Conference Agenda

This article explores the European Union's (EU) legal approaches to balancing market-related individual rights with public health needs during the COVID-19 pandemic, focusing on border management within the EU’s Internal Market. The EU Commission's response, characterized by 'effective border management', involved 'restrictive selection' or 'selective mobility', facilitating the movement of 'essential workers' in critical sectors like health and food while limiting general human mobility to control the virus spread. The article examines the legal complexities of these measures in light of the EU's commitment to free movement. It analyzes the intersection of pandemic responses, such as travel restrictions and quarantine protocols, with internal market principles and individual freedoms, within the broader EU legal framework. This includes assessing how EU law manages the balance between national public health measures and market freedoms. Key to this discussion is the evolving jurisprudence of the Court of Justice of the EU, exemplified by cases like NORDIC INFO (C-128/22). The ruling confirms that national pandemic measures, when aligned with EU law's conditions and safeguards, do not constitute violations. This case law underscores Member States' discretion in public health protection, but it also embodies respect for the EU’s shared competence in health law, emphasizing the need for proportionate, non-discriminatory measures that respect fundamental rights.

As the technology to collect, process and analyse data has improved, there has been a growing awareness of the importance of harnessing the economic and social value of health data to drive scientific progress and improve the quality of care. To maximise the societal benefits of health data, the EU Commission proposed the adoption of a regulation on European Health Data Space (EHDSR) in 2022, which will promote the use and sharing of such data for improving health care and planning (primary use) and scientific research and innovation (secondary use), while respecting the values and rights inherent to European constitutionalism. In this way, the EHDSR aims to achieve two of the Union’s strategic objectives: the creation of the Digital Single Market and the establishment of the European Health Union. This paper aims to assess the legitimacy of the proposed EHDSR in relation to the existing EU legal competences. Although it is unrealistic to think that the objectives pursued by this proposal can be achieved by the Member States individually, as the EU is a Union based on the rule of law, we question whether the EHDSR respects the general principles of the EU legal order. After briefly tracing the evolution of the European integration process in this area, the paper will highlight the problematic features of the current version of the EHDSR. It will then consider possible ways forward, including the possibility of launching a process of Treaty reform or, in the absence of political will, institutional reform without changing the constitutional framework

The paper aims to provide an up-to-date assessment of the proposals for a revision of EU pharmaceutical legislation (e.g., COM(2023) 192 final and COM(2023) 193 final), which the European Commission has adopted on 26 April 2023, intending to introduce the most comprehensive changes in the sector in over two decades as part of the substantial push for reform towards the creation of a European Health Union. The new measures cover a broad range of crucial aspects of the existing legislative framework, and the proposed considerations focus on those having a significant impact on the EU internal market that represents the broader legislative and policy context in which the reform is meant to take effect. The amendments span from the revision of market and data exclusivity periods to balance innovation and competition in drug development processes to the streamlining of marketing authorisation procedures and the regulatory bodies within the European Medicines Agency (EMA) and further to the measures to counter health emergencies such as the implementation of contingency stocks in situations of medicines shortages and compulsory licences. Against this background, the paper will attempt to analyse whether the revised framework may be fit-for-purpose to attain a future-proof body of legislation for pharmaceuticals for human use in the EU, in compliance with the long-standing goal of creating a ‘Single Market for Pharmaceuticals’.