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European Blood Alliance

EBA

As the leading voice of public and not-for-profit blood establishments in Europe, EBA provides a reliable source of expertise and evidence-based information to both National and European Institutions and to stakeholders in the wider global Blood community.

Lobbying Activity

Meeting with Tiemo Wölken (Member of the European Parliament, Shadow rapporteur) and Sandoz International GmbH

14 Jul 2025 · Critical Medicines Act

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur) and Miltenyi Biomedicine GmbH

2 Jul 2025 · Health policy

Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

20 Mar 2025

The European Blood Alliance (EBA), representing public and non-profit blood establishments in 29 countries in Europe, welcomed the MDR and IVDR and their decisive contribution to a more harmonised framework across Europe, which we believe can lead to an improvement in the quality and performance of medical devices and in vitro diagnostic medical devices. The safety and quality of these devices is absolutely paramount and must remain a priority to any future changes to this legal framework. However, we stress that the implementation of the current MDR and IVDR raised many challenges and had unintended consequences which impact blood establishments today and are expected to continue doing so in the future. Firstly, we need a simpler and more coherent system. The current CE-marking system, relying on notified bodies, has shown its limits. The transition period was extremely problematic and despite a recent improvement of the situation due to increased capacity, the system remains fragmented, lacks consistency of practice and, in some notified bodies, specific expertise. Ultimately, the additional complexity and costs the new system introduced is having a considerable impact in the access to MDs and IVDs. Its also important to note that the MDR and IVDR exist in a wider legal framework and this raises additional challenges. EBA would highlight in particular the new SoHO Regulation and the ECDC and EDQM guidelines that establishments must comply with to meet the regulation standards. We stress the need for a close coordination between the two systems, to ensure optimal implementation of the rules and that legal complexity and costs are limited as much as possible. Given this context, and despite the recent increase in the capacity of notified bodies, EBA remains convinced that the EU must work towards the establishment of a pan-EU body for MDs and IVDs, with a role similar to the one played by the European Medicines Agency with regards to medicines. Secondly, we remain concerned that in some situations of rare blood conditions, the implementation of article 5 of the IVDR will be detrimental to the interests of some patients. The rules raise considerable obstacles (bureaucratic and financial) to testing for certain conditions and would considerably stifle the innovation developed inside and between reference laboratories for immunohaematology. In the paper attached EBA details the constraints faced by blood establishments in this area. EBA appreciates the ongoing dialogue that the European Commission has established with blood establishments, and we will continue contributing to ensure the availability of safe and effective devices.
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Response to Critical Medicines Act

25 Feb 2025

There are 17 plasma-derived medicinal products in the Union list of critical medicines (version 2). The starting material for these medicines is human plasma, some of which is imported from the US. In the attached response to the consultation, public and non-profit blood establishments, as the larger collectors of plasma in Europe, identify the main supply chain vulnerabilities and propose concrete ways to address them. Supply chain vulnerability 1: dependency on US for starting material and the need for increased plasma collection in Europe. Action required: The Critical Medicines Act, in line with the SoHO Regulation, should include provisions to support and encourage public investment in plasma collection programmes to increase Europe's strategic independence of the starting material for plasma-derived medicinal products. Such programmes must aim to build broad donor bases on the basis of voluntary and unpaid donations, with a view to establishing a longstanding and more resilient supply of these critical starting components. Support to these programmes should be promptly available from national authorities and from European programmes, such as the European Regional Development Fund or the Cohesion Fund. Supply chain vulnerability 2: a fragmented and complex donor-to-patient supply chain of PMDPs Action required: The Critical Medicines Act should launch the process to drafting a European strategy for a strategic independence of plasma-derived medicinal products, with the close involvement of all key stakeholders in the donor-to-patient supply chain, including donors, collectors, fractionators, manufacturers, physicians and patients. On a final but essential note, we must never forget that we are dealing with substance of human origin and with human donors, and ethical considerations and the wellbeing of donors must be priority considerations at all times, as mandated by European law and international agreements on bioethics.
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Meeting with Sirpa Pietikäinen (Member of the European Parliament)

