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Biomedical Alliance in Europe

the BioMed Alliance

The BioMed Alliance represents over 400,000 healthcare professionals and researchers across Europe.

Lobbying Activity

Meeting with Flora Giorgio (Head of Unit Health and Food Safety) and European Patients' Forum (EPF)

15 Dec 2025 · Exchange of views on the current state of play of the medical devices Regulations reform proposal and discussion on the organisation of a conference on medical devices on the 16th of March 2026.

Meeting with Flora Giorgio (Head of Unit Health and Food Safety) and European Society of Cardiology

12 Dec 2025 · Exchange on matters related to the MDCG CIEPSE WG and on the upcoming conference on medical devices

Meeting with Flora Giorgio (Head of Unit Health and Food Safety) and European Hospital and Healthcare Federation

28 Nov 2025 · Exchange of views on the state of play and next steps for the medical devices sector.

BioMed Alliance demands ringfenced health funding in EU budget

12 Nov 2025
Topic — The consultation seeks input on the EU’s post-2027 budget and competitiveness funding.
Message — The alliance calls for a standalone, ringfenced health window within the new budget to address public health and patient needs. They argue that EU funding must look beyond commercial competitiveness to support medical research and preventative care.123
Why — Specific health windows would provide the financial stability needed for long-term medical research planning.4
Impact — Patients and civil society lose influence and care quality if health funding is deprioritized.56
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BioMed Alliance Urges Sector-Specific Rules for Digital Health

14 Oct 2025
Topic — The Commission's proposal to simplify digital regulations and reduce administrative burdens for businesses.
Message — The group requests tailored guidance for healthcare and relief for non-profit researchers. They also call for clarity on overlapping laws like the GDPR and AI Act.123
Why — This would allow medical researchers in resource-strapped hospitals to focus on patient outcomes.45
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Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics

6 Oct 2025

--Please find our response to the call for evidence attached-- SUMMARY: The BioMed Alliance supports the objectives of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to safeguard patient safety and ensure innovation. However, implementation has revealed significant challenges that must be addressed to protect patients access to safe, effective, and innovative technologies. The Alliance believes that the most pressing need is central coordination at EU level. Unlike the pharmaceutical sector, the current EU system for medical devices lacks a robust, centralised scientific and clinical authority. Fragmented advice from national authorities and notified bodies creates inefficiency, unpredictability, and duplication, with negative consequences for both patient safety and innovation. The EMA is best placed to assume this role. It already manages the Expert Panels and has a proven track record in regulatory science. Expanding EMAs remit to establish a medical devices division would provide the expertise, structure, and oversight which is urgently needed. This division should: offer early EU-level scientific and clinical advice to developers, coordinate and strengthen the work of Expert Panels, coordinate involvement by clinical assessors from notified bodies and National Competent Authorities (together with Expert Panels to provide advice and develop guidance), lead the development of common specifications and methodological frameworks for clinical evidence, oversee special regulatory pathways for breakthrough, orphan, and paediatric devices, provide a single point of contact for healthcare professionals and patients to report shortages, safety concerns, or device discontinuations. Beyond central coordination, the revision of MDR and IVDR should focus on: transparency of evidence (full publication of clinical studies and clinical evaluation reports is essential to support evidence-based practice), proportionate requirements (a methodological framework and common specifications are needed for medical devices; for IVDs, utilisation of laboratory quality data for post-market surveillance, and a patient-focus for in-house IVDs is needed), support for new technologies in special circumstances (specific pathways and requirements must be provided in legislation for breakthrough, orphan, and paediatric medical devices, and for niche IVDs), and system sustainability (a harmonised EU approach is required for issues such as the safe reprocessing of single-use devices, reducing waste and unnecessary costs).
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Response to European Research Area (ERA) Act

