Question 1

What is Personalised Medicine?

Accepted Answer

Personalised medicine is an approach to health and care that uses information about a person’s biology, environment, lifestyle, and disease characteristics to guide prevention, diagnosis, and treatment more precisely. In practice, this can mean identifying which patients are most likely to benefit from a certain medicine, which people are at higher risk of a disease, or which preventive measures are most suitable for a defined group.

In Europe, personalised medicine is usually understood as more than genetics alone. It can include molecular profiling, medical imaging, clinical records, family history, environmental exposure, and behavioural data. The goal is not to create a unique treatment for every single person, but to match the right intervention to the right patient or patient group at the right time.

Personalised medicine matters because it can improve outcomes, reduce avoidable side effects, support earlier diagnosis, and make health systems more efficient. It requires coordination across research, regulation, data policy, healthcare delivery, and citizen engagement. That is why it has become a major focus of European research and health policy.

Question 2

How Does Personalised Medicine Differ From Traditional Healthcare Approaches?

Accepted Answer

Traditional healthcare often relies on standard treatments developed for broad patient populations. Those treatments can be highly effective, but they do not work equally well for everyone. Personalised medicine aims to improve this by using more detailed information to understand why patients respond differently and by tailoring decisions more precisely.

The difference is especially important in areas such as cancer, rare diseases, pharmacogenomics, and prevention. In these settings, a treatment decision may depend on a biomarker, a genomic variant, a molecular subtype, or a person’s likelihood of side effects. Personalised medicine therefore shifts healthcare from a “one-size-fits-most” model towards a more stratified, data-informed, and patient-centred model.

For European health systems, this shift has practical consequences. It affects how diagnostics are used, how evidence is generated, how hospitals organise care pathways, and how payers and regulators assess value. It also means that policy must support interoperability, secure data use, training, and equitable access. Personalised medicine does not replace public health or standard care; rather, it adds precision where evidence shows precision can improve outcomes and use resources more wisely.

Question 3

What Is Personalised Prevention?

Accepted Answer

Personalised prevention applies the same logic as personalised medicine, but at an earlier stage in the healthcare pathway. Using information such as genetic predisposition, biomarkers, family history, environmental exposure, lifestyle and other risk factors, it helps to identify those who would benefit most from targeted prevention, screening or early intervention. This targeted approach to prevention can reduce the financial burden on healthcare systems by detecting and treating diseases at an early stage, thereby increasing recovery rates and reducing long-term treatment costs.

In Europe, personalised prevention is gaining attention because many major health burdens, including cancer, cardiovascular disease, and metabolic disorders, could be reduced through earlier and more precise action. Instead of offering identical prevention strategies to everyone, health systems may combine population-level approaches with more tailored prevention for people or groups at higher risk in the future.

This approach must be introduced carefully. European stakeholders need to ensure that risk prediction is evidence-based, understandable, and ethically sound. Personalised prevention should support empowerment, not anxiety or discrimination. It also needs clear governance on data use, informed consent, communication, and access. For EP PerMed, personalised prevention is especially relevant because it connects research, implementation, citizen engagement, and health-system sustainability.

Question 4

Which Diseases or Health Areas Can Benefit Most From Personalised Medicine?

Accepted Answer

Personalised medicine is already making a visible difference in several disease areas, although the level of maturity varies. Oncology is the best-known example: tumour profiling can help match patients to targeted treatments, immunotherapies, or specific clinical trials. Rare diseases are another important field, because genomic analysis can improve diagnosis and help identify the biological cause of disease more quickly.

Other areas with strong potential include cardiovascular disease, neurological disorders, infectious disease, metabolic disease, and inflammatory conditions. Pharmacogenomics can improve prescribing decisions across many therapeutic areas by showing how a patient may metabolise a medication. Preventive genomics and biomarker-based screening may also become increasingly relevant for public health. This is why EP PerMed focused its Joint Transnational Calls (JTCs) on these topics.