13 Feb 2025 · Blood donations in EU

Meeting with Catherine Amalric (Member of the European Parliament) and European Brain Council and

18 Mar 2024 · Renew Europe Workshop on Healthcare in Europe and the patient-centric approach

Response to Report on the application of the General Data Protection Regulation

7 Feb 2024

The European Blood Alliance (EBA) represents public and non-profit blood establishments. Blood establishments are responsible for the collection, testing, and preparation of blood products for hospitals and pharmaceutical companies, and as such provide a public service that is essential for the functioning of healthcare systems. They also play a critical role in ensuring the safety and well-being of donors, recipients and patients, including through research. To be conclusive and verifiable, this work relies on a cross-border 'big data' approach, combining data from donor databases, electronic health records and public health registries. Eight years after the adoption of the GDPR, the main challenges to its successful implementation remain the fragmentation of the law and the lack of harmonised interpretation of certain aspects of the regulation. These two aspects were already highlighted in 2020, in the European Commission's first report evaluating the application of the GDPR which specifically addresses the lawful basis of Consent, Public Task and Legitimate Interests. Furthermore, it considers specific guidance on the processing of personal data for scientific research so that clarity is provided on the meaning of Recital 50 of the GDPR. This element is crucial as the vast majority of activity in blood establishments involves data processing for the provision of health and social care and research. It means, rather than the use of Consent, Public Task is used as the lawful basis of processing where the aim of the processing is linked to the processing of special category personal data as defined in Article 9 (1), balanced against the ability to process that same data lawfully, (in accordance with either Article 9(2)(h) or 9(2)(j)) which in turn permits compliance with Article 89(1). Using the legislation in this specific way facilitates overall compliance with Data Protection principles, in particular Article 5(1)(f). This should be encouraged throughout the EU. As big data processing becomes more prevalent across all member states, it should be noted that several EU legislative initiatives are currently making important contributions to this work, such as the Substances of Human Origin (SoHO) Regulation and the European Health Data Space (EHDS) Regulation. The future EU SoHO platform will support the exchange of information between competent authorities and SoHO establishments (e.g. blood establishments) and, importantly, allow the collection, monitoring and publication of data on donations, clinical use and adverse reactions involving SoHO. The future EHDS should enable blood establishments to link donor and transfused patient data and to accurately assess health-related events in both donors and patients. To be useful resources for the protection of donor and patient health, these tools must allow for the unambiguous linking of donor and transfused patient data and the accurate assessment of health-related events in both donors and patients. EBA is concerned about the interaction of these initiatives with the GDPR. From our experience in the EU-funded SUPPORT-E project, which supports a high-quality evaluation of COVID Convalescent Plasma (CCP) across Europe, many countries have different approaches to data sharing and the definition and understanding of both pseudonymised and anonymised data. This prevented many countries from sharing their data in the EU CCP database at a critical time when the world was racing to find solutions to tackle the pandemic. Even in such urgent circumstances, this was only partly resolved when the European Commission issued an official clarification. Even then, some countries, such as Denmark, were still unable to publish key data for this work. This example amply illustrates the need to understand the application of key definitions to deliver a stricter, harmonised framework across the EU. The success of the GDPR, and of all the instruments based on it, depends on this.
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Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

