Better safety and quality standards for substances of human origin 

MEPs are expected to adopt new measures to better protect citizens who donate blood, tissues or cells, or are treated with these substances.

The Committee on the Environment, Public Health and Food Safety (ENVI) adopted its position in July on new EU rules governing the use of so-called substances of human origin (SoHO). The safety measures apply to substances - such as blood and its components (red/white cells, plasma), tissues and cells – that are used for transfusions, therapies, transplantations or medically assisted reproduction.

MEPs insist that such donations must be voluntary and unpaid, with donors able to receive compensation or reimbursement for losses or expenses.

To ensure the EU has its own independent supply of these substances, MEPs want an EU strategy to ensure their availability, an EU list of critical SoHOs as well as the establishment of “national emergency and continuity of supply plans”.


The draft rules put forward by the Commission on 14 July 2022 repeal 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).

Procedure Code: 2022/0216(COD)

Procedure: ordinary legislative procedure, first reading

Vote: Tuesday, 12 September