Health literacy, shared decision-making, and digital access — the EU’s evolving framework for patient-centred care has produced significant policy architecture. Whether it translates into genuine empowerment for the 47 percent of Europeans with limited health literacy is a more complicated question.
Patient empowerment has become one of the more prominent organising concepts in EU health policy over the past decade. It appears in Commission communications, in the preamble to the European Health Union, in pharmaceutical strategy documents, and in the political framing of the European Health Data Space. The concept itself is not new — it draws on decades of clinical research into shared decision-making, health literacy, and the relationship between informed patients and better outcomes. What has shifted is its elevation to a structural policy priority at the EU level, where it now functions as both a public health objective and a legitimising frame for data governance reforms that carry significant political weight.
The shift reflects a genuine body of evidence. Patients who are actively involved in decisions about their treatment adhere more consistently to treatment plans, report higher satisfaction, and — in multiple clinical settings — achieve better outcomes than those who receive information passively. But converting that clinical insight into workable EU-wide policy requires navigating a health system landscape that remains deeply heterogeneous: 27 member states, multiple languages, radically different levels of health expenditure, and persistent gaps in the foundational condition that empowerment requires — namely, that people can read, understand, and act on health information in the first place.
The Health Literacy Deficit
The European Health Literacy Population Survey 2019–2021 (HLS19), coordinated through the WHO Action Network on Measuring Population and Organisational Health Literacy (M-POHL), produced the most comprehensive recent dataset on the subject. Conducted across 17 European countries with over 42,000 interviews, it confirmed findings that earlier surveys had signalled: limited health literacy is not a marginal problem. In the earlier HLS-EU survey — which covers a partially overlapping set of countries — 47.6 percent of respondents were found to have limited or inadequate health literacy. The HLS19 data, using a refined instrument, showed comparable and in some countries higher rates of limitation in the population’s ability to find, understand, appraise, and apply health information.
Health literacy is not simply a matter of reading ability. It encompasses the capacity to navigate health systems, to evaluate the reliability of information — including online information — and to engage meaningfully with clinical professionals. Its determinants are social as much as educational: income, occupation, chronic disease status, and age all shape health literacy levels significantly. Older Europeans and those with lower socioeconomic status show consistently lower scores across the HLS surveys, a pattern that directly complicates any policy framework that treats patient empowerment as an individual capacity rather than a structural condition.
For the EU, this creates a foundational tension. Policies designed to empower patients — giving them access to their own health data, enabling them to seek treatment across borders, encouraging shared decision-making with clinicians — rest on an assumption of health literacy that a substantial share of the population does not currently meet. Designing for the average informed patient, rather than for the distribution of actual literacy levels, risks deepening health inequalities rather than narrowing them.
The Legislative Framework: From Rights to Union
The EU’s legal architecture for patient empowerment begins most concretely with Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare — a piece of legislation that celebrated its fourteenth year in 2025 and remains the primary EU-level instrument for cross-border patient rights. The directive established a legal framework under which EU citizens can seek healthcare in another member state and receive reimbursement from their home system up to the cost that treatment would have incurred domestically. It created national contact points in each member state to provide information about healthcare providers, quality standards, complaint mechanisms, and patients’ rights in the country of treatment.
The directive’s ambitions were — and remain — significant. In practice, however, administrative complexity and uneven transposition have limited its reach. The reimbursement framework works best for elective, planned procedures where patients have the time, resources, and knowledge to navigate a foreign health system. For the kinds of patients who might most benefit from cross-border access — those with rare diseases, those seeking expertise not available in their home country, those from smaller member states with narrower specialist capacity — the procedural and financial barriers have often proved prohibitive. Research published in subsequent Commission evaluations noted that awareness of the directive among European citizens remained low, and that actual cross-border patient flows attributable to the directive’s provisions represent a small fraction of total EU health expenditure.
The European Health Union, proposed by the Commission in 2020 and shaped substantially by the experience of the COVID-19 pandemic, reframed the patient at the centre of a broader European health security architecture. Its legislative package — including a strengthened Health Security Committee, revised mandates for the European Medicines Agency and the European Centre for Disease Prevention and Control — was primarily oriented toward crisis preparedness and supply chain resilience. But the political communication around it consistently invoked citizen empowerment as a guiding value, linking access to medicines, transparency in pharmaceutical pricing, and patients’ involvement in research design as interconnected components of the same vision.
The Pharmaceutical Strategy for Europe, adopted in November 2020, made patient empowerment explicit within the medicines lifecycle. The strategy called for aligning pharmaceutical innovation more closely with patient needs and unmet medical demand, for increasing patients’ involvement in the evaluation of medicines and in the definition of added therapeutic value, and for improving access to affordable treatments across all member states — an access gap that had become politically visible through price divergence for cancer medicines and rare disease treatments. The European Patients’ Forum, a Brussels-based umbrella organisation representing over 80 patient organisations, welcomed the strategy’s framing while noting that translating patient-centred language into binding regulatory obligations would require sustained political will through the legislative process that followed.