24 Oct 2023 · SoHO

Response to Evaluation and revision of the general pharmaceutical legislation

17 Oct 2023

The European Blood Alliance, representing public/not-for-profit blood establishments, welcomes the European Commissions publication of its proposal for a reform of the EU pharmaceutical legislation. The review aims to reach a number of important goals, such as improving access to innovative medicines, promoting innovation in the sector and addressing shortages. These important objectives should not be reached at the detriment of other key sectors in public health, such as the safe and sustainable supply of blood components and other substances of human origin (SoHO) to everyone in Europe. - Need for a better defined border between SoHO and medicinal products It is therefore crucial that the proposal for a Directive on the Union code relating to medicinal products for human use is as clear and categorical as possible in defining SoHO-derived medicinal product. The proposal needs to be improved in this respect. The definition of SoHO-derived medicinal product other than ATMPs in Article 4 number 1 (31) of the proposed directive leaves too much room for interpretation and there is a serious risk of inadvertently including blood components that should and must be regulated by the current blood directive and, in the future, by the SoHO Regulation. Examples of what could be interpreted as medicinal products include platelet concentrates, granulocytes concentrates, serum eye drops, and blood components which have undergone pathogen inactivation and/or other processes that keep blood products safe. To consider these as medicinal products would be incorrect and would bring severe disruption to the work of blood establishments in ensuring the safe and sufficient supply of blood components. While legislators must ensure that the definition is as clear as possible, we acknowledge that there will be doubts when new products are developed on the border between SoHO and medicines. EBA welcomes the provisions in article 201 of the proposed directive stating that in the event of doubt about the regulatory status of a human border product, the European Medicines Agency (EMA) must consult the SoHO Coordination Committee (SCB). This should lead to more consistent advice. - Protection of donors and patients EBA also welcomes the important reminder, in Article 1 number 7 of the Directive, of the ethical framework within which the collection of substances of human origin used in the production of medicinal products must take place. Such collection must always happen respecting the principle of voluntary unpaid donation, as defined by the future SoHO Regulation, as a way to ensure the safety and wellbeing of donors and patients. - ATMPs prepared under hospital exemption Finally, EBA welcomes the proposal to safeguard and strengthen of the Hospital Exemption. The introduction of measures for data collection, reporting and regular reviewing will improve transparency while the increased responsibility of Member States regarding GMP compliance, traceability, pharmacovigilance and notification of revoked authorisations will ensure harmonisation of HE practices and safety for patients. EBA will now work closely with all legislators in the process ahead to seek clarifications and complement this proposal. About EBA The European Blood Alliance (EBA) represents public and not-for-profit blood establishments in 25 countries and which in total account for over 20 million donations every year. Blood establishments are responsible for the collection, testing, preparation of blood products to hospitals and pharmaceutical companies and as such they provide a public service, essential to the functioning of health systems.
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Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

25 Jan 2023 · SoHO

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament, Rapporteur)

25 Jan 2023 · SoHO Regulation

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament, Rapporteur)

25 Oct 2022 · SoHO regulation

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

29 Sept 2022 · Blood, Tissues and Cells Regulation

Response to Revision of the Union legislation on blood, tissues and cells

7 Sept 2022

The European Blood Alliance, representing public/not-for-profit blood establishments, welcomes the European Commission’s proposal for a SoHO Regulation and is pleased with the general direction of the proposal and its level of ambition. We welcome in particular the strengthening of the health protection for donors and patients and recipients and were pleased to read the references to the European Charter of Human Rights (ECHR) and specifically to “integrity of the person”. The setting up of the SoHO platform and of cross-entity registry exchanges have great potential to enhance donor and patient health, both on a day-to-day basis as well as in terms of long-term research. More detail is now required to ensure they become useful tools, while avoiding unnecessary burdens on the system. Some elements still need work, for instance the notions of “frequent and repeated” donation or “donors that donate repeatedly” need to be more detailed. Still on donor health, EBA believes it is important that the regulation also reaffirms the principle of “absence of profit on the part of the establishments involved in blood transfusion services”, currently in the blood Directive. Another very positive element in the regulation, key to donor and patient health, is the reaffirming of the principle of voluntary non-remunerated donation. In addition to referencing the work of the Council of Europe in this area, EBA would nevertheless welcome a clearer definition of “compensation”, as well as a clearer European framework on how member states can ensure that financial neutrality is respected, in particular when fixed rate allowances are considered. When it comes to the scope of the regulation, EBA would like to see a firmer delimitation of the legal framework when it comes to the relationship with other EU regulation. EBA was pleased to see the recognition of the importance of building and supporting a strong public and non-profit sector for ensuring resilience and continuity in supply of SoHO. We believe that the EU should be even more ambitious: the regulation should require Member States to develop national plans addressing the sufficiency of supply of blood components through voluntary non-remunerated donations. Specifically on plasma, the regulation should foresee the development of a EU strategy, with timeframes, to address the current European dependency on third countries for the plasma required for plasma-derived medicinal products (PDMPs). Still with the aim of strengthening supply, the Regulation should be clear that building resilience and continuity hinges on Member States developing a broad donor-base composed of mostly infrequent donors. EBA welcomes the proposal to incorporate the expertise of EDQM and ECDC. While this should allow for a regulatory framework that is future-proof and better equipped to deal with crisis, the regulation is silent on the requirements for these bodies to ensure the appropriate level of expertise and transparency. EBA also welcomes the introduction of an appropriate risk-based frequency for inspection of SOHO facilities, with a maximum interval between two on-site inspections extended to four years instead of the current two years. Finally, EBA wishes to point out that provisions related to SoHO safety during infectious disease outbreaks are missing, in particular regarding the roles that different levels and institutions should play during national or multi-country outbreaks, in terms of risk assessment and risk management. Also missing are references to technical capacity in our SoHO systems. Although not an EU competence, Member States must be encouraged to establish transfusion medicine as an independent medical subject with structured training, including programmes for continuous medical education for all medical staff. We urge the European Commission and other legislators to continue working with blood establishments in the legislative process ahead. Attached is a more detailed response.
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Response to A European Health Data Space

