PRECISEU POLICY PROGRAMME 1^ST EDITION

Montse Daban opened the programme by framing the PRECISEU Policy Programme as a key capacity-building and policy dialogue initiative within the PRECISEU Regional Innovation Valley. She explained that PRECISEU is not only a project focused on innovation and personalised medicine, but also a platform to generate evidence, guidance and policy recommendations that can support implementation at regional, national and European levels.

She highlighted the strategic position of PRECISEU within the European innovation landscape. The project has been recognised as one of the leading Regional Innovation Valleys and is strongly connected with European institutions, the European Parliament, the European Commission, TEDAS2, ICPerMed-related initiatives and other major policy processes. The aim is to ensure that project outputs — on ATMPs, health data, reimbursement, market access and personalised medicine adoption — are translated into practical policy tools and escalated to decision-makers.

Montse explained that the Policy Programme was designed around three thematic tracks: ATMPs, Health Data and Planetary Health. These were selected because they represent major strategic priorities for Europe and for Catalonia. ATMPs are linked to Europe’s competitiveness and life sciences agenda; health data is essential for learning health systems and the implementation of the European Health Data Space; and planetary health responds to the need to make healthcare systems sustainable, resilient and aligned with environmental objectives.

She also presented the methodology of the programme. The pilot combines an online expert session, an onsite Design Thinking workshop and subsequent asynchronous teamwork. Participants are organised into multidisciplinary teams including policymakers, payers, procurers, innovators, healthcare professionals, regulators, industry representatives and other stakeholders. The objective is not only to discuss barriers, but to prototype actionable policy recommendations.

Her core message was that regions should not be seen as passive recipients of European policy, but as living labs for implementation. The programme aims to change how policy is made: moving away from static recommendations and towards adaptive, evidence-based and co-created policy instruments that can accelerate the adoption of personalised medicine and health innovation.

He shared key indicators from the BioRegion Report: Catalonia has more than 1,650 companies, nearly 100 research institutions, leading hospitals, scientific infrastructures, technology centres and innovation actors. The sector represents around 7.5% of Catalonia’s GDP and employment, with a global turnover close to €50 billion. Catalonia is also one of Europe’s leading regions in clinical trials, ranking highly both in Europe and globally, with more than 5,700 active clinical trials and strong performance in advanced therapies.

Robert identified five major strategic challenges for the BioRegion. The first is healthcare system transformation: ageing, chronicity and limited resources require the public health system to adopt innovation faster and more effectively. The second is business growth and consolidation: Catalonia has become strong in technology transfer and startup creation, but now needs to strengthen industrialisation, production and scale-up capacities.

The third challenge is new therapeutic strategies**, especially personalised medicine and advanced therapies. Catalonia has successful examples such as academic CAR-T therapies, but needs new models of public-private collaboration, manufacturing, reimbursement and risk-sharing to make these therapies more accessible and affordable. The fourth challenge is talent attraction and development, including the need to upskill and reskill healthcare professionals, industry workers and innovation teams. The fifth is international positioning, meaning that Catalonia should be present in the European and global forums where the future of health innovation is being shaped.

He concluded by presenting some of Biocat’s strategic programmes, including the Advanced Therapies Platform, the Catalan Health System Innovation Access Programme and initiatives related to the European Health Data Space. His central message was that Catalonia has strong innovation capacity, but the next challenge is to connect solutions with real healthcare system needs and accelerate adoption at scale.

Ramon Maspons focused on the gap between innovation generation and innovation adoption. He argued that healthcare systems are increasingly good at producing innovation — through companies, universities, research centres and hospitals — but much less effective at bringing those innovations into routine practice and scaling them across the system.

His key point was that this is not mainly a technical problem, but a **systemic and policy problem**. The health innovation ecosystem includes ministries, payers, providers, innovators, startups, clinicians, regulators, knowledge actors and evidence-generation bodies. Although this architecture is rich and capable, it is often fragmented and poorly aligned. Instruments such as public procurement, EU funds, innovation programmes and hospital-driven initiatives exist, but they do not always translate into systematic adoption.

Ramon identified several major bottlenecks: complex regulation, insufficient adoption-focused funding, risk-averse procurement, fragmented data governance, uneven infrastructure readiness, lack of trust among stakeholders and inadequate metrics. He stressed that systems are familiar with Technology Readiness Levels (TRLs), but much less familiar with **Adoption Readiness Levels (ARLs)**. The key question is not only whether an innovation works, but whether it will actually be used, scaled and benefit patients.

