One of the pillars of cutting-edge healthcare is personalised care, which involves transitioning from standardised prescribing models to individualised dosing strategies. Within this field, advanced population pharmacokinetics and modelling enable the characterisation of inter-individual variability and the prediction of drug exposure based on clinical covariates.6 In practice, this approach involves implementing model-informed precision dosing (MIPD) programmes, integrating algorithm-based clinical decision support tools, and using biomarkers and pharmacogenomic data.7

In Spain, the integration of clinical pharmacogenomics into the National Health System has accelerated in recent years through coordinated strategies, primarily promoted within the framework of the PERTE for Cutting-Edge Healthcare. These initiatives range from developing pilot implementation projects to including pharmacogenetic testing in the Common Catalogue of Genetic and Genomic Tests of the National Health System,8 thereby contributing to ensuring equitable access. Similarly, the Spanish Agency for Medicines and Medical Devices is at the forefront in this field by including relevant pharmacogenomic information in Summaries of Product Characteristics for medicines9 and developing a database of pharmacogenetic biomarkers that provides recommendations for their clinical implementation.10

Advanced therapy medicinal products (ATMPs)—gene, cell, and tissue engineering therapies—introduce substantial technical and organisational complexity into the medicine value chain. In Spain, the recently updated Advanced Therapies Plan11 of the National Health System establishes a structured framework for care pathway organisation, interinstitutional coordination, and outcomes evaluation. Hospital pharmacy plays a key role in ATMP preparation, management, and monitoring, and in long-term pharmacovigilance.

Furthermore, the regulatory framework for authorising the use of non-industrially manufactured ATMPs has enabled the consolidation of a distinctive model of academic and hospital-based production, which is supported by research networks and publicly funded infrastructures, particularly through the Carlos III Health Institute. These capacities are being reinforced within the framework of the PERTE for Cutting-Edge Healthcare through initiatives such as the State Consortium for Advanced Therapies (CERTERA), which aims to structure manufacturing capacities, promoting decentralised platforms, and consolidating an integrated ecosystem of development, production, and clinical evaluation.

Digitalisation is a key enabler of precision medicine. The availability of clinical, genomic, and health outcomes data enables the development of predictive models and the generation of real-world evidence. The use of artificial intelligence (AI) facilitates the early detection of adverse drug events, prediction of individual responses to drugs, and optimisation of precision therapeutic strategies.12 Furthermore, AI and machine learning have significant potential for therapeutic repositioning, particularly when large amounts of genomic data and real-world clinical evidence are available.2

Within this framework, and in line with European Health Data Space regulations, the development of the National Health Data Space constitutes a strategic infrastructure for accessing, interoperating, and reusing data for secondary purposes.13 In turn, the Plan to Promote Sectoral Data Spaces14 and the Artificial Intelligence Strategy for the National Health System15 reinforce the ecosystem necessary for its deployment. Hospital pharmacy is integrated into these environments both as a producer and user of health data, while contributing to outcomes evaluation and the continuous improvement of clinical practice.

In this new landscape, the role of hospital pharmacists is evolving to include expertise in precision medicine, advanced therapies, and data science. This process promotes greater participation in data-driven clinical decision-making and deeper integration within multidisciplinary teams engagedin the development and implementarion of innovative therapies.

This transformation directly impacts the organisation of hospital pharmacy services, which have the opportunity to adapt by developing specialised units, integrating the fields of genetics, bioinformatics, and data analysis, and investing in infrastructure. At the same time, it is essential to consolidate governance frameworks that guarantee data quality and security, equitable access to innovative therapies, and the sustainability of the healthcare system.

Despite progress, significant challenges remain regarding technological complexity, investment needs, professional training, and ethical data management. Nevertheless, this new paradigm offers significant opportunities to improve health outcomes, optimise resources, and strategically position hospital pharmacy within the healthcare innovation ecosystem. This process is redefining care models and has the potential to position hospital pharmacy at the intersection of scientific innovation, clinical practice, and a sustainable healthcare system.

Raquel Yotti: Conceptualisation, Writing – original draft, Writing – review & editing.

None declared.