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Accelerating Clinical Translation. Charting the Politics of Translation in the European Union

Periodic Reporting for period 1 - ACTrans (Accelerating Clinical Translation. Charting the Politics of Translation in the European Union)

Reporting period: 2018-02-12 to 2020-02-11

The project has focused on studying the social and political implications of the regulatory and policy initiatives put in place by the European Union (EU) to remove the barriers hindering the translation of scientific findings into tangible innovation outcomes within the continent. The acceleration of biomedical innovation – which is increasingly based on data-intensive digital practices and technologies – has emerged as a foremost policy objective of the Union in recent years. Yet, whilst their beneficial consequences are mostly taken to be self-evident, a number of challenges characterize the pursuit of innovation-driven research practices in the biomedical domain.
This project set out to investigate, scrutinize and critically discuss such challenges. Notably, the project has pursued three parallel objectives. First, to chart how ‘translation’ is framed and articulated in EU regulatory and science policy. Secondly, to empirically investigate and tease out the sociotechnical dynamics underpinning regulatory and policy initiatives geared to accelerate biomedical innovation. Thirdly, to critically assess the socio–political import of translational initiatives in the political macro–area of the EU.
Given the increased emphasis placed by policymakers upon biomedical innovation policies as one of the privileged means to advance a European knowledge-intensive society and economy, this project has covered a theme of significant social and political relevance, and could bring its findings to bear on major policy discussions and initiatives at the national and European level.
"The work conducted within the project has moved along three main axes geared to address the project’s threefold objective, namely (i) the charting of European framings and imaginaries of translation, (ii) the analysis of the sociotechnical dynamics underpinning regulatory and policy initiatives geared to accelerate biomedical innovation, and (iii) the assessment of the socio–political import of translational initiatives in the political macro–area of the EU.

First, drawing from the tools of discursive and argumentative policy analysis, I conducted a thorough charting of EU policy and regulatory documents to identify distinct framings of translation, and how they relate to those advanced by specific actor groups and domestic governmental agencies. This work has resulted in a co-authored and forthcoming article comparing framings and imaginaries of translation in the EU and the US (Aarden, Marelli and Blasimme, in review for Science, Technology & Human Values).

Second, I focused at length on scrutinizing regulatory (e.g. Regulation (EU) 2016/679 on data protection, Regulation (EU) 536/2014 on clinical trials) and policy initiatives geared to accelerate biomedical innovation in the continent, with the aim to identify and critically assess the governance challenges and the social, political, and ethical implications of such undertakings. This work – conducted through an interdisciplinary perspective rooted in STS and cognate disciplines – has resulted in a number of published and forthcoming studies, which identified and aimed to shed light on the challenges faced by current governance and regulatory approaches and their relevant implications in the following domains:
(i) digital health (Marelli et al. 2020; Sanchini and Marelli 2019);
(ii) genomics (Shabani and Marelli 2019; Shabani, Dyke, Marelli and Borry 2018);
(iii) translational research (De Miguel, Marelli et al. 2020; Marelli, Testa and Van Hoyweghen in submission);
(iv) biobanking (Shabani, Chassang and Marelli 2021);

In addition, I analyzed the broader political import of the efforts to advance data-intensive (biomedical) innovation for the European Union within an edited volume with contribution from world-leading STS, science policy, data governance and legal scholars (Marelli, Dratwa, Verschraegen, Van Hoyweghen, in preparation).

Finally, I was able to bring the insights gathered during the course of the project to bear on a number of high-level policy initiatives:

(i) In August 2018 I was appointed as Scientific Secretary of the ACC-GDPR Committee (comprising 25 leading experts from multidisciplinary backgrounds) set up under the aegis of the Italian Ministry of Health and the Executive Committee of Alliance Against Cancer (the leading oncologic research network in Italy) to devise ministerial guidelines for the implementation of national and EU legislation of data protection for the health research activities of the 51 leading Italian research hospitals.

(ii) In July 2019, I was appointed as Member of the Scientific Committee within the Research Ethics and Bioethics Committee, Italian National Research Council (CNR).

(iii) In April 2020, I took part as country expert for Italy in an initiative put in place by the EU Commission (DG SANTE and CHAFEA) to comprehensively chart the legal and governance landscape around health data processing across EU Member States, so as to identify challenges and affordances for the development of a European Health Data Space.

All these initiatives represented a prominent way to disseminate and ""translate"" the scholarly findings of the project into tangible policy outcomes."
From a scholarly perspective, the Action led to a threefold progress beyond the state of the art.

The targeted document analysis of EU policy documents mandating for the acceleration of translation was guided by the aim to identify distinctive European framings underpin the translational discourse. This work has resulted in one co-authored comparative piece in which, it is argued, translation is typically framed in terms of ‘translation deficits’, which are constructed through particular ‘sociotechnical imaginaries’ (Jasanoff and Kim 2009, 2015) in the US and the EU respectively. Through an analysis of key policy documents, the paper intends to carve out two different framings of translation deficits in the two different socio-political environments under scrutiny: a market failure narrative in the US, and a statecraft problem in the EU. The paper has been submitted in Spring 2019, and is currently under first review with Science, Technology, & Human Values (Aarden, Marelli, Blasimme, in review with Science, Technology, & Human Values).

Secondly, the analysis of regulatory and policy initiatives geared to accelerate biomedical innovation was conducive to identifying and describing a number of challenges and shortcomings, such as fragmentation in ethical oversight mechanisms across Member States, and misalignments between established data governance models and emerging technologies and R&I practices.

Finally, from a broader conceptual perspective, the Action resulted in a co-edited volume (forthcoming), which, through a comprehensive mix of substantive theoretical reflection and empirical case-studies, tackles head on the issue of how novel digital orders ushered in by R&I efforts are co-produced along with distinctively European social, political and economic identities, institutions and practices.