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European Association of Urology

EAU

To act as the representative body for European urologists and facilitate the continued development of urology and all its supraspecialties; • To foster the highest standards of urological care throughout Europe; • To encourage urological research and enable the broadcasting of its results; • To promote contributions to the medical and scientific literature by its members; • To promote European urological achievements worldwide; • To establish European standards for training and urological practice; • To contribute to the determination of European urological health care policies; • To disseminate high quality urological information to patients and public

Lobbying Activity

Meeting with Maria Walsh (Member of the European Parliament, Shadow rapporteur)

19 Jan 2026 · Incontinence Care

Response to EU cardiovascular health plan

16 Sept 2025

We strongly support this effort to address the growing burden of cardiovascular diseases (CVDs) across Europe. However, we urge policymakers to explicitly include CVD and comorbidities as a pillar of the plan. CVDs do not occur in isolation, they are intricately linked with a range of other health conditions, including genito-urinary cancers and urological disorders such as bladder problems and erectile dysfunction, which are often early indicators or consequences of underlying cardiovascular issues. Prevention and early detection strategies, as well as effective management and treatment pathways require a multidisciplinary approach.
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Response to Gender Equality Strategy 2026-2030

11 Aug 2025

The European Association of Urology (EAU) welcomes the opportunity to contribute to the EU Gender Equality Strategy for 2026-2030. As the leading authority within the field of urology and with over 19 000 members from across the EU, the EAU remains dedicated to supporting policy-making that ensures access to quality urological care for all Europeans. We believe that collaboration between our organization and the European Commission can significantly contribute to the advancement of resilient and sustainable policies. In line with WHO European Region strategies, we would strongly encourage greater initiatives to understand how gender intersects with social, economic, environmental, political and cultural determinants of health, which influence exposure to risk factors and interactions with health systems. Addressing how all genders intersect with other social determinants of health is essential for evidence-based strategies that serve all communities (men, women, and LGBTQI+). Explicit actions and commitments to encourage engagement from civil society where there is underrepresentation are necessary. The goal should be active engagement from all communities - men, women, and LGBTQI+. Our full response is attached herewith.
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Meeting with Billy Kelleher (Member of the European Parliament, Rapporteur)

23 Jun 2025 · Inequality in health

Response to Apply AI Strategy

3 Jun 2025

The European Association of Urology (EAU) welcomes the opportunity to contribute to the AI Strategy -strengthening the AI continent call for evidence. As a leading authority in urological research and clinical practice, we are committed to advancing healthcare through innovative data initiatives and evidence-based approaches. One of our flagship initiatives is the UroEvidenceHub, a comprehensive platform designed to harness the power of big data, artificial intelligence (AI), and real-world evidence (RWE) to improve patient care across all urological conditions. This initiative aims to bridge the gap between clinical practice guidelines and individual patient characteristics, ensuring personalized and effective treatment options. The UroEvidenceHub will integrate data from various sources, including clinical trials, electronic health records, and patient-reported outcomes. By analysing this data, we can generate insights that inform clinical guidelines and decision support tools, ultimately enhancing the diagnosis, treatment, and management of urological diseases. For example, the Innovative Medicines Initiative (IMI) funded PIONEER project, a key component of the UroEvidenceHub, focuses on prostate cancer and has successfully standardized and integrated data from over 3.5 million patients. Our commitment to data-driven healthcare is further exemplified by our collaboration with other IMI projects, such as OPTIMA. These projects have significantly contributed to the development of the UroEvidenceHub, enabling us to provide personalized healthcare recommendations and optimize treatment strategies for urological cancers (around a 1/3 of all cancers), bladder disorders including incontinence, and kidney diseases. We believe that ethical use of RWE and Big Data becomes the building block of the development of AI tools which can drive better outcomes for urological patients. In order to underpin the potential opportunities of AI in healthcare we recommend the following: Ensure health as a critical sector in the development of the AI strategy. As part of this, urological health stands well positioned as a sector for development. Provide EU funds to speed up adoption of AI in health, including healthcare professionals as patients as key actors in the co-development of these tools in health. Dedicated testing and experimentation infrastructures in health, including sandboxes, to facilitate real-world AI validation require investment as well as interoperable federated data infrastructures, aligning with the European Health Data Space (EHDS) to support robust, cross-border health AI research. Ensure alignment with other pre-existing data initiatives in health, such as the EHDS, and data initiatives established under Europes Beating Cancer Plan, such as the European Cancer Imaging Initiative. Digital innovation is already underway, for example in the Uro Evidence Hub, and should be supported and enhanced by access to EU funds and capacity building. Foster Adoption of AI in health by supporting the upskilling and education of healthcare professionals and patients to become confident co-developers and users of responsible and ethical AI tools in health. Medical societies such as EAU with the UEH are already involving clinical members and patient organisations in this endeavour and can benefit from increased EU support. Ensure legal clarity and harmonisation on the implementation of AI tools in health, ironing out areas of legal complexity and confusion.
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Response to A European Strategy for AI in science – paving the way for a European AI research council

