Members' Research Service By / September 6, 2023

Standards of quality and safety for substances of human origin intended for human application [EU Legislation in Progress]

SoHO-based treatments are of high value. They provide large numbers of life-saving and life-enhancing therapies every year: 25 million units of blood for transfusion (e.g. for surgery or trauma care); 36 000 stem cell transplants for blood cancers, life-creating therapies (medically assisted reproduction treatments, e.g. 940 000 cycles of in vitro fertilisation), and life-improving therapies (e.g.14 500 cornea transplants for restoring sight, and 2 000 skin transplants for burn wounds and other injuries).

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Written by Laurence Amand-Eeckhout (1st edition).

On 14 July 2022, the European Commission tabled a proposal to update and expand EU legislation on blood, tissues and cells. The aim is to establish high standards of quality and safety for substances of human origin (SoHOs) intended for human application, to improve the protection of donors, recipients, and offspring born from medically assisted reproduction, and to ensure that the legislation can respond to future challenges. To improve harmonisation, ensuring a uniform level of protection across the EU and simplifying cross-border exchange and access of SoHO therapies, the Commission is proposing to repeal the existing directives and replace them with a single regulation that will be equally applicable in all Member States.

In Parliament, the Committee on the Environment, Public Health and Food Safety (ENVI), is responsible for the file. It adopted its report on the proposal on 18 July 2023.

Versions

Proposal for a regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
Committee responsible:Environment, Public Health and Food Safety (ENVI)COM(2022)338
14.7.2022
Rapporteur:Nathalie Colin-Oesterlé (EPP, France)2022/0216 (COD)
Shadow rapporteurs:Nicolás González Casares (S&D, Spain)
Andreas Glueck (Renew, Germany)
Tilly Metz (Greens/EFA, Luxembourg)
Joanna Kopcińska (ECR, Poland)
Kateřina Konečná (The Left, Czechia)
Ordinary legislative procedure
(COD) (Parliament and Council
on equal footing – formerly ‘co-decision’)
Next steps expected: Vote on report in plenary

timeline-10 steps-voted in plenary

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