ENVI Committee adopts compromise SoHO text

On February 13, World Anemia Awareness Day, the global community of anemia patients, their relatives, doctors, health professionals, policymakers and other stakeholders recalls anemia which is among the most underrecognized, underdiagnosed and under-treated conditions impacting human health.

The next day, the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) voted in favor of the compromise text of the European Union (EU) Regulation on Substances of Human Origin (SoHO). The SoHO Regulation updates existing EU legislation on substances that include blood and blood components. The Regulation will be instrumental in improving the lives of the millions of anemia patients in Europe. In the Council of the EU, Deputy Ambassadors of the EU Member States (Coreper I) adopted their position on the text in late January. With the ENVI Committee’s vote, the EU has moved closer to adopting the SoHO Regulation which is now subject to a plenary vote in the European Parliament in April, after which the Regulation will become EU law.

Blood and Beyond pays tribute to Members of the European Parliament, including the legislative file’s rapporteur, MEP Nathalie Colin-Oesterlé and her team, and the Council of the EU, for their diligent work in finalizing this important legislative text. Once enacted, the EU SoHO Regulation will benefit and protect European patients who receive SoHO and safeguard the quality of SoHO products used in the EU. The Regulation will contribute to enhancing the functioning of the EU’s blood ecosystem.

Blood and Beyond commends the EU institutions for acknowledging the benefits of implementing Patient Blood Management (PBM) in improving patient outcomes and in ensuring the supply of valuable and scarce substances of human origin such as blood in the compromise text. Blood and Beyond welcomes the recognition of PBM’s value in reducing the financial burden on health systems in Europe.  Blood and Beyond welcomes the recognition of the merits of making efficient use of SoHOs and the potential value of therapeutic alternatives to prevent practices such as unnecessary blood transfusions. Blood and Beyond is encouraged to see in the compromise text that the role of stakeholders in the design of guidelines to ensure the supply of critical SoHOs such as blood and blood components is enhanced.