EU agrees on new rules for substances of human origin 

The Council and the European Parliament agreed on revising safe and quality standards for substances of human origin (SoHO) and setting new safety rules to ensure the quality of transplants and the EU’s autonomy. 

The Commission estimates that 25 million units of blood are transfused every year. During the same period, 165,000 babies are born with medically assisted reproduction, 4,500 cornea transplants are carried out to restore sight, and 2,000 skin transplants treat burn injuries. 

While all of these substances are used every day in the EU for transfusions, therapies, transplantations or medically assisted reproduction, the rules that regulate them were set 20 years ago.

To update them, the European Commission presented a new framework based on a proposal published in July, with the Council and Parliament reaching a provisional agreement on Thursday (14 December). 

“The proposed new rules aim to strengthen the existing legal framework while also increasing flexibility to keep up with scientific and technical developments”, reads a Council press release published after the meeting.

The new framework will apply to blood, plasma, skin, embryo, sperm, and corneas, adding two additional substances: breast milk and microbiota. 

Additionally, the deal has been reached to provide the donors and patients with a future-proof and harmonised framework for transplants and donations while maintaining some limits on the supply side of these therapies.

“Today’s agreement not only guarantees the highest possible standards of safety and quality for SoHOs, it also makes it easier for patients to access potentially life-saving health products across member-state borders”, said Spanish Health Minister Mónica García in the press release. 

Deal on donations

Since the beginning of the conversations at the EU level, the most controversial aspect was the nature of donation and whether and how it should be compensated. 

Settling the discussion, the new agreement states that donations should be voluntary and unpaid, with donors not receiving any kind of financial incentive.

This is in line with the EU Charter of Fundamental Rights, which prohibits the commercialisation of the human body but “does not prevent compensation of living donors for loss of earnings and reimbursement of any other justifiable expenses related to the medical procedure”.

The new SoHO rules establish that donors may receive compensation or reimbursement as appropriate in line with national legislation.

Importance of the EU’s autonomy

With the idea of ensuring the EU’s independence in the supply of these substances, a list of critical SoHOs and a national emergency and continuity of supply plans will be created. 

EU institutions have agreed on setting measures to increase harmonisation and facilitate exchanges between member states. 

This includes introducing common EU-wide procedures for authorising and assessing SoHO preparations, requiring member states to designate a SoHO national authority and other competent authorities to authorise SoHO preparations and ensure independent and transparent oversight of SoHO-related activities.

Additionally, it sets out additional authorisation and inspection requirements for establishments that both process and store, release, import or export substances of human origin. 

Finally, and aiming to improve cross-border information exchange, an EU SoHO coordination board will support national systems with the implementation of the regulation, and a new EU SoHO platform will register and exchange information. 

[Edited by Giedrė Peseckytė/Alice Taylor]

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