The JTC2024 focused on identifying or validating targets for personalised medicine approaches and developing companion biomarkers. The JTC2025 focused on pharmacogenomic strategies for personalised medicine approaches. The JTC2026 focused on personalised medicine for cardiovascular, metabolic and kidney diseases.

The key point is that personalised medicine is not one specialty but a cross-cutting model. Its uptake depends on the quality of diagnostics, the clinical evidence, national reimbursement rules, data infrastructure, and workforce readiness. The most immediate benefits often appear where diseases are heterogeneous, treatment options are costly or toxic, and good biomarkers exist. Over time, the approach is likely to expand further as evidence and infrastructure improve across Europe.

Question 5

Where Does Personalised Medicine Stand Today, and Where Is It Heading?

Accepted Answer

Personalised medicine in Europe has moved from a mainly research-driven concept to an increasingly practical reality in selected areas of care. Genomic testing, biomarker-guided treatment decisions, molecular tumour boards, advanced therapies, and data-enabled decision support are already part of care in many centres. At the same time, adoption remains uneven between countries, regions, hospitals, and disease areas.

EP PerMed’s Success Stories and Best Practices help illustrate this landscape by showcasing concrete cases of implementation, transferable approaches, and lessons learned from across Europe. Through our Twinning Calls, EP PerMed is accelerating the implementation of personalised medicine solutions from one country or region to another by facilitating peer-to-peer exchanges. Funded twinning partnerships aim to support local, regional and national health and care providers who wish to adopt personalised medicine solutions that can be transferred between providers. The Twinning Call pairs two or three institutions. The donor institution shares its relevant experience, knowledge and practices with the receiving organisations.

The current situation can be described as a transition phase. The science and technologies have advanced quickly, but implementation still lags behind in many settings. The next stage in Europe will depend less on isolated scientific breakthroughs and more on system-wide progress: interoperable data systems, regulatory clarity, reimbursement pathways, workforce training, better diagnostics, stronger clinical evidence, and fair access.

Looking ahead, the field is likely to become more integrated, more digital, and more prevention-oriented. Genomics will increasingly be combined with imaging, clinical data, and other omics. Artificial intelligence may help interpret complex data, but only if it is trustworthy, validated, and used within a clear legal framework. For European policymakers and funders, the future of personalised medicine is therefore not only about innovation, but also about implementation, governance, and sustainability.

Question 6

What is the Difference Between Personalised Medicine, Precision Medicine, Individualised Medicine, Stratified Medicine, Tailored Medicine, and Personalised Healthcare?

Accepted Answer

These terms are closely related and are sometimes used interchangeably, but they can emphasise different aspects of the same broader approach.

Personalised medicine is the term most commonly used in the European policy context. It refers to using information about a person’s biology, lifestyle, environment, and health status to guide prevention, diagnosis, and treatment more precisely. It does not necessarily mean creating a unique therapy for every individual; often, it means identifying the most appropriate intervention for a particular person or subgroup.

Precision medicine is widely used internationally, especially in the United States. It has a very similar meaning but often places stronger emphasis on the use of molecular data, biomarkers, genomics, and other advanced technologies to improve clinical decisions.

Individualised medicine and tailored medicine are broader descriptive terms. They stress that care should be adapted to the needs and characteristics of the individual patient. However, they are less consistently defined in research and policy documents.

Stratified medicine usually refers to dividing patients into subgroups based on shared characteristics, such as a biomarker, genetic variant, disease subtype, or likely treatment response. It is therefore an important method within personalised medicine, but it is not always identical to the broader concept.

Personalised healthcare has the widest scope. It can include personalised medicine, but also prevention, care organisation, digital tools, patient preferences, self-management, and wider social or behavioural factors. It focuses not only on selecting the right treatment, but on adapting the whole health and care pathway to the person.

In practice, the boundaries between these terms are not fixed. For European stakeholders, personalised medicine is usually the most suitable umbrella term because it covers research, innovation, prevention, diagnosis, treatment, and implementation across healthcare systems.

Question 7

Which Technologies Are Driving the Development of Personalised Medicine?

