This issue of Health Economics, Policy and Law arrives at a moment when health systems across Europe are being asked to reconcile competing imperatives that resist easy resolution: making better decisions about what to fund, how to regulate innovation, and whom to prioritise, while doing so under conditions of institutional flux. Across pharmaceuticals, medical devices, digital services, and broader public health obligations, the papers published in this issue show that the central question is no longer whether health systems should be evidence-based, but rather what kinds of evidence, values, institutions, and legal frameworks are needed to govern fairly under conditions of uncertainty, scarcity, and technological change. They map an emerging policy landscape in which effectiveness, price, evidence generation, procedural authority, and equity are increasingly intertwined and in which the governance of health technology is becoming a European question as much as a national one.

Health system design and rationing now extend beyond the traditional moment of market entry. This is true across domains. In pharmaceuticals, decisions about coverage and reimbursement are not just isolated technical exercises, but instead, they are iterative and normatively loaded. In medical devices, initial approval generates only limited and often short-term evidence, leaving the risks and benefits of sustained real-world use inadequately determined. In digital health, implementation depends on institutional, professional, and patient alignment that no regulatory decision can easily mandate. What unites these domains is the shared inadequacy that governance architectures designed around market entry are being asked to manage the full lifecycle of technologies that evolve in use, generate new evidence over time, and produce outcomes (i.e., clinical, organisational, and distributional) that only become visible later. The old model of one-off assessment is giving way to continuous governance, but the institutional infrastructure to support that shift remains incomplete.

The legal analysis by Domenici et al. (Reference Domenici, Günther and Becker2026) is especially important in this regard. Their comparative study of France, Germany, and England argues that effectiveness should be understood as a general legal principle of public healthcare systems, with both substantive and formal dimensions. Substantively, effectiveness concerns the capacity of an intervention to generate clinical benefit while accounting for risk; formally, it depends on the delegated authority of Health Technology Assessment (HTA) bodies and related agencies to specify evidentiary standards and issue binding guidance. The paper is important because it reframes effectiveness as a foundational principle of public reimbursement law. In doing so, it also reminds us that effectiveness is distinct from cost-effectiveness, even when the two are often entangled in policy debate.

That distinction matters because contemporary health policy tends to collapse different evaluative languages into one. Effectiveness, value, innovation, affordability, and fairness are often treated as though they were interchangeable. This issue shows they are not. Gandjour’s (Reference Gandjour2025) analysis of reimbursement prices for innovative medicines in Germany makes precisely this point from a different angle. Comparing negotiated prices under the Arzneimittelmarktneuordnungsgesetz (only the German language can come up with such a word!) with prices implied by the efficiency frontier and cost-utility analysis, the paper shows that methodological decisions can have direct distributive consequences. Negotiation appears to generate prices above those implied by the efficiency frontier, while cost-utility analysis based on opportunity-cost thresholds could generate even higher prices still. The paper’s contribution is the demonstration that there is no neutral pricing rule. Bargaining power, algorithmic consistency, and welfare-based thresholds produce different answers because they rest on different conceptions of legitimate authority.

The Kleinhout-Vliek et al. (Reference Kleinhout-Vliek, Geiger, Hagendijk, Hilberg, Martin, Perehudoff, Wadmann and Wested2025) perspective piece widens this lens from Germany to the European Union (EU). Their argument is timely and provocative: the EU’s pharmaceutical reforms seek to create a single market for medicines while largely avoiding the question of price. Access is tied to exclusivities; competition is modulated through regulatory incentives; yet pricing remains opaque and primarily national. The result, as the authors suggest, is a single market that does not operate through transparent price formation. This is a crucial insight. European pharmaceutical policy increasingly aspires to solidarity, resilience, and equitable access, although without confronting how opaque prices and fragmented purchasing arrangements undermine these goals. The paper pushes the debate beyond the familiar opposition of innovation versus access and towards a more institutionally serious question: what would it mean to construct a governable pharmaceutical market?

If the pharmaceutical contributions in this issue expose the political economy of value, the papers on medical technology show why governance cannot end at approval or initial coverage. Manetti et al.’s. (Reference Manetti, Guidotti, Vola and Vainieri2025) systematic review of real-world evidence on post-market assessment of medical devices reveals a mismatch between the complexity of devices in practice and the evidence systems used to evaluate them. Across 145 studies, administrative datasets dominate, short- and medium-term clinical and economic outcomes are most reported, organisational impacts are underexamined, and patient perspectives remain marginal. The review identifies an important pattern, namely that we continue to evaluate dynamic technologies with evidence architectures better suited to more stable interventions. The paper argues, implicitly, for a lifecycle model of assessment in which adoption, monitoring, and possible withdrawal are all evidence-generating moments rather than afterthoughts.

