A widening authority–legitimacy gap in EU regulatory governance? An experimental study of the European Medicines Agency’s legitimacy in health security regulation

ABSTRACT

Agencification in the EU stretches the confines of the European regulatory state to the maximum by extending to policy domains that were formerly the exclusive terrain of national institutions. Although the challenge to legitimize EU-level agencies is widely acknowledged, scant empirical research has been done on the conditions under which EU-level epistemic authority prevails or fails. To fill this gap, we examine whether EU agencies are perceived as more legitimate when the scientific nature of their regulatory outputs is made explicit and whether they start facing grave legitimacy challenges when national-level stakeholders signal disapproval with their scientific recommendations. We draw on a survey experiment with Dutch local politicians to study their legitimacy perceptions about the European Medicines Agency (EMA) and its mandate to authorize vaccines in view of cross-border health security risks. Our data suggest that the EMA is regarded as a highly legitimate agency and that disapproval by national-level politicians and citizens does not undermine its epistemic authority in the eyes of local decision-makers. This study contributes to the scholarship on non-majoritarian institutions’ legitimation imperatives by introducing novel research avenues and analytical tools to continue rigorous empirical testing of the well-established theoretical and normative claims.

KEYWORDS:

• European Medicines Agency (EMA)
• health security
• legitimacy
• risk regulation
• survey experiment

Acknowledgements

This article was presented at ‘The Rise of the Regulatory Security State in Europe’ workshop (funded by the Fritz Thyssen Foundation) in Munich, 12–13 November 2021, ECPR General conference in Innsbruck, 22–26 August 2022, and internal research seminar at Leiden University. We would like to thank the participants of the conferences – Anke Obendiek, Timo Seidl, Catherine Hoeffler, Daniel Mügge, Sandra Eckert, Martin Lodge, Takuya Onoda, Kutsal Yesilkagit, Ken Meier, Andrei Poama, Dimiter Toshov, Johan Christensen, and Eefje Cuppen – and the three anonymous reviewers for their constructive feedback. We would also like to thank the editors of the special issue, Andreas Kruck and Moritz Weiss, for their excellent suggestions and guidance. Last but not least, we thank Joris van der Voet for introducing us to the Dutch context as well as his invaluable methodological advice.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability

The data that support the findings of this study are openly available in OSF at osf.io/qhtg9 [doi:10.17605/OSF.IO/QHTG9]

Correction Statement

This article has been corrected with minor changes. These changes do not impact the academic content of the article.

Notes

1 Reservations about extensive delegation to EU-level regulatory bodies resulted in rich theoretical, conceptual, and normative contributions on how EU non-majoritarian institutions and their regulatory authority are or could be legitimized (e.g., Busuioc & Rimkutė, 2020b; Follesdal & Hix, 2006; Majone, 1998, 1999; Schmidt & Wood, 2019). Furthermore, contested legitimacy debates have prompted a myriad of empirical studies. Scholars have examined how diverse accountability mechanisms and stakeholder involvement constitute a considerable source of legitimacy (e.g., Braun & Busuioc, 2020; Busuioc & Jevnaker, 2022; Fink & Ruffing, 2020). Scholars have also studied the efforts of EU agencies to legitimize their outputs, processes, and behaviour to relevant audiences (e.g., Busuioc & Rimkutė, 2020a; Fjørtoft, 2020; Groenleer, 2014; Müller & Braun, 2021; Rimkutė, 2020a, 2020b; Wood, 2018, 2021).

2 Quite regularly the ‘non-majoritarian’ and ‘derived/democratic’ legitimacy standards are regarded as competing, however, in practice they can coexist, therefore, we treat them as potentially complementary.

3 See the dataset and code by following the link: osf.io/qhtg9

4 All participants agreed with the study’s conditions detailed in our online consent form (Appendix II). Also, see Appendix III for further details on the ethics committee approval.

5 See the pre-registration by following the link: https://osf.io/8wyhs/?view_only=3289661eb5ab49b193d22f19bacb5b5f

Additional information

Funding

This study was supported by the Dutch Research Council (Nederlandse Organisatie voor Wetenschappelijk Onderzoek [NWO]) [grant no VI.Veni.191R.078]