Accepted Answer

Personalised medicine depends on a combination of enabling technologies rather than a single innovation. Key examples include genomic sequencing, molecular diagnostics, in vitro diagnostics, biomarker testing, advanced imaging, digital pathology, health data platforms, bioinformatics, and increasingly artificial intelligence tools for analysis and decision support. These technologies make it possible to detect variations between patients and to turn that knowledge into clinical action.

In Europe, one important development is the growing connection between laboratory science and health system infrastructure. Sequencing and other omics technologies are becoming more affordable and scalable, while digital health tools make it easier to combine different kinds of data. At the same time, diagnostic regulation, quality assurance, and clinical validation remain crucial. A technology only supports personalised medicine when it produces reliable information that clinicians can use safely and meaningfully.

European stakeholders therefore need to consider more than just discovery. The important questions are whether a technology is clinically useful, interoperable, affordable, understandable to patients and in line with regulatory and reimbursement requirements. EP PerMed recognises these connections through its work in the areas of research, innovation, implementation and policy, rather than treating technology as an isolated issue.

Question 8

What Types of Data Are Used in Personalised Medicine?

Accepted Answer

Personalised medicine uses many types of data because health outcomes are shaped by more than a single biological factor. Relevant data can include genomic and other omics data, laboratory values, pathology results, imaging results, electronic health records, treatment history, family history, lifestyle information, environmental exposures, and patient-reported outcomes. In some settings, data from wearables and digital tools may also be useful.

What matters is not only the quantity of data, but how well it can be interpreted and connected. A genomic result on its own may be of limited value unless it is linked to clinical context, phenotype, and treatment information. This is why interoperability, metadata standards, data quality, and secure access are so important. Without them, large volumes of data do not automatically translate into better care.

In Europe, data use must also respect legal and ethical requirements. Health and genetic data are sensitive, and their use must be based on clear governance, public trust, and robust safeguards. Initiatives such as the European Health Data Space and the Beyond 1 Million Genomes plus (B1MGplus) initiative are important because they aim to improve data availability and to ensure trustworthy cross-border use.

Question 9

What Does “multi-Omics” Mean in Personalised Medicine?

Accepted Answer

“Multi-omics” refers to combining different layers of biological information to understand health and disease more comprehensively. These layers can include genomics (genes and DNA), epigenomics (chemical modifications that influence how genes are switched on or off), transcriptomics (RNA), proteomics (proteins), metabolomics (metabolites) and other forms of molecular analysis. Instead of looking at only one biological dimension, multi-omics aims to capture a more complete picture of how a disease develops and how a patient may respond to treatment.

In personalised medicine, multi-omics is valuable because many diseases are biologically complex. A genomic alteration may not fully explain what happens in a tumour, for example, unless it is considered together with gene expression, protein activity, clinical phenotype, and treatment history. By integrating several types of information, researchers and clinicians may identify more precise biomarkers, disease subtypes, or therapeutic targets.

For Europe, the promise of multi-omics is closely linked to infrastructure and collaboration. It requires advanced laboratories, bioinformatics capacity, agreed standards, and access to high-quality data from many institutions. This is exactly why European and international coordination matters. Multi-omics can be powerful, but only when research, data governance, validation, and implementation are aligned it becomes clinically useful.

Question 10

What Is Pharmacogenomics, and How Does It Support Personalised Medicine?

Accepted Answer

Pharmacogenomics studies how genetic variation influences a person’s response to medicines. Some patients metabolise a medicine quickly, others slowly, and some may be at greater risk of side effects or may not benefit at all. Pharmacogenomics can help clinicians choose the right drug or dose more safely and effectively.

This is one of the clearest examples of personalised medicine already moving into practice. In Europe, pharmacogenomics is relevant in many clinical areas, including oncology, psychiatry, cardiovascular medicine, pain management, and infectious disease. It can reduce trial-and-error prescribing and may help avoid adverse drug reactions, which are costly for both patients and health systems.

