BTA Statement on the proposal for an EU Regulation on Substances of Human Origin

The BTA, the international non-profit trade association representing blood bag set manufacturers, welcomes the new proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application. The proposal, published in July 2022, signifies an important step in modernizing the EU legislative framework surrounding blood, tissues and cells after twenty years.

The BTA and its members appreciate that innovation has been prioritized in the draft legislation, providing a flexible framework to allow for the introduction of new technical developments and blood components. Plans to ensure SoHO supply continuity at national level also represent a positive addition.

The proposal outlines new digital tools and coordination mechanisms that are expected to lead to increased safety for patients and donors. The BTA is pleased to see that the protection of patients and donors is a crucial element of the proposal. However, we emphasize the importance of ensuring that the introduction of these measures does not create additional administrative burdens which may hinder blood and blood component collection in the EU.

The BTA notes the wording of the proposal which states that the donation of certain SoHO products should be considered a “significant risk”. Such a statement may impede future SoHO product collections within the EU and worsen the dependency on imported products.

The BTA now looks forward to working with the EU institutions to finalize a framework that can prioritize patient and donor safety, ensure sustainability of supply, and expand blood and blood component collection within the EU in the years to come.


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