Deal on higher safety and quality standards for substances of human origin

New step towards building a strong European Health Union

Reinforcing the principle of voluntary and unpaid donation in the EU

High level of human health protection and strengthened supply

On Thursday, EU institutions reached a provisional agreement on new rules to ensure improved protection for citizens that donate or are treated with blood, tissues or cells.

Parliament and Council negotiators agreed on updated measures governing the use of so-called substances of human origin (SoHO), such as blood and its components (red/white cells, plasma), tissues and cells – used for transfusions, therapies, transplantations or medically assisted reproduction.

Voluntary and unpaid donations

Negotiators agreed that member states can compensate living SoHO donors, in accordance with the principle of voluntary and unpaid donation and based on transparent criteria, including through fixed allowances or through non-financial forms of compensation. The conditions for such compensation will be established in national legislation, including by setting an upper limit for compensation that aims to guarantee that no financial gain or loss is incurred by the donor as a result of the donation (“financial neutrality”).

Member states will have to ensure that promotion and publicity activities in support of SoHO donations (for example, campaign bill-boards or posters, television, newspaper or magazine advertisements) do not make references to compensation. Compensation should therefore not be used as an incentive to recruit donors, nor lead to the exploitation of vulnerable people.

Safeguarding supply

EU countries will establish and regularly update “national SoHO emergency plans”, setting out measures to be applied when the demand or the supply situation for critical SoHO present or are likely to present a serious risk to human health. The plans will be developped in cooperation and consultation with their health surveillance bodies, military medical services, civil protection services and other services routinely involved in emergency responses.

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Rapporteur Nathalie Colin-Oesterlé (EPP, FR) said: “I warmly welcome the agreement we reached today! This text constitutes a new chapter in building a strong European Health Union that guarantees the highest safety standards for those that donate and receive substances of human origin, strengthens the national collection systems to lower the risks of shortages and is based on the fundamental ethical principle of voluntary and unpaid donation.”

Next steps

Following the completion of work at technical level, Parliament and Council need to formally approve the agreement before it can come into force.

Background

The draft rules put forward by the Commission on 14 July 2022 repeals the blood and tissues and cells directives, in light of new scientific, technical and societal developments. Every year, EU patients benefit from over 25 million blood transfusions, a million cycles of medically assisted reproduction, over 35 000 transplants of stem cells (mainly for blood cancers) and hundreds of thousands of replacement tissues (e.g., for orthopaedic, skin, cardiac or eye problems).