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Donation of substances of human origin (SoHO) such as blood and its components, tissues and cells used for transfusion, therapies, transplantations, or medically assisted reproduction are to be voluntary and unpaid, with donors able to receive compensation or reimbursement fair losses or expenses incurred during the donation process.
On Tuesday 13th, September 2023, the European Parliament had endorsed the new saftey rules in the EU regarding substances of human origin to better protect citizens who donate blood, tissues or cells, or undergoing treatment with those substances. MEPs adopted the report with 483 votes in favor, 52 against and 89 abstentions.
SoHO are to be voluntarily donated and unpaid with procedures in place for compensation or reimbursement fair losses but not an incentive to recruit donors nor exploit vulnerable people.
“This law is crucial to the safety of donors, the well-being of patients, the security of supply, and the development of innovative medical techniques in Europe,” emphasized rapporteur Nathalie Colin-Oesterlé (EPP, FR).
Every year, EU patients receive more than 25 million blood transfusions, a million cycles of medically assisted reproduction, over 35,000 transplant of stem cells (mainly for blood cancers) and hundreds of replacement tissues. To ensure that the EU has its own independent supply of these substances, MEPs desire an EU strategy to ensure their availability, an EU list of critical SoHOs, and the establishment of “national emergency and continuity of supply plans”.
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Colin-Oesterlé continued:
“By improving the coordination and exchange of information, the flow of SoHO and associated medical expertise will be facilitated for the benefit of European patients. While Europe currently imports a portion of its SoHO needs, including 40% of the plasma we use, the compromise we reached commits the EU to securing its long-term supply.”
In implementing this report, Parliament is responding to citizens’ expectations to establish common minimum healthcare standards at EU level, as stated in proposal 10(1) of the conclusions of the Conference on the Future of Europe.
MEPs are ready to begin the discussions on the final stage of the legislation, once the Council agrees on its position.
Source: European Parliament Press Release
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