10 Sept 2025

The BioMed Alliance welcomes the European Commissions intention to improve research in Europe through the development of a new European Research Area Act. We hope that the Act will play a role in supporting the fifth freedom, the free movement of researchers, scientific knowledge, and technology in the EU single market, but it needs to be fit for purpose and not add unnecessary regulatory complexity. We support the intention to bring up national commitments to reach the 3% R&D target: by developing new legal mechanisms to support and incentivise public and private-sector R&D spending, alongside national plans to achieve the 3% of GDP investment target. We believe that national investment must be matched by strong funding at EU level, including for the next Horizon Europe, to support collaborative and cross-border research. In addition, funding for health research must be ringfenced due to its importance for European wellbeing and the economy. Strong health research funding is also necessary to strengthen European resilience against health threats and challenges such as population ageing, anti-microbial resistance, an increasing incidence of chronic diseases, climate change geopolitical tensions, and the emergence of new pathogens with pandemic potential. We also welcome the second policy action to reinforce the alignment of investments, policies and programmes around strategic priority areas between the EU and Member States and across Member States, by ensuring political coordination to promote joined-up EU and national-level investment in R&D and synergies with related policies. We believe that this is of particular importance in the health field, due to its unique nature and its impact on the health of European citizens and the strategic importance of the health and life science sector for the European economy and competitiveness. The COVID-19 pandemic has been a wake-up call, and in response to the crisis the EC implemented many new instruments and activities to foster collaboration and coordination among member states. The ERA Act should ensure strategic coordination across all health programs at national and European level based on the experiences and expertise of the different actors, by involving and consulting academia, patients, and private sector actors, as carried out in part by the EU public-private partnership program Innovative Health Initiative (IHI). Different stakeholders have been calling for strengthened coordination for years, starting with earlier support from BioMed Alliance and the Scientific Panel for Health for a unified oversight structure. The various stakeholders should continue the work to enhance coordination related to health and societal challenges, especially considering the increasing challenges that are on the horizon for the EU. BioMed Alliance also agrees that improvements in framework conditions for researchers can help promote a better circulation of researchers and scientific knowledge. However, the impact of any proposed changes on the sector must be carefully evaluated so that they facilitate research and not create any unnecessary barriers. For instance, improved legal frameworks and strengthening ethics and integrity must not add to regulatory complexity and put an additional burden on researchers. For more information, please also see the BioMed Alliance recommendations for FP10 as published in FEBS letters here: https://febs.onlinelibrary.wiley.com/doi/10.1002/1873-3468.70079
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Meeting with Sandra Gallina (Director-General Health and Food Safety) and

16 Jul 2025 · Exchange of views on the state of play and next steps for the medical devices sector.

BioMed Alliance demands health priority in EU AI strategy

5 Jun 2025
Topic — The European Commission is developing a strategy for AI use in science.
Message — The group demands health be a priority and insists medical experts lead policy recommendations. They advocate for transparency and rigorous clinical trials for AI-based medical software.123
Why — Professional involvement ensures healthcare practitioners retain authority over clinical AI standards.4
Impact — AI developers may face higher burdens through mandatory clinical trials and transparency rules.5
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Meeting with Rainer Becker (Director Health and Food Safety)

5 Jun 2025 · Biomedical Alliance in Europe workshop on “The Role of Health in the next EU legislative Framework”

BioMed Alliance calls for reform of European life science sector

17 Apr 2025
Topic — The European Commission is consulting on a strategy to strengthen European life sciences.
Message — They call for a reform of the life science sector through strengthening investment in research. They propose creating a multi-stakeholder structure to provide leadership and coordination for health research.12
Why — These measures would streamline research processes and formalize the time professionals spend on innovation.3
Impact — Competing sectors like defense and artificial intelligence would lose potential budget allocations to health research.4
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

21 Mar 2025

Clinicians in Europe were among those who advocated for reform of the previous EU medical device directives which was initiated by a public consultation in 2009. However, in the current MDR & IVDR there are still some persisting challenges affecting healthcare in Europe. European medical societies within the BioMed Alliance have written an elaborate analysis of key challenges and opportunities in the system based on the experiences of clinicians and laboratory professionals (see attachment). The analysis demonstrates that the reform of the EU medical device directives was needed, but both the MDR and IVDR have had unintended consequences. Issues that concern healthcare professionals include disappearing devices, the absence of special regulatory pathways, insufficient central capacity for managing the EU regulatory system, limited engagement of clinical experts, and insufficient transparency of clinical evidence. The report provides evidence and insights from the experience of healthcare professionals, of the consequences and impact of the EU regulations for medical devices and in vitro diagnostic medical devices. Detailed recommendations are made to address both shared concerns and those particular to each sector. The major need is development of a new coordinating management structure. The BioMed Alliance recommends that a medical devices division should be established within an expanded European Medicines Agency. Investment must support the establishment of EU networks of specialist regulators with clinical experience, supported by scientific and medical experts, with the shared capacity to advise and interact with developers, trialists, and manufacturers. Transparency, flexibility, and predictability are key. These need freely accessible specific standards and guidance for each major device type, within an overarching framework designed on scientific principles. Progress towards international regulatory convergence should also be accelerated.
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Response to Health technology assessment – Joint scientific consultations on medicinal products for human use