He used Catalonia as an example of a system trying to address this gap through demand-driven innovation and public procurement. He also referred to international examples: Israel’s prioritisation and HTA mechanisms, NHS England’s national programmes and mandates, and Denmark’s digital infrastructure and interoperability. These examples show that there is no single perfect model, but different policy levers can support prioritisation, scale and uptake.

For the next 24 months, he proposed three priority actions: creating fast-track adoption pathways, reforming procurement and data governance to support scaling, and shifting metrics towards clinical impact. He suggested indicators such as time from pilot to adoption, percentage of innovations reaching system-wide use and measurable patient-level impact. His central challenge to the group was: **How might we reduce time to adoption by 50% without compromising safety, evidence or equity?**

Jorge González Olalla addressed one of the most persistent problems in publicly funded innovation: the fact that many successful pilots and projects are never adopted. He described this as a systemic “innovation theatre”, where stakeholders become highly skilled at identifying calls, writing proposals, managing projects and producing deliverables, but much less effective at moving results from TRL 7 or 8 to TRL 9, adoption and scale.

He stressed that this failure has serious consequences. Public money and professional time are wasted, companies lose credibility when pilots do not lead to adoption, and healthcare professionals become frustrated because they invest effort in innovation projects that never change their daily work. This can damage the culture of innovation itself, because clinicians and nurses may become reluctant to participate in future projects.

Jorge’s main message was that **pilots are not adoption**. If adoption is left until the end of a project, it is usually too late. Adoption must be anticipated from the beginning through clear governance, top management commitment, budget planning, procurement involvement, IT and legal engagement, and early discussion of price and affordability. He emphasised the word **commitment**: organisations should only start innovation projects if there is a real commitment to adopt successful results.

He proposed the concept of “adoption touchpoints” throughout the innovation process. These include involving decision-makers from the start, ensuring top management support, preparing budget provisions before the project ends, engaging procurement and legal teams, and defining who will take responsibility for deployment after the pilot. Without this governance bridge, results often fall into the “valley of death”.

He also called for “meta-innovation”: innovating the way innovation itself is managed. Existing instruments such as demand-driven innovation and pre-commercial procurement are useful, but not sufficient. Europe, Spain and the regions need leaner, faster and more effective instruments to connect demand and supply and ensure that successful innovations are adopted. His overall message was that adoption requires anticipation, governance and personal responsibility from all actors involved.

Gloria Martín provided a regulatory perspective on health technology development, with a particular focus on advanced therapy medicinal products. She explained that the current EU regulatory framework for ATMPs is much more mature and developed than it was ten years ago. It now covers most of the key stages of product development up to marketing authorisation.

However, she also stressed that the framework can be difficult to navigate. Developers, especially academic groups, hospitals and early-stage innovators, often face a complex set of regulations and guidelines. The system may be mature, but it is not always user-friendly, and it is not always adapted to the specific characteristics of advanced therapies compared with traditional medicinal products.

Gloria highlighted several support mechanisms that already exist. At Spanish level, the Spanish Medicines Agency has an Innovation Office aimed at academic groups, independent researchers, hospitals, patient foundations and non-profit organisations. This office can provide early regulatory guidance, including on project classification, development strategy, manufacturing facilities and GMP-related aspects. At European level, the EMA offers similar support through the Innovation Task Force, the academia entry point, qualification of novel methodologies, orphan designation, scientific advice, protocol assistance and PRIME.

She encouraged developers to contact these bodies early, even if they have little regulatory knowledge, provided they understand their product well. Early regulatory advice can prevent mistakes that later cause delays, additional costs or major development problems.

She also identified recurring development challenges, particularly around **comparability**. ATMP developers often need to change manufacturing processes as they scale up, but regulators require evidence that the product before and after the change remains comparable. This remains a frequent bottleneck.

Finally, she discussed the European Biotech Act as a potential opportunity to improve the regulatory environment. From a regulatory perspective, its main objectives include speeding up clinical trials, accelerating approvals, improving regulatory pathways and introducing regulatory sandboxes. She noted that Europe remains slower than other regions in clinical trial authorisation and that there is room to improve the system, for example by simplifying procedures and better tailoring requirements to ATMPs.

