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

The paper interrogates how the widely cited translational lag—where clinical innovation is perceived to trail behind rapid advances in basic biomedical research—is constructed and mobilized in policy discourse in the US and the EU. Motivated by post–Human Genome Project expectations and ensuing concerns over bottlenecks from discovery to application, the study asks how policy actors diagnose impediments to translation and what sociotechnical imaginaries of progress and state roles these diagnoses imply. The purpose is to compare US and EU framings to reveal how translation policies are co-produced with broader visions of technological progress, governance, and societal benefit.

The discourse of clinical translation is saturated with metaphors such as bottlenecks, roadblocks, gaps, and the 'valley of death', which cast translation as urgent and linear (bench-to-bedside). Biomedical and social science commentators have critiqued linearity, emphasizing bidirectional, recursive relations between lab and clinic and the need to distinguish multiple phases of translation (e.g., basic research, technology development, clinical application, and population health). Policy discourse around translational deficits echoes longer-standing debates in science and innovation policy challenging the assumption that scientific progress seamlessly yields innovation, while also reproducing the linear model as a simplifying 'thought figure' guiding funding and governance. Expectations of therapeutic promise and broader political-economic restructuring (e.g., knowledge-based economy) underpin these narratives.

The authors conducted a qualitative content analysis of 28 policy documents (2000–2018) from key US and EU actors central to clinical translation. Purposive sampling targeted science policy and funding institutions and translational infrastructures: in the US, NIH and NCATS, FDA, and NAM/IoM; in the EU, the European Commission, European Parliament and Council, EMA, IMI, and EATRIS. Documents were identified via institutional website searches for policies/initiatives to accelerate biomedical innovation. Using an inductive, bottom-up coding approach, the authors analyzed how obstacles ('impediments') and proposed solutions ('cures') to translation were framed, then grouped codes into broader categories (scientific/epistemic, organizational/institutional, regulatory, and systemic). Guided by discourse-analytic perspectives (Hajer) and informed by preliminary observations of 'pipeline' deficit framing, the analysis examined how policy problem definitions relate to underlying sociotechnical imaginaries.

- Across both jurisdictions, policy documents diagnose impediments to translation across four domains: scientific/epistemic, organizational/institutional, regulatory, and systemic. - United States: • Underdeveloped science of translation: Calls for 'regulatory science' and new product development tools to make development more efficient and align regulation with cutting-edge biomedicine (FDA, 2004, 2011). • Organizational deficits: Limited academia–industry collaboration, need for hybrid clinician-scientists, and creation of translational institutions (e.g., NCATS) to develop a distinct science of translation and new collaborative paradigms. • Regulatory deceleration: Regulation viewed as lengthy and burdensome; emphasis on 'smart, science-based regulation' to protect public health while speeding market access and patient availability. • Systemic barriers: Insufficient patient/public engagement, complex and costly healthcare system, and uncertain markets; engagement framed to improve research quality and access to patients while supporting innovation uptake. • Imaginary: A technical innovation imaginary seeking to re-instate linearity from knowledge production to marketable clinical products, privileging commercialization by private actors with the state as enabler. - European Union: • The 'European Paradox': Strong knowledge production but weaker conversion into innovation and growth; policy aims to accelerate movement from discovery to application and close competitiveness gaps with the US/Japan/emerging economies. • Fragmentation of R&I ecosystem: Emphasis on overcoming fragmentation via public–private partnerships (e.g., IMI), pan-European infrastructures (EATRIS), and policy coordination within the European Research Area. • Regulatory impediments: EMA initiatives (accelerated assessment, conditional marketing authorization, Adaptive Pathways) to balance timely access with evidence; major focus on harmonizing fragmented national regulatory regimes (e.g., Regulation 536/2014 for clinical trials). • Systemic barriers: Unsustainable healthcare ecosystem and complex societal challenges requiring multidisciplinary, multi-stakeholder collaboration, including citizen/patient participation; mobilization of European corporate actors and SMEs. • Imaginary: Innovation-as-statecraft—translation embedded within broader EU projects (Lisbon Strategy, Innovation Union) to build a cohesive knowledge-based economy, foster political integration, and legitimize EU-level intervention. - Shared trends: Despite differing imaginaries, both contexts orient translation toward marketable products, reinforcing commercialization, downstreaming of research, and audit cultures, while maintaining simplified (often linear) models of innovation. The study period covered 28 documents collected 2000–2018.

The comparative analysis shows that similar categories of impediments (scientific, organizational, regulatory, systemic) are articulated within distinct sociotechnical imaginaries and roles for the state. In the US, translation is framed as a failure of science–market coupling to yield expected products, prompting state action to streamline regulation and foster public–private collaboration to re-establish a linear pipeline toward commercialization. In the EU, translation is interwoven with a broader innovation agenda; addressing fragmentation and building partnerships and infrastructures are cast as means of economic growth and political integration, legitimizing EU-level governance. These findings illuminate how policy problem definitions and proposed cures are co-produced with political cultures: a US market-making orientation versus a European market-shaping, integration-oriented project. At the same time, both discourses converge on promoting commercialization and product-focused applications, sustaining linear models that obscure richer social contexts of innovation and casting the state as facilitator of market actors, even as it governs society through national and supranational projects and identity formation.

The study demonstrates that the translational lag narrative functions differently across the US and EU, encoding state-specific visions of progress and statecraft. In the US, policy discourse emphasizes re-establishing linear knowledge-to-innovation flows through regulatory streamlining and institutional collaborations geared toward product development. In the EU, translation is subsumed within an innovation-as-statecraft agenda to construct a cohesive knowledge-based economy via harmonization, infrastructures, and coordinated policies. By mapping impediments and cures across scientific, organizational, regulatory, and systemic layers, the analysis shows how narratives about clinical translation are co-produced with distinct sociotechnical imaginaries and governance aims, shaping the trajectory of biomedical research and innovation.

The study analyzes a purposively sampled corpus of 28 policy documents from key institutions in the US and EU between 2000 and 2018, focusing on publicly available texts from major funders, regulators, and translational infrastructures. The analysis centers on policy discourses rather than empirical outcomes, and does not include perspectives from all stakeholder groups or jurisdictions beyond the US and EU. Findings reflect the selected timeframe and institutional sources.