3 Jun 2025

The European Association of Urology (EAU) welcomes the opportunity to contribute to the European Strategy for AI in science. As a leading authority in urological research and clinical practice, we are committed to advancing healthcare through innovative data initiatives and evidence-based approaches. One of our flagship initiatives is the UroEvidenceHub, a comprehensive platform designed to harness the power of big data, artificial intelligence (AI), and real-world evidence (RWE) to improve patient care across all urological conditions. This initiative aims to bridge the gap between clinical practice guidelines and individual patient characteristics, ensuring personalized and effective treatment options. The UroEvidenceHub will integrate data from various sources, including clinical trials, electronic health records, and patient-reported outcomes. By analysing this data, we can generate insights that inform clinical guidelines and decision support tools, ultimately enhancing the diagnosis, treatment, and management of urological diseases. For example, the Innovative Medicines Initiative (IMI) funded PIONEER project, a key component of the UroEvidenceHub, focuses on prostate cancer and has successfully standardized and integrated data from over 3.5 million patients. Our commitment to data-driven healthcare is further exemplified by our collaboration with other IMI projects, such as OPTIMA. These projects have significantly contributed to the development of the UroEvidenceHub, enabling us to provide personalized healthcare recommendations and optimize treatment strategies for urological cancers (around a 1/3 of all cancers), bladder disorders including incontinence, and kidney diseases. We believe that ethical use of RWE and Big Data becomes the building block of the development of AI tools which can drive urological research and innovation. As such the EAU is mobilizing clinical researchers and research infrastructure to transform urological research and care. Recommendations to the European Strategy for AI in science: Health is a critical sector where there are many potential opportunities for scientific research and funding. Currently missing from the call for evidence, health must be a key priority. A central pillar of the future AI research council should be AI research in health. Research and funding for AI science in health should be maintained and increased during the next multi-annual financial framework. Dedicated testing and experimentation infrastructures in health, including sandboxes, to facilitate real-world AI validation require investment as well as interoperable federated data infrastructures, aligning with EHDS to support robust, cross-border health AI research. The AI Research Council should work closely with the AI Scientific Panel and Stakeholder Forum to ensure clinical and patient expertise is embedded in governance. Healthcare professionals and patients must be a cornerstone of the development and implementation of the AI in health. The AI research council should also mobilise their involvement, not only focusing on research institutions and universities, but also medical societies and patient coalitions as drivers of scientific change in medical fields. An AI research council should also assist with ensuring a clear understanding of the legal framework governing AI science in health.
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Response to EU Strategy on medical countermeasures

8 May 2025

Please find attached the contribution from the European Association of Urology.
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Response to EU Life sciences strategy