Aneta Tyszkiewicz presented the European life sciences policy landscape from the perspective of the innovative pharmaceutical industry. She framed the sector as a strategic asset for Europe, not only because it delivers medicines and health benefits, but because it contributes to economic growth, trade balance, strategic autonomy and competitiveness.

She explained that Europe is under strong pressure from the United States and China. The number of clinical trials in Europe has declined over the past decade, while activity has increased in competing regions. In advanced therapies, Europe continues to produce excellent science, but clinical development and implementation often happen elsewhere. This means that European ideas may not translate into benefits for European patients.

Aneta highlighted the emerging EU competitiveness agenda, including the Draghi report, the Competitiveness Compass and the European Biotech Act. She presented the Biotech Act as a positive response to long-standing industry concerns, especially around clinical trials. The Act proposes faster and better-coordinated clinical trial approvals, reduced duplication across Member States and improved legal clarity around data processing. In her view, these provisions should be retained throughout the legislative process.

She also discussed five key areas of the Biotech Act relevant to life sciences: incentives for biotechnology-derived medicines, improvements to the clinical trials ecosystem, high-impact strategic projects, access to funding for SMEs and the role of AI and digitalisation. While she welcomed the direction of travel, she warned that some elements remain uncertain, including the duration and predictability of funding schemes and the risk of creating additional governance layers instead of connecting existing clusters.

On AI, she explained that the pharmaceutical sector already uses AI in research, development, manufacturing and process optimisation. However, many AI applications in the sector are not medical devices and should not be overregulated under frameworks designed for higher-risk use cases. EFPIA’s position is that AI should be reliable, validated and accountable, but regulation should avoid unnecessary burdens for low-risk applications.

Her key message was that Europe needs to invest in health, improve clinical trial competitiveness, support public-private collaboration, connect regional and national clusters, attract talent and ensure that EU initiatives translate into practical improvements at Member State and regional level.

Ruben Prol explained how EU health-related legislation is made, with particular attention to the ordinary legislative procedure and trilogues. He began by clarifying that EU competence in health is limited. Article 168 of the Treaty on the Functioning of the European Union gives Member States core responsibility for healthcare systems and medical care organisation. As a result, much EU health legislation relies on a combination of Article 168 and Article 114, which concerns the internal market and allows stronger harmonisation.

This is particularly relevant for files such as the European Health Data Space, pharmaceutical legislation and the Biotech Act, where health objectives are linked to market integration, competitiveness and harmonisation. Ruben explained that EU health policy is therefore often constructed through parallel competences and adjacent policy areas, including medicines, medical devices, data protection, fundamental rights and industrial policy.

He then described the ordinary legislative procedure. Formally, it involves readings by the European Parliament and the Council, but in practice much of the political negotiation happens through **trilogues**: informal negotiations between the Parliament, the Council and the Commission. The Commission acts as the initiator of legislation and as a mediator, while the Parliament and Council negotiate to reach a consolidated text.

Ruben emphasised that negotiations are shaped by multiple layers of political arithmetic. In Parliament, majorities depend on party groups and shifting coalitions. In Council, positions depend on qualified majority voting, which considers both the number of Member States and their population. Large Member States such as Germany, France, Italy, Spain and Poland have significant weight, but smaller Member States can also exert influence when they act together, for example through Nordic, Baltic or regional coalitions.

He also explained the current tension between **better regulation** and **faster regulation**. Traditionally, EU legislative proposals are expected to be supported by impact assessments, but recent initiatives such as omnibus packages and the Biotech Act show a growing political desire to accelerate procedures and simplify rules. However, Ruben warned that simplification alone does not necessarily create competitiveness. In some cases, regulation is needed to shape markets, align investment and create the conditions for meaningful innovation.

On the role of regions, he stressed that biotech and health innovation often emerge from specific clusters rather than from entire countries. Therefore, connecting regional clusters across Europe is essential. The Biotech Act could help create stronger links between these clusters, allowing Europe to scale innovation while preserving the strengths of local ecosystems.

Jordi Serrano Pons offered a global and future-oriented view of medicine, expanding the traditional “P medicine” framework. He explained that the classic model includes concepts such as personalised, predictive, preventive, participatory and population medicine, but argued that additional “Ps” are needed, including proactive, primary care, planetary health, purpose and performance.