29 Oct 2024

The BioMed Alliance, representing 35 European medical and research societies, welcomes the proposed implementing regulation outlining the procedures for joint scientific consultations on medicinal products for human use at the Union level, as part of Regulation (EU) 2021/2282. Healthcare professionals and researchers agree that HTA should have a strong scientific basis, and we would like to offer the following remarks and suggestions for consideration: Experts selection: Evidence-based, high-quality HTA requires the participation of knowledgeable experts from diverse medical fields and stakeholder organizations. European medical societies can play a crucial role in helping to identify and recruit these experts. Furthermore, referring to "knowledgeable experts," it is important to clarify that expertise alone is not sufficient. EU HTA should prioritise the involvement of the best available expertsthose with specific, high-level expertise most relevant to the issue at handrather than relying on individuals who are generally knowledgeable. This distinction ensures that the HTA process benefits from the most relevant and impactful contributions. Medical societies depend on the timely sharing of information and clear and appropriate timelines for providing feedback, taking into account the busy schedules of clinical experts. Conflict of Interest: we emphasise that conflict of interest must be appropriately declared and managed, but that we take a balanced approach taking into account the realities of a sector where high-level experts are often engaged in multiple initiatives involving a wide range of stakeholders, including institutions and industry .
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Meeting with Tiemo Wölken (Member of the European Parliament) and European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry

14 Oct 2024 · Exchange on MDR/IVDR (staff level)

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

24 Jul 2024

The BioMed Alliance welcomes the proposed implementing regulation detailing procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment (HTA) and the Commission with the European Medicines Agency. We support the provisions in the implementing regulation that contribute to an efficient and timely exchange of information, and that enhance alignment between the European Medicines Agency (EMA), the HTA coordination group and the European Commission. Cooperation and coordination with the EMA is essential for the assessment of medicines, but also for medical devices including, but not limited to, through alignment with the Expert Panels on medical devices. The pursuit of synergies could help speed up HTA processes, improve their quality and reduce duplication. Evidence-based and high quality HTA depends on the involvement of knowledgeable experts from different medical fields and stakeholder organisations. We therefore support the exchange of information related to the identification of patients, clinicians and other individual experts to be involved in Joint Scientific Consultations and Joint Scientific Assessments. European medical societies can be important partners in helping to identify and recruit experts, but they rely on the timely sharing of information and appropriate timelines for providing feedback. We also reiterate that a balanced conflict of interest policy is necessary to ensure that the required expertise for the clinical assessment of medicines, medical devices and IVDs can be found. The HTA Coordination Group, European Commission and European Medicines Agency must agree on a common policy for assessing and managing conflicts of interest, that is pragmatic, transparent and takes a needs-based approach . We welcome the explicit statement in recital 6 that experts' involvement in EMA evaluations does not preclude their involvement in joint scientific assessments or joint clinical assessments for HTA purposes or vice versa, as long as transparency is ensured.
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Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

