Case C-616/17 Blaise and Others: The precautionary principle and its role in judicial review – Glyphosate and the regulatory framework for pesticides

The approval renewal of glyphosate as an active substance for pesticides in the EU has also kept the Court of Justice occupied. Within this line of case law, the Blaise case is the most recent one. In this preliminary reference procedure the Court was asked to review the validity of the Plant Protection Products Regulation 1107/2009, examined against the precautionary principle as benchmark. The case is relevant not only for the questions raised about the Regulation, but also as it sheds a light on the – albeit limited – use of the precautionary principle in the judicial review of EU legislative measure

D.2.3 Glyphosate case study:Contribution to the REconciling sCience, Innovation and Precaution through the Engagement of Stakeholders Project (RECIPES). Horizon 2020 Framework Programme of the European Union under Grant Agreement no. 824665.

Glyphosate is the world’s most widely used herbicides and the debates surrounding potential risks associated with it have dominated its recent re-approval in 2017 and will continue to play a role in the ongoing renewal procedure which was applied for in December 2019. Paying attention to the risk assessment and risk management phase at EU level as well as the position of various stakeholders, this case study will analyse the role that the precautionary principle played in the EU procedures for the re-approval of glyphosate. It will also discuss how the application of the precautionary principle in this case interacts with innovation and especially the ‘innovation principle’ which is recently gaining traction in the EU discours

Independence under threat - the role of private actors in the setting of global pharmaceutical standards and resulting challenges for European public law

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