However, wider use depends on more than science. European implementation requires validated tests, clinical guidelines, digital decision support, reimbursement, professional training, and national policies to regulate when testing should be offered. It also needs coordination between regulators, laboratories, clinicians, and payers. Pharmacogenomics therefore illustrates a broader lesson: even when evidence is strong, adoption depends on whether the healthcare system is ready to act on it.

EP PerMed is funding 22 research and innovation projects in the area of pharmacogenomic strategies for personalised medicine approaches through the EP PerMed Joint Transnational Call (JTC) 2025. Further details on these projects can be found in the JTC2025 Project Booklet and the EP PerMed project database.

Question 11

What Are Advanced Therapy Medicinal Products (ATMPs), and How Are They Linked to Personalised Medicine?

Accepted Answer

Advanced Therapy Medicinal Products, or ATMPs, are medicines based on genes, cells, or tissue engineering. They include gene therapies, somatic cell therapies, and tissue-engineered products. In Europe, ATMPs are regulated through a specific framework at EU level, with the European Medicines Agency playing a central role in scientific evaluation.

ATMPs are linked to personalised medicine because many of them are highly targeted and based on the biological characteristics of a patient or a disease. Some are developed for very specific patient groups, including people with rare diseases or cancers, defined by precise molecular features. They can offer major clinical benefit, but they also raise complex questions about manufacturing, evidence generation, long-term follow-up, affordability, and access.

For European stakeholders, ATMPs show both the opportunity and the challenge of innovation. Scientific progress alone is not enough. Health systems need pathways for assessment, delivery, specialised centres, and payment models that can handle high upfront costs and uncertain long-term outcomes. This makes ATMPs an important topic for personalised medicine, especially for policymakers, funders, clinicians, and innovators.

Question 12

What Is the Role of Artificial Intelligence and Digital Tools in Personalised Medicine?

Accepted Answer

Artificial intelligence and digital tools can help make personalised medicine more usable in real-world care. They can support image analysis, risk prediction, biomarker interpretation, patient stratification, clinical decision support, and the integration of large datasets from different sources. In research, they can also accelerate hypothesis generation and help identify patterns that would be difficult to detect manually.

In Europe, the value of Artificial Intelligence in healthcare, particularly in personalised medicine, hinges on trustworthiness and governance. Health data is sensitive and clinical decisions carry high stakes, so biased or poorly validated systems can cause harm. This is why European frameworks such as the AI Act, alongside medical device and data regulations, are so important. These frameworks aim to encourage innovation while ensuring safety, transparency, human oversight and legal certainty.

AI should therefore be seen as an enabler, not a substitute for evidence or clinical judgement. Its real contribution is to help professionals and systems manage complexity more effectively. The strategic challenge is to deploy AI where it adds value, validate it properly, and integrate it into care pathways in a way that supports both innovation and public trust.

Question 13

How Can Personalised Medicine Improve Diagnosis and Treatment Decisions?

Accepted Answer

Personalised medicine can improve diagnosis by helping clinicians understand the biological basis of a disease more precisely. In some cases, it can shorten the path to diagnosis, especially in rare diseases or cancers with complex molecular profiles. More accurate diagnosis can then lead to more informed treatment choices, better patient stratification, and reduced use of ineffective therapies.

On the treatment side, personalised medicine can support decisions about which drug, dose, or therapeutic strategy is most likely to work for a given patient or subgroup. This can improve outcomes and lower the risk of side effects. It can also help identify patients who may benefit from monitoring, earlier intervention, or referral to specialised centres and clinical trials.

For Europe, the benefit is not only clinical but also systemic. Better matching of patients to interventions may reduce avoidable expenses on treatments that do not work well. However, these gains depend on access to validated diagnostics, timely testing, multidisciplinary expertise, and digital systems that bring the right information into the clinical workflow. The challenge is therefore to embed personalised medicine into care pathways, not just to generate more data.

Question 14

What Are the Main Challenges in Bringing Personalised Medicine Into Everyday Healthcare?