His intervention was intentionally broad, aiming to show that health system transformation cannot be understood only through technology or biomedical innovation. It must also include prevention, value-based care, digital tools, planetary health and stronger integration with primary care and public health.

He used several global examples. Singapore was presented as a leading case of proactive and preventive medicine. Its national health programme includes government-supported screening, family doctor engagement, digital tools and personalised prevention plans. Singapore is also linking prevention with precision medicine through population genomics initiatives.

He also referred to other international precision medicine programmes, including All of Us in the United States, programmes in Qatar and Saudi Arabia, and genomic and advanced therapy initiatives in China. He highlighted that different countries are investing in large-scale health data, genomics and prevention programmes, often with strong government leadership.

Jordi also addressed prevention and global health capacity. He mentioned the WHO and African Union mRNA vaccine hub as an example of how technology transfer and manufacturing capacity can be built outside traditional high-income settings. He suggested that such infrastructures could eventually support broader applications, including gene therapies or advanced therapies for diseases that are rare in Europe but common in Africa.

Planetary health was another major theme. He argued that healthcare must recognise that human health is inseparable from environmental systems. He cited Malaysia’s national planetary health action plan as an example of a country embedding planetary health into policy. He also referred to the digital exposome, environmental determinants of health and the need to measure how neighbourhoods and environments affect health outcomes.

His final message was that future medicine must move beyond hospitals and become more proactive, preventive, planetary and value-based. Governments should invest in longer, more meaningful primary care interactions, prevention and early intervention because this can generate enormous long-term value for both people and systems.

Taowen Xue brought a business and Asia-Europe collaboration perspective, drawing on her experience supporting Catalan and Spanish companies in China. She began by noting that Europe has strong historical, scientific and institutional assets, but Asia can offer useful lessons in speed, implementation, data integration and coordinated action.

She opened with a practical example from her time at ACCIÓ in Shanghai. When Alibaba wanted to connect with Spanish companies, the request did not fit neatly within the formal KPIs of a public agency. However, by involving Barcelona City Council and the Port of Barcelona, she helped create a collaborative event that connected hundreds of companies with Alibaba’s e-commerce platform. The lesson was that even within public-sector constraints, proactive coordination and institutional creativity can unlock opportunities.

She then presented several Asian examples. Japan’s **Sakigake pathway** offers a fast-track approval route for highly innovative and promising medicines, with conditional access and post-market evidence requirements. Singapore’s **SG10K Health** programme shows how a small country can build a coordinated precision medicine strategy based on genomic data and volunteer participation, while addressing the underrepresentation of Asian populations in global datasets.

South Korea’s **My HealthWay** platform was presented as an example of patient-centred digital health infrastructure. It enables citizens to access and share health data across institutions through a digital platform, based on consent. Taowen suggested that Europe could reflect on whether privacy and data protection can coexist with more effective data integration and real-world data use.

She then discussed China’s **Hainan real-world data pilot zone**, where healthcare, medical insurance and pharmaceutical systems are linked in a controlled environment to support drug evaluation, access and pricing decisions. China is also introducing policies to support advanced therapies, AI-enabled drug development, gene therapy, cell therapy and brain-computer interfaces, with clear government funding priorities and mechanisms to attract young STEM researchers.

Her main message was that Europe and Asia should not approach the relationship as one side teaching the other. Instead, both have complementary strengths. Europe has scientific excellence, clinical quality and trust-based systems; Asia, and China in particular, often has speed, coordination, integrated data and implementation capacity. She argued that Europe should remain open to joint trials, shared real-world evidence standards, parallel HTA discussions and broader collaboration with Asia, while respecting different systems and safeguards.

Núria Gavaldà presented the Catalan ecosystem for advanced therapy medicinal products (ATMPs), focusing on the transition from research to clinical adoption. Her intervention framed Catalonia as a region with strong scientific, clinical and manufacturing assets, including leading hospitals, academic institutions, research centres, the Blood and Tissue Bank, and emerging advanced therapy infrastructure.

A central message was that Catalonia has built a growing and increasingly coordinated ecosystem around advanced therapies. This includes clinical expertise, academic research capacity, GMP manufacturing facilities, public-sector involvement and collaborations with hospitals and innovation actors. The creation and consolidation of specialised platforms and clean-room infrastructures were presented as essential assets for accelerating the development and translation of ATMPs.

