Time: Thursday, 22/May/2025: 11:00am - 12:30pm Session Chair: Philippe Mongrain Discussant: Philippe Mongrain |
Location: Room A.0.05, Building A |
EU Pharmaceutical Regulation goes global: Pathways of influence, role of EU agencies, and non-European perspectives
This panel explores the external dimension of European Union (EU) pharmaceutical regulation in a world facing growing geopolitical tensions. Through several pathways, this panel will examine the mechanism of Europeanisation beyond Union borders, and the external engagement tools the EU employs in pharmaceutical regulation to extend its influence globally. This panel will also consider how foreign (i.e., non-European actors), especially from low- and middle-income countries (LMICs), respond to, engage with, and are influenced by EU regulatory norms. These influences are palpable both in the legal and policy responses in foreign jurisdictions, as well as in foreign actors’ engagement in EU authorities, such as the European Medicines Agency.
Together, the papers on this panel address the themes:
- The international dimension of EU policy making focusing on how the EU’s rules, norms, and regulatory approaches to pharmaceuticals travel worldwide.
- The formal and informal tools of European foreign engagement, and how they extend the EU’s global influence.
- The perspectives and actions of non-EU authorities, such as those in Brazil and Argentina, regarding how they engage with EU regulatory frameworks and borrow capacity from Union agencies.
This panel explores the process of “regulatory reliance” – that is, when a less developed regulatory authority uses assessments and decisions of a trusted external authority (e.g. EU) to expedite time and resources while ensuring that products are safe - as a crucial method of collaboration. The panel also engages with the emerging concept of “regulatory diplomacy”, which involves sharing standards and ensuring that they are not undermined by other geopolitical entities. In these ways, this panel offers a timely and essential conversation on the EU’s role in shaping global product regulation, which is highly interdependent across different fora yet still fragmented in LMICs.
Presentations of the Symposium
From Brussels to the World: The Diffusion of EU Pharmaceutical Legislation towards Developing Economies
Regulatory norms and rules enshrined in and established by EU pharmaceutical law travel internationally and influence foreign legal systems, regulatory practices, pharmaceutical company conduct, health systems’ functioning, and ultimately patient access to medicines and human health worldwide. This paper applies the four mechanisms of Europeanisation to explain how these EU norms and rules are diffused to developing economies. Conditionality (mechanism 1) involves offering third countries certain rewards or incentives that are contingent upon those countries’ compliance with EU requirements. Socialisation (mechanism 2) is a form of co-option in which EU regulatory norms or rules are actively promoted abroad and assimilated by foreign actors. The externalisation of EU norms or rules (mechanism 3) occurs when they are copied by foreign actors (e.g. foreign pharmaceutical companies or regulators) who seek certain rewards or efficiencies that can result. Foreign actors make the unilateral decision to emulate or mimic EU norms or rules (mechanism 4) because they offer a template to address local problems. Then, using the ongoing revision of the EU’s pharmaceutical legislation as a case study, this paper selects three innovative legislative proposals therein (i.e. environmental risk assessments for antimicrobials; reporting of public funding for medicines R&D; revised clinical test data and market protection, including a transferrable exclusivity voucher). Through the lens of Europeanisation, this paper postulates how these three legislative proposals, if adopted, would travel globally to developing economies, under which conditions, and with which likely impacts. This paper addresses several gaps in the literature, namely by introducing a global lens to the existing analyses of the EU’s revision of pharmaceutical law, by revealing the theory behind the emerging evidence of the EU’s influence over global pharmaceutical markets, and by positioning the case of pharmaceutical regulation among the scholarship on the global regulatory influence of EU internal market law.
Borrowing Regulatory Capacity in Middle-Income Countries during Public Health Crises: Brazil, Regulatory Reliance, and the Politics of COVD-19 Vaccine Regulation
This paper explores how LMICs, which often face capacity constraints in their regulatory systems, manage to adopt and implement advanced pharmaceutical standards. Drawing on the case of Brazil during the COVID-19 pandemic, the paper will assess the concept of “regulatory reliance,” where LMICs borrow regulatory capacity from more developed regulatory agencies, such as the European Medicines Agency, to accelerate drug and vaccine approvals during health crises. This presentation illustrates how engagement through regulatory reliance helps LMICs overcome internal regulatory weaknesses and resist domestic political pressures. From a developing country perspective, regulatory reliance on EU agencies can be an important mechanism of global cooperation in the absence of full regulatory convergence.
The Making of Pharmaceutical Business Power in Crisis: State-Led Selection and Vaccine Politics in Argentina
The COVID-19 pandemic has exposed vulnerabilities in global health systems and underscored the complexities of pharmaceutical regulation amid increasing interdependence and geopolitical tensions. Argentina serves as a unique case study among low- and middle-income countries (LMICs), where a significant portion of the pharmaceutical market is supplied by national companies. I argue that the strong presence of domestic corporations plays a crucial role in shaping vaccine approval mechanisms during health crises, raising important questions about how national regulatory practices interact with and are influenced by international standards in LMICs.
This paper explores how the influence and resources of national pharmaceutical corporations shape vaccine approval processes in Argentina, particularly in comparison to international agencies like the European Medicines Agency (EMA). The central research question is: How do the preferences of national pharmaceutical companies influence Argentina's reliance on international regulatory frameworks during crises, and what implications does this have for adopting global pharmaceutical standards in low- and middle-income countries (LMICs)?
This study hypothesizes that mechanisms of regulatory reliance—where Argentina adopts standards from external authorities—are significantly shaped by local market dynamics and the strategic preferences of domestic pharmaceutical corporations. It posits that when national laboratories prioritize specific vaccines that align with their corporate interests, the reliance on the European Medicines Agency (EMA) and its global regulatory practices diminishes. Conversely, in contexts where domestic capacities are constrained or specific technologies are inaccessible, the EMA's frameworks provide essential guidance and support. This analysis aims to elucidate how local corporate interests can shape vaccine approval mechanisms in Argentina while also restricting the global influence of international regulatory standards.
Contested unilateralism: The Brazilian normative reception of the European Union Deforestation Regulation
Brasilia University, Brazil
With the goal of instituting mandatory compliance for forest-risk commodities, the European Union Deforestation Regulation (EUDR) has been created as a response to the shortcomings of voluntary initiatives in curbing global deforestation. The EUDR has nonetheless faced strong contestation from many developing countries supplying European markets. This study examines the case of Brazil to assess producer countries’ response to European attempts to institutionalize mandatory zero deforestation as a norm within global supply chains. Through interviews with stakeholders from Brazilian civil society, agribusiness and public officials conducted from April 2023 to March 2024, we explore the basis for contestation of the regulation in recent years. The norm literature within international relations provides a conceptual point of departure for exploring how the regulation’s procedural, validity, and effectiveness-related aspects shape reactions and modes of contestation in a Brazilian context. We find that the main point of contention relates to the procedural domain, rather than the validity of the zero-deforestation norm per se. This trend appears to have been evident across all stakeholder groups interviewed, albeit some moderate degree of validity contestation could be detected amongst public officials and private entities. Hence, Brazilian actors are not necessarily opposed to combatting deforestation, but rather to the specific conceptualization and operationalization of this goal through the EUDR. Our results therefore raise doubts about the expediency of the unilateralism embodied within the EUDR in advancing environmental compliance. More broadly, in a global context of a weakened Liberal International Order, the study highlights the need for a reinvigorated multilateralism to ensure inclusive deliberations about how to confront planetary crises.