Accepted Answer

The biggest challenge is that scientific progress often moves faster than changes to healthcare systems. Even when promising technologies exist, implementation can be slowed by fragmented infrastructure, uneven access to diagnostics, limited interoperability, insufficient training, uncertain reimbursement, and differences in national regulation or care pathways. As a result, patients in Europe may face very different levels of access depending on where they live.

Evidence generation is another key issue. Health systems need to know not only whether a technology works in principle, but also whether it improves outcomes in real clinical practice and is worth funding at scale. This can be difficult for highly targeted interventions, small patient populations, or rapidly evolving technologies. At the same time, introducing personalised medicine requires trustworthy handling of sensitive data and strong communication with citizens and patients.

In Europe, implementation is therefore both a technical and a governance challenge. The field needs cooperation between ministries, funders, hospitals, laboratories, regulators, health technology assessment (HTA) bodies, patient organisations, and digital-health actors. This is one reason why EP PerMed and ICPerMed place such strong emphasis on coordination, implementation support, and practical facilitators rather than research alone.

Question 15

How Can Personalised Medicine Be Integrated Into Healthcare Systems?

Accepted Answer

Integration begins with organisation, not just technology. Health systems need clear pathways for when diagnostic testing is indicated, who interprets results, how decisions are recorded, and how patients are informed. In practice, this often requires multidisciplinary collaboration between clinicians, laboratory specialists, genetic counsellors, pharmacists, data experts, and patient-facing professionals.

A second requirement is system readiness. Hospitals and healthcare networks need access to high-quality diagnostics, interoperable records, quality standards, digital infrastructure, and procurement or reimbursement models that do not separate testing from treatment decision-making. At policy level, integration also depends on regulation, health technology assessment, and evidence frameworks that are adapted to more targeted interventions.

For Europe, integration is closely tied to equity. Personalised medicine should not remain concentrated in a small number of highly specialised centres. Regional networks, reference centres, cross-border collaboration, shared data spaces, and common standards can help make adoption more consistent. The long-term goal is not to build a separate personalised medicine system, but to embed precision approaches into mainstream healthcare wherever they add value for patients and society.

Question 16

What Skills and Training Are Needed to Implement Personalised Medicine?

Accepted Answer

Personalised medicine requires a broader skill set than many traditional care pathways. Not all healthcare professionals need to become genomic experts, but they do need enough understanding to use molecular information appropriately, communicate uncertainty, and know when to refer to specialists. Depending on the setting, important competences may include genomics, biomarker interpretation, pharmacogenomics, bioinformatics, ethics, data literacy, and patient communication.

Training is needed across the system, not only for physicians. Nurses, pharmacists, laboratory professionals, bioinformaticians, clinical scientists, HTA experts, health administrators, and educators also play key roles. In many European countries, workforce preparedness is now one of the limiting factors for implementation. Without sufficient skills, even well-funded technologies may not be used effectively.

This makes education a strategic issue for Europe. Training should be embedded in undergraduate curricula and continuous professional development, as well as in multidisciplinary practice. It should also reflect the realities of different health systems and regions. EP PerMed can add value by identifying educational gaps, sharing best practices and aligning implementation requirements with funding and policy priorities. Along this line EP PerMed has published an Education Call and organises training sessions, workshops, summer schools and implementation schools.

Question 17

How Is Research and Innovation in Personalised Medicine Being Supported?

Accepted Answer

In Europe, personalised medicine is supported through a combination of EU programmes, national funding, regional initiatives, public-private collaboration, and strategic partnerships. Horizon Europe is the main EU framework for research and innovation, and personalised medicine is addressed through Horizon Europe Cluster 1: Health, infrastructures, data initiatives, and European Partnerships. At the same time, national ministries and funding organisations remain essential because healthcare and research capacities are organised differently across Member States.

Support is no longer limited to basic research. Increasingly, European action covers the full value continuum: discovery, validation, clinical studies, implementation, demonstration, data infrastructure, stakeholder engagement, and policy alignment. This is especially important in personalised medicine, where promising science often fails to translate unless the surrounding system is also prepared.

