European Parliament Adopts New Rules for Substances of Human Origin

September 15, 2023

Members of the European Parliament (MEPs) voted this week to adopt new measures to protect citizens who donate or are treated with substances of human origin (SoHO) in the European Union by reinforcing the principle of voluntary and unpaid donation. The measures apply to whole blood, blood components, tissues and cells used for transfusions, therapies, transplantations or medically assisted reproduction.

The legislation stipulated that SoHO donations must always be voluntary and unpaid, with donors able to receive compensation or reimbursement for losses or expenses incurred during the donation process. The report also states that compensation should not be used as an incentive to recruit donors or lead to the exploitation of vulnerable people.

To ensure the EU has its own independent supply of these substances, MEPs also want an EU strategy to ensure SoHO availability, a list of critical SoHOs and the establishment of national emergency and continuity of supply plans.

Following the vote, MEPs are now ready to start talks on the final shape of the legislation, should the European Council agree on its position. AABB will update the blood and biotherapies community as the legislation progresses.