The Digital Dimension: EHDS as Enabler
The most structurally significant development for patient empowerment in the current EU legislative cycle is the European Health Data Space regulation (EHDS), which was published in the EU’s Official Journal in March 2025 and entered into force in the same month. The regulation establishes, for the first time in EU law, a binding right for citizens to access their own electronic health data — free of charge and in a standard European format — and to share that data with health professionals across borders.
The practical implications are substantial. Under the EHDS framework, patients will have the right to view their electronic health records, to restrict which professionals can access specific parts of their data, to add personal health information, to see a log of who has accessed their record, and to request corrections where data is inaccurate. The regulation mandates interoperability between national health data systems using common technical standards, which addresses one of the most persistent structural barriers to cross-border care: the incompatibility of health record formats between member states.
Patient summaries and ePrescriptions are identified as the first priority data categories, with the obligation to exchange these across all member states entering into application from March 2029. This is the dimension most immediately relevant to patient empowerment in its everyday sense: a patient from Portugal seeking emergency treatment in Sweden, or a resident of Germany filling a prescription in the Netherlands, will have their core clinical data accessible to treating clinicians without the current dependency on paper documentation or the patient’s own recall of their medical history.
The EHDS connects directly to the wellbeing economy approach that several member states and the Commission itself have begun articulating — the idea that health systems should be evaluated not only by output efficiency but by their contribution to citizens’ capacity to manage their own lives and health trajectories. Data sovereignty — the citizen’s ability to control who sees their health information and for what purpose — is, in this framing, not merely a technical matter but a dimension of autonomy that health policy should protect.
There are, however, significant caveats. The EHDS regulation applies uniform standards to highly uneven digital infrastructure. Member states differ substantially in the digitisation of health records, in citizens’ digital literacy, and in the governance frameworks for health data. Countries like Estonia and Denmark operate advanced national health data systems; others are still migrating clinical records from paper or incompatible legacy formats. The transition period built into the EHDS acknowledges this, but it also means that the empowerment benefits of the regulation will not be uniformly available in 2029.
Barriers That Policy Documents Do Not Always Name
Language is among the most underacknowledged barriers in the EU’s patient empowerment discourse. The EU operates in 24 official languages, and health information — from patient leaflets to clinical consent forms to national contact point websites — is not consistently available in languages accessible to migrant populations, recent arrivals, or speakers of minority languages. For EU citizens exercising cross-border care rights, or for patients with chronic conditions navigating a health system not primarily designed for them, the language barrier operates as a de facto exclusion mechanism that formal legal rights cannot simply override.
Cultural dimensions add further complexity. The concept of shared decision-making — in which clinician and patient together weigh treatment options, consider patient preferences, and arrive at an agreed plan — assumes a patient-clinician relationship that varies considerably across the EU’s diverse medical cultures. In health systems with strong paternalistic traditions, the transition to shared decision-making requires not only patient education but substantial investment in clinical training and in the redesign of consultation frameworks. Neither is primarily a matter of EU-level legislation; both fall within the competence of member states, which retain primary responsibility for organising and delivering health services under EU treaty provisions.
Inequality is perhaps the starkest structural barrier. The HLS19 data and prior surveys consistently show that health literacy — the prerequisite for meaningful empowerment — is lowest among the populations with the greatest health burden: older adults, people with chronic conditions, those with lower education and income. Policies that expand access to health data, or that enable patients to navigate cross-border care, reach those groups least easily. Designing empowerment policy that deliberately prioritises these populations — rather than treating them as edge cases — would require a different kind of political attention than the framework documents currently reflect.
What Genuine Patient-Centredness Would Require
The distance between the EU’s stated patient empowerment objectives and the conditions required to realise them is not primarily a matter of policy design. The directives, strategies, and regulations produced in Brussels over the past fifteen years have, taken together, created a more patient-facing legal framework than existed at the turn of the century. The Patients’ Rights Directive established cross-border entitlements. The Pharmaceutical Strategy introduced patient involvement in medicines assessment. The EHDS creates data access rights that have no precedent in EU law.
What the legislative framework cannot directly produce is the health literacy that makes those rights usable; the digital infrastructure that makes data portability practical; the clinical culture that makes shared decision-making the norm rather than the exception; or the resource distribution that would allow lower-income member states to invest in the health system capacity that empowerment policies assume. These require sustained investment — in health promotion, in professional education, in digital infrastructure, and in the social determinants of health — that operates largely outside the EU’s direct competence and depends on national political priorities that vary considerably across 27 governments.
The EU’s role in this space is best understood as framework-setting and pressure-generating rather than delivering. It creates legal floors, mandates interoperability, funds research, and — through reporting requirements and infringement mechanisms — creates accountability for member state performance. Whether those pressures translate into genuine citizen empowerment, or remain aspirational language in policy documents, depends on the implementation choices made at national and regional level over the coming decade.