15 Apr 2025

The European Association of Urology (EAU) welcomes the opportunity to contribute to the EU Life Science Strategy call for evidence. As a leading authority in urological research and clinical practice, we are committed to advancing healthcare through innovative data initiatives and evidence-based approaches. We recommend the following to ensure the success of the EU Life Sciences Strategy: 1) The development of a governance and coordination mechanism for health research and innovation. This would support multi-disciplinary infrastructures and building blocks that act as the foundations of all research and innovation in health in a horizontal manner; 2) Support for research clusters, following the model of EUs Cancer Mission and Europes Beating Cancer Plan, on areas of health where there is a collective interest to develop and drive innovation. These clusters become a funnel for consistent EU investment and funding. We believe that urological health is well positioned to be developed as a health cluster where there is much underway to drive innovation. The initiatives started during the Cancer Mission and Europes Beating Cancer Plan should also be maintained and enhanced to continue deliver better cancer outcomes in the long term; 3) The health community must also receive regulatory support through legal clarity and harmonised frameworks. There are multiple regulations impacting the health sector, including horizontal legislation such as the AI Act and General Data Protection Regulation (GDPR) and sectoral legislation such as the Clinical Trials Regulation, the Health Technology Assessment Regulation, the Pharmaceutical Package, the European Health Data Space, the Medical Devices Regulation and IVD Regulation. This layering of Regulatory approaches means in practice that there can be a much confusion amongst practitioners, and sometimes duplicative and contradictory messages from implementing authorities. We believe there is a great value in implementing authorities working together, building collective expertise and issuing joint guidance for researchers and manufacturers. Additional support such as help desks will be necessary for some actors such as public health researchers, start-ups and non-profits. These help desks must be well resourced to give advice and support on legal pathways. Regulatory sandboxes for collaborative efforts with a clear public health benefit will be necessary. 4) Research and funding for health research should be maintained and increased during the next multi-annual financial framework. 5) Healthcare professionals and patient involvement must be a cornerstone of the development and implementation of the EU Life Science Strategy. Additional support and capacity building may be necessary to include these stakeholders in an effective manner. Please see the full feedback attached.
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Meeting with András Tivadar Kulja (Member of the European Parliament)

13 Mar 2025 · Urological diseases

Meeting with Elena Nevado Del Campo (Member of the European Parliament)

14 Feb 2025 · Health priorities

Meeting with András Tivadar Kulja (Member of the European Parliament)

4 Sept 2024 · European Cancer Plan

Response to Health technology assessment – Cooperation with the European Medicines Agency

22 Jul 2024

The EAU welcomes the draft procedural rules for exchange of information between the Commission, the European Medicines Agency and the Member State Coordination Group on HTA. The timely and effective exchange of information between these organisations will be vital to ensure implementation of the Regulation. It is also necessary and commendable to support synergies and complementarity between EU HTA and the regulatory approval processes (EMA and notified bodies). We would like to emphasise the important role that structured dialogue with clinicians and patients will play in both JSC and JCAs in describing the clinical and patient benefit derived from new technologies. Without this level of stakeholder consultation with the broader health system, it is unlikely that this information can be generated. We therefore supports the exchange of information related to the identification of patients, clinicians and other individual experts to be involved in JSC and JCA and call for this to happen in a timely manner. While some areas of the current procedural guidance benefit from clear timeframes for information exchange between the various actors, the information sharing with external experts does not. We believe it is important that the exchange of information between EMA and HTA Secretariat & Coordination Group does not delay the sharing of timely information with stakeholder organisations (asked to assist with expert identification) and individual experts (asked to contribute to JSC and JCA). We believe that the link with reputable stakeholder organisations is critical in facilitating access to individual experts, and sufficient time must be given to allow organisation to react and mobilise expert members of scientific committees and guidelines panels. We also welcome the explicit statement (recital 6) that experts' involvement in EMA evaluations does not preclude their involvement in JSC or JCA, and vice versa, as long as transparency of such engagement is ensured; In line with our previous response to the consultation on Conflict of Interest in HTA procedures (see here) we urge all decisions makers to agree on a common, pragmatic, transparent, needs-based approach to assessing COI, which fully recognises the dynamic role of scientific organisations and medical societies. This approach should fully recognize the dynamic role of scientific organizations and medical societies. It is essential that COI policies are implemented in a way that enhances transparency while ensuring that necessary expertise can be brought in for the benefit of patients and public health systems. Is this line we recommend: 1. Flexible COI Policies: We recommend a balanced, pragmatic and sufficiently flexible COI policy to prevent the exclusion of high-quality clinical expertise, especially in niche fields and rare diseases where expert pools are limited. 2. Consultation with Medical Societies: Medical societies should be consulted in identifying the best available experts. These societies have their own COI policies to manage bias and ensure high-quality expertise in their activities. 3. Transparency and Balanced Approach: Transparency in managing competing interests is key to maintaining high-quality HTA processes. Experts' involvement in EMA evaluations should not preclude their participation in JSC or JCA, provided transparency is maintained.
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Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