28 Jul 2022

The European Blood Alliance (EBA) welcomes this proposal on the European Health Data Space (EHDS). European blood establishments represented by EBA have regularly asked for more and better data to increase donor protection and reinforce patient care; we believe that the EHDS can be a fundamental tool in working towards these goals. EBA has been calling on the EU and Member States to reinforce donor vigilance requirements through a pan-European donor vigilance programme. We believe that the reporting of data on Substances of Human Origin (SoHO) should be further developed and that such systems should provide public access to key anonymised data on European registries, including clinical follow up, which would support enhanced transparency on donor health. EBA has also called for data across the EU to be pooled, in full compliance with the General Data Protection Regulation (GDPR). Allowing researchers and clinicians access to these registries would be an incentive to improve their reporting and enable practitioners to evaluate the efficacy of SoHO safety measures. EHDS should provide the basis for this work. EBA is pleased that the new Commission’s proposal for a Regulation on substances of human origin also goes in this direction and we urge legislators to ensure both EHDS and the SoHO Regulation are well aligned in this respect. There are many examples of how pooling this data across Europe can enable enhanced protection of both donors and recipients. For example, as Europe works to limit its dependency on third countries for human plasma to develop plasma derived medicinal products (PDMPs), it is extremely important to understand the long-term effects of plasma donation, particularly in situations where frequency is increased. There are also several studies trying to understand possible transfusion-transmission of certain conditions through donations, such as cerebral amyloid angiopathy (CAA). To be conclusive and verified, these studies rely on a ‘big-data’ approach to hemovigilance with the use of data from electronic healthcare records and health registers. EBA would like to stress that for EHDS to be a useful resource in this respect, it must include methods to unambiguously identify and trace individuals (donors or transfused patients) as they come in contact with the health care system throughout the rest of their lives. Despite the potential of the EHDS, EBA also has some concerns regarding the proposal in its current state. Future implementing and delegated acts must ensure that EHDS does not become a burden to healthcare professionals in general and workers in blood establishments in particular. EBA is also concerned about the interplay with other EU legislation, such as GDPR. From our experience in the EU-funded SUPPORT-E Project, which supports a high-quality evaluation of COVID Convalescent Plasma (CCP) throughout Europe, many countries have varying regulations regarding data sharing and the definition of anonymised data. This blocked many countries from sharing their data on the EU CCP Database and was only minorly resolved when an official statement from the EU was issued. However, some countries, such as Denmark, were still unable to publish their data. Finally, EU legislators should ensure that EHDS-related measures are compatible with the digital infrastructure and capacity in Member States, or foresee the resources and time required to set those in place. Blood establishments play a central role in the supply of blood components and are therefore crucial players in a high-performing and resilient European health system. We urge EU legislators to establish forms of regular dialogue with blood establishments to ensure that the EHDS architecture becomes a tool for both better donor vigilance and patient safety while avoiding adding complexity to an already challenging environment.
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Meeting with Maria da Graça Carvalho (Member of the European Parliament)

