been institutionalized at the EU level since the first directive in 1965 established that medicines must receive a marketing authorization (MA) before entering the market, based on the evaluation of safety, therapeutic efficacy and quality of the product (Krapohl 2008: 70;Hauray and Urfalino 2009). The regulatory system now covers the complete life-cycle of a medicine from product development, testing and manufacturing to approval for sale by MA and post-market monitoring of adverse effects (Hauray 2013).…”

Section: Case Methods and Datamentioning

confidence: 99%

Pooling administrative resources through EU regulatory networks

Vestlund¹

2015

Journal of European Public Policy

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Do EU administrative networks help to preserve executive power at the member-state level, or centralize executive power at the EU level? This article examines how resource pooling takes place in the European Medicines Regulatory Network (EMRN), and the relevance of organizational structure in explaining this. By doing so the article adds both empirically and theoretically to the literature. The article presents new insights on intra-network decision behaviour, showing how network participants, under the coordination of an EU agency, pool resources by sharing knowledge, information, practices and experiences, and by routinized division of labour. Furthermore, applying an organizational perspective the article identifies some organizational structural factors that facilitate resource pooling and contribute to centralization of the EMRN. The findings thus have implications for the debate on the effects of establishing EU regulaory networks.

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Section: Case Methods and Datamentioning

confidence: 99%

Pooling administrative resources through EU regulatory networks

Vestlund¹

2015

Journal of European Public Policy

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“…All these interactions are brought together under a framework of mechanisms and they are susceptible to temporal aspects. Hauray and Urfalino (2009) in their study on the formation of the medicines licensing system concentrate on the policy space of interactions and what they call 'mutual transformation' -they are less concerned about drawing a line between what is European and what is domestic. Empirically, the fusion of different levels into a single European executive order has been supported by studies based on organisational theory and the public administration model -Trondal (2010) provides robust evidence.…”

Section: Alternative Designsmentioning

confidence: 98%

Research Methods in European Union Studies

Lynggaard

Manners

Löfgren

2015

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“…These sorts of agencies soon hosted and ran national systems of collection of adverse drug reaction reports and databases. By competing and interacting among themselves, national regulatory agencies allowed the development of a common European space for the regulation of pharmaceuticals (Hauray 2006;Hauray and Urfalino 2009).…”

Section: Towards Global Standards and Operationsmentioning

confidence: 99%

The tools of globalization: ways of regulating and the structure of the international regime for pharmaceuticals

Demortain

2015

Review of International Political Economy

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This article investigates the relationship between regulatory globalization and neoliberal standard-setting arrangements building on industry capacities and responsibilities. Focusing on international pharmacovigilance, it recounts the history of the World Health Organization programme for the international drug monitoring, to shed light and explain the concomitant rise of the International Conference on Harmonization and of its standards. It shows that the neoliberalization of a regime or installation of a regulatory standardsetting arrangement responsibilizing the industry is inseparable from the emergence of an altogether different way of regulating pharmaceuticals (including a different definition of the problem of pharmaceuticals safety, of the organizations in charge of this problem and of the kinds of expertise and information used to make decisions about it). This happens incrementally, through gradual changes and hybridization of the existing regime, much more than all-out replacement of the regime. The rise of a market-oriented regulatory arrangement can therefore not be reduced to the influence of a neoliberal scheme, but is on the contrary linked to the ways in which a tool gains legitimacy as a way of tackling a global issue.

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Mutual transformation and the development of European policy spaces. The case of medicines licensing

Cited by 19 publications

References 28 publications

Pooling administrative resources through EU regulatory networks

Pooling administrative resources through EU regulatory networks

Research Methods in European Union Studies

The tools of globalization: ways of regulating and the structure of the international regime for pharmaceuticals

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