24 Jun 2024

The EAU welcomes the implementing Regulation on CoI in HTA, noting that it is essential to lay down clear CoI principles in order to apply transparency, impartiality and independence of views on these important assessments that play a crucial role in uptake of new technologies in healthcare systems across Europe. While the focus is rightly on representatives of the Coordination Group or individual experts invited to take part in a Joint Clinical Assessment, we would like to note that this does not recognise the significant role that medical societies such as the EAU play in supporting impartial and independent clinical and scientific guidance. Within the EAU, we use Cochrane methods to systematically review the most recent evidence in all areas of urological care (more information on methods found here). These reviews are used to annually update our clinical practice guidelines. Each guideline panel involves several members and key opinion leaders from across the EAU membership, and we have a strong CoI policy and process which is outlined here. Thus, in practice, when the EAU (as the leading medical society in urology in Europe) is asked by HTA agencies or regulators to submit names of individual experts for Joint Clinical Assessments, we submit names from the guidelines panels, who have the most up to date collective knowledge on the particular area. Thus, the individuals recommended via the EAU have already gone through our own CoI process in order to be able to work on a panel. More often than not, the individuals will respond on behalf of the guideline panel (not their own individual view), benefiting from the wealth of scrutiny and balance that working through panels and committees, relying on robust Cochrane methods, brings. Our own conflict of interest policy also acknowledges that The only person who does not have some vested interest in a subject is somebody who knows nothing about it (Smith R. Conflict of interest and the BMJ. BMJ. 1994 Jan 1;308(6920):45. PMID: 8298354). We note with some concern that the mere appearance of a conflict of interest may lead to individual representatives from being incompatible with joint assessments. We think this could lead to misunderstanding and confusion in practice. We call upon a level of pragmatism in terms of applying this implementing decision, ideally one that recognises where processes are already in place to bring to light any competing or conflicting interests, and where individual experts may be benefiting from methods in place within a broader panel/ scientific committee (such as those aligned with EAUs clinical practice guideline revision). We also note that in particular for rare conditions, most, if not all, individual experts will have some level of contact with the industry. Please find a copy with links attached.
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Response to A comprehensive approach to mental health

13 Feb 2023

While the EAU warmly welcomes the Commissions initiative on mental health, we have joined forces with members of the EAU Patient Advocacy Group (EPAG) such as the World Federation of Incontinence and Pelvic Problems and the International Continence Society to highlight the bi-directional relationship between mental health and incontinence. Mental health problems can trigger incontinence, and the difficulties faced by people living with incontinence and their loved ones can lead to stigmatization, stress and isolation, that fuels mental health challenges. Therefore, we strongly believe that the link between urological symptoms and mental health conditions needs recognition in any comprehensive mental health strategy at EU level and should be addressed through a cross-cutting theme on co-morbidities, including incontinence. Furthermore, research is urgently needed. We therefore call for translational research on mental health, including its related co-morbidities such as incontinence, to be included as a separate, additional workstream in the strategy. Please see our full response in attachment.
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Response to A European Health Data Space

25 Jul 2022

The European Association of Urology welcomes the Commission's Proposal. Please find attached our feedback and suggestions.
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Response to Cancer Screening Recommendation

21 Feb 2022

Please find attached the feedback from the European Association of Urology to the Call for Evidence.
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Meeting with Stella Kyriakides (Commissioner) and