EP PerMed reflects this broader approach. Its role is not only to fund or coordinate research and innovation, but also to connect actors, align priorities, support implementation, and encourage learning across countries and sectors. This makes personalised medicine support more strategic and more practical. The question is not simply how to generate innovation, but how to make it usable, scalable, and equitable.

Question 18

Why Is International Collaboration Important for Personalised Medicine?

Accepted Answer

Personalised medicine depends on collaboration because many of its core challenges are too large for one institution or even one country to solve alone. Genomic and clinical datasets need to be large and diverse. Standards must be interoperable. Rare disease cohorts are often internationally distributed. Evidence, infrastructure, and expertise are spread across borders. This makes collaboration a scientific necessity as well as a policy choice.

In Europe, collaboration also helps reduce fragmentation. Without it, countries may develop separate standards, duplicate efforts, and struggle to achieve critical mass. European cooperation makes it easier to align funding priorities, share data securely, build reference networks, compare implementation models, and learn from successful practices in other systems. That is particularly important for smaller countries and regions that may not have the same infrastructure as larger Member States.

For EP PerMed, international collaboration is central because the partnership is built around coordination. Its value lies not only in funding projects, but also in bringing together ministries, agencies, funders, researchers, healthcare providers, citizens, patient groups, and innovators. In personalised medicine, collaboration is not an optional extra; it is one of the conditions that makes progress possible.

Question 19

What Role Do Regulation and Policy Play in Enabling Personalised Medicine?

Accepted Answer

Regulation and policy help determine whether innovation can be translated into safe, effective, and accessible care. In personalised medicine, this includes rules for medicines, diagnostics, data protection, AI, clinical studies, evidence generation, reimbursement, and cross-border data use. Without clear frameworks, even strong science may fail to reach patients in a timely or equitable way.

In Europe, regulation serves a double purpose. It protects patients and citizens by setting requirements for safety, quality, transparency, and rights. At the same time, it can create predictability for innovators and health systems. Examples include EU frameworks for medicines and diagnostics, the AI Act for high-risk AI systems, and the European Health Data Space for access to and reuse of electronic health data under defined conditions.

Policy is equally important because implementation depends on choices made by ministries, payers, funders, and public authorities. Those choices affect procurement, reimbursement, training, data infrastructure, and access. Personalised medicine is therefore as much a governance issue as a scientific one. Good policy can accelerate responsible uptake; poor policy can leave innovation stuck in isolated pilots.

Question 20

How Does EP PerMed Support Personalised Medicine in Europe and Beyond?

Accepted Answer

EP PerMed supports personalised medicine by acting as a coordination platform across countries, sectors, and stakeholder groups. Its role goes beyond funding research projects. It also helps align strategies, connect national and regional actors, foster dialogue, support implementation, and encourage the sharing of knowledge, tools, and good practice across Europe and internationally.

One of EP PerMed’s key strenghts is that it covers the entire value continuum of personalised medicine. That means it can support not only research and innovation, but also the conditions needed for real-world use: regulation, policy, education, end-user engagement, implementation, and strategic priority setting. This is particularly relevant in Europe, where responsibility is distributed across EU institutions, Member States, regions, health systems, and funding bodies.

For stakeholders, EP PerMed offers a platform for cooperation rather than a single programme with a narrow scope. It can help translate fragmented efforts into more coherent European action. In doing so, it contributes to a shared goal: improving health outcomes within sustainable healthcare systems through more targeted, evidence-based, and people-centred approaches.

Question 21

What Are the Benefits of Personalised Medicine for Patients and Society?

Accepted Answer

For patients, the main promise of personalised medicine is better matching between health needs and interventions. This can mean earlier diagnosis, more effective treatment, fewer side effects, more informed prevention, and care pathways that reflect the biological and personal context of disease more accurately. It may also help patients avoid unnecessary treatments and reduce the uncertainty that often comes with trial-and-error care.

The value for society and health systems lies in using resources more intelligently. If diagnostics can identify those most likely to benefit from a therapy, health systems may be able to improve outcomes while reducing unnecessary testing and treatment. Better targeting can also support sustainability, especially when therapies are expensive or when avoidable adverse effects place a burden on patients and hospitals.