However, Núria also highlighted that the pathway from research to patient access remains complex. Translation is limited by several bottlenecks: manufacturing capacity, regulatory complexity, lack of standardised platforms, funding constraints, quality control requirements, and the difficulty of moving from academic innovation to clinically validated products. She emphasised that manufacturing is not a purely technical step, but a strategic enabler for clinical translation.

A key challenge is the tension between product customisation and standardisation. Academic research often develops highly specific processes for each product, but every modification has regulatory consequences and can slow down development. Therefore, there is a need to move towards more standardised, process-based and platform-based approaches, while preserving the flexibility required for personalised and innovative therapies.

Her overall message was that Catalonia has the ingredients to become a strong ATMP hub, but this will require coordinated action across hospitals, research centres, manufacturers, regulators and policymakers. The next step is to align infrastructure, regulatory pathways, funding and clinical needs so that promising therapies can move more efficiently from the laboratory to patients.

Montse Daban presented the Catalan perspective on the implementation of the European Health Data Space (EHDS) and the secondary use of health data. She framed Catalonia as a region with strong existing assets: decades of electronic health records, connected primary and hospital care data, administrative and reimbursement data, registries, clinical data and other health-related datasets. This gives Catalonia a solid starting point to contribute to the European data space.

A central element of her presentation was **PADRIS**, the Catalan programme for data analysis for research and innovation in health. PADRIS has historically enabled the reuse of Catalan health system data mainly for public research. In the context of the EHDS, this model is now being reoriented towards broader secondary use, including research, innovation, evaluation, policy-making and personalised medicine.

She explained that AQuAS is adapting the existing Catalan infrastructure through the creation of **ODAS**, the Office for Secondary Use of Health Data, which is expected to act as the regional health data access body and connect with Spanish and European governance levels. This is an important step towards aligning Catalonia with the EHDS requirements, including health data access body functions, secure processing environments, data catalogues, metadata, transparent governance, privacy, ethics and citizen trust.

Montse also shared findings from PRECISEU’s regional and national readiness analysis. The project applied a maturity grid to compare regions and Member States across dimensions such as legal and governance frameworks, data access mechanisms, secure processing environments, data quality, interoperability and operational capacity. The analysis identified strengths but also several bottlenecks.

The main challenges highlighted were **fragmented governance** across Spain’s 17 autonomous regions, restricted access to health data for secondary use, multiple interpretations of GDPR, limited data-sharing culture among healthcare professionals, insufficient patient and citizen involvement in data governance, and limitations linked to anonymisation-only access. Her key message was that Catalonia has advanced infrastructure and experience, but the next challenge is to transform these assets into a trusted, interoperable and policy-relevant health data hub.

David Dalmau focused on how health systems can move from **climate awareness to clinical action**. His central argument was that climate change is already affecting health outcomes, especially through heat-related cardiovascular, respiratory and mortality risks, but healthcare systems remain structurally unprepared to integrate these risks into routine clinical decision-making.

He stressed that the problem is not a lack of evidence, but a **failure of integration**. Health systems already have climate alerts, health data infrastructure and sustainability strategies, but these tools often operate in parallel rather than as a connected system. Current heat-health plans may work at population level, but they rarely translate into patient-level clinical action.

Using the example of an integrated Catalan health system covering around 300,000 people, he explained how clinical, administrative and environmental data can be combined to identify patients most vulnerable to heat-related health events. This allows health systems to activate preventive care pathways, coordinate with primary care and community resources, and move towards anticipatory healthcare.

His key message was that **implementation is not an innovation problem, but an alignment problem**. To make climate resilience operational, health systems need governance mandates, interoperable data, clinical decision-support tools, incentives for prevention and measurable indicators. Health equity should guide climate resilience, because without clinical integration the most vulnerable patients remain unprotected.

José María Piulats presented the perspective of a clinical oncologist and academic researcher working on advanced therapies in cancer. His talk focused on the real-world challenges of developing ATMPs from an academic hospital environment, especially for rare tumours and small patient populations where commercial incentives are limited.