Michels et al. (Reference Michels, Delnoij, Bramer and Graaff2025) complement that empirical diagnosis with a conceptual one. Their discourse analysis of the role of European HTA agencies in MedTech governance identifies five discourses, ranging from the HTA agency as independent evaluator to promoter of evidence generation, to convenor of stakeholders, and finally to more critical accounts concerned with normative reflection and clinical nuance. This finding shows that disputes over Medtech policy are are disagreements about institutional identity rather than methods. Is the HTA body an arbiter standing apart from innovation, a partner shaping evidence development, or a forum for negotiation among affected parties? The paper is especially valuable considering the EU Health Technology Assessment Regulation, under which joint clinical assessment is now mandated but the question of what role, building on the EUnetHTA legacy, is expected of national bodies remains open. As MedTech governance becomes more visible and more Europeanised, the credibility of HTA agencies will depend on technical competence and an honest account of the functions they are being asked to perform.

The telemedicine paper by Schmitt et al. (Reference Schmitt, Habimana, Gottlob, Habl, Plomariti, Farmaki, Bogiatzidis, Leclercq, Delnord and Van den Bulcke2026) brings these institutional questions into the fast-moving world of digital cancer care. Drawing on surveys from 14 Member States, eight cancer patient associations, and a workshop, the study provides a comparative map of how implementation conditions vary across legal frameworks, reimbursement arrangements, infrastructure quality, and patient expectations. Its findings reveal that support for telemedicine as a complement to in-person care is widespread but that the conditions enabling safe and equitable implementation are far from uniform. Its recommendations suggest clearer legal frameworks, more transparent reimbursement, stronger digital literacy, and greater patient involvement in design.

The paper by Germain and Newdick (Reference Germain and Newdick2025) then brings the issue’s governing normative concern into direct focus. Their argument is that recent legal duties in England require National Health Service bodies to do more than behave procedurally fairly (Friebel and Wallenburg, Reference Friebel and Wallenburg2025; Voorhoeve et al., Reference Voorhoeve, Dale and Gopinathan2025); they require substantive engagement with inequalities in access and outcomes. Existing ethical frameworks for treatment allocation are therefore insufficient. The authors’ turn to intersectionality and to a pragmatic, Marmot-informed, ‘non-ideal’ framework which connects the institutional concerns running through this issue to the population-level consequences they ultimately produce. Priority setting is shaped by legal principle, institutional design, evidentiary standards, and pricing rules, and its outcomes are experienced as differential access, unequal treatment, and preventable harm. Equity, this paper insists, is not external to health system governance; it is one of its defining tests and one that cannot be discharged through procedural compliance alone.

Three propositions follow from what these papers collectively show.

First, value is lifecycle-based, but institutions and their governance routines are not. Initial authorisation or reimbursement decisions are made under uncertainty that post-market evidence is intended to resolve, yet the systems for generating, governing, and acting on that evidence remain fragmented and underpowered. Devices require continuous monitoring; digital services need phased evaluation; pharmaceuticals raise ongoing questions of price legitimacy. Legal principles like effectiveness are no different. All of these are lifecycle problems.

Second, evidence is inseparable from institutional design, and that design is now contested at European level. HTA agencies, ministries, payers, courts, and local commissioners do not simply receive evidence. Instead, they define what counts as evidence, how much uncertainty is tolerable, and which trade-offs are politically acceptable. (Friebel and Wallenburg, Reference Friebel and Wallenburg2024) The EU Health Technology Assessment Regulation has formalised a European role in joint clinical assessment, but the papers in this issue suggest that the more difficult questions about institutional role and evidentiary standards have not yet been answered. The problem is not an absence of evidence per se, but the absence of settled institutions for using evidence with democratic authority.

Third, equity must be treated as a structural feature of health system governance, not an ethical supplement to it. Whether the topic is access to innovative medicines across Europe, telemedicine uptake in cancer care, or statutory duties to reduce health inequalities in England, the question of who benefits and who is left behind runs through every instrument discussed in this issue – pricing rules, post-market surveillance systems, implementation frameworks, and legal principles. Building institutions capable of being at once evidence-informed, innovation-sensitive, and explicitly equity-oriented is the actual task that health systems are being asked to perform.

Contemporary health systems are governed through overlapping regimes of law, economics, evidence, and ethics, and those regimes are increasingly organised at European as well as national level. The task ahead is not to choose one language over the others, but to make them answer to one another and to accept that this will produce conflict as well as clarity.