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Fragmented Transparency: The Visibility of Agency Science in European Union Risk Regulation
European Journal of Risk Regulation Pub Date : 2023-01-25 , DOI: 10.1017/err.2022.47
Alie de Boer , Marta Morvillo , Sabrina Röttger-Wirtz

Responding to mistrust in the European agencies’ risk assessments in politically salient cases, the European Union (EU) legislator, the European Food Safety Authority and the European Medicines Agency alike have accelerated their efforts to foster EU regulatory science transparency. These simultaneous endeavours have, however, taken place in a fragmented legislative and administrative context, with each agency operating under a different legal framework. By focusing on authorisation procedures, from registration of studies to authorisation of novel foods, pesticides and human medicines, this article examines the resulting regimes governing the disclosure of scientific data by EU agencies to identify common trends and sectoral specificities. Against the background of an overall shift towards enhanced transparency, we shed light on, first, the circulation of institutional arrangements and practices among agencies and, second, the new dimensions of transparency emerging from these developments. We also highlight the remaining sectoral differences and argue that they could have potentially large impacts on the amount and type of information disclosed and on the level of transparency perceived by stakeholders and citizens. We argue that more coherence across the sectoral transparency regimes is needed, in particular in light of the agencies’ contested legitimacy and of their increasing cooperation on cross-cutting issues like antimicrobial resistance and medicine and pesticide residues in food.



中文翻译:

零散的透明度:机构科学在欧盟风险监管中的可见性

为了应对对欧洲机构在政治突出案件中的风险评估的不信任,欧盟 (EU) 立法者、欧洲食品安全局和欧洲药品管理局都加快了促进欧盟监管科学透明度的努力。然而,这些同时进行的努力发生在支离破碎的立法和行政环境中,每个机构都在不同的法律框架下运作。通过关注授权程序,从研究注册到新型食品、杀虫剂和人类药物的授权,本文检查了由此产生的管理欧盟机构科学数据披露的制度,以确定共同趋势和部门特殊性。在整体转向提高透明度的背景下,我们首先阐明,机构间制度安排和做法的流通,其次,这些发展带来的新的透明度方面。我们还强调了其余的部门差异,并认为它们可能会对披露的信息的数量和类型以及利益相关者和公民所感知的透明度水平产生重大影响。我们认为,需要加强跨部门透明度制度的一致性,特别是考虑到各机构的合法性存在争议,以及它们在诸如抗菌素耐药性以及食品中的药物和农药残留等交叉问题上加强合作。我们还强调了其余的部门差异,并认为它们可能会对披露的信息的数量和类型以及利益相关者和公民所感知的透明度水平产生重大影响。我们认为,需要加强跨部门透明度制度的一致性,特别是考虑到各机构的合法性存在争议,以及它们在诸如抗菌素耐药性以及食品中的药物和农药残留等交叉问题上加强合作。我们还强调了其余的部门差异,并认为它们可能会对披露的信息的数量和类型以及利益相关者和公民所感知的透明度水平产生重大影响。我们认为,需要加强跨部门透明度制度的一致性,特别是考虑到各机构的合法性存在争议,以及它们在诸如抗菌素耐药性以及食品中的药物和农药残留等交叉问题上加强合作。

更新日期:2023-01-25
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