Rationale. Health technology assessment (HTA) is the principal instrument wealthy health systems use to decide what to fund, and it measures the health a technology adds for treated patients rigorously. Yet population-health considerations—disease burden, prevention, externalities such as herd protection, fairness between groups, and democratically chosen priorities—are weakly built into how HTA judges value. Aims and objectives. To specify the nature of this gap and to offer a conceptual framework that clarifies it: to distinguish three paradigms of value assessment (clinical, cost-effectiveness and public-health HTA), and to separate two frequently conflated ideas—respecting public-health priorities versus yielding to political pressure. Method. A conceptual analysis informed by a narrative reading of HTA methodological guidance and the health-economics, public-health and priority-setting literatures. Results. First, contemporary HTA clusters around two paradigms—clinical assessment and cost-effectiveness assessment—while a population-health paradigm is named but instantiated in no major agency’s reference case. Second, public-health objectives (burden, prevention, transmission externalities, distribution, priorities) are only partially operationalised—acknowledged but rarely weighed in the formal value calculation. Third, the three-paradigm model shows the gap is systematic, not incidental: today’s methods ask “does it help the patient?” and “how much health per euro?”, seldom “how do we improve population health, fairly?”. Fourth, the gap is tractable—the necessary instruments exist and are compatible with opportunity cost, and two common objections (that QALYs already capture population value, and that priorities equal interference) do not withstand scrutiny. Conclusion. A public-health-informed HTA—explicit disease-burden assessment, transmission modelling, transparent treatment of priorities and formal equity analysis—could better align appraisal with population health, fairly distributed. We call on EUPHA and HTAi to convene a joint working group.

The EU Health Technology Assessment Regulation makes the joint clinical assessment dossier the foundation of a single European appraisal of the relative effectiveness and safety of new medicines, and Article 9 conditions that foundation on the completeness of the evidence a developer submits. Drawing only on the first publicly observable outputs of the new system — two completeness reviews and one completed assessment — this article asks how the European Commission and the HTA Coordination Group are giving operational meaning to “completeness”. It argues that an exacting interpretation is emerging, closer to the logic of systematic review than of regulatory submission, but that the evidentiary base remains too thin to call it a settled doctrine. Two structural tensions follow: a certainty paradox, in which uncertainty is catalogued exhaustively yet never converted into a graded judgment of certainty; and an evidence-generation paradox, in which developers of orphan and highly innovative therapies may face analytical demands whose outcome is largely foreseeable. The article situates these tensions within the principle of proportionality, the duty to give reasons and the limits of judicial review, and sets out a research agenda for the Regulation’s scheduled 2028 evaluation.

Four years after the European Regulation on Health Technology Assessment (EU HTAR) came into force and a little over a year after the implementation phase of the Regulation started, with the publication of the first Joint Clinical Assessment (JCA) report imminent, it is good timing to take a step back and revisit what has been achieved and look at what the main challenges on the way forward are

Rationale. Evidence-based medicine (EBM) and health technology assessment (HTA) rest on a positivist epistemology in which value is treated as objective, measurable and generalisable across populations. This framing struggles to represent how individual patients construct the meaning and value of health states. Aims and Objectives. To analyse the epistemological tension between positivist and constructivist approaches to evidence, value and decision-making in EBM and HTA, and to examine its consequences for clinical practice and reimbursement. Method. Conceptual analysis. A philosophical account of positivism and constructivism was combined with six illustrative clinical vignettes drawn from clinical practice and selected to make the tension visible, and each vignette was mapped onto the methodological rules that govern HTA. Results. Across the vignettes, valid positivist endpoints (survival, relapse rates, quality-adjusted life years) systematically diverged from what individual patients valued (dignity, identity, meaning, cultural belonging). Utility weights, surrogate endpoints and cost-effectiveness rules could not represent this constructed value; and HTA, in turn, shapes clinical practice through reimbursement, service availability and opposable guidance. Modern HTA increasingly incorporates patient involvement, patient-reported outcomes, discrete choice experiments, deliberative processes and multi-criteria decision analysis, but these remain structurally secondary to population-level quantitative evidence. Conclusion. Positivism and constructivism are complementary rather than opposed. A more pluralist HTA — one that makes preference heterogeneity, experienced utility and the underlying facts, norms and values explicit — would be more, not less, evidence-based, and would widen the room clinicians have to practise person-centred care. The vignettes are pedagogical illustrations, not empirical evidence.

The Health Technology Assessment Regulation makes the assessment dossier the foundation of a single European appraisal of new medicines, and Article 9 conditions that foundation on the completeness of the evidence submitted. This commentary examines how the European Commission and the HTA Coordination Group are giving operational meaning to that condition. Drawing on the first two completeness reviews, it argues that an exacting interpretation is emerging – one that treats the dossier as an auditable evidence-synthesis document and makes the handling of evidence a condition of admissibility. Under Article 10, a dossier that fails this test after a second request leads to discontinuation of the assessment, a consequence whose reviewability is uncertain. The commentary considers the legal character of this incipient doctrine – its dependence on soft guidance, its enforcement through discontinuation, and the due-process questions it raises – and cautions that the argument is hypothesis-generating, not doctrinally conclusive.