Conference Agenda

In the wake of the proposals for a new European pharmaceutical package, controversy emerges around the inclusion of one-year transferable data exclusivity vouchers (TDEV) as an incentive granted to pharmaceutical companies for the development of priority antimicrobials. The threat of antimicrobial resistance is widely recognised; however, the promise of such vouchers remains unclear while their cost to health systems is likely to be considerable. Moreover, stakeholders have raised concerns regarding the commodification of time through TDEV. Similar to patents, they are based on a logic of turning periods of market exclusivity into a reward for previous innovation, which thus makes these time periods valuable assets for the recipient. This has been shown to privilege private, market-driven actors over public actors and thus threaten equitable and balanced cooperations. Considering the widespread suspicion that similar effects may occur upon introduction of TDEV, it thus remains puzzling why the European Commission has included such a novel, seemingly unpopular policy instrument in its proposal even against widely expressed resistance. The proposed paper employs qualitative analysis of documents and interviews to trace the inclusion of TDEV within the proposals for an EU pharmaceutical strategy, aiming to unravel different influences upon the decision-making process. On that basis, it considers a range of alternative explanations to show that the role of industry lobbying is likely to have been substantial. By understanding the decision-making behind TDEV as a case study, this paper contributes to a broader understanding of power and influence within the EU’s framework for pharmaceutical regulation.

The European Union (EU) plays an increasingly pivotal role in global health governance, particularly in addressing equitable access to medicines for vulnerable populations. This paper explores the EU’s extraterritorial legal obligations under the Convention on the Rights of Persons with Disabilities (CRPD), focusing on its role in facilitating access to pharmaceuticals for people with disabilities in low- and middle-income countries (LMICs). This is a unique perspective because the EU’s accession to the CRPD marks the first time a regional international organization became a contracting party to a UN human rights treaty.

The findings reveal that Article 25 (right to health) of the CRPD mandates states to take two critical measures: first, providing persons with disabilities the same standard of healthcare available to others, including sexual and reproductive health services, public health programs, and preventive care such as vaccines. Second, offering disability-specific services and treatments, such as early intervention therapies or medicines that prevent further impairments. Examples of essential medicines include insulin for diabetes, clotting factors for hemophilia, and antiviral treatments like sofosbuvir for Hepatitis C. The EU, as a contracting party to the CRPD, bears these responsibilities both internally and externally. Specifically, Article 32 (international cooperation) requires states to facilitate capacity building, technology transfer, and knowledge sharing to ensure affordable and quality healthcare globally. However, global inequities in access persist, underscoring the need for stronger EU efforts to align its policies with CRPD commitments and address systemic barriers to equitable healthcare access.

This study continues to critically examine two EU initiatives through the above legal lens of the CRPD: the joint procurement of COVID-19 vaccines (internal market example) and the Team Europe Manufacturing and Access to Vaccines, Medicines, and Health Technologies (MAV+) initiative (development cooperation example). The findings reveal gaps in aligning the EU’s policies with its CRPD obligations, particularly in facilitating international cooperation and technology transfer for global medicine access.

Overall, the EU’s approach to vaccine procurement and manufacturing assistance demonstrates potential but falls short in addressing the systemic inequities in global health systems that disproportionately affect people with disabilities. To meet its legal and ethical responsibilities, the EU must strengthen its commitments to intellectual property sharing, capacity-building, and technology transfer, fostering sustainable and equitable access to essential medicines worldwide. By addressing these gaps, the EU can enhance its credibility as a normative power in global health governance while fulfilling its legally binding obligations under international human rights law.

In 2015 the Rockefeller Foundation-Lancet Commission defined the concept of planetary health as built on an ecological model that integrates the material, biological, social, and cultural aspects of public health and accepts the complexity and non-linearity of the dynamics of natural systems. The zoonotic COVID-19 pandemic hastened this awaking to the symbiotic nature of planetary health politics (PHP), with the EU and UNEP formally joining forces to address the triple planetary crisis of climate change, pollution, and biodiversity.

The paper examines the slow realisation of the impact of the planetary organic crisis of PHP within the EU in three steps. First, the paper examines the extent to which EU approaches to PHP are ecocentric in the primacy given to the entirety of the planet rather than an egocentric emphasis on those parts of the environment that provide services for humans. Second, the looks at the way in which the EU’s PHP’s are symbiotic in recognising the mutual co-dependency between different individuals or groups of species or organisms. Third, the paper analyses the holistic aspect of the EU’s PHP’s, meaning the way in which the symbiotic parts of the planet co-constitute each other in terms of the analytical whole.

In January 2025, the European Parliament enacted the European Health Data Space Regulation, so facilitating the conclusion of the legislative process following the Council's anticipated adoption of the legislation this autumn. The development of the European Health Data Space (EHDS) is scheduled to proceed systematically, with numerous critical phases anticipated in the forthcoming years. During the subsequent two years (2025-27), the emphasis will be on formulating the requisite secondary legislation to delineate the technical requirements essential for EHDS operations. Subsequently, member states must plan to fulfil their duties under the EHDS, including the establishment of data hubs and integration with the EU-wide data infrastructure, including the Patient Summary exchange network. It is not anticipated that the regulation will be fully implemented before 2029. It is not anticipated that the regulation will be fully implemented before 2029.

Throughout the implementation phase, the European Commission will work with member states and partners on joint pilot projects and initiatives to create the essential infrastructure and technical details. This is expected to be difficult because the regulation aims to put citizens at the centre of their healthcare by giving them complete control over their data, with the goal of improving healthcare across the EU, while also providing more opportunities for research and innovation. Essentially, the EU has always played a complementary role to the Member States in areas of health policy. According to the Treaties, its functions have largely been designed to coordinate Member State action by encouraging cooperation and formulating recommendations. Nevertheless, the Commission has managed through ”distinctive mechanisms for accountability, monitoring, and compliance enforcement” respond to ever more complex demands in situations in which ”precise policy goals and methods of achieving them cannot be determined ex ante” (Sabel & Zeitlin 2011).

Drawing on an expanding literature on experimentalist governance, this contribution aims to highlight how the position of supranational institutions, particularly the European Commission, will need to adapt in order to address the inherent tensions between the intended goals of guaranteeing data protection and supporting innovation by implementing robust data protection measures and fostering a supportive environment for research and innovation. At the same time, it intends to offer a detailed understanding on the EU aims to create a health data space that benefits both patients and the broader healthcare ecosystem.

Wellness devices are more and more common in our daily lives. Smartwatches can not only check our heartbeat but also react quickly when something is wrong, eventually saving lives. Given their diffusion and their underlying easy connection, the cybersecurity of such devices is crucial to avoid both data breaches and malicious attacks able to manipulate their functioning. Therefore, cybersecurity should approach both ex-ante prevention and ex-post response. It is interesting that in the recent European Cyber Resilience Act (CRA), the importance of identifying risks in terms of vulnerabilities and reacting to them fit into increasingly integrated technical, legal and procedural frameworks is acknowledged.

However, no clear pathway emerges in case a vulnerability in a device is exploited. In this case, the CRA framework should be coordinated with the Updated Product Liability Directive where the chain of liability along the supply chain is regulated. This relationship is only hinted at in the two legislative interventions and requires additional analysis to identify the consequences that may occur in terms of liability from the moment a vulnerability is disclosed to the one that is eventually exploited. A lack of attention towards these issues could affect the effectiveness of any preventive action.