Diagnostic infrastructure reveals significant geographical disparities. Japan shows threefold variations in imaging equipment availability between prefectures,66 while Italy reports that 37.3% of diagnostic equipment is more than 10 years old. Precision diagnostics face even more restricted access: Japan limits cancer gene panel testing to patients who have exhausted standard treatments,67 while Greece’s biomarker testing depends on ad hoc charitable grants rather than systematic coverage. Innovative medicine development is weakening in some contexts. European clinical trial activity and regulatory approvals are declining, with European Medicines Agency (EMA) approvals falling from 71% of new active substances in 2018 to just 30% in 2024, while in 2023 the four largest EU member countries saw the lowest number of new drug launches since 2014, representing a widening gap with the US.68 In 2024, the Joint Clinical Assessment, a coordinated EU-level evaluation mechanism for new medicines, was introduced for two oncology products. This represents initial progress towards a more streamlined evaluation, though implementation remains at an early stage.69 Access to innovative medicines shows progress alongside persistent delays. Germany achieves a median 52 days from regulatory approval to availability, the fastest among comparable countries.70 Italy’s €500 million Innovative Drugs Funds and France’s “direct access” pilot demonstrate innovative financing mechanisms. Yet substantial delays persist: France faces a median 523 days to availability for high-priority drugs, while Greece exceeds 600 days from approval to reimbursement.71 In Japan, 72.4% of US/ EU-approved medications remained unavailable between 2016 and 2020.72 Despite near-universal EMR adoption in several countries, interoperability and data-sharing between providers remain significant barriers to coordinated and proactive care. Only eight of Spain’s 17 regions can share medical data,73 while Italy’s systems cannot exchange information between care settings. Germany’s 44 approved digital therapeutics face integration challenges, with physicians uncertain about prescribing protocols.74 Populations most affected by NCDs face systematic digital exclusion. In Japan, which has the world’s oldest population, 50.9% of citizens aged over 70 are not familiar with smartphones,75 while 78% of Spanish NCD patients over 70 lack digital autonomy,76 creating barriers that training alone cannot overcome.Current landscape –Accelerate access to innovations: Reform approval and reimbursement pathways to reduce delays between regulatory approval and patient access. Implement fast-track processes for breakthrough NCD therapies with clear timelines, early-access programmes and dedicated innovation funds. Consider risk- sharing agreements for expensive therapies with uncertain benefits. –Ensure equitable diagnostic infrastructure: Address regional disparities through minimum standards for technology accessibility based on equity criteria and population health benefits. Introduce systematic renewal programmes, mobile diagnostic units for underserved areas and hub-and-spoke models. Expand public coverage for molecular testing where results may influence treatment decisions. –Build interoperable digital infrastructure: Establish mandatory open standards enabling care coordination. Create governance structures with genuine authority to enforce standards and resolve stakeholder disputes. Balance privacy protection with research needs through trusted environments. –Reform clinical trial infrastructure: Address barriers causing countries to lose their competitive position. Unify ethics approval processes, streamline administrative requirements and invest in clinical trial networks. Develop real-world evidence capabilities by leveraging electronic health records. –Bridge the digital divide: Address evidence that half of citizens aged over 70 in some countries cannot use digital devices. Mandate accessibility standards for health interfaces, provide support services and maintain non- digital alternatives.Policy levers3.4 Medicines and technologies Acting Early on Non-Communicable Diseases: A Framework for Health System Transformation 20

Acting Early on Non-Communicable Diseases 2026