Quality and safety standards for substances of human origin intended for human application

This regulation includes a much-needed update of the more than 20-year-old rules on the safety and quality of substances of human origin (SoHO) and strengthened rules on the protection of SoHO donors, SoHO recipients and the offspring of medically assisted reproduction.It is essential to ensure that SoHO donation is carried out in accordance with Article 3 of the Charter of Fundamental Rights of the European Union and on the basis of the fundamental principle that the human body or its parts cannot be a source of financial gain.

This regulation therefore places great emphasis on the principle of voluntary unpaid donations (VPD), even while it allows for donor compensation in some cases, based on the principle of financial neutrality.The regulation also seeks to strengthen the continuity of the supply of SoHO, especially plasma, which is currently used as a raw material for many new treatments and is therefore often in short supply.

I voted in favor.

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