He explained that many rare cancers and highly specific tumour subgroups may be biologically suitable for advanced therapies, but they often lack commercial attractiveness because of their small markets. Academic centres therefore play a critical role in developing therapies for unmet needs that industry may not prioritise. His own research group works on several approaches, including mesenchymal stem cells carrying oncolytic viruses, oncolytic viruses, academic CAR-Ts, TCRs and tumour-infiltrating lymphocyte therapies.

Using the example of an academic product combining allogeneic mesenchymal stem cells with an oncolytic virus, he illustrated a core translational bottleneck: researchers may identify better biological options in the lab, but clinical development is often constrained by what is already available under GMP conditions. Any change in cell source, viral component or transgene can be treated as a new product, requiring new GMP production and regulatory work. This can force teams to use the “available GMP product” rather than the biologically optimal one.

He also described the difficulty for academic centres to keep pace with industry. While hospitals are investing in clean rooms and ex vivo CAR-T manufacturing infrastructure, companies are already moving towards faster or in vivo approaches. This creates uncertainty about which infrastructure model should be prioritised. He argued that Catalonia is at a strategic crossroads: a fully decentralised model where every hospital works independently could create duplication and inefficiency, while a fully centralised model may reduce flexibility for researchers and clinicians.

His preferred direction was a **hybrid model**, combining centralised or shared core facilities with some hospital-based capabilities. He also stressed the importance of hospital exemption as a tool for academic development, while noting that its interpretation is not always consistent. His final message was clear: if advanced therapies are developed only where there is a market, many patients will never benefit. Academic hospitals must therefore remain part of the ATMP development pathway.

Laura Centeno provided a legal and ethical analysis of health data governance in Spain, with a particular focus on the implementation of the EHDS and the secondary use of health data. She began by stressing that **legal frameworks and ethical frameworks are not the same**, even though they must work together. Different actors — hospitals, researchers, pharmaceutical companies, ethics committees, public institutions or data users — face different obligations, risks and dilemmas.

She explained that Spain’s decentralised health system is both a challenge and an opportunity. With 17 autonomous regions, different levels of care, different technical infrastructures and fragmented data silos, Spain needs strong coordination to ensure that health data can be shared across regions and institutions. The Ministry of Health plays a coordinating role, but many legal and operational responsibilities remain at regional level.

Laura described the EHDS as a major opportunity to create minimum harmonisation and clearer structures for cross-border and cross-regional data sharing. However, she also warned that the system is complex: EHDS, GDPR, the Data Governance Act, the AI Act, clinical trials regulation, medical devices regulation and national health laws all interact. GDPR and EHDS should be understood as complementary frameworks: GDPR remains essential, especially because health data is a special category of personal data, while EHDS introduces more specific legal bases and governance mechanisms for health data sharing.

A key point of her talk was the distinction between primary and secondary use. Primary use involves personal data and patients’ rights over their data. Secondary use may involve anonymised or pseudonymised data, but the choice between anonymisation and pseudonymisation is not always straightforward. This is especially critical for rare diseases, where anonymisation can reduce data usefulness or may be difficult because patient populations are very small.

She identified several implementation bottlenecks: obligations advancing faster than operational capacity, legal uncertainty, lack of clarity on which legal basis and safeguards apply to specific projects, limited long-term financing, procurement challenges, data governance gaps, insufficient impact assessment practices, and lack of citizen engagement. She emphasised the importance of **use cases**, practical implementation guidelines, capacity building, digital health literacy, patient involvement and clear opt-out mechanisms.

Her central message was that the EHDS will only work if legal compliance is translated into operational practice. Regions and institutions need to understand their roles as data holders or data users, identify their obligations, prepare their datasets, build trust with citizens and patients, and create realistic governance frameworks that protect rights while enabling research and innovation.

Alba Ancochea presented the Spanish policy landscape for climate and health integration, combining the perspective of national policy, regional action and public-private collaboration. She framed the health sector as both **vulnerable to climate change** and **part of the solution**, given its contribution to greenhouse gas emissions and its responsibility to protect vulnerable populations.

She explained that Spain is particularly exposed to climate-related health risks, including deaths linked to air pollution and extreme temperatures. Therefore, policies must address both mitigation — reducing the environmental impact of healthcare — and adaptation — ensuring health systems are resilient and able to care for populations affected by climate change.

