SoHO Regulation: Vibrant discussion in European Parliament

There was a packed room in the European Parliament for “Blood establishments and the new SoHO Regulation: Protecting donors, delivering for patients”, the event organised by EBA on 25 January. Co-hosted by MEPs Nathalie Colin-Oesterlé, Nicolás González Casares, and Tilly Metz, over 70 people on-site and over 150 on-line attendees also heard from representatives of EBA, the European Commission, donors, patients, and health professionals.  

Ahead of submitting her report to the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) on February 9, French MEP, and rapporteur for the Proposal, Nathalie Colin-Oesterlé used the event to share her three priorities in the report: protection of donors and recipients; upholding of principle of voluntary and unpaid donation; and increased harmonization between Member States. Read report summary

Spanish MEP González Casares, shadow rapporteur for the S&D Group, highlighted the need to bring EU rules up to speed to facilitate scientific developments and the urgency in focusing on plasma sufficiency in EU while maintaining compatibility with the principle of voluntary and non-remunerated donation (VNRD).  

When closing the event, MEP Tilly Metz, shadow rapporteur for the Greens, highlighted three proposed additions to the proposal: the importance to keep voluntary unpaid donations and to support public services; the strengthening of stakeholder involvement; and the need to prioritise data protection of donors. 

Opening the event, EBA president Pierre Tiberghien welcomed the new proposal, reminding legislators that 15 million blood donors allow 4.6 million patients to be transfused every year and that we cannot afford to get this revision wrong. Representing DG SANTE of the European Commission, Stefaan Van der Spiegel spoke of how the new proposal for a SOHO Regulation improves protection and wellbeing of donors as well as patients (Read presentation), referencing also the SUPPLY project. 

This was followed by an excellent presentation of EBA’s position on the SoHO Regulation proposal by Marjolaine Jacques, co-chair of EBA’s working group on EU Directives. A new leaflet summarising EBA position was shared with participants. Download leaflet

Alice Simonetti from FIODS, speaking on behalf of donors associations, welcomed the EU proposal’s focus on donor protection but stressed that blood and plasma donors are equally committed and that the new rules should not introduce changes to how we treat donors based on type of donation as that would undermine donations in Europe. 

Moving the focus to sufficiency of supply, Philippe Vandekerckhove from Belgian Red Cross-Flanders gave an inspiring talk on how Europe can ensure a sustainable supply of blood components, and plasma in particular, on a voluntary non-remunerated basis. He emphasised that not only is this possible but it is also the most desirable strategy to ensure lower costs of plasma-derived medicines, increased donor safety, and strengthened resilience in the supply system. Read presentation 

Jean-Philippe Plançon, from the European Patient Organisation for Dysimmune and Inflammatory Neuropathies (EPODIN), presented the position of patients. He stated his preference for VNRD but said there is a need for clearer definitions, to include incentives, compensation, and the financial neutrality principle. Read presentation

Robin Doeswijk of the European Hematology Association (EHA) echoed many of the points made earlier and highlighted the need to increase investment in public plasma collection programmes. 

During the event, EBA Executive Director and moderator of the event Peter O’Leary thanked the MEPs for co-hosting and all contributors and attendees and encouraged viewing of both EBA’s and CoRe SoHO’s position papers on the proposed SoHO Regulation.