Can independent regulatory agencies mend Europe’s democracy? The case of the European Medicines Agency’s public hearing on Valproate
| Author | Matthew Wood |
| DOI | http://doi.org/10.1177/13691481211054319 |
| Published date | 01 November 2022 |
| Date | 01 November 2022 |
| Subject Matter | Original Articles |
https://doi.org/10.1177/13691481211054319
The British Journal of Politics and
International Relations
2022, Vol. 24(4) 607 –630
© The Author(s) 2021
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DOI: 10.1177/13691481211054319
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Can independent regulatory
agencies mend Europe’s
democracy? The case of the
European Medicines Agency’s
public hearing on Valproate
Matthew Wood
Abstract
In 2017, the European Medicines Agency staged the first effort at democratic innovation within
transnational European Union institutions directly influencing the transnational regulation of
medicines. Alongside its public consultation on epilepsy drug Valproate, European Medicines
Agency included a public hearing involving representatives of patients and testimony from
those directly affected by the medicines. Using this critical case study, the article argues from
a deliberative democratic perspective that although the hearing in many ways exhibited the
traditional shortcomings of elite-driven deliberation, it also demonstrated unexpected and
surprising deliberative qualities. Based on new quantitative analysis of the hearing using the
Discourse Quality Index, and qualitative observation of over 4 hours of footage, the article
argues European Medicines Agency’s hearing facilitated equitable access and influence of patients
and members of the public who had previously been excluded from decision making on drug
distribution. These findings provide important new evidence of the deliberative democratic value
of public hearings.
Keywords
deliberative democracy, democratic governance, democratic innovation, European Union,
institutions, medicines regulation
Independent regulatory agencies (IRAs) like the European Medicines Agency (EMA) and
European Food Safety Authority (EFSA) have been touted since the 1990s as potentially
important bodies for improving the European Union’s (EU) ‘democratic deficit’. Some
have argued they provide ‘output legitimacy’ by ensuring the safety of consumer products
distributed in the European Single Market (e.g. medicines and food), while others
have added their democratic potential in ‘reaching out’ to a range of relevant societal and
Department of Politics and International Relations, The University of Sheffield, Sheffield, UK
Corresponding author:
Matthew Wood, Department of Politics and International Relations, The University of Sheffield, Elmfield
Building, Northumberland Road, Sheffield S10 2TU, UK.
Email: m.wood@sheffield.ac.uk
1054319BPI0010.1177/13691481211054319The British Journal of Politics and International RelationsWood
research-article2021
Original Article
608 The British Journal of Politics and International Relations 24(4)
economic ‘stakeholders’ (Braun and Busuioc, 2020). The latter claim raises the expecta-
tion IRAs might contribute to open and inclusive public reasoning at a transnational level
or ‘deliberative democracy’ (Maggetti, 2010). This prospect was raised by the European
Commission in its 2001 White Paper on Governance (Parker, 2019) and has been hinted
at by existing studies (Schmidt and Wood, 2019). However, IRAs’ engagement has gener-
ally been limited to relatively close groups of stakeholders in industry and non-govern-
mental organisations, and to issue-based consultations (Pérez-Durán, 2019). While such
constraints can be justified on functionalist grounds, they seem disappointing and ‘tech-
nocratic’ by ideal deliberative democratic standards. Is it possible that IRAs can really
enable deliberative democracy in a way that squares with their regulatory functions? This
article suggests it can, by applying the concept of democratic mending to a case study of
IRA engagement activities, specifically the public hearing (Hendriks et al., 2020).
In 2017, EMA staged not only a public consultation on Valproate, an epilepsy medi-
cine whose safety had come under question, but a public hearing involving representa-
tives of patients and testimony from those directly affected by the medicine. The EMA
promotes public hearings as opportunities for ‘working directly with people affected
by [a] medicine’, which have real impact on Agency decisions: ‘Contribution(s) from
the public at hearings will inform PRAC (Pharmacovigilance Risk Assessment
Committee) decision making’ (EMA, 2018: 2). Public hearings are more ambitious
than standard stakeholder engagement exercises. Any member of the public can apply
to attend the hearing and individuals who have a specific interest in the policy issue
being debated are encouraged to attend and report their experience in person. This
procedure provides an important opportunity to understand how EU IRAs can under-
take what Hendriks et al. (2020) call ‘democratic mending’ by enhancing deliberation
between underrepresented groups and regulatory decision-making processes. It hence
provides an unlikely, but potentially compelling, case study of an IRA enabling ‘con-
nectivity’ between elite and non-elite groups in deliberating a key regulatory issue,
thus potentially contributing to a wider ‘deliberative democratic system’ (Parkinson
and Mansbridge, 2012).
This article assesses the extent to which the EMA’s public hearing was successful in
achieving criteria for good democratic deliberation. Using the Discourse Quality Index
(DQI), I coded 4 hours of a video of the hearing (https://www.youtube.com/watch?reloa
d=9&v=CzeJSzkrygM#action=share). I complemented this with qualitative analysis
interpreting the value and limits of the hearing. The core argument is EMA’s public hear-
ing on Valproate-enabled deliberative democracy to the extent that it facilitated equita-
ble access and influence of patients and members of the public who had previously been
excluded from decision making on the distribution of the drug. I emphasise the way the
hearing was set up in the style of a law court, with a democratic representative from the
European Parliament (EP) present, and participants were allowed to use visual props to
facilitate their argument. This allowed patients to tell profoundly powerful stories about
the injustices they, and their families, had experienced. These stories compelled ‘elite’
actors, including industry and professional participants, to respect their demands and led
to a transformation in how Valproate is regulated within the EU. The article shows how,
when introduced in carefully curated ways, public hearings can facilitate moments of
relatively ‘radical’ deliberation in IRAs usually defined by ‘output-oriented’ technical
goals and ‘traditional’ stakeholder engagement (Pérez-Durán, 2019). In doing so, it
identifies three methods of ‘democratic mending’ IRA officials can use during public
hearings:
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