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.
Highlights
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, 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
IRAs’ engagement has generally been limited to relatively close groups of stakeholders in industry and non-governmental organisations, and to issue-based consultations (Pérez-Durán, 2019). While such constraints can be justified on functionalist grounds, they seem disappointing and ‘technocratic’ 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, the public hearing (Hendriks et al, 2020)
In 2017, EMA staged a public consultation on Valproate, an epilepsy medicine whose safety had come under question, but a public hearing involving representatives of patients and testimony from those directly affected by the medicine
Summary
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’. This article suggests it can, by applying the concept of democratic mending to a case study of IRA engagement activities, the public hearing (Hendriks et al, 2020).
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