10 Feb 2022 · Blood-related diseases and related policy

Response to European Health Emergency Response Authority

23 Feb 2021

The European Blood Alliance (EBA) agrees with the context, problems, issues and objectives identified in the Inception Impact Assessment (IIA). The EBA highlights that the EC response must be flexible and generic for all major crisis not just pandemics. The risks to the EU and its member states of not having a safe and sustainable blood supply is life threatening. Blood and Blood Components (BABC) are the lifeline of the European healthcare system. Without it people will die. A safe and sustainable blood supply is a basic human right for every European citizen. All EBA member were directly impacted by COVID-19 via their day-to-day operations, their ability to provide possible solutions (e.g. Convalesent Plasma, the development of Hyper immune products), and their capacity to provide urgent testing, quickly and on mass. Blood Establishments (BE) in the EU already contribute to surveillance depositories and emerging viruses. EU funding for R + D in these areas is critical. There are risks inherent to open and free trade to the EU and Member States of not recognizing or regulating the supply of outsourced critical material in time of acute need. EU legislators must ensure the EU can scale up vital supplies of certain products e.g., vaccines and PPE ensuring supply to all member states is fast, equitable, fair and efficient. EU members different lockdowns and internal travel restrictions caused BE major challenges re. donors attending clinics, clinic venue availability and BABC supply contingencies becoming vulnerable. EU legislators must recognise and support European Blood Establishments to ensure supply of BABC in times of crisis. Furthermore EBA can assist the EU to prepare better for future crisis. EBA supports the creation of a Europe of health that will be based on the capacity to respond to and cope with future pandemics in a spirit of solidarity, but also on better coordination of preventive actions and the search for industrial autonomy in the field of health. On the 4 suggested policy options: The EBA favours the creation of a stand alone authority (HERA) as described in option 2 able to act on decisions quickly. The sub-options as currently described are incomplete solutions, both must be realistic and need more elaboration. The EBA reasserts the importance of individual EU members maintaining the right (legislation) to act at a regional, and national level to respond to such crisis on an individual basis if necessary. Contingency planning and crisis preparedness are already successfully performed by many EU members. Option 0 : An adhoc (unprepared) solution with limited input from the Health programme will not deliver an effective crisis response for all member states. Option 1 : The coordination describe brings an added value but it should be done under the supervision of a permanent authority and not the EC. Sub- option 2.1: The scope, role and tasks of HERA should be well defined, especially when it comes to its interaction with other EU agencies e.g. ECDC and EMA. Stockpiling of medical products and PPE, the development of joint public procurement and research and innovation policies must be a high priority to ensure our preparedness for future pandemics. However, smart stockpiling is key as there are complexities of stockpiling specialist products for EU members involving - different quality standards / specifications, expiry dates, FIFO, product recall, narrowing – interfering with the free market. Complicated logistical requirements must be identified and resolved. Sub- option 2.2 In addition to all the above, further clarification on the scope and the meaning of “access network” are required. Option 3 The EBA believes this option is workable but as it stands it could be too autocratic and inflexible. Further clarifications on who decides when a crisis is ongoing and where actions are are needed.
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Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

1 Feb 2021

The European Blood Alliance (EBA, www.europeanbloodalliance.eu) welcomes the proposal for a European Medicines Agency (EMA) increased role in crises preparedness and management of Plasma-Derived Medicinal Products (PDMPs) supply. Not-for-profit Blood Establishments provide plasma for the manufacture of PDMPs within the EU Blood Directives, EU Medicinal Directives and the EU Medical Devices/in vitro regulations, under different frameworks defined at national level. As the impact of current COVID-19 pandemic has demonstrated, the significant dependency of the EU Member States on US plasma for PDMPs may lead to shortages in some Member States. It is therefore EBA’s opinion that PDMPs should be included in the proposed regulation on a reinforced role for the EMA in crisis preparedness and management for medicinal products and medical devices. It is important, however, that the EMA consults EU Substance of Human Origins (SoHO) authorities with the same collaborative approach that is already in place between national competent authorities for blood and medicinal products in order to jointly ensure that all European blood establishments are fully involved into the decision-making process for PDMPs. The usage of polyvalent immunoglobulins, which are currently the driving product of PDMPs manufacturing processes, including the volume of plasma needed to guarantee their adequate levels of self-sufficiency, should be systematically monitored in the European and national contexts. Furthermore, the definition of the levels/goals of national and European self-sufficiency of plasma from non-remunerated donors should be made in conjunction with Member States. In order to provide the EMA with an extended role as set in this proposal, it is essential that the epidemiological data are made public in order to justify its decisions through a transparent and evidence-based approach.
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Response to Revision of the Union legislation on blood, tissues and cells

