In many parts of Europe, existing healthcare systems still fail to address a wide range of unmet needs among patients and society. While innovation in healthcare has progressed, much of it remains supply-driven, often prioritising market returns over societal benefit. Public health challenges such as mental health disorders and antimicrobial resistance frequently remain underfunded and under-researched. Against this backdrop, the Belgian Health Care Knowledge Centre (KCE), in collaboration with Sciensano, developed the NEED (Needs Examination, Evaluation and Dissemination) assessment framework.
The framework offers a structured approach to identifying gaps in healthcare provision and guiding policy and innovation towards areas of genuine need. To ensure its applicability across the European Union, a modified Delphi study was carried out, bringing together expert consensus to validate and refine the framework. This process has resulted in a robust model aimed at promoting more equitable, efficient and responsive healthcare systems.
Developing Consensus Around Health Needs
The NEED framework is designed to systematically assess health-related needs that are not adequately met by current interventions. It operates across four dimensions—patient, societal, future and equity—and three core domains: health, healthcare and social needs. Within these categories, it initially proposed 25 needs-related criteria and 46 indicators. These were intended to form the basis for a European database of unmet needs, supporting policy-makers, health professionals and researchers in identifying priority areas for action.
To validate the framework at EU level, researchers used the Delphi method, a well-established approach for gathering expert consensus. Experts were selected from a range of sectors, including health technology assessment (HTA) agencies, public health bodies, medicine regulation authorities, pricing and reimbursement agencies and patient organisations. The process involved two rounds of online surveys in which experts assessed each element of the framework. Consensus was defined as at least 85 percent agreement among respondents. Where this level was not reached, items were either revised based on feedback or excluded from the final model.
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This method allowed for the inclusion of diverse perspectives, ensuring that the framework reflected the broad range of contexts across Europe. In total, experts from 17 EU Member States participated, with a strong presence from Belgium and Germany. While the majority of experts had backgrounds in HTA, the panel also included voices from public health, regulatory bodies and patient advocacy.
Framework Refinements and Structural Updates
The Delphi study led to important refinements of the original NEED framework. Out of the 25 proposed criteria, 21 achieved immediate consensus in the first round. Similarly, 42 of the 46 indicators were initially accepted. The remaining items were reconsidered in a second round, during which further consensus was reached on additional components. Items that continued to fall short were either revised or removed following internal discussions informed by expert comments.
Notably, antimicrobial resistance was excluded as a criterion due to insufficient consensus. While it was recognised as a major public health concern, experts felt that its specificity warranted a separate assessment framework. Several indicators were also reworded for clarity and applicability. For instance, the vague measure “Experience with the organisation of care” was replaced by “Coordination and continuity of care,” drawing on established concepts within integrated care. Similarly, indicators measuring the volume and quality of information received by patients were merged into a single item, “Usefulness of information received,” based on recommendations from the OECD’s Patient-Reported Indicator Survey.
An important structural change involved replacing the indicator “Existence of clinical practice guidelines” with “Research Gaps.” This was due to concerns that clinical guidelines often lag behind emerging evidence and may not accurately reflect current research availability. The revised indicator better captures the absence of scientific knowledge in specific areas. Two criteria concerning future impact—“Future burden of disease” and “Future economic burden”—were also adjusted to “Forecasted burden of disease” and “Forecasted economic burden,” aligning the terminology with global standards such as the Global Burden of Disease Study.
Following these revisions, the final NEED framework now comprises 24 criteria and 43 indicators, offering a streamlined and consensus-based approach to needs assessment across the EU.
Policy Impact and Future Directions
The validated NEED framework offers a valuable tool for guiding healthcare planning, funding and research priorities. Its multi-dimensional approach allows policy-makers to identify areas where current interventions fall short and to direct resources more effectively. The framework also facilitates cross-country comparisons, helping EU Member States to share insights and align strategies around common challenges.
Moreover, by integrating patient and societal perspectives, the framework helps ensure that innovation in healthcare is guided by actual needs rather than market dynamics. It promotes a shift towards more equitable healthcare systems that prioritise prevention, quality of care and long-term planning.
Future research could explore the framework’s application across different populations and health conditions, including children, rare diseases and public health emergencies. Further validation in underrepresented regions and among additional stakeholder groups, such as frontline healthcare providers, may also enhance its relevance and utility.
The NEED assessment framework, validated through an EU-wide Delphi study, represents a major advance in the identification of unmet health needs. By securing expert consensus across Member States, the framework provides a solid foundation for more needs-driven policy and innovation in healthcare. Though it may evolve further with future evidence and use, it already offers a practical and adaptable structure to support decision-makers in allocating resources, planning interventions and improving health outcomes across Europe.
Source: European Journal of Public Health
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