24 Mar 2021 · Exchange of views on Europe's Beating Cancer Plan and the European Health Data Space

Response to A European Health Data Space

2 Feb 2021

We warmly welcome the much needed initiative of the European Health Data Space. Please find below the summary of recommendations from the EAU. A full explanation of our feedback is attached as a pdf. Governance – a shared vision based on trust - Ambitious resourcing and financing is needed to ensure strong engagement across the EU and with multiple stakeholders. It needs to bring together all the initiatives occurring at European level with a clear strategic agenda. - The eHealth stakeholder group could also act as a catalyst for engagement and communication but it would need increased resourcing, clear strategy, broader membership and various sub working groups to look into specific areas - In the same vein, the TEHDAS joint action of member states on GDPR governance is an excellent opportunity to involve stakeholders outside of national agencies in the decision making and knowledge sharing between member states. Healthcare professionals, professional medical societies, researchers and patients are critical stakeholders. Likewise, the targeted consultations mentioned in this inception impact assessment must include these groups in the decision-making process. - The EHDS must find a way for discussing governance models for ethics committees across EU member state. Multi-stakeholder ethics committees which incorporate members from citizens, patients, etc may be best placed to discuss the difficult issues around confidentiality and use of health data. Greater harmonization of GDPR - Greater harmonisation is incredibly valuable but must not come at the cost of being prohibitive to necessary and currently allowable health research. - The Commission must conduct a full assessment to establish a clear legal pathway for a harmonized approach which will not add an additional layer of bureaucracy to national legislation on derogations. - The GDPR codes of conduct mentioned in Art 40 are a bottom-up approach by different sectors. We strongly advocate for a bottom-up approach for codes, working through issues identified by the particular community in question, rather than a top down approach. - The EHDS needs to be grounded in a legal basis that acknowledges the complementarity of all health and research related legal basis in Arts 6 & 9 (2) of the GDPR rather than to reinforce unhelpful silos. One legal basis (ie consent) should not be favoured against the others for research. - The EHDS needs to work with EU Member States to build a European ecosystem of trustworthy health data sharing which may then allow for citizen opt outs for secondary processing. Harmonising standards - For research purposes, the EHDS should ensure that the OMOP CDM is added to the standards accepted and promoted by the EHDS, as well as the excellent work of EDSHI on EHR formats. - Incentivising data conversion: the cost of OMOP CDM data conversion is significant. More investment is needed to streamline the process, including funding for training and capacity building by professional medical societies. Incentivising data sharing bodies - Provide incentives for all member states to align with EHDS - The EDHS needs to provide a mechanism for European initiatives and build upon the experience of existing programmes. - EU funding should be earmarked for non-profit organisations such as the EAU who facilitate and promote secure and ethical data sharing platforms Capacity building and skills - Specific funding will need to be available for digital health and digital literacy programmes for professional medical societies and patients. - Invest in training programmes for efficient data conversion to OMOP common data model (CDM), especially persons with a combination of medical knowledge and basic understanding of process for OMOP CDM data conversion. - Encourage robust training methodologies - Fund joint initiatives on standardization and certification of healthcare professionals
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Response to Requirements for Artificial Intelligence

9 Sept 2020

The European Association of Urology, a membership organisation of more than 18 000 urologists from all over Europe, sees value in the use of Artificial Intelligence (AI) both in terms of the activities of our professional association (e.g and decision support and development of evidence based clinical guidelines), and in our clinical roles as medical professionals (e.g. in the early detection of cancer, treatment of tumours and other urological conditions, robotic surgery and for use in clinical trials). In urology, we already have experience of this important interaction between the uptake / use of novel technology and medical practice in the field of robotic surgery. In the use of AI technologies, medical professionals will often be users and/or deployers of these tools and will often be responsible for the ‘human oversight’ when they are used in care settings. It is therefore essential that these new technologies have checks and balances in place that ensure that they are safe and effective for their intended use, just as they would need to be in place for new medical devices or pharmaceuticals. Many of the AI tools we use in a clinical setting are likely to fall under ‘high risk’ devices mentioned in option 3b. Indeed, many are likely to have important legal and physical impacts on our patients (supporting decisions on treatments, for example) and the general public (when it comes to decisions regarding risk based screening, for example). These technologies will have an important impact on the medical profession, requiring the need for new skills and training, and a clear legal framework outlining responsibility and liability when things go wrong. Just like any new technology or pharmaceutical, it must be clear what functions any new AI tool has been proven to be effective and safe in delivering. In the case of AI, the limitations of the tool will directly relate to the limitations of the data driving the tool in the first place. The limitations of the data used must be explained in a clear and transparent way. A mandatory, stand alone, legal standard for high risk AI defined in 3b using a conformity assessment procedure (mentioned in the White Paper on AI) would give legal clarity on a number of these issues. For medical devices, this may also be achieved by updating of the relevant standards (ieg IEC 82304) linked to the Medical Devices Regulation. In terms of application of such legislation in the health sector, it must make provision for feedback from experts from healthcare professionals, patients and the general public. The medical world is rightly highly regulated already. It is a sector well used to asking ethical questions. The risks and benefits will need to be defined by all actors, including healthcare professionals and patients, payers and industry. There will be interaction with data protection, pharmaceutical and medical device legislation and the boundaries and complementarity must be carefully defined. It will be essential to understand the human oversight and control/ responsibility over which aspects of the AI device and this information must be clearly described to the user by the manufacturer. For this reason, there must be provision for opinions from healthcare professionals and experts imbedded into the AI conformity assessment process in the health sector. The Medical Devices Regulation, for example, has a included the creation of Medical Expert Panels through the JRC who will play a role in the assessment process of new medical devices. This model could be considered as a model to be replicated in any proposed AI legislation. The new regulatory approach must go hand in hand with a broader package of education, training and skills for medical professionals so that these tools can be safely deployed in the most effective manner, as outlined in the AI White Paper. European medical societies such as the EAU can support these initiatives.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

29 Jun 2020

The European Association of Urology commends the EC for addressing the availability and affordability of medicines across the EU and would like to make the following recommendations to the EU on its pharmaceutical strategy: *Patient centered innovation on basis of unmet need We join with other medical associations and patient organizations across disciplines who are unanimously calling for urgent actions to diminish bureaucratic burdens and move towards more patient-centered, independent (investigator-led), risk-based, pragmatic, efficient and cheaper clinical trials. In particular, our concerns are around the over interpretation of: - GDPR compliance – the work of the Joint Action on GDPR compliance for health data will be critical in trying to establish a more pragmatic, harmonized approach. - guidance documents (in particular ICH E6: GCP) need to be revised to ensure that the guidance is clear, concise, consistent and proportionate.The Guidance on the Management of Clinical Trials during the COVID-19 pandemic issued by European regulators shows this is achievable. Horizon Europe must also continue funding of evidence for the uptake of treatment post marketing authorization for clinical optimization and management of treatments available on the market. PROMs can act as tools to better capture value. Example: Towards the end of the year we expect the first PARP inhibitor to be approved for prostate cancer in Europe. The how and when to do costly molecular diagnostics is important and unsolved. We should avoid unnecessary testing but be prepared to initiate testing not too late on the course of the disease, think ahead for tissue samples or liquid biopsies, define a standard for the testing. Significant costs will arise in this area and we should be aware of new burdens and uncertainties to come for prostate cancer patients and the health care systems. *Harnessing the benefits of digital advances We support the Strategy’s commitment to this and underline the importance of involvement of all stakeholders in defining the evidence gaps and needs. Successful and effective stakeholder integration leads to the generation of relevant evidence to address uncertainties and support decision-making in relation to regulatory approval, HTA recommendation, reimbursement approval and patient access. A big challenge will be ensuring the maintenance of both the individual registries as well as the integrated data platforms (ie https://prostate-pioneer.eu/) to enable continued accessibility to researchers and clinicians looking to improve patient management. The evolution of the European health data space will play a critical role in how big data platforms can be maintained. As outlined by the Strategy, the Commission’s AI White Paper and future regulatory framework will influence how AI can safely and ethically support operations which will bring better treatments for patients. If AI is to be included into real-life clinical settings as a tool to support development of medicines for unmet need in health, healthcare professionals and patients must be included as essential stakeholders on its application to health. *Capacity building We would like to highlight the huge capacity and educational value of European medical societies in bringing new treatments and technologies to patients. Clinical practice guidelines, congresses and education work conducted by the EAU and other medical societies are key enablers of bringing innovation into clinical practice, and of establishing clear working arrangements of a multi-disciplinary team around patients, including on training of the appropriate application of medicinal products. The Strategy will need a vision of how to invest in medical societies impacted by providing supporting measures to ensure medical societies can continue fulfilling their role. *HTA Regulation We welcome the European Commission’s commitment to the HTA regulation - finding a way through the current impasse is essential.
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