14 Dec 2020

EBA agrees with the gaps and issues identified in the 1st part of the IIA and highlights the following: Reliance on 3rd countries on plasma for PDMPs is in part due to off-label non-evidence-based use.The EU needs to support more research on efficacy of the plasma-based products for a number of diseases while Member States (MS) need to increase their plasma collection from the not-for-profit sector EBA strongly supports the principle of voluntary unpaid donation (VUD). Although the EU should respect MS’ competence, VUD, being a fundamental notion, should not be left entirely up to MS. EBA urges EU legislators to maintain it in the next texts. Leaving the choice to MS on whether or not to implement VUD would deny the very concept of a common European framework.The EC should promote and support activities which would increase plasma donations from VUD donors. On the evidence available one cannot conclude that potential shortages of supply are due to VUD On the 4 policy options Blood is not a commodity and its specificities should not be dealt with through the ECJ. It should be legislated for at EU level based on Public Health principles and not on internal market ones irrespective of its end use. EBA favours Policy option 2 as the best solution. The role and tasks of ECDC and EDQM should be well defined. Strengthening oversight and audit by the EC are welcomed as per option 1 but must be realistic and performed by experts in the field. EBA supports a change in the scope of the BTC legislation in terms of clarity and increased flexibility and to include novel substances of human origin both those currently used in an unregulated fashion, as well as new ones coming on line. EBA reasserts the importance of VUD while reviewing novel substances of human origin EBA welcomes the proposal to strengthen donor vigilance, in particular in reporting adverse reactions and ensuring more donor protection. However, the latter should not be confused with testing donors, in particular in the tissues and cells sector. Contingency planning and crisis preparedness, mostly through a constant monitoring of supply and demand, is already performed at national level even in the context of COVID-19. A pan-European central hub for data pertaining to supply and demand would be welcomed*. Support by the EC to allow IT systems interoperability would help in reaching this goal Policy option 1 will not support cross-country harmonisation and trust,which could be a source of an inhomogeneous situation in the EC.The option will be difficult to implement for smaller countries. It could also generate heavy bureaucracy and reporting duties. Policy option 3 is similar to the existing legislative framework which proved to be too slow and not flexible enough. The role of the comitology would be a duplication of the EDQM and ECDC; it would call for additional costs and resources Combining policy options would require very robust definitions. On the basis of experience acquired with COVID-19 Convalescent Plasma, in circumstances where an acute novel response is required, the EC should only make recommendations on minimum requirements and not enforce strict binding technical rules as these may eventually fall foul of emerging evidence. On the preliminary assessment of expected impacts EBA supports the analysis on likely economic and social impacts, underlining the importance of donor protection, although option 1 risks increasing inequalities on the latter When addressing likely impacts on fundamental rights, the legislators must bear in mind VUD and non-discrimination principles for all donors. Donor selection should be made on the grounds of a risk assessment respecting the right of blood recipients to the protection of their health. On the impacts on simplification and/or administrative burden, EBA notes that option 1 would not allow simplification for blood establishments and the additional costs for the latter and competent authorities will be a source of inequality
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Meeting with Anne Bucher (Director-General Health and Food Safety)

17 Jan 2019 · courtesy visit, presentation of activities

Meeting with Vytenis Andriukaitis (Commissioner) and

2 May 2016 · Voluntary and unpaid donations, EU legislation on blood