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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.

Personalised nutrition, the tailoring of nutrition products, services or advice to individual characteristics such as genetics, phenotype, nutritional intake and/or exercise routine, is increasingly attracting the interest of industry, consumers and researchers. This article provides an overview of the current European Union (EU) regulatory framework as applying to personalised nutrition and draws attention to the important role of EU food law in the regulation of this innovative approach to nutrition. It is argued that personalised nutrition challenges the regulatory borderline between health and lifestyle products or services and, furthermore, also pushes the boundaries of current food safety and health claims legislation.

This article examines the development of mutual recognition of marketing authorizations for pharmaceuticals, arguing that the sui generis approach to mutual recognition in this policy area is based, first of all, on the harmonisation of regulatory requirements. However, it additionally also required the procedural integration of mutual recognition in trans-national administrative procedures, and institutional innovation. This has created a curious mix of centralized and decentralized authorisation routes with various stages of collaboration and arbitration. In this regard, the creation of the complex, composite procedures in place to facilitate the mutual recognition of pharmaceuticals raises several questions with regard to the judicial and political accountability of the actors involved. The developments and problems described in this article with regard to pharmaceuticals are also mirrored in other risk regulation areas, where mutual recognition seems to require the integration into administrative procedures on intra-administrative and/or EU level, leading to proliferation of sui generis approaches to mutual recognition.

In the EU, pharmaceuticals are subject to a marketing authorisation requirement that, depending on the type of product concerned, can be obtained either centrally through a Commission decision with EU-wide effects or in the Member States, potentially subject to mutual recognition in composite authorisation procedures. These composite decision-making processes can nowadays be considered a standard way of administrative decision-making in the EU internal market. Yet, judicial supervision remains anchored in the separation of jurisdictions between the national and the EU level, and between national levels. This article explores the challenges posed to judicial review in the case of pharmaceutical marketing authorisations when European administrative composite structures are used.

This article analyses the setting of global pharmaceutical standards in the International Council for Harmonization (ICH) and the implementation of these global standards in the European framework of pharmaceutical regulation. It thereby highlights the conflict between the publicprivate nature of the ICH process and the European administrative law principle of independence of public regulators. While the ICH is a public-private partnership between regulatory authorities and pharmaceutical industry associations, in the regulation of pharmaceuticals in the European Union public regulators are subject to a strict requirement of independence from the industry they are regulating. Nonetheless, the ICH standards are implemented into the regulatory framework for pharmaceuticals in the European Union, although the standard-setting process on the global level fundamentally contradicts the procedural standards of EU administrative law. In this regard, the article calls for a more coherent approach for the EU’s participation in global standard-setting bodies and the implementation of global standards in the EU.

The PhD research ‘The Interplay of Global Standards and EU Pharmaceutical Regulation’ discusses the EU implementation of pharmaceutical standards set by the International Council for Harmonisation (ICH). It is argued that the process of standard-setting in the ICH does not adhere to the same level of participation, transparency and independence of expertise as would be ensured through administrative procedure in the Union. This leads to legitimacy flaws of the ICH standards. With the implementation of ICH standards in the Union, its flaws are imported as well. These legitimacy flaws are not compensated through the Union’s implementation procedure.

The European Union in its risk regulation activities is increasingly relying on standards set by international entities. Using the example of standards for pharmaceutical products set by the International Conference for Harmonisation (ICH), this paper points out problems of transparency, participation and the use of expertise in standard-setting processes. It furthermore argues that regardless of the soft law nature of these standards, in fact the European Union without fail implements them into its risk regulation framework, where they receive ‘quasi-binding’ value regardless of the flaws in global process.

On behalf of the Interest Group on Supranational Biolaw of the European Association of Health Law (EAHL IG Biolaw) and the I-BioLex research project (ANR-20-CE26-0007-01), Éloïse Gennet and Aurélie Mahalatchimy have been coordinating, since September 2021, the thematic network on the pharmaceutical strategy on the European Health Policy Platform (EUHPP) of the European Commission. The thematic network of the EAHL IG Biolaw, selected by the European Commission and by the users of the EUHPP platform, is entitled “Health as a fundamental value. Towards an inclusive and equitable pharmaceutical strategy for the European Union”. This network enables to link the EAHL IG Biolaw, exclusively constituted by researchers and academics in the field of health law in Europe, on the one hand with the European Commission and in particular DG Health, and on the other hand with socio-economic actors interested in EU law applicable to medicinal products and medical devices (patient representatives, representatives of health professionals or non-governmental organizations in the field of health). After several months of fruitful exchanges, the final joint statement which was very favorably received by DG Health and endorsed by several organizations (including the President of Aix-Marseille University and the CNRS) has been presented at the EU Health Policy Platform Annual Meeting 2022 at the European Commission and published on the EUHPP in May 2022.