Summary: EU Pharmaceutical Activity Webinar January 2023

EUhealthgov |

EUHealthGov started 2023 with its seventh quarterly seminar on 25th January – a roundtable on EU pharmaceutical activity which encompassed challenges from the much-awaited revisions to the EU pharmaceutical strategy and beyond. We were delighted to be joined by a range of experts to consider different aspects, notably solidarity and vulnerability in access to pharmaceuticals; how the EU regards pharmaceuticals through the lens of competition policy; and global access to medicines through EU action. 

Dr Mary Guy (LJMU) introduced the discussions with an overview of the development of EU activity regarding the pharmaceutical sector – from responding to the Thalidomide crisis in the mid-1960s to the revision of the EU pharmaceutical strategy in response to the COVID-19 pandemic. In contrast to health and healthcare more generally, the pharmaceutical sector has highlighted specific tensions, being located between public health and the internal market.  

Dr Éloïse Gennet (Aix-Marseille) and Dr Aurélie Mahalatchimy (Aix-Marseille) discussed their experience of working with the European Association for Health Law and the European Health Policy Platform (DGSANTE) to establish a 2021 Thematic Network (now permanent) on an inclusive and equitable pharmaceutical strategy. This network produced webinars and a Joint Statement against the backdrop of pre-existing health inequalities highlighted since COVID-19, and unprecedented EU solidarity and renewed efforts to promote equitable access to medical supplies and vaccines. The main recommendations of the Joint Statement include targeting unmet medical needs by identifying vulnerability situations, increasing institutional dialogue and cooperation beyond emergency situations, and promoting affordability throughout the pharmaceutical lifecycle. 

Professor Wolf Sauter (VU Amsterdam) outlined how competition works in the pharmaceutical sector across four stages: monopoly, oligopoly, generic/biosimilar competition and multi-source competition. This set the scene for a review of EU competition policy in pharma, from DGCOMP’s 2008/9 sector inquiry and the 2012 AstraZeneca case, via pay-for-delay cases at EU level, to more recent interactions between the Commission and national competition authorities. What emerges is a particular focus on excessive pricing, which has seen an evolving approach in cases from United Brands to AKKA/LAA, with cases at both EU and national levels, leading to the identification of trends of price hikes, consumer lock-ins and an emphasis on niche generics (and one orphan drug). Overall there is scope for both competition and non-competition remedies which may be explored beyond wider considerations of EU competition law and pharmaceuticals. 

Dr Katrina Perehudoff (University of Amsterdam) focused on the EU Pharmaceutical Strategy to draw attention to challenges ahead for the EU’s role in global health. These challenges fall into three categories. Firstly, the conceptual challenge of why the EU should have a strong voice globally, which can relate, inter alia, to investment (in the EU), as well as health security and social justice (for EU citizens). The second challenge is theoretical, framed around the question of how the EU will achieve its aims globally. This sees the identification of three pathways of EU influence: unilateral EU action influencing third countries; bilateral trade, accession and aid agendas, and multilateral influence. A final challenge is empirical: what will the EU do? Here considerations encompass regulatory standard-setting and technology transfer.  

We look forward to developing this discussion in the future! 

A recording of the event is available here.