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Cerus Europe B.V.

Cerus Corporation is dedicated solely to safeguarding the world’s blood supply.

Lobbying Activity

Meeting with Tiemo Wölken (Member of the European Parliament, Shadow rapporteur) and Flint Europe

19 May 2025 · Critical Medicines Act

Response to EU Strategy on medical countermeasures

9 May 2025

Cerus welcomes the Commissions ambition to strengthen the development and availability of crisis-relevant medical countermeasures (MCMs) in the EU. We strongly advocate for the recognition of sufficient and safe blood supplies as critical MCMs, underpinned by innovative technologies like pathogen inactivation, to enhance the EUs resilience against a wide range of health threats. The attached comments address key aspects of this call for evidence, highlighting blood supply resilience.
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Response to Critical Medicines Act

27 Feb 2025

Cerus Corporation welcomes the European Commission's initiative to establish a Critical Medicines Act. We urge the Commission to acknowledge the critical role of blood, blood components, and enabling medical devices in ensuring a resilient healthcare system. The attached document provides detailed recommendations on how to incorporate these essential elements into the scope of the Act, emphasizing the need for: Recognizing blood as a critical medicine alongside pharmaceuticals. Addressing blood supply sufficiency and resilience, particularly in light of emerging pathogens and climate-related disruptions. Ensuring the availability of critical medical devices required for the effective delivery of medicines, including blood components. Harmonizing implementation of the SoHO regulation and converging national procedures to guarantee high safety standards for blood products. We believe that a comprehensive approach, encompassing both medicines and the essential infrastructure for their delivery, will strengthen the EU's ability to respond to public health emergencies and safeguard the health of its citizens.
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Meeting with András Tivadar Kulja (Member of the European Parliament)

15 Oct 2024 · World’s blood supply

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

8 Feb 2023 · SoHO

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

6 Sept 2022

Cerus welcomes the European Commission's proposal for a Regulation on standards of quality and safety for substances of human origin (SoHO), as it presents an opportunity to further foster innovation and address the above challenges. Cerus supports the following policy objectives: • Equity of care and the elimination of transfusion-transmitted infections (TTIs) and related deaths via the implementation of high and uniform blood safety standards across the EU; • An innovation-friendly Regulation mandating regulatory bodies to provide guidance by setting out which technology or combination of technologies are eligible for use to deliver such results reliably; • An EU vigilance system reliably capturing all Severe Adverse Occurrences and implementing appropriate blood safety education and training for all relevant health care professionals; • A solid blood sufficiency and resilience strategy leveraging innovation to increase blood supply self-sufficiency and pandemic preparedness. Although the Commission's text proposes concrete and substantial improvements to the existing framework, Cerus is convinced that it could be further improved by: • Taking better account of the risks of contamination arising from the inherent properties of SoHOs, which are equally important to the risks arising from environmental factors; • Providing clearer incentives for Member States and SoHO entities to use processing technologies that reduce or eliminate any potential communicable pathogens; • Setting greater ambition for national emergency plans, including stronger provisions around risk assessment and periodic review so they become effective and reliable pandemic preparedness tools; • Ensuring that the ECDC’s standards-setting abilities take precedence and are efficiently implemented. Cerus looks forward to working collaboratively with the EU, health authorities, and SoHO stakeholders to ensure this Regulation creates a safer and more equitable future for all Europeans.
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