At the same time, the benefits do not arise automatically. They depend on evidence, fair access, health literacy, trust, and implementation capacity. From a European perspective, the societal value of personalised medicine includes not only innovation and competitiveness, but also more patient-centred care and a stronger ability to respond to diverse health needs across populations. Its success should therefore be judged by real outcomes for citizens, not only by technological progress.

Question 22

What Role Do Patient Organisations Play in Advancing Personalised Medicine?

Accepted Answer

Patient organisations play an important role because personalised medicine should be developed with patients, not only for them. These organisations can help shape research priorities, highlight unmet needs, improve study designs, support recruitment and communication, and ensure that implementation reflects lived experience rather than technical assumptions alone. They also help translate complex developments into a language that citizens can understand.

In the European context, patient organisations are especially valuable in debates on access, ethics, equity, data use, and evidence. They can point to where systems are not working, where communication is unclear, or where innovation is reaching only a limited part of the population. In fields such as rare diseases and cancer, patient groups have often been important drivers of policy change and awareness.

Their contribution is strongest when involvement is meaningful and structured. That means early engagement, transparency, fair recognition of expertise, and support for capacity building. European initiatives such as EUPATI have shown that patient involvement works best when patients are given real opportunities to contribute across the research and innovation pathway. For EP PerMed, patient organisations are therefore strategic partners rather than external observers. As one of the first European Partnerships, EP PerMed has therefore developed a way to fund patient and citizen organisations as full consortium partners in the funded research and innovation projects.

Question 23

How Are Patients and Citizens Involved in Personalised Medicine Research and Implementation?

Accepted Answer

Patients and citizens can contribute at several levels. In research, they may help define priorities, co-design studies, shape informed-consent materials, improve communication strategies, and identify outcomes that matter in real life. In implementation, they can support awareness-raising, acceptability testing, service design, governance discussions, and evaluation of whether a new approach is understandable, useful, and fair.

Citizen involvement is particularly important in personalised medicine because the field relies heavily on sensitive data and public trust. People need confidence that data will be used responsibly, that benefits will be shared fairly, and that personalised approaches will not increase exclusion or discrimination. Engagement therefore has both a democratic and a practical function: it improves legitimacy and often leads to better solutions.

Across Europe, engagement practices are still uneven. Some initiatives have moved towards participatory models, while others remain mainly expert-driven. The direction of travel, however, is clear. Sustainable personalised medicine requires informed citizens, empowered patients, and governance structures that treat engagement as part of quality, not as an optional communication exercise.

Question 24

Why Are Health Data Governance, Privacy, and Ethics Important in Personalised Medicine?

Accepted Answer

Personalised medicine depends on access to health and genetic data, but these data are highly sensitive. Strong governance is therefore essential to protect fundamental rights, maintain public trust, and make sure data are used only for legitimate and well-defined purposes. Privacy, security, transparency, accountability, and appropriate safeguards are not barriers to personalised medicine; they are conditions for its responsible development.

Ethics also matters because personalised medicine raises questions about consent, incidental findings, fairness, explainability, discrimination, and unequal access. For example, a genomic test may reveal information relevant not only to one person but also to family members. Data-driven tools may work less well for underrepresented populations. People need to understand what is being collected, why it is used, and what protections are in place.

In Europe, this conversation is shaped by the GDPR, the European Health Data Space, and related legal and policy frameworks. The broader goal is to create a trustworthy environment in which data can support care, research, and policy without weakening citizens’ rights. Responsible governance is therefore a strategic enabler of personalised medicine, not just a compliance issue.

Question 25

What Is the Economic Value of Personalised Medicine?

Accepted Answer

The economic value of personalised medicine lies in its potential to improve outcomes while using resources more effectively. If diagnostics can identify which patients are most likely to benefit from a treatment, health systems may reduce spending on interventions that are unlikely to work and avoid some preventable side effects, hospitalisations, and delays. This is especially relevant where therapies are costly or where treatment response varies widely.

