The translational lag narrative in policy discourse in the United States and the European Union: a comparative study

Erik Aarden,Alessandro Blasimme,Luca Marelli

doi:10.1057/s41599-021-00777-y

Erik Aarden, Alessandro Blasimme + Show 1 more

Open Access

https://doi.org/10.1057/s41599-021-00777-y

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Abstract

Whilst basic science rapidly produces new insights into the biological determinants of human health and disease, clinical innovation is often said to lag behind, as it fails to rapidly turn such knowledge into new tools for innovative patient care. This view of biomedical innovation constitutes a ‘translational lag narrative’, which is widely present in current research policy. This paper presents a qualitative content analysis of a corpus of documents (n = 28) issued by key policy actors in the domain of clinical translation between 2000 and 2018 in the United States and the European Union. The aim is to reconstruct how policy discourse articulates the translational lag narrative, and to analyze how the latter relates to specific sociotechnical imaginaries of progress and of the role of policymaking in their realization. The article identifies key impediments to clinical translation and highlights salient differences in the sociotechnical imaginaries of translation in the US and the EU. In the US, policy discourse around translation is mostly driven by the perceived need to re-instate linearity in the transition from knowledge-production to clinical innovation. In the European context, instead, the driving imaginary of the policy discourse around clinical translation has to do with constructing a distinctly European model of economic growth centered around the idea of a knowledge-based economy, thereby connecting policy stimuli for translation with broader political imaginations. This analysis elucidates how publicly staged narratives about science and technology in the biomedical field simultaneously contain state-specific visions of progress and statecraft.

Highlights

In June 2000, the first draft sequence of the human genome was announced
Comparing the framing of the translational discourse in the United States (US) and the European Union (EU), in this paper we show that different constructions of the translational lag cater to distinct ‘sociotechnical imaginaries’ (Jasanoff and Kim, 2015; Pfotenhauer and Jasanoff, 2017)
It reflects a narrow focus on advancing marketable technology development or broader imaginations of how technology contributes to the shaping and consolidation of a political collective through scientific and technological practices and infrastructures (Misa and Schot, 2005), in how the respective political cultures of the United States and the European Union approach science and technology

Summary

Introduction

In June 2000, the first draft sequence of the human genome was announced. In his remarks on this historical accomplishment, President Clinton stated: “we are learning the language in which God created life” (The White House, 2000). A second prominent strand of the European translational discourse revolves around the envisaged need to overcome the major impediment represented by the fragmentation of the EU research and innovation landscape In this respect, the development of appropriate infrastructures and governance models geared to enhance the integration of public and private resources is considered essential. The latter is meant to address “problems which have long existed in medicines regulation but have grown more acute in recent years”, like the so-called “access-versus-evidence conundrum” (EMA, 2016), which relates to the trade-off between gathering robust evidence and ensure a swift commercialization of novel therapies Despite these concerted efforts, there is still a perceived need, from the part of EU regulators, “to further reinforce regulatory and scientific support to foster development of new medicines addressing major public health needs” and “contribut[e] to a vibrant life science sector in Europe.” (EMA, 2015). Initiatives directed at harmonization of standards and infrastructures, and increased coordination of research and innovation policies, are all seen as necessary prerequisites for the economic and political integration of Europe itself (Callon, 2004)

Discussion

Conclusion