At national level, she highlighted several relevant policy developments: mandatory carbon footprint reporting for large organisations, the upcoming inclusion of scope 3 emissions, the implementation challenges linked to the Urban Wastewater Treatment Directive, and the progressive incorporation of sustainability criteria into pharmaceutical policy, procurement, ProFarma evaluation and the draft medicines law.

She also emphasised the importance of **collaborative implementation**. Examples included nature-based solutions for water quality, hospital carbon footprint measurement tools, sustainable prescribing guidance, regional initiatives in Galicia, the Canary Islands and Andalusia, and partnerships between companies, public administrations, research organisations and patient groups. Her main message was that policy is a powerful driver for decarbonisation, but it must be accompanied by tools, incentives, common metrics and cross-sector collaboration.

Esteve Trias provided a European regulatory and market access perspective on ATMPs. He argued that Europe has excellent research, clinical leadership and academic institutions, but risks falling behind the United States, China, Japan and potentially India if regulation, funding and implementation pathways do not become more flexible and coordinated.

He began by explaining the fragmented European regulatory architecture. ATMPs interact with several regulatory frameworks: substances of human origin, advanced therapies regulation, medical devices, the centralised marketing authorisation procedure, and national-level mechanisms such as hospital exemption. This creates multiple “doors” for developers, unlike the FDA model, where products enter through a more unified regulatory route.

A major part of his talk focused on the new and upcoming regulatory tools that could help Europe accelerate ATMP development. He highlighted four instruments in particular:

1. **Hospital exemption**
This can allow certain ATMPs to be used outside full centralised marketing authorisation, under national authorisation, based on clinical evidence, GMP production and defined conditions. Esteve emphasised that Spain’s model is relatively advanced, but Europe still lacks harmonisation and transparency. Hospital exemption should not be seen as a competitor to commercial development, but as a specific tool that can serve unmet needs and potentially act as a bridge towards centralised authorisation.

2. **Decentralised or multi-site manufacturing**
For personalised therapies, production close to patients may be necessary. However, demonstrating comparability and equivalence between different production sites is currently expensive, slow and burdensome. He stressed that Europe needs more flexible criteria for multi-site manufacturing, while avoiding uncontrolled local variations that prevent aggregation of evidence.

3. **Technological platforms**
Esteve presented open technological platforms as a major opportunity. Common pre-competitive platforms — for example lentiviral vectors, CAR-T production systems or other shared manufacturing processes — could reduce costs, accelerate development and lower investment risk. Once a platform is accepted, new products using the same validated process should not have to repeat unnecessary regulatory steps.

4. **Regulatory sandboxes**
Sandboxes could allow developers and regulators to test new approaches and adapt regulatory practice to the specific needs of advanced therapies. He argued that sandboxes should be used not only for individual projects, but to transform the system.

He also discussed international examples. China is moving extremely fast, with flexible regulation, strong government support and aggressive investment. The FDA offers more integrated and supportive pathways, and Japan has experimented with conditional authorisation. The UK, after Brexit, has introduced some flexibility, for example allowing certain comparative studies to use historical data rather than requiring large prospective comparator arms.

His closing message was that Europe must act with **generosity and flexibility**. Generosity means building networks, sharing knowledge and creating open platforms; flexibility means using regulatory tools intelligently to reduce friction while maintaining safety. He emphasised that stakeholders have more capacity to influence the system than they may think, but only if they work together in a coordinated way.

Apostolos Dimitriadis presented the European implementation perspective, drawing on his experience in PRECISEU and discussions from the EHDS-related event in Cyprus. His main concern was the **uneven readiness of Member States** and the risk that the EHDS becomes a “paper regulation” if countries do not develop the governance structures, funding, infrastructure and human capacities required for implementation.

He highlighted that Europe is entering a decisive implementation phase. The EHDS regulation has entered into force, but Member States are progressing at different speeds. Only a limited number have formally designated health data access bodies, and only a minority have discussed or approved dedicated budget allocations. This creates an asymmetry in digital infrastructure and political commitment, which could undermine the vision of a unified European health data space.

Apostolos stressed that this affects all stakeholders. Patients in less prepared countries may not be able to exercise their data rights effectively. Researchers and AI innovators may continue to face long, uncertain and fragmented access procedures. Healthcare professionals may experience increased burden if digital tools are not integrated into clinical workflows. National health systems may remain dependent on fragmented and paper-based processes, limiting their capacity for planning, resilience and innovation.