However, the economic picture is not always simple. Personalised medicine can require new tests, data infrastructure, specialised staff, and updated care pathways. Some interventions may have high upfront costs even if they offer long-term benefit. This means value cannot be judged by the price of a test or therapy alone. It must be assessed in relation to outcomes, the avoidance of ineffective or unnecessary interventions, time to diagnosis, quality of life, and wider effects on the healthcare system.

For Europe, economic value is closely linked to sustainability and access. Health systems need evidence that personalised approaches are both clinically meaningful and feasible at scale. This is why health technology assessment, real-world evidence, and implementation studies are so important. Personalised medicine should not only create innovation; it should also contribute to smarter, fairer, and more resilient healthcare.

Question 26

How Can Personalised Medicine Help Make Healthcare More Efficient and Sustainable?

Accepted Answer

Personalised medicine can support efficiency by reducing mismatch between patients and interventions. When clinicians have better information about disease mechanisms, likely treatment response, or risk of side effects, they can make more targeted decisions. This may lead to better outcomes, less repetition, fewer avoidable complications, and more appropriate use of limited resources.

Sustainability is also linked to prevention and earlier diagnosis. If health systems can identify high-risk groups more precisely and intervene sooner, they may reduce the burden of advanced disease and long-term complications. In the European context, this matters because many countries face ageing populations, workforce shortages, and pressure on health budgets. Personalised approaches can help, but only if they are introduced with evidence and system thinking.

This is why implementation matters so much. A personalised approach is not sustainable if it adds complexity without improving care. Europe’s challenge is to identify where precision genuinely creates value and then build the policies, data spaces, workforce, and financing models needed to support it. Sustainability in personalised medicine therefore depends on both innovation and responsible adoption.

Question 27

What Is Happening in Personalised Medicine at the Regional, National, and European Levels?

Accepted Answer

Action is taking place at all three levels, and each level plays a different role. At regional and hospital level, personalised medicine often advances through pilot services, specialised centres, laboratory networks, cancer programmes, rare-disease pathways, and local innovation ecosystems. Nationally, ministries, funding organisations, health authorities, and payers shape strategies, regulation, reimbursement, and capacity building. At European level, the EU supports research, partnerships, data infrastructure, coordination, and policy frameworks that help countries work together.

This multi-level landscape is both a strength and a challenge. It allows solutions to be tailored to local health-system realities, but it can also create fragmentation. Some countries move faster than others, and successful approaches are not always shared or scaled. That is why European coordination is so important in areas such as standards, data use, genomics, implementation learning, and strategic alignment.

Personalised medicine in Europe actually develops not through one single system, but through many interconnected layers. Understanding that reality helps explain why collaboration across governance levels is essential for making progress both faster and fairer.

Question 28

Why Is Coordination Across Regional, National, European, and International Levels so Important for Personalised Medicine?

Accepted Answer

Personalised medicine cuts across policy areas that are organised at different levels. Research funding may be coordinated nationally or at EU level, healthcare delivery is often regional or national, regulation may be European, and data infrastructures may require cross-border standards. Without coordination, each part can move in a different direction, creating inefficiencies, duplication, and unequal access.

Coordination helps align priorities and connect the full value chain, from discovery to implementation. It allows countries and regions to share evidence, harmonise approaches where useful, and learn from one another’s successes and challenges. This is especially important for rare diseases, genomics, health data, and advanced therapies, where scale and interoperability matter.

For Europe-based actors, coordination is also a question of solidarity and competitiveness. Better alignment can help ensure that innovation benefits more citizens, not only those in the best-resourced systems. At the same time, it strengthens Europe’s ability to develop trustworthy frameworks, world-class infrastructures, and collaborative research ecosystems. EP PerMed exists precisely because personalised medicine needs this kind of structured, multi-level coordination.

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Frequently Asked Questions (FAQ) on Personalised Medicine and EP PerMed

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Table of Content

Fundamentals of Personalised Medicine