This panel offers a timely examination of EU activity in pharmaceuticals with particular focus on the revised EU pharmaceutical legislation, the European Medicines Agency, and the EU’s influence on medicines in the developing world.

Proposals to revise the EU pharmaceutical legislation gained momentum in connection with responses to the COVID-19 pandemic, particularly regarding the diverse aspects of the European Health Union. The proposed Regulation for EU procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency (COM (2023) 193 final) was adopted on 26 April 2023, and represents the most substantial changes in over two decades. However, at the heart of existing (and likely also) future legislation is a fundamental tension between the internal market rules and public health consideration. Further essential dimensions to EU pharmaceutical activity include (perceptions of) the EU’s dedicated body, the European Medicines Agency, and the nature and scope of EU influence on medicines beyond the EU, notably in the developing world. This exciting panel tackles all of these.

Danieli and Hosseini address the revised EU pharmaceutical legislation from distinct approaches. Danieli’s focus is on asking whether the revised framework is able to create a future-proof body of pharma legislation within the context of the EU’s long-standing goal of creating a ‘Single Market for Pharmaceuticals’. In contrast, Hosseini starts from COVID-19 lessons, situating the revised EU pharma regulation alongside pandemic response instruments such as the Single Market Emergency Instrument and HERA, and examining whether the right regulatory balance has been struck with regard to health crises.

Parwani examines the WHO’s promotion of regulatory reliance among national regulatory authorities via the lens of international trust placed in the EMA. Parwani uses the notion of “technocratic trust” to identify implications, opportunities, and challenges in the context of trust placed by Least Developed Countries (LDCs) in the EMA within its role in ensuring timely and equitable access to safe and affordable medicines.

Perehudoff addresses the widespread focus on international trade law (notably TRIPS) in influencing access to pharmaceuticals in developing countries, by examining how regional integration, thus the EU level, action impacts on medicines in developing countries. This examination involves interventions developed within the internal market context which have been transferred extraterritorially: EU market authorization decisions for new medicines, and EU data exclusivity provisions applied to clinical trials data.

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’.

The COVID-19 pandemic lessons presented unique opportunities for enhancing the EU's policies and balancing pharmaceutical innovation, market competition, and patient access. The pandemic’s challenges caused many changes in the law and policy in the pharmaceutical sector. Besides initiatives such as the Pharmaceutical Strategy For Europe, the Single Market Emergency Instrument (SMEI) and the establishment of Health Emergency Preparedness and Response (HERA), a significant change in the EU pharmaceutical regulation is expected, including a proposal for a regulation on compulsory licensing for crisis management. This paper aims to assess critical elements of EU pharma law and policy’s proposed reform in light of lessons learned from the pandemic’s responses. Through analysing these proposed changes, the paper evaluates how prepared the EU system is to balance innovation incentives, market competition (such as enhancing generic and biosimilar competition), and equitable access during future health emergencies while considering solidarity objectives in a broader global health context. The analysis aims to determine whether the EU's pharma policies struck the right regulatory balance in a pandemic and whether current reform proposals adequately incorporate some tools and mechanisms for coordinating these inherently different goals, especially during a health crisis.

The World Health Organization has been strongly promoting regulatory reliance amongst national regulatory authorities (NRAs) as a means to promote timely access to safe and effective medicines. As a recognized Stringent Regulatory Authority (SRA), the European Medicines Agency has a massive impact externally. Recent studies shows uni-directional regulatory reliance by low-and-middle-income countries on EMA evaluations and decisions. I examine this regulatory reliance in the context of international trust in the EMA – specifically, trust placed by least-developed-countries (LDC) NRAs in the EMA. The WHO has recognized trust as a critical factor enabling regulatory reliance. I examine the notion of ‘technocratic trust’ which refers to “trust that individuals within systems (here LDC NRAs) place in the technical output of other systems (here the EMA).” I argue that this trust is developed and sustained due to different avenues of external regulatory influence which reinforce each other. I then examine these various pathways through which the EMA extends its influence, including the EU-Medicines4all programme, its participation in transnational regulatory networks such as the ICH etc. Finally, I examine the potential implications of this trust placed by third country NRAs in the EMA, and the consequent external regulatory influence exerted by the EMA, on access to medicines in LDCs. I point out some opportunities and challenges arising out of this trust and highlight the need for the EMA to be more cognizant of its (intended and unintended) role in ensuring timely and equitable access to safe and affordable medicines for all.

Until now, most literature has focused on international trade law as a primary ‘culprit’ capable of influencing access to pharmaceuticals in developing countries (specifically, the TRIPS Agreement⁠). These fields have received a disproportionate amount of attention from scholars, leaving the potential external impacts of regional integration organisations such as the EU relatively unexplored. This paper asks: How is EU action impacting on access to medicines in developing countries? There is extremely limited direct evidence of the EU’s global influence on pharmaceuticals, and most of this evidence reveals little about the actors and sequences of events leading to impact.⁠ Through a legal epidemiological approach, this paper poses new hypotheses and evidence about how EU action towards pharmaceuticals is translated through institutions and actors into access to medicines outcomes in developing countries. This paper explores two EU legal interventions that originated on its internal market and have been transferred extraterritorially: EU market authorization decisions for new medicines and EU data exclusivity provisions applied to clinical trials data. This paper will critically evaluate the motivations of the EU law-makers and explain the pathways/sequence of events, modulators, and potential impacts of these internal EU measures towards access to medicines in developing countries. The central conclusion of this paper is that the EU’s legal interventions (particularly on its internal market) have important global ‘side effects’ on domestic pharmaceutical law, markets, and access to medicines in developing countries.