A major part of his presentation focused on the role of **artificial intelligence**. AI will be essential not only for training models, but also for processing, analysing and learning from health data. However, trustworthy AI requires large, diverse and interoperable European datasets. The EHDS and the EU AI Act therefore need to work together: the EHDS can provide access to high-quality data, while the AI Act regulates the safety, transparency, validation and accountability of high-risk AI systems in healthcare.

He also warned that the regulatory landscape — EHDS, GDPR, AI Act, medical device regulation and national rules — can be extremely difficult to navigate, especially for SMEs, researchers and universities without large legal teams. This could create barriers to innovation unless support structures, guidance and capacity building are put in place.

Using Greece as an example, he explained that the country has made progress in e-prescription, electronic health records and digital health services, partly accelerated by COVID-19 and EU Recovery and Resilience Facility funding. However, secondary use governance remains underdeveloped, with no fully operational health data access body and continued barriers to obtaining data access permissions.

His proposed priority actions for the next 24 months included strengthening AI literacy and digital skills, updating medical curricula, validating AI tools before clinical deployment, funding implementation and hospital infrastructure, strengthening EHDS governance, creating citizen information points and ensuring transparent opt-out mechanisms. His key message was that primary and secondary use should not be treated as separate workstreams, but as a **continuous learning cycle**: high-quality care data should feed secure secondary use, research and AI development, and then return to the system as better clinical decisions and patient outcomes.

Marta Pahissa provided a European and planetary health perspective. She argued that healthcare sustainability should not be seen only as an environmental issue, but as a **health system transformation challenge**. Health systems are affected by climate change, but they also contribute to it, and therefore must become active agents of change.

She introduced the concept of **planetary health**, stressing that human health depends on stable Earth systems. Climate change, biodiversity loss, pollution, food systems, mobility and urban design are interconnected, and health impacts can appear before planetary boundaries are fully crossed. She highlighted the importance of focusing on co-benefits: actions that are good for the planet and good for human health, such as active mobility, healthy sustainable diets and pollution reduction.

A major point of the talk was that decarbonisation must go beyond carbon accounting. While carbon footprint is important, healthcare sustainability also involves water, materials, biodiversity, waste, toxicity and equity. She noted that most healthcare emissions come from scope 3 sources such as pharmaceuticals, medical devices, supply chains, food, transport and procurement, meaning that decarbonisation is not only an engineering issue but also a governance and procurement challenge.

Using Catalonia as an example, she referred to evidence showing that the Catalan healthcare system generates significant emissions, mostly from scope 3, and that demographic ageing could increase emissions if care models do not change. She argued that prevention and new care models are also sustainability strategies. Her final message identified four main gaps: governance, scaling, financing/incentives and measurement. Health systems need standardized indicators covering environmental footprint, health co-benefits and system resilience.

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Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi.
Lorem ipsum dolor sit amet, cons ectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat.
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Tamara Hoveling focused on circular healthcare from the perspective of **medical device design**. She explained that healthcare has a significant climate footprint and that medical devices are increasingly digital, electronic, battery-powered and disposable. This trend increases mining, waste, critical material use and emissions.

Her presentation contrasted the current linear model of medical device production, use and disposal with a more circular model based on strategies such as reuse, reprocessing, remanufacturing, repair, recycling and reduction. However, she noted that many circular strategies remain underused in healthcare. In a review of 1,400 active medical devices, only a minority used at least one circular strategy, and most of these were simply reusable.

She identified several major barriers to circular medical devices: perceived and real safety risks, regulatory compliance, technological limitations, financial constraints, social acceptance, unclear responsibility and the lack of reverse supply chains. She explained that EU policy does not necessarily prohibit circular healthcare, but the current combination of safety regulation, liability risk, procurement practices and linear business models makes circular solutions difficult to scale.

Through the example of a laparoscopic device, she illustrated how a hybrid circular design could reuse high-impact electronic components while redesigning other parts for sterilisation, recycling or disposal. However, such designs often do not fit neatly into regulatory categories, may trigger recertification concerns and are disadvantaged by procurement systems focused on purchase price rather than life-cycle cost. Her proposed response is a circular design guide for medical devices, developed within the DICE project, to help companies integrate circularity from the beginning of product development.