26 Jun 2024

The Biomedical Alliance in Europe (BioMed Alliance) and its 34 European medical and research member societies welcome enhanced cooperation on joint Health Technology Assessment (HTA). Such assessments must be evidence-based, and depend on the feedback of patients, clinicians and other experts in the health field. Transparency throughout this process is key. Declarations of interest must be shared, and risks of potential competing interests managed to reduce the risk of bias. The BioMed Alliance has supported the initial approach of the European Commission (EC) and European Medicines Agency (EMA) towards managing Conflict of Interest (COI). It was sufficient in minimising the risk of bias while facilitating the inclusion of relevant expertise in evidence-based policy making and regulatory decision making. Nonetheless, we are concerned that the recent Court of Justice ruling seems to be leading to more restrictive application of COI policies by the EMA and the EC. It is essential that the Implementing Act helps avoid overly and unnecessarily rigid interpretation of COI policies, and that all regulatory authorities and HTA bodies align and collaborate to ensure that COI policies are implemented in a way that enhances transparency whilst ensuring that the necessary expertise can be brought in, in the interest of patients and public health systems. Conflicts of interest cannot all be eliminated but the risk of bias can be managed. Many scientists and clinicians with the necessary expertise to provide an authoritative review of a new medicine or medical device, and particularly the leading experts, are likely to be involved in a variety of research, academic and regulatory roles. Transparency on these activities is key, and clear conflicts of interests that impact the quality of HTA processes must be addressed. However, a balanced and sufficiently flexible approach is necessary to prevent the exclusion of high-quality clinical expertise while taking into account the specificities of different medical fields. Recommendations: 1) Involving clinical experts must happen in a transparent manner, with mandatory declaration of interests and assessment of (potentially) competing interests on case-by-case basis. | 2) There is a need for sufficiently flexible policies for managing competing interests, taking into account that high level and competent experts may fulfil a broad range of roles and conflicts of interest cannot be fully eliminated. | 3) Medical societies should be consulted on and help with the identification of the best available experts, including and especially when very specific expertise is needed. These societies have their own conflict of interest policies, to manage bias and ensure high-quality expertise is included in their various activities. | 4) There is a need for differential approaches for niche fields, including in rare diseases, taking into account the smaller pools of experts with relevant knowledge. By maintaining too narrow conflict of interest policies it may not be possible to identify and involve any relevant expert in those specific fields. |
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BioMed Alliance urges mandatory expert involvement in clinical assessments

2 Apr 2024
Topic — The consultation concerns new rules for joint clinical assessments of medicinal products.
Message — The group calls for making expert consultation mandatory by changing the wording from 'may' to 'shall' in the regulation. They also request more flexible conflict of interest policies to allow niche experts with industry ties to participate.12
Why — This would ensure medical societies have a guaranteed role in selecting clinical experts.3
Impact — Transparency advocates lose if conflict of interest rules are weakened for industry-linked experts.4
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BioMed Alliance seeks flexible definition for unmet medical needs

8 Nov 2023
Topic — This consultation reviews EU pharmaceutical laws to improve medicine access and innovation.
Message — The alliance requests a flexible definition of unmet medical needs developed with professionals. They argue for retaining the Paediatric Committee and incentivizing drug repurposing.123
Why — Support for registries and expert bodies secures the alliance's professional influence.45
Impact — Public health systems may face higher costs from new antibiotic development incentives.6
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Response to Proposal for a Directive on cross-border activities of associations

28 Oct 2022

The Biomedical Alliance in Europe (BioMed Alliance) welcomes the efforts of the European Commission to ensure a full single market freedoms for associations, simplifying their cross-EU activities and promoting their fundamental rights. The BioMed Alliance is a non-profit organisation representing 36 leading European research and medical societies whose members are actively involved in health care and research from bench to diagnosis and from clinical practice to bench. Our members are professional non-profit medical association based in various European countries and they organize many cross-border activities. The particularity of European medical societies is that they provide services to the health community across Europe such as: congresses, educational events, courses, guidelines, health research and clinical practice activities. The current rules in different countries create obstacles and many barriers additional registrations, different VAT rules, lack of harmonization of cross border employment, different legal provisions of annual revenue allowance for NPOs, lack of mutual recognition of services provided by associations and NPOs such as training certifications (congresses, courses, educational events) from one Member State to another. We encourage the European Commission to take this seriously as it affects a 90 billion EURO a year industry, but also the capacity of medical societies to deliver unbiased services for EU health community. In the table below you can find concrete input and recommendations provided by the BioMed Alliance members to consider when putting together a legislative framework aiming at creating a single market for associations.
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Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur)

27 Oct 2022 · European Health Data Space - EHDS

BioMed Alliance Urges Stakeholder Role in European Health Data Space

27 Jul 2022
Topic — A proposal to facilitate the sharing of health data for research and patient care.
Message — The group calls for structural stakeholder involvement and scientific advice in the health data space's governance. They emphasize the need for harmonized data protection rules to remove barriers to collaborative research.12
Why — Harmonized rules would reduce the time and administrative effort currently spent navigating overlapping national regulations.3
Impact — Third-party researchers would lose immediate access to raw clinical data before primary research teams publish results.4
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Meeting with Margaritis Schinas (Vice-President) and

8 Apr 2021 · Health Union

Response to European Health Emergency Response Authority

24 Feb 2021

BioMed Alliance supports the intention to establish HERA and welcomes the inception impact assessment. We believe that with the necessary support, it may effectively address both current and future health threats, provide long-term horizon scanning and focus on unmet medical needs. The COVID-19 pandemic showed that the EU was insufficiently prepared for widespread cross-border health threats. We therefore recognise the need for a new agency that supports coordination of operations across the whole value chain and strategic investments for research, development, and deployment of medical countermeasures. HERA must receive the necessary resources and competencies so it can properly fulfill its intended purposes. It must be established as a full end-to-end authority to play a leading role in health emergencies (in line with policy option 3 in the inception impact assessment). If we want to bring health research in Europe to the next level, we must implement a HERA that is inclusive of all stakeholders. Stakeholders, and particularly researchers and health professionals, are a key element of health emergency response and should thus be important drivers of HERA. If appropriately developed, HERA will offer a unique opportunity to the EU to exercise scientific leadership, enable enhance inter-sector cooperation and increase exchanges between stakeholders and policy makers. HERA is a much-needed initiative to coordinate health emergency responses, but it is also time to implement a long-term approach to a European Health Union. We believe that HERA should be embedded in a forward-looking and science-driven environment facilitating research and innovation as a whole. Health issues are connected and a broad approach in health research is necessary, not only restricted to infectious diseases but also taking into account the increasing incidence of chronic diseases in an ageing population. It is thus time to be ambitious and explore what other structures are necessary to enhance coordination and effectivity of health research. Only by enhancing coordination at EU level for the entire biomedical health research landscape we will be able to strengthen European resilience against all future health threats and address pressing health issues. In short, we believe the following elements should be considered: - To be effective, HERA must receive the necessary support and should be established as a full end-to-end authority in order to streamline EU level initiatives to ensure a unified response to serious cross-border health threats (in line with policy option 3 in the inception impact assessment). - HERA should ensure synergies and coordination through different EU instruments and initiatives, including EU4Health, Horizon Europe and the next public-private partnership for health. - Proper implementation, cooperation and coordination among relevant EU entities, including EMA, ECDC, DG SANTE, DG RTD is vital. - Appropriate engagement of stakeholders in the development, implementation and operation of HERA is essential. Stakeholders must play a leading role in the implementation of HERA and must be involved from the early stages of its development. - Effective communication is necessary to obtain strong political support from Member States, the public and stakeholders. - We welcome the inclusion of training. Training of researchers and healthcare professionals in biomedical science should be an essential part of health emergency responses and the work of HERA. European medical societies have the expertise, facilities and contacts to assist HERA and would be happy to partner up. - It is time to look beyond and envisage the need for additional EU structures to enhance coordination and effectivity of biomedical health research. See our attached statement for more information, this should be read in conjunction with other replies of our members and EUHA. We look forward to continuing the conversation on this important new initiative.
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Response to A European Health Data Space

3 Feb 2021

The BioMed Alliance welcomes the European Health Data Space (EHDS). We believe it can play an important role in facilitating health data sharing to improve the health of European citizens. The 35 members of the BioMed Alliance contribute to this mission in multiple ways; they conduct health research, provide information and education to healthcare professionals and strive to improve European healthcare in general. They directly contribute to health data sharing, for example through data-driven research projects and databases and patient registries. EHDS can play an important role in facilitating health data exchange, which benefits biomedical research and allows healthcare workers to take better informed decisions regarding patient care. Eventually, EHDS could support the entire process from basic research, to the development of new health innovations, patient treatment and follow-up. To ensure the new EHDS becomes a success and plays an impactful role it must be implemented properly. It should follow a balanced approach, protecting privacy and ensuring patient trust in the system on the one hand while ensuring easy and appropriate data access and sharing for healthcare workers and researchers on the other. Careful planning, a broad discussion and involvement of all stakeholders are necessary to make it a success. The following elements should be considered: - EHDS should embrace the complexity of data and take an inclusive approach by ensuring the incorporation of a broad range of patient groups and disease areas and a number of data types. - It should integrate existing initiatives and data sources, and data gathered in clinical studies and patient registers, including joint analyses from different sources. - It should interlink with other efforts in the digitalisation of health and health data sharing and focus on addressing obstacles to the interoperability of IT infrastructure in the healthcare sector. - It should take a patient-centric vision and clearly identify objectives and challenges. - The involvement of a broad range of stakeholders should be actively sought throughout the preparation and implementation process and beyond. - A transparent approach is essential, and information for stakeholders like patients, healthcare professionals and researchers needs to be clear and concise. - The data in the EHDS should be high-quality, up to date and usable for health research and treatment decisions so researchers and healthcare workers are able to make full use of the system. - Trustworthy data processing depends on several elements, such as good communication, motivation for data sharing, impact of the results of data usage on improvement of patient outcomes, reducing harm, improving health systems efficiency and reducing cost. - Diverging application and interpretation of the GDPR among different actors has created barriers to health data sharing, and a uniform and balanced application across the EU is necessary. A code of conduct for use of personal data in health research will be a useful tool for greater harmonisation of approaches in the EU. The work of the TEHDAS Joint Action led by SITRA is thus essential for the success of the European Health Data Space. This code must be driven by key stakeholders and designed with and for researchers to ensure it considers the full complexity of data sharing in health research. - Education and skills development of health professionals and researchers using the EHDS is essential. CME/CPD activities could help familiarise them with technological developments and ensure the necessary skills to actively contribute to and use the EHDS. Medical societies are important players in CME/CPD, BioMed Alliance members can thus play a role by communicating to our broad network of healthcare professionals and researchers and partner with institutions to deliver capacity building through our scientific content and education activities. See our attached statement for more information.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

The Biomedical Alliance in Europe (BioMed Alliance) welcomes the new Pharmaceutical Strategy for Europe and the European Commission’s intention to create a holistic, patient-centred, forward-looking Strategy. We believe that it could play a key role in ensuring EU initiatives complement each other and help to further strengthen our much-valued healthcare system. Clinicians’ and researchers’ involvement in the lifecycle of pharmaceutical products is essential as they are active in the forefront of scientific discoveries, in academic clinical trials and in ensuring optimal patient treatment. We welcome the Roadmap and would like to draw your attention to the following points: Research should play a key role in accelerating scientific developments. Health research requires investment and prioritisation to make substantial leaps in advancing the health of European citizens and transform health systems. Health research is often scattered and operates in silos. EU initiatives have been a step in the right direction, but there are still missing links that should be considered. • There is a need for long-term strategic planning accompanied by a visionary leadership to strengthen biomedical and clinical research in Europe. • All stages in biomedical research from basic research to translation and clinical practice are interlinked and should receive necessary funding. • Skills development and continuing medical education of doctors are essential in ensuring outstanding care for patients. Medical and research societies have organised congresses, courses, e-learning but their work was heavily impacted by COVID-19 and they need help to continue their important activities. Academic clinical trials and publicly funded research should be facilitated to ensure important unanswered questions are addressed and medicines meet patients’ needs. While we acknowledge the key role played by the pharmaceutical industry in our health system, there are important research questions that will never be fully answered by a market-driven industry. • Public funds for clinical trials are key to ensure qualitative, evidence-based medicine, which reflects the needs of European citizens. • Market access should be supported by sound evidence for the clinical utility of new drugs. Independent research should also focus on treatment optimisation to ensure the most effective, efficient, and safe use of new drugs. • Support for repurposing studies, especially for old off-patent drugs, is needed to boost therapeutic progress. Academic research plays a crucial role, as the pharmaceutical industry does not always have the incentive to conduct these studies. • Guidance documents on clinical trials (especially ICHE6: Good Clinical Practice) need to be revised to ensure that the guidance is clear and proportionate and does not lead to excessive bureaucratic hurdles for academic clinical trials. The regulatory framework should be fully adjusted for the use of real-world data to encourage innovation in health research. The secure sharing of health data has numerous benefits in biomedical research and can help accelerate scientific developments. Nonetheless, researchers continue to face practical barriers to the analysis and sharing of health data that should be addressed. • Guidance on the GDPR application for health research, e.g. through the work of the Joint Action on GDPR implementation in the health sector, will be essential to ensure a harmonised framework. Cooperation on Health Technology Assessment is much needed to ensure patient access to innovative medicines. For medical and research societies, clinicians and patients, cooperation on HTA could streamline regulatory procedures, avoid duplication and enhance the quality and equity of healthcare across the EU. • It is essential that progress on the new regulation on cooperation on HTA is made as soon as possible. We look forward to continuing the discussions around this important new strategy.
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Meeting with Mariya Gabriel (Commissioner)

5 Feb 2020 · Health research, ERA, Horizon Europe priorities

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

8 Mar